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WO2018161769A1 - 一种组合取物器及其使用方法 - Google Patents

一种组合取物器及其使用方法 Download PDF

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Publication number
WO2018161769A1
WO2018161769A1 PCT/CN2018/075806 CN2018075806W WO2018161769A1 WO 2018161769 A1 WO2018161769 A1 WO 2018161769A1 CN 2018075806 W CN2018075806 W CN 2018075806W WO 2018161769 A1 WO2018161769 A1 WO 2018161769A1
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WO
WIPO (PCT)
Prior art keywords
specimen bag
bag
specimen
tunnel
state
Prior art date
Application number
PCT/CN2018/075806
Other languages
English (en)
French (fr)
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 WO2018161769A1 publication Critical patent/WO2018161769A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments 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
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/50—Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00287—Bags for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing

Definitions

  • the present invention relates to a minimally invasive surgical instrument, and more particularly to a combined retrieval device.
  • 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.
  • a single specimen bag is simple in construction and inexpensive to manufacture, but generally does not meet clinical needs, especially when large tissues or organs need to be removed during surgery, a single specimen bag is generally inconvenient to undertake tissue.
  • U.S. Patent No. 8,408,112 discloses a combination picker that includes a single specimen bag and a reusable mechanism that both reduces costs and compensates for the inconvenience of a single specimen bag.
  • the combined extractor disclosed in US Pat. No. 8,401,112 cannot accommodate the specimen bag in a curled state because it does not have a catheter necessary for the prior art device.
  • the specimen When it is fed into the patient's body cavity through the puncture cannula, the specimen is taken.
  • the disordered deformation of the bag causes the specimen bag to block the puncture cannula passage or requires a large amount of force to feed the specimen bag into the patient's body cavity.
  • the bag body of the specimen bag In the case of blockage or large resistance, the bag body of the specimen bag is easily damaged, and is 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 combined extractor disclosed in US Pat. No. 8,401,112 is also inconvenient for taking the specimen bag or the diseased tissue and taking it out of the patient's body. How to improve the clinical application performance of a single specimen bag is one of the important issues to be solved in the field.
  • a combination retrieval device comprising a pre-curled disposable specimen bag and a repetitive use deployment device.
  • a combination retrieval device comprising a disposable specimen bag product package and a repeating deployment mechanism.
  • the single-use specimen bag product package includes a specimen bag and an aseptic packaging system and is sold in a sterile state for use by a customer, the aseptic packaging system ensuring that the specimen bag is sterile.
  • 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 further includes a tunnel surrounding the pocket and a pull wire interposed in the tunnel, the tunnel including a first tunnel opening and a second tunnel opening.
  • the specimen bag further includes two guiding tubes, and the guiding tubes are respectively inserted into and fixed to the first tunnel opening and the second tunnel opening.
  • the specimen bag includes a stretched state and a curled state; in the curled state, the tunnel is folded in half and the first tunnel opening and the second tunnel opening are substantially aligned, and the bag body is substantially parallel
  • the tunnel is folded into a slender shape or rolled up into a scroll shape.
  • the specimen bag further includes a tie coil for fixing the specimen bag in 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 of tying a specimen bag for the curled state comprising the following main steps:
  • Another method of tying a specimen bag for the crimped state comprises the following main steps:
  • a repeating distraction mechanism in still another aspect of the invention, includes a handle assembly, an elongated rod assembly, and an inner core assembly.
  • the inner core assembly includes a first elongated working edge and a second extended working edge, and the handle assembly is operable to drive the first elongated working edge and the second elongated working blade to open or close.
  • the repeating distraction mechanism includes a handle assembly, an elongated rod assembly and an inner core assembly, the inner core assembly including a first resilient working edge and a second resilient working edge.
  • the first elastic working blade includes a first rigid segment, a first elastic arc segment and a first elastic straight segment;
  • the second elastic working blade includes a second rigid segment, a second elastic arc segment and a second elasticity Straight section.
  • the first curved segment and the second curved segment have a flexible and shape memory function.
  • the repeating expansion mechanism includes an extension rod, a first elastic piece and a second elastic piece.
  • the first elastic piece includes a first curved segment and a first straight segment
  • the second elastic piece includes a second curved segment and a second straight segment.
  • the first elastic piece and the second elastic piece have a flexible and shape memory function.
  • a method of using a combination retrieval device 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 prior art lossless gripper
  • Figure 10 is a schematic illustration of a modified inner core assembly 440
  • Figure 11 is a schematic view showing the first and second working edges of the gripper 400 inserted into the tunnel opening of the specimen bag;
  • Figure 12 is a partially enlarged schematic view of the tunnel opening of Figure 11;
  • Figure 13 is a schematic view showing the insertion of the specimen bag into the puncture cannula as shown in Figure 11;
  • Figure 14 is a schematic view of the specimen bag being inserted into the patient through the puncture cannula as shown in Figure 13;
  • Figure 15 is a schematic view of the pull wire release live buckle
  • Figure 16 is a schematic illustration of operation in a patient to cause the specimen bag to become stretched
  • Figure 17 is a schematic view showing the operation of the gripper to open the mouth of the specimen bag
  • Figure 18 is a schematic view of pulling out the gripper and tightening the mouth of the bag
  • Figure 19 is a schematic view showing the tissue bag containing the tissue pulled out of the body
  • Figure 20 is a perspective view showing the folding of the specimen bag 100a of another embodiment
  • Figure 21 is a schematic illustration of another embodiment of the inner core assembly 440a
  • Figure 22 is a schematic illustration of yet another embodiment of the repeating distraction device 700.
  • Figure 23 is a schematic view of the repeating spreader 700 inserted into the tunnel opening of the specimen bag
  • Figure 24 is a schematic illustration of the repeating distraction instrument 700 and the insertion of the specimen bag into the puncture cannula channel.
  • 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, and the tunnel 109 includes a first tunnel opening 111 and a second tunnel opening 113.
  • the film 101 is folded in two oppositely along a geometrically symmetrical axis 102 (not shown) substantially perpendicular to the direction of the tunnel 109 to form substantially opposite pocket faces 103 and pockets 104, wherein the first tunnel opening 111 and the second tunnel Port 113 is substantially aligned.
  • 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.
  • 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 the elongated bag-like 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.
  • a combination retrieval device 500 is presented.
  • the retrieval device 500 includes a specimen bag packaging assembly 10 and a grasping forceps 400 having an elongated working edge.
  • 9 depicts a non-destructive grasping forceps 300 dedicated to minimally invasive surgery of the prior art, the lossless grasping forceps 300 including a handle assembly 310, a runner assembly 320, an extension rod assembly 330, and an inner core assembly 340.
  • the handle assembly 310 includes a rear handle 313 and a front handle 315.
  • the runner assembly 320 and the extension rod assembly 330 are coupled to the handle assembly 310 in a non-detachable or quick-disconnectable connection.
  • the inner core assembly 340 includes a pull rod 343, a transmission assembly 345, a first working edge 347, and a second working edge 349.
  • the transmission assembly includes two types of linkage mechanisms and chute mechanisms, and the transmission assembly 345 shown in this example is a linkage mechanism.
  • the extension rod assembly 330 includes a hollow structure, the inner core assembly 340 is inserted into the interior of the extension rod assembly 330 and forms a quick-disconnectable connection thereto, and the tie rod 343 is coupled to the rear handle 313.
  • the rear handle 343 can rotate and pull the axial movement of the pull rod 343 along the extension rod assembly, thereby driving the transmission assembly 345 to move, thereby driving the first working edge 347 and the second working edge 349 to open or closure.
  • the gripper 400 is slightly modified by the first working blade 347 and the second working blade 349 of the gripper 300, that is, the first working blade 347 and the second working blade.
  • the 349 is elongated and the head is designed to facilitate insertion into the elongated smooth structure of the specimen bag tunnel 109.
  • the gripper 400 includes a handle assembly 310, a runner assembly 320, an extension rod assembly 330, and an inner core assembly 440.
  • the inner core assembly 440 includes a pull rod 343, a transmission assembly 345, a first working edge 447 and a second working edge 449.
  • the 20 depicts an improved specimen bag 100a that includes a specimen bag 100, a pull wire 130 (not shown), and two guide tubes 117.
  • the guide tube 117 is made of a material such as polytetrafluoroethylene, polypropylene, a thermoplastic elastomer, a thermosetting elastomer, or the like, and may be rigid or flexible.
  • the guiding tube 117 is fixed to the first tunnel opening 111 and the second tunnel opening 113 by means of bonding or interference fit.
  • 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 guide tube 117 simultaneously, and the pull wire proximal end 139 passes through the slide joint 131 to form a loop 132 that is substantially the same size as the pocket.
  • the specimen bag 100a can be in a reeled state as described above, and the specimen bag 100 that can replace the aforementioned combination retrieval device 500 can be used to remove tissue or specimen from the patient during surgery.
  • the guide tube 117 facilitates rapid alignment of the first working edge 447 and the second working edge 449 with the first tunnel opening 111 and the second tunnel opening 113.
  • FIG. 21 depicts an improved grasping forceps 400a that includes a handle assembly 310, a runner assembly 320, an extension rod assembly 330, and an inner core assembly 440a.
  • the inner core assembly 440a includes a pull rod 343, a transmission assembly 345, a first working edge 447a and a second working edge 449a. Only the first working edge 447a and the second working edge 449a are depicted in Fig. 21, other structures are omitted in this figure, and can be seen with reference to Figs.
  • the first working blade 447a includes a working blade 347 and a first elastic piece 450 fixed thereto, and the first elastic piece 450 includes a straight section 453 and an arc segment 455.
  • the second working edge 449a includes a working edge 349 and a second elastic piece 460 fixed thereto, and the second elastic piece 460 includes a straight section 463 and a curved section 465.
  • the first elastic piece 450 and the second elastic piece 460 have a flexible and shape memory function.
  • the arcuate segments 455 (465) of the first and second elastic pieces may be deformed into an approximately straight section and elongated along the axial direction of the tie rod 343; when the external force is removed, First, the curved section 455 (465) of the second elastic piece can be restored into an arc shape and retracted in the axial direction of the pull rod 343.
  • the grasping forceps 400a can be used in place of the grasping forceps 400 in the prior art combination device 500 to remove tissue or specimen from the patient during surgery.
  • Figure 22 depicts another modified dedicated re-use distraction instrument 700.
  • the distraction instrument 700 includes a metal elongated rod 710 and a first elastic piece 750 and a second elastic piece 760 connected thereto.
  • the first elastic piece 750 includes a straight section 753 and an arcuate section 755.
  • the second elastic piece 760 includes a straight section 763 and an arcuate section 765.
  • the first elastic piece 750 and the second elastic piece 760 have a flexible and shape memory function.
  • the arcuate section 755 (765) of the first and second elastic pieces may be deformed into an approximately straight section and elongated along an axial direction of the rod 710 when pressed by an external force; First, the arcuate section 755 (765) of the second shrapnel can be restored to an arc shape and retracted in the axial direction of the rod 710.
  • the distraction instrument 700 can be used in place of the grasping forceps 400 in the combination retrieval device 500 described above for applying tissue or specimens from a patient during surgery. Referring to FIGS.
  • the straight section 753 of the first elastic piece 750 and the straight section 763 of the second elastic piece 760 are respectively inserted into the first tunnel opening 111 and the second tunnel opening 113 of the specimen bag 100 in the curled state. Inserting the first elastic piece 750 and the second elastic piece 760 substantially completely into the tunnel 109, and then inserting the specimen bag 100 and the instrument 700 into the patient through the puncture cannula passage 60 and maintaining the wire.
  • the proximal end 139 of 130 is outside the patient's body. Since the first elastic piece 750 and the elastic piece 760 have flexibility, they can be automatically deformed to pass through the casing passage 60 with little resistance and smoothness. After the pull wire is released to release the live buckle according to the method described above, since the first elastic piece 750 and the second elastic piece 760 have a shape memory function and are automatically restored, the specimen bag 100 can be automatically deployed.

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  • Radiology & Medical Imaging (AREA)

Abstract

一种组合取物器械（500）及其使用方法，该组合取物器械（500）包含一次性使用标本袋产品包（10）和重复撑开机构，该产品包（10）包含标本袋（100）及无菌包装系统（200），并以无菌状态销售和供客户使用，无菌包装系统（200）确保标本袋（100）处于无菌状态；标本袋（100）包含可打开和收拢的袋口（110），以及从袋口（110）延伸而成的封闭的袋体（120）；标本袋（100）还包括环绕袋口（110）的隧道（109）和穿插在隧道（109）中的拉线（130），隧道（109）包含第一隧道口（111）和第二隧道口（113）；标本袋（100）包含舒展状态和卷曲状态；卷曲状态时，隧道（109）被对折且第一隧道口（111）和第二隧道口（113）基本对齐，袋体（120）以基本平行隧道（109）的方式折叠成细长形或卷起成卷轴形；标本袋（100）还包括扎线圈（135，141）用以将标本袋（100）固定为卷曲状态，阻止标本袋（100）自动的从卷曲状态变成舒展状态。

Description

一种组合取物器及其使用方法 技术领域
本发明涉及微创手术器械，尤其涉及一种组合取物器械。
背景技术
在微创手术中(尤其是硬管腔镜手术)，通常需经由患者皮肤小切口或经由穿刺导管取出内部组织或病变器官。如何安全的便捷的取出腔内组织或病变器官，一直是困扰微创手术的难题。自硬管腔镜手术首次临床应用以来，国内外研制了多种腔镜手术专用标本袋。虽然所述标本袋的结构和使用方式各有差异，但总体可分为两类：第一类，单一标本袋。美国发明专利US5037379中披露了一种单边开口的带线标本袋，使用时需使用抓钳夹持标本袋体再经过穿刺导管或小切口进入患者体内。第二类，包含标本袋，导管和撑开机构的取物器械。US5465731，US5480404，US6383197等美国发明专利中披露了多种取物器械，其标本袋被卷起并收纳于导管之内，使用时所述取物器械经过穿刺套管进入患者体内，再推动其撑开机构将所述卷起的标本袋推出到导管之外，并由撑开机构将标本袋撑开，方便装入手术中切割的组织或病变器官。
前述单一标本袋和取物器械均为一次性使用的产品，取物器械的结构复杂且生产制造成本较高，急需降低成本。单一标本袋的结构简单且制造成本低廉，然而通常不能满足临床需求，特别是手术中需要切除较大的组织或器官时，单一标本袋通常不方便承接组织。美国发明专利US8409112中披露了一种含有单一标本袋和重复性使用机构的组合取物器，既可以降低成本又可以弥补单一标本袋不方便承接组织的缺陷。然而US8409112披露的组合取物器由于没有设置现有技术取物器械所必备的导管，因此无法将其标本袋以卷曲的状态收纳，当经由穿刺套管通道送入患者体腔内时，其标本袋杂乱无章的变形从而导致标本袋堵塞穿刺套管通道或者需要较大力量才可以将标本袋送入患者体腔。堵塞或较大阻力情形下，容易损伤标本袋的袋体，从而在标本袋盛装病变组织后拔出体外的过程中，受较大挤压力破裂。另外US8409112中披露的组合取物器也不方便标本袋盛装标本或病变组织后取出至患者体外。如何改善单一标本袋的临床应用性能为本领域亟待解决的重要问题之一。
发明内容
因此，本发明一个目的是提供一种包含预先卷曲的一次性使用标本袋和重复性使 用撑开器械的组合取物器械(装置)。
在本发明的一个方面，提供一种组合取物器械，包含一次性使用标本袋产品包和重复撑开机构。所述一次性使用标本袋产品包包含标本袋及无菌包装系统，并以无菌状态销售和供客户使用，所述无菌包装系统确保所述标本袋处于无菌状态。所述标本袋包含可打开和收拢的袋口，以及从袋口延伸而成的封闭的袋体。所述标本袋还包括环绕袋口的隧道和穿插在所述隧道中的拉线，所述隧道包含第一隧道口和第二隧道口。一种可选的方案中，所述标本袋还包含2个导向管，所述导向管分别插入所述第一隧道口和第二隧道口并与其固定。
一种方案中，所述标本袋包含舒展状态和卷曲状态；所述卷曲状态时，所述隧道被对折且所述第一隧道口和第二隧道口基本对齐，所述袋体以基本平行所述隧道的方式折叠成细长形或卷起成卷轴形。所述标本袋还包括扎线圈用以将所述标本袋固定为卷曲状态，阻止所述标本袋自动的从卷曲状态变成舒展状态。
一种实现方案中，所述扎线圈由细长的线绳形成，包括至少两个活扣结，或包含至少一个死扣结和一个活扣结。所述活扣结，即拉动构成所述活扣结的线绳的末端，所述活扣结自动解开；而所述死扣结，即拉动构成所述死扣结的线绳的末端，所述死扣结被越拉越紧而不会自动解开。一种优选的方案中，所述扎线圈，活扣结或死扣结由所述标本袋自带的拉线构成。另一种可选的方案中，所述扎线圈，活扣结或死扣结由由额外附加的线绳构成。
在本发明的另一个方面，提供一种用于所述标本袋产品包的标本袋的卷曲状态制造方法，包含以下主要步骤：
S1:首先将所述标本袋的袋口的卷轴结构对折压缩；
S2:然后沿袋底向袋体颈部将所述标本袋的袋面卷曲和/或折叠，并与对折的卷轴结构形成细长形或卷轴形的标本袋；
S3:用所述标本袋的拉线构造扎线圈将卷曲状态的标本袋绑接；所述扎线圈包含两个活扣结，或包含少一个死扣结和一个活扣结，并可以通过拉动所述拉线的近端解开所述活扣结。
在本发明的又一个方面，提供一种用于所述卷曲状态的标本袋的绑扎方法，包含以下主要步骤：
S1:先将拉线的拉线绳的合适位置在卷曲状态的标本袋上缠绕形成3个及以上的扎线圈将标本袋初步的绑扎固定，且预留出一个被所述扎线圈绑扎固定的第一活扣结。
S2:再将拉线绳的合适位置再折叠成第二活扣结并穿过所述第一活扣结，拉紧所述拉线绳 使所述第一活扣结缩小至将所述第二活扣结固定，完成整个标本袋的卷曲状态的绑接。
另一种用于所述卷曲状态的标本袋的绑扎方法，包含以下主要步骤：
S1:首先将拉线的拉线绳上的合适位置打一个死扣结；
S2:再将拉线绳再围绕卷曲状态的标本袋缠绕形成扎线圈；再将拉线绳的合适位置折叠成活扣结并穿过所述死扣结，拉紧拉线绳使所述死扣结缩小至将所述活扣结固定；
S3:最后调整死扣结和活扣结的位置使得所述扎线圈将所述卷曲状态的标本袋绑接固定。
在本发明的又一个方面，提供一种重复撑开机构，所述重复撑开机构包含手柄组件，加长杆组件和内芯组件。所述内芯组件包含第一加长工作刃和第二加长工作刃，操作所述手柄组件可驱动所述第一加长工作刃和第二加长工作刃张开或闭合。另一种实现方案中，所述重复撑开机构包含手柄组件，加长杆组件和内芯组件，所述内芯组件包含第一弹性工作刃和第二弹性工作刃。所述第一弹性工作刃包含第一刚性段，第一弹性弧形段和第一弹性平直段；所述第二弹性工作刃包含第二刚性段，第二弹性弧形段和第二弹性平直段。所述第一弧形段和第二弧形段具有柔性和形状记忆功能。又一种实现方案中，所述重复撑开机构包含加长杆，第一弹片和第二弹片。所述第一弹片包括第一弧形段和第一平直段，所述第二弹片包括第二弧形段和第二平直段。所述第一弹片和第二弹片具有柔性和形状记忆功能。
在本发明的又一个方面，提供一种组合取物器械的使用方法，包含以下主要步骤：
S1：首先以标准的无菌手法撕开或打开标本袋产品包的无菌包装系统；
S2：再用微创手术通用无损抓钳夹持或徒手握持处于卷曲状态的标本袋，将所述第一加长工作刃和第二加长工作刃分别插入所述第一隧道口和第二隧道口中，并插入到底；
S3：操作所述手柄组件使所述第一加长工作刃和第二加长工作刃保持在隧道中并处于闭合状态，在经由穿刺套管通道进入患者体腔，且使所述拉线近端处于患者体外；
S4：拉动所述近端使捆扎所述标本袋的扎线圈的活扣结脱开，则扎线圈随之松开，再调整使所述袋体展开，即标本袋由卷曲状态切换为舒展状态；
S5：将标本袋完全展开并定位到需要切割标本或病变组织的目标位置，操作所述重复撑开机构使第一加长工作刃和第二加长工作刃相互张开，从而打开袋口和袋体；再将标本或病变组织装入标本袋中。
S6：移走所述重复撑开机构，再拉动拉线绳将所述袋口封闭。
S7：最后将穿刺套管和装有标本或病变组织的标本袋拔出至患者体外。
附图说明
为了更充分的了解本发明的实质，下面将结合附图进行详细的描述，其中：
图1是本发明第一实施例标本袋展开的立体图；
图2是图1所示标本袋的对折示意图；
图3A-3C是图2所示标本袋的袋体卷起成卷轴形的示意图；
图4A-4C是图2所示标本袋的袋体折叠成细长条形的示意图；
图5A-5I是图3或图4所示标本袋的一种双活扣结的绑扎示意图；
图6A-6G是图3或图4所示标本袋的一种死扣结加活扣结的绑扎示意图；
图7是本发明之标本袋产品包的包装立体示意图；
图8是本发明之标本袋产品包的拆包示意图；
图9是一种现有技术的无损抓钳的示意图；
图10是一种改进型的内心组件440的示意图；
图11是将抓钳400的第一、第二工作刃插入标本袋隧道口的示意图；
图12是图11所述隧道口局部放大示意图；
图13是如图11所示夹持标本袋插入穿刺套管通道的示意图；
图14是如图13所示夹持标本袋经由穿刺套管进入患者体内的示意图；
图15是拉动拉线释放活扣结的示意图；
图16是在患者体内操作使标本袋变成舒展状态的示意图；
图17是操作抓钳使标本袋袋口张开的示意图；
图18是拔出抓钳并收紧袋口的示意图；
图19是将装有组织的标本袋拔出体外的示意图；
图20是另一个实施例标本袋100a的对折示意图；
图21是另一个实施例内心组件440a的示意图；
图22是又一个实施例重复撑开器械700的示意图；
图23是重复撑开器械700插入标本袋隧道口的示意图；
图24是重复撑开器械700和标本袋插入穿刺套管通道的示意图。
在所有的视图中，相同的标号表示等同或类似的零件或部件。
具体实施方式
这里公开了本发明的实施方案，但是，应该理解所公开的实施方案仅是本发明的 示例，本发明可以通过不同的方式实现。因此，这里公开的内容不是被解释为限制性的，而是仅作为权利要求的基础，以及作为教导本领域技术人员如何使用本发明的基础。
现将参照附图详细描述本公开的实施例，为方便表述，后续凡接近操作者的一方定义为近端，而远离操作者的一方定义为远端。
图1-2详细描绘了本发明的第一个实施例标本袋100的结构和组成。所述标本袋100通常由单片薄膜对折重叠焊接而成，或两片薄膜重叠焊接而成。薄膜的材料包括但不限于聚乙烯，聚氯乙烯，聚丙烯，尼龙，特氟龙，热固性弹性体和热塑性弹性体(例如聚氨酯)。薄膜焊接的工艺包括但不限于加热焊接，超声波焊接，高频焊接，辐射焊接，脉冲焊接等。一种实现方案中，所述标本袋100由单片聚氨酯薄膜101对折重叠后加热焊接而成。所述薄膜101的其中一端卷起并焊接形成隧道109，所述隧道109包含第一隧道口111和第二隧道口113。所述薄膜101沿大致垂直于所述隧道109的方向的几何对称轴线102(未示出)对折形成基本相互重合的袋面103和袋面104，其中所述第一隧道口111和第二隧道口113基本对齐。沿着所述袋面103和袋面104重叠的外边缘形进行加热焊接形成热合焊缝105。所述袋面103，袋面104，焊缝105和隧道109共同限定出袋口110以及从所述袋口110延伸而成的封闭的袋体120。更细致的描述，所述隧道109沿着所述袋口110近似环向分布，所述袋体120从隧道109开始向远离所述袋口110的方向延伸至袋底107。所述袋体120由所述袋口110开始向远端逐渐减小，其形状为近似截圆锥形。然而一个普通技术人员可以想到，所述袋体120也可设计成其他任意形状。
参考图1-2，所述标本袋100还包括拉线130。所述拉线130包含远端滑动节131和拉线近端139以及从近端延伸至远端的拉线绳133。所述拉线130的远端部分穿过隧道109而拉线近端139穿过所述滑动节131，形成与袋口尺寸大致相同的扎线环132。通过牵拉所述拉线近端139使所述拉线绳133在所述滑动节131中滑动可将所述扎线环132减小直到将所述袋口110收紧。本领域的技术人员可以想到，所述滑动节131或所述近端139还可以连接固定拉环等辅助零件。
在本发明的一个方面，提供一种预制卷轴型的单一标本袋100，所述标本袋100包含舒展状态(如图1-2所示)和卷曲状态(如图)。所述卷曲状态即先将所述标本袋100折叠成细长形或卷起成卷轴形，再将其用细线(绳索)或其他扎束装置固定，使其保持卷曲状态，再装入包装袋中灭菌后供临床应用，以解决现有技术的单一标本袋临床应用的缺陷。
一种实施方案中，所述标本袋100以大致平行于所述隧道109的方向卷起(参考 图3A-3C)或折叠(参考图4A-4C)形成卷曲状态。再利用所述标本袋100自带的拉线130形成包含至少两个活扣结(参考图5A-5I)或包含至少一个死扣结加上一个活扣结(参考图6A-6G)的扎线圈将所述标本袋100扎紧并始终保持为卷曲状态。所述活扣结即拉动所述拉线130的近端139，拉线构成的绳节自动解开；而所述死扣结即拉动所述近端139，拉线构成的绳节越拉越紧而不会自动解开。
图3A-3C详细描述了一种将标本袋100预制成卷曲状态的方法。具体步骤如下：
S1：先将标本袋100的隧道109对折压缩，使标本袋100整体处于对折状态且所述第一隧道口111和第二隧道口113基本对齐(见图2)；
S2:再将袋底107向袋口110方向把所述袋体120卷起来。这个过程中，袋底107首先形成一个小圆柱体，通过进一步卷起，袋面120被卷附在小圆柱体上形成较大的圆柱体，直至卷起到与隧道109紧贴在一起，形成卷曲状态的标本袋100(见图3A-3B)。
S3:用所述标本袋100的拉线130将卷曲状态的标本袋100绑扎，所述绑接方式为双活扣结(或采用死扣结加活扣结)的方式，完成整个预制过程。
图4A-4C详细描述了另一种将标本袋100预制成卷曲状态的方法。具体步骤如下：
S1：先将标本袋100的隧道109对折压缩，使标本袋100整体处于对折状态且所述第一隧道口111和第二隧道口113基本对齐(见图2)；
S2:再将袋底107向袋口110方向把所述袋体120进行折叠。这个过程中，袋底107通过折叠首先形成一个折叠段，通过进一步折叠，袋体120被多次折叠后形成褶皱型的褶皱体，并与隧道107紧贴在一起，形成卷曲状态的标本袋100(见图4A-4B)。
S3:用所述标本袋100的拉线130将卷曲状态的标本袋100绑扎，所述绑接方式为双活扣结(或采用死扣结加活扣结)的方式，完成整个预制过程。
在以上标本袋100预制成卷曲状态的过程中，第二步骤可以通过卷起或折叠完成袋体120与隧道109形成一个细长条状的标本袋100。本领域的普通技术人员容易想到，可以将袋体120前半段采用卷起，而袋体120后半段采用折叠；也可以将袋体120前半段采用折叠，而袋体120后半段采用卷起。虽然已展示的案例中折叠或卷起的方向大致平行于所述隧道109，然而其折叠或卷起的方向与所述隧道109的方向成任意角度也可行的。类似的变化折叠方式也是本发明保护的范围。
图5A-5I详细的描述了采用双活扣结的方式将处于卷曲状态的标本袋100固定的方法。首先将拉线130的拉线绳133的合适位置在卷曲状态的标本袋100上缠绕形成3个及以上的扎线圈135将标本袋初步的绑扎固定，且预留出一个被所述扎线圈135绑扎固 定的第一活扣结134(如图5B-5E)。然后将拉线绳133的合适位置再折叠成第二活扣结136并穿过所述第一活扣结134，拉紧拉线绳133使所述第一活扣结缩小至将所述第二活扣结135固定(如图5F-5I)，完成整个标本袋100的卷曲状态的绑接。本领域的技术人员应该可以理解，拉动所述拉线130的近端139，可使所述第二活扣结136缩小并最终完全从所述第一活扣结134中脱出，则扎线圈135也可随之解开。
图6A-6G详细的描述了死扣结加活扣结的方式将处于卷曲状态的标本袋100固定的方法。首先将拉线130的拉线绳133上的合适位置打一个死扣结137(如图6B-6C)；然后将拉线绳133再围绕卷曲状态的标本袋100缠绕形成扎线圈141(如图6D)；再将线绳133的合适位置折叠成活扣结138并穿过所述死扣结137(如图6E)，拉紧拉线绳133使所述死扣结缩小至将所述活扣结137固定(如图6F-6G)，并调整死扣结136和活扣结137的位置使得所述扎线圈141将所述卷曲状态的标本袋100绑接固定。本领域的技术人员应该可以理解，拉动所述拉线130的近端139，可使所述活扣结138缩小并最终完全从所述死扣结137中脱出，则扎线圈141也随之解开。图5A-5I和图6A-6G详细描述了常见的双活扣结方式和死扣结加活扣结方式，一个普通的技术人员可以想到可以增加活结的数量，或者采用其他的活扣方式均可实现，在此不再累述。
本发明的另一个方面，标本袋包装组件10包含预制成卷曲状态的标本袋100和无菌包装系统200。本领域的技术人员容易了解，无菌包装袋通常包括无孔塑料袋，高密度聚乙烯合成纸袋，无孔物料和多孔灭菌纸合成袋。而灭菌方式应与其包装方式相适应，所述灭菌方法通常包括伽马射线灭菌，X射线或高能电子灭菌，环氧乙烷灭菌等。图7-8描述了一种典型的无菌包装系统200。所述无菌包装系统200由聚氯乙烯片材210和杜邦特卫强医用纸220焊接而成。优选的，首先将所述标本袋100预制成卷曲状态；再将其装入所述包装系统200中；再将所述包装系统袋200进行焊接熔合成密闭系统；最后进行灭菌使所述标本袋100达到无菌状态。所述无菌包装系统200能保证所述标本袋100的无菌状态直到在特定的医疗设施中打开包装为止。
在本发明的又一个方面，提出一种组合取物器械500。所述取物器械500包含标本袋包装组件10和具有加长工作刃的抓钳400。图9描绘了现有技术的微创手术专用的一种无损抓钳300，所述无损抓钳300包含手柄组件310，转轮组件320，加长杆组件330和内芯组件340。所述手柄组件310包含后手柄313和前手柄315，所述转轮组件320和加长杆组件330与所述手柄组件310连接在一起，其连接方式为不可拆卸连接或可快速拆卸的连接。所述内芯组件340包括拉杆343，传动组件345，第一工作刃347和第二工作 刃349。已披露的现有技术中，所述传动组件包括连杆机构和滑槽机构两大类，本实例中展示的传动组件345为连杆机构。所述加长杆组件330包含中空结构，所述内芯组件340插入到所述加长杆组件330内部并与之形成可快速拆卸的连接，而所述拉杆343与所述后手柄313连接，所述后手柄343可旋转并拉动所述拉杆343沿所述加长杆组件的轴向移动，从而带动所述传动组件345运动，进而驱动所述第一个工作刃347和第二工作刃349张开或闭合。不同现有技术披露的微创手术专用抓钳，各项功能的具体实现方式略有差异，在此不再赘述。一种实现方案中，所述抓钳400由所述抓钳300的第一工作刃347和第二工作刃349稍作适应性修改而成，即将所述第一工作刃347和第二工作刃349加长且将其头部设计成方便插入标本袋隧道109的细长光滑结构。更具体的，所述抓钳400包含手柄组件310，转轮组件320，加长杆组件330和内芯组件440。所述内芯组件440包含拉杆343，传动组件345，第一工作刃447和第二工作刃449。
图11-19描绘了本发明之组合取物器械500的临床使用方法，其具体步骤如下：
S1：以标准的无菌手法撕开或打开标本袋包装组件10(见图8)。
S2：再用抓钳300夹起(或徒手拿起)卷曲状态的标本袋100，将所述抓钳400的第一工作刃447和第二工作刃449分别插入所述标本袋100的第一隧道口111和第二隧道口113中，并插入到底使所述第一、第二工作刃完全进入隧道109中(见图11-12)。
S3：保持所述抓钳400为夹持状态，确保使所述第一工作刃447和第二工作刃449处于隧道109中，再经由穿刺套管通道60进入患者体腔，且保持所述拉线近端139处于患者体外(见图13-14)。
S4：拉动所述近端139使捆扎所述标本袋100的扎线圈的活扣结脱开，则扎线圈随之松开，再调整使所述袋体120展开，即标本袋100由卷曲状态切换为舒展状态(见图15-16)。
S5：将标本袋100完全展开并定位到需要切割标本或病变组织的目标位置，操作所述抓钳400使第一工作刃447和第二工作刃449相互张开，从而打开袋口110和袋体120。再将标本或病变组织装入标本袋100中(见图17)。
S6：移走所述抓钳400，再拉动拉线绳133使所述扎线环132缩小直到将所述袋口110封闭(见图18)。
S7：将穿刺套管60和装有标本或病变组织的标本袋100拔出至患者体外(见图19)。
图20描绘了一种改进的标本袋100a，所述标本袋带100a包含标本袋100，拉线130(未示出)和2个导向管117。所述导向管117由聚四氟乙烯，聚丙烯，热塑性弹性体，热固性弹性体等材料制成，刚性或柔性均可。所述导向管117粘接或过盈配合的方式 与所述第一隧道口111和第二隧道口113固定。所述拉线130包含远端滑动节131和拉线近端139以及从近端延伸至远端的拉线绳133。所述拉线130的远端部分同时穿过隧道109和导向管117，而拉线近端139穿过所述滑动节131，形成与袋口尺寸大致相同的扎线环132。本领域技术人员可以想到，所述标本袋100a可按前述方法与制成卷轴状态，且可替换前述组合取物器械500的标本袋100应用手术中从患者体内取出组织或标本。所述导向管117有利于所述第一工作刃447和第二工作刃449快速的对准所述第一隧道口111和第二隧道口113。
图21描绘了一种改进的抓钳400a，所述抓钳400a包含手柄组件310，转轮组件320，加长杆组件330和内芯组件440a。所述内芯组件440a包括拉杆343，传动组件345，第一工作刃447a和第二工作刃449a。图21中仅描绘出所述第一工作刃447a和第二工作刃449a，其他结构在此图中略去，可参考图9-10得知。所述第一工作刃447a包含工作刃347和与之固定成一体的第一弹片450，所述第一弹片450包含平直段453和弧形段455。所述第二工作刃449a包含工作刃349和与之固定成一体的第二弹片460，所述第二弹片460包含平直段463和弧形段465。所述第一弹片450和第二弹片460具有柔性和形状记忆功能。当受到外力挤压时，所述第一，第二弹片的弧形段455(465)可以变形成近似平直段并沿着所述拉杆343的轴向方向伸长；当外力除去时所述第一，第二弹片的弧形段455(465)可以复原成弧形并沿着所述拉杆343的轴向方向缩回。所述抓钳400a可替代前述组合取物器械500中的抓钳400应用于手术中从患者体内取出组织或标本。
图22描绘了另一种改进的专用的重复使用撑开器械700。所述撑开器械700包括金属长杆710和与之连接的第一弹片750和第二弹片760。所述第一弹片750包含平直段753和弧形段755。所述第二弹片760包含平直段763和弧形段765。所述第一弹片750和第二弹片760具有柔性和形状记忆功能。当受到外力挤压时，所述第一，第二弹片的弧形段755(765)可以变形成近似平直段并沿着所述杆710的轴向方向伸长；当外力除去时所述第一，第二弹片的弧形段755(765)可以复原成弧形并沿着所述杆710的轴向方向缩回。所述撑开器械700可替代前述组合取物器械500中的抓钳400应用于手术中从患者体内取出组织或标本。参考图23-24，将所述第一弹片750的平直段753，第二弹片760的平直段763分别插入所述卷曲状态的标本袋100的第一隧道口111和第二隧道口113中，插入到底使得所述第一弹片750和第二弹片760基本完全进入所述隧道109中，再将所述标本袋100和所述器械700一同经由穿刺套管通道60进入患者体内并保持拉线130的近端139处于患者体外。由于所述第一弹片750和弹片760具有柔性，因此可自动变形 使其通过所述套管通道60时阻力小且顺畅。当按前文所述的方法拉动拉线解开活扣结后，由于所述第一弹片750和第二弹片760具有形状记忆功能而自动复原，因此可将所述标本袋100自动展开。
已经展示和描述了本发明的很多不同的实施方案和实例。本领域的一个普通技术人员，在不脱离本发明范围的前提下，通过适当修改能对所述方法和器械做出适应性改进。例如利用其他发明中披露的绑接的活扣方式做简单适应性修改。好几种修正方案已经被提到，对于本领域的技术人员来说，其他修正方案也是可以想到的。因此本发明的范围应该依照附加权利要求，同时不应被理解为由说明书及附图显示和记载的结构，材料或行为的具体内容所限定。

Claims (10)

  1. 一种组合取物器械，包含一次性使用标本袋产品包和重复撑开机构，所述标本袋产品包包含标本袋及无菌包装系统，并以无菌状态销售和供客户使用，所述无菌包装系统确保所述标本袋处于无菌状态；所述标本袋包含可打开和收拢的袋口，以及从袋口延伸而成的封闭的袋体；所述标本袋还包括环绕袋口的隧道和穿插在所述隧道中的拉线，其特征在于：
    1)所述隧道包含第一隧道口和第二隧道口；
    2)所述标本袋包含舒展状态和卷曲状态；
    3)所述卷曲状态时，所述隧道被对折且所述第一隧道口和第二隧道口基本对齐，所述袋体以基本平行所述隧道的方式折叠成细长形或卷起成卷轴形；
    4)所述标本袋还包括扎线圈用以将所述标本袋固定为卷曲状态，阻止所述标本袋自动的从卷曲状态变成舒展状态。
  2. 如权利要求1所述组合取物器械，其特征在于，所述扎线圈由细长的线绳形成，包括至少两个活扣结，或包含至少一个死扣结和一个活扣结。
  3. 如权利要求2所述的组合取物器械，其特征在于，所述扎线圈由所述标本袋自带的拉线构成。
  4. 如权利要求2所述的组合取物器械，其特征在于，所述标本袋还包含2个导向管，所述导向管分别插入所述第一隧道口和第二隧道口并与其固定。
  5. 如权利要求1所述的组合取物器械，其特征在于，所述重复撑开机构包含手柄组件，加长杆组件和内芯组件；所述内芯组件包含第一加长工作刃和第二加长工作刃，操作所述手柄组件可驱动所述第一加长工作刃和第二加长工作刃张开或闭合。
  6. 如权利要求1所述的组合取物器械，其特征在于，所述重复撑开机构包含加长杆，第一弹片和第二弹片。所述第一弹片包括第一弧形段和第一平直段，所述第二弹片包括第二弧形段和第二平直段。所述第一弹片和第二弹片具有柔性和形状记忆功能。
  7. 一种用于如权利要求3所述的组合取物器械的标本袋的卷曲状态制造方法，其特征在于，包含以下主要步骤：
    S1:首先将所述标本袋的袋口的卷轴结构对折压缩；
    S2:然后沿袋底向袋体颈部将所述标本袋的袋面卷曲和/或折叠，并与对折的卷轴结构形成细长形或卷轴形的标本袋；
    S3:用所述标本袋的拉线构造扎线圈将卷曲状态的标本袋绑接；所述扎线圈包含两个活扣结，或包含少一个死扣结和一个活扣结，并可以通过拉动所述拉线的近端解开所述活扣结。
  8. 一种用于如权利要求3所述的组合取物器械的标本袋的绑扎方法，其特征在于，包含以下主要步骤：
    S1:先将拉线的拉线绳的合适位置在卷曲状态的标本袋上缠绕形成3个及以上的扎线圈将标本袋初步的绑扎固定，且预留出一个被所述扎线圈绑扎固定的第一活扣结。
    S2:再将拉线绳的合适位置再折叠成第二活扣结并穿过所述第一活扣结，拉紧所述拉线绳使所述第一活扣结缩小至将所述第二活扣结固定，完成整个标本袋的卷曲状态的绑接。
  9. 一种用于如权利要求3所述的组合取物器械的标本袋的绑扎方法，其特征在于，包含以下主要步骤：
    S1:首先将拉线的拉线绳上的合适位置打一个死扣结；
    S2:再将拉线绳再围绕卷曲状态的标本袋缠绕形成扎线圈；再将拉线绳的合适位置折叠成活扣结并穿过所述死扣结，拉紧拉线绳使所述死扣结缩小至将所述活扣结固定；
    S3:最后调整死扣结和活扣结的位置使得所述扎线圈将所述卷曲状态的标本袋绑接固定。
  10. 一种如权利要求3或5任一所述的组合取物器械的使用方法，其特征在于，包含以下主要步骤：
    S1：首先以标准的无菌手法撕开或打开标本袋产品包的无菌包装系统；
    S2：再用微创手术通用无损抓钳夹持或徒手握持处于卷曲状态的标本袋，将所述第一加长工作刃和第二加长工作刃分别插入所述第一隧道口和第二隧道口中，并插入到底；
    S3：操作所述手柄组件使所述第一加长工作刃和第二加长工作刃保持在隧道中并处于闭合状态，在经由穿刺套管通道进入患者体腔，且使所述拉线近端处于患者体外；
    S4：拉动所述近端使捆扎所述标本袋的扎线圈的活扣结脱开，则扎线圈随之松开，再调整使所述袋体展开，即标本袋由卷曲状态切换为舒展状态；
    S5：将标本袋完全展开并定位到需要切割标本或病变组织的目标位置，操作所述重复撑开机构使第一加长工作刃和第二加长工作刃相互张开，从而打开袋口和袋体；再将标本或病变组织装入标本袋中。S6：移走所述重复撑开机构，再拉动拉线绳将所述袋口封闭。S7：最后将穿刺套管和装有标本或病变组织的标本袋拔出至患者体外。
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CN111685817B (zh) * 2020-07-09 2022-03-25 杭州洁伊医疗器械有限公司 一种用于医用取物器的中空管
CN111685823A (zh) * 2020-07-09 2020-09-22 重庆橙壹科技有限公司 一种包含袋面隧道的微创手术取物器
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
CN111685819B (zh) * 2020-07-09 2021-07-02 天津市第四中心医院 一种容易展开的医用取物器及其制造方法
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
CN111685821B (zh) * 2020-07-09 2021-07-02 中南大学湘雅医院 一种蓬松态医用取物器
CN111685824B (zh) * 2020-07-16 2022-08-09 重庆橙壹科技有限公司 一种包含多条腰带轨道的医用取物器
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