NEEDLE ASSEMBLY FOR A PREFILLED SYRINGE SYSTEM

• US 20090171296A1
• Filed: 08/03/2006
• Published: 07/02/2009
• Est. Priority Date: 08/30/2005
• Status: Abandoned Application

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Kovac, Jasminka, Eberle, Andreas, Beyeler, Stefan, Fabian, Arthur
• Application Number:
  US12/064,252
• Publication Number:
  US 20090171296A1
• Time in Patent Office: Days
• US Class Current: 604/192
• 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 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 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49904 Assembling a subassembly, then assembling with a second subassembly

Abstract

A needle assembly (10; 210) for a prefilled injection syringe is described. A needle holder (12; 212) has a needle (14; 214) secured to it and is adapted to be secured to a syringe barrel of the injection syringe. A needle sheath (16; 216) has a distal end forming a releasable sterile seal with the needle holder (12; 212), and surrounds and shields the needle (14; 214). A needle seal (18; 218) surmounts the needle tip and is arranged at least in part in the proximal end of the needle sheath (16; 216) and closed off by a closure element (20; 220). A closure connection between the closure element (20; 220) and the needle sheath (16; 216) is configured as a non-releasable and sterile barrier (54; 254) produced by means of bonding or welding.

Claims

1. A needle assembly (10;

210) for a prefilled injection syringe, comprising;

a needle holder (12;

212) adapted to be secured to a syringe barrel of the injection syringe and a needle (14;

214) secured to the needle holder (12;

212);

a needle sheath (16;

216), releasably connected at its distal end to the needle holder (12;

212) to form a sterile seal, and surrounding and shielding the needle (14;

214);

a needle seal (18;

218) located on the needle tip and arranged at least in part in the proximal end of the needle sheath (16;

216); and

a closure element (20;

220) that closes off the proximal end of the needle seal;

characterized by;

a closure connection between the closure element (20;

220) and the needle sheath (16;

216), configured as a non-releasable and sterile barrier (54;

254) produced by means of bonding or welding.

2. The needle assembly as set forth in claim 1, characterized in that said sterile barrier (54;

254) is produced by ultrasonic welding.

3. The needle assembly as set forth in claim 1, characterized in that said sterile barrier (54;

254) is produced by laser welding.

4. The needle assembly as set forth in claim 1, characterized by the use of non-toxic acrylic-based adhesives for curing by means of UV light or at room temperature for producing said sterile barrier (54;

254) by means of a bonding technique.

5. The needle assembly as set forth in any of the claims 1 to 4, characterized in that said closure element (20;

220) is a cap (56;

256) with a cylindrical shell (60;

260), and said needle sheath (16;

216) is a tubular member (32;

232), the proximal end of which is provided with a ring flange (34;

234), the distal rim (62;

262) of said cap shell (60;

260) connecting said ring flange (34;

234) of said needle sheath (16;

216) in forming a sterile barrier (54;

254).

6. The needle assembly as set forth in claim 5, characterized in that said ring flange (34:

234) of said needle sheath (16;

216) is provided at the outer edge of its proximal side with an annular face (36;

236) for securing said distal rim (62;

262) of said cap shell (60, 260).

7. The needle assembly as set forth in any of the preceding claims, characterized by:

a supporting collar (38;

238) jutting forwards from the proximal side of said ring flange (34, 234) of said needle sheath (16;

216) radially within said outer annular securing face (36;

236) for said closure element (20;

220),

a flange-type extension (48;

248) of the upper end of said needle seal (18;

218) with which said needle seal (18;

218) is supported by said supporting collar (38;

238) of said needle sheath (16;

216) thereof, and

the distal side (70) of said closure element (20;

220) contacting a proximal end of said needle seal (18;

218).

8. The needle assembly as set forth in claim 7, characterized in that the proximal end of said flange-type extension (48;

248) of said needle seal (18;

218) is provided with a ring collar (50;

250) contacting the distal side (70;

270) of said header plate (58;

258) of said closure element (20;

220)

9. The needle assembly as set forth in claim 7, characterized in that said ring flange (34) of said needle sheath (16) and said supporting collar (38) each comprise at said ring flange (34) of said needle sheath (16;

216) a cylindrical inner surface area (46) whose bore corresponds to the bore of said cylindrical inner surface area of said needle sheath (16).

10. The needle assembly as set forth in claim 7, characterized in that said inner surface area (246) of said supporting collar (238) of said needle sheath (216) is flared conically proximally and that said flange-type extension (248) of said needle seal (218) has a circumferential surface area which at least over a portion (249) of its distal end matches the shape of said conical inner surface area (246) of said supporting collar (238) and is supported by this conical partial portion (248) at said inner surface area (246) of said supporting collar (238).

11. The needle assembly as set forth in one or more of the preceding claims, characterized in that the distal end of said needle seal (18) receiving said needle tip contains a central opening (42) for said needle (14).

12. The needle assembly as set forth in one or more of the preceding claims, characterized in that a portion (40;

240) of said needle seal (18;

218) arranged distally of said flange-type extension (48;

248) extends into said supporting collar (38;

238) into the proximal end of said needle sheath (16;

216), and comprises a diameter substantially equal to that of the inner space of said needle sheath (16;

216).

13. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle sheath (16;

216) is integrally connected at its distal end by a designed frangible connection (52;

252) to a proximal portion of said needle holder.

14. The needle assembly as set forth in one or more of the preceding claims, characterized in that said closure element (20;

220) and said needle sheath (16;

216) are made of an amorphous or partly crystalline thermoplastic, such as polypropylene or polythene.

15. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle seal (18;

218) is made of a pharmaceutical rubber or a thermoplastic elastomer.

16. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle (14;

214) is made of a stainless steel.

17. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle (14;

214) is fixedly bonded in said needle holder (12;

212) coaxially to said needle sheath (16;

216).

18. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle (14;

214) is fixedly connected to said needle holder (12;

212) by a plastics potting.

19. The needle assembly as set forth in one or more of the preceding claims, characterized in that said needle holder (12;

212) is made of a thermoplastic such as polycarbonate, polypropylene or polyamide.

20. A method of manufacturing a needle assembly (10;

210) for a prefilled injection syringe, comprising;

securing a needle to a needle holder (12;

212) that is adapted to be secured to a syringe barrel of the injection syringe;

releasably connecting the distal end of a needle sheath (16;

216) to the needle holder (12;

212) to form a sterile seal, and to surround and shield the needle (14;

214);

locating a needle seal (18;

218) on the needle tip and at least in part in the proximal end of the needle sheath (16;

216); and

closing off the proximal end of the needle seal with a closure element (20;

220); and

characterized by;

forming a closure connection between the closure element (20;

220) and the needle sheath (16;

216), configured as a non-releasable and sterile barrier (54;

254), by means of bonding or welding.

21. The method of claim 20, in which:

a first subassembly of the needle seal (18;

218), closure element (20;

220) and needle sheath (16;

216) is formed, in which the needle seal (18;

218) is arranged at least in part in the proximal end of the needle sheath (16;

216) and the closure element (20;

220) closes off the proximal end of the needle seal;

a second subassembly is formed by securing the needle (14;

214) to the needle holder (12;

212); and

the first and second subassemblies are offered up to one another so that the needle sheath. (16;

216) releasably connects at its distal end to the needle holder (12;

212) to form a sterile seal, and surrounds and shields the needle (14;

214), and the needle seal (18;

218) locates on the needle tip.

22. A method according to claim 20, in which:

a first subassembly is formed by securing the needle (14;

214) to the needle holder (12;

212);

a second subassembly is formed by inserting the first subassembly into the needle sheath (16;

216);

a third subassembly is formed by mounting the needle seal (18, 218) onto needle tip and needle sheath (16;

216) of the second subassembly; and

the needle assembly is completed by forming the closure connection between the closure element (20;

220) and the needle sheath (16;

216) of the third subassembly.