WO1997014460A1

WO1997014460A1 - Fluid delivery device

Info

Publication number: WO1997014460A1
Application number: PCT/EP1996/004520
Authority: WO
Inventors: William John Ward
Original assignee: Synthelabo, S.A.
Priority date: 1995-10-18
Filing date: 1996-10-15
Publication date: 1997-04-24
Also published as: GB9521287D0

Abstract

A device for use in delivering fluid from a cartridge via a delivery nozzle includes a holder for a cartridge, a plunger, means provided by the plunger for puncturing a cartridge in the holder, an aperture in the puncturing means for receiving fluid from a punctured cartridge, a nozzle, a conduit for fluid connecting the aperture and the nozzle, and means to seal the plunger against the spillage of fluid when in use.

Description

FLUID DELIVERY DEVICE

The present invention relates to a device for delivering a fluid, especially a liquid, out of a nozzle. The device may be particularly useful for introducing a medicament in liquid form into a human or animal body via a catheter, especially for delivery of a liquid medicament into the bladder.

Conventional methods of delivering a small quantity of liquid into a human or animal body may often require the use of a syringe. Usually the syringe is filled immediately prior to use and the liquid is then injected by means of a needle. Use of a syringe requires a certain degree of skill and manual dexterity and thus the administering of a drug by syringe may be confined to trained healthcare personnel. Pre-filled syringes are available, chiefly for use in emergencies, e.g. by para^¬ medical personnel. Certain types of syringe which inject liquid from a pre-filled cartridge are also known and used, again usually by healthcare professionals.

An alternative method of delivering liquid into a human or animal body is by the use of a 'drip', whereby a large quantity of fluid is dripped, under gravity, into a catheter over a relatively long period of time.

The present invention is particularly useful for use in self-administration of liquid medicaments, i.e. where a person, who may not be medically trained, is required to inject himself, for example in cases where the person has a chronic condition which requires frequent administration of a drug or drugs. One example of such a case is paraplegia, i.e. where a person suffers paralysis of the lower half of the body, which may include a loss of sensation in the bladder and loss of control of the bladder sphincter muscle. In these cases some control of the bladder sphincter may be achieved by means of a drug, e.g. oxylentynin sold by Smith & Nephew Healthcare Ltd under the Trade Mark DITROPAN. These drugs may be administered orally but often have undesirable side- effects such as promoting thirst when given in that way. Also, treatment of the whole body with such a drug may require higher doses to be administered than would be necessary to produce the desired effect in the desired region if the drug were supplied only to that region. It is therefore preferable to introduce the drug directly into the bladder. Many people who require such treatment already routinely make use of a catheter to empty their bladder and so direct access to the bladder is already possible in those cases. However, the use of syringe to administer a drug may cause difficulty or many people, especially older people who may experience some loss of manual dexterity either as a result of their illness or through ageing. Also, syringes may be associated with the use of illegal drugs in the minds of many people and so the carrying of syringes in public may be socially unacceptable .

It is a feature of arrangements to be described below, by way of example, in illustration of the present invention, that some, at least, of the foregoing problems are overcome.

In a particular arrangement to be described below, by way of example, in illustration of the present invention, a device for delivering a predetermined amount of a fluid via a nozzle includes a sealed cartridge for containing the fluid, a plunger assembly having a rigid body with a delivery nozzle, an apertured plunger and a fluid conduit connecting the nozzle to the apertured plunger, and means to seal the plunger to the cartridge, whereby the potential leakage of fluid from the device during use is minimised. The particular device is operated by forcing the plunger through the seal into the cartridge so that fluid is expelled by the force applied to the fluid by the plunger through the aperture in the plunger along the conduit and out of the nozzle.

In addition to delivering a fluid medicament into a human or animal body, the device may also be useful for irrigating a part of a body such as an eye, for example, or for other uses, which may be non-clinical.

The sealed cartridge is preferably a rigid container, for example of glass or, more preferably, a transparent plastics material. The container is sealed by a material which may be ruptured by a pointed plunger when a force is applied to the plunger. The cartridge is of a size appropriate to the amount of fluid which is to be delivered but will typically have a capacity of A between 5ml and 150ml. A preferred capacity for many uses will be in the range 10ml to 75ml. The cartridge may have any suitable shape, but will typically be of round, square or oval cross-section and have an integral rigid base and an open top which is sealed by a suitable material after it has been filled with the fluid to be delivered.

In a preferred form, the cartridge is cylindrical, having a rigid base and a sealed top. The seal is advantageously concave, bowing towards the base of the container in its central region, so that a pointed plunger may locate itself towards the central region of the seal when moved towards the seal to puncture it.

In some forms, the cartridge may have a base which is shaped to conform to the shape of the plunger, i.e. it may be pointed, having an apex directed away from the top of the container. In this form, the plunger, which is of a size to fill the container, may be moved into contact with substantially the entire area of the base, enabling the contents of the container to be completely expelled. The sealing material is preferably selected to part cleanly when it is punctured or ruptured i.e. it should remain intact around the aperture produced on puncturing it and should not produce loose fragments of material which may enter the cartridge and then be expelled from the cartridge with the fluid. Preferred materials include plastics films, metal foil and plastics/foil laminate material. A suitable plastics film will be relatively plastic at normal temperatures and may include low density polyethylene, for example.

The cartridge and seal are preferably sterilisable and so the materials and method of sealing the cartridge are preferably selected to be able to withstand a suitable sterilisation process.

The cartridge may be embossed, printed or labelled with information relevant to its contents or use but it is preferred to avoid printing or labelling the seal material because of the risk of particles of the print or label entering the container. The cartridge may optionally be provided with a protective cap over the seal, to prevent premature rupture of the seal, which must be removed prior to use. An alternative form of cartridge may comprise a sealed bag which, in use is disposed within a rigid holder. The bag is preferably formed of a plastics film or film/metal foil laminate which is sealed after filling. The seal must be sufficiently strong to be able to withstand the hydrostatic pressure applied during the act of puncturing the bag with a pointed plunger. The material of the bag and any information carrier thereon must not fragment on puncturing in a way which may lead to a risk of loose fragments of material entering the liquid in the container.

The plunger assembly has an apertured plunger and a delivery nozzle spaced apart and connected by a fluid conduit so as to allow fluid to pass through the aperture of the plunger to the nozzle. The orientation and position of the plunger relative to the nozzle may be arranged in any way which is convenient for the intended user of the device. Most commonly the nozzle and plunger will be arranged on opposite sides of the assembly and will be connected by a linear conduit. The conduit may, however, be curved or angled where necessary to provide a fluid passage between the nozzle and plunger. The conduit is preferably formed as an integral part of the plunger assembly but it may comprise a flexible tube connected at either end to the plunger and nozzle.

The plunger should be of such a size and shape as to be able substantially to fill the container.

The plunger assembly may be provided with a handle or handles to assist the user with its positioning and operation. The handles may be linear extensions of the assembly or they may be integral loops forming apertures into which the user may insert a finger, thumb or hand.

The nozzle is preferably tapered and of round cross- section. It is most suitably sized so as to be able to fit closely into a catheter tube. The taper is preferably such as to allow a variety of standard catheter tubes to be accommodated.

The plunger is pointed, so as to be able to puncture the sealed container, and is preferably conical in shape. The aperture, which forms one end of the fluid conduit, may be located anywhere on the face of the plunger but is preferably located centrally. In this form the edges of the aperture should be relatively sharply angled or finely cut so as to be able to pierce and puncture the container. In order to reduce the risk of punching out a piece of the container when the apertured plunger pierces the container material, it may be advantageous to sharpen the aperture edge around only a part of the aperture or to arrange the position of the edge so that one part of the edge pierces the container before the rest of the edge. As an alternative, the aperture may be located away from the penetration point of the plunger to further reduce the risk of material fragments from the ruptured seal entering the aperture. More than one aperture may be provided, each defining a fluid conduit which preferably joints a single main conduit. The means to seal the plunger to the cartridge may conveniently comprise a resilient gasket or flange located around the sides of the plunger facing the inner surface of the walls of the container. The gasket is arranged to provide a close sliding contact between the plunger and container so as to prevent leakage of fluid around the plunger. Alternatively, but less preferably, the sealing means may comprise a conformable flange located around the sealed top of the cartridge to contact the plunger as it forces its way through the seal. Such a flange may form an integral part of the cartridge body or seal or it may be a separate item, e.g. to fit over the seal and attach to the cartridge prior to operation of the device. As a further alternative, the material of the cartridge and of the plunger may be selected to seal to one another when brought into close contact.

The plunger assembly may, optionally, include a guide to assist the user to locate the plunger centrally on the cartridge and to guide the plunger into the cartridge as it is depressed. The guide is preferably designed to engage the outer walls of the cartridge. In one form, the guide has a collar which extends from a region of the plunger assembly at the base of the plunger and substantially parallel to the plunger. Preferably the collar extends beyond the end of the plunger so that it may engage the cartridge before the plunger pierces the sealed top of the cartridge. The collar is preferably of the same or similar cross-sectional shape as the cartridge. The collar may extend around the periphery of the cartridge for optimal guiding effect. Preferably, however, the collar is not continuous around the periphery of the cartridge over the whole of its length. That is, the walls of the collar are interrupted at at least two locations to allow access to the cartridge for easy removal from the plunger assembly. The device may additionally include a cartridge holder in which the cartridge may be located during the operation of the device. Preferably the cartridge holder is designed to improve the ease with which the device can be used, for example by providing a handle or grip to assist in forcing the plunger and cartridge together, or simply to ensure that the holder provides a stable base on which to arrange the cartridge and plunger assembly prior to operating the device. The cartridge holder may also enable the plunger to be correctly aligned with the cartridge prior to breaking the seal. Optionally the cartridge holder may be designed for storage of more than one cartridge and/or to provide a safe and clean storage space for the plunger assembly.

The following description and drawings disclose, by means of examples, the invention which is characterised in the appended claims, whose terms determine the scope of the protection conferred hereby. In the drawings :-

Fig. 1 is a diagrammatic longitudinal sectional view through a fluid delivering device, Fig. 2 is a diagrammatic longitudinal sectional view through a second form of fluid delivery device,

Fig. 3 is a diagrammatic longitudinal sectional view through yet another form of fluid delivery.

Figs. 4a and 4b show respectively diagrammatic sectional views of a fourth embodiment with parts in different relative positions,

Fig. 5 is a diagrammatic longitudinal sectional view of a fifth embodiment, and

Fig. 6 is a diagrammatic transverse section through the arrangement shown in Fig. 5.

Fig. 1 shows a cylindrical cartridge 10, made of a rigid transparent polyethylene which contains a fluid 11. The cartridge is sealed by a layer 12 of aluminium foil laminated to a low density polyethylene film which is heat sealed to the edges of the top of the cartridge. The sealing layer 12 has been applied to the cartridge 10 in such a way as to deform it inwardly in a concave manner. This deformation assists in locating the plunger point centrally on the seal prior to rupturing it.

A plunger assembly 13 has a plunger 14, a nozzle 15 and handles 16. A fluid conduit 17 links the plunger aperture 18, which is located at the apex of the plunger point, to the nozzle 15. The plunger 14 is of a similar cross-sectional shape to the cartridge 10, i.e. cylindrical and is of such a size as to be able to be inserted into the cartridge and substantially to fill it. The plunger 14 has a peripheral gasket 20 made of a resilient polymeric material, e.g. silicon rubber. The cartridge 10 is located in a cartridge holder 19.

The cartridge 10 may or may not be stored or carried around in the holder 19 prior to use. When required, the user places the cartridge in the holder 19 and locates the nozzle 15 wherever the fluid is required e.g. into one end of a catheter. He then places the plunger 14 onto the seal of the cartridge and squeezes the plunger assembly and cartridge or cartridge holder together with sufficient force to rupture the seal 12. On entering the cartridge the plunger displaces the liquid 11 so that it is expelled from the cartridge through aperture 18 and conduit 17, to emerge from the nozzle 15 into e.g. a catheter into which the nozzle has been inserted. As the plunger moves towards the base 21 of the cartridge, the gasket 20 contacts the inner walls of the cartridge to prevent leakage of fluid around the sides of the plunger. In the form shown, the base 21 of the cartridge is flat whilst the plunger 14 is pointed. The end face 22 of the plunger cannot therefore contact the base over the whole of its surface. The space between the plunger face and the base of the cartridge may be filled during insertion of the plunger by air, which may enter the cartridge or which may have been present in the cartridge prior to its use. The collection of air in such a space may prevent that air from being forced down the conduit 17. If a user is using the device to administer a drug through a bladder catheter, the catheter is likely to have been used to empty the bladder immediately prior to the introduction of the liquid medicament 11. The conduit 17 may therefore be wholly or partially filled with urine from the catheter which will reduce the amount of air contained in the conduit 17 prior to operation of the device.

Fig. 2 shows an alternative form of plunger assembly 13 and cartridge holder 19. In this form, the nozzle 15 is recessed into the body of the assembly to protect it from dirt and to protect the user from contacting the nozzle. The handles 16 extend linearly from the body, forming a relatively compact device. The cartridge holder 19 comprises a central space 25, in which a cartridge is placed during operation of the device, and further spaces 26 for storage of cartridges for future use. The stored cartridges 27 may be held in place by a resilient part 28 of the holder 19 or by other means. The plunger may be placed into the space 25 when not in use .

In Fig. 3 the plunger assembly 13 is provided with an extension 29 to protect the nozzle 15. The cartridge 10 is shown with a base 30 which is formed in the shape of the plunger face 12 in order to allow the plunger 14 to completely fill the cartridge 10 and thus expel the whole of its contents. In this case the cartridge holder 19 has a space 25 which conforms to the shape of the cartridge 10.

Fig. 4 shows a further embodiment of the device. The plunger assembly 13 is shaped so that the nozzle 15 faces the same direction as the plunger 14, the conduit 17 being angled appropriately so as to connect the nozzle 15 to the plunger aperture 18. This arrangement may be convenient in that it allows the user better access to and viewing of the nozzle during set up and operation of the device than the above-described embodiments. The holder 19 has three spaces 25, 26 and 31. When the device is not in use, as shown in Fig. 4a, the plunger assembly and a cartridge 10 may be conveniently stored in the holder 19. The plunger 14 fits into space 25, the cartridge 10 into space 26 and nozzle 15 into space 31. The cartridge 10 is shown stored with a removable cap 32 in place over the seal 12. The assembly 13 may be secured to the holder by any convenient method, e.g. by a snap-fit cap or a strap (not shown) .

Fig. 4b shows the device after it has been operated. The cartridge 10 has been uncapped and placed in space 26. The assembly 13 has been removed from holder 19 and oriented as shown in the drawing, with the plunger located in the cartridge 10 in space 26. The contents of the cartridge have been expelled through nozzle 15.

It will be clear from the above descriptions and the drawings that any of the plunger assemblies 13 shown in Figs. 1-4 may be used with any of the cartridge 10 and holders 19 shown.

In Figs. 5 and 6 a plunger assembly 13 has a collar _33 formed integrally with the assembly. The collar extends away from the base of the assembly 13 to a point beyond the end of plunger 14. Both collar 33 and cartridge 10 are round in cross-section and the diameter of collar 33 is slightly larger than that of cartridge 10 so that cartridge 10 can fit securely within collar 33. Collar 33 serves as a guide to locate the plunger centrally within the cartridge and to ensure that the plunger can be depressed into cartridge 10 whilst the cartridge is held securely within the guide formed by collar 33. The collar is not continuous around its circumference. Spaces 34 allow the user to hold the cartridge 10 through the collar 33 so that the cartridge can be pulled away from the plunger after use.

The fluid delivery device of the invention is useful as a convenient and portable device for a patient to use to administer a liquid medicament to himself. The pre¬ filled cartridges enable a predetermined quantity of the medicament to be administered from a sterile package. The device may be used repeatedly and may be cleaned and stored between uses.

It will be understood that, although the invention has been illustrated, by way of example, with reference to particular embodiments, variations and modifications thereof, as well as other embodiments, may be made within the scope of the protection sought by the appended claims .

Claims

CLAIMS 1. A device for use in delivering fluid from a cartridge via a delivery nozzle, including a holder for holding a cartridge, a plunger assembly having a plunger, means provided by the plunger for puncturing a cartridge in the holder, an aperture in the puncturing means for receiving fluid from a punctured cartridge, a nozzle, and a conduit for fluid connecting the aperture and the nozzle, and means to seal the plunger against the spillage of fluid when in use. 2. A device as claimed in claim 1 having a plunger and a nozzle which extend in opposite directions.

3. A device as claimed in either claim 1 or claim 2 in which the plunger assembly incorporates a handle. . A device as claimed in any one of the preceding claims in which the nozzle is recessed into the body of the plunger assembly.

5. A device as claimed in claim 1 having a plunger and a nozzle which extend in the same direction.

6. A device as claimed in either claim 1 or claim 5 in which the holder provides a space in which the plunger may be stored when it is not in use.

7. A device as claimed in any one of the preceding claims in which the sealing means provides a seal between the plunger assembly and the holder. 8. A device as claimed in any one of claims 1 to 6 in which the sealing means provides a seal between the plunger assembly and a cartridge.