Delivery apparatus for delivering an in particular intraocular implant

Abstract

The present invention relates to a delivery apparatus for delivering an in particular intraocular implant, wherein the delivery apparatus comprises a housing, a cannula, a plunger and an implant arranged in the cannula. By actuating the delivery apparatus, the plunger is moved from a starting position to an end position relative to the housing in order to deliver the implant. According to one aspect, plunger and housing cooperate in such a way that, when actuating the delivery apparatus, a break-loose force of at least 2 N or 5 N is required. According to a further aspect, the friction between plunger and housing varies along the length of the plunger. According to a further aspect, a plurality of implants are arranged in the cannula.

Description

[0001] Delivery apparatus for delivering an in particular intraocular implant

[0002] The present invention relates to a delivery apparatus for delivering an in particular intraocular implant according to the preamble of claim 1 .

[0003] The present invention relates in particular to a delivery apparatus for delivering / in- jecting an implant into the tissue of a patient, such as a human or an animal. In particular, the delivery apparatus according to the present invention is designed to deliver and / or inject an implant intraocularly I into the eye of the patient. The implant preferably has a pharmaceutical active substance which is delivered in the tissue, in particular the eye, over a longer period of time, in particular several days, weeks or months.

[0004] Such delivery apparatuses are known in principle from the prior art.

[0005] For example, US 2014 / 0031833 A1 discloses a delivery apparatus for delivering an implant, wherein the delivery apparatus comprises a housing, a cannula, a plunger and an intraocular implant.

[0006] WO 2022 / 204374 A1 discloses an implant injector device having a body, a plunger, a wire and a needle. An axial force exerted on the distal end of the plunger advances the wire into the lumen of shaft of the needle to deploy an implant.

[0007] EP 3 773 332 B1 discloses an injector for injecting an intraocular lens into an eye, comprising an elongated injector body with at least one retractable and deployable wing grip, wherein an operating mode is set to pushing operation by the deployed position and an operating mode is set to screwing operation by the retracted position.

[0008] WO 2023 / 232963 A1 discloses an implanting device for inserting an implant into tissue, comprising a housing, a plunger received in the housing and a hollow needle. The plunger is axially movable relative to the housing. The implanting device has an actuator for moving the plunger relative to the housing, the actuator forming a lever mechanism.

[0009] WO 2022 / 221107 A1 discloses an implant delivery device using an automatic implant delivery mechanism that eliminates variability in pusher wire speed by providing a

[0010] 01-3590-WO-1 - PCT + FF / 25-4208 needle assembly having one or more implants positioned within a proximal end of a needle cannula, a dampener assembly and a shuttle assembly.

[0011] WO 2013 / 148275 A2 discloses a system for delivering multiple ocular implants to reduce intraocular pressure. The system can include an injector mechanism configured to serially engage and drive each of the implants.

[0012] The present invention is based on the object of providing an improved delivery apparatus for delivering an in particular intraocular implant, preferably wherein a user- friendly, simple, intuitive and safe use is made possible or supported and / or the ap- plication / administration is improved and / or simplified.

[0013] The object on which the invention is based is achieved by the delivery apparatus according to claim 1. Advantageous developments are the subject matter of the dependent claims.

[0014] The proposed delivery apparatus is embodied for delivering / injecting / administering an implant into the tissue of a patient, such as a human or an animal. Particularly preferably, the delivery apparatus is embodied to deliver and / or inject an implant in- traocularly I into the eye, in particular the vitreous body, the anterior chamber of the eye and / or the posterior chamber of the eye.

[0015] The proposed delivery apparatus preferably operates purely mechanically. In particular, the actuation of the delivery apparatus and the delivery of the implant take place exclusively manually and / or by a user and / or by their muscle power.

[0016] The delivery apparatus preferably has an in particular hollow-cylindrical housing, a cannula connected in particular firmly / immovably to the housing, a plunger with an optional pusher and an implant arranged in the cannula, wherein by (manually) actuating the delivery apparatus, the plunger is movable from a starting position to an end position relative to the housing in order to deliver the implant and / or to press the implant out of the cannula in particular by means of the pusher.

[0017] According to a first aspect of the present invention, the plunger and the housing and / or their sliding surfaces cooperate (mechanically) in such a way that, when actuating the delivery apparatus, a (maximum) break-loose force / breakaway force of

[0018] 01-3590-WO-1 - PCT + FF / 25-4208 at least 2 N or 5 N is required, in particular in order to move the plunger from the starting position to the end position.

[0019] Preferably, the (cooperating) sliding surfaces of plunger and / or housing are adapted in such a way and / or the friction between plunger and housing is (locally) increased in such a way that the force profile for delivering the implant by means of the delivery apparatus corresponds to the force profile of a (commercially available) (disposable I single-use) syringe, for example with a volume of 0.5 ml, 1 ml or 2 ml, in particular according to DIN EN ISO 7886-1 :2020-11 , for delivering a fluid, such as an isotonic saline solution.

[0020] It is thus provided in the proposed delivery apparatus that the mechanical properties of a commercially available (disposable I single-use) syringe are imitated.

[0021] The handling of delivery apparatuses known from the prior art for delivering an implant differs in part considerably from the handling of commercially available syringes. Since no fluid, but rather a solid implant is delivered, the required break-loose force for actuating the delivery apparatuses known from the prior art is significantly lower than the required break-loose force for actuating commercially available syringes. Since medical personnel, in particular physicians, are accustomed to handling syringes for delivering a fluid, however, this can lead to the delivery apparatuses known from the prior art not being actuated correctly and in particular not in a controlled manner. In particular, there is the risk that, due to the accustomed required application of feree, the implant is delivered too early, too quickly and / or at the wrong location.

[0022] The characteristic force profile of a commercially available (disposable I single-use) syringe, for example with a volume of 0.5 ml, 1 ml or 2 ml, in particular according to DIN EN ISO 7886-1 :2020-11 , for delivering a fluid, such as an isotonic saline solution, is characterized in particular on account of the piston seal in that, for actuating the syringe, in particular starting from the starting position within a stroke of the plunger of 2 mm or 4 mm, a (maximum) break-loose force of at least 2 N or 5 N is required and / or the static friction between plunger and housing is at least 1.5 times as great as the sliding friction between plunger and housing.

[0023] In the proposed delivery apparatus, it is consequently provided that the sliding surfaces of the plunger and / or of the housing are adapted in such a way and / or the

[0024] 01-3590-WO-1 - PCT + FF / 25-4208 friction between plunger and housing is (locally) increased in such a way that, for actuating the delivery apparatus, in particular starting from the starting position within a stroke of the plunger of 2 mm or 4 mm, a (maximum) break-loose force of at least 2 N or 5 N is required and / or the static friction between plunger and housing is at least 1.5 times as great as the sliding friction between plunger and housing, in particular when delivering the implant.

[0025] It is preferred to provide a break-loose force of at least 5 N since this will result in a very reliable and controllable handling of the delivery apparatus. Many medical personnel, in particular physicians, are accustomed to handling larger syringes for delivering a fluid, e.g., with a volume of at least 1 ml. This is the reason why a breakloose force of less than 5 N can still include the risk that the implant is delivered too early, too quickly and / or at the wrong location. Thus, a break-loose force of at least 5 N is preferred.

[0026] Preferably, the housing has an in particular hollow-cylindrical main body and an in particular annular closure, in particular wherein the closure is clipped axially into the housing and / or forms a radial guide for the plunger.

[0027] The housing, in particular the closure, has at least one spring element which rests radially against the plunger with a predefined spring force and / or presses against the plunger, wherein the spring element preferably rests against a notch of the plunger in the starting position and is deflected counter to the spring force by actuating the delivery apparatus, in particular by displacing the plunger relative to the housing.

[0028] By means of the spring element and / or the spring force to be overcome and generated by the spring element, the required and / or desired (maximum) break-loose force is consequently generated.

[0029] Due to the proposed delivery apparatus, a particularly safe, user-friendly, intuitive handling known from commercially available syringes is made possible. In particular, the risk of a misuse is reduced in comparison to delivery apparatuses known from the prior art.

[0030] According to a further aspect of the present invention, which can also be realized independently, the friction between plunger and housing varies along the length of the plunger. In particular, it is provided that, for actuating the delivery apparatus, in

[0031] 01-3590-WO-1 - PCT + FF / 25-4208 particular starting from the starting position within a stroke of the plunger of 4 mm, a greater friction is present than at the end of the actuation of the delivery apparatus. In this way, corresponding advantages are realized.

[0032] Furthermore, it is possible that, due to the variation of the friction between plunger and housing along the length of the plunger, a haptic and / or acoustic signal is generated at one or more predefined positions and / or a haptic and / or acoustic feedback is given to a user. In this way, the user can be reliably informed when the implant has been delivered.

[0033] Preferably, the plunger and the housing, in particular the spring element, latch / en- gage / snap radially into one another at a predefined position, in particular the end position and / or after delivery of the implant, in order to generate a haptically and / or acoustically perceptible signal.

[0034] According to a further aspect of the present invention, which can also be realized independently, a plurality of, in particular axially spaced apart from one another, intraocular implants are arranged in the cannula, wherein the implants can be formed identically or differently. In this way, it is possible to deliver a plurality of implants with the same delivery apparatus. For example, a first implant can be delivered at a first location in the tissue and a second implant can be delivered at a second location in the tissue which is different from the first location. This is advantageous in particular when locally only a limited amount of the pharmaceutical active substance is to be released. Furthermore, with only one injection, a greater amount of an active substance can be delivered and / or the active substance can be delivered at different locations.

[0035] It is provided that, after delivery of the first implant and / or in an intermediate position of the plunger, a haptic and / or acoustic signal is generated and / or a haptic and / or acoustic feedback is given to a user. Particularly preferably, the plunger and the housing, in particular the spring element, latch / engage / snap radially into one another in order to generate the haptic and / or acoustic feedback.

[0036] The haptic and / or acoustic signal preferably has a sound pressure level of more than 30 dB or 50 dB, measured at a distance of 30 cm.

[0037] 01-3590-WO-1 - PCT + FF / 25-4208 In this way, the user is informed when the delivery of the first implant has taken place. The user can then, for example, adapt the (delivery) angle of the delivery apparatus in order to subsequently deliver a further and / or the second implant.

[0038] Additionally or alternatively, it can be provided that, after delivery of a further and / or the second implant and / or in an end position of the plunger, a haptic and / or acoustic signal is generated and / or a haptic and / or acoustic feedback is given to a user. Preferably, for this purpose, the plunger and the housing, in particular the spring element, latch / engage / snap radially into one another.

[0039] In this way, the user is informed when the delivery of all implants has taken place.

[0040] The construction of the housing, in particular the spring element, can consequently comprise two functions, namely on the one hand to increase the break-loose force and on the other hand to generate a haptic and / or acoustic signal.

[0041] The term “break-loose force” I “breakaway force” in the sense of the present invention is preferably to be understood as meaning that maximum (pressure) force which — starting from the starting position — is required for and / or during the (complete) actuation of the delivery apparatus, in particular for displacing / pushing the plunger from the starting position into the end position. Preferably, the break-loose force I breakaway force is that force which is required for overcoming the static friction of the components of the delivery apparatus moving relative to one another, in particular of the plunger, the housing, the pusher, the implant(s) and / or the cannula.

[0042] The term “static friction” in the sense of the present invention is preferably to be understood as meaning that (average) force which prevents the sliding of the components of the delivery apparatus moving relative to one another, in particular of the plunger, the housing, the pusher, the implant(s) and / or the cannula.

[0043] The term “sliding friction” in the sense of the present invention is preferably to be understood as meaning that (average) force which — after overcoming the static friction and / or the break-loose force — has to be applied for a (continuous) sliding of the components of the delivery apparatus moving relative to one another, in particular of the plunger, the housing, the pusher, the implant(s) and / or the cannula.

[0044] 01-3590-WO-1 - PCT + FF / 25-4208 In the proposed delivery apparatus, the components moving relative to one another and directly touching one another are the plunger and the housing and / or the closure on the one hand and the pusher, the implant and the cannula on the other hand.

[0045] An acoustic and / or haptic signal and / or acoustic and / or haptic feedback in the sense of the present invention is preferably to be understood as meaning a (mechanical) oscillation in the form of a vibration and / or in the form of a sound wave, in particular a sound, such as a click sound, which can be perceived by a user.

[0046] The starting position is preferably to be understood as meaning that position of the actuation device and / or of the plunger in which the actuation device and / or the plunger is in the as-delivered state and / or in the non-actuated state. In particular, in the starting position, the plunger projects maximally far out of the housing. Preferably, in the starting position, the spring element engages in a first notch of the plunger.

[0047] The end position is preferably to be understood as meaning that position of the actuation device and / or of the plunger in which the actuation device and / or the plunger is in the completely actuated state. In particular, in the end position, the plunger projects maximally far into the housing. Preferably, the implant or, in the case of a plurality of implants, all the implants are completely delivered and / or pressed out of the cannula when the end position is reached and / or, in the end position, the spring element engages in a second notch of the plunger.

[0048] The intermediate position is preferably to be understood as meaning a predefined position of the actuation device and / or of the plunger in which the actuation device and / or the plunger is between the starting position and the end position. Particularly preferably, a first implant in the case of a plurality of implants is completely delivered and / or pressed out of the cannula when the intermediate position is reached and / or, in the intermediate position, the spring element engages in a third notch of the plunger.

[0049] The aforementioned aspects and / or features of the present invention as well as the aspects and features of the present invention resulting from the claims and the following description can be realized in principle independently of one another, but also in any combination.

[0050] 01-3590-WO-1 - PCT + FF / 25-4208 Further aspects, advantages, features, properties as well as advantageous developments of the present invention result from the claims and the following description of preferred embodiments with reference to the figures. Shown in a schematic, not true- to-scale representation are:

[0051] Fig. 1 a perspective view of a proposed delivery apparatus according to a first embodiment, wherein the delivery apparatus has a transport securing device and a plugged-on protective cap;

[0052] Fig. 2 the delivery apparatus according to Fig. 1 without protective cap and transport securing device;

[0053] Fig. 3 the delivery apparatus according to Fig. 2 with components spatially separated from one another;

[0054] Fig. 4 a schematic longitudinal section of the delivery apparatus in a starting position;

[0055] Fig. 5 a schematic longitudinal section of the delivery apparatus according to Fig. 4 with the plunger pressed down and / or in an end position;

[0056] Fig. 6 a perspective representation of the delivery apparatus with the housing partially cut away in the starting position;

[0057] Fig. 7 a perspective representation of the delivery apparatus according to Fig. 6 with the plunger pressed down and / or in the end position;

[0058] Fig. 8 a schematic longitudinal section of a delivery apparatus according to a second embodiment with the plunger in the starting position;

[0059] Fig. 9 a schematic longitudinal section of the delivery apparatus according to Fig. 8 with the plunger in an intermediate position;

[0060] Fig. 10 a schematic diagram with the profile of the required force as a function of the displacement of the plunger;

[0061] 01-3590-WO-1 - PCT + FF / 25-4208 Fig. 11 a schematic diagram with the profile of the required force as a function of the displacement of the plunger with latching of the plunger in an intermediate position; and

[0062] Fig. 12 a schematic diagram with the profile of the required force as a function of the displacement of the plunger with increased friction between plunger and housing after reaching the intermediate position.

[0063] In the partially not true-to-scale, only schematic figures, the same reference numerals are used for identical, alike or similar structural parts and components, wherein corresponding or comparable properties or advantages are achieved, even if a repeated description is dispensed with.

[0064] Fig. 1 shows a perspective view of the proposed delivery apparatus 1.

[0065] The delivery apparatus 1 is preferably of multi-part construction and / or has a plurality of parts / components, preferably wherein some or all of the components of the delivery apparatus 1 are connected to one another in a form-fitting, force-fitting and / or materially bonded manner, in particular in a screwless manner.

[0066] The delivery apparatus 1 is preferably elongated and / or rod-shaped. Particularly preferably, the delivery apparatus 1 is embodied as a (disposable I single-use) syringe and / or embodied to be held and actuated in one hand by a user, such as a physician.

[0067] The delivery apparatus 1 preferably has a housing 2, an actuation device 3, a cannula or injection needle 4, a protective cap 5 and / or an optional transport securing device 6.

[0068] The delivery apparatus 1 , in particular the housing 2 and / or the actuation device 3, are preferably rotationally symmetrical.

[0069] The delivery apparatus 1 , in particular the housing 2, the actuation device 3 and / or the cannula 4, preferably defines / define an axis A, wherein the axis A forms a main, longitudinal, symmetry and / or movement axis of the delivery apparatus 1 , in particular of the housing 2, the actuation device 3 and / or the cannula 4, and / or wherein the

[0070] 01-3590-WO-1 - PCT + FF / 25-4208 axis A runs centrally through the delivery apparatus 1 , in particular the housing 2, the actuation device 3 and / or the cannula 4.

[0071] In the following, the spatial orientation, the spatial position and / or the spatial assignment, in particular the terms “radial”, “axial”, “inner” and / or “outer”, relate to the axis A, unless explicitly explained otherwise.

[0072] Preferably, a plurality of components of the delivery apparatus 1 , in particular the housing 2, the actuation device 3, the protective cap 5 and / or the transport securing device 6, are produced and / or injection-moulded from plastic, in particular polyethylene, polypropylene, polycarbonate, polyoxymethylene and / or acrylonitrile-butadi- ene-styrene copolymer.

[0073] The cannula 4 is preferably produced from stainless steel.

[0074] Fig. 2 shows the delivery apparatus 1 without the protective cap 5 and the transport securing device 6 and / or in the ready-to-deliver state. Fig. 3 shows the delivery apparatus 1 in an exploded view, in which the main components of the delivery apparatus 1 are spatially spaced apart from one another.

[0075] The housing 2 is preferably of multi-part construction.

[0076] Preferably, the housing 2 has a main body 7, a closure 8 and / or a cannula holder 9, wherein the main body 7, the closure 8 and the cannula holder 9 form separate components or separate structural parts of the housing 2. However, it is also possible for the housing 2 to be of one-piece construction.

[0077] The main body 7, the closure 8 and the cannula holder 9 are preferably inserted and / or plugged and / or clipped axially into one another. The housing 2, in particular the main body 7, is preferably hollow-cylindrical.

[0078] The housing 2, in particular the main body 7, preferably has a shaft 10 and a finger rest 11 , wherein the finger rest 11 is preferably formed by an annular projection on the main body 7. In particular, the outer diameter of the finger rest 11 is greater than the outer diameter of the shaft 10, in particular by more than 1 cm.

[0079] 01-3590-WO-1 - PCT + FF / 25-4208 Preferably, the closure 8 is inserted / plugged axially into the main body 7 from a first side or distal side and the cannula holder 9 from a second side or proximal side.

[0080] The cannula holder 9 is preferably formed / embodied to hold the cannula 4 firmly and / or immovably. In particular, the cannula 4 is held and / or fixed in the cannula holder 9 in a form-fitting, force-fitting and / or materially bonded manner.

[0081] The delivery apparatus 1 preferably has an implant 12, wherein the implant 12 is preferably arranged in the cannula 4.

[0082] As already explained at the outset, the delivery apparatus 1 is embodied to inject the implant 12 into the tissue of a patient (not shown), in particular by actuating the actuation device 3.

[0083] The actuation device 3 is preferably embodied to push the implant 12 out of the cannula 4 by actuating the actuation device 3.

[0084] For this purpose, the actuation device 3 is (axially) movable relative to the housing 2. In particular, the actuation device 3 can be pressed into the housing 2 in order to push and / or press the implant 12 out of the cannula 4.

[0085] The actuation device 3 is preferably elongated and / or punch-like I stamp-like.

[0086] Preferably, the actuation device 3 has a plunger 13, a pusher 14 and / or a thumb rest 15.

[0087] The actuation device 3, in particular the plunger 13, is preferably guided laterally and / or radially in the housing 2, in particular the closure 8, as will be explained in more detail in the following.

[0088] The transport securing device 6 is preferably formed / embodied / configured to prevent an (undesired) movement of the actuation device 3 relative to the housing 2, for example during the transport of the delivery apparatus 1. In the illustrated embodiment, the transport securing device 6 is formed as a radially removable sleeve which at least partially encases the plunger 13 between the finger rest 11 and the thumb rest 15. The transport securing device 6 is preferably radially removable and / or can

[0089] 01-3590-WO-1 - PCT + FF / 25-4208 preferably be radially pulled off, so that by removing and / or pulling off the transport securing device 6, the plunger 13 is released and can be pressed down.

[0090] The protective cap 5 is preferably axially plugged onto the delivery apparatus 1 and / or the housing 2, particularly preferably the cannula holder 9, in particular such that the cannula 4 is protected axially and / or radially. The protective cap 5 preferably has an integrated seal (not illustrated) which projects axially into the cannula 4 in order to secure the implant 12 against falling out of the cannula 4.

[0091] The protective cap 5 is preferably axially removable and / or can preferably be axially pulled off in order to release the cannula 4 and / or the implant 12.

[0092] As already explained, the actuation device 3 is preferably axially pressable into the housing 2 in order to push the implant 12 out of the cannula 4. In particular, by actuating the delivery apparatus 1 , the plunger 13 is movable from a starting position to an end position relative to the housing 2 in order to deliver the implant 12, in particular into the eye of a patient, particularly preferably the vitreous body, the anterior chamber of the eye and / or the posterior chamber of the eye.

[0093] The implant 12 is preferably an intraocular, in particular intravitreal, implant. The implant 12 preferably comprises at least one pharmaceutical active substance and / or the implant 12 is embodied / configured to deliver a pharmaceutical active substance after injection of the implant 12.

[0094] The implant 12 is preferably an elongated capsule, in particular a hard or soft capsule.

[0095] Particularly preferably, the implant 12 comprises a capsule shell and / or capsule membrane in which the active substance is introduced / provided. In particular, the implant 12 has a permeable or semipermeable membrane, wherein the pharmaceutical active substance is preferably encased by the membrane and / or arranged in the membrane.

[0096] The implant 12 preferably has a length of at most 10 mm, particularly preferably 5 mm or 2 mm, and / or a (maximum) width or a diameter of at most 1 mm, particularly preferably 0.5 mm or 0.3 mm.

[0097] 01-3590-WO-1 - PCT + FF / 25-4208 Fig. 4 shows a schematic longitudinal section of the delivery apparatus 1 in the nonactuated state and / or with the plunger 13 in the starting position. Fig. 5 shows a schematic longitudinal section of the delivery apparatus 1 in the actuated position and / or with the plunger 13 in the end position. Fig. 6 shows a perspective view of the delivery apparatus 1 in the non-actuated state. Fig. 7 shows a perspective view of the delivery apparatus 1 in the actuated state. The housing 2 is illustrated partially in section or cut away both in Fig. 6 and in Fig. 7.

[0098] As already explained, the actuation device 3 preferably has a pusher 14, wherein a (first) end of the pusher 14 is at least partially inserted into the cannula 4, as illustrated in particular in Fig. 4.

[0099] The pusher 14 is preferably (formed as) a wire which extends from the end of the plunger 13 into the cannula 4.

[0100] The pusher 14 is preferably connected to the plunger 13 in a form-fitting, force-fitting and / or materially bonded manner. In the illustrated embodiment, a (second) end of the pusher 14 is clamped in a receptacle 13Aof the plunger 13. A plurality of clamping elements 13B are provided in the receptacle 13A and fix the pusher 14 and / or the (second) end of the pusher 14 in a force-fitting manner. However, other solutions are also possible, for example in which the plunger 13 and the pusher 14 are of one- piece construction or are connected to one another in a materially bonded manner.

[0101] The pusher 14 can be pushed into the cannula 4 by actuating the delivery apparatus

[0102] 1 , in particular the actuation device 3, specifically in such a way that the implant 12 is pressed out of the cannula 4 by means of the pusher 14.

[0103] As already explained, the plunger 13 is guided radially and / or laterally in the housing

[0104] 2, in particular the closure 8 and the shaft 10.

[0105] The closure 8 is preferably (formed as) a separate structural part and is clipped and / or plugged into the housing 2, in particular into the finger rest 11.

[0106] The closure 8 is preferably at least substantially annular.

[0107] 01-3590-WO-1 - PCT + FF / 25-4208 Preferably, the closure 8 has one or more holding elements 8A, wherein the holding elements 8A are latched to the main body 7 and / or engage radially in corresponding recesses 7A of the main body 7.

[0108] The closure 8 preferably has at least one spring element and / or sliding element 8B, wherein the spring element and / or sliding element 8B, referred to as spring element 8B in the following, presses and / or is pretensioned laterally and / or radially against the plunger 13.

[0109] Preferably, the closure 8 has a plurality of, in particular two or three, spring elements 8B, in particular wherein the spring elements 8B are distributed equidistantly around the plunger 13 and press against the plunger 13 from different sides. All features which are explained in the following in connection with a spring element 8B are preferably also provided in the other spring elements 8B.

[0110] The closure 8 preferably has an annular base 8C, from which the holding elements 8A project radially outward and / or the spring element 8B projects radially inward.

[0111] The spring element 8B preferably projects radially inward from the base 8C in the direction of the cannula 4. In particular, the spring element 8B is inclined relative to the axis A.

[0112] The spring element 8B is preferably elongated and / or tab-like.

[0113] The spring element 8B is preferably yielding and / or flexible and / or connected to the base 8C, in particular such that the spring element 8B can be bent radially outward by means of the plunger 13 during the actuation of the delivery apparatus 1.

[0114] Preferably, the closure 8, in particular the spring element 8B, is pretensioned against the plunger 13. In other words, the closure 8 exerts a pressure laterally and / or radially against the plunger 13 by means of the spring element 8B, so that the axial movement of the plunger 13 is inhibited and / or the force necessary for actuating the delivery apparatus 1 is increased, as will be explained in more detail in the following.

[0115] The actuation device 3, in particular the plunger 13, preferably has an in particular circumferential (first) notch 16, wherein the spring element 8B preferably engages in

[0116] 01-3590-WO-1 - PCT + FF / 25-4208 the notch 16 in the starting position and / or rests against the notch 16 of the plunger 13.

[0117] The notch 16 is formed by an in particular circumferential step 16A and an in particular circumferential slope 16B.

[0118] Starting from the end of the plunger 13 facing the cannula holder 9, the diameter and / or the (maximum) width of the plunger 13 abruptly decreases at the location of the notch 16 and / or the step 16A and continuously increases in the region of the slope 16B.

[0119] In the starting position, the end face of the spring element 8B rests axially against the step 16A of the notch 16, in particular such that the notch 16 and / or the step 16A forms a stop and / or secures the actuation device 3 against being pulled out of the housing 2.

[0120] In the starting position, the inner side of the spring element 8B rests against the slope 16B of the notch 16. Consequently, the inner side of the spring element 8B forms a sliding surface of the housing 2 and the slope 16B forms a sliding surface of the plunger 13.

[0121] If the delivery apparatus 1 is actuated and / or the plunger 13 is pressed into the housing 2, the plunger 13, in particular the slope 16B, presses the spring element 8B radially outwards counter to the spring force.

[0122] It is consequently provided that a resistance generated by the spring element 8B has to be overcome in order to actuate the delivery apparatus 1. In this way, the breakloose force for actuating the delivery apparatus 1 is increased such that it corresponds to the break-loose force of a delivery apparatus for delivering a fluid, such as a (commercially available) (disposable I single-use) syringe, in particular according to DIN EN ISO 7886-1 :2020-11 , as will be explained in more detail in the following with reference to Figs. 10 to 12.

[0123] Additionally or alternatively, the break-loose force can also be increased in another way, preferably by locally increasing the friction between plunger 13 and housing 2. In particular, the surface properties of the plunger 13 can be changed locally. For

[0124] 01-3590-WO-1 - PCT + FF / 25-4208 example, the surface of the plunger 13 can be locally roughened, structured and / or coated.

[0125] Preferably, the plunger 13 and the housing 2, in particular the spring element 8B, latch, engage or snap radially into one another at one or more predefined positions during the actuation of the delivery apparatus 1 , in particular in the end position and / or an intermediate position, in order to generate a haptic and / or acoustic signal. In particular, the plunger 13 and the housing 2, in particular the spring element 8B, latch, engage or snap into one another in the end position and / or after delivery of the implant 12.

[0126] Preferably, the actuation device 3, in particular the plunger 13, has a plurality of notches 16 and / or 17. In the illustrated first embodiment, a second notch 17 is provided, wherein the closure 8, in particular the spring element 8B, latches / en- gages / snaps into the second notch 17 in the end position, as illustrated in particular in Figs. 5 and 7.

[0127] The second notch 17 preferably has a step 17A and a slope 17B.

[0128] Due to the spring force, the spring element 8B abruptly springs radially inward by means of the step 17A in the end position. In this way, a haptic and / or acoustic signal is generated, so that the user is informed when the end position has been reached and / or the implant 12 has been delivered.

[0129] The signal when reaching the end position preferably has a sound pressure level of more than 30 dB or 50 dB at a distance of 30 cm.

[0130] Furthermore, in the end position, the spring element 8B rests axially against the step 17B of the second notch 17 with an end face, whereby pulling the actuation device 3 out of the housing 2 is prevented.

[0131] The spring element 8B and the notches 16 and / or 17 can consequently have a plurality of functions, namely to increase the break-loose force, to generate a haptic and / or acoustic signal and / or to prevent the plunger 13 from being pulled out.

[0132] 01-3590-WO-1 - PCT + FF / 25-4208 Fig. 10 shows a schematic diagram, in which the required force F for actuating the delivery apparatus 1 is shown over the traveled path / stroke X of the actuation device 3 and / or of the plunger 13.

[0133] In the delivery apparatus 1 , it is provided that the plunger 13, in particular the slope 16B of the (first) notch 16, and the housing 2, in particular the closure 8, particularly preferably the spring element 8B and / or the inner side thereof, cooperate in such a way that, when actuating the delivery apparatus 1 , a (maximum) break-loose force FL of at least 2 N, 5 N or 10 N is required, preferably starting from the starting position within a stroke of the plunger 13 of 2 mm or 4 mm.

[0134] In the case of the force profile illustrated in Fig. 10, the required force F increases from 0 N to approximately 12.5 N within a stroke of approximately 0.5 mm. In this region, the spring element 8 is to be pressed radially outwards by means of the slope 16B counter to the spring force. After overcoming the slope 16B, the spring element 8B slides on the cylindrical (lateral) surface of the plunger 13, so that the required force F drops to the force for overcoming the sliding friction, in the case of the illustrated force profile to the level of approximately 3 N.

[0135] Subsequently, the plunger 13 can thus be displaced / pushed into the housing 2 with an at least substantially constant application of force.

[0136] Only when the end position EP is reached, in the case of the illustrated force profile at approximately 20 mm, does the force F initially decrease, since the spring element 8B latches, engages or snaps into the second notch 17. Since the thumb rest 15 comes to rest axially on the closure 8, a further movement of the plunger 13 is not possible in a non-destructive manner, so that the force F subsequently increases abruptly.

[0137] In the following, a second embodiment of the proposed delivery apparatus 1 will be described with reference to Figs. 8, 9, 11 and 12.

[0138] The delivery apparatus 1 according to the second embodiment has one, a plurality or all of the features of the delivery apparatus 1 according to the first embodiment, even if a repeated description is dispensed with. In the following, only the essential differences of the delivery apparatus 1 according to the second embodiment in

[0139] 01-3590-WO-1 - PCT + FF / 25-4208 comparison to the delivery apparatus 1 according to the first embodiment will be explained.

[0140] Fig. 8 shows the delivery apparatus 1 in a schematic longitudinal section, wherein the plunger 13 is in the starting position and / or the actuation device 3 has not yet been actuated. Fig. 9 shows the delivery apparatus 1 , wherein the plunger 13 is in an intermediate position but has not yet reached the end position.

[0141] The delivery apparatus 1 according to the second embodiment has a plurality of, in this case two, implants 12A and 12B. Thus, a plurality of, in this case two, implants 12A and 12B are arranged in the cannula 4.

[0142] The implants 12Aand 12B are arranged axially one behind the other and / or are preferably axially spaced apart from one another.

[0143] Preferably, a free space 19 is located between the implants 12A and 12B, as illustrated in particular in Fig. 8. The free space 19 is preferably filled with a fluid, in particular an isotonic saline solution. The volume of the free space 19 and / or of the fluid is preferably more than 0.1 pl and / or less than 100 pl. However, it is also possible for the implants 12A and 12B to be arranged directly one behind the other.

[0144] The implants 12A and / or 12B can be formed differently or identically. In particular, the implants 12A and / or 12B can contain different pharmaceutical active substances. Additionally or alternatively, the (active substance) doses of the implants 12A and / or 12B can differ.

[0145] The first and / or anterior implant 12A in the cannula 4 is preferably arranged in front of the second and / or posterior implant 12B in the cannula 4. In particular, the first implant 12A is delivered prior to the second implant 12B by actuating the actuation device 3.

[0146] Preferably, the first implant 12A is (completely) delivered when the plunger 13 has reached the intermediate position.

[0147] After reaching the intermediate position and / or delivery of the first implant 12A, the user can deliver the second implant 12B by renewed / further actuation of the actuation device 3 at the same location or at another location.

[0148] 01-3590-WO-1 - PCT + FF / 25-4208 The second implant 12B is preferably (completely) delivered when the plunger 13 has reached the end position.

[0149] In order to signal to the user that the intermediate position and / or end position has been reached and / or that the delivery of the first implant 12A and / or of the second implant 12B has taken place, it is provided that the delivery apparatus 1 generates a haptic and / or acoustic signal when the intermediate position and / or end position is reached and / or directly after the delivery of the first implant 12A and / or of the second implant 12B.

[0150] Particularly preferably, the haptic and / or acoustic signal is generated by the plunger 13 and the housing 2, in particular the spring element 8B, latching / engaging / snap- ping radially into one another at a predefined position, in particular the end position and / or the intermediate position.

[0151] In the illustrated embodiment, the actuation device 3, in particular the plunger 13, has an additional and / or third notch 18, wherein the notch 18 is preferably arranged axially between the first notch 16 and the second notch 17.

[0152] The additional / third notch 18 preferably has one, a plurality or all of the features of the first notch 16 and / or of the second notch 17.

[0153] Preferably, the additional / third notch has an in particular circumferential step 18A and / or an in particular circumferential slope 18B.

[0154] The step 18A is preferably formed by an abrupt reduction in cross section of the plunger 13.

[0155] The slope 18B is preferably formed by a continuous increase in cross section of the plunger 13.

[0156] When or directly after reaching the intermediate position and / or delivery of the first implant 12A, the spring element 8B moves radially inward due to the step 18A, in particular in such a way that the inner sides of the spring element 8B come to rest at least partially against the slope 18B. By snapping in of the spring element 8B, a haptic and / or acoustic signal is generated which can be perceived by the user.

[0157] 01-3590-WO-1 - PCT + FF / 25-4208 When or directly after reaching the end position and / or delivery of the second implant 12B, the spring element 8B moves radially inward due to the step 17A, in particular in such a way that the inner sides of the spring element 8B come to rest at least partially against the slope 17B. By snapping in of the spring element 8B, a haptic and / or acoustic signal is generated which can be perceived by the user.

[0158] The signal when reaching the intermediate position and / or end position preferably has a sound pressure level of more than 30 dB or 50 dB at a distance of 30 cm.

[0159] Fig. 11 shows a schematic profile of the required force F for actuating the delivery apparatus 1 over the stroke and / or the traveled path X of the plunger 13.

[0160] The force profile according to Fig. 11 differs from the force profile according to Fig. 10 in that the force F decreases and / or the force profile has a local minimum when reaching the intermediate position ZP, in the illustrated example at a stroke of approximately 11 mm.

[0161] Due to the additional / third notch 18 at the intermediate position ZP, the required force F temporarily drops. Due to the slope 18B, the spring element 8B must subsequently be pressed radially outwards, namely counter to the spring force generated by the spring element 8B, so that the required force F increases again.

[0162] By further actuation of the actuation device 3 and / or by a movement of the plunger 13 from the intermediate position ZP to the end position EP, the second implant 12B is subsequently delivered.

[0163] According to a preferred variant of the second embodiment, the plunger 13 and the housing 2, in particular the spring element 8B, cooperate in such a way that, when (again) actuating the delivery apparatus 1 and / or for delivering the second implant 12B, a (maximum) break-loose force FL of at least 2 N, 5 N or 10 N is (again) required.

[0164] Very particularly preferably, the sliding surfaces of the plunger 13, in particular of the slope 18B of the additional / third notch 18, and of the housing 2, in particular of the spring element 8B, are adapted in such a way that, for (again) actuating the delivery apparatus 1 and / or for delivering the second implant 12B, in particular starting from

[0165] 01-3590-WO-1 - PCT + FF / 25-4208 the intermediate position ZP within a stroke of the plunger 13 of 2 mm or 4 mm, a (maximum) break-loose force FL of at least 2 N, 5 N or 10 N is required and / or the static friction between the plunger 13, in particular the slope 18B of the addi- tional / third notch 18, and the housing 2, in particular the spring element 8B, is at least 1.5 times as great as the sliding friction between the plunger 13 and the housing 2, in particular the spring element 8B.

[0166] Fig. 12 shows a schematic force profile in which, after reaching the intermediate position ZP, in the illustrated profile at approximately 11 mm, due to the sliding surfaces of the plunger 13 and the housing 2, the required force F for moving the plunger 13 initially increases greatly, reaches its (local) maximum at approximately 12.5 N and subsequently drops. After overcoming the maximum and / or the break-loose force FL, the sliding friction between the plunger 13 and the housing 2 has to be overcome for further actuation of the delivery apparatus 1 , in the case of the illustrated force profile at the level of approximately 3 N.

[0167] It is preferred that the break-loose force FL for delivering the first implant 12A at least substantially corresponds to the break-loose force FL for delivering the second implant 12B. However, solutions are also possible in which the (maximum) break-loose force FL for delivering the first implant 12A and the break-loose force FL for delivering the second implant 12B are of different magnitudes.

[0168] After delivering the second implant 12B and / or when reaching the end position EP, it is preferred that the plunger 13 and the housing 2, in particular the spring element 8B, latch, engage or snap (again) into one another, as already explained.

[0169] In the proposed apparatus 1 , it is provided that the friction between the plunger 13 and the housing 2, in particular the spring element 8B, varies along the length of the plunger 13, in particular due to the different notches 16, 17 and / or 18. In particular, the friction decreases and increases at predefined positions, in order on the one hand to signal to a user that the intermediate and / or end position has been reached and on the other hand to imitate the handling of a commercially available disposable syringe / single-use syringe.

[0170] Due to the proposed delivery apparatus 1 , a particularly safe, user-friendly, intuitive handling is consequently made possible or supported, preferably wherein the risk of

[0171] 01-3590-WO-1 - PCT + FF / 25-4208 a misuse is minimized or at least reduced. Furthermore, a plurality of implants 12A and / or 12B can be delivered precisely at the same or different locations.

[0172] Individual features and aspects of the present invention can be realized inde- pendently of one another, but also in any combination.

[0173] 01-3590-WO-1 - PCT + FF / 25-4208 List of reference numerals: Delivery apparatus 18 Third notch Housing 18A Step Actuation device 18B Slope Cannula 19 Free Space Protective cap Transport securing device A Axis

[0174] F Force Main body X PathA Recess Closure A Holding element B Spring element C Base Cannula holder 0 Shaft 1 Finger rest 2 Implant 2A First implant 2B Second implant 3 Plunger 3A Receptacle 3B Clamping element 4 Pusher 5 Thumb rest 6 First notch 6 A Step 6B Slope 7 Second notch 7A Step 7B Slope

[0175] 01-3590-WO-1 - PCT + FF / 25-4208

Claims

Claims:1 . Delivery apparatus (1 ) for delivering an in particular intraocular implant (12), wherein the delivery apparatus (1) comprises a housing (2), a cannula (4), a plunger (13) and an implant (12) arranged in the cannula, wherein by actuating the delivery apparatus (1 ), the plunger (13) is movable from a starting position to an end position relative to the housing (2) to deliver the implant (12), characterized in that plunger (13) and housing (2), in particular a spring element (2) of the housing (2), cooperate in such a way that, when actuating the delivery apparatus (1 ), a breakloose force of at least 2 N is required, and / or in that the friction between plunger (13) and housing (2) varies along the length of the plunger (13), and / or in that a plurality of implants (12) are arranged in the cannula (4).

2. Delivery apparatus according to claim 1 , characterized in that the housing (2) has a main body (7) and a closure (8).

3. Delivery apparatus according to claim 2, characterized in that the closure (8) is clipped axially into the housing (2) and / or forms a radial guide for the plunger (13).

4. Delivery apparatus according to one of the preceding claims, characterized in that the housing (2), in particular the closure (8), comprises or forms a spring element (8B) which presses radially against the plunger (13).

5. Delivery apparatus according to claim 4, characterized in that the spring element (8B) latches in a notch (16, 17) of the plunger (13) in the starting position and / or in the end position of the plunger (13).

6. Delivery apparatus according to one of the preceding claims, characterized in that sliding surfaces of plunger (13) and / or housing (2) are adapted in such a way and / or the friction between plunger (13) and housing (2) is locally increased in such a way that, for actuating the delivery apparatus (1 ), in particular starting from the01-3590-WO-1 - PCT + FF / 25-4208starting position within a stroke of the plunger (13) of 2 mm or 4 mm, a (maximum) break-loose force of at least 2 N or 5 N is required and / or the static friction between plunger (13) and housing (2) is at least 1.5 times as great as the sliding friction between plunger (13) and housing (2), in particular when delivering the implant (12).

7. Delivery apparatus according to one of the preceding claims, characterized in that the sliding surfaces of plunger (13) and / or housing (2) are adapted in such a way and / or the friction between plunger (13) and housing (2) is locally increased in such a way that the force profile for delivering the implant (12) corresponds to the force profile of a delivery apparatus (1 ), in particular a syringe with a volume of 0.5 ml, 1 ml or 2 ml according to DIN EN ISO 7886-1 :2020-11 , for delivering a fluid, in particular an isotonic saline solution.

8. Delivery apparatus according to one of the preceding claims, characterized in that the plunger (13) and the housing (2), in particular the spring element (8B), latch radially into one another at a predefined position, in particular the end position and / or after delivery of the implant (12), in order to generate a haptic and / or acoustic signal.

9. Delivery apparatus according to one of the preceding claims, characterized in that the delivery apparatus (1 ), in particular the housing (2), is rotationally symmetrical.

10. Delivery apparatus according to one of the preceding claims, characterized in that the implant (12) has a length of more than 0.5 mm and / or less than 5 mm and / or a (maximum) width or a diameter of more than 0.1 mm and / or less than 0.5 mm.

11. Delivery apparatus according to one of the preceding claims, characterized in that the implant (12) comprises at least one pharmaceutical active substance and / or is biodegradable.

12. Delivery apparatus according to one of the preceding claims, characterized in that a plurality of implants (12A, 12B) spaced apart from one another are arranged in the cannula (4).

13. Delivery apparatus according to claim 12, characterized in that the implants (12A, 12B) are identical.01-3590-WO-1 - PCT + FF / 25-420814. Delivery apparatus according to claim 12, characterized in that the implants (12A, 12B) are different from each other.

15. Delivery apparatus according to claim 14, characterized in that the pharmaceutical active substances of the implants (12A, 12B) and / or the doses of the implants (12A, 12B) differ.

16. Delivery apparatus according to one of the preceding claims, characterized in that the plunger (13) and the housing (2), in particular the spring element (8B), latch radially into one another after delivery of a first implant (12A) and / or in an intermediate position of the plunger (13) in order to generate a haptic and / or acoustic signal.

17. Delivery apparatus according to one of the preceding claims, characterized in that plunger (13) and housing (2) cooperate in such a way that, when reaching the intermediate position and / or for delivering a second implant (12B), a (maximum) break-loose force of at least 2 N or 5 N is required.

18. Delivery apparatus according to one of the preceding claims, characterized in that the plunger (13) and the housing (2), in particular the spring element (8B), latch radially into one another after delivery of a second implant (12B) and / or in the end position in order to generate a haptic and / or acoustic signal.01-3590-WO-1 - PCT + FF / 25-4208

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