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WO2015101226A1 - 直线缝合切割装置 - Google Patents

直线缝合切割装置 Download PDF

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Publication number
WO2015101226A1
WO2015101226A1 PCT/CN2014/095149 CN2014095149W WO2015101226A1 WO 2015101226 A1 WO2015101226 A1 WO 2015101226A1 CN 2014095149 W CN2014095149 W CN 2014095149W WO 2015101226 A1 WO2015101226 A1 WO 2015101226A1
Authority
WO
WIPO (PCT)
Prior art keywords
cutter
staple cartridge
cutting device
safety member
suture cutting
Prior art date
Application number
PCT/CN2014/095149
Other languages
English (en)
French (fr)
Inventor
陈望东
舒拓
裴永旺
Original Assignee
苏州天臣国际医疗科技有限公司
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
Priority claimed from CN201310749269.5A external-priority patent/CN103720499B/zh
Priority claimed from CN201320887855.1U external-priority patent/CN203634231U/zh
Application filed by 苏州天臣国际医疗科技有限公司 filed Critical 苏州天臣国际医疗科技有限公司
Priority to EP14877249.4A priority Critical patent/EP3090690B1/en
Priority to US15/108,896 priority patent/US10265070B2/en
Priority to ES14877249T priority patent/ES2824426T3/es
Priority to JP2016542761A priority patent/JP6328250B2/ja
Publication of WO2015101226A1 publication Critical patent/WO2015101226A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A61B2090/0812—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument indicating loosening or shifting of parts of an instrument, signaling maladjustment of parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0814—Preventing re-use

Definitions

  • the invention belongs to the technical field of medical device manufacturing, and in particular relates to a linear suture cutting device.
  • Linear slitters are widely used in surgical procedures for wound suturing, internal tissue suturing and cutting.
  • a typical linear slitting device is disclosed in US Pat. No. 5,129,570, which has two functions of suturing and cutting, and is used for suturing wounds. At the same time, the excess tissue is removed.
  • the linear slitter generally comprises two upper and lower jaws, and a closing handle for closing the upper and lower jaws, and an anvil and a staple cartridge opposite to the distal ends of the upper and lower jaws, and are arranged on the nail
  • a firing piece that can be moved relative to the staple cartridge at the same time and a pusher bar with a cutter at the distal end, and a push button for driving the firing piece and the pusher bar to move. Studs are arranged in the staple cartridge, and the firing sheets sequentially push the pusher sheets in sequence and push the staples toward the anvil, which cuts the tissue between the staple cartridge and the anvil.
  • the staple cartridge of the linear seam cutter can be replaced and used multiple times.
  • the instrument needs to be reset first, then the upper and lower jaws are opened, and the device is withdrawn from the operation. The site, and then the staple cartridge is replaced, so that the linear suture cutting device can be used for the next suture cutting operation.
  • the present invention provides a linear suture cutting device comprising upper and lower jaws that can be closed or opened to each other, the upper jaw including an anvil, the lower jaw including a staple holder, a staple cartridge is detachably disposed on the staple cartridge frame, and the pusher cartridge is movably disposed with a pusher bar and a cutter disposed at a distal end of the pusher bar, wherein the cutter is movable on the pusher bar Actuating from the proximal end of the staple cartridge distally to disengage the target tissue placed between the anvil and the staple cartridge, wherein the linear suture cutting device further comprises a nail mountable on the nail Insurance on the warehouse; said The cutter includes a slot engaged with the safety member and a resisting portion formed above the slot, the insurance when the cutter is located at a proximal end of the staple cartridge and is in an unlocked state a member is located at a first position abutting against a top wall of the abutting portion to prevent the safety member
  • the abutting portion extends proximally from a distal end of the cutter, the cutter further comprising a stopper disposed at a proximal end of the slot, and when the safety member is located In the slot position, the securing member abuts the stopping portion in a direction in which the cutter moves distally; the proximal end of the abutting portion and the stopping portion Forming a socket and defining a socket together with the slot, the safety member can enter the slot from the socket.
  • the bottom wall of the abutting portion is inclined upward or parallel to the plane of motion of the cutter in a direction extending from the distal end of the cutter to the proximal end.
  • the top wall of the abutting portion is parallel to the plane of motion of the cutter or the top wall is inclined downward in a direction extending from the distal end of the cutter to the proximal end.
  • the safety member is in a free position; the free position is higher or lower than or equal to the second position.
  • the proximal end of the stopping portion is provided with a guiding portion having a guide capable of guiding the safety member from the free position to the top wall of the stopping portion.
  • a guiding surface in the direction from the proximal end to the distal end of the cutter, the guiding surface is an upwardly inclined slope or a smoothly transitioning curved surface.
  • the proximal end of the guiding surface extends downwardly below the free position.
  • the safety member is made of a deformable material and has elasticity in the up and down direction.
  • the safety member has a Rockwell hardness HRC of 28 to 35 degrees. More preferably, the safety member has a Rockwell hardness HRC of 30 degrees.
  • the safety member is detachably mounted on the staple cartridge.
  • a pair of side walls of the staple cartridge are respectively provided with mounting holes for the safety member to be inserted, and the mounting holes are blind holes for closing the outer end.
  • the linear suture cutting device further includes a safety knife cover detachably mounted at a proximal end of the staple cartridge, the safety member being detachably mounted in the safety knife sleeve, and
  • the longitudinal axis of the fuse is perpendicular to the longitudinal axis of the staple cartridge.
  • the safety guard includes two mounting walls opposite to each other, and an interconnecting wall connected between the two mounting walls, the mounting walls are respectively provided with bumps, the staple cartridges Provided with the bump Fit the groove.
  • the pair of mounting walls are respectively provided with mounting holes for inserting the securing member, the mounting holes are lower than the top wall of the abutting portion, and the securing member is The deformation material is prepared, and when the safety member abuts against the top wall of the abutting portion, the safety member is in a forced deformation state.
  • the mounting aperture is substantially equal to or slightly larger than the thickness of the fuse.
  • the mounting aperture is higher or higher than the bottom of the slot.
  • the top of the stop portion is higher than the mounting hole, and the proximal end of the stop portion is provided with a guiding portion, and the proximal end of the guiding portion is lower than the mounting hole.
  • the pair of mounting walls are respectively provided with mounting holes for inserting the securing member
  • the securing member is a non-deformable plate
  • the height of the mounting hole allows the securing member to rise To the top wall of the abutment and allow the safety member to descend below the top wall of the stop.
  • the linear suture cutting device provided by the present invention cooperates with the cutter by a specially arranged safety member, and the safety member and the top wall of the cutter abutting portion are resisted during installation, and the safety member does not fall.
  • the safety member In the slot below the abutting portion, the safety member is in an unlocked state, and the cutter and the firing piece can be moved from the proximal end of the staple cartridge to the distal end to complete the sewing process, and when the cutter is pulled back, the insurance is performed.
  • the piece enters and snaps into the slot, and the safety piece further restricts the movement of the cutter, preventing the device from being secondarily fired without replacing the staple cartridge, thereby avoiding the occurrence of a medical accident.
  • FIG. 1 is a schematic structural view of an embodiment of a linear suture cutting device of the present invention
  • FIG. 2 is an exploded perspective view of an embodiment of a linear suture cutting device of the present invention
  • FIG. 3 is a schematic structural view of a cutter in an embodiment of the linear suture cutting device of the present invention.
  • FIG. 4 is a schematic structural view of an embodiment of the linear suture cutting device of the present invention in which the cutter is not fired;
  • Figure 5 is a cross-sectional view taken along line A-A of Figure 4.
  • Figure 6 is a cross-sectional view taken along line B-B of Figure 4.
  • Figure 7 is a schematic view showing the structure of the linear suture cutting device of the present invention, which is pulled back to the proximal end of the staple cartridge after the cutter is fired;
  • Figure 8 is a cross-sectional view taken along line A-A of Figure 7;
  • the linear suture cutting device 100 includes an upper jaw 101 and a lower jaw 102 that can be closed or opened to each other. It should be noted that the terms “upper” and “lower” as used herein do not denote absolute distinctions in position, but merely for convenience of description.
  • the upper jaw 101 includes an anvil 50
  • the lower jaw 102 includes a cartridge holder 103
  • the cartridge holder 103 is detachably provided with a staple cartridge 10
  • the upper and lower jaws 101, 102 can be closed relative to each other to target tissue Clamped between the anvil 50 and the staple cartridge 10.
  • the nail holder 103 is also movably provided with a pusher bar (not shown) and a cutter 20 placed at the distal end of the pusher bar.
  • the cutter 20 can be from the proximal end of the staple cartridge 10 under the action of the pusher bar. N moves toward the distal end F to break the target tissue placed between the anvil 50 and the staple cartridge 10.
  • the bottom surface S of the cutter 20 is a plane of motion S in which the cutter 20 moves back and forth between the proximal end and the distal end of the staple cartridge 10.
  • the linear suture cutting device 100 further includes a safety member 30 fixedly disposed opposite the staple cartridge 10 (herein, "relatively fixed to the staple cartridge 10" means that the safety member 30 is mounted on the staple cartridge 10 so as to be movable up and down.).
  • a safety member 30 fixedly disposed opposite the staple cartridge 10
  • the safety member 30 and the staple cartridge 10 are relatively fixed, and the vertical direction fastener 30 can be moved up and down with respect to the staple cartridge 10, for example, in the up and down direction.
  • the longitudinal axis of the securing member 30 is perpendicular to the longitudinal axis of the staple cartridge 10.
  • the securing member 30 is formed in a thin elastic shape or made of a deformable material, which can be easily formed in the thickness direction. Bending, but the invention is not limited thereto.
  • the linear suture cutting device 100 has a safety knife cover 40 detachably mounted at a proximal end N of the staple cartridge 10, the safety knife sleeve 40 including two mounting walls 41 opposed to each other, and a interconnection wall connected between the two mounting walls 41. 42.
  • the pair of mounting walls 41 are respectively provided with mounting holes 411 for inserting the securing members 30.
  • the two ends of the securing members 30 respectively cooperate with the mounting holes 411 of the pair of mounting walls 41 to be mounted on the safety guard 40.
  • the two mounting walls 41 are respectively provided with a protrusion 412, and the staple cartridge 10 is provided with a groove 11 engageable with the protrusion 412.
  • the safety knife sleeve 40 is made of a deformable material, and when installed, the two mounting walls 41 are passed through. By applying a relative force, the bumps 412 on the blade holder 40 can be fitted into the recesses 11 to secure the blade holder 40 and the staple cartridge 10 to each other.
  • the manner of fixing the blade holder 40 and the staple cartridge 10 to each other by "bumps and grooves" as described herein is merely exemplary, and in more alternative embodiments, it may also be, for example, A groove is formed in the blade holder 40, and a projection is provided on the magazine 10 to achieve the same fixing effect.
  • the securing member 30 is mounted in the sling 40 as described herein, and is merely an example in which the securing member 30 is mounted on the staple cartridge 10; in other variant embodiments, for example, without the burr 40 In case of insurance
  • the fittings may also be directly mounted on the side wall of the staple cartridge, and a pair of side walls of the staple cartridge are respectively provided with mounting holes for inserting the safety member, and the mounting holes are blind holes closed by the outer ends.
  • the cutter 20 includes a slot 21 that is adapted to the securing member 30.
  • the movement of the cutter 20 is also limited.
  • “restricting the movement of the cutter” It means that the cutter 20 cannot be fired and cuts the tissue, and the cutter 20 does not need to be fully clamped.
  • a resisting portion 22 is formed above the slot 21, and the top wall of the resisting portion 22 can abut against the securing member 30 to prevent the securing member 30 from fitting into the slot 21.
  • the securing member 30 When the cutter 20 is located at the proximal end N of the staple cartridge 10, the securing member 30 is selectively located in the second position (i.e., as shown in Figure 8, the security member 30 is snapped into the slot 21) or the first position (i.e., The safety member 30 shown in FIG. 5 abuts against the top wall of the abutting portion 22, so that if the staple cartridge 10 is not used, the safety member 30 can be placed in the first position (ie, the safety member 30 is erected against the abutting portion).
  • the cutter 20 is in an unlocked state (or to be fired), the doctor can fire the instrument to complete the slitting of the target tissue, and if the staple cartridge 10 needs to be replaced or the staple cartridge 10 is fired, it returns to the proximal end N.
  • the safety member 30 is in the second position (ie, the safety member 30 is clamped in the slot 21 on the cutter 20), the cutter 20 is in the locked state, and the device cannot be fired at this time, thereby playing a secondary insurance function.
  • the safety member 30 is released from the cutter 20 in a free position.
  • the height of the free position is substantially equal to the height of the second position (the second position of the safety member 30 is higher than or equal to the position of the slot 21 after the safety member 30 falls into the slot 21 The bottom wall), in actual use, due to the elasticity of the securing member 30, slight deformation may occur after the resisting portion 22 of the cutter 20 is disengaged, so that the height of the free position is slightly higher than the first Two locations.
  • the height of the free position may be higher than the second position (but not higher than the height of the socket 212 described below).
  • the height of the free position may be lower than the second position (ie, the height of the inner bottom wall of the slot 21 is higher than the height of the free position).
  • the cutter 20 can engage the slot 21 thereon with the safety member 30 in the direction from the distal end F of the staple cartridge 10 to the proximal end N. Since the knife needs to be pulled back from the distal end F of the staple cartridge 10 after the instrument has been fired once, the safety member 30 enters the slot 21 of the cutter 20 when the cutter 20 is pulled back to the proximal end N of the staple cartridge 20. Therefore, it plays an insurance role to prevent secondary firing when empty positions, and is more suitable for actual operational needs.
  • the resisting portion 22 extends from the distal end F1 of the cutter 20 toward the proximal end N1 and is defined together with the stopper portion 24 disposed at the proximal end N1 of the cutter 20 to form a With the slot 21 of the socket 212, the securing member 30 can be fitted into the slot 21 from the socket 212.
  • the mounting hole 411 is lower than the top wall of the abutting portion 22 (ie, the mounting hole 411 is closer to the bottom wall of the staple cartridge 10 than the top wall of the abutting portion 22); and the upper wall of the mounting hole 411 is The rounded transition (see Figures 5 and 8) can better accommodate the securing member 30 that elastically deforms when the securing member 30 is erected against the top wall (i.e., the first position) of the abutment portion 22.
  • the security member 30 is in the form of a thin shrapnel or is deformable
  • the material is made, which can be easily bent in the thickness direction, so that when the safety member 30 abuts against the top wall of the abutting portion 22, the safety member 30 is in a forced deformation state, that is, in the first position. .
  • the top of the stop portion 24 is higher than the mounting hole 411 (ie, the top of the side wall 211 of the slot 21 adjacent to the socket 212) and the bottom wall of the staple cartridge 10 is larger than the distance between the mounting hole 411 and the bottom wall of the staple cartridge 10. the distance.
  • the proximal end of the stop portion 24 (ie, the slot 21 is adjacent between a side wall 211 of the socket 212 and the proximal end N1 of the cutter 20) is further provided with a guiding portion 23, the proximal end of the guiding portion 23 Lower than the mounting hole 411 (ie, the distance between the proximal end of the guiding portion 23 and the bottom wall of the staple cartridge 10 is smaller than the distance between the mounting hole 411 and the bottom wall of the staple cartridge 10).
  • the safety member 30 can be lifted up by the engagement of the guide portion 23 and gradually enter the slot through the top wall of the stop portion 24. In 21, the position is restricted by the side wall 211 to achieve the effect of preventing secondary firing.
  • the guiding portion 23 is a guiding surface capable of guiding the securing member 30 from the free position to the top wall of the stopping portion 24; in the direction from the proximal end to the distal end, the guiding portion
  • the guiding surface is an upwardly inclined inclined surface or a smoothly transitioning curved surface, wherein the smooth transitional curved surface may be an upwardly convex circular arc surface, or the front end may form a curved surface similar to a "hook shape" and concave downward, or may be A smooth, "wavy" curved surface.
  • the proximal end of the guiding surface extends downwardly below the free position. In this way, it is possible to better ensure that the guide member 30 is moved upward beyond the stop portion 24 after the guide surface comes into contact with the safety member.
  • the securing member 30 is formed in a thin elastic shape or made of a deformable material which is elastic in the thickness direction.
  • the safety member 30 needs to have a certain hardness, the hardness should not be too high, otherwise it is not easy to deform, it is not convenient to hold it up to the first position, the hardness should not be too low, otherwise the insurance 30 may be first Plastic deformation occurs at the position, and may not be restored to the original shape after leaving the first position, thereby making it difficult for the safety member 30 to smoothly enter the socket 212 to achieve the function of preventing secondary firing.
  • the safety member 30 has a Rockwell hardness HRC of 28 to 35 degrees. More preferably, the safety member has a Rockwell hardness HRC of 30 degrees.
  • the distance between the mounting hole 411 and the bottom wall of the staple cartridge 10 is greater than or equal to the distance between the bottom of the slot 21 and the bottom wall of the staple cartridge 10, and extends to the proximal end N1 at the distal end F1 of the cutter 20.
  • the guiding portion 23 is inclined downward (i.e., the distance between the guiding portion 23 and the bottom wall of the staple cartridge 10 is gradually decreased) to provide a better guiding effect on the securing member 30.
  • the bottom wall of the abutting portion 22 is inclined upward (that is, the distance between the bottom wall of the abutting portion 22 and the bottom of the groove 21 is gradually increased) to fit the guiding portion 23, and more smoothly The fuse 30 is guided into the slot 21.
  • the top wall of the abutting portion 22 is parallel to the plane of motion S of the cutter 20 (the thickness of the abutting portion 22 is gradually decreased, but between the top wall of the abutting portion 22 and the bottom of the groove 21 The distance remains the same, so that when the device is fired, it will have a relatively stable firing guide and will not form a resistance to the travel path of the cutter 20.
  • the bottom wall of the abutting portion 22 is parallel to the plane of motion S of the cutter 20 in the direction in which the distal end F1 of the cutter 20 extends toward the proximal end N1.
  • the top wall of the abutting portion 22 is slightly inclined downward, and the cutter 20 is pushed from the proximal end to the distal end. At this time, the safety member 30 can be smoothly detached from the abutting portion 22 of the cutter.
  • the safety component 30 is inserted into the safety knife sleeve 40 , and the cutter 20 is mounted to the proximal end N of the staple cartridge 10 , and then the safety knife sleeve 40 is installed.
  • the fastening member 30 is engaged with the abutting portion 22 of the cutter 20, and the safety member 30 is forced to be bent upwardly (as shown in FIGS.
  • the firing device drives the cutter 20; After the movement, the safety member 30 is straightened under the action of its own restoring force, and is in a free state; when the process of one cutting and suturing is finished, the cutter 20 is pulled back from the distal end F of the staple cartridge 10 to the proximal end N, the safety piece 30 is slightly raised under the guidance of the guiding portion 23 of the cutter 20, and then gradually passes over the stopping portion 24 to gradually enter the slot 21 and is locked therein, thereby achieving the limit of the cutter 20 and preventing the instrument from being secondarily fired. .
  • the linear suture cutting device provided by the invention can prevent the second secondary firing of the device without the replacement of the staple cartridge by the special arrangement of the safety member and the cutter, and the medical accident is avoided, and the structure is simple and the operation is used. Convenience.
  • the hole height h of the mounting hole 411 is substantially equal to or slightly larger than the thickness H of the elastic piece 30 (see FIG. 8).
  • the securing member 30 can also be a non-deformable sheet, the height of the mounting hole allowing the securing member 30 to rise to the top wall of the abutting portion 22 and allowing the securing member 30 to descend below the stop portion 24 The top wall.

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Abstract

一种直线缝合切割装置（100），包括可互相闭合或打开的上、下钳夹（101，102），上钳夹（101）包括钉砧（50），下钳夹（102）包括钉仓架（103），钉仓架（103）上可拆卸地设置有钉仓（10），钉仓（10）内可移动地设置有切刀（20），该装置（100）还包括可上下移动地安装在钉仓（10）上的保险件（30），切刀（20）包括与保险件（30）卡配的槽位（21）、及形成于槽位（21）上方的抵持部（22），当切刀（20）位于钉仓（10）的近端且处于非锁定状态时，保险件（30）位于与抵持部（22）的顶壁相抵持的第一位置以防止保险件（30）进入槽位（21）内，切刀（20）可自钉仓（10）的近端向远端运动以完成缝切过程；当切刀（20）脱离保险件（30）时，保险件（30）处于自由位置；且切刀（20）可在自远端向近端运动回复至近端且处于锁定状态时，保险件（30）位于卡挚于槽位（21）内的第二位置，以限制切刀（20）的运动，防止在未更换钉仓（10）的情况下装置被二次击发。

Description

直线缝合切割装置 技术领域
本发明属于医疗器械制造技术领域，具体涉及一种直线缝合切割装置。
背景技术
直线型缝切器被广泛用于外科手术中用于伤口缝合、内部组织缝合与切割，典型的直线型缝切器如美国专利US5129570所揭示，具有缝合与切割两个功能，在进行伤口缝合的同时，将多余的组织切除。该类直线型缝切器一般包括上、下两个钳夹，以及用于闭合上、下钳夹的闭合把手，相对设置在上、下钳夹远端的钉砧和钉仓，设于钉仓内并可同时相对所述钉仓移动的击发片和远端设有切刀的推刀杆，以及用于驱动所述击发片和推刀杆移动的推钮。所述钉仓内排列设置有缝合钉，所述击发片依次按顺序推动推钉片并将缝合钉推向钉砧，所述切刀将位于钉仓和钉砧之间的组织切断。
现有技术中，直线型缝切器的钉仓是可以更换多次使用的。在临床使用时，经常需要多次缝合切割组织，因此在手术时需要多次更换钉仓，即医生完成一次缝切动作后，首先需要将器械复位后打开上、下钳夹，将器械退出手术部位，继而更换钉仓，以便直线缝合切割装置进行下一次的缝切手术。
但是由于一些粗心的医生或者经验不足的医生，会在未更换已击发的钉仓的情况下再次进行击发器械的动作，这样会导致医疗事故的产生，即进行了切除却没有缝合。为了防止此类事故的发生，需要在直线缝合切割装置中增设二次保险防二次击发的保险机构，以避免由于医生的误操作而产生的医疗事故。
发明内容
本发明的目的在于提供一种直线缝合切割装置，其可以防止器械在未更换钉仓的情况下被二次击发。
为实现上述发明目的，本发明提供一种直线缝合切割装置，包括可互相闭合或打开的上、下钳夹，所述上钳夹包括钉砧，所述下钳夹包括钉仓架，所述钉仓架上可拆卸地设置有钉仓，所述钉仓架内可移动地设置有推刀杆及置于推刀杆远端的切刀，所述切刀可在所述推刀杆的作用下自所述钉仓近端向远端运动以离断置于所述钉砧和钉仓之间的目标组织，其中，所述直线缝合切割装置还包括可上下移动地安装在所述钉仓上的保险件；所述 切刀包括与所述保险件卡配的槽位、以及形成于所述槽位上方的抵持部，当所述切刀位于所述钉仓的近端且处于非锁定状态时，所述保险件位于与所述抵持部的顶壁相抵持的第一位置以防止所述保险件进入所述槽位内；当所述切刀脱离所述保险件时，所述保险件处于自由位置；且所述切刀可在自所述钉仓的远端向近端运动的方向上回复至位于所述钉仓的近端且处于锁定状态时，所述保险件位于卡挚于所述槽位内的第二位置，以限制所述切刀的运动。
作为本发明的进一步改进，所述抵持部自所述切刀的远端向近端延伸，所述切刀还包括设置在槽位近端的止挡部，且当所述的保险件位于所述的槽位内时，在所述切刀向远端运动的方向上，所述的保险件与所述的止挡部相抵；所述抵持部的近端与所述止挡部之间形成一插口并与所述槽位共同限定一插口，所述保险件可自所述插口进入所述槽位内。
作为本发明的进一步改进，在自所述切刀的远端向近端延伸的方向上，所述抵持部的底壁呈上升式倾斜或与所述切刀的运动平面平行。
作为本发明的进一步改进，所述抵持部的顶壁与所述切刀的运动平面平行或者所述顶壁自切刀的远端向近端延伸的方向上呈下降式倾斜。
作为本发明的进一步改进，当所述切刀与所述的保险件脱离后，所述保险件处于自由位置；所述自由位置高于或低于或等于所述第二位置。
作为本发明的进一步改进，所述止挡部近端设有一导引部，所述导引部具有能将所述保险件由所述自由位置引导至所述止挡部的顶壁上的导引表面；在自所述切刀的近端到远端的方向上，所述导引表面呈向上倾斜的斜面或平滑过渡的弧面。
作为本发明的进一步改进，所述导引表面的近端向下延伸至所述自由位置的下方。
作为本发明的进一步改进，所述保险件由可形变材质制得，且在上下方向具有弹性。作为本发明的进一步改进，所述保险件的洛氏硬度HRC为28度～35度。更优选的，所述保险件的洛氏硬度HRC为30度。
作为本发明的进一步改进，所述保险件可拆卸地安装在所述钉仓上。
作为本发明的进一步改进，所述钉仓的一对侧壁上分别设置有可供所述保险件插置的安装孔，所述安装孔为外端封闭的盲孔。
作为本发明的进一步改进，所述直线缝合切割装置还包括可拆卸地安装在所述钉仓近端的保险刀套，所述保险件可拆卸地安装在所述保险刀套内，且所述保险件的纵长轴与所述钉仓的纵长轴垂直。
作为本发明的进一步改进，所述保险刀套包括彼此相对的两安装壁、以及连接在所述两安装壁之间的互联壁，所述两安装壁上分别设置有凸块，所述钉仓上设有可与所述凸块 配合的凹槽。
作为本发明的进一步改进，所述一对安装壁上分别设置有可供所述保险件插置的安装孔，所述安装孔低于所述抵持部的顶壁，所述保险件由可形变材质制得，且当所述保险件与所述抵持部的顶壁相抵持时，所述保险件处于受迫形变状态。
作为本发明的进一步改进，所述安装孔基本等于或稍大于所述保险件的厚度。
作为本发明的进一步改进，所述安装孔高于或等高于所述槽位的底部。
作为本发明的进一步改进，所述止挡部的顶部高于所述安装孔，所述止挡部的近端设置有导引部，所述导引部的近端低于所述安装孔。
作为本发明的进一步改进，所述一对安装壁上分别设置有可供所述保险件插置的安装孔，所述保险件为非形变板材，所述安装孔的高度允许所述保险件上升至位于所述抵持部的顶壁，并且允许所述保险件下降至低于所述止挡部的顶壁。
与现有技术相比，本发明提供的直线缝合切割装置通过特殊设置的保险件与切刀的配合，安装时，将保险件与切刀抵持部的顶壁相抵持，保险件不会落入抵持部下方的槽位中，保险件处于非锁定状态，切刀和击发片可自钉仓的近端向远端运动以完成缝切过程，并且，当切刀被拉回时，保险件进入并卡挚于槽位内，保险件进而限制切刀的运动，防止在未更换钉仓的情况下器械被二次击发，避免了医疗事故的发生。
附图说明
图1是本发明直线缝合切割装置一实施方式的结构示意图；
图2是本发明直线缝合切割装置一实施方式的分解示意图；
图3是本发明直线缝合切割装置一实施方式中切刀的结构示意图；
图4是本发明直线缝合切割装置一实施方式中切刀未被击发时的结构示意图；
图5是图4中A-A方向的剖视图；
图6是图4中B-B方向的剖视图；
图7是本发明直线缝合切割装置一实施方式中切刀击发后，被拉回至钉仓近端的结构示意图；
图8是图7中A-A方向的剖视图。
具体实施方式
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限制本发明，本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变 换均包含在本发明的保护范围内。
本发明内所描述的表达位置与方向的词，均是以器械操作者作为参照，靠近操作者的一端为近端，远离操作者的一端为远端。
参图1和图2，介绍本发明直线缝合切割装置100的一具体实施方式。在本实施方式中，该直线缝合切割装置100包括可互相闭合或打开的上钳夹101、下钳夹102。需要说明的是，这里所说的“上”、“下”并不代表位置上的绝对区分关系，而仅仅是为了描述的方便。
上钳夹101包括钉砧50，下钳夹102包括钉仓架103，该钉仓架103上可拆卸地设置有钉仓10，上、下钳夹101、102可彼此相对闭合以将目标组织夹持于钉砧50和钉仓10之间。钉仓架103内还可移动地设置有推刀杆(图未示)及置于推刀杆远端的切刀20，切刀20可在推刀杆的作用下自钉仓10的近端N向远端F运动以离断置于钉砧50和钉仓10之间的目标组织。切刀20的底面S为切刀20在钉仓10的近端和远端之间来回移动的运动平面S。
该直线缝合切割装置100还包括与钉仓10相对固定设置的保险件30(这里的“与钉仓10相对固定设置”是指：保险件30可上下移动地安装在钉仓10上。)。在本实施方式中，在切刀20的运动方向上，保险件30与钉仓10相对固定，而在上下方向保险件30可以相对于钉仓10上下移动，例如上下方向的变形。
本实施方式中，该保险件30的纵长轴与钉仓10的纵长轴垂直设置，保险件30呈一薄弹片状或由可形变材质制得，其可以在厚度方向上较易被弯折，但本发明并不限于此。
直线缝合切割装置100具有一可拆卸地安装在钉仓10近端N的保险刀套40，该保险刀套40包括彼此相对的两安装壁41、以及连接在两安装壁41之间的互联壁42，该一对安装壁41上分别设置有可供保险件30插置的安装孔411，保险件30的两端分别与一对安装壁41上的安装孔411配合以安装在保险刀套40内。两安装壁41上还分别设置有凸块412，钉仓10上设有可与凸块412配合的凹槽11，保险刀套40由可形变材质制得，安装时，通过对两安装壁41施加相对的作用力，可以将保险刀套40上的凸块412配合至凹槽11内，以将保险刀套40与钉仓10彼此固定。需要说明的是，这里所说的将保险刀套40与钉仓10通过“凸块和凹槽”彼此固定的方式仅仅是示范性地，在更多替换的实施方式中，也可以例如是在保险刀套40上设置凹槽，而在钉仓10上设置凸块以达到同样的固定作用。此外，这里所说的将保险件30安装在保险刀套40内，仅是保险件30安装在钉仓10上的一个示范例；在其他变型实施例中，例如，在没有保险刀套40的情况下，保险 件也可以是直接安装在钉仓的侧壁上，所述钉仓的一对侧壁上分别设置有可供所述保险件插置的安装孔，安装孔为外端封闭的盲孔。
切刀20包括与保险件30适配的槽位21，当保险件30卡挚于该槽位21内时，切刀20的运动也即受到限制，这里所说的“限制切刀的运动”是指切刀20不可被击发并进行组织的切割，而并非切刀20需要被完全卡紧固定。槽位21上方形成有一抵持部22，该抵持部22的顶壁可与保险件30相抵持以阻止保险件30配合至槽位21内。当切刀20位于钉仓10的近端N时，保险件30可选择地位于第二位置(即如图8所示，保险件30卡挚于槽位21内)或第一位置(即如图5所示保险件30与抵持部22的顶壁相抵持)，这样，如果钉仓10未被使用，可以将保险件30处于第一位置(即保险件30架设抵持在抵持部22的顶壁)，切刀20处于非锁定状态(或待击发状态)，医生可以击发器械完成目标组织的缝切，而若需要更换钉仓10或钉仓10被击发过后回到近端N时，则使保险件30处于第二位置(即保险件30卡挚于切刀20上的槽位21内)，切刀20处于锁定状态，此时器械不能被击发，起到二次保险作用。此外，当切刀20离开钉仓10的近端N后，保险件30脱离切刀20后处于自由位置。在本实施例中，自由位置的高度基本上等于第二位置的高度(保险件30落入槽位21内后，保险件30所处于的第二位置高于或等高于槽位21的内底壁)，在实际使用过程中，由于保险件30由于自身的弹性，在脱开切刀20的抵持部22之后可能会发生轻微变形，使得所述自由位置的高度略高于所述第二位置。在其他变型实施例中，所述自由位置的高度可以高于所述第二位置(但不会高于下述的插口212的高度)。在其他变型实施例中，所述自由位置的高度可以低于所述第二位置(即槽位21的内底壁的高度高于所述自由位置的高度)。
切刀20可在自钉仓10的远端F向近端N运动的方向上将其上的槽位21与保险件30相配合。由于器械被击发一次后，切刀需要被从钉仓10的远端F拉回，在切刀20被拉回至钉仓的近端N时，保险件30进入切刀20的槽位21内，从而起到防止空仓时二次击发的保险作用，更加适应实际的操作需求。
配合参照图3至图6，具体的结构中：抵持部22自切刀20的远端F1向近端N1延伸，并与设于切刀20近端N1的止挡部24共同限定形成一具有插口212的槽位21，保险件30可自插口212配合至槽位21内。在本实施例中，安装孔411低于抵持部22的顶壁(即安装孔411相较抵持部22的顶壁更加临近钉仓10的底壁)；并且安装孔411的上壁内缘圆滑过渡(参见图5和图8)，该构造可以更好地适应当保险件30架设抵持在抵持部22顶壁(即第一位置)时发生弹性形变的保险件30。由于保险件30呈一薄弹片状或由可形变 材质制得，其可以在厚度方向上较易被弯折，从而，当保险件30与抵持部22的顶壁相抵持时，保险件30处于受迫形变状态，即处于所述第一位置。
止挡部24的顶部高于安装孔411(即槽位21临近插口212的一侧壁211的顶部)与钉仓10的底壁之间的距离大于安装孔411与钉仓10底壁之间的距离。此外，止挡部24的近端(即该槽位21临近插口212的一侧壁211与切刀20的近端N1之间)还设置有导引部23，该导引部23的近端低于安装孔411(即该导引部23的近端与钉仓10底壁之间的距离小于安装孔411与钉仓10底壁之间的距离)。如此，在切刀20自钉仓10的远端F向近端N运动时，保险件30可以通过该导引部23的配合，被顶起并经过止挡部24的顶壁逐渐进入槽位21内，进而被侧壁211限制位置，实现防二次击发的作用。
在本实施例中，导引部23为能将保险件30由所述自由位置引导至止挡部24的顶壁上的导引表面；在自近端到远端的方向上，所述导引表面呈向上倾斜的斜面或平滑过渡的弧面，其中平滑过渡的弧面可以是向上凸的圆弧面，也可以是前端形成类似“勾形”且向下凹的弧面，还可以是平滑过渡的“波浪形”弧面。所述导引表面的近端向下延伸至所述自由位置的下方。这样，可以更好地确保导引表面与保险件接触后，能够导引保险件30向上移动越过止挡部24。
在本实施例中，保险件30呈一薄弹片状或由可形变材质制得，其可以在厚度方向上具有弹性。另外，保险件30需有一定的硬度，硬度不宜过高，否则不容易发生形变，不便于将其向上抵持至第一位置，硬度也不宜过低，否则可能会使得保险件30在第一位置时发生塑性变形，离开第一位置后可能无法恢复到原始形态，从而导致保险件30难以顺利进入插口212来实现防二次击发的功能。
作为优选的实施方式，保险件30的洛氏硬度HRC为28度～35度。更优选的，保险件的洛氏硬度HRC为30度。
作为优选的实施方式，安装孔411与钉仓10底壁之间的距离大于等于槽位21底部与钉仓10底壁之间的距离，且在切刀20的远端F1向近端N1延伸的方向上，导引部23呈下降式倾斜(即导引部23与钉仓10底壁之间的距离逐渐减小)，以对保险件30起一较佳的引导作用。在该方向上，抵持部22的底壁呈上升式倾斜(即抵持部22的底壁与槽位21底部之间的距离逐渐增大)，以与导引部23配合，更顺畅地将保险件30引导至槽位21内。优选地，在该方向上，抵持部22的顶壁与切刀20的运动平面S平行(抵持部22的厚度逐渐减小，但抵持部22的顶壁与槽位21底部之间的距离保持不变)，这样在器械被击发时，会具有较为稳定的击发导向，不会对切刀20的行进路线形成阻力。
在其他变形实施例中，在切刀20的远端F1向近端N1延伸的方向上，抵持部22的底壁与所述切刀20的运动平面S平行。在其他变形实施例中，在切刀20的远端F1向近端N1延伸的方向上，抵持部22的顶壁略呈下降式倾斜，在切刀20被推动自近端向远端运动时，保险件30可顺利地自所述切刀的抵持部22上脱离。
配合参照图5至图8，具体使用时：首先将保险件30插置固定于保险刀套40内，并将切刀20安装到钉仓10上的近端N，随后，将保险刀套40与钉仓10扣合，此时保险件30与切刀20的抵持部22相抵持，保险件30受迫向上弯折形变(如图5和图6所示)；击发器械带动切刀20移动后，保险件30在自身回复力的作用下伸直，处于自由状态；当一次切割缝合的过程结束后，将切刀20自钉仓10的远端F向近端N拉回，保险件30在切刀20的导引部23的引导下先稍微上升，再越过止挡部24下降逐渐进入槽位21并卡挚于其中，实现对切刀20的限位，防止器械被二次击发。
本发明提供的直线缝合切割装置通过特殊设置的保险件与切刀的配合，可以防止在未更换钉仓的情况下，器械被二次击发，避免了医疗事故的发生，其结构简单，使用操作方便。
其他变型实施例：
在图5至图8所示的实施例中，安装孔411的孔高h基本等于或稍大于弹片状保险件30的厚度H(参见图8)。
但在其他变型实施例中，保险件30也可以为非形变板材，安装孔的高度允许保险件30上升至位于抵持部22的顶壁，并且允许保险件30下降至低于止挡部24的顶壁。
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施方式中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明，它们并非用以限制本发明的保护范围，凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。

Claims (19)

  1. 一种直线缝合切割装置，包括可互相闭合或打开的上、下钳夹，所述上钳夹包括钉砧，所述下钳夹包括钉仓架，所述钉仓架上可拆卸地设置有钉仓，所述钉仓架内可移动地设置有推刀杆及置于推刀杆远端的切刀，所述切刀可在所述推刀杆的作用下自所述钉仓近端向远端运动以离断置于所述钉砧和钉仓之间的目标组织，其中，
    所述直线缝合切割装置还包括可上下移动地安装在所述钉仓上的保险件；所述切刀包括与所述保险件卡配的槽位、以及形成于所述槽位上方的抵持部，当所述切刀位于所述钉仓的近端且处于非锁定状态时，所述保险件位于与所述抵持部的顶壁相抵持的第一位置以防止所述保险件进入所述槽位内；当所述切刀脱离所述保险件时，所述保险件处于自由位置；且所述切刀可在自所述钉仓的远端向近端运动的方向上回复至位于所述钉仓的近端且处于锁定状态时，所述保险件位于卡挚于所述槽位内的第二位置，以限制所述切刀的运动。
  2. 根据权利要求1所述的直线缝合切割装置，其中，所述抵持部自所述切刀的远端向近端延伸，所述切刀还包括设置在槽位近端的止挡部，且当所述的保险件位于所述的槽位内时，在所述切刀向远端运动的方向上，所述的保险件与所述的止挡部相抵；所述抵持部的近端与所述止挡部之间形成一插口并与所述槽位共同限定一插口，所述保险件可自所述插口进入所述槽位内。
  3. 根据权利要求2所述的直线缝合切割装置，其中，在自所述切刀的远端向近端延伸的方向上，所述抵持部的底壁呈上升式倾斜或与所述切刀的运动平面平行。
  4. 根据权利要求3所述的直线缝合切割装置，其中，所述抵持部的顶壁与所述切刀的运动平面平行或者所述顶壁自切刀的远端向近端延伸的方向上呈下降式倾斜。
  5. 根据权利要求2所述的直线缝合切割装置，其中，当所述切刀与所述的保险件脱离后，所述保险件处于自由位置；所述自由位置高于或低于或等于所述第二位置。
  6. 根据权利要求5所述的直线缝合切割装置，其中，所述止挡部近端设有一导引部，所述导引部具有能将所述保险件由所述自由位置引导至所述止挡部的顶壁上的导引表面；在自所述切刀的近端到远端的方向上，所述导引表面呈向上倾斜的斜面或平滑过渡的弧面。
  7. 根据权利要求6所述的直线缝合切割装置，其中，所述导引表面的近端向下延伸至所述自由位置的下方。
  8. 根据权利要求1所述的直线缝合切割装置，其中，所述保险件由可形变材质制得，且在上下方向具有弹性。
  9. 根据权利要求1所述的直线缝合切割装置，其中，所述保险件的洛氏硬度HRC 为28度～35度。
  10. 根据权利要求9所述的直线缝合切割装置，其中，所述保险件的洛氏硬度HRC为30度。
  11. 根据权利要求1所述的直线缝合切割装置，其中，所述保险件可拆卸地安装在所述钉仓上。
  12. 根据权利要求11所述的直线缝合切割装置，其中，所述钉仓的一对侧壁上分别设置有可供所述保险件插置的安装孔，所述安装孔为外端封闭的盲孔。
  13. 根据权利要求1所述的直线缝合切割装置，其中，所述直线缝合切割装置还包括可拆卸地安装在所述钉仓近端的保险刀套，所述保险件可拆卸地安装在所述保险刀套内，且所述保险件的纵长轴与所述钉仓的纵长轴垂直。
  14. 根据权利要求13所述的直线缝合切割装置，其中，所述保险刀套包括彼此相对的两安装壁、以及连接在所述两安装壁之间的互联壁，所述两安装壁上分别设置有凸块，所述钉仓上设有可与所述凸块配合的凹槽。
  15. 根据权利要求14所述的直线缝合切割装置，其中，所述一对安装壁上分别设置有可供所述保险件插置的安装孔，所述安装孔低于所述抵持部的顶壁，所述保险件由可形变材质制得，且当所述保险件与所述抵持部的顶壁相抵持时，所述保险件处于受迫形变状态。
  16. 根据权利要求15所述的直线缝合切割装置，其中，所述安装孔基本等于或稍大于所述保险件的厚度。
  17. 根据权利要求15所述的直线缝合切割装置，其中，所述安装孔高于或等高于所述槽位的底部。
  18. 根据权利要求15所述的直线缝合切割装置，其中，所述止挡部的顶部高于所述安装孔，所述止挡部的近端设置有导引部，所述导引部的近端低于所述安装孔。
  19. 根据权利要求14所述的直线缝合切割装置，其中，所述一对安装壁上分别设置有可供所述保险件插置的安装孔，所述保险件为非形变板材，所述安装孔的高度允许所述保险件上升至位于所述抵持部的顶壁，并且允许所述保险件下降至低于所述止挡部的顶壁。
PCT/CN2014/095149 2013-12-31 2014-12-26 直线缝合切割装置 WO2015101226A1 (zh)

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