MXPA98010351A - Medical linen with regionally imprinted performance areas - Google Patents

Abstract

Se describen campo estéril y bata quirúrgicos, en los que regiones de los mismos están impresas con revestimientos mejoradores de desempeño. La bata tiene regiones en lasáreas de pecho y mangas, impresas con un revestimiento repelente de líquidos para proteger al usuario de los fluidos. El campo estéril tiene preferiblemente un revestimiento absorbente o superabsorbente rodeando una fenestración a través de la cual puede realizarse una cirugía. El campo estéril puede tener también regiones revestidas con materiales repelentes al agua o de mejoramiento de fricción. El campo estéril tiene también cierres adhesivos en lugar de nudos.

Description

SURGICAL CLOTHING PROVIDED WITH REGIONALLY PRINTED PERFORMANCE AREAS FIELD OF THE INVENTION The present invention relates to surgical clothing, such as sterile fields and gowns, and more particularly to surgical clothing having regions thereon printed with performance enhancing materials.

BACKGROUND OF THE INVENTION Surgical clothing, such as sterile fields and gowns, are intended to protect both patients and medical personnel from microbial contamination. The patient is protected from germs in the atmosphere or from medical personnel, and medical personnel are protected from the body fluids of patients who contain harmful infectious agents, such as the virus that causes AIDS. Certain surgical clothing is reusable and constructed of firm fabrics such as woven cotton, which can be washed and sterilized repeatedly. Other gowns are disposable, and are constructed of less expensive fabrics, such as non-woven materials. Suitable examples of each are well known in the art. In manufacturing a surgical gown that will be worn by the medical professional during surgery or other medical procedures in which bodily fluids may be present, various methods for providing fluid impermeability in the area of the gown exposed to body fluids are commonly known. If the gown is constructed of panels that are sewn together, as in most gowns, said panels that require repellency can be formed from a water repellent material, such as a plastic film. Alternatively, to improve comfort, said panels may be provided with a laminated construction comprising a layer-of a non-woven fabric or other comfortable material, and a second layer of repellent film. As shown in the patent of E.U.A. No. 5,444,871 issued August 29, 1995, U.S. Patent No. 4,494,977 of King et al. issued March 13, 1985, and the US patent. of Rothrum No. 5,673,433 issued October 17, 1997, each of which is incorporated herein by reference, films of material may be applied suddenly to local regions such as the sleeves or chest of the surgical gown. Similarly, sterile surgical fields that are used to cover a patient during a medical procedure generally require material that has highly absorbent properties and often high liquid repellency properties. To improve patient comfort and decrease the cost of the sterile field, such sterile fields are often constructed with such properties limited to specific regions of the sterile field. So far, this has been achieved with panels or laminations of absorbent and fluid repellent materials only in specific areas that require such absorbency and repellency. For example, in a sterile field intended for a surgical procedure, the sterile field is folded over the patient, and the procedure is typically performed through a fenestration through the sterile field. The sterile field is typically provided with some form of reinforcement in the fenestration for greater physical integrity, and also with an area of greater absorbency. For example, the sterile field may cover the entire patient, but bodily fluids may be present only in a small location adjacent to the fenestration. In such a case, a panel of absorbent material can be laminated to the sterile field around the fenestration to keep the sterile field area free of smeared liquids. In cases where large amounts of liquid may be present, a fluid repellent lamination can be provided to direct the fluid away from the fenestration to a point where it can be captured and disposed of properly. This can be combined with the absorbent panel. The other currently known alternative that provides laminated construction that provides these regional performance characteristics, is to build the gown from panels joined together at their edges, with separate panels having different performance characteristics, such as high absorbency. It can be problematic to build a sterile coat or field with local areas of laminations. Likewise, it can be problematic to build a sterile coat or field that uses different materials for the different panels in a multi-panel construction. When using different materials, to achieve highly localized performance characteristics, the design of the gown often requires additional panels or a more complicated construction to provide the fluid repellent materials in specific locations. When laminations are applied, it can be difficult to accurately align the laminate. The present invention overcomes these and other limitations of the prior art.

BRIEF DESCRIPTION OF THE INVENTION The surgical garment according to the present invention comprises a cloth substrate; and a printed coating on one or more regions of the substrate, the coating modifying a performance characteristic of the fabric substrate. The surgical garment preferably comprises a sterile surgical gown or field. The substrate preferably comprises a non-woven fabric. The coating can increase the repellency of the substrate to liquids, increase the friction of the substrate, or improve the absorption capacity of liquids by the substrate. The surgical gown comprises preferably a portion covering the body, and sleeves extending from the body portion to end in cuffs, wherein one or more regions comprise a central operative area of said body-covering portion and further comprise portions of the body portion. the sleeves adjacent to the cuffs. Preferably, the coating is impermeable to liquids. It can comprise polyvinyl chloride plastisol. Additionally, the gown may further comprise one or more areas coated with a repellent enhancing material to improve repellency in these areas to at least 20 cm of static charge. The surgical sterile field preferably has a fenestration therethrough, with the coating being absorbent to water and being located adjacent to the fenestration. Preferably, said coating comprises a superabsorbent material based on acrylic acid. A method for manufacturing surgical clothing having a fabric substrate with a region having different performance characteristics than the substrate comprises the step of applying and adhering a fluid substance to the region to form a coating thereon, the coating having a performance characteristic different from the substrate.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a front elevation view of a gown in accordance with the present invention; Figure 2 is a rear elevation view of the gown of Figure 1; Figure 3 is a sectional view taken along lines 3-3 of Figure 2, illustrating a closure of the gown; Figure 4 is a sectional view taken along lines 4-4 of Figure 3; Figure 5 is a partially schematic perspective view of the closure of Figure 3; Figure 6 is a sectional view taken along lines 6-6 of Figure 3; Figures 7 to 10 are sectional views similar to Figure 6, illustrating the operation of the closure; Figure 11 is a rear elevation view of the gown of Figure 2, shown closed; Figure 12 is a plan view of a sterile field in accordance with the present invention, shown before assembly; Figure 13 is a plan view of the assembled sterile field of Figure 12; Figure 14 is a sectional view of a rotary screen printer that prints performance enhancing materials on selected regions of surgical clothing in accordance with the present invention; Figure 15 is a rear elevational view of one more embodiment of a gown in accordance with the present invention; Figures 16 to 19 are sectional views through a closure of the waist of the gown of Figure 15, showing its operation; Figure 20 is a rear elevational view of the gown of Figure 15, shown closed; and Figure 21 is a perspective view of a neck closure of the gown of Figure 15.

DETAILED DESCRIPTION OF THE INVENTION Figure 1 illustrates a surgical gown 10 in accordance with the present invention. It comprises a body 12 having a front portion 14 and a rear portion 16 and a pair of sleeves 18. The body and sleeves are formed of a suitable nonwoven material to provide a disposable gown; however, a reusable fabric, such as cotton, polyester, and mixtures thereof, can also be used. Preferably, said material is breathable, allowing the transpiration of air and water vapor to improve user comfort. Suitable fabrics include hydroentangled polyester-wood pulp nonwovens treated with fluorocarbons to improve their repellency, such as FABRIC 450 from Johnson &; Johnson Medical, Inc., and SONTARA, available from DuPont. The back portion 16 can be formed from less substantial and untreated fabrics. For example, the front portion 14 preferably exhibits a static charge repellency between 20 and 30 cm, more preferably about 25 cm, but the rear portion 16 may have a value less than 20, and preferably about 10 to reduce the cost and improve the overall breathing ability of the gown. The test method of AATCC 127-1989 measures the resistance of the fabrics to the penetration of water under static pressure, the water column being measured in centimeters. Test specimens are mounted under the hole of a conical well, and are subjected to water pressure increasing at a constant speed (1 cm / sec), until three leak points occur through the fabric. The emergency standard 21 and 22 of ASTM defines the impermeability for surgical gowns. One side of a sample of test cloth is exposed to synthetic blood medium (with a bacteriophage for method 22). Pressure is applied through the sample of test cloth based on the following procedure: 5 minutes at atmospheric pressure (on both sides of the fabric) 1 minute with .1406 kg / cm2 applied to the fluid side of the fabric, the another side remaining at atmospheric pressure, followed by 54 minutes with both sides at atmospheric pressure. A coating of impermeable material is applied to an area of the chest 20 and to areas of the sleeve 22. Generally, the lining of the chest 20 need not necessarily extend to the neck 24 or down to a lower edge 26 of the dressing gown 10, but the cover wider with coating 20 provides improved protection. It should extend laterally to cover a front portion of the user's body (not shown). The gown 10 in Fig. 1 is shown in a slightly open configuration before being worn by the wearer, and it is to be expected that when so worn, the lining of the chest 20 laterally covers the front area of the wearer's body. The sleeve covers 22 extend from a cuff 28 towards the shoulder seam 30, where the sleeves 18 are attached to the body 12 of the gown; however, the sleeve liner 22 need not extend all the way to the shoulder seam 28. The precise location of the chest liner and the sleeve liner 22 can be manipulated by those skilled in the art to meet the particular needs of a gown or surgical procedure given for which they are intended. Preferably, the liquid impervious coatings 20 and 22 are provided by coating a liquid repellent material, such as a film forming polymer, selectively on areas of the fabric substrate, and then drying the polymer to form a coherent film on the substrate of the substrate. liquid impervious fabric. Preferably, the liners 20 and 22 are applied before the gown is stitched or otherwise assembled, but may be applied after the gown is constructed. The preferred application method will be determined primarily by the performance requirement, the desired coating weight, and the cost. Preferably, a scalpel, pneumatic knife, reverse roll coating or a rotary screen printing process is used. Each of these methods is capable of depositing coating weights in the range of 50 to 200 microns. More preferably, a rotary screen printing method is used, since it allows the coating to be more easily deposited in a desired pattern. Said process will be described below with respect to Figure 15. There are many film forming polymer systems capable of providing impervious barriers to body fluids. A suitable polymer must be selected based on its ability to be cast from the solution, its flexibility after the coating is dried, and its cost. A preferred material is polyvinyl chloride plastisol, which has a high solids content (greater than 95%), which limits the cost of treating solvent emissions released during the drying and curing process. Other suitable coatings include latexes, especially synthetic latexes, polyurethanes, polyureturethanes, polyethylenes and polypropylenes. In any case, the coated fabric must be impermeable to body fluids. Figure 2 shows the back part of the gown 10 and a frill-like neck closure 30 and waist closure 32. The neck closure 30 comprises a clip 34 coated with an adhesive and overlaid with a releasable liner 36, such as paper siliconized To adhere the neck closure 30, the releasable liner 36 is removed and the clip 34 is folded over, and fixed to, the back 16 of the gown. Alternatively, an area of the back portion 16 of the gown on the neck 24 can be coated with an adhesive and have a releasable liner (not shown in FIG. 2) fixed thereon. The closure can then be effected by removing the releasable liner and adhering the two sides of the back part 16 of the gown to the adhesive. Figures 3 to 5 illustrate in more detail the waist closure 34. The dressing gown 10 has an opening 38 in the rear part 16. A first edge 30 and a second edge 42 are joined together to effect closure. The waist closure 32 comprises a first adhesive layer 44 on an interior surface 46 of the back part 16 of the gown on the first edge 40. A releasable material 48 is applied to an opposite surface 50 in register with the first layer of adhesive 44. The releasable surface 48 may comprise a releasable liner 52 adhered to the outer surface 50 with an adhesive 54. A special releasable strip 56 covers the first adhesive layer 44 and facilitates the application of the waist closure 32 in sterile form. The releasable strip 56 is formed of a long strip of releasable liner 58 having one end thereof folded to form a loop 60. From the clip 60, the releasable liner 58 extends through the first layer of adhesive 44, and surrounds to the first edge 40. The adhesive 62 on the releasable liner 58 adheres to the releasable surface 48 on the outer surface 50. The releasable liner 58 ends in a bipleded clip 64, wherein the releasable liner is first folded away from the releasable surface. 48 and then back on itself to cover the adhesive 62. The releasable strip 56 carries indications to indicate the steps in the sterile application of the waist closure 32. For example, the clip 60 carries indicia 66, such as the number "1". ", indicating that the first step in the application of the waist closure 32 is to pull the clip 60 and release the releasable strip 56 of the first layer of adhesive 44. Second signs 68, such as the number" 2", appear n on the releasable strip, where they cover the releasable surface 48, and third indicia 70, such as the number "3", appear on the bipleded clip 64. Figures 6 to 10 illustrate the procedure for applying the waist closure 32. First, the user holds the clip 60 to remove the releasable strip 56 from the first layer of adhesive 44, as illustrated in Figure 7. This procedure can be carried out with a non-sterile hand, and still perform the sterile closure of the adhesive. waist closure 32 as will be illustrated below. By grasping the clip 60, the first adhesive layer 44 can be suitably positioned on the back part 16 of the gown, adjacent the second edge 42. Applying pressure on the second indicia 68, such as with a finger, the first adhesive layer 44 Adheres to the back 16 of the gown. Finally, the bipleded clip 64 is clamped, and the releasable strip 56 is removed and discarded. During the procedure, only the releasable strip 56, which is discarded, is touched by non-sterile hands. The final closure is illustrated in Figure 11. Other treatments can be applied to the underlying fabric to provide regional performance characteristics to a robe, or also to a sterile surgical field. For example, some coatings and sterile field applications, for example, those used for less wet processes, do not require complete impermeability, so that some lower levels of water repellency may be adequate. Currently, this is achieved by immersing the entire fabric in a fluorocarbon-based repellent agent. The excess liquid is then removed, and the fabric is dried. The treatment is repeated to achieve an acceptable level of repellency, characterized by a static charge between 20 and 30 cm, preferably about 25 cm.

Using the method of the present invention as an alternative, an acrylic ester emulsion based on water, or another repellent enhancing substance, such as a fluorocarbon or silicone, may be printed on the fabric substrate. In many non-woven substrates, the preferred weight of the dry coating for the acrylic ester is about 2.39 g / m, which corresponds to a cloth coated with a 25 cm hydrostatic head. The person skilled in the art can determine the appropriate level of coating to achieve the desired repellency levels with a given cloth substrate and coating material without undue experimentation. Achieving the 25 cm repellency level does not critically depend on a particular printing process, and techniques such as rotogravure or flexography that provide lower coating weights are adequate. Using the method of the present invention, the emulsion or other superior repellent material only needs to be applied where additional repellency is required. For example, the back portion 15 of the dressing 10 can be made from a rather insubstantial nonwoven fabric with reduced repellency, and still have its repellency elevated in this manner. It may be convenient, especially in the case of sterile fields, to have an area with improved absorption. Currently, this is provided by laminating a layer of absorbent material to the fabric of the sterile field. This material is able to absorb body fluids, such as blood, to create a relatively dry area where the surgeon can work more easily. Instead, in accordance with the present invention, it is possible to print a layer of absorbent material, such as a superabsorbent based on acrylic acid, either as a finished polymer or as a water-based suspension of the precursor compounds, a localized region to provide improved fluid absorption capacity. Preferably, this would be provided adjacent to a fenestration through which a surgical procedure is performed. Employing any of the well-known acid-based superabsorbent materials, said coating would be capable of absorbing a larger volume of liquid than conventional laminated fabric materials. Based on the present disclosure, other printable absorbent materials will be apparent to the skilled person. Figures 12 and 13 illustrate a sterile field T-shaped 72 (a common sterile field configuration) having an increased absorption region 74 printed around a fenestration 76 therethrough. Figure 12 illustrates the sterile field 72 before assembly. A rectangular sheet 80 of a nonwoven fabric has the increased absorption area 74 printed thereon at the fenestration 76. A rectangular corner 80 is cut from the sheet 78. Figure 13 illustrates the sterile field 72 with the corner 80 attached at a side edge 82 of the sheet 78 to form the T configuration.

It may also be convenient to increase the friction in certain regions of a sterile field or coat. For example, sterile fields sometimes carry a thin layer of open cell foam located adjacent to the incision site. This material has a high coefficient of friction and the surgeon is able to place his instruments on the pad with the certainty that regardless of the angle, the item will not slip. A similar effect can be achieved by using a plastisol film of polyvinyl chloride while maintaining a high concentration of non-migratory plastisol trimellitate ester. When the solvent has been removed and the plastisol has been cured, the resulting film has an extremely high level of adhesiveness and behaves in a manner similar to a conventional foam instrument pad. Said high adhesive coating on a cloth base, can also be used as a liner for an instrument tray. Other coatings of increased adhesiveness will be apparent to the person skilled in the art. The performance enhancing coating can be applied to the fabric substrate in any appropriate manner. A fluid coating material is applied and adhered to the substrate. The fluid may comprise the performance enhancing material dissolved in a solvent, or mixed in a suspension with a liquid vehicle, in which case the solvent or vehicle will typically evaporate or at least partially be removed to fix the material to the substrate.

Alternatively, the fluid material may comprise a fluid granular powder of the material, in which case it may be fixed to the substrate electrostatically or by means of fusion. Any conventional method of printing or spray coating may be employed as long as there is some way to control the location of the coating application, so as to cover different regions of the substrate. Other methods for adhering a fluid coating to the substrate will be apparent to the person skilled in the art. Figure 14 illustrates a rotary screen printing mechanism 86 suitable for applying performance enhancing coatings. It comprises a rotating drum 88 having perforations 90 in a pattern adapted to print the predetermined design. A doctor blade 91 inside the drum 88 forces a fluid coating material 92 through the perforations 90, where there is to apply a pattern of the coating material 92 on a cloth substrate 94. The substrate 94 passes over a roller 96, which can be driven, and that places the substrate 94 in contact with the drum 88. Figure 15 illustrates a dressing gown 98 having closures 100 and 102 alternative neck and waist. An opening 104 extends upward in the back portion 106 of the gown to provide left and right rear panels 108 and 110. The right rear panel 110 is bent outward along its length to form a flap 112. A region is provided. of adhesive 114 on the flap 112 near the neck of the dressing gown 116. This may be printed on it, preferably simultaneously or contemporaneously with the repellent coatings to accelerate the construction of the dressing gown 98, or may comprise a two-sided tape. A releasable liner 118 with a free end clip 120 covers the adhesive 114. The neck closure 100 operates by removing the releasable liner 118 by means of the clip 120 and then bending the flap 112 in the region of the adhesive 114 on the left rear panel 108 wherein the adhesive 114 joins the two rear panels 108 and 110 together. See also Figure 21. Another way in which the clip can function is to place the adhesive on the clip, the clip being opened away from the body and then attached to the body through the opening 104. The waist closure 102 has a step feature that achieves an effect similar to the pass cards used in some surgical gowns with knots at the waist. With these gowns, the knots are attached to a card that a user passes to an assistant that does not require to be sterile but only clean. The attendant then passes one of the knots around the back of the user by touching only the card. The user then holds the knot and the non-sterile card is removed. The closure 102 comprises a strip 102, which is preferably formed of the same material as the gown 98, and which extends laterally from a first end 124 thereof joined to the flap 112, to a second end 126 attached on the side 128 of the gown 98. A face 130 of the strip 122 facing outwards carries an adhesive with a releasable liner 132 thereon. The releasable liner similarly has a first end 134 and a second end 136, corresponding to the first and second ends of the strip 124 and 126. The first end 134 of the releasable liner extends slightly from the adhesive to form a loop 138 and the second end 136 is releasably attached to the second end of the strip 126, but with significantly greater force than the attraction between the adhesive and the releasable liner 132. For example, it may be physically attached thereto, such as with a stronger bonding adhesive or bonding. thermal Figures 16 to 19 illustrate the operation of the closure 102. First, the user's assistant grasps the clip 138 and lifts the releasable liner 132 away from the strip 122, except where the two join at their second ends 126 and 136. Holding only the releasable liner 132, the assistant passes the second end 126 of the strip behind the user's back to a location 140 on the side or front of the gown 98. The user, with sterile hands, presses only against the strip 122 to adhere the strip 122 to the gown 98 and perform the closure. Then, the assistant removes the releasable liner 132. The user never touches the releasable liner 132, and the assistant touches only the releasable liner 132. Figure 20 shows the closed gown 98 and FIG. 21 illustrates the neck closure 100, described above in greater detail. In any of the adhesive closures, an acrylic adhesive is preferred, but substitutions for them will be apparent to the person skilled in the art. Said substitutions may also include hook and loop closures. Various modifications and alterations of this invention will be apparent to the person skilled in the art, without departing from the spirit and scope of this invention. It should be understood that this invention is not limited to the embodiments described herein, and that the claims should be interpreted as broadly as the prior art allows. For example, one skilled in the art can find suitable alternatives to the specific performance enhancer coatings described herein without much experimentation.

Claims (24)

NOVELTY OF THE INVENTION CLAIMS

1. - Surgical clothing comprising: a cloth substrate; and a coating printed on one or more regions of the substrate, said coating modifies a performance characteristic of the fabric substrate.

2. - Surgical clothing according to claim 1, selected from the group consisting of: a surgical gown and a sterile surgical field.

3. - Surgical clothing according to claim 1, further characterized in that the substrate comprises a nonwoven fabric.

4. - Surgical clothing according to claim 1, further characterized in that the coating modifies the performance of the substrate in a selected manner from the list consisting of: increasing the liquid repellency of the substrate, increasing the friction of the substrate, and improving the fluid absorption capacity of the substrate.

5. - Surgical clothing according to claim 1, further characterized in that it comprises a surgical gown comprising a portion covering the body and sleeves extending from the body portion to end in cuffs, wherein one or more regions comprise a central operative area of said portion covering the body and further comprising portions of said sleeves adjacent said cuffs, and wherein said liner is impermeable to liquids.

6. - Surgical clothing according to claim 5, further characterized in that said coating comprises plastisol of polyvinyl chloride.

7. - Surgical clothing according to claim 5, further characterized in that the gown further comprises one or more areas coated with a repellent improved material to increase repellency in one or more areas up to at least 20 cm of static charge.

8. - Surgical clothing according to claim 1, further characterized in that it comprises a surgical gown having through it a fenestration.

9. - Surgical clothing according to claim 8, further characterized in that the coating absorbs water and is placed adjacent to the fenestration.

10. - Surgical clothing according to claim 9, further characterized in that the coating comprises an absorbent material based on acrylic acid.

11. - A method for preparing surgical clothing having a fabric substrate with a region having different performance characteristics than the substrate, the method comprises the step of applying and adhering a fluid substance to said region to form a coating thereon , said coating having a performance characteristic different from that of the substrate.

12. - A method according to claim 11, further characterized in that it comprises the step of forming the substrate in surgical clothing having sleeves and a body portion, and wherein the region comprises at least a portion of the sleeves and a area on the body in the chest of a user thereof, and where the coating is water repellent.

13. - A method in accordance with the claim 11, further characterized in that it comprises the step of forming the substrate in a sterile surgical field.

14. - A method according to claim 13, further characterized in that it comprises the step of forming a fenestration through the sterile field, and wherein the coating comprises an absorbent material and is applied adjacent to the fenestration.

15. - A surgical gown comprising a portion covering the body and sleeves extending from the body portion; the body portion has an opening for wearing the gown and at least one closure for closing the opening; the closure comprises an adhesive on a first side of the opening; and a region on the second side of the opening in which the adhesive is bonded to close said opening.

16. A surgical gown according to claim 15, further characterized in that the portion covering the body is formed of a non-woven fabric.

17. A surgical gown according to claim 16, further characterized in that the adhesive is printed directly on the fabric of the dressing gown on the first side.

18. - A surgical gown according to claim 16, further characterized in that the adhesive comprises a fixed two-sided piece of tape on the first side.

19. A surgical gown according to claim 15, further characterized in that the gown is sterile, wherein an adhesive is located on a first side of a gown binding portion, and wherein the gown further comprises a removable member. on a second side of the joint portion; whereby a non-sterile hand can press against the removable member to adhere the adhesive to the second side and then remove the removable member leaving a completely sterile dressing gown.

20. A surgical gown according to claim 19, further characterized in that the removable member comprises a releasable member removably placed on the adhesive.

21. A surgical gown according to claim 20, further characterized in that the closure (at least one) comprises indicia indicating a sequence of steps for applying said closure in a sterile form.

22. - A surgical gown according to claim 15, further characterized in that the closure (at least one) comprises indicia indicating a sequence of steps to apply said closure in a sterile form.

23. - A surgical gown according to claim 15, further characterized in that the closure comprises removable means adjacent to the opening to manipulate the closure in position to adhere the adhesive and gown, whereby a non-sterile hand can place the closure in said position and then remove the removable media to leave a closed sterile dressing gown.

24. - A method of closing a surgical gown comprising the steps of: exposing an adhesive on a first side of an opening in the gown; and joining the adhesive in a location on the second side of the opening.