CN115209835A - Package for holding and dispensing delivery shaft assemblies for delivering implants - Google Patents

Abstract

A package (100) for holding and dispensing a delivery shaft assembly (200) for delivering an implant (230) is provided, the package (100) comprising a vial (400) and an insert (300) mounted within a vial holding space (410), wherein the insert (300) comprises: -a force receiving body (308), the force receiving body (308) being configured to support the adapter (210) of the delivery shaft assembly (200) during coupling to the inserter tool (500), -a delivery shaft retaining mechanism (310), the delivery shaft retaining mechanism (310) being configured to releasably retain the delivery shaft, wherein a force exerted by the inserter tool (500) during coupling to the adapter (210) actuates the delivery shaft retaining mechanism (310) to release the retained delivery shaft (220) for withdrawing the delivery shaft assembly (200) from the inserter (300) and the vial (400).

Description

Package for holding and dispensing delivery shaft assemblies for delivering implants

Technical Field

A package for holding and dispensing a delivery shaft assembly for delivering an implant for implantation in a subject is provided herein.

Background

Implants are commonly used to treat situations where drug therapy is ineffective or unavailable. Techniques for placing implants typically rely on an inserter tool that temporarily holds the implant and provides an elongated range for placement at the implantation site and a mechanism for ejection from the inserter. The implant may be very small, for example, implants for treating glaucoma typically have a length of 5mm and a width of 1 mm. Examples of implants and inserters for the treatment of glaucoma are also disclosed, for example, in WO 2017/108498.

The problem in the art is how to store the implant before use in order to keep it in an optimal state. Small implants may be difficult to fit into the inserter just prior to use. Some implants need to be kept under liquid storage without damage or exposure to air pockets.

Disclosure of Invention

Described herein is a package (100) for holding and dispensing a delivery shaft assembly (200) for delivering an implant (230), wherein

A delivery shaft assembly (200) comprising a delivery shaft (220) and an adapter (210), the delivery shaft (220) having a lumen (222) holding an implant (230), the adapter (210) configured for coupling to an inserter tool (500),

an inserter tool (500) is provided with a discharge shaft (510) configured to be received by the delivery shaft assembly lumen (222), and with an adapter coupler (520) configured to couple with the adapter (210), wherein the delivery shaft (220) and/or the discharge shaft (510) is movable such that the implant (230) is released from the lumen,

the package (100) comprises:

-a vial (400) and an insert (300) mounted within the vial-holding space (410), wherein the insert (300) comprises:

a force receiving body (308), the force receiving body (308) being configured to support the adapter (210) during coupling to the inserter tool (500),

a delivery shaft retaining mechanism (310), the delivery shaft retaining mechanism (310) being configured to releasably retain the delivery shaft,

wherein a force exerted by the inserter tool (500) during coupling to the adapter (210) actuates the delivery shaft retention mechanism (310) to release the retained delivery shaft (220) for withdrawal of the delivery shaft assembly (200) from the inserter (300) and vial (400).

The delivery shaft retaining mechanism (310) may include a first body (312) and a second body (314), the first body (312) and the second body (314) configured to cooperate to clamp at least a portion of the delivery shaft (220).

The first body (312) may be disposed in a fixed relationship with the force receiving body (308), and the second body (314) is configured to move at least partially away from the first body (312) upon actuation of the delivery shaft retaining mechanism (310), thereby releasing the retained delivery shaft (220).

The delivery shaft retention mechanism (310) may further include an actuation pin (316) and a moving guide (318), wherein a force exerted by the inserter tool during coupling advances the pin (316) and the moving guide (318) from a retention position to a release position, wherein the moving guide (318) slidably coupled to the second body (314) effects movement of the second body (314) from the retention position to the release position.

The moving guide (318) may include at least one guide slot (320) having at least a portion of a cam path, the second body (314) may include at least one protrusion (322) engaged in the guide slot (320), and movement of the moving guide (318) from the hold position to the release position may effect sliding of the guide slot (320) and movement of the at least one protrusion (322) along the cam path to disengage at least a portion of the second body (314) from the first body (312).

The first body (312) and the second body (314) may be connected by a hinge, preferably by a living hinge. The vial-holding space (410) may be configured for holding a liquid. The vial (400) may have an opening (412) that can be closed by a lid or removable seal.

The first body (312) may be provided with a retainer (324), the retainer (324) configured to limit movement of the implant (230) in the direction of the distal end (40) in the lumen (222) of the delivery shaft (220).

The retainer may include a protrusion configured to at least partially engage the lumen (222) of the delivery shaft (220).

The first body (312) and the second body (314) cooperate to clamp at least a portion of the delivery shaft in the clamping region such that the delivery shaft lumen (222) in the clamping region (312 a, 314 a) is at least partially narrowed, thereby restricting movement of the implant (230) in the proximal (20) direction.

The insert (300) may further comprise one or more fluid displacers (340), the fluid displacers (340) being configured to displace the (aqueous) solution from the vial-holding space (410) during coupling of the insert (300) to the vial-holding space (410).

The insert (300) may further comprise an overflow outlet (342), the overflow outlet (342) being configured for passage of solution displaced from the vial. The package (100) may further comprise a delivery shaft assembly (200) as defined herein.

Drawings

FIG. 1 is a view of a delivery shaft assembly as is described herein.

Fig. 2 is a view of a package as described herein.

Parts a to C of fig. 3 are a series of views showing actuation of the retention shaft mechanism and release of the delivery shaft assembly.

Fig. 4 shows a package as described herein, highlighting the gripping portions of the first and second bodies that narrow the transport shaft, and showing the holder.

Fig. 5 shows a portion of an inserter tool as described herein.

Parts a-C of fig. 6 show a series of views in which the inserter tool is coupled to the delivery shaft assembly and the retention shaft mechanism is actuated to release the delivery shaft assembly.

Parts a and B of fig. 7 show the inserter instrument in both the ready (part a) and deployed (part B) configurations.

Fig. 8 depicts a package as described herein further provided with a plurality of liquid displacing bodies.

Detailed Description

Before the present systems and methods are described, it is to be understood that this invention is not limited to the particular systems and methods or combinations described, as such systems and methods and combinations can, of course, vary. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

As used herein, the singular forms "a", "an" and "the" include both the singular and the plural referents unless the context clearly dictates otherwise.

As used herein, the terms "comprising," including, "and" consisting of are synonymous with "including," "containing," or "containing," "having," and are inclusive or open-ended and do not exclude additional, unrecited elements, components, or method steps. It is to be understood that the terms "comprising," including, "and" consisting of, "as used herein, include the terms" consisting of, "" consisting of, "and" including.

The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within the respective range and the recited endpoint.

As used herein, the term "about" or "approximately" in reference to a measurable value such as a parameter, amount, duration, etc., is intended to include variations of the specified value and +/-10% or less, preferably +/-5% or less, more preferably +/-1% or less, and more preferably +/-0.1% or less, relative to the specified value, so long as such variations are suitable for implementation in the disclosed invention. It is to be understood that the value to which the modifier "about" or "approximately" refers is also specifically and preferably disclosed per se.

Although the term "one or more" or "at least one", such as one or more of a group of components or at least one component, is clear per se, by way of further illustration the term especially includes a reference to any one of said components or to any two or more of said components, such as for example any 3, 4, 5, 6 or 7 etc. and up to all of said components.

All references cited in the text section of this application are hereby incorporated by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated herein by reference.

Unless otherwise defined, all terms including technical and scientific terms used to disclose the invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By way of further guidance, definitions of terms are included to better understand the teachings of the present invention.

In the following paragraphs, the different aspects of the invention are defined in more detail. Each aspect so defined may be combined with any other aspect or aspects unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.

Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. Moreover, although some embodiments described herein include some but not other features in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention and form different embodiments, as would be understood by those of skill in the art. For example, in the appended claims, any of the claimed embodiments may be used in any combination.

In the present specification of the invention, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. Parenthetical or bolded reference numerals attached to the various elements are merely illustrative of the various elements by way of example, and are not intended to limit the various elements. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

Throughout the text of this specification, the terms "distal" or "away from" and "proximal" or "near" are used, and these terms are terms commonly understood in the art to refer to the side of the user (practitioner) that is toward (near) or away from (far) the device. Thus, "proximal" or "near" refers to the side toward the user, and thus away from the subject (patient). Conversely, "distal" or "away from" refers to the side toward the subject, and thus away from the user side. The term "subject" refers to a human or animal that receives an implant. The term "user" refers to a person (e.g., surgeon, specialist, practitioner) performing an implant.

As exemplified, for example, in fig. 1 and 2, a package (100) for holding and dispensing a delivery shaft assembly (200) for delivering an implant (230) is provided herein. The package (100) includes a vial (400) and an insert (300) mounted within a vial-holding space (410). The vial-holding space (410) is typically provided with a liquid to hold the implant (230) in, for example, a hydrated state for implantation. The inserter (300) includes a force receiving body (308), the force receiving body (308) configured to support an adapter (210) of a delivery shaft assembly (200) during coupling to an inserter tool (500). The insert (300) further includes a shaft retention mechanism (310), the shaft retention mechanism (310) configured to releasably retain the delivery shaft (220) of the delivery shaft assembly (200). The shaft retention mechanism (310) is configured such that a force exerted by the inserter tool (500) during coupling to the adapter (210) actuates the shaft retention mechanism (310) to release the retained delivery shaft (220) for withdrawal of the delivery shaft assembly (200) from the inserter (300) and vial (400).

Advantageously, the package (100) stabilizes the position of the delivery shaft assembly (200) within the vial (400) during transport and storage, thereby preventing accidental loss of the implant from the delivery shaft due to transport and handling agitation. By correlating the released or held state of the shaft holding mechanism (310) with the force exerted by the inserter tool (500), the delivery shaft assembly (200) is held in the vial holding space (410) and the liquid is raised until the moment of use, and the delivery shaft assembly (200) is released from the inserter (300) while the inserter tool is coupled thereto. The package (100) may or may not include a delivery shaft assembly (200). The package (100) may or may not include an inserter tool (500).

The delivery shaft assembly (200) includes an adapter (210) and a delivery shaft (220). The delivery shaft (220) is provided with a lumen (222) holding an implant (230) and an adapter (210) configured for coupling to an inserter tool (500). The implant (230) is disposed at or toward the distal end (40) of the delivery shaft (220). An adapter (210) is disposed at the proximal end (20) of the delivery shaft (220). The adapter (210) has a body provided with a receiving space (212) for a portion of the inserter tool (500) and an aperture (214) connecting the receiving space (212) to a lumen (222) of the delivery shaft (220). The lumen (222) is configured for passage of a discharge shaft (510) of an inserter tool (500) therethrough. The implant (230) may be ejected from the delivery shaft (220) by actuation of the inserter tool (500) to deliver the implant (230) to the target. An exemplary delivery shaft assembly (200) is disclosed in WO2017/108498, which is incorporated herein by reference.

The inserter tool (500) is provided with a discharge shaft (510) configured to be received by the delivery shaft assembly lumen (220). The discharge shaft (510) may be configured to abut the implant (230). Movement of the delivery shaft (220) and/or the discharge shaft (510) causes the implant (230) to be released from the lumen (222).

Advancement of the discharge shaft (510) in the distal direction (40) may exert a force on the implant (230) causing the implant (230) to be ejected from the shaft assembly lumen (220). Alternatively or additionally, withdrawal of the delivery shaft (220) relative to the fixed discharge shaft (510) causes the implant (230) to be ejected from the shaft assembly lumen (220).

The inserter tool (500) is provided with an adapter coupler (520) configured to couple with the adapter (210). The coupling between the adapter coupler (520) and the adapter (210) may be releasable or non-releasable. For example, a non-releasable coupling may be achieved by providing a compliant member on one of the adapter coupler (520) or the adapter (210) and a reciprocating stop member on the other, wherein the compliant member slides over the stop member in one direction during coupling of the components (520, 210) and the compliant member engages the stop member in the other sliding direction to prevent release of the components (520, 210). This mechanism resembles the unidirectional movement of a ratchet mechanism.

The adapter coupler (520) is slidable relative to the fixed discharge shaft (510) with the implant ejected by withdrawing the delivery shaft (220) relative to the fixed discharge shaft (510). The slidable adapter coupler (520) has a ready and deployed position. In the ready position, the slidable adapter coupler (520) places the adapter (210) and the delivery shaft lumen (222) in a distal-most position. The fixation drainage shaft (510) may abut the implant (230) and the delivery shaft lumen (222) may cover the implant (230). In the deployed position, the slidable adapter coupler (520) places the adapter (210) and the delivery shaft lumen (222) in a proximal-most position. The discharge shaft (510) abuts the implant (230) and the delivery shaft lumen (222) is withdrawn in the proximal (20) direction and the implant (230) is released. In the event that the implant is ejected by advancement of the discharge shaft (510), which is slidable relative to the fixation adapter coupler (520), exerts an ejection force on the implant (230) in the distal direction, thereby ejecting the implant (230) from the lumen (222).

An example of a portion of an inserter tool (500) is provided in fig. 5, which shows an inserter housing or chassis (550) (fixed) and a slidable adapter coupling (520) configured to engage with an adapter (210) of a delivery shaft assembly (200). The discharge shaft (510) is disposed in a fixed relationship with the housing (550). When the adapter (210) is engaged in the adapter coupler (520), the delivery shaft assembly (200) can be lifted from the package (100) while the moving guide (318) is in the release position. In this example, the adapter coupler (520) is slidable relative to the housing (550) and is shown in a ready position; it should be understood that there are other configurations of the inserter tool (500), for example, where the adapter coupler (520) is disposed in a fixed relationship to the inserter tool housing and the discharge shaft (510) is slidable.

Fig. 7 illustrates a portion of the inserter tool (500) showing the inserter housing or chassis (550) (fixed) and the slidable adapter coupling (520) coupled with the adapter (210) of the delivery shaft assembly (200). In part a, the inserter tool (500) is shown in a ready position; the adapter coupler (520) is in a distal (40) position. In the ready position, the implant (230) is retained in the delivery shaft lumen (222). In part B, the inserter tool (500) is shown in the deployed position; the adapter coupler (520) is withdrawn to the proximal (20) position. In the deployed position, the delivery shaft is withdrawn, releasing the implant (230) from the delivery shaft lumen (222).

An exemplary inserter tool (500) is disclosed in WO2017/108498, which is incorporated herein by reference.

The shaft retaining mechanism (310) may have a retained state (in which the transport shaft (222) and thus the transport shaft assembly (200) is securely retained by the shaft retaining mechanism (310)) and a released state (in which the transport shaft (222) and thus the transport shaft assembly (200) is free of the insert (300)). During coupling to the adapter (210), movement from the retained state to the released state is actuated by the force of the inserter tool (500). An exemplary shaft retention mechanism (310) is shown in fig. 2, a through C of fig. 3, fig. 4.

The shaft retaining mechanism (310) may include a first body (312) and a second body (314), the first body (312) and the second body (314) configured to cooperate (in a retained state) to clamp at least a portion of the delivery shaft (222). The delivery shaft (220) may be clamped in a fixed relationship to the force receiving body.

The first body (312) and the second body (314) may cooperate in a retained state to clamp at least a portion of the delivery shaft in a clamping region (312 a, 314 a) such that the delivery shaft lumen (222) in the clamping region is at least partially narrowed, thereby restricting movement of the implant (230) in a proximal (20) direction. Exemplary clamping regions (312 a, 314 a) that narrow the delivery shaft lumen (222) are shown in fig. 4.

The first body (312) may be disposed in a fixed (non-movable) relationship with the force-receiving body (308). The second body (314) may be configured to move at least partially away from the first body (312) upon actuation of the shaft retention mechanism (310) to release the retained delivery shaft (220).

The first body (312) and the second body (314) may be longitudinal. The first body (312) and the second body (314) may be longitudinal in a proximal-distal direction. The first body (312) and the second body (314) may be connected by a hinge (e.g., a living hinge).

The shaft retention mechanism (310) may also include an actuation pin (316) and a movement guide (318). An actuation pin (316) may be attached to the moving guide (318) in a fixed relationship. The force exerted by the inserter tool (500) during coupling urges the pin (316) and the moving guide (318) from the retained position to the released position. A movement guide (318) slidably coupled to the second body (314) effects movement of the second body (314) from the hold position to the release position.

The movement guide (318) comprises at least 1 or 2 or more, preferably 2, guide grooves (320), the guide grooves (320) having at least part of the cam path. The cam path is a linear cam that converts linear motion in a first direction (e.g., a proximal-distal direction) to linear motion in a second direction (e.g., a direction perpendicular to the first direction).

The second body (314) may include a protrusion (322) engaged in the guide groove (320). Each guide groove (320) may have a protrusion (322). The protrusion (322) may be in a fixed relationship with the second body. The protrusion (322) may be a follower for the cam path.

Movement of the moving guide (318) from the hold position to the release position effects sliding of the guide slot (320) (in the first direction) and movement of the protrusion (322) along the cam path (in the second direction), thereby separating at least a portion of the second body (314) from the first body (312).

Parts a to C of fig. 3 show a package (100) provided with a transport shaft assembly (200) as described herein, illustrating the steps of activating the shaft retention mechanism (310) to move it from a retained state (part a) to a released state (parts B and C). In part a, a shaft holding mechanism (310) in a held state sandwiches a conveying shaft (220) between a first body (312) and a second body (314). In part B, a downward force (proximal-distal) (317) applied to the actuation pin (316) displaces the moving guide (318) in a downward direction. The protrusion (322) or follower (322) engaged in the guide groove (320) is laterally (319) displaced, causing the second body to move in the lateral direction, thereby moving the shaft holding mechanism (310) to the released state. The delivery shaft assembly (200) is released and the delivery shaft assembly (200) can be withdrawn (205) from the insert (300) and thus from the package (100) (part C).

Parts a-C of fig. 6 show a package (100) provided with a delivery shaft assembly (200) as described herein, illustrating the steps of activating the shaft retention mechanism (310) to move it from a retained state (part a) to a released state (part B), coupling the adapter coupler (520) with the adapter (210) (part B), and withdrawing the delivery shaft assembly (200) from the package (100) (part C). In part a, the adapter coupling (520) is in the ready position and the discharge shaft (510) is inserted into the delivery shaft lumen (222). In part B, the inserter housing (550) pushes the actuation pin (316) downward, thereby actuating the moving guide (318), causing the second body (314) to move to the release position. In part B, the inserter adapter coupler (520) in the ready position is coupled with the delivery shaft assembly adapter (210). The adapter (210) is supported at its distal end by the force receiving surface (308) while the inserter adapter coupler (520) is pressed down (in the distal direction) against the adapter (210) to effect coupling. In part C, with the inserter adapter coupler (520) still in the ready position and the shaft retention mechanism (310) in the release position, the delivery shaft assembly (200) may be withdrawn from the package (100) coupled with the inserter tool (500).

The first body (312) or the second body (314), preferably the first body (312), may be provided with a holder (324). The holder may be disposed in a fixed (non-movable) relationship with the first body (312) or the second body (314), respectively. The retainer (324) is configured to cooperate with the distal tip of the delivery shaft (220) to limit movement of the implant (230) in the direction of the distal end (40). The retainer (324) can include a protrusion (e.g., a tapered protrusion) configured to at least partially engage the lumen (222) of the delivery shaft (220). The retainer (324) may be a solid body extending laterally (perpendicular to the proximal-distal direction). Fig. 4 illustrates the retainer (324) secured to the distal end (40) of the first body (312). A retainer (324) covers the distal end (40) of the delivery shaft lumen (222) and retains the implant (230) by blocking passage of the distal end (40) of the implant (230). The retainer (324) limits movement of the implant in the distal direction (40).

The insert (300) may also include one or more fluid displacement bodies (340). The fluid displacer (340) is configured to displace liquid from the vial-holding space (410) during placement of the insert (300) during assembly of the package (100). This allows the vial-holding space (410) to be filled with minimal air bubbles. The liquid displacement body (340) may have a ring-like appearance. The insert (300) may further comprise an overflow outlet (342), the overflow outlet (342) being configured for passage of liquid displaced from the vial. The overflow outlet (342) may extend as a channel in a proximal direction into the one or more liquid displacing bodies (340). Fig. 8 shows a plurality of liquid displacing bodies (340) arranged at the proximal (20) end of the insert (300) and an overflow outlet (342) through which excess liquid is drained from the holding space (410).

The vial (400) may be formed of a vial body (402) defining a vial-holding space (410). The vial-holding space (410) is configured for holding a liquid, e.g. an aqueous solution, an organic solvent. The vial (400) has an opening (412) at the proximal end (20), the opening (412) configured to receive a distal portion of the inserter tool (500). The opening (412) may be closed by a lid or removable seal. The vial (400) may be provided with one or more support members (420) configured to support the insert (300). The support member (420) is configured to limit movement of the insert (300) in the distal end (40) direction. In particular, the support member (420) prevents movement and damage of the insert (300) when the inserter tool (500) applies a force to the force-receiving surface (308). The support member (420) may be provided as a ridge on the vial body (402) engaged with the force receiving body (308). An exemplary vial is shown in detail in fig. 2.

Implant (230) may be any implant that may be placed in a subject (animal, human) using an inserter instrument. In particular, the implant (230) may be an implant for treating glaucoma. In particular, the implant (230) may be an intraocular shunt. The implant (230) may be for implantation between the sclera and the choroid, i.e., in the suprachoroidal space. The implant (230) is an implant as described in WO 2017/108498. In particular, the implant may be as described in WO2017/108498, page 13, line 1 to page 14, line 5 and/or page 21, line 25 to page 22, line 21, which is incorporated herein by reference.

The inserter tool (500) may be an implant device as described in WO 2017/108498. The delivery shaft assembly (200) may comprise a one-touch fitting connecting element or adapter (210) as described in WO 2017/108498. For example, WO2017/108498, on pages 26 to 33, describes an implantation device (500) and a delivery shaft assembly (200), which is incorporated herein by reference.

Claims (14)

1. A package (100) for holding and dispensing a delivery shaft assembly (200) for delivering an implant (230), wherein

-the delivery shaft assembly (200) comprises a delivery shaft (220) and an adapter (210), the delivery shaft (220) having a lumen (222) holding the implant (230), the adapter (210) configured for coupling to an inserter tool (500),

-the inserter tool (500) is provided with a discharge shaft (510) configured to be received by a lumen (222) of the delivery shaft assembly, and with an adapter coupling (520) configured to couple with the adapter (210), wherein the delivery shaft (220) and/or the discharge shaft (510) are movable such that the implant (230) is released from the lumen,

the package (100) comprises:

-a vial (400) and an insert (300) mounted within a vial holding space (410), wherein the insert (300) comprises:

a force receiving body (308), the force receiving body (308) being configured to support the adapter (210) during coupling to the inserter tool (500),

a delivery shaft retaining mechanism (310), the delivery shaft retaining mechanism (310) configured to releasably retain the delivery shaft,

wherein a force exerted by the inserter tool (500) during coupling to the adapter (210) actuates the delivery shaft retention mechanism (310) to release the retained delivery shaft (220) for withdrawal of the delivery shaft assembly (200) from the inserter (300) and vial (400).

2. The package (100) of claim 1, wherein the delivery shaft retaining mechanism (310) comprises a first body (312) and a second body (314), the first body (312) and second body (314) configured to cooperate to grip at least a portion of the delivery shaft (220).

3. The package (100) of claim 2, wherein the first body (312) is disposed in a fixed relationship with the force-receiving body (308), and the second body (314) is configured to move at least partially away from the first body (312) upon actuation of the delivery shaft retention mechanism (310) to release the retained delivery shaft (220).

4. The package (100) of claim 3, wherein the delivery shaft retention mechanism (310) further comprises an actuation pin (316) and a moving guide (318), wherein a force exerted by the inserter tool during coupling advances the pin (316) and the moving guide (318) from a retained position to a released position, wherein the moving guide (318) slidably coupled to the second body (314) effects movement of the second body (314) from the retained position to the released position.

5. The package (100) of claim 4, wherein

-the moving guide (318) comprises at least one guide groove (320) having at least a partial cam path,

-the second body (314) comprises at least one protrusion (322) engaged in the guide groove (320),

-movement of the moving guide (318) from a retaining position to a releasing position effects sliding of the guide slot (320) and movement of the at least one protrusion (322) along the cam path, thereby separating at least a portion of the second body (314) from the first body (312).

6. The package (100) of any of claims 2 to 5, wherein the first body (312) and the second body (314) are connected by a hinge, preferably a living hinge.

7. The package (100) of any of claims 1 to 6, wherein the vial-holding space (410) is configured for holding a liquid.

8. The package (100) of any of claims 1 to 7, wherein the vial (400) has an opening (412) that can be closed by a lid or removable seal.

9. The package (100) of any of claims 1 to 8, wherein the first body (312) is provided with a retainer (324), the retainer (324) configured to limit movement of the implant (230) in the lumen (222) of the delivery shaft (220) in the direction of the distal end (40).

10. The package (100) of claim 9, wherein the retainer comprises a protrusion configured to at least partially engage the lumen (222) of the delivery shaft (220).

11. The package (100) of any of claims 2 to 10, wherein the first body (312) and the second body (314) cooperate to clamp at least a portion of the delivery shaft in a clamping region such that a lumen (222) of the delivery shaft in the clamping region (312 a, 314 a) at least partially narrows, thereby restricting movement of the implant (230) in a proximal (20) direction.

12. The package (100) of any of claims 1 to 11, wherein the insert (300) further comprises one or more fluid displacers (340), the one or more fluid displacers (340) configured to displace (aqueous) solution from the vial-holding space (410) during coupling of the insert (300) to the vial-holding space (410).

13. The package (100) of claim 12, wherein the insert (300) further comprises an overflow outlet (342), the overflow outlet (342) configured for passage of solution displaced from the vial.

14. The package (100) of any of claims 1 to 13, further comprising the delivery shaft assembly (200) of claim 1.

Images