EP3370665A1

EP3370665A1 - Medical accessories

Info

Publication number: EP3370665A1
Application number: EP17705457.4A
Authority: EP
Inventors: Donna FORSYTH; Cathy HOPKINSON
Original assignee: National Health Service Trust Development Authority
Current assignee: National Health Service Trust Development Authority
Priority date: 2016-02-09
Filing date: 2017-02-08
Publication date: 2018-09-12
Also published as: CN109069308A; GB201602307D0; WO2017137739A1

Abstract

An article for use in a medical or surgical procedure comprises a main absorbent portion 2,2';2"; 14, a tether portion 4 secured at a proximal end thereof to the main absorbent portion 2,2';2"; 14 and a securing member (10) secured to a distal end of the tether portion 4. The tether portion 4 comprises a material resistant to taking on a colour of blood when coming into contact therewith and the securing member (10) is arranged to be operable to frictionally grip a fabric item.

Description

Medical Accessories

This invention relates to accessories for use in certain medical and surgical procedures. It relates partly, although not exclusively, to absorbent articles for use in certain post-natal maternity procedures.

There are some post-natal maternity procedures such as episiotomy repair in which it is necessary for the clinician to insert a surgical swab or tampon into the mother's vagina in order to absorb blood and other fluids while the procedure is undertaken. However, a problem has been identified in that, on rare occasions, the swab is accidently retained in the vagina after the procedure has finished and which could represent a significant risk to the patient from infection. Part of the difficulty with existing swabs is that they readily take on the colour of blood and so become difficult to see, separate, count and account for. Whilst most clinicians adhere to the practice of counting swabs used and accounting for all of them at the end of the procedure, this system is not always 100% reliable. For example, if the before and after count do not tally there cannot be complete confidence that the original count was correct and even if it is identified that a swab is missing, it may be necessary to carry out an x-ray with the additional time, cost and exposure risk that this brings, in order to establish this definitively.

When viewed from a first aspect the present invention provides an article for use in a medical or surgical procedure comprising a main absorbent portion, a tether portion secured at a proximal end thereof to the main absorbent portion, and a securing member secured to a distal end of the tether portion, the tether portion comprising a material resistant to taking on a colour of blood when coming into contact therewith and the securing member being arranged to be operable to frictionally grip a fabric item.

Thus it will be seen by those skilled in the art that in accordance with the present invention a swab or other absorbent article has an attached tether portion which connects it to a securing member which allows it to be attached to a surgical drape or the like. The securing member and the tether will thus remain visible outside the body cavity into which the main absorbent portion has been inserted to provide a highly visible reminder of its presence therein. It is believed that when used properly and exclusively, this has the potential to eliminate the problem of retained swabs almost completely. Since the tether portion comprises a material that will not take on the colour of blood, it will remain visually distinctive even after it has come into contact with blood in use. It could, for example, be non-absorbent. Preferably, the tether portion is brightly coloured in order to assist this. For example, it may be yellow. In other embodiment s the material could adopt a different colour than blood when coming into contact therewith to provide a visual distinction with other items in the vicinity which generally readily adopt the colour of blood.

The tether portion could be made entirely of the material resistant to taking on the colour of blood when coming into contact therewith. Alternatively said material could form only part of the tether portion - e.g. making up bands, stripes or the like - so that a further contrast is apparent between parts of the tether portion when it comes into contact with blood.

In a set of embodiments, the tether portion is provided with markings. These may simply increase the visibility of the tether portion, but preferably act as a

reminder/instruction not to remove or severe the tether portion. For example, in a set of preferred embodiments the tether portion bears the words "DO NOT CUT" repeatedly. Preferably the markings (e.g. the wording mentioned above) is provided on both sides of a flat-section tether portion. Preferably the text is provided in a contrasting colour to that of the tether portion itself, for example black or dark blue where the tether portion is yellow. The text should preferably be provided in a way that does not degrade or become less clear in use or during sterilisation or storage.

The tether portion should be strong enough that it cannot easily be broken with manual force but comfortable enough that it does not cause irritation to the patient when in and against parts of their body. In a set of embodiments, the tether portion comprises cotton. However this is not essential and other materials could be used. Similarly, where text, coating or treatment is added to the tether portion, this should preferably not be done in such a way as to cause degradation, harm or irritation to a patient or other user. The tether portion could have a round section e.g. similar to a string. In a set of embodiments however the tether portion has a flattened cross-section akin to a tape or ribbon.

The tether portion will typically also be secured to the absorbent portion sufficiently strongly to prevent it from being separated with manual force. For example it may be sewn into the absorbent portion. The securing member could take any convenient form although in a set of embodiments it comprises a resilient clip. Preferably the securing member is adapted such that it is operable with one hand only. The securing member could, for example, be made of a plastic material e.g. acrylic. Preferably the securing member is also visually distinctive and contrasting to the tether portion. It may, for example, be blue. The securing member is operable to grip a fabric item in use. This could, for example, be a surgical drape, clothing, bedding or the like. Of course a securing member suitable for such a purpose could equally be used to grip something else such as a piece of equipment, bed frame etc. The tether portion will typically also be secured to the securing member sufficiently strongly to prevent it from being separated with manual force. For example the securing member may be moulded onto or riveted to the distal end of the tether portion. In a further set of embodiments, a temporary retainer is provided to retain the tether portion in a folded configuration. This allows for neat and efficient packaging, avoids tangling and allows for easy deployment to a specific length required. The retainer could, for example, comprise a loop. The loop could be made of the same material as the tether portion. In a set of embodiments the tether portion passes through the loop and the loop has an opening small enough such that it cannot become detached from the article either at the proximal or distal end of the tether portion.

Articles in accordance with the invention could be used in any medical or surgical procedure. In a set of embodiments the main absorbent portion comprises an absorbent sheet. This would be suitable for a wide variety of invasive and noninvasive procedures. The sheet may be sized and shaped to suit the procedure for which it is intended or could come in one or more standard sizes which can be used for several different procedures.

An advantageous application of embodiments of the invention is to pre-natal maternity procedures. In such embodiments the main absorbent portion may comprise a tampon pledget. When viewed from a second aspect the invention provides a sterile pack comprising therein an article for use in a medical or surgical procedure comprising a main absorbent portion, a tether portion secured at a proximal end thereof to the main absorbent portion, and a securing member secured to a distal end of the tether portion, the securing member being arranged to be operable to frictionally grip a fabric item.

Preferably the tether portion of the article of the second aspect of the invention comprises a material resistant to taking on a colour of blood when coming into contact therewith as described hereinabove. The article otherwise may have the same optional and preferable as the first aspect of the invention.

Certain embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Fig. 1 shows a vaginal swab in accordance with a first embodiment of the invention; Fig. 2 shows a larger variant of the swab with the tether and sheet unfurled, ready for use;

Fig. 3 shows the clip and tether of the swab of Fig. 1 in more detail;

Fig. 4 shows a third embodiment of the invention; and

Fig. 5 shows a tampon in accordance with a fourth embodiment of the invention.

Turning first to Fig. 1 there may be seen an article embodying the invention in the form of a vaginal swab. These are commonly used in hospital maternity units for a number of procedures e.g. episiotomy repair which require blood and other fluids inside the vagina to be absorbed. The swab comprises a main absorbent portion in the form of a sheet 2 for example in the form of a twelve-ply white gauze material, well known per se in the art. The dimensions may be chosen depending upon the particular intended application. Merely by way of example the main absorbent portion may be 36cm x 1 1 cm and 1 mm thick which is depicted in Fig. 1. This can be used opened out as shown or, alternatively, it can be rolled up to act as a tampon pledget if that is preferred by a particular clinician user. A variant of this is shown in Fig. 2 in which the swab has an abosorbent portion 2' which is 22.5 cm x 22.5cm and 1 mm thick.

Securely sewn onto the gauze sheet 2 is a tether 4. The tether 4 may be made of woven cotton e.g. dyed bright yellow with a biologically inert hypoallergenic dye. The tether 4 is of a substantially flat section - for example it may have a width of 12 mm and a thickness of 1 mm. However such a shape and dimensions are not essential. Its length may be chosen according to the intended use but may, for example, be 75 cm.

The tether 4 bears text 6, namely the words "DO NOT CUT" repeatedly along its length on both sides, in a contrasting colour such as black or dark blue. This enhances the visually striking nature of the tether 4 but more importantly acts as a strong reminder to users not to sever the tether and thus compromise its efficacy. The text 6 may be added to the tether 4 for example by a dye impregnation technique which ensures that it does not give the tether a texture which might be irritating to the patient.

The tether 4 may be coated or impregnated with a clinically inert hydrophobic substance This prevents the tether from taking up the colour of blood in use which would render it much less distinctive. However other ways of achieving this could be used. It is also foreseen that just the text 6 is prevented from taking up the colour of blood.

Fig. 1 shows the tether 4 folded as it would be when packaged in a sterile wrapper (not shown) prior to use. It is held in place by a small loop 8 of the same or similar ribbon material as the tether itself, also bearing the text "DO NOT CUT". At the distal end of the tether 4 it is secured to a clip 10 made, for example, of blue acrylic. The clip may be attached to a surgical drape, gown or other item of clothing. The clip 10 is held closed by a spring (not shown) which has a spring force which is sufficiently low to allow the clip to be opened with one hand bur sufficiently high that it cannot easily be pulled from a drape or the like once it has been attached. Serrations 12 on the respective inner surfaces of the jaws of the clip facilitate a secure connection.

In use the clinician removes the swab from a sterile wrapper (not shown) and unfurls the main absorbent sheet 2, 2'. He or she then slips the loop 8 from the folded section of the tether 4 and pulls the tether to unfold it. The swab then has the appearance shown in Fig. 2.

As may be seen from the more detailed view of Fig. 3, the tether 4 passes through the loop 8 so that even when it has been slipped off as described above, the loop 8 cannot become detached, The opening of the loop is clearly too small to allow it to pass over ether the absorbent sheet 2 or the clip 10. This is important as it is necessary to ensure that no small parts from the swab can inadvertently become detached and/or be left inside the patient/mother.

Once the swab has been prepared as described above, the absorbent sheet 2 is inserted into the patient's vagina to absorb blood or other fluids which might result from performance of the necessary procedure. The absorbent sheet 2 may be fully inserted into the vaginal cavity but the tether 4 remains outside so that it passes through the vaginal opening. The clip 10 at the distal end of the tether 4 is attached to a convenient surgical drape (not shown) so as to keep the tether out of the way. However the tether 4 and clip 10 both provide a highly visible reminder of the swab's presence in the patient. Whilst the internally retained absorbent sheet 2 is likely to take on the colour of blood during the procedure, the coating or lettering on the tether 4 and the non- absorbent nature of the clip 10 prevents these from doing the same and thus they remain bright in colour with contrasting (e.g. blue/black) lettering on the tether 4. At the end of the procedure the absorbent sheet 2 is removed from the patient's vagina and the clip 10 is detached from the drape so that the swab can be disposed of appropriately. The tether 4 and clip 10 mean that it is effectively impossible in practice for the intact swab used as described above to be inadvertently retained in the vagina. Furthermore if a clinician wishes to perform an additional check, the tether 4 and clip 10 will also mean that the swab stands out against equipment used during the procedure even though the absorbent sheet has taken on the colour of blood, allowing the swab easily to be accounted for. Fig. 4 shows a second embodiment of the invention in the form of a vaginal pack. This has the same basic elements as the swab of the first and second

embodiments but in this case the absorbent sheet 2" is significantly larger - e.g. 500 x 90 cm and is both folded and rolled. This is typically unfurled prior to use and used as a packing material.

Fig. 5 shows another embodiment of the invention in which the basic elements are still the same but the main absorbent portion takes the form of a tampon pledget 14. This is used in the same way as the absorbent sheet described with reference to the first embodiment and is preferred by some clinicians.

It will be appreciated by those skilled in the art that the foregoing description of particular embodiments is merely exemplary and that many modifications and variations thereof within the scope of the invention are possible. For example it is not essential for articles in accordance with the invention to be used for or adapted for maternity procedures; they could be used for any other medical or surgical - e.g. invasive procedure. Moreover the specific construction of the elements is not essential and thus, for example, the clip could take a different form or another type of securement could be used. Similarly the colours and materials mentioned could be changed without departing form the scope of the invention.

Claims

1. An article for use in a medical or surgical procedure comprising a main absorbent portion, a tether portion secured at a proximal end thereof to the main absorbent portion, and a securing member secured to a distal end of the tether portion, the tether portion comprising a material resistant to taking on a colour of blood when coming into contact therewith and the securing member being arranged to be operable to frictionally grip a fabric item.

2. The article as claimed in claim 1 wherein the tether portion is non- absorbent.

3. The article as claimed in claim 1 or 2 wherein the tether portion is brightly coloured.

4. The article as claimed in claim 1 , 2 or 3 wherein the tether portion material adopts a different colour than blood when coming into contact therewith.

5. The article as claimed in any preceding claim wherein the tether portion is provided with markings.

6. The article as claimed in claim 5 wherein said markings act as a

reminder/instruction not to remove or severe the tether portion.

7. The article as claimed in claim 5 or 6 wherein the markings are provided on both sides of a flat-section tether portion.

8. The article as claimed in any of claims 5 to 7 wherein the markings comprise text provided in a contrasting colour to that of the tether portion itself.

9. The article as claimed in any preceding claim wherein the tether portion comprises cotton.

10. The article as claimed in any preceding claim wherein the tether portion has a flattened cross-section.

11. The article as claimed in any preceding claim wherein the tether portion is sewn into the main absorbent portion.

12. The article as claimed in any preceding claim wherein the securing member comprises a resilient clip.

13. The article as claimed in any preceding claim wherein the securing member is adapted such that it is operable with one hand only.

14. The article as claimed in any preceding claim wherein the securing member is visually distinctive from and contrasting to the tether portion.

15. The article as claimed in any preceding claim wherein the securing member is moulded onto or riveted to the distal end of the tether portion.

16. The article as claimed in any preceding claim comprising a temporary retainer to retain the tether portion in a folded configuration.

17. The article as claimed in claim 16 wherein the temporary retainer comprises a loop.

18. The article as claimed in claim 17 wherein the loop is made of the same material as the tether portion.

19. The article as claimed in claim 17 or 18 wherein the tether portion passes through the loop and the loop has an opening small enough such that it cannot become detached from the article either at the proximal or distal end of the tether portion.

20. The article as claimed in any preceding claim wherein the main absorbent portion comprises an absorbent sheet.

21. The article as claimed in any of claims 1 to 19 wherein the main absorbent portion may comprise a tampon pledget.

22. A sterile pack comprising therein an article for use in a medical or surgical procedure comprising a main absorbent portion, a tether portion secured at a proximal end thereof to the main absorbent portion, and a securing member secured to a distal end of the tether portion, the securing member being arranged to be operable to frictionally grip a fabric item.

23. The sterile pack as claimed in claim 22 wherein the tether portion of the article comprises a material resistant to taking on a colour of blood when coming into contact therewith.

24. The sterile pack as claimed in claim 22 or 23 wherein the article is as claimed in any of claims 2 to 21.