METHOD OF ASSEMBLING MEDICAMENT INJECTION DEVICE

• US 20130174518A1
• Filed: 09/06/2011
• Published: 07/11/2013
• Est. Priority Date: 09/24/2010
• Status: Abandoned Application

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: Ogawa, Junichi, Tachikawa, Kouichi
• Application Number:
  US13/825,391
• Publication Number:
  US 20130174518A1
• Time in Patent Office: Days
• US Class Current: 53/425
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3293 characterised by features of the needle hub
• CPC Class Codes: A61M 5/343 Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub A61M5/322 takes precedence
• CPC Class Codes: A61M 5/348 snap lock, i.e. upon axial displacement of needle assembly A61M5/344 takes precedence
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 55/06 by heat
• CPC Class Codes: B65B 55/08 by irradiation
• CPC Class Codes: B65B 7/2821 applying plugs or threadless stoppers for bottles or jars B67B1/04

Abstract

Disclosed is a method of assembling a medicament injection device including the following steps: a step of integrally fixing a needle tube to a needle hub by high-frequency welding; a step of radiation sterilizing the needle tube and the needle hub; a step of subjecting a container to be filled with a medicament to a sterilization treatment which involves generation of heat; a step of aseptically transporting the needle hub which has been subjected to the radiation sterilization into an isolator device; a step of fixing the needle hub to the container in a sterile environment in the isolator device; and a step of filling the container fixing the needle hub with the medicament in the sterile environment.

Claims

1. A method of assembling a medicament injection device, comprising:

integrally fixing a needle tube to a needle hub for holding the needle tube by high-frequency welding, and the needle tube having a needle tip capable of puncturing a living body;

subjecting the needle tube and the needle hub fixing the needle tube to a radiation sterilization treatment;

subjecting a container to be filled with a medicament to a sterilization treatment which involves generation of heat;

aseptically transporting the needle hub having been subjected to the radiation sterilization treatment into an isolator device;

fixing the needle hub having been subjected to the radiation sterilization treatment to the container having been subjected to the sterilization treatment which involves the generation of heat in a sterile environment in the isolator device; and

filling the container fixing the needle hub with the medicament in the sterile environment.

2. The method of assembling the medicament injection device according to claim 1,

wherein the fixing the needle hub to the container is carried out by a mechanical fixing method.

3. The method of assembling the medicament injection device according to claim 2,

wherein the needle hub includes a hub-side engaging claw or a hub-side engaging receptor, and

the container includes a container-side engaging receptor for engagement with the hub-side engaging claw or a container-side engaging claw for engagement with the hub-side engaging receptor.

4. The method of assembling the medicament injection device according to claim 2,

wherein the needle hub and the container are fixed to each other in a liquid-tight manner by taper fit.

5. The method of assembling the medicament injection device according to claim 1 further comprising

putting a gasket into the container filled with the medicament, in the sterile environment.