WO2018120873A1 - 防止留置针正压接头污染的装置及基于该装置的方法 - Google Patents

防止留置针正压接头污染的装置及基于该装置的方法 Download PDF

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Publication number
WO2018120873A1
WO2018120873A1 PCT/CN2017/099018 CN2017099018W WO2018120873A1 WO 2018120873 A1 WO2018120873 A1 WO 2018120873A1 CN 2017099018 W CN2017099018 W CN 2017099018W WO 2018120873 A1 WO2018120873 A1 WO 2018120873A1
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WIPO (PCT)
Prior art keywords
positive pressure
filter membrane
membrane
balance hole
pressure balance
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Application number
PCT/CN2017/099018
Other languages
English (en)
French (fr)
Inventor
毛振民
詹晓平
隆艳
王朝廷
Original Assignee
上海交通大学
上海金色医药科技发展有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海交通大学, 上海金色医药科技发展有限公司 filed Critical 上海交通大学
Priority to US16/473,626 priority Critical patent/US11697014B2/en
Priority to EP17886627.3A priority patent/EP3563893B1/en
Publication of WO2018120873A1 publication Critical patent/WO2018120873A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D46/00—Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
    • B01D46/54—Particle separators, e.g. dust precipitators, using ultra-fine filter sheets or diaphragms
    • B01D46/543—Particle separators, e.g. dust precipitators, using ultra-fine filter sheets or diaphragms using membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D46/00—Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
    • B01D46/56—Filters or filtering processes specially modified for separating dispersed particles from gases or vapours with multiple filtering elements, characterised by their mutual disposition
    • B01D46/62—Filters or filtering processes specially modified for separating dispersed particles from gases or vapours with multiple filtering elements, characterised by their mutual disposition connected in series
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/58—Multistep processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
    • B01D69/02—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor characterised by their properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
    • A61M2005/1657—Filter with membrane, e.g. membrane, flat sheet type infusion filter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A61M2039/205—Closure caps or plugs for connectors or open ends of tubes comprising air venting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7509—General characteristics of the apparatus with filters for virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7518—General characteristics of the apparatus with filters bacterial
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7545—General characteristics of the apparatus with filters for solid matter, e.g. microaggregates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2279/00—Filters adapted for separating dispersed particles from gases or vapours specially modified for specific uses
    • B01D2279/35—Filters adapted for separating dispersed particles from gases or vapours specially modified for specific uses for venting arrangements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2319/00—Membrane assemblies within one housing
    • B01D2319/02—Elements in series
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2325/00—Details relating to properties of membranes
    • B01D2325/02—Details relating to pores or porosity of the membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2325/00—Details relating to properties of membranes
    • B01D2325/02—Details relating to pores or porosity of the membranes
    • B01D2325/0283—Pore size
    • B01D2325/02834—Pore size more than 0.1 and up to 1 µm

Definitions

  • the invention belongs to the technical field of medical instruments, and relates to a device for preventing contamination of a positive pressure connector of an indwelling needle and a method based on the device.
  • intravenous indwelling needles not only greatly reduces the pain caused by repeated punctures in patients' long-term treatment, but also reduces the workload of nursing.
  • the intravenous indwelling needle with a positive pressure connector can prevent the medical staff from being pinched by the needle because the needle is not needed, thereby ensuring the personal safety of the nursing staff.
  • the positive pressure joint is not a one-time use product.
  • the replacement of the positive pressure joint is generally based on the replacement period of the indwelling needle.
  • the positive pressure joint after one infusion is easily contaminated.
  • the medical workers use the sterile gauze to wrap the interface of the positive pressure joint to prevent the interface of the positive pressure joint from being contaminated.
  • the medical staff wipes the interface of the positive pressure joint with 70%-75% alcohol. After the natural dry, access to the infusion system.
  • the interface of the positive pressure joint still has the possibility of being contaminated by microorganisms, chemicals and dust particles in the air, because: (1) the sterile gauze package is positive The interface of the pressure joint does not prevent microorganisms, chemicals and dust particles in the air from depositing on the interface of the positive pressure joint; (2) 70%-75% alcohol can only kill bacteria, can not kill spores and viruses; Iodophor disinfection, although it can kill bacterial propagules, spores, fungi, protozoa and some viruses, but iodophor is not volatile, and light is easy to decompose, resulting in chemical reagents will remain on the interface of positive pressure joints, such as infusion Chemical reagents are introduced into the body, causing allergic reactions; (3) positive pressure valves of positive pressure joints have seams with the inner wall of the positive pressure joint housing, and some positive pressure valves are also provided with a word or cross guide groove
  • CN201519335U discloses an anti-pollution structure of a medical indwelling needle positive pressure joint, the technical feature is a cylindrical interface cap with one end closed and the other end forming an internal thread, and the internal thread of one end of the interface cap and The external threads of the positive pressure joint can be tightly coupled.
  • the utility model patent can prevent the positive pressure joint from being exposed, the utility model allows the positive pressure joint to be in a closed space, which destroys the positive pressure condition of the positive pressure joint.
  • CN204745199U discloses a protective cap for preventing pollution of a medical indwelling needle positive pressure joint.
  • the protective cap comprises a cap and a tubular cap wall, and the tubular cap wall is provided with an internal thread adapted to the external thread of the positive pressure joint.
  • the cap is provided with a wiping device, and the wiping device has built-in cotton. After the infusion, the protective cap of the utility model is installed on the positive pressure joint, and before the infusion, the wiping device is rotated, the whole operation step is cumbersome, and the built-in cotton cannot completely disinfect the positive pressure joint.
  • the object of the present invention is to provide a device which is simple in structure, economical and practical, and convenient in operation for preventing contamination of a positive pressure connector of an indwelling needle in order to overcome the above-mentioned drawbacks of the prior art.
  • Another object of the present invention is to provide a method based on the apparatus for preventing contamination of a positive pressure connector of an indwelling needle.
  • a device for preventing contamination of a positive pressure connector of an indwelling needle comprising a casing, a connection port fixedly connected to the casing and connected to the positive pressure joint, a pressure balance hole disposed opposite to the connection port and being opened on the outer casing, and being disposed at the air pressure A filter membrane between the balance hole and the connection port.
  • the air pressure balance hole is provided with one or more, and the filter film is provided with one or more layers.
  • the air pressure balance hole is opened at the top of the outer casing, and the filter film is a single-layer filter film and is disposed close to the bottom of the air pressure balance hole, and the connection port is provided with the external thread of the positive pressure joint. Fitted with internal thread.
  • the pressure balance hole is opened at the top of the outer casing, and the filter membrane comprises a head filter membrane disposed at a bottom of the pressure balance hole and a second filter membrane directly under the head filter membrane, the connection
  • the internal thread is provided in the mouth to match the external thread of the positive pressure joint.
  • the top of the outer casing is provided with an upward protrusion, and the air pressure balance hole is opened at the convex portion.
  • the filter membrane comprises a head filter membrane disposed at a bottom of the pressure balance hole, a second filter membrane disposed under the head filter membrane from the top to the bottom, and a third filter membrane, the third filter membrane Adjacent to the top of the connection port, the connection port is provided with an internal thread adapted to the external thread of the positive pressure connector.
  • the top of the outer casing is provided with a downward groove, the air pressure balance hole is opened at the groove, the outer casing is provided with an upwardly convex platform, and the filter film comprises a pressure balance hole.
  • the top layer filter membrane disposed at the bottom and the second layer filter membrane disposed on the platform are provided with internal threads adapted to the external threads of the positive pressure joint.
  • the air pressure balance hole is opened on a side wall of the outer casing, and the outer casing is provided with an upwardly convex platform, and the filter film comprises a head layer filter film disposed on the platform and a filter film disposed on the head layer.
  • the platform is provided with an air guiding hole, which can open the air of the upper and lower cavities.
  • the shape of the air guiding hole includes, but is not limited to, a circle, an ellipse, a square, a rectangle or a triangle.
  • the number of the air guiding holes is at least one.
  • the air pressure balance hole is opened at the top of the outer casing, and the filter film comprises a head layer filter film disposed at a bottom of the air pressure balance hole and a second layer filter film disposed at a top of the connection port, the connection
  • the internal thread is provided in the mouth to match the external thread of the positive pressure joint.
  • the filtration membrane has a pore size of nanometer to micrometer, and the filtration membrane includes, but is not limited to, a polyethersulfone membrane, a cellulose membrane, a nuclear pore membrane, an ion membrane, a nylon membrane, a polytetrafluoroethylene membrane, Polyvinylidene fluoride film or polypropylene film.
  • the filter membrane can be made of the same material or different materials.
  • the filtration membrane has a pore diameter of 0.02 to 2 ⁇ m.
  • the filtration membrane has a pore diameter of 0.22 ⁇ m.
  • the shape of the outer casing includes, but is not limited to, a cylindrical shape, a spherical shape, an ellipsoidal shape, a rectangular shape, a gourd shape, an upper convex lower shape, an upper flat lower convex shape, an upper large lower small shape or a upper small lower shape, and the air pressure balance.
  • the pore size of the pores is on the order of nanometers to millimeters, and the shape of the gas pressure balance pores includes, but is not limited to, a circle, an ellipse, a square, a rectangle, or a triangle.
  • the material of the outer casing, the filter membrane and the connection port should be suitable for medical polymer materials or suitable Medical inorganic materials.
  • the material of the outer casing and the connecting port includes, but is not limited to, a copolymer of polypropylene, nylon, polyethylene, polystyrene, polycarbonate, acrylonitrile-butadiene-styrene, and a mixture. Vinyl fluoride, polytetrafluoroethylene or polyvinyl chloride.
  • the outer casing and the connecting port may be of the same material or different materials.
  • the design method of the device for preventing the contamination of the positive pressure connector of the indwelling needle is to isolate the pollution source through the filter membrane, and maintain the positive pressure condition of the indwelling needle positive pressure joint antifouling device through the air pressure balance hole, and the filter membrane can effectively filter microorganisms, bacteria, viruses, Dust, particulate matter, and positive pressure joints exchange gas with the outside through the air pressure balance hole to achieve positive pressure conditions.
  • the device is equipped with an appropriate connection port, which is compatible with all screw or non-threaded positive pressure joints.
  • the air pressure balance hole may be opened at any position of the outer casing, but the air balance balance hole and the positive pressure joint must be separated by at least one filter film.
  • the air pressure balance hole may be located at the side wall, the top, the protrusion or the recess of the outer casing.
  • the method for preventing the contamination of the positive pressure connector of the indwelling needle wherein the filter membrane is disposed between the air pressure balance hole and the connection port, and the microbial, bacteria, virus, dust, particulate matter pollution source is filtered through the filter membrane, and the air pressure is passed through the air pressure.
  • the balance hole communicates the inner cavity of the outer casing with the outside to realize gas exchange and ensures that the device is in a positive pressure state.
  • the device of the present invention is used during indwelling of the infusion interval to prevent the positive pressure connector from being exposed to the air and maintaining its sterility during indwelling of the infusion interval. Since the outer casing is provided with a pressure balance hole, the air in the device can be exchanged with the outside. When the positive pressure joint is connected with the antifouling device, the positive pressure of the positive pressure joint can be maintained for a long time. Since the pore size of the filter membrane is from nanometer to micrometer, the rejection is high, and the microorganism, bacteria, virus, dust, particulate matter and the like can be effectively filtered.
  • one of the filter membranes is preferably placed in close contact with the bottom of the gas pressure balance orifice to prevent moisture from depositing in the antifouling device.
  • the nursing staff only needs to put on the anti-fouling device of the present invention on the positive pressure joint after each infusion, and the anti-fouling device of the upper sleeve of the positive pressure joint is disassembled in the next infusion, and then the conventional infusion can be performed. Since the interface of the positive pressure joint is not exposed to the air, the caregiver does not need to wipe the interface of the positive pressure joint with alcohol, which not only improves the working efficiency of the medical staff, but also avoids contamination of the positive pressure joint which is not completely disinfected during the infusion process.
  • the drug causes the patient to have an accident.
  • the device of the invention has a simple overall structure, is economical and practical, and adopts a filter membrane structure. Designed to effectively filter suspected sources of microorganisms, bacteria, viruses, dust, particulates, etc., used during the indwelling period of infusion, to prevent the positive pressure joints from being exposed to the air, to maintain their sterility during the infusion period.
  • the pressure condition while omitting the operation of the medical staff to wrap the positive pressure joint with sterile gauze after one infusion and the operation of wiping the positive pressure head before re-infusion, improve the working efficiency of the medical staff.
  • Figure 1 is a cross-sectional view of the first embodiment
  • Figure 2 is a cross-sectional view of the embodiment 2
  • Figure 3 is a cross-sectional view of a third embodiment
  • Figure 4 is a cross-sectional view of the fourth embodiment
  • Figure 5 is a cross-sectional view showing a section 5
  • Figure 6 is a cross-sectional view of the sixth embodiment
  • Figure 7 is a schematic view showing the structure of the apparatus of the present invention and the positive pressure joint assembly.
  • the apparatus of the present embodiment comprises a casing 1, a single-layer filter membrane 2 and a connection port 3.
  • the connection port 3 is provided with an internal thread 4 adapted to the external thread of the positive pressure joint 6, and the air pressure balance hole 5 is located.
  • a single-layer filter membrane 2 is placed in close contact with the bottom of the gas pressure balance hole 5.
  • the pore size of the filtration membrane is from nanometer to micrometer, and the filtration membrane includes but is not limited to polyethersulfone membrane, cellulose membrane, nuclear pore membrane, ion membrane, nylon membrane, polytetrafluoroethylene membrane, poly A vinylidene fluoride film or a polypropylene film.
  • the shape of the outer casing 1 includes, but is not limited to, a cylindrical shape, a spherical shape, an ellipsoidal shape, a rectangular shape, a gourd shape, an upper convex lower flat shape, an upper flat lower convex shape, an upper large lower small shape, or an upper small lower large shape.
  • the pore diameter of the gas pressure balance hole 5 is on the order of nanometers to millimeters, and the shape of the gas pressure balance hole 5 includes, but is not limited to, a circle, an ellipse, a square, a rectangle, or a triangle.
  • the device of this embodiment is provided with an adapted connection port 3, which can be connected to the positive pressure connector 6.
  • the filter membrane is disposed between the air pressure balance hole and the connection port, and the microbial, bacteria, virus, dust, particulate matter pollution source is isolated and filtered through the filter membrane, and the inside of the outer casing is passed through the air pressure balance hole.
  • the cavity communicates with the outside to achieve gas exchange, ensuring that the device is in a positive pressure state.
  • the apparatus of the present embodiment includes a casing 1, a connection port 3 fixedly connected to the casing 1 and connected to the positive pressure joint 6, a pressure balance hole 5 disposed opposite to the connection port 3 and opened on the casing 1, and A filter membrane is disposed between the air pressure balance hole 5 and the connection port 3.
  • the air pressure balance hole 5 is opened at the top of the outer casing 1, and the filter film includes a head layer filter film 2a disposed at the bottom of the air pressure balance hole 5 and a second layer filter film 2b directly below the head layer filter film 2a, the connection port 3 is provided with an internal thread 4 adapted to the external thread of the positive pressure joint 6.
  • the rest are the same as in the first embodiment.
  • the apparatus of the present embodiment includes a casing 1, a connection port 3 fixedly connected to the casing 1 and connected to the positive pressure joint 6, a pressure balance hole 5 disposed opposite to the connection port 3 and opened on the casing 1, and A filter membrane is disposed between the air pressure balance hole 5 and the connection port 3.
  • the top of the outer casing 1 is provided with an upward convex portion, and the air pressure balance hole 5 is opened at the convex portion.
  • the filter membrane comprises a head layer filter membrane 2a disposed at the bottom of the air pressure balance hole 5, and is arranged in the head layer from top to bottom. a second filter membrane 2b and a third filter membrane 2c under the membrane 2a, the third filter membrane 2c is disposed close to the top of the connection port 3, and the connection port 3 is provided with the external thread of the positive pressure joint 6. Fitted with internal thread 4.
  • the rest are the same as in the first embodiment.
  • the apparatus of the present embodiment includes a casing 1, a connection port 3 fixedly connected to the casing 1 and connected to the positive pressure joint 6, a pressure balance hole 5 disposed opposite to the connection port 3 and opened on the casing 1, and A filter membrane is disposed between the air pressure balance hole 5 and the connection port 3.
  • the top of the outer casing 1 is provided with a downward groove, and the air balance hole 5 is opened at the groove, and the inside of the outer casing 1
  • the platform is provided with an upward convexity, and the platform is provided with at least one air guiding hole, and the air guiding hole can conduct the air of the upper and lower cavities.
  • the shape of the air vents includes, but is not limited to, a circle, an ellipse, a square, a rectangle, or a triangle.
  • the filter membrane includes a head filter membrane 2a disposed at the bottom of the pressure balance hole 5 and a second filter membrane 2b disposed on the platform.
  • the joint port 3 is provided with an inner thread adapted to the external thread of the positive pressure joint 6. Thread 4.
  • the rest are the same as in the first embodiment.
  • the apparatus of the present embodiment includes a casing 1, a connection port 3 fixedly connected to the casing 1 and connected to the positive pressure joint 6, a gas pressure balance hole 5 opened on the casing 1, and a balance pressure hole 5 and A filter membrane between the ports 3.
  • the air balance hole 5 is formed on the side wall of the outer casing 1.
  • the inner portion of the outer casing 1 is provided with an upwardly convex platform.
  • the platform is provided with at least one air guiding hole, and the air guiding hole can open the air of the upper and lower cavities.
  • the shape of the air vents includes, but is not limited to, a circle, an ellipse, a square, a rectangle, or a triangle.
  • the filter membrane comprises a head filtration membrane 2a disposed on the platform and a second filtration membrane 2b disposed between the head filtration membrane 2a and the connection port 3, and the external thread of the positive pressure joint 6 is disposed in the connection port 3. Fitted internal thread 4.
  • the rest are the same as in the first embodiment.
  • the apparatus of the present embodiment includes a casing 1, a connection port 3 fixedly connected to the casing 1 and connected to the positive pressure joint 6, a pressure balance hole 5 disposed opposite to the connection port 3 and opened on the casing 1, and A filter membrane is disposed between the air pressure balance hole 5 and the connection port 3.
  • the air pressure balance hole 5 is opened at the top of the outer casing 1.
  • the filter film includes a head layer filter film 2a disposed at the bottom of the air balance hole 5 and a second layer filter film 2b disposed at the top of the connection port 3, and the connection port 3 is provided.
  • An internal thread 4 is provided which is adapted to the external thread of the positive pressure connection 6.
  • the rest are the same as in the first embodiment.
  • the internal thread 4 of the apparatus of the present embodiment is connected to the external thread of the positive pressure joint 6.
  • the rest is the same as in the third embodiment.
  • the device After an infusion, the device is mounted at the interface end of the positive pressure joint 6 through the connection port 3, preventing the interface of the positive pressure joint 6 from being contaminated by potential contaminants due to prolonged exposure to the air. Under In the case of secondary infusion, the anti-fouling device of the upper positive pressure joint 6 is released, and then the conventional infusion can be performed. Since the air pressure balance hole 5 is provided on the outer casing 1 of the apparatus, the positive pressure can be maintained for a long time. Due to the high rejection rate of the filter membrane, effective filtration of microorganisms, dust, particulate matter, etc. can be achieved without contaminating the interface of the positive pressure joint 6. Due to the design of the multilayer filter membrane, the deposition of moisture in the air within the outer casing 1 can be avoided. Since the interface of the positive pressure connector 6 is not exposed to the air, the caregiver does not need to wipe the interface of the positive pressure connector with alcohol, thereby improving the working efficiency of the medical staff.

Abstract

一种防止留置针正压接头（6）污染的装置及基于该装置的方法。该装置包括外壳（1）、与外壳（1）固定连接且用于连接正压接头（6）的连接口（3）、与连接口（3）相对设置且开设在外壳（1）上的气压平衡孔（5）、以及设置在气压平衡孔（5）与连接口（3）之间的过滤膜（2）。该装置结构简单，采用过滤膜（2）结构设计，可以过滤微生物、细菌、病毒、粉尘和颗粒物污染源，在输液间歇的留置期间使用，防止正压接头（6）暴露在空气中，保持正压接头（6）在留置期间的无菌状态和正压条件。省略了医护人员在输液后用无菌纱布包裹正压接头（6）以及在输液前用酒精擦拭正压接头（6）的操作，提高了医护人员的工作效率。

Description

防止留置针正压接头污染的装置及基于该装置的方法 技术领域
本发明属于医疗器械技术领域，涉及一种防止留置针正压接头污染的装置及基于该装置的方法。
背景技术
静脉留置针的广泛应用，不仅大大减少了患者长期治疗中需反复穿刺所造成的痛苦，也减轻了护理工作量。尤其是带有正压接头的静脉留置针，由于无需使用针头，可以避免医护人员被针头扎伤，保障了护理人员的人身安全。
正压接头不是一次性使用的产品，正压接头的更换一般根据留置针的更换期而定，在患者连续输液的期间，一次输液后的正压接头极易被污染。目前，医护工作者均采用输液后，用无菌纱布包裹正压接头的接口，防止正压接头的接口被污染，再次输液前，医护人员用70％—75％酒精擦拭正压接头的接口，待自然干后，接入输液系统。这样的操作，不仅过程繁琐，增加了医护人员的劳动强度，而且正压接头的接口仍存在被微生物、化学物质以及空气中的粉尘颗粒物污染的可能，原因在于：(1)无菌纱布包裹正压接头的接口，并不能阻止微生物、化学物质以及空气中的粉尘颗粒物沉积在正压接头的接口；(2)70％—75％酒精只能杀死细菌，不能杀死芽孢和病毒；若用碘伏消毒，虽然可杀灭细菌繁殖体、芽孢、真菌、原虫和部分病毒，但碘伏不挥发，且见光易分解，导致化学试剂会残留在正压接头的接口上，输液时这类化学试剂被带入体内，会导致过敏反应；(3)正压接头的正压阀与正压接头外壳的内壁有接缝，有的正压阀还设有一字或十字的导流槽，这些狭窄的空间通常会导致药物、微生物或杂质的滞留，即使用70％—75％的酒精擦拭，也很难清洗干净，输液时给病人造成潜在风险。
CN201519335U公开了一种医用留置针正压接头的防污染结构，其技术特点是一端封闭，另一端形成内螺纹的圆筒状接口帽，该接口帽一端的内螺纹与 正压接头的外螺纹可紧密结合。该实用新型专利虽然可以避免正压接头处于暴露状态，但该实用新型让正压接头处于一个封闭的空间，破坏了正压接头的正压条件。
CN204745199U公开了一种防止医用留置针正压接头污染的防护帽，其技术特点是防护帽包括帽盖和管状帽壁，其管状帽壁内设置有与正压接头的外螺纹相适应的内螺纹，其盖帽上设置有擦拭装置，擦拭装置内置棉花。输液后将该实用新型的防护帽安装在正压接头上，再次输液前，旋转擦拭装置，整个操作步骤繁琐，而且内置的棉花并不能彻底消毒正压接头。
现有的关于防止正压接头污染的技术都没有使用到膜隔离方法。其实，膜隔离方法在药品生产过程中，尤其是液体药品的制造过程中被广泛使用，因为过滤膜可以有效地祛除细菌及颗粒，是一种安全、可靠的方法。
发明内容
本发明的目的就是为了克服上述现有技术存在的缺陷而提供一种结构简单，经济实用，操作方便的防止留置针正压接头污染的装置。
本发明的另一个目的就是提供基于所述防止留置针正压接头污染的装置的方法。
本发明的目的可以通过以下技术方案来实现：
一种防止留置针正压接头污染的装置，该装置包括外壳、与外壳固定连接且用于连接正压接头的连接口、与连接口相对设置且开设在外壳上的气压平衡孔以及设置在气压平衡孔与连接口之间的过滤膜。
所述的气压平衡孔设有一个或多个，所述的过滤膜设有一层或多层。
所述的气压平衡孔开设在外壳的顶部，所述的过滤膜为单层过滤膜，并紧贴气压平衡孔的底部设置，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的气压平衡孔开设在外壳的顶部，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及位于头层过滤膜正下方的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的外壳的顶部设有向上的凸起，所述的气压平衡孔开设在凸起处，所 述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜、由上而下依次设置在头层过滤膜下方的第二层过滤膜及第三层过滤膜，该第三层过滤膜紧贴连接口的顶部设置，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的外壳的顶部设有向下的凹槽，所述的气压平衡孔开设在凹槽处，所述的外壳内部设有向上凸起的平台，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及布设在平台上的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的气压平衡孔开设在外壳的侧壁上，所述的外壳内部设有向上凸起的平台，所述的过滤膜包括布设在平台上的头层过滤膜以及设置在头层过滤膜与连接口之间的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的平台上开设有导气孔，能将上下两空腔的空气导通。
所述的导气孔的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。
所述的导气孔的数量为至少1个。
所述的气压平衡孔开设在外壳的顶部，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及紧贴连接口的顶部设置的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
所述的过滤膜的孔径为纳米级至微米级，并且所述的过滤膜包括但不限于聚醚砜膜、纤维素滤膜、核孔膜、离子膜、尼龙膜、聚四氟乙烯膜、聚偏氟乙烯膜或聚丙烯膜。
所述的过滤膜可以采用同种材质或不同种材质。
所述的过滤膜的孔径为0.02-2μm。
作为优选的技术方案，所述的过滤膜的孔径为0.22μm。
所述的外壳的形状包括但不限于圆柱形、球形、椭球形、矩形、葫芦形、上凸下平形、上平下凸形、上大下小形或上小下大形，所述的气压平衡孔的孔径为纳米级至毫米级，并且气压平衡孔的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。
所述的外壳、过滤膜、连接口的材料应该是适合医用的高分子材料或适合 医用的无机材料。
作为优选的技术方案，所述的外壳、连接口的材质包括但不限于聚丙烯、尼龙、聚乙烯、聚苯乙烯、聚碳酸酯、丙烯腈-丁二烯-苯乙烯的共聚物、聚偏氟乙烯、聚四氟乙烯或聚氯乙烯。
所述的外壳与连接口可以采用同种材质或不同种材质。
本发明防止留置针正压接头污染的装置的设计思路是通过过滤膜隔绝污染源，通过气压平衡孔保持正压条件的留置针正压接头防污装置，过滤膜可以有效过滤微生物、细菌、病毒、粉尘、颗粒物，正压接头通过气压平衡孔与外界进行气体交换，从而达到正压条件，装置设有适配的连接口，可以兼容所有的螺口或非螺口的正压接头。
在实际的结构设计中，所述的气压平衡孔可以开设在外壳的任何一个位置，但气压平衡孔与正压接头之间必须被至少一层过滤膜隔离。所述的气压平衡孔可以位于外壳的侧壁处、顶部、凸起处或凹陷处。
基于上述防止留置针正压接头污染的装置的方法，该方法是在气压平衡孔与连接口之间设置过滤膜，通过过滤膜隔离并过滤微生物、细菌、病毒、粉尘、颗粒物污染源，并通过气压平衡孔将外壳的内腔与外界连通，实现气体交换，保证装置处于正压状态。
在实际应用时，本发明装置在输液间歇的留置期间使用，可以防止正压接头暴露在空气中，保持其在输液间歇的留置期间的无菌状态。由于外壳设有气压平衡孔，装置内的空气可与外界进行交换，当正压接头与防污装置连接后，可长时间保持正压接头的正压作用。由于过滤膜的孔径为纳米级至微米级，截留率高，可对微生物、细菌、病毒、粉尘、颗粒物等达到有效过滤。在优选两层过滤膜的情况下，其中一层过滤膜优选紧紧贴在气压平衡孔的底部设置，可避免水汽沉积在防污装置中。护理人员只需要在每次输液后，在正压接头上套上本发明的防污装置，下次输液时，解下正压接头上套的防污装置，再进行常规输液即可。由于正压接头的接口不暴露在空气中，护理人员不需要用酒精擦拭消毒正压接头的接口，不仅提高了医护人员的工作效率，也避免了消毒不彻底的正压接头在输液过程中污染药物，导致患者发生意外事故。
与现有技术相比，本发明装置整体结构简单，经济实用，采用过滤膜结构 设计，可以有效过滤微生物、细菌、病毒、粉尘、颗粒物等可疑污染源，在输液间歇的留置期间使用，可以防止正压接头暴露在空气中，保持其在输液间歇的留置期间的无菌状态和正压条件，同时省略了医护人员在一次输液后用无菌纱布包裹正压接头的操作以及再次输液前酒精擦拭正压头的操作，提高医护人员的工作效率。
附图说明
图1是实施例1截面剖视图；
图2是实施例2截面剖视图；
图3是实施例3截面剖视图；
图4是实施例4截面剖视图；
图5是实施例5截面剖视图；
图6是实施例6截面剖视图；
图7是本发明装置与正压接头装配处的结构示意图。
图中标记说明：
1—外壳，2—单层过滤膜，2a—头层过滤膜，2b—第二层过滤膜，2c—第三层过滤膜，3—连接口，4—内螺纹，5—气压平衡孔，6—正压接头。
具体实施方式
下面结合附图和具体实施例对本发明进行详细说明。
实施例1：
如图1所示，本实施例装置包括外壳1、单层过滤膜2和连接口3，连接口3内设置有与正压接头6的外螺纹相适应的内螺纹4，气压平衡孔5位于外壳1的顶部，单层过滤膜2紧贴在气压平衡孔5的底部设置。
本实施例中，过滤膜的孔径为纳米级至微米级，并且过滤膜包括但不限于聚醚砜膜、纤维素滤膜、核孔膜、离子膜、尼龙膜、聚四氟乙烯膜、聚偏氟乙烯膜或聚丙烯膜。
在进行结构设计时，外壳1的形状包括但不限于圆柱形、球形、椭球形、矩形、葫芦形、上凸下平形、上平下凸形、上大下小形或上小下大形。
气压平衡孔5的孔径为纳米级至毫米级，并且气压平衡孔5的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。
本实施例装置设有适配的连接口3，可以与正压接头6相连接。
基于本实施例装置的方法，该方法是在气压平衡孔与连接口之间设置过滤膜，通过过滤膜隔离并过滤微生物、细菌、病毒、粉尘、颗粒物污染源，并通过气压平衡孔将外壳的内腔与外界连通，实现气体交换，保证装置处于正压状态。
实施例2：
如图2所示，本实施例装置包括外壳1、与外壳1固定连接且用于连接正压接头6的连接口3、与连接口3相对设置且开设在外壳1上的气压平衡孔5以及设置在气压平衡孔5与连接口3之间的过滤膜。
其中，气压平衡孔5开设在外壳1的顶部，过滤膜包括紧贴气压平衡孔5的底部设置的头层过滤膜2a以及位于头层过滤膜2a正下方的第二层过滤膜2b，连接口3内设有与正压接头6的外螺纹相适配的内螺纹4。
其余同实施例1。
实施例3：
如图3所示，本实施例装置包括外壳1、与外壳1固定连接且用于连接正压接头6的连接口3、与连接口3相对设置且开设在外壳1上的气压平衡孔5以及设置在气压平衡孔5与连接口3之间的过滤膜。
外壳1的顶部设有向上的凸起，气压平衡孔5开设在凸起处，过滤膜包括紧贴气压平衡孔5的底部设置的头层过滤膜2a、由上而下依次设置在头层过滤膜2a下方的第二层过滤膜2b及第三层过滤膜2c，该第三层过滤膜2c紧贴连接口3的顶部设置，连接口3内设有与正压接头6的外螺纹相适配的内螺纹4。
其余同实施例1。
实施例4：
如图4所示，本实施例装置包括外壳1、与外壳1固定连接且用于连接正压接头6的连接口3、与连接口3相对设置且开设在外壳1上的气压平衡孔5以及设置在气压平衡孔5与连接口3之间的过滤膜。
外壳1的顶部设有向下的凹槽，气压平衡孔5开设在凹槽处，外壳1内部 设有向上凸起的平台，该平台上开设有至少1个导气孔，该导气孔能将上下两空腔的空气导通。导气孔的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。过滤膜包括紧贴气压平衡孔5的底部设置的头层过滤膜2a以及布设在平台上的第二层过滤膜2b，连接口3内设有与正压接头6的外螺纹相适配的内螺纹4。
其余同实施例1。
实施例5：
如图5所示，本实施例装置包括外壳1、与外壳1固定连接且用于连接正压接头6的连接口3、开设在外壳1上的气压平衡孔5以及设置在气压平衡孔5与连接口3之间的过滤膜。
气压平衡孔5开设在外壳1的侧壁上，外壳1内部设有向上凸起的平台，该平台上开设有至少1个导气孔，该导气孔能将上下两空腔的空气导通。导气孔的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。过滤膜包括布设在平台上的头层过滤膜2a以及设置在头层过滤膜2a与连接口3之间的第二层过滤膜2b，连接口3内设有与正压接头6的外螺纹相适配的内螺纹4。
其余同实施例1。
实施例6：
如图6所示，本实施例装置包括外壳1、与外壳1固定连接且用于连接正压接头6的连接口3、与连接口3相对设置且开设在外壳1上的气压平衡孔5以及设置在气压平衡孔5与连接口3之间的过滤膜。
气压平衡孔5开设在外壳1的顶部，过滤膜包括紧贴气压平衡孔5的底部设置的头层过滤膜2a以及紧贴连接口3的顶部设置的第二层过滤膜2b，连接口3内设有与正压接头6的外螺纹相适配的内螺纹4。
其余同实施例1。
实施例7：
如图7所示，本实施例装置的内螺纹4与正压接头6的外螺纹相连接。
其余同实施例3。
在一次输液后，将装置通过连接口3安装在正压接头6的接口端，防止正压接头6的接口由于长时间暴露在空气中，而被潜在污染物污染的可能。在下 次输液时，解除下正压接头6上套的防污装置，再进行常规输液即可。由于装置的外壳1上设有气压平衡孔5，可长时间保持正压的作用。由于过滤膜截留率高，可对微生物、粉尘、颗粒物等达到有效过滤，不会污染正压接头6的接口。由于多层过滤膜的设计，可以避免空气中的水分在外壳1内的沉积。由于正压接头6的接口不暴露在空气中，护理人员不需要用酒精擦拭消毒正压接头的接口，提高了医护人员的工作效率。
上述的对实施例的描述是为便于该技术领域的普通技术人员能理解和使用发明。熟悉本领域技术的人员显然可以容易地对这些实施例做出各种修改，并把在此说明的一般原理应用到其他实施例中而不必经过创造性的劳动。因此，本发明不限于上述实施例，本领域技术人员根据本发明的揭示，不脱离本发明范畴所做出的改进和修改都应该在本发明的保护范围之内。

Claims (10)

  1. 防止留置针正压接头污染的装置，其特征在于，该装置包括外壳、与外壳固定连接且用于连接正压接头的连接口、与连接口相对设置且开设在外壳上的气压平衡孔以及设置在气压平衡孔与连接口之间的过滤膜。
  2. 根据权利要求1所述的防止留置针正压接头污染的装置，其特征在于，所述的气压平衡孔设有一个或多个，所述的过滤膜设有一层或多层。
  3. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的气压平衡孔开设在外壳的顶部，所述的过滤膜为单层过滤膜，并紧贴气压平衡孔的底部设置，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  4. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的气压平衡孔开设在外壳的顶部，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及位于头层过滤膜正下方的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  5. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的外壳的顶部设有向上的凸起，所述的气压平衡孔开设在凸起处，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜、由上而下依次设置在头层过滤膜下方的第二层过滤膜及第三层过滤膜，该第三层过滤膜紧贴连接口的顶部设置，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  6. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的外壳的顶部设有向下的凹槽，所述的气压平衡孔开设在凹槽处，所述的外壳内部设有向上凸起的平台，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及布设在平台上的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  7. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的气压平衡孔开设在外壳的侧壁上，所述的外壳内部设有向上凸起的平台，所述的过滤膜包括布设在平台上的头层过滤膜以及设置在头层过滤膜与连接口 之间的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  8. 根据权利要求2所述的防止留置针正压接头污染的装置，其特征在于，所述的气压平衡孔开设在外壳的顶部，所述的过滤膜包括紧贴气压平衡孔的底部设置的头层过滤膜以及紧贴连接口的顶部设置的第二层过滤膜，所述的连接口内设有与正压接头的外螺纹相适配的内螺纹。
  9. 根据权利要求1至8任一项所述的防止留置针正压接头污染的装置，其特征在于，所述的过滤膜的孔径为0.02-2μm，并且所述的过滤膜包括但不限于聚醚砜膜、纤维素滤膜、核孔膜、离子膜、尼龙膜、聚四氟乙烯膜、聚偏氟乙烯膜或聚丙烯膜；
    所述的外壳的形状包括但不限于圆柱形、球形、椭球形、矩形、葫芦形、上凸下平形、上平下凸形、上大下小形或上小下大形；
    所述的气压平衡孔的孔径为纳米级至毫米级，并且气压平衡孔的形状包括但不限于圆形、椭圆形、正方形、长方形或三角形。
  10. 基于权利要求1所述的防止留置针正压接头污染的装置的方法，其特征在于，该方法是在气压平衡孔与连接口之间设置过滤膜，通过过滤膜隔离并过滤微生物、细菌、病毒、粉尘、颗粒物污染源，并通过气压平衡孔将外壳的内腔与外界连通，实现气体交换，保证装置处于正压状态。
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