WO2022155993A1 - 无纺布手术垫、无纺布手术垫灭菌包及其应用 - Google Patents

无纺布手术垫、无纺布手术垫灭菌包及其应用 Download PDF

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Publication number
WO2022155993A1
WO2022155993A1 PCT/CN2021/074597 CN2021074597W WO2022155993A1 WO 2022155993 A1 WO2022155993 A1 WO 2022155993A1 CN 2021074597 W CN2021074597 W CN 2021074597W WO 2022155993 A1 WO2022155993 A1 WO 2022155993A1
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Prior art keywords
pad
ray tracing
surgical
woven
color
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PCT/CN2021/074597
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English (en)
French (fr)
Inventor
陈仲璜
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珠海高先手术用品科技有限公司
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Priority claimed from CN202110069117.5A external-priority patent/CN112932798A/zh
Priority claimed from CN202120143672.3U external-priority patent/CN215307434U/zh
Application filed by 珠海高先手术用品科技有限公司 filed Critical 珠海高先手术用品科技有限公司
Publication of WO2022155993A1 publication Critical patent/WO2022155993A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/36—Surgical swabs, e.g. for absorbency or packing body cavities during surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/44—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with radio-opaque material or signalling means for residual material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F15/00—Auxiliary appliances for wound dressings; Dispensing containers for dressings or bandages
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/44—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
    • D04H1/46—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres
    • D04H1/492—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres by fluid jet
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H1/00—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres
    • D04H1/40—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties
    • D04H1/44—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
    • D04H1/46—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres
    • D04H1/498—Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling by needling or like operations to cause entanglement of fibres entanglement of layered webs
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04H—MAKING TEXTILE FABRICS, e.g. FROM FIBRES OR FILAMENTARY MATERIAL; FABRICS MADE BY SUCH PROCESSES OR APPARATUS, e.g. FELTS, NON-WOVEN FABRICS; COTTON-WOOL; WADDING ; NON-WOVEN FABRICS FROM STAPLE FIBRES, FILAMENTS OR YARNS, BONDED WITH AT LEAST ONE WEB-LIKE MATERIAL DURING THEIR CONSOLIDATION
    • D04H3/00—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length
    • D04H3/08—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the method of strengthening or consolidating
    • D04H3/10—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the method of strengthening or consolidating with bonds between yarns or filaments made mechanically
    • D04H3/11—Non-woven fabrics formed wholly or mainly of yarns or like filamentary material of substantial length characterised by the method of strengthening or consolidating with bonds between yarns or filaments made mechanically by fluid jet

Definitions

  • the invention relates to the technical field of medical dressings, in particular to a non-woven surgical pad, a non-woven surgical pad sterilization package and applications thereof.
  • Surgical pads with X-ray tracing lines are used to absorb blood and exudates from the surgical site on the patient's body during surgery.
  • most conventional surgical pads include an absorbent pad made of gauze and an X-ray tracing wire attached to its surface, which is usually made of PVC rubber and contains about 60% by weight of barium sulfate powder. %. Barium sulfate is included in PVC rubber to increase its radiopacity so that the X-ray tracing material can be detected during X-ray inspection.
  • the surgical pad with X-ray tracing lines of the present invention is provided with two X-ray tracing lines, each X-ray has a color, and the colors of the two X-rays are different from each other.
  • the color of one of the X-ray tracing lines is significantly darker than the color of the liquid absorbing pad before the operation, so that it is more convenient and accurate to count and count multiple pieces of non-woven surgical pads before the operation.
  • the color of the other X-ray tracing line is much lighter than that of the blood-soaked absorbent pad after surgery, which improves the visibility of the blood-soaked surgical pad in the patient's body, thereby helping to remove the entire surgical pad , which improves the safety of the surgical pad, and makes the counting and statistics of multiple non-woven surgical pads after surgery more convenient and accurate.
  • Surgical pads with X-ray tracing lines are usually packaged in airtight bags or trays prior to use in surgery, and then sterilized by common sterilization methods such as ethylene oxide (ETO), gamma radiation, electron beam radiation or steam ) for sterilization.
  • ETO ethylene oxide
  • gamma radiation gamma radiation
  • electron beam radiation or steam gamma radiation
  • the number of surgical pads in a sterile package can range from 2 to 10, but usually 5 or 10 are included per package for ease of counting. Depending on the complexity and site of the procedure, one or more packs of sterile X-ray tracing line surgical pads are required.
  • the X-ray tracking film used for the large size gauze pad is smaller in size.
  • sterile packs of five surgical pads as an example of a typical surgical counting procedure, the operating room staff will count the number of surgical pads in each sterile pack to ensure that there are indeed five gauze pads in it. If multiple sterile packs are required for the procedure, all packs are opened and counted to ensure that each pack contains five gauze pads. The total number of surgical pads used for surgery will be equal to (number of packs used x five). If the number of tablets in any sterilization package is inconsistent, the defective sterilization package will not be used and a complaint will be filed with the supplier after filing it. After surgery, the used surgical pads are collected in a dressing counter and counted to ensure the same number of surgical pads before and after surgery. If the numbers are not equal, the patient will be X-rayed to find the missing surgical pad inside the patient.
  • gauze material In addition to the general shortcomings of X-ray tracing materials currently on the market, another major problem has been the gauze material that has been used to make surgical pads since the First World War.
  • the disadvantages of gauze in general in terms of safety and performance are: (1) too much fluff leads to infection of the surgical site; (2) there is no selvage on the edge of the gauze, resulting in yarn ends and loose particles; (3) the multi-layer gauze pad cannot be opened (4) The gauze pad will stick to the wound, (5) The water absorption rate is relatively low compared with other materials, (6) The labor intensity is high due to the difficulty of production automation.
  • the present invention aims to solve one of the technical problems in the related art at least to a certain extent. Therefore, the purpose of the present invention is to propose a non-woven surgical pad, a non-woven surgical pad sterilization package and its application.
  • the non-woven surgical pad according to the embodiment of the present invention includes:
  • a liquid absorbing pad is made of a spunlace non-woven fabric with a predetermined tensile strength, and the predetermined tensile strength meets the strength requirements of surgical dressings;
  • Two X-ray tracing lines of different colors are connected to the surface of the liquid absorbing pad through an ultrasonic welding process;
  • the color of one of the two X-ray tracing lines is different before the operation relative to the color of the suction pad, and the color of the other of the two X-ray tracing lines is different after the operation relative to the color of the soaked blood
  • the color of the absorbent pads varies.
  • non-woven surgical pad according to the above embodiments of the present invention may also have the following additional technical features:
  • the color combination of the two X-ray tracing lines is any one of dark blue and light blue, dark green and light green, dark blue and light green, dark green and light blue.
  • the liquid-absorbing pad is made of viscose fiber, bamboo fiber or cotton fiber, or the liquid-absorbing pad is made of a mixture of first fibers and second fibers, and the first fibers are One of viscose fiber, bamboo fiber or cotton fiber, and the second fiber is polyester fiber.
  • the liquid absorbing pad is made by a cross-laid spunlace process.
  • the two X-ray tracing lines are arranged on the same surface of the liquid absorbing pad.
  • the two X-ray tracing lines are arranged on different surfaces of the liquid absorbing pad.
  • the weight of the spunlace non-woven fabric ranges from 40 g/m2 to 120 g/m2, and its tensile strength in both the longitudinal direction and the transverse direction is not less than 15 Newtons
  • the tensile strength test method is to cut a 5 cm x 10 cm test sample from the fabric and test it with a tensile tester at a speed of 20 cm per minute with a cross head.
  • the X-ray tracing wire is a rubber wire, and its width is in the range of 0.1 mm to 2 mm, and the thickness is in the range of 0.01 mm to 1 mm.
  • the X-ray tracing line is in the shape of a straight line or a wavy line.
  • the X-ray tracing wire is made of barium sulfate-containing polyvinyl chloride or thermoplastic elastomer rubber.
  • the unfolded size of the liquid absorbent pad ranges from 5 cm to 200 cm in width, 5 cm to 200 cm in length, and 1 to 16 folded layers.
  • the non-woven surgical pad further comprises a retrieval handle, the retrieval handle is connected to the surface of the absorbent pad by an ultrasonic welding process, wherein the retrieval handle is The hands are made of polypropylene or polyester.
  • a non-woven surgical pad sterilization package includes:
  • At least one piece of the above non-woven surgical pad at least one piece of the non-woven surgical pad is sterilized and sealed in the outer package.
  • the present invention provides an application of the above non-woven surgical pad in surgery or wound care.
  • the non-woven surgical pad, the non-woven surgical pad sterilization package and the application thereof provided according to the embodiments of the present invention utilize two X-ray tracing lines of different colors to increase the visibility of visual counting before and after surgery, and greatly improve the X-ray radiopacity when probing a patient's body.
  • the absorbent pad is made of spunlace non-woven fabric, which has the characteristics of less fluff, high liquid absorption and high tensile strength. In short, the safety and use performance of the non-woven surgical pads of the present invention are superior to traditional surgical pads made of gauze or other fabrics.
  • FIG. 1 is a schematic structural diagram of a non-woven surgical pad (two X-ray tracing lines are located on the same surface) according to an embodiment of the present invention
  • FIG. 2 is a schematic structural diagram of a non-woven surgical pad (two X-ray tracing lines are located on different surfaces) according to an embodiment of the present invention
  • FIG. 3 is a schematic structural diagram of a non-woven surgical pad (with a retrieval handle) according to an embodiment of the present invention
  • FIG. 4 is a schematic structural diagram of a non-woven surgical pad sterilization package according to an embodiment of the present invention.
  • first and second are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implying the number of indicated technical features. Thus, a feature defined as “first” or “second” may expressly or implicitly include one or more of that feature.
  • “plurality” means two or more, unless otherwise expressly and specifically defined.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , or integrally connected; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or the internal communication between the two components.
  • installed e.g., it may be a fixed connection or a detachable connection , or integrally connected; it can be a mechanical connection or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or the internal communication between the two components.
  • a first feature "on” or “under” a second feature may include the first and second features in direct contact, or may include the first and second features Not directly but through additional features between them.
  • the first feature being “above”, “over” and “above” the second feature includes the first feature being directly above and obliquely above the second feature, or simply means that the first feature is level higher than the second feature.
  • the first feature is “below”, “below” and “below” the second feature includes the first feature being directly below and diagonally below the second feature, or simply means that the first feature has a lower level than the second feature.
  • gauze pads have a number of disadvantages listed below: (1) Low water absorption of gauze: The water absorption of gauze is about 4 grams of water per gram of gauze material. In contrast, the absorbent capacity of a spunlace nonwoven made of viscose fibers is about 8 grams of water per gram of nonwoven material. (2) The capillary action of gauze absorbs water slowly: compared with viscose non-woven fabrics, the capillary action of gauze absorbs water significantly slower. (3) A lot of fluff, yarn ends and loose particles: Since the gauze has no selvedge, when the gauze is opened, the fluff, yarn ends and loose particles are easily dropped from the edge.
  • Johnson & Johnson introduced a spunlace nonwoven absorbent made of a mixture of viscose and polyester (70%/30%) pad, which is softer but less tensile than gauze.
  • Johnson & Johnson non-woven fabrics have the following advantages: (1) the water absorption of non-woven fabrics is higher, which is about 2 times that of gauze; (2) due to the capillary action of its fibers, the capillary water absorption of non-woven fabrics Faster (3) There is much less fluff, yarn ends and loose particles because the edges of the nonwoven do not spread out like gauze. (4) The manufacturing process from fiber to finished product is more automated than products made of gauze.
  • Johnson & Johnson nonwoven fabrics are currently only used to manufacture ordinary medical dressings with low performance requirements, and are not suitable for manufacturing surgical pads required for surgery.
  • weak fabric with low tensile strength In order to make the non-woven fabric softer than gauze, the Johnson & Johnson non-woven fabric has relatively low tensile strength, especially in the transverse direction of the fabric. Such low tensile strength non-woven fabrics are easily broken during the operation, so they are not suitable for surgical operations. Most surgical operations require the absorbent pad to have a certain strength.
  • Another object of the present invention is to enhance the safety performance of the X-ray tracing line on the surgical pad.
  • Rubber threads made of PVC (polyvinyl chloride) or TPE (thermoplastic elastomer) rubber for small size pads, which are attached to the surface of the gauze by hot pressing or weaving. This style is the most commonly used style for surgical pads of all sizes.
  • Rubber sheet made of PVC or TPE rubber, attached to gauze by hand sewing. Due to its higher material cost, this style is mainly used for larger size surgical pads.
  • All of the above styles of X-ray tracing material contain about 60% by weight barium sulfate to increase radiopacity and detectable during X-ray tracing probes.
  • the rubber thread style is the most commonly used because of its low material cost and the cost of attaching the thread to the gauze.
  • the rubber thread is placed on the surface of the mesh gauze, and above the rubber thread is a high temperature roller, so that the rubber thread is sandwiched in the middle, and the rubber thread is softened, sticky and adhered to the gauze by the high temperature.
  • the temperature is set at about 200°C, and the X-ray tracing wire can be heated in an instant to soften and become sticky and stick to the gauze.
  • the gauze After the X-ray tracing wire is adhered to the gauze, the gauze is folded into different sizes and layers by an automatic machine. For small size surgical gauze patches (4x4 inches), they usually have only one X-ray trace line per patch. For larger size surgical gauze pads (8x 4 inches), there are usually two X-ray tracing lines on each pad. The purpose of the additional X-ray tracing line is to improve the visibility of the gauze pad during counting and to enhance the radiopacity of the gauze when it is probed by X-ray exposure inside the patient. Usually, the dual X-ray tracing lines on the gauze surgical pad are the same color and are usually placed side by side.
  • non-woven surgical absorbent pads currently available on the market, they are also manufactured using a high temperature roll process to attach the rubber threads of the X-ray tracing wire to the non-woven fabric.
  • the viscose spunlace non-woven fabric will degrade and burn when subjected to a temperature of 160°C or higher, so there are some serious problems in using this method on viscose non-woven fabric.
  • the temperature of the heat-pressing roller needs to be set at about 180 to 200° C. to soften the rubber thread so that it can adhere to the surface of the nonwoven fabric. As a result, it is difficult to achieve consistent adhesion of the X-ray tracing lines on the non-woven pad.
  • non-woven surgical pads with X-ray tracing lines is a common concern for most end-users, which is the reason for their very limited use. Since most spunlace nonwovens are thermally damaged when exposed to high temperatures, it is not feasible to use a high temperature roller to bond the two X-ray tracing lines to the nonwoven surgical pad, even though it is preferred for larger size surgical pads of.
  • the ultrasonic welding method is a safe and clean joining method that does not produce any odors or chemicals.
  • the PVC and TPE rubber threads and viscose non-woven fabrics used by the inventors to make surgical pads with X-ray tracing threads are compatible with the ultrasonic welding process.
  • the ultrasonic welding method does not generate excessive heat and will not damage the non-woven material and rubber thread.
  • the ultrasonic welding method when the ultrasonic welding method is bonded to the non-woven fabric, it is not necessary to apply high pressure on the rubber wire. Therefore, when using the ultrasonic welding method, the problems of breaking the rubber thread and flattening the surface texture of the non-woven fabric can be avoided. Furthermore, it can be used to connect multiple rubber threads to different positions of the nonwoven in an automatic production line.
  • the non-woven surgical pad provided according to an embodiment of the present invention includes a liquid absorbing pad 10 and two X-ray tracing lines 20a and 20b of different colors.
  • the liquid absorbing pad 10 is made of a spunlace non-woven fabric with a predetermined tensile strength, and the predetermined tensile strength meets the strength requirements of surgical dressings. Barbed nonwovens have higher tensile strengths in both machine direction (MD) and transverse direction (CD).
  • the two X-ray tracing wires 20a, 20b are connected to the surface of the liquid absorbing pad 10 by an ultrasonic welding process.
  • the color of one of the two X-ray tracing lines 20a is different from the color of the suction pad 10 before the operation, and the color of the other one 20b of the two X-ray tracing lines is different after the operation.
  • the color of the soaking pad 10 soaked with blood is different.
  • the color of one of the X-ray tracing lines 20a is much darker than the color of the liquid absorbing pad 10 before the operation, which is convenient for counting and counting multiple pieces of non-woven surgical pads before the operation.
  • the color of the other X-ray tracing line 20b is much lighter than that of the blood-soaked liquid absorbing pad 10 after the operation, which is convenient for counting and counting multiple pieces of non-woven surgical pads after the operation.
  • the use of X-ray tracing lines 20a and 20b of different colors can make the non-woven surgical pad of the present application easier to detect to a large extent.
  • the color of one X-ray tracing line 20a is significantly different from the color of the suction pad 10 before the operation, and the color of the other X-ray tracing line 20b after the operation is different from the blood-soaked suction liquid The color of the pad 10 is distinctly different, thus making it much easier to count the non-woven surgical pad before and after surgery.
  • two X-ray tracing lines 20a, 20b are arranged in different parts (different positions on the same surface or different surfaces), which greatly enhances the performance of the traditional surgical pad with only one X-ray tracing line 20.
  • the X-ray traceability greatly reduces the risk of leaving the surgical pad in the patient during the operation, and improves the safety of the operation.
  • the non-woven surgical pad provided according to the embodiment of the present invention utilizes two X-ray tracing lines 20a and 20b of different colors, which increases the visibility of visual counts before and after surgery, and greatly improves the X-rays when exploring the patient's body. radiopacity.
  • the liquid absorbing pad 10 is made of spunlace non-woven fabric, which has the characteristics of less fluff, high liquid absorption and high tensile strength. In short, the safety and use performance of the non-woven surgical pads of the present invention are superior to traditional surgical pads made of gauze or other fabrics.
  • the color combination of the two X-ray tracing lines 20a and 20b is any one of dark blue and light blue, dark green and light green, dark blue and light green, dark green and light blue.
  • the combination of depth and light can achieve better preoperative and postoperative rapid and accurate counting results.
  • the absorbent pad 10 is made of viscose fiber, bamboo fiber or cotton fiber, that is, the absorbent pad 10 is made of 100% viscose fiber, bamboo fiber or cotton fiber.
  • the liquid absorbing pad 10 can also be made of a mixture of first fibers and second fibers, the first fibers are viscose fibers, bamboo fibers or cotton fibers, and the second fibers are polyester fibers.
  • the weight ratio of the two fibers is 20 to 40%, more preferably, the weight ratio of the second fibers is 30%.
  • the liquid absorbing pad 10 made of the above-mentioned fibers has a tensile strength at least equal to that of gauze, a higher water absorption rate than gauze, and less fluff, which can be suitable for surgical use.
  • the absorbent pad 10 is made by a cross-laid spunlace process.
  • the non-woven fabric produced by the parallel-laid spunlace process in which the fiber layers are arranged in the longitudinal direction of the production line, results in low strength in the cross direction.
  • the spunlace non-woven fabric used to manufacture the surgical pad is made by the cross-laying process, and the non-woven fiber layers are laid on the production line at 45° or perpendicular to each other.
  • the absorbent pad 10 can be made to have higher tensile strength in both longitudinal and transverse directions, so that it can meet the tensile strength requirements of surgical dressings ,
  • using the cross-laying process to make the non-woven fabric can make the tensile strength of the non-woven fabric meet the surgical requirements, so that the non-woven fabric can be applied to the surgical pad.
  • the two X-ray tracing lines 20a, 20b may be arranged on the same surface of the liquid absorbing pad 10, or the two X-ray tracing lines 20a, 20b may be arranged on the liquid absorbing pad 10
  • one X-ray tracing line 20 a is arranged on the front side of the liquid absorbing pad 10
  • the other X-ray tracing line 20 b is arranged on the reverse side of the liquid absorbing pad 10 .
  • the weight of the spunlace nonwoven fabric ranges from 40 g/m2 to 120 g/m2, and its tensile strength in both the longitudinal direction and the transverse direction is not less than 15 Newtons, the The tensile strength is tested by cutting a 5 cm x 10 cm test sample from the fabric and testing it with a tensile tester at a crosshead speed of 20 cm per minute.
  • the spunlace non-woven fabric with the above parameters has tensile strength in the longitudinal and transverse directions that can meet the requirements of surgical dressings, and has higher water absorption than gauze.
  • the X-ray tracking wires 20a and 20b are rubber wires, the width of which ranges from 0.1 mm to 2 mm, and the thickness ranges from 0.01 mm to 1 mm.
  • the X-ray tracing lines 20a, 20b may be in the shape of straight lines or wavy lines.
  • the X-ray tracing lines 20a and 20b are made of polyvinyl chloride (PVC) or thermoplastic elastomer (TPE) rubber containing barium sulfate.
  • PVC polyvinyl chloride
  • TPE thermoplastic elastomer
  • the weight ratio of barium sulfate in the X-ray tracing lines 20a and 20b is about 60%. .
  • the ultrasonic welding method does not generate excessive heat and will not damage the non-woven material and rubber thread.
  • the ultrasonic welding method is combined to the non-woven fabric, there is no need to apply high pressure on the rubber wire, so when the ultrasonic welding method is used, the problems of breaking the rubber wire and flattening the surface texture of the non-woven fabric can be avoided. Further, it can be used to connect multiple rubber threads to different positions of the non-woven fabric in an automatic production line, realizing batch processing and high production efficiency.
  • the unfolded size range of the liquid absorbent pad 10 is: the width ranges from 5 cm to 200 cm, the length ranges from 5 cm to 200 cm, and the number of folded layers is 1 to 16 layers. Nursing needs for various applications.
  • the non-woven surgical pad further includes a retrieval handle 30, the retrieval handle 30 is connected to the surface of the liquid absorbent pad 10 through an ultrasonic welding process, wherein the retrieval handle 30 is
  • the return handle 30 is made of polypropylene or polyester, so that it is convenient to use the retrieval handle 30 to take out the non-woven surgical pad from the human body after surgery.
  • a non-woven surgical pad sterilization package includes an outer package 200 and at least one piece of the non-woven surgical pad 100 described in the above-mentioned embodiment.
  • the outer package 200 is a sterile sealed package, which can be In the form of a bag or tray, at least one piece of the non-woven surgical pad 100 is sterilized and sealed in the outer package.
  • the present invention provides the application of the above non-woven surgical pad in surgery or wound care.
  • the spunlace non-woven fabric, its fibers, and X-ray tracing lines 20a and 20b for manufacturing non-woven surgical pads of the present invention are introduced below, and they are compared with the equivalent gauze and Johnson & Johnson type non-woven fabrics in combination with the embodiments. , the characteristics of the X-ray tracing lines 20a, 20b are compared.
  • spunlace non-woven fabrics of different fibers are used to make various sample groups, wherein the tensile strength, water absorption properties of surgical pads made of gauze, Johnson & Johnson type non-woven fabric and the spunlace non-woven fabric of the present application are compared , fluff level.
  • viscose fiber, bamboo fiber, cotton fiber, polyester fiber and cotton fabric were used to make samples of non-woven surgical pads, wherein the tensile strength of the surgical pads made of various spunlace non-woven fabrics in the present application was compared Strength, absorbency, fluff level.
  • the samples and test results for this study are shown in Table 2.
  • the results show the physical properties of the spunlace non-woven fabric of the present application made of viscose fiber, bamboo fiber, cotton fiber, and viscose, respectively, a mixture of polyester and cotton. All of their physical properties are suitable for surgery.
  • Table 3 is used for the performance comparison of X-ray tracing line of gauze, Johnson & Johnson non-woven fabric and spunlace non-woven fabric of the present application
  • Each X-ray tracing line 20 described in the above table is a solid color.
  • the non-woven surgical pad of the present application includes: (a) a liquid-absorbing pad 10 made of a layer of spunlace non-woven fabric, the physical properties of which are suitable for surgical use, and (b) two rubber
  • the X-ray tracing lines 20 a and 20 b in the form of lines are connected to the liquid absorbing pad 10 .
  • each X-ray tracing line 20a, 20b on the liquid absorbing pad 10 is a solid color
  • the colors of different X-ray tracing lines 20a, 20b are different from each other, and the color of one X-ray tracing line 20a is higher than the color of the surgical pad before surgery Much darker; the other X-ray tracing line 20b is much lighter in color than the blood-soaked surgical pad after surgery.
  • the multi-color X-rays of the present invention can make the surgical pads of the present invention much easier to detect and make the surgical pads very easy to detect before and after surgery. Much easier to count.
  • Having two X-ray tracing lines 20a, 20b in different parts of the surgical pad also enhances the X-ray traceability of the surgical pad to a large extent over conventional surgical pads with only one X-ray tracing line.
  • a highly secure and reliable connection of the rubber thread to the non-woven fabric is achieved by using a special ultrasonic welding process instead of the high-temperature roll process that is usually used for gauze but not non-woven fabrics.
  • Soft and strong non-woven absorbent pad 10 is made of 100% viscose, bamboo or cotton, or a mixture of these three fibers with 30% polyester or cotton respectively;
  • the tracking wires 20a, 20b are made of PVC or TPE rubber, in which the weight percentage of barium sulfate is about 60%.
  • the non-woven fabric used to manufacture the liquid absorbing pad 10 has a fabric weight ranging from 40 g/m2 to 120 g/m2.
  • the tensile strength of the non-woven fabric in both the longitudinal and transverse directions is not less than 15 Newtons, and the 5 ⁇ 10 cm sample cut from the non-woven fabric is tested by a tensile tester at a crosshead speed of about 20 cm per minute.
  • the rubber X-ray tracing lines 20a, 20b can be placed on the same or opposite sides of the non-woven fabric, and their colors can be the same or significantly different from each other. Furthermore, these lines are characterized by having the form of straight or wavy lines.
  • the width of the X-ray tracing lines 20a and 20b ranges from 0.1 to 2 mm, and the thickness ranges from 0.01 to 1 mm.
  • the unfolded size of the liquid absorbing pad 10 is characterized in that its width is in the range of 5-200 cm, the length is in the range of 5-200 cm, and the number of folded layers is in the range of 1-16 layers.
  • the retrieval handle 30 may be ultrasonically welded to the surface of the absorbent pad 10, wherein the retrieval handle 30 may be made of polypropylene or polyester.
  • One or more non-woven absorbent pads 10 are enclosed in a sealed bag or tray for sterilization, for applications related to surgery or wound care.
  • the non-woven surgical pad with X-ray tracing lines 20a, 20b of the present application not only improves the safety and overall performance, but also can provide a better solution for surgery. Save a lot of money.

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  • Heart & Thoracic Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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Abstract

一种无纺布手术垫、无纺布手术垫灭菌包及其应用，其中，该无纺布手术垫包括吸液垫（10）及两根不同颜色的X光追踪线（20a、20b），吸液垫（10）由具有预定拉伸强度的水刺无纺布制成，所述预定拉伸强度满足手术敷料强度要求；两根所述X光追踪线（20a、20b）通过超声波焊接工艺连接至所述吸液垫（10）的表面，两根所述X光追踪线（20a、20b）中的一根（20a）的颜色在手术前相对于所述吸液垫的颜色不同，两根所述X光追踪线（20a、20b）中另一根（20b）的颜色在手术后相对于浸满血液的所述吸液垫的颜色不同。所述无纺布手术垫、无纺布手术垫灭菌包及其应用，利用两根不同颜色的X光追踪线（20a、20b），增加了手术前和手术后视觉计数的可见度，极大降低了手术过程中将手术垫遗留在病人体内的风险,其安全性和使用性能优于由纱布或其他织物制成的传统手术垫。

Description

无纺布手术垫、无纺布手术垫灭菌包及其应用 技术领域
本发明涉及医疗敷料技术领域，尤其涉及一种无纺布手术垫、无纺布手术垫灭菌包及其应用。
背景技术
带X光追踪线手术垫用于在手术期间吸收来自患者身体手术部位的血液和渗出物。当前，大多数常规手术垫包括由纱布制成的吸液垫和附着在其表面上的X光追踪线，该X光追踪线通常由PVC橡胶制成，含有硫酸钡粉末的重量占比约60％。PVC橡胶中包含硫酸钡是为了增加其射线不透性，因此X光追踪材料可以在进行X光辐照检查时被探测得到。
手术后，手术垫应全部从病人体内取出，而不能遗留在体内。本发明的带X光追踪线手术垫带有两根X光追踪线，每根X线是一个颜色，两根X线颜色互不相同。其中一根X光追踪线的颜色在手术前相对于所述吸液垫的颜色明显深的多，如此，使手术前对多片无纺布手术垫进行计数统计更加方便和准确。其中另一根X光追踪线的颜色在手术后相对于浸满血液的吸液垫颜色浅得多，如此，提高了浸满血液的手术垫在病人体内的辨识度，从而帮助全部取出手术垫，提高了手术垫的安全性，并使取出后对多片无纺布手术垫进行手术后的计数统计更加方便和准确。
对于较少渗出液量的较小部位的手术，使用通常被称为带X光追踪线敷料片的较小手术垫。常见的“折叠后成型”尺寸为(3.5 x 3.5英寸)，(4 x 4英寸)和(8 x 4英寸)。对于带有大量渗出液量的更大、更深部位的手术，通常使用称为腹部垫或手术巾的较大尺寸的手术敷料垫。常见的“展开尺寸”是(18 x 18英寸)，(15 x 15英寸)和(12 x 12英寸)。为了帮助在手术部位对手术垫进行定位并在手术后将其拉出，较大尺寸的手术垫通常有一根连接到手术垫侧边的取回提手。取回提手通常由棉纺材料或合成材料制成。
带X光追踪线手术垫在使用于手术之前，通常将它们包装在密封袋或托盘 中，然后通过常见的灭菌方法(例如环氧乙烷(ETO)、伽玛射线、电子束辐射或蒸汽)进行灭菌。无菌包装中手术垫的数量范围为2片到10片，但通常为便于计数每包装入5片或10片。根据手术的复杂程度和部位，需要一包或多包无菌的带X光追踪线手术垫。
应当指出，手术垫是在20世纪80年代末期发明的。从那时起，尽管存在下述许多缺点，传统手术垫在设计和总体性能上并未进行过重大变化和改进：
(1)纱布垫上的棉绒、松散颗粒和纱线头过多，可能导致手术部位感染。
(2)纱布垫的吸水性相对较低。
(3)X光追踪线断裂或从纱布垫表面脱落。
(4)用于大尺寸纱布垫的X光追踪片尺寸较小。
(5)尤其用于大尺寸纱布垫时，细的X光追踪线的X光追踪性较差。
(6)深色X光追踪材料在手术后浸满血液的纱布垫上的可视性差。
(7)手术垫在手术后遗留在患者体内。
对于需要多包无菌手术垫的手术，可能会使用超过50片手术垫。手术吸液垫的主要安全问题是在手术过程中可能会遗留在患者体内。使用包入五片手术垫的无菌包作为一个典型的手术计数程序示例，手术室工作人员将对每个无菌包中手术垫的数量进行计数，以确保其中确实有五片纱布垫。如果手术需要多个无菌包，则将所有无菌包打开并计数，以确保每包里面都装有五块纱布垫。用于手术的手术垫的总片数将等于(使用包数x五片)。如果任何灭菌包里的片数不一致，则这包有缺陷的灭菌包将不能使用，并对其进行归档后向供应商提出投诉。手术后，将用过的手术垫收集在敷料计数器中并进行计数，以确保手术前后手术垫的数量相同。如果数量不相等，则将对患者进行X光追踪检查，以在患者体内找到丢失的手术垫。
据美国统计，手术过程中约有0.02％的手术垫被意外遗留在患者体内，这意味着每年意外发生遗留手术垫有4,000例。对于发展中国家，患者体内遗留手术垫的统计数据可能更高。当前，有两种获得专利的方法可以减少手术期间将手术垫遗留在患者体内的可能性：(1)将一小片射频(RF)芯片连接在手术垫上，并使用扫描仪检测病人体内是否有射频芯片。(2)将二维码(嵌入到一片塑料附件上)粘附到每个吸液垫上，并在手术前后扫描二维码以确保已计入所有吸液垫的数量。尽管以上两种方法可以使吸液垫的安全性得到 一些改善，但它们仍存在一些重大问题。首先，因为仍然要求将X光追踪材料连接到每片单独的手术垫上，这些专利的系统和设备并不完全安全。对于射频RF芯片和扫描系统，众所周知RF设备可能会发生故障并不时导致错误信号，这会使扫描仪不可靠。对于二维码系统，仍然需要对所有无菌包装的吸液垫进行人工计数。此外，在手术之前，将单片二维码粘附在手术垫上非常耗费人工和时间；在手术之后，对每个二维码的扫描也同样耗费大量人工和时间。除了上述问题之外，以上两个安全系统都需要附加一些设备和监视系统，这些非常昂贵。使用这些系统需要另外一名专门负责执行任务的人员。此外，这两个安全系统都仅发出信号，提示缺少手术垫，但无法帮助在患者体内定位遗留的吸液垫。
当前市场上除了X光追踪材料的一般缺点之外，自第一次世界大战以来，另一个主要问题是，一直用于制造手术垫的纱布材料有一些缺点。纱布一般在安全和性能上的缺点有：(1)绒毛太多导致手术部位感染；(2)纱布边缘没有织边，导致纱线头和松动的颗粒；(3)多层纱布垫不能被打开来使用；(4)纱布垫会粘连住伤口，(5)与其他材料相比吸水率相对较低，(6)由于生产自动化的难度很大，因此劳动强度高。在80年代末期，强生公司曾试图用柔软和低强度的水刺无纺布代替纱布，该水刺无纺布由重量比为70/30的粘胶纤维/聚酯混合材料制成。由于工艺简单和自动化程度高，无纺布比机织布便宜，并且已被用于制造多种用途广泛的一次性产品。然而，由于手术吸液垫有严格要求，无纺布垫拉伸强度低且太软不适合于外科手术，强生类型的无纺材料目前仅用于制造性能要求低的通用类型医用敷料。
发明内容
本发明旨在至少在一定程度上解决相关技术中的技术问题之一。为此，本发明的目的在于提出一种无纺布手术垫、无纺布手术垫灭菌包及其应用。
为实现上述目的，一方面，根据本发明实施例的无纺布手术垫，包括：
吸液垫，所述吸液垫由具有预定拉伸强度的水刺无纺布制成，所述预定拉伸强度满足手术敷料强度要求；
两根不同颜色的X光追踪线，两根所述X光追踪线通过超声波焊接工艺连接至所述吸液垫的表面；
两根所述X光追踪线中的一根的颜色在手术前相对于所述吸液垫的颜色不同，两根所述X光追踪线中另一根的颜色在手术后相对于浸满血液的所述吸液垫的颜色不同。
另外，根据本发明上述实施例的无纺布手术垫还可以具有如下附加的技术特征：
根据本发明的一个实施例，两根所述X光追踪线的颜色组合为深蓝和浅蓝，深绿和浅绿，深蓝和浅绿，深绿和浅蓝中的任意一种。
根据本发明的一个实施例，所述吸液垫为粘胶纤维、竹纤维或棉纤维制成，或者所述吸液垫为第一纤维和第二纤维混合制成，所述第一纤维为粘胶纤维、竹纤维或棉纤维中的一种，所述第二纤维为聚酯纤维。
根据本发明的一个实施例，所述吸液垫为采用交叉铺网水刺工艺制成。
根据本发明的一个实施例，两根所述X光追踪线设在所述吸液垫的同一表面。
根据本发明的一个实施例，两根所述X光追踪线设在所述吸液垫的不同表面。
根据本发明的一个实施例，所述水刺无纺布的重量范围为40克/平方米至120克/平方米，其在纵向方向和横向方向上的拉伸强度均不低于15牛顿，该拉伸强度的测试方法是从织物上切下5厘米×10厘米的测试样品，用拉力检测机以十字头每分钟20厘米的速度进行测试。
根据本发明的一个实施例，所述X光追踪线为橡胶线，其宽度范围为0.1毫米至2毫米，厚度范围为0.01毫米至1毫米。
根据本发明的一个实施例，所述X光追踪线呈直线或波浪线形状。
根据本发明的一个实施例，所述X光追踪线由含有硫酸钡的聚氯乙烯或热塑弹性体橡胶制成。
根据本发明的一个实施例，所述吸液垫的展开尺寸范围为：宽度范围为5厘米至200厘米，长度范围为5厘米至200厘米，折叠层数为1至16层。
根据本发明的一个实施例，所述无纺布手术垫还包括一取回提手，所述取回提手通过超声波焊接工艺连接到所述吸液垫的表面，其中，所述取回提手由聚丙烯或聚酯制成。
另一方面，根据本发明实施例的无纺布手术垫灭菌包，包括：
外包，为无菌密封包装；
至少一片如上所述的无纺布手术垫，至少一片所述的无纺布手术垫灭菌密封于所述外包内。
又一方面，本发明提供了一种如上的无纺布手术垫在外科手术或伤口护理过程中的应用。
根据本发明实施例提供的无纺布手术垫、无纺布手术垫灭菌包及其应用，利用两根不同颜色的X光追踪线，增加了手术前后视觉计数的可见度，并极大提高了对患者体内进行探查时的X光辐射不透过性。此外，吸液垫采用水刺无纺布制成，具有少绒毛、高液体吸收性和高拉伸强度特点。简言之，本发明的无纺布手术垫的安全性和使用性能优于由纱布或其他织物制成的传统手术垫。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图示出的结构获得其他的附图。
图1是本发明实施例无纺布手术垫(两根X光追踪线位于同一表面)的结构示意图；
图2是本发明实施例无纺布手术垫(两根X光追踪线位于不同表面)的结构示意图；
图3是本发明实施例无纺布手术垫(带取回提手)的结构示意图；
图4是本发明实施例无纺布手术垫灭菌包的结构示意图。
本发明目的的实现、功能特点及优点将结合实施例，参照附图做进一步说明。
具体实施方式
下面详细描述本发明的实施例，所述实施例的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施例是示例性的，旨在用于解释本发明，而不能理解为对本发明的限制，基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
在本发明的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”“内”、“外”、“顺时针”、“逆时针”“轴向”、“周向”、“径向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
在本发明中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。
在本发明中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。
下面参照附图详细描述本发明实施例的无纺布手术垫、无纺布手术垫灭菌包及其应用。
本发明是基于发明人的下列研究和发现而完成的：
鉴于相关技术中传统手术垫的缺点，证实了强烈需要一种革命性的带X光追踪线的手术垫，其整体物理性能得到极大改善，安全性得到增强，但成本却没有任何显著的增加，也不增加任何新的附件和配件而增加使用的复杂性。因此，本发明的目的是提供具有优越性能的手术垫和X光追踪材料，视觉计数时具有更高可见度，和在X光探查时具有增强的辐射不透过性。
当前，市场上几乎所有的手术吸液垫都由棉纱布制成。但是，下面将列出纱布垫有许多缺点：(1)纱布的吸水性低：纱布的吸水性是每克纱布材料吸收约4克水。相反，由粘胶纤维制成的水刺无纺布的吸收能力为每克无纺布材料吸收约8克水。(2)纱布的毛细作用吸水速度慢：与粘胶无纺布相比，纱布的毛细作用吸水速度明显更慢。(3)大量的绒毛、纱线头和松散颗粒：由于纱布没有织边，当纱布打开时，绒毛、纱线头和松散颗粒很容易从边缘掉落。医学期刊上有许多已发表的研究表明，绒毛、纱线头和松散颗粒可能导致手术部位感染，并且在手术过程中还可能引起栓塞和血管阻塞。实际上，许多发展中国家要求在使用前应洗净并烘干纱布制成的手术用敷料，以除去绒毛、纱线头和松散颗粒。然而，由于清洗和干燥的操作成本相对较高，在大多数欠发达国家中没有遵循手术垫的清洗和干燥操作。(4)纱布的价格高：因为需要大量人的手工操作而无法克服实现自动化的内在困难，纱布及后续制成纱布垫的生产制造特点使手术垫的生产不能完全自动化。
在二十世纪80年代，为了解决上述问题，强生公司(Johnson&Johnson)(J&J)推出了由粘胶纤维和聚酯纤维(70％/30％)的混合材料制成的水刺无纺布吸液垫，该吸液垫比纱布更柔软但拉伸强度更低。与纱布相比强生型无纺布具有以下优点：(1)无纺布的吸水性更高，约为纱布吸水性的2倍；(2)由于其纤维的毛细作用，无纺布的毛细吸水速度更快(3)绒毛、纱线头和松散颗粒的少得多，因为无纺布的边缘不会像纱布一样散开。(4)从纤维到成品的制造过程比纱布制成的产品自动化程度更高。但是，如上所述，强生型无纺布目前仅用于制造对性能要求低的普通医用敷料，而并不适合制造手术所需的手术垫。
通过广泛的研究，发明人发现妨碍用广泛使用的无纺布来制造带X光追踪线手术垫的主要原因如下：
(1)低拉伸强度的弱布料：为了使无纺布比纱布柔软，强生型无纺布具有相对低的拉伸强度，尤其是沿布料的横向。这样低拉伸强度的无纺布在手术过程中很容易破裂，因而不适用于外科手术，大多数外科手术都要求吸液垫具有一定的强度。
(2)光滑的表面：对于许多外科手术和伤口清创术，吸液垫需要一个粗糙的表面。强生型的无纺布具有粗糙的表面，但其粗糙程度远不及纱布。
(3)薄的布料：强生型无纺布的织物重量约为30至40克每平方米，相对于蓬松的网眼纱布而言是相当薄的。
(4)无法展开使用。由于低拉伸强度的无纺布会撕裂，因此薄而弱的无纺布不能在手术期间打开使用。
为了纠正传统强生类型无纺布的上述缺点，发明人开发了以下方法和要求，以制造一种具有符合手术应用物理性能的新型无纺布垫：
(1)在织物的两个方向上都具有更高的拉伸强度：强生类型的柔软无纺布是采用平行铺网水刺工艺制成的，其中纤维层沿生产线的纵向排列，导致交叉方向的强度低。为了获得更高的抗拉伸强度，用于制造手术垫的无纺布应采用交叉铺网工艺制成，其无纺纤维层以45°或彼此垂直的方式铺在生产线上，称为半交叉铺网和交叉铺网。
(2)大网眼或凹凸纹表面：在水刺工艺的最后阶段使用具有较大网眼或带有凹凸纹的图案，以在水刺无纺布上做出大网眼或凹凸纹效果的表面，这使无纺布表面比传统强生型无纺布表面粗糙得多。
(3)具有较高拉伸强度的较厚较大的无纺布，用于制造较大尺寸的手术垫。对用于较大手术部位所用的手术垫，发明人制作了一些更大更厚且具有高拉伸强度的手术垫。
(4)可以展开使用：由于布料更厚，更结实，因此可以展开使用手术垫而无需担心无纺布会撕裂。
本发明的另一目的是增强手术垫上X光追踪线的安全性能。当前，通常存在三种用于纱布手术垫的X光追踪材料：
(1)由PVC(聚氯乙烯)或TPE(热塑弹性体)橡胶(用于小尺寸垫板) 制成的橡胶线，它们通过热压辊或织入方式连接到纱布的表面上。这种样式是所有尺寸的手术垫最常用的样式。
(2)由PVC或TPE橡胶制成的橡胶片(比线更宽更厚)，通过手工缝制将其连接到纱布上。由于其材料成本较高，因此这种样式主要用于较大尺寸的手术垫。
(3)由合成长丝制成的缝纫线，在纱布的制造过程中缝制到纱布中。请注意，很少使用这种样式，因为缝纫线细得多，导致可见度和追踪线的X光追踪性很差。
所有上述样式的X光追踪材料均包含按重量计约60％的硫酸钡，以增加射线不透性，并在X光追踪探查时可以检测得到。在这三种样式中，橡胶线样式是最常用的，因为其材料成本低以及将线连接到纱布的成本也低。通常，将橡胶线置于网眼纱布表面，橡胶线的上面是高温辊，使橡胶线像三明治一样夹在中间，通过高温使橡胶线软化、变粘并粘附到纱网，从而将线连接到网眼纱布的表面。温度设定在大约200℃，可以在瞬间加热X光追踪线使其软化变粘，并粘在纱布上。在将X光追踪线粘附到纱布上之后，再通过自动机器将纱布折叠成不同的尺寸和层数。对于小尺寸的手术用纱布片(4x 4英寸)，它们通常在每个片上只有一条X光追踪线。对于较大尺寸的手术用纱布垫(8x 4英寸)，通常在每个垫上有两条X光追踪线。额外增加X光追踪线的目的是提高纱布垫在计数时的可视性，并增强纱布在患者体内被进行X光照射探查时的不透过射线性。通常，纱布手术垫上的双X光追踪线具有相同的颜色，并且通常并排放置。
对于当前市场上可买到的无纺布外科手术吸液垫，它们也使用高温辊工艺来制造，以将X光追踪线的橡胶线连接到无纺布上。然而，即使持续很短的时间，经受160℃或更高的温度，粘胶水刺无纺布会降解和燃烧，因此在粘胶无纺布上使用这种方法存在一些严重的问题。另一方面，热压辊的温度需要设定为约180至200℃，以软化橡胶线，使得其可以粘附至无纺布表面。结果，难以实现X光追踪线在无纺布垫上的一致性粘附。因此，带X光追踪线无纺布手术垫的质量是大多数最终用户普遍关心的问题，这是其使用非常有限的原因。由于大多数水刺无纺布暴露在高温下会有热损伤，即使对较大尺寸手术垫来说是首选，使用高温辊将两条X光追踪线粘合到无纺布手术垫上也是不可 行的。
由于X光追踪橡胶线是最常用的，因此发明人将研究工作集中在改善其可制造性上，并尽力克服上述质量问题。经过许多实验室研究，发明人发现超声波焊接比用传统的高温辊将X光追踪橡胶线连接到无纺布上更为合适。总的来说，超声波焊接方法是一种安全清洁的连接方法，不会产生任何气味或化学物质。发明人用于制造带X光追踪线手术垫的PVC和TPE橡胶线以及粘胶无纺布均与超声波焊接工艺兼容。超声波焊接方法不会产生过多的热量，不会损坏无纺布材料和橡胶线。此外，当将超声波焊接方法结合到无纺布上时，不需要在橡胶线上施加高压。因此，当使用超声波焊接方法时，可以避免橡胶线断裂和使无纺布表面纹理变平的问题。此外，它可用于在自动生产线中将多条橡胶线连接到无纺布的不同位置。
参照图1至图3所示，根据本发明实施例提供的无纺布手术垫，包括吸液垫10及两根不同颜色的X光追踪线20a、20b。
其中，吸液垫10由具有预定拉伸强度的水刺无纺布制成，所述预定拉伸强度满足手术敷料强度要求，相对于传统的无纺布，本申请制造吸液垫10的水刺无纺布具有在纵向(MD)和横向(CD)上具有更高的拉伸强度。
两根所述X光追踪线20a、20b通过超声波焊接工艺连接至所述吸液垫10的表面。两根所述X光追踪线中的一根20a的颜色在手术前相对于所述吸液垫10的颜色不同，两根所述X光追踪线中另一根20b的颜色在手术后相对于浸满血液的所述吸液垫10的颜色不同。例如：其中一根X光追踪线20a的颜色在手术前比吸液垫10颜色要深得多，方便于在手术前对多片无纺布手术垫进行手术前的计数统计。另一根X光追踪线20b的颜色在手术后相对于浸满血液的吸液垫10颜色浅得多，方便于在手术后对多片无纺布手术垫进行手术后的计数统计。
本申请中，采用不同颜色的X光追踪线20a、20b，可以使本申请的无纺布手术垫在很大程度上更加容易被检测得到。此外，一根X光追踪线20a的颜色在手术前相对于所述吸液垫10的颜色明显不同，另一根X光追踪线20b的颜色在手术后相对于浸满血液的所述吸液垫10的颜色明显不同，如此，可以使该无纺布手术垫在手术前后在很大程度上更加容易计数。而在无纺布手术垫上不同部位(同一表面的不同位置或不同表面)设置两根X光追踪线20a、 20b，从很大程度上比只有一根X光追踪线20的传统手术垫增强了X光可追踪性，极大降低了手术过程中将手术垫遗留在病人体内的风险，提高了手术的安全性。
根据本发明实施例提供的无纺布手术垫，利用两根不同颜色的X光追踪线20a、20b，增加了手术前后视觉计数的可见度，并极大提高了对患者体内进行探查时的X光辐射不透过性。此外，吸液垫10采用水刺无纺布制成，具有少绒毛、高液体吸收性和高拉伸强度特点。简言之，本发明的无纺布手术垫的安全性和使用性能优于由纱布或其他织物制成的传统手术垫。
较佳地，两根所述X光追踪线20a、20b的颜色组合为深蓝和浅蓝，深绿和浅绿，深蓝和浅绿，深绿和浅蓝中的任意一种，采用上述颜色的深浅组合，可以达到更好的术前及术后快速准确计数的效果。
在本发明的一些实施例中，吸液垫10为粘胶纤维、竹纤维或棉纤维制成，也即是，吸液垫10采用100％的粘胶纤维、竹纤维或棉纤维制成。
此外，吸液垫10还可以采用第一纤维和第二纤维混合制成，第一纤维为粘胶纤维、竹纤维或棉纤维中的一种，第二纤维为聚酯纤维，优选地，第二纤维的重量比为20至40％，更为优选地，第二纤维的重量比为30％。
采用上述纤维制成的吸液垫10，具有至少与纱布同等的拉伸强度，而相对于纱布更高的吸水率，此外，绒毛少，能够适合于手术使用。
在本发明的一些实施例中，吸液垫10为采用交叉铺网水刺工艺制成。
如上所述，采用平行铺网水刺工艺制成的无纺布，其中，纤维层沿生产线的纵向排列，导致交叉方向的强度低。为了获得更高的抗拉伸强度，本实施例中，用于制造手术垫的水刺无纺布采用交叉铺网工艺制成，其无纺纤维层以45°或彼此垂直的方式铺在生产线上，称为半交叉铺网和交叉铺网，如此，可以使得制成的吸液垫10在纵向和横向方向上均具有更高的拉伸强度，使其能够满足手术敷料的拉伸强度要求，换言之，采用交叉铺网工艺制作无纺布，可以使得无纺布的拉伸强度满足手术要求，以便于无纺布能够应用于手术垫。
可以理解的是，两根所述X光追踪线20a、20b可以设在所述吸液垫10的同一表面，或者，两根所述X光追踪线20a、20b设在所述吸液垫10的不同表面，例如一根X光追踪线20a设在吸液垫10的正面，另一根X光追踪线 20b设在吸液垫10的反面。
在本发明的一个实施例中，水刺无纺布的重量范围为40克/平方米至120克/平方米，其在纵向方向和横向方向上的拉伸强度均不低于15牛顿，该拉伸强度的测试方法是从织物上切下5厘米×10厘米的测试样品，用拉力检测机以十字头每分钟20厘米的速度进行测试。
采用上述参数的水刺无纺布，其纵向和横向方向上的拉伸强度能够满足手术敷料要求，并且，具有相对于纱布更高的吸水性。
较佳地，X光追踪线20a、20b为橡胶线，其宽度范围为0.1毫米至2毫米，厚度范围为0.01毫米至1毫米。该X光追踪线20a、20b可以呈直线或波浪线形状。X光追踪线20a、20b由含有硫酸钡的聚氯乙烯(PVC)或热塑弹性体(TPE)橡胶制成，例如该X光追踪线20a、20b中硫酸钡的重量占比约为60％。
发明人发现，采用PVC和TPE橡胶线的X光追踪线20a、20b以及粘胶无纺布均与超声波焊接工艺兼容。超声波焊接方法不会产生过多的热量，不会损坏无纺布材料和橡胶线。此外，当将超声波焊接方法结合到无纺布上时，不需要在橡胶线上施加高压，因此，当使用超声波焊接方法时，可以避免橡胶线断裂和使无纺布表面纹理变平的问题。进一步地，它可用于在自动生产线中将多条橡胶线连接到无纺布的不同位置，实现批量加工，生产效率高。
较佳地，吸液垫10的展开尺寸范围为：宽度范围为5厘米至200厘米，长度范围为5厘米至200厘米，折叠层数为1至16层，采用上述尺寸范围，可以满足手术及护理中的各种应用需要。
在本发明的一些实施例中，无纺布手术垫还包括一取回提手30，所述取回提手30通过超声波焊接工艺连接到所述吸液垫10的表面，其中，所述取回提手30由聚丙烯或聚酯制成，如此，方便在手术后利用取回提手30，将无纺布手术垫从人体中取出。
参照图4所示，根据本发明实施例的无纺布手术垫灭菌包，包括外包200及至少一片如上述实施例所述的无纺布手术垫100，外包200为无菌密封包装，可以为一个袋子或托盘，至少一片所述的无纺布手术垫100灭菌密封于所述外包内。
本发明提供了一种如上的无纺布手术垫在外科手术或伤口护理过程中的 应用。
下面介绍本发明制造无纺布手术垫的水刺无纺布、及其纤维、X光追踪线20a、20b的各个实施例，并结合实施例将它们与对等的纱布、强生型无纺布、X光追踪线20a、20b的特性进行比较。
实施例1
本实施例采用不同纤维的水刺无纺布制作各种样品组，其中，比较了纱布、强生型无纺布和本申请的水刺无纺布制成的手术垫的拉伸强度、吸水性、绒毛水平。
该研究的样品和测试结果参见表1所示。结果显示，特别是对于具有更高克重(克/平方米)的较厚无纺布，本申请的水刺无纺布的拉伸强度与纱布的拉伸强度大致相同。与纱布相比，本申请的水刺无纺布的吸水率要高得多，而绒毛程度要低得多。此外，所有本申请的水刺无纺布样品的拉伸强度都比强生型无纺布样品高。因此，本申请的水刺无纺布应该适合外科手术使用。
表1本申请中所使用的水刺无纺布与纱布以及强生型无纺布的性能比较
Figure PCTCN2021074597-appb-000001
Figure PCTCN2021074597-appb-000002
实施例2
本实施例中使用粘胶纤维，竹纤维，棉纤维，聚酯纤维和棉织物制作了无纺布手术垫样品，其中，比较了本申请各个水刺无纺布制成的手术垫的拉伸强度、吸水性、绒毛水平。
该研究的样品和测试结果参见表2所示。结果显示，由粘胶纤维，竹纤维，棉纤维以及粘胶分别涤纶和棉的混合物制成的本申请的水刺无纺布的物理性能。它们的所有物理特性均可适用于外科手术。
表2由粘胶纤维、竹纤维、棉纤维以及粘胶分别与涤纶和棉的混合物制成的本申请的水刺无纺布性能比较
Figure PCTCN2021074597-appb-000003
Figure PCTCN2021074597-appb-000004
实施例3
本实施例使用了超声波焊接方法来制作各种样品组，其中，比较了纱布、强生型无纺布和本申请的水刺无纺布制成的手术垫的可见性和X光追踪性。研究了以下不同项目：
(a)一根X光追踪线，用于我们发明样式的无纺布、纱布、及强生型无纺布三种材料制成的手术垫。
(b)一根及两根X光追踪线。
(c)用于样品的两根颜色相同和颜色不同的X光追踪线20a、20b。
该研究的样品和测试结果参见表3所示。结果显示，具有两根颜色各不相同的X光追踪线20a、20b的手术垫综合得分最高，其次是具有相同颜色的两根X光追踪线20a、20b的手术垫，然后是其余类别手术垫，具有同等较低值的得分。
表3用于纱布、强生型无纺布及本申请水刺无纺布的X光追踪线性能比较
Figure PCTCN2021074597-appb-000005
Figure PCTCN2021074597-appb-000006
备注：上表所述的每根X光追踪线20是纯色。
综上所述，本申请的无纺布手术垫，包括：(a)由一层水刺无纺布制成的吸液垫10，其物理性能适合于手术用途，以及(b)两根橡胶线形态的X光追踪线20a、20b，连接在吸液垫10上。优选的，吸液垫10上每根X光追踪线20a、20b为纯色，不同X光追踪线20a、20b的颜色互不相同，一根X光追踪线20a的颜色比手术前的手术垫颜色深得多；另一根X光追踪线20b的颜色比手术后浸满血液的手术垫颜色浅得多。与只有一根X光追踪线的传 统手术垫相比，本发明的多色X线可以使本发明中的手术垫在很大程度上更加容易被检测得到，并使手术垫在手术前后在很大程度上更加容易计数。在手术垫不同部位有两根X光追踪线20a、20b还能够从很大程度上比只有一根X光追踪线的传统手术垫增强了手术垫的X光可追踪性。通过使用特殊的超声波焊接工艺来实现将橡胶线高度安全可靠地连接到无纺布上，而不采用通常用于纱布但不适用于无纺布的高温辊工艺。柔软而有强力的无纺布吸液垫10是由100％粘胶纤维、竹纤维或棉纤维制成，或者由这三种纤维分别与30％的聚酯或棉纤维混合制成；X光追踪线20a、20b是由PVC或TPE橡胶制成的，其中硫酸钡的重量占百分比约为60％。用于制造吸液垫10的无纺布，其织物重量范围为40克/平方米～120克/平方米。其中，无纺布在纵向和横向上的拉伸强度均不低于15牛顿，通过拉力测试仪对从无纺布上切下的5×10cm样品以每分钟约20厘米的十字头速度进行测试。此外，可以将橡胶X光追踪线20a、20b放置在无纺布的相同面或相反面上，它们的颜色可以彼此相同或明显不同。此外，这些线的特征是具有直线或波浪线形式。其中，X光追踪线20a、20b的宽度范围为0.1～2mm，厚度为0.01～1mm。吸液垫10的展开尺寸特征在于其宽度范围为5～200cm，长度范围为5～200cm，折叠层数范围为1～16层。如果需要，可以将取回提手30通过超声波焊接连接到吸液垫10的表面，其中，该取回提手30可以由聚丙烯或聚酯制成。一块或多块无纺布吸液垫10被封入密封的袋子或托盘中进行灭菌，其应用与外科手术或伤口护理相关。
需注意，过去所有用于改善手术垫安全性能的专利发明都集中在使用昂贵的附件以及外部电子设备和计算机来对手术前后的手术垫进行计数，而完全忽视了改善手术垫的重要性应该在于改善实际产品本身。相反，本申请集中在改进实际产品的关键部分，即吸液垫10和X光追踪线20a、20b。应该注意的是，因为不需要昂贵的附件或配件，本申请带X光追踪线20a、20b的无纺布手术垫不会增加成本。而且由于材料成本更低，制造工艺更加自动化，因此与传统的纱布手术垫相比，本申请带X光追踪线20a、20b无纺布手术垫不仅提高了安全性和整体性能，还可以为手术节省大量成本。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描 述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不必须针对的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任一个或多个实施例或示例中以合适的方式结合。此外，在不相互矛盾的情况下，本领域的技术人员可以将本说明书中描述的不同实施例或示例以及不同实施例或示例的特征进行结合和组合。
以上所述仅为本发明的优选实施例，并非因此限制本发明的专利范围，凡是在本发明的发明构思下，利用本发明说明书及附图内容所作的等效结构变换，或直接/间接运用在其他相关的技术领域均包括在本发明的专利保护范围内。

Claims (14)

  1. 一种无纺布手术垫，其特征在于，包括：
    吸液垫，所述吸液垫由具有预定拉伸强度的水刺无纺布制成，所述预定拉伸强度满足手术敷料强度要求；
    两根不同颜色的X光追踪线，两根所述X光追踪线通过超声波焊接工艺连接至所述吸液垫的表面；
    两根所述X光追踪线中的一根的颜色在手术前相对于所述吸液垫的颜色不同，两根所述X光追踪线中另一根的颜色在手术后相对于浸满血液的所述吸液垫的颜色不同。
  2. 根据权利要求1所述的无纺布手术垫，其特征在于，两根所述X光追踪线的颜色组合为深蓝和浅蓝，深绿和浅绿，深蓝和浅绿，深绿和浅蓝中的任意一种。
  3. 根据权利要求1所述的无纺布手术垫，其特征在于，所述吸液垫为粘胶纤维、竹纤维或棉纤维制成，或者所述吸液垫为第一纤维和第二纤维混合制成，所述第一纤维为粘胶纤维、竹纤维或棉纤维中的一种，所述第二纤维为聚酯纤维。
  4. 根据权利要求1所述的无纺布手术垫，其特征在于，所述吸液垫为采用交叉铺网水刺工艺制成。
  5. 根据权利要求1所述的无纺布手术垫，其特征在于，两根所述X光追踪线设在所述吸液垫的同一表面。
  6. 根据权利要求1所述的无纺布手术垫，其特征在于，两根所述X光追踪线设在所述吸液垫的不同表面。
  7. 根据权利要求1所述的无纺布手术垫，其特征在于，所述水刺无纺布的重量范围为40克/平方米至120克/平方米，其在纵向方向和横向方向上的拉伸强度均不低于15牛顿，该拉伸强度的测试方法是从织物上切下5厘米×10厘米的测试样品，用拉力检测机以十字头每分钟20厘米的速度进行测试。
  8. 根据权利要求1所述的无纺布手术垫，其特征在于，所述X光追踪线为橡胶线，其宽度范围为0.1毫米至2毫米，厚度范围为0.01毫米至1毫米。
  9. 根据权利要求1所述的无纺布手术垫，其特征在于，所述X光追踪线呈直线或波浪线形状。
  10. 根据权利要求1所述的无纺布手术垫，其特征在于，所述X光追踪线由含有硫酸钡的聚氯乙烯或热塑弹性体橡胶制成。
  11. 根据权利要求1所述的无纺布手术垫，其特征在于，所述吸液垫的展开尺寸范围为：宽度范围为5厘米至200厘米，长度范围为5厘米至200厘米，折叠层数为1至16层。
  12. 根据权利要求1所述的无纺布手术垫，其特征在于，所述无纺布手术垫还包括一取回提手，所述取回提手通过超声波焊接工艺连接到所述吸液垫的表面，其中，所述取回提手由聚丙烯或聚酯制成。
  13. 一种无纺布手术垫灭菌包，其特征在于，包括：
    外包，为无菌密封包装；
    至少一片如权利要求1至12中任一项所述的无纺布手术垫，至少一片所述的无纺布手术垫灭菌密封于所述外包内。
  14. 如权利要求1至13中的无纺布手术垫在外科手术或伤口护理过程中的应用。
PCT/CN2021/074597 2021-01-19 2021-02-01 无纺布手术垫、无纺布手术垫灭菌包及其应用 WO2022155993A1 (zh)

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