WO2003051430A1

WO2003051430A1 - Injecting into iv bags

Info

Publication number: WO2003051430A1
Application number: PCT/GB2002/005723
Authority: WO
Inventors: Charles Dudley
Original assignee: Safe-T Medical Devices Limited
Priority date: 2001-12-17
Filing date: 2002-12-17
Publication date: 2003-06-26
Also published as: AU2002352408A1

Abstract

A device for injecting a substance into an IV bag (10) comprises a support body (22) having a hollow needle (24) extending therefrom whose free end terminates in a sharp tip. The support body has an inlet port (28) for connection directly to such as a syringe (20) or to one of a number of commonly used self-sealing, needle-free ports which in turn could act as the connection between the syringe (20) and the port (28). An open-ended guard (30) surrounds the needle (24) and extends beyond its tip to avoid needlestick injury at least after, preferably also before and during, use.

Description

TITLE : INJECTING INTO IV BAGS

FIELD OF INVENTION

This invention relates to injecting into bags for intravenous (IV) supplies. BACKGROUND TO INVENTION

IV bags typically contain saline and/or glucose solutions for direct supply into veins, whether of people or maybe other animals. It can be useful to supply other medicaments, such as particular drugs or combinations of drugs, intravenously by addition to contents of IV bags. Accordingly, IV bags typically have a site at which such additions can be made, usually by way of a hollow needle penetrated through a seal preferably of a type capable of closing up when the needle is removed. Use of a standard hypodermic syringe of replaceable needle or needle-less type is the norm; and represents significant "needle-stick" risk, including for cross- infection; whether to whomever carries out the procedure, or later when it may not be clear whether a free needle has been used thus may be contaminated, nor (if used) upon whom it may have been used. SUMMARY OF INVENTION

According to one aspect of the present invention there is provided a device for injecting a substance, usually liquid, into an IV bag, wherein the device comprises a support body from which extends a hollow needle terminating in a sharp tip, the support body including an inlet port for supply to the needle, and an open-ended guard surrounding the needle and extending beyond its tip.

IV bags are well known with their injection sites as integral tubular extensions with piercable seals internally towards or at their ends, and usually extending downwardly from the bottoms of the IV bags, hence being called "tailed injection sites" or "injection tails". This device aspect of the invention is particularly advantageous for such injection tails where the guard as fixed about the needle can accommodate such injection tail sufficiently for needle penetration of the seal, and the needle will still be guarded at and after removal of the needle and device from the site concerned. Another inventive aspect resides in IV apparatus comprising a device as specified above and an IV bag having an injection tail, the injection tail entering the open end of the guard and being penetrated by the needle. These aspects of the invention meet perceived need for safely accessing an IV bag through its injection tail in a manner in which the needle is fully covered and untouchable at all times, i.e. before, during and after use. Continuously walled tubular guards are preferably of light-transmitting nature so that the needle can be seen. Alternatively, the guard may be discontinuously walled, preferably to allow needle sight; or even of cage-like structure or nature. Extension of guards hereof beyond what is effectively limited by target injection tails can be provided by length-adjustable guards, say shortening during injection but capable of reversion to greater length afterwards. Such reversion may be automatic, say by spring biasing of telescopic or otherwise overlapping parts or by self-recovery due to resilience or geometric memory action. In the limit, such length adjustment provisions can service injection sites with no protrusion, even recessed sites. Such guards may be fit-on components relative to the support body and/or the needle so that a method aspect of invention arises from fitting same as and when required or desired, say at least after use for injecting into an IV bag. However, guards hereof may be fitted-on in intendedly permanent association with the support body, indeed may be integrally moulded with the support body. BRIEF DESCRIPTION OF DRAWINGS

Embodiments of the invention will now be described, by way of example, with reference to the accompanying diagrammatic drawings, in which:

Fig. 1 shows a hitherto conventional method of injecting medicament into an IV bag;

Fig. 2 is a perspective view of one embodiment of the invention; Figs . 3 - 6 show modified embodiments of the invention;

Figs. 7(a) - (c) show another embodiment of the invention;

Figs. 8(a), (b) show a further embodiment of the invention;

Figs. 9(a) - (c) are a longitudinal sectional view of the embodiment of Fig. 7 and cross-sectional views on lines B-B and C-C;

Figs. 10(a), (b) show a yet further embodiment of the invention;

Fig. 11 shows mounting on a needle-less syringe;

Figs. 12(a) and 12(b) illustrate a method of injecting medicament into an IV bag using an embodiment of the invention; and Figs. 13 and 14 show embodiments with length adjustable guards.

DESCRIPTION OF ILLUSTRATED EMBODIMENTS

In Fig. 1, a conventional IV bag 10 has an IV administration set 12 and a tailed injection site 14 presenting an injection tail as a tube 16 containing a self-closing member 18, for example a thick latex/silicone septum. The bag 10 normally contains a saline and/or glucose solution and, when other medicament is also to be administered intravenously, it can be added to the IV bag contents by injection through the septum 18 using a standard hypodermic syringe 20.

Turning to the first illustrated embodiment of this invention, see Fig. 2, a device 100 for injecting a liquid into the injection tail of an IV fluids bag comprises a moulded plastics support body 22 and a hollow needle 24 having one end embedded the body 22. The needle 24 extends from the body 22 to its free end terminating in a sharp tip 26. The support body 22 includes a liquid inlet port 28 for usually liquid supply to the needle 24. As illustrated, the port 28 is of female luerlok connector type. In general, the port 28 can comprise a male and/or female luer or luerlok connector, or any other connector, typically of needle- free medical type. In order to avoid needle-stick injury, the device

100 further includes a tubular guard 30 which surrounds the needle 24 and extends beyond the needle tip 26. The guard 30 has an open end 32 to allow access to the needle 24 by the injection tail of an IV bag. This guard 30 is shown mounted on the support body 22 usually permanently, for example using adhesive or solvent welding or any other effective fixing method or means .

However, a viable guard could be fitted at time of use, say directly to a part of the needle 24 adjacent to the body 22, say as an interference fit; or likewise to a part of the body 22 adjacent the needle 24 for which alternative fitting could be by such as a click-fit.

The tubular guard 30 is shown with typical circular cross-section and is shown coaxially surrounding the needle 24. Figs . 3 - 6 show variations by way of flared open end 32A of guard 30A to aid fitting in use as to be described (Fig. 3) ; incorporating into support body 22A customary one-way valve 40 typically of disc type to prevent reverse flow from the IV bag (Fig. 4) ; closure of input port 28 by such as a screw-on cap 38 as can be useful in infection control (Fig. 5) ; and closure of the free end of guard 30 by a stopper or cap 60 shown attached to the guard by an integral moulded tether 62 (Fig. 6) .

In Fig. 7, support body 22B, including luerlok port 28 and one-way valve 40, has a part formed as a screw cap 23 which inter-fits with a reduced diameter end 42 of tubular guard 30B. The end 42 has helically disposed ribs 44 which are engaged by complementary ribs (not shown) inside the cap 23 in screw-thread fashion, say after the manner of and pitched to standard luerlok devices .

In Figs. 8 and 9, the support body 22B, including luerlok port 28, is snap-fitted to a resiliently deformable plastics guard 30C. In particular, guard 30C has a transverse end wall 46 with a square hole 48 and a transverse internal wall 50 with a smaller round hole 52, the two walls defining an internal compartment 54 at the end of the guard remote from the open end 32 and the two holes 48, 52 being axially aligned. Support body 22B has a tapered, flighted portion 25 which, after the needle 24 is first entrant the hole 52, is forced through the hole 48, deforming it slightly until finally it snaps back into position behind the flights 56.

In Fig. 10, one end of guard 30D is moulded in such a way as to form a close-fitting receptacle 51, see Fig. 10 (a) , shaped in complementary manner to that of a standard hypodermic needle 50. The needle 50 is then inserted into the receptacle 51, see Fig. 10(b), and secured there using adhesive or by solvent welding or however else suitable. This conventional needle 50 having a luerlok connection as standard will provide a suitable further connection if required to any luer or luerlok syringe, needlefree port, one way valve, fluids filter or simple closing cap depending on the eventual requirements of the manufacturer.

In use, see Fig. 11 specifically using the embodiment of Fig. 2, connector 28 is fitted to a complementary connector 34 of a device, such as a needle- less syringe 20, containing medicament to be injected into the IV bag.

The guard 30 is lined up approximately with the injection tail 14 of the bag 10, see Fig. 12(a), and the syringe advanced so that the tail 14 enters the open end 32 of the guard 30 and the needle 24 penetrates the septum 18, see Fig. 12(b) . To facilitate insertion of the needle 24 into the septum 18 at least a part of the tubular guard 30 can usefully be sufficiently light- transmissive to allow the needle tip to be visible through the guard by the user, perhaps preferably, fully transparent .

The syringe plunger 36 is then depressed to expel the medicament in the syringe into the bag 10, and the syringe 20 is removed. After removal of the syringe 20, the device 100 itself may be removed from the injection tail 14 and discarded, or it may be left in position on the tail 14 for subsequent use in injecting further doses of drugs or other liquids into the bag 10. If so, the exposed port 28 can be closed with the screw-on cap 38. The device could, of course, be attached to one of a number of self-sealing needle-free ports that are commonly available.

Although the device 100 of Fig.2 has been described in use with a needle-less syringe 20, it (as well as the other embodiments) can be used with any medical device which fits the particular design of port 28.

In all embodiments the diameter of the guard, and the extent to which the guard extends beyond the needle tip, are mutually chosen to ensure that an adult human finger of normal dimensions cannot accidentally come into contact with needle tip, while the guard must obviously be sufficiently wide to enable the injection tail to enter it . Fig. 13 shows a device with length adjustability for its guard by way of telescopic parts 31, 33 that are preferably capable of being set as to desired maximum extension by such as cooperating internal ribbing 31R and 33R, respectively, shown separately for co-action by twisting to take grooving 31R onto the toe of sock-shaped grooving 33R otherwise affording guidance during sliding length reduction. Use can involve twist release of such co-action for sliding, then sliding extension and twist- lock into each co-action after use. Twist-reliant co- action could be replaced by automatic return by spring- biasing between the guard parts 31, 33.

Fig. 14 shows alternative length-adjustment for its guard by way of what can be of basically concertina-type action, but shown with advantageous self-recovery due to helical member 30H of spring or geometric memory type.

The helical member 3OH is indicated with a flexible cover 30C, but such is not essential.

Claims

1. Device for injecting a substance into an IV bag, wherein the device comprises a support body from which extends a hollow needle terminating in a sharp tip, the support body including an inlet port for supply to the needle, and an open-ended guard surrounding the needle and extending beyond its tip.

2. Device as claimed in claim 1, wherein the open end of the guard accommodates an injection tail of the IV bag.

3. Device as claimed in claim 1 or claim 2, wherein the guard is fitted to the support body and/or the needle.

4. Device as claimed in any preceding claim, wherein the guard is mounted permanently on the support body.

5. Device as claimed in any preceding claim, wherein the guard is tubular with a substantially circular cross- section.

6. Device as claimed in any preceding claim, wherein the guard substantially coaxially surrounds the needle.

7. Device as claimed in any preceding claim, wherein the open end of the guard is flared.

8. Device as claimed in any preceding claim, wherein the guard is light-transmissive to allow the needle tip to be visible through the guard.

9. Device as claimed in any preceding claim, wherein the inlet port comprises a luerlok connector.

10. A device as claimed in any preceding claim, wherein the inlet port has a replaceable closure member.

11. Device as claimed in any preceding claim, wherein the open end of the guard has a replaceable closure member.

12. Device as claimed in any preceding claim, wherein the support body further includes a one-way valve to prevent reverse flow of liquid from the port.

13. An IV apparatus comprising a device as claimed in any preceding claim and an IV bag having an injection tail, the injection tail entering the open end of the guard and being penetrated by the needle.