BLOOD COLLECTION SAFETY DEVICES AND METHODS OF USE AND MANUFACTURE

• US 20120323142A1
• Filed: 05/30/2012
• Published: 12/20/2012
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Sta-Med LLC
• Original Assignee: Sta-Med LLC
• Inventors: Browka, Edward P., Penny, Matthew R., Foshee, David L., Mosler, Theodore J., Allen, David P., Delgado, Jessie
• Granted Patent: US 8,663,129 B2
• Time in Patent Office: Days
• 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 having at least a first mode and a second mode, comprising:

a housing comprising a chamber and a longitudinal axis;

a needle comprising a proximal tip and a distal tip, the proximal tip positioned in the chamber;

a plunger assembly configured to be received at least partly in the housing, the plunger assembly comprising a first needle cover and a second needle cover and a biasing member therebetween, the first needle cover and the second needle each configured to move along the longitudinal axis; and

wherein in the first mode the first needle cover and the second needle cover are at least partly nested along the longitudinal axis, and in the second mode the first needle cover and the second needle cover are spaced apart along the longitudinal axis.

2. The blood collection safety device of claim 1, wherein the second needle cover is configured to engage a blood collection vial.

3. The blood collection safety device of claim 1, wherein in the second mode a portion of the first needle cover is positioned distal of the distal tip of the needle.

4. The blood collection safety device of claim 1, wherein the first needle cover further comprises an extension locking member.

5. The blood collection safety device of claim 1, wherein the first needle cover further comprises a rotational locking member and the housing further comprises a cam member.

6. The blood collection safety device of claim 1, wherein in the first mode the first needle cover longitudinally receives at least part of the second needle cover.

7. The blood collection safety device of claim 1, wherein the second needle cover further comprises a plurality of tracks, and the first needle cover further comprises a guide member configured to slide along the plurality of tracks.

8. The blood collection safety device of claim 7, wherein at least one of the tracks is an angled track, the angled track being angled with respect to the longitudinal axis.

9. The blood collection safety device of claim 8, wherein the sliding of the guide member in the angled track rotates the second needle cover.

10. The blood collection safety device of claim 1, wherein the housing further comprises a needle support connected with the needle and the second needle cover further comprises a channel configured to slidingly receive the needle support.

11. A blood collection safety device, comprising:

a housing comprising a chamber and a longitudinal axis;

a needle comprising a proximal tip and a distal tip, the proximal tip positioned in the chamber;

a proximal needle cover configured to move 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 configured to move 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 configured to retain the distal needle cover in the retracted position, the locking member being released by the proximal needle cover moving to the engaged position.

12. The blood collection safety device of claim 11, wherein the locking member comprises an axially extending arm.

13. The blood collection safety device of claim 11, wherein the locking member is connected with a distal portion of the distal needle cover.

14. The blood collection safety device of claim 11, wherein the housing further comprises a radially inwardly extending shoulder and a notch, and wherein the locking member engages the shoulder.

15. The blood collection safety device of claim 11, wherein the locking member is released by rotation of the distal needle cover relative to the housing.

16. The blood collection safety device of claim 11, further comprising a reuse prevention member configured to inhibit proximal movement of the distal needle cover after the distal needle cover has moved to the extended position.

17. A method of manufacturing a blood collection safety device having at least a first mode and a second mode, the method comprising:

providing a housing having a longitudinal axis and a needle;

providing a first needle cover;

providing a second needle cover, the second needle cover configured to engage a blood collection vial, the second needle cover at least partly nested along the longitudinal axis with the first needle cover in the first mode; and

compressing a biasing member between the first needle cover and the second needle cover, the biasing member configured to encourage the first needle cover and the second needle cover to move to spaced apart positions along the longitudinal axis in the second mode.

18. The method of claim 17, wherein in the second mode a portion of the first needle cover is positioned distal of the distal tip of the needle.

19. The blood collection safety device of claim 17, wherein the first needle cover further comprises an extension locking member.

20. The blood collection safety device of claim 17, wherein the first needle cover further comprises a rotational locking member and the housing further comprises a cam member.

21. The blood collection safety device of claim 17, wherein in the first mode the first needle cover longitudinally receives at least part of the second needle cover.

22. The blood collection safety device of claim 17, wherein the second needle cover further comprises a plurality of tracks, and the first needle cover further comprises a guide member configured to slide along the plurality of tracks.

23. The blood collection safety device of claim 22, wherein at least one of the tracks is an angled track, the angled track being angled with respect to the longitudinal axis.

24. The blood collection safety device of claim 23, wherein the sliding of the guide member in the angled track rotates the second needle cover.

25. The blood collection safety device of claim 17, wherein the housing further comprises a needle support connected with the needle and the second needle cover further comprises a channel configured to slidingly receive the needle support.

26. A method of using a blood collection safety device having a distal needle cover, a proximal needle cover, 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 vial;

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

reducing the amount of distally-directed force such that the distal needle cover is moved distally by a biasing member of the blood collection safety device;

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

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

forming at least some of a protective enclosure around the needle by;

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 prevent the distal end of the needle from moving distal of the portion of the distal needle cover; and

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

disposing of the blood collection safety device in a non-sharps waste receptacle.

27. A method of using a blood collection safety device having a distal end, a proximal needle cover, and a needle, the method comprising:

connecting the distal end of the blood collection device with a medical connector configured to be in fluid communication with a patient'"'"'s blood;

placing the needle in fluid communication with the medical connector;

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

allowing blood to flow from the patient into the vial via the medical connector and the needle;

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

forming at least some of a protective enclosure around the needle by;

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; and

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

disposing of the blood collection safety device in a non-sharps waste receptacle.