WO2013041976A1

WO2013041976A1 - Surgical pad

Info

Publication number: WO2013041976A1
Application number: PCT/IB2012/050606
Authority: WO
Inventors: Carlo BRAGA
Original assignee: Braga Carlo
Priority date: 2011-02-14
Filing date: 2012-02-10
Publication date: 2013-03-28
Also published as: ITMI20110216A1

Abstract

It is provided a surgical pad (1) adapted to be introduced into a surgical site comprising a body fluid; the surgical pad (1) comprises an absorbent element (2) adapted to absorb said body fluid, and colouring means (3) adapted to at least partly vary the coloration of the absorbent element (2) after the absorbent element (2) has absorbed said body fluid, so as to visually highlight said surgical pad (1) relative to said surgical site.

Description

SURGICAL PAD

The present invention relates to a surgical pad of the type pointed out in the preamble of the first claim.

It is known that retention of surgical instruments within the surgical site or place, i.e. the patient's body, represents a particularly widespread event capable of generating obstructions or infections in said patient.

This problem is particularly frequent for pads because, as they absorb blood or other body fluids, pads are adapted to disguise themselves in an almost perfect manner in the surgical site making it very difficult to trace and find them.

In addition to the above aspect, among the main factors that can give rise to pad retention in the surgical site, the following ones can be mentioned: surgical procedures carried out under emergency conditions; unforeseen and therefore unprogrammed changes in the procedures during the surgical operation; patient's obesity; operations involving more than one surgical team; complexity of the operation; fatigue or tiredness of the surgical team and situations promoting a mistake in counting, such as pads attached to each other.

Taking into account said complexity and variety of causes, the different public and private responsible bodies have drawn up a plurality of regulations adapted to coordinate the different operations in order to avoid falling into such types of forgetfulness and oversight. In particular, among the different memoranda drawn up by the Ministry of Health, the memorandum of March 2, 2008 entitled "Raccomandazione per prevenire la ritenzione di garze, strumenti o altro materia!e all'interno del sito chirurgico" (Recommendation for preventing retention of pads, instruments or other materia! inside the surgical site) is to be mentioned.

In spite of all possible precautions hitherto adopted, retention of surgical instruments, and in particular surgical pads inside the surgical site is still particularly frequent and therefore special pads have been conceived which are adapted to facilitate identification of the pads themselves.

A first example contemplates use of a pad provided with an element opaque to X- rays. In detail, in this patent it is described a system for identifying a residual pad by radiography taken at the end of the surgical operation or at any subsequent moment.

A second example contemplates use of pads provided with a bar code. In this case, before starting the surgical operation, an operator arranges the surgical pads on a trolley, and through a suitable optical reader stores the number of same. At the end of the operation, the operator records the number of pads present on the trolley and, by comparing the number of pads present at the beginning of the operation with the number of those present at the end, evaluates whether and how many pads have remained inside the patient.

Another system contemplates tracing and finding of a pad inside a surgical site through use of pads provided with a chip adapted to emit detectable radio frequencies, and of a suitable receiver for detecting said frequencies.

These particular pads, while offering improvements, are characterised by important drawbacks.

A first aspect is represented by the complexity of the operations required for tracing and finding the pads in the surgical site. In fact; for identifying them use of particular receivers adapted to detect the aforesaid radio frequencies or of suitable machines for taking X-ray images is required.

Another problem is the cost for producing these surgical pads.

A further type of surgical pad, disclosed in patent CA-B-2022868 contemplates use of a pad coloured in dark colours. This system makes the pad recognisable but in this case it is not possible to distinguish whether it is impregnated with blood or not. It is therefore impossible to examine whether the pad is performing its task or not. In addition, the last-mentioned type of pad is not appreciated by physicians and users because, as it is not white, it does not enable to recognise whether it is clean and does not transmit a feeling of cleanliness and sterility.

Under this situation, the technical task underlying the present invention is to conceive a surgical pad capable of substantially obviating the mentioned drawbacks.

Within the scope of this technical task, it is an important aim of the invention to create a surgical pad tracing of which inside a surgical site can be done with particular ease.

Another important aim of the invention is to provide a pad that does not require use of specific machines and/or techniques for carrying out particularly complicated identification.

A further aim of the invention is to create a pad of easy identification and reduced cost.

The technical task and the aims specified are achieved by a surgical pad as claimed in the appended claim 1.

Preferred embodiments are highlighted in the sub-claims.

The features and advantages of the invention are hereinafter clarified by the detailed description of a preferred embodiment, with reference to the accompanying drawings, in which:

Fig. 1 shows a first example of surgical pad according to the invention;

Fig. 2a is a sectional view of an example of surgical pad according to the invention;

Fig. 2b shows a further example in section of surgical pad according to the invention;

Fig. 3 shows a second example of surgical pad according to the invention;

Fig. 4 is a section of a surgical pad as shown in Fig. 3.

With reference to the drawings, a surgical pad according to the invention is generally identified by reference numeral 1.

It is adapted to be used in a surgical operation and, in detail, to be introduced into a surgical site in order to absorb the body fluid, in particular blood, thus improving visibility inside the site during the operation. In detail, the expression "surgical site" identifies, in known manner, the body portion in which the surgeon/physician operates and inside which it is possible to find the presence of body fluids, such as blood, that can determine weak visibility.

The surgical pad 1 comprises an absorbent element 2 that, at the moment of use, i.e. when the pad 1 is introduced into the surgical site, is adapted to absorb the body fluid, and colouring means 3 adapted to colour the absorbent element 2 when in contact with said body fluid, in such a manner that, when the absorbent element 2 has absorbed said body fluid, the surgical pad 1 is visually highlighted relative to the surgical site, as better pointed out hereinafter, while at the same time enabling the absorbed fluid to be highlighted.

Element 2 substantially constitutes the shape of pad 1. It can essentially consist of - a classic surgical pad of known type. Preferably it is made up of a series of superposed layers consisting of fibres/threads having extension directions inclined to each other and, in particular, substantially perpendicular. In detail, said fibres/threads have a substantially helical extension so as to define cavities inside which the colouring means 3 can be housed.

The absorbent element 2 can be made of natural materials and/or synthetic materials such as cotton, fabric, or others.

In addition, this absorbent element 2 and consequently said surgical pad 1 before use is suitably of light colour and more preferably it is white.

The colouring means 3 comprises substances adapted to make at least part of the absorbent element 2, and therefore the surgical pad 1 , take a colour enabling the pad 1 to be visually identified, under any type of natural light or particular illumination such as ultraviolet or infrared rays, when said pad is in the surgical site and is impregnated with said body fluid. In detail, the colouring means 3 is adapted to give the surgical pad such a colour that, in spite of the fact that it has absorbed body fluid (blood, for example), it is still easily distinguishable from the surgical site in which it is placed. Preferably the colouring means 3 is adapted to make the pad 1 appear of dark colour, such as black, brown or blue.

The colouring means 3 therefore comprises non-toxic colours, preferably of the type for food, adapted to perform the aforesaid colouring function on pad 1. Preferably, these food colouring substances are adapted to determine a colour belonging to one of classes E150-159, E314 and the like, typical of the known classification carried out by the EFSA i.e. the European Food Safety Authority. In particular, the substances belonging to class E314 are classified as antioxidants and therefore safe for health.

The colouring means 3 is housed inside the absorbent element 2 and is adapted to colour the absorbent element 2 and therefore pad 1 only in the presence of body fluid.

Preferably, the colouring means 3 comprises highlighting substances 3a that substantially impregnate at least part or the whole of the surface of the absorbent element 2 and react in contact with body fluid, in particular blood, varying their coloration from a light colour to a dark colour (Fig. 2). The highlighting substances 3a are fastened to the surface of element 2 (Fig. 2a) or disposed inside (Fig. 2b) and optionally on the surface of said element, in a manner adapted not to come out of element 2.

In addition, the highlighting substances 3a can cover pad 2 so as to form stains of particular or random shapes, so as to make said pad more manifest. Or the absorbent element may comprise portions that cannot be coloured on their surface, such as portions of polytetrafluoroethylene or the like.

In particular, the highlighting substance 3a comprises a substance causing a mycological chemical reaction or the like. In detail, the highlighting substance 3a comprises bendidine and derivatives thereof, in particular tetramethylbenzidine, more particularly 3,3',5,5'-tetramethylbenzidine. The last-mentioned substance is a liquid light-coloured substance that, in contact with blood under suitable chemical conditions, takes blue or dark coloration. This substance is for example marketed under the trademark "Combur Test" from the company Roche^®.

Reactions of the type "Kastle-Meyer test" with phenolphthalein can be used, or other reactions based on peroxidase, or on use of leuco derivatives or similar substances and chemical phenomena.

The highlighting substance 3a can comprise phenoloxidase reactants arid similar substances.

In particular, the highlighting substance 3a comprises compounds derived from Guaiacum officinale, some of which belong to class E314. In particular, guaiac resin or guaiac dye is preferably used, preferably in an alcohol solution preferably in percentages included between 60% and 70% and preferably combined with hydrogen peroxide or the like. This substance too is a liquid and light-coloured substance and, in contact with blood, takes a blue or dark coloration as a result of oxidation of Guaiacum by means of hydrogen peroxide. In particular the company Beckman Coulter Inc., California, U.S.A. markets a substance including Guaiacum dye under the trademark Hemoc-cult^®, which is used for blood tests and can be advantageously employed as the highlighting substance 3a. In particular, the pad is treated with guaiac resin in suitable amounts and chemical conditions.

Another similar substance consists of guaiacol in water solution.

Other possible highlighting substances 3a are 4-(dimethylamino)-1 ,5(dimethyl-2- phenylpyrazol-3-one, commercially known as "Aminophenazone" or "Piramidone"; naphthol-a, preferably in 30% alcohol solution, 2(S)-amino-3-(4- hydroxiphenyl)propanoic acid, known as tyrosine and still others.

These highlighting substances 3a are particularly advantageous because they do not escape from the absorbent element 2, once fixed, and therefore do not stain the surgical site, instruments or gloves. In fact, these highlighting substances 3a vary the coloration of pad 1 but do not vary that of blood.

Alternatively, other substances can be used that are employed for the so-called "Fecal occult blood test", which substances are known by themselves and preferably use an immunochromatographic test suitably applied through a human anti haemoglobin monoclonal/polyclonal antibodies.

Another alternative solution consists in using a highlighting substance made up of colorimetric reactants specific for blood, of known type and generally used for detecting blood traces for example in Police investigations such as tests known as: BPA, Crimescope, Luminol (as previously mentioned); Combur-tritest (through tetramethylbenzidine), Obti-test (immunochromatographic reaction test).

Other possible highlighting substances 3a can be black starch, comassie blue,

DAB acid Fuchsine, Hungarian red, ABTS.

Another possible highlighting substance 3a is the substance known by itself with the trademark Luminol^® which is adapted to display a colour variation if illuminated with ultraviolet light. A further possibility is offered by use of highlighting substances 3a consisting of pH indicators adapted to vary their coloration in contact with the body fluid or yet other potentially toxic reactants that however are used in suitable amounts or under safe conditions.

Alternatively, the colouring means 3 can be housed inside the fibres/threads constituting the absorbent element 2 and, more specifically, in the cavities defined by them and previously described.

In detail, each of said bodies, before use of pad 1 and therefore before absorption of the body fluid, constitutes an object fully disposed inside element 2 so that, before use of pad 1 , the colouring means 3 is visually hidden by the absorbent element 2, as shown in Figs. 3 and 4.

In the last-mentioned case, the colouring means 3, in addition to said dyes, comprises a substance suitably mixed with said dyes which initially has a solid or liquid state at high viscosity and is diluted when coming into contact with a suitable fluid. In particular, this substance consists of hygroscopic substances.

In addition to the above components, the surgical pad 1 can have a selective membrane 4 adapted to wrap the absorbent element 2. In detail, said selective membrane 4 is suitable to exclusively enable passage of body fluids, therefore preventing escape of dyes from the surgical pad 1.

In detail, the selective membrane 4 by exploiting the greater sizes of the particles constituting the colouring means 3 as compared with those belonging to the body fluid, enables said body fluid to freely enter and exit the surgical pad 1 while it prevents escape of means 3 from pad 1. In detail, this type of selective membrane 4 is known to those skilled in the art as it is used in many technical fields and for making sanitary towels.

Alternatively, the colouring means 3 comprises a highlighting substance 3a that can be only seen under a particular light, such as ultraviolet or infrared light and suitable viewers. In this case the highlighting substance could also not change its colour.

Use of a surgical pad 1 described above in terms of structure, is the following.

First, pads 1 are sterilised and kept in accordance with the regulations in force. At the moment of use, the surgical pads 1 are disposed inside the surgical site and therefore come into contact with the body fluid which thus starts being absorbed by said pads. In detail, the body fluid passes through the membrane 4 and is absorbed by the absorbent element 2 finally coming into contact with the colouring means 3.

The colouring means 3, under the action of the body fluid, starts reacting in a chemical manner and changes its colour or is diluted in said fluid, being therefore absorbed by element 2 that consequently begins colouring.

When the surgical operation is almost terminated, the different pads 2 used are identified due to the different colour, and possibly by virtue of a particular illumination, from the rest of the surgical site, and are then extracted from said site and subsequently the operation is completed by closure of the site.

The invention achieves important advantages.

A first advantage resides in that the surgical pad 1 can be identified in a very simple and quick manner. In fact, the particular colour used is of easy identification irrespective of the amount of body fluid absorbed.

A further advantage of the invention is represented by the fact that the surgical pad 1 makes the surgical operation easier. In fact pad 1 is immediately distinguishable from the surrounding portions of the surgical site, such as blood, inner organs and the like.

Another important advantage resides in that pad 1 before use has an agreeable aspect and is of high quality. In particular, the surgical pad 1, before use, is substantially white, which is a colour adapted to emphasise sterility and cleanliness, i.e. qualities characterising pad 1 before being introduced into the surgical site.

The invention is susceptible of variations falling within the scope of the inventive idea set out in the claims. Within the claims all described and claimed elements can be replaced by equivalent elements and the details, materials, shapes and sizes can be of any nature and magnitude.

Claims

1. A surgical pad (1) adapted to be introduced into a surgical site comprising a body fluid; said surgical pad (1) comprising an absorbent element (2) adapted to absorb said body fluid; and characterised in that it comprises colouring means (3) adapted to at least partly vary the coloration of said absorbent element (2) after said absorbent element (2) has absorbed said body fluid, so as to visually highlight said surgical pad (1) relative to said surgical site.

2. A surgical pad (1) as claimed in claim 1 , wherein said colouring means (3) comprises highlighting substances (3a) substantially impregnating at least part of at least the surface of said absorbent element (2) and reacting upon contact with said body fluid varying their coloration and changing from a light colour to a dark colour.

3. A surgical pad (1) as claimed in claim 2, wherein said highlighting substance (3a) comprises tetramethylbenzidine.

4. A surgical pad (1) as claimed in claim 2 or 3, wherein said highlighting substance (3a) comprises derivatives of Guaiacum officinale.

5. A surgical pad (1) as claimed in claim 4, wherein said highlighting substance (3a) comprises guaiac resin.

6. A surgical pad (1) as claimed in one or more of the preceding claims, wherein said colouring means (3) is adapted to be diluted by said body fluid and absorbed by said absorbent element (2) thus colouring saic surgical pad (1).

7. A surgical pad (1) as claimed in claim 1 , wherein said absorbent element (2) is permanently at least partly coloured by said colouring means (3).

8. A surgical pad (1) as claimed in one or more of the preceding claims, wherein said colouring means (3) comprises food dyes.

9. A surgical pad (1) as claimed in the preceding claim, wherein said food dyes belong to classes E150, E159 and E314.

10. A surgical pad (1) as claimed in one or more of the preceding claims, comprising a selective membrane (4) adapted to wrap said absorbent element (2) and suitable to enable passage of said body fluid and inhibit said colouring means (3) from escaping from said surgical pad (1).

11. A surgical pad (1) as claimed in one or more of the preceding claims, wherein said colour variation can be seen under light at frequencies close to and included in the ultraviolet or infrared.