WO1997042899A1

WO1997042899A1 - Apparatus for administering medicament

Info

Publication number: WO1997042899A1
Application number: PCT/US1997/008142
Authority: WO
Inventors: John Douglas Rohrbough
Original assignee: Faulding Inc.
Priority date: 1996-05-14
Filing date: 1997-05-09
Publication date: 1997-11-20
Also published as: AR007132A1; AUPN981996A0; EP0906066A1; CA2254766A1

Abstract

A reservoir module (50) which is connected to a peristaltic pump to administer carefully metered quantities of medicament to a patient is disclosed. The reservoir module (50) comprises broadly two connector assemblies (1) and two vials (5). Each connector assembly (1) comprises a support member (2), an adaptor (3) for attaching to a vial (5), and a vial cover (4). The adaptor (3) defines a flow path therethrough which places medicament within the vial in fluid communication with the suction conduit of a pump. The vial cover (4) encloses and receives the adaptor (3) and vial (5) and holds them securely to the support member (2). Apparatus for administering medicament to a patient in need thereof including a reservoir module as described above in combination with a peristaltic pump is also disclosed.

Description

APPARATUS FOR ADMINISTERING MEDICAMENT

This invention relates generally to apparatus for administering medicament to a patient in need thereof. More specifically this invention relates to a connector assembly and a reservoir module for operatively connecting a vial to a pump, and to apparatus for administering medicament to a patient.

It is often necessary to administer a medicament intravenously to a patient in need thereof. Sometimes gravity feed systems in which a medicament reservoir is held at an elevation above the administration site are used to perform this function. However where accurate metering of a medicament is required, it is advantageous to use a negative pressure pump such as a peristaltic pump to administer the correct amounts. A connector assembly and reservoir module for coupling to a peristaltic pump is disclosed in the Applicant's prior Australian Patent Application 32111/93 filed on 29 January 1993 and entitled Drug Delivery System. The entire contents of this specification are incorporated herein by reference.

While the apparatus disclosed in the specification identified above enables a shell glass vial containing medicament to be operatively connected to a peristaltic pump it does have some shortcomings. For example, it is possible for the vial to become detached from the rest of the apparatus causing the vial to get broken and medicament within the vial to be lost. With this apparatus it is also possible for an unauthorised person to gain access to medicament, eg morphine, within the vial as there are no tamper resistant features associated therewith.

It would clearly be highly desirable if apparatus could be provided which provided an efficacious attachment of the vial to the apparatus with little risk of detachment during use. It would also be highly desirable if the attachment of the vial to the apparatus was tamper resistant so as to resist unauthorised access to medicament within the vial. According to a first aspect of this invention there is provided a connector assembly for operatively connecting a vial to a suction conduit of a pump, the assembly including: a support member; an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump; a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein; and means for attaching the vial cover to the support member.

Thus the vial cover receives and surrounds the vial and holds it firmly and securely to the support member.

Typically the means for attaching the vial cover to the support member comprises complementary locking formations on the vial cover and the support member. Advantageously the complementary locking formations comprise at least one locking finger on the vial cover engaging at least one complementary cut-out defined in the support member. Preferably the locking finger and cut¬ out are configured such as to engage with a snap fitting connection and to be non-releasable. In a most preferred form, there are two said locking fingers and two said cut-outs.

This feature ensures that the vial cover is not easily detached from the support member once it has been attached thereto. This provides the connector assembly with a tamper resistant feature.

The connector assembly may include further attachment means for releasably attaching the adaptor to the support member. Typically said further attachment means for attaching the adaptor to the support member comprises complementary locking formations on the adaptor and the support member. In a preferred form the complementary locking formations comprise a circumferentially extending groove defined in the adaptor and at least one locking formation on the support member for engaging said circumferentially extending groove. In a most preferred form, there are two said locking formations on the support member.

The connector assembly may further include means for releasing said further attachment means attaching said adaptor to said support member, when said vial cover is attached to said support member.

Advantageously the means for releasing the further attachment means comprises having each locking formation of the further attachment means configured such that it is progressively moved in a direction out of the circumferentially extending groove as the vial cover is progressively moved into attaching engagement with the support member. In a most preferred form each of the locking formations on the support member is ramped to accomplish this.

These features provide that the adaptor is firmly and securely attached to the support member prior to its attachment to the vial which makes the process of attachment of the adaptor to the vial a lot easier to accomplish. The action of mounting the vial cover over the vial releases the adaptor from the support member enabling it to move relative to the vial.

Typically the vial is a circular cylindrical glass container containing medicament, eg morphine, and having a moveable plunger of resilient material.

Typically the adaptor includes a cannula for penetrating the plunger of the vial and placing medicament within the vial in fluid communication with the flow path defined through the adaptor.

Advantageously the adaptor also includes means for attaching the adaptor to the plunger of the vial. Typically these means include a female formation on the adaptor for receiving a male formation on the plunger. In a preferred form the female formation comprises a bore having a screw thread and the male formation comprises a protrusion having a complementary screw thread. Alternatively the female formation comprises a bore having a plurality of longitudinally extending rib formations and the male formation comprises a complementary protrusion which engages the female formation by means of a friction fit.

Typically the vial cover is a substantially cylindrical hollow body having one closed end, and having a resilient element, eg a pad of foam, located in the closed end. This enables the vial cover to accommodate tolerances in the size of the vial and to snugly receive the vial within the vial cover.

According to a second aspect of this invention there is provided a reservoir module for use in administering medicament to a patient, the module including: at least one connector assembly which in turn includes, a support member, an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump, a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein, and means for attaching the vial cover to the support member.

Typically the reservoir module further includes at least one vial containing medicament and having a stopper.

Typically the reservoir module includes a base on which each said support member is mounted. Preferably the base is a support platform and each support member is permanently fixed to the support platform.

Typically the reservoir module further includes a housing within which the support platform and each support member is received. In a preferred form, the reservoir module includes two said connector assemblies arranged side by side on the base and also includes two said vials.

Each of the connector assemblies may include any one or more of the preferred features described above, with respect to the first aspect of the invention.

Advantageously the reservoir module further includes means for sealing the vial cover to the housing, eg to resist ingress of moisture between the vial cover and the housing. Preferably the sealing means comprises a sealing O- ring extending circumferentially around the vial cover which in use engages a complementary surface defined by a bore in the housing.

The reservoir module may include means for aligning the vial cover with the support member such that the complementary locking formations of the attachment means can engage each other. In a preferred form the alignment means comprises complementary formations on respectively the vial cover and the housing.

Typically the reservoir module includes a length of flexible tubing passing from the adaptor to the suction conduit of the pump. In the preferred form, the reservoir module contains two said lengths of tubing, one from each of the adaptors of the connector assemblies, said two lengths of tubing merging to form a single length of tubing which passes to the suction inlet of the pump.

According to a third aspect of this invention there is provided apparatus for administering medicament to a patient in need thereof, the apparatus including: a support member; an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump; a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein; and attachment means for attaching the vial cover to the support member.

Typically the apparatus further includes a pump which in use is operatively connected to the adaptor.

According to a fourth aspect of this invention there is provided an apparatus for administering medicament to a patient in need thereof including: a reservoir module as described above with respect to the second aspect of the invention; and a pump operatively connected to the reservoir module.

The reservoir module may include any one or more of the preferred features described above with respect to the second aspect of the invention.

Typically the pump is a negative pressure pump, eg a peristaltic pump.

In a preferred form, the apparatus including the pump and the reservoir module are contained within a single portable unit. Typically the unit can be held in a patient's hand, received in a patient's pocket, clipped onto a patient's belt and received in other clothing of the patient.

A connector assembly and a reservoir module in accordance with this invention may come in a variety of forms. It will be convenient to hereinafter describe two specific embodiments of the invention in detail with reference to a set of drawings. It is to be understood however that the specific nature of this description does not derogate from the generality of the preceding statements. In the drawings: Fig. 1 is an exploded bottom three-dimensional view of a connector assembly and vial in accordance with one embodiment of this invention;

Fig. 2 is a top three-dimensional view of a support member of the connector assembly of Fig. 1 ; Fig. 3 is a three-dimensional view of a reservoir module in accordance with one embodiment of this invention, with parts omitted for clarity;

Fig. 4 is a sectional front elevation of part of the reservoir module of Fig. 3; Fig. 5 is a schematic three-dimensional view of the reservoir module of

Fig. 3; and

Fig. 6 is a three-dimensional view of a reservoir module in accordance with a second embodiment of the invention, with parts omitted for clarity.

Fig. 1 illustrates a connector assembly 1 for operatively connecting a vial to a suction conduit of a pump.

The connector assembly 1 comprises broadly a support member 2, an adaptor 3 releasably attached to the support member 2 and a vial cover 4 which fits over and receives the adaptor 3. The support member 2 provides the support for the adaptor 3 and for the vial cover 4.

When the connector assembly 1 is assembled for use a vial 5 containing medicament, typically a shell glass vial with a displaceable resilient plunger 6 is attached to the adaptor 3 and the vial cover 4 is attached to the support member 2. The detailed structure of each of the components and their interrelationship with each other is described below.

Fig. 2 shows the support member 2 in some detail. The member 2 comprises a base portion 10 and two diametrically opposed wall portions 11 and 12 extending perpendicularly upwardly away from the base portion 10. Each of the wall portions 11 and 12 defines a cut-out 16 for engaging a complementary locking formation or locking finger 17 on the vial cover 4. The engagement of the cut-outs 16 and locking fingers 17 acts to attach the vial cover 4 to the support member 2. Each cut-out 16 has a substantially rectangular configuration. Each of the wall portions 11 and 12 also has a locking formation 18 for engaging a complementary groove 19 on the adaptor 3. The two locking formations 18 are resiliently biased radially inwardly such that they would tend to engage with the groove 19. The formations 18 have longitudinally extending ramps 20 which cause them to be displaced out of engagement with the groove 19 by the vial cover 4. The ramps 20 are shown particularly clearly in Fig. 2. Thus the locking formations 18 are released or detached from the groove 19 when the vial cover 4 is engaged with the support member 2.

A further feature of the support member 2 is a cut-out 21 in the base portion 10 through which flexible tubing attached to the adaptor 3 is passed. The cut-out 21 is ramped or sloped as indicated by numeral 15 to assist with the feeding of tubing therethrough.

The adaptor 3 is illustrated particularly clearly in Figs. 1 , 3 and 4.

Broadly the adaptor 3 comprises a body defining a flow path therethrough which acts to place medicament within the vial 5 in fluid communication with a suction conduit of a pump. One end of the flow path is defined by a cannula 7 having a sharp tip for penetrating the plunger 6 and the other end of the flow path is connected to flexible tubing which leads to the suction inlet of a pump (not shown).

In general the body of the adaptor 3 is substantially circular-cylindrical having opposed ends 22 and 23 and is sized to be received with clearance within the wall portions 11 and 12 of the support member 2. The adaptor 3 has a locking formation for releasably attaching it to the support member 2, namely the peripheral groove 19 described above, which is located towards the end 23 thereof. As Fig. 3 illustrates the end 22 of the adaptor 3 defines a female formation or tubular bore 26 which is co-axial with the cannula 7 for receiving a complementary male engagement formation 27 on the vial plunger 6 (illustrated in Fig. 1). Each of the formations 26 and 27 defines a screw thread which engage to attach the adaptor 3 to the vial plunger 6. The end 22 of the adaptor 3 may be rounded slightly to ease passage of the adaptor 3 into the vial 5. As Fig. 1 illustrates the end 23 of the adaptor defines a circular recess

28 receiving a section of tubing in a coiled configuration. During the manufacturing stage, tubing is drawn into the recess 28 so as to provide an excess length of tubing to the give the adaptor 3 the ability to move down the vial 5 as medicament is withdrawn therefrom.

The vial 5 has a circular cylindrical configuration and the plunger 6 is received within the open end of the vial. The plunger 6 seals against the surface of the vial 5 and the material thereof is chosen such that it can easily be penetrated by the cannula 7. As described above, the plunger 6 includes a male engagement formation 27 which has an external screw thread formation thereon. The screw thread on the formation 27 engages the complementary screw thread defined on the formation 26 of the adaptor 3, as described above.

The vial cover 4 is a hollow circular cylindrical container one end of which 31 is closed and the other end of which 32 is open. The two locking formations or locking fingers 17 described above are located towards the end 32. The fingers 17 are deformable to some extent radially inwardly so that they can be received within the wall portions 11 and 12 of the support member 2. These locking fingers 17 engage the cut-outs 16 defined in the support member 2 to attach the vial cover 4 to the support member 2. The locking formations or fingers 17 are configured such that they cannot be removed from the cut-outs 16 once they are fully inserted.

Alignment means in the form of elongated slots 35 cut out of the vial cover 4 and complementary alignment ribs (not shown) are provided for correctly aligning the fingers 17 with the cut-outs 16 on the support member 2 on structure adjacent the support member 2. To enable the vial cover 4 to be pushed home over the vial 5 and adaptor 3, the slots 35 must be aligned with the alignment ribs which in turn ensures that the formations or snap fingers 17 are aligned with the cut-outs 16. A resilient element 37 is placed inside the vial cover 4 between the closed end 31 thereof and the vial 5 to absorb any excess length in the vial cover 4. In this way the vial 5 is received in the vial cover 4 with a snug fit.

Figs. 3 to 5 illustrate a medicament reservoir module 50 in accordance with one embodiment of the invention. Broadly the module 50 comprises two connector assemblies of the type illustrated in Fig. 1 mounted side by side on a base which is a support platform 51. The connector assemblies 1 are permanently attached to the support platform 51 for example, by ultrasonic welding. Alternatively the connector assemblies may be moulded integral with the platform 51 as a one-piece unit.

Lengths of tubing from each of the connector assemblies 1 are passed downwardly through the platform 51 and thereafter merged in a Y junction or a T junction into a single length of tubing (not shown) which is passed through to the suction inlet of the pump (not shown). The support platform 51 and the two adjacent support members 2 are enclosed in an outer case or housing 55 which is hermetically sealed to the platform 51. The housing 55 defines two circular openings around the bores defined by the two support members 1.

An O-ring seal 56 is mounted on the external surface on each vial cover 4 spaced axially inwardly of the locking formations 17. The O ring 56 seals the vial cover 4 to the housing 55 thereby resisting ingress of moisture into the housing 55.

Advantageously a protective cover 60 is mounted over the cannula 7 prior to use of the reservoir module to preserve the sterility of the cannula 7 which during use is brought into fluid contact with the medicament. The protective cover 60 which is illustrated in Figs. 3 and 5 is typically attached to the cannula 7 by means of a friction grip.

In use the reservoir module 50 illustrated in Fig. 5 is operatively coupled to a pump which is a peristaltic pump. Peristaltic pumps are particularly well suited to administering medicament because the peristaltic pumping action is applied externally of the tube carrying medicament and therefore it is easy to maintain sterility. Further the pumping action is well suited to delivering accurately metered quantities of medicament. Well known peristaltic pumps comprise a plurality of cams which impart a linear wave motion to a set of pressure fingers. This in turn squeezes a section of tubing to drive fluid within the tubing along the tubing with a pulsatile flow. While such a peristaltic pump has not been illustrated in the drawings the structure and functioning of such a pump would be well known to a person skilled in the art.

Fig. 6 illustrates a reservoir module 50 in accordance with a second embodiment of the invention. Unless otherwise indicated the same reference numerals will be used for the Fig. 6 embodiment as were used for the embodiment in Fig. 5. The principal difference between the Fig. 6 embodiment and the Fig. 5 embodiment is that longitudinal rib formations 70 replace the internal screw threads defined in the bore 26 of the adaptor 5. The longitudinal rib formations 70 are located at spaced intervals around the circumference of the bore 26 and provide for the attachment of the plunger 26 to the adaptor 3 by means of a friction fit.

Each of the components such as the support member 2, adaptor 3, vial cover 4, support platform 51 and outer case 55 are typically manufactured separately from each other prior to assembly. These components may be made out of any suitable material although plastic is well suited because of its light weight. Typically the support member 2, adaptor 3, vial cover 4, and housing 55 are made from a polycarbonate plastic by an injection moulding process. The cover 60 for the cannula 7 is typically injection moulded from a thermoplastic rubber. The various sections of tubing typically are extruded PVC tubing which can be bought off the shelf.

Typically the adaptor body would be moulded in distinct elements, for example an inner hub and an outer hub which hubs are then swedged together to form a single article. Prior to swedging the inner and outer hubs together, the cannula 7 would be attached to the inner hub by inserting it into a flow passage defined by the inner hub and bonding it thereto using cyanoacrylate glue. The outer hub would then be mounted concentrically over the inner hub and ultrasonically welded thereto, and tubing would be attached to the body, completing the assembly of the adaptor 3.

While the shell glass for the vial 5 typically has a standard configuration and standard dimensions, the plunger 6 would be specifically manufactured for use with the connector assembly 1 of this invention.

Turning now to the assembly of the reservoir module 50, one or two support members 2 depending on the particular configuration of reservoir module being assembled, are appropriately positioned on a support platform 51 and ultrasonically welded to the platform 51. A corresponding number of adaptors 3 would then be snap fitted into retaining engagement with the support member 2. The engagement of the locking formations 18 on the support member 2 with the peripheral groove 19 of the adaptor 3 permits rotation of the adaptor 3 relative to the support member 2 which enables tubing 25 to be drawn into the recess 28 in the bottom end of the adaptor 3. Advantageously the adaptor 3 has a ratcheted design which permits rotation thereof in only one direction. The sub-assembly comprising the platform 51 , two support members 2 and two adaptors 3 are then placed inside the housing

55 which is ultrasonically welded to the platform 51. The attachment of the housing 55 to the platform 51 provides a hermetic seal.

The vial cover 4 is easily assembled by inserting the pad 37 into the cover 4 and moving it down to the closed far end thereof. In addition the O-ring

56 is mounted circumferentially around the vial cover 4. It is to be clearly understood that prior to use the vial cover 4 is kept quite separate from the support member 2.

The reservoir module 50 would typically be sold packaged as a kit. The two vials and the vial covers would be separate from the sub-assembly contained within the outer case 55 comprising the platform 51 , support members 2 and attached adaptors 3.

When preparing the reservoir module 50 for use, the two vials 5 would be operatively attached to the two adaptors 3. This would be accomplished by inserting each cannula 7 through the plunger 6 of the corresponding vial 5 and engaging the complementary screw threaded formations 26 and 27. Vial covers 4 would then be mounted over the vials 5 and snapped into locking engagement with the support member 2. Once the vials have been snapped into locking engagement with the support member 2, they are not detachable from the support member 2. The action of engaging the vial cover 4 with the support member releases the adaptor 3 from the support member 2 leaving it free to move within the vial 5.

At this point the reservoir module 50 is ready for use. When the peristaltic pump to which the reservoir module is connected is started, medicament is drawn out of the vial 5. The tubing 25 coiled within the recess 28 at the end of the adaptor 3 permits the adaptor 3 to move lengthwise down the vial 5 as medicament is withdrawn from the vial 5. When the supply of medicament within the vial 5 is exhausted, the tamper proof nature of the reservoir module 50 requires that the entire module 50 be thrown away and replaced with a fresh module.

It is an advantage of a reservoir module in accordance with a preferred embodiment of this invention, that it provides an efficacious, secure and tamper resistant attachment of a shell glass vial to a peristaltic pump. Further the attachment of the shell glass vial to the pump is relatively uncomplicated and can be effected by a lay person, eg a nurse or patient.

A further advantage of a preferred form of the invention is that it provides a convenient portable unit for administering a pain killing drug to a patient which can easily be carried around by a patient on his/her person. It is to be understood that various alterations, modifications and/or additions may be introduced into the construction and arrangement of the components previously described without departing from the ambit of the present invention disclosed herein.

Claims

1. A connector assembly for operatively connecting a vial to a suction conduit of a pump, the assembly including: a support member; an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump; a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein; and means for attaching the vial cover to the support member.

2. A connector assembly according to claim 1 , wherein said means for attaching the vial cover to the support member comprises complementary locking formations on the vial cover and the support member.

3. A connector assembly according to claim 2, wherein said complementary locking formations comprise at least one locking finger on the vial cover engaging at least one complementary cut-out defined in the support member.

4. A connector assembly according to claim 3, wherein the locking finger and cut-out are configured such as to engage with a snap fitting connection and to be non-releasable.

5. A connector assembly according to any one of claims 1 to 4, including further attachment means for releasably attaching the adaptor to the support member.

6. A connector assembly according to claim 5, wherein said further attachment means for attaching the adaptor to the support member comprises complementary locking formations on the adaptor and the support member.

7. A connector assembly according to claim 6, wherein the complementary locking formations comprise a circumferentially extending groove defined in the adaptor and at least one locking formation on the support member for engaging said circumferentially extending groove.

8. A connector assembly according to claim 7, further including means for releasing said further attachment means attaching said adaptor to said support member, when said vial cover is attached to said support member.

9. A connector assembly according to claim 8, wherein said means for releasing said further attachment means comprises having each locking formation of said further attachment means configured such that it is progressively moved in a direction out of the circumferentially extending groove as the vial cover is progressively moved into attaching engagement with the support member.

10. A connector assembly according to any one of claims 1 to 9, wherein the adaptor includes a cannula for penetrating the plunger of the vial and placing medicament within the vial in fluid communication with the flow path defined through the adaptor.

11. A connector assembly according to claim 10, wherein the adaptor includes means for attaching the adaptor to the plunger of a vial.

12. A connector assembly according to claim 11 , wherein the means for attaching the adaptor to the plunger includes a female formation on the adaptor for receiving a male formation on the plunger.

13. A connector assembly according to claim 12, wherein the female formation comprises a bore having a screw thread and the male formation comprises a protrusion having a complementary screw thread.

14. A connector assembly according to any one of claims 1 to 13, wherein the vial cover is a substantially cylindrical hollow body having one closed end, and wherein a resilient element is located in the closed end of the vial cover.

15. A reservoir module for use in administering medicament to a patient, the module including: at least one connector assembly which in turn includes, a support member, an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump, a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein, and means for attaching the vial cover to the support member.

16. A reservoir module according to claim 15, further including at least one vial containing medicament and having a stopper.

17. A reservoir module according to claim 15 or claim 16, including a base on which each support member is mounted.

18. A reservoir module according to claim 17, wherein the base is a support platform and each support member is permanently fixed to the support platform.

19. A reservoir module according to claim 18, further including a housing within which the support platform and each support member is received.

20. A reservoir module according to any one of claims 15 to 19, including two said connector assemblies arranged side by side on the base and also including two said vials.

21. A reservoir module according to any one of claims 15 to 20, wherein each connector assembly is in accordance with any one of claims 2 to 14.

22. A reservoir module according to any one of claims 15 to 21 , wherein the reservoir module further includes means for sealing the vial cover to the housing.

23. A reservoir module according to claim 22, wherein the sealing means comprises a sealing O-ring extending circumferentially around the vial cover which in use engages a complementary surface defined by a bore in the housing.

24. A reservoir module according to claim 21 , which includes means for aligning the vial cover with the support member such that the complementary locking formations of the attachment means can engage each other.

25. A reservoir module according to claim 24, wherein said alignment means comprises complementary formations on respectively the vial cover and the housing.

26. Apparatus for administering medicament to a patient in need thereof, the apparatus including: a support member; an adaptor for attaching to a vial having a stopper and containing medicament, the adaptor defining a flow path therethrough which acts to place medicament within the vial in fluid communication with a suction conduit of a pump; a vial cover for mounting over the vial and adaptor such that the vial and adaptor are received therein; and attachment means for attaching the vial cover to the support member.

27. Apparatus according to claim 26, further including a pump which in use is operatively connected to the adaptor.

28. Apparatus for administering medicament to a patient in need thereof including: a reservoir module as claimed in claim 15; and a pump operatively connected to the reservoir module.

29. Apparatus according to claim 28, wherein the reservoir module is in accordance with any one of claims 15 to 25.

30. Apparatus according to claim 28 or claim 29, wherein the pump is a negative pressure pump.

31. Apparatus according to according to any one of claims 28 to 30, wherein the pump and the reservoir module are contained within a single portable unit.