REUSABLE OPERATION DRAPE

Abstract: Reusable protective drapes for use in operations made of two fabric sheets placed on top of each other with a plastic film or other impervious sheet placed between these sheets. The fabric sheets are made with a cut in the fabric allowing the plastic film to stick out beyond the edge trimming of the cut, so the film and the sheet can be taped to the skin of the patient in a way so blood or body fluids can't pass through the sealed area.

Description: REUSABLE OPERATION DRAPE Background In all surgery there are risk for infections. Nosocomial infections (infections from the hospital environment) has become a real treat since some bacteria strains has become penicillin resistant. The need for a good protection against infections is therefore greater than ever. Different kind of protective clothings have existed for many years. The operation room personal have been wearing protective clothing like gowns, head wear, face masks and glows to protect themselves and the patient from infections and as a general protection against blood and other body fluids. The patient have been protected by different kind of drapes arranged to only leave an opening for the surgery. Reusable sterilized cotton textile fabrics are one of the most common materials for this purpose. Since the fabric itself does not give enough protection against bacteria and blood penetration a protective sheet of thin plastic film is normally placed between double folded fabric sheets. One of the most common arrangements for patient protection is the so called universal sets which consists of four sheets placed so if forms a square openingg around the surgery area, normally tape are used to hold the sheets tight to the skin of the patient around the area of surgery. Figure 1 shows four textile fabric sheets (1) ready to be placed on the patientt to give a square opening over the surgery area (4) the sheets are held to the skin of the patient with the tape (3). Figure 2 shows a cross section on commonly used type of universal set made of double folded sheet of fabric (1) with a plastic film (2) placed between the sheets and a tape (3) that holds the sheet to the skin (5) of the patient, (6) shows the surgery wound. SUBSTITUTE SHEET When fluids comes out from the surgery wound (6) and is spread around, it is absorbed by the fabric (1), the plastic film (2) gives the basic protection against the fluid going directly trough the sheets to the skin of the patient. However this solution can not protect blood and body fluids from spreading around the edge of the plastic film and give a passage of body fluids from the outside of the sheets to the inside of the sheets to the patients skin. This wicking in the fabric sheet can easily transport bacteria from the patients body to the surgery site. The tape can also easily come lose from the wet fabric. This is a commonly known problem with the use of textile fabric as protective sheets and the risk for spreading of bacteria and infections are apparent. This invention describes a solution to this problem and makes it possible for the first time to perform surgery with reusable fabric sheets without possibilityty for bacteria or body fluid penetration between the area of surgery and other parts of the patients skin. Description of the invention. Figure 3 shows one of the four sheets in a universal set made by the invention. In the double folded sheet (1) a rectangular opening (7) has been cut out. Inside the double folded textile fabric sheet a plastic film (2) is placed and part of it sticks out (2) in the rectangular opening (7). The strip (8) shows a impregnated layer of fabric fastened on top of the sheet. The strip (8) reduces the risk for the tape adhesive to penetrate into the sheet during the sterilization process and makes the tape stick to the sheet even when it is wet. Figure 4 shows a cross section trough the rectangular opening on figure 3. The plastic film (2) is placed between the sheets (1), a the tape (3) is fastened on the impregnated strip (8) and on the plastic film (2) and to the patients skin (5). SUBSTITUTE SHEET This construction effectively restricts any transportation of body fluids from the surgery wound to the skin of the patient and forms a bacteria tight protection around the operation site. The invention works the following way, figure 4, blood or body fluids from the surgery wound (6) are spread over the tape (3) to the sheet (1) were it is absorbed, the fluids can however not pass the trough the plastic film (2) and have no possibility to reach the skin of the patient since the tape (3) is sealed to the protective film (2) and to the skin of the patient (5). This unique construction makes it possible for the first time to perform surgeryy with a bacteria and fluid tight area between the patients skin and the surgery site with reusable sets. Figure 5 shows another type of operation set, so called single set, with an circular opening were two sheets (1) placed on top of each other with a plastic film placed between them (2) having a circular hole (9) cut trough booth the sheets and a smaller hole in the plastic film (10) placed in the center of the hole of the fabric sheets leaving a section of plastic film free to be taped to the skin of the patient, (4) is the surgery site. The sheet area adjacent to the circular hole can also be impregnated to be impervious or have a impervious strip sawn or fastened on top of the sheet (11). The set in figure 5 can be taped to the skin of the patient in the same way as described on the universal set and gives an absolute bacteria tight protectiveon between the patients skin and the surgery site. Figure 6 shows a U set for special types of surgery around limbs etc. ,made of two sheets in the same way as the circular set on figure 5, leaving a small section of the plastic film (1) to stick out in the U shape, the U sheet is taped to the skin of the patient as described before. The hole or opening in this so called single sets could be made in many shapes ea. oval, rectangular or square, suitable for the kind of surgery to be performed. The dimension of the rectangular opening in the universal set can vary from 5 - 120 mm , preferably 20 - 100 mm. SUBSTITUTE SHEET The size of the hole in a hole drape can vary depending on the need for different type of operations from a diameter between 300 - 5 mm preferably 200 - 10 mm. The size of the rectangular cut out in the universal sets can vary from a lengthh between 500 -30 mm preferably 50- 250 mm and a width between 5 - 300 mm preferably 10- 100 mm. The shape of the cut can be rectangular, oval, square or any other shape suitable. The protective sheet is normally some what smaller than the textile fabric sheetts but can be so small that it just about covers the opening cut in the fabric sheets. The protective sheets is preferably made of a material resistant to sterilization either by steam, rays or ethylene oxide. Material suitable could be e a PVC, HD or MD Polyethylene, Polypropylene films or of rubber sheets or reusable impervious or partly impervious fabrics like "Gortex", "Cambric" etc, or other well known fabrics for the persons skilled in the art. The thickness of the films can vary from 0.005 mm to 0.250 mm, preferably 0.015 - 0.060 mm. The impregnation of the edge around the opening in the sheets can be made with silicone, hot melts of different kinds, or other impregnations that holds the tape on the sheet when wet and prevent adhesive to penetrate into the sheet after sterilization, preferably silicone specially made to stick to fabric, these type of silicones are standard well known by the manufacturers of silicones and could be of one or two component types, with or without built in primers in order to improve sticking properties on textile fabrics. Instead of direct impregnation of the fabric sheet an impregnated strip can be fastened around the edge of the opening in the sheets. The width of the impregnated area or the strip can be anything from 5-100 mm preferably 5 - 50 mm, the length should be so it extends well beyond the rectangular opening in the universal sets and around the opening in the single sets. SUBSTITUTE SHEET The textile fabric sheets can be made of woven cotton fabric or synthetic materials such as polyester, polyamids or other suitable fibers or mixes thereof. The sheets can also be made of different kind of non woven qualities, ea. polypropylene , polyester, or other man made fibers or mixes of natural fibers suitable for laundry and re use. A commonly used textile sheet is a 100 % cotton fabric with a weight of between 200- 800 gr. /m2, these qualities are well known by persons skilled in the art. The tape used in the sets can be of a conventional type used in these type of applications, well known by persons skilled in the art. Description of preparation and dressing of the patient with the invention. Figure 7 shows a not folded sheet in a universal set, with the rectangular cut (7) in the center of the sheet, the protective film (2) is located so it covers half of the opening in the sheet. The sheet is then folded so it leaves part of the plastic film sticking out in the rectangular opening in the sheet. A tape (3) is then placed over the opening in the sheet so it covers the impregnated area of the sheet and the plastic film and sticks out beyond the plastic film, the free sticky area of the tape is then covered with a release paper on the back side. The sheet can after this preparation be folded to a suitable form and packed for sterilization. The dressing of the patient is made by removing the release paper from the tape on one of the sheets and press the tape so it sticks to the patients skin. The same procedure is made with the other three sheets were the rectangular opening in the sheets are placed so they overlap each other. In the single sets the sheets are placed on top of each other, with the protective film between them so a hole is formed as showed in figure 5 and 6. SUBSTITUTE SHEET The tape is then fastened on the sheet and film in the same way as on the universal sets, the tape could be put on in sections or a round tape could also be prepared. The whole dressing could also be made in the operation theatre with all single parts , sheets, protective film and tapes being delivered separately. SUBSTITUTE SHEET

Claims: Claims 1. Reusable fabric drape for surgical operations made of double fabric sheets with a protective bacteria and fluid resistant sheet placed between the fabric sheets c h a r a c t e r i z e d by that an opening in the fabric sheets has been cut out allowing the protective sheet to stick out beyond the opening in the sheets to such an extend that the protective sheet and fabric sheet can be taped to the patients skin without leavening an opening for body fluids or bacteria to pass trough the sealed area. 2. Reusable fabric drape according to claim l c h a r a c te r i z e d in that the border area of the cut outs are impregnated or covered with a fluid impervious material. 3. Reusable fabric drape according to claim 1 and 2 c h a r a c t e r- i z e d by that the cut out in the sheets are rectangular, oval, square, round V or U shaped. 4. Reusable fabric drape according to claim 1 ,2 or 3 c h a r a c t e r i- z e d in that the protective sheet located between the fabric sheets are steam, ray or Ethylene oxide sterilizable. 5. Reusable fabric drape according to claim 1 ,2 , 3 or 4 c h a r a c- t e r i z e d in that the protective sheet is made of sterilizable plastic film. 6. Reusable fabric drape according to claim 1 ,2 , 3 or 4 c h a r a c- t e r i z e d in that the protective sheet is made of impervious sterilizable woven or nonwoven fabric. 7. Reusable fabric drape according to claim 1 -6 c h a r a c- t e r i z e d in that the reusable fabric drape is sterilizable made of cotton, man made fibers or mixes there of, and are made of woven or nonwoven materials. SUBSTITUTE SHEET

Inventors: BJOERKLUND MATS, BJOERKLUND, MATS
Applicants: BJOERKLUND MATS, BJOERKLUND, MATS
Application year: 1995
Main classification: A61B19
IPC codes: A61B19