HK1164093A - A device useful for collecting bodily fluid from a patient - Google Patents

Description

Device for collecting body fluid of patient

Cross Reference to Related Applications

This application is a partial continuation of pending U.S. patent application No. 12/846,402 filed on 29/7/2010, and No. 12/846,402 is a partial continuation of pending U.S. patent application No. 12/136,462 filed on 10/6/2008.

Technical Field

The present invention relates to a medical device that may be used to collect a body fluid of a patient, and more particularly, for example, to a vascular blood collection device that is non-reusable and provides protection from accidental needle sticks.

Background

Conventional devices for drawing blood from a blood vessel or other bodily fluids of a patient expose the needle tip when pulled from the patient, thereby exposing the user of the device to possible needle sticks and contamination due to contact with pathogens present in the bodily fluids. There is a need for a device that provides greater protection to users and patients, that is not easily reused by other patients, that is convenient to use, that can be used with, for example, conventional blood collection tubes, and that can be reliably manufactured in large quantities at relatively low cost. Such an apparatus is disclosed in the present application.

Disclosure of Invention

The invention disclosed herein is a medical device that can be used to draw blood or other bodily fluids from a patient or animal using a conventional collection tube having a stopper of resilient material (typically rubber) at one end. Desirably, the forwardly extending end of the device has a sharpened needle tip that can be inserted into, for example, a patient's vein. Desirably, the rearward end of the needle also has a sharpened needle tip that can be inserted through a resilient material closure (typically a rubber stopper) that seals the open end of the blood collection tube. The rearward end of the needle is initially covered by a flexible, resilient material sheath that can be pierced by a rearwardly extending needle tip, which is then pushed forward and retracted as the needle tip also penetrates the closure to establish fluid communication through the needle between the patient's vein and the blood collection tube. The shrinkable elastomeric sheath over the rearward facing needle tip also prevents bodily fluids from escaping from behind the needle prior to the time the needle is inserted into the blood collection tube. Once the desired amount of body fluid has been collected, and as the collection tube is withdrawn from contact with the needle tip, the retracted elastomeric sheath simultaneously unfolds to its original position covering the needle tip. This prevents any blood remaining in the needle before withdrawal from exiting from behind the needle or device.

Another desirable feature of the invention is that the forwardly extending needle tip may be retracted into the device body to prevent accidental needle sticks. Ideally, the retraction is initiated by depressing a trigger hinged near the rear of the device, without first removing the needle from the patient. When the front end of the trigger is pressed against the device body, the rearwardly extending needle tip is urged into a retraction cavity inside the trigger by a compressed retraction spring. The forward needle tip remains inside the device body after the retraction spring is deployed during needle retraction.

Another desirable feature of the present invention is a release mechanism for initiating needle retraction. The needle is secured prior to retraction on a needle holder that is biased rearwardly by a compressed retraction spring and held in this position by a lug ring that is rotatably mounted inside the device body. After fluid collection, when the trigger is depressed to initiate needle retraction, the trigger contacts a tab projecting radially from the tab ring, causing the tab ring to rotate inside the device body. As the lug ring rotates, the aperture in the ring moves into alignment with the cooperatively shaped transverse flange on the needle holder, allowing the previously constrained needle holder to pass through the aperture. With the transverse flange passing through the aperture in the lug ring, the compressed retraction spring is released to drive the needle holder rearwardly into the retraction cavity inside the trigger. This rotational release mechanism is believed to be distinct from the mechanism for releasing the retraction spring in any prior art device having a retractable needle and combines reliable support with a smooth operating release action that requires a relatively low activation force to be applied by the clinician using the device.

In accordance with a preferred embodiment of the present invention, a non-reusable device for collecting body fluid (e.g., vascular blood) from a patient is disclosed, the device being configured to receive, for example, a blood collection tube and having a retractable needle attached to a rearwardly biased needle holder that is restrained by a rotatably mounted lug ring prior to needle retraction and that is released during retraction by depressing a trigger that is pivotally connected to the device body to rotate the lug ring so that the needle holder is driven into a retraction cavity within the trigger and the forward tip of the needle remains inside the device body.

Drawings

The device of the invention is further described and explained below with reference to the drawings, in which,

FIG. 1 is a simplified perspective view of a preferred embodiment of a device for collecting bodily fluids, such as blood, wherein the device is oriented in a substantially upright position with a forward extending portion of the device pointing in a generally downward direction;

FIG. 2 is an exploded view of the device of FIG. 1;

FIG. 3 is a top plan view of the device of FIG. 1 when oriented in a horizontal position;

FIG. 4 is a side view of the device of FIG. 1 oriented as in FIG. 2;

FIG. 5 is a left side view of the device of FIG. 1 oriented as in FIG. 4;

FIG. 6 is a cross-sectional view taken along line 6-6 of the device of FIG. 3, showing the device in its pre-use configuration prior to insertion of a liquid collection tube into the interior of the device;

FIG. 7 is a cross-sectional view of the device of FIG. 6 after insertion of a liquid collection tube into the interior of the device;

FIG. 8 is a cross-sectional view of the device of FIG. 6 in its post-use and retracted configuration with the retraction spring deployed and the forward needle tip retracted within the device body;

FIG. 9 is a simplified and reduced size view of FIG. 4, with section lines showing the location and orientation of the cut-away view of FIG. 10;

FIG. 10 is a simplified cross-sectional view taken along line 10-10 in FIG. 9;

FIG. 11 is an enlarged detail view taken from the cross-sectional view of FIG. 10 showing the lug ring, lug and lug interface of the trigger in pre-use and pre-retracted positions;

FIG. 12 is the device shown in FIG. 10, but with the trigger depressed relative to the body and the lug ring and lugs rotated to a retracted position;

FIG. 13 is an enlarged detail view taken from the cross-sectional view of FIG. 10 showing the lug ring, lug, and lug interface of the trigger in a retracted position;

FIG. 14 is the device shown in FIG. 12, but after retraction;

FIG. 15 is an enlarged detail view taken from FIG. 7;

FIG. 16 is a simplified rear top perspective view of another preferred embodiment of a device for collecting bodily fluids such as blood wherein the needle and trigger (or pivotable drive) are disposed in a protruding, pre-retraction position and the device body is provided with a cross bar that limits upward pivotal movement of the rear portion of the trigger relative to the rear portion of the body after retraction of the needle;

FIG. 17 is a detail view taken from FIG. 16;

FIG. 18 is a cross-sectional front view taken along line 18-18 of FIG. 17;

FIG. 19 is a simplified rear top perspective view of another preferred embodiment of the device of FIG. 16, wherein the needle is retracted and the trigger is disposed in a retracted position, and the device body is provided with a transverse bar that limits upward pivotal movement of the rear portion of the trigger relative to the rear portion of the body after retraction of the needle;

FIG. 20 is a detail view taken from FIG. 19; and

fig. 21 is a cross-sectional front view taken along line 21-21 of fig. 20.

Like reference numerals are used to describe like parts throughout the drawings.

Detailed Description

The device 20, shown in whole or in part in the various figures of the drawings, is desirably configured to facilitate the collection of bodily fluids, preferably vascular fluids, from a patient. The device 20 is generally intended for use with blood collection tubes such as those shown in fig. 7 and 8 and further described below with reference to these figures. Desirably, the device 20 comprises a needle having two sharpened ends connected by a common bore which places the two sharpened ends in fluid communication so that any liquid flowing into the forward end, for example, can flow out of the rearward end unless it is prevented in some way. Ideally, the needle is supported inside the device 20 by a needle holder. Ideally, the rearward facing sharp end of the needle is covered by a soft rubber sheath which is secured to the rear end of the needle holder by friction, adhesive or the like.

In a clinical procedure for taking a sample of a patient's bodily fluid (e.g., blood from a blood vessel), the forward projecting end of the needle is inserted into a patient's vein or artery. The device 20 is provided with a textured gripping surface to facilitate this attempt, and ideally the underside of the device 20 is substantially flat to allow the needle to be inserted at a nearly straight angle relative to the patient's body. Desirably, a liquid collection tube with a rubber stopper is inserted into the device 20 through an opening at the rear end and moved forward inside the device 20 until the rear end of the needle encounters the stop of the rubber stopper. When this occurs, because the rubber sheath is generally more flexible than the rubber stopper, the needle tip pierces the sheath and the sheath folds around the needle, advancing the needle tip through the stopper. Once the rearward facing needle tip pierces the stopper of the liquid collection tube, body fluid flowing into the needle from within the patient at the forward end can flow through the needle and into the liquid collection tube. The liquid collection tube is typically sufficiently evacuated to allow liquid to flow into the tube without venting. When the desired amount of liquid has been collected, the tube is withdrawn from the device 20 and as the rearward facing needle tip exits the stopper, the rubber sheath again unfolds and covers the now exposed needle tip. Ideally, the rubber used to make the rubber sheath is sufficiently elastic that the hole created by the needle closes when the needle is withdrawn, thereby preventing unintended liquid flow out from behind the needle while the forward needle tip is still inserted in the patient.

During the phase of clinical vascular fluid extraction using conventional devices, the forward needle tip is withdrawn from the patient's vein or artery, and the bare needle tip, which may be contaminated with blood-borne pathogens, poses a threat to the clinician when placed in a prescribed sharps container or the like. In many instances, this is the time when accidental needle sticks and infections occur. For this reason, the device 20 is specifically adapted and configured to withdraw the front needle tip from the patient and place it into the body of the device 20 to substantially reduce the chance of any accidental needle stick or contamination due to direct contact with the needle tip or bodily fluids carried thereon.

Referring to fig. 1-2, device 20 desirably includes a body 22, an elongate trigger 24, a needle holder 50, and a retractable needle 28. Desirably, the body 22 further includes a front opening of a spout 40 at the front end, a rear opening 34, outwardly projecting flange members 38, and finger grips 30 disposed on each side. Desirably, the finger grip 32 is also present on the upwardly facing end of the trigger 24 opposite the hinge support 36 of the body 22 to which the trigger 24 is pivotally connected. Desirably, the forward tip 26 of the needle holder 50 to which the retractable needle 28 is connected extends slightly beyond the nozzle 40 of the body 22 through the forward opening of the nozzle 40, which is not shown in fig. 1-2.

The structure and assembly of the device 20 is further described and explained with reference to fig. 1-7. The trigger 24 is preferably an elongated member, generally shaped like an inverted U, having a forward facing open end 96 (fig. 7) and an oppositely disposed closed end including two opposed, laterally projecting projections 44 (fig. 2, 4 and 5). In this embodiment of the invention, the projections 44 serve as hinge pins that snap into engagement with the hinge supports 36 on the body 22 during assembly of the device 20, although other similarly effective structures could equally be used to pivotally connect the rear portion of the trigger 24 to the body 22. Desirably, the frictional engagement between the protrusion 44 and the hinge support 36 is sufficient to prevent inadvertent disengagement of the trigger 24 from the body 22 during use of the device 20, but is insufficient to provide sufficient resistance to rotation of the protrusion 44 within the mating recess of the hinge support 36 after assembly. A rearwardly projecting stop 46 is preferably provided to limit upward rotation of the trigger 24 relative to the body 22 during use of the device 20. Preferably, the underside of the trigger 24 (when oriented as in fig. 7) is open for most of its length, with a bottom wall portion 47 disposed near the rear end. As discussed in more detail below, the interior space in the trigger 24 serves as a retraction cavity 90 into which most of the retractable needle 28 and other parts of the needle retraction assembly are received during retraction after body fluid collection. Preferably, a textured finger gripping surface comprising, for example, a plurality of spaced apart laterally disposed ridges 32 is provided on the upper surface of the trigger 24 proximate the free open end 96. Referring to fig. 7, desirably, an undercut lug contact surface 94 is also provided adjacent the open end 96 and generally facing downward relative to the body 20. The function of the lug contact surface 94 is described further below.

Body 22 has a generally tubular sidewall defining an internal cavity 92, in the preferred embodiment, the internal cavity 92 has a diameter large enough to receive a conventional fluid container such as a blood collection tube 76, as shown in FIGS. 6 and 7, with blood collection tube 76 slidably inserted into rear opening 34 during use of the device. Desirably, the side wall of body 22 serves as a guide to maintain blood collection tube 76 in substantial coaxial alignment with body 22 and needle 28 during use of device 20, the length of body 22 preferably being such that a portion of tube 76 remains readily graspable by the clinician to facilitate removal of tube 76 after collection of body fluid. Referring to fig. 1-5, a finger grip 30 including a surface portion, such as with a plurality of closely spaced ridges, is desirably provided on each side of the body 22 to assist the clinician in gripping the body 22 during use of the device 20.

2-4, 6, and 7, the body 22 preferably further includes an elongated, longitudinally extending, upwardly facing slot 72, the slot 72 being sized and configured for receiving a portion of the trigger 24 therein when the open end 96 of the trigger 24 is pivoted downwardly relative to the body 22 from the hinge support 36. Recessed front 42 at the sides and front of slot 72 facilitates the downward movement of the front of trigger 24 into slot 72. Desirably, the forward end of the body 22 includes a tapered nozzle 40 and a forward opening, the tapered nozzle 40 having an inwardly stepped inner diameter, the inner diameter of the forward opening being slightly larger than the outer diameter of the forward tip 26 of the needle holder 50. Referring to fig. 1 and 7, the length of the nozzle 40 is desirably such that the forward tip 26 of the needle holder 50 extends slightly beyond the nozzle to facilitate connection of the needle 28 with the needle holder 50 after the needle holder 50 is mounted inside the body 22, if desired.

Referring particularly to fig. 2 and 7, a needle retraction assembly, preferably comprising a lug ring 62, a needle holder 50 and a compressible retraction spring, is desirably disposed within the front portion of body 22. While it is understood that other similarly effective structures may be used to position the needle retraction assembly within the forward portion of body 22, one satisfactory structure includes a plurality of circumferentially spaced hooks or segments 104 and 106 that are configured to be sufficiently flexible to permit passage of earring 62 in the forward direction during installation, but are configured to be sufficiently stiff to retain the needle retraction assembly in the axial position shown in FIG. 7 against the biasing force of compression spring 70 prior to retraction. When the lug ring 62 is disposed and supported within the body 22 in this manner, the lug ring 62 may rotate about the longitudinal axis of the device 20, but such rotational movement is limited by other structures described below with reference to fig. 10-14. Needle holder 50 preferably includes a centrally disposed longitudinal bore sized and configured to allow needle 28 to pass therethrough. Desirably, the needle holder 50 is provided with a transverse flange 52 on the exterior. Desirably, transverse flange 52 is sized and configured for retaining a compressed retraction spring 70 disposed about needle holder 50 within nosepiece 40. Ideally, the forward end of spring 70 abuts an annular shoulder located directly behind the forward opening of spout 40.

During assembly of the device 20, a soft elastomeric sheath 56 having an open end 58 and a closed end 74 is desirably connected to the head 54 and neck 60 of the needle holder 50, such as by frictional engagement. The lug ring 62 is placed over the sheath 56 and head 54 of the needle holder 50. Forward tip 26 of needle holder 50 is inserted into spring 70 and the assembly is inserted into body 22 with lug ring 62 such that centrally disposed aperture 102 (as seen in fig. 10 and 14) in lug ring 62 is misaligned to allow lateral flange 52 (seen in fig. 12) of needle holder 50 to pass through aperture 102. When earring 62 is arranged in this manner, needle holder 50 is preferably maintained in the position shown in FIGS. 6 and 7 prior to needle retraction. The lug ring 62 preferably further includes at least one outwardly projecting lug 64 as seen in fig. 10-14 and discussed in more detail below. After the needle retraction assembly is disposed within the interior of the body 22, the rearward needle tip 68 of the needle 28 may be inserted through the forward tip 26 of the needle holder 50 and advanced rearwardly until the rearward needle tip 68 approaches, but does not contact, the closed end 74 of the soft elastomeric sheath 56 (FIG. 2). When properly positioned relative to the needle holder 50, the needle 28 is preferably attached to the needle holder 50 using a suitable conventional means such as adhesive, laser welding, or the like. As shown in fig. 2 and 7, the needle 28 preferably has an upwardly facing bevel at the forward needle tip 66 and an oppositely facing bevel at the rearward needle tip 68.

Referring to fig. 1-5, body 22, trigger 24, lug ring 62 and needle holder 50 are desirably all made of an injection moldable polymeric resin commonly used to manufacture similar types of medical devices, but without requiring the use of polymeric materials. Where polymeric materials are used, it is not required that all parts be made of the same polymeric material.

Referring to fig. 6, one preferred embodiment of the device 20 described herein is shown in its pre-use configuration, although it will be appreciated that a needle cap (not shown) may also be provided to protect the front needle tip 66 prior to use, although desirably the device 20 is shipped and stored inside sterile packaging. In the pre-use position, the front of the trigger 24 may be pivoted downwardly into a rest position of the body 22 facing upwardly inside the slot, as shown. As liquid collection tube 76 is advanced forward as shown by arrow 84 into body 22 via rear opening 34, the top of rubber stopper 80 contacts the underside of trigger 24 and rotates the forward end of trigger 24 upwardly relative to body 22 to the position shown in FIG. 7. When the trigger 24 is in the position of fig. 7, a rearward facing ledge 46 of the trigger 24 contacts and abuts a bottom of a recess 48 (visible in fig. 2) to limit upward movement of the trigger 24 relative to the body 22. As the liquid collection tube 76 (fig. 6) is advanced, the rear needle tip 68 pierces the elastomeric sheath 56 and then pierces the rubber stopper 80 to establish fluid communication with the interior 92 of the tubing 78. When this occurs (as best seen in fig. 15 taken from fig. 7), the elastomeric sheath 56 collapses into an annular space around the needle 28 in front of the rubber stopper 80.

Referring to fig. 10 and 11, desirably, the lugs 64 that preferably project radially outward from the lug ring 62 are located in detents (detents) behind smoothly configured protrusions 100, the protrusions 100 projecting inward from a portion of the body 22 opposite the lugs 64. The protrusion 100 prevents the lug ring 62 from rotating relative to the body 22 and the transverse flange 52 of the needle holder 50 prior to needle retraction. When the lug 62 is positioned as shown in FIGS. 10 and 11, the transverse flange 52 of the needle holder cannot pass through the hole 102 in the lug 62. The biasing force exerted by the spring 70 (fig. 7) on the forward facing surface of the transverse flange 52 is limited by the lug ring 62 until the lug ring 62 is rotatably repositioned within the body 22. Upon reading the above, it should be understood that each transverse flange 52 and aperture 102 can have a myriad of different shapes, however, the relative sizes and shapes of the transverse flanges 52 and apertures 102 are such that the transverse flanges 52 can pass through the apertures 102 only when the lug ring 62 has been rotated from the restraining position shown in fig. 10-11 to the non-restraining position shown in fig. 12-14.

Referring to FIG. 8, after the fluid collection tube has been filled to a desired degree with bodily fluids withdrawn from the patient, the clinician using device 20 will grasp collection tube 76 and withdraw it from lumen 86, as indicated by arrow 87. When this occurs, the rubber stopper 80 closes off the tube 76 to prevent liquid leakage from the tube, and the resilient material sheath deploys back over the rear needle tip 68 to prevent any body fluid still contained in the needle 28 from leaking out the rear of the body 22. The needle 28 may then be withdrawn directly from the patient by pressing the free end of the trigger 24 located inside the upwardly facing slot of the body 22 beyond the rest point shown in fig. 6 to a point where needle retraction can occur.

Referring to fig. 12-14, when the forward end of the trigger 24 is pressed into the interior of the body 22, the downwardly facing contact surface 94 of the trigger 24 contacts the opposing, upwardly facing surface of the tab 64 of the lug ring 62, thereby urging the tab 64 past the projection 100 of the body 22, while simultaneously rotating the lug ring 62 as indicated by arrow 65 (fig. 13) to a position where the transverse flange 52 is aligned with the aperture 102 in a position where the transverse flange 52 is no longer restrained by the lug ring 62. Referring again to FIG. 8, when the lug ring 62 reaches the position where the needle holder 50 is released, the spring 70 rapidly expands and acts on the front surface of the lateral flange 52 of the needle holder 50, driving the needle holder 50 with the attached resilient material sheath 56 and needle 28 back into the retraction cavity 90 of the trigger 24. When this occurs, the lug ring 62 and lug 64 remain in the position shown in fig. 12, the needle 28 is tilted upwardly, and the forward tip 66 of the needle 28 is retracted to a position inside the nozzle 40 of the body 22 where no accidental needle stick and/or infection by a potentially contaminated needle is encountered by either the patient, clinician or another bystander. Because the needle 28 is captured within the device 20, the possibility of reuse of the device 20 is also eliminated.

Referring to fig. 16-21, there is disclosed another embodiment 200 of the present invention which is substantially identical to that previously described except that a transverse bar 220 is disposed between upright, opposed hinge supports 213 and 214 to limit upward movement or movement of a rearwardly projecting stop 222 (best shown in fig. 18 and 21) relative to the body 210 during needle retraction before and after the forwardly extending end of the transverse bar 220 has been depressed relative to the body 210. Fig. 16-18 illustrate a rest position of the trigger 212 relative to the body 210 prior to needle retraction, and fig. 19-21 illustrate a rest position of the trigger 212 relative to the body 210 after needle retraction. The raised position of the trigger 212 relative to the body 210, achieved by the transverse rod 220 prior to needle retraction, is an indicator that the needle has not been retracted and also helps to prevent premature retraction during shipping.

During needle retraction, when the front of trigger 212 is depressed into body 210, rearwardly projecting stops 222 rise up from notches 224 and engage the underside of transverse rod 220. Depending on the thickness of the transverse bar and the material used to make the transverse bar, the transverse bar will flex or bend more or less upwardly when the trigger 212 is pressed against the body 210 to initiate retraction. In a bent or flexed position (not shown) relative to the body 210, the transverse rod 220 will limit the extent to which the front of the trigger 212 travels downward relative to the front of the body 210.

The natural resiliency of the material used to make the transverse bar 220 may allow it to return substantially to its pre-retraction position relative to the body 210 after the needle is retracted by the user, and after the user no longer presses down on the trigger 212, but more typically, the post-retraction resting position of the front of the trigger 212 relative to the front of the body 210 is lower than the pre-retraction position due to some upward bending or deformation of the transverse bar 220 that remains after retraction. The change in the rest position after retraction is shown, for example, in fig. 19-21. While the transverse bar 220 may be separately manufactured and then attached to the opposing hinge supports 213 and 214 using any suitable known fastener, adhesive, or welding technique, the transverse bar 220 is preferably molded as part of the body 210 and/or the hinge supports 213 and 214.

Other variations and modifications of the invention will become apparent to those skilled in the art upon reading the specification and by referring to the accompanying drawings, and the scope of the invention disclosed herein is limited only by the broadest interpretation of the appended claims to which the inventors are entitled.

Claims (25)

1. A device for collecting a body fluid of a patient, the device comprising:

a body having a forwardly projecting, rearwardly biased, releasably restrained, selectively retractable needle, said body being configured for receiving a liquid collection tube in selective releasable fluid communication with a rearward end of the retractable needle;

a trigger movably coupled relative to the body, the trigger including an activation member selectively engageable with a lug ring rotatably mounted within the body;

wherein movement of the trigger relative to the body upon release of the liquid collection tube from the body causes the lug ring to rotate and thereby release the restrained, rearwardly biased needle for retraction into the retraction cavity within the body and trigger.

2. The device of claim 1, wherein the bodily fluid is blood.

3. The device of claim 1, wherein the liquid collection tube is a blood collection tube.

4. The device of claim 1, wherein the retractable needle has a sharpened forward needle tip and a rearward needle tip.

5. The device of claim 1, wherein the retractable needle is attached to a needle holder disposed inside the body.

6. The device of claim 5, wherein the needle holder has a transverse flange.

7. The device of claim 1, wherein the needle is biased rearward by a compressed retraction spring.

8. The device of claim 1, wherein the retractable needle is constrained by a lug ring.

9. The device of claim 5, wherein the needle holder is constrained by a lug ring.

10. The apparatus of claim 1, wherein the lug ring is rotatably mounted within the body.

11. The device of claim 1, wherein the body comprises an open rear end into which a liquid collection tube can be releasably inserted.

12. The device of claim 1, wherein the body includes an upwardly facing slot.

13. The device of claim 1, wherein the trigger is pivotably connected to the body.

14. The apparatus of claim 12, wherein the trigger is pressed into the slot to rotate the lug ring.

15. The device of claim 13, wherein the trigger pivots relative to the body to rotate the lug ring.

16. The device of claim 1, wherein the body comprises at least one laterally protruding flange member.

17. The device of claim 16, wherein at least one laterally projecting flange member has a substantially flat bottom.

18. The device of claim 1, wherein the trigger actuation member is a surface engageable with a tab projecting from a tab ring.

19. The device of claim 9, wherein the lug ring comprises a centrally disposed hole alignable with a lateral flange of a needle holder.

20. The device of claim 5 wherein a portion of the needle holder protrudes forward of the body.

21. The device of claim 4, wherein the retractable needle has an upward facing bevel on the forward needle tip and a downward facing bevel on the rearward needle tip.

22. The device of claim 1, wherein the body, trigger, and earring are made of molded plastic.

23. The device of claim 4, wherein the rearward needle tip is surrounded by a soft elastomeric sheath.

24. The device of claim 23, wherein the sheath is connected to a needle holder disposed inside the body.

25. The device of claim 1, wherein the body further comprises a plurality of spaced apart hinge supports and a transverse bar disposed above a rearwardly projecting stop provided at a rear portion of the trigger.