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WO2018161770A1 - Emballage de produit jetable comprenant un sac d'échantillon de type enroulable - Google Patents

Emballage de produit jetable comprenant un sac d'échantillon de type enroulable Download PDF

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Publication number
WO2018161770A1
WO2018161770A1 PCT/CN2018/075807 CN2018075807W WO2018161770A1 WO 2018161770 A1 WO2018161770 A1 WO 2018161770A1 CN 2018075807 W CN2018075807 W CN 2018075807W WO 2018161770 A1 WO2018161770 A1 WO 2018161770A1
Authority
WO
WIPO (PCT)
Prior art keywords
specimen bag
bag
specimen
state
buckle
Prior art date
Application number
PCT/CN2018/075807
Other languages
English (en)
Chinese (zh)
Inventor
朱莫恕
Original Assignee
成都五义医疗科技有限公司
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 成都五义医疗科技有限公司 filed Critical 成都五义医疗科技有限公司
Publication of WO2018161770A1 publication Critical patent/WO2018161770A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/04Endoscopic instruments, e.g. catheter-type instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/50Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B31MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31BMAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00Making flexible containers, e.g. envelopes or bags
    • B31B70/26Folding sheets, blanks or webs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B31MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31BMAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00Making flexible containers, e.g. envelopes or bags
    • B31B70/74Auxiliary operations
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B31MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31BMAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
    • B31B70/00Making flexible containers, e.g. envelopes or bags
    • B31B70/74Auxiliary operations
    • B31B70/81Forming or attaching accessories, e.g. opening devices, closures or tear strings
    • B31B70/813Applying closures
    • B31B70/8134Applying strings; Making string-closed bags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00287Bags for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00296Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means mounted on an endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00526Methods of manufacturing

Definitions

  • the present invention relates to minimally invasive surgical instruments, and more particularly to a disposable specimen bag product package.
  • the second category consists of a specimen bag, a catheter and a retrieval device for the distraction mechanism.
  • the opening mechanism pushes the rolled specimen bag out of the catheter, and the specimen bag is opened by the opening mechanism to facilitate the insertion of the cut tissue or the diseased organ during the operation.
  • the aforementioned single specimen bag and the retrieval device are single-use products, and the structure of the retrieval device is complicated and the manufacturing cost is high, and the cost is urgently required.
  • the single specimen bag has a simple structure and low manufacturing cost, but generally cannot meet the clinical needs. How to improve the clinical application performance of the single specimen bag is one of the important problems to be solved in the field.
  • Prior art single specimen bag products are typically packaged and sterilized for clinical use in a tiled state.
  • the doctor first needs to wrap the specimen bag into a slender strip to facilitate the entry of the specimen bag into the patient's body cavity through the puncture cannula channel.
  • wrapping the specimen bag by hand in a surgical environment is often a waste of time and destroys the sterility of the specimen bag. Therefore, usually the doctor can only choose not to wrap the specimen bag, and directly use the surgical forceps to hold the specimen bag body and then feed it into the patient's body cavity through the puncture cannula channel, which causes the specimen bag to be disorganized and deformed, thereby causing the specimen bag to block the puncture cannula channel.
  • the surgical forceps may easily damage the bag body of the specimen bag, and may be broken by a large pressing force during the process of pulling out the body after the specimen bag is filled with the diseased tissue.
  • the clinical application of the single specimen bag product is not extensive due to inconvenient use or frequent rupture accidents.
  • the single specimen bag solution can significantly reduce costs and help reduce costs.
  • a retrieval device with a complicated expansion mechanism is usually not required, and only a single specimen bag is sufficient. Therefore, the clinical application convenience and rupture accident problem of the single specimen bag can be properly solved, and it is expected to promote the clinical application of the single specimen bag and reduce the operation cost.
  • a pre-crimped single specimen bag which is first folded into an elongated shape or rolled up into a reel shape and then used as a thin wire (rope) or other tie-wound device. It is fixed, kept in a curled state, and then sterilized in a packaging bag for clinical application to solve the defects of the prior art single specimen bag clinical application.
  • a disposable specimen bag product package comprising a specimen bag and an aseptic packaging system for sale in a sterile state and for use by a customer
  • the aseptic packaging system ensuring that the specimen bag is in Aseptic.
  • the specimen bag includes a bag opening that can be opened and closed, and a closed bag body that extends from the mouth of the bag.
  • the specimen bag also includes a tunnel surrounding the pocket and a pull wire interspersed in the tunnel.
  • the specimen bag includes a stretched state and a curled state; in the crimped state, the specimen bag is folded into an elongated shape or rolled up into a roll shape.
  • the specimen bag further includes a tie coil for fixing the specimen bag to a curled state to prevent the specimen bag from automatically changing from a curled state to a stretched state.
  • the tie coil is formed from an elongated cord, including at least two live clasps, or includes at least one dead clasp and one clasp.
  • the live clasp that is, pulling the end of the cord constituting the clasp, the clasp is automatically unwrapped; and the dead clasp, that is, pulling the end of the cord constituting the dead clasp, The dead knot is tightened and tightened and does not automatically unravel.
  • the tie coil, the live clasp or the dead clasp is composed of a pull wire provided by the specimen bag.
  • the tie coil, the live clasp or the dead clasp is composed of an additional additional cord.
  • a method of manufacturing a crimped state of a specimen bag for the specimen bag product package comprising the following main steps:
  • the wire coil comprises two live buckles, or comprises one dead knot and one live buckle, and can be pulled by pulling The proximal end of the pull wire unwinds the live clasp.
  • a method for tying the specimen bag product package comprising the following main steps:
  • Another method of tying the specimen bag product package includes the following main steps:
  • a method of using the specimen bag product package comprising the following main steps:
  • Figure 1 is a perspective view showing the development of a specimen bag according to a first embodiment of the present invention
  • Figure 2 is a schematic view showing the folding of the specimen bag shown in Figure 1;
  • 3A-3C are schematic views showing the bag body of the specimen bag shown in Fig. 2 rolled up into a roll shape;
  • FIGS. 4A-4C are schematic views of the bag body of the specimen bag shown in Fig. 2 folded into an elongated strip shape;
  • 5A-5I are schematic diagrams of the binding of a double-lived buckle of the specimen bag shown in FIG. 3 or FIG. 4;
  • 6A-6G are schematic diagrams of the binding of a dead buckle knot and a live buckle of the specimen bag shown in FIG. 3 or FIG. 4;
  • Figure 7 is a perspective view showing the package of the specimen bag product package of the present invention.
  • Figure 8 is a schematic view showing the unpacking of the specimen bag product package of the present invention.
  • Figure 9 is a schematic view of a specimen bag holding a crimped state using a universal non-destructive gripper
  • Figure 10 is a schematic view of the specimen bag being inserted into the patient through the puncture cannula as shown in Figure 9;
  • Figure 11 is a schematic view of the pull wire release live buckle
  • Figure 12 is a schematic view of the operation of the patient to make the specimen bag into a stretched state
  • Figure 13 is a schematic view showing the operation of the specimen bag containing the specimen or the diseased tissue
  • Figure 14 is a schematic view of the bag opening of the specimen bag
  • Figure 15 is a schematic illustration of the removal of a tissue-loaded specimen bag from the body.
  • FIGS 1-2 detail the construction and composition of the specimen pouch 100 of the first embodiment of the present invention.
  • the specimen bag 100 is usually formed by overlapping and welding a single piece of film, or by welding two pieces of film.
  • Materials for the film include, but are not limited to, polyethylene, polyvinyl chloride, polypropylene, nylon, Teflon, thermoset elastomers, and thermoplastic elastomers such as polyurethane.
  • Film bonding processes include, but are not limited to, heat welding, ultrasonic welding, high frequency welding, radiation welding, pulse welding, and the like.
  • the specimen bag 100 is formed by folding and laminating a single piece of polyurethane film 101. One end of the film 101 is rolled up and welded to form a tunnel 109.
  • the film 101 is folded in two oppositely along a geometrically symmetrical axis 102 (not shown) that is generally perpendicular to the direction of the tunnel 109 to form pocket faces 103 and pocket faces 104 that substantially coincide with one another.
  • Heat sealing is formed along the outer edge shape in which the pocket surface 103 and the pocket surface 104 overlap to form a heat seal weld 105.
  • the pocket surface 103, the pocket surface 104, the weld bead 105 and the tunnel 109 collectively define a pocket 110 and a closed pocket 120 extending from the pocket 110. More specifically, the tunnel 109 is approximately circumferentially distributed along the pocket 110, and the pocket 120 extends from the tunnel 109 in a direction away from the pocket 110 to the pocket bottom 107.
  • the bag body 120 is gradually reduced toward the distal end by the pocket opening 110, and has a shape of an approximately truncated cone shape. However, one of ordinary skill in the art will appreciate that the bag 120 can be designed in any other shape as well.
  • the specimen bag 100 further includes a pull wire 130.
  • the pull wire 130 includes a distal sliding section 131 and a pull wire proximal end 139 and a pull cord 133 extending from the proximal end to the distal end.
  • the distal end portion of the pull wire 130 passes through the tunnel 109 and the pull wire proximal end 139 passes through the sliding joint 131 to form a tie loop 132 that is substantially the same size as the pocket opening.
  • the pull cord 132 can be reduced by pulling the pull cord proximal end 139 to slide the pull cord 133 in the sliding section 131 until the pocket opening 110 is tightened.
  • the sliding section 131 or the proximal end 139 may also be connected to an auxiliary part such as a fixed tab.
  • a prefabricated reel-type single specimen pouch 100 that includes a stretched state (as shown in Figures 1-2) and a crimped state (as shown).
  • the curled state is that the specimen bag 100 is first folded into an elongated shape or rolled up into a roll shape, and then fixed by a thin wire (rope) or other binding device to keep it curled, and then loaded into a package.
  • the bag is sterilized for clinical application to solve the defects of the prior art single specimen bag clinical application.
  • the specimen bag 100 is rolled up (refer to Figures 3A-3C) or folded (refer to Figures 4A-4C) in a direction generally parallel to the tunnel 109 to form a crimped condition.
  • Reusing the pull wire 130 of the specimen bag 100 to form a tie coil comprising at least two live clasps (refer to FIGS. 5A-5I) or comprising at least one dead clasp and a live clasp (refer to FIGS. 6A-6G)
  • the specimen bag 100 is tied and always kept in a curled state.
  • the live buckle is pulled to pull the proximal end 139 of the pull wire 130, and the knot formed by the pull wire is automatically unwound; and the dead buckle is pulled to pull the proximal end 139, and the knot formed by the pull wire is tightened tightly without Automatically unlocked.
  • the specimen bag 100 can be crimped by folding (rolling up) in a direction substantially perpendicular to the tunnel 109, or folding (rolling up) in a direction at an arbitrary acute angle to the tunnel 109.
  • an additional tie coil configuration may be constructed without the use of the pull wire 130, or an elastic loop (e.g., a silicone ring) may be used in place of the tie coil.
  • 3A-3C detail a method of pre-forming the specimen bag 100 into a crimped condition. Specific steps are as follows:
  • the bag body 120 is further wound up in the direction of the bag opening 110.
  • the bottom 107 of the bag first forms a small cylinder, and by further rolling up, the bag surface 120 is wound on the small cylinder to form a larger cylinder until the roll is brought into close contact with the tunnel 109 to form The specimen bag 100 in a curled state (see Figures 3A-3B).
  • the specimen bag 100 in the curled state is bundled by the pull wire 130 of the specimen bag 100, and the binding method is a double-lived buckle (or a dead buckle knot and a live buckle) to complete the entire prefabrication process.
  • 4A-4C detail another method of pre-forming the specimen bag 100 into a crimped condition. Specific steps are as follows:
  • the bag body 120 is further folded in the direction of the bag opening 110.
  • the bag bottom 107 is first formed into a folded section by folding, and by further folding, the bag body 120 is folded a plurality of times to form a pleated type pleat body, and is closely attached to the tunnel 107 to form a specimen bag 100 in a curled state. (See Figures 4A-4B).
  • the specimen bag 100 in the curled state is bundled by the pull wire 130 of the specimen bag 100, and the binding method is a double-lived buckle (or a dead buckle knot and a live buckle) to complete the entire prefabrication process.
  • the second step may form an elongated strip-shaped specimen bag 100 by rolling up or folding the bag body 120 and the tunnel 109.
  • the first half of the bag body 120 can be rolled up, and the second half of the bag body 120 can be folded; the first half of the bag body 120 can be folded, and the second half of the bag body 120 can be rolled.
  • the direction of folding or rolling in the illustrated case is generally parallel to the tunnel 109, it is also possible that the direction in which it is folded or rolled is at an arbitrary angle to the direction of the tunnel 109. Similar variations in folding are also within the scope of the invention.
  • 5A-5I detail a method of securing the specimen bag 100 in a curled state by means of a double-snap fastener.
  • the appropriate position of the pull cord 133 of the pull wire 130 is wound on the specimen bag 100 in the curled state to form three or more tie coils 135, and the specimen bag is initially tied and fixed, and one of the tie coils 135 is reserved for binding.
  • the first live clasp 134 (as shown in Figures 5B-5E).
  • the buckle 135 is fixed (as shown in FIGS.
  • Figures 6A-6G detail a method of securing the specimen bag 100 in a crimped state in a manner that the dead knot is affixed to the knot.
  • the appropriate position on the pull cord 133 of the pull wire 130 is hit by a dead buckle 137 (as shown in FIGS. 6B-6C); then the pull cord 133 is wound around the specimen bag 100 in the curled state to form a tie coil 141 (FIG. 6D); Fitting the appropriate position of the cord 133 into the live clasp 138 and passing through the dead clasp 137 (as shown in FIG. 6E), and tightening the cord 133 to reduce the dead clasp to fix the clasp 137 (Fig.
  • FIGS. 6A-6G describe in detail the common double-live fastening method and the dead-knot fastening and fastening method.
  • One of ordinary people may think that the number of slips can be increased, or other buckles can be used. Implementation, no longer described here.
  • the specimen bag package assembly 10 includes a specimen bag 100 and a sterile packaging system 200 that are pre-formed in a crimped state.
  • aseptic packaging bags typically include non-porous plastic bags, high density polyethylene synthetic paper bags, non-porous materials, and poult-made paper synthetic bags.
  • the sterilization method should be adapted to the packaging method, which usually includes gamma ray sterilization, X-ray or high-energy electron sterilization, ethylene oxide sterilization, and the like.
  • Figures 7-8 depict a typical aseptic packaging system 200.
  • the aseptic packaging system 200 is formed by welding a polyvinyl chloride sheet 210 and a DuPont Tyvek medical paper 220.
  • the specimen bag 100 is first pre-formed into a crimped state; it is then loaded into the packaging system 200; the packaging system bag 200 is then welded and melted into a closed system; finally, the sterilization is performed.
  • the specimen bag 100 is sterile.
  • the aseptic packaging system 200 can assure the sterility of the specimen bag 100 until the package is opened in a particular medical facility.
  • the minimally invasive surgery (endoscopic surgery) universal non-destructive grasping forceps 30 is used to clamp the specimen bag 100 in a curled state, enter the patient's body cavity through the puncture cannula passage 60, and keep the proximal end 139 of the pull wire outside the patient's body (see Figure 9-10).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un emballage de produit de sac d'échantillon jetable qui comprend un sac d'échantillon (100) et un système d'emballage stérile (200), et reste stérile lorsqu'il est vendu et utilisé par un client. Le système d'emballage stérile (200) assure que le sac d'échantillon (100) est dans un état stérile. Le sac d'échantillon (100) comprend une extrémité ouverte (110) pouvant être ouverte et fermée, et un corps de sac étanche (120) s'étendant à partir de l'extrémité ouverte (110). Le sac d'échantillon (100) comprend encore un ourlet (109) entourant l'extrémité ouverte (110) et un cordon de serrage (130) inséré dans l'ourlet (109). Le sac d'échantillon (100) peut être dans un état déroulé et un état enroulé. Lorsque le sac d'échantillon (100) est à l'état enroulé, le sac d'échantillon (100) est plié en une bande allongée ou enroulé en un rouleau. Le sac de tissu chirurgical (100) comprend en outre des cordes de fixation (135, 141) pour maintenir le sac d'échantillon (100) dans l'état enroulé, empêchant ainsi le sac d'échantillon (100) d'entrer automatiquement dans l'état déroulé à partir de l'état enroulé.
PCT/CN2018/075807 2017-03-06 2018-02-08 Emballage de produit jetable comprenant un sac d'échantillon de type enroulable WO2018161770A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201710129294.1A CN106618747B (zh) 2017-03-06 2017-03-06 一种包含卷曲型标本袋的一次性使用产品包
CN201710129294.1 2017-03-06

Publications (1)

Publication Number Publication Date
WO2018161770A1 true WO2018161770A1 (fr) 2018-09-13

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PCT/CN2018/075807 WO2018161770A1 (fr) 2017-03-06 2018-02-08 Emballage de produit jetable comprenant un sac d'échantillon de type enroulable

Country Status (2)

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CN (2) CN109646056A (fr)
WO (1) WO2018161770A1 (fr)

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CN113116536A (zh) * 2021-04-01 2021-07-16 江西诺捷科技股份有限公司 一种医疗用一次性使用内窥镜标本取物袋快速取用装置
US12150639B2 (en) 2018-09-20 2024-11-26 Applied Medical Resources Corporation Tissue removal containment systems

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CN109646056A (zh) * 2017-03-06 2019-04-19 成都五义医疗科技有限公司 一种包含卷曲型标本袋的一次性使用产品包
CN109646055A (zh) * 2017-03-06 2019-04-19 成都五义医疗科技有限公司 一种组合取物器及其使用方法
CN107095712B (zh) * 2017-06-03 2023-05-26 成都五义医疗科技有限公司 一种带卷线拉环的标本袋取物器械及其使用方法
EP4108184B1 (fr) 2020-06-28 2025-02-12 Vhmed (Nantong) Co. Ltd. Appareil d'extraction d'échantillon chirurgical mini-invasif simple et procédé d'utilisation
CN111616754B (zh) * 2020-06-28 2023-04-07 万恒医疗科技(南通)有限公司 一种简易微创手术标本取出装置及使用方法
CN113331884A (zh) * 2020-07-03 2021-09-03 重庆橙壹科技有限公司 一种适用于腔镜手术的定制生产的医用取物袋
CN113303843A (zh) * 2020-07-03 2021-08-27 重庆橙壹科技有限公司 一种用于微创手术的医用取出器
CN111700655B (zh) * 2020-07-09 2022-11-25 合肥亚卡普机械科技有限公司 一种包含疏松态的医用取物器
CN111685820A (zh) * 2020-07-09 2020-09-22 重庆橙壹科技有限公司 一种带收缩中空管的医用取物器
US12383244B2 (en) 2021-11-30 2025-08-12 Vhmed (Nantong) Co. Ltd. Specimen retrieval bag, specimen retrieval device and method for using specimen retrieval device

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CN106618747A (zh) * 2017-03-06 2017-05-10 成都五义医疗科技有限公司 一种包含卷曲型标本袋的一次性使用产品包
CN106798579A (zh) * 2017-03-06 2017-06-06 成都五义医疗科技有限公司 一种组合取物器及其使用方法

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US12150639B2 (en) 2018-09-20 2024-11-26 Applied Medical Resources Corporation Tissue removal containment systems
CN113116536A (zh) * 2021-04-01 2021-07-16 江西诺捷科技股份有限公司 一种医疗用一次性使用内窥镜标本取物袋快速取用装置
CN113116536B (zh) * 2021-04-01 2022-07-05 江西诺捷科技股份有限公司 一种医疗用一次性使用内窥镜标本取物袋快速取用装置

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