Needle puncture prevention device

A device for preventing accidental needle puncture injuries comprises a sleeve for attachment to a needle or a needle and syringe assembly prior to use. The sleeve has a relaxed condition in which the needle is passed through an eccentrically positioned opening in a top member and exposed for use. The needle hub and/or syringe is firmly anchored by a base member. The top and base members are interconnected by living hinges to a pair of opposedly inverted sidewalls each comprising two members of unequal length interconnected by sidewall living hinges which are open when the device is in a relaxed condition. After needle use, the sidewalls are manually biased toward each other by the user, thereby closing the sidewall hinges, and the device assumes an extended condition. The needle is thereby extracted from the top member opening and the needle tip is engaged by top member needle tip engaging configuration. Elements are also provided for trapping the needle in the device after use.

BACKGROUND 
Accidental needle puncture injuries are a major concern among health care 
workers worldwide. The risk of infection with hepatitis viruses, Acquired 
Immune Deficiency Syndrome (AIDS) virus and other blood-borne pathogens, 
due to inadvertent injury by contaminated needles, is genuine and well 
documented in the medical literature. 
Many attempts have been made to design safety devices that minimize the 
risk of accidental needle sticks after needle use and during and after 
disposal. The safety devices fall into several categories. These include 
spring-loaded needle guards and needle sheaths which are manually or 
automatically activated to cover or blunt the needle tip after use; 
syringes with devices that retract the needle into the syringe after use; 
syringes with attached hinged needle enclosures which are manually rotated 
or pivoted into place to shield the needle and needle tip after use; and 
syringes fitted with outer barrel sheaths which manually or automatically 
slide up and lock over the needle tip after use. 
However, there are many disadvantages associated with the afore-mentioned 
devices. Foremost among the disadvantages is that the devices have 
multiple components, require tight tolerances in fabrication, and are 
expensive to manufacture, thereby contributing to rising medical costs. 
Moreover, the sheathed syringes have added bulk which contributes to 
disposal problems. The complicated nature of spring-loaded needle guards 
and sheaths makes them more prone to failure during use and after disposal 
and they are more expensive than conventional needles and syringes. These 
devices are also limited in usage, as few can be adapted to fit a range of 
standard disposable hypodermic needles and syringes, vacuum-tube 
phlebotomy needles, intravenous catheters and winged steel needles. 
Therefore, there is still a need for a simple, reliable, inexpensive and 
cost-effective needle safety device to prevent accidental needle puncture 
injuries. 
SUMMARY 
The present invention is directed to a simple, one-piece device designed to 
prevent needle puncture injuries after the needle is used and during 
disposal. The device comprises a base member connected to a top member by 
two substantially identical opposed sidewalls which are inverted with 
respect to each other. Each of the sidewalls comprises two sidewall 
members of unequal length which are connected to each other by sidewall 
living hinges. The base member, top member and the sidewalls are also 
interconnected by living hinges. 
The base member comprises a first opening aligned with a second opening in 
a contiguous needle hub housing. The top member comprises a third opening 
which is positioned eccentrically on the longitudinal axis of the top 
member. When the device is in a relaxed condition, the sidewall living 
hinges are open, and the first and second openings in the base member are 
aligned with the third opening in the top member. A needle and needle hub 
may then be passed through the openings in the base member and the needle 
extended through the opening in the top member so that the needle is 
exposed for use. The needle hub is frictionally engaged by the needle hub 
housing of the base member and, if the needle is attached to a syringe, 
the needle hub housing is further threadably engaged to the syringe. 
After use, the device is biased by the user into an extended condition, in 
which the needle is housed within the device. To accomplish this, the user 
manually biases the sidewall living hinges to a closed position by biasing 
the opposed sidewalls toward each other. The eccentric opening in the top 
member is now no longer aligned with the openings in the base member and 
the needle is extracted from the opening in the top member. Because the 
device has a reflexive tendency to try to be in the relaxed condition, the 
top member seats itself onto the needle tip and the needle tip is engaged 
by a needle tip engaging configuration, adjacent to the eccentric opening, 
on the bottom surface of the top member. Thus, the needle tip is securely 
housed within the device after use, and unintended needle punctures are 
prevented. 
The needle puncture prevention device disclosed herein is inexpensive to 
manufacture, easy to use, and does not require specialized training of the 
user. The device is designed to be reliable and not become detached from 
the needle during or after disposal. Further, it is not bulky and does not 
add to disposal problems. It is envisioned that the device can be 
manufactured to adapt to any size or shape of needle and needle hub 
including, but not limited to, industry-standard hypodermic needles, 
intravenous catheter needles, vacuum-tube phlebotomy needles and winged 
steel needles. It is also envisioned that the device may be attached to 
the needle hub manually by the user before use, or may be integrated with 
a needle hub and/or a needle and syringe assembly at the point of 
manufacture. 
These and other features, aspects, and advantages of the present invention 
will become better understood with regard to the following description, 
appended claims, and accompanying drawings.

DETAILED DESCRIPTION 
In general, the needle puncture prevention device of the present invention 
comprises a one-piece sleeve (10) shown in a relaxed condition in FIG. 1. 
The sleeve (10) comprises a base member (12) which, on its bottom surface, 
is contiguous with a needle hub housing (14). The base member has a first 
opening (16) therethrough which is aligned with a second opening (18) in 
the needle hub housing (14) to allow passage of a needle (20) and a needle 
hub (22). At least one of the openings (16) and (18) is shaped to 
frictionally engage the needle hub (22). The needle hub housing (14) may 
further comprise a lip (24) for threadably engaging the threads (48) of a 
syringe (130) attached to the needle (20) and needle hub (22), as shown in 
FIG. 3. The needle hub housing may be adapted to fit any size or shape of 
needle hub and any type of syringe. 
The device of the present invention, as shown in FIG. 1, further comprises 
a top member (26) which has a bore (28) therethrough centrally positioned 
on the transverse axis and eccentrically positioned on the longitudinal 
axis of the top member (26), and sized to allow passage of the needle (20) 
therethrough. Adjacent to the bore (28), on the bottom surface of the top 
member there is a needle tip engaging configuration which, in this 
embodiment, is a plurality of parallel ribs (30) which run perpendicular 
to the longitudinal axis of top member (26). (See also FIG. 5A). The rib 
immediately adjacent to the bore (28) is of greater height with respect to 
the other ribs (30) and comprises a lip (32). 
The sleeve (10) of FIG. 1 further comprises a pair of sidewalls (34) and 
(36) which are inverted with respect to each other and are connected to 
the base member (12) and to the top member (26) by means of living hinges 
(42). Each of the sidewalls (34) and (36) comprises a first sidewall 
member (38) and a second sidewall member (40) of unequal lengths which are 
also connected to each other by living hinges (44). When the device (10) 
is in the relaxed condition shown in FIG. 1, the base member (12) and the 
top member (26) are substantially parallel to each other, the first 
sidewall members (38) are substantially parallel to each other and the 
second sidewall members (40) are substantially parallel to each other. 
Thus, in the relaxed condition, the sidewall living hinges (44) are open 
and the device (10) substantially forms a parallelogram. In this 
condition, the eccentrically positioned bore (28) in the top member (26) 
is aligned with the first opening (16) in the base member (12) and the 
second opening (18) in the needle hub housing (14), thereby allowing the 
user to thread the needle and needle hub through the second opening (18) 
and the first opening (16) and to further thread the needle (20) through 
the bore (28). The user then slides the device (10) down to anchor it to 
the needle (20) and needle hub (22). The needle (20) is then free for use. 
If, as in FIG. 3, the needle hub (22) is attached to a syringe (130), the 
device (10) is then rotated and the lip (24) of the needle hub housing 
(14) threadably engages the syringe (130). 
After the needle has been used, the sleeve (10) is raised to its extended 
position to protect the needle tip, as shown in FIG. 2. This is 
accomplished by the user manually biasing the sidewalls (34) and (36) 
toward each other by squeezing them between thumb and forefinger (not 
shown), thereby closing the sidewall living hinges (44). The sleeve (10) 
in the extended condition is substantially rectangular in shape in the 
embodiment of FIG. 2, and has an internal longitudinal dimension just 
sufficient for enclosing the tip (46) of the needle (20). When the sleeve 
(10) is extended by the user, the needle (20) is extracted from the 
eccentrically positioned bore (28) in the top member (26), and the bore 
(28) is no longer aligned with the first opening (16) in the base member 
(12) and the second opening (18) in the needle hub member (14). Because 
the sleeve has a reflexive tendency to try to be in the relaxed condition, 
the top member (26) seats itself onto the needle tip (46) and the needle 
tip (46) is engaged by the parallel ribs (30) on the bottom surface of the 
top member (26). The lip (32) and parallel ribs (30) prevent the needle 
tip (46) from reentering the eccentrically positioned bore (28). The 
needle tip (46) is now firmly capped inside the protective sleeve (10) and 
will remain there, thereby preventing accidental needle puncture injury to 
the user and to others during disposal. 
Alternative embodiments of the sleeve (10) are shown in FIGS. 4, 5, and 6. 
The sleeve (10) is shown in the relaxed position in these figures and the 
extended position, although not shown, corresponds to that of FIG. 2. In 
FIG. 4, rather than being a bore, the eccentrically positioned opening for 
the needle (20) in the top member (26) is a groove (50) for receiving the 
needle (20). To attach the sleeve (10) to the needle (20), the user 
threads the needle (20) and needle hub (22) through the second opening 
(18) in the needle hub housing (14) and the first opening (16) in the base 
member (12) and lays the needle down into the groove (50). The user then 
slides the sleeve (10) down to anchor it to the needle (20) and needle hub 
(22). If, as in FIG. 3, the needle hub (22) is attached to a syringe 
(130), the sleeve (10) is then rotated and the lip (24) of the needle hub 
housing (14) threadably engages the syringe (130). 
The embodiment shown in FIGS. 5, 5A and 5B is similar to that of FIG. 4, in 
that the eccentric opening in the top member (26) is a groove (50) shaped 
to receive the needle (20). In this embodiment, the first opening in the 
base member (12) is a groove (52) aligned with a second groove (54) in the 
needle hub housing (14) and both grooves (52) and (54) are further aligned 
with groove (50) and at least one of grooves (52) and (54) is shaped to 
frictionally engage the needle hub (22). To attach the sleeve (10) to the 
needle (20), the user simply lays down the needle and needle hub into the 
grooves, then slides the sleeve (10) down to engage the needle hub (22). 
If, as in FIG. 3, the needle hub (22) is attached to a syringe (130), the 
sleeve (10) is then rotated and the lip (24) of the needle hub housing 
(14) threadably engages the syringe (130). 
In the embodiment shown in FIG. 6, the opening in the top member (26) of 
the sleeve (10) is the eccentrically positioned bore (28) as shown in FIG. 
1, for allowing passage of the needle (20). The grooves (52) and (54) in 
the base member (12) and needle hub housing (14), for frictionally 
engaging the needle hub (22), are as shown in FIGS. 5 and 5B. In this 
embodiment, to attach the sleeve (10) to the needle (20), the user threads 
the needle (20) through the bore (28), lays the needle hub (22) down into 
the grooves (52) and (54), and then slides the sleeve (10) down to engage 
the needle hub (22). If, as in FIG. 3, the needle hub (22) is attached to 
a syringe (130), the sleeve (10) is then rotated and the lip (24) of the 
needle hub housing (14) threadably engages the syringe (130). 
In the embodiment presented in FIGS. 7A, 7B and 7C, the device has finger 
tabs (60) extending outwardly from the sidewall members (38). The finger 
tabs could alternatively be extensions of sidewall members (40) and/or 
(38). The finger tabs (60) may be integral extensions of the sidewall 
members (38) and/or (40) or, alternatively, may be attached separately and 
may also be removable. To enclose the needle (20) and needle tip (46) in 
the sleeve (10), the user manually squeezes the outwardly extending finger 
tabs (60) toward each other and thereby biases the sidewall living hinges 
into a closed position. The needle tip (46) is engaged by the ribs (30) 
and (32) and the finger tabs (60) now extend inwardly to the sleeve. The 
shape of the figure tabs (60) is not limited to the embodiment shown in 
FIGS. 7A, 7B and 7C, but can be any shape which will provide the leverage 
means to bias the sidewall hinges (44) into the closed position. The 
finger tabs (60) may also be provided with a friction means (62), to allow 
a better grip by the user. 
An embodiment shown in FIG. 8A is modified in several respects from that 
shown in the previous figures. In this embodiment, the needle hub housing 
(14) has been shortened. This shortening allows the needle hub housing 
(14) to ride lower on the needle hub (22), allowing for more of the needle 
(20) to be exposed for use. The walls of the needle hub housing (14) also 
have been thickened to allow for more strength when the lip (24) is 
threaded into the syringe (shown in FIG. 3). In this embodiment, the 
needle hub housing (14) is eccentrically positioned on the longitudinal 
axis of the base member (12). The opening (16) in the base member (12) and 
the opening (18) in the needle hub housing (14) may be a bore (18) as 
shown in FIGS. 1-4, or a groove, as shown in FIGS. 5 and 6. The opening 
(64) in the top member (26) may be a bore as shown in FIGS. 1-3 and 6, or 
a groove, as shown in FIGS. 4 and 5. In this embodiment, the shape of the 
sleeve (10) in the relaxed condition is a trapezoid, rather then a 
parallelogram, in order that the alignment of the openings (16) and (18) 
in the base member (12), the needle hub housing (14) and the eccentrically 
positioned opening (64) in the top member (26) is preserved. As shown in 
FIG. 8A, the eccentrically positioned opening in top member (26) of the 
sleeve (10) is a groove (64), shown further in FIG. 8B, which is sized to 
receive a needle cap (66) placed over the needle (20). This modification 
allows the user, after attaching the device (10) to a needle and syringe 
assembly (see FIG. 3), to fill the syringe (130) with reagent before use 
and then recap the needle (20) before transport to the treatment area. The 
needle is then uncapped, the treatment administered, and the sleeve (10) 
biased manually into the extended condition by the user, as before, by 
closing the sidewall living hinges (44). The needle tip (46) is then 
engaged by the ribs (30) adjacent to the groove (64) and prevented from 
reentering the groove (64) by the raised rib (32). 
Another embodiment of the device is illustrated in FIGS. 9A and 9B. In this 
embodiment, needle trapping arms (68) and (72) are provided in addition to 
the needle tip engaging configuration (30) and (32) shown in the previous 
figures. Although the embodiment is illustrated with the needle (20) 
enclosed in the needle cap (66) contained in the groove (64), the needle 
trapping arms (68) and (72) may be used with any of the illustrated 
embodiments of the device. As shown in FIG. 9A, the needle trapping arms 
(68) and (72) are integral with sidewall members (38) and (40), and extend 
downwardly and substantially perpendicularly therefrom. It is not 
essential that the arms extend perpendicularly, but any angle between the 
arms and the sidewall members that achieves the purpose of the arms is 
acceptable. Each of the arms (68) and (72) is positioned substantially 
adjacent to and biased toward the bottom surface of the top member (26). 
The arm (68) is of greater length than the arm (72). Each of the arms (68) 
and (72) has an end comprising a needle trapping means (70) and (74) 
which, in this embodiment comprises complementary notches. However, any 
means which will serve this purpose is acceptable. When the sleeve (10) is 
in the relaxed condition, the arms (68) and (72) are biased toward each 
other forming an opening to allow passage of the needle (20) and/or the 
needle (20) with needle cap (66) therebetween. When the sleeve (10) is in 
the extended condition, the needle (20) is housed within the sleeve (10), 
the needle tip (46) is engaged by the ribs (30) and (32), the arms (68) 
and (72) are further biased toward each other and the bottom surface of 
the top member (26). The arm (68) is sufficient in length to shield the 
opening (64) in the top member (26) and the needle trapping means (70) and 
(74) trap the needle (20) and prevent the needle tip (46) from moving off 
of the ribs (30) and (32). This embodiment particularly assures that the 
sleeve (10) will not become disengaged from the needle tip (46) during and 
after disposal. 
Another embodiment of the device is illustrated in FIGS. 10A, 10B and 10C. 
This embodiment is similar to that illustrated in FIG. 8A. As in FIG. 8A, 
the needle hub housing (14) has been shortened to allow the needle hub 
housing (14) to ride lower on the needle hub, allowing for more of the 
needle to be exposed for use. The walls of the needle hub housing (14) are 
thick to provide strength when the lip (24) is threaded into the syringe 
(130) (shown in FIG. 3). The needle hub housing (14) is eccentrically 
positioned on the longitudinal axis of the base member (12). The opening 
(82) in the base member (12) and the opening (84) in the needle hub 
housing (14) may be a bore as shown in FIGS. 1-4 and 8-9 or a groove, as 
shown in FIGS. 5 and 6. In this embodiment, the shape of the sleeve (10) 
in the relaxed condition is a trapezoid, rather then a parallelogram, in 
order that the alignment of the openings (82) and (84) and the 
eccentrically positioned opening (80) in the top member (26) is preserved. 
The opening (80) in top member (26) of the sleeve (10) may be a bore, as 
illustrated in FIGS. 1-3 and 6 or a groove, as illustrated in FIGS. 4, 5, 
8A, 8B, 9A and 9B. 
In the embodiment illustrated in FIGS. 10A, 10B and 10C, the top member 
(26) further comprises a first wall (86) which is contiguous with the 
bottom surface of the top member (26) and which extends substantially 
perpendicularly therefrom. The first wall (86) is positioned proximal to 
and substantially parallel to the needle tip engaging ribs (30) and (32) 
and is distal to the opening (80) in the top member (26). The top member 
(26) further comprises a second wall (88) which is contiguous with the 
bottom surface of the top member (26) and extends substantially 
perpendicularly therefrom. The second wall (88) is positioned adjacent to 
and substantially perpendicular to the needle tip engaging ribs (30) and 
(32) and is distal to the opening (80). The first and second walls (86) 
and (88) are contiguous with each other and form substantially a 
90.degree. angle with each other. Together with the bottom surface of the 
top member (26), the first and second walls (86) and (88) substantially 
form three sides of a needle trapping box (90), shown in FIG. 10B. The 
needle trapping box (90) further comprises an arm (92) integral with a 
first or second sidewall member (38) adjacent to and hinged to an end of 
the top member (26) proximal to the opening (80). The arm (92), which has 
an end comprising a needle trapping means (94), such as a notch, extends 
downwardly from the sidewall member (38) and is positioned substantially 
adjacent to and is biased toward the bottom surface of the top member (26) 
and the three-sided needle trapping box (90). When the sleeve (10) is in 
the relaxed condition, the arm (92) is biased toward the three-sided 
needle trapping box (90), forming an opening to allow passage of the 
needle (20) and/or the needle (20) and needle cap (66) (not shown) 
therebetween, and through the opening (80). When the sleeve is in the 
extended condition, the needle (20) is housed within the sleeve (10), the 
needle tip (46) is engaged by the ribs (30) and (32), the arm (92) is 
further biased toward the three-sided needle trapping box (90) to form 
substantially a fourth side of the box to trap the needle therebetween. 
In all of the illustrated embodiments, the members of the sleeve are shown 
to be "plank-shaped"; however, any shape of the members that serves the 
purpose of the invention is acceptable. The device may be injection molded 
and made from a thermoplastic material, such as polypropylene. However, it 
is envisioned that the device could be made from any material, including 
metals. 
Although the present invention has been described in considerable detail 
with reference to certain preferred embodiments thereof, it is not 
intended to limit the scope of the invention to particular embodiments set 
forth but, to the contrary, it is intended to cover such alternatives, 
modifications, and equivalents as may be included within the spirit and 
scope of the invention as defined by the appended claims.