MXPA99009433A - Absorbent pad for use with surgical drapes - Google Patents

Abstract

An absorbent pad (1) for use with surgical drapes has an upper layer (3) of fluid absorbent material and a backing layer (2) of fluid impervious material. An adhesive strip (4) protected by a release liner (5) extends along one edge of the backing layer. In use, the release liner is removed and the pad is attached, by the adhesive, to the upper surface of a surgical drape in any desired location when increased fluid absorptive capacity is required during a surgical procedure. The pad can be removed or repositioned on the drape when desired.

Description

ABSORBENT PAD FOR USE WITH SURGICAL PANOS FIELD OF THE INVENTION The present invention relates to cloths that are used to cover the body of a patient during a surgical procedure and, more especially, to an absorbent pad for use with surgical drapes and to a method of using the absorbent pad.

BACKGROUND OF THE INVENTION The use of surgical drapes in the theaters of operations is well established. Cloths are used to cover, and to separate, the non-sterile part of a patient's body, the sterile environment of the theater of operations and the theater staff. The cloths are available in many different shapes and constructions, depending on the nature of the surgical procedure that is to be carried out, and the manner in which the cloths are to be used.

REF. : 31500 To provide an effective barrier and prevent cross-contamination, the system of wipes used during a surgical procedure should provide a fluid-impermeable layer that will prevent the fluids generated during the procedure from coming into contact with the patient's skin. It is also desirable that a drapery system be capable of absorbing at least a portion of the fluid generated during a surgical procedure although, when the presence of large amounts of fluid is expected, conveniently adapted drapes containing sacks or bags for collection may be used. of fluids, as described for example in US-A-4 616 642 and US-A-5 038 798. Surgical drapes, for one-time use, are being used more and more to overcome the problems associated with the sterilization of cloth materials reut i 1 iz ab 1 es. Disposable wipes are supplied, either sterilized, in sterile packs and disposed of after use. They are often provided with adhesive strips that can be used to hold the cloths in position on the patient's body. A disposable cloth form comprises a layer of a fluid impervious material (eg, a plastic film) which when worn is placed "closest to the body of the patient and to which a fluid absorbing layer is laminated (FIG. for example, a non-woven material.) A disadvantage of that type of construction is that the: absorbent layer may not be sufficiently absorbent to capture the fluid generated during a surgical procedure, resulting in fluid being spilled on the floor of the body. theater of operations and present a danger to personnel in the theater of operations Another form of disposable cloth comprises a non-woven material that can be chemically treated to repel fluids and that, in a smaller area that serves placed adjacent to the site of the surgical procedure, is provided with an integral absorbent pad.The absorbent pad may comprise, on the upper side therein, a layer of absorbent material and, on the underside thereof a layer of material impermeable to fluids which, during manufacture, is permanently fixed to the cloth in a particular location, by means of an adhesive. A disadvantage of constructions of this type is the lack of alternatives provided to the theater staff, in the use and location of the absorbent pad. The use in a surgical sheet, of adhesive strips that allow the attachment of additional cloths or sheets, is described in US-A-3 916 887. In that case, the location of the adhesive strips determines the points in which they are placed. they can fix additional cloths or sheets. Despite the advantages of disposable wipes, there are circumstances in which wipes that are to be washed and then sterilized between use and use are more appropriate. The cloths. reut i 1 i z abl e s are frequently formed of cotton or woven linen, absorbent, and often do not provide a barrier impervious to fluids, effective. To try to overcome this problem, US-A-5 078 154 describes a system of cloths comprising a woven cloth r eut iiiz abi e, which has been treated to make it water repellent and, in combination with it, at least a woven towel, reut i 1 abl e, which has been treated to make it absorbent and which, if used, is placed on the water-repellent cloth, adjacent to the site of the operation. US-A-5 538 012 discloses the use, in combination with a cloth reut i 11 z ab le, of a disposable cloth. waterproof, which surrounds the site of the operation and which is secured to the reusable cloth by means of an adhesive. The present invention concerns allowing the utility and api i cabiity of the cloth systems to be in a comparatively simple manner. The present invention provides an absorbent pad for use with surgical wipes, the pad is package and comprises, on one side, a layer of absorbent material and, on the other side, fi means whereby the pad can be attached multiple times to the outer surface of a surgical drape, in any desired condition .

In accordance with another aspect of the invention, an absorbent pad for use with surgical drapes, is packaged and comprises, on one side, a layer of absorbent material having an absorption capacity (as defined hereinabove) of meno. s 500 and - on the other side, a clamping means by which the pad can be attached to the outer surface of a surgical drape, in any desired position. In accordance with still another aspect of the invention, an absorbent pad for use with surgical drapes comprises, on one side, a layer of absorbent material having an abso- lution capacity (as defined above in the present patent). ) of at least 500% and, on the other side, an adhesive by which the pad can be fixed to the outer surface of a surgical drape in any desired position, the adhesive is covered by a "removable protective material layer. An absorbent pad according to the invention is typically, but not necessarily, rectangular, and the adhesive is in the form of a strip and is located in a position adjacent to an edge of the pad. The absorbent material of the pad may comprise a nonwoven cellulosic material or a cellulosic mixing material and may be a non-woven material, in particular. An absorbent pad according to the invention may include a fluid impermeable layer, for example a plastic film, between the absorbent material and the adhesive. The absorbent material can be thermally bonded to the fluid impermeable layer. The term "non-woven" as used herein, means a material that is produced differently from a fabric made by weaving or by spike work and, more specifically, means a material that is produced "joining and / or interlacing fibers, which is achieved through mechanical, chemical means" or with solvents and combinations thereof. Only by way of example will the embodiments of the invention be described with reference to the accompanying drawings, in which: Figure 1 is a top plan view of an absorbent pad in accordance with the present invention; Figure 2 is a cross section on line II - Figure 1 of figure 1, partially detached, in which the thicknesses of the different layers of the pad are greatly exaggerated for reasons of clarity; Figure 3 is a schematic plan view of a standard cloth arrangement; Y Figure 4 shows the same cloth arrangement with the addition of two absorbent pads in accordance with the present invention.

The "absorbent 1" pad shown in Figures 1 and 2 is, in general, rectangular in shape and comprises a support layer 2. (not visible in Figure 1) composed of a material impermeable to fluids, a layer 3 of. absorbent material - over the entire upper surface of the support layer, and a strip of adhesive 4 along one of the longer edges of the back surface of the layer of the adhesive layer. removable liner 5. The supporting layer 2 comprises any suitable fluid-impermeable material, for example a plastic film or a microporous film, or a foam of closed cells In one embodiment, the supporting layer is a film polyethylene having a thickness of 12 Um but could also be formed, for example, of polypropylene, nylon, polyester, urethane, ethyl acetate, spunbonded olefin and could have a thickness in the range of 3 to 2500 Um. Generally, any material impervious to fluids, suitable for use in surgical drapes or with them, and especially any plastic film material suitable for use in cloths. or with them, could be used as the support layer 2. However,Other materials may also be desirable since the primary function of the "support layer 2", as will be apparent from the later description, is to form a liquid barrier rather than imparting resistance to the pad i. The absorbent layer 3 is made of a non-woven material, for example a dry cellulose material. In one embodiment, layer 3 is a dry cellulose material, inyl acetate, available under the trade designation "FG403" from Walkisoft of Mt. Holly, North Carolina, United States of America. In that embodiment, the layer 3 is thermally bonded to the support layer 2. The appropriate, customary materials for layer 3 include the blown polyethylene and polypropylene microfiber materials, and paper, and also Its materials were sorbents that do not release particles. Alternatively, the absorbent layer 3 may be a woven material (formed, for example, of cotton, linen or cellulose) or may be a foamed material (eg, a urethane foam). The layer 3 may be formed of a material that is naturally absorbent or that has been treated to render it absorbent.Usually, as will be apparent from the description below, the material for layer 3 is effected by its absorption capacity rather than its inherent strength, and from that point of view, when a non-woven material is used, a cellulosic material is preferable than, for example, a spin-bonded material. The layer 3 preferably has an absorption capacity of at least 500% and preferably of at least 600%, measured as described in 'ISO 9073-6 (Methods of analysis for the absorption of non-woven materials), paragraph 5 ( Liquid absorption capacity), using water as test liquid. Layer 3 preferably also has an absorbance time of less than 6 seconds, measured as defined in ISO 9073-6, paragraph 4 (Time of liquid absorbance), using water as the test liquid. The absorbent layer 3 can be attached to the upper surface of the support layer 2 in any suitable form including, for example, the use of an adhesive. The adhesive 4, as described below, allows the absorbent pad 1 to adhere to the upper surface of the surgical drape material, in a secure manner and to subsequently be removed without damaging the material of the drape. Advantageously, the adhesive 4 is an adhesive that can be removed and applied multiple times and that allows the pad 1 to adhere multiple times to the material of the cloth, usually in a secure manner. Consider the material of the surgical drape with which the absorbent pad is intended to be used, and it can be proposed to further enhance by laminating a tape coated with adhesive, along one edge of the backing layer 2. For the Use with the material of the cloth having as the upper surface, a "non-woven polyester (or a material containing polyester), the adhesive 4 can be an acrylate adhesive and can be provided conveniently and effectively by the doubly coated medical tape, under the commercial designation of "1509", of the Minnesota Mining and Manuf acuring Company of St. Paul, Minnesota, United States of America. However, other forms of adhesive can be used and applied to the support layer 2 in any suitable manner (including, for example, "" spraying, coated or aminated on the support layer). adhesive 4 is protected, as is conventional, by a release liner 5 (typically a coated and sprinkled paper that is removed before the absorbent pad 1 is used. - The absorbent pad 1 may be of any suitable size but the sides of the pad typically have a length that is in the range of 10 to 200 cm, and more specifically within the range of 3 0 to 100 cm.The sizes particularly suitable for the absorbent pad are 38"x 38 cm. and 50 x 7 ~ 0 cm The adhesive strip 4 is typically about 5 cm wide and the release liner 5 is slightly more "wide to provide a piece for lifting with the finger, through which you can remove the. coating of the pillow. _ Although it was previously described that the. The absorbent pad 1 has two main layers only "(ie, the support layer 2 and the absorbent layer 3), other layers could be injected provided that the absorbent layer 3 is present on the upper surface of the absorbent layer 3. pad and that the adhesive strip 4 is present on the lower surface of the pad For example, as mentioned above, there could be a layer of adhesive between the absorbent layer 3 and the support layer 2. Alternately, the absorbent layer 3 and / or the support layer 2 could be multiple layer materials The absorbent layer 3 could comprise, for example, a top layer selected to have a short absorbance time and a bottom layer selected to have a In addition, although the inclusion of the pad 1 of the support layer 2. impermeable to fluids is advantageous, it is not essential and in some cases the support layer can be omitted. The absorbent pads such as those described above serve to be used in combination with surgical drapes to absorb fluids generated during the process of a surgical operation. They are of particular use, as will be described below, in combination with surgical drapes which are capable of absorbing a certain amount of fluid, but which, under certain circumstances, do not have as high an absorption capacity as one might wish. They are also useful in combination with cloths that do not have an absorption capacity at all, for example because of that. They have been treated to make them repellent to fluids. The cloths would typically be supplied to the end user in some form of package, more particularly, in the form of a sterile package. They could be packaged, eg, as individual items or as part of a set of cloths. Figure 3 illustrates a particular cloth arrangement with which the absorbent pads 1 of the type shown in Figure 1 can be used. The cloth arrangement shown schematically, in Figure 3, is a system of disposable cloths, conventional, "four-towel", comprising two large rectangular cloths 10"and two side towels 11. When used in a theater of operations, the large cloths 10 are used to protect the upper and lower parts, respectively, of the A patient's body is on an operating table, and the side towels 11 are placed on the sides, producing the arrangement shown in Figure 3 and defining a rectangular operating area 12 on the patient's body. laterals 11, which are generally smaller than the drapes 10, each have an adhesive strip 13 on the lower surface and along the long edge and are placed on the patient by means of these adhesive strips. before "the cloths 10 are placed in their position. Each of the cloths 10 also has an adhesive strip 14 on the lower surface, at least along the central region of a long cord, and is fixed, by means of the adhesive strip, to the patient and to the upper surfaces of the towels. side 11. "The cloths 10 and ____the side towels 11 may be formed of a laminate material comprising at least one layer impervious to the fluids and, on the" upper surface, a fluid absorbing layer. The fluid impervious layer is typically a plastic film, for example a polyethylene or polypropylene film, and the absorbent layer may be a nonwoven material, for example a polypropylene material bonded by water. The laminate can, however, include other layers, for example an additional cap of a nonwoven material, between the absorbent top layer and the fluid impermeable layer and / or a layer of material on the lower surface of the impermeable layer to the refugees. Alternatively, the cloths 10 and the side towels 11 _ may comprise a fluid repellent material, which, in the region that is to be adjacent to the operation area 12 (Figure 3), is provided with an integral absorbent area. The fluid-repellent material may comprise, for example, a non-woven material that has been chemically treated to make it fluid-repellent.The integral absorbent area may comprise a pad of absorbent material with a fluid-impermeable backing. which is permanently attached to the non-woven cloth material, with the absorbent material placed up to the top The conventional cloth system illustrated in Figure 3 is generally adequate in most cases where it is used. Disposable 10 and side towels 11 are generally constructed to provide a fluid impermeable layer that will prevent the fluids generated during a surgical procedure from coming into contact with the patient's body, and thus serve to separate the non-sterile part of the patient from the patient. Patient's body from the sterile environment of the theater of operations and the staff of the theater of operations.The disposable cloths 1 0 and the side towels 11 are also generally capable of absorbing the fluid generated during a surgical procedure, either because the entire upper surface of the cloth / towel comprises a material with some absorption capacity "or because they have an absorption area, integral Immediately adjacent to the area of operation 12. However, in certain circumstances, the amount of fluid may exceed the absorption capacity of the conventional cloths, and in that case a more specialized type is ideally employed. of cloth that incorporates a bag or bag for collection of fluid. When this is not possible, it is common practice to cover dirty cloths with new cloths and repeat that procedure as often as necessary during the course of an operation. As a further alternative, in accordance with the present invention, one or more of the absorbent pads 1 described above can be "fixed, by the adhesive strip 4, to the wipes and towels 10, 11 of Figure 3 adjacent to the area 12 of The operation of the 11T (s) can be fixed at an appropriate location where an increased absorption capacity is required and can remain in place for as long as it is "" required and, if it is necessary, they can be placed in another place Alternatively, if a pad gets dirty, it can be removed and replaced with a new one Figure 4 shows the same cloth arrangement as the one in Figure 3 to which two pads have been added absorbers 1 in the -sides of the operating area 12, immediately above the side towels 11. However, it will be appreciated that any number of pads 1 may be used and that the 11th pillow (s) could be fixed in any er site adjacent to area 12 of operation. When the absorbent pads 1 are worn as shown in Figure 4, they will be held in a generally vertical position, on the sides of the patient, in which case the absorbance time of the absorbent material, on the upper surface of the absorbent materials. pad, is of greater importance (and preferably is shorter) than when the pads are used in a generally horizontal position. Because the adhesive strip 4 on 1 a ^ "to the pad 1 is positioned exactly along the upper edge of the pad, the formation of an undesirable" bag "in which the fluid could be collected between the pad and the pad is prevented. surface under the cloth, depending on the circumstances under which the pad is used, - this may be less important if pad 1 has an absorbent material on its bottom surface, instead of the fluid impervious material 2. It will be appreciated that when a pad 1 has been fixed to a surface of a clean cloth, and subsequently removed, either during the course of an operation or at the end of the operation, "the surface of the cloth immediately below the pad will not be dirty." If the pads are placed around the entire operating area At the beginning of an operation, a clean area can be obtained when required (for example, when an incision is closed) by simply removing the pads, because the absorbent pad 1"is used in combination with other surgical drapes and by itself. While it does not provide the barrier between the patient's body and the sterile environment of the operating diameter, the pad does not need to have the same degree of rigidity and tear strength as would have been required by a surgical drape. As mentioned above, the adhesive strip 4 on the absorbent pad 1 is selected to allow the pad to be secured securely to the material of the cloth and so that it can be removed without damaging the cloth material. The adhesive strip 4 also allows, advantageously, that the pad can be placed and removed multiple times, at least once, on the cloth material. A test carried out to evaluate the adhesion of the adhesive tape "1509" (mentioned above) on samples of various cloth materials, has indicated that it is suitable for use as an adhesive 4. The test procedure that was used It is as follows: i " i) A sample of cloth material, with measurements of 40 x 150 mm was placed, with the upper surface located in the position above, on a flat surface. (ii) A strip of the "1509" tape, with measurements of 25.4 x 152.4"mm, was placed, with the adhesive facing down, on the sample, in such a way that the strip was parallel to the length of the" sample and centered below it (to which reference is made as the first application of the tape. ~~ (iii) The tape was pressed on the sample with a roller "of 5 Kg moved at a speed of approximately 50 mm / (iv) The tape "and the sample were hung one by one on a respective jaw of a voltage analyzer apparatus (a Hounsfield apparatus of the H10KM type), allowing the tape / sample assembly to hang freely. * - machine were as follows: force registration interval, 10 N, elongation record interval, 300 m (v) The jaws of the stress analyzer were moved apart at a rate of 304.8 mm / minute, and the force required to detach the tape from the sample was recorded. They hoisted at a temperature of 23 ° C and a relative humidity of 50%. vi) Where possible, steps (i) through (v) were repeated, using the same strip strip and a fresh sample cut from the same batch of cloth material (referred to later as the second application of the tape vii) When possible, the pas_p (vi) "was repeated (as referred to by third as the third application of the tapes).

The cloth materials that were used for the analysis procedure described above were as follows: The results of the tests are summarized in the following Table (the force of delamination in each case is the average value obtained from the measurements in eight sections of samples of a batch of material for cloth "* indicates that only one application was possible because the tape could not be removed without damaging the sample.

The results of the samples indicated that the adhesive tape "1509" was readily adhered to all the samples of the cloth materials, used, and, except for one material, could be removed without damaging the material and reapplied twice, It was also noted that the same adhesive tape was adhered to woven, untreated cotton cloths, and could be reattached thereon, although the above description refers to the absorbent pad of Figure 1. Used in combination with disposable cloths, it could also be used in combination with cloths when it is required an increased absorption capacity. In that case, the effect of the pad to keep clean the cloths immediately adjacent to the area 12 of the operation, could be particularly advantageous when the cloths are not completely impermeable to fluids. It will be appreciated that the use of absorbent pads, as described above with reference to Figures 1 and 2, is not restricted to four-towel cloth systems as illustrated in Figure 3. The pads could be used with many other systems of cloths that include, for example, cloths of divided sheets, cloths with openings, cloths for the "perineal" area and cloths for extremities.It is not essential that the cloths are of rectangular shape: when used with a sheet of divided sheet, for example, a pad could be divided in the same way as the cloth. ~ The use of the adhesive strip 4 as the means for holding the absorbent pad 1 to a cloth, although it is advantageous, is not essential, for example, it could be replaced by the hook component of a hook-and-loop type fastener, wherein the hook component is secured so as to attach directly to the surface of the cloth material with which it is attached. will use the pad. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention. Having described the invention as above, property is claimed as contained in the following:

Claims (11)

1. For use in combination with surgical drapes, an absorbent pad, packaged, characterized in that it comprises, on one side, a layer of absorbent material and, on the other side, fastening means by which the pad can be fixed, so that can be removed and replaced, to the outer surface * of a surgical drape, in any desired position.

2. An absorbent pad according to the rei indication 1, characterized in that the layer of absorbent material has an absorption capacity (as defined hereinabove) of at least 500%. "" "

3. An absorbent pad according to claim 1 or claim 2, characterized in that the fixing means comprises an adhesive.

An orbent abs cushion according to claim 1, characterized in that the adhesive is covered by a layer of removable protective material.

5. An absorbent pad, in accordance with the indication 1, characterized in that the adhesive is in the form of a tape which is laminated to the pillow.

6. An absorbent pad according to the rei indication '1, characterized in that the absorbent material comprises a non-woven material.

7. An absorbent pad in accordance with the rei indication 1, characterized in that it includes a layer of fluid-impermeable material, between the absorbent material and the adhesive.

8. An absorbent pad according to claim 1, in combination with a surgical drape, characterized in that it has an outer surface to which the pad can be fixed through the fastening means.

9. A method for the use of a surgical drape, characterized in that it includes the steps of: placing the drape over the body of a patient; providing an absorbent pad in accordance with rei indication 1; ~ and fix the pad directly to the outer surface of the cloth, in any desired location, by means of the adhesive.

10. A method according to claim 9, characterized in that it includes the additional step of removing the pad from the cloth.

11. A method "according to claim 10, characterized in that it includes the additional step of replacing the pad on the same surgical drape or on another surgical drape, and re-attaching the pad in the new position, directly on the outer surface of the pad. cloth, using the adhesive.