Automatic injection device

• US 7,976,499 B2
• Filed: 04/11/2007
• Issued: 07/12/2011
• Est. Priority Date: 04/11/2006
• Status: Active Grant

• Current Assignee: Becton Dickinson France (Becton, Dickinson & Co)
• Original Assignee: Becton, Dickinson & Co
• Inventors: Maritan, Lionel, Perot, Frederic, Grunhut, Guillaume
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Holloway; Ian K
• Application Number:
  US12/296,730
• Publication Number:
  US 20090312705A1
• Time in Patent Office: 1,553 Days
• Field of Search: 604/110, 604/117
• US Class Current: 604/110
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/208 Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
• 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 2005/3215 Tools enabling the cap placement
• CPC Class Codes: A61M 2205/192 Avoiding coring, e.g. preventing formation of particles during puncture
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• 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 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/326 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 a device (1) for automatic injection of a product (3) and a needle (6). The device comprises:—a housing (8) for the container (5), the container being movable relative to the housing between an initial position, in which a tip of the needle does not extend beyond a distal end of the housing and in which the container is in one of a passive state and an active state, to an insertion position, distally spaced relative to the initial position and in which the tip of the needle extends beyond the distal end of the housing, movement of the container out of its first position being prevented when the container is in its passive state, and being permitted when the container is in its active state, and—a safety shield (10) coupled to the housing (8) for movement between a first position and a second position in which the tip of the needle does not extend beyond a distal end of the shield—a needle shield (2) coupled with said housing and covering the needle prior to use of said device, removal of said needle shield being with limited or no rotation of said needle shield.

Claims

1. A device for automatic injection of a product into an injection site, the product being carried by a container having an open proximal end and a substantially closed distal end and having a reservoir defined therebetween, and a needle provided at the distal end and in fluid communication with the reservoir to provide an outlet port for the product from the container, and a piston provided in the container and movable with respect to the container, the movement of the piston causing the product to be expelled from the container through the needle, said device comprising:

a housing for the container, the container being movable relative to said housing between an initial position, in which a tip of the needle does not extend beyond a distal end of said housing and in which the container is in one of a passive state and an active state, to an insertion position, distally spaced relative to said initial position and in which the tip of the needle extends beyond said distal end of said housing, movement of the container out of its initial position being prevented when the container is in its passive state, and being permitted when the container is in its active state,

a safety shield coupled to said housing for movement between a first position and a second position in which the tip of the needle does not extend beyond a distal end of said safety shield, movement of said safety shield out of its first position placing the container in its active state, said safety shield being movable to its second position when the container is in said insertion position, said safety shield being secured against proximal movement when in said second position, and

a needle shield coupled with said housing and covering the needle prior to use of said device, removal of said needle shield from the device being with limited or no rotation of said needle shield.

2. A device according to claim 1, wherein said needle shield and said housing are provided with guiding means designed to allow the longitudinal translation of the needle shield with respect to said housing while preventing its rotation, when said needle shield is removed from the device.

3. A device according to claim 2, wherein said guiding means include at least one longitudinal groove provided on said needle shield or on said housing, and at least one longitudinal rib, provided respectively on said housing or on said needle shield, said rib being engaged in said groove and sliding within said groove when said needle shield is removed from the device.

4. A device according to claim 2, wherein said needle shield is coupled to a deshielder, and part of said guiding means is provided on said deshielder.

5. A device according to claim 1, wherein said device further comprises:

first biasing means coupled to said housing for biasing the container toward said insertion position, said first biasing means being in one of a compressed and an extended condition, and

second biasing means coupled to said safety shield for biasing said safety shield toward its second position.

6. A device according to claim 5 wherein said device further comprises:

first retaining means in said housing and arranged to maintain said first biasing means in its compressed condition,

first deactivating means being activatable to release said first retaining means, said first deactivating means being in one of a passive state, in which said first deactivating means cannot cause the release of said first retaining means, and an active state in which said first deactivating means can cause the release of said first retaining means, wherein movement of said safety shield out of its first position causes passage of said first deactivating means from its passive state to its active state.

7. A device according to claim 6, wherein said device further comprises second retaining means provided on at least one of said housing and said safety shield to prevent movement of said safety shield to its second position.

8. A device according to claim 7, wherein said second retaining means comprises a flexible tongue and an abutment surface.

9. A device according to claim 7, wherein said device further comprises:

first engaging means capable of releasing said second retaining means thereby enabling movement of said safety shield to its second position under the bias of said second biasing means.

10. A device according to claim 9, wherein said first engaging means comprises an inner ring coupled to the container, and a leg cooperating with said flexible tongue so as to disengage said flexible tongue from said abutment surface when the container moves to said insertion position.

11. A device according to claim 6, wherein said first deactivating means is a push button having a distal end, and in that said device further comprises:

third retaining means, arranged to maintain said push button in its passive state, said third retaining means comprising a radially flexible leg provided on an outer sleeve, said outer sleeve being coupled to said housing, said distal end of said push button being blocked in axial and distal translation by said radially flexible leg, said safety shield further comprising a tooth that engages said third retaining means when said safety shield is moved out of its first position so as to deflect said radially flexible leg and enable passage of said push button from its passive state to its active state.

12. A device according to claim 11, wherein said device further comprises a plunger rod for causing the piston to move with respect to the container,

said first retaining means comprising a flexible tooth, provided on one of said outer sleeve and said plunger rod, and engaged with a radial stop provided on one of said plunger rod and said outer sleeve,

said push button comprising a tooth capable of cooperating with said flexible tooth so as to disengage said flexible tooth from said radial stop, under manual pressure exerted on said push button in its active state, thereby deactivating said first retaining means and causing the container to move from its initial position to its insertion position.

13. A device according to claim 10, wherein said device further comprises locking means arranged to prevent movement of said inner ring when said first deactivating means is in its passive state, said locking means being able to be unlocked through the movement of said safety shield out of its first position.

14. A device according to claim 11, wherein said first biasing means comprises automatic injection means, arranged in such a way as to cause said plunger rod to move said piston within the container when the container is in said insertion position, thereby causing the product to be automatically expelled from the container without any manual operation from the user.

15. A device according to claim 14, wherein said automatic injection means is disposed around said plunger rod.

16. A device according to claim 14, wherein said automatic injection means is disposed within said plunger rod.

17. A device according to claim 1, wherein said device further comprises injection controlling means to produce an audible indicator when the piston is proximate said distal end of the container and the product is substantially completely expelled from the container thereby informing the user that injection of the product is completed, said injection controlling means producing an audible indicator regardless of whether a user maintains pressure on said first deactivating means.

18. A device according to claim 17, wherein said injection controlling means comprises,

a plunger rod for causing the piston to move with respect to the container,

first biasing means coupled to at least one of said housing and said plunger rod, said first biasing means being in one of a compressed and an extended condition, and

means for interacting with said first biasing means to provide an injection status indication to a user of said device.

19. A device according to claim 18, wherein said means for interacting comprises a radial projection in contact with said first biasing means so as to produce an audible indication as said radial projection moves with respect to said biasing means.

20. A device according to claim 5, wherein said first biasing means and said second biasing means each comprise at least a spring.

21. A device according to claim 1, wherein said device further comprises tamper-evidence means 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.

22. A device according to claim 21, wherein said device further comprises tamper-evidence means 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 providing a visual indication that said tamper evidence means has been removed from said device.

23. A device according to claim 21, wherein said tamper-evidence means comprises a deshielder coupled to said needle shield, said post-use condition proving an indication that said temper-evidence means has been removed from said device.

24. A kit for a device for automatic injection of a product into an injection site, the product being carried by a container having an open proximal end and a substantially closed distal end and having a reservoir defined therebetween, and a needle provided at the distal end and in fluid communication with the reservoir to provide an outlet port for the product from the container, and a piston provided in the container and movable with respect to the container, the movement of the piston causing the product to be expelled from the container through the needle, wherein said kit comprises:

a housing assembly comprising;

an upper housing assembly, a lower housing assembly, at least one of said upper and said lower housing assembly being adapted to receive part of the container, the container being movable, when received within said at least one of said upper and said lower housing assembly, between an initial position, in which a tip of the needle does not extend beyond a distal end of said lower housing assembly and in which the container is in one of a passive state and an active state, to an insertion position, distally spaced relative to said initial position and in which the tip of the needle extends beyond said distal end of said lower housing assembly, movement of the container out of its first position being prevented when the container is in its passive state, and being permitted when the container is in its active state;

means for connecting said upper housing and said lower housing together, and

a safety shield coupled to one of said upper and said lower housing assembly for movement between a first position and a second position in which the tip of the needle does not extend beyond a distal end of said safety shield, movement of said safety shield out of its first position placing the container in its active state, said safety shield being movable to its second position when the container is in said insertion position, said safety shield being secured against proximal movement when in said second position, and a needle shield coupled with one of said upper and said lower housing assembly and covering the needle prior to use of said device, removal of said needle shield being with limited or no rotation of said needle shield.

25. A kit according to claim 24, wherein said kit further comprises means for carrying at least one of said upper housing assembly and said lower housing assembly, said carrying means carrying said one of said upper housing assembly and said lower housing assembly in a predetermined orientation.