• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    INJECTION DEVICE. Injection device comprising a housing; a container holder arranged within said housing, said container holder being configured to accommodate a medicine container, having a needle attached to one of its ends and a sealable and slidably disposable stopper within said medicine container in its other far end; a first and a second energy accumulation element arranged within the housing of the injection device and adapted to accumulate and store energy; a glove being slidably arranged in relation to the housing; a plunger support arranged to be connectable to the container support, said plunger support being operationally associated with said first energy accumulation element such that, due to an axial output force from said first accumulation element of energy, the plunger holder and the container holder are movable axially with respect to the housing at a predetermined distance towards the proximal end of the injection device from an initial position to a position after needle penetration, and a plunger rod being disposed with its proximal end, which can be contacted by said stopper and (...).
    公开号:BR112014005036B1
    申请号:R112014005036-8
    申请日:2012-08-28
    公开日:2020-12-29
    发明作者:Anders Boström；Elin Gabrielsson
    申请人:Shl Medical Ag；
    IPC主号:
    专利说明:

    Field of the Invention
    [0001] The present invention relates to an injection device having several automatic functions, such as automatic penetration, automatic injection and automatic security means to prevent accidental needle sticks and, in particular, an injection device for single use, disposable, having a mechanism that provides all these functions in a safe and space-saving manner and that can be used for self-injection. Background of the Invention
    [0002] The present invention relates to injection devices for injecting drugs or medicinal substances, such as insulin or hormones, in the form of fluid through a needle.
    [0003] Auto-injectors or injection pens have been on the market for many years. One of the first auto injectors was developed for wartime and was activated by compressing the injector against a part of the body. The main concern was to have the medication injected as quickly as possible, without caring too much about the patient or aspects of safe handling. developed that have to be injected by the patients themselves. Therefore, depending on the intended use and the type of medicine, injection devices, having a varying degree of automatic functions, have been developed to facilitate the injection of medicines in a reliable and safe way for patients and even for trained personnel, for example, doctors , nurses.
    [0004] Self-injecting devices, having a penetrating function, often comprise a housing, a container support carrying a medicine container with a needle and plunger, as well as a coiled compression spring. When the devices are actuated, the container support and the plunger rod, which are slidable in the housing, are operable together towards the patient's skin by the force of a compression spring. In this way, the needle penetrates. Typically, the devices are operated by the user by pressing a mobile button. The action of the mobile button can be inhibited until the device is positioned in a distribution location and a mobile needle cover, which protrudes from the housing, is pushed against a patient's skin. However, many patients and medical professionals prefer automatic penetration, once the device is positioned at the distribution site.
    [0005] Self-injection devices that also have an automatic injection function often comprise an additional spiral-wound compression spring that acts on the plunger rod, which in turn acts on a stopper inside a medicine container to expel a medication through the needle. The drug is often injected after penetration, as the container holder and plunger are moved together to a predetermined position.
    [0006] Some self-injecting devices may have an automatic safety function to prevent accidental needle sticks when covering the needle with a needle cover when the device is removed from the patient's skin.
    [0007] Normally, self-injection devices do not provide all of the desired automatic functions and / or require several mechanisms with multiple individual moving parts, including small elements and parts with complex shapes, in order to do so. However, this can lead to devices that do not provide all the functions desired by patients and, in addition, devices that are larger and comprise more components than necessary and difficult to manufacture and assemble.
    [0008] US 7361160 discloses an injection device including a receptacle for an active substance, which is connected to an injection needle and is accommodated inside a sliding sleeve, which can be moved inside a housing by means of a actuation force. A glove-shaped needle guard device is movable within the housing by means of a spring so that said needle guard device moves forward and extends beyond the injection needle in an axial direction when the needle injection is removed from the body tissue. A lock prevents the needle guard from being pushed back manually. The device can be activated when a sliding sleeve is back in its stowed position. However, the device does not automatically penetrate when positioned at the distribution site and is also difficult to manufacture and assemble since several independent parts, mobile and non-mobile, are required to provide penetration, injection and safety functions.
    [0009] US 2006/0224124 discloses a device for administering an injectable product, including a drive unit for driving a drive element in an administration direction, a release mechanism for releasing the drive unit and a locking mechanism. locking which, when locked, prevents the release mechanism from being operated. The locking mechanism is movable along the longitudinal axis of the device from a locked position to an unlocked position and the release mechanism can be moved radially with respect to the longitudinal axis for release purposes, when the locking mechanism is in the unlocked position. However, this device also does not provide automatic penetration when positioned in a distribution location. In addition, several individual parts are required in order to provide the functions mentioned above;
    [0010] US 4642099 discloses a rumen injector having a body, an interaction piston and a cylinder mounted inside the body and a needle attached to the cylinder. The cylinder is movable from a resting position to a cocked position and the piston is movable within the cylinder from a resting position to a cocked position, so that, in use of the injector, the cylinder is first released to cause the needle to be inserted and then the piston is released to cause a dose to be injected into the animal's rumen. Although the cylinder is released when a guard, mounted on the front end of the body, is compressed against the animals' skin, the device, INTER ALIA, does not provide the safety functions required to prevent accidental needle sticks after the device is used. Summary of the Invention
    [0011] In order to overcome one or more of the problems mentioned above, an injection device according to independent claim 1 is provided.
    [0012] Other aspects, improvements and variations are disclosed in the dependent claims, figures and description.
    [0013] In the present application, when the term "distal" is used, it refers to the direction that points away from the dose distribution site. When the term "distal part / end" is used, it refers to the part / end of the delivery device, or the parts / ends of its elements, which are / are located further away from the dose delivery site. Correspondingly, when the term "proximal" is used, it refers to the direction that points to the dose distribution location. When the term "proximal part / end" is used, it refers to the part / end of the delivery device, or the parts / ends of its elements, which are / are located closer to the dose delivery site.
    The injection device of the present invention comprises a housing and a container support disposed within the housing. The container holder is configured to accommodate a medicine container. The medicine container can be a commonly used medicine container, having a needle attached to one of its ends and a stopper disposable sealingly and slidably within said medicine container at its other end. However, according to the embodiments of the invention, the needle can also be attached to the medicine container support and be fluidly connectable to a medicine container inserted in said support.
    [0015] The person skilled in the art will note that the medicine container is an optional component of the injection device because it can be inserted into the injection device by the user, for example, by replacing an empty medicine container after use of the injection device. In addition, the injection device is not necessarily delivered in its fully assembled state, that is, with the medicine container already accommodated in the injection device by dispensing the injection device.
    [0016] The container support may comprise one or more structures for supporting the medicine container. For example, the container support may comprise a flexible collar which is pushed outward when the container is inserted and subsequently snaps back, surrounding and supporting the container.
    [0017] Initially, the medicine container preferably contains a defined dose of a substance to be injected, such as a medicine, insulin or hormones. Initially, the stopper is preferably arranged at the distal end of the medication container.
    [0018] The housing may comprise an external body, a rear cover and a window. In the assembled state of the injection device, the rear cover can close a distal opening of the external body. The outer body and the back cover can form the outer surface or appearance of the injection device. However, the invention also involves configurations where the housing comprises fewer or more housing parts.
    [0019] The housing parts may have a generally cylindrical configuration or have the general shape of a prism and may have a circular, elliptical, square or substantially square cross section, perpendicular to the longitudinal axis of the device. A removable front cover can close the proximal opening of the housing.
    [0020] In a preferred embodiment, the rear cover is connected coaxially to the external body. The outer surface of the rear cover can be provided with corresponding locking structures that provide a shape fit towards the outer body. However, the rear cover and the outer body can also be snapped together. The connection may be release or not.
    [0021] The window can be a transparent or semi-transparent element inserted or covering an opening of the external body.
    [0022] The injection device of the present invention further comprises at least one sleeve, which is slidably arranged to be connectable to the container support, for example, by a pressure connection with hooks provided in the plunger support and / or in the support of container. The plunger support is operationally associated with at least one first energy accumulation element, so that, due to an axial output force from said first energy accumulation element, the plunger support and the container support are mobile axially in relation to the housing by a predetermined distance towards the proximal end of the injection device. The first energy accumulation element can be partially arranged around the plunger support.
    [0023] The plunger holder may have the general shape of a hollow cylinder. In addition, the plunger support may comprise circumferentially extending openings and / or ribs and / or other stop structures, the functionality of which will be detailed below.
    [0024] Preferably, when the injection device of the present invention is in an initial position, the first energy accumulation element is propelled and pushes the plunger support towards the proximal end of the device. However, the movement of the plunger holder is inhibited, so that the plunger holder and the container holder are moved axially when the container holder is released. In this position, the movement of the plunger support towards the proximal end of the device is substantially inhibited by at least one pushable element interacting with the plunger support. Preferably, the first movable element is superimposed by the glove and, therefore, unable to deflect and / or recoil until it is superimposed by a first opening and / or first recesses provided in said glove.
    [0025] The starting position can be the position where the device is distributed to the patient after removing the removable cover. In the starting position, the container support is preferably located inside the outer body. More preferably, the container support is located within the outer body, so that the needle is covered by and / or retracted on the outer body. According to embodiments of the invention, penetration of the needle can be effected by moving the plunger holder and the container holder in the proximal direction from the initial position to a position following needle penetration, when the plunger holder is released.
    [0026] The external body can have a stepped configuration to stop the container support at the final penetration depth. However, alternatively, the outer body may not have a staggered configuration, but rather the same cross-sectional size and shape at its proximal and distal ends. In that case, said stops, if required, can be provided by other parts, such as additional housing parts or stop ribs.
    [0027] In addition, the external body may comprise ribs and / or recesses to guide the movement of the glove and / or a needle cover operatively associated with said glove. The sleeve and / or the needle cover, in turn, may comprise ribs and / or recesses to guide the movement of the container support.
    [0028] The at least one first pushable element may comprise at least one pushable lever, preferably a pushable lever with a hook. In embodiments, the injection device of the present invention comprises an internal body that is substantially and fixedly arranged with respect to the housing. The at least one first pushable member can be integrally formed with said inner body and, more preferably, is integrally formed with a tubular portion of the inner body that is arranged, at least partially, between the plunger support and the sleeve. The inner body can be loosely connected to the outer body, preferably, snapped into the outer body.
    [0029] According to the embodiments of the invention, the surface of the at least one first pushable element and / or the surface of the plunger support that interact in order to inhibit the movement of the plunger support in the proximal direction, when the plunger support is in the starting position is tapered and / or forms an angle, so that when the pushable element is able to recede because it is overlapped by the first opening and / or the first recess of the sleeve, the pushable element is deflected by the plunger support that it is being pushed in the proximal direction by the axial force of exit from the first energy accumulation element. Preferably, the at least one first pusher element is deflected in a radially outward direction, i.e., away from the longitudinal axis of the injection device. Alternatively, the pushable element can be pushed when assembling the device and recede independently, when overlapped by the opening or recess of the glove, so that tapered surfaces are not required.
    [0030] The injection device of the present invention further comprises a plunger rod, which is arranged so that a proximal end thereof can contact the stopper of the medication container. The plunger rod is slidable with respect to the plunger holder and slidable with respect to the container holder. In addition, the piston rod is operationally associated with a second energy accumulation element, so that, due to an axial output force of said second energy accumulation element, the piston rod is axially movable with respect to the container support towards the proximal end and / or the plunger rod can be arranged around the second energy accumulation element.
    [0031] In the initial position of the injection device, the plunger rod is preferably in a locked position. In said locked position, the movement of the plunger rod relative to the container support towards the proximal end of the injection device is preferably substantially inhibited by means of at least one pushable element of the plunger support, i.e., a second pushable element, interacting with the plunger rod. The second pushable element can be configured to recoil and / or be deflected when the plunger support reaches the final penetration depth so that the plunger rod is released and moved towards the proximal end of the injection device by the axial force of exit of said second energy accumulation element, moving from a locked position to a position after the injection of medication and thus injecting the medication contained in the medication container.
    [0032] In one embodiment, the container holder can be configured to guide the plunger rod in the medicine container and / or during the injection of medicine. Additionally or alternatively, the container holder can also be configured to stop the plunger when the correct dose has been delivered. The container support can be provided with appropriate structures or stops for any of the above purposes. In addition, the container support may comprise a flange that interacts with the stepped or stop structures of the outer body to restrict the movement of the container support when the final penetration depth is reached.
    [0033] Preferably, the recoil and / or deflection of the at least one second pushable element is inhibited until the plunger support reaches the final penetration depth through the inner body supporting the pushable element. For example, the at least one second pushable element can rest against the tubular portion of the inner body. More preferably, when the plunger support moves towards the proximal end of the injection device and reaches the final penetration depth, the at least one second pushable element moves beyond the proximal end of the tubular portion of the inner body and therefore is capable of retreating and / or can be deflected. However, the recoil and / or deflection of the at least one second pushable element can also be inhibited by the other components of the device, for example, the sleeve or the outer body. In addition, the at least one second pushable element may not have to move beyond the proximal end of any of these components, but it may also recoil and / or deflect when reaching an opening or recess in the respective component.
    [0034] The second pushable element can interact with a slot provided in the piston rod. In particular, the at least one second pushable element may comprise at least one pushable lever, preferably at least one pushable lever with a hook. According to the embodiments of the invention, the surface of the at least one second pushable element and / or the surface of the plunger rod that interact in order to inhibit movement of the plunger rod in the proximal direction, when the plunger rod is in position locked is tapered and / or at an angle, so that when the pushable element is able to recede, the pushable element is deflected by the plunger rod being pushed in the proximal direction by the axial force of output of the second energy accumulation element . Preferably, the at least one second pusher element is deflected in a radially outward direction, away from the longitudinal axis of the injection device.
    [0035] According to embodiments of the invention, the injection device further comprises a third element of accumulation of energy. The glove can be operationally associated with said third energy accumulation element, so that the glove is movable axially with respect to the housing, towards the distal end of the injection device from a starting position to a retracted position against an axial force of said third energy accumulation element and / or so that the sleeve is axially movable with respect to the housing by a predetermined distance, towards the proximal end of the injection device due to an axial force of exit from said third energy accumulation element from the retracted position to an end position.
    [0036] The starting position of the glove can be the initial position of the glove, that is, the position of the glove after the front cover has been removed from the device and before the device has been located at the distribution site. In this position, the glove can extend beyond the outer body or protrude from said outer body in a proximal direction of the device, for example, when the front cover is removed. Alternatively or additionally, the needle cover can be operationally associated with said glove and extend outward from the external body or protrude from it in a proximal direction of the device. The glove and / or the needle cover can cover the needle before penetration is performed.
    [0037] The retracted position of the glove can be the position of the glove when the device is positioned at the delivery site and pushed against a patient's skin. When the glove, or alternatively, the needle cover protrudes from the proximal end of the outer body, the glove can be moved towards the distal end of the injection device from the starting position to the stowed position, against the axial force of the third energy accumulation element pushing the device against the distribution place. Incidentally, when the glove is moved towards the distal end of the injection device, at least a first opening and / or at least a first recess in the glove will overlap with at least one first push element, triggering penetration and injection, as described above.
    [0038] Following the injection of medication, when the device is retracted from the dispensing site, the glove can be moved axially in relation to the housing by a predetermined distance towards the proximal end of the injection device due to an axial output force of the third element of energy accumulation from the retracted position to the final position. When reaching the final position, the movement of the glove in relation to the housing, towards the distal end of the injection device, can be inhibited, substantially, by means of at least one third pushable element, receding and interacting with the glove.
    [0039] At least one third pushable element may comprise at least one pushable lever. In embodiments, at least a third pushable member is formed integrally with the inner body and, more preferably, is integrally formed with a tubular portion of the inner body, which is arranged, at least partially, between the plunger support and the sleeve. The glove can thus be partially arranged around the inner body.
    [0040] According to embodiments of the invention the plunger holder interacts with the sleeve to substantially inhibit the movement of the sleeve towards the proximal end of the injection device from the starting position to the final position, when the plunger holder is in the starting position. For example, the plunger support can be provided with a stop structure that restricts the movement of the glove in the proximal direction of the device. In this case, the glove will be able to move further, towards the proximal end of the injection device once the plunger holder has moved from the initial position to the position that follows the penetration of the needle and, thus, the glove will be only able to reach its final position after needle penetration is performed. The needle, which protrudes from the outer body after needle penetration, because the container holder has been moved towards the proximal end of the injection device, is preferably covered by the glove and / or the needle cover, when the glove reaches the final position.
    [0041] Preferably, at least one third pushable element, for example, the corresponding lever of the internal body, is in a relaxed state, when the glove is in the starting position. For this purpose, the glove can be provided with at least a second opening and / or at least a second recess overlapping said third pushable element in the starting position and in the retracted position. The third pushable element can be arranged so that it is deflected when the sleeve is moved towards the proximal end of the injection device from the retracted position to the final position and subsequently recedes when it is overlapped by at least one opening and / or at least one recess in the glove. The third pushable element can be arranged so that the movement of the sleeve towards the distal end of the injection device is then inhibited. For example, the third pushable element may have a tapered and / or angled configuration, so that it can only be deflected by the sleeve, when said sleeve moves towards the proximal end of the injection device.
    [0042] The first energy accumulation element, the second energy accumulation element and the third energy accumulation element can be arranged inside the injection device housing and can be adapted to accumulate and store energy. The first, second and third energy-accumulating elements can be compression springs wound in a spiral. In embodiments, the first energy accumulation element is fitted to the tubular portion of the inner body and arranged between the plunger support and the inner body. The second energy accumulation element can be fitted to the piston rod and compressed between a proximal bottom of the piston rod and a distal end of the piston holder. The third energy accumulation element can be fitted between the sleeve and the inner body. The first and second energy accumulation elements can be compressed, at least partially, in the initial position of the device.
    [0043] In accordance with the present invention, the injection device may further comprise a spring guide rod. The spring guide rod can be positioned on the plunger rod and rest against the plunger support in order to guide the second energy accumulation element. In addition, a glove guide can be provided. The glove guide can be fixedly supported by the inner body and / or integrally on the back cover and can guide the movement of the glove when the glove is moved towards the distal end of the injection device.
    [0044] In embodiments, the window can be configured to allow inspection of the drug before use. In addition, the window can be configured to allow assessing whether the device has been used or not and / or to assess whether a dose has been injected completely. For example, the window can give a clear view of the medicine container before use and a clear view of the plunger rod disposed inside the medicine container afterwards. When arranged around the container holder, the sleeve and / or the needle cover may comprise openings to allow inspection of the medicine container. Brief Description of the Figures
    [0045] The figures below disclose an embodiment of the invention for purposes of illustration only. In particular, exposure within the figures is not intended to limit the protection range of the invention. The embodiment shown can be modified in many ways within the scope of the claims.
    [0046] Figure 1 shows a perspective view of an injection device according to a preferred embodiment of the invention;
    [0047] Figure 2 shows a first exploded view of the injection device according to the preferred embodiment of figure 1;
    [0048] Figure 3 shows a perspective view of a container holder and a medicine container of the injection device according to the preferred embodiment of figure 1;
    [0049] Figure 4 shows a perspective view of a sleeve of the injection device according to the preferred embodiment of figure 1;
    [0050] Figure 5 shows a perspective view of a plunger support of the injection device according to the preferred embodiment of figure 1;
    [0051] Figure 6 shows a perspective view of an internal body of the injection device according to the preferred embodiment of figure 1;
    [0052] Figure 7 shows a perspective view of a needle cover of the injection device according to the preferred embodiment of figure 1;
    [0053] Figure 8 shows a cross-sectional view of the injection device according to the preferred embodiment of Figure 1, the sectional plane being perpendicular to the longitudinal axis of the device;
    [0054] Figure 9 shows a cross sectional view of the injection device according to the preferred embodiment of Figure 1 in the initial position, the sectional plane being parallel to the longitudinal axis of the device;
    [0055] Figure 10 shows an additional cross-sectional view of the injection device according to the preferred embodiment of Figure 1 in the initial position, the sectional plane being parallel to the longitudinal axis of the device;
    [0056] Figure 11 shows a detail of the cross-sectional view of figure 10;
    [0057] Figure 13 shows a cross sectional view of the injection device according to the preferred embodiment of figure 1, the sectional plane being parallel to the longitudinal axis of the device and the glove being in the retracted position;
    [0058] Figure 13 shows an additional cross-sectional view of the injection device according to the preferred embodiment of figure 1, the sectional plane being parallel to the longitudinal axis of the device and the glove being in the retracted position;
    [0059] Figure 14 shows a cross sectional view of the injection device according to the preferred embodiment of Figure 1, following the penetration of the needle with the plunger rod being in the locked position, the sectional plane being parallel to the longitudinal axis of the device ;
    [0060] Figure 15 shows a cross sectional view of the injection device according to the preferred embodiment of figure 1, following the injection of medication, the sectional plane being parallel to the longitudinal axis of the device;
    [0061] Figure 16 shows a cross sectional view of the injection device according to the preferred embodiment of figure 1, with the glove being in the final position, the sectional plane being parallel to the longitudinal axis of the device; and
    [0062] Figure 17 shows a cross sectional view of the distal part of the injection device according to the preferred embodiment of Figure 1, in the initial position, the sectional plane being parallel to the longitudinal axis of the device. Detailed Description of the Invention
    [0063] Figure 1 shows a perspective view of an injection device according to a preferred embodiment of the present invention. The injection device 1 has a housing comprising an outer body 2 and a rear cover 3.
    [0064] As shown in figure 1, the external body 2 comprises at least one window 6. This window allows the user to see the injection status, that is, if the injection device 1 is still in its initial position, with the medication not yet injected or if the medicine container is already empty. Through window 6, the user can see the medicine container accommodated inside the external body 2.
    [0065] In addition, figure 1 shows the front cover 14, which closes the proximal opening of the external body 2 until the injection device 1 is used.
    [0066] Figure 2 shows a first exploded view of the injection device 1 according to the preferred embodiment of figure 1. In this exploded view of figure 2, the outer body 2, the rear cover 3, the window 6, as well as the front cover 14, are shown "removed" from the injection device 1. In the mounted state of the injection device, the rear cover can close the distal opening of the outer body. As shown in figure 2, the rear cover 3 can be provided with interlocking structures such as structures with circumferential grooves and ribs for attaching the rear cover to the outer body. In addition, as best seen in figure 13, the rear cover 3 comprises slits which are fitted by hooks of the inner body 50 in order to hold the rear cover 3 firmly on the outer body 2. However, the rear cover can also comprise slits and / or hooks to be fitted directly to the outer body 2. In addition, the connection can be released. In this case, the outer body 2 and the back cover 3 can be easily disconnected so that the internal components of the device can be pulled out of the outer body 2 and a medicine container can be inserted or removed from the injection device 1. Still A sleeve guide (not shown) is positioned between the rear cover 3 and the inner body, which can be fixedly supported by the internal body and / or integrally with the rear cover.
    [0067] As still shown in figure 2, the injection device according to the preferred embodiment of figure 1 also comprises a medicine container holder 10 disposed within the outer body 2. The container holder 10 is configured to accommodate a container of medicine 11. As shown in figure 2, the medicine container 11 can be a commonly used medicine container, having a needle 12 attached to one of its ends and a stopper 13 arranged, sealable and slidably, inside said medicine container medicine 11 at its other end. However, according to the other embodiments of the invention, the needle can also be attached to the container holder 10 and be fluidly connectable to a medicine container 11, when that container is inserted into the container holder 10. Preferably, the container medicine contains a defined dose of a substance to be injected, such as a medicine, insulin or hormones.
    [0068] In the fully assembled state of the injection device 1, the medicine container holder 10 is, with at least its proximal end, located inside the outer body 2. This will be described in more detail below with reference to figure 9. In preferred embodiment shown in figure 2, the medicine container support 10 comprises at least one container support guide 19.
    [0069] As also shown in figure 2, the injection device according to the preferred embodiment of figure 1 still comprises a sleeve 45, which can be operationally associated with a third energy accumulation element 75 (third compression spring 75) and a plunger support 35, which is operationally associated with a first energy accumulation element 65 (first compression spring 65). In addition, a piston rod 20, operationally associated with a second energy accumulation element 70 (second compression spring 70) located therein, and an internal body 50 are provided. Although the first, second and third energy accumulation elements are preferably compression springs wound in a spiral, other structures capable of storing the required amount of energy can also be provided within the scope of the invention.
    [0070] According to the preferred embodiment, the injection device also comprises a needle cover 60, located on the outer body 2. However, it should be noted that the needle cover 60 can be incorporated in sleeve 45, that is, that the needle cover 60 and the sleeve 45 can be integrally formed and constitute a single element.
    [0071] As best seen in figure 3, the container holder may further comprise a flexible collar 18. The flexible collar 18 is curved open when the medicine container 11 is inserted into the medicine container holder 10 and subsequently secured, surrounding and holding container 11.
    [0072] Figure 4 shows a perspective view of the sleeve 45 of the injection device 1, according to the preferred embodiment of figure 1. As shown, the sleeve 45 can have a general shape of a hollow cylinder. However, any other suitable shape can be used and, for example, the glove can also be in the form of a hollow prism.
    [0073] According to the preferred embodiment, the glove 45 has tabs 49 that extend in its longitudinal direction towards the distal end of the injection device on opposite sides of the glove. As shown in Figure 4, according to the preferred embodiment, the sleeve 45 comprises a first pair of openings 46, which can be provided on the tabs 49, a second pair of openings 47 and a third pair of openings 48. The openings of each of these pairs can be provided on opposite sides of the sleeve 45. As shown in figures 1 and 4, the sleeve 45 may comprise a circumferential rib or other support structures to support the third energy accumulation element 75.
    [0074] Figure 5 shows a perspective view of the plunger holder 35 of the injection device 1 according to the preferred embodiment of figure 1. Also, the plunger holder 35 is shown having the general shape of a hollow cylinder. However, the plunger holder 35 can also have any other suitable shape and, for example, it can be in the form of a hollow prism.
    [0075] As shown in figure 5, the plunger support of the injection device 1 according to the preferred embodiment comprises second pushable elements 36, which are provided as second levers 36. Preferably, the second levers 36 are integrally formed with the plunger support 35. The plunger support 35 is further provided with an inspection opening 37, which is aligned with the second pair of openings 47 to inspect whether the plunger rod is in place when assembling the device.
    [0076] According to the preferred embodiment, the plunger support 35 is arranged to be connectable to the container support by a pressure connection provided at the proximal end of the plunger support 35 and featuring lockable hooks 38. Said hooks 38 can interact with slits, recesses or protuberances provided for the container support 10. When the device is in the starting position, the stop structure 39, which will be described in more detail with reference to figure 11 below, prevents the sleeve 45 from being pushed into the proximal end of the injection device 1.
    [0077] Figure 6 shows a perspective view of the inner body 50. According to the preferred embodiment, two first push elements are provided as first levers 51 (not shown in figure 6) and two third push elements are provided as second levers 52, the first levers 51 and second levers 52 being integrally formed with a tubular portion 53 of the inner body 50. In addition, the inner body 50 comprises slots 54 to be fitted under pressure with the outer body 2 and hooks 55 to support the cover. rear 3.
    [0078] Figure 7 illustrates a perspective view of the needle cover 60 of the injection device 1 according to the preferred embodiment of figure 1. As shown, the needle cover 60 can comprise protruding protrusions 62 to guide the cover of needle 60 along ribs provided in the external body 2.
    [0079] As best seen in figure 8, the container support 10 can comprise several container support guides 19 which are arranged on opposite sides of the container support and extend in its longitudinal direction. According to the preferred embodiment, the container support guides 19 can be received in corresponding guide slots 61, provided on the inner surface of the needle cover 60.
    [0080] Figure 9 shows a cross-sectional view of the injection device according to the preferred embodiment of Figure 1, the sectional plane being parallel to the longitudinal axis of the device. The device is shown in the starting position, that is, how it can be delivered to the patient. The device is shown without the front cover 14.
    [0081] As shown in figure 9, the container holder 10 is preferably located inside the outer body 2, so that the needle 12 is covered by said outer body. The first compression spring 65 is compressed between the plunger support 35 and the inner body 50, so that the plunger support is pushed towards the proximal end of the device 1. However, the hooks provided at the end of the first levers 51 interact with a notch provided in the plunger support 35 and thus inhibit the movement of the plunger support 35 towards the proximal end of the device 1 along the longitudinal axis 16. As shown, for example, in figure 9, the first levers 51 can be formed integrally with the internal body 50.
    [0082] Similar to figure 9, figure 10 also shows a cross sectional view of the injection device according to the preferred embodiment of figure 1, the sectional plane being parallel to the longitudinal axis of the device. However, the position of the device is rotated by 90 °.
    [0083] According to the preferred embodiment, the injection device 1 comprises a plunger rod 20 which is arranged so that its proximal end contacts the stopper 13 of the medication container 11. The plunger rod 20 is slidable with respect to the plunger support 35 and slidable with respect to the container support 10. In addition, plunger support 35 is operatively associated with the second compression spring 70, so that, due to an axial force of output from said second spring of compression 70, the piston rod 20 is moved axially with respect to the container holder 10 towards the proximal end of the injection device 1. The piston holder 35 can be arranged around the piston rod 20 and / or the rod piston 20 can be arranged around the second compression spring 70.
    [0084] When the injection device 1 is in the initial position, the second compression spring 70 is preferably compressed between a proximal bottom of the plunger rod 20 and a distal end of the plunger holder, so that the plunger rod the plunger is pushed to the proximal end of the device 1. However, according to the preferred embodiment shown in figure 10, the hooks provided at the end of the second levers 36 interact with a rib provided in the plunger rod 20 and thus inhibit movement of the plunger rod 20 towards the proximal end of the device 1. Thus, the plunger rod 20 is in a locked position. It will be clear to the person skilled in the art that, instead of a rib, the piston rod 20 can be provided with a recess.
    [0085] The injection device 1 can comprise a spring guide rod 25 in order to guide the second compression spring 70.
    [0086] As further illustrated in figures 9 and 10, in the preferred embodiment, the injection device 1 comprises the needle cover 60, which is attached to the sleeve 45. In addition, the device 1 comprises a third compression spring 75, which it is operationally associated with glove 45 and pushes glove 45 and needle cover 60 towards the proximal end of the device. As shown in the detail in figure 11, the movement of the sleeve 45 and the needle cover 60 towards the proximal end of the injection device is restricted by the sleeve 45 resting on the stop structure 39 of the plunger holder 35. The cover of needle 60 protrudes partially from the external body 2 in the proximal direction of the device, when the device 1 is in the initial position.
    [0087] In the initial position shown in figures 9 and 10, the first levers 51 are overlapped by the sleeve 45 and, thus, are unable to be deflected and / or to retreat. Figure 12, however, shows the device when located at an injection site and being pushed against a patient's skin. In this case, the sleeve 45 is moved axially in relation to the housing towards the distal end of the injection device 1 from the starting position to a retracted position, against the axial force of the third compression spring 75. The sleeve is then in the stowed position and the first pair of openings 46 overlap the first levers 51. Since the first levers 51 are capable of recoiling and / or can be deflected, the plunger support 35 and the container support 10 are moved towards the end proximal to the injection device 1 by the output force of the first compression spring 65. In this way, penetration is carried out.
    [0088] In this way, as illustrated in the sequence of figures 13 to 16, the second levers 36 continue to rest against the inner body 50 (see figure 13) until the needle 12 reaches the final penetration depth and the second levers 36 move beyond the proximal end of said internal body 50. In this way, the piston rod 20 is held in the locked position until the final penetration depth is reached. As shown in figure 14, a flange of the container support 10 can rest on a step of the outer body 2 to restrict the movement of the container support 10 and the plunger support 35 towards the proximal end of the device 1, when the depth final penetration is achieved.
    [0089] According to the preferred embodiment shown in figure 14, the second levers 36 move beyond the proximal end of the inner body 50, when the final penetration depth is reached. The second levers 36 are therefore capable of recoiling and / or being deflected, releasing the piston rod 20.
    [0090] As shown in figure 15, the plunger rod is then moved towards the proximal end of the injection device 1 by the axial output force of the second compression spring 70, thus pushing the stopper 13 along the container of medication 11 and injecting the medication.
    [0091] Following the injection of the medication, when the device 1 is retracted from the distribution site, the sleeve 45 is moved axially in relation to the housing by a predetermined distance towards the proximal end of the injection device 1, due to the axial force exit of the third compression spring 75 from the retracted position to an end position. As shown in figure 16, the sleeve 45 can now reach its final position since the plunger support 35 has been moved in the proximal direction during the penetration of the needle. Thus, the sleeve 45 can still move towards the proximal end of the injection device before reaching the stop structure 39.
    [0092] As still shown in figure 16, the movement of the sleeve 45 in relation to the housing towards the distal end of the injection device 1 is inhibited by the third levers 52 receding and resting against the first pair of openings 46 provided in the sleeve 45 , once the glove reaches its final position.
    [0093] As best seen in figure 17, the surface of the first levers 51 and / or the surface of the plunger support 35, which support each other in order to inhibit the movement of the plunger support in the proximal direction when the plunger support is in starting position is tapered, according to the preferred embodiment. Therefore, when the first levers 51 are superimposed by the first opening 46 of the sleeve and are able to recede, the levers 51 are deflected by the piston support 35, the latter being pushed in the proximal direction by the axial force of output of the first compression spring 65 As shown in figure 17, the surfaces can be tapered so that the levers 51 are deflected away from the longitudinal axis of the injection device. However, the levers can also be pushed when assembling the device, in which case tapered surfaces might not be required. Similarly, the surface of the second levers 36 and / or the surface of the piston rod 20, which support each other in order to inhibit the movement of the piston support in the proximal direction until penetration is carried out can also be tapered.
    [0094] As will be recognized by those skilled in the art, the present invention provides an injection device requiring few parts to provide reliable, accurate and safe drug injection. In addition, the device is comparatively easy to manufacture and can be mounted by sliding the components of the device one after the other. Therefore, several disadvantages of the prior art are overcome.
    [0095] Although the invention has been illustrated and described in detail in the drawings and in the preceding description, such illustration and description should be considered illustrative or exemplary and not restrictive. It should be noted that the invention covers all aspects shown in the figures individually, although they may not have been described in the previous description and it will be understood that changes and modifications can be made by those of ordinary skill within the scope of the following claims. In particular, the present invention further covers embodiments with any combination of characteristics of different embodiments described above and below.
    [0096] Furthermore, in the claims, the word "comprising" does not exclude other elements or steps and the terms "one", "one", "first", "second" do not exclude a plurality. A single unit can fulfill the functions of several resources cited in the claims. The terms "essentially", "about", "approximately" and the like in connection with an attribute or a value, in particular, also define exactly the attribute or exactly the value, respectively. Any reference signs in the claims should not be construed as limiting the scope.
    权利要求:
    Claims (9)
    [0001]
    1. Injection device (1) characterized by the fact that it comprises: a housing comprising an external body (2) and a rear cover (3) which closes an opening distal to the external body (2); an internal body (50); a container support (10), disposed within said housing, comprising a flexible collar (18) which is configured to surround the medicine container (11) with a needle (12) connected to one end and a cap (13) of watertight and sliding way inside said medicine container (11) at the other end, wherein the container support (10) is moved axially in relation to the housing by a predetermined distance towards the proximal end of the injection device (1 ) between an initial position where the container support (10) is located inside the outer body (2) so that the needle (12) is covered by and / or retracted on the outer body (2), and a final position after needle penetration, where the needle protrudes from the external body after needle penetration, since the container holder (10) moves towards the proximal end of the injection device (1); a sleeve (45) which is slidably arranged in the housing; a plunger rod (20) configured to be moved in the medicament container (11) to deliver at least one dose of medicament, wherein an end close to the plunger rod (20) can contact the lid (13) of the medicament container (11); a plunger support (35) having at least one polarizable element (36) inhibiting the movement of the plunger rod (20) in a locked position relative to the container support (10) towards the proximal end of the injection device (1) ; a first energy accumulator element (65) which is operationally associated with the piston support (35) due to an axial output force from said first energy accumulator element (65), the piston support (35) and the container support (10) are movable axially with respect to the housing at a predetermined distance towards the proximal end of the injection device (1) from an initial position to a position after the needle has penetrated; a second energy accumulator element (70) configured to apply an axial output force to the piston rod (20) so that the container holder (10) is configured to guide the piston rod (20) within the medication container (11) and / or during the injection of medication, in which the piston rod (20) is axially movable in relation to the container support (10) towards the proximal end of the injection device (1); wherein the flange of the container support (10) can rest on a step of the outer body (2) to restrict the movement of the container support (10) and the plunger support (35) towards the proximal end of the device injection (1), when the final penetration depth is reached and the locking mechanism (36) moves beyond the proximal end of the inner body (50) when the final penetration depth is reached and the piston rod (20) is then moved towards the proximal end of the injection device (1) through the axial force of the second energy accumulator element (70), thus pushing the cap (13) through the medicine container (11) and injecting the medicine ; wherein the locking mechanism comprises at least one deflecting member (36) and where the inner body (50) is configured to allow at least one deflecting member (36) to allow a deflection of at least one deflecting member (36) out of the plunger rod (20) when the medicament container (11) and plunger holder (35) are advanced to the final position after needle penetration; wherein the inner body (50) is fixedly configured in relation to the housing and releasably connected to the outer body (2).
    [0002]
    2. Injection device (1) according to claim 1, characterized in that the device further comprises a third energy accumulator element (75), the sleeve (45) being operationally associated with said third energy accumulator element energy (75) such that the sleeve (45) can be moved axially with respect to the housing towards the distal end of the injection device (1) from an initial position to a retracted position against an axial force from the said energy accumulator element (75) and / or in such a way that due to an axial output force from said third energy accumulator element (75), the sleeve (45) is movable axially with respect to the housing of a distance predetermined towards the proximal end of the injection device (1) from a retracted position to an end position.
    [0003]
    3. Injection device (1) according to any one of the preceding claims, characterized by the fact that, when the sleeve (45) reaches its final position, the movement of the sleeve (45) in relation to the housing towards the distal end of the injection device (1) is inhibited by at least one third polarizable element (51, 52) sliding and interacting with the sleeve (45).
    [0004]
    Injection device (1) according to any one of the preceding claims, characterized in that, in the initial position of the plunger support (35), the movement of the sleeve (45) in the direction of the proximal end of the injection device injection (1) from a starting position to an end position is inhibited by the piston support (35) which interacts with the sleeve (45).
    [0005]
    5. Injection device (1) according to any one of the preceding claims, characterized by the fact that, in the starting position and / or in the final position, the needle (12) is covered by the sleeve (45) and / or a needle cap (60) which is operatively associated with the sleeve (45).
    [0006]
    Injection device (1) according to any one of the preceding claims, characterized in that the device further comprises an internal body (50) being substantially fixed in relation to the housing (2, 3).
    [0007]
    Injection device (1) according to claim 6, characterized by the fact that the at least one first polarizable element (51) is formed integrally with the inner body (50), in which in the initial position of the support of the plunger (35), the movement of the plunger holder (35) towards the proximal end of the injection device (1) is inhibited by at least one first polarizable element (51) interacting with the plunger holder (35), the the first polarizable element (51) recedes when it is overlapped by an opening and / or recess of the sleeve (45) in such a way that the plunger support (35) is released.
    [0008]
    Injection device (1) according to claim 7, characterized in that the at least one first polarizable element (51) is formed integrally with a tubular portion of the inner body (50), at least partially arranged between the plunger support (35) and the sleeve (45).
    [0009]
    Injection device (1) according to any one of claims 3 and 6 to 8, characterized in that the at least one third polarizable element (51) is integrally formed with the internal body (50).
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    同族专利:
    公开号 | 公开日
    JP2014525315A|2014-09-29|
    MX2014002337A|2014-09-15|
    PL2902058T3|2020-11-02|
    CA2915225A1|2013-03-07|
    JP6138129B2|2017-05-31|
    US20140257193A1|2014-09-11|
    AU2012302281B2|2015-05-07|
    KR20150038607A|2015-04-08|
    JP6100840B2|2017-03-22|
    KR20140050753A|2014-04-29|
    TWI547296B|2016-09-01|
    EP2902058A1|2015-08-05|
    DK2902058T3|2020-07-27|
    MX348444B|2017-06-12|
    TW201534365A|2015-09-16|
    CN103889484A|2014-06-25|
    EP2750738A4|2015-08-05|
    CA2915225C|2019-02-26|
    JP2015166017A|2015-09-24|
    CN103889484B|2016-08-24|
    EP2750738A1|2014-07-09|
    AU2012302281A1|2014-03-27|
    TW201325645A|2013-07-01|
    US10933193B2|2021-03-02|
    CA2846491C|2017-08-22|
    CA2846491A1|2013-03-07|
    TWI498138B|2015-09-01|
    CN104667387B|2019-03-01|
    WO2013032389A1|2013-03-07|
    CN104667387A|2015-06-03|
    KR101946682B1|2019-02-11|
    US20170182250A1|2017-06-29|
    US9656025B2|2017-05-23|
    BR112014005036A2|2017-03-21|
    EP2902058B1|2020-05-06|
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-02-27| B25A| Requested transfer of rights approved|Owner name: SHL MEDICAL AG (CH) |
    2020-04-07| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-12-01| B09A| Decision: intention to grant|
    2020-12-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161529325P| true| 2011-08-31|2011-08-31|
    SE1150788-6|2011-08-31|
    US61/529,325|2011-08-31|
    SE1150788|2011-08-31|
    PCT/SE2012/050908|WO2013032389A1|2011-08-31|2012-08-28|Injection device|
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