WO2012042202A2

WO2012042202A2 - Cover apparatus

Info

Publication number: WO2012042202A2
Application number: PCT/GB2011/001401
Authority: WO
Inventors: Patrick Stuart Thorp
Original assignee: Patrick Stuart Thorp
Priority date: 2010-09-28
Filing date: 2011-09-27
Publication date: 2012-04-05
Also published as: WO2012042202A3; GB201016263D0

Abstract

A medical injection port assembly (10) with an injection port (12) and a cover apparatus (14). The apparatus (14) locates an end of the port (12), and three spaced annular engagement portions (20) on the inside of the cover apparatus (14) retain the end of the port (12) therein a friction fit. A pledget (24) soaked with a sterilising solution is provided adjacent a membrane (22) at the closed end of the cover apparatus (14), with a block (26) of a resilient foam plastics material at the far closed end to urge the pledget (24) against the end of the injection port (12) when locked in the apparatus (14).

Description

Cover Apparatus

This invention relates to cover apparatus for medical injection ports, and medical injection port assemblies.

Needleless injection ports are used to a significant extent in medicine in combination with cannulae or catheters to provide intravenous access to the body. They are used extensively in emergency and intensive care situations, with extremely low birth weight infants and others requiring parenteral nutrition, and chemotherapy in oncology patients

Previously injection ports included a polymer membrane which could be pierced by a needle. However, in view inter alia of the possibility of needle stick injuries, needleless ports were introduced, with the tip of a syringe or for example IV tubing displacing contiguous surfaces to establish a channel.

There is however a significant infection risk with such ports, which ports include a gap of approximately 0.3mm leading to the interior of the port which currently is left unprotected when not in use. Conventionally such ports should be sterilised by a 30 second, or two 10 second, wipes with a swab impregnated with an antimicrobial solution. This is not however always wholly effective, and is also often not fully carried out.

Blood stream infections arising through such ports can be particularly serious to patients whose immune systems may already be weakened or ineffective due to the medical situation which has required the use of the injection port in the first instance. Infections with multiple resistant organisms, e.g. MRSA, are a major international problem. As well as the dangers to the health of patients by such infections, there is also a very significant cost implication for health authorities in dealing with such infections when they occur. In vitro studies have revealed a contamination rate of 6 to 36 per cent. According to the present invention there is provided a cover apparatus for a medical injection port, the apparatus including a body member with a recess open at one end and closed at the other, which recess can locate the proximal end of a medical injection port therein so as to sealingly close the injection port, and engagement means for retaining the proximal end of the injection port in the recess.

The engagement means may include one or more formations on the inside of the recess, engageable with an injection port to retain the injection port in the recess in a friction fit.

The engagement formation or formations may be in the form of an annular ring of a flexible material, with an internal diameter which is less than that of the exterior of the injection port.

The engagement formation or formations may be integrally formed with the body member.

The engagement formation may comprise a groove on the inside of the recess to receive a projection on the outside of the proximal end of a medical injection port.

The locking groove may be contoured to prevent the projection from exiting therefrom without the port being urged further into the body member.

The locking groove may comprise a first portion leading into the recess from the open end, connecting to a second circumferentially extending portion, which connects to a third blind portion extending back towards the open end.

A source of sterilising material may be provided in the main recess of the cover apparatus. The sterilising material may be held in a porous material, and the porous material may be located in the cover assembly such that as an injection port is introduced into the main recess it will be urged against the porous material causing sterilising material to be released therefrom.

The sterilising material may be an antimicrobial solution, and may be any of isopropyl alcohol, alcoholic or aqueous iodine, or chlorhexidine solution. The sterilising material may be coloured, or may include a coloured material so as to provide a visual indication when a port has engaged with the sterilising material.

The sterilising material may include a dye, which may be any of gentian violet, cresyl green, acridine orange or potassium permanganate.

The dye may be antimicrobial. The dye may be a powder or a liquid.

A window may be provided in the body member so that it can be seen when a port has engaged with the sterilising material.

The porous material may be a pad or sponge.

A resilient part may be provided at the closed end of the recess, which resilient part may urge the source of sterilising material against the proximal end of an injection port located in the recess. The resilient part may be in the form of a block of resilient material, which material may be a foamed plastics material. An impermeable barrier may be provided between the resilient part and the source of sterilising material, and the barrier may be in the form of a membrane. A pressure relief opening may be provided in the closed end of the recess. The cover apparatus may include visual indicator means to show when an apparatus has been used. The cover apparatus may initially be provided with a removable seal closing the recess to maintain sterility and to provide a visual indication once removed that the cover apparatus has been used. The invention also provides a medical injection port assembly, the assembly including a cover apparatus according to any of the preceding eighteen paragraphs, and an injection port with a proximal end beatable in the recess of the cover apparatus. One or more projections may be provided on the outside of the injection port engageable with the engagement formation or formations provided within the recess of the cover apparatus. The projection or projections may be in the form of circumferential ribs, a screw thread, or a discrete upstanding projection.

Injection ports with different size and/or shapes of projections may be provided, such that different forces are required to release the respective injection ports from engagement in the cover apparatus recess. Locking formations may be provided on the outside of the cover apparatus, which formations are selectively engageable with an injection port extending into the cover apparatus, to lock the injection port and cover apparatus together. The invention still further provides a method of maintaining the sterility of a medical injection port, the method including after each injection locating a fresh cover apparatus according to any of said eighteen paragraphs on the proximal end of the injection port.

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

Fig. 1 is a diagrammatic cross sectional side view of a first medical injection port assembly according to the invention; Fig. 2 is a diagrammatic cross sectional side view of part of a second medical injection port assembly according to the invention;

Fig. 3 is a similar view to Fig. 2 of a third medical injection port assembly according to the invention;

Fig. 4 is a diagrammatic perspective end view of a fourth medical injection port assembly according to the invention; and

Fig. 5 is an opposite end perspective view of part of the assembly shown in Fig, 4.

Fig.1 shows a medical injection port assembly 10 comprising an injection port 12 and a cover apparatus 14 according to the invention. The injection port 12 may connect to a cannula or catheter, and can mount a needleless syringe or IV tubing or otherwise.

The cover apparatus 14 comprises a body 16 with a recess 18 closed at the right hand end as shown in Fig. 1 . Three spaced annular engagement formations 20 are provided on the inside of the recess 18 towards the left hand end as shown in the drawing. The annular formations 20 are flexible and resilient, and may be integrally formed with the remainder of the apparatus 14, the formations 20 being resilient and flexible due to the thickness of the material used. Alternatively, the formations 20 could be made of a different material with the required physical properties relative to the remainder of the cover apparatus 14. A flexible impermeable membrane 22 extends across the recess 18 spaced from the right hand end as shown. Mounted to the left hand side of the membrane 22 is a pledget 24 in the form of a pad soaked with a sterilising solution such as 70% isopropyl alcohol. Mounted on the right hand side as shown of the membrane 22 is a block 26 of a foamed plastics material. A screw thread 28 is provided around the proximal end of the injection port 12.

In use, the cover apparatus 14 will usually be supplied with a sterile cover (not shown) closing the open end of the recess 18. This cover indicates that the apparatus 14 has not yet been used, and can be removed when it is required to use the apparatus 14. The injection port 12 can then be pushed into the recess 18 until it can be pushed no further due to engagement with the membrane 22 pressing against the block 26.

The formations 20 will engage against the port 12 to retain the port 12 in the recess 18 in a friction fit. The thread 28 may also engage with the formations 20. The block 26 of resilient material will urge the membrane 22 and hence pledget 24 against the open end of the port 12 releasing antimicrobial material thereonto. The engagement of the formations 20 with the port 2 will also provide a substantial sterilising closure to the injection port 12. This therefore provides a significantly improved situation relative to infection, in comparison to the situation where the distal end of the injection port 12 is left uncovered. Fig. 2 shows a similar cover apparatus 30, but with annular formations

32 extending further into the recess 34 defined by the cover 30, and with the formations 32 at different spacings. A similar pledget 36 membrane 38 and block 40 are provided.

It may be required to provide a visual indication that an injection port 12 has come into contact with the pledget 24 or 36 and thus with sterilising material held therein. In order to achieve this a colouring material may be provided in the sterilising material or simply on the pledget 24,36. The colouring material may be a powder or liquid, and may be a dye which may be antimicrobial. Suitable dyes are gentian violet, cresyl green, acridine orange or potassium permanganate, the latter of which kills cysts of tapeworms.

Fig. 3 shows a further cover apparatus 50 which is similar to the cover apparatus 30 except that a window 52 is provided through the body 54 of the apparatus 50, adjacent the pledget 36. This means that a visual indication will be given through the window 52 once the port 12 has engaged against the pledget 36 and thus come into contact with the coloured dye or other colouring material.

Figs. 4 and 5 show a further cover apparatus 60 with a body 62 with a recess 64 with a closed end 66. An engagement formation in the form of a locking groove 68 is provided on the inside of the recess 64 adjacent the open end 70 thereof. The locking groove 68 comprises a first portion 72 extending from the open end 70. The first portion 72 connects to a second circumferentially extending portion 74 which connects to a third portion 78 which extends back towards the open end 70, but is blind.

A projection (not shown) in the form of a discrete upstanding projection on the outside of an injection port, will be locatable in the locking groove 68, and once located in the blind third portion 78 should prevent inadvertent removal of the port from the cover apparatus 60. Again a flexible membrane 80 is provided with a pledget 82 on the side thereof towards the open end 70. In this instance an air gap 84 is provided between the flexible member 80 and the closed end 66. A pressure relief hole 86 is provided centrally in the closed end 66. The hole 86 relieves any pressure generated when an injection port is initially attached to the cover apparatus 60.

There are thus described injection port assemblies, and a cover apparatus for an injection port, which provide for significant advantages in maintaining the injection ports sterile between injections. A physical and chemical barrier are both provided. The apparatus is however of relatively straightforward construction and can thus be inexpensively manufactured in large quantities for consistent use, and can readily be disposed of following use.

A number of other modifications may be made without departing from the scope of the invention. For instance, different materials could be used for the membrane, pledget and/or block. Different sterilising materials such as alcoholic or aqueous iodine or chlorhexidine solution could be used. A different number, spacing or shape of formations could be provided.

In some instances it may be required to provide a locking arrangement on the outside of the cover apparatus which can engage with the injection port to securely lock these together. This may be required for long term use and/or where a patient is relatively active.

Whilst endeavouring in the foregoing specification to draw attention to those features of the invention believed to be of particular importance it should be understood that the Applicant claims protection in respect of any patentable feature or combination of features hereinbefore referred to and/or shown in the drawings whether or not particular emphasis has been placed thereon.

Claims

1. A cover apparatus for a medical injection port, the apparatus including a body member with a recess open at one end and closed at the other, which recess can locate the proximal end of a medical injection port therein so as to sealingly close the injection port, and engagement means for retaining the proximal end of the injection port in the recess.

2. Apparatus according to claim 1 , in which the engagement means

includes one or more formations on the inside of the recess, engageable with an injection port to retain the injection port in the recess in a friction fit.

3. Apparatus according to claim 2, in which the engagement formation or formations are in the form of an annular ring of a flexible material, with an internal diameter which is less than that of the exterior of the injection port.

4. Apparatus according to claims 2 or 3, in which the engagement

formation or formations is integrally formed with the body member. 5. Apparatus according to claim 1 , in which the engagement formation comprises a groove on the inside of the recess to receive a projection on the outside of the proximal end of a medical injection port.

6. Apparatus according to claim 5, in which the locking groove is

contoured to prevent the projection from exiting therefrom without the port being urged further into the body member.

7. Apparatus according to claim 6, in which the locking groove comprises a first portion leading into the recess from the open end, connecting to a second circumferentially extending portion, which connects to a third blind portion extending back towards the open end.

8. Apparatus according to any of the preceding claims, in which a source of sterilising material is provided in the main recess of the cover apparatus

9. Apparatus according to claim 8, in which the sterilising material is held in a porous material 0. Apparatus according to, claim 9, in which the porous material is located in the cover assembly such that as an injection port is introduced into the main recess it will be urged against the porous material causing sterilising material to be released therefrom.

11. Apparatus according to claim 10, in which the porous material is a pad or sponge. 12. Apparatus according to any of claims 8 to 1 1 , in which the sterilising material is an antimicrobial solution.

13. Apparatus according to claim 12, in which the sterilising material is any of isopropyl alcohol, alcoholic or aqueous iodine, or chlorhexidine solution.

14. Apparatus according to any of claims 8 to 13, in which the sterilising material is coloured so as to provide a visual indication when a port has engaged with the sterilising material. 15. Apparatus according to any of claims 8 to 1 , in which the sterilising material includes a coloured material so as to provide a visual indication when a port has engaged with the sterilising material.

16. Apparatus according to claim 15, in which the sterilising material

includes a dye.

17. Apparatus according to claim 16, in which the dye is any of gentian violet, cresyl green, acridine orange or potassium permanganate.

18. Apparatus according to claims 16 or 17, in which the dye is

antimicrobial.

19. Apparatus according to any of the preceding claims, in which a window is provided in the body member so that it can be seen when a port has engaged with the sterilising material.

20. Apparatus according to claim 8 or any of claims 9 to 19 when

dependent on claim 8, in which a resilient part is provided at the closed end of the recess, which resilient part urges the source of sterilising material against the proximal end of an injection port located in the recess.

21. Apparatus according to claim 20, in which a window is provided in the body member so that it can be seen when a port has engaged with the sterilising material. 22. Apparatus according to claim 21 , in which the resilient material is a foamed plastics material.

23. Apparatus according to any of claims 20 to 22, in which an

impermeable barrier is provided between the resilient part and the source of sterilising material.

24. Apparatus according to claim 23, in which the barrier is in the form of a membrane.

25. Apparatus according to any of the preceding claims, in which a

pressure relief opening is provided in the closed end of the recess.

26. Apparatus according to any of the preceding claims, in which the cover apparatus includes visual indicator means to show when an apparatus has been used. 27. Apparatus according to claim 26, in which an impermeable barrier is provided between the resilient part and the source of sterilising material,

28. A medical injection port assembly, the assembly including a cover apparatus according to any of the preceding eighteen paragraphs, and an injection port with a proximal end locatable in the recess of the cover apparatus.

29. An assembly according to claim 28, in which one or more projections is provided on the outside of the injection port engageable with the engagement formation or formations provided within the recess of the cover apparatus.

30. An assembly according to claim 29, in which the projection or

projections may be in the form of circumferential ribs, a screw thread, or a discrete upstanding projection.

31. An assembly according to claims 28 or 29, in which injection ports with different size and/or shapes of projections are provided, such that different forces are required to release the respective injection ports from

engagement in the cover apparatus recess.

32. An assembly according to claim any of claims 28 to 3 , in which

locking formations are provided on the outside of the cover apparatus, which formations are selectively engageable with an injection port extending into the cover apparatus, to lock the injection port and cover apparatus together.

33. A method of maintaining the sterility of a medical injection port, the method including after each injection locating a fresh cover apparatus according to any of claims 1 to 27 on the proximal end of the injection port. 34. A cover apparatus for a medical injection port, the apparatus being substantially as hereinbefore described and with reference to the accompanying drawings.

35. A medical injection port and assembly, the assembly being

substantially as hereinbefore described and with reference to the accompanying drawings.

36. A method of maintaining the sterility of a medical injection port, the method being substantially as hereinbefore described and with reference to the accompanying drawings.

37. Any novel subject matter or combination including novel subject matter disclosed herein, whether or not within the scope of or relating to the same invention as any of the preceding claims