Patent Application
20210353862
Implementations relate to the field of medical injection devices for the administration of liquid substances, including drugs or medicinal substances such as insulin and hormone preparations, and more specifically relate to the use of small-volume product containers in injection devices for nominally large-volume product containers.
Injection devices or injection appliances for the simplified administration of a substance include inter alia so-called autoinjectors, which comprise an energy storage or drive element, with which the discharge can be carried out automatically, that is to say without a force to be applied or exerted from the outside by a user. The energy storage or drive element stores the energy necessary for an automatic substance release in a mechanical form. Such an energy storage or drive element can be a spring, which, in a tensed state, is incorporated in the injection device and releases energy due to relaxation. The energy release occurs to a plunger rod or a pressure element, which inserts or drives a plunger in a product container. The energy storage or drive element can also be provided in order to automate the process of insertion of an injection needle. Alternatively, for this purpose, an additional separate drive element can be provided, or the insertion process occurs manually, thus exclusively by a user, without using energy stored in the injection device for this purpose.
The injection device can comprise a product container holder for receiving a product container, where, in the product container holder, the product container can be held in a manner such that it is fixed radially, axially, and preferably also rotationally. The product container holder can be connected in an axially and rotationally fixed manner to the housing of the injection device, or it can be movable relative to the housing during the insertion and/or needle retraction process. The product container can be a carpule for repeated detachable connection with disposable injection needles or a disposable pre-filled syringe with an injection needle which is nondetachably connected therewith. The product container has a hollow-cylindrical product container portion, which shiftably supports a plunger or stopper. The plunger can form a sealing gap with the inner periphery of the product container portion and be shifted by means of the plunger rod in a distal direction in order to discharge a product from the product container via the injection needle.
The injection device can comprise a needle protection sleeve, which protrudes distally over the distal end of the injection needle after the injection has occurred, or which is shifted relative to the housing with relaxation of a needle protection sleeve spring into this position, in order to prevent accidental access to the injection needle and thereby reduce the risk of injury. In an autoinjector, the needle protection sleeve can also be used as a trigger element for triggering the product discharge, where, for this purpose, the needle protection sleeve may be shifted relative to the housing in the proximal direction. Alternatively, triggering of the autoinjector may be through actuating a trigger button of the autoinjector, where the needle protection sleeve 40 may be used at least as sight protection before the use of the autoinjector.
The patent application publication WO2016/205963 A1 describes an autoinjector as an example, comprising a housing with a longitudinal axis, release device, and a product container firmly arranged in the housing. The autoinjector moreover comprises a needle protection sleeve which can be shifted in a longitudinal direction between a proximal and a distal position and which is coupled to a needle protection sleeve spring as separate drive element. A first feedback device with a first support element accelerated by the discharge spring signals the start of the substance release. The second feedback device with a second support element accelerated by the needle protection sleeve spring toward the abutment is used for generating an acoustic signal after the release of a certain quantity of substance. A spiral or drive spring in which energy for the automatic discharge of product can be stored is coupled to the trigger device, wherein a first end of the spiral spring is connected to the housing, and a second end of the spiral spring is connected in a rotationally fixed manner to a rotation element, arranged coaxially to the longitudinal axis, in the form of a threaded rod. The threaded rod engages, via a threading, into a non-rotating advance element in the housing, in the form of a sleeve-shaped plunger rod, which, during a shifting in the distal direction, entrains the stopper of the product container at an at least approximately constant discharge speed. The autoinjector may be configured for pre-filled syringes comprising a product container with a predetermined size and a nominal filling volume of 2.25 mL, where the spiral spring may also suitable for a product to be discharged with a high viscosity of at least 5, or at least 15 cP (0.015 kgm−1s−1). The pre-filled syringe moreover may include a needle which, before use, may be surrounded by an elastic needle guard element and a firm needle protection cap or Rigid Needle Shield (RNS) to ensure the sterility and intactness.
Patent application publication EP 2968063 A1 describes a product container holder or drug container support for a first product or drug container with a first predetermined size, which can contain more than one first volume of a drug. The container support comprises a body and an adapter connected to the body, wherein the adapter is configured to support a second drug container with a second predetermined size, which can contain no more than the first volume of the drug. The second drug container is secured in an axially and rotationally fixed manner to the adapter, and the adapter in turn is held in an axially and rotationally fixed manner in the container support. For this purpose, the adapter comprises an arm with a first and a second support surface, which engages with a proximal flange of the second drug container. The adapter has a peripheral, non-flexible distal rib or support surface, against which a distal end or a shoulder of the second drug container rests and which receives an axial force acting on the drug container via the stopper.
The Patent application publication WO 2012/164389 A2 describes, in FIGS. 13 to 15, a similar adapter with flexible fingers, which are arranged distally on a sleeve and which comprise, on their end, a proximally directed support surface for a product container shoulder. In the assembly of a pre-filled syringe, its needle protection cap is pressed through an opening formed by the fingers, wherein the fingers are deflected radially outward. Subsequently, the securing ring is shifted forward, and, as a result, the fingers are deflected again inward and the support surfaces are blocked in a holding position in engagement with the product container shoulder. Thereby, in the blocked state, the opening formed by the inner edges of the support surfaces has a diameter which is smaller than an outer diameter of the needle protection cap. The support surfaces then are arranged at least partially between the needle protection cap and the product container shoulder and also enable a receiving of axial forces of the product container shoulder, if their outer diameter is only insignificantly greater than or not greater than the diameter of the needle protection cap.
In this context, the term “product,” “drug,” or “medical substance” comprises any flowable medical formulation which is suitable for the controlled administration by means of a cannula or a hollow needle, for example, of a liquid, a solution, a gel or a fine suspension containing one or more medical active substances. A drug can thus be a composition with a single active substance or a premixed or co-formulated composition with a plurality of active substances from a single container. In particular, the term covers medicines such as peptides (for example, insulins, insulin-containing drugs, GLP-1-containing as well as derived or analogous preparations), proteins and hormones, biologically prepared or active substances, active substances based on hormones or genes, nutrition formulations, enzymes and additional substances in solid (suspended) or liquid form. The term moreover also covers polysaccharides, vaccines, DNA or RNA (including mRNA) or oligonucleotides, antibodies or parts of antibodies as well as suitable base, adjuvant, and carrier substances.
The term “distal” refers to the front, insertion-side end of the administration device, or to the side or direction directed toward the tip of the injection needle. On the other hand, the term “proximal” refers to a side or direction directed toward the rear end of the administration device, which is opposite the insertion-side end.
In the present disclosure, the terms “injection system” or “injector” is understood to refer to a device in which, after a controlled quantity of the medical substance has been discharged, the injection needle is removed from the tissue. Thus, in an injection system or in an injector, in contrast to an infusion system, the injection needle does not remain in the tissue for a longer time period of several hours.
Implementations provide product containers with a small filling volume in an injection device for typical use with product containers with a large filling volume by providing modular syringe holders, and methods for assembling injection devices including such modular syringe holders.
According to implementations, a modular syringe holder may include an adapter and an adapter holder for holding a ready-to-use or pre-filled syringe in a syringe unit of an injection device with a housing, which housing may be gripped by a user and defines a longitudinal axis. The adapter holder may differ from the housing and the needle protection sleeve of the injection device and may be introduced in a separate assembly step into the housing, where the adapter holder may be held in an axially and rotationally fixed manner. The adapter may include a hollow-cylindrical, rigid adapter body, a support element coupled to the adapter body which may be at least radially deflectable, and the support element may be configured for receipt of or contact with a syringe shoulder of the pre-filled syringe, where the syringe shoulder may be formed distally with respect to a hollow-cylindrical product container portion by a radial narrowing of the syringe body. The adapter may be configured or prepared for introducing the pre-filled syringe in the direction of the longitudinal axis with a deflection of the support element of the adapter by a needle protection cap of the pre-filled syringe. The adapter holder may be configured or prepared for receiving the adapter, such that the support element may be blocked by a rigid holding portion of the adapter holder and not, for example, by the housing of the injection device, against the radial deflection or a shearing in a holding position of the support element of the adapter in which the support element may be in an engagement with the syringe shoulder.
A flexible shoulder extension, such as a support element, may be configured for diverting axial forces of a product container, and after the reception of the adapter and the product container in the adapter holder, may be secured by the adapter holder itself against lateral deflection, and may not require a manual shifting of a separate securing ring in the distal direction for this purpose. A corresponding assembly method may involve the steps of:
In some implementations, the adapter of the modular syringe holder may include a flexible finger with an at least approximately constant cross section, which may be fastened on the adapter body and which may support, on its distal end, the support element configured for receiving distal axial forces of the syringe shoulder of a pre-filled syringe assembled therein. In the direction of rotation about the longitudinal axis L, e.g., in a direction transverse to the longitudinal axis, the extension of the support element may be greater than the corresponding extension or width of the flexible finger, and the support element may protrude at least in one direction of rotation and may protrude in both directions of rotation away from the flexible finger. The support element may include a section or a segment of a circular ring with an average diameter corresponding to a diameter of the syringe shoulder; and an associated arc length may exceed the width of the finger. Due to this combination, a relatively enlarged support surface of the support element and a pre-defined mobility or flexibility of the flexible finger may be provided at the same time.
In some implementations, the adapter and the adapter holder may be configured such that, in the assembled state of the syringe holder in the injection device, the support element may be directly in contact, in the axial direction, with a proximally oriented surface of the housing. Axial forces may thus be transmitted from the syringe shoulder to the support element and from a distally directed front side of the support element directly to the housing, and may not be transmitted first onto the adapter holder. This may facilitate avoiding holding the syringe in a proximal position, where for instance, in the case of a predetermined needle length, a desired insertion depth may not be reached. For this purpose, the adapter holder may include, on the distal end, a minimum inner diameter, which may be greater than an outer diameter of the adapter or of the support element of the adapter.
In some implementations, the adapter holder and the housing of the injection device may include securing elements such as catches or flexible arms, which may engage in recesses, and may fix the introduced adapter holder in the housing in an axially and rotationally fixed manner. In addition, the adapter and the adapter holder may be configured such that, in the assembled state of the syringe holder in the injection device, the pre-filled syringe may rotate about the longitudinal axis. The pre-filled syringe such as a finger flange of the syringe may thus not be prevented from rotating by the housing or by the adapter holder assembled in a rotationally fixed manner in the housing. The adapter itself may be received in a rotationally fixed manner in the adapter holder, and a proximal end of the adapter may be sufficiently widened and/or spaced from the finger flange and may enable a rotation of the pre-filled syringe. A syringe freely rotatable in the injection device may avoid transmitting a rotation or rational forces of the injection device to the injection site and as a result may cause less pain in the patient for instance during injection and/or needle insertion. A lateral widening or broadening of the adapter or adapter holder, which may be provided for enabling free rotation of the syringe, may additionally be used as a front-side or proximal end support in the housing.
In some implementations, the adapter of the modular syringe holder may include two flexible fingers, which may be coupled or fastened to the adapter body. On their distal ends, each of the flexible fingers may support a support element for receiving distal axial forces of the syringe shoulder of a pre-filled syringe assembled therein. Alternatively, the support element may include a flexible collar directed radially inward, which may be interrupted by at least one slot or gap in the radial direction and which may be widened temporarily by for example an insertion of a needle protection cap of the pre-filled syringe. In some implementations, a diameter of a distal opening of the adapter, which may be formed by the support element(s), may be smaller than the maximum outer diameter of the needle protection cap of the pre-filled syringe. In addition, an axial length of the support element at each support point of the syringe shoulder may be smaller than an axial distance between a proximal end of the needle protection cap and the support point of the syringe shoulder. As a result, the syringe may contact and be distally held by the support element of the adapter, the needle protection cap may not be loaded by the support element, and an accidental movement or shifting of the needle protection cap by the adapter may be avoided, which may otherwise jeopardize the sterility of the needle.
According to implementations, a method for assembling a pre-filled syringe in a syringe unit of an injection device housing defining a longitudinal axis, the housing for example configured to be gripped by a user, may include the following steps:
For the introduction of the pre-filled syringe into the syringe holder, the syringe holder may be out of engagement with the holding portion of the housing. When the pre-filled syringe is inserted completely into the syringe holder and the support element is engaged in a gap between the syringe shoulder and the needle protection cap, the syringe holder may be brought in engagement with the holding portion of the housing. In this engagement position, the support element may be prevented from moving transversely or deflecting radially relative to the longitudinal axis out of the engagement with the syringe holder. A support element configured as a flexible shoulder for diverting axial forces of a product container may thus also be secured here against lateral deflection after the reception of the syringe holder and of the product container in the housing by the housing itself, for instance without requiring a manual shifting of a separate securing ring in the distal direction for this purpose.
According to implementations of the present disclosure, in the assembly method, the blocking of the syringe holder may occur via use of an assembly tool, which may engage on a distally oriented assembly supporting element of the syringe holder. For example, the assembly tool may be introduced laterally through an inspection window in the housing into a region of the syringe holder, and, after shifting of the syringe holder until the support element is in abutment with the assembly tool, the assembly tool may be removed, for instance to unblock movement of the syringe holder after the pre-filled syringe is introduced into the syringe holder and for completion of the assembly method.
In connection with the appended figures, implementations of the present disclosure are described herein. They are intended to show basic possibilities of the disclosed implementations and should in no way be interpreted to be limiting.
In the syringe holder 11, a pre-filled syringe 2 may be received and held therein. The pre-filled syringe 2 may include a cylindrical syringe body 21 that may be configured as a product container, which may define a product receiving space 24 between a syringe shoulder 22 and a piston or stopper 23, where the stopper may be shifted along the longitudinal axis L (
The injection needle 25 of the pre-filled syringe 2 may be covered by a needle protection cap 27, which may be configured as a so-called Rigid Needle Shield (RNS) and may include a flexible or rubber-elastic needle guard element and a sleeve made of hard plastic. The needle protection cap 27 may protect the injection needle 25 from unintentional detachment or other mechanical actions and from soiling and thus may maintain the sterility of the injection needle and the product contained in the pre-filled syringe 2. Between the syringe shoulder 22 and the proximal end of the sleeve of the needle protection cap 27, at least a portion of which may be made of hard plastic, a gap may be formed. On the distal end of the autoinjector, in the delivery state thereof, a pull cap 30 may be arranged, which, before the use of the autoinjector, may be axially pulled and/or twisted off and completely removed. The pull cap 30 may include snap hooks or a separate protection cap remover 31 that may at least be axially held in the pull cap 30, and the snap hooks or protection cap remover 31 may be arranged in the gap and removal of the pull cap 30 may result in release of the needle protection cap 27 from the pre-filled syringe 2.
The injection needle 25 may be surrounded by a needle protection sleeve 40 mounted in an axially shiftable manner relative to the housing 10 and insertable or slidable into the housing 10. In the starting position of the needle protection sleeve 40, the distal end of the needle protection sleeve 40 may protrude distally over the needle tip of the injection needle 25, so that access to the needle tip may be initially prevented. The needle protection sleeve 40, at a distal or front side, may include an opening through which the injection needle 25 may protrude, and during a relative movement of the needle protection sleeve 40 and the injection needle 25, the injection needle 25 may enter through the opening and into an injection site. The needle protection sleeve 40 may also be used as a trigger element for triggering the product discharge, where, for this purpose, the needle protection sleeve 40, which may be biased by a needle protection sleeve spring 41, may be shifted relative to the housing 10 in the proximal direction. For instance, the needle protection sleeve 40 may include two sleeve arms 40a, which may be arranged offset or rotated by 90° about the longitudinal axis L with respect to two inspections windows 10a or two recesses of the housing 10, which may be referred to as inspection windows. After an injection has occurred, the needle protection sleeve 40 may be shifted relative to the housing 10 from the actuated position along the longitudinal axis L in the distal direction into a needle protection position and may be blocked from being pushed back in the proximal direction.
The autoinjector may include a switching module with a switching sleeve 42 and a blocking sleeve 43 surrounded by the switching sleeve 42. The switching sleeve 42 may be connected to a proximal end of the sleeve arms 40a of the needle protection sleeve 40 and to a distal end of the needle protection sleeve spring 41. The needle protection sleeve spring 41 may be formed as a spring made of metal and may serve as a compression spring and may be configured as a coil spring.
The autoinjector may include a drive with an axially shiftable plunger rod 50 that may be configured as an advancing element for moving the piston 23 in the discharge direction. The autoinjector may include a holding element 51 with two flexible holding arms 51a, where, on a distal end of each holding arm 51a, a first engagement element 51b and a second engagement element 51c may be arranged. The first engagement element 51b may extend radially toward the longitudinal axis L, and the second engagement element 51c may extend radially away from the longitudinal axis L. In the delivery state of the device, the first engagement element 51b may be held in an engagement with a recess 50a of the plunger rod 50 by the inner periphery of the blocking sleeve 43, which may be in contact with the second engagement element 51c, where a movement of the plunger rod 50 relative to the holding element 51 in the discharge direction may be prevented. The needle protection sleeve spring 41 may be supported by its proximal end on the holding element 51, for instance on a projection 51d of the holding element 51, which may engage in an axially shiftable and rotationally fixed manner in the housing 10.
The drive may additionally include a spring pack 6 (
The pre-filled syringe 2 may be received in the syringe holder 11 and may be secured at least against a movement along the longitudinal axis L in the distal direction relative to the syringe holder 11. For instance, the syringe holder 11 may include at least one inwardly protruding and proximally directed axial support element 11a on which the spring shoulder 22 may be supported against movement in the distal direction. In order to prevent a proximal movement of the pre-filled syringe 2, the pre-filled syringe 2 may be pressed by a holding spring portion 13a of a mechanism holder 13, which may engage on the finger flange 26 of the pre-filled syringe 2, into an engagement with the support element 11a. In some implementations, the holding spring portion 13a may account for longitudinal differences of the syringe body 21, which may be generated due to manufacturing tolerances. Between the finger flange 26 and the proximal end of the syringe holder 11, a gap may be formed. The housing 10 may include an annular peripheral holding portion 10b (
The pre-filled syringe 2 represented in
As second step, the pre-filled syringe 2 may be axially inserted into the one-piece syringe holder 11 (
Instead of the two assembly supporting elements 11g, which may be arranged opposite one another on the one-piece syringe holder 11, a single assembly supporting element or more than two assembly supporting elements may also be provided. The process of supporting the one-piece syringe holder 11 may involve configuring one or more assembly supporting elements that are adapted to suitable recesses in the housing 10 and/or to capabilities of the assembly tool, with the goal of enabling a simple or streamlined intermediate assembly step, e.g., involving the first and second assembly steps. In implementations when the assembly tool can be positioned before the introduction of the one-piece syringe holder 11, the syringe holder 11 may be configured without the second snap elements 11e when otherwise used in connection with positioning the one-piece syringe holder 11 in the first axial position (e.g.,
The adapter body 14c of the adapter 14 may include two adapter arms which may be connected on their distal end via webs and on their proximal end via an extension. The arms may define and delimit, in the direction of the longitudinal axis L, two longitudinal recesses in the adapter body 14c, which, in the assembled state, each of the recesses may be aligned with one of the inspection windows 10a of the housing 10 and may thereby avoid obstructing a view into the syringe body 21 of the pre-filled syringe 2. The proximal extension may form an adapter shoulder and an inner space with a diameter, which may be enlarged with respect to the adapter body, for receiving the finger flange 26 of the pre-filled syringe 2. The adapter 14 moreover may include two elastic fingers 14b, which may be attached on their proximal ends to the adapter body 14c and which may each include, on their distal ends, an axial support element 14a for supporting the syringe shoulder 22 of the pre-filled syringe 2.
The holder sleeve 15a of the adapter holder 15 may include an annular peripheral holding portion 15b on its inner side, which may surround the distal end of the assembled adapter 14 in a circumferential manner, and which may secure the support elements 14a against radial deflections. The distal end of the holder sleeve 15a may not include holding elements or narrowings. In this manner, the adapter 14 may rest with its distal ends of the support elements 14a directly against the housing 10 of the autoinjector, and axial forces may be diverted onto the product container of the pre-filled syringe 2 from the syringe shoulder 22 via the support elements 14a to the housing 10. In this position, the finger flange 26 of the pre-filled syringe 2 may not be in contact with the adapter shoulder of the adapter body 14c and the pre-filled syringe 2 may not be prevented from rotating by the adapter extension or by the adapter holder 15 or another housing portion, so that the assembled pre-filled syringe 2 may freely rotate. On the holder sleeve 15a, two first snap elements 15c or securing elements may be provided and may be arranged opposite one another and the snap elements 15c may be used for engagement in the housing 10; and two second and third snap elements 15d, 15e or securing elements, each of which may be arranged opposite one another may be used for engagement in recesses of the needle protection sleeve 40.
For assembly of the pre-filled syringe 2, the adapter holder 15 may be first introduced into the housing 10 of the autoinjector and snapped with two mutually opposite first snap elements 15c into recesses of the housing 10, which may be complementary thereto, in an axially nondetachable and rotationally fixed manner. Subsequently, outside of the injection device, the pre-filled syringe 2 may be introduced axially in the distal direction into the adapter 14. In the process, the needle protection cap 27 may be pressed through an opening formed by the fingers 14b, where the fingers 14b may be deflected radially outward through the sleeve of the needle protection cap. As soon as the proximal end of the needle protection cap has cleared the opening, the fingers may snap radially inward, e.g., into the gap formed between the needle protection cap 27 and the syringe shoulder 22 of the syringe body 21, and position the support elements 14a in a holding position in engagement with the syringe shoulder 22. Finally, the adapter and the syringe may be introduced in a rotatably correct position into the adapter holder. In order to prevent a proximal movement of the pre-filled syringe 2, the pre-filled syringe may be pressed by a holding spring portion 13a of the mechanism holder 13, which may engage on the finger flange 26, into engagement with the support element 14a.
In the two implementations described herein, each support element 11a, 14a may include a portion or a section of a circular ring with an average diameter corresponding to a diameter of the syringe shoulder 22. The support element 11a, 14a may be coupled to a distal end of their respective finger 11b or 14b and may protrude from the finger in a direction transverse to the longitudinal axis. For example, the support element 11a, 14a and/or a central arc length of the section thereof may be greater than a width of the finger (11b, 14b) The support element 11a, 14a may protrude in both directions of rotation from the finger (11b, 14b), and the finger and the support element may together define the shape of an anchor. During the assembly of a pre-filled syringe 2, the needle protection cap 27 of the pre-filled syringe 2 may be pressed through the opening formed by the fingers 11b, 14b, where the fingers 11b, 14b may be deflected radially outward by the sleeve portion of the needle protection cap 27. As soon as the proximal end of the needle protection cap 27 has cleared the opening, the fingers 11b, 14b may snap radially inward and position the support elements 11a, 14a in a holding position in engagement with the syringe shoulder 22. Thereby, the opening formed by the inner edges of the support elements 11a, 14a may be in an engagement with the pre-filled syringe 2 and may have a diameter which is smaller than an outer diameter of the needle protection cap 27. The support surfaces of the support elements 11a, 14a may thus be arranged at least partially in the gap between the needle protection cap 27 and the syringe shoulder 22, and may also make it possible for axial forces of the pre-filled syringe 2 to be received by the support elements 11a, 14a when an outer diameter of the pre-filled syringe 2 is not significantly greater than, or not greater than, the outer diameter of the needle protection cap. By means of the holding portion 10b, 15b of the respective housing 10 or of the adapter holder 15, which may ensure engagement and which may rest with little play against an outer periphery of the fingers 11b, 14b, the fingers may be prevented from moving transversely to the longitudinal axis, and, in the process, may prevent compromising the axial support provided by the support elements 11a, 14a against the syringe shoulder 22.
As an alternative to providing two support elements 11a, 14a on two fingers 11b, 14b, one support element may instead be provided in the form of a radially inward directed collar or a narrowing, which may be temporarily widened by the needle protection cap. The collar may be discontinuous and may include a radial slot to form a C-shaped circular arc section spanning over 180°, which may be elastically spread apart, e.g., perpendicular to the longitudinal axis L, by the needle protection cap 27 and may be pushed away. In addition or alternatively, more than two fingers and/or, instead of anchor-shaped support elements, only support elements having the width of the respective finger may be provided. The spatial volume in which the finger(s) 11b of the first embodiment may be deflected when the pre-filled syringe 2 is introduced, and/or the holding portion 10b, 15b of the respective housing 10 and of the adapter holder 15 may be adjusted in accordance with the number of fingers and the extension of the support elements and/or in terms of shape. Instead of the elastic fingers, flexible non-elastic fingers may instead be provided, for example, with a joint, such as a film joint or flexible hinge joint, in the transition to the holder sleeve 15a or to the adapter body 14c. In this case, the support element 11a, 14a may be guided first by appropriate inclinations on the proximal end of the holding portion 10b of the housing 10 and of the adapter holder 15 during the final movement of the pre-filled syringe 2 into engagement with the syringe shoulder 22.
By the use of a syringe holder 11 according to the first implementation, or of a modular syringe holder 14, 15 according to the second implementation, an injection device configured for nominally large-volume product containers may also be used with small-volume product containers. The transition to a product container with a smaller diameter and a shorter length according to the present disclosure may additionally require at least, or at most, an exchange of a plunger rod and of a mechanism holder. A plunger rod with a smaller diameter may fit into the smaller product container of the present disclosure, and a longer mechanism holder and/or a longer holding spring portion may also be capable of distally pushing with sufficient force a shorter product container in an engagement with the support element 11a, 14a of the present disclosure.
The syringe holder 11 of the first implementation and the adapter holder 15 of the second implementation may be provided for subsequent add-on functions in the assembled state. For this purpose, the second snap elements 11e, 15d of the respective syringe holder 11 and of the adapter holder 15 may engage in a complementary manner with second slot-shaped recesses 40c of the needle protection sleeve 40. In the starting position of the needle protection sleeve 40 (
The first, second and third snap elements 11d, 11e, 11f and 15c, 15d, 15e may each be provided in pairs on mutually opposite sides of their respective syringe holder 11 and of the adapter holder 15, where in each case, the use of only one element or multiple snap elements distributed over a periphery may also be provided as an alternative. The syringe holder 11 and the adapter holder 15 may be made of a plastic having, in comparison to the housing 10, different material properties, for instance to facilitate the formation of the elastic snap elements 11d, 11e, 11f and 15c, 15d, 15e. In contrast to the housing 10, the syringe holder 11 and the adapter holder 15 may also be optically transparent, and as a result, may facilitate protecting the product container from breakage or shattering without obscuring the visibility of the product through the recesses of the inspection windows 10a in the housing 10.
As illustrated in
The centering, orientation and snap elements provided herein may also be attached on the respective other component. For example, a concentric distal elongation of the end cap 12 may be provided instead of an elongation of the housing 10, and/or the snap elements 10c of the housing 10 may instead be attached to or formed by the end cap 12 and engage in a corresponding opening of the housing 10. As an alternative to a continuous elongation provided along the housing periphery, axially oriented arms may alternatively be provided, which may protrude from the proximal end of the housing 10 or from the distal end of the end cap 12, may support the snap elements, e.g., snap elements 10c, and may ensure a centering and/or alignment of the end cap 12 during the assembly. Instead of the releasable holding cams 12c, other connection means such as engagement elements or bayonet and threaded connections may also be provided for the preassembly, and, instead of the snap elements 10c, non-releasable connectors may also be used.
The spiral spring 62, e.g., a spring strip configured as a flat metal strip, may be anchored in the spring axis 61b and then be wound around the cylinder shaft 61 between the two end flanges 61a, 61c which flanges 61a, 61c may be permanently and firmly, e.g., non-detachably, connected to the spring axis 61b. Subsequently, the spring shaft 61 and the spiral spring 62 may be introduced in the proximal direction into the spring sleeve 63, and the spiral spring 62 may be connected to the spring sleeve 63. For this purpose, the outer end of the spiral spring 62 may include four openings, holes or eyelets 62a, which may lie next to one another along the spring axis in the spring strip, and the spring sleeve 63 may include four prongs or teeth 63a arranged next to one another in the form of a comb in the direction of the spring axis. The four prongs 62a of the spiral spring 62 may point in the spring tensioning direction and may be received by a complementary recess in the spring sleeve 63. The openings 62a of the spiral spring 62 may be pulled under slight tensioning of the spiral spring 62 via the prongs 63a of the spring sleeve 63 and may be hooked in or hooked on the prongs 63a. Due to the engagement of the toothing, an axial positioning of the spiral spring 62 with the spring sleeve 63 occurs.
Alternatively to the prongs 63a formed in the sleeve material of the spring sleeve 63, prongs or hooks protruding radially from the sleeve material may be attached or molded on the spring sleeve 63, e.g., on a sleeve jacket. If the prongs are applied to the inner side of the spring sleeve 63, recesses or slots in the sleeve material may need to be provided. The spring strip of the spiral spring 62 can also be led outward through the recesses, for instance by means of an outward leading stair step in the spring tensioning direction, so that the separate slot, e.g., slot 63b, in the spring sleeve 63 may be avoided. Likewise, more or fewer than four openings in the spiral spring 63 and prongs in the spring sleeve 63 may also be provided, and/or other forms of spiral spring 62 openings other than circular forms, such as openings formed with an edge parallel to the spring axis, together with corresponding hooks in the sleeve material of the spring sleeve 63, which may be configured to be wider. The number of openings in the spiral spring 62 may exceed the number of hooks in the spring sleeve 63. The openings, the recess and the web may be produced in a simple manner for instance punching or laser cutting from the spring strip of the spiral spring 62 and the sheet metal of the sleeve material of the spring sleeve 63.
In some implementations, the spring sleeve 63 may be formed from a metal sheet on which the locking catch 63c, which may be configured as a flexible arm, together with the tooth 63d and the control element 63e, may be formed by mechanical punching or laser cutting. On the free end of the arm of the locking catch 63c, the tooth 63d may be formed as a tab and may be bent inward and the control element 63e may be formed as a tab and may be bent outward. The stopping element 63g of the spring sleeve may also be cut out of the sleeve jacket of the spring sleeve 63 and may be bent inward. In the embodiments shown, two locking catches 63c and two stopping elements 63g with corresponding stops may be distributed over the periphery of the spring pack 6 and offset with respect to one another by 180° in each case. Here, it is also possible to provide only one locking catch 63c and/or stopping element 63g, or more than two locking catches 63c and/or stopping elements 63g.
After the spiral spring has been fully tensioned, the tooth 63d may be brought in engagement with the stop 61e, for example, by a plastic deformation of the arm of the locking catch 63c. Alternatively, an elastic deformation of the arm of the locking catch 63c is also conceivable, where the locking catch 63c may be blocked by the control element 63e by engagement with the stop 61e. The control element 63e may include least one engagement surface for the release element 71 for instance in the form of a threaded surface, a bevel or a wedge. The securing-releasing deflection of the control element 63e may occur in the radial direction as shown, or in the axial or tangential direction. The securing elements for rotational securing may also include a flexible locking catch on the spring shaft 61 and an abutment on the spring sleeve 63. The stop 61e or the locking catch 63c may also be positioned directly on the spring shaft 61, on an additional flange connected in a rotationally fixed manner to the flange, or on a spoke connected in a rotationally fixed manner to the shaft, at any desired radial distance from the spring shaft 61. The complementary locking catch or abutment may be brought to an appropriate distance from the spring axis 61b on a torque transmission means connected in a rotationally fixed manner to the spring sleeve 63. Likewise, the stopping element 63g of the spring sleeve 63 and the complementary counter-abutment 72 of the drive unit 7 may also be arranged at a small distance from the spring axis 61b. During the twisting of the spring pack 6, the release element 71 may also deflect or shift the control element 63e away axially instead of radially. The release movement of the control element 63e may also occur during the axial movement of the spring pack 6 and the drive unit 7, so that the subsequent twisting may be omitted. At least the proximal end flange 61a, as a radial boundary surface, may also be firmly connected to the spring sleeve 63 instead of the spring shaft 61.
Instead of the spiral, clock or drive spring, the spring packs 6, 6′ may also include an energy store in the form of other tension, torsion or rotation springs, for example, a coil or helix spring wound from a spring steel, in which the potential energy necessary for the product discharge may be charged by applying a torque between the two spring ends. As an alternative to providing an autoinjector with a non-adjustable dose, the spring packs 6, 6′ may be provided in an automatic injection device configured with dose setting functions, also referred to as autopens.
The patent application publication WO2016/205963 described herein also discloses a spring pack that includes a spring shaft with a distal end flange, a spiral spring, a spring sleeve and a spring sleeve cover, which, depending on a spiral spring width, can be detachably fastened in different axial positions on the spring shaft. The spring shaft has an axially formed holding rib, in which the inner end of the spiral spring, configured as a holding tab, can be anchored in a rotationally fixed manner, and the spring sleeve has an axially oriented holding edge, on which the outer end of the spiral spring, which is configured as a holding tab, can be anchored in a rotationally fixed manner. The holding tab includes a holding tongue, which, in the case of a bending edge, is angled in the spring strip by more than 90° with respect to the spring tensioning direction and which faces in the direction toward the inner end of the spiral spring. For the anchoring, the holding tab is tensioned via the holding edge and, with relaxation of the spring tensioning, guided so that it hooks to the holding edge. The bending edge in the spring strip is stressed even more strongly by the twisting of the spring sleeve, which occurs after the anchoring relative to the spring axis for loading potential energy into the spiral spring.
A spring pack for an injection device according to prior approaches includes the following elements:
a spring shaft with a spring axis, a torsion or rotation spring, in particular a spiral or drive spring wound from a spring strip, and a spring sleeve, where the torsion spring is connected in a rotationally fixed manner by an inner end with the spring shaft and by an outer end with the spring sleeve in each case with respect to the spring axis;
a first and a second securing element, which are firmly arranged on the spring sleeve and on the spring shaft and, in engagement, secure the spring sleeve in a rotationally fixed manner relative to the spring shaft with respect to the spring axis, where the engagement can be released by a release movement of the first securing element;
a control element which, during the assembly of the spring pack, can be moved onto a drive unit of the injection device by a release element of the drive unit, so that the first securing element performs a release movement and a torque stored in the spring pack is coupled to the drive unit.
According to implementations of the present disclosure, the spring packs 6, 6′ may be further configured such that:
a) the outer end of the spiral spring 62, 62′ may form a loop or have an opening, which, with tensioning of the spiral spring 62, 62′ in a spring tensioning direction, e.g., by gripping, tensioning or guiding of the outer end of the spiral spring strip, may be hooked to a prong or a hook of the spring sleeve 63, e.g., prongs 63a;
b) the prong of the spring sleeve 63 may point in the spring tensioning direction and may be formed by a recess in a sleeve material of the spring sleeve 63;
c) the spiral spring strip of the spiral spring 62, 62′ may have a step in the region of the opening, and may have a step height which may be at least approximately equal to a thickness of the spiral spring strip of the spiral spring 62, 62′ and of the sleeve jacket of the spring sleeve 63;
d) the first securing element, e.g., the locking catch 63c of the locking sleeve 63, may perform a release movement in the direction of the spring axis; and/or
e) the spring strip of the spiral spring 62, 62′ may be arranged between two end flanges 61a, 61a′, 61c, 61c′ and may be connected in a nondetachable and/or axially fixed manner to the spring shaft 61, 61′.
With the disclosed spring packs 6, 6′, a group of modular spring pack assemblies may be provided, which may include a first and a second spring pack, such as spring packs 6, 6′, in which the first spring pack, e.g., spring pack 6, may include a first spring shaft with two firmly attached flanges, a first spiral spring which may be wound between the two flanges around the spring shaft and the width of which may correspond to the distance of the flange, and a spring sleeve which may surround the spiral spring; and in which the second spring pack, e.g., spring pack 6′, may include a second spring shaft with two firmly attached flanges, a second spiral spring, which may be wound between the two flanges around the spring shaft and the width of which may correspond to the distance of the flange, and a spring sleeve, which may surround the second spiral spring. The first and the second spring shafts, such as spring shafts 61, 61′ as well as the widths of the first and the second spiral springs, such as spiral springs 62, 62′ may be different, but the spring sleeve, such as spring sleeve 63, and thus the shape and the coupling elements with the drive unit 7 may be identical across the two spring packs. Springs having a different spring strip width may thus also be assembled in an administration device, and may avoid the need to otherwise adjust the device. Thus, identically constructed administration devices may be provided with the differing spring packs providing for an adjustment of the force to be exerted during the administration of a certain drug.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19157362.5 | Feb 2019 | EP | regional |
This application claims priority to International Patent Application No. PCT/EP2020/052127, filed Jan. 29, 2020, entitled “MODULAR SYRINGE HOLDER AND SYRINGE ASSEMBLY METHOD,” which in turn claims priority to European Patent Application No. 19157362.5, filed Feb. 15, 2019, entitled “MODULAR SYRINGE HOLDER AND SYRINGE ASSEMBLY METHOD”, each of which is incorporated by reference herein, in the entirety and for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/EP2020/052127 | Jan 2020 | US |
| Child | 17388507 | US |
