WO2014044108A1 - 一种改进的外科器械的执行器 - Google Patents

一种改进的外科器械的执行器 Download PDF

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Publication number
WO2014044108A1
WO2014044108A1 PCT/CN2013/082025 CN2013082025W WO2014044108A1 WO 2014044108 A1 WO2014044108 A1 WO 2014044108A1 CN 2013082025 W CN2013082025 W CN 2013082025W WO 2014044108 A1 WO2014044108 A1 WO 2014044108A1
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WO
WIPO (PCT)
Prior art keywords
nail
nail anvil
anvil
surgical instrument
assembly
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2013/082025
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English (en)
French (fr)
Inventor
郑民华
张析量
李安华
冯波
马君俊
孙晶
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
Original Assignee
SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
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 SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd filed Critical SHANGHAI YISI MEDICAL TECHNOLOGY Co Ltd
Priority to US14/429,358 priority Critical patent/US9924945B2/en
Priority to EP13839357.4A priority patent/EP2886065B1/en
Priority to BR112015005971-6A priority patent/BR112015005971B1/pt
Priority to ES13839357.4T priority patent/ES2637740T3/es
Publication of WO2014044108A1 publication Critical patent/WO2014044108A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B2017/07257—Stapler heads characterised by its anvil

Definitions

  • the present invention relates to surgical instruments, and more particularly to a surgical stapler, and in particular to an improved surgical instrument actuator.
  • the principle of the surgical stapler is to close the tissue by two corresponding jaws (commonly referred to as the anvil assembly and the cartridge assembly), and then push the metal staples in the stapler cartridge out of the staples to suture the tissue. Together.
  • a cutting knife is also provided for cutting the stitched tissue.
  • the stapler having the above functions includes an actuator, an intermediate connector, and a controller.
  • the actuator consists of an anvil assembly, a cartridge assembly and a drive assembly.
  • the anvil assembly includes a staple forming surface, the staple forming surface includes a plurality of rows of staple slots, and the staple slots are used to form metal staples.
  • the cartridge assembly generally includes a staple cartridge, a staple, a pusher block, and a pusher slider and a staple cartridge.
  • the upper surface of the staple cartridge is a tissue contacting surface, and the staple cartridge is mounted in the staple cartridge holder.
  • the anvil assembly is movably coupled proximally to the proximal end of the cartridge assembly and is switchable between an open state and a closed state.
  • the drive assembly is coupled to the drive mechanism for converting the action of the firing trigger to the closing, firing and opening action of the actuator.
  • the anvil assembly and the cartridge holder each also include a longitudinal slot for receiving the drive assembly.
  • the drive assembly When the drive assembly is moved toward the distal end of the actuator through the longitudinal slot, the anvil assembly and the cartridge assembly are driven from the open state to the closed state, and the pusher slider and the pusher block are driven out of the staple and Formed in the staple groove of the nail forming surface of the anvil assembly.
  • the drive assembly also includes a cutting knife for cutting tissue between rows of staple lines after the tissue is stapled.
  • the controller is used to manually control the operating instrument, and generally includes a fixed handle, a firing trigger that is movably coupled to the fixed handle, and a set of transmission mechanisms that transmit the firing trigger to the actuator.
  • the intermediate connector is movably coupled to the distal end of the controller and coupled to the proximal end of the actuator, the intermediate connector forming a connecting passage for effecting the action of firing the trigger to the actuator.
  • the Endo GIA Universal cutting stapler from Tyco Healthcare (later renamed Covidien) and the Echelon cutting stapler from Ethicon Endo-Surgery in the United States are representative products for this function.
  • the above products have been sold for many years and have been proven by the market to have good clinical application effects.
  • the actuator of the blue staple cartridge of the above product will organize the human tissue (such as stomach tissue, lung group) when the anvil assembly and the cartridge assembly are closed. Weaving, intestinal tissue, etc.) from 5 hidden-8 hidden natural thickness compression to 1.5 hidden close thickness.
  • the thickness of the closure of the tissue should be uniform from the proximal end to the distal end of the anvil, so as to ensure that the forming height of the suture is uniform after forming, the quality of the suture is stable, and the suture effect is guaranteed. . Therefore, the anvil assembly needs to have a high bending strength.
  • the material of the nail groove is largely displaced during the stamping and forming of the mold. Objectively, the material of the anvil assembly is required to have good fluidity and is prone to large-scale plastic deformation. The anvil assembly has a contradiction between the plasticity requirements of the material and the bending strength requirements.
  • Endo GIA Universal cutting stapler and Echelon cutting stapler use the technical solution to better resolve the above contradictions, but there is still room for improvement, such as: Endo GIA Universal cutting stapler anvil component bending strength in some clinical applications The process is not high enough, and the processing technology is difficult; the Echelon cutting stapler has sufficient bending strength, but the processing technology is complicated and the cost is high.
  • Tyco Healthcare describes the anvil assembly of the Endo GIA Universal cutting stapler.
  • the anvil assembly is formed by welding the nail anvil and the back cover.
  • the cavity formed between the upper surface of the back cover and the anvil piece is a space for the pin of the tool holder to slide, and the function of the back cover is to prevent the tissue from being pinned by the tool holder during the process of closing the anvil assembly and the anastomosis. hurt.
  • the depth of the nail groove reaches half the thickness of the nail anvil material, which causes severe work hardening of the surface of the material contacted between the nail anvil and the top of the die punch during the cold stamping process of the nail groove, which hinders the further development of the nail groove. Forming also causes the wear of the die punch to be intensified, and the life of the die is reduced, which in turn leads to an increase in the size fluctuation of the nail groove and a decrease in precision, which ultimately affects the molding quality of the staple.
  • the Endo GIA Universal cutting stapler uses an annealed 304 stainless steel sheet in the manufacture of the nail anvil to minimize the initial hardness of the material, improve the nail groove forming precision and the mold. life.
  • the anvil piece processed from the annealed 304 stainless steel has a reduced flexural strength, which in turn leads to a low bending strength of the anvil assembly, so that the product is applied to some thick tissue anastomosis and cutting occasions.
  • the anvil assembly undergoes severe bending deformation, and the consistency of the compressed thickness of the clamped tissue in the jaw cannot be ensured, especially since the tissue at the distal end of the jaw is not fully compressed to close the effect. Poor, resulting in easy tissue leakage to the distal end of the jaw during cutting, so that the width of the tissue after the anastomosis is greater than the original compression length of the tissue, in some cases, the need to increase the number of staple cartridges during surgery, increase medical care Cost; in severe cases, Poorly formed the staples.
  • the stapler can achieve tissue clamping to achieve at least one row of staples; under certain application conditions, tissue cutting can also be performed to cut tissue between multiple rows of staple lines open.
  • an improved surgical instrument actuator comprising an associated cartridge assembly and anvil assembly, and a drive assembly for controlling a transition state of the cartridge assembly and the anvil assembly, the staple
  • the anvil assembly includes a nail anvil, a nail anvil disposed on an inner side of the nail anvil, the nail anvil being processed by a cold stamping process of a stainless steel sheet, the stainless steel sheet having a low thickness a first guiding groove is disposed on the nail anvil piece, and a second guiding groove is disposed on the nail anvil piece, the first guiding groove and the second guiding groove are disposed at a maximum forming depth of the nail groove of the anvil piece Arranged along the coaxial, the drive assembly slides under the guidance of the first guide slot and the second guide slot.
  • the anvil piece is processed by a stainless steel sheet by a stamping and drawing process.
  • the tensile strength of the material used in the nail anvil is higher than the tensile strength of the stainless steel sheet.
  • the nail anvil is machined by a combination of one or more of a hot forging process, a powder metallurgy forming process, a casting process or a mechanical cutting process.
  • the powder metallurgy molding process includes MIM (Metal Injection Molding) and powder press molding technology.
  • the method further includes a back cover, wherein the back cover is disposed on an outer side of the nail anvil, the outer side of the nail anvil includes a rail surface, and the back cover and the nail anvil There is a cavity between the rail faces, and the drive assembly moves along the rail faces within the cavity.
  • the components of the anvil assembly are joined together by welding and/or mechanical riveting into a unitary structure.
  • the nail grooves on the nail anvil are selectively arranged in a plurality of rows of parallel straight lines or parallel curves.
  • the nail grooves on the nail anvil are arranged in 4 rows or 6 rows.
  • an improved surgical instrument comprising a controller, an intermediate connector, an actuator, wherein the actuator, the intermediate connector, and the controller are sequentially connected.
  • the nail anvil and the nail anvil are mainly made of different materials to form the anvil assembly, thereby satisfying the plastic requirement and bending strength requirement of the anvil assembly, wherein the nail anvil is made of a thin stainless steel sheet.
  • the tensile strength of the material used in the nail anvil is higher than the tensile strength of the material used in the anvil, so that the nail anvil provides higher tensile strength and bending strength, making the anvil easier to stretch.
  • the anvil assembly is composed of multiple components with different functions, which enhances the uniformity of the thickness of the clamped tissue when the actuator is closed. Compared with the existing product design, the closing effect of the actuator is more Good, lower manufacturing costs, and less clinical risk.
  • the cold stamping process for processing the nail anvil can be performed by using a stamping and drawing process instead of forming a nail groove on the thick plate.
  • the embossing process improves the accuracy of the nail groove size.
  • FIG. 1 is a schematic structural view of a surgical instrument according to a first embodiment of the present invention
  • Figure 2 is a schematic exploded view of the surgical instrument shown in Figure 1;
  • Figure 3 is a partially enlarged schematic view showing the actuator of the surgical instrument shown in Figure 1;
  • Figure 4 is a front elevational view showing the anvil assembly of the surgical instrument shown in Figure 1;
  • Figure 5 is a three-dimensional structural view of the anvil assembly in the surgical instrument shown in Figure 1;
  • Figure 6 is a schematic structural view of a nail anvil in the surgical instrument shown in Figure 1;
  • Figure 7 is a partial cross-sectional structural view of the anvil in the surgical instrument shown in Figure 1 at A-A in Figure 6;
  • Figure 8 is a schematic structural view of the anvil in the surgical instrument shown in Figure 1;
  • Figure 9 is a front elevational view showing the nail anvil shown in Figure 8.
  • Figure 10 is a cross-sectional structural view of the nail anvil shown in Figure 9 at B-B;
  • Figure 11 is a schematic view showing the structure of a nail anvil in the improved surgical instrument according to the second embodiment of the present invention
  • Figure 12 is a schematic sectional view showing the nail anvil shown in Figure 11 at D-D.
  • the present invention is applied to an actuator of a surgical instrument, and the actuator is manufactured using a special part combination scheme, a material combination scheme, and a processing scheme to obtain an anvil assembly having superior comprehensive bending strength.
  • the improved surgical instrument includes a controller (300), an intermediate connector (200), an actuator (100), wherein the actuator (100), The intermediate connector (200) and the controller (300) are connected in sequence.
  • the controller 300 generally includes a first fixed handle 301, a second fixed handle 302, a movable firing trigger 303, a firing trigger return spring 310, and a transmission rod 204 that transmits the rotational motion of the firing trigger 303 to the intermediate connector 200. And drive the transmission and motion conversion mechanism that linearly moves in the longitudinal direction.
  • the transmission and motion conversion mechanism includes a tooth extraction 313, a tooth extraction pin 311, a tooth extraction spring 312, and a rack 304.
  • the rack 304 is reciprocally mounted in a guide rail inside the first fixed handle 301 and the second fixed handle 302.
  • the tooth extraction 313 is rotatably mounted on one end of the firing trigger 303 by the tooth extraction pin 311, and the tooth extraction spring 312 is held.
  • the extraction teeth 313 are always biased toward the rack 304.
  • the controller 300 typically also includes a rack reset mechanism for returning the rack 304 after completion of the instrument function to its original position.
  • the rack reset mechanism includes a first reset cap 305, a second reset cap 306, a reset pin 308, a rack return spring 309, and a tooth lift trip tab 307.
  • the operator pulls the first reset cap 305 and the second reset cap 306 to the proximal end, and firstly drives the tooth releasing trip plate 307 to move by the reset pin 308.
  • the tooth 313 is disengaged from the position of the rack 304; when the first reset cap 305 and the second reset cap 306 are continuously pulled, the reset pin 308 continues to retreat until the reset pin 308 is in rigid contact with the rack 304, and then continues to pull toward the proximal end.
  • the rack 304 will move proximally with the reset pin 308 until reset.
  • the intermediate connector 200 is coupled to the distal end of the controller 300.
  • the intermediate connector 200 includes: a first rotary connector 211, a second rotary connector 212, a transmission rod 204, a barrel 205, a barrel 206, and a first magazine
  • the barrel 205 is coaxial with the axis of the first inner tube 202 and the second inner tube 203, and the direction of the axis constitutes the longitudinal direction as described in this embodiment.
  • the proximal end of the barrel 205 passes through the first rotary joint 211, the second rotary joint 212 and the controller
  • the distal end of 300 is movably coupled.
  • the transmission rod 204 is disposed in the barrel 205 and the first inner tube 202, the second inner tube 203, and is available in the barrel 205 and the first inner tube 202 and the second inner tube 203.
  • the lumen is free to move in the longitudinal direction.
  • the distal end of the drive rod 204 is coupled to the proximal end of the drive assembly 109, and the proximal end of the drive rod 204 is coupled to the rack 304.
  • the drive rod 204 transmits longitudinal motion of the rack 304 to the drive assembly 109.
  • the intermediate connector 200 further includes a load securing mechanism that is detachable from the actuator 100, including: a load return spring 207, a load block 208, and a load stop block 209.
  • a load securing mechanism that is detachable from the actuator 100, including: a load return spring 207, a load block 208, and a load stop block 209.
  • the actuator 100 is primarily comprised of an anvil assembly 1001, a cartridge assembly 1002, and a drive assembly 1003.
  • the cartridge assembly 1002 generally includes a staple cartridge 104, a plurality of staples 105, a plurality of pusher blocks 106, a pusher slider 108, and a staple cartridge 107.
  • the upper surface of the staple cartridge 104 is a tissue contacting surface, and the staple cartridge 104 is mounted.
  • the anvil assembly 1001 includes a nail anvil 103 and a nail anvil 102
  • the anvil piece 103 includes a first guiding groove 1031 and a plurality of nail grooves 1032.
  • the driving assembly 1003 can be guided to slide in the first guiding groove 1031.
  • the surface of the anvil piece 103 facing the side of the clamping tissue comprises a plurality of rows of staple grooves 1032.
  • the staples 105 When the staples 105 are driven to move toward the anvil piece 103, the staples 105 enter the nail grooves 1032 and are guided by the curved surface inside the nail grooves 1032. Bottom formed into a B-shape or a B-like shape.
  • the anvil piece 103 is processed by a cold stamping process from a stainless steel sheet.
  • the thickness t of the stainless steel sheet is lower than the maximum forming depth of the nail groove 1032 of the anvil piece 103.
  • h BP t ⁇ ho
  • the range of the maximum forming depth h of the nail groove 1032 is usually in the range of 0. 4 - 0. 6
  • the range of the maximum forming depth h of the nail groove 1032 is usually in the range of 0. 45 -0. 7
  • the cold stamping process for processing the anvil piece 103 may use a stamping and drawing process instead of the embossing process employed in forming the staple groove 1032 on the slab.
  • the nail anvil 102 includes an inner side surface 1022, an outer side surface 1023 and a second guiding groove 1021.
  • the nail anvil piece 103 is disposed on the inner side surface 1022 of the nail anvil 102, and the first piece of the nail anvil piece 103
  • the guiding groove 1031 is arranged along the same axis Z as the second guiding groove 1021 of the nail anvil 102.
  • the axis Z is a straight line.
  • the staple grooves 1032 of the anvil piece 103 are selectively arranged in a plurality of rows of parallel straight lines.
  • the number of parallel rows of the plurality of rows includes 2 rows and 8 rows, preferably 6 rows or 4 rows.
  • the difference from the embodiment shown in Fig. 4 is that, in the present variation, the axis Z is a curve, and at this time, the staple grooves 1032 of the anvil piece 103 are selectively arranged in a plurality of rows. Row curve.
  • the plurality of rows of curves may be a plurality of concentric arcs, or may be a plurality of parallel asymptotes, or may be other types of curves or a combination of curves.
  • the number of the plurality of rows of curves includes 2 rows and 8 rows, preferably 6 rows or 4 rows.
  • the selective arrangement in multiple rows refers to the position between the adjacent two rows of nail grooves 1032, and the positions of the nail grooves 1032 are staggered.
  • the nail anvil piece 103 is provided with a positioning hole 1033, and the nail anvil 102 is provided with a positioning pin 1024, and the nail anvil piece 103
  • the upper positioning hole 1033 is positioned and matched with the positioning pin 1024 on the nail anvil 102.
  • the nail anvil 102 is machined by a hot forging process.
  • the nail anvil 102 can also be machined by a powder metallurgy molding process, or a mechanical cutting process.
  • the anvil assembly 1001 also includes a back cover 101.
  • the back cover 101 is disposed on the outer side of the nail anvil 102.
  • the components of the anvil assembly may be integrally connected by welding, mechanical riveting, or a combination of the two.
  • the welding methods include laser welding, electric resistance welding, and fusion welding.
  • the anvil piece 103 is made of 304 stainless steel material
  • the nail anvil 102 is made of 420 stainless steel material
  • the 420 stainless steel material can obtain a tensile strength of not less than 1300 MPa after a suitable heat treatment process, 304 After the H1/2 heat treatment of the stainless steel material, the tensile strength is usually not higher than 1050 MPa.
  • FIGS. 11 and 12 show schematic views of an improved surgical instrument in accordance with a second embodiment of the present invention.
  • a second embodiment shown in Fig. 12 can be understood by those skilled in the art as a variation of the first embodiment shown in Fig. 1.
  • the difference between the present embodiment and the first embodiment shown in FIG. 1 is that, in the embodiment, the back cover is omitted, and more specifically, as shown in FIGS. 11-12, the anvil assembly
  • the 1001 includes a nail anvil 103 and a nail anvil 102, excluding the back cover.
  • the nail anvil 102 includes an inner side surface 1022, an outer side surface 1023 and a second guiding groove 1021.
  • the nail anvil piece 103 is disposed on the inner side surface 1022 of the nail anvil 102, and the first guiding groove 1031 of the nail cutting piece 103 and the nail anvil 102
  • the second guiding grooves 102 are arranged along the same axis Z.

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

Description

说 明 书 一种改进的外科器械的执行器 技术领域
本发明涉及外科器械， 尤其是一种外科手术吻合器， 具体地， 涉及改进的外科器械 的执行器。
背景技术
外科吻合器的作用原理， 是通过二个对应的钳口 （通常称为钉砧组件和钉仓组件) 闭合以夹持组织， 然后将吻合器钉仓中的金属缝合钉推出成型， 将组织缝合在一起。 在 有些吻合器中， 还装有一把切割刀， 用于将缝合好的组织切断开。
具有上述功能的吻合器包括有一个执行器、 中间连接体和控制器。 执行器由钉砧组 件、 钉仓组件和驱动组件组成。 钉砧组件包含一个钉成型面， 钉成型面包含多排钉槽， 钉槽用于金属缝合钉的成型。 钉仓组件一般包括钉仓、 缝合钉、 推钉块和推钉滑块和钉 仓座， 钉仓的上表面为组织接触面， 钉仓安装在钉仓座中。 钉砧组件在近端与钉仓组件 的近端可动地连接在一起， 并可以在张开状态和关闭状态之间转换。 驱动组件与传动机 构连接， 用于把击发扳机的动作转换为执行器的关闭、 击发和张开动作。 一般情况下， 钉砧组件和钉仓座还各包含一个纵向槽， 上述纵向槽用于容纳驱动组件通过。 当驱动组 件通过上述纵向槽向执行器的远端运动时，会驱使钉砧组件和钉仓组件从张开状态转换 为关闭状态， 并且驱使推钉滑块和推钉块顶出缝合钉并在钉砧组件的钉成型面的钉槽中 成型。 一般情况下， 驱动组件还包括一个切割刀， 用于在组织被缝合钉缝合后， 在多排 钉线之间切割组织。 控制器用于手动控制操作器械， 一般包括有一个固定手柄， 一个与 固定手柄相对可动连接的击发扳机， 一组传递击发扳机动作至执行器的传动机构。 中间 连接体与控制器的远端可动地连接， 并与执行器的近端连接在一起， 中间连接体构成一 个连接通道， 用于实现将击发扳机的动作传递给执行器。
美国 Tyco Healthcare公司 （后改称为 Covidien) 的 Endo GIA Universal切割吻 合器， 以及美国 Ethicon Endo-Surgery公司的 Echelon切割吻合器是实现上述功能的 有代表性的产品。 上述产品销售多年， 也被市场证明具有良好的临床应用效果。 上述产 品的蓝色钉仓的执行器在钉砧组件与钉仓组件关闭时， 将把人体组织 （如胃组织、 肺组 织、 肠组织等）从 5隱 -8隱的自然厚度压縮至 1. 5隱的关闭厚度。 从产品功能的角度来 看， 组织的关闭厚度从钉砧的近端至远端都应均匀一致， 以保证缝合钉在成型后成型高 度一致， 缝合钉缝合组织的质量稳定， 缝合效果才有保障。 因此， 钉砧组件需要具备较 高的抗弯强度。 钉砧组件在制造过程中， 钉槽在模具冲压成型时材料发生大量位移， 客 观上要求钉砧组件的材料具有良好的流动性， 易于产生大规模塑性变形。 钉砧组件对材 料的塑性需求与抗弯强度需求是矛盾的。 Endo GIA Universal 切割吻合器和 Echelon 切割吻合器采用的技术方案比较好地解决上述矛盾， 但仍然有需要完善的地方， 比如： Endo GIA Universal切割吻合器的钉砧组件抗弯强度在某些临床应用中还不够高， 加工 工艺难度高； Echelon切割吻合器的抗弯强度足够， 但加工工艺复杂， 成本高。
例如， 在专利 US5, 865， 361中， Tyco Healthcare对 Endo GIA Universal切割吻合 器的钉砧组件进行了描述。 参考专利 US5, 865， 361的描述， 结合市场上销售的真实产品 采用的设计， 钉砧组件由钉砧片和背盖板经焊接连接而成。 背盖板的上表面与钉砧片之 间形成的空腔是刀架的销滑动的空间， 背盖板的作用是在钉砧组件关闭组织和吻合过程 中， 防止组织被刀架的销夹伤。 背盖板采用 0. 2mm - 0. 3mm厚的不锈钢薄板冲压而成， 钉砧片采用大约 lmm厚度的不锈钢板冲压而成。 这二个零件均采用 304不锈钢材料， 这 种材料可以通过热处理强化， 在机加工过程中能够产生明显的加工硬化。 在钉砧片的下 表面， 分布着经过冷冲压工艺成型的许多钉槽。 对于 Endo GIA Universal的 45隱钉线 规格的钉砧片， 在 45mm X 9mm的平面上， 冲压 （冷礅） 出 6排 X 11个 =66个钉槽， 钉槽 的深度大约 0. 5mm。 钉槽的深度达到钉砧片材料厚度的一半， 这导致在钉槽的冷冲压成 型过程中， 钉砧片与模具冲头顶部所接触的材料表面产生严重的加工硬化， 既阻碍钉槽 的进一步成型，也导致模具冲头磨损加剧，模具寿命降低，进而导致钉槽尺寸波动加大、 精度降低， 最终影响缝合钉的成型质量。
针对钉槽成型的上述困难，推测 Endo GIA Universal切割吻合器在制造钉砧片时， 钉砧片使用退火态的 304不锈钢薄板， 以最大限度地降低材料的初始硬度， 提升钉槽成 型精度和模具寿命。但是，由退火态的 304不锈钢加工而成的钉砧片，其抗弯强度降低， 进而导致钉砧组件的抗弯强度低， 使该产品在应用于一些厚组织吻合和切割的场合时， 钉砧组件与钉仓组件关闭后， 钉砧组件发生严重弯曲变形， 无法保证钳口内被夹持组织 的压縮厚度的一致性， 尤其是钳口远端的组织因没有被完全压縮以至关闭效果不佳， 导 致在切割时容易产生组织向钳口远端外溢，致使组织在吻合后的宽度大于组织的原始压 縮长度， 某些情况下会导致在手术中需要增加钉仓的数量， 增加医疗费用； 严重时， 可 使缝合钉成型不良。 发明内容
针对现有技术中的缺陷，本发明的目的是提供一种改进的外科器械的执行器及包 含所述执行器的吻合器。 根据本发明提供的器械 （即吻合器） 可以实现组织夹持， 实现至少一排缝合钉的成型； 在某些应用条件下， 还可以实现组织切割， 在多排缝 合钉线之间将组织切割开。
根据本发明的一个方面， 提供一种改进的外科器械的执行器， 包括相连接的钉仓 组件和钉砧组件、 以及控制钉仓组件与钉砧组件转换开合状态的驱动组件， 所述钉砧组 件包括钉砧片、 钉砧座， 所述钉砧片设置在所述钉砧座的内侧面， 所述钉砧片由不锈钢 薄板经过冷冲压工艺加工而成，所述不锈钢薄板的厚度低于所述钉砧片的钉槽的最大成 型深度， 所述钉砧片上设置有第一导向槽， 所述钉砧座上设置有第二导向槽， 所述第一 导向槽与第二导向槽沿同轴布置， 所述驱动组件在所述第一导向槽与第二导向槽的导 向下滑动。
优选地， 所述钉砧片由不锈钢薄板经过冲压拉伸工艺加工而成。
优选地， 所述不锈钢薄板的厚度为 0. 1-0. 4mm
优选地， 所述不锈钢薄板的厚度为 0. 2-0. 3mm。
优选地， 所述钉砧座所使用的材料的拉伸强度高于所述不锈钢薄板的拉伸强度。 优选地， 所述钉砧座通过热锻工艺、 粉末冶金成型工艺、 铸造工艺或机械切削加 工工艺中的一种或几种工艺的组合加工而成。 其中， 粉末冶金成型工艺包括了粉末注 射成型技术 （MIM, Metal Inject ion Molding ) 和粉末压制成型技术。
优选地， 还包括背盖板， 其中， 所述背盖板设置在所述钉砧座的外侧面， 所述钉 砧座的外侧面包括一个导轨面， 所述背盖板与钉砧座的导轨面之间存在一个空腔， 驱动组件在空腔内沿导轨面运动。
优选地， 所述钉砧组件的各组件之间通过焊接和 /或机械铆接方式连接为一整体结 构。
优选地， 所述钉砧片上的钉槽有选择性地排列成多排平行直线或者平行曲线。 优选地， 所述钉砧片上的钉槽排列成 4排或者 6排。
根据本发明的另一个方面，还提供一种改进的外科器械，包括控制器、中间连接体、 执行器， 其中， 所述执行器、 中间连接体、 控制器依次连接。 与现有技术相比， 本发明具有如下的有益效果：
1、主要采用不同材料制成的钉砧片和钉砧座构成钉砧组件， 从而同时满足了钉 砧组件对材料的塑性需求与抗弯强度需求， 其中， 钉砧片采用较薄的不锈钢薄板， 通 过拉伸工艺成型， 以改善钉槽的成型难度， 提供高精度的钉槽； 钉砧座采用能提供 高抗弯性能的结构、 材料和加工工艺方案， 给整体钉砧组件提供较强的抗弯性能；
2、 钉砧座使用的材料的拉伸强度高于钉砧片使用的材料的拉伸强度， 从而使 钉砧座提供更高的拉伸强度和抗弯强度， 使钉砧片更容易拉伸成型， 克服了现有器 械设计中存在的钉砧组件抗弯强度不足而导致的组织外溢和缝合钉成型不良的问 题；
3、 钉砧组件由具有不同功能的多个部件组合而成， 增强了执行器关闭组织时 被夹持组织的厚度的均均性， 与现有产品设计方案相比， 执行器的关闭效果更好、 制造成本更低， 临床风险更小。
4、 加工钉砧片的不锈钢薄板的厚度 t小于钉槽的最大成型深度 h时， 从而使得加 工钉砧片的冷冲压工艺可以使用冲压拉伸工艺， 以代替在厚板上成型钉槽时采用的压印 工艺， 提高了钉槽尺寸的精度。
附图说明
通过阅读参照以下附图对非限制性实施例所作的详细描述， 本发明的其它特征、 目的和优点将会变得更明显：
图 1是根据本发明的第一实施例的改进的外科器械的结构示意图；
图 2是图 1所示的外科器械的爆炸结构示意图；
图 3是图 1所示的外科器械中的执行器的局部放大结构示意图；
图 4是图 1所示的外科器械中的钉砧组件的正视结构示意图；
图 5是图 1所示的外科器械中的钉砧组件的三维结构示意图；
图 6是图 1所示的外科器械中的钉砧片的结构示意图；
图 7是图 1所示的外科器械中的钉砧片在图 6中 A-A处的局部剖面结构示意图； 图 8是图 1所示的外科器械中的钉砧座的结构示意图；
图 9是图 8所示的钉砧座的正视结构示意图；
图 10是图 9所示的钉砧座在 B-B处的剖面结构示意图；
图 11是根据本发明的第二实施例的改进的外科器械中的钉砧座的结构示意图； 图 12是图 11所示的钉砧座在 D-D处的剖面结构示意图。
具体实施方式 下面结合具体实施例对本发明进行详细说明。 以下实施例将有助于本领域的技术人 员进一步理解本发明， 但不以任何形式限制本发明。 应当指出的是， 对本领域的普通技 术人员来说， 在不脱离本发明构思的前提下， 还可以做出若干变形和改进。 这些都属于 本发明的保护范围。
本发明应用于外科器械的执行器， 使用特殊的零件组合方案、 材料组合方案和加工 工艺方案制造执行器， 以获得综合抗弯强度更优秀的钉砧组件。
图 1至图 10示出根据本发明的第一实施例的改进的外科器械的示意图。 具体地， 在本实施例中，参见图 1-图 2，所述改进的外科器械包括控制器 ( 300)、中间连接体 ( 200)、 执行器 （100)， 其中， 执行器 （100)、 中间连接体 （200)、 控制器 （300) 依次连接。
控制器 300—般包括第一固定手柄 301、 第二固定手柄 302， 一个可动的击发扳机 303， 击发扳机复位簧 310和一个把击发扳机 303的旋转运动传递给中间连接体 200的 传动杆 204并驱使其沿纵向作直线运动的传动和运动转换机构。 如图 2所示， 所述的传 动和运动转换机构包括拔齿 313、 拔齿销 311、 拔齿弹簧 312、 齿条 304。 齿条 304可往 复运动地安装在第一固定手柄 301、 第二固定手柄 302内部的导轨中， 拔齿 313通过拔 齿销 311可旋转运动地安装在击发扳机 303的一端，拔齿弹簧 312保持拔齿 313始终偏 向与齿条 304啮合。 当操作击发扳机 303时， 击发扳机 303的旋转运动通过拔齿 313传 递给齿条 304， 驱动齿条 304向远端直线运动。 控制器 300通常还包括一套齿条复位机 构， 用于将完成器械功能后的齿条 304恢复原位。 如图 2所示， 所述的齿条复位机构包 括第一复位帽 305、 第二复位帽 306， 复位销 308， 齿条复位簧 309， 拔齿脱扣片 307。 当齿条 304因操作击发扳机 303而脱离初始位置时， 操作者向近端拉第一复位帽 305、 第二复位帽 306， 通过复位销 308， 首先驱使拔齿脱扣片 307运动， 带动拔齿 313脱离 与齿条 304啮合的位置； 继续拉第一复位帽 305、 第二复位帽 306时， 复位销 308继续 后退直到复位销 308与齿条 304刚性接触， 此时继续向近端拉第一复位帽 305、 第二复 位帽 306时， 齿条 304将随同复位销 308—起向近端运动， 直到复位。
中间连接体 200连接在控制器 300的远端。 在图 2所示的外科吻合器实施例中， 中 间连接体 200包括：第一旋转连接头 211、第二旋转连接头 212，传动杆 204，枪管 205， 枪套管 206， 第一钉匣内管 202、 第二钉匣内管 203， 钉匣套管 201等组件。 枪管 205 和第一钉匣内管 202、 第二钉匣内管 203的轴线同轴， 该轴线的方向构成本实施例所述 的纵向方向。 枪管 205的近端通过第一旋转连接头 211、 第二旋转连接头 212与控制器 300的远端可动地连接。 传动杆 204布置在枪管 205和第一钉匣内管 202、 第二钉匣内 管 203的内腔， 并且可在枪管 205和第一钉匣内管 202、 第二钉匣内管 203的内腔沿纵 向自由运动。 传动杆 204的远端与驱动组件 109的近端连接， 传动杆 204的近端与齿条 304连接， 传动杆 204可将齿条 304的纵向运动传递给驱动组件 109
在图 2所示的外科吻合器实施例中， 中间连接体 200还包括一个与执行器 100可卸 载的装载保险机构， 包括： 装载复位簧 207， 装载保险块 208， 装载限位块 209。 在执行 器 100与中间连接体装载到一起后， 装载保险块 208在装载复位簧 207的弹力作用下， 阻止执行器 100与中间连接体 200发生相对旋转和卸载。
参见图 2-图 3， 执行器 100主要由钉砧组件 1001、 钉仓组件 1002和驱动组件 1003 组成。 钉仓组件 1002—般包括钉仓 104、 多个缝合钉 105、 多个推钉块 106、 推钉滑块 108和钉仓座 107， 钉仓 104的上表面为组织接触面， 钉仓 104安装在钉仓座 107中。 钉砧组件 1001包含钉砧片 103和钉砧座 102
如图 6-图 7所示，在本实施例中，钉砧片 103包含第一导向槽 1031和多个钉槽 1032 驱动组件 1003可以在第一导向槽 1031中导向滑动。钉砧片 103朝向夹持组织一侧的表 面包含多排钉槽 1032， 当缝合钉 105受驱动向钉砧片 103运动时，缝合钉 105进入钉槽 1032, 并在钉槽 1032内部的曲面引导下成型为 B字形或类似 B字形。
在本实施例中， 钉砧片 103由不锈钢薄板经过冷冲压工艺加工而成， 不锈钢薄板的 厚度 t低于钉砧片 103的钉槽 1032的最大成型深度 h BP : t < ho 在实际应用中， 对 于直径为 0. 2mm-0. 25mm的缝合钉 105，为保证在缝合钉 105成型时能提供足够的引导性 能，钉槽 1032的最大成型深度 h的范围通常在 0. 4 - 0. 6 ;对于直径为 0. 25mm- 0. 35 的缝合钉 105， 为保证在缝合钉 105成型时能提供足够的引导性能，钉槽 1032的最大成 型深度 h的范围通常在 0. 45 -0. 7 当加工钉砧片 103的不锈钢薄板的厚度 t小于钉 槽 1032的最大成型深度 h时。 优选地， 加工钉砧片 103的冷冲压工艺可以使用冲压拉 伸工艺， 代替在厚板上成型钉槽 1032时采用的压印工艺。
参见图 4、图 8-图 10，钉砧座 102包括内侧面 1022、外侧面 1023和第二导向槽 1021 钉砧片 103布置在钉砧座 102的内侧面 1022， 钉砧片 103的第一导向槽 1031与钉砧座 102的第二导向槽 1021沿相同的轴线 Z布置。
如图 4所示， 轴线 Z为直线。 此时， 钉砧片 103的钉槽 1032有选择性的排列成多 排平行直线。 所述的多排平行直线的数量， 包括 2排 -8排， 优选地， 为 6排或 4排。 而 在本实施例的一个变化例中， 与图 4所示实施例的区别在于， 在本变化例中， 轴线 Z为 曲线， 此时， 钉砧片 103的钉槽 1032有选择性的排列成多排曲线。 所述的多排曲线可 以是多条同心圆弧， 也可以是多条平行的渐近线， 也可以是其它类型的曲线或多种曲线 的组合曲线。 所述的多排曲线的数量， 包括 2排 -8排， 优选地， 为 6排或 4排。 所述的 有选择性的排列成多排，是指相邻的二排钉槽 1032之间，钉槽 1032的位置呈交错布置。
为确保钉砧片 103与钉砧座 102进行准确定位，如图 4-图 6所示，钉砧片 103上设 置有定位孔 1033， 钉砧座 102上设置有定位销 1024， 钉砧片 103上的定位孔 1033与钉 砧座 102上的定位销 1024匹配定位。
钉砧座 102通过热锻工艺加工而成。 在本实施例的变化例中， 钉砧座 102也可以通 过粉末冶金成型工艺、 或机械切削加工工艺加工而成。
钉砧组件 1001还包括一个背盖板 101。 背盖板 101布置在钉砧座 102的外侧面。 在本实施例的一个优选例中， 所述的钉砧组件的各组件之间可以通过焊接方式、 机 械铆接方式、 或者二者的组合连接为一个整体。 其中， 焊接方式包括激光焊接、 电阻焊 接、 融焊等方式。
在本实施例的另一个优选例中， 钉砧片 103使用 304不锈钢材料， 钉砧座 102使用 420不锈钢材料， 420不锈钢材料在经过适当热处理工艺后可获得不低于 1300MPa的拉 伸强度， 304不锈钢材料在 H1/2热处理后， 拉伸强度通常不高于 1050MPa。
图 11和图 12示出根据本发明的第二实施例的改进的外科器械的示意图。本领域技 术人员可以将图 12示出的第二实施例理解为图 1所示出第一实施例的一个变化例。 具 体地，本实施例与图 1所示第一实施例的区别在于，在本实施例中，所述背盖板被省略， 更为具体地， 如图 11-图 12所示， 钉砧组件 1001包含钉砧片 103和钉砧座 102， 不包 括背盖板。 钉砧座 102包括内侧面 1022、 外侧面 1023和第二导向槽 1021， 钉砧片 103 布置在钉砧座 102的内侧面 1022， 钉砧片 103的第一导向槽 1031与钉砧座 102的第二 导向槽 102 沿相同的轴线 Z布置。
以上对本发明的具体实施例进行了描述。 需要理解的是， 本发明并不局限于上述特 定实施方式， 本领域技术人员可以在权利要求的范围内做出各种变形或修改， 这并不影 响本发明的实质内容。

Claims

权 利 要 求 书
1、一种改进的外科器械的执行器，包括相连接的钉仓组件（1002)和钉砧组件（1001)、 以及控制钉仓组件 （1002) 与钉砧组件 （1001) 转换开合状态的驱动组件 （1003)， 其 特征在于，所述钉砧组件（1001)包括钉砧片（103)、钉砧座（102)，所述钉砧片（103) 设置在所述钉砧座 （102) 的内侧面 （1022)， 所述钉砧片 （103) 由不锈钢薄板经过冷 冲压工艺加工而成， 所述不锈钢薄板的厚度低于所述钉砧片 （103) 的钉槽 （1032) 的 最大成型深度， 所述钉砧片 （103) 上设置有第一导向槽 （1031)， 所述钉砧座 （102) 上设置有第二导向槽 （1032)， 所述第一导向槽 （1031) 与第二导向槽 （1032) 沿同轴 布置， 所述驱动组件 （ 1003) 在所述第一导向槽 （1031) 与第二导向槽 （1032) 的导 向下滑动。
2、根据权利要求 1所述的改进的外科器械的执行器，其特征在于，所述钉砧片（ 103) 由不锈钢薄板经过冲压拉伸工艺加工而成。
3、 根据权利要求 1所述的改进的外科器械的执行器， 其特征在于， 所述不锈钢薄 板的厚度为 0.1-0.4mm
4、 根据权利要求 3所述的改进的外科器械的执行器， 其特征在于， 所述不锈钢薄 板的厚度为 0.2-0.3mm
5、根据权利要求 1所述的改进的外科器械的执行器，其特征在于，所述钉砧座（ 102) 所使用的材料的拉伸强度高于所述不锈钢薄板的拉伸强度。
6、根据权利要求 1所述的改进的外科器械的执行器，其特征在于，所述钉砧座（ 102) 通过热锻工艺、 粉末冶金成型工艺、 铸造工艺或机械切削加工工艺中的一种或几种工艺 的组合加工而成。
7、 根据权利要求 1所述的改进的外科器械的执行器， 其特征在于， 还包括背盖板 (101)， 其中， 所述背盖板 （101) 设置在所述钉砧座 （102) 的外侧面 （1023)， 所述 钉砧座（102)的外侧面（1023)包括一个导轨面，所述背盖板（101)与钉砧座（102) 的导轨面之间存在一个空腔， 驱动组件 （1003) 在空腔内沿导轨面运动。
8、 根据权利要求 1或 7所述的改进的外科器械的执行器， 其特征在于， 所述钉砧 组件 （1001) 的各组件之间通过焊接和 /或机械铆接方式连接为一整体结构。
9、根据权利要求 1所述的改进的外科器械的执行器，其特征在于，所述钉砧片（ 103) 上的钉槽 （1032) 有选择性地排列成多排平行直线或者平行曲线。
10、根据权利要求 9所述的改进的外科器械的执行器，其特征在于，所述钉砧片（ 103) 上的钉槽 ( 1032) 排列成 4排或者 6排。
11、 一种改进的外科器械， 其特征在于， 包括控制器 （300)、 中间连接体 （200)， 其特征在于， 还包括权利要求 1所述的执行器 （100)， 其中， 所述执行器 （100)、 中间 连接体 （200)、 控制器 （300) 依次连接。
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US9924945B2 (en) 2018-03-27
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US20150230795A1 (en) 2015-08-20

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Free format text: - SOLICITA-SE APRESENTAR A TRADUCAO SIMPLES DA FOLHA DE ROSTO DA CERTIDAO DE DEPOSITO DA PRIORIDADE CN201210349356.7, DE 18/09/2012; OU DECLARACAO DE QUE OS DADOS DO PEDIDO INTERNACIONAL ESTAO FIELMENTE CONTIDOS NA PRIORIDADE REIVINDICADA, CONTENDO TODOS OS SEUS DADOS IDENTIFICADORES (TITULARES, NUMERO DE REGISTRO, DATA E TITULO), UMA VEZ QUE A DOCUMENTACAO APRESENTADA REFERE-SE SOMENTE AO PCT/CN2013/082025, QUE JA TEM COMO TITULAR O MESMO DEPOSITANTE DA FASE NACIONAL;- SOLICITA-SE APRESENTAR DOCUMENTO COMPROBATORIO ASSINADO PELOS INVENTORES RELACIONADOS NA PUBLICACAO INTERNACIONAL E PELO INVENTOR A SER ADICIONADO, REGULARIZANDO A INCLUSAO DESTE NA FASE NACIONAL DO PEDIDO.

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