FR2742655A1 - Ultra=absorbent surgical compress - Google Patents

Abstract

The compress consists of an upper moisture absorbent layer of paper made from vegetable fibres for improved distribution of fluids inside its pad, a moisture repellant backing layer, an ultra-absorbent pad made from layers of cotton between the two layers and an outer envelope of gauze. It has a removable external indicator which is detectable visually, fitted to a strip and removed by cutting a knot so that it can be kept as a check on the number of compresses used. The compress has two additional indicators, comprising a coloured woven thread along the length of the outer envelope, and a coloured strip of material, between 20 and 40 cm long which has one end attached to the compress and the other left outside the operating site. The outer detachable indicator is coated with an easily-visible material, such as a photoluminescent or iridescent material which is non-toxic and not radioactive.

Description

ULTRA ABSORBENT COMPRESS WITH REMOVABLE INTERNAL INDICATOR AND REMOVABLE
Surgical compresses are widely used. The patents concerning them are very numerous. Some are very old and have now fallen into the public domain; they have been deposited to satisfy various uses. The most recent attempts to respond only to a concern for security by the use of various cookies, all incorporated permanently in the compress, generally ra.o-opaque, detectable by X-rays.

Despite this, to date, the use of a compress, whatever its type, continues to pose a major risk: that one of them may be forgotten by a surgeon in the operating site. This risk. at pnori is greater during interventions where the number of compresses used is very high. This is the case, in particular. when the operating conditions are difficult, hemorrhagic or of multiple sites, in particular on the occasion of intra-operative complications which mobilize the attention of the whole operating room team to the detriment of the vigilance which usually presides over the course of the operation. a perfectly regulated surgical intervention, or when interventions are carried out with several concomitant teams or compresses. normally separated into very distinct batches according to the operating teams, are sometimes by inadvertence or precipitation used without distinction in particular by operating aids.

The processes proposed so far cannot fully offset this risk, since the only regulatory obligation imposed on the
Health to avoid such omissions, is the pre-operative count of compresses, followed by a comparative recount of the same compresses at the end of the intervention.

However, such a procedure does not protect against human error. Thus, for example, the error in counting a default compress exposes an oversight in the operating field. because the recount would be, in case of effective forgetting. falsely reassuring.

Also, to eradicate any risk of forgetting, which has become intolerable due to its
Human and financial implications, two Innovations are described in this patent: - a mobile witness, fixed on the pad, and removable, because it is intended to be removed when using the pad and to be kept on a support in order to serve as a reference count.

- an ultra-absorbent compress, in order to reduce the number of compresses used, which should incidentally compensate for the additional cost of this type of high security compress.

Indeed. to reduce this risk, the innovative process hitherto usually used in the most recent patents. was to provide the pads with an X-ray detectable system.

This process, certainly effective in finding a forgotten compress of this type.

is done at the cost of a costly and harmful irradiation for the health of the patient.

However, it must absolutely be added that the use of such compresses does not allow one to do without compulsory counting, radiographic screening represents only a remedial solution in the event of an error associated with an oversight. In fact, a falsely reassuring count can lead the surgeon, who is in a hurry, for whatever reason, to close the operating wound by postponing the completion of the control x-ray to the early post-operative period, rather than having it performed, as logic does. prompt at the end of the procedure before closing the operating wound. which obliges then, but fortunately seldom to a reintervention.

Before considering the various witnesses, used as recognition, and having been the subject of filing of patents referenced in the study of prior art which follows, it should also be emphasized that the use of these radiopaque pads n 'being not compulsory and often subject to I'
Improbation of the managers due to the additional cost, thus the risk of forgetting by counting error, remains.

The methods of marking compresses, proposed, using a control, are varied; the various possibilities noted in the prior art study are, to provide the compresses, - either, a flexible witness opaque to X-rays (anteriority WO 9104723), but which can lead to the patient, as previously cited, irradiation and a blow high, - or a sponge using an internally detectable witness visually thanks to Iridescent wires. fluorescers already used in the context of many surgical sponges (prior art FR 2377187), but nevertheless requiring the help of X-rays for greater safety, - either an absorbent body also having a material detectable by rays
X, but the inventor himself cites that, despite all precautions, one cannot however completely exclude the possibility that tampons remain by mistake in the operating field "- that is, on the other hand, the compresses used on the basis of muslin and layers of glued fibers, delivered in a non-sterile state, having to go through an autoclave at 134 degrees, which can, according to the alternating principle "pressure and vacuum" cause fear at the deterioration of the matrix of the radiographic contrast material consisting of thermoplastic polymers and polymers with the addition of plasticizers (FR 2580172), but the latter may
deforming said matrix rendering this witness null, - either an internal compress made of absorbent fabric on which a polymeric fluid opaque to X-rays is applied according to a distinctive pattern visible to the naked eye but which alone does not constitute sufficient security, - either a laminated surgical sponge made of compressed textile fibers, with an external non-adherent porous plastic layer. The sponge contains an element detectable by X-rays and a cord attached to the sponge to facilitate identification (WO 9324086 ), but again according to the length of the cord which can escape the vigilance of the surgeon and enter the operative field the use of X-rays in post-operative as a control therefore remains compulsory, and by this fact the witness of this surgical sponge does not systematically fulfill its safety objective, - either compresses reinforced externally by an inert tissue and comprising s radio-opaque markers such as coated metal wire, wire impregnated with metal salts, films made of inert plastic (FR 2480596), but again no external security, which also requires the search for compresses by X-rays, - either sponges surgical instruments equipped with a handle opaque to radiation (X-rays) (FR 2470585) but here again no accumulation of safety witness, - either a surgical compress formed of a layer of gauze in which is fixed a piece of metal Identifiable by a magnetic field (Document FR 2580172), but in the present case, here again it is an internal witness, the latter requiring in case of forgetfulness the use of a magnetic field (preferably X-rays) with a risk of significant error in the case of proximity of metallic prosthesis
The compress, subject of this patent. therefore comprises, as it was specified at the beginning, two parts: - a compress, proper, described as ultra-absorbent, and, - a mobile, removable witness, mounted on a strip forming an integral part of the compress , and is intended to be removed and stored during an intervention, just before using the compress. to serve as an indisputable reference for counting compresses at the end of the intervention.

The compress, itself, is innovative, because it relates to a new constitution of association of materials, some of which have already been partially used in the field of surgical compresses but never in association, for compresses for internal use. It also includes three different safety markers, designed to protect the patient and his health as much as possible. In addition to the mobile, removable marker, detailed below, two visual markers are incorporated into the compress itself to facilitate research in operating sites. The first, a woven cotton strip (already fallen into the public domain for a length 20 cm), intended to remain outside the operating field and to carry the removable reference mobile witness, increases to a length of 40 cm to minimize the risk of inadvertently seeing the said strip disappear while in the operating field, especially at obese in abdominal surgery, during untimely and repeated maneuvers of repression of the viscera; any length deemed excessive according to the operator's appreciation, can easily be adjusted by a simple reduction scissor stroke. The second, to facilitate recognition, consists of a blue net (also fallen into the public domain) in cotton , woven over the entire length of the compress in the selvedge on the back side; the edges of the hydrophilic gauze being used lengthwise in order to avoid any deformation of said gauze.

Indeed, s in the field of surgical compresses; the most diverse materials could be used to wrap, wipe, clean, absorb the interior of the wounds, to date, it is clear that the quality of the materials and witnesses put in place, mentioned above in studies of , do not give complete satisfaction with regard to security.

On the other hand, the ultra-absorbent pad provided with a removable indicator, therefore the subject of this present patent. responds well to security requirements, and can be used both externally and internally.

For example, in the event of a very hemorrhagic external lesion such as the traumas of the skull with a large scalp or open fractures, a single compress of this type, provided that you choose a sufficient size, is sufficient thanks to its properties ultra-absorption.

This compress can contain and absorb bleeding by exerting optimum compression. what simple compresses, necessarily multiple or non-hydrophobic emergency dressings, do not allow, which can be passed through beyond their periphery, exposing to greater blood loss
In the event of internal use, as during a laparotomy, for example, this compress allows the surgeon on the one hand, to expose the operating area by repressing the organs not concerned by said operation, on the other hand, to '' absorb sero-bloody flows of high importance, requiring beforehand the use of very many compresses. These are frequently and quickly replaced. even compacted at the bottom of a crude hemorrhagic area in an attempt to reduce the amount of bleeding. This compaction intended to be temporary but, the operating difficulties helping and the compress soaked in blood merging with the tissues, exposed to too much classic accident of forgotten compresses. This is where an external, mobile, removable, reference witness takes on its full value as a guarantee of security.

It should be noted that, if we want to completely eliminate in the future the risk of the discovery of 'textomes' in the operated, it would also be necessary to'
Prohibit the use of operating drapes, which, too, are sometimes forgotten in a womb, in favor of the use of such a large pad with removable witness, unless the fields conventionally used are fitted up to date of such an original witness and subject of this patent.

This compress (FIG. 1) with a width of 100 to 200 mm, a length of 100 to 400 mm, and a thickness which can range from 2.5 to 5 mm, consists of an envelope of cotton wool gauze (Fig. 1 a) sewn on each end (to protect very unlikely leakage of cotton wool (Fig. ld) component of the compress). This seam (Fig. 3a) is visible on the back , hydrophobic side (Fig. 3), as well as the overlock on the same hydrophobic back (Fig. 3b) on which is fixed the 1st internal control (Fig. 3b) in blue color, integral with the compress, in order to contrast with the color of the blood (but this classic witness fell in the pubiic field)
Under the envelope of cotton wool gauze (Fig. 1a), in order to allow the absorbed blood a better distribution in the compress, a film of paper made from vegetable fibers (Fig. 1b) with a thickness of 1 / 10th of mm, will be interposed between the hydrophilic gauze and the absorbent hydrophilic cotton (Fig.lc) whose thickness can range from 0 2.4 mm to 5 mm, and whose degree of absorption is 40 times its own mass . This amounts to finding that such a 100mm / 200mm compress alone can replace 8 to 10 conventional surgical compresses made of cotton gauze of comparable size, without the enveloping hydrophilic gauze of this ultra-absorbent cotton being deformed by the weight of the blood absorbed.

So that the blood does not spill all of the compress, it is incorporated between the hydrophilic cotton (Fig. 1 c) and the hydrophilic gauze (Fig. La bis) a sheet of hydrophobic cellulose of vegetable composition (Fig. Tu) , the latter then allows the blood to remain stored in the cotton wool.

Referring to (Fig. 1), 50 to 80 mm of a blue ribbon or cord, indicator (Fig. 4), with a width of 10 mm, with a total length of 400 mm, is fixed in one of the two side seams (Fig 1); the free part is intended to remain outside the operating site as a second witness, him external
The second external witness (Fig. 5), mobile, removable because detachable by simple sliding on the strip by crossing the knot (4a) which retains it represents the most original part of this patent, char. so far never offered.

This mobile external witness is the only process which provides total security in the use of compresses and surgical drapes during surgical procedures.

This mobile external witness (Fig. 5) may have all shapes and volumes, for example a disc with a diameter of 20 to 70 mm.

It may be made of composite, plastic, polymer, treated cardboard, or any other material supporting the sterilization of autoclaves in operating theaters, namely 134 degrees, or otherwise supporting any other sterilization method.

It can be of any bright color, photoluminescent, iridescent, non-toxic, and containing no radioactive product
This removable external indicator is perforated with a central cross of approximately 10 mm on 10 mm (Fig. 5) in order to slide the indicator tape (Fig. 4).

Through this opening (Fig. 5) thus opened in the center of the witness. this control tape will, when assembling the product at the manufacturer, be tied to avoid, before using this ultra-absorbent pad, the loss of the external, removable control.

This removable external witness (Fig. 5), once torn from the compress just before its use during a surgical operation, will therefore be kept by the instrumentalist or the dresser responsible for counting and recounting the compresses and operating fields at the end intervention, and will serve as an indisputable reference count, making it henceforth impossible to forget any textile in an operated area.

In order to fulfill their duties perfectly, these witnesses must therefore be kept very carefully throughout the duration of an Intervention.

Better than a container such as a cup or surgical bowl. suitable support as there is for filing invoices. but in the present case with a blunt end, it will easily allow threading of the witnesses already perforated, without the risk of losing them or of being injured.

Claims (9)

1- Surgical absorbent body formed; - an ultra-absorbent pad (1) comprising: a hydrophilic upper sheet (6) allowing a better distribution of the liquids in the tampon. a hydrophobic support sheet (8) forming a barrier against liquids received in said buffer. an ultra-absorbent pad (7) disposed between said upper (6) and support (8) sheets, the compress being surrounded by an external envelope (5). - a visually removable removable external witness (3) mounted on the strip (2) and detachable by simple sliding on the strip by crossing the knot (4) which retains it intended to be removed when the body is used absorbent and be stored on a support to serve as a reference count. 2-absorbent body according to claim 1 characterized in that it comprises two additional witnesses, a first visually characterized witness consists of a colored net (9) woven over the length of the outer envelope (Fig3), back side, a second witness consisting of a colored ribbon (or strip) (2) one end of which is fixed to the compress, intended to remain outside the operating field, 3- absorbent body according to claim 1 characterized in that the hydrophilic upper sheet (6) consists of a paper film made of vegetable fibers. 4- absorbent body according to one of claims 1 or 2 characterized in that the hydrophobic support sheet (8) consists of cellulosic fibers. 5- absorbent body according to one of claims 1 to 3 characterized in that the ultra-absorbent pad (7) consists of several layers of hydrophilic cotton, the whole having a degree of absorption up to 40 times its own mass. 6- absorbent body according to one of claims i to 4 characterized in that the outer envelope (5) of the compress consists of gauze, the seam of the gauze (10) being visible on the back of the compress (of side of the support sheet (Fig 3)) 7- Absorbent body according to claim 5, characterized in that the woven colored net (9) serving as a visually detectable indicator is located on the visible seam (10) of the gauze. 8- absorbent body according to one of claims 1 to 6 characterized in that the colored tape (2) has a length varying between 20 and 40 cm, which allows it to be gripped, better manual manipulation of the compress to the inside or around a surgical incision, as well as the recovery of the compress. 9- absorbent body according to one of claims 1 to 7 characterized in that the visually detectable indicators consisting of the colored net (9) and the colored tape (2) have a color contrasting with the color of blood, such as for example a blue in color, so as to significantly increase their visibility in the patient's body when they are saturated with bodily fluids. 10- absorbent body according to one of claims 1 to 8 characterized in that the removable movable external indicator (3) consists of a matrix of material supporting the stenlisation temperature of the autoclaves in operating theaters (namely approximately 134) and is in the form of a disc for example, perforated with an orifice (11) in order to slide it along the strip (2). 11- absorbent body according to one of claims 1 to 9 characterized in that on the removable movable external indicator (3) is applied a visually detectable material. preferably a photoluminescent material, Iridescent, non-toxic and non-radioactive.