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CN112168271B - A medical device that can be opened and closed repeatedly - Google Patents

A medical device that can be opened and closed repeatedly Download PDF

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Publication number
CN112168271B
CN112168271B CN201910586362.6A CN201910586362A CN112168271B CN 112168271 B CN112168271 B CN 112168271B CN 201910586362 A CN201910586362 A CN 201910586362A CN 112168271 B CN112168271 B CN 112168271B
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CN
China
Prior art keywords
distal end
expansion
proximal end
medical device
openable
Prior art date
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Application number
CN201910586362.6A
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Chinese (zh)
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CN112168271A (en
Inventor
唐志
范茗侨
冷德嵘
李常青
李宁
奚杰峰
金鸿雁
韦建宇
刘春俊
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Micro Tech Nanjing Co Ltd
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Micro Tech Nanjing Co Ltd
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Priority to CN201910586362.6A priority Critical patent/CN112168271B/en
Priority to PCT/CN2020/098130 priority patent/WO2021000782A1/en
Publication of CN112168271A publication Critical patent/CN112168271A/en
Application granted granted Critical
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083Clips, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227Spring clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/128Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord for applying or removing clamps or clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/03Automatic limiting or abutting means, e.g. for safety

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

Abstract

一种可重复开闭的医用装置,包括:闭合夹;夹座;控制线;外套管;致动器;可释放连接部件,所述可释放连接部件具有大致为管状结构,在其远端侧具有径向上可扩张结构,所述可扩张结构的远端部与所述夹座近端部的外壁接合;控制线远端设有扩张致动部件,当控制线向近端拉动时,所述扩张致动部件与所述可扩张结构抵接并驱动所述可扩张结构远端侧径向上扩张,进而释放所述夹座。基于上述设置可以实现对可重复开闭的医用装置的简化,并可优化使用手感。

A medical device that can be opened and closed repeatedly comprises: a closing clamp; a clamp seat; a control line; an outer sleeve; an actuator; a releasable connecting component, wherein the releasable connecting component has a generally tubular structure, and has a radially expandable structure at its distal end, wherein the distal end of the expandable structure is engaged with the outer wall of the proximal end of the clamp seat; an expansion actuating component is provided at the distal end of the control line, and when the control line is pulled toward the proximal end, the expansion actuating component abuts against the expandable structure and drives the distal end side of the expandable structure to expand radially, thereby releasing the clamp seat. Based on the above arrangement, the medical device that can be opened and closed repeatedly can be simplified, and the hand feeling of use can be optimized.

Description

Medical device capable of being repeatedly opened and closed
Technical Field
The invention relates to a device for closing tissues, belonging to a medical device used in a human body.
Background
In existing medical devices for tissue closure in the human body, releasable tissue closure clips are commonly used devices that deliver a clip body to a location to be closed in the human body by a delivery device, close the clip by actuating a wire and retain the clip body in the body after the clip has gripped the tissue and closed the lock by self-locking or other locking the clip body, thereby achieving tissue closure. How to realize a rapid and effective release process is a key point of safe and effective use of such devices and is also a difficulty in improving the structure.
The prior patent CN103989500A discloses that the clip assembly comprises a clamping assembly and a clamping seat, a release part connected with the clamping seat comprises a transition cap, a connecting part, a buckle, a pawl and other parts, the sleeved structure among the parts is relatively complex, the pawl needs to be precisely matched with a hole at the proximal end of the clamping seat, and the difficulty of the assembly and manufacturing process is relatively high. Document EP1328199B1 discloses a plurality of modes of releasably connecting the outer sheath tube of the locking clip arm with the connecting tube, and in various modes adopted by the method, sliding friction exists between the connecting tube and the outer sheath tube in the release process, namely, when the connecting tube is separated from the outer sheath tube, the connecting tube needs to overcome the friction force between the connecting tube and the outer sheath tube, so that the release can be realized, the separation principle leads to poor smoothness degree in the process of closing the clip assembly, and an operator needs to pay greater pulling force in the release process so as to realize the release of the clip, and correspondingly, greater difficulty also exists in the assembly process.
In view of this, the present invention has been made.
Disclosure of Invention
Based on the technical problems of relatively complex structure, difficult assembly, insufficient hand feeling, inconvenient smooth operation and the like existing in the prior art, the invention provides a tissue closing device capable of repeatedly opening and closing, which has simple structure and better operation hand feeling, and comprises:
The device comprises a closing clamp, a clamp seat, a control wire, an outer sleeve, an actuator, a releasable connecting component and a release connecting component, wherein the distal end of the clamp seat is pivoted to the clamp seat through a positioning pin shaft, the distal end of the control wire is connected with the proximal end of the clamp leg to drive the closing clamp to open or close, the outer sleeve is sleeved outside the control wire, the actuator is fixedly connected with the proximal end of the control wire to drive the control wire to move by moving the actuator, the releasable connecting component is provided with a generally tubular structure, the distal end side of the releasable connecting component is provided with a radial expandable structure, the distal end part of the expandable structure is connected with the outer wall of the proximal end of the clamp seat, and the control wire is provided with an expansion actuating component which is abutted with the expandable structure when the control wire is pulled proximally, so as to drive the distal end side of the expandable structure to be radially expanded, and further release the clamp seat.
Further, the closure clip has two oppositely disposed clip legs, the proximal end of each clip leg having a chute for receiving the locating pin, the chute having at least a first region at the proximal end and a second region at the distal end, the first region being at an angle to the second region, thereby defining that the two clip legs can be repeatedly opened or closed when the locating pin moves within the first region, the two clip legs forming a locked closed condition when the locating pin enters the second region, wherein the chute inner diameter at the intersection of the first region and the second region is less than the diameter of the locating pin, and the locating pin enters the second region from the first region when the proximally directed driving force applied by the actuator is greater than the threshold.
Further, the first zone centerline is distal from the leg closure staple line from the proximal end, and the second zone centerline is parallel to the leg closure staple line.
Further, a locking protrusion is provided on the inner wall of the chute at the intersection of the first region and the second region, and when the proximal driving force applied by the actuator is greater than the threshold value, the positioning pin enters the second region from the first region.
Further, the locking bulge is positioned on the inner wall of the chute close to one side of the closed staple line of the clamping leg.
Further, the locking protrusion has a hole portion, and when the locking protrusion is pressed by the positioning pin, the hole portion deforms, and the positioning pin enters the second area.
Further, the clamping legs are integrally formed and provided with a clamping part with a far end for clamping tissues and a movable part capable of being contained in the clamping seat, and the sliding groove is located on the movable part.
Further, the releasable connecting member is generally cylindrical and at least one slot extending proximally from the distal end is formed in the sidewall to form the expandable structure such that when the expansion actuating member is moved proximally and in abutment with the sidewall, the slot expands such that the distal end of the releasable connecting member is disengaged from the proximal outer wall of the cartridge, releasing the cartridge.
Further, the side wall of the releasable connecting member is preferably provided with 4 slots extending from the distal end to the proximal end at equal intervals.
Further, the releasable attachment means comprises a generally tubular expandable structure formed by at least two axially extending and spaced apart expansion tabs, wherein the proximal end of each expansion tab is fixedly engaged with the distal end of the expansion tab base such that the distal end of the expansion tab expands outwardly around a retaining ring on the outer wall of the expansion tab base upon application of a proximally directed compressive force by the expansion actuating means to release the clip.
Further, the expansion piece distal side outer wall is provided with an expansion groove extending in a circumferential direction to accommodate a resiliently retractable ring member surrounding the expandable structure.
Further, the distal end of the expansion sheet base is provided with a clamping groove fixedly combined with the distal end of the expansion sheet, and the outer walls of the expansion sheet and the expansion sheet base are provided with continuous fixing grooves extending along the axial direction so as to accommodate the positioning ring.
Further, the expandable structure is made of an elastically deformable material that is recoverable upon removal of the compressive force.
Further, the expansion actuating component is of an inverse conical table structure sleeved at the far end of the control line and gradually reduced from far to near along the axial direction, an expansion boss is arranged on the inner wall of the expandable structure in the release connecting component, and when the control line moves towards the near end, the expansion actuating component is driven to move towards the near end and abut against the expansion boss to drive the far end side of the expandable structure to expand radially.
The expanding actuating component is sleeved at the far end of the control line, the sliding block structure is spherical or cylindrical, the inner wall of the expandable structure in the release connecting component is in a funnel shape with gradually reduced distance from the central shaft from far to near, and when the control line moves towards the near end, the expanding actuating component is driven to move towards the near end and abut against the inner wall of the expandable structure to drive the far end side of the expandable structure to expand radially.
Further, the proximal ends of the clamping legs are pivotally connected through an actuating pin shaft, the distal ends of the control wires are provided with hook structures or closing hole structures, and the hook structures or closing hole structures are also pivoted to the actuating pin shaft and actuate the clamping legs to open or close through a cam structure.
Further, the proximal ends of the clamping legs are provided with clamping hooks which are clamped with locking convex tables on the inner wall of the proximal end of the clamping seat in a locking closed state.
Further, the distal end of the control wire has a stepped structure that abuts the distal end surface of the expansion actuating member to drive the expansion actuating member to move proximally when the control wire is moved proximally.
Further, a transition tube is provided between the proximal end of the releasable connecting member and the distal end of the outer cannula, and a return spring is provided within the transition tube to engage the expansion actuating member and provide a spring force to return the expansion actuating member.
Further, the control wire has at least two regions, the control wire is wound from a plurality of strands of steel wire at a distal end and from a single strand of steel wire at a proximal end.
Further, the distal end of the releasable connecting member is provided with a locking key, the outer wall of the proximal end of the holder is provided with a locking groove along the circumferential direction, the locking key is located in the locking groove in a natural state to realize the engagement of the holder and the releasable connecting member, and the locking key preferably extends vertically to the central axis of the releasable connecting member.
Further, the outer sleeve is of a double-layer structure formed by sleeving the outer tube and the inner tube in a clearance manner, and the inner tube is made of a high polymer material with a low friction coefficient.
Based on the technical scheme, the invention has the following advantages:
1. The releasable connecting structure of the existing clip assembly is optimized, the component for realizing release of the repeatable opening and closing device only comprises the releasable connecting component which can be expanded in the radial direction and the expansion actuating component which is sleeved at the distal end of the control wire, the structure is simpler, and the corresponding assembly process is more convenient.
2. In the invention, in the releasing process of the clamping seat, the clamping seat and the releasable connecting component do not have any sliding friction, when the releasable connecting component is radially expanded under the drive of the expansion actuating component, the clamping seat is immediately released, the whole process does not need to overcome the retardation caused by the sliding friction, and the clamping seat has better operation hand feeling.
3. Based on the release structure in the invention, the clip assembly has the advantages of smooth hand feeling and reliable locking of the pivotally connected clip arm structure, simple structure, small release resistance and the like of the radial release structure. Compared with the prior art, the invention effectively solves the difficult problems of actuation and locking of two clamping pieces under the pivot connection, and compared with the existing U-shaped clamp which is elastically bent by itself (such as an elastic biasing clamp assembly produced by Olin Bass and Boston scientifically), the invention skillfully solves the difficult problems through a radial release structure, and realizes the rapid and smooth release of the clamp assembly.
Drawings
FIG. 1 is an overall view of a reclosable closure arrangement in a first embodiment;
FIG. 2 is a distal perspective view of a reclosable closure device;
FIG. 3 is a perspective view of a releasable connecting component;
FIG. 4 is a side view of a closure clip;
FIG. 5 is an enlarged view of a portion of the closure clip chute;
FIG. 6 is an enlarged view of the proximal end of the cartridge in the closed clip locked state;
FIG. 7 is a side view of a clip leg;
FIG. 8 is a side view of the closure clip in an open state;
FIG. 9 is an enlarged view of a portion of the clip connected to the control line in the open state;
FIG. 10 is a perspective view of a holder;
FIG. 11 is a partial cross-sectional view of a reclosable closure transition duct;
FIG. 12 is a distal perspective view of a reclosable closure device in a second embodiment;
FIG. 13 is a perspective view of the distal end of the releasable connecting member of the reclosable closure device in a second embodiment;
FIG. 14 is an enlarged view of the distal end of the releasable connecting member in the second embodiment;
FIG. 15 is a perspective view of the distal end of the releasable connecting member in the second embodiment in an expanded state;
FIG. 16 is a schematic view of the assembly of control lines with an expansion actuation component;
FIG. 17 is a schematic illustration of a control line connection to an expansion actuation component;
FIG. 18 is a schematic illustration of a control line connection to an expansion actuation component;
FIG. 19 is a schematic illustration of the connection of a control line to an expansion actuation component.
Reference numerals illustrate:
1-closing clip, 11-clip leg, 12-clip part, 13-movable part, 14-first zone, 15-second zone, 16-locking tab, 17-eyelet, 18-clip leg eyelet, 19-hook, 2-clip seat, 21-dowel pin, 22-actuation pin, 23-dowel pin hole, 24-U-shaped notch, 25-guide slot, 26-snap groove, 27-locking boss, 3-releasable connecting member, 31-expandable structure, 32-slot, 33-snap key, 3 '-releasable connecting member, 31' -expansion tab, 32 '-expansion tab base, 33' -expansion groove, 34 '-loop, 35' -retaining ring, 36 '-securing groove, 37' -snap key, 4-outer sleeve, 41-transition tube, 42-return spring, 5-control wire, 51-control wire distal, 52-control wire connecting tube, 53-control wire proximal, 54-control wire closing hole structure, 55-expansion actuating member, 56-proximal guide, 57-distal handle, 6-actuator, 7-actuator
Detailed Description
The technical contents of the present invention will be described in detail with reference to the accompanying drawings and specific embodiments.
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention.
Some of the terms involved in the present invention will be described. The proximal end refers to a section proximal to an operator outside the body, the distal end refers to an end of tissue to be closed in the body, the axial direction refers to a longitudinal direction extending along a control line, the radial direction refers to a direction extending perpendicular to the axial direction, the circumferential direction refers to a circumferential direction around the axial direction, the locked state, the state in which each of the legs is in the closed state and irreversibly locked by the holder, the threshold value refers to a value of force upon separation of the releasable connecting member from the holder after the closure clip is in the locked closed state, and the line of closure staple, the longitudinal centerline in the closed anastomosis state of each of the legs.
Fig. 1-11 illustrate a first embodiment of the present invention, wherein fig. 1 is an overall view of a reclosable tissue closure device according to the first embodiment. As shown in FIG. 1, the tissue closure device capable of being opened and closed repeatedly comprises a closure clip 1, which is provided with two clip legs 11 with distal ends capable of being opened or closed relatively; the device comprises a clamping seat 2, a clamping leg 11, a control wire 5, an outer sleeve 4, an actuator 7, a handle 6 and a control wire, wherein the proximal end of the clamping leg 11 is pivoted to the clamping seat 2 through a positioning pin 21 fixed to the distal end of the clamping seat 2, when the closed clamp 1 is in a closed state, the proximal end of the clamping leg 11 is accommodated in the clamping seat 2, the distal end of the control wire 5 is pivoted with the proximal end of the clamping leg 11 through an actuating pin 22 and further drives the closed clamp 1 to open or close through pulling the control wire 5, the outer sleeve 4 is sleeved outside the control wire 5 and is used for protecting the control wire and supporting the control wire to axially move, the distal end side of the outer sleeve can rotate relative to the proximal end side, the proximal end side of the outer sleeve is connected with the handle, the actuator 7 is fixedly connected with the proximal end of the control wire 5 and drives the control wire 5 to move along the axial direction, the handle 6 is fixedly connected with the proximal end of the outer sleeve 4 and limits the displacement of the actuator 7 along the axial line, the proximal end of the control wire 5 is provided with a step pipe so as to be in clamping connection with the inner wall step of the distal end of the handle, and the step of the proximal end of the control wire is in a circular pipe shape, and the outer step pipe of the proximal end of the control wire is used for realizing a special-shaped structure which is not in the handle.
As shown in fig. 2-3 and 11, the re-openable and closable tissue closure device further comprises a releasable connecting member 3 having a generally tubular structure, a proximal end of which is coupled to the outer sleeve 4, and a radially expandable structure 31 at a distal end side thereof, a distal end portion of the expandable structure 31 being engaged with an outer wall of a proximal end portion of the holder 2, and an expansion actuating member 55 provided at a distal end of the control wire 5, the expansion actuating member 55 abutting against an inner wall of the expandable structure 31 and providing a driving force for radially expanding the expandable structure 31 when the control wire 5 is pulled proximally, and driving the distal end side of the expandable structure 31 to radially expand, thereby releasing the holder 2. Wherein the expandable structure 31 is made of an elastically deformable material, a shape recovery can be achieved upon removal of the compressive force provided by the expansion actuating member 55. In addition, in this embodiment, the distal end of the releasable connecting member 3 has an engaging key 33, the outer wall of the proximal end of the holder 2 is provided with an engaging groove 26 in the circumferential direction, and the engaging key 33 is located in the engaging groove 26 in a natural state to achieve engagement of the holder 2 with the releasable connecting member 3, and the engaging key 33 preferably extends perpendicularly to the central axis of the releasable connecting member 3.
In this embodiment, in operation, the outer sleeve 4 is fixed on the core rod of the handle 6 and plays a role in supporting the backward force of the control wire 5 when the actuator 7, which is limited and slid by the control wire 5 on the handle 6, moves backward relative to the core rod of the handle 6, so as to force the distal end of the control wire 5 to break or deform, or the proximal actuating pin 22 to deform or break, so that the expandable structure 31 is opened by the lateral compression force generated by the expansion actuating member 55 when the control wire 5 moves backward when the distal end of the control wire is separated from the actuating pin 22, and at this time, the engagement key 33 at the distal end of the expandable structure 31 is separated from the engagement groove 26 circumferentially arranged on the outer wall of the proximal end of the clip, thereby realizing the separation of the closure clip 1 from the releasable connecting member 3, and thus being retained in the body. In operation, torque generated when the handle 6 is rotated can be transmitted forward through the control wire 5, and the axial direction cannot move back and forth, but rotational movement about the axial direction can be realized due to the clearance fit of the engagement groove 26 on the outer wall of the proximal end of the holder 2 and the engagement key 33 at the distal end of the expandable structure 31.
Based on the above design, the operator only needs to pull the control wire 5 to the proximal end, so that the closing clip 1 is in a locking closing state, and when the pulling force is greater than a threshold value, the expandable structure 31 is pressed and expanded by the expansion actuating component 55, the clip seat can realize release, and the structure is simple, no sliding friction exists in the whole release process, the operation hand feeling is smoother, and the application convenience of the user is greatly improved. Compared with the existing self-closing clip release structure, the invention has the greatest improvement innovation that the radial expansion release structure and the clip assembly which is connected through the pivot are effectively and organically combined together, so that the advantages of simple structure, quick release and the like of the radial expansion release component are reserved, and the advantages of no friction, smooth hand feeling and the like of the pivotally-combined clip assembly are also reserved. In particular, the clip assembly in the prior art can be classified into a self-closing clip made of metal material (for example, patent document EP1328199B 1) and a pivoting connection clip similar to a biopsy forceps structure (for example, patent document CN103989500 a), the former is in a normally closed state under the condition of no external force by relying on the elastic memory effect of the clip, so the release structure is designed without considering the problem of release process and clip closing linkage, the clip has the defects of uncontrollable holding force caused by self-closing, difficult design of the clip opening structure, and the like, while the pivoting connection clip has the design difficulty due to the connection of the pivoting structure and the control wire, and the conventional solution for the skilled person is to design the clip holder or the outer sleeve of the fixing clip assembly into a cylindrical structure with a fixed clamping channel so as to meet the relatively stable opening or closing position of the clip assembly, and it is difficult to think that the clip holder or the outer sleeve playing the fixing and limiting roles is designed into radial deformation. The research and development personnel of the invention continuously explore and try in the test, creatively combine the radial expansion support and the pivot connection clip assembly, and realize the tissue closing device which has simple structure and better operation hand feeling and can be repeatedly opened and closed through the specific structural design mode.
The specific structure of the releasable connecting member 3 in this embodiment will be further described based on fig. 2 to 3. The releasable connecting member 3 is a cylindrical structure having a central passage, and 4 slits 32 extending from a distal end to a proximal end are formed on a side wall thereof at equal intervals, so that an expandable structure 31 having a distal end side capable of expanding outwardly is formed, so that when the expansion actuating member 55 moves proximally and abuts against an inner wall of the expandable structure 31, the slits 32 are caused to expand under the driving of a pressing force, and an engagement key 33 on the distal end side of the expandable structure 31 is disengaged from the engagement groove 26 on the proximal outer wall of the holder, thereby releasing the holder. Of course, the number of slots 32 may vary depending on the actual device size, such as 2, 3, 4, 5, etc., all of which enable expansion of the expandable structure 31.
The specific structure of the closure clip 1 and the clip holder 2 in the first embodiment will be described based on fig. 4 to 9. The closure clip 1 according to the invention preferably has two oppositely disposed legs 11, the proximal end of each leg 11 having a slot for receiving a locating pin 21, the slot having a first region 14 at the proximal end and a second region 15 at the distal end, the first region 14 and the second region 15 having an angle which is dimensioned to control the maximum angle of opening between the legs. Defined by the first and second sections, the two legs 11 can be repeatedly opened or closed when the positioning pin 21 moves in the first section 14, and the two legs 11 are brought into a locked closed state when the positioning pin 21 enters the second section 15. Wherein, the intersection part of the first area 14 and the second area 15 is provided with a locking protrusion 16, so that the inner diameter of the chute is smaller than the diameter of the positioning pin 21, and when the driving force applied by the actuator 7 towards the proximal end is larger than a threshold value, the positioning pin 21 presses the locking protrusion 16 to deform, and then the first area 14 enters the second area 15. In this embodiment, the center line of the first region 14 is far away from the closed staple line of the clamping legs from the proximal end to the distal end, and the center line of the second region 15 is parallel to the closed staple line a of the clamping legs, so that when the positioning pin 21 moves in the first region 14, the two clamping legs 11 can be repeatedly opened or closed, and when the positioning pin enters the second region 15, the two clamping legs can be tightly closed. In this embodiment, as shown in fig. 7, the locking protrusion 16 is located on the inner wall of the chute near the side of the closing line a of the leg, and the locking protrusion 16 has a hole 17, when the locking protrusion 16 is pressed by the positioning pin 21, the hole 17 is compressively deformed, the inner diameter of the chute at the inflection point increases, and the positioning pin 21 enters the second region 15.
The clip leg 11 is preferably an integrally formed structure, and has a distal end for holding tissue, a holding portion 12, and a movable portion 13 that can be accommodated in the clip holder 2, and the chute is located in the movable portion 13. The proximal end of each clamping leg 11 is provided with a clamping leg tail hole 18, an actuating pin shaft 22 passes through the clamping leg tail hole 18, so that each clamping leg is pivotally connected through the actuating pin shaft 22, meanwhile, the distal end of the control wire 5 is provided with a closing hole structure 54, and the closing hole structure 54 is also pivoted on the actuating pin shaft 22, so that the two clamping legs 11 are driven to be opened or closed relatively in the process of pulling the control wire 5 through a cam structure at the tail part of each clamping leg. Wherein, the closed hole structure 54 at the distal end of the control wire 5 can be replaced by a hook structure, and the hook structure or the closed hole structure 54 at the distal end of the control wire 5 breaks or deforms to separate from the actuating pin 22 or the actuating pin 22 breaks or breaks to separate from the distal end structure of the control wire 5 during the process of locking the closed clamp 1. In addition, the leg tail holes 18 at the tail ends of the legs may be circular or oblong to provide a pivotal connection.
As shown in fig. 6, the proximal ends of the two clamping legs 11 of the closing clamp 1 are respectively provided with a clamping hook 19, and after the control line moves proximally to drive the two clamping legs to be closed, the clamping hooks 19 are clamped with the locking bosses 27 on the proximal inner wall of the clamping seat 2, so that a locking closed state is formed, and the clamping legs 11 cannot be opened again.
In this embodiment, in order to make the control wire 5 better transmit torque and the front end have flexibility to smoothly pass through the endoscope channel, the control wire 5 may be composed of a multi-segment wire in which the distal end portion 51 is wound with a plurality of strands of steel wires and the proximal end portion 53 is made of a single strand of steel wire and has high hardness to transmit axial force and rotational torque. The control wire connection tube 52 serves to connect the distal end portion 51 and the proximal end portion 53, and may be fixed by caulking or welding 92 at both ends. Further, a polymer plastic tube for controlling the gap and reducing the friction force is arranged in the outer sleeve 4, preferably, the outer sleeve 4 has a double-layer structure formed by the gap nesting of an outer tube and an inner tube, and the inner tube is made of a polymer material with a low friction coefficient.
As shown in fig. 10, the holder 2 has a U-shaped structure with a U-shaped notch 24 for receiving the holder leg 11 and a pin shaft hole 23 for fixing the pin shaft at the distal end, a guide groove 25 for restraining the actuating pin 22 is provided on the inner wall at the proximal end, and an engaging groove 26 for detachably engaging with an engaging key 33 at the distal end side of the expandable structure 31 is provided on the outer wall at the proximal end.
As shown in FIG. 11, which is a preferred outer sleeve configuration, a transition tube 41 is provided between the proximal end of the releasable connecting member 3 and the distal end of the outer sleeve 4. A return spring 42 is provided in the transition tube 41, and is fixedly engaged with or abutted against the proximal end surface of the expansion actuating member 55 sleeved outside the control wire 5, so as to provide an elastic force for distally returning the expansion actuating member 55, so as to ensure that after the pulling force of the control wire to the proximal end is eliminated, the expansion actuating member 55 is restored to the distal end of the releasable connecting member 3 under the action of the return spring, and further, the pressing force for expanding the expandable structure 31 outwards is eliminated, and the expandable structure 31 elastically returns to the original natural state. By employing a return spring, the releasable connecting member 3 can be returned to the original state in a minimum time.
In the second embodiment shown in fig. 12-15, the structure of the releasable connecting member 3 in the first embodiment is modified. In this embodiment, the releasable attachment means 3 'comprises a generally tubular expandable structure formed by four axially extending and spaced apart expansion tabs 31', and an expansion tab base 32', wherein the proximal end of each expansion tab 31' is fixedly engaged with the distal end of the expansion tab base 32 'such that the distal end of the expansion tab 31' expands outwardly around a retaining ring 35 'on the outer wall of the expansion tab base 32' when subjected to a proximally directed compressive force by the expansion actuating means 55, thereby releasing the clip 2. Wherein the distal outer wall of the expansion plate 31' is provided with a circumferentially extending ring 33' for receiving a resiliently retractable ring 34' surrounding the expandable structure. The distal end of the expansion sheet base 32' is provided with a clamping groove fixedly combined with the distal end of the expansion sheet 31', the outer walls of the expansion sheet 31' and the expansion sheet base 32' are provided with continuous fixing grooves 36' extending along the axial direction so as to accommodate the positioning rings 35', and the outer wall of the distal end side of the expansion sheet 31' is provided with expansion grooves 33' extending along the circumferential direction so as to accommodate the elastically retractable annular piece 34' surrounding the expandable structure.
In this embodiment, in operation, when the control wire 5 moves backward, the expansion actuating member 55 generates a lateral compression force, at this time, the proximal ends of the expansion pieces 31 'are tightly connected with the expansion base 32' under the fastening action of the positioning ring 35', and the distal ends of the expansion pieces 31' are subjected to the lateral compression force, the elastically retractable ring 34 'expands, and the expansion pieces 31' expand outward with the positioning ring 35 'as an axis, thereby separating the closure clip 1 from the releasable connecting member 3', so that the closure clip 1 stays in the body.
In the configuration structure of the control wire 5 and the expansion actuating member 55 shown in fig. 16-17, the expansion actuating member 55 is a reverse taper structure sleeved at the distal end of the control wire 5 and gradually reduced from far to near along the axial direction, the inner wall of the expandable structure 31 in the releasable connecting member 3 is provided with an expansion boss 38, and when the control wire 5 moves proximally, the expansion actuating member 55 is driven to move proximally and abut against the expansion boss 38 to drive the distal end side of the expandable structure 31 to expand radially. Further, the distal end of the control wire 5 has a stepped structure that abuts the distal end surface of the expansion actuating member 55 to drive the expansion actuating member 55 to move proximally when the control wire 5 moves proximally.
In another preferred configuration of the control wire 5 and the expansion actuating member 55 shown in fig. 18-19, the expansion actuating member 55 may be replaced by a cylindrical or spherical structure, wherein the inner wall of the expandable structure 31 in the releasable connecting member 3 is funnel-shaped with a decreasing distance from the central axis from the distal end to the proximal end, and when the control wire 5 is moved proximally, the expansion actuating member 55 is moved proximally and abuts the inner wall of the expandable structure 31 to drive the distal end of the expandable structure 31 to expand radially.
It should be noted that the above embodiments are merely for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the above embodiments, it should be understood by those skilled in the art that the technical solution described in the above embodiments may be modified or some or all of the technical features may be equivalently replaced, and these modifications or substitutions do not deviate from the essence of the corresponding technical solution from the scope of the technical solution of the embodiments of the present invention.

Claims (18)

1.一种可重复开闭的医用装置,包括:1. A re-openable and re-closable medical device, comprising: 闭合夹,具有远端可打开或闭合的至少两片夹腿;A closing clamp having at least two clamp legs whose distal ends can be opened or closed; 夹座,所述夹腿近端部通过定位销轴枢接于所述夹座;A clamp seat, the proximal end of the clamp leg is pivotally connected to the clamp seat via a positioning pin; 控制线,其远端与所述夹腿近端连接以驱动所述闭合夹打开或闭合;A control line, the distal end of which is connected to the proximal end of the clamp leg to drive the closure clamp to open or close; 外套管,套设于所述控制线外部;An outer sleeve, sleeved on the outside of the control line; 致动器,其与所述控制线近端固定连接,通过移动所述致动器以驱动所述控制线移动;an actuator fixedly connected to the proximal end of the control line, and driving the control line to move by moving the actuator; 其特征在于:Features: 包括可释放连接部件,所述可释放连接部件具有大致为管状结构,在其远端侧具有径向上可扩张结构,所述可扩张结构的远端部与所述夹座近端部的外壁接合;控制线远端设有扩张致动部件,当控制线向近端拉动时,所述扩张致动部件与所述可扩张结构抵接并驱动所述可扩张结构远端侧径向上扩张,进而释放所述夹座;The releasable connecting component comprises a generally tubular structure, a radially expandable structure at its distal end, and a distal end of the expandable structure engages with an outer wall of a proximal end of the clamp seat; an expansion actuating component is provided at the distal end of the control line, and when the control line is pulled toward the proximal end, the expansion actuating component abuts against the expandable structure and drives the distal end side of the expandable structure to expand radially, thereby releasing the clamp seat; 所述可释放连接部件包括:由至少两条沿轴向延伸且相互间隔设置的扩展片形成的大致管状的所述可扩张结构;扩展片基座,其中,每一扩展片近端与所述扩展片基座远端固定接合,以使扩展片远端在受到所述扩张致动部件向近端的压迫力时,可围绕所述扩展片基座外壁的定位环向外扩展,进而释放所述夹座;The releasable connection component comprises: a substantially tubular expandable structure formed by at least two expansion pieces extending axially and spaced apart from each other; an expansion piece base, wherein the proximal end of each expansion piece is fixedly engaged with the distal end of the expansion piece base, so that the distal end of the expansion piece can expand outwardly around the positioning ring of the outer wall of the expansion piece base when the expansion actuating component compresses the distal end toward the proximal end, thereby releasing the clamp seat; 所述扩展片远端侧外壁设有沿周向延伸的扩展凹槽,以容纳环绕所述可扩张结构的可弹性回缩的环形件;The outer wall of the distal end of the expansion piece is provided with an expansion groove extending in the circumferential direction to accommodate an elastically retractable annular member surrounding the expandable structure; 所述扩展片基座远端设有与所述扩展片远端固定结合的卡槽,所述扩展片和扩展片基座的外壁上设有连续的沿轴向延伸的固定凹槽,以容纳所述定位环。The distal end of the expansion piece base is provided with a slot fixedly combined with the distal end of the expansion piece, and the outer walls of the expansion piece and the expansion piece base are provided with a continuous fixing groove extending in the axial direction to accommodate the positioning ring. 2.根据权利要求1所述的可重复开闭的医用装置,其特征在于:所述闭合夹具有两个相对设置的夹腿,每个所述夹腿的近端具有容纳所述定位销轴的滑槽,所述滑槽至少具有近端的第一区和位于远端的第二区,所述第一区与所述第二区具有一定夹角,从而限定出:当所述定位销轴在所述第一区内移动时,所述两个夹腿可重复打开或闭合,当所述定位销轴进入所述第二区时,所述两个夹腿形成锁止闭合状态,其中,2. The medical device that can be repeatedly opened and closed according to claim 1 is characterized in that: the closing clamp has two clamp legs arranged opposite to each other, the proximal end of each clamp leg has a slide groove for accommodating the positioning pin shaft, the slide groove has at least a first area at the proximal end and a second area at the distal end, the first area and the second area have a certain angle, thereby defining: when the positioning pin shaft moves in the first area, the two clamp legs can be repeatedly opened or closed, and when the positioning pin shaft enters the second area, the two clamp legs form a locked closed state, wherein, 所述第一区和所述第二区相交部分的滑槽内径小于所述定位销轴的直径,当所述致动器施加的朝向近端的驱动力大于阈值时,所述定位销轴由所述第一区进入所述第二区。The inner diameter of the slide groove at the intersection of the first zone and the second zone is smaller than the diameter of the positioning pin shaft. When the driving force toward the proximal end applied by the actuator is greater than a threshold value, the positioning pin shaft enters the second zone from the first zone. 3.根据权利要求2所述的可重复开闭的医用装置,其特征在于:所述第一区中心线由近端向远端远离夹腿闭合吻合线,所述第二区中心线与所述夹腿闭合吻合线平行。3. The re-openable and reclosable medical device according to claim 2, characterized in that: the center line of the first zone is away from the clamp leg closure anastomosis line from the proximal end to the distal end, and the center line of the second zone is parallel to the clamp leg closure anastomosis line. 4.根据权利要求2所述的可重复开闭的医用装置,其特征在于:所述第一区和第二区相交部分的滑槽内壁上具有一锁止凸起,当所述致动器施加的朝向近端的驱动力大于所述阈值时,定位销轴由所述第一区进入所述第二区。4. The re-openable and reclosable medical device according to claim 2 is characterized in that: a locking protrusion is provided on the inner wall of the slide groove at the intersection of the first zone and the second zone, and when the driving force toward the proximal end applied by the actuator is greater than the threshold value, the positioning pin shaft enters the second zone from the first zone. 5.根据权利要求4所述的可重复开闭的医用装置,其特征在于:所述锁止凸起位于靠近夹腿闭合吻合线一侧的滑槽内壁上。5. The re-openable and re-closable medical device according to claim 4, characterized in that the locking protrusion is located on the inner wall of the slide groove close to the side of the leg closing anastomosis line. 6.根据权利要求4所述的可重复开闭的医用装置,其特征在于:所述锁止凸起具有孔状部,当所述锁止凸起受到所述定位销轴压迫,所述孔状部形变,进而所述定位销轴进入第二区。6. The re-openable and reclosable medical device according to claim 4, characterized in that: the locking protrusion has a hole-shaped portion, and when the locking protrusion is pressed by the positioning pin shaft, the hole-shaped portion is deformed, and then the positioning pin shaft enters the second area. 7.根据权利要求2所述的可重复开闭的医用装置,其特征在于:所述夹腿一体成型,具有远端用于夹持组织的夹持部及能够收纳于夹座内的活动部,所述滑槽位于所述活动部。7. The re-openable and reclosable medical device according to claim 2, characterized in that: the clamping legs are integrally formed, and have a clamping portion at the distal end for clamping tissue and a movable portion that can be received in the clamp seat, and the slide groove is located in the movable portion. 8.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述可扩张结构由弹性形变材料制成,在撤去压迫力后可复原。8. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that the expandable structure is made of elastically deformable material and can be restored after the compressive force is removed. 9.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述扩张致动部件为套设于控制线远端的沿轴向由远至近逐渐减小的倒锥台结构,所述可释放连接部件中的所述可扩张结构内壁设有扩张凸台;9. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that: the expansion actuation component is an inverted frustum structure which is sleeved on the distal end of the control line and gradually decreases from far to near along the axial direction, and the inner wall of the expandable structure in the releasable connection component is provided with an expansion boss; 当控制线向近端移动时,带动所述扩张致动部件向近端移动并与所述扩张凸台抵接以驱动所述可扩张结构远端侧径向上扩张。When the control line moves toward the proximal end, the expansion actuation component is driven to move toward the proximal end and abut against the expansion boss to drive the distal end side of the expandable structure to expand radially. 10.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述扩张致动部件为套设于控制线远端的滑块结构,所述滑块结构为球形、或圆柱形;所述可释放连接部件中的所述可扩张结构内壁呈距中心轴距离由远至近逐渐减小的漏斗形;10. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that: the expansion actuation component is a slider structure sleeved on the distal end of the control line, and the slider structure is spherical or cylindrical; the inner wall of the expandable structure in the releasable connection component is in a funnel shape with a distance from the central axis gradually decreasing from far to near; 当控制线向近端移动时,带动所述扩张致动部件向近端移动并与所述可扩张结构内壁抵接以驱动所述可扩张结构远端侧径向上扩张。When the control line moves toward the proximal end, the expansion actuation component is driven to move toward the proximal end and abut against the inner wall of the expandable structure to drive the distal end side of the expandable structure to expand radially. 11.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述各夹腿近端通过一致动销轴枢转连接,控制线远端具有弯钩结构、或闭合孔结构,且所述弯钩结构、或闭合孔结构同样枢接于所述致动销轴并通过凸轮结构致动所述夹腿打开或闭合。11. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that the proximal ends of the clamping legs are pivotally connected via an actuating pin, the distal end of the control line has a hook structure or a closed hole structure, and the hook structure or the closed hole structure is also pivotally connected to the actuating pin and actuates the clamping legs to open or close via a cam structure. 12.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述夹腿近端具有卡钩,在锁定闭合状态下,与夹座近端内壁锁定凸台卡合。12. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that: the proximal end of the clamp leg has a hook, which is engaged with the locking boss on the inner wall of the proximal end of the clamp seat in a locked closed state. 13.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述控制线远端具有台阶结构,当控制线向近端移动时,所述台阶结构与所述扩张致动部件远端面抵接以驱动所述扩张致动部件向近端移动。13. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that the distal end of the control line has a step structure, and when the control line moves toward the proximal end, the step structure abuts against the distal end surface of the expansion actuator component to drive the expansion actuator component to move toward the proximal end. 14.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述可释放连接部件近端与所述外套管远端间设有过渡管,所述过渡管内设有复位弹簧,与所述扩张致动部件接合,并提供使所述扩张致动部件复位的弹力。14. The re-openable and reclosable medical device according to any one of claims 1 to 7 is characterized in that a transition tube is provided between the proximal end of the releasable connecting component and the distal end of the outer sleeve, and a return spring is provided in the transition tube, which engages with the expansion actuator component and provides elastic force to return the expansion actuator component to its original position. 15.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述控制线具有至少两个区域,所述控制线远端由多股钢丝绕制而成,近端由单股钢丝制成。15. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that the control line has at least two regions, the distal end of the control line is wound with multiple strands of steel wire, and the proximal end is made of a single strand of steel wire. 16.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述可释放连接部件远端具有卡合键,所述夹座近端外壁沿圆周向设有卡合凹槽,在自然状态下所述卡合键位于所述卡合凹槽以实现夹座与所述可释放连接部件的接合。16. The re-openable and reclosable medical device according to any one of claims 1 to 7 is characterized in that: the distal end of the releasable connecting component has a snap-fit key, and the proximal outer wall of the clamp seat is provided with a snap-fit groove along the circumferential direction, and in a natural state, the snap-fit key is located in the snap-fit groove to achieve the engagement between the clamp seat and the releasable connecting component. 17.根据权利要求16所述的可重复开闭的医用装置,其特征在于:所述卡合键向所述可释放连接部件中心轴垂直延伸。17. The re-openable and reclosable medical device according to claim 16, wherein the locking key extends perpendicularly to the central axis of the releasable connecting component. 18.根据权利要求1-7任一项所述的可重复开闭的医用装置,其特征在于:所述外套管具有由外管与内管间隙套叠而成的双层结构,内管为低摩擦系数的高分子材质制成。18. The re-openable and reclosable medical device according to any one of claims 1 to 7, characterized in that the outer sleeve has a double-layer structure formed by an outer tube and an inner tube overlapped with each other, and the inner tube is made of a polymer material with a low friction coefficient.
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