Blood collection safety devices and methods of use and manufacture

• US 8,663,129 B2
• Filed: 05/30/2012
• Issued: 03/04/2014
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Sta-Med LLC
• Original Assignee: Sta-Med LLC
• Inventors: Allen, David P., Browka, Edward P., Delgado, Jessie, Penny, Matthew R., Foshee, David L., Mosler, Theodore J.
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US13/483,878
• Publication Number:
  US 20120323142A1
• Time in Patent Office: 643 Days
• Field of Search: 600/576, 600/579, 604/6.15, 604/6.16, 604/36, 604/264, 604/272, 604/403, 604/411
• US Class Current: 600/576
• CPC Class Codes: A61B 5/1444 Safety means, e.g. for locking cannula removing or disposing of used needles or syringes A61M5/3205
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150641 comprising means to impede repositioning of protection sleeve from covering to uncovering position
• CPC Class Codes: A61B 5/150656 semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

An automatically locking safety device, e.g., for use in a blood collection procedure, can include a housing, first and second needle covers that are at least partly received in the housing, and a needle that is at least partly received in at least one of the first and second needle covers. The needle can include a proximal tip configured for placement into a patient and a distal tip configured for placement into a blood collection vial. In some embodiments, the first and second needle covers are biased by a biasing member. In some cases, one or both of the first and second needle covers can be locked to prevent axial movement thereof after the blood collection procedure. In certain embodiments, a distal end of the device is configured to connect with a medical connector, such as a needleless IV access device.

Claims

1. A blood collection safety device, comprising:

a housing comprising a motion regulating frame, a chamber, and a longitudinal axis;

a needle comprising a proximal tip and a distal tip;

a proximal needle cover comprising a ramp and configured to move relative to the housing between an engaged position and a disengaged position, the engaged position being at least partly distal of the disengaged position, the disengaged position configured such that the proximal tip of the needle is positioned distal of a portion of the proximal needle cover;

a distal needle cover comprising a guiding member and configured to move relative to the housing between a retracted position and an extended position, the distal needle cover being positioned proximal of the distal tip of the needle in the retracted position, the distal needle cover being positioned distal of the distal tip of the needle in the extended position; and

a locking member comprising a wing configured to engage the motion regulating frame to retain the distal needle cover in the retracted position,

wherein the ramp of the proximal needle cover and the guiding member of the distal needle cover are configured to engage as the proximal needle cover is moving to the engaged position, thereby rotating the locking member relative to the motion regulating frame and releasing the distal needle cover to move distally toward the extended position.

2. The blood collection safety device of claim 1, wherein the locking member extends radially outward.

3. The blood collection safety device of claim 1, wherein the locking member is connected with a distal portion of the distal needle cover.

4. The blood collection safety device of claim 1, wherein the motion regulating frame of the housing further comprises a notch.

5. The blood collection safety device of claim 1, wherein the locking member further comprises a circumferentially extending winglet configured to engage the housing.

6. The blood collection safety device of claim 1, further comprising a reuse prevention member configured to engage the distal needle cover to inhibit proximal movement of the distal needle cover after the distal needle cover has moved to the extended position.

7. The blood collection safety device of claim 1, wherein the guiding member comprises a foot.

8. The blood collection safety device of claim 1, wherein the ramp extends along a portion of a helical path about the longitudinal axis.

9. The blood collection safety device of claim 1, wherein the proximal needle cover is configured to be pushed to the engaged position by a blood collection vial.

10. The blood collection safety device of claim 1, further comprising a distal tooth that passively secures the distal needle cover in the extended position.

11. The blood collection safety device of claim 10, further comprising a proximal tooth that passively secures the proximal needle cover in the disengaged position.

12. The blood collection safety device of claim 11, wherein the distal tooth and the proximal tooth extend radially inward.

13. The blood collection safety device of claim 1, further comprising a sleeve having an opening configured to receive a proximal end of the proximal needle cover.

14. The blood collection safety device of claim 13, wherein the sleeve is removably connected with the housing.

15. The blood collection safety device of claim 14, wherein the sleeve is configured such that connecting the sleeve with the housing deflects a tooth that secures the proximal needle cover in the disengaged position.

16. The blood collection safety device of claim 1, wherein a portion of the distal needle cover is received in the proximal needle cover during the engagement of the ramp and the guiding member.

17. The blood collection safety device of claim 1, wherein the distal needle cover further comprises the locking member.

18. The blood collection safety device of claim 1, wherein the rotation of the locking member is about the longitudinal axis.

19. The blood collection safety device of claim 1, further comprising a resilient boot that receives the proximal tip of the needle.

20. The blood collection safety device of claim 1, further comprising a flash assembly that indicates the presence of blood, the flash assembly comprising a filter that allows air to pass therethrough but inhibits the passage of blood therethrough.

21. The blood collection safety device of claim 20, wherein the filter is opaque and changes color after contacting blood.