GB2342752A - Indicating tag to show the number of uses a piece of apparatus has undergone - Google Patents

Abstract

An indicating tag 1 adapted to be secured to an apparatus for indicating the number of uses the apparatus has undergone comprises a body portion 2 from which one or more limbs 3 extend, each limb having one or more elements 4 thereon. One element may be removed from the tag following each use of the apparatus to which the tag is secured. The tag may comprise N elements, N being the number of permitted uses of the apparatus. The apparatus may be a surgical apparatus and the uses sterilisation cycles, in which case the tag may be made from a mouldable material which retains its shape when subjected to a sterilisation cycle, e.g. a thermoplastic elastomer or silicon rubber.

Description

STERILISATION CYCLE INDICATOR TAG The present invention relates to indication means for use in monitoring cycles of treatment experienced by an item of apparatus. In particular the present invention relates to a tag for use in monitoring the number of cycles of sterilisation treatment to which an item of surgical apparatus is subjected.

In surgical operating theatres, electrical cables are required for the powering of surgical and monitoring equipment. In addition, high-frequency electrical currents are required in a number of surgical procedures in the surgical area of the theatre. One such procedure is diathermy, where an electrical current is used on a patient in order to produce coagulation or necrosis of skin cells.

As with all equipment that is used in the surgical area, the cables carrying these currents are required to be sterile.'Thus, after each use, the cables are put through a sterilisation cycle in order to be sterilised. For sterilisation, the sterilising cycles commonly use either high energy ionising radiation, steam autoclaving, or ethylene oxide exposure on the cables. With any of these sterilisation cycles, degradation of the cable will occur. Thus, the cables may only be used for a certain number of cycles before they fail, and a new cable is required.

However, using a cable to failure is a hazardous practice, as it is common for the person using the cable to receive a painful burn from the spark produced when the cable fails. As a precaution, therefore, cable manufacturers only recommend that their cables be used for a particular number of cycles before they should be replaced. In practice, however, it has so far proved difficult and inconvenient for surgical staff to record each cycle that a cable is put through.

A number of methods have been suggested for keeping track of the number of cycles that cables have been through. In theory, a straightforward method would be to assign each individual cable a code number in the manufacturing process. The surgical staff would then note each time they sterilised a particular cable. In practice, however, staff would find this hugely impractical to record each cycle on a daily basis. A simpler method would be to print a dot or mark on the cable. This mark would then diminish after every cycle until it disappeared entirely, and the cable would then be thrown away. This method is particularly inexact, as there would be no way of knowing the exact number of cycles the cable had been through.

It is therefore the aim of the present invention to provide a simple, straightforward, and practical indication means that can show exactly how many times a cable or other item of surgical apparatus has been sterilised. Thus, the cable may be discarded after the manufacturer's recommended number of cycles is reached without any ambiguity, and without any risk of injury to those who come into contact with the degraded cables.

According to a first aspect of the present invention, there is provided an indicating tag adapted to be secured to an apparatus in which the number of uses of said apparatus must be monitored, wherein said indicating tag comprises a body portion and one or more limbs extending from said body portion, each of said limbs having one or more elements thereon, said elements being arranged such that an element may be removed from said tag following each use of the apparatus to which the tag is secured.

Preferably, the apparatus is a surgical apparatus and the use is a sterilisation cycle.

Preferably the tag has N elements where N is the number of permitted uses of the apparatus.

Preferably the tag comprises a plurality of limbs.

Preferably each limb has a plurality of elements thereon. Preferably each limb is an elongate member.

Preferably said elements comprise thickened portions of said limb arranged longitudinally along said elongate member.

Preferably, said limb comprises a substantially cylindrical member having a first diameter or a flat member having a first thickness. Preferably, each element comprises a substantially spherical portion having a second diameter greater than said first diameter or thickness. Alternatively each element may comprise a disc shaped portion or a block shaped portion having an overall transverse dimension greater than said first diameter or first thickness.

Preferably said tag is made from a mouldable material which retains its physical shape when subjected to sterilisation. Preferably, said tag is made from a thermoplastic elastomer material such as Santopréne@.

Alternatively, said tag is made from silicon rubber.

Preferably, said tag further comprises fastening means for attaching said tag to the apparatus. The fastening means may comprise male and female cable tie members, an aperture adapted to surround a portion of the apparatus, or other suitable fastening means.

According to a second aspect of the present invention, there is provided a method for counting the number of uses of an apparatus, said method comprising attaching a tag according to the first aspect of the present invention to an apparatus, wherein the tag has N elements where N is the number of permitted uses of the apparatus, and wherein one of the elements is removed from said tag each time the apparatus is used, such that no elements remain on the tag after N uses.

Preferred embodiments of the present invention will now be described, by way of example only, with reference to the following drawings, in which: Figure 1 shows plan and cross-sectional views of a first embodiment of the present invention.

Figure 2 shows plan and cross-sectional views of a detail of a second embodiment of the present invention.

Figure 1 shows an indicating tag 1 in accordance with the present invention. The indicating tag 1 of Figure 1 is intended for use in conjunction with cables in operating theatres, where said cables must be sterilised after each use. As discussed above, the cables degrade after each sterilisation cycle, and as a precaution manufacturers recommend a maximum number of cycles before the cable should be replaced.

The indicating tag 1 has a cylindrical body portion 2 from which extend a number of limbs 3, and equidistantly spaced along the length of each limb 3 are a number of protruding portions or dimples 4. The number of limbs 3 and the number of dimples 4 on each limb 3 is dictated by the number of cycles that the manufacturer of the cables recommends should not be exceeded. For example, if it is recommended that a cable should not be subjected to more than forty sterilisation cycles, then eight limbs 3 with five dimples 4 on each limb 3 would be provided around the circumference of the cylindrical body 2.

The aim of the present invention is to provide very simple means with which to monitor the number of cycles that a piece of equipment-in this example, cableshas been through. After each cycle, the operator who has sterilised the cable simply takes a pair of scissors or the like, and removes the outermost dimple 4 from one of the limbs 3. Alternatively the limbs may be thin enough to allow a dimple to be removed by hand by pulling the end dimple. This process is repeated after each cycle until such time as there are no dimples 4 or, as a consequence, limbs 3 remaining.

Once the final dimple 4 has been removed, this then tells the operator that the cable has been sterilised the recommended number of times, and that it should now be discarded and replaced by a new cable.

Figure 1 shows an embodiment of the present invention where the centre aperture 5 of the cylindrical body 2 is circular to accommodate a standard single cable.

Figure 2, however, shows a second embodiment of the present invention wherein the indicating means 1 has a modified centre aperture 5. The aperture 5 has been modified into the shape of a slot 6, so that dual cables can be accommodated and held securely by the aperture 5.

In the preferred embodiments of the present invention, the indicating means 1 is manufactured from the thermoplastic elastomer Santoprene and moulded in one piece. Santoprene is produced by Advanced Elastomer Systems and has a wide variety of uses in the medical products field. Santoprene benefits from having the same properties as a conventional thermoset rubber allied to the easy processability of a thermoplastic.

In addition, as Santoprene is totally synthetic and not derived from natural rubber, it is free from the problems associated with natural rubber in medical applications, such as allergic reactions and the like.

Although Santoprenes is the preferred material from which to produce the present invention, other materials may be used. For example, silicon rubber shares similar properties to Santoprene.

Other modifications and improvements may be incorporated without departing from the scope of the present invention. For example, the present invention need not only be used in conjunction with cables. As well as other medical apparatus such as laryngeal masks, for example, the present invention could be used with any equipment in which the number of uses of said equipment must be monitored. The means of attachment may be a cable tie instead of an aperture. This would enable the tag to be put on a cable after the end plugs have been attached to the cable. Other means of attachment are possible, such as riveting, bolting, clamping, adhesives etc.

The shape of the tag is not limited to that shown in the drawings. Although the drawings show disc shaped protruding elements, these may be spheres, cuboid blocks, rods or other polygonal shapes.

These and other modifications and improvements can be incorporated without departing from the scope of the invention.

Claims (16)

1. CLAIMS: 1. An indicating tag adapted to be secured to an apparatus in which the number of uses of said apparatus must be monitored, wherein said indicating tag comprises a body portion and one or more limbs extending from said body portion, each of said limbs having one or more elements thereon, said elements being arranged such that an element may be removed from said tag following each use of the apparatus to which the tag is secured.
2. 2. An indication tag according to Claim 1, wherein said tag has N elements where N is the number of permitted uses of the apparatus.
3. 3. An indicating tag according to either Claim 1 or Claim 2, wherein said tag comprises a plurality of limbs.
4. 4. An indicating tag according to Claim 3, wherein each of said plurality of limbs has a plurality of elements thereon.
5. 5. An indicating tag according to any preceding claim, wherein each of said one or more limbs is an elongate member.
6. 6. An indicating tag according to Claim 5, wherein each of said one or more elements comprise thickened portions of said limb arranged longitudinally along said elongate member.
7. 7. An indicating tag according to any preceding claim, wherein said apparatus is a surgical apparatus and the use is a sterilisation cycle.
8. 8. An indicating tag according to Claim 7, wherein said tag is made from a mouldable material which retains its physical shape when subjected to the sterilisation cycle.
9. 9. An indicating tag according to Claim 8, wherein said tag is made from a thermoplastic elastomer material.
10. 10. An indicating tag according to Claim 8, wherein said tag is made from silicon rubber.
11. 11. An indicating tag according to any preceding claim, wherein said tag further comprises fastening means for attaching said tag to the apparatus.
12. 12. An indicating tag according to Claim 11, wherein said fastening means comprises male and female cable tie members.
13. 13. An indicating tag according to Claim 11, wherein said fastening means comprises an aperture adapted to surround a portion of the apparatus.
14. 14. A method for counting the number of uses of an apparatus, said method comprising attaching a tag according to any of Claims 1 to 13 to an apparatus, wherein the tag has N elements where N is the number of permitted uses of the apparatus, and wherein one of the elements is removed from said tag each time the apparatus is used, such that no elements remain on the tag after N uses.
15. 15. An indicating tag as substantially hereinbefore described and illustrated in the accompanying drawings.
16. 16. A method for counting the number of uses of an apparatus as substantially hereinbefore described.