# US 9,039,673 B2 · Unitary withdrawal spike unit suitable for factory fitting > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,039,673 B2 - Document ID: US9039673B2 - Status: Granted - Kind: B2 - Application number: 12/812,015 - Filed: 2009-01-09 - Published: 2011-01-27 - Granted: 2015-05-26 - Earliest claimed: 2008-01-09 - Assignees: Novartis AG - Applicants: Dietmar Weitzel; Astrid Hoffmann - Inventors: Dietmar Weitzel; Astrid Hoffmann - Web page: https://patentgrep.com/patent/US9039673B2 ## CPC - A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents} - A61J 1/1412: {Containers with closing means, e.g. caps} - A61J 1/1443: {Containers with means for dispensing liquid medicaments in a filtered or sterile way, e.g. with bacterial filters} - A61J 1/18: Arrangements for indicating condition of container contents, e.g. sterile condition - A61J 1/1425: {Snap-fit type} - A61J 1/201: {having one piercing end} - A61J 1/2055: {having gripping means} - A61J 1/2075: {for external venting} - A61J 1/2082: {for gas filtration} - A61J 1/2086: {for fluid filtration} - Y10T 29/49826: Assembling or joining - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract A withdrawal spike unit (200) comprises a withdrawal spike component (30′) and an integrally formed adapter component (60′) that is adapted to couple with a vial (10) in a safe and secure manner. The integral formation of the component parts (30′, 60′) makes fully automated manufacture and assembly of assemblies comprising such a withdrawal spike unit (200) coupled to a vial (10) possible. As such, human errors associated with the assembly at the point of use are mitigated. ## Claims ### Claim 1 A withdrawal spike unit including a withdrawal spike and an integral adapter configured to couple with a multidose vial, wherein the configuration of the withdrawal spike and the integral adaptor irreversibly engaged with the multidose vial will maintain sterility therein during and after withdrawal of a first sterile dose therefrom into a first device and will maintain sterility of a second dose withdrawn therefrom into a second device, the adapter comprising: a hollow body defined by an outer wall having a first end and a second end formed integrally with the withdrawal spike; and a retaining member at the first end adapted to irreversibly engage at least a portion of the multidose vial such that the withdrawal spike is locatable in a predetermined position with respect to the multidose vial. ### Claim 2 (depends on 1) The withdrawal spike unit of claim 1, wherein the retaining member comprises at least one inwardly extending projection. ### Claim 3 (depends on 2) The withdrawal spike unit of claim 2, wherein the or each projection is disposed at a free end of an associated resiliently deflectable tab that is defined by a pair of slots in the outer wall of the adapter body, the slots extending at least partially from the first end towards the second end of the outer wall. ### Claim 4 (depends on 3) The withdrawal spike unit of claim 3, wherein the or each projection includes a camming surface for engagement by at least a portion of the multidose vial. ### Claim 5 (depends on 3) The withdrawal spike unit of claim 3, wherein the outer wall includes a thinned portion between the ends of the pair of slots at the fixed end of the or each tab to aid tab deflection. ### Claim 6 (depends on 1) The withdrawal spike unit of claim 1, wherein the withdrawal spike comprises: a housing; and a piercing thorn, the thorn protruding centrally and perpendicularly from the housing, wherein a fluid flowpath is defined through the housing and the thorn. ### Claim 7 (depends on 6) The withdrawal spike unit of claim 6, wherein the withdrawal spike includes a swabbable valve in the flowpath within the housing. ### Claim 8 (depends on 6) The withdrawal spike unit of claim 6, further comprising a flange extending from the second end of the adapter body, the flange being formed integrally with the housing of the withdrawal spike. ### Claim 9 (depends on 8) The withdrawal spike unit of claim 8, wherein the flange comprises an annular disc that includes a rim extending about at least a portion of the flange periphery, the flange and rim being contiguous with the housing of the withdrawal spike. ### Claim 10 (depends on 1) The withdrawal spike unit of claim 1, further comprising a skirt projecting from the first end of the adapter body. ### Claim 11 (depends on 10) The withdrawal spike unit of claim 10, wherein the skirt is configured to enshroud at least a portion of the multidose vial, with an inner surface of the skirt having a shape that is adapted to match the contours of the relevant portion of the multidose vial. ### Claim 12 (depends on 1) The withdrawal spike unit of claim 1, further comprising at least one gripping surface. ### Claim 13 (depends on 12) The withdrawal spike unit of claim 12, wherein there is a pair of opposed gripping surfaces, each disposed on an outer surface of a boss projecting outwardly from the outer wall of the adapter body. ### Claim 14 (depends on 1) The withdrawal spike unit of claim 1, wherein the withdrawal spike and integral adapter comprises a unitary thermoplastic moulding. ### Claim 15 (depends on 1) An assembly comprising: a multidose vial; and the withdrawal spike unit of claim 1. ### Claim 16 (depends on 15) The assembly of claim 15, wherein the multidose vial comprises: a shell defining an interior chamber having an opening; and a cap hermetically sealing the opening. ### Claim 17 (depends on 16) The assembly claim 16, wherein the cap comprises a plug portion. ### Claim 18 (depends on 16) The assembly of claim 16, wherein the chamber contains multiple doses of a component. ### Claim 19 (depends on 18) The assembly of claim 18, wherein the component is preservative free. ### Claim 20 (depends on 18) The assembly of claim 18, wherein the component comprises an influenza vaccine. ### Claim 21 (depends on 15) The assembly of claim 15, wherein the retaining member at the first end of the adapter body retains at least a portion of the multidose vial such that the withdrawal spike is located in a predetermined position with respect to the multidose vial. ### Claim 22 (depends on 21) The assembly of claim 21, wherein the multidose vial comprises: a shell defining an interior chamber having an opening; and a cap hermetically sealing the opening and wherein the multidose vial cap is received in the hollow body of the adapter and is engaged by the retaining member. ### Claim 23 (depends on 21) The assembly of claim 21, wherein the withdrawal spike comprises: a housing; and a piercing thorn, the thorn protruding centrally and perpendicularly from the housing, wherein a fluid flowpath is defined through the housing and the thorn, and wherein said predetermined position comprises the thorn of the withdrawal spike being inserted through the multidose vial cap by a predetermined distance. ### Claim 24 (depends on 15) The assembly of claim 15, further comprising packaging encapsulating the multidose vial and withdrawal spike unit. ### Claim 25 (depends on 24) The assembly of claim 24, wherein the packaging comprises: a base; and a cover secured to the base, the base and cover together defining a compartment within which are housed the withdrawal spike unit and the multidose vial. ### Claim 26 (depends on 25) The assembly of claim 25, wherein the base comprises a board. ### Claim 27 (depends on 25) The assembly of claim 25, wherein the cover is a moulded plastics component. ### Claim 28 (depends on 1) A method of assembling an assembly for administering multiple doses of a component, comprising the steps of: providing a multidose vial containing the component; providing a withdrawal spike unit as defined in claim 1; and fitting the withdrawal spike unit onto the multidose vial. ### Claim 29 (depends on 28) The method of claim 28, wherein the step of providing the multidose vial comprises the sub-steps of: providing a shell defining an interior chamber having an opening; filling the chamber with contents; and hermetically sealing the opening with a cap. ### Claim 30 (depends on 29) The method of claim 29, wherein the sub-step of hermetically sealing the opening with a cap comprises: pushing a plug portion into the opening; and adding a skirt enshrouding the plug portion and at least a portion of the multidose vial. ### Claim 31 (depends on 29) The method of claim 29, wherein the or each projection includes a camming surface for engagement by at least a portion of the multidose vial and the fitting step comprising: engaging the camming surface of the or each projection with the multidose vial cap; resiliently deflecting outwardly the associated deflectable tab to a deflected position via a relative axial force between the multidose vial and the adapter; and passing the cap beyond the or each projection, the or each projection hence returning from the deflected position to retain the cap within the hollow adapter body. ### Claim 32 (depends on 28) The method of claim 28, further including the step of removing a flip-off disk from the multidose vial prior to the fitting step. ### Claim 33 (depends on 28) The method of claim 28, further comprising a step of encapsulating the multidose vial and withdrawal spike unit in packaging. ### Claim 34 (depends on 33) The method of claim 33, wherein the encapsulating step takes place prior to the fitting step, the fitting step occurring after subsequent removal of the withdrawal spike unit and the multidose vial from the packaging. ### Claim 35 (depends on 34) The method of claim 34, wherein the steps of removing the packaging and fitting the withdrawal spike unit onto the multidose vial take place at the point of use. ### Claim 36 (depends on 28) The method of claim 28, wherein each step is carried out at the place of manufacture. ### Claim 37 (depends on 36) The method of claim 36, wherein the fitting step is carried out in an automated manner. ### Claim 38 (depends on 28) The method of claim 28, wherein the component comprises a vaccine. ### Claim 39 (depends on 38) The method of claim 38, wherein the component is preservative free. ### Claim 40 (depends on 38) The method of claim 38, wherein the component comprises an influenza vaccine. ### Claim 41 (depends on 28) A method of preparing multiple doses of a component comprising the steps of: assembling the assembly in accordance with the method of claim 28; inserting an injection device into the withdrawal spike unit; withdrawing a sterile dose of component from the multidose vial into the injection device through the withdrawal spike unit; and repeating the inserting and withdrawal steps using further injection devices. ### Claim 42 (depends on 1) The withdrawal spike unit of claim 1, wherein the withdrawal spike further comprises a connecting piece adapted to independently engage said first and said second devices, wherein the connecting piece is in fluid connection with the multidose vial. ### Claim 43 (depends on 42) The withdrawal spike unit of claim 42, wherein the connecting piece is configured as a Luer-Lock connector.