Automatic injection device with temporizing means

• US 7,976,514 B2
• Filed: 09/05/2007
• Issued: 07/12/2011
• Est. Priority Date: 09/06/2006
• Status: Active Grant

• Current Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Original Assignee: Becton, Dickinson & Co
• Inventors: Carrel, Franck, Maritan, Lionel, Abry, Herve, Perot, Frederic, Grunhut, Guillaume
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/440,145
• Publication Number:
  US 20100094214A1
• Time in Patent Office: 1,406 Days
• Field of Search: 604/110, 604/134, 604/135, 604/157, 604/187, 604/192, 604/198, 604/208, 604/218, 604/228, 604/234, 604/246, 604/263
• US Class Current: 604/246
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/2086 having piston damping means, e.g. axially or rotationally acting retarders
• CPC Class Codes: A61M 2005/2407 from the rear
• CPC Class Codes: A61M 2005/244 by flexible clip
• 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 2005/3143 Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
• CPC Class Codes: A61M 2005/3261 triggered by radial deflection of the anchoring parts between sleeve and syringe barrel, e.g. spreading of sleeve retaining hooks having slanted surfaces by engagement with conically shaped collet of the piston rod during the last portion of the injection stroke of the plunger
• CPC Class Codes: A61M 2205/192 Avoiding coring, e.g. preventing formation of particles during puncture
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• 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 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/31566 Means improving security or handling thereof
• 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/322 Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston devices for protecting guide needles in combination with catheters A61M25/0612
• CPC Class Codes: A61M 5/326 : Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile

Abstract

The present invention relates to an injection device (1) comprising:—a container (5) receiving a product, and provided with an injection needle (6),—a housing (9, 11) receiving said container, said container being movable relative to said housing between an initial position, an insertion position, and a final position,—retaining means (12, 15), for maintaining said container in said insertion position,—deactivating means (20), for releasing said retaining means, said device being characterized in that it comprises:—temporizing means (19, 26, 27), for controlling the release of said retaining means until substantially all of the product contained within said container has passed through said injection needle before said container moves to said final position, and—a needle shield (2) coupled with said housing (9, 11) removal of said needle shield being with limited or no rotation of said needle shield. The invention also concerns a kit comprising such a device.

Claims

1. A device (1) for automatic injection of a product (3) into an injection site (4), the injection device comprising:

a container (5) having an open proximal end and a substantially closed distal end and being intended to receive the product, and provided at its distal end (5a) with an injection needle (6) providing an outlet port of said container,

a housing (9, 11;

68;

72;

93) intended to receive, at least partially, said container, said container being movable relative to said housing between an initial position, in which said needle is contained within said housing, an insertion position, distally spaced relative to said initial position and in which said needle is exposed over a predetermined length, and a final position in which said needle is contained within said housing (9, 11;

68;

72),

retaining means (12, 15;

46, 47;

104, 105, 107), arranged to maintain said container in said insertion position,

deactivating means (20;

49;

99), arranged to release automatically said retaining means and cause said container to move to said final position,

temporizing means (19, 26, 27;

41, 43;

50;

51;

52;

53;

55, 56;

57, 58;

59, 63;

79, 75, 76;

96, 97, 98), arranged to control the release of said retaining means by said deactivating means until substantially all of the product contained within said container has been caused to pass through said outlet port and said injection needle before said container moves to said final position, said device being characterized in that it further comprises;

a needle shield (2) coupled with said housing (9, 11;

93) and covering the needle prior to use of said device,

and, in that before use, said housing (9, 11;

93) is coupled to a deshielder (2a) comprising a cap (90) to which is fixed said needle shield (2), said housing comprising grooves (95) for guiding the translation of said cap (90) in an axial direction without rotation of said cap when said cap (90) is removed together with the removal of said deshielder (2a) in view of using said device (1).

2. Device (1) according to claim 1, characterized in that said temporizing means comprises a chamber (26;

59;

79;

96) comprising a vent outlet (19;

63;

75, 76;

97, 98), said chamber being tightly closed by a sealing cover (27;

29a;

60;

75, 76;

97, 98) in an initial state, and defining an initial volume of said chamber and in which a determined amount of fluid is contained within said initial volume, said sealing cover being movable within said chamber from said initial state to a final state in which at least part of said fluid has escaped through said vent outlet.

3. Device (1) according to claim 2, characterized in that said device further comprises elastic return means (24, 87) coupled to said chamber (26;

79;

96) for moving said sealing cover (27;

76;

98) from said initial state to said final state, said deactivating means (20;

99) being coupled to said chamber (29;

96) so that said deactivating means releases said retaining means (12, 15;

104, 105, 107) only when said sealing cover (27;

76;

98) is in said final state.

4. Device (1) according to claim 2, characterized in that said chamber (26, 29) comprises the proximal part of a sleeve (16;

30) having a closed proximal end (17;

30a) and an open distal end (18;

30b), said closed proximal end comprising a vent outlet and said open distal end comprising an outer radial rim (20), said device further comprising a piston (7) provided in said container and movable with respect to said container, and a plunger rod (8;

40) coupled to said piston so as to cause said piston to move with respect to said container, the movement of said piston causing said product to be expelled from said container through said injection needle, —

said sealing cover (27;

29a), in its initial state, closing the inner proximal space of said sleeve thereby defining said chamber, said sealing cover being coupled to said plunger rod, —

said outer radial rim (20) being able to cooperate with and release said retaining means when said sealing cover comes into contact with said closed proximal end of said sleeve.

5. Device (1) according to claim 4, characterized in that it further comprises first elastic return means (24) coupled to said housing (9, 11) for moving said container from said initial position to said insertion position, second elastic return means (25) coupled to said housing for moving said container from said insertion position to said final position, and a ring (14), said ring being coupled to said container at least from said insertion position to said final position of said container,

said retaining means comprises a flexible tongue (12) provided on said housing and engaged on an abutment surface (15a) situated on said ring, when said container is in said insertion position,

said outer radial rim deflecting said flexible tongue and thereby disengaging said tongue from said ring, when said sealing cover comes into contact with said closed proximal end of said sleeve, thereby freeing said second elastic return means and causing said container to move to said final position.

6. Device (1) according to claim 5, characterized in that it further comprises first retaining means (10, 20;

31, 32), arranged to maintain said container in said initial position, and first deactivating means (22, 23;

30), arranged to release said first retaining means and cause the insertion of said needle at the injection site (4), wherein said first retaining means comprises a flexible tooth (10) provided on said housing, said flexible tooth being engaged with said outer radial rim (20) of said sleeve when said container is in said initial position,

said first deactivating means comprises a push button (22) comprising at least one distal leg (23),

said distal leg cooperating with at least said flexible tooth so as to deflect and disengage said flexible tooth from said outer radial rim, under the effect of a manual pressure exerted on said push button, thereby freeing said first elastic return means and causing said container to move from said initial position to said insertion position.

7. Device (1) according to claim 1, characterized in that it further comprises first retaining means (10, 20;

31, 32) arranged to maintain said container in said initial position, and first deactivating means (22, 23;

30) arranged to release said first retaining means and cause the insertion of said needle at the injection site (4), wherein said first deactivating means (22, 23;

30) are manually actuated.

8. Device according to claim 1, characterized in that said device further comprises means for indicating to a user that substantially all of the product contained within said container has been caused to pass through said outlet port and said injection needle.

9. Device according to claim 1, characterized in that said device further comprises tamper-evidence means (2, 2a) removably coupled with said housing to shield said needle prior to use of said device, said tamper-evidence means being in one of a pre-use condition and a post-use condition, said post- use condition preventing re-use of said tamper evidence means with said device.

10. Device according to claim 9, wherein said post-use condition provides a visual indication that said tamper evidence means has been removed from said device.

11. Device according to claim 9, wherein said tamper-evidence means comprises said deshielder (2a) and said needle shield (2), said post-use condition proving an indication that said tamper-evidence means has been removed from said device.

12. Device (1) according to claim 2, characterized in that:

said device further comprising a piston (7) provided in said container (5) and movable within said container, the distal movement of said piston causing said product to be expelled from said container through said injection needle (6),

said chamber (59) being partly defined by the inner part (61) of the container (5) situated proximally to said piston and partly defined by the proximal part of said housing (68), said sealing cover (60) joining the proximal end (5b) of said inner part (61) to said housing (68) through a friction force of absolute value F,

said chamber being filled in said initial state of said sealing cover with a pressurized fluid (64) exerting a pressure of absolute value Pc on said container in the distal direction, with the intermediary of the piston (7),

said device further comprising elastic return means (62) for moving said container (5) from the insertion position to the final position, said elastic return means being coupled to said container so as to exert on said container a return force of absolute value Pe when said elastic return means is at least in a partly compressed state,

wherein Pc is strictly greater than (Pe+F) in the initial state of the sealing cover,

wherein Pc decreases as part of the pressurized fluid (64) is escaping the chamber via the vent outlet (63), said retaining means are formed by Pc being greater than (Pe+F), said retaining means being released when Pe becomes equal or greater than (Pc+F).

13. Device (1) according to claim 12, wherein said pressurized fluid (64) is provided to said chamber (59) from a recipient (65) present within said chamber (59), said recipient being sealingly closed when said container is in its initial position, said device being provided with a puncturing button (66) capable of creating an opening (67) in said recipient when a manual force is exerted on said puncturing button, said pressurized fluid being then allowed to escape from said recipient and to fill said chamber.

14. Device (1) according to claim 2, wherein said sealing cover (75, 76;

97, 98) is porous and forms said vent outlet.

15. Device (1) according to claim 14, wherein said device further comprises:

a piston (7) provided in said container (5) and movable within said container, the distal movement of said piston causing said product to be expelled from said container through said injection needle (6),

a piston rod (74) provided with a head (73) and a distal end (77), said piston rod (74) being independent from said piston (7), said chamber (79;

96) is defined by the volume delimited by the inner part (71) of the container (5) situated proximally to said piston, the wall of the housing (72) and the head (73) of the piston rod, the proximal end (5b) of said container (5) joining the wall of the housing via a first porous sealing cover (75;

97) and the head (73) of the piston rod (74) joining the wall of the housing via a second porous sealing cover (76;

98).

16. Device (1) according to claim 15, wherein:

the two sealing covers (75, 76) present a friction force against the wall of said housing (72) of absolute value F,

said chamber (79) is filled in the initial state of said second sealing cover (76) with a pressurized fluid (88) exerting a pressure of absolute value Pc on said container (5) in the distal direction, with the intermediary of the piston (7),

said device further comprising first elastic return means (87) for moving said container (5) from the initial position to the insertion position, said first elastic return means being coupled to said piston rod (74) so as to exert on said piston rod (74) a return force of absolute value Pi when said first elastic return means is at least in a partly compressed state,

said device further comprising second elastic return means (81) for moving said container (5) from the insertion position to the final position, said second elastic return means being coupled to said container so as to exert on said container a return force of absolute value Pe when said second elastic return means is at least in a partly compressed state, wherein (Pc+Pi) is greater than (Pe+F) in the initial sate of said second sealing cover (76), wherein Pc decreases as part of the pressurized fluid (88) is escaping the chamber (79) via the vent outlet (75, 76), said retaining means are formed by (Pc+Pi) being greater than (Pe+F), said retaining means being released when Pe becomes equal or greater than (Pc+F+Pi).

17. Device (1) according to claim 15, wherein the deactivating means comprise a valve (99) situated on said first porous sealing cover (97), said valve being closed when said second porous sealing cover (98) is in its initial state and opened when said second porous sealing cover is in its final state, the opening of said valve (99) releasing part of said retaining means (104, 105, 107).