Blood collection safety devices and methods of use and manufacture

• US 9,848,810 B2
• Filed: 09/16/2016
• Issued: 12/26/2017
• 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): CERIONI, DANIEL LEE
• Application Number:
  US15/268,132
• Publication Number:
  US 20170065216A1
• Time in Patent Office: 466 Days
• Field of Search: 600576
• 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 method of using a blood collection safety device comprising a distal needle cover, a proximal needle cover, a spring, and a needle, the method comprising:

positioning a distal end of the needle against a patient'"'"'s skin;

applying an amount of distally-directed force on the blood collection safety device such that the distal end of the needle pierces the patient'"'"'s skin;

engaging a blood collection vial with a proximal end of the needle, thereby placing the needle in fluid communication with the blood collection vial;

allowing blood to flow from the patient into the blood collection vial via the needle;

reducing the amount of distally-directed force such that the distal needle cover is moved distally, relative to the needle, by the spring;

removing the distal end of the needle from the patient'"'"'s skin;

disengaging the blood collection vial and the proximal end of the needle; and

forming a protective enclosure around the needle, wherein forming the protective enclosure around the needle comprises;

positioning at least a portion of the distal needle cover distal of the distal end of the needle, thereby covering the distal end of the needle;

positioning at least a portion of the proximal needle cover proximal of the proximal end of the needle, thereby covering the proximal end of the needle;

passively securing the distal needle cover to inhibit the portion of the distal needle cover from moving proximal of the distal end of the needle; and

securing the proximal needle cover to inhibit the portion of the proximal needle cover from moving distal of the proximal end of the needle, wherein securing the proximal needle cover comprises disengaging a sleeve from a proximal end of the blood collection safety device, thereby engaging a locking mechanism that inhibits movement of the proximal needle cover relative to the needle.

2. The method of claim 1, wherein forming a protective enclosure around the needle further comprises:

surrounding, with a substantially continuous physical wall, substantially the entire longitudinal length of the needle.

3. The method of claim 1, wherein forming a protective enclosure around the needle further comprises:

providing a physical interference along substantially the entire longitudinal length of the needle, such that a user is blocked from contacting the sidewall of the needle along substantially the entire longitudinal length of the needle.

4. The method of claim 1, further comprising substantially obscuring, with the enclosure, substantially the entire longitudinal length of the needle.

5. The method of claim 1, further comprising disposing of the blood collection safety device in a non-sharps waste receptacle.

6. The method of claim 1, wherein the locking mechanism comprises a tooth that is received in an opening in the proximal needle cover.

7. The method of claim 1, further comprising using the blood collection vial to move the proximal needle cover distally, wherein the proximal needle cover comprises an aperture that receives a portion of a resilient boot of the blood collection safety device.

8. The method of claim 7, further comprising piercing the resilient boot with the proximal end of the needle.

9. The method of claim 1, wherein, during at least some of the distal movement of the distal needle cover, the distal needle cover translates and rotates.

10. The method of claim 1, wherein, during at least some of the distal movement of the distal needle cover, the distal needle cover slides along a rail that is received in a channel of the distal needle cover, the rail having a channel that receives a portion of the needle.

11. The method of claim 1, wherein passively securing the distal needle cover comprises engaging a tooth of a housing of the blood collection safety device with the distal needle cover.

12. The method of claim 1, further comprising allowing blood to flow from the patient into a flash chamber of the blood collection safety device.

13. The method of claim 12, further comprising observing an indicator of the flash chamber change from a first color to a second color.

14. The method of claim 13, wherein the second color is a color other than red.

15. The method of claim 1, further comprising visually observing, from a vantage point external of the blood collection safety device, an indication that the distal needle cover is generally in a fully distal position.

16. The method of claim 15, wherein the indication comprises a portion of the distal needle cover being received in a channel on a distal end of a housing of the blood collection safety device.

17. A method of using a blood collection safety device comprising a distal needle cover, a proximal needle cover, a spring, and a needle, the method comprising:

connecting a sleeve with a housing of the blood collection safety device, the sleeve comprising an interior chamber configured to receive a distal end of a blood collection vial;

in response to the connection of the sleeve and the housing, disengaging a locking mechanism that is configured to inhibit movement of the proximal needle cover relative to the needle;

positioning a distal end of the needle against a patient'"'"'s skin;

applying an amount of distally-directed force on the blood collection safety device such that the distal end of the needle pierces the patient'"'"'s skin;

engaging the blood collection vial with a proximal end of the needle, thereby placing the needle in fluid communication with the blood collection vial;

allowing blood to flow from the patient into the blood collection vial via the needle;

reducing the amount of distally-directed force such that the distal needle cover is moved distally, relative to the needle, by the spring;

removing the distal end of the needle from the patient'"'"'s skin;

disengaging the blood collection vial and the proximal end of the needle; and

forming a protective enclosure around the needle, wherein forming the protective enclosure around the needle comprises;

positioning at least a portion of the distal needle cover distal of the distal end of the needle, thereby covering the distal end of the needle;

positioning at least a portion of the proximal needle cover proximal of the proximal end of the needle, thereby covering the proximal end of the needle;

passively securing the distal needle cover to inhibit the portion of the distal needle cover from moving proximal of the distal end of the needle; and

securing the proximal needle cover to inhibit the portion of the proximal needle cover from moving distal of the proximal end of the needle.

18. The method of claim 17, wherein securing the proximal needle cover comprises disengaging the sleeve, thereby engaging the locking mechanism.

19. The method of claim 17, wherein connecting the sleeve with the housing comprises threadably connecting the sleeve and the housing.

20. The method of claim 17, further comprising using the blood collection vial to move the proximal needle cover distally, wherein the proximal needle cover comprises an aperture that receives a portion of a resilient boot of the blood collection safety device.

21. The method of claim 20, further comprising piercing the resilient boot with the proximal end of the needle.

22. The method of claim 17, wherein, during at least some of the distal movement of the distal needle cover, the distal needle cover translates and rotates.

23. The method of claim 17, wherein, during at least some of the distal movement of the distal needle cover, the distal needle cover slides along a rail that is received in a channel of the distal needle cover, the rail having a channel that receives a portion of the needle.

24. The method of claim 17, wherein passively securing the distal needle cover comprises engaging a tooth of a housing of the blood collection safety device with the distal needle cover.

25. The method of claim 17, further comprising allowing blood to flow from the patient into a flash chamber of the blood collection safety device.

26. The method of claim 25, further comprising observing an indicator of the flash chamber change from a first color to a second color.

27. The method of claim 26, wherein the second color is a color other than red.

28. The method of claim 17, further comprising visually observing, from a vantage point external of the blood collection safety device, an indication that the distal needle cover is generally in a fully distal position.

29. The method of claim 28, wherein the indication comprises a portion of the distal needle cover being received in a channel on a distal end of a housing of the blood collection safety device.