US 12,377,220 B2
Assembly for an injection or infustion device
Christian Schrul, Burgdorf (CH); Stefan Burren, Schwarzenburg (CH); Mario Bernhard, Burgdorf (CH); Bernhard Bigler, Niederönz (CH); and Simon Scheurer, Bern (CH)
Assigned to Ypsomed AG, Burgdorf (CH)
Filed by Ypsomed AG, Burgdorf (CH)
Filed on Sep. 10, 2020, as Appl. No. 17/017,182.
Application 17/017,182 is a continuation of application No. PCT/IB2019/051357, filed on Feb. 20, 2019.
Claims priority of application No. 18161873 (EP), filed on Mar. 15, 2018.
Prior Publication US 2021/0001048 A1, Jan. 7, 2021
Int. Cl. A61M 5/24 (2006.01); A61M 5/142 (2006.01)
CPC A61M 5/2466 (2013.01) [A61M 5/14248 (2013.01); A61M 2005/247 (2013.01); A61M 2207/00 (2013.01)] 20 Claims
OG exemplary drawing
 
1. An assembly for an injection or infusion device, the assembly comprising
a cartridge for a sterile liquid medicament, formed as a barrel, the cartridge being closed by a septum fastened to the barrel by a crimp, wherein a first surface of the septum opposite a second surface contacting the liquid medicament is recessed from a surface of the crimp, is sterile and is covered by a first area of a first continuous flexible strip, the first area of a first continuous flexible strip being attached to the surface of the crimp without contacting the first surface of the septum, thereby keeping the first surface of the septum in a sterile condition; and
a fluid path unit comprising a cartridge holder and a fluid path compartment comprising a needle or spike in an interior of the fluid path compartment, wherein the needle or spike is configured to penetrate the septum of the cartridge through a passage defined in a surface of the fluid path compartment, wherein the passage of the fluid path compartment is closed by a second continuous flexible strip attached to the surface of the fluid path compartment, the second continuous flexible strip comprising a second area covering the passage thereby keeping the interior of the fluid path compartment in a sterile condition,
wherein the cartridge is arranged in the cartridge holder of the fluid path unit such that the septum is aligned with the passage of the fluid path compartment and the first continuous flexible strip and the second continuous flexible strip contact each other and are sandwiched between the septum and the fluid path compartment,
wherein the first continuous flexible strip has a first free end and the second continuous flexible strip has a second free end, the first and second free ends are arranged substantially parallel to one another adjacent the passage of the fluid path compartment, and
wherein, by simultaneously pulling the first free end and the second free end, the first continuous flexible strip and the second continuous flexible strip are detachable from the assembly upon removal from the surface of the crimp and the surface of the fluid path compartment for establishing a sterile connection between the opposite first surface of the septum and the interior of the fluid path compartment.
 
14. A method for assembling an assembly for an injection or infusion device, comprising the steps of:
providing a cartridge comprising a sterile liquid medicament, formed as a barrel, the cartridge being closed by a septum fastened to the barrel by a crimp, a surface of the septum opposite to a surface contacting the liquid medicament being sterile and covered by a first area of a first continuous flexible strip attached to a surface of the crimp, thereby keeping the opposite surface of the septum in a sterile condition;
providing a fluid path unit comprising a cartridge holder and a fluid path compartment comprising a needle or spike in an interior of the fluid path compartment, wherein the needle or spike is configured to penetrate the septum of the cartridge through a passage defined in a surface of the fluid path compartment, wherein the passage is closed by a second continuous flexible strip that is attached to the surface of the fluid path compartment, the second continuous flexible strip having a second area covering the passage thereby keeping the interior of the fluid path compartment in a sterile condition; and
inserting the cartridge in the cartridge holder of the fluid path unit such that the septum is aligned with the passage of the fluid path compartment and that the first continuous flexible strip and the second continuous flexible strip contact each other and are sandwiched between the septum and the fluid path compartment,
wherein the first continuous flexible strip comprises a first free end and the second continuous flexible strip comprises a second free end, the first free end and the second free end arranged substantially parallel to another adjacent from the passage during insertion, and
wherein, by pulling the first and second free ends, the first and second continuous flexible strips are detachable from the assembly upon removal from the surface of the crimp and the surface of the fluid path compartment.
 
19. An injection or infusion device comprising an assembly which has been assembled in which:
the assembly comprises:
a cartridge comprising a sterile liquid medicament, formed as a barrel, the cartridge being closed by a septum fastened to the barrel by a crimp, wherein a surface of the septum opposite a surface contacting the liquid medicament being sterile and covered by a first area of a first continuous flexible strip attached to a surface of the crimp, thereby keeping the opposite surface of the septum in a sterile condition; and
a fluid path unit comprising a cartridge holder and a fluid path compartment comprising a needle or spike in an interior of the fluid path compartment, wherein the needle or spike is configured to penetrate the septum of the cartridge through a passage defined in a surface of the fluid path compartment, wherein the passage of the fluid path compartment is closed by a second continuous flexible strip attached to the surface of the fluid path compartment, the second continuous flexible strip comprising a second area covering the passage thereby keeping the interior of the fluid path compartment in a sterile condition, and
wherein:
the cartridge is inside in the cartridge holder of the fluid path unit such that the septum of the cartridge is aligned with the passage of the fluid path compartment and the first continuous flexible strip and the second continuous flexible strip contact each other and are sandwiched between the septum and the fluid path compartment,
wherein the first continuous flexible strip comprises a first free end and the second continuous flexible strip comprises a second free end, the first free end and the second free end arranged substantially parallel to another adjacent from the passage, and
wherein, by pulling the first free end and the second free end, the first continuous flexible strip and the second continuous flexible strip are detachable from the assembly upon removal from the surface of the crimp and the surface of the fluid path compartment for establishing a sterile connection between the first surface of the septum and the interior of the fluid path compartment.