WO1993002651A1

WO1993002651A1 - Closure device and method of utilising same

Info

Publication number: WO1993002651A1
Application number: PCT/GB1992/001410
Authority: WO
Inventors: Peter John Pitt White; David Gordon Raitt
Original assignee: Leicestershire Health Authority
Priority date: 1991-07-31
Filing date: 1992-07-30
Publication date: 1993-02-18
Also published as: GB9116489D0; GB2272647A; GB2272647B; GB9400519D0

Abstract

A closure device (14) for medication supply apparatus (12), and a method of connecting such apparatus to medication delivery means such as a needle or an indwelling cannula, provides the closure device (14) with a route-specific indication thereon identifying the specific route for administration of the medication in question. The route-indicating closure is manually removed immediately before the step of connecting the medication supply (12) to the delivery means, whereby the practitioner is reminded as to the correct route for administration at the last possible moment before the medication is administered. The route-specific indication is preferably provided by the physical form of a portion of the closure device.

Description

CLOSURE DEVICE AND METHOD OF UTILISING SAME

This invention relates to a closure device and a method of utilising same. The field of use of the invention relates to the charging or preparing of apparatus for the administration of liquid medication, for example injectable medication. More particularly, but not exclusively, the invention relates to the administration of medication in liquid form by the use of apparatus such as a syringe. From the syringe, the liquid medication is dispensed either through a needle for direct penetration into a patient's body, or the liquid medication is delivered to the patient through alternative conduit means, in a manner well known in the field of medicine, eg an in-dwelling cannula, or any other known or to-be-developed conduit means. The method of the invention is concerned exclusively with steps taken prior to the administration of the medication, ie in the preparation and charging of the apparatus, including the interconnection of parts of the apparatus, and the identification of an intended administration route. The invention does not relate at all to the actual administration of the medication.

It will be understood that the invention more specifically relates to a method of preparing or charging novel and modified apparatus for the administration of medication, so that human errors previously made in such administration are reduced or eliminated. The modifications relate to the techniques and apparatus for connecting medication supply means, such as a syringe, to medication delivery means, such as a needle or catheter, and thus do not relate to the actual treatment of a patient as such, at all. Moreover, the invention can be seen to be more specifically a method of connecting medication supply means to medication delivery means, incorporating the use of a novel and modified closure means, or a device to minimise the possibility of errors in the chosen route for administration of the medication.

In the case of such administration of injectable medications, of any kind whatever, it is most important that the medication is injected or otherwise administered to the patient in the appropriate manner. For example, injections can be applied in various ways, these including- intravenous administration, intramuscular administration, intrathecal administration, and sub-cutaneous administration.

Likewise, so far as concerns applying liquid medications in a non-injected manner, there are various different techniques including oral, topical (ie application to the surface of the skin) , irrigation (of wounds, body cavities etc) , and eye/ear /nose drops.

Over the past few years, a significant number of fatal accidents involving the incorrect administration of injectable medication have been reported in the medical literature and elsewhere. In these particular incidents the appropriate dose of the correct drug had been administered to the patient, but death had occurred because the wrong route had been used for injection.

Many of these fatalities involved intrathecal administration of cytotoxic agents, which were highly neuro-toxic and were intended (and labelled) for intravenous use only.

One possible approach to the solution of this latter specific problem would be to devise modifications for the equipment used for intrathecal injections, so that this equipment would by physically incompatible with other injection equipment. However, although this could be achieved in a relatively straightforward way it does not represent a particularly useful solution to the problem since there is a very wide range of injection equipment in widespread use, and the complications inherent in providing for physical incompatibility are too great. In any case, a syringe and needle are capable of a variety of modes of administration and only the practitioner can ensure the correct one is used.

Moreover, mistakes in administration also occur in other routes such as intramuscular administration, and these are also relatively commonplace, though the results have usually been less catastrophic than with erroneous administration of intrathecal medication.

A further factor in the administration of injectable medication relates to the standardisation of all connections on administration equipment such as syringes, catheters, needles. filters, taps etc. Currently, these all largely conform to a single international specification for taper-fit joints, known as "Luerslip", with an optional cam-lock securing system known as "Luer-lock".

In the above circumstances it is extremely difficult to see how any direct and positive means could be provided to actually prevent the administration of medication by an erroneous route, and it would appear that the best that can be achieved is to provide some means whereby a medical practitioner is less likely to overlook his instructions concerning the appropriate administration route.

An object of the present invention is to provide apparatus and a method of using same offering improvements in this respect, or generally.

It is common practice in the USA and in some European countries that most injectable medications are presented to nursing or medical staff in a form suitable for immediate administration to specific patients. Thus, ready-for-use injections are provided on a large scale by the pharmaceutical industry, or are prepared on an individualised basis, for specific patients, by hospital pharmacy departments. Thus, the sterile medication is usually presented as a pre-filled syringe, containing the appropriate dose for a particular therapeutic course. Labelling on the side of the syringe always indicates the correct route for administration, as well as the drug name and dosage information. If the medication is for a particular patient, the label also includes patient details.

The fluid outlet of a pre-filled syringe is closed under sterile conditions by a cap or closure known as a "blind hub" which prevents leakage and maintains sterility of the contents of the syringe. The blind hub possesses a female Luer taper, which fits over the syringe's male taper outlet, and is usually secured by the Luer-lock arrangement to avoid loosening in transit.. Immediately before a clinician or nurse can administer the injection, they must remove the blind hub, so that the syringe can either be connected to an in-dwelling cannula or can be fitted with a needle.for direct penetration of the skin. The sterile blind hubs serve merely as closure devices, and vary in design merely from maker to maker and are discarded after use. Other medication supply devices likewise have removable closures to enable connection to a delivery system, for example a system which remains connected to the patient even while the medication supply is being changed.

There is disclosed in GB-A-448,038 (O'Brien) a reverse- thread stopper for a poison container to alert a user to the contents of the container.

There is disclosed in US 4,402,420 (Chernac) a colour-coded cap for an outlet of a medically-used reservoir, to indicate the function of the outlet.

US 4,150,673 discloses a coded entry system for a blood bag. GB-A-1,397,925 discloses a temperatureresponsive colour-changing indicator to signal the readiness for use of the container contents upon appropriate heat treatment of the container. US 3,791,009 discloses apparatus for filling and labelling and closing containers such as medical syringes.

According to the invention there is provided a method of connecting medication delivery apparatus to a supply of medication, and apparatus for administering medication, as defined in the accompanying claims.

In a preferred embodiment of the invention there is provided a closure device for the delivery nozzle of a medical syringe, constituting medication supply means. The closure device may, for example, be in a form (so far as concerns its mode of cooperation with the syringe itself) similar to that of previously proposed closure devices, such as "blind hubs". The closure device is selected form a series of related closure devices, each one specifically corresponding to one particular route for administration of liquid medication such as for injection into a vein or a muscle or the spine etc, this route being the required route for the medication to be administered at any given time. The series of closure devices are each adapted to close the delivery nozzle of the syringe apparatus, and thus protect its contents from contamination, while at the same time being, by virtue of its form and/or colour and/or marking or notation, specific and distinctly different from each of the other members of the series, whereby a medical practitioner can clearly identify, solely by virtue of the closure device itself, the correct intended route for administration of the medication in the syringe or other medication supply means.

Because the hubs or closure devices are removed immediately prior to administration of the medication, they offer excellent anti-confusion potential, by being made in a form which is unmistakably specific to the correct route for administration of the medication.

Although there are a large number of injection methods, the following commonly used routes account for more than 98% of all medication administrations :-

Intravenous (I/V)

Intramuscular (I/M)

Intrathecal (I/T)

Sub-cutaneous (S/C)

There is also the technique of irrigation, which is not an injection technique.

There are also a wide range of more specialised techniques eg intra-articular, intra-ocular which could be grouped together as "special routes", in which mistakes of the above kind are unlikely to occur.

In the embodiment of the invention, the use of a range of differentiated closure devices each corresponding to one of the above routes, enables the chance of administration errors "under pressure" to be dramatically reduced, without the need for large- scale re-design of injection equipment, or major disruption of established operational systems. The reminder as to the correct administration route is given immediately before administration. There is no chance to forget, or become confused when several injections are to be simultaneously administered to a particular patient, via different routes.

In the preferred embodiment, route-specific hubs or closure devices employ a combination of colour, shape and notation, using the universally accepted abbreviations as listed above in parentheses. The flat "tags" or tabs on the hubs or closure devices provide printed unambiguous indication of the administration route. They also offer an improved technique for removing the hub, without touch-contaminating the sterile pathway. By providing the closure devices in addition with characteristic shapes, touch-identification of the injection route by clinicians (eg anaesthetists) who may be continuously monitoring a wide range of instrumentation while administering a series of medications via catheters, is possible.

The hubs or closure devices themselves are of course correctly selected for the intended route of administration of any given medication, and this is usually done within a pharmaceutical factory or a hospital pharmacy department. The process is subjected to very stringent procedural controls, and several independent checks.

In apparatus for administering medication, and a method of preparing and charging same, syringe apparatus is charged with medication and otherwise prepared for administration of same to a patient. A closure device for the syringe apparatus is selected from the said series of said closure devices. The closure device corresponds by virtue of its form and/or colour and/or marking or coding to the medication itself and the intended route of administration of same. When the syringe and the attached closure device is taken up by the medical practitioner for administration to the patient, the very last action of this person before administering the medication is to remove the closure device before applying to the syringe either a needle, or conduit means for conducting the medication to the patient- By virtue of the form and/or colour and/or marking or labelling of the closure device, the medical practitioner is reminded, at this last and most important moment before making his decision as to the mode of administration, of the correct one of the various modes of administration. In this manner, the possibilities of misunderstanding and/or forgetfulness are substantially reduced.

In one preferred embodiment, the closure device incorporates a generally linear or f.lat flange or tab or label area on which is marked the mode of medication administration eg "I/V" for intravenous administration. In this manner, this marking avoids substantially all possibilities of misunderstanding. The use of a flat surface to carry the identifying marking avoids misunderstandings which could arise from printing the information on a curved surface where possibly only a part of the symbol or sign may be visible at any one time.

An embodiment of the invention will now be described by way of example with reference to the accompanying drawings in which

Figs 1 and 2 show plan and elevation views of a first form of closure device; and figs 3, 4 and 5, 6 and 7, 8 show corresponding plan and elevation views of three further closure devices relating to three further medication administration routes;

Fig 9 shows a longitudinal section, on a larger scale, through part of medication supply means and an associated closure device;

Figs 10 and 11 show a modification of the first embodiment; and

Fig 12 shows a further embodiment applicable to a medication delivery system for the administration of parenteral medication delivered via tubing.

As shown in Fig 9 apparatus 10 for administering an injectable liquid medication comprises medication supply means 12, closure means 14 therefor, and medication delivery means (not shown) .

Medication supply means 12 is in the form of a syringe 16 having a barrel 18 containing a piston or plunger 20 and a delivery novel 22. A collar 24 in concentric relationship to nozzle 22 is provided with an internal screw thread 26 to cooperate with an external formation 28 on closure means 14, so that the two screw-threadedly cooperate and engage. Piston 20 is operated by a rod 30 in the conventional manner. .

Nozzle 22 has an externally tapered form which cooperates with a complementary internally tapered form on a socket 32 provided on closure means 14, the socket 32 having a closed end 34, whereby, when the two interfit, the delivery nozzle is thereby sealed.

The medication delivery means (not shown) , such as an injection needle or catheter, has a corresponding socket to receive nozzle 22 in liquid-tight sealing engagement, in much the same manner as is shown in Fig 9. The closure means not only maintains the delivery nozzle sealed and closed, prior to use of the medication, but also maintains the medication in proper and sterile condition. The removal of the closure means and its replacement, for example, by a sterile needle, is the work of a few seconds.

Turning now to Figs 1 to 8, it will be seen that these show various forms for the closure means 14 described above in relation to Fig 9. Thus, the form of closure device shown in Fig 1 is intended to denote a medication for administration by the intrathecal route (I/T) , that of Figs 3 and 4 a medication for administration by the intravenous route (I/V) , that of Figs 5 and 6 denote the intramuscular (I/M) route, and that of Fig 7 the sub-cutaneous route (S/C) .

As shown in Figs 1 and 2, closure device 14 has mounted above socket 32 an upstanding tab 34 of generally rounded rectangular form. Printed on the upper half of tab 34 is the symbol "I/T" in order to denote in the conventional notation that the closure device is used with medication for administration by the intrathecal route. In addition, the closure device is provided with a form-distinguishing element 36 lying in a plane at right angles to that of tab 34, and in this embodiment being of circular .form, as seen in Fig 1. Thus, the medical practitioner can readily determine, merely by tactile means through his/her fingertips on form distinguishing element 36, and even without reading the designation "I/T" that the closure means 14 in this case denotes a medication for intrathecal administration.

In the embodiment of Figs 3 and 4, the closure means 14A is otherwise as described above in relation to Figs 1 and 2, but the form distinguishing element 36A is itself of rounded rectangular form (ie as tab 34A, and thus denotes a medication for intravenous administration. Tab 34A is likewise printed "I/V" accordingly.

Likewise, in the embodiment of Figs 5 and 6, tab 34B carries the designation "I/M" denoting intramuscular administration. The form distinguishing element 36B in this embodiment is planar and lies in a vertical plane, at right angles to that of the tab 34B, and lies below the portion of tab 34B carrying the designation "I/M".

In the embodiment of Figs 7 and 8, the tab 34C has printed thereon the designation "S/C" for sub-cutaneous administration of the medication, and the form distinguishing element 36C is generally star-shaped as seen in plan view in Fig 7, and thus readily provides for tactile recognition.

In use, syringe 16 is delivered charged with medication and sealed by closure element 14. The closure element corresponds to the correct administration route for the medication. Immediately prior to administration, the practitioner removes closure element 14 and is reminded both visually and by^' the physical form of element 36 as to the correct administration route. He then connects the syringe to a needle or catheter, and delivers the medication by that route.

In the embodiments of Figs 10 and 11, the closure device 50 is otherwise constructed and numbered as in the embodiment of Fig 1, with a socket 52 having threads which engage collar 24 as described above. In addition, there is provided a cylindrical shroud 54 which provides a surface for a full textual statement corresponding to the particular a administration route (in this case intravenous) . In this way, the closure 50 is provided with route-specific information in three forms, namely by the physical form provided by tabs 34 and 36, the letter code "I/V" on tab 34, and by the word "intravenous" on shroud 54.

In the embodiment of Fig 12, a closure 60 for a medication delivery tube for supplying parenteral medication is in the form of a polypropylene moulding. A route-specific indication is provided on a projecting arm 62. A wrap-around portion 64 has a hinge 66 and a non-releasable catch 68, whereby the closure can be closed around the end of the tubing by flexing hinge 66. Closure of the tubing may be provided by means of a disposable sterile sheet material (not shown) secured around the tube end by closure 60, or by use of a cylindrical tube-end cap around which the member 60 is secured for identification purposes. In Fig 12, item 70 designates the delivery tube itself, or the cap.

Interestingly, in the above embodiments the closure means 14 provides an immediate and positive reminder to the practitioner as to the correct administration route. This reminder is inevitably given to the practitioner as the last information which he receives prior to administering the medication. Thus, the opportunity for overlooking this information, or indeed forgetting it, is minimised.

Amongst modifications which could be made in the above embodiments while remaining within the scope of the invention are the following. Firstly, the forms for the route- indicating portion of the closure means can of course be varied. Those described above are merely by way of example. Clearly, standardisation in this respect will be needed. Likewise, the form of the closure device itself may vary according to the requirements of equipment manufacturers and in accordance with any agreed changes in the present International system for coordination of such equipment. The invention is applicable not only to injectable medication, but also to medication which is administered by, for example, irrigation. Closure devices in accordance with the invention could be provided for infusions or injections contained in bottles, PVC pouches or any other existing or to-be-developed pharmaceutical delivery system.

Claims

11

CLAIMS :-

1 A method of connecting medication delivery apparatus to a supply of medication, the method comprising : a) providing medication supply means having a supply of a medication for delivery to structure defining a medication delivery opening through which said medication can be delivered to medication delivery means; b) providing a closure device for said medication delivery opening; and c) providing medication delivery means to receive medication from said medication supply means and to deliver the medication to a patient, for example by means of a needle or catheter; and d) connecting said medication supply means to said medication delivery means by manually removing said closure and effecting connection; characterised by e) said closure device having a route-specific indication indicating the specific route for administration of said medication, and said indicated route being related to said medication itself by being a correct administration route therefor; and f) said step of manually removing said route-indicating closure, which is performed immediately before said step of connecting, including by virtue of said route-specific indication, the step of reminding the medical practitioner (who effects administration of the medication through said delivery means) of the appropriate administration route immediately before he or she effects same.

2 A method of connecting medication delivery apparatus to a supply of medication characterised by the step of manually removing a closure device having a route-specific indication thereon, said removal step being performed immediately before connecting the medication supply means to medication delivery means.

3 A method according to claim 1 or claim 2 characterised by said closure device being applied to said medication supply means in a pharmaceutical factory or in a pharmacy department.

4 A method according to claim 3 characterised by the step of carrying out at least two independent checks that the correct relationship exists between said medication and said medication route indicated by said closure device.

5 A method according to any one of claims 1 to 4 characterised by said route-specific indication being provided by the physical form of said closure device, and the method including the step of holding the closure device by a portion thereof having said route-specific distinctive form.

6 A method according to claim 5 characterised by said portion of said closure device having said route-specific distinctive form being the end thereof remote from the portion of the closure device which actually closes said medication delivery means, and the method comprising the step of noting by the sense of touch through the fingers, the route-specific form of said closure device.

7 A method according to claim 5 characterised by the step of determining the intended route of administration of said medication by the sense of touch on said route-specific physical form.

8 A method according to any one of claims 5 to 7 characterised by said route-specific indication also comprising colour and/or notation or markings, or letters or text on said closure device, in confirmation of said specific route.

9 A method according to claim 8 characterised by said notation or markings or letters or text being provided on an upstanding tab on said closure device.

10 A method according to any one of the preceding claims characterised by said closure device being one of several groups of route-specific indicating closure devices adapted to identify the administration route for two or more types of medication for administration by two or more of the following routes : 13

Intravenous administration Intramuscular administration Intrathecal administration Sub-cutaneous administration Irrigation administration.

11 Apparatus for administering medication comprising : - a) medication supply means having a supply of medication for delivery to structure defining a medication delivery opening through which said medication can be delivered to medication delivery means; b) a closure device for said medication delivery opening; and c) medication delivery means to receive medication from said supply means and to deliver same to a patient; and d) said medication supply means being connectable to said medication delivery means by removing said closure device and effecting such connection; characterised by e) said closure device having a route-specific indication indicating the specific route for administration of said medication, and said indicated route being related to said medication itself by being a correct administration route therefor.

12 Apparatus according to claim 11 characterised in that said route-specific indication on said closure device comprises the physical form of said closure device, whereby a medical practitioner may hold the closure device by a portion thereof having a route-specific distinctive form.

13 Apparatus according to claim 12 characterised by, in addition to said route-specific distinctive form, corresponding colour and/or notation or markings or letters or text on said closure device in confirmation of said specific route.

14 Apparatus according to claim 13 characterised by said colour or notation or markings or letters or text being provided on an up standing tab or on a depending flange on 14 said closure device.

15 Apparatus according to any one of claims 11 to 14 characterised in that said closure device forms one of two or more series of closure devices, each series having route- specific indicator means identifying a medication administration route selected from the group consisting of : intravenous administration intramuscular administration intrathecal administration sub-cutaneous administration irrigation administration.

16 A closure device for a delivery opening of medication supply means, said closure device having a route-specific indication thereon, said indication identifying the specific route for administration of a type of medication.