公开(公告)号：US11565006B2

公开(公告)日：2023-01-31

申请号：US16950312

申请日：2020-11-17

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: G01N23/00 ,  H01J27/00 ,  A61N5/00 ,  G21F5/00 ,  A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

Abstract: An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

公开(公告)号：USD962472S1

公开(公告)日：2022-08-30

申请号：US29743494

申请日：2020-07-22

Applicant: AMGEN INC.

Designer： Anthony Bantug ,  Wael Mismar ,  Kenneth Tan ,  Tark Abed ,  Justin Allen Marsh ,  Mario Bogdan ,  Scott Comiso

公开(公告)号：US20210330880A1

公开(公告)日：2021-10-28

申请号：US16625208

申请日：2018-07-11

Applicant: AMGEN INC.

Inventor： Sheldon Moberg ,  Matthew Wayne Janke ,  Wael Mismar ,  Alexis Dechelette

IPC: A61M5/162 ,  A61M5/142 ,  A61M5/20

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a container including a wall with an interior surface and a seal member with an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir filled with a drug. A fluid pathway assembly may be connected to the container and include an overmold member that covers a length of a container access needle and which defines an enclosed space with the seal member. The overmold member may be moveable relative to the seal member to carry the container access needle between a storage position, where a point of the container access needle is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.

公开(公告)号：US20200338271A1

公开(公告)日：2020-10-29

申请号：US16761149

申请日：2018-11-06

Applicant: AMGEN INC.

Inventor： Justin Harris ,  Matthew Wayne Janke ,  Wael Mismar ,  Jerome Olivas ,  Thomas Clark Pearson ,  Sudeshna Dutta Ray ,  Ryan M. Agard ,  Alexis Dechelette ,  Michael Gammelager ,  Mads Hansen ,  Valerio Mazzon ,  Owen Ryan ,  Clive Smith

IPC: A61M5/28 ,  A61M5/31 ,  A61M5/24 ,  A61M5/178

Abstract: Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly. The carrier may be configured to hold the container, the insertion mechanism, and the fluid pathway connection assembly in alignment with each other.

公开(公告)号：USD894423S1

公开(公告)日：2020-08-25

申请号：US29657240

申请日：2018-07-20

Applicant: AMGEN INC.

Designer： Anthony Bantug ,  Wael Mismar ,  Kenneth Tan ,  Tark Abed ,  Justin Allen Marsh ,  Mario Bogdan ,  Scott Comiso

公开(公告)号：US12240652B2

公开(公告)日：2025-03-04

申请号：US17183515

申请日：2021-02-24

Applicant: AMGEN INC.

Inventor： Anthony Bitong ,  Jessica Liu ,  Mads Schjoth Due ,  Wael Mismar ,  Greg Payne

IPC: B65D25/04 ,  A61L2/00

Abstract: A container and systems for use during an external sterilization process of a plurality of drug delivery devices are provided. The container may include an outer housing and at least one partition at least partially enclosed by the outer housing. The at least one partition may include a plurality of first dividers and a plurality of second dividers. The at least one partition may also be positioned an open configuration, wherein the plurality of first dividers and the plurality of second dividers cooperate with each other to define a plurality of chambers configured to receive at least one of the plurality of drug delivery devices. The at least one partition may also be positioned in a closed configuration wherein the plurality of chambers are substantially completely collapsed.

公开(公告)号：US12233177B2

公开(公告)日：2025-02-25

申请号：US17022695

申请日：2020-09-16

Applicant: AMGEN INC.

Inventor： Wael Mismar ,  Jessica Hai Liu ,  Chia-Jung Wu ,  Shermeen A. Abbas ,  Shaun Devitt ,  Kenneth G. Schalhoub ,  Anthony Bitong ,  Mads Schjoth Due ,  Malak Guirguis ,  Rami Saifan

IPC: A61L2/20 ,  A61L2/26

Abstract: A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.

公开(公告)号：US11826480B2

公开(公告)日：2023-11-28

申请号：US16179399

申请日：2018-11-02

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: A61L2/00 ,  G01N21/00 ,  A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

CPC classification number: A61L2/08 ,  A61L2/081 ,  A61L2/087 ,  A61L2/26 ,  A61M5/008 ,  A61M5/285 ,  B65B3/003 ,  B65B55/08 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08 ,  A61L2202/23 ,  A61M5/001 ,  A61M5/002

Abstract: A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.

公开(公告)号：US11305026B2

公开(公告)日：2022-04-19

申请号：US16179450

申请日：2018-11-02

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: A61M5/00 ,  A61L2/26 ,  A61L2/08 ,  A61M5/28 ,  B65B3/00 ,  B65B55/08 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

Abstract: A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

公开(公告)号：US20210361529A1

公开(公告)日：2021-11-25

申请号：US16629330

申请日：2018-07-11

Applicant: AMGEN INC.

Inventor： Cheng-Chieh Chou ,  Mingda Eu ,  Ren-Yo Forng ,  Wael Mismar

IPC: A61J1/14 ,  A61L2/07 ,  A61L2/20 ,  A61L2/26

Abstract: Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.