Needle shielding assemblies and infusion devices for use therewith

• US 9,889,255 B2
• Filed: 12/07/2012
• Issued: 02/13/2018
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sonderegger, Ralph, Politis, Victor, Richards, Stephen, Searle, Gary, Ben, Eric
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/362,102
• Publication Number:
  US 20140316379A1
• Time in Patent Office: 1,894 Days
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/3249 Means to disalign the needle tip and the distal needle passage of a needle protection sleeve
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3216 Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
• 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 5/326 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 5/3275 being connected to the needle hub or syringe by radially deflectable members, e.g. longitudinal slats, cords or bands

Abstract

A needle assembly includes a needle and a needle shield device. The needle shield device includes an inner shield connectable to at least one a base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

Claims

1. A needle assembly, comprising:

a needle having a sharpened end and an opposing end, the needle being insertable through a base; and

a needle shield device, comprising;

an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and

an outer shield fixedly connected to the opposing end of the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield;

wherein during or after proximal displacement of the outer shield from the first position to the second position, interaction between portions of the inner and outer shields automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

2. The assembly according to claim 1, wherein:

the inner shield comprises a cantilevered latch beam with a shield latch thereon; and

the outer shield comprises a hub latch that engages the latch beam and prevents radially outward displacement of the latch beam to maintain connection between the inner shield and the base when the outer shield is disposed in the first position; and

when the outer shield is disposed in the second position, the hub latch engages the shield latch, thereby permitting radially outward displacement of the latch beam and preventing further proximal displacement of the outer shield relative to the inner shield.

3. The assembly according to claim 2, wherein the engagement of the hub latch and the shield latch also prevents distal displacement of the outer shield relative to the inner shield.

4. The assembly according to claim 2, wherein:

the inner shield further comprises an inner shield latch;

the outer shield comprises a hub beam; and

when the outer shield is disposed in the second position, the hub beam engages the inner shield latch to prevent distal displacement of the outer shield relative to the inner shield.

5. The assembly according to claim 4, wherein the inner shield latch is disposed on a cantilevered inner shield latch beam.

6. The assembly according to claim 4, wherein the hub beam is cantilevered.

7. The assembly according to claim 1, wherein:

the inner shield comprises an inner shield latch;

the outer shield comprises an outer shield latch; and

when the outer shield is disposed in the second position, the shield latch engages the inner shield latch to prevent distal displacement of the outer shield relative to the inner shield.

8. The assembly according to claim 7, wherein:

the inner shield comprises at least one cantilevered latch beam for selectively connecting the needle shield device to the at least one of the base and the fluid connector, the latch beam having a shield latch thereon;

the outer shield comprises a hub latch that engages the latch beam and prevents outward displacement of the latch beam to maintain connection between the inner shield and the at least one of the base and the fluid connector when the outer shield is disposed in the first position; and

when the outer shield is disposed in the second position, the hub latch engages the shield latch, thereby permitting outward displacement of the latch beam and preventing further proximal displacement of the outer shield relative to the inner shield.

9. The assembly according to claim 8, wherein the at least one cantilevered latch beam comprises a pair of retention beams, each having a recess for accommodating tubing of the fluid connector to connect the inner shield to the fluid connector.

10. The assembly according to claim 1, wherein:

the outer shield has a cavity therein for housing the inner shield when the outer shield is in the first position; and

the inner shield comprises a spring element disposed about the introducer needle, the spring element having a shield tip, wherein upon proximal displacement of the sharpened end of the needle past the shield tip when the outer shield displaces to the second position, the shield tip automatically displaces laterally to cover the sharpened end of the needle.

11. The assembly according to claim 10, wherein:

the spring element comprises a spring clip with latch tabs that connect with hub latches on the fluid connector, the spring clip having a retention hole disposed at a proximal end thereof and an additional hole disposed on a cantilevered arm of the spring clip and having a diameter greater than that of the retention hole, the respective centers of the retention hole and the additional hole being substantially axially aligned;

the needle comprises a bump sized to fit through the additional hole but not the retention hole;

the shield tip extends from the latch tabs and contacts the needle when the outer shield is in the first position, thereby biasing the spring clip; and

as the outer shield displaces to the second position,

the bump passes proximally through the additional hole and engages the retention hole; and

the sharpened end of the needle displaces proximally past the shield tip, thereby unbiasing the spring clip to laterally displace the shield tip to cover the sharpened end of the needle, and disengage the latch tabs from the hub latches of the fluid connector.

12. The assembly according to claim 11, wherein:

the proximal end of the spring clip, on which retention hole is disposed, comprises a top tab cantilevered with respect to a main body portion of the spring clip; and

the cantilevered arm of the spring clip comprises an L-shaped arm extending from a front of the top tab.

13. The assembly according to claim 11, wherein:

the proximal end of the spring clip, on which retention hole is disposed, comprises a top tab cantilevered with respect to a main body portion of the spring clip; and

the cantilevered arm of the spring clip comprises an L-shaped arm extending from a lateral side of the top tab.

14. The assembly according to claim 10, wherein:

the spring element comprises a biased spring having a plurality of slotted holes through which the needle passes, and a distal hole and a tip pocket at a distal end thereof; and

as the outer shield displaces to the second position, the biased spring expands along the needle until the sharpened end of the needle displaces proximally past the distal hole, thereby unbiasing the spring clip to laterally displace the tip pocket to cover the sharpened end of the needle.

15. The assembly according to claim 1, wherein when the outer shield is in the first position and the needle is fully inserted through the base and the cannula, the outer shield contacts the base.

16. The assembly according to claim 1, wherein the first and second shields are tubular.

17. A needle assembly, comprising:

a needle having a sharpened end and an opposing end, the needle being insertable through a base; and

a needle shield device, comprising;

an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and

an outer shield fixedly connected to the opposing end of the needle;

wherein during or after the outer shield is proximally displaced relative to the inner shield by a predetermined distance, interaction between portions of the inner and outer shields causes automatic release or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

18. A method comprising:

providing a needle assembly, the needle assembly comprising;

a needle with a sharpened end and an opposing end, the needle being insertable through a base; and

a needle shield device, comprising;

an inner shield connectable to at least one of the base and a fluid connector connectable to the base; and

an outer shield fixedly connected to the opposing end of the needle; and

displacing the outer shield by a predetermined distance relative to the inner shield, and, by interaction between portions of the inner and outer shields during or after the outer shield is proximally displaced, releasing the inner shield from connection to the at least one of the base and the fluid connector.

19. A needle assembly, comprising:

a needle having a sharpened end and an opposing end, the needle being insertable through a base; and

a needle shield device, comprising;

a first shield; and

a second shield displaceable relative to the first shield between a first position, in which the sharpened end of the needle is exposed outside the first and second shields, and a second position, in which the sharpened end of the needle is shielded by the first and second shields;

wherein one of the first and second shields is connectable to at least one of the base and a fluid connector connectable to the base;

wherein one of the first and second shields is fixedly connected to the opposing end of the needle; and

wherein during or after proximal displacement of the second shield from the first position to the second position, interaction between portions of the first and second shields automatically releases or permits release of the one of the first and second shields from connection to the at least one of the base and the fluid connector.