GB2411387A

GB2411387A - Envelope containing a sterile field and sterile item

Info

Publication number: GB2411387A
Application number: GB0502135A
Authority: GB
Inventors: Leslie Miles Blustin; Gregory James Murray
Original assignee: BM Polyco Ltd
Current assignee: BM Polyco Ltd
Priority date: 2004-02-25
Filing date: 2005-02-02
Publication date: 2005-08-31
Anticipated expiration: 2025-02-02
Also published as: GB0404132D0; GB2411387B; GB0502135D0

Abstract

A package for surgical accessories, particularly gloves, consists of sheet of paper impregnated with a liquid proofing material wrapped, which is then folded around the surgical gloves, and placed within an envelope. Upon unfolding the package the user is presented with a sterile field upon which to work. Typically surgical gloves and a disposal bag are placed upon the sheet of paper and it is folded so that the contents fit into standard surgical glove packaging for neat storage and easy dispensing. Sterilisation of the finished pack is undertaken using a method appropriate to the contents contained within. The liquid proofing material impregnated within the paper serves to enable the paper to lie flat when opened, and repels spilt liquids. In the same instance the paper serves to lend weight to the liquid proofing material so that it is not disturbed in an air current.

Description

241 1 387 Sterile pack The present invention relates to a pack for use in

the sterile packaging of items for use in a medical environment, particularly sterile medical gloves.

When changing a patient's dressing, the items that are used must be kept sterile in order that no microbial contamination reaches the site of the patient's body, to which the dressing is applied. Suitably, the items are provided within a sterile pack. To ensure item sterility, the pack is typically arranged to define a sterile field in which the items may rest without becoming contaminated during the process of opening of the pack. It will therefore be understood that the sterile field comprises a sterile area or region that is designed to remain so during pack opening.

Traditional packaging involves the use of pack comprising a paper sheet that allows for the establishment of a sterile field. The pack is then provided with all of the items required to complete the dressing procedure such as gloves and a disposal bag. The paper sheet of the pack is folded in such a way that the surface facing inwards and in contact with the gloves and bag does not come into contact with the work surface as the paper sheet is unfolded, so that this surface forms the upper surface when it is completely unfolded onto a work surface. Thus, by carefully unfolding the paper sheet so as not to contaminate, as far as possible, this upper surface, the sterile field may be established.

Once the pack is opened and the paper sheet unfolded, the sterile item contents of the pack lie on the top surface of the paper sheet ready for use. The items may then be accessed by the health care professional. Typically, the items comprise gloves, which are donned by the health care professional who is then free to touch the sterile surface of the paper sheet further without contaminating it. Similarly, the gloves will not be contaminated by this contact. It will be appreciated that the underside of the paper sheet is no longer sterile because it is contaminated by the unfolding procedure (e.g. by being placed on a non-sterile surface).

Evidence however suggests that the sheet defining the sterile field does not readily lie flat under its own weight and there is a tendency for the sheet to re-fold back in towards the area where the items required for dressing are to be placed. The temptation therefore exists for the health professional to seek to smooth the sheet out during the process of opening the pack and thus contaminate the area with un gloved hands. In addition any items placed upon a surface, which is not flat have the potential to be unstable and fall over possibly leading to contamination.

GO 2,274,823 A1 describes a medical dressing aid pack, in which the sheet is formed of a lightweight plastics material, which is adapted to lie substantially flat under its own weight upon being unfolded. Applicant has now however established that the physical characteristics of sheet formed of such a lightweight plastics material are such that any air disturbance can cause it to fold in to itself with the potential to contaminate the field and the items placed upon it. Any attempt to return the field back to its flat state may in itself result in contamination.

Further, due to the impervious nature of the lightweight plastic material any spillage of a liquid inevitably has the potential to flow across the sterile field on to the outlying non-sterile surface. Dressing packs of this nature are regularly used when caring for patients in the community, and hence respect and care of their property is paramount.

The present invention overcomes these problems in that it comprises of a sterile sheet produced from paper sheet impregnated with a liquid proofing material, for example wax. The impregnation creates a heavier material that is less prone to forming permanent creases, thus avoiding the tendency for the sterile field to fold in upon itself and become contaminated.

The heavier weight of the paper sheet impregnated with the liquid proofing material also ensures that there is lesser tendency for any air disturbance (for example from ventilation systems or passing trolleys) to cause the sterile field to fold in on itself either prior to, or during use, thereby minimizing the risk of contamination.

Further, the impregnated paper sheet is more substantial in character, thus minimizing the risk of damage of the pack, particularly along the length of the folds

and the exterior edges of the sterile field.

Additionally, in use, any spillages of liquids typically form globules on the impregnated paper sheet, thereby ensuring that there is a reduced tendency for liquids to either permeate the sheet or to run off the sterile field.

According to one aspect of the present invention there is provided a sterile pack comprising an outer envelope containing at least a sterile sheet and a sterile item, in which the sterile sheet is folded such that it encloses the sterile item, and such that, when the outer envelope is removed, the sterile sheet may be unfolded to expose the sterlie item, the upper surface of the unfolded sterile sheet thus providing a sterile field, and in which the sterile sheet is formed of a paper sheet impregnated with a liquid proofing material.

There is provided a sterile pack. The term 'sterile' herein is used to mean sufficiently sterile for use in medical purposes. Sterilization of the pack and its contents is undertaken using a known sterilization method that is appropriate to both the pack and to its contents.

The sterile pack comprises an outer envelope containing at least a sterile sheet and a sterile item. Preferably, the sterile item comprises a pair of sterile gloves. Suitably, the sterile item also comprises a sterile waste bag.

-

The sterile sheet is folded such that it encloses the sterile item. When the outer envelope is removed, the sterile sheet may be unfolded to expose the sterile item.

The upper surface of the unfolded sterile sheet thus provides a sterile field.

Any suitable kind of folding method may be employed in folding the impregnated paper sheet including those folding operations described in United Kingdom patent application no. GB 2,274,823 A1.

The sterile sheet herein, is formed of a paper sheet impregnated with a liquid proofing material. Suitably, the paper sheet is of medical grade. Suitably, the paper sheet has a thickness of from 0.05 to 0.1mm, particularly 0.06 to 0.08mm, such as 0.07mm. The size of the sheet is selected partly in reference to the sizing of the items to be packaged. One suitable paper sheet herein has a size of 420mm x 500mm.

Preferably, the whole of the paper sheet is impregnated with the proofing material.

Embodiments may however, be envisaged in which only selected parts of the paper sheet are impregnated such as those that will come into contact with the items to be packaged.

Suitably, only one side of the paper sheet is impregnated with the liquid proofing material, but embodiments are also envisaged where both sides of the paper sheet are impregnated.

Preferably, the liquid proofing material is wax. Wax is selected that has physical characteristics suitable for the purpose of impregnation of the paper sheet.

Preferably, the sterile sheet is adapted to lie substantially flat under its own weight upon being unfolded. Suitably, the sheet of the sterile pack lies substantially flat under its own weight at every stage of the unfolding procedure, even where there are still several layers at a fold line, and not just once the sterile sheet is completely unfolded. Suitably, the sterile sheet lies flat at each stage without the need for additional smoothing or pressing down operations by the health care professional.

Desirably, the sterile pack is relatively compact. It is therefore usual when packing the contents of the sterile pack containing gloves and a waste bag to arrange them such that the individual gloves and bag lie on top of one another when the pack is sealed.

It is also desirable for the contents of the pack to be displayed conveniently to the user once the sheet is completely unfolded. Suitably, the pack is therefore arranged and the sheet folded such that the individual gloves of the pair lie side-by-side when the sheet is fully unfolded. The waste bag may either be provided on top of or underneath the gloves.

Suitably, gloves also lie flat in the pack such that their turned-back cuffs are readily accessible such that the gloves may be donned in a sterile manner.

According to another aspect of the present invention there is provided a method of assembling a sterile pack, comprising the steps of: placing a pair of gloves side-by side on the upper surface of a fully opened sterile sheet, said sterile sheet being formed of a paper sheet impregnated with a liquid proofing material; folding one side of the paper sheet along a line close to the gloves which is substantially perpendicular to the line dividing the gloves, such that the flap formed thereby substantially covers the gloves; folding the opposite side of the paper sheet such that it overlaps the flap formed by the first folded side; placing the folded sheet within an outer envelope; sealing the envelope; and sterilizing the sealed pack.

Embodiments of the present invention will now be described with reference to the accompanying drawings in which.

Figure 1 shows a top view of a sterile pack herein containing a pair of sterile gloves; Figure 2 shows a top view of the sterile pack of Figure 1 additionally containing a sterile waste bag; and Figures 3a to 3c shows top views of successive folding steps for folding up the sterile pack of Figure 2.

Referring now to the drawings, Figure 1 shows the unfolded sterile sheet 10 of a sterile pack 1 herein containing a pair of sterile gloves 20a, 20b having cuffs 22a, 22b that are upturned to assist in the donning thereof by a user in a sterile manner.

In accord with the present invention, the sterile sheet 10 is formed of a paper sheet impregnated with a wax liquid proofing material.

The upper surface 12 of the unfolded sterile sheet 10 provides a sterile field. It will be noted that the gloves 20a, 20b lie side-by-side and that various folds (to be described in more detail later) are provided to the sheet 10.

Figure 2 shows the sterile pack 1 of Figure 1, which is now also provided with a sterile waste bag 24 that sits on top of the right hand glove 20b.

A method of folding the sterile pack of Figure 2 is now described by reference to Figures 3a to 3c. For clarity, only those parts of Figures 3a to 3c referred to in the description thereof are labelled on the relevant Figure.

In Figure 3a, the side edges 30a, 30b of the sterile sheet have been folded one towards each other such as to cover each glove 20a, 20b and the waste bag 24.

In Figure 3b, the top 32 edge has been folded in and the bottom edge 34 then also folded in and over the folded-in top edge 32.

In Figure 3c, the sheet 10 has been folded along its central axis 36 such that the right hand glove 20b lies on top of the left hand glove 20a (not therefore visible).

To complete the pack herein, the folded arrangement of Figure 3c is then placed in an outer envelope, which is sealed in sterile fashion. - ! 8

Claims

Claims 1. A sterile pack comprising an outer envelope containing at least

a sterile sheet and a sterile item, in which the sterile sheet is folded such that it encloses the sterile item, and such that, when the outer envelope is removed, the sterile sheet may be unfolded to expose the sterile item, the upper surface of the unfolded sterile sheet thus providing a sterile field, and in which the sterile sheet is formed of a paper sheet impregnated with a liquid proofing material.
2. A sterile pack according to claim 1, wherein the sterile item comprises a pair of sterile gloves.
3. A sterile pack according to claim 2, wherein the sterile item additionally comprises a sterile waste bag.
4. A sterile pack according to any of claims 1 to 3, wherein said paper sheet has a thickness of from 0.06 to 0.08mm.
5. A sterile pack according to any of claims 1 to 4, wherein the whole of the paper sheet is impregnated with the liquid proofing material.
6. A sterile pack according to any of claims 1 to 4, wherein only those parts of the paper sheet that Will come into contact with the sterile item is impregnated with the liquid proofing material.
7. A sterile pack according to any of claims 1to 6, wherein only one side of the paper sheet is impregnated with the liquid proofing material.
8. A sterile pack according to any of claims 1 to 7, wherein the liquid proofing material is wax.
9. A sterile pack substantially as described in the accompanying description and drawings.
10. A method of assembling a sterile pack, comprising the steps of: placing a pair of gloves side-by-side on the upper surface of a fully opened sterile sheet, said sterile sheet being formed of a paper sheet impregnated with a liquid proofing material; folding one side of the paper sheet along a line close to the gloves which is substantially perpendicular to the line dividing the gloves, such that the flap formed thereby substantially covers the gloves; folding the opposite side of the paper sheet such that it overlaps the flap formed by the first folded side; placing the folded sheet within an outer envelope; sealing the envelope; and sterilizing the sealed pack.
11. A method according to claim 10, wherein said liquid proofing material is wax.
12. A method of assembling a sterile pack substantially as described in the

accompanying description and drawings.