Process for manufacturing an injection device of the pre-filled type containing a dose of liquid for injection and injection device produced

• US 5,855,839 A
• Filed: 04/29/1996
• Issued: 01/05/1999
• Est. Priority Date: 05/04/1995
• Status: Expired due to Term

• Current Assignee: Glaxo Group Limited (GSK plc)
• Original Assignee: Sanofi
• Inventors: Brunel, Marc
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): Nguyen, A T
• Application Number:
  US08/638,832
• Time in Patent Office: 981 Days
• Field of Search: 264/524, 264/537, 222/94, 222/92, 604/110, 604/111, 604/192, 604/194, 604/195-198
• US Class Current: 264/524
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/287 by displacing occluding plugs
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2005/3139 Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
• CPC Class Codes: A61M 2005/3247 Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
• CPC Class Codes: A61M 2005/342 Off-center needles, i.e. needle connections not being coaxial with the longitudinal symmetry axis of syringe barrel
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/28 Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
• CPC Class Codes: A61M 5/286 upon internal pressure increase, e.g. pierced or burst A61M5/283 takes precedence
• 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 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

The invention relates to a process for manufacturing an injection device of the pre-filled type comprising producing, in a deformable plastics material, a tubular syringe body (101) equipped with an external locking element (104) suitable for deforming radially between retracted and dilated positions, producing a tubular sheath (109) equipped with an internal locking element (110, 111) paired with that of the syringe body (101), fitting the sheath (109) round the syringe body (101), by a relative sliding of these latter permitted by the radial retraction of the locking element (104) of the syringe body (101), and introducing into the syringe body (101) a rigid pre-filled container suitable for bringing the locking element (104) of the said syringe body into its dilated position, enabling an irreversible locking of the sheath (109) to be obtained once it has been brought, after injection, into an advanced, post-use protection position.

Claims

1. A process for manufacturing and assembling a pre-filled injection device including an injection needle (116, 15, 23, 47), said process comprising the steps of:

producing a tubular syringe body (101, 121, 1, 20,

     42) of a deformable plastic material having a distal end and a proximal end, equipping said proximal end with finger-hold elements (105, 5, 26,

     53) and equipping said distal end with an external locking element (104, 123, 7-9, 27-29, 54-56) suitable for deforming radially between a retracted position and a dilated position,

producing a tubular sheath (109, 10, 31,

     58) of a shape suitable for sliding along said syringe body, providing said tubular sheath with an internal locking element (110, 111, 11, 32,

     59) located at a proximal end of said tubular sheath;

locating said proximal end of said sheath adjacent the distal end of said syringe body and slidably inserting said sheath into said syringe body, said sliding being accommodated by radial retraction of said locking element and bringing the said proximal end of said sheath to a position adjacent to said finger-hold elements of said syringe body;

introducing into said syringe body a rigid pre-filled container (114, 13, 34,

     61) having an external cross-section which cooperates with the internal cross-section of said syringe body and suitable for bringing said external locking element of said syringe body into a dilated position thereby preventing further radial deformation of said locking element, and equipping said rigid container with means (119, 120;

18, 19;

37, 38;

     62) for injecting liquid from said pre-filled container and locking said syringe body and said rigid container against further longitudinal movement with respect to each other.

2. A process as defined in claim 1 further including the step of providing said syringe body with a peripheral wall having at least one longitudinal slot (102, 2, 24, 51) opposite said external locking element suitable for permitting said radial deformation of said locking element.

3. A process as defined in claim 2 further including the steps of

equipping said syringe body (20) toward its distal end with a nose (21) pierced longitudinally by a bore (22) of cross-section suitable for accommodating said injection needle (23),

introducing said injection needle into said bore of said nose of said syringe body (20), so that said injection needle has an active injection portion (23a) in the extension of said syringe body and a piercing portion (23b) opening into an interior thereof,

securing said injection needle (23) in said bore (22) of said nose (21) of said syringe body (20), and introducing into said syringe body a rigid, pre-filled container (34) having a sealing element (35) suitable for being pierced by said piercing portion (23b) of said injection needle (23).

4. A process as defined in claim 2 further including the steps of:

equipping said syringe body (42) with a front end sealed by a front end wall (43) pierced by an aperture (44), and having a longitudinal bore (45) arranged in a peripheral wall thereof, extending between said front wall and a radial internal duct (46) opening into the interior of said syringe body (42), said radial duct (46) being arranged at a distance from said front wall and being juxtaposed longitudinally to a shoulder (49) thus providing inside said syringe body an end chamber (50) incorporating said radial duct (46) thereby providing a smaller cross-section than said internal cross-section of said syringe body,

introducing an injection needle (47) into said longitudinal bore (45) so that it has an active injection portion (47a) in the extension of said front wall (43) of said syringe body (42),

securing said injection needle 47 in said longitudinal bore (45) of said syringe body (42),

and introducing into the interior of said syringe body (42) a rigid pre-filled tube (61) having a cross-section suitable for engaging said shoulder (49) of said syringe body, said rigid tube being sealed adjacent opposite ends thereof by a sliding plug (62,

     63), one end of said plug (63) having a shape for fitting within said end chamber (50) when said plug (62) is located to rest against said front wall (43) for disengaging said radial duct (46).

5. A process as defined in claim 1 further including the steps of producing said syringe body to comprise a front end portion (122) in the form of a truncated-cone-shaped portion of decreasing cross-section in the direction of said distal end of said syringe body, and providing said cone-shaped portion with longitudinally extending weakness zones (124) for allowing radial dilation thereof for disabling said locking element (123).

6. A process as defined in claim 1 further including the steps of securing said respective proximal ends of said sheath and of said syringe body in an injection position with holding means suitable for yielding under the effect of longitudinal tensile force applied to said sheath for sliding said sheath over the distal end of said syringe body.

7. a process as defined in claim 1 further including the steps of

equipping said syringe body (101;

1) with a distal end in the form of a sleeve (3),

inserting into said syringe body a rigid container comprising a pre-filled syringe (114;

     13) with an injection needle (116;

     15) and having a distal portion of a shape suitable for being accommodated in said sleeve (3) of said syringe body (101;

     1), so that said injection needle (116;

     15) extends from said distal end of said syringe body.

8. A process as defined in claim 1 including the step of providing a front end of said syringe body (101, 121, 1, 20, 42) with a closure cap.