Needle safety device for medical devices
By designing a needle safety device that includes a hub, cannula, load-bearing element, and connecting device, the cannula is automatically removed from the diaphragm, solving the problems of drug contamination after use of medical injection devices and user contact with the needle, thus improving safety and user experience.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SENSILE MEDICAL AG
- Filing Date
- 2024-11-12
- Publication Date
- 2026-06-23
AI Technical Summary
Existing medical injection devices are prone to drug contamination and user contact with the needle after use, and existing needle safety devices have failed to effectively address these issues.
Design a needle safety device including a hub, a cannula, a carrier element, and a tubular arrangement. The cannula is automatically removed from the diaphragm via a connecting device to ensure that the cannula is disconnected from the reservoir after injection, preventing contamination, and safely concealing the needle without requiring manual operation by the user.
It effectively prevents drug contamination, improves user safety and comfort, reduces the risk of needle exposure, simplifies the usage process, and reduces the frequency of needle replacement. It is suitable for medical devices such as auto-injectors and injection pens.
Smart Images
Figure CN122270313A_ABST
Abstract
Description
Technical Field
[0001] This disclosure relates to a needle safety device for medical devices, particularly medical injection devices, and a medical device including the needle safety device. Background Technology
[0002] Medical devices, particularly medical injection devices such as autoinjectors or injection pens, are known and popular among users because they offer a variety of benefits and can be used in a wide range of applications. An autoinjector is a device with a syringe or vial pre-filled with medication. It is typically designed to be automated, meaning the user may not need to manually load the medication or set the dosage. Autoinjectors are often designed to be more user-friendly and may have features such as automatic needle insertion and the ability to administer medication by pressing a button. An injection pen is a device that typically includes a cartridge or vial containing medication and a pen-shaped device with a needle at the tip. It usually requires manual assembly of the cartridge or vial into the pen and setting the desired dosage before injection. The user typically needs to push a button or plunger to release the medication.
[0003] Autoinjectors are typically designed for a single purpose. An example could be an autoinjector for administering emergency medications (such as adrenaline) in the event of anaphylactic shock. In this case, post-use exposure to microbial contamination may be harmless to the user because the injection is essentially complete. Furthermore, autoinjectors can be operated periodically by non-medical personnel. Injection pens with a cartridge (or more generally, any type of reservoir containing the medication) can be designed as single-patient pens. Users are typically instructed to change the needle after each injection. If the user does not change the needle after each injection, the cartridge seal remains in a punctured state through the needle. The seal can be a diaphragm, intended to prevent contamination of the medication. Because the seal remains in this punctured state until the next injection, contamination can occur. This disadvantage can be particularly noticeable when the medical injection device is used less frequently for injections.
[0004] The potential risk of drug contamination described above applies to any type of medical device, particularly medical injection devices, such as those operated by non-medical personnel, like auto-injectors or injection pens. For example, when a medical injection device is used in the injection area, a seal should be ensured to the cartridge. This has the potential to prevent drug contamination. For example, it can prevent microbial growth through the needle into the reservoir. Furthermore, it should be ensured that the user does not come into contact with the needle when the medical device has been used to prevent any contamination of the user and the needle.
[0005] Needle safety devices have been proposed in the past to address some of the aforementioned needs. As background to this application, the following documents may be referenced. Unpublished EP applications No. 23154701.9 and No. 23154698.7 both relate to a needle safety device.
[0006] However, the proposed solution still does not achieve optimal results. Therefore, improvements are needed.
[0007] Therefore, one object of this disclosure is to provide a needle safety device for medical devices, particularly for medical injection devices, which meets the above-mentioned requirements and at least partially overcomes the shortcomings of current solutions. Summary of the Invention
[0008] The above-mentioned objectives are achieved, at least in part, by the subject matter of the independent claims. Preferred embodiments are the subject matter of the dependent claims, and other suitable aspects of the invention are described in the overall disclosure of this application.
[0009] This objective is achieved by a needle safety device for a medical device, particularly for a medical injection device, the needle safety device comprising: a hub portion defining a longitudinal axis, wherein the hub portion includes a cannula extending substantially along the longitudinal axis from the hub portion and a carrier element disposed on the cannula, wherein the cannula and the carrier element are configured to move together relative to the hub portion along the longitudinal axis; and a tubular arrangement movably disposed on the hub portion to move relative to the hub portion along the longitudinal axis, wherein the tubular arrangement is configured to move between at least an initial position and an injection position, wherein in the injection position, a proximal end of the cannula is configured to protrude through a diaphragm of the medical device such that the cannula is in fluid communication with a reservoir of the medical device, wherein the tubular arrangement includes a coupling device configured to engage with the carrier element such that when the tubular arrangement moves from the injection position to the initial position, the proximal end of the cannula is configured to retract from the diaphragm.
[0010] In this way, this disclosure provides an improved needle safety device compared to known needle safety devices. Specifically, the needle safety device of this disclosure helps to mitigate or reduce contamination of the reservoir containing the medication. In some cases, such contamination can be completely prevented. Thus, the user may not need to worry about whether the puncture device (e.g., the cannula) has been removed from the diaphragm and / or from the reservoir containing the medication. This is because the needle safety device according to this disclosure is configured to substantially automatically remove the proximal end of the cannula when pressure is released on the contact surface of the injection area. In this way, a safer and more sterile medical device that is substantially malfunction-proof can be provided to the user. This makes it more convenient, comfortable, and less troublesome for the user to use the needle safety device, especially medical devices including this needle safety device. In particular, the user does not have to manually remove the cannula after each use of the medical device. The needle device can be fixedly disposed on the housing of the medical device. In some examples, the fixation can be substantially permanent. However, this disclosure also covers needle safety devices releasably fixed to the housing of the medical device. In this way, user comfort and the applicability of needle safety devices and / or medical devices can be improved.
[0011] As used in this disclosure, "hub portion" can refer to an elongated hub portion. In some examples, the longitudinal axis of the hub portion can also be the longitudinal central axis of the hub portion. This is especially likely if the hub portion has a substantially cylindrical shape. It should be understood that manufacturing tolerances may need to be taken into account. Therefore, even when a hub portion is referred to as having a cylindrical shape, the shape of the hub portion may deviate slightly from a cylindrical shape. In some examples, the cross-section of the hub portion may have a substantially annular shape. The hub portion can be configured such that it may not be able to rotate and / or move relative to the medical device when the needle safety device is attached to the medical device.
[0012] As used in this disclosure, "cannula" may additionally or alternatively be referred to as a needle or injection needle. The cannula may be hollow to allow fluid to pass through it. Furthermore, the cannula may be attached directly or indirectly to the hub portion. The cannula may be part of a cannula arrangement. For example, a cannula arrangement may include multiple cannulas. Multiple cannulas may be connected to each other, for example, along one direction, particularly along the longitudinal axis of the hub portion. Multiple cannulas may partially overlap each other along the longitudinal axis, which can be used to secure the cannula assembly.
[0013] As used in this disclosure, "carrying element" can be understood as an element arranged to carry a cannula. The term "carry" simply means that the carrying element should be arranged such that it can move the cannula at least partially by its own movement. This can be achieved, for example, by attaching the cannula and the carrying element to each other. Any suitable attachment means of any kind are covered in this disclosure. Such attachment and variations thereof include engaging the cannula and the carrying element directly or indirectly to each other. The engagement can be fixed (e.g., permanent or fixed) or movable (e.g., removable or releasable). The engagement can be achieved by directly connecting the two components (cannula and carrying element) to each other, by using a separate intermediate component and / or any additional intermediate component connected to each other, or by using an intermediate component integrally formed with one of the two components as a single body. Attachment can include any mechanical attachment means. In addition, attachment can include a form-fit connection of the two components. This can produce a tight and secure fit without the need for additional fasteners or adhesives. Thus, the attachment can depend on the geometry of the cannula and the carrying element to produce a stable and reliable attachment. However, the use of additional means for attachment is not excluded. In one example, the cannula and the carrier element can be permanently or at least for a period of time fixed to each other, so that the relative positions of the components remain substantially unchanged.
[0014] The cannula and carrier element can be designed to be movable. Specifically, they are configured to move together relative to the hub portion "along a longitudinal axis." In this way, the cannula can achieve penetration of the reservoir within the medical device, as described in more detail elsewhere herein. It should be noted that the cannula and carrier element can also additionally or alternatively move together along different axes not parallel to the longitudinal axis. This may depend on the use of a needle safety device. However, during normal use of the needle safety device, they can specifically move together along the longitudinal axis. In a preferred example, the cannula and carrier element can move together parallel to the injection direction. In a preferred example, the longitudinal axis can be parallel to the injection direction.
[0015] A tubular arrangement may include one or more elements as described elsewhere herein. The tubular arrangement and / or one or more elements included therein may be components or structures having a cylindrical or tubular shape. It should be understood that manufacturing tolerances need to be included, making it necessary to account for deviations from the cylindrical or tubular shape. In some examples, the tubular arrangement may have a circular shape. The tubular arrangement and / or one or more elements included therein may define a hollow portion, such as a chamber within its perimeter. This hollow portion may extend entirely through the tubular arrangement in the axial direction to accommodate one or more other components. As described elsewhere herein, the tubular arrangement may include a first tubular element and a second tubular element.
[0016] It should be noted that when this document describes one or more components “moving along the longitudinal axis,” this may in some examples refer specifically to movement along the longitudinal axis. However, in other examples, movement along an axis not parallel to the longitudinal axis is not excluded. It should be understood that in some cases, such movement along different axes may be desirable. This may depend on the specific application of the needle safety device.
[0017] When a tubular arrangement is described as being configured to move between at least an "initial position" and an "injection position," this encompasses multiple intermediate positions between the initial and injection positions. Furthermore, the tubular arrangement can be configured to move in a "post-injection position." In some examples, the post-injection position may correspond to the initial position; however, this is not required. At least the initial position and the injection position may correspond to two end positions of the tubular arrangement. These two end positions can be two end positions along a longitudinal axis. This can mean that each of more than two end positions may not be able to move further. For example, when the tubular arrangement is in the injection position, it may not be able to move further along the longitudinal axis in the proximal direction, although this is not excluded in some examples. Furthermore, when the tubular arrangement is in the initial position, it may not be able to move further along the longitudinal axis in the distal direction, although this is not excluded in some examples. It should be understood that the tubular arrangement can move in the post-injection position. In some examples, the post-injection position may be the same as the initial position. However, in some examples, the post-injection position may be different from the initial position. In one example, when the tubular arrangement is in the post-injection position, it can be positioned closer to the proximal direction compared to the initial position. In another example, when the tubular arrangement is in the post-injection position, it can be positioned closer to the distal direction compared to the initial position.
[0018] "Injection site" can be the location where medication can be guided through a cannula to the injection area (such as the user's skin). Injection site usually refers to the location where injection can be performed.
[0019] The “initial position” can be a position where, when the tubular arrangement is in the injection position, medication guided via the cannula can no longer be guided through the cannula. However, as those skilled in the art will understand, the cannula may still contain residual components of the medication, such as components that may not have yet reached the injection area. Furthermore, the cannula itself may still allow medication to be guided through it, for example, by pouring medication into it. However, as described elsewhere, in the initial position, there may no longer be fluid communication between the reservoir of the medical device and the cannula.
[0020] The "post-injection position" can be (the same as the initial position) a position in which, when the tubular arrangement is in the injection position, medication guided via cannulation can no longer be guided via cannulation. Whenever the tubular arrangement is in the post-injection position, it is positioned more distally than in the injection position.
[0021] In the injection position, the proximal end of the cannula is configured to protrude through the septum of the medical device, allowing fluid communication between the cannula and the reservoir of the medical device. The "proximal end" of the cannula can be the end facing the septum of the medical device when the needle safety device is typically attached. The term "protrusion" can refer to the septum being punctured, or to any means being provided to allow fluid communication through the septum.
[0022] "Fluid communication" means that a fluid (e.g., gas, liquid) can be guided from the reservoir to the cannula and / or from the cannula to the reservoir. It should be noted that a direct flow path, i.e., a flow path from the reservoir to the cannula, is not required, although such an arrangement is not excluded and is preferred in some cases. As an example, in an injection site, the cannula may be in fluid communication with one or more chambers, and said one or more chambers may be in fluid communication with the reservoir. Preferably, the reservoir contains the drug, enabling the drug to be guided through the cannula to the user's injection site for injection.
[0023] It should be noted that the needle safety device does not include a diaphragm and reservoir; however, the needle safety device needs to be configured to allow the proximal end of the cannula to protrude from the diaphragm and to allow its removal from the diaphragm as described elsewhere herein. Therefore, it should be understood that the needle safety device needs to exhibit these features, for example, when mounted on any medical device. Thus, those skilled in the art will readily recognize and appreciate the features and benefits offered by the needle safety device without relying on a specific medical device.
[0024] As used in this disclosure, "coupling device" can be understood as any device capable of being coupled, particularly releasably coupled, to a load-bearing element. Specifically, the coupling device is configured to engage with the load-bearing element. "Engagement" can refer to contact between them, such that movement of the coupling device can be transmitted to the load-bearing element. This engagement can be direct or indirect. For example, the coupling device and the load-bearing element can be in direct contact with each other. In other examples, the coupling device and the load-bearing element can be indirect contact with each other. The latter can be achieved by employing one or more components, particularly intermediate components, to engage with one or both of the load-bearing element and the coupling device. The coupling device can be fixedly arranged in a tubular configuration such that they move as a unit. Preferably, the coupling device is a coupling element. More preferably, the coupling device is a coupling arm.
[0025] As the tubular arrangement moves from the injection position to the initial position, the proximal end of the cannula exits the septum. This does not mean that the cannula exits the septum only when the tubular arrangement reaches the initial position. As described elsewhere in this document, multiple positions are covered. Therefore, the cannula can exit the septum at any time along the route from the injection position to the initial position. Consequently, it should also be understood that the proximal end of the cannula exits the septum as the tubular arrangement moves from the injection position to the post-injection position.
[0026] Removing the cannula from the diaphragm can mean that the proximal end of the cannula is no longer in contact with the diaphragm. As described elsewhere in this document, this has the advantage of reducing contamination of the medication within the reservoir. In one example, it may be sufficient that the cannula is no longer in fluid communication with the reservoir of the medical device when the tubular arrangement is moved from the injection position to the initial position. This also achieves the desired effect of reducing the risk of contamination. In some examples, this can have the additional advantage of allowing the needle safety device to be easily removed from the medical device and replaced with another needle safety device. This other needle safety device can be attached to the housing of the medical device as described elsewhere in this document. This allows the main part of the medical device to be used multiple times, with only the needle safety device needing to be replaced. This reduces costs.
[0027] The medical device can be a medical injection device. Any kind of medical injection device is included in this disclosure. Exemplarily, a medical injection device can be an autoinjector, an injection pen, and / or a syringe. Preferably, the medical injection device is an autoinjector. This is especially likely because autoinjectors are typically operated by non-medical personnel (e.g., in emergency situations). Therefore, the advancements described in this disclosure are particularly significant for these examples. However, injection pens and other medical injection devices can also significantly benefit from the advantages described herein.
[0028] The diaphragm provides a sealing function. The diaphragm helps maintain the integrity and sterility of the medication within the reservoir. The diaphragm can be provided from any suitable material, including but not limited to rubber or elastomer materials. The diaphragm can be positioned at the end of the reservoir. When the tubular arrangement is moved back from the injection site to its initial position, the diaphragm can at least partially close the perforation provided by the cannula.
[0029] It should be understood that the advantages described can also be applied to the following preferred embodiments.
[0030] In a preferred embodiment of the needle safety device of this disclosure, the coupling device is configured to displace relative to the carrier element when the tubular arrangement moves from an initial position to an injection position, preferably in a direction substantially perpendicular to the longitudinal axis. This facilitates that the coupling device can be guided around the carrier element as it moves from the initial position to the injection position. It is possible that the coupling device can displace in other directions not substantially perpendicular to the longitudinal axis.
[0031] In a preferred embodiment of the needle safety device of this disclosure, the coupling device is configured to slide engage with the carrier element as the tubular arrangement moves from an initial position to an injection position. This has the advantage that the force required to move the tubular arrangement is substantially no greater than in the absence of the coupling device. For example, sliding engagement requires lower friction between the coupling device and the carrier element. Nevertheless, engagement as described above can be ensured when the tubular arrangement moves from the injection position to the initial position. It should be noted that sliding engagement differs from the engagement described above.
[0032] In a preferred embodiment of the needle safety device of this disclosure, the coupling device is resilient, providing a restoring force in a direction substantially perpendicular to the longitudinal axis. This facilitates that the coupling device can be at least partially repositioned once it has shifted and once the force causing the shift has been reversed. For example, the coupling device can be configured to spring back. As an example, the coupling device, or a portion thereof, can spring back once it is at least partially located beyond the distal end of the carrier element in the proximal direction (i.e., when the tubular arrangement moves from the initial position to the injection position). This has the advantage of providing engagement when the tubular arrangement moves from the injection position (backwards) to the initial position.
[0033] In a preferred embodiment of the needle safety device disclosed herein, the coupling device has an elongated shape, wherein the longitudinal axis of the coupling device is substantially parallel to the longitudinal axis of the hub portion. This has the advantage that the coupling device can be easily integrated into the needle safety device. This is possible because the cannula is typically also elongated. The term "elongated" refers to the existence of a dimension along one axis that can be larger than one of two dimensions along the remaining axes, and preferably both, which are substantially perpendicular to said one axis. It should be understood that manufacturing tolerances must generally be taken into account when dimensions are described herein. Therefore, the dimensions described herein may vary slightly.
[0034] In a preferred embodiment of the needle safety device disclosed herein, the longitudinal axis of the coupling device is spaced apart from the longitudinal axis of the hub portion. For example, the longitudinal axis of the coupling device may be offset relative to the longitudinal axis of the hub portion. This can have the advantages that the coupling device does not substantially interfere with the movement of the cannula and / or the coupling device is also protected from external impacts, making the design more robust and / or more durable.
[0035] In a preferred embodiment of the needle safety device of this disclosure, the coupling device includes a snap-fit portion configured to engage with a carrier element when moved from an injection position to an initial position, and configured to slide engage with the carrier element when moved from the initial position to the injection position. The snap-fit portion may be located proximally to the coupling device, i.e., closer to the end of the medical device when the needle safety device is mounted on it. This snap-fit portion facilitates the engagement and sliding engagement with the carrier element according to the direction of movement of the tubular arrangement and thus the direction of movement of the coupling device. The snap-fit portion may be integrally formed with the coupling device or attached to the coupling device. Any suitable attachment means are covered, as described elsewhere herein. As described elsewhere herein, multiple positions of the tubular arrangement (e.g., at least the initial position, the injection position, and the post-injection position) are covered in this disclosure. Therefore, it is possible that the snap-fit portion is configured to engage with the carrier element when the diaphragm is removed at any time during the journey from the injection position to the initial position. Thus, it should also be understood that the snap-fit portion is configured to engage with the carrier element when the tubular arrangement moves from the injection position to the post-injection position.
[0036] In a preferred embodiment of the needle safety device disclosed herein, the latching portion has a tapered shape when viewed along the longitudinal axis from the distal end of the connecting device toward the proximal end. This has the advantage that the connecting device can easily slide past the carrier element in one direction and engage with the carrier element in the opposite direction. The tapered shape can be a geometry that gradually narrows or becomes narrower toward one end, particularly toward the proximal end of the latching portion. The tapered shape can correspond to a conical or pyramidal appearance.
[0037] In a preferred embodiment of the needle safety device of this disclosure, the snap-fit portion has an inclined surface configured to slide on a carrier element, particularly on a protrusion of the carrier element, and an abutment surface for engaging with the carrier element, particularly the protrusion of the carrier element, wherein the inclined surface is arranged near the proximal end of the coupling device, and the abutment surface is arranged relative to the inclined surface at a more distal end of the coupling device. This further facilitates the advantage of relatively smooth movement of the coupling device in one direction (e.g., sliding engagement) and engagement in the opposite direction. When the needle safety device is attached to a medical device, the proximal end of the coupling device can face the medical device. The distal end of the coupling device can be substantially opposite the proximal end. During normal use of the medical device, the distal end of the coupling device can be closer to the injection area.
[0038] In a preferred embodiment of the needle safety device of this disclosure, the inclined surface defines an angle of at least 10°, preferably at least 20°, more preferably at least 30°, more preferably at least 40°, more preferably at least 45°, and / or at most 80°, preferably at most 70°, more preferably at most 60°, more preferably at most 50°, and most preferably at most 45° relative to the longitudinal axis of the hub portion. This further contributes to the advantages described elsewhere herein, such as providing relatively smooth movement in one direction without compromising the structure of the coupling device, and providing engagement in the opposite direction. The angle should not be too large, as this would impair the smooth movement of the coupling device from the initial position to the injection position. Furthermore, the angle should not be too small, as this would unnecessarily lengthen the snap-fit portion, thus requiring more material. Utilizing the angle specified in this embodiment, an optimal balance can be achieved between these different and conflicting requirements.
[0039] In a preferred embodiment of the needle safety device disclosed herein, the abutment surface is arranged substantially perpendicular to the longitudinal axis of the hub portion. This allows for a relatively easy structural engagement of the coupling device and the carrier element. Furthermore, such an abutment surface can be manufactured in a simplified manner.
[0040] In a preferred embodiment of the needle safety device disclosed herein, the carrier element includes a protrusion for engaging with the coupling device, particularly a snap-fit portion thereof. This further complements the advantages outlined elsewhere.
[0041] In a preferred embodiment of the needle safety device disclosed herein, the protrusion extends in a direction substantially perpendicular to the longitudinal axis. This embodiment, combined with the abutment surface of the snap-fit portion, provides the advantageous effect that the abutment surface and the protrusion can make substantially flat contact when they engage during movement from the injection position to the initial position. Thus, the movement of the carrier element can be provided more reliably by means of the movement of the coupling device.
[0042] In a preferred embodiment of the needle safety device disclosed herein, the needle safety device further includes a spring element that biases the tubular arrangement relative to the hub portion in a distal direction. This can have the advantage that when pressure on the contact surface of the tubular arrangement is released (e.g., when the contact surface is not in pressure contact with the injection area (e.g., the user's skin), the tubular arrangement can automatically move from the injection position to the initial position by means of the spring.
[0043] In a preferred embodiment of the needle safety device disclosed herein, the connecting device is a single arm. This simplifies the design of the needle safety device.
[0044] The object of this disclosure is also achieved by a medical device, particularly a medical injection device, which includes a needle safety device as described herein. It should be understood that, since the medical device includes a needle safety device as described elsewhere herein, it should also be understood that the features and / or advantages described with reference to the needle safety device can also be applied to the medical device, and vice versa.
[0045] In a preferred embodiment of the medical device disclosed herein, the medical device further includes a housing that engages with a tubular arrangement, particularly with a second tubular element of the tubular arrangement, such that the second tubular element of the tubular arrangement does not rotate substantially relative to a hub portion, wherein the hub portion is optionally fixed to the housing.
[0046] The object of this disclosure is also achieved by using the needle safety device as described herein in medical devices, particularly medical injection devices, to remove the cannula from the diaphragm after injection. The corresponding advantages described with reference to the needle safety device can also be applied to the use of the needle safety device. Attached Figure Description
[0047] The invention will be described in more detail below with reference to the following figures:
[0048] Figure 1 The diagram shows a cross-sectional view of the needle safety device according to the invention before injection.
[0049] Figure 2 The diagram shows a cross-sectional view of the needle safety device during injection.
[0050] Figure 3 The diagram shows a cross-sectional view of the needle safety device after injection.
[0051] Figure 4 This illustrates a medical device according to the present disclosure. Detailed Implementation
[0052] The following describes only some possible embodiments of the invention in detail. However, the invention is not limited to these, and many other embodiments are applicable without departing from the scope of the invention. The presented embodiments can be modified in various ways and combined with each other when compatible, and certain features may be omitted where unnecessary. In particular, the disclosed embodiments can be modified by combining certain features of one embodiment with one or more features of another embodiment.
[0053] Throughout these drawings and description, the same reference numerals refer to the same elements. For clarity and brevity, certain aspects of components or steps in some embodiments are presented without undue detail, wherein such detail will be obvious to those skilled in the art in light of the teachings herein, and / or wherein such detail may obscure the understanding of more relevant aspects of the embodiments.
[0054] definition
[0055] The term "proximal" as used herein is used only to refer to one of the two ends of a part. The proximal end of a part is best understood in conjunction with the distal end of the same part. The terms proximal and distal should not be construed as limiting. These ends may additionally or alternatively be referred to as the first end and the second end, or the second end and the first end, respectively.
[0056] The distal end of a portion is typically the end further from the center of the medical device compared to the proximal end of that portion. Furthermore, when the medical device is used for its normal purpose, the distal end of a portion is typically the end closer to the injection area compared to the proximal end of that portion.
[0057] The same applies to the terms "proximal direction" and "distal direction." That is, these terms may additionally or alternatively be referred to as a first direction and a second direction, or a second direction and a first direction. The proximal direction can be a direction from distal to proximal. The distal direction can be a direction from proximal to distal.
[0058] Unless otherwise stated, the term "substantially" as used in this context may be understood as largely, in most cases, or essentially. In particular, manufacturing tolerances are included in this term.
[0059] Description of preferred embodiments
[0060] Figures 1 to 3 A needle safety device 1 and / or its components according to this disclosure are shown. The needle safety device 1 can be used in medical devices, particularly for medical injection devices 100 (such as those from...). Figure 4(As can be known from the text). The needle safety device 1 includes a hub portion 10 defining a longitudinal axis 11, wherein the hub portion 10 includes a cannula 12 extending substantially along the longitudinal axis 11 from the hub portion 10. The needle safety device 1 also includes a carrier element 60 disposed on the cannula 12, wherein the cannula 12 and the carrier element 60 are configured to move together relative to the hub portion 10 along the longitudinal axis 11. The needle safety device 1 also includes a tubular arrangement 20 movably disposed on the hub portion 10 to move relative to the hub portion 10 along the longitudinal axis 11, wherein the tubular arrangement 20 is configured at least in an initial position 24 ( Figure 1 and Figure 3 ) and injection site 25 ( Figure 2 The cannula 12 moves between the two locations. In injection position 25, the proximal end 12b of the cannula 12 is configured to protrude through the diaphragm 50 of the medical injection device 100, such that the cannula 12 is positioned relative to the reservoir of the medical device (not shown, but the reservoir may be further arranged along the longitudinal axis 11). Figures 1 to 3 The tubular arrangement 20 includes a coupling device 35 configured to engage with the carrier element 60, such that when the tubular arrangement 20 is dispensing from the injection position 25 (on the right side), fluid communication is achieved. Figure 2 Move to the initial position 24 ( Figure 1 and Figure 3 When the cannula 12 is inserted, the proximal end 12b is configured to remove the diaphragm 50.
[0061] In one example, the initial position is 24 ( Figure 1 and Figure 3 The movement between the injection site 25 and the injection position 25 can refer to axial movement.
[0062] The cannula 12 can be attached to the carrier element 60. Whenever the attachment of two or more components is mentioned, various attachment methods are generally encompassed in this disclosure. Such attachment methods include one or more or all of the following non-exhaustive list: fasteners (e.g., screws, bolts, nuts, rivets, clamps, staples), adhesives and glues (various types of viscous substances that can bond together when dry or cured, double-sided tape including adhesive on both sides), welding (at least partially melting a portion of the components and fusing them together), soldering (melting cryogenic components for joining), mechanical connections (latches and hooks, hooks and loops, cable ties), magnetic attachments, and snap-fit connections (interlocking components that snap together). As those skilled in the art will understand, the manner in which two components are attached to each other can depend on the materials involved and / or the specific intended purpose.
[0063] The longitudinal axis 11 of the hub portion 10 can be substantially parallel to the longitudinal axis of the connecting device 35. The longitudinal axis of the connecting device 35 can be offset relative to the longitudinal axis 11 of the hub portion 10. Furthermore, the longitudinal axis of the connecting device 35 can be offset relative to the longitudinal axis of the cannula 12. This helps to prevent the connecting device 35 from impairing the movement of the cannula 12.
[0064] The reservoir can be a cartridge, tube, etc. In various examples, the reservoir may be housed within a cylindrical glass or plastic container. The reservoir may include a drug or a component thereof. It should be noted that the reservoir may alternatively or additionally be positioned further away from the diaphragm 50. The fluid communication mentioned herein is for the purpose of enabling drug delivery only and may be unrelated to whether the reservoir is directly adjacent to the diaphragm 50.
[0065] The diaphragm 50 prevents air, contaminants, and moisture from entering the reservoir and affecting the stability and efficacy of the medication. Typically, when the medical device is activated, the cannula 12 punctures or penetrates the diaphragm 50 to access the medication. This puncture or penetration facilitates the removal of the medication from the reservoir. The diaphragm 50 ensures that the medication remains sterile before administration.
[0066] The carrier element 60 can contact the hub portion 10. Specifically, the outer peripheral surface of the carrier element 60 can contact the inner peripheral surface of the hub portion 10. Thus, the carrier element 60 and the cannula 12 can be guided together within a portion of the hub portion 10. Therefore, the cannula 12 is movable relative to the hub portion 10 to achieve penetration of the reservoir within the medical injection device.
[0067] The cannula 12 can be any kind of puncture device, such as a needle.
[0068] It should be noted that at the injection site 25 ( Figure 2 After that, the tubular arrangement 20 was moved to its initial position 24. Figure 1 and Figure 3 In some examples, it may be additionally or alternatively referred to as final position 26 (e.g.) Figure 3 (As shown). This may refer to the needle safety device 1 ensuring that the medical device may not be used a second time, although this is not excluded. In the final position 26, one or more components of the needle safety device 1 may have a different arrangement compared to the initial position 24 (e.g., one or more components of the needle safety device 1 may have been rotated). However, the axial arrangement of the tubular arrangement 20 may be substantially similar in the initial position 24 and the final position 26. In some examples, the final position 26 corresponds to the post-injection position described elsewhere in this document.
[0069] The connecting device 35 can be configured to shift relative to the carrier element 60 when the tubular arrangement 20 moves from the initial position 24 to the injection position 25, preferably in a direction substantially perpendicular to the longitudinal axis 11. Specifically, the connecting device 35 can be configured to slide engage with the carrier element 60 when the tubular arrangement 20 moves from the initial position 24 to the injection position 25. When observing... Figure 1 and Figure 2 It is conceivable that the connecting device 35 can be elastic, providing a restoring force in a direction substantially perpendicular to the longitudinal axis 11. Furthermore, the connecting device 35 can have an elongated shape, wherein the longitudinal axis of the connecting device 35 is substantially parallel to the longitudinal axis 11 of the hub portion 10. Specifically, as... Figure 1 , Figure 2 and Figure 3 As shown, the connecting device 35 is a connecting element 35, specifically a connecting arm 35. In some examples, two or more connecting arms 35 may be included.
[0070] The coupling device 35 may include a snap-fit portion 36 configured to engage with the carrier element 60 when moved from the injection position 25 to the initial position 24, and the snap-fit portion 36 may be configured to slide engage with the carrier element 60 when moved from the initial position 24 to the injection position 25. The snap-fit portion 36 may have a tapered shape when viewed along the longitudinal axis 11 from the distal end 35a of the coupling device 35 toward the proximal end 35b of the coupling device 35.
[0071] The snap-fit portion 36 may have an inclined surface 37 configured to slide on the support element 60, particularly on the protrusion 61 of the support element 60, and an abutment surface 38 for engaging with the support element 60, particularly with the protrusion 61, wherein the inclined surface 37 is arranged near the proximal end 35b of the connecting device 35, and wherein the abutment surface 38 is arranged relative to the inclined surface 37 at the distal end 35a of the connecting device 35.
[0072] The protrusion 61 of the support element 60 can be configured to engage with the coupling device 35, particularly with the snap-fit portion 36 of the coupling device 35. The protrusion 61 can be something extending from a surface or object (e.g., the support element 60) (also referred to as a projection). The protrusion 61 can be used to describe any part of an object or structure that protrudes, extends, or protrudes from a surrounding surface or boundary. In one example, the protrusion 61 can be a three-dimensional extension or protrusion extending outward from a surface or object. The protrusion 61 can be provided in various sizes. The size, shape, etc., of the protrusion 61 can vary depending on the intended purpose. Essentially all technically feasible sizes and shapes are covered in this disclosure.
[0073] The protrusion 61 contributes to structural benefits and / or can add more specific functionality to the carrier element 60. For example, the protrusion 61 may be specifically designed to provide engagement and sliding engagement with the coupling device 35, particularly with the snap-fit portion 36 of the reset arm 35. The protrusion 61 may be integrally formed with the carrier element 60, or may be attached to the carrier element 60 using any kind of attachment means described elsewhere herein.
[0074] The inclined surface 37 may define an angle of at least 10° and at most 80° relative to the longitudinal axis 11 of the hub portion 10, as described elsewhere herein. The abutment surface 38 may be arranged substantially perpendicular to the longitudinal axis 11 of the hub portion 10. Furthermore, the protrusion 61 may also extend in a direction substantially perpendicular to the longitudinal axis 11 of the hub portion 10. This provides the advantageous effect of the combination, namely that the abutment surface 38 and the protrusion 61 are able to make substantially flat contact.
[0075] The needle safety device 1 may also include a spring element 40 that biases the tubular arrangement 20 relative to the hub portion 10 in a distal direction. The distal direction may be from the injection position 25 to the initial position 24. It should be noted that, for example, movement of the tubular arrangement 20 from the injection position 25 to the initial position 24 can occur when pressure is released on the contact surface 31 of the tubular arrangement 20 (described further below). The spring element 40 may abut against the hub portion 10 and the second tubular element 30. This configuration has proven advantageous in preventing the spring element 40 from adversely affecting the rotation of the first tubular element 21 (described below). Furthermore, the spring element 40 may be arranged at the periphery of the carrier element 60 and / or the coupling device 35.
[0076] Best in Figure 2 As can be seen, the connecting device 35 can have a length along the longitudinal axis 11 such that when the connecting device 35 engages with the carrier element 60, the distal end 12a of the cannula 12 is substantially positioned near the plane defined by the contact surface 31 of the tubular arrangement 20 for establishing pressure contact with the injection area. This has the advantage that the connecting device 35 is long enough to substantially prevent the user from contacting the cannula 12, or at least reduce the likelihood of such contact. For example, since the distal end 12a of the cannula 12 does not protrude from the plane defined by the contact surface 31, the user may not easily come into contact with it. It should be understood that the aforementioned engagement of the connecting device 35 with the carrier element 60 may occur when the tubular arrangement 20 moves from the injection position 25 to the initial position 24.
[0077] The tubular arrangement 20, particularly the second tubular element 30 (described in more detail below), includes a tubular protrusion 39 extending from the contact surface 31 toward the proximal end of the tubular arrangement 20, wherein the distal end 35a of the connecting device 35 is attached to the tubular protrusion 39 (ideally at...). Figure 3 (As can be seen from the image). In one example, the connecting device 35 can be integrally formed with the tubular arrangement 20, and in particular with the tubular protrusion 39. The proximal end of the tubular protrusion 39 can contact the carrier element 60 in the injection position 25 (ideally in...). Figure 2 (As can be seen from the image). This can have the following advantages: it can prevent the cannula 12 from being further guided into the user's injection area.
[0078] The tubular arrangement 20, particularly the contact surface 31 of the second tubular element 30, is used to establish pressure contact with the injection area. The spring element 40 is configured such that when the contact surface is not in pressure contact with the injection area ( Figure 1 and Figure 3 The contact surface 31 is spaced further away from the hub portion 10 along the longitudinal axis 11 than the distal end 12a of the cannula 12.
[0079] It can also be seen that the longitudinal axis of the connecting device 35 can be spaced apart from the longitudinal axis 11 of the hub portion 10. In addition, the connecting device 35 can be a single arm.
[0080] The following text explains in more detail some general features of the needle safety device 1 of this disclosure, particularly with reference to... Figures 1 to 3 .
[0081] The tubular arrangement 20 may include a first tubular element 21 and a second tubular element 30. The first tubular element 21 may be movably arranged on the hub portion 10 for movement along a longitudinal axis 11. The first tubular element 21 may include a guide rail slidably engaging with a guide pin of the hub portion 10. The guide rail may be configured such that the first tubular element 21 rotates relative to the hub portion 10 as the guide pin moves along the guide rail, wherein the guide rail may include elements configured to hold the guide pin in its final position. The second tubular element 30 may be arranged on the first tubular element 21 such that the second tubular element 30 is movable along the longitudinal axis 11 together with the first tubular element 21. The first tubular element 21 may be at least partially surrounded by the second tubular element 30. The second tubular element 30 may include a contact surface 31 for establishing pressure contact with the injection area.
[0082] In addition to the advantages already set forth in this disclosure, the needle safety device 1 has the following benefits: it can be used to prevent the reuse of medical devices, particularly the medical injection device 100, and to prevent accidental contact with the cannula 12. This can be achieved by means of the guide pin of the aforementioned hub portion 10. When the first tubular element 21 rotates relative to the hub portion 10, i.e., when the tubular arrangement 20 moves from the initial position 24 to the injection position 25, the guide pin can move substantially along a guide rail, wherein the guide rail includes components configured to hold the guide pin in its final position. This likely refers to preventing the guide pin from returning to other parts of the guide rail.
[0083] Figure 4 A medical device according to this disclosure, particularly a medical injection device 100, is shown, which includes the needle safety device 1 as described above. The medical injection device 100 includes a housing 110 that engages with a tubular arrangement 20, particularly a second tubular element 30 of the tubular arrangement 20, such that the second tubular element 30 is substantially non-rotating relative to the hub portion 10. Optionally, the hub portion 10 is fixed to the housing 110. This fixation between the hub portion 10 and the housing 110 can be substantially permanent. However, the hub portion 10 can alternatively be releasably fixed to the housing 110. In this way, user comfort and the applicability of the needle safety device 1 and / or the medical device can be improved. The medical injection device 100 can be an auto-injector or an injection pen, etc.
[0084] It should be noted that one or more of any embodiments and / or examples described herein may be combined with other aspects described herein, and those skilled in the art will understand that details of the embodiments and / or examples may also be omitted. The scope of protection is determined by the claims and is not limited to the embodiments and / or examples disclosed in the foregoing drawings.
[0085] [List of reference numerals]
[0086] 1. Needle safety device
[0087] 10 Hub Section
[0088] 11. Longitudinal axis
[0089] 12. Intubation
[0090] 12a Distal end of the cannula
[0091] 12b Proximal end of the cannula
[0092] 20 Tubular Arrangement
[0093] 21 First tubular element
[0094] 24 Initial Position
[0095] 25. Injection site
[0096] 26 Final Position
[0097] 30 Second tubular element
[0098] 31. Contact surface of the tubular arrangement / second tubular element
[0099] 32. Openings in the contact surface
[0100] 35. Connecting device
[0101] 35a Remote end of the connecting device
[0102] 35b Proximal end of the coupling device
[0103] 36. Buckle section
[0104] 37 Inclined surface
[0105] 38 contact surface
[0106] 39. Tubular protrusion
[0107] 50 diaphragm
[0108] 60 load-bearing elements
[0109] 61. Protrusion
[0110] 40 Spring elements
[0111] 100 Medical Injection Devices
[0112] 110 Casing
Claims
1. A needle safety device (1) for a medical device, particularly for a medical injection device (100), said needle safety device (1) comprising: A hub portion (10) defining a longitudinal axis (11), wherein the hub portion (10) includes a cannula (12) extending substantially along the longitudinal axis (11) from the hub portion (10) and a carrier element (60) disposed on the cannula (12), wherein the cannula (12) and the carrier element (60) are configured to move together relative to the hub portion (10) along the longitudinal axis (11); A tubular arrangement (20) movably disposed on the hub portion (10) to move relative to the hub portion (10) along the longitudinal axis (11), wherein the tubular arrangement (20) is configured to move between at least an initial position (24) and an injection position (25). In the injection position (25), the proximal end (12b) of the cannula (12) is configured to protrude through the septum (50) of the medical device, such that the cannula (12) is in fluid communication with the reservoir of the medical device. The tubular arrangement (20) includes a coupling device (35) configured to engage with the carrier element (60) such that when the tubular arrangement (20) moves from the injection position (25) to the initial position (24), the proximal end (12b) of the cannula (12) is configured to be removed from the diaphragm (50).
2. The needle safety device (1) according to the preceding claim, wherein the coupling device (35) is configured to shift relative to the carrier element (60) when the tubular arrangement (20) moves from the initial position (24) to the injection position (25).
3. The needle safety device (1) according to the preceding claim, wherein the coupling device (35) is configured to shift relative to the carrier element (60) in a direction substantially perpendicular to the longitudinal axis (11) when the tubular arrangement (20) moves from the initial position (24) to the injection position (25).
4. The needle safety device (1) according to any one of the preceding claims, wherein the coupling device (35) is configured to slidably engage with the carrier element (60) when the tubular arrangement (20) moves from the initial position (24) to the injection position (25).
5. The needle safety device (1) according to any one of the preceding claims, wherein the connecting device (35) is resilient, such that it provides a restoring force in a direction substantially perpendicular to the longitudinal axis (11).
6. The needle safety device (1) according to any one of the preceding claims, wherein the connecting device (35) has an elongated shape, wherein the longitudinal axis of the connecting device (35) is substantially parallel to the longitudinal axis (11) of the hub portion (10).
7. The needle safety device (1) according to any one of the preceding claims, wherein the longitudinal axis of the connecting device (35) is spaced apart from the longitudinal axis (11) of the hub portion (10).
8. The needle safety device (1) according to any one of the preceding claims, wherein the coupling device (35) includes a snap-fit portion (36) configured to engage with the carrier element (60) when moved from the injection position (25) to the initial position (24), and configured to slidably engage with the carrier element (60) when moved from the initial position (24) to the injection position (25).
9. The needle safety device (1) according to claim 8, wherein the latching portion (36) has a tapered shape when viewed along the longitudinal axis (11) from the distal end (35a) of the connecting device (35) toward the proximal end (35b) of the connecting device (35).
10. The needle safety device (1) according to claim 8 or 9, wherein the snap-fit portion (36) has an inclined surface (37) and an abutment surface (38), the inclined surface (37) being configured to slide on the carrier element (60), particularly on the protrusion (61) of the carrier element (60), the abutment surface (38) being for engaging with the carrier element (60), particularly with the protrusion (61) of the carrier element (60), wherein the inclined surface (37) is arranged near the proximal end of the connecting device (35), wherein the abutment surface (38) is arranged relative to the inclined surface (37) at a more distal end closer to the connecting device (35).
11. The needle safety device (1) according to claim 10, wherein the inclined surface (37) defines an angle of at least 10°, preferably at least 20°, more preferably at least 30°, more preferably at least 40°, more preferably at least 45°, and / or at most 80°, preferably at most 70°, more preferably at most 60°, more preferably at most 50°, and most preferably at most 45° relative to the longitudinal axis (11) of the hub portion.
12. The needle safety device (1) according to claim 10 or 11, wherein the abutment surface (38) is arranged substantially perpendicular to the longitudinal axis (11) of the hub portion (10).
13. The needle safety device (1) according to any one of the preceding claims, wherein the carrying element (60) includes a protrusion (61) for engaging with the connecting device (35), particularly with the snap-fit portion (36) of the connecting device (35).
14. The needle safety device (1) according to claim 13, wherein the protrusion (61) extends in a direction substantially perpendicular to the longitudinal axis (11).
15. The needle safety device (1) according to any one of the preceding claims further includes a spring element (40) that biases the tubular arrangement (20) relative to the hub portion (10) in a distal direction.
16. The needle safety device (1) according to any one of the preceding claims, wherein the connecting device (35) is a single arm.
17. A medical device, particularly a medical injection device (100), comprising a needle safety device (1) according to any one of the preceding claims.
18. The medical device according to the preceding claim, wherein the medical injection device (100) is an auto-injector or injection pen.