CN-115209835-B - Package for holding and dispensing a delivery shaft assembly for delivering an implant

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 the vial holding space (410), wherein the insert (300) comprises-a force receiving body (308) configured to support an adapter (210) of the delivery shaft assembly (200) during coupling to an inserter tool (500), -a delivery shaft holding mechanism (310), the delivery shaft holding mechanism (310) configured to releasably hold the delivery shaft, wherein a force applied by the inserter tool (500) during coupling to the adapter (210) actuates the delivery shaft holding mechanism (310) to release the held delivery shaft (220) for withdrawing the delivery shaft assembly (200) from the insert (300) and the vial (400).

Inventors

• Bernua Detree
• Isabel Bush
• Stefan Ulant
• Adrian Bernard Girod

Assignees

• 伊斯塔尔医疗公司

Dates

Publication Date

20260505

Application Date

20210226

Priority Date

20200227

Claims (14)

1. 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) being 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 coupler (520) configured to be coupled 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 in a vial holding space (410), wherein the insert (300) comprises: a force receiving body (308), the force receiving body (308) configured to support the adapter (210) during coupling to the inserter tool (500), A delivery shaft holding mechanism (310), the delivery shaft holding mechanism (310) configured to releasably hold the delivery shaft, Wherein a force applied 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 insert (300) and the vial (400), Wherein the delivery shaft retaining mechanism (310) comprises a first body (312) and a second body (314), the first body (312) and the second body (314) being configured to cooperate to grip at least a portion of the delivery shaft (220), and 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 retaining mechanism (310) to release the retained delivery shaft (220).
2. 2. The package (100) of claim 1, wherein the delivery shaft retention mechanism (310) further comprises an actuation pin (316) and a movement guide (318), wherein a force applied by the inserter tool during coupling advances the pin (316) and the movement guide (318) from a retention position to a release position, wherein the movement guide (318) slidably coupled to the second body (314) effects movement of the second body (314) from the retention position to the release position.
3. 3. The package (100) of claim 2, wherein The movement guide (318) comprises at least one guide slot (320) with at least part of a cam path, -Said second body (314) comprises at least one protrusion (322) engaged in said guiding groove (320), -Movement of the moving guide (318) from the holding position to the release position effects sliding of the guide slot (320) and movement of the at least one projection (322) along the cam path, thereby disengaging at least a portion of the second body (314) from the first body (312).
4. 4. The package (100) of claim 1, wherein the first body (312) and the second body (314) are connected by a hinge.
5. 5. The package (100) of claim 4, wherein the hinge is a living hinge.
6. 6. The package (100) of claim 1, wherein the first body (312) is provided with a retainer (324), the retainer (324) being configured to limit movement of the implant (230) in the distal end (40) direction in the lumen (222) of the delivery shaft (220).
7. 7. The package (100) of claim 6, wherein the retainer includes a protrusion configured to at least partially engage a lumen (222) of the delivery shaft (220).
8. 8. The package (100) of any one of claims 1 to 7, 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) is at least partially narrowed, thereby restricting movement of the implant (230) in a proximal (20) direction.
9. 9. The package (100) of any one of claims 1 to 7, wherein the vial-holding space (410) is configured for holding a liquid.
10. 10. The package (100) of any of claims 1 to 7, wherein the vial (400) has an opening (412) closable by a cap or removable seal.
11. 11. The package (100) of any one of claims 1 to 7, wherein the insert (300) further comprises one or more fluid displacing bodies (340), the one or more fluid displacing bodies (340) being configured to displace solution from the vial holding space (410) during coupling of the insert (300) into the vial holding space (410).
12. 12. The package (100) of claim 11, wherein the solution is an aqueous solution.
13. 13. The package (100) of claim 11, wherein the insert (300) further comprises an overflow outlet (342), the overflow outlet (342) configured for passing solution displaced from the vial.
14. 14. The package (100) of any one of claims 1 to 7, further comprising a delivery shaft assembly (200) of claim 1.

Description

Package for holding and dispensing a delivery shaft assembly for delivering an implant Technical Field Provided herein is a package for holding and dispensing a delivery shaft assembly for delivering an implant for implantation in a subject. Background Implants are commonly used to treat conditions where drug therapy is ineffective or unusable. Techniques for placement of implants typically rely on an inserter tool that temporarily holds the implant and provides an extension for placement at the implant site and a mechanism for ejection from the inserter. The implant may be very small, e.g., 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 e.g. in WO 2017/108498. A problem in the art is how to store the implant to optimize it prior to use. Small implants can be difficult to load into an inserter just prior to use. Some implants need to remain in liquid storage without damage or exposure to cavitation. Disclosure of Invention Described herein is a package (100) for holding and dispensing a delivery shaft assembly (200) for delivering an implant (230), wherein The delivery shaft assembly (200) includes a delivery shaft (220) having a lumen (222) for holding an implant (230) and an adapter (210), 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 the delivery shaft assembly lumen (222) and with an adapter coupler (520) configured to be coupled 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 in the vial-holding space (410), wherein the insert (300) comprises: A force receiving body (308), the force receiving body (308) configured to support the adapter (210) during coupling to the inserter tool (500), A delivery shaft holding mechanism (310), the delivery shaft holding mechanism (310) being configured to releasably hold a delivery shaft, Wherein a force applied 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 insert (300) and vial (400). The delivery shaft retention 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 grip 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) to release the retained delivery shaft (220). The delivery shaft retention mechanism (310) may further include an actuation pin (316) and a movement guide (318), wherein a force applied by the inserter tool during coupling advances the pin (316) and movement guide (318) from the retention position to the release position, wherein the movement 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 movement 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 movement 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, thereby disengaging 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 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 cap 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 distal end (40) direction within the lumen (222) of the delivery shaft (220). The retainer may include a protrusion configured to at least partially engage a lumen (222) of a 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 displacing bodies (340), the fluid displacing bodies (340) being configured to displace (aqueous) so