CA2022166A1 - Medicament vial end cap membrane piercing device - Google Patents

Abstract

ABSTRACT
A spear-like device for puncturing the membrane or diaphragm stopper of a liquid medicament vial. The spear-like device includes a fluid supply port from which liquid can be d e l i v e r e d t o a h o o d e d n e e d l e .

Description

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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hypodermic needle and using personnel, 7 either during insertion and assembly of the components or as 8 they are being withdrawn and disassembled.

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.

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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'.,~.~ ~."'' ~ 2~22~6 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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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 . ~ .. . . .. ~ ~ , ..... . . : , -2~2 2~ ~

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 s : ~

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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 ~ '1 " ' ' ~ ' " . ' " ' ' ' ;i . .

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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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Claims (4)

1. A conventional medicament vial end cap membrane piercing device comprising a leading ported conical point insertable through said membrane closure, said point joined to a smaller diameter shank in communication with a stoppered fitting of a diameter that permits engagement of said fitting by a shrouded syringe.

2. The piercing device of claim 18 wherein said shank has a radially extending flange thereon of a diameter greater than said stoppered fitting.

3. The piercing device of claim 18 wherein said stoppered fitting comprises a ported cylindrical member provided with a membrane end.

4. The piercing device of claim 21 wherein said stoppered fitting comprises a ported cylindrical member provided with a membrane end.