Syringe safety device

Details Syringe safety device Syringe safety device

2001-11-07

2004-05-04

Casler, Brian L. (Department: 3763)

Fluent material handling, with receiver or receiver coacting mea

Filling means with receiver or receiver coacting means

With puncturing connecting means

C604S187000, C604S411000

Reexamination Certificate

active

06729370

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention is directed to a syringe safety device and, more specifically, to a syringe device that allows a user to reconstitute medicine in sealed vials without risk of the user being stuck by a needle needed to access the contents of the vial. It is often desirable to store drugs in a concentrated or powdered (e.g., lyophilized) form until just prior to administering the drug to a patient at which time the medicine is mixed with a solvent of diluent or rehydrant. Several different arrangements for mixing such drugs and liquids have been disclosed.
U.S. Pat. No. 5,653,698 discloses a safety coupling system for reconstituting medications that employ a special tubular coupling (
10
) having a hub (
20
) containing a shielded needle cannula (
12
). The coupling system (
10
) can be joined with a special syringe that receives a special medication containing cartridge (
40
). The opposing end of the hub can be provided with Luer threads or can be designed to mate with an adapter in the form of a “pre-slit injection site” (
72
), which is threaded to be mounted on a tubular receiver. The requirement for use with a special cartridge containing syringe limits its broad utility. Also, the cannula, which has a smooth uniform outside diameter must be absolutely secured against sliding movement with respect to the hub or the cannula will be pushed from the hub when the syringe is pressed into its fluid coupling position in the proximal end (
22
) of the first sleeve (
30
) of the hub (
20
).
U.S. Pat. No. 5,827,262 discloses another device for coupling together a conventional syringe and a medicament containing vial. A number of embodiments are disclosed but vary only slightly in detail. Each embodiment includes a tubular guide (e.g.,
14
) designed to receive a conventional vial at one end and a conventional syringe at the opposing end. The tubular guide (
14
) directs the needle (
34
) of a conventional syringe (
12
) into contact with of the stopper (
22
) of the vial (
10
) by providing a tubular slide member (
48
) which receives a distal end of the syringe and slidingly supports the distal end of the syringe as the needle of the syringe passes through a penetrable barrier (
40
) or small diameter opening in the center of the guide tube. All embodiments are designed to release the syringe with its needle after a medicament has been drawn into the syringe from the vial. Thus, there is always a possibility of a needle stick.
U.S. Pat. No. 6,019,750 discloses a tubular connector device (
10
) that is designed to fluidly couple a conventional medicinal vial with piercable stopper and a flexible solution container or bag of the type having an injection port in the form of a separate tube extending from the bag and having its end sealed with a piercable stopper or other penetrable septum. The device (
10
) has first and second sleeves or tubes (
30
,
32
), which are telescopically coupled together and which contain a double ended piercing member (
34
) or cannula. The device (
10
) further includes a foil (
58
) and a sealing member (
103
) in the two sleeves (
32
,
34
) to seal the cannula (
34
) within the extended sleeves before use. In use, the sleeves (
30
,
32
) are compressed together. One pointed end of the cannula within the second sleeve (
32
) is moved to the distal end of the sleeve in a position where it can pierce the stopper of a vial. The distal end of the first sleeve (
30
) has an annular gap between the sidewall of the sleeve and the cannula (
34
) to receive the tubular port (
20
) of the flexible bag (
12
) and to pierce the septum (
22
) located in the distal end of that port (
20
). The distal end (
82
) of the second tube (
32
) has an enlarged cavity (
86
) with plural spring fingers (
84
a
) to secure the end of a vial (
14
) so that the vial could not normally be removed once attached without visible damage to the fingers (
84
a
). The device also includes locking elements (
50
,
144
,
146
) to prevent the sleeves from being re-extended once they are compressed into the activated state. The same means prevent relative rotational movement of the sleeves with respect to one another in the activated state.
The U.S. Pat. No. 6,019,750 connector is designed to attach a medicinal vial (
14
) to a flexible fluid bag (
12
) for dilution and requires that once the vial is attached to the bag and in communication with the fluid in the bag, the bag must be squeezed to deliver fluid to the interior of the vial. Then the bag, the connector and the vial all shaken together to mix the original vial contents with the added liquid in the bag. The bag is then again manipulated and re-squeezed to force compressed air into the vial so that when the bag is released from compression and the vial held upside down over the bag, its fluid contents will leak through the cannula into the bag. All three devices should again be shaken to fully mix the reconstituted medication with the remaining fluid in the bag. Such a mode of operation is not always convenient. If the caregiver has time to attach the connector and vial to the fluid bag before the bag is connected to the patient, such manipulation and agitation can take place away from the patient without disturbing the patient. However, that is not always possible. The drug may have to be given to the patent while the patient is already connected with the bag. Agitation of the bag and vial at that can be disturbing to the patient and can sometimes result in separation of the catheter tube from the needle connecting the bag to the patient or of the catheter needle from the patient.
It would be desirable to provide a similar safety device which permits mixing of hazardous ingredients in a stoppered vial with the contents of a fluid bag without exposing the user to the possibility of a needle stick and yet minimizes the manipulation of the bag.
SUMMARY OF THE INVENTION
A syringe safety device configured to form a fluid coupling between a sealed vial and a syringe, the syringe safety device comprising: a tubular connector having opposing first and second axial open ends, the first open axial end being adapted to engage an end of a conventional medicine vial with stopper; and a sliding joint received in the second open axial end of the tubular connector, the sliding joint having opposing first and second axial ends and a passageway between the first and second axial open ends, the first axial open end being adapted to engage with an enlarged, blunt mounting end of a syringe needle, the second axial end of the sliding joint further being adapted to releasably engage at least a releasable needle receiver on a distal end of a barrel of a conventional syringe without needle, the syringe being releasably removable from the sliding joint after fluid coupling with the vial through the passageway of the sliding joint without removal of the sliding joint from the tubular connector and without the needle.


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