WO2001054755A1

WO2001054755A1 - Delivery system & apparatus therefor

Info

Publication number: WO2001054755A1
Application number: PCT/AU2001/000065
Authority: WO
Inventors: Colin Campbell Marshall Moore; Ian Marshall Moore
Original assignee: FERRIER INTERNATIONAL Ltd; PROTECTIVE SHIELD Ltd
Current assignee: FERRIER INTERNATIONAL Ltd; PROTECTIVE SHIELD Ltd
Priority date: 2000-01-25
Filing date: 2001-01-25
Publication date: 2001-08-02
Anticipated expiration: 2002-07-25
Also published as: AUPQ526200A0; AUPQ526100A0; WO2001054756A1

Abstract

A drug delivery system comprising self-contained storage means adapted to sealingly retain a substance of predetermined volume comprising a pre-determined dosage of a drug or drugs for transport from a first location to a second location; said storage means having actuator means engagement means at a first end thereof; said storage means having delivery means engagement means at a second end thereof.

Description

DELIVERY SYSTEM & APPARATUS THEREFOR

The present invention relates to a delivery system and apparatus therefor, and in particular to a system particularly suited for use with single use syringes and, more particularly, to syringes which, in at least some embodiments, restrict reflux to a significant extent.

BACKGROUND

Drug delivery and, particularly, drug delivery by way of syringe has heretofore left the way open for unauthorised persons to gain access to the drugs together with the syringes or, alternatively, to obtain access to used syringes for refilling with other drugs.

It is perceived as desirable to minimise the possibility of unauthorised access to syringes and the drugs together.

A separate problem concerns mistakes which can arise, even in authorised use by practitioners skilled in the art, whereby incorrect dosages are loaded into the syringe . Mistakes can also occur where the correct dosage is loaded into the syringe but not all of the dosage is delivered. This can happen, for example, where over priming of the syringe occurs prior to use of the syringe for drug delivery resulting in insufficient quantity of drug remaining in the syringe for actual delivery. As discussed in Australian Patent 708445 there is a perceived requirement for syringes adapted for delivery of drugs in such a way that the syringe, when assembled, can be used but once for the delivery of a drug contained within the syringe. It is further perceived as desirable in some forms that the syringe can never be used in a reverse direction or otherwise permit reflux whereby liquids move within the syringe in a reverse direction to the delivery direction.

Australian Patent 708445 discloses a basic assembly which, in at least some embodiments, can provide this type of functionality. The disclosure of Australian Patent 708445 is incorporated herein by cross-reference.

It is an object of at least preferred forms of the present invention to provide alternative or improved modes of operation and delivery or at least provide a useful choice.

BRIEF DESCRIPTION OF INVENTION

Accordingly, in one broad form of the invention there is provided a drug delivery system comprising self-contained storage means adapted to sealingly retain a substance of predetermined volume comprising a pre-determined dosage of a drug or drugs for transport from a first location to a second location; said storage means having actuator means engagement means at a first end thereof; said storage means having delivery means engagement means at a second end thereof.

Preferably said delivery means engagement means includes a frangible seal which maintains said liquid in said storage means during transport; said frangible seal adapted to be breached when delivery means is brought into engagement with said delivery means engagement means.

Preferably said system further includes delivery means.

Preferably said delivery means includes valve means. Preferably said valve means is a one-way valve.

Preferably said delivery means is non-releasably attachable to said second end of said self-contained storage means .

Preferably said storage means includes one-way valve means integral therewith.

Preferably said delivery means comprises a needle assembly.

Preferably said delivery means comprises a connection to another delivery system. Preferably said delivery means includes an adapter sleeve; said adapter sleeve including non-releasable engagement means for the non-releasable attachment of said adapter sleeve to said second end of said self-contained storage means . Preferably said non-releasable engagement means of said adapter sleeve incorporates a multi-stage, spiral-action locking means .

Preferably said multi-stage, spiral-action locking means includes tynes associated with said delivery means and said storage means; said tynes profiled so as to permit forward progression of said storage means into engagement with said delivery means but to resist separation of said storage means from said delivery means. Preferably said one way valve comprises a bulbous chamber having a ball therein.

Preferably said one way valve is located within said adapter sleeve.

Preferably said one way valve is located within said delivery means.

Preferably said one way valve is located within said storage means .

Preferably said system further includes actuator means.

Preferably said actuator means comprises a plunger. Preferably said actuator means includes storage means engagement means for releasable engagement with a moveable seal in said storage means .

Preferably said system further includes a moveable seal and wherein said moveable seal defines a storage volume within said storage means; the volume of said storage volume varying in accordance with the position of said moveable seal within said storage means.

Preferably said actuator means includes a moveable barrier which acts to limit actuation on said moveable seal by said actuator means to a pre-load movement whereby movement of said plunger relative to said storage means is stopped at a pre-load position.

Preferably said pre-load movement causes priming of said delivery means by the substance located in said storage means .

Preferably said pre-load position corresponds to a volume of substance in said predetermined volume being said pre-determined dosage of said drug. Preferably said actuator means is disengageable from said moveable seal in a manner which prevents said actuator means from causing said moveable seal to move in a way which will increase the volume defined in said storage means.

In yet a further broad form of the invention there is provided a needle assembly for use with the above described system.

In yet a further broad form of the invention there is provided a plunger for use with the above described system. In yet a further broad form of the invention there is provided a one-way valve for use with the above described system.

In yet a further broad form of the invention there is provided an adapter sleeve for use with the above described system.

In yet a further broad form of the invention there is provided a kit incorporating components of the above described system. In yet a further broad form of the invention there is provided a single use syringe for use with the above described system; said syringe comprising self-contained storage means adapted to sealingly retain a substance of predetermined volume comprising a pre-determined dosage of a drug; said storage means having actuator means engagement means at a first end thereof; said storage means having delivery means engagement means at a second end thereof.

In yet a further broad form of the invention there is provided a method of drug delivery comprising the steps of: (a) providing a self-contained storage means of the type described above; (b) transporting said self-contained storage means from said first location to said second location; (c) administering said predetermined volume comprising a predetermined dosage of a drug by the steps of : aa. connecting said delivery means to said storage means; bb. causing said storage means to discharge said predetermined volume comprising a predetermined dosage of a drug through said delivery means thereby to deliver said predetermined volume comprising a predetermined dosage of a drug to a designated source . Preferably said designated source is the body of a mammal .

In yet a further broad form of the invention there is provided a system for the safe delivery of a drug or drugs from a delivery container, said container adapted for independent storage from delivery means.

Preferably said delivery means is provided separately to a user. Preferably each component part of said system including said container and said delivery means is unusable for drug administration in its own right unless and until united by conscious act into a single delivery assembly. BRIEF DESCRIPTION OF DRAWINGS

Embodiments of the present invention will now be described wherein:

Fig. 1 is a block diagram of a drug delivery system according to a first embodiment of the invention;

Fig. 2 is a side section, exploded view of a single use syringe assembly adopted for use with the system of Fig. 1;

Figs. 3A-3I illustrate consecutive steps in the assembly and use for drug delivery of the syringe of Fig. 2 for the system of Fig. 1;

Figs. 4A-4L further illustrate steps of assembly and use for injection of the single use syringe assembly of Fig. 2 in the system of Fig. 1;

Fig. 5 is a view of a kit for use with the system of Fig. 1.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

With reference to Fig. 1 there is illustrated a drug delivery system 1 adapted for transmission of a predetermined quantity of a drug from a first location 2 to a second location 3.

At the first location the drug dosage is compiled into a discrete quantity suitable for delivery as a single dosage, for example by way of injection into a mammalian body. This predetermined quantity is then loaded into a self contained storage means, in this instance, in the form of a barrel shaped container 4 which has actuator means engagement means in the form of a moveable seal 5 at a first end thereof and, further, has delivery means engagement means in the form of sealed outlet 6 at a second end thereof.

When it is required to deliver the predetermined quantity 7 of drug or other substance for example to a patient 8 by way of injection at second location 3 then the container 4 is transported to the second location where it has attached to it an appropriate delivery means in the form of needle assembly 9 and an appropriate actuation means in the form of plunger 9A. After priming of the completed syringe assembly 9B injection of the predetermined quantity 7 of drug into patient 8 takes place.

After use the syringe assembly 9B can be deactivated and made safe by, for example, inserting at least the needle portion of needle assembly 9 into a receiving aperture 9C in plunger 9A as illustrated in the inset in Fig. 5. In a particular form the container 4 can be part of a single use syringe assembly 10 as will now be described with reference to Figs. 2, 3 and 4.

In the description which follows the term "liquid" is used to describe the substance which is stored in and ultimately delivered by the syringe assembly. It is to be understood that in addition to delivering a liquid the syringe assembly may be utilised for delivering other substances such as, for example, an admixture of a liquid and solid suspension, an admixture of liquids, an admixture of fluids or a combination thereof .

With reference to Fig. 2 there is illustrated a single use syringe assembly 10 for use with the system of the first preferred embodiment of the invention. In this instance the assembly 10 comprises storage means in the form of a barrel-shaped container 11 having a storage volume 12 defined therein. The precise volume of the storage volume 12 is determined by a moveable seal 13 sealingly, slidably moveable along longitudinal axis 14 of container 11 at all times, during movement, retaining sealing contact with inner wall 15 of container 11. First end 16 of container 11 is adapted to slidingly receive therein an elongate plunger 17. The plunger 17 is elongate and adapted to be aligned along its longitudinal axis with axis 14 of container 11 and to be advanced into first end 16 of container 11 such that non-retaining seal connector 18 at a leading edge thereof seats within plunger connector seat 19 located in rear surface 20 of moveable seal 13. In this instance the plunger connector seat 19 is in the form of a cavity adapted to receive non-retaining seal connector in the form of a boss or dowel pin 18. The seating of the non-retaining seal connector 18 within the plunger connector seat 19 is such that the plunger 17 can always be withdrawn from its engagement with the moveable seal 13 simply by reversing the movement of plunger 17 so that it moves out of container 11 and away from first end 16 along longitudinal axis 14 and leaving the moveable seal 13 retained within container 11 at the position it was at when the direction of movement of plunger 17 was reversed.

The plunger 17 is of sufficient length that it may be utilised to urge moveable seal 13 along longitudinal axis 14 all the way to an end position 21 within container 11 which, in so doing, forces the contents in storage volume 12 in the direction of container outlet 22.

In this instance the container 11 includes a frangible seal in the form of a membrane 23 which, for transport of container 11, seals container outlet 22 thereby to prevent egress, during transport, of liquid within storage volume 12. Second end 24 (the delivery end) of container 11 also incorporates delivery means engagement means in this instance in the form of first engagement tyne 25 and second engagement tyne 26, both mounted on substantially cylindrical tyne support unit 27 which itself extends from second end 24 of container 11.

With reference to Figs. 4C, 4D the tyne support unit 27 includes opposed slots 28 therein which are of sufficient width to allow at least limited flexing inwardly of tynes 25, 26 for the purpose of assisting the engagement of the tynes 25, 26 with the delivery means as to be described and discussed below.

The delivery means, in this instance, comprises an adapter sleeve 29 which receives at a first or delivery end 30 thereof a delivery device such as a needle assembly 31 or an infusion connector 32 or connection to another delivery system as can be performed for example by a Luer-type fitting. The adapter sleeve 29 at a second end or receiving end 33 thereof is adapted to non-releasably engage with the delivery means engagement means of the container 11 which, in this instance, comprise the engagement tynes 25, 26 and the container outlet 22. The tynes 25, 26 engage in a spiral shaped channel 34 located on or in the inside wall 35 of sleeve 29 and progress along the channel as and when the container 11 is twisted relative to the sleeve 29 until they encounter first tyne barriers 36. At this point further engagement of the container 11 with the adapter sleeve 29 is achieved by a forward urging of container 11 along longitudinal axis 14 in the direction of sleeve 29 whereby the tynes 25, 26 ride up and over inclined surfaces 37 (refer Fig. 3A) of barriers 36 thereby to permit continued travel of the tynes 25, 26 in channel 34 upon continued twisting movement of container 11 relative to sleeve 29.

In this embodiment second tyne barriers 38 are placed further along channel 34 from the first tyne barriers 36, which barriers must also be surmounted by tynes 25, 26 in the manner described in relation to the first tyne barriers 36 before final and complete, sealing and non-releasable engagement of container 11 is achieved with adapter sleeve 29. In this instance the delivery means includes, in addition to the sleeve 29, a needle assembly 31 engaged within the first end or delivery end 30 of the adapter sleeve 29.

Specifically the needle assembly 31 (refer Fig. 2 and Fig. 3A) comprises elongate needle 39 having a contoured tip 40 at a delivery end thereof adapted for facilitating insertion into living tissue.

At a receiving end 41 of the needle 39 is a bulbous chamber 42 adapted to receive valve ball 43 therewithin. The bulbous chamber 42 has sufficient volume compared with the dimensions of the valve ball 43 and is arranged in such a way that the ball 43 cannot impede forward progress of a liquid through chamber 42 in the direction of elongate delivery channel 44 within needle 39.

Needle housing 45 grips receiving end 41 of needle 39 and includes adapter sleeve engagement tynes 46 which, upon insertion of the receiving end 41 of needle assembly 31 into the delivery end of adapter sleeve 29 mechanically engage with the adapter sleeve 29 so that the receiving end 41 of the needle assembly 31 is retained within adapter sleeve 29 in a manner whereby delivery channel 44 including bulbous chamber 42 are placed in liquid communication with the delivery end of adapter delivery tube 47 which is housed within and forms part of adapter sleeve 29. In addition the engagement thus described causes the bulbous chamber 42 in conjunction with valve ball 43 to act as a one way valve in that valve ball 43 is sized so as to substantially impede if not entirely exclude reflux of liquid within chamber 42 into adapter delivery tube 47. This action is achieved by mechanical sealing of the surface of valve ball 43 against delivery end 48 of adapter delivery tube 47 as ball 43 is urged by the reverse flow of liquid against delivery end 48. This one-way or anti-reflux function can be assisted by biasing the ball in the direction of delivery end 48, for example by means of a spring.

Receiving end 49 of adapter delivery tube 47 is profiled so as to include a sharp apex 50 adapted to pierce membrane 23 during engagement of adapter sleeve 29 with container 11 thereby to provide a channel of liquid communication from storage volume 12 of container 11 through adapter delivery tube 47, through bulbous chamber 42 and through needle delivery channel 44 through the needle tip 40. It will be appreciated by those skilled in the art that at least adapter sleeve 29 is rendered difficult to disengage from container 11 by ledges 51 on the delivery side of barriers 36, 38 which are in planar engagement with corresponding ledges 52 on the receiving side of engagement tynes 25, 26.

In a particular form plunger 17 includes moveable barrier 52 which is pivotally connected to plunger 17 so as to perform the function, in an arresting position, of a preload arrestor which prevents sliding movement of plunger 17 into container 11 beyond a predetermined insertion limit. The moveable barrier 52 is shown in its arresting position 53 in Figs. 4G and 4H.

The moveable barrier 52 can be rotated about hinge line 54 so that its leading (arresting) edge 55 lies within slot 56 of plunger body 57 in a non-arresting position where it no longer engages with first end 16 of container 11 thereby permitting plunger body 57 to progress into container 11 so as to cause moveable seal 13 to shrink storage volume 12 so as to urge liquid contained therein through container outlet 22, through adapter delivery tube 47, through bulbous chamber 42, through delivery channel 44 and out of tip 40 of needle 39.

Manner of Use

In use, with reference to Figs. 3A-3I and Figs 4A-4L an intending user of the single use syringe assembly 10 first assembles the components of the assembly by taking a container 11 which is loaded with a drug in liquid form in storage volume 12, being of a predetermined volume and comprising a predetermined dosage of the drug for the particular use intended. Next the user (not shown) gains access to and assembles the delivery means by inserting valve ball 43 in bulbous chamber 42 in needle assembly 31, then connecting the needle assembly 31 (this step may be performed in the course of manufacture and prior to delivery to the final user) to the delivery end of adapter sleeve 29 in the manner previously described and as best seen in Figs. 4C and 4D. The user then non-releasably connects the delivery means comprising the assembled needle assembly 31 and adapter sleeve 29 by an urging, twisting action as previously described to the delivery end of container 11. In so doing membrane 23 is pierced by receiving end 49 of the adapter delivery tube 47 thereby bringing storage volume 12 into liquid engagement with needle assembly 31.

The user then inserts plunger 17 (with moveable barrier 52 in arresting position 53) into first end 16 of container 11 so that non-retaining seal connector 18 engages in plunger connector seat 19 and so as to urge moveable seal 13 in a delivery direction along axis 14 until moveable barrier 52 encounters container 11.

In reaching this pre-load position a predetermined pre- load volume of liquid from within storage volume 12 will have passed into adapter delivery tube 47 and on into delivery channel 44 thereby removing air from within these passages and ensuring that the entire needle assembly 31 is fully primed ready for use. By design this position of moveable seal 13 will be the position which defines exactly the intended predetermined volume of predetermined dosage of drug within storage volume 12. The user now moves moveable barrier 52 from the arresting position and continues the movement of plunger 17 into container 11 to the full extent of its permitted passage, being to the point wherein moveable seal 13 encounters walls of the container 11 at its delivery end. At this point the predetermined volume of predetermined dosage of drug will have been delivered through tip 40.

The plunger 17 can then be withdrawn without disturbing moveable seal 13 (as previously described) . It will be understood that variations on this exemplary arrangement can be made which will still fall within the scope of the invention. For example the valve means can be manufactured as an entirely separate entity for separate coupling into the syringe assembly. In one particular example the valve means can be interposed between the needle assembly and the storage means .

Similarly the frangible seal may take the form of a mechanically operable valve or other device performing an equivalent function. With reference to Fig. 5 the delivery system 1 thus described can be formulated, in one form, as a kit 60, in this instance comprising a sealable plastic bag 61 into which container 4, plunger 9A and needle assembly 9 are inserted. Upon transport to a location where it is desired to inject the predetermined quantity 7 of drug from the container 4 a user first removes the needle assembly 9 from within aperture 9C of plunger 9A, then assembles the syringe assembly in the manner previously described and injects the contents of container 4 in the manner previously described, for example in detail with reference to Figs. 3 and 4.

The user then disassembles the syringe assembly and can, for example, render safe the sharps portion of the needle assembly 9 by insertion of the needle portion of the needle assembly 9 into aperture 9C of plunger 9A.

Where the single use syringe assembly 10 is utilised it will be appreciated that an increased level of safety is achieved by virtue of the features of the syringe assembly 10, either alone or in combination, which render the container 11 that embodiment difficult if not impossible to re-use .

The above describes only some embodiments of the present invention and modifications, obvious to those skilled in the art can be made thereto without departing from the scope and spirit of the present invention. INDUSTRIAL APPLICABILITY

The innovation is applicable to the field of medicine and is particularly applied to syringes and like injection devices .

Claims

1. A drug delivery system comprising self-contained storage means adapted to sealingly retain a substance of predetermined volume comprising a pre-determined dosage of a drug or drugs for transport from a first location to a second location; said storage means having actuator means engagement means at a first end thereof; said storage means having delivery means engagement means at a second end thereof .

2. The system of Claim 1 wherein said delivery means engagement means includes a frangible seal which maintains said liquid in said storage means during transport; said frangible seal adapted to be breached when delivery means is brought into engagement with said delivery means engagement means.

3. The system of Claim 1 or Claim 2 further including delivery means.

4. The system of Claim 3 wherein said delivery means includes valve means .

5. The system of Claim 4 wherein said valve means is a oneway valve .

6. The system of any previous claim wherein said delivery means is non-releasably attachable to said second end of said self-contained storage means.

7. The system of Claim 1 wherein said storage means includes one-way valve means integral therewith.

8. The system of any previous claim wherein said delivery means comprises a needle assembly.

9. The system of any previous claim wherein said delivery means comprises a connection to another delivery system.

10. The system of any one of Claims 3 to 9 wherein said delivery means includes an adapter sleeve; said adapter sleeve including non-releasable engagement means for the non-releasable attachment of said adapter sleeve to said second end of said self-contained storage means.

11. The system of Claim 10 wherein said non-releasable engagement means of said adapter sleeve incorporates a multi-stage, spiral-action locking means.

12. The system of Claim 11 wherein said multi-stage, spiral- action locking means includes tynes associated with said delivery means and said storage means; said tynes profiled so as to permit forward progression of said storage means into engagement with said delivery means but to resist separation of said storage means from said delivery means.

13. The system of any one of Claims 5 to 12 wherein said one way valve comprises a bulbous chamber having a ball therein.

14. The system of any one of claims 5 to 13 wherein said one way valve is located within said adapter sleeve.

15. The system of any one of claims 5 to 13 wherein said one way valve is located within said delivery means.

16. The system of any one of claims 5 to 13 wherein said one way valve is located within said storage means.

17. The system of any previous claim further including actuator means.

18. The system of Claim 17 wherein said actuator means comprises a plunger.

19. The system of Claim 17 or 18 wherein said actuator means includes storage means engagement means for releasable engagement with a moveable seal in said storage means.

20. The system of any previous claim further including a moveable seal and wherein said moveable seal defines a storage volume within said storage means; the volume of said storage volume varying in accordance with the position of said moveable seal within said storage means .

21. The system of any one of claims 18 to 20 wherein said actuator means includes a moveable barrier which acts to limit actuation on said moveable seal by said actuator means to a pre-load movement whereby movement of said plunger relative to said storage means is stopped at a pre-load position.

22. The system of Claim 21 wherein said pre-load movement causes priming of said delivery means by the substance located in said storage means .

23. The system of Claim 20 or 21 wherein said pre-load position corresponds to a volume of substance in said predetermined volume being said pre-determined dosage of said drug.

24. The system of any one of claims 17 to 22 wherein said actuator means is disengageable from said moveable seal in a manner which prevents said actuator means from causing said moveable seal to move in a way which will increase the volume defined in said storage means.

25. A needle assembly for use with the system of any one of claims 1 to 24.

26. A plunger for use with the system of any one of claims 1 to 25.

27. A one-way valve for use with the system of any one of claims 1 to 26.

28. An adapter sleeve for use with the system of any one of claims 1 to 27.

29. A kit incorporating components of the system of any one of claims 1 to 24.

30. A system of drug delivery as hereinbefore particularly described with reference to what is shown in Figs. 1, 2A-2I and Figs. 3A-3L.

31. A single use syringe for use with the system of any one of claims 1 to 24 comprising self-contained storage means adapted to sealingly retain a substance of predetermined volume comprising a pre-determined dosage of a drug; said storage means having actuator means engagement means at a first end thereof; said storage means having delivery means engagement means at a second end thereof .

32. A method of drug delivery comprising the steps of:

(a) providing a self-contained storage means of the type claimed in any one of Claims 1 to 24; (b) transporting said self-contained storage means from said first location to said second location; (c) administering said predetermined volume comprising a predetermined dosage of a drug by the steps of : aa. connecting said delivery means to said storage means ; bb. causing said storage means to discharge said predetermined volume comprising a predetermined dosage of a drug through said delivery means thereby to deliver said predetermined volume comprising a predetermined dosage of a drug to a designated source .

33. The method of Claim 32 wherein said designated source is the body of a mammal .

34. A system for the safe delivery of a drug or drugs from a delivery container, said container adapted for independent storage from delivery means.

35. The system of Claim 34 wherein said delivery means is provided separately to a user.

36. The system of Claim 34 wherein each component part of said system including said container and said delivery means is unusable for drug administration in its own right unless and until united by conscious act into a single delivery assembly.