Holder with safety shield for a drug delivery device

• US 8,932,265 B2
• Filed: 01/30/2004
• Issued: 01/13/2015
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Francavilla, Frank
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US10/543,878
• Publication Number:
  US 20060276756A1
• Time in Patent Office: 4,001 Days
• Field of Search: 604/110, 604192-198
• US Class Current: 604/197
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6063 Optical identification systems
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• 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
• CPC Class Codes: A61M 5/3257 Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• 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 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A holder with a safety shield for a drug delivery device; the shield obstructing access to a needle of the drug delivery device following use thereof. The safety shield may be actively deployed, in which case the health care worker must perform an action beyond complete depression of the pusher into the body of the drug delivery device to deploy the shield. Alternatively, the safety shield may be deployed passively or automatically, in which case deployment of the shield occurs upon complete depression of the pusher into the body, with no additional action required of the health care worker. The safety shield is spring-loaded and released to its extended position by a mechanical coupling of a series of position members, including levers, formed on the holder and the drug delivery device.

Claims

1. An injection device comprising:

a drug delivery device comprising;

a body having a reservoir for containing a fluid, said body having a distal port through which the fluid may exit, said body further having a proximal port;

a pusher including a pusher cap having a cap wall,

a pusher stem connected in coaxial relation to said pusher cap and a stopper provided at an end of said pusher stem, said stopper being movable in said reservoir in a proximal to distal direction over a length defining an injection stroke, wherein said cap wall extends coextensively, in a spaced relationship, about a portion of said pusher stem;

a needle cannula provided on said body in fluid communication with said reservoir; and

a holder comprising;

a housing having a longitudinal housing cavity;

a safety shield coaxially supported in said housing cavity, said safety shield being longitudinally displaceable relative to said housing from a retracted position, in which said forward tip of said needle cannula is exposed, to an extended position, in which said forward tip of said needle cannula is contained within said safety shield, said safety shield further comprising a shield latch deflectable between ready and released positions, said shield latch engaging said housing when said shield latch is in said ready position to hold said safety shield in said retracted position;

a retainer ring comprising a ring body which is coaxially supported around said body, said retainer ring further comprising a ring lever connected to said ring body for radially inward deflection between ready and released positions;

a spring supported within said housing and coupled to said safety shield to urge said safety shield toward said extended position; and

a means for deflection connected to said housing;

said cap wall being insertable between said deflection means and ring lever, said deflection means providing for inward radial deflection of said cap wall resulting in said deflection of said ring lever to said released position thereof causing said deflection of said shield latch to said released position thereof resulting in said shield latch disengaging from said housing and movement of said safety shield toward said extended position,

wherein said deflection means comprises a pushbutton connected to said housing for inward radial deflection from ready to released positions, said pushbutton, said ring lever and said shield latch being positioned and sized to provide a sufficient radial clearance such that, prior to insertion of said cap wall between said pushbutton and said ring lever, said deflection of said pushbutton to said released position does not cause disengagement of said shield latch from said housing, wherein insertion of said cap wall between said pushbutton and said ring lever allowing for said pushbutton, said ring lever and said shield latch to be deflected to said respective ready positions thereof with said deflection of said pushbutton to said released position of said pushbutton causing inward radial deflection of said cap wall resulting in said deflection of said ring lever to said released position thereof causing said deflection of said shield latch to said released position thereof resulting in said shield latch disengaging from said housing and movement of said safety shield toward said extended position.

2. An injection device according to claim 1, wherein said cap wall is cylindrical.

3. An injection device according to claim 1, wherein a maximum extent of said insertion of said stopper into said reservoir defines an end of said injection stroke, said pusher stem having a sufficient length and said pusher cap being longitudinally positioned thereon such that said cap wall is inserted between said deflection means and ring lever upon said end of said injection stroke.

4. An injection device according to claim 1, wherein said housing having a longitudinal slot for radially aligning said ring lever and shield latch relative to said deflection means, a housing edge extending into said slot engaged by said shield latch when said shield latch is in said ready position for holding of said safety shield in said retracted position.

5. An injection device according to claim 1, wherein said safety shield comprises a cylindrical shield body.

6. An injection device according to claim 1, wherein said ring body is coupled to said body such that said ring body is adjacent to a proximal end of said safety shield when said safety shield is in said retracted position.

7. An injection device according to claim 1, wherein said retainer ring is coupled to said body, said spring being helical and in coaxial relation to said syringe body, said spring being external of said body and longitudinally positioned between said retainer ring and said safety shield with compression of said spring providing said urging by said spring of said safety shield to said extended position.

8. An injection device according to claim 1, wherein said deflection of said shield latch to said released position thereof is radially inward.

9. An injection device according to claim 1, wherein said drug delivery device comprises a limiter at a distal end of said body, said limiter defining a skin engaging surface, said forward tip of said needle cannula extending beyond said skin engaging surface a distance ranging from 0.5 mm to 3 mm.

10. A combination of a drug delivery device and a holder for the drug delivery device, said combination comprising:

a drug delivery device comprising;

a body having a reservoir for containing a fluid, said body having a proximal port and a distal port through which the fluid may exit;

a retainer ring comprising a ring body which is coaxially supported around said body, said retainer ring further comprising a ring lever connected to said ring body for radially inward deflection between ready and released positions;

a pusher including a pusher cap having a cap wall, a pusher stem connected in coaxial relation to said pusher cap, and a stopper provided at an end of said pusher stem, said stopper being movable in said reservoir in a proximal to distal direction over a length defining an injection stroke; and

a needle cannula secured to said body in fluid communication with said reservoir,

a holder comprising;

a housing defining a longitudinal housing cavity for accommodating the drug delivery device;

a safety shield coaxially supported in said housing cavity, said safety shield being longitudinally displaceable relative to said housing in a proximal to distal direction from a retracted position to an extended position;

latch means deflectable between ready and released positions, said latch means engaging said housing when said latch means is in said ready position to hold said shield in said retracted position;

biasing means for biasing said safety shield toward said extended position; and

deflection means radially aligned with, and positioned radially outwardly of, said latch means, a gap being defined between said deflection means and said latch means, said gap being formed to receive a portion of the drug delivery device, wherein, with said gap being open, deflection of said deflection means does not cause disengagement of said latch means from said housing, and, wherein, with a portion of the drug delivery device being received in the gap and interposed between said deflection means and said latch means, deflection of said deflection means results in deflection of said latch means to said released position thereof with said latch means disengaging from said housing and movement of said safety shield toward said extended position,

wherein said deflection means comprises a pushbutton connected to said housing for inward radial deflection from ready to released positions, wherein insertion of said cap wall between said pushbutton and said ring lever allows for said pushbutton, said ring lever and said latch means to be deflected to said respective ready positions thereof with said deflection of said pushbutton to said released position of said pushbutton causing inward radial deflection of said cap wall resulting in said deflection of said ring lever to said released position thereof causing said deflection of said latch means to said released position thereof resulting in said latch means disengaging from said housing and movement of said safety shield toward said extended position.

11. A combination according to claim 10, wherein said deflection means requires manual activation by a user.

12. A combination according to claim 10, wherein said gap is defined between said pushbutton and said ring lever.

13. A combination according to claim 10, wherein said ring lever is radially aligned with said pushbutton.

14. A combination according to claim 10, wherein said drug delivery device further comprises a limiter at a distal end of said body, said limiter defining a skin engaging surface, said forward tip of said needle cannula extending beyond said skin engaging surface a distance ranging from 0.5 mm to 3 mm.

15. A combination according to claim 10, wherein said biasing means comprises a spring supported within said housing and positioned to urge said safety shield toward said extended position.

16. A combination according to claim 10, wherein said latch means comprises a shield latch deflectable between said ready and released positions, said shield latch engaging said housing when said shield latch is in said ready position to hold said safety shield in said retracted position.