MXPA99010182A

MXPA99010182A - Surgical incise drape

Info

Publication number: MXPA99010182A
Application number: MXPA/A/1999/010182A
Authority: MX
Inventors: T Scholz Matthew; E Bruno John; l baker Dennis; A Eull Patricia; Schlei Dietmar
Original assignee: Minnesota Mining And Manufacturing Company
Priority date: 1997-05-16
Filing date: 1999-11-05
Publication date: 2000-06-01

Abstract

A surgical incise drape (10, 80, 90, 120, 103, 160) comprising a flexible film having a leading edge (31) and a trailing edge (32), and a film handle (18, 86) connected to the leading edge (31) of the flexible film (12, 81, 91, 122, 162). A liner (16, 83, 94, 125, 166) substantially covers the major portion of the flexible film (12, 81, 91, 122, 162), which is coated with an adhesive (14, 81, 99, 124, 163). The liner (16, 83, 94, 125, 166) may include a liner handle (22) at the leading edge (35), and one of the liner handle (22) and film handle (18, 86) are of a size for wrapping about at least a portion of the drape (10, 80, 90, 120, 103, 160) when the drape (10, 80, 90, 120, 103, 160) is in a folded configuration. A tensioning strip (20, 84, 98, 128, 104, 168, 169) on the liner (16, 83, 94, 125, 166) holds at least a portion of the flexible film (12, 81, 91, 122, 162) lying between the film handle (22, 86) and the tensioning strip (20, 84, 98, 128, 104, 168, 169) in a wrinkle-free state when the liner (16, 83, 94, 125, 166) is being removed from the major portion of the flexible film (12, 81, 91, 122, 162). Further, the liner (16, 83, 94, 125, 166) may be stiff relativeto the flexible film (12, 81, 91, 122, 162) such that the liner (16, 83, 94, 125, 166) and the film handle (18, 86) hold the flexible film (12, 81, 91, 122, 162) in a wrinkle-free state when the liner (16, 83, 94, 125, 166) is being removed from the major portion of the flexible film (12, 81, 91, 122, 162). Methods for using these surgical incise drapes, tear lines (208, 308), and connecting or reinforcement strips (302) are also described.

Description

INCISION-SURGICAL CLOTH Field of the Invention The present invention relates to the field of surgical incision drapes. More particularly, the present invention pertains to surgical incision drapes having protective coatings that provide tension for these drapes during application.

BACKGROUND OF THE INVENTION Many of the current surgical procedures involve the use of a surgical incision cloth. The material for the incision is usually a r polymeric film with an adhesive on one side that is covered with a protective release liner. Two suppliers of incision materials are Minnesota Mining and Manufacturing Company, St. Paul, Minnesota, and T.J. Smith and Nephe Ltd. Examples of material for the incision can be found in U.S. Patent Nos. 4,310,509; 4,323,557; 4,452,845; Re. 31,886; and Re. 31, 887. Typically, the material for the incision is used in connection with towels or surgical drapes for REF: 31803 keep the surgical area as n and sterile as possible to help reduce the risk of infection. Once the patient's surgical area has been ned and treated with an antimicrobial agent, the surgical site is arranged by the use of sterile towels and a surgical drape that has a fenestration (ie, a specifically designed shape and an opening formed in the same) of a size that is larger than the expected size of the incision. A material is then used for the incision to cover all or a portion of the patient's skin left exposed by the towels or fenestration on the surgical drape or main leaf. One purpose for using the material for the incision is to help reduce the migration of germs and bacteria at the incision site. This reduction is necessary, because despite the purification of the skin, the pores still contain additional germs and bacteria, which can migrate to the surface when the skin is moved and worked during the course of the surgical procedure. By covering the skin with the material for the incision, it has been found that a lower incidence of contamination of the surgical site occurs.

The common practice is to remove the sterile incision cloth from a disposable, protective bag (for example made of polyethylene), in addition to remove any other protective cover and supply it to the sterile field in an aseptic manner. For example, the protective covers may be materials such as wrapping paper wrappers around the cloth to allow the cloth to be inserted into the disposable, protective bag without ripping or wrinkling of the cloth in the packaging process. The use of multiple protective covers results in added waste in the surgical area. The surgical incision cloth typically comes in sizes as small as 13 x 18 cm (5 x 7 inches) but are usually 40 x 30 cm (16 x 12 inches) up to 90 x 120 cm (36 x 48 inches) and larger. Conventional surgical incision drapes usually consist of a material for the incision coated with adhesive, covered by a release liner, coated paper, in one piece with equal dimensions as the film so that the adhesive is protected. The typical practice is for two people standing on opposite sides of the operating table, each within the sterile field with their hands wearing sterile gloves. One person grabs a portion of the cloth's handle (a margin of 10 to 15 cm film free of adhesive) while the other person takes the protective paper coating and removes it from the underside to expose the adhesive. The cloth is then applied to the patient at the surgical site and subsequently smoothed and pressed onto the patient with a sterile towel. With larger cloths, this could require three or more people. The current incision pads are usually large and difficult to apply to the patient without wrinkles and without adhesion of the cloth to the same in the process. As described above, the application of the stick usually requires two or three people, creating wear and tear on the staff of the operating room and helping to raise hospital costs. The application of conventional incision pads can be a frustrating experience, even for those skilled in the art of applying these wipes. The cloth is fragile (to be very conformable to the contours of the skin) with an adhesive sensitive to aggressive pressure for adhesion to the skin. These two characteristics, when combined with the large size of many cloths for the incision, often result in the application of a wrinkled cloth.

For the proper functioning of a surgical incision cloth, it is important that the incision cloth be free of wrinkles after it is applied, especially directly at the point of the incision so that the surgeon is able to make a clean surgical incision. Wrinkles on the cloth make it difficult for the surgeon to see through the skin (transparency and visibility are important). In addition, if the incision cloth includes wrinkles, the incision cloth can not prevent the collection of bacteria on the skin in the wound. By keeping a sterile surface at the incision point it helps prevent infections from surgical wounds. In addition, it is important that the incision cloth be applied easily with as few steps as possible, and that the debris resulting from the use of the incision cloth be minimized.

Brief Description of the Invention This invention provides a surgical incision cloth that can be effectively and efficiently applied to a patient in wrinkle-free form to minimize the chance of infection, improve visibility through the film when the cloth is applied to a patient and reduce the amount of waste resulting from the use of the cloth. A surgical incision cloth according to the present invention includes a flexible film having a main portion coated with an adhesive. The flexible film has a leading edge and a trailing edge. The cloth also includes a film grip on the leading edge of the flexible film with the handle of the film which is stiffer than the flexible film. Still further, the cloth includes a protective coating having a leading edge and a trailing edge corresponding to the leading edge and the trailing edge of the flexible film. The protective coating includes a handle of the protective coating on the leading edge and the protective coating substantially covers the main portion of the flexible film coated with the adhesive. Either the handle of the protective coating or the handle of the film is of a size for wrapping around at least a portion of the cloth when the cloth is in a bent configuration. In one embodiment of the cloth, either the handle of the protective liner or the handle of the film is of a size for wrapping around the entire periphery of the cloth when the cloth is in the folded configuration. In another embodiment of the cloth, the cloth further includes a closure element attached to the handle of the protective liner or to the handle of the film and which extends for attachment to another portion of the cloth when the cloth is in the folded configuration. In yet another embodiment of the cloth, the cloth in the folded configuration is flattened such that the cloth includes folds in the respective opposing regions thereof. In another embodiment of the cloth, the protective coating is relatively rigid compared to the flexible film such that the protective coating and the handle of the film keep the flexible film in a wrinkle-free state when the coating is to be removed from the main portion of the film. flexible movie. For example, the protective coating may be a polyolefin protective coating having a thickness of at least about 50 microns and preferably at least about 75 microns. In addition, for example, the protective coating may be a polyethylene protective coating, such as a medium density or high density polyethylene protective coating. In another embodiment of the cloth, the protective coating includes at least one tension strip at a portion away from the leading edge of the protective coating to maintain at least a portion of the flexible film lying between the film grip and one or more tension strips. in a wrinkle-free state when the protective coating must be removed from the main portion of the flexible film. For example, a tension strip may be on the trailing edge of the protective coating and / or at any position between the leading edge and the trailing edge of the protective coating. In another embodiment of the cloth, the adhesive coating the main portion of the flexible film includes a first region of adhesive near the leading edge of the flexible film and a second region of adhesive at or near the trailing edge of the flexible film. A greater force is required to remove the protective coating from the second region of relative adhesive for removal of the protective coating from the first adhesive region. Another surgical incision cloth according to the present invention includes a flexible film having a main portion coated with an adhesive. The flexible film has a leading edge and a trailing edge. A film handle is included in the leading edge of the flexible film. The cloth further includes a back coating having a leading edge and a trailing edge corresponding to the leading edge and the trailing edge of the flexible film. The protective coating substantially covers the main portion of the flexible film coated with the adhesive. In addition, the protective coating includes at least one tension strip at a position away from the leading edge of the protective coating to hold at least a portion of the flexible film lying between the film grip and the tension strip in a wrinkle free state. when the protective coating must be removed from the main portion of the flexible film. The tension strip is stiffer than the protective coating. A method for use with a surgical incision cloth according to the present invention is also disclosed. The method includes providing a substantially flat surgical incision cloth. The plane includes a flexible film having a main portion coated with an adhesive. The flexible film has a leading edge and a trailing edge with a handle of the film applied to the leading edge of the flexible film. In addition, the cloth includes a protective coating having a leading edge and a trailing edge corresponding to the leading edge and the trailing edge of the flexible film. The protective coating substantially covers the main portion of the flexible film coated with the adhesive. The method further includes folding the cloth from the trailing edge to the leading edge and then wrapping one of the film handle and the handle of the protective coating around at least a portion of the folded cloth. Methods for the use of these cloths for surgical incisions are also described. In general, the methods include providing a cloth, grabbing the handle of the cloth film, pulling the protective coating to remove at least a portion of the protective coating to expose at least a portion of the adhesive coating the main portion of the flexible film, maintaining the surgical incision cloth in such a position that at least a portion of the adhesive is brought into contact with the patient, and then removing the remaining portions of the protective coating. In yet another aspect of the invention, the surgical drape generally comprises an elastomeric film having a main portion coated with an adhesive. The flexible film has a leading edge, a trailing edge and opposite side edges. A handle is provided at the leading edge of the flexible film. The handle is formed of the laminated material that is stiffer than the elastomeric film. A tear line is provided in the elastomeric film which extends generally adjacent, and generally parallel to, the leading edge to facilitate the propagation of the tear of the film along the tear line to separate the handle from the elastomeric film. The tear line has opposite ends spaced from the opposite side edges of the film. Preferentially, the tear line comprises a line of perforations, and the opposite ends of the tear line are separated from the opposite lateral edges of the elastomeric film by at least 0.5 cm. More preferably, the opposite ends of the tear line are spaced apart from the opposite lateral ends of the elastomeric film by at least 1 cm, and more preferably 2 cm or even 2.5 cm. Also, preferably, the elastomeric film has a thickness not greater than 75 microns, more preferably no greater than 52 microns.

Alternatively, the tear line comprises the elastomeric film that is marked or otherwise thinned along the tear line that runs along the elastomeric film to generally facilitate the propagation of the tear as desired. length of the tear line. In yet another aspect of the invention, the surgical incision cloth generally comprises an elastomeric film having a main portion coated with an adhesive. The flexible film having a leading edge, a trailing edge and opposite side edges. A handle is provided adjacent the leading edge of the flexible film, and an elongation strip connects the film and the handle along the leading edge of the film. The strip has more resistance to tearing than the elastomeric film. The strip has one or more tear lines to facilitate the propagation of the tear of the strip along the tear line to separate the handle from the elastomeric film. Preferably, the tear line comprises a line of perforations. Also, preferably, the handle is formed of a laminated material that is stiffer than the elastomeric film.

The elongation strip preferably comprises a reinforcing tape that is more tear resistant than the film or handle different from along the tear line. Preferably, the reinforcing tape is a film tape having a surface coated with an adhesive, more preferably a pressure sensitive adhesive. For example, the film tape may comprise a low density polyethylene film ribbon, and the adhesive comprises an acrylate adhesive.

BRIEF DESCRIPTION OF THE DRAWINGS Figures 1A-1E are sectional views of the surgical incision cuff according to the present invention at various points in the method for applying the surgical incision cuff to a patient. Figure 2 is a plan view of the side of the upper film of the surgical incision cloth shown in Figure 1. Figure 3 is a plan view of the side of the protective covering of the bottom of the surgical incision cloth shown in Figure 1 .

Figures 4A-4E are views of portions of the handle of the film and the protective coating of alternative configurations of the surgical incision cloth. Figures 5A-5F are sectional views of the portions of the tension strip of the alternative configurations of the surgical incision cloth. Figure 6 is a plan view of the side of the bottom protective liner of an alternative configuration of the surgical incision cloth having surgical attachments, e.g., receptacles. Figure 7 is a sectional view of an alternative surgical incision cloth wherein the protective liner itself provides tensioning as opposed to the use of a tension strip associated with the protective liner. Figures 8A-8C are sectional views of alternate, bent surgical incisions, and having creases therein sufficient to prevent unwinding of the drape under its own weight. Figure 9 is a plan view of the bottom of yet another embodiment of a surgical incision cloth with the handle incorporating a tear line. Figure 10 is a plan view of the bottom of yet another embodiment of a surgical incision cloth with a handle releasably held in place by a perforated tape.

Detailed Description of the Preferred Modes The present invention provides surgical incision drapes and methods to effectively and efficiently apply these steps to a patient in a wrinkle-free manner to minimize the opportunity for infection and to improve visibility during step application. of incision to the patient. As previously describedIt is important that the incision cloth be free of wrinkles after it is applied, especially directly at the incision site so that the surgeon is able to make a clean surgical incision and reduce the chance of microbial contamination. In addition, it is important that the cloth for the incision is easily applied with as few steps as possible and with minimum waste products resulting from such application. With reference to Figures 1-3, a surgical incision cloth 10 according to the present invention is described. In addition, with particular reference to Figures 1A-1E, a method for applying the surgical incision cloth 10 to a patient is described. The remaining Figures 4-10 show the alternative configurations of the cloth for such a cloth for surgical incisions. As shown in Figures 1-3, the surgical incision cloth 10 is generally of a rectangular configuration, however, any size or shape may be suitable since the surgical incision drape provides the benefits as further described in detail later. For example, the cloth 10 can have a width (A) of about 10 cm to about 150 cm and a length (L) of about 10 cm to about 150 cm. The surgical incision cloth 10 includes a film 12, such as a flexible, transparent film. The flexible film 12 includes an upper surface 13 and a lower surface 15 extending from a leading edge 31 of the flexible film 12 to a trailing edge 32 of the flexible film 12. The flexible film 12 of the cloth for the incision is formed of a transparent or translucent polymeric material. The material preferentially allows the evaporation of moisture through the film during prolonged surgeries. Suitable materials include polyolefins, such as low density polyethylene and particularly metallocene polyethylenes such as commercially available Engage ™ polyethylenes from Dow Chemical, polyurethanes such as polyester polyurethanes and polyethers (e.g. "Estane ™ thermoplastic polyurethane, commercially available from BF Goodrich, Cleveland Ohio), polyesters such as polyether polyester (e.g. "HytrelMR polyester elastomer" commercially available from Du Pont Co., ilmington, Delaware) and polyamides such as polyether polyamides (for example "PebaxMR Resins" commercially available from ELF Atochem, North America, Inc., Philadelphia, Pennsylvania). In addition, the film 12 is flexible, and preferably somewhat elastomeric, to improve the formability when applied to a patient. For these reasons, the preferred films are polyurethanes, polyester polyesters, and polyether polyamides. The film 12 will typically have a thickness of about 200 microns, preferably between about 6 microns to about 130 microns, and more preferably between about 13 microns and about 52 microns. At least a main portion of the lower surface 15 of the flexible film 12 is coated with a pressure sensitive adhesive 14. Although Figure 1 shows that the full length of the flexible film 12 is coated with the adhesive 14, any major portion it can be coated which allows the surgical incision cloth to serve its useful function, for example, the adhesive does not need to coat the full width or length of the cloth. For example, the uncoated portions may be included in either edge of the flexible film to aid in the removal of the patient's cloth or to assist in the attachment of a handle to the film. The adhesive 14 that coats the flexible film 12 is preferably a pressure sensitive adhesive, sticky to the body temperature that will aggressively adhere to the skin. Uniform attachment to the surface of the skin helps maintain a surgical, sterile field. Aggressive adhesives are preferred because film 12 is under tension during surgery as a result of wound retraction, hot humid environment, and abrasion that film 12 may encounter when the surgeon's hands and instruments move. inside and outside the wound. Suitable adhesives include acrylic adhesives, Kraton ™ based adhesives or Kraton ™ polymers (Shell Chemical Company, Houston, Texas), rubber based adhesives such as those based on natural rubber, polyisobutylene, butylene rubbers and the like, the adhesives of the type of polyurethane, and polyvinylethylether and copolymers or mixtures thereof. Preferably, the adhesive also contains an antimicrobial such as iodine, triiode complexes, lactam-triiodide complexes such as povidone-iodine, chlorhexidine salts such as chlorhexidine gluconate and chlorhexidine acetate, polybutylene biguanides, hexachlorophene, parachloromethaxyleneol ( PCMX), triclosan, phenols, fatty acid monoesters such as Lauricidin (glycerol monolaurate), quaternary surfactants, silver and silver salts such as silver chloride, silver and silver oxide, hydrogen peroxide and the like. The adhesive 14 is preferably one of those described in US Patent Nos. 4,323,557; 4,931,282; 4,701,509; 4,732,808; 5,156,911; ,017,625; and 5,204,110. In addition, the adhesive 14 may be a continuous coating or may be a coated pattern as described in U.S. Patent Nos. 4,798,201 and 5,290,615. These types of adhesive may also include various chemical modifiers, for example, thickening agents, crosslinkers, stabilizers, initiators, etc. to improve the physical properties such as stability, viscosity, adhesion and the like. The pressure sensitive adhesive 14 is covered by a protective release liner 16. The protective release liner 16 includes an upper surface 17 in contact with the pressure sensitive adhesive 14. The upper surface 17 and a lower surface 19 extend between the leading edge 35 and the trailing edge 34 of the protective coating 16. The leading edge 35 of the protective coating 16 generally corresponds to the leading edge 31 of the film 12 and the trailing edge 34 of the protective coating 16 generally corresponds to the trailing edge 32 of the movie 12. Although the edges 35, 31, as well as the edges 34, 32, do not need to be overlaid, that is, the protective coating 16 may be smaller or larger than the film 12, the protective coating 16 must completely cover the adhesive 14. The protective coating of Release 16 could be made from a variety of materials such as paper, plastic coated paper, plastic film, woven, non-woven, knitted textiles, as well as laminated textile materials of the film. The protective coating 16 can be hydrophilic to allow fluid absorbency or it can be hydrophobic without absorbency. Preferred protective release liner materials include clear, polymeric protective coatings that allow the clinician to see through the patient and thereby accurately position the film 12 during application of the film 12 to a patient as described also later. Preferred clear, polymeric protective coatings include polyolefins such as polyethylene and polypropylene or polyester protective coatings, as well as laminated materials such as polyolefin coated polyester. For the proposed products for gamma-ray sterilization, the use of a protective coating of paper, polyethylene, polyester, or polyethylene coated polyester is preferred.

One method for making the incision cloth involves coating a solvent solution of adhesive in the protective coating, removing the solvent in a furnace and subsequently laminating this protective coating coated with adhesive to the backing of the film. Since the solvent is typically removed at an elevated temperature in a furnace, certain polymeric protective coatings, low melting point thermoplastics such as those made of low or medium density polyethylene can be adversely produced. And the protective coatings incorporating a higher melting point thermoplastic polymer such as a polyester layer, which are able to withstand the high temperature during drying, are not very flexible and can be very noisy during application. A preferred approach is to form the protective coatings of the film by laminating the polymers with high melting points and polymers with low melting points. Preferred high melting polymers for laminated film are characterized by having a melting temperature in excess of about 175 ° C and preferably in excess of about 190 ° C (as listed in Modern Plastics Encyclopedia Vol. 66 No. 11, 1989, McGraw Hill). Polymers useful for this layer include but are not limited to polyester (e.g. polyethylene terephthalate, polybutylene terephthalate etc.), polyamides (e.g., nylon 6, 6, nylon 6), cellulose acetate, and the like. The high melting point polymer layer should generally be present in the laminate in a total thickness (ie, the sum total of all the layers) of at least about 6 microns, preferably at least 12 microns and in more preferably at least about 25 microns. Low melting point polymers, desirable for the laminated film, are preferred to have a melting temperature of about 175 ° C and preferably below about 150 ° C). Polymers useful for this layer include but are not limited to polyolefins (eg, polyethylene, polypropylene, polybutylene, ethylene / vinyl acetate, ethylene methacrylate, and the like). The low melting point polymer layer should generally be present in the laminate in a total thickness (ie, the sum of all layers) of at least about 12 microns, preferably at least 25 microns and in the form more preferably at least about 50 microns.

The protective coating of the preferred laminated film can be formed of two or more layers of the thermoplastic polymer, although one of the layers could be a thermoset if desired. For example, a layer of the high melting point polymer can be laminated on one or both sides by a low melting point polymer. In this way, the high melting point polymer layer is able to withstand the stresses imparted by the drying oven while the low melting point polymer layer provides flexibility. In addition to the polymer layers, a low adhesion filler (LAB) coating can be applied to one or both of the major surfaces of the multilayer laminated film. These laminated films can be formed by lamination of pre-made films, formed by any suitable method such as extrusion melting or blowing. Alternatively, laminated materials can be formed by coextrusion or extrusion lamination techniques. A silicone release liner, a long chain alkyl containing material, which contains fluorochemicals, or other low energy surface coating, is applied to the upper surface 17 of the protective coating 16. This coating allows the coating protector 16 is detached from adhesive 14 with a force of less than about 120 g / cm, preferably less than 80 g / cm, more preferably less than 40 g / cm, and much more preferably less than 25 g / cm when measured in a peel at 180 ° C at a speed of 225 cm per minute, at 25 ° C and at a humidity relative of 50 percent. A preferred release coating is "GE Silicone SS4331 Low Temperature, Fast Cure Paper Premium Relay Coating" available from General Electric Company, Waterford, N.Y. The amount of the release coating will vary depending on the level of adhesion and coating thickness of the adhesive 14. A preferred polyethylene release protective coating is available from Rexam Reléase (Eagan, MN) as Grade 10521 54 thousand NT LDP A16 / 000. A preferred polypropylene protective coating is also available from Rexam Relay as Grade 15529D 2 thousand CL BOP Exp / 000. The flexible film 12 is provided with a handle of the film 18 at the leading edge 31 of the film 12. The handle of the film 18 is preferably formed of a relatively rigid material as compared to the flexible film 12. When Testing according to the test method of ASTM D4032-92 (Standard Test Method for Stiffness of Fabric by the Circular Bend Procedure), the flexible film has an average stiffness of generally less than about 1.1N and preferably less than about 0.5N. The grip of the film 18 generally has a stiffness greater than about 2N, preferably greater than about 4N, more preferably greater than about 8N, and much more preferably greater than about 20N. As shown in Figure IA, the handle of the film 18 is attached to the upper surface 13 of the flexible film 12 at the leading edge 31 and joins along the full width () of the film 12 as shown in Figures 2 and 3. Alternatively, the handle of the film can be attached to the underside of the flexible film using the adhesive covering the flexible film, as shown and described later with reference to Figure 4D. In addition, alternatively, various adhesives can be used for bonding the film grip to the flexible film. The handle of the film 18 can be formed of paper, cardboard, plastic or paper coated with plastic. The preferred papers have base weights of about 80 g / m2 to about 400 g / m2, more preferably about 100 g / m2 to about 300 g / m2, and much more preferably about 150 g / m2 to about 225 g / m2. The plastic films are preferably high density polyester or polyethylene having a thickness of about 52 microns to about 250 microns, preferably 75 microns to about 225 microns, and most preferably about 100 microns to about 200 microns. The handle of the film 18 can be applied to the leading edge 31 of the film 12 in one of several ways, including the use of a releasable adhesive as further described below. For example, the handle 18 can be applied to the film 12 by thermal bonding; ultrasonic welding; or with the use of a pressure sensitive adhesive, such as double coated pressure sensitive adhesive, tape with pressure sensitive adhesive, curable pressure sensitive adhesive, as well as solvent or aqueous base adhesives , which include the pressure sensitive adhesive 14 used to ensure good adhesion to the skin. The protective coating 16 is provided with a handle of the protective coating 22 at the leading edge 35 of the protective coating 16. The handle 22 is preferably formed of a relatively rigid material as compared to the flexible film 12. The preferred stiffness range of the handle 22 is substantially the same as that for the handle 18. However, it is not necessary for the handle 22 to be more rigid than the protective coating 16 to derive benefits from the use of the present invention. As shown in Figure IA, the handle 22 is attached to the lower surface 19 of the protective coating 16 at the leading edge 35 and is preferably joined along the full width (W) of the protective coating 16 as shown in Figure 3. The handle of the protective coating 22 can be formed of materials similar or identical to the material of the handles 18 or it can be formed of the same material as the protective coating 16, which includes multiple layers of the coating 16 as it can be formed by folding a projecting edge 35 of the protective coating 16 thereon. The handle of the protective coating 22 can be applied to the leading edge 35 of the protective coating 16 in one of several ways, including that it is an integral portion of the protective coating 16 itself extending beyond the adhesive 14 covering the film 12. example, the handle of the protective coating 22 can be applied to the protective coating 16 by methods and materials similar or identical to those used to apply the handle 18 to the film 12. The handles 18 and 22 are preferably at least about 2.5 cm of width (W ', W "), more preferably at least about 3.5 cm, and much more preferably about 5 cm or more to allow easy grasping by a gloved applicator At least one of the handles is preferably of a size suitable for use in protecting the cloth after winding and folding the cloth as further described below with reference to the alternative configurations of the cloth of Figures 8A-8C. As shown in Figure IA, the handle of the film 18 is larger than the handle of the protective coating 22 to serve this function. However, it is readily apparent that the handle of the protective coating could be larger than the handle of the film to serve the same function. Figures 4A-4E are detailed views of the handle portions of the film and the handle of the protective coating of the alternative configurations of the surgical incision cloth. As shown in the alternative configuration of the cloth 40 of Figure 4A, both a handle of the film 47 and the handle of the protective coating 45 are attached to the respective front edges of the flexible film 42 and the protective release liner 46 by the pressure sensitive adhesives. The handle of the protective coating 45 is attached to the release protective coating 46 by the pressure sensitive adhesive 49. The handle of the film 47 is attached to the flexible film 42 coated with the pressure sensitive adhesive 44 by the sensitive adhesive. the pressure 48. The pressure sensitive adhesive 48 coated on the leading edge of the flexible film 42 or the handle itself allows all or part of the handle 47 to be removed after application of the film 42 to a patient. The adhesive 49 coated on the leading edge of the protective release liner 46 allows the handle of the protective liner 45 to be removed such that the adhesive 49 can be used to place the protective liner 46., once completely removing the film 42, in a different location to function as an additional cloth as further described below. As shown in the alternative configuration of the cloth 50 of Figure 4B, the handle of the film 54 is releasably attached to the flexible film 51 by the pressure sensitive adhesive 56 so that the handle 54 can be removed after the application of flexible film 51 to a patient. Preferably, the adhesive 56 is removed together with the handle 54. This can be accomplished by using an adhesive 56 that does not permanently bond to the film 51 (e.g., the coating film 51 with a low energy material of the surface at least on the edge where the adhesive 56 is applied). Such low surface energy materials are commonly referred to as low adhesion fillers and may be polysiloxin, fluorochemical or hydrocarbon based materials, as well as combinations or mixtures thereof. The protective release liner 53 that is applied to the pressure sensitive adhesive 52 coated on the film 51 is provided with a handle of the protective coating 55 that is integral with the protective release liner 53 and extends beyond the adhesive 52 coated on it. the surface of the flexible film 51. The handle of the protective coating 55 can be grasped for the application of the flexible film 51 as generally described below.

As shown in the alternative configuration of the cloth 60 of Figure 4C, the handle of the film 64 removably attaches to the flexible film 61 using the perforation 66. As shown, the handle 64 is permanently attached to the film 61 at the leading edge 67 of the film 61 and a perforation 66 is provided such that a portion of the grip extending beyond the leading edge 67 of the film 61 can be removed after application to a patient. In the configuration of the cloth 60, the handle of the protective coating 65 is permanently attached to the protective release liner 63 that covers the adhesive 62 coated on the film 61 by any known joining technique such as, for example, thermal bonding, welding ultrasonic, etc. Alternatively, as shown in Figure 4E, a perforation or hole 77 can be made in the flexible film 78. Preferably, this perforation is placed in a section not coated with film adhesive (as shown), which facilitates the tear for the removal of the handle of the film. Also, as shown in Figure 4C, the handle of the protective coating 65 extends in addition to the leading edge 67 that the handle of the film 64, ie, the handle of the protective coating 65 is larger than the handle of the film 64. The extended length of the handle of the protective cover 65 facilitates the location of the handles for the application of the cloth. Alternatively, the length of the handle of the film 64 can extend beyond the handle 65, a handle can be of a different color, pattern or have some other configuration that distinguishes the feature that would differentiate one handle from the other. In addition, the extended length of the handle of the protective coating 65 is preferably suitable for use in protecting the cloth after winding or folding the cloth as further described below with reference to Figures 8A-8C. As shown in the alternative configuration of the cloth 70 of Figure 4D, the handle of the film 76 is releasably attached to the flexible film 71 by the pressure sensitive adhesive 72 on the underside of the film 71 such that the handle 76 can be removed after application of the flexible film 71 to a patient. The protective release liner 73 that is applied to the pressure sensitive adhesive 72 coated on the film 71 is provided with a protective liner handle 75 that extends beyond the handle 76 and is applied in any manner as previously described in FIG. I presented. Further with reference to Figure 1, the release protective liner 16 of the surgical incision cloth 10 is also provided with a tension strip 20 at the trailing edge 34 of the protective liner 16. The tension strip 20 is formed of a relatively material rigid as compared to flexible film 12. The tension strip when tested in accordance with ASTM D4032-92 has a general stiffness greater than about 2N, preferably greater than about 4N, more preferably greater than about 8N, and much more preferably greater than about 20N. As shown in Figure IA, the tension strip 20 is attached to the lower surface 19 of the protective coating 16 at the trailing edge 34 and is preferably joined along the entire width (W) of the protective coating 16 as is shown in Figure 3. The use of a tension strip is particularly beneficial when the protective coating is relatively flexible, i.e., the stiffness of the protective coating is less than about 20N, and especially beneficial if the stiffness of the protective coating is less. that approximately ION. However, as described with reference to Figure 7, the tension strip is optionally included in accordance with the present invention. In particular, a tension strip may not be necessary when the protective coating is rigid enough to provide adequate tension of the flexible film during the application of the film to a patient. However, one or more tension strips can be used irrespective of the rigidity of the protective coating. The tension strip 20 can be formed of materials similar or identical to those to form the handles 18 and 22. The tension strip 20 is preferably 8 mm wide, more preferably 16 mm wide, and much more preferably 24 mm in width. The tension strip 20 can be applied to the protective coating on the trailing edge 34 or a position between the leading edge 35 and the trailing edge 34 of the protective coating 16 in one of various shapes. For example, the tension strip 20 can be removably applied to the protective coating 16 with the use of a pressure sensitive adhesive or other pressure sensitive materials, similar as previously described herein, or alternatively by a laminated, thermal material that can be detached. In addition, for example, the tension strip can be applied permanently to the protective coating 16 using similar methods and materials for the attachment of the handles 18, 22. The tension strip 20 can also be a protective release liner, further attached to the protective release liner 16 using a pressure sensitive adhesive, suitable such that when removing the protective release liner further, a strip with adhesive is developed. The strip with adhesive can be used to join the protective liner 16 after removal of the flexible film 12 to other positions or instruments that need to be covered during surgery, as further described below. Figures 5A-5F are detailed views of the portions of the tension strip of the alternative configurations of the surgical incision cloth. As shown in the alternative configuration of the cloth 80 of Figure 5A, the tension strip 84 is permanently bonded to the upper surface 86 of the release protective liner 83. In addition, the tension strip 84 can be permanently bonded. or can be releasably attached to the flexible film 81 when the adhesive 82 covering the film 81 does not extend to the trailing edge of the film 81. If the tension strip 84 is permanently attached to the flexible film 81, then the portion 85 of the flexible film 81 at the trailing edge thereof can be separated with the tension strip 84 after application of the remainder of the flexible film 81 to a patient. Such separation can be performed, for example, by cutting with scissors, by tearing along the perforation 89 of the film 81, or by any other known separation technique. If the tension strip 84 is releasably joined such as with the use of a pressure sensitive adhesive, then the protective coating 83 with the tension strip 84 can be removed by peeling off the protective coating 83 and the tension strip 84. of the film 81. The handle of the film 86 is shown to be permanently attached to the film 81 and the handle of the protective coating 88 which is integral with the protective release liner 83.; however, any configuration can be used for such handholds as described herein.

As shown in the alternative configuration of the cloth 90 of Figure 5B, the tension strip 98 is permanently attached to a lower surface 97 of the release protective liner 94 at the trailing edge thereof. The protective coating 94 covers the pressure sensitive adhesive 92 that lines the lower surface 95 of the flexible film 91. The film grip and the protective coating handle are shown in the same manner as shown in Figure 5A. As described with reference to Figure 5A, any configuration of the handle can be used. In addition, as shown in Figure 5B, the adhesive 92 in the flexible film 91 includes two regions of adhesive that include the adhesive region 93 and the adhesive region 99. These two adhesive regions 93, 99 require differential forces to detach the adhesive. release protective coating 94 thereof. For example, the combination of the adhesive region 93 and the protective coating 94 is such that the protective coating 94 can be peeled from the adhesive region 93 with a force of less than about 120 g / cm, preferably less than about 80 g / cm, more preferably less than about 40 g / cm, and much more preferably less than 25 g / cm, when measured in a 180 ° peel at a speed of 225 cm per minute. On the other hand, the force required to detach the release protective coating 94 from the adhesive region 99 is such that the force required is distinguishable by the user from the force necessary to detach the protective coating 94 from the adhesive region 93. For example, the force required to remove the protective coating 94 from the adhesive region 99 may be a force greater than that required to remove the protective coating 94 from the adhesive region 93 by at least about 10%, preferably at least about 20% and more preferably by at least about 30%. The differential adhesive regions 93, 99 provide an indication to the user or applicator of the cloth that the user must stop the detachment of the protective coating 94 from the adhesive 92 and must initiate the application of the adhesive region 93 and the film 91 to the patient of a way as described further below. Such differential force technique can be used alone or in combination with other markers that indicate this point in the process, for example the markers 26 as shown in Figure 2. The force required to remove the protective coating 94 from the adhesive regions 93, 99 can be changed either by modifying a characteristic of the adhesive regions 93, 99 or by modifying a characteristic of the protective coating 94. For example, the properties of the adhesive can be changed by changing the adhesive chemistry, changing the weight of the coating, or by heating the adhesive to better wet the protective coating. Furthermore, for example, the characteristics of the protective coating can be changed by oxidizing the surface by processes such as corona discharge and flame treatment or by the application of a coating, etc. As shown in Figure 5C, which is an alternative configuration of the cloth to Figure 5B, the highest force release region 99 needs not to extend to the trailing edge of the film 91 and can take any form as it provides a differential force function. For example, the highest release region 99 may take the form of a strip between two smaller force regions 93 as shown in Figure 5C. In addition, the highest force region needs not to extend along the full width (W) of the cloth.

Differential forces for regions 93, 99 can be provided by using a ndividual adhesive with different release coatings applied to the adhesive or the protective coating to achieve differential adhesive characteristics, by using two different adhesives having different adhesive characteristics, or by calendering or thermally stamping the region 99 to increase the detachment force of that region. However, the present invention is not limited in any way by such techniques listed above as any known method for providing differential adhesive characteristics by two regions can be used. In addition, more than two regions of differential adhesive can be used to provide the user with intermediate indications that the user must stop the detachment in some rapidly approaching time. In another preferred embodiment, the tension region or strip can be printed with appropriate information or symbols to provide an additional indication to the applicator to stop removal of the protective coating and apply the cloth. The tension region or strip helps reduce the wrinkling and curving of the cloth when the protective coating is removed during application.

As shown in the alternative configuration of the cloth 120 of Figure 5D, the tension strip 128 is removably attached to the protective liner 125 by a pressure sensitive adhesive 126. As such, the tension strip 128 can be removed. exposing the adhesive 126. The liner 125 may be placed using the adhesive 126 at another location to perform a function of the cloth after the protective liner 125 is completely removed from the adhesive 124 covering the flexible film 122. Similarly, as described above with reference to Figure 4A, the handle of the protective coating 45 can be removably attached, additionally or alternatively using a pressure sensitive adhesive 49 applied to the protective coating 46 such that when the handle of the protective coating 45 is removed, it is exposed the adhesive 49. The protective coating 4 6 can then be used to cover another location when using the ad 49. For example, the protective liner 46 could be moved to another location of the patient, the surgical table, or instrument, such that another cloth currently used for such purposes can be removed. In addition, alternatively, as shown by the configuration of the cloth 103 of Figure 5E, a tension strip 104 is paired to both the protective coating 94 and the film 91 such that the complete adhesive coating 92 can be exposed beforehand. from the application of the cloth to the patient. Once applied, the protective coating 94 can be removed by tearing or removing using a releasable adhesive coating applied to adhere the tension strip 104 to the film 91. If, for example, the tension strip 104 is formed of paper, the tear It can be done through a tear alone. Otherwise, the tear can also be made using the optional perforation 107. In yet another alternative configuration of the cloth 160 of Figure 5F, it is shown that one or more tension strips can be placed in different positions at the rear edge of the cloth . As shown in Figure 5F, the tension strip 168 is attached to a lower surface 165 of the release release liner 166 at a position between the leading and trailing edge of the release protective liner 166. Preferably, the tension strip 168 is positioned closer to the trailing edge than to the leading edge and preferably extends along the entire width of the wipe. The protective coating 166 covers the pressure sensitive adhesive 163 which covers the lower surface of the flexible film 162. The handle of the film and the handle of the protective coating are shown in the same manner as shown in Figure 5A. As described with reference to Figure 5A, any configuration of the handle can be used. With respect to the embodiments as shown in Figures 5B and 5C, the tension strip 168 is advantageously positioned at the point where the adhesive section 93 meets the section 99. Alternatively, if the strip Tension 168 is sufficiently rigid with respect to the protective coating 166, a greater release force will be required to remove the protective coating 166 from the adhesive 163 in the section thereof corresponding to the tension strip 168. It is believed that such a greater detachment force it is due to a significant change in the detachment angle resulting from a much larger radius of the curvature created when the relatively rigid tension strip is bent backwards when the protective coating 166 is removed. In this way, the tension strip 168 It serves both to keep the cloth in a relatively flat and wrinkle-free state while also alerting the doctor who has been exposed or sufficient adhesive-coated area of the flexible film 162 such that the cloth can now be applied to the patient before the protective coating 166 is completely removed, for example, a marker of when the user must stop the detachment of the protective coating 166 from the flexible film 162. Also, as shown in Figure 5F, with a tension strip 168 that is placed somewhere between the leading edges. and after the protective coating 166, another tension strip 169 may also be used at the trailing edge of the protective coating 166. Such an additional tension strip 169 may be applied and positioned in any manner as described herein. It is readily apparent that any number of tension strips according to the present invention can be used in various protective coating positions, and also that the present invention is in no way limited to any particular number of tension strips in any particular position. of the protective coating. The placement of one or more tension strips in the middle part of the cloth as opposed to the trailing edge of the cloth (and / or in addition to a tension strip at the trailing edge), has certain advantages in various circumstances. As described herein, the cloth is typically provided to the user in a rolled or folded configuration. For example, the rolled / folded configurations of the wipes are shown in Figures 8A-8C. In many application techniques, the adhesive is exposed by grabbing the handles and detaching a portion of the protective coating from the adhesive coating the film. The adhesive is then applied to the skin before the cloth is completely unrolled. With the tension strip in the middle of the cloth, tension is first applied in the application process such that wrinkles are prevented. Such an application technique is common when the cloth is applied to an extremity. The location of the tension strip 168 inside the cloth, as shown in Figure 5F, stiffens the cloth in the center, the grip of the leading edge of the film 162 stiffens the cloth at the leading edge, and the remaining rolled cloth and tension strip of the rear edge, additional 169 gives rigidity to the back portion of the cloth. In an alternative configuration of the surgical incision cloth as shown in Figure 6, the protective liner 112 of the cloth 110 having a handle of the protective liner 116 includes one or more joints, generally represented by the union 117. The connections 117 can Include sacks, pipe organizers, cautery covers, instrument holders, sacks for fluid collection, etc. The joints can be formed, for example, by sealing a piece of plastic film, paper or textile fabric to the surface of the protective coating 112. It will be apparent to one skilled in the art that any of the configurations described herein, or portions thereof, including the film handle configurations, the handle of the protective coating, differential adhesive regions and tension strips, can be used in any number of combinations according to the present invention. For example, a configuration of the cloth may utilize a handle of the film that can be removed by piercing, a handle of the protective coating that is integral with the protective coating, and a tension strip that is permanently attached to the protective coating.; Another configuration of the cloth may use a film handle that is removable by using a releasable adhesive, a protective coating handle that is removable by using a releasable adhesive, and a tension strip that is removable from the protective coating when using a releasable adhesive . Another configuration of the cloth may use a removable film handle, a permanently attached protective coating handle and a permanently attached tension strip. The combinations are diverse and numerous and the present invention is limited only in accordance with the accompanying claims. In addition, any of such configurations described herein, or portions thereof, may be used alternatively to the portions of, or in combination with, the cloth 130 as shown in the alternative configuration described below with reference to Figure 7. With respect to the cloth 130, FIG. 7, the tension function is provided by the protective coating itself, without the need for a separate tension strip. In other words, the protective coating acts as the tension strip, that is, it provides a voltage function during the entire removal and application process. However, one or more tension strips can be used in various positions to provide additional tension benefits. The cloth 130 includes a protective coating 134 that is sufficiently rigid to help prevent wrinkling of the flexible film 131 having the adhesive 132 coated thereon during application. Preferably, the protective coating 134 is a polyolefin protective coating having a thickness of at least about 50 microns, and more preferably a thickness of at least about 75 microns. For example, the protective coating 134 may be a polypropylene protective coating, preferably a biaxially oriented polypropylene protective coating, of a thickness of at least about 75 microns, preferably of at least about 100 microns. In addition, the protective coating 134 may be a low or medium density polyethylene protective coating having a thickness of at least about 75 microns, preferably at least about 100 microns, or a high density polyethylene protective coating having a thickness of at least about 100 microns. thickness of at least about 50 microns, preferably at least about 75 microns. Such protective coatings preferably have an average stiffness as measured in accordance with ASTM D4032-92 of at least about 2N, preferably at least about 3N, and most preferably at least about 4N. The cloth 130 further includes a handle of the film 135 that extends beyond the leading edge 139 of the cloth that the handle of the protective coating 137, ie, the handle of the film 135 is larger than the handle of the protective coating 137. As such, the handle of the film 135 can be used to protect the cloth after the winding or folding of the cloth, as mentioned previously with respect to the handle of the film 18 shown in Figure IA and which is further described below with reference to Figures 8A-8C. The handle that protects the cloth when the cloth is rolled or folded, can be of any size or configuration. Suited to provide such protection, for example the shape does not need to be rectangular, although such shape is preferred to match the shape of the cloth . Any of the configurations of the surgical incision cloth previously described can be folded or rolled in any way for packaging prior to delivery. Hereinafter, and as used in the accompanying claims, the term fold / fold used in conjunction with a cloth includes the winding of a cloth or a rolled cloth configuration. For example, a folded cloth refers to a cloth wrapped around a core, a cloth rolled without the core, a cloth folded two or three times, etc. A bent, illustrative configuration is shown and described further herein with reference to Figure 8A. The configuration of the folded cloth 140 as shown in Figure 8A includes the cloth 130 of Figure 7 folded a number of times starting at the trailing edge 133 of the cloth 130 and moving to the leading edge 139. The cloth 130 is folded with the film flexible 131 on the outside. The handle of the film 135 is of a size sufficient to extend around the outer periphery, complete with the folded cloth to protect the cloth 130. A locking tab 141 is provided for attachment to the handle of the film 135 and portions of the cloth 130 to keep the handle of the film 135 in place. As shown in Figure 8A, the locking tab 141 is attached to the handle of the film 135 in two locations. The closing tab 141 can be any releasable element of the cloth but sufficient to keep the handle of the film 135 in place around the periphery of the folded cloth such that the folded cloth is protected. The handle of the film 135 includes a perforation 145 to allow the user to remove the handle 135 after it is applied to a patient, although some of the handhold removal techniques may be used as previously described herein. Either the handle of the film or the handle of the protective coating can be made in a size to protect the folded cloth. The cloth 130 is bent starting at the trailing edge 133 of the cloth 130 where an optional tension strip 148 may be placed. Of course, a tension strip may be placed at some location away from the leading edge 139 of the cloth 130. Such a strip of Optional tension 148 can function as the "core" in which the cloth is rolled. Furthermore, it is readily apparent that the cloth 130 can be folded in such a way that either the protective coating 134 or the flexible film 131 is on the outer side. Preferably, the configuration of the folded cloth 140 is achieved by winding and subsequently flattening the rolled cloth 130 such that folds are generated in the respective regions 151 and 153 to hold the cloth in the folded, generally planar configuration 140. If using a protective paper coating, once the product is rolled up and the permanent, flat folds compressed, help prevent the product from unrolling prematurely such that it could fall on a non-sterile surface, for example the patient's skin. Preferably, the protective coating is sufficiently rigid and the folds are formed sufficiently well that the cloth will not unroll under its own weight. With the use of a polymeric protective coating, such as a polyolefin protective coating, the protective coating is preferably sufficiently thick and the modulus of elasticity of the material sufficiently high to maintain such folds but to prevent the permanence of such folds. Such permanent folds are typical with conventional surgical incision drapes, such as those that use protective paper coatings, which are folded and / or flattened prior to delivery. Such permanent folds * result in irregular "pumping" and abrupt differences in the force required when the cloth is unrolled before or during application. This inconsistent supply can lead to wrinkles. With the removal of such deep, permanent folds, the polymeric protective coating provides a flexible film supplied to the patient which in turn avoids such problems. With the protective coatings that do not take a stable, permanent fold to the cloth may, in certain application techniques, tend to unwind prematurely. In this caseIt is advantageous to apply a pressure sensitive adhesive either along the edges of the cloth or inside the cloth. For example, a small amount of pressure-sensitive adhesive may be exposed at the edges of the cloth or may be deliberately applied to the edges of the cloth that can be used to lightly bind the cloth in the rolled or folded configuration. Alternatively, a pressure sensitive adhesive may be applied in small areas on the upper side of the film to join the rolled or folded cloth at strategic locations in order to prevent the cloth from unwinding partially or completely during application. A particularly preferred adhesive for this purpose is 3M 9415 Hagt Tack / Low Tack Double Coated Tape. In another alternative, the edges of the cloth can be joined slightly using heat, for example hot iron or hot air, in such a way that the cloth will not unroll prematurely but can still be easily unfolded during application. This method is particularly beneficial for products that incorporate a protective, polymeric coating. In addition, with the use of a polymeric protective coating, such as a polyolefin protective coating (preferably a polyethylene protective coating), the surgical incision cloth 140 can be folded to fit into packages and drawers without tearing the protective coating during the application of the flexible film coated with adhesive to the patient. On the other hand, paper protective coatings appear to be affected by permanent folds and creases in the protective coating, which tends to lead to the initiation and propagation of the tear. In addition, the polymeric protective coating allows the user to cut multiple layers of cloth in a desired size and shape. This is typically difficult to accomplish with the use of a heavy paper protective coating. In addition, once the cloth has been rolled up, the cloth using the plastic protective coating can be flattened under pressure and / or heat to ensure a sufficient crease. Alternatively, as shown in the configuration of the cloth 170 of Figure 8B, the handle 172 may be of a size such that the handle 172 is not wrapped completely around the periphery of the cloth 171. A locking tab 175 is placed to maintain handle 172 in place such that cloth 171 remains in a bent configuration. Alternatively, another means may be used to provide the closure to hold the cloth in a folded configuration. For example, a sheet of paper or plastic can be wrapped around the folded cloth as an overwrap. In addition, as shown in the configuration of the cloth 180 of Figure 8C, an extended handle 182 may have a portion coated with a pressure sensitive adhesive 185 for attachment to a portion of the cloth 181 to hold the handle 182 in place. such that the cloth 181 remains in a bent configuration. In general, in such configurations of the cloth 170, 180, the handles are of a suitable size and are joined by some technique to another portion of the cloth to hold the cloth in the folded configuration. In general, the cloth configurations, as described herein, maintain a flexible film in a wrinkle-free state when a protective coating is peeled off and the flexible film is applied to a patient as described below. The different cloth configurations can be applied to a patient in a number of ways. First, the application of the cloth 10 shown in Figures 1-3 will be described. Then, the application of the cloth 130 will be described. Figure IA and Figures 2 and 3 illustrate the surgical incision cloth 10 before starting the application procedure. Figure IB illustrates the start of the removal of the protective release liner 16 of the adhesive 14 covering the film 12. To start the application process, the user grasps the handle of the film 18 and another user grasps the handle of the protective liner 22 of a rolled cloth. An illustrative example of a rolled cloth is shown in Figure 8A. After the cloth 10 is at least partially unrolled, the protective release liner 16 is then further detached from the adhesive 14. As illustrated in Figure 1C, the release liner 16 is peeled off again such that the trailing edge 34 of the release protective liner 16 is still attached to the adhesive 14 at the trailing edge 32 of the film 12. At this point, the flexible film 12 is ready for application to the patient. The user can be signaled to stop the unwinding of the release liner of the adhesive 14 in a number of ways. For example, as shown in Figure 2, the flexible film 12 may have marks 26 to indicate to the user the point at which the user must stop unwinding and proceed to the application of the film 12 to the patient. In addition, the indication to stop unwinding can be provided, for example, using a technique as described with reference to Figure 5E. Alternatively, the indication can be provided using differential adhesive regions as described above with reference to Figure 5B and 5C; the differential regions provide the user with a recognizable differential force at a point during the removal of the release protective coating 16, ie, the force required to remove the protective coating 16 changes at the mark 26. As shown in Figure ID, the user, preferably, keeps the surgical incision cloth 10 with the protective coating partially removed such that the flexible film 12 having the adhesive 14 coated thereon is in a substantially relaxed "U", i.e. a configuration of the type "depression". The U-type configuration has a lower, central adhesive portion 37 for initial contact with and adhesion to the patient, such as, for example, on the patient's chest or back. With the central, lower portion 37 in contact and adhered to the patient, the remainder of the flexible film 12, i.e., the flexible film on each side of the central portion 37, is smoothed on the patient's surface. It should be apparent that in many circumstances a U-type configuration is not used. For example, when the application of the cloth is to an extremity, only a small portion of the adhesive 14 can be exposed prior to the application of the adhesive to the extremity. Then, the adhesive is further unrolled and applied to the limb. After the film 12 is smoothed over the patient, then the rest of the release protective coating 16 is removed from the flexible film 12 and the adhesive 14. As such, the flexible film 12 provided with the handle 18, as shown in FIG. Figure 1E, is applied to the patient in a substantially wrinkle-free condition. In addition, after application, the cloth has only one remaining handle 18. The handle 18 can then be removed from the flexible film 12, such as, for example, with the use of a releasable adhesive or perforation. With only a handle 18 left on the cloth 10 to remove after the application of the film 12 to the patient, the steps of the process for using the cloth are reduced in relation to other cloth application techniques, such as techniques using two handholds .

With the use of a protective, polymeric, clear coating, users who apply the cloth can more easily observe the field in which the cloth must be applied. 10. The advantage of a protective, polymeric, clear coating is shown by the illustration of the Figure ID. When users keep the cloth 10 in this substantially U-type configuration, it is clearly advantageous to observe through the protective coating during application to the patient. Figure 8A illustrates the surgical incision cloth 130 before starting the application procedure. The surgical incision cloth 130 as shown in Figure 8A would typically be contained within a disposable protective ball (e.g., made of polyethylene). The handle of the film 135 wrapped around the periphery allows the cloth 130 to be easily inserted into a protective bag during packaging. In addition, the handle of the film 135, prevents damage to the cloth insertion process. For example, without a protective cover, for example, a wrapped film handle 135 or a separate, undesirable protective cover, a portion of the cloth may trap the protective bag during insertion therein which results in a deconfigured cloth, for example, a broken protective coating, a wrinkled film, etc. A separate, protective cover is undesirable due to the added waste of a separate, additional material. By using the handle of the film 135 (or alternatively a handle of the extended protective coating), such as the protective cover, a separate piece of waste is removed. After removal of the cloth 130 from the protective bag (not shown), a user removes the locking tab 141. The user then grasps the handle of the film 135 and unwinds the handle of the film 135 from the remainder of the cloth 130 to expose the handle of the protective lining 137. Another user then grasps the handle of the protective lining 137 of the folded cloth. The protective release liner 134 is then peeled back from the adhesive 132. Users can peel back the protective liner 134 as desired, but with a portion of the protective liner 134 still attached to the adhesive 132. The user can be signaled to stop the unwinding the release protective coating 134 in the same manner as described above with reference to Figure 1.

At any time when the adhesive 132 is exposed, the flexible film coated with adhesive 131 is ready for application to the patient. After a major portion of the adhesive 132 is exposed and the flexible film 131 is smoothed over the patient, the remainder of the protective release liner 134 is then removed from the flexible film 131 and the adhesive 132. As such, the flexible film 131 provided with handle 135 is applied to the patient in a substantially wrinkle-free condition. In addition, after application, the cloth has only one remaining handle 135. The handle 135 can then be removed from the flexible film 12, such as, for example, with the use of the perforation 145. As shown in Figures 2 and 3, one or more of the handles 18, 22 or the strip voltage 20 may have printed information 24 therein. For example, the printed information 24 may include instructions for the use of the cloth 10 or any other information. This reduces the amount of packaging required for the cloth 10. Preferably, the printed information 24 is placed on the handle attached to the film 12 so that it is in view for a longer period of time during the application process and serves to indicate which side should be "up" during the application. In addition, according to the present invention, the film, the protective coating, the adhesive or any combination of such elements, can be treated to ensure that the cloth does not have excessive static. Preferred wipes have a surface resistivity of less than about 1013 ohms, preferably less than about 1012 ohms, and more preferably less than about 1011 ohms as measured using a Keithley Model 487 picometer voltage source set to 500 volts with a Keithley Model 8008 Resistivity Test Device. This can be achieved by the addition of hydrophilic or conductive agents to the adhesive such as salts, glycols, hydrophilic polar substituents of the adhesive itself (for example, in an acrylate adhesive one can incorporating monomers such as acrylic acid and its derivatives, acrylamide and its derivatives, N-vinyl lactams, hydroxyalkyl acrylates and their derivatives including polyethoxylated hydroxyalkyl acrylates and the like; in a polyurethane adhesive the adhesives may contain hydrophilic polyols such as polyethylene glycol and copolymers of ethylene oxide and propylene oxide). Alternatively and additionally, antistatic agents can be applied to or incorporated into the flexible film and / or the protective coating. Suitable antistatic agents include nonionic, anionic, cationic and amphoteric ion surfactants as well as hydrophilic or conductive polymers. Figure 9 shows yet another embodiment of the cloth 200. The cloth 200 comprises the back of the film 202, which is coated with the adhesive 206 along a major surface thereof, the handle 204. A line of ripping 208 (e.g., a line of perforations), with the perforations 208 spaced from the edges of the back of the film 202 by a margin or the opening G. As previously described, the back of the flexible film 202 is preferably elastomeric and very thin, frequently having a thickness of less than about 75 microns and preferably less than about 52 microns. Since the flexible film 202 is too thin, if the film is perforated all the way to the edge of the film or if a hole is placed at the edge of the film the forces exerted during application may result in the tearing of the film. perforation during the application. Therefore, it would be desirable to have a section of the cloth at the edges that will resist tearing but can be broken under sufficient force followed by a readily propagated rip line. In order to prevent undesired tearing of the perforation from occurring during application, a section G of the non-perforated film is preferably left in the margins of the cloth. In this way, the cloth is solid and the perforation will not start until a significant tearing force is applied such as would occur when one would deliberately remove the handle. Preferably, the margin G of the non-perforated film at the edge of the film is at least 0.5 cm, more preferably at least 1 cm, and much more preferably 2 cm, for example a margin of approximately 2.5 cm to work well. Alternatively, the elastically flexible film can be completely punched to the edge and an edge reinforcement such as a piece of the tear tape can be applied to reinforce this section (e.g., the same area shown in "G" in the figure). 9). The reinforcing "tape" can be a piece of paper coated with adhesive, plastic or other stress-resisting material which occurs during application but can be broken when the physician wishes to remove the handle 204. As shown in Fig. 10 , the handle 300 may include a reinforcing tape 302 extending the full width of the cloth. The reinforcing tape 302 is attached to the film 304, the handle of the film 306, or preferentially for both bridging or connecting the film 304 and the handle of the film 306. The reinforcing tape 302 preferably has a plurality of perforations 308 forming a tear line, although it is contemplated that the tear line could be formed by other suitable means, such as by marking the tape along with its length or providing a zone of weakness extending longitudinally. While the film and the handle of the film may be overlapped, the reinforcing tape 302 is preferably placed to connect or bridge the film 304 and the handle of the film 306 so that overlap does not occur. The line of perforations 308 is preferably located in the reinforcing tape 302 between the film 304 and the handle of the film 306 so that when the line of perforations 308 is broken neither the film 304 nor the handle of the film 306 is break.

In a preferred embodiment, the perforated reinforcement tape 302 is a tape of low density polyethylene film, punched with acrylate adhesive, such as the tape available from Minnesota Mining and Manufacturing under the trade designation "3M Transpore ™" tape. 3M Traspore ™ preferred has multiple lines of perforations and can be used to attach the handle of the film to the film without overlaying. In this way, the handle is removed cleanly when tearing through the perforated tape. The non-perforated margin G and the reinforcing tape constitute exemplary embodiments of a means for resisting tearing adjacent the edge of the cloth. The line of perforations constitutes a mode of a tear line or means for propagating tearing along the line. Alternative modalities of this tear line or means to propagate tearing along a line include marking the film along the line, decrease the thickness of the film along the line, for example, by using heat and compression, or provide any suitable drilling configuration. Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope of the invention as defined in the claims, and it should be understood that this invention is not unduly limited to the illustrative embodiments and methods set forth in the present.

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, the content of the following claims is claimed as property.

Claims

1. A surgical incision cloth, characterized in that it comprises: a flexible film having a main portion coated with an adhesive, the flexible film having a leading edge and a trailing edge; a film grip on the leading edge of the flexible film; and a protective coating having a leading edge and a trailing edge corresponding to the leading edge and trailing edge of the flexible film, the protective coating substantially covering the main portion of the flexible film coated with the adhesive, the protective coating that includes one or more tension strips applied to the protective coating at a position away from the leading edge of the protective coating to maintain at least a portion of the flexible film that is lying between the film grip and the tension strip in a wrinkle free state When the protective coating must be removed from the main portion of the flexible film, the tension strip is more rigid than the flexible film.

2. The cloth according to claim 1, further characterized in that at least one of one or more tension strips is located at the trailing edge of the protective coating.

3. The cloth according to claim 1 or 2, further characterized in that one or more tension strips include a tension strip applied at a position between the leading edge and the trailing edge of the protective coating.

4. The cloth according to any of the preceding claims, further characterized in that the protective coating comprises polyolefin.

5. The cloth according to any of claims 1-4, further characterized in that the protective coating comprises a laminated film comprising two or more layers of the polymer.

6. The sheet according to claim 5, further characterized in that the laminated film includes at least one layer of low melting point polymer and at least one layer of high melting point polymer.

7. The cloth according to claim 6, further characterized in that at least one layer of high melting polymer is a layer of polyester or cellulose acetate having a melting temperature greater than about 175 ° C.

8. The cloth according to any of the preceding claims, further characterized in that the protective coating has a thickness of at least about 50 microns.

9. The cloth according to any of the preceding claims, further characterized in that the protective coating has a thickness of at least about 75 microns.

10. The cloth according to any one of the preceding claims, further characterized in that the protective coating is relatively rigid compared to the flexible film such that the protective coating and the handle of the film keep the flexible film in a wrinkle-free state when the protective coating it must be removed from the main portion of the flexible film.

11. The cloth according to any of the preceding claims, further characterized in that the handle of the film is removably connected to the leading edge of the flexible film.

12. The drape according to claim 11, further characterized in that the film handle is removably connected to the flexible film by a releasable adhesive coated on the film handle and a load of undercoated adhesive on a portion of the film. flexible.

13. The cloth according to claim 11, further characterized in that the handle of the film is removably connected to the flexible film by a perforation of the grip of the film.

14. The drape according to claim 11, further characterized in that the handle of the film is removably connected to the flexible film by a reinforcing tape having a tear line to tear the reinforcing tape to separate the handle from the film. of the flexible film.

15. The cloth according to claim 11, further characterized in that the flexible film is formed of elastomeric material and further comprises: opposite, lateral edges extending between the leading and trailing edges of the flexible film; and a tear line in the flexible film generally extending adjacent and generally parallel with, the leading edge to facilitate the propagation of the tear of the film along the tear line to separate the handle of the film from the flexible film, the tear line having opposite ends spaced from the opposite side edges of the film.

16. The drape according to any of the preceding claims, further characterized in that at least one of the handle of the film, the tension strip and the protective coating includes information printed thereon.

17. The cloth according to any of the preceding claims, further characterized in that the adhesive covering the main portion of the flexible film includes a first region of adhesive near the leading edge of the flexible film and a second region of adhesive at or near the edge. At the front of the flexible film, a greater force is required to remove the protective coating from the second region of adhesive relative to the removal of the protective coating from the first region of adhesive.

18. The cloth according to any of the preceding claims, further characterized in that it comprises a removal mark to indicate the stop point when a user is removing the protective coating of the flexible film.

19. The cloth according to any of the preceding claims, further characterized in that the cloth further comprises a handle of the protective coating attached to the protective coating.

20. The cloth according to claim 19, further characterized in that one of the handle of the protective coating and the handle of the film is of a size to wrap around at least a portion of the cloth when the cloth is in a folded configuration.

21. A method for use with a surgical incision cloth, the method is characterized in that it comprises: providing a substantially flat surgical incision cloth, the cloth including a flexible film having a main portion covered with an adhesive, the flexible film having a leading edge and a trailing edge with a handle of the film applied to the leading edge of the flexible film, and the cloth including a protective coating having a leading edge and a trailing edge corresponding to the leading edge and the trailing edge of the flexible film and a handle of the protective coating attached to the protective coating, the protective coating substantially covering the main portion of the flexible film covered with the adhesive; fold the cloth from the trailing edge to the leading edge; and wrapping one of the film handle and the handle of the protective coating around at least a portion of the folded cloth.

22. The method according to claim 21, further characterized in that it comprises the step of flattening the folded cloth to create folds in the respective, opposite regions of the folded cloth.

23. The method according to claim 21 or 22, further characterized in that the step of wrapping includes the step of wrapping one of the handle of the film and the handle of the protective coating around the entire periphery of the folded cloth, the method further comprising the step of applying a closure member associated with one of the film handle 'and the handle of the protective coating to another portion of the cloth to prevent the folded cloth from unfolding.

24. The method according to any of claims 21-23, characterized in that the cloth further includes opposite lateral edges extending between the leading and trailing edges of the flexible film, the method further comprising the step of selectively melting the portions of the edges of the folded cloth to releasably hold the cloth in its folded configuration.

25. The method according to claim 21-23 further characterized in that it comprises the step of applying a releasable adhesive to the cloth for releasably attaching one portion of the cloth to another to releasably maintain the cloth in its folded configuration.

26. A method for applying the surgical incision cloth according to any of claims 1-20, the method is characterized by: grasping the grip of the film; pulling the protective coating to remove at least a portion of the protective coating and exposing at least a portion of the adhesive coating, the main portion of the flexible film; maintaining the surgical incision cloth such that at least a portion of the adhesive is in contact with a surface; and removing the rest of the protective coating from the leading edge of the flexible film after the flexible film is smoothed on the surface.

27. The method according to claim 26, further characterized in that the flexible film achieves a substantially U-shaped configuration after grasping the handle of the film and pulling the protective coating and is further characterized in that the adhesive in a lower portion of the configuration substantially U-shaped is the portion with adhesive that makes contact with the surface before smoothing. SUMMARY OF THE INVENTION A cloth for surgical incisions (10, 80, 90, 120, 103, 160) comprising a flexible film having a leading edge (31) and a trailing edge (32), and a handle of the film (18, 86) connected to the leading edge (31) of the flexible film (12, 81, 91, 122, 162). A protective coating (16, 83, 94, 125, 166) substantially covers the main portion of the flexible film (12, 81, 91, 122, 162), which is coated with an adhesive (14, 81, 99, 124 163). The protective coating (16, 83, 94, 125, 166) may include a handle of the protective coating (22) on the leading edge (35), and one of the handle of the protective coating (22) and the handle of the film (18). , 86) are of a size to wrap around at least a portion of the cloth (10, 80, 90, 120, 103, 160) when the cloth (10, 80, 90, 120, 103, 160) is in a configuration bent A tension strip (20, 84, 98, 128, 104, 168, 169) on the protective coating (16, 83, 94, 125, 166) maintains at least a portion of the flexible film (12, 81, 91, 122, 162) lying between the handle of the film (22, 86) and the tension strip (20, 84, 98, 128, 104, 168, 169) in a wrinkle-free state when the protective coating (16, 83). , 94, 125, 166) should be removed from the main portion of the flexible film (12, 81, 91, 122, 162). In addition, the protective coating (16, 83, 94, 125, 166) can be rigid with respect to the flexible film (12, 81, 91, 122, 162) such that the protective coating (16, 83, 94, 125, 166) and the handle of the film (18, 86) maintain the flexible film (12, 81, 91, 122, 162) in a wrinkle-free state when the protective coating (16, 83, 94, 125, 166) is must remove from the main portion of the flexible film (12, 81, 91, 122, 162). Methods for using these cloths for surgical incisions, tear lines (208, 308) and connection or reinforcement strips (302) are also described.