WO2021022905A1 - 一种组织夹闭装置 - Google Patents

一种组织夹闭装置 Download PDF

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Publication number
WO2021022905A1
WO2021022905A1 PCT/CN2020/095867 CN2020095867W WO2021022905A1 WO 2021022905 A1 WO2021022905 A1 WO 2021022905A1 CN 2020095867 W CN2020095867 W CN 2020095867W WO 2021022905 A1 WO2021022905 A1 WO 2021022905A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
clip
elastic
clipping device
groove
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Application number
PCT/CN2020/095867
Other languages
English (en)
French (fr)
Inventor
金鸿雁
冷德嵘
李常青
唐志
仇卫勤
Original Assignee
南微医学科技股份有限公司
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.)
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Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to DE212020000695.4U priority Critical patent/DE212020000695U1/de
Priority to ES202290001U priority patent/ES1289331Y/es
Publication of WO2021022905A1 publication Critical patent/WO2021022905A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • This application relates to the technical field of endoscopic medical devices, and in particular to a tissue clipping device.
  • the tissue clipping device is a minimally invasive surgical instrument that is often used to stop bleeding from wounds in patients, such as the digestive tract.
  • the tissue clipping device can be delivered to the surgical site in the patient through the endoscope clamp channel, and the clipping operation can be performed outside the body to complete hemostatic treatment.
  • the tissue clipping device usually, after the hemostasis treatment by the tissue clipping device, the local tissue inflammation process forms a granuloma, which falls off by itself and is excreted through the digestive tract.
  • the operation has the advantages of less damage, fast hemostasis, low incidence of rebleeding, fewer complications, and definite curative effect.
  • a typical tissue clipping device includes a jaw component, an introduction component, and an operating component.
  • the clamping part and the introduction part can be sent into the digestive tract of the patient through the endoscope clamp channel, so that the clamping part reaches the predetermined surgical position in the patient's body, and then the surgical action is performed through the operating part, and the implemented surgical action is then introduced
  • the components are transferred to the jaws, so that the jaws produce an action response to stop bleeding or clip the surgical wound.
  • the clamping part and the introduction part are separated by the operating part, so that the clamping part remaining in the patient can clamp the blood vessel and surrounding tissues to achieve the purpose of hemostasis and clamping.
  • the clamping part is a metal hemostatic clamp.
  • the above-mentioned tissue clipping device is generally provided with a deformable structure at the proximal end (tail) of the metal hemostatic clip, so that the force transmitted by the introduction part promotes the clamping part and Separation between the imported parts.
  • the deformable structure causes the instability of the connection between the jaw part and the introduction part, so that the aforementioned tissue clipping device can often only be opened and closed once.
  • the working environment of the endoscopy restricts the operator to perform precise operations, so that the clamping components cannot be clamped at one time. Therefore, the surgical success rate of the traditional tissue clipping device is low.
  • the existing tissue clipping device not only has a clipping function, but also has a rotation function. Due to the increased functions of the device, the structure of the device is relatively complex, the cost of device manufacturing and quality control costs have increased a lot, and the stability of the device's use is also very low.
  • This application provides a tissue clipping device that makes full use of the material's own elastic properties to achieve the required basic functions such as clipping and locking with an extremely simple structure, while also achieving important functions such as multiple opening and closing and rotation , Solve the problem that the traditional tissue clamping device has a complicated structure and a large number of parts, which is not conducive to processing and quality control.
  • the present application provides a tissue clipping device, comprising: an operating assembly and a chuck assembly detachably connected to the operating assembly; wherein, the chuck assembly includes a clip and a sleeve; the clip is provided with two integrated structures A sheet-shaped clip arm, the clip is arranged in the sleeve near the distal end; the operating assembly includes an elastic release member and a separate outer cylinder; the elastic release member is detachably connected to the two clip arms of the clip The middle part, so that the clip can be opened and closed multiple times, the separating outer cylinder is arranged at the proximal end of the sleeve, and the separating outer cylinder is detachably connected to the sleeve;
  • the middle part of the two clamping arms of the clip is provided with a clamping part, and the distal end of the elastic release member is provided with a connecting part that matches with the clamping part;
  • the connecting arm of the elastic release member is shaped as an outwardly bent structure , So that the connecting arm of the elastic release member can be compressed by the inner wall of the sleeve to produce elastic deformation; the connecting portion can enter the clamping portion to leave the sleeve when the connecting arm of the elastic release member When the inner wall is used, the connecting part is separated from the clamping part.
  • the clamping portion is a groove; the connecting portion is a connecting groove, and the clamping portion and the connecting portion are matched with each other through the buckling of the groove and the connecting groove.
  • both side edges of the middle of the two clamping arms of the clip are provided with the groove;
  • the elastic release member includes two connecting arms with the same shape, and the distal end of each connecting arm is provided with a ⁇ The connection.
  • a limit groove is provided on the distal end surface of the sleeve; a guide piece is provided on the clamping arm of the clip; the guide piece can enter the limit groove and contact the limit groove bottom.
  • the operating assembly further includes an elastic connector, the sleeve is provided with a connecting hole, and the inner wall of the separation outer cylinder is provided with a slot; the elastic connector passes through the connecting hole and is arranged in In the card slot, the separate outer cylinder can be detachably connected to the sleeve.
  • the elastic connecting member is an elastic sheet that can be bent and deformed.
  • the sleeve is provided with a guide groove
  • the clamping arm of the clip is provided with an elastic protrusion inserted into the guide groove, and the elastic protrusion can slide in the guide groove, In order to make the clip switch between the two states of opening and closing.
  • the sleeve is provided with a twisted tip; the twisted tip is a sheet-like structure obliquely arranged on the circumferential surface of the sleeve; the twisted tip can enter the groove on the inner wall of the separate outer cylinder to The outer cylinder can be detachably connected to the sleeve.
  • the sleeve is provided with a connecting hole collinear with the guide groove, and the elastic protrusion on the clip arm includes a plurality of hanging stands; the hanging stand near the proximal end of the clip can be removed from the guide groove Enter the connecting hole to realize the locking of the clip in the sleeve.
  • the tissue clipping device further includes: a catheter, an operating wire and a handle;
  • the proximal end of the separate outer cylinder is connected to the handle through the catheter; the operating wire is arranged in the catheter and can move in the catheter; the distal end of the operating wire is connected to the elastic release member , The proximal end of the operating wire is connected to the sliding part on the handle to control the clip to complete the opening and closing action.
  • the present application provides a tissue clipping device, which includes an operating component and a chuck component.
  • the operating wire in the operating assembly can drive the elastic release member to move, so that the clip in the chuck assembly can slide in the sleeve, and the elasticity of the clip and the barrel wall of the sleeve can make the clip complete Times to open and close.
  • the inner wall of the sleeve restricts and releases the elastic release member to realize the detachable connection between the clamping part of the middle part of the clip and the distal end connecting part of the elastic release member.
  • the tissue clamping device provided by the present application has simple structure, stable connection, easy batch and stable production, and greatly reduces production process cost and quality control cost.
  • FIG. 1 is a schematic structural diagram of a tissue clipping device of this application
  • FIG. 2 is a schematic cross-sectional structure diagram of a tissue clipping device of the present application
  • FIG. 3 is a schematic structural diagram of a clip of this application.
  • Fig. 4 is a schematic structural diagram of an elastic release member of this application.
  • Figure 5 is a schematic diagram of the structure of a sleeve of this application.
  • Fig. 6 is a schematic structural diagram of a separate outer cylinder of this application.
  • FIG. 7 is a schematic structural diagram of a connecting piece of this application.
  • FIG. 8 is a schematic structural diagram of a separation stage of a tissue clipping device of this application.
  • Figure 9 is a schematic structural diagram of another sleeve of the application.
  • FIG. 10 is a schematic structural diagram of another clip of this application.
  • FIG. 11 is a schematic structural diagram of another elastic release member of this application.
  • FIG. 12 is a schematic diagram of the structure of the clamping part in an embodiment of the application.
  • FIG. 13 is a schematic diagram of the structure of the connecting portion in an embodiment of the application.
  • the distal end the end of the entire device placed in the human body
  • this end is mainly used to perform surgical actions on the tissue
  • the end outside the body is called the proximal end, and this end is mainly used Operate by the operator.
  • the distal end of each component refers to the end close to the internal body
  • the proximal end of each component refers to the end close to the external body.
  • a tissue clipping device provided by the present application includes: an operating component 1 and a chuck component 2 that are detachably connected to each other.
  • the chuck assembly 2 includes a clip 21 and a sleeve 22.
  • the clip 21 is set at the distal end of the sleeve 22 and can slide in the sleeve 22 to form a clamping space to clamp the patient’s wound surface, that is, the clip 21 is set on the sleeve. Near the far end within 22.
  • the clip 21 is provided with two sheet-shaped clamping arms of an integral structure. As shown in Fig. 3, the clip 21 can be forged or stamped from a sheet-like structure shrapnel. When no force is applied, the two clamping arms of the clip 21 maintain a certain opening angle with each other, that is, the two clamping arms present a V-shaped structure. In practical applications, the inner wall of the sleeve 22 can exert a force on the back of the clamp arm of the clip 21, so that when the clamp 21 is moved in the proximal direction, the angle between the two clamping arms that are open to each other will become smaller. That is to realize the mutual closure of the two clamping arms.
  • the entire clamp 21 assumes a folded state.
  • the action position of the inner wall of the sleeve 22 on the clip arm is changed, that is, the force arm is changed, and the clip 21 can rely on its own elastic action to expand the opening and closing angle again.
  • moving the clip 21 in the proximal direction can close the two clamping arms by the limiting effect of the sleeve 22; moving the clip 21 in the distal direction, the two clamping arms of the clip 21 can be Restore the open state through the elastic action of the material itself.
  • the clip 21 should be made of a material with better elasticity, and the thickness of the connecting position of the two clamping arms of the clip 21 should not be too large, so as to reduce the driving force requirement while ensuring the elastic effect.
  • the sleeve 22 is provided with a guide groove 222, and the clamp arm of the clip 21 is provided with an elastic protrusion 211 inserted into the guide groove 222,
  • the elastic protrusion 211 can slide in the guide groove 222.
  • the sliding of the elastic protrusion 211 in the guide groove 222 can prevent the clip 21 from rotating deviation during the opening and closing process, thereby improving the stability.
  • the elastic protrusion 211 is always in the guide groove 222, which is beneficial to the smooth opening and closing of the clip 21, thereby realizing repeated opening and closing.
  • a limiting groove 223 is provided on the distal end surface of the sleeve 22; a guide piece 212 is provided on the clamping arm of the clip 21; The guide piece 212 can enter the limiting groove 223 and contact the bottom of the limiting groove 223. The limit groove 223 can further maintain the clip 21 to move smoothly. In addition, through the cooperation between the limiting groove 223 and the guide piece 212, the closing direction between the two clamping arms of the clip 21 can be effectively restricted, thereby indirectly increasing the clamping force of the clip 21.
  • the clamp 21 and the sleeve 22 need to be left in the patient's body to continuously clamp the tissue to promote the healing of the tissue.
  • the present application needs to separate the operating assembly 1 and the chuck assembly 2 after the clip 21 clamps the tissue. That is, the operating assembly 1 includes an elastic release member 11 and a separate outer tube 13; the elastic release member 11 is detachably connected to the middle of the two clamping arms of the clip 21 to control the clip 21 to complete multiple opening and closing.
  • the separating outer cylinder 13 is arranged at the proximal end of the sleeve 22, and the separating outer cylinder 13 is detachably connected to the sleeve 22. It can be seen that in practical applications, the separation between the operating assembly 1 and the chuck assembly 2 can be achieved by the separation between the clip 21 and the elastic release member 11 and the separation between the sleeve 22 and the separation outer cylinder 13.
  • the specific separation method can be as follows: as shown in FIG. 3, the middle part of the two clamping arms of the clip 21 is provided with a clamping portion 214, and the distal end of the elastic release member 11 is provided with a connection that cooperates with the clamping portion 214. Section 14; the connecting arm of the elastic release member 11 is shaped as a curved structure, so that the connecting arm of the elastic release member 11 can be compressed by the inner wall of the sleeve 22 to produce elastic deformation; the connecting portion 14 can enter Inside the clamping portion 214, when the connecting arm of the elastic release member 11 leaves the inner wall of the sleeve 22, the connecting portion 14 is separated from the clamping portion 214.
  • the clip 21 may include two working phases, namely the repeated opening and closing phase and the separation phase; the repeated opening and closing phase maintains a continuous connection between the elastic release member 11 and the clip 21, and the elastic release member 11 drives the clip 21 to move.
  • the elastic release member 11 continues to pull the clip 21 to move distally, so that the elastic projection 211 slides out of the guide groove 222, and then slides out a certain distance to make the elastic
  • the distal end of the release member 11 is free from the restraint of the inner wall of the sleeve 22, and the elastic release member 11 will recover its shape, so that the connecting portion 14 is separated from the clamping portion 214, that is, the separation between the clip 21 and the elastic release member 11 is realized, as shown in FIG. 8 shown.
  • the clamping portion 214 is a groove; the connecting portion 14 is a connecting groove, and the clamping portion 214 and the connecting portion 14 are realized by buckling the groove and the connecting groove. Cooperate. Through the mutual buckling between the connecting groove and the groove, a more stable connection can be obtained on the premise of ensuring mutual separation.
  • the mutual cooperation relationship between the clamping portion 214 and the connecting portion 14 can be realized in a variety of forms, for example, two groove-shaped structures can be buckled together. It can be realized by matching the notch with the clamping block.
  • the clamping portion 214 may be a protruding structure protruding from the side of the clip, and the connecting portion 14 may be a hole provided at the distal end of the elastic release member 11. structure. Under the squeeze inside the sleeve, the protrusion of the clamping portion 214 can enter the hole of the connecting portion 14. After being released from the squeezing, the two connecting arms of the elastic release member 11 relies on elasticity to restore the outwardly opened structure, so that The connecting portion 14 and the clamping portion 214 are separated from each other.
  • the clamping portion 214 may also be configured as a hole structure, and the connecting portion 14 may be configured as a protruding structure.
  • both the elastic release member 11 and the clip 21 can have a symmetrical structure.
  • this symmetrical structure can enable the elastic release member 11 and the clip 21 to maintain a stable connection state when the opening and closing stages are repeated. In order to transmit the sliding moment; on the other hand, it is convenient to maintain the balance of the elastic force, so that after leaving the inner wall of the sleeve 22, it can be separated from the groove.
  • the distal end of the elastic release member 11 in order to make the elastic release member 11 in the sleeve 22, can receive the pressure of the inner wall of the sleeve 22, the distal end of the elastic release member 11 can also be bent outwards so as to contact the sleeve 22 Inner wall.
  • the operating assembly 1 further includes an elastic connecting member 12, and the sleeve 22
  • a connecting hole 221 is provided on the upper part, and a clamping groove 131 is provided on the inner wall of the separating outer cylinder 13; the elastic connecting member 12 passes through the connecting hole 221 and is disposed in the clamping groove 131 to realize the separation outer
  • the barrel 13 is detachably connected to the sleeve 22.
  • the elastic connecting member 12 is a flexible elastic piece, and the width of the middle portion of the elastic connecting member 12 may be smaller than the width at both ends, which can provide space for the two connecting arms of the elastic releasing member 11 to move.
  • the elastic connecting member 12 is not compressed and is in a straight state. Both ends of the elastic connecting member 12 pass through the connecting hole 221 to separate the inner wall of the outer cylinder 13 In the clamping groove 131, at this time, the sleeve 22 and the separating outer cylinder 13 are connected to each other by the restriction of the elastic connecting member 12.
  • the elastic connecting member 12 can be rotated in the circumferential direction in the groove 131, so that the sleeve 22 and the separating outer cylinder 13 can be relatively rotated, thereby facilitating the adjustment of the angle of the clip 21.
  • the sleeve 22 is provided with a twisted tip 224; the twisted tip 224 is a sheet-like structure obliquely arranged on the circumferential surface of the sleeve 22; As shown in FIG. 9, the twisted tip 224 can enter the groove 131 on the inner wall of the separating outer cylinder 13 to realize that the separating outer cylinder 13 is detachably connected to the sleeve 22.
  • the twisted tip 224 has a large inclination angle relative to the circumferential surface of the sleeve 22 at the repeated opening and closing node, so that the outer edge of the twisted tip 224 enters the slot 131 and connects the separating outer cylinder 13 and the sleeve 22 together.
  • the back of the clamp arm of the clip 21 touches the inner edge of the twisted tip 224 to make it elastically twisted relative to the circumferential wall of the sleeve 22.
  • the outer edge of the twisted tip 224 is detached from the slot 131 to realize the sleeve.
  • the sleeve 22 is provided with a connecting hole 221 collinear with the guide groove 222, and the elastic protrusion 211 on the clamp arm of the clip 21 includes a plurality of hanging stands 213;
  • the hanging stand 213 at the proximal end of 21 can enter the connecting hole 221 from the guide groove 222.
  • the sleeve 22 and the clip 21 can be fixed together through the cooperation between the proximal hanging stand 213 and the connecting hole 221, thereby achieving the purpose of locking the closed state of the clip 21 .
  • the tissue clipping device further includes: a catheter 3, an operating wire 4, and a handle 5; specifically, the proximal end of the separating outer cylinder 13 passes through the The catheter 3 is connected to the handle 5; the operating wire 4 is arranged in the catheter 3 and can move in the catheter 3; the distal end of the operating wire 4 is connected to the elastic release member 11, the The proximal end of the operating wire 4 is connected to the sliding part on the handle 5 to control the clip 21 to complete the opening and closing action.
  • the endoscope is used for conventional ESD surgical treatment. After the treatment, the wound is ready to be clamped for finishing work; take out a tissue closure device that has been assembled, and gently pull the sliding part on the handle 5.
  • the operating wire 4 is driven to move, so as to drive the elastic release member 11, so that the clip 21 is opened and closed within the guide groove 222 of the sleeve 22.
  • the device is inserted into the forceps of the endoscope and sent to the wound, and the sliding part is pushed to open the two clamping arms of the clip 21 to prepare to close the wound; after clamping the tissue Pull the sliding part again to close the clip 21 and clamp the tissue.
  • the handle 5 If necessary, rotate the handle 5 to find the most suitable clamping position.
  • the clip 21 is closed, by continuing to apply a greater pulling force, the sleeve 22 and the separating outer cylinder 13 are separated from each other, and the clip 21 and the elastic release member 11 are separated from each other, and finally the chuck assembly 2 is released.
  • the operating component 1 can be taken out from the clamp channel; according to the different needs of the size of the wound, the device can be delivered according to the above steps until the wound is completely closed.
  • the tissue clipping device provided by the present application has a simple structure and a simple manufacturing process: there are only two to three mutually locked parts that are finally left in the patient's body, including the clip 21, the sleeve 22 or the clip 21,
  • the sleeve 22 and the elastic connecting member 12 greatly reduce the number of parts that stay in the human body.
  • the clip 21, sleeve 22, and elastic connector 12 can all be formed by stamping and laser engraving with cross-beam processing for mass production and quality control; the overall performance of the device is stable, with multiple openings and closings and continuous rotation. The main function is required to solve the clinical problems such as bleeding and wound closure to the greatest extent.

Abstract

一种组织夹闭装置，包括：操作组件(1)和夹头组件(2)。实际应用中，操作组件(1)中的操作丝(4)可带动弹性释放件(11)运动，以使夹头组件(2)中的夹子(21)可在套筒(22)中滑动，并通过夹子(21)的自身弹性和套筒(22)的筒壁作用，使夹子(21)完成多次开闭。通过套筒(22)内壁对弹性释放件(11)的约束和放开约束，实现夹子(21)中部凹槽与弹性释放件(11)远端连接部的可分离连接。该组织夹闭装置结构简单，连接稳定且易于批量、稳定制作，大幅度降低生产过程成本和质量控制成本。

Description

一种组织夹闭装置
本申请要求在2019年8月6日提交中国专利局、申请号为201910719593.X、发明名称为“一种组织夹闭装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及内镜医疗器械技术领域，尤其涉及一种组织夹闭装置。
背景技术
组织夹闭装置是一种微创手术器械，常用于患者体内创面止血，例如消化道止血等。组织夹闭装置可通过内窥镜钳道送入患者体内的手术位置，并在体外实施夹闭操作，完成止血治疗。通常，经组织夹闭装置止血治疗后，局部组织炎症过程形成肉芽肿，自行脱落并经过消化道排出体外。使得手术具有损伤小、止血速度快、再出血发生率低、并发症少、疗效确切等优点。
典型的组织夹闭装置包括钳夹部件、导入部件以及操作部件。实际应用中，钳夹部件和导入部件可通过内窥镜钳道送入患者消化道，使钳夹部件到达患者体内的预定手术位置，再通过操作部件实施手术动作，实施的手术动作再通过导入部件传递至钳夹部件，使钳夹部件产生动作响应，对手术创面进行止血或夹闭操作。然后通过操作部件将钳夹部件与导入部件进行分离，以使存留在患者体内的钳夹部件，夹紧血管及周围组织，达到止血夹闭的目的。通常钳夹部件为金属止血夹等。
为了实现钳夹部件与导入部件之间的分离，上述组织夹闭装置一般在金属止血夹的近端(尾部)位置设置可发生形变的结构，以通过导入部件传递的作用力促使钳夹部件与导入部件之间发生分离。但可发生形变的结构造成钳夹部件与导入部件之间连接的不稳定，使得上述组织夹闭装置往往只能进行一次开闭。而内镜工作环境限制手术实施者进行精确操作，使钳夹部件不能一次完成夹闭。因此，传统组织夹闭装置的手术成功率低。另外，现有组织夹闭装置除具备夹闭功能外，还同时具备旋转功能。由于器械增加了功能，导致器械的结构相对复杂、器械制作的成本和质量控制成本都增加很多，且器械使用的稳定性也很低。
发明内容
本申请提供了一种组织夹闭装置，充分利用材料的自身弹性特性，以极其简单的结构来实现所需的夹闭、锁定等基本功能，同时也实现了多次开闭和旋转等重要功能，解决传统组织夹闭装置结构复杂，零件数量多，不利于加工制作和质量控制的问题。
本申请提供一种组织夹闭装置，包括：操作组件和可分离地连接所述操作组件的夹头组件；其中，所述夹头组件包括夹子和套筒；所述夹子设有一体结构的两个片状夹臂，所述夹子设置在所述套筒内靠近远端位置；所述操作组件包括弹性释放件和分离外筒；所述弹性释放件可分离地连接所述夹子两夹臂的中部,以使所述夹子完成多次开闭，所述分离 外筒设置在所述套筒的近端，所述分离外筒可分离地连接所述套筒；
所述夹子两夹臂的中部设有卡接部，所述弹性释放件的远端设有与所述卡接部相配合的连接部；所述弹性释放件的连接臂定型为外张弯曲结构，以使所述弹性释放件的连接臂可受到所述套筒的内壁压缩，产生弹性形变；所述连接部可进入所述卡接部内，以在弹性释放件的连接臂离开所述套筒内壁时，使所述连接部从所述卡接部内脱离。
可选的，所述卡接部为凹槽；所述连接部为连接槽，所述卡接部与所述连接部通过凹槽与连接槽的扣合实现相配合。
可选的，所述夹子两夹臂的中部两侧边缘均设有所述凹槽；所述弹性释放件包括两个形状相同的连接臂，每个所述连接臂的远端均设有所述连接部。
可选的，所述套筒的远端端面上设有限位槽；所述夹子的夹臂上设有导向片；所述导向片可进入所述限位槽，并接触所述限位槽的底部。
可选的，所述操作组件还包括弹性连接件，所述套筒上设有连接孔，所述分离外筒的内壁上设有卡槽；所述弹性连接件穿过所述连接孔设置在所述卡槽内，以实现所述分离外筒可分离地连接所述套筒。
可选的，所述弹性连接件为可弯折变形的弹片。
可选的，所述套筒上设有导向槽，所述夹子的夹臂上设有置入所述导向槽的弹性凸出部，所述弹性凸出部可在所述导向槽中滑动，以使夹片在打开和关闭的两种状态之间转换。
可选的，所述套筒上设有扭曲尖端；所述扭曲尖端为倾斜设置在所述套筒圆周面上的片状结构；所述扭曲尖端可进入分离外筒内壁的卡槽内，以实现分离外筒可分离地连接所述套筒。
可选的，所述套筒上设有与导向槽共线的连接孔，夹子夹臂上的弹性凸出部包括多个挂台；靠近所述夹子近端的挂台可从所述导向槽进入所述连接孔，以实现夹子在套筒内的锁定。
可选的，所述组织夹闭装置还包括：导管、操作丝以及手柄；
所述分离外筒的近端通过所述导管连接所述手柄；所述操作丝设置在所述导管内，并可在所述导管内移动；所述操作丝的远端连接所述弹性释放件，所述操作丝的近端连接所述手柄上的滑动部件，以控制所述夹子完成开闭动作。
由以上技术方案可知，本申请提供一种组织夹闭装置，包括：操作组件和夹头组件。实际应用中，操作组件中的操作丝可带动弹性释放件运动，以使夹头组件中的夹子可在套筒中滑动，并通过夹子的自身弹性和套筒的筒壁作用，使夹子完成多次开闭。通过套筒内壁对弹性释放件的约束和放开约束，实现夹子中部卡接部与弹性释放件远端连接部的可分离连接。本申请提供的组织夹闭装置结构简单，连接稳定且易于批量、稳定制作，大幅度降低生产过程成本和质量控制成本。
附图说明
图1为本申请一种组织夹闭装置的结构示意图；
图2为本申请一种组织夹闭装置的剖面结构示意图；
图3为本申请一种夹子的结构示意图；
图4为本申请一种弹性释放件的结构示意图；
图5为本申请一种套筒的结构示意图；
图6为本申请一种分离外筒的结构示意图；
图7为本申请一种连接片的结构示意图；
图8为本申请一种组织夹闭装置分离阶段的结构示意图；
图9为本申请另一种套筒的结构示意图；
图10为本申请另一种夹子的结构示意图；
图11为本申请另一种弹性释放件的结构示意图；
图12为本申请一个实施例中卡接部的结构示意图；
图13为本申请一个实施例中连接部的结构示意图。
具体实施方式
下面将详细地对实施例进行说明，其示例表示在附图中。下面的描述涉及附图时，除非另有表示，不同附图中的相同数字表示相同或相似的要素。以下实施例中描述的实施方式并不代表与本申请相一致的所有实施方式。仅是与权利要求书中所详述的、本申请的一些方面相一致的系统和方法的示例。
本申请提供的技术方案中，为了便于描述，将整个装置置入人体内的一端称为远端，这一端主要用于对组织实施手术动作；位于体外的一端称为近端，这一端主要用于手术实施者进行操作。本申请除另有说明外，各部件所称的远端都是靠近体内一侧的一端，各部件所称的近端都是指靠近体外一侧的一端。
参见图1，为本申请一种组织夹闭装置的结构示意图。参见图2，为本申请一种组织夹闭装置的剖面结构示意图。由图1、图2可知，本申请提供的一种组织夹闭装置包括：相互可分离连接的操作组件1和夹头组件2。所述夹头组件2包括夹子21和套筒22。实际应用中，夹子21设置在套筒22的远端位置，并且能够在套筒22中进行滑动，以形成夹闭空间，对患者创面实施夹闭，即所述夹子21设置在所述套筒22内靠近远端位置。
为了实现夹紧动作和重复开闭；所述夹子21设有一体结构的两个片状夹臂。如图3所示，夹子21可以由一个片状结构的弹片锻造或冲压成型。在不施加任何作用力时，夹子21的两个夹臂之间相互保持一定的张开角度，即两夹臂呈现V字形结构。实际应用中，套筒22的内壁可以对夹子21的夹臂背面施加作用力，使夹子21在被向近端的方向移动的过程中，相互张开的两夹臂之间角度会变小，即实现两夹臂的相互闭合。在两夹臂完全闭合后，整个夹子21呈现折叠状态。而当夹子21向远端方向运动时，套筒22的内壁对夹臂的作用位置改变，即改变了力臂，夹子21可以依靠自身的弹性作用，再次张大开合角度。
可见，本申请提供的技术方案中，向近端方向移动夹子21，可通过套筒22的限位作用，使两个夹臂闭合；向远端方向移动夹子21，夹子21的两夹臂可通过材料本身的弹性作用恢复张开状态。另外，为了使操作更加灵活，夹子21应当采用弹性较好的材料制成，并且夹子21两个夹臂相连接的位置厚度不宜过大，以在保证弹性作用的前提下，减少驱动力需求。
在实际应用中，如图3、图5所示，由于套筒22一般为圆管结构，而夹子21夹臂背面为圆弧形状，并且为了保证能够张开预设角度，夹子21的夹臂较小，因此套筒22与夹子21的接触面积较小，会导致在重复开闭过程中的运动不稳定，容易发生转动偏移，并且由于转动偏移缺陷，还可能影响夹子21对组织的夹闭作用。因此，为了使夹子21在开 闭过程中保持稳定，所述套筒22上设有导向槽222，所述夹子21的夹臂上设有置入所述导向槽222的弹性凸出部211，所述弹性凸出部211可在所述导向槽222中滑动。实际应用中，通过弹性凸出部211在导向槽222中的滑动，可以使夹子21在开闭过程中不会产生转动偏移，提高稳定性。同时，在夹子21重复进行开闭时，弹性凸出部211始终处于导向槽222内，有益于夹子21的顺畅开闭，从而实现重复开闭。
在本申请的部分实施例中，如图3、图5所示，所述套筒22的远端端面上设有限位槽223；所述夹子21的夹臂上设有导向片212；所述导向片212可进入所述限位槽223，并接触所述限位槽223的底部。通过限位槽223可以进一步维持夹子21进行平稳运动。另外，通过限位槽223与导向片212之间的配合，可以使夹子21两个夹臂之间的闭合方向得到有效限制，从而间接增加了夹子21的夹持力。
手术中，在夹子21对组织进行夹紧后，夹子21和套筒22需要留在患者体内，以持续对组织进行夹紧，以促使组织愈合。为了实现夹子21和套筒22能够留在患者体内，本申请需要在夹子21夹紧组织后，使操作组件1和夹头组件2分离。即所述操作组件1包括弹性释放件11和分离外筒13；所述弹性释放件11可分离地连接所述夹子21两夹臂的中部,以控制所述夹子21完成多次开闭，所述分离外筒13设置在所述套筒22的近端，所述分离外筒13可分离地连接所述套筒22。可见，在实际应用中，操作组件1和夹头组件2之间的分离可以通过夹子21与弹性释放件11之间的分离以及套筒22与分离外筒13之间的分离实现。
具体分离方式可以为：如图3所示，所述夹子21两夹臂的中部设有卡接部214，所述弹性释放件11的远端设有与所述卡接部214相配合的连接部14；所述弹性释放件11的连接臂定型为弯曲结构，以使所述弹性释放件11的连接臂可受到所述套筒22的内壁压缩，产生弹性形变；所述连接部14可进入所述卡接部214内，以在弹性释放件11的连接臂离开所述套筒22内壁时，使所述连接部14从所述卡接部214内脱离。
实际应用中，夹子21可以包括两个工作阶段，即重复开闭阶段和分离阶段；重复开闭阶段弹性释放件11与夹子21之间保持持续连接，通过弹性释放件11带动夹子21进行移动。分离阶段在确定夹子21已经夹紧组织后，通过弹性释放件11继续拉动夹子21向远端移动，使弹性凸出部211从导向槽222中滑出，并再滑出一定距离后，使弹性释放件11的远端脱离套筒22内壁的束缚，弹性释放件11会恢复形状，使连接部14从卡接部214中脱离，即实现夹子21与弹性释放件11之间的分离，如图8所示。
在本申请的部分实施例中，所述卡接部214为凹槽；所述连接部14为连接槽，所述卡接部214与所述连接部14通过凹槽与连接槽的扣合实现相配合。通过连接槽与凹槽之间的相互扣合，可以在保证相互分离的前提下，能够获得更稳定的连接。
需要说明的是，在本申请提供的技术方案中，卡接部214与连接部14之间的相互配合关系可以通过多种形式实现，例如可以采用两个槽型结构相扣合的方式，也可以通过槽口与卡块相配合实现。如图12、13所示，在本申请的另一个实施例中，卡接部214可以为凸出于夹子侧边的凸起结构，连接部14可以为设置在弹性释放件11远端的孔结构。在套筒内部的挤压下，卡接部214的凸起可以进入连接部14的孔中，当脱离挤压后，弹性释放件11两个连接臂依靠弹性恢复向外张开的结构，使连接部14与卡接部214之间相互分离。
本申请的其他实施例中，也可以将卡接部214设置为孔结构，将连接部14设置为凸起结构，本领域技术人员在根据上述实施例所能够联想到的可分离连接形式，均属于本申请的保护范围。
进一步地，如图4所示，所述夹子21两夹臂的中部两侧边缘均设有所述凹槽；所述弹性释放件11包括两个形状相同的连接臂，每个所述连接臂的远端均设有所述连接部14。即在实际应用中，弹性释放件11和夹子21均可以为对称结构，这种对称结构形式一方面可以使重复开闭阶段时，弹性释放件11和夹子21之间能够保持稳定的连接状态，以便传递滑动力矩；另一方面，便于维持弹力平衡，以在离开套筒22的内壁束缚后，即可从凹槽中分离。另外，如图11所示，为了使弹性释放件11在套筒22中时，能够受到套筒22内壁的压力，弹性释放件11的远端还可以向外弯曲，以便接触到套筒22的内壁。
为了实现套筒22与分离外筒13之间的分离，在本申请的一个实施例中，如图6、图7所示，所述操作组件1还包括弹性连接件12，所述套筒22上设有连接孔221，所述分离外筒13的内壁上设有卡槽131；所述弹性连接件12穿过所述连接孔221设置在所述卡槽131内，以实现所述分离外筒13可分离地连接所述套筒22。进一步地，所述弹性连接件12为可弯折变形的弹片，弹性连接件12的中部宽度可以小于两端宽度，可以为弹性释放件11的两个连接臂提供活动的空间。
实际应用中，在重复开闭阶段，如图1所示，弹性连接件12未被压缩，处于平直的状态，弹性连接件12的两端穿过连接孔221进图分离外筒13内壁的卡槽131中，此时，套筒22和分离外筒13通过弹性连接件12的限制，相互之间连接在一起。另外，弹性连接件12可以在卡槽131内沿圆周向转动，从而使套筒22与分离外筒13之间可相对转动，从而便于对夹子21转角进行调整。
在夹子21完成闭合进入分离阶段时，如图2所示，随着夹子21向近端的移动，弹性连接件12被夹子21中部挤压变形，使得其边缘从卡槽131中分离。此时，分离外筒13和套筒22之间不再受到弹性连接件12的限制，即可实现分离外筒13与套筒22之间的分离。
在本申请的另一个实施例中，如图10所示，所述套筒22上设有扭曲尖端224；所述扭曲尖端224为倾斜设置在所述套筒22圆周面上的片状结构；如图9所示，所述扭曲尖端224可进入所述分离外筒13内壁的卡槽131内，以实现所述分离外筒13可分离地连接所述套筒22。实际应用中，扭曲尖端224在重复开闭节点相对于套筒22的圆周面倾斜角度较大，使得其外侧边缘进入卡槽131内，使分离外筒13和套筒22之间连接在一起。在分离阶段，夹子21的夹臂背面触动扭曲尖端224的内侧边缘，使其相对于套筒22的圆周壁发生弹性扭转，此时，扭曲尖端224的外侧边缘从卡槽131中脱离，实现套筒22与分离外筒13之间的分离。
进一步地，如图9所示，所述套筒22上设有与导向槽222共线的连接孔221，夹子21夹臂上的弹性凸出部211包括多个挂台213；靠近所述夹子21近端的挂台213可从所述导向槽222进入所述连接孔221。通过挂台213可以在夹子21进入分离状态时，通过近端的挂台213与连接孔221之间的配合，使套筒22与夹子21固定在一起，从而达到锁止夹子21闭合状态的目的。
实际应用中，如图1所示，为了在体外完成手术操作，所述组织夹闭装置还包括：导 管3、操作丝4以及手柄5；具体的，所述分离外筒13的近端通过所述导管3连接所述手柄5；所述操作丝4设置在所述导管3内，并可在所述导管3内移动；所述操作丝4的远端连接所述弹性释放件11，所述操作丝4的近端连接所述手柄5上的滑动部件，以控制所述夹子21完成开闭动作。
以夹闭胃部创面为例，下内窥镜进行常规ESD手术治疗，治疗完毕后准备夹闭创面进行收尾工作；取出一把已经装配完毕的组织闭合装置，轻拉手柄5上的滑动部件，使其带动操作丝4进行运动，以致带动弹性释放件11，使得夹子21在套筒22的导向槽222范围内做开合运动。再在夹子21在导向槽222范围内，处闭合状态后，将此装置穿入内窥镜钳道送至创面处，推动滑动部件使夹子21两夹臂张开，准备闭合创面；夹合组织后再拉动滑动部件使夹子21闭合，夹闭组织，必要时旋转手柄5，以找到最合适的夹闭位置。在将夹子21闭合后，通过继续施加更大的拉力，使套筒22与分离外筒13相互分离，以及将夹子21与弹性释放件11相互分离，最终释放夹头组件2。最后，将操作组件1从钳道取出即可；根据创面大小的不同需要，可以按照如上步骤继续输送此装置直至创面完全闭合。
由以上技术方案可知，本申请提供的组织夹闭装置结构简单，制造工艺简易：最终留置在患者体内的只有两至三个相互锁定在一起的零件，包括夹子21、套筒22或夹子21、套筒22、弹性连接件12，极大减少了滞留人体的零件数量。夹子21、套筒22、弹性连接件12均可采用冲压成型和激光雕刻加工配以串光处理完成，以便批量制作以及质量控制；器械整体性能稳定，具备多次开闭及连续旋转等临床所需主要功能，最大程度解决了出血及创面闭合等临床问题。
本申请提供的实施例之间的相似部分相互参见即可，以上提供的具体实施方式只是本申请总的构思下的几个示例，并不构成本申请保护范围的限定。对于本领域的技术人员而言，在不付出创造性劳动的前提下依据本申请方案所扩展出的任何其他实施方式都属于本申请的保护范围。

Claims (10)

  1. 一种组织夹闭装置，其特征在于，包括：
    操作组件(1)；
    夹头组件(2)，可分离地连接所述操作组件(1)；
    其中，所述夹头组件(2)包括夹子(21)和套筒(22)；所述夹子(21)设有一体结构的两个片状夹臂，所述夹子(21)设置在所述套筒(22)内靠近远端位置；所述操作组件(1)包括弹性释放件(11)和分离外筒(13)；所述弹性释放件(11)可分离地连接所述夹子(21)两夹臂的中部,以使所述夹子(21)完成多次开闭，所述分离外筒(13)设置在所述套筒(22)的近端，所述分离外筒(13)可分离地连接所述套筒(22)；
    所述夹子(21)两夹臂的中部设有卡接部(214)，所述弹性释放件(11)的远端设有与所述卡接部(214)相配合的连接部(14)；所述弹性释放件(11)的连接臂定型为外张弯曲结构，以使所述弹性释放件(11)的连接臂可受到所述套筒(22)的内壁压缩，产生弹性形变；所述连接部(14)可进入所述卡接部(214)内，以在弹性释放件(11)的连接臂离开所述套筒(22)内壁时，使所述连接部(14)从所述卡接部(214)内脱离。
  2. 根据权利要求1所述的组织夹闭装置，其特征在于，所述卡接部(214)为凹槽；所述连接部(14)为连接槽，所述卡接部(214)与所述连接部(14)之间通过凹槽与连接槽的扣合实现相配合。
  3. 根据权利要求2所述的组织夹闭装置，其特征在于，所述夹子(21)两夹臂的中部两侧边缘均设有所述凹槽；所述弹性释放件(11)包括两个形状相同的连接臂，每个所述连接臂的远端均设有所述连接部(14)。
  4. 根据权利要求1所述的组织夹闭装置，其特征在于，所述套筒(22)的远端端面上设有限位槽(223)；所述夹子(21)的夹臂上设有导向片(212)；所述导向片(212)可进入所述限位槽(223)，并接触所述限位槽(223)的底部。
  5. 根据权利要求1所述的组织夹闭装置，其特征在于，所述操作组件(1)还包括弹性连接件(12)，所述套筒(22)上设有连接孔(221)，所述分离外筒(13)的内壁上设有卡槽(131)；所述弹性连接件(12)穿过所述连接孔(221)设置在所述卡槽(131)内，以实现所述分离外筒(13)可分离地连接所述套筒(22)。
  6. 根据权利要求5所述的组织夹闭装置，其特征在于，所述弹性连接件(12)为可弯折变形的弹片。
  7. 根据权利要求1所述的组织夹闭装置，其特征在于，所述套筒(22)上设有导向槽(222)，所述夹子(21)的夹臂上设有置入所述导向槽(222)的弹性凸出部(211)， 所述弹性凸出部(211)可在所述导向槽(222)中滑动。
  8. 根据权利要求7所述的组织夹闭装置，其特征在于，所述套筒(22)上设有扭曲尖端(224)；所述扭曲尖端(224)为倾斜设置在所述套筒(22)圆周面上的片状结构；所述扭曲尖端(224)可进入分离外筒(13)内壁的卡槽(131)内，以实现分离外筒(13)可分离地连接所述套筒(22)。
  9. 根据权利要求8所述的组织夹闭装置，其特征在于，所述套筒(22)上设有与导向槽(222)共线的连接孔(221)，夹子(21)夹臂上的弹性凸出部(211)包括多个挂台(213)；靠近所述夹子(21)近端的挂台(213)可从所述导向槽(222)进入所述连接孔(221)。
  10. 根据权利要求1所述的组织夹闭装置，其特征在于，所述组织夹闭装置还包括：导管(3)、操作丝(4)以及手柄(5)；
    所述分离外筒(13)的近端通过所述导管(3)连接所述手柄(5)；所述操作丝(4)设置在所述导管(3)内，并可在所述导管(3)内移动；所述操作丝(4)的远端连接所述弹性释放件(11)，所述操作丝(4)的近端连接所述手柄(5)上的滑动部件，以控制所述夹子(21)完成开闭动作。
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