Note: Descriptions are shown in the official language in which they were submitted.
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1 FIELD OF THE INVENTION
2 This invention relates generally, to hypodermic syringes
3 for withdrawing, transporting and injecting liquid medicines
4 and other fluids, and more particularly, to an improved
apparatus for accomplishing such fluid transfer without fear
6 of contact between the hypodermic needle and using personnel,
7 either during insertion and assembly of the components or as
8 they are being withdrawn and disassembled.
9 BACKGROUND OF THE INVENTION
Intravenous fluid dispensing bags are provided with a
11 fluid supply port, into which the needle of a hypodermic
12 syringe can be introduced and through which fluid medicines are
13 injected into the bag for dispensing to the patient
14 intravenously. The process of withdrawing medicine from a vial
into a hypodermic syringe, transporting it safely without
16 contamination and injecting it into an intravenous fluid
17 dispensing bag has been the subject of much prior art devoted
18 to preventing needle breakage and preventing needle
19 contamination from the environment to which the syringe is
exposed. Protective sheaths and hoods encircling the needle
21 are well-known, as are removable protective covers and needle
22 guides, all intended to relieve these problems.
23 However, the increase in incurable infectious diseases has
24 raised new concerns for the safety of people who use hypodermic
syringes, particularly from accidental needle pricks which
26 penetrate the skin. The prior art does not address this
27 problem, at least as far as disclosing apparatus and methods
28 which make accidental needle punctures essentially impossible.
29 It will be acknowledged that the wearing of surgical gloves by
attending personnel is a reliable first line of defense with
31 regards to spilled fluids but such a precaution offers no
32 protection against needle pricks wherein either the needle or
33 fluid carried thereby have become contaminated.
34 Liquid medicine to be given to patients intravenously are
supplied from the drug manufacturers in vials or bottles having
36 a rubber stopper seal held in place by a crimped band of
37 aluminum or other metal. To transfer medicaments from this
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1 vial a hypodermic syringe needle is inserted through the rubber
2 stopper, perforating it and entering the vial. The medicament
3 is drawn off into the syringe until the syringe holds the
4 required measured amount. The needle is then withdrawn from
the vial and inserted into the fluid supply port of an
6 intravenous fluid dispensing bag containing the carrier fluid
7 to be dispensed intravenously. The medicine injected into the
8 bag's fluid contents is mixed therewith and is then ready for
9 administering to the patient.
This process, which involves handling the syringe
11 frequently, makes needle breakage and skin pricks a recurring
12 problem. Transporting the syringe after filling and before
13 injection can also create opportunities for the needle to be
14 exposed to the environment for extended periods. Much of the
prior art discloses devices which attempt to relieve these
16 problems, generally by sheathing the needle and providing it
17 with a protective cover both for guiding the needle over a
18 medicament port and for protecting the withdrawn solution from
19 contamination.
U.S. Patent No. 3,826,261 to Killinger discloses a syringe
21 with the needle surrounded by a cylindrical sheath, adapted for
22 communication with a tubular conduit comprising part of a
23 sealed cap which closes the neck of a medicament vial and seals
24 it.
U.S. Patent 4,128,098 issued to Bloom et al discloses a
26 valved spike for insertion into the rubber stopper of a sealed
27 medicament vial, and requires only one puncture of the stopper
28 instead of the repeated punctures from syringe needles normally
29 encountered when syringes are filled repeatedly from the same
vial.
31 U.S. Patent 4,232,699 to Nitshke discloses a syringe for
32 use with flexible bags, the syringe having a cylindrical sheath
33 surrounding the needle portion and serving to guide and support
34 the needle. This patent also discloses a cap for the sheath
to protect the needle for use.
36 However, none of this prior art is devoted to means for
37 preventing human contact with the sharpened needle during all
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1 the steps in transforming medicament from vials to IV plastic
2 bags, nor is the connection between the syringe, vials and IV
3 bags necessarily the same.
4 SUMMARY OF THE INVENTION
An object is to provide a piercing spear device to
6 puncture the flat diaphragm stopper on a liquid medicine vial,
7 penetrate it and by projecting barb means prevent withdrawal,
8 with the spear device having a fluid supply port for mating
9 engagement with a hooded needle.
Another still further object is to provide a kit for
11 transferring liquid medicine comprising a hooded needle and
12 hypodermic syringe with a concentric end cap to cover and seal
13 the recessed needle, a fluid supply port and stopper for
14 maintaining by standard means a medicine vial, and a piercing
spear device and fluid supply port for piercingly mounting on
16 a standard flattop medicine vial.
17 Another object is to provide a method for manufacturing
18 the apparatus of this invention.
19 A further object is to provide a method for assembling the
medical fluid dispensing apparatus of this invention.
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1 BRIEF DESCRIPTION OF THE DRAWINGS ~;
2 Fig. 1 is a perspective view of the components comprising
3 the medicament injection device; ~ -
4 Fig. 2 is a side elevation, partly in section, of a
medicament vial usable with the present invention;
6 Fig. 3 is a perspective view of an IV bag usable with the
7 present invention;
8 Fig. 4 is an enlarged vertical sectional view of the
9 device of Fig. 1;
Fig. 5 is a view similar to Fig. 2, or an alternate
11 medicament vial; and
12 Fig. 6 is a side elevation of a piercing device used with
13 the present invention.
14 Similar reference characters designate corresponding parts
15 throughout the several views of the drawings.
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1 DESCRIPTION OF THE PREFERRED EMBODIMENT
2 Referring now to the drawings, particularly Figs. 1 and
3 2, the present invention will be seen to comprise an assembly
4 or kit of elements as employed in preparation for the
administration of intravenous or IV fluids. Included is the
6 primary component namely, a hypodermic syringe H, having a
7 barrel 1 provided with a forward nose 2, to which is affixed
8 a cannula or needle 3 terminating in the conventional distal,
9 sharpened tip 4.
The usual IV procedure involves insertion of the needle
11 tip 4 through the rupturable membrane 5 included in the cap 6
12 of a hand-held medicament vial V, following which the plunger
13 assembly 7 of the syringe H is manipulated to withdraw the
14 prescribed volume of liquid from the vial V. Subsequently, the
15 measured medicament is introduced into the carrier fluid as
16 contained in an IV bag I, such as illustrated in Fig. 3 of the
17 drawings. To facilitate this latter procedure, a suitable
18 input fitting 8 is supplied on the IV bag I and includes a
19 cylindrical end cap 9 likewise having a rupturable seal or
20 membrane through which the needle 3 is inserted to allow
21 discharge of the measured medicament into the IV fluid existing
22 within the bag I. An appropriate output port 10 of any
23 suitable well known construction is included on the bag to
24 allow delivery of the fluid to an IV line 11 for administration
25 to the patient.
26 During the above manipulations, when using the
27 conventional apparatus, attending personnel are constantly
28 vulnerable to the dangers of the exposed, sharpened tip 4 of
29 the hypodermic needle 3. Such exposure often results in using
30 personnel sticking or pricking themselves, no matter the degree
31 of precaution being exercised. A prick may be received at any
32 time following removal of the hypodermic syringe H from its
33 sterile packaging and thus may occur before or after
34 withdrawing of the medicament from the vial V or preceding or
35 following the subsequent introduction of the measured
36 medicament into the IV bag I.
37 The above related danger of needle sticks is of all the
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1 more concern in view of the heightened awareness of the
2 transmission of communicable diseases to personnel involved in
3 the direct treatment of patients. Even though treatment
4 personnel regularly wear surgical gloves while administering
or withdrawing fluids from patients, such gloves quite
6 obviously offer no protection against needle pricks and
7 accordingly, the following described construction of the
8 present invention will be understood to offer a positive
9 advancement toward precluding attending personnel from
receiving needle sticks during the subject procedures.
11 To overcome the above shortcomings, the assembly of the
12 present invention is provided. As shown most clearly in Figs.
13 1 and 4, a shroud or hood member 12 completely surrounds the
14 axial extent of the needle 3 in a manner which isolates its tip
4 from any body contact by using personnel. It will be
16 understood that the syringe utilized with the shroud member is
17 of any conventional construction. The hood 12 includes a rear,
18 attachment base 13 which may be tapered or otherwise
19 configured, to provide a fixed attachment to either the needle
hub or nose 2 of the hypodermic syringe H. A rearmost flange
21 13' radially projects from the attachment base and from Fig.
22 1 will be seen to include an elongated or irregularly
23 configured periphery to provide an enhanced engagement by a
24 user during the frictional attachment of the shroud member
about the syringe nose or needle hub. Extending forwardly of
26 the base 13 is an outwardly tapered section 14 having an inner
27 wall 15 which will be seen to be radially spaced from the shank
28 of the needle 3 to define an inner cavity 16 within the hood
29 12. Projecting forwardly of the tapered section 14 is a
forwardmost, cylindrical section 17 terminating in an end face
31 18 disposed in a plane well forward of the needle tip 14. The
32 inner wall 15' of the cylindrical section 17 will be understood
33 to form a constant diameter throughout its length for reasons
34 which will become obvious hereinafter.
The internal diameter defined by the inner wall 151 of the
36 cylindrical section 17 and which is designated by the line 19,
37 is no greater than 3/8 inch and is selected to provide a close,
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1 sliding fit when applied about the ported fitting of both
2 medicine vials V and IV bags I. Just as important is the
3 disposition of the hood end face 18 significantly forward of
4 the needle tip 4. This tip is preferably recessed from the
plane of the shroud end face at least 1/8 inch. In this
6 manner, physical contact between the sharpened tip 4 and any
7 part of a user's anatomy is precluded, even the tip of one's
8 little finger, in view of the radially masked needle.
9 The above shroud assembly 12 may be offered as a separate
member, to be affixed to a syringe H at the time of use but
11 preferably, is supplied to the end user already attached as
12 illustrated in Figs. 1 and 4. In this manner, the completed
13 assembly is provided in a sterile package and at no time is an
14 exposed needle 3 handled by any personnel, thereby insuring the
protective feature of the invention, throughout all
16 manipulations of the syringe. As initially delivers to the
17 user, the syringe-hood assembly is completely enclosed by means
18 of an end or safety cap 20 having a skirt 21 provided with an
19 inner wall 22 which presents a friction fit about the external
periphery 23 of the hood cylindrical section 17. A plurality
21 of longitudinally extending ribs 24 on the exterior of the cap
22 skirt 21 insure a positive grip as the user grasps the cap to
23 remove it from its frictional engagement about the hood 12.
24 As will be noted, a plurality of similarly configured ribs 25
may be provided on the exterior of the hod tapered section 14
26 to facilitate the application and/or removal of the hood
27 assembly from the syringe nose 2.
28 In the use of the hooded syringe of the present invention,
29 the safety cap 20 is removed in preparation for withdrawal of
a prescribed volume of medicament from a selected vial V. This
31 vial may comprise the type shown in Fig. 2 wherein the cap 26
32 thereon is provided with the conventional flat diaphragm type
33 stopper 5 intended to be punctured by the conventional exposed
34 hypodermic cannula. With such an arrangement, provision must
be made to adapt such a vial stopper to the hooded syringe of
36 the present invention. An appropriate adaptation is provided
37 by means of the piercing or spear device 28 shown in ~ig. 6 and
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1 which includes a leading, conical point 29 joined to a smaller
2 diameter shank 30 having a radially extending flange or
3 shoulder 31 thereon. Rearwardly of the flange 31 is a
4 stoppered fitting comprising a ported cylindrical member 32
provided with an end seal 33 adapted to be pierced by a
6 cannula. The conical point 29 is provided with a port 34 and
7 which communicates with the hollow interior of the shank 30.
8 The configuration of the ported member 32 is identical to that
9 of the standard ported input fitting 8 on an IV bag I such that
the present hooded syringe H may be sequentially attached to
11 both fittings as the medicament is first withdrawn from the
12 vial V and then introduced into the IV bag I. Thus, it will
13 be appreciated that the external periphery of both end caps or
14 seal's 9 and 33 provide a close sliding fit within the confines
of the hood cylindrical section 17. In this respect, it should
16 be noted that the end face 18 of the hood envelopes the end cap
17 9 or 33 before the tip 4 punctures the respective membrane and
18 then, after the needle tip has passed therethrough, the syringe
19 is further advanced until the fitting end cap abuts the
restricted internal diameter of the hood tapered section 14.
21 At this point, the needle tip 4 is advanced well inwardly of
22 the cap seal or stopper so that manipulation of the syringe
23 plunger 7 will withdraw or expel the medicament. The above
24 mating fit between the shroud 12 and end cap also serves to
discourage needle breakage during piercing of the membrane
26 seal. This feature will be understood in view of the central,
27 axial position of the needle 3 within the shroud 12 and the
28 fact that the forward portion of the shroud section 17
29 initially captively engages the end cap before the needle tip
4 punctures the membrane. Such construction assures a
31 straight, axial movement of the needle as it punctures the very
32 center of the membrane.
33 Fig. 5 depicts a medicament vial V' as initially supplied
34 with a ported stopper 35 ready to use with the shrouded syringe
of the present invention. Thus, it follows that the end cap
36 36 thereof is of identical configuration to the end cap 33 of
37 the piercing device of Fig. 6 as well as end cap 09 of the
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1 input fitting 8 on the IV bag I such that a mating engagement
2 is obtained whenever the hooded syringe H is combined with
3 either stopper construction. Accordingly, it will be
4 appreciated that all three described end caps or fittings 9,
33, 36 include a rupturable seal and define a cylindrical
6 periphery having a diameter presenting a close, sliding fit
7 with respect to the inner wall 15' of the shroud forward
8 cylindrical section 17.
9 From the foregoing description it will be seen that an
improved construction is provided enabling the safe, no-stick :
11 manipulation of a hypodermic syringe when used in combination
12 with both medicament vials of varying construction as well as
13 with IV bags.
14 It is to be understood that the present invention is not
limited to the sole embodiment described above, but encompasses
16 any and all variations falling within the scope of the appended ~ ~:
17 claims.
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