WO2021000782A1

WO2021000782A1 - Medical device capable of repeatedly opening and closing

Info

Publication number: WO2021000782A1
Application number: PCT/CN2020/098130
Authority: WO
Inventors: 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
Original assignee: 南微医学科技股份有限公司
Priority date: 2019-07-01
Filing date: 2020-06-24
Publication date: 2021-01-07
Also published as: CN112168271A

Abstract

A medical device capable of repeatedly opening and closing, comprising: a closing clip; a clip base; a control wire; an outer sleeve; an actuator; and a releasable connecting member; the releasable connecting member has a largely tubular structure, and has a radially expandable structure on a distal end side thereof, a distal end part of the expandable structure being engaged with an outer wall of a proximal end part of the clip base; a distal end of the control wire is provided with an expansion actuation component, and when the control wire is pulled toward a 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 clip base. On the basis of the described arrangement, simplification may be achieved for the medical device capable of repeatedly opening and closing, and the feel of use may be optimized.

Description

Medical device capable of repeatedly opening and closing

Cross references to related applications

This application claims the priority of the Chinese patent application with the application number CN201910586362.6 and the title "a reopenable medical device" which was filed with the Chinese Patent Office on July 1, 2019, and the entire content is incorporated by reference. In this application.

Technical field

This application relates to a device for closing tissue, which belongs to a medical device used in the human body.

Background technique

Among the existing medical devices used for tissue closure in the human body, the releasable tissue closure clip is a conventionally used device, which delivers the clip body to the position to be closed in the human body through a delivery device, closes the clip through an actuation wire and closes the clip through self-locking or Other locking clip bodies allow the clip to clamp the tissue and close and lock the clip body to stay in the body, thereby achieving tissue closure. How to achieve a quick and effective release process is a key point for the safe and effective use of this type of device, and it is also a difficult point for structural improvement.

The existing patent CN103989500A discloses that the clip assembly includes a clamping assembly and a clamping base. The release parts connected to the clamping base include transition caps, connectors, buckles and claws. The structure of the sleeves between the components is relatively complicated. It needs to be precisely matched with the hole at the proximal end of the clamp base, and the assembly manufacturing process is relatively difficult. The document EP1328199B1 discloses a variety of ways in which the outer sheath of the locking clamp arm can be releasably connected to the connecting tube, and the connecting tube and the outer sheath have sliding friction during the release process, that is, the connecting tube and the connecting tube When the outer sheath is separated, the connecting tube needs to overcome the friction between it and the outer sheath to achieve release. This separation principle leads to poor smoothness during the closing of the clip assembly, and the operator needs to pay more during the release process. Only a large pulling force can release the clip, and accordingly, there will be greater difficulties in the assembly process.

In view of this, this application is hereby submitted.

Summary of the invention

Based on the technical problems existing in the prior art, either the structure is relatively complex and difficult to assemble, or the hand feel is not smooth enough, the operation is inconvenient and other technical problems, the present application provides a tissue closure device that can be repeatedly opened and closed with a simple structure and a better operating feel. include:

A closing clip has at least two clamping legs whose distal ends can be opened or closed; a clamping base, the proximal end of the clamping leg is pivotally connected to the clamping base through a positioning pin shaft; a control line, the distal end of which is connected to the clamping leg The proximal end is connected to drive the closing clip to open or close; the outer tube is sleeved outside the control wire; the actuator is fixedly connected to the proximal end of the control wire, and the actuator is moved to drive the The control wire moves; further comprising a releasable connecting member having a substantially tubular structure with a radially expandable structure on its distal side, and the distal end of the expandable structure and the clip base The outer wall of the proximal part is engaged; the distal end of the control wire is provided with an expansion actuation member, when the control wire is pulled to the proximal end, the expansion actuation member abuts the expandable structure and drives the distal end of the expandable structure The side expands radially, thereby releasing the clip seat.

Further, the closing clip has two oppositely arranged clamping legs, the proximal end of each clamping leg has a sliding groove for accommodating the positioning pin, and the sliding groove has at least a first area at the proximal end and The second zone at the distal end, the first zone and the second zone have a certain included angle, thereby defining: when the positioning pin moves in the first zone, the two clamping legs can be opened repeatedly Or closed, when the positioning pin enters the second zone, the two clamping legs form a locked closed state, wherein the inner diameter of the sliding groove at the intersection of the first zone and the second zone is smaller than the positioning pin Diameter, when the driving force applied by the actuator toward the proximal end is greater than the threshold, the positioning pin enters the second area from the first area.

Further, the center line of the first area is away from the closed anastomosis line of the clamp leg from the proximal end to the distal end, and the center line of the second area is parallel to the closed anastomosis line of the clamp leg.

Further, the inner wall of the sliding groove at the intersection of the first zone and the second zone is provided with a locking protrusion, when the driving force applied by the actuator toward the proximal end is greater than the threshold, the positioning pin is The first zone enters the second zone.

Further, the locking protrusion is located on the inner wall of the sliding groove on the side close to the closed anastomosis line of the clamping leg.

Further, 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 the positioning pin shaft enters the second area.

Further, the clamping leg is integrally formed, and has a clamping part configured to clamp tissue at a distal end and a movable part that can be housed in the clamping seat, and the sliding groove is located at the movable part.

Further, the releasable connecting member is nearly cylindrical, and at least one slot extending from the distal end to the proximal end is provided on the side wall to form the expandable structure, so that the expansion actuation member When moving to the proximal end and abutting against the side wall, the slot expands, and the distal end of the releasable connecting member is detached from the outer wall of the proximal end of the clamp base, releasing the clamp base.

Further, the sidewall 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 connecting member includes: the substantially tubular expandable structure formed by at least two expansion pieces extending in the axial direction and spaced apart from each other; an expansion piece base, wherein the proximal end of each expansion piece 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 on the outer wall of the expansion piece base when the distal end of the expansion piece is pressed proximally by the expansion actuation component, Then release the clip seat.

Further, the outer wall of the distal end side of the expansion piece is provided with an expansion groove extending in the circumferential direction to accommodate an elastically retractable ring member surrounding the expandable structure.

Further, the distal end of the expansion piece base is provided with a clamping groove 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.

Further, the expandable structure is made of an elastically deformable material, and can be restored after the compressive force is removed.

Further, the expansion actuation component is an inverted frustum structure that is sheathed at the distal end of the control wire and gradually decreases from far to near in the axial direction, and the inner wall of the expandable structure in the release connecting component is provided with an expansion convex When the control wire moves to the proximal end, it drives the expansion actuation component to move proximally and abuts against the expansion boss to drive the expandable structure to expand radially on the distal side.

Further, the expansion actuation component is a sliding block structure sheathed at the distal end of the control wire, the sliding block structure is spherical or cylindrical; the inner wall of the expandable structure in the release connecting component is located away from the central axis A funnel shape with a gradually decreasing distance from far to near. When the control line moves to the proximal end, the expansion actuating component is driven to move proximally and abuts against the inner wall of the expandable structure to drive the distal end of the expandable structure The side expands radially.

Further, the proximal ends of the clamp legs are pivotally connected by an actuating pin, the distal end of the control wire 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 the clamping leg is actuated to open or close through the cam structure.

Further, the proximal end of the clamping leg is provided with a hook which engages with the locking protrusion on the inner wall of the proximal end of the clamping base in the locked and closed state.

Further, the distal end of the control wire has a stepped structure, and when the control wire moves to the proximal end, the stepped structure abuts against the distal surface of the expansion actuation member to drive the expansion actuation member to move proximally .

Further, a transition tube is provided between the proximal end of the releasable connecting member and the distal end of the outer sleeve, and a return spring is provided in the transition tube to engage with the expansion actuation member and provide the expansion actuation The elasticity of component reset.

Further, the control wire has at least two regions, the distal end of the control wire is made of multiple strands of steel wire, and the proximal end is made of a single strand of steel wire.

Further, the distal end of the releasable connecting member has an engaging key, and the outer wall of the proximal end of the clip base is provided with an engaging groove along the circumferential direction. In a natural state, the engaging key is located at the engaging groove. To achieve the engagement between the clip base and the releasable connecting component, the engagement key preferably extends perpendicularly to the central axis of the releasable connecting component.

Further, the outer tube has a double-layer structure formed by a gap between an outer tube and an inner tube, and the inner tube is made of a polymer material with a low friction coefficient.

Based on the above technical solution, this application has the following advantages:

1. Optimize the releasable connection structure of the existing clip assembly. The releasable components of the re-opening and closing device described in this application only include the releasable connection component that is expandable in the radial direction, and the expansion that is sleeved at the distal end of the control wire. The moving parts have a simpler structure and the corresponding assembly process is also more convenient.

2. In the present application, during the release process of the clip seat, there is no sliding friction between the clip seat and the releasable connecting part. When the releasable connecting part is radially expanded by the expansion actuation part, the clip seat is immediately released. The process does not need to overcome the block caused by sliding friction, and has a better operating feel.

3. Based on the release structure in the present application, the clip assembly has the advantages of a pivotally connected clip arm structure that is smooth in hand and reliable in locking, and the radial release structure has the advantages of simple structure and low release resistance. Compared with the prior art, the present application effectively solves the problem of the actuation and locking of the two clips under pivotal connection. Compared with the existing U-shaped clip that is elastically bent by itself (such as Olympus or Boston) Scientifically produced elastic biasing clip assembly), how to achieve a series of key operations such as actuation, clamping, locking and release of two clips with pivotal connection are technical points that are difficult to design and overcome in this field. The application cleverly solves the problem through the radial release structure, and realizes the quick and smooth release of the clip assembly.

Description of the drawings

Figure 1 is an overall view of the reopenable closing device in the first embodiment;

Fig. 2 is a perspective view of the distal end of the closing device that can be opened and closed repeatedly;

Figure 3 is a three-dimensional view of the releasable connecting part;

Figure 4 is a side view of the closing clip;

Figure 5 is a partial enlarged view of the chute of the closing clip;

Figure 6 is an enlarged view of the proximal end of the clip holder when the closed clip is locked;

Figure 7 is a side view of the clamp leg;

Figure 8 is a side view of the closed clip in an open state;

Figure 9 is a partial enlarged view of the connection part with the control line when the closing clip is opened;

Figure 10 is a perspective view of the holder;

Figure 11 is a partial cross-sectional view of a transition tube of a closing device that can be repeatedly opened and closed;

Figure 12 is a perspective view of the distal end of the reopenable closing device in the second embodiment;

Figure 13 is a perspective view of the expanded state of the distal end of the releasable connecting member of the releasable closing device in the second embodiment;

Figure 14 is an enlarged view of the distal end of the releasable connecting member in the second embodiment;

15 is a perspective view of the expanded state of the distal end of the releasable connecting member in the second embodiment;

Figure 16 is a schematic diagram of the assembly of the control line and the expansion actuation component;

Figure 17 is a schematic diagram of the connection between the control line and the expansion actuation component;

Figure 18 is a schematic diagram of the connection between the control line and the expansion actuation component;

Figure 19 is a schematic diagram of the connection between the control line and the expansion actuation component.

Description of reference signs:

1-Closed clip, 11-Clamp leg, 12-Clamping part, 13-Moving part, 14-First zone, 15-Second zone, 16-Locking protrusion, 17-Hole-shaped part, 18-Clamping leg Tail hole, 19-hook, 2-clamp seat, 21-locating pin, 22-actuating pin, 23-locating pin hole, 24-U-shaped notch, 25-guide groove, 26-locking groove , 27-locking boss, 3-releasable connecting part, 31-expandable structure, 32-slotting, 33-locking key, 3'-releasable connecting part, 31'-expansion piece, 32'-expansion piece Base, 33'-expansion groove, 34'-ring, 35'-locating ring, 36'-fixing groove, 37'-locking key, 4-outer tube, 41-transition tube, 42-return spring , 5-Control line, 51- Control line distal end, 52- Control line connecting tube, 53- Control line proximal end, 54- Control line closed hole structure, 55- Expansion actuation component, 56- Proximal guide part, 57 -Distal face, 6-handle, 7-actuator

Detailed ways

The technical content of this application will be described in detail with reference to the drawings and specific embodiments.

The embodiments of the present application will be described in detail below in conjunction with examples, but those skilled in the art will understand that the following examples are only used to illustrate the present application and should not be regarded as limiting the scope of the present application.

Some terms involved in this application are explained. The proximal end refers to the section close to the operator outside the body; the distal end refers to the end of the tissue to be closed in the body; the axial direction refers to the longitudinal direction extending along the control line; the radial refers to the direction perpendicular to the axial direction; the circumferential direction is Refers to the circumferential direction along the axial direction; in the locked state, each clamp leg is in the closed state and is irreversibly locked by the clamp seat; the threshold refers to the release of the connecting part and the clamp after the closing clamp is in the locked and closed state The value of the force when the seat is separated; the longitudinal centerline of the closed anastomosis line and the closed anastomosis state of each clamp leg.

Figures 1-11 show the first embodiment of this application, wherein Figure 1 is an overall view of the reopenable and closable tissue closure device in the first embodiment. As shown in Figure 1, the reopenable and closable tissue closure device includes: a closure clip 1, which has two clamping legs 11 whose distal ends can be relatively opened or closed; a clamping seat 2, the proximal end of the clamping leg 11 is fixed to The positioning pin 21 at the distal end of the clamp base 2 is pivotally connected to the clamp base 2, and when the closing clamp 1 is in the closed state, the proximal end of the clamp leg 11 is housed in the clamp base 2; the control wire 5, the distal end of which is connected with the clamp leg 11 The proximal end is pivotally connected by the actuating pin 22, and then the closing clip 1 is opened or closed by pulling the control wire 5; the outer sleeve 4, which is sleeved outside the control wire 5, is configured to protect the control wire and be the control wire In the axially movable support, the distal side of the outer sleeve can be rotated relative to the proximal side, and the proximal side is connected to the handle; the actuator 7 is fixedly connected to the proximal end of the control wire 5, and is moved forward and backward in the axial direction. The actuator 7 drives the control wire 5 to move; the handle 6 is fixedly connected to the proximal end of the outer sleeve 4 and defines the displacement of the actuator 7 along the axis, wherein the proximal end of the control wire 5 has a stepped tube, The stepped tube at the proximal end of the control line is in a non-circular shaped structure to realize the transmission of the rotating torque exerted by the handle.

As shown in Figures 2-3 and 11, the reopenable and closable tissue closure device also includes a releasable connecting member 3, which has a substantially tubular structure, the proximal end of which is connected to the outer sleeve 4, and the distal side of A radially expandable structure 31, the distal end of the expandable structure 31 is engaged with the outer wall of the proximal end of the clip holder 2; the distal end of the control wire 5 is provided with an expansion actuation component 55, when the control wire 5 is pulled toward the proximal end, The expansion actuating member 55 abuts against the inner wall of the expandable structure 31 and provides a driving force for the expandable structure 31 to expand radially, and drives the distal end of the expandable structure 31 to expand radially, thereby releasing the clip base 2. The expandable structure 31 is made of an elastically deformable material, so the shape can be restored after the compressive force provided by the expansion actuation member 55 is removed. In addition, in this embodiment, the distal end of the releasable connecting member 3 has an engaging key 33, and the outer wall of the proximal end of the clip base 2 is provided with an engaging groove 26 along the circumferential direction. In a natural state, the engaging key 33 is located in the engaging groove. 26 in order to realize the engagement between the clip base 2 and 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, during operation, when the actuator 7 with the control wire 5 sliding at the upper limit of the handle 6 moves backwards relative to the core rod of the handle 6, the outer sleeve 4 is fixed on the core rod of the handle 6 and supports the control wire. 5 The backward force is applied to force the distal end of the control wire 5 to break or deform, or the proximal actuation pin 22 is deformed or broken, so that the distal end of the control wire is separated from the actuation pin 22 using the control wire 5 The lateral pressing force generated by the expansion actuating member 55 during the backward movement causes the expandable structure 31 to expand. At this time, the engaging key 33 at the distal end of the expandable structure 31 and the engaging groove 26 circumferentially arranged on the outer wall of the proximal end of the holder base Separation, so that the closure clip 1 is separated from the releasable connecting part 3, and then stays in the body. During operation, when the handle 6 rotates, the torque generated can transmit the torque forward through the control line 5. Because the engaging groove 26 on the outer wall of the proximal end of the holder 2 is in clearance fit with the engaging key 33 on the distal end of the expandable structure 31, the shaft It can’t move forward and backward, but can realize the rotation movement around the axis.

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 locked and closed state, and when the pulling force is greater than a threshold, the expandable structure 31 is compressed and expanded by the expansion actuation member 55, and the clip is seated The release can be realized, the structure is simple, and there is no sliding friction in the entire release process, the operation feel is smoother, and the convenience of the user is greatly improved. Compared with the existing self-closing clip release structure, the biggest improvement and innovation of this application lies in the effective combination of the radial expansion release structure and the clip assembly that will be connected by a pivot, which not only retains the radial expansion The release member has the advantages of simple structure and quick release, while retaining the advantages of frictionless and smooth hand feeling of the pivotally combined clip assembly. Specifically, the clip assembly in the prior art can be divided into a self-closing clip made of metal materials (such as patent document EP1328199B1) and a pivotal connection clip similar to a biopsy forceps structure (such as patent document CN103989500A). The former depends on the clip. The self-elastic memory effect is in a normally closed state without external force, so there is no need to consider the release process and the clip closure linkage problem when designing the release structure, and this kind of clip has uncontrollable buffing force caused by self-closing and difficulty in opening the clip structure design However, the pivotal connection clip is difficult to design due to the connection of the pivoting structure and the control line. The conventional solution for those skilled in the art is to design the clip seat or the outer tube of the fixed clip assembly into a cylindrical shape with a fixed clamping channel The structure satisfies the relatively stable opening or closing position of the clip assembly, but it is difficult to think that it is difficult to realize that the clip seat or the outer sleeve that plays the role of fixing and limiting is designed to be radially deformed. The R&D personnel of this application have continuously explored and tried in the experiment, innovatively combined the radial expansion support and the pivotal connection clip assembly, and realized the simple structure and better operating feel through the above-mentioned specific structural design method. Tissue closure device that can be opened and closed repeatedly.

Next, the specific structure of the releasable connecting member 3 in this embodiment will be further explained based on FIGS. 2-3. The releasable connecting member 3 is a cylindrical structure with a central channel, and four slots 32 extending from the distal end to the proximal end are equally spaced on the side wall, thereby forming an expandable distal end that can expand outward. The structure 31 is such that when the expansion actuating member 55 abuts against the inner wall of the expandable structure 31 when it moves proximally, it is driven by the pressing force to cause the slot 32 to expand, and the engaging key on the distal side of the expandable structure 31 33 is disengaged from the engaging groove 26 on the outer wall of the proximal end of the clamp base, thereby releasing the clamp base. Of course, the number of slots 32 can be changed according to the actual device size, such as 2, 3, 4, 5, etc., which can all realize the expansion of the expandable structure 31.

The specific structures of the closing clip 1 and the clip base 2 in the first embodiment will be described based on FIGS. 4-9. In the present application, it is preferable that the closing clip 1 has two oppositely arranged clamping legs 11. The proximal end of each clamping leg 11 has a sliding groove for accommodating the positioning pin 21, and the sliding groove has a first region 14 at the proximal end and a first region 14 at the distal end. The second zone 15, the first zone 14 and the second zone 15 have an included angle, and the size of the included angle is designed to control the maximum opening angle between the clamp legs. The first and second zones define: when the positioning pin 21 moves in the first zone 14, the two clamping legs 11 can be repeatedly opened or closed. When the positioning pin 21 enters the second zone 15, the two clamps The leg 11 forms a locked closed state. Wherein, the intersecting part of the first zone 14 and the second zone 15 has a locking protrusion 16, so that the inner diameter of the sliding groove here is smaller than the diameter of the positioning pin 21, when the actuator 7 exerts a driving force toward the proximal end When the value is greater than a threshold, the positioning pin 21 presses the locking protrusion 16 to deform, and then enters the second area 15 from the first zone 14. In this embodiment, the center line of the first zone 14 is away from the clamp leg closed anastomosis line from the proximal end to the distal end, and the center line of the second zone 15 is parallel to the clamp leg closed anastomosis line A, so that the positioning pin 21 is in the first zone When moving inside 14, the two clamping legs 11 can be repeatedly opened or closed, and when entering the second zone 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 sliding groove on the side close to the closed anastomosis line A of the clamping leg, and the locking protrusion 16 has a hole 17. When the locking protrusion 16 When pressed by the positioning pin 21, the hole 17 is compressed and deformed, the inner diameter of the sliding groove at the inflection point increases, and the positioning pin 21 enters the second zone 15.

In addition, the clamping leg 11 is preferably an integral structure with a clamping portion 12 configured to clamp tissue at the distal end and a movable portion 13 that can be stored in the clamping base 2, and the sliding groove is located at the movable portion 13. The proximal end of each clamping leg 11 has a clamping leg tail hole 18, and the actuating pin 22 passes through the clamping leg tail hole 18, so that the clamping legs are pivotally connected by the actuating pin 22, and the distal end of the control wire 5 has a closed hole structure 54, and the closed hole structure 54 is also pivotally connected to the actuating pin 22, and the cam structure at the end of the clamping leg is used to drive the two clamping legs 11 to relatively open or close during the process of pulling the control wire 5. The closed hole structure 54 at the distal end of the control wire 5 can also be replaced with a hook structure. During the process of locking the closing clip 1, the hook structure or the closed hole structure 54 at the distal end of the control wire 5 is broken or deformed to achieve and cause The moving pin 22 is separated, or the actuating pin 22 is deformed or broken to separate from the distal structure of the control wire 5. In addition, the leg clamping tail hole 18 at the end of the clamping leg may be circular or oblong to achieve pivotal connection.

As shown in Figure 6, the two clamping legs 11 of the closure clip 1 have hooks 19 at the proximal ends. After the control line moves to the proximal end to drive the two clamping legs to close, the hooks 19 are locked with the proximal inner wall of the clip base 2 The table 27 is engaged to form a locked and closed state, and the clamping leg 11 cannot be opened again.

In this embodiment, in order to make the control wire 5 better transmit torque and have a flexible front end to smoothly pass through the endoscope channel, the control wire 5 may be composed of a multi-segment wire, wherein the distal end 51 is wound by multiple strands of steel wire. The proximal portion 53 is made of a single-strand steel wire and has high hardness to transmit axial force and rotational torque. The control line connecting tube 52 serves to connect the distal end 51 and the proximal end 53 and can be fixed by riveting or welding 92 ends. Further, the outer tube 4 is provided with a polymer plastic tube that controls the gap and reduces friction. Preferably, the outer tube 4 has a double-layer structure formed by a gap between the outer tube and the inner tube, and the inner tube has a low friction coefficient. Made of high polymer material.

As shown in Figure 10, the specific structure of the clamp base is shown in Fig. 10. The clamp base 2 has a U-shaped structure with a U-shaped notch 24 for accommodating the clamping leg 11 and a positioning pin shaft hole 23 for fixing the distal pin. The outer wall of the proximal end of the guide groove 25 of the movable pin shaft 22 has an engaging groove 26 detachably engaged with the engaging key 33 on the distal side of the expandable structure 31.

As shown in FIG. 11, the outer sleeve structure is preferred, and 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. The transition tube 41 is provided with a return spring 42 which can be fixedly engaged or abutted with the proximal end surface of the expansion actuation member 55 sheathed outside the control wire 5, and the purpose is to provide the expansion actuation member 55 to reset distally. The elastic force to ensure that after the proximal end of the control line 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, thereby eliminating the compression force that causes the expandable structure 31 to expand outward , The expandable structure 31 returns to its original natural state in its elasticity. By adopting the return spring, the releasable connecting member 3 can be restored to the initial state in the shortest time.

In the second embodiment as shown in Figs. 12-15, the structure of the releasable connecting member 3 in the first embodiment is changed. In this embodiment, the releasable connecting member 3'includes: a substantially tubular expandable structure formed by four expansion sheets 31' extending in the axial direction and spaced apart from each other; and an expansion sheet base 32', wherein each expansion The proximal end of the piece 31' is fixedly engaged with the distal end of the expansion piece base 32', so that the distal end of the expansion piece 31' can surround the outer wall of the expansion piece base 32' when the distal end of the expansion piece 31' is pressed proximally by the expansion actuating member 55 The positioning ring 35' expands outward, thereby releasing the clamp base 2. Wherein, the outer wall of the distal end of the expansion piece 31' is provided with 33' extending in the circumferential direction to accommodate an elastically retractable ring member 34' surrounding the expandable structure. The distal end of the expansion piece base 32' is provided with a card slot fixedly combined with the distal end of the expansion piece 31', and the outer walls of the expansion piece 31' and the expansion piece base 32' are provided with a continuous fixing groove 36 extending in the axial direction. 'To accommodate the positioning ring 35', while the outer wall of the distal end of the expansion piece 31' is provided with an expansion groove 33' extending in the circumferential direction to accommodate the elastically retractable ring member 34' surrounding the expandable structure.

In this embodiment, during operation, when the control wire 5 moves backwards, the expansion actuation member 55 generates a lateral pressing force. At this time, the proximal end of the expansion piece 31' is fastened by the positioning ring 35' to the expansion base 32' is tightly connected, and the distal end of each expansion piece 31' is subjected to lateral pressure, the elastically retractable ring piece 34' expands, and each expansion piece 31' takes the positioning ring 35' as the axis and expands outwards to achieve The separation of the closing clip 1 and the releasable connecting part 3'makes the closing clip 1 stay in the body.

As shown in Figs. 16-17, the control wire 5 and the expansion actuating member 55 are arranged in a structure diagram. The expansion actuation member 55 is an inverted frustum that is sheathed at the distal end of the control wire 5 and gradually decreases from far to near in the axial direction Structure, the inner wall of the expandable structure 31 in the releasable connecting member 3 is provided with an expansion boss 38, when the control wire 5 moves proximally, the expansion actuation member 55 is driven to move proximally and abuts against the expansion boss 38 The distal end side of the expandable structure 31 is driven to expand radially. In addition, the distal end of the control wire 5 has a stepped structure. When the control wire 5 moves to the proximal end, the stepped structure abuts the distal end surface of the expansion actuation member 55 to drive the expansion actuation member 55 to move proximally.

As shown in Figs. 18-19, another preferred control line 5 and expansion actuation component 55 configuration diagram, the structure of the expansion actuation component 55 can be replaced with a cylindrical or spherical shape, and the expandable structure 31 in the connecting component 3 can be released. The inner wall is in the shape of a funnel whose distance from the central axis gradually decreases from far to near. When the control wire 5 moves to the proximal end, the expansion actuating member 55 is driven to move proximally and abuts against the inner wall of the expandable structure 31 to drive the expandable structure. 31 The distal side expands radially.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the application, not to limit it; although the application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand: It is still possible to modify the technical solutions described in the foregoing embodiments, or equivalently replace some or all of the technical features; these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the application Range.

Claims

A medical device that can be opened and closed repeatedly, including:

Closing clamp, with at least two clamp legs that can be opened or closed at the distal end;

A clamp base, the proximal end of the clamp leg is pivotally connected to the clamp base through a positioning pin shaft;

A control wire whose distal end is connected to the proximal end of the clamp leg to drive the closing clamp to open or close;

The outer sleeve is sleeved outside the control line;

An actuator, which is fixedly connected to the proximal end of the control wire, and drives the control wire to move by moving the actuator;

Its characteristics are:

It includes a releasable connecting member, the releasable connecting member has a substantially tubular structure with a radially expandable structure on its distal side, and the distal end of the expandable structure engages with the outer wall of the proximal end of the clip base The distal end of the control wire is provided with an expansion actuation member, when the control wire is pulled proximally, the expansion actuation member abuts the expandable structure and drives the distal side of the expandable structure to expand radially, and then Release the clamp seat.
The medical device that can be opened and closed repeatedly according to claim 1, wherein the closing clip has two oppositely arranged clamping legs, and the proximal end of each of the clamping legs has a sliding plate for accommodating the positioning pin. Groove, the sliding 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 is in When moving in the first zone, the two clamping legs can be repeatedly opened or closed. When the positioning pin enters the second zone, the two clamping legs form a locked closed state, wherein,

The inner diameter of the sliding groove at the intersection of the first zone and the second zone is smaller than the diameter of the positioning pin. When the driving force applied by the actuator toward the proximal end is greater than the threshold, the positioning pin is moved by the first zone. Enter the second zone.
The medical device that can be opened and closed repeatedly according to claim 2, wherein the center line of the first zone is away from the clamp leg from the proximal end to the distal end to close the anastomosis line, and the center line of the second zone is connected to the clamp The legs are closed and the anastomosis line is parallel.
The medical device that can be opened and closed repeatedly according to claim 2, wherein the inner wall of the sliding groove at the intersection of the first zone and the second zone is provided with a locking protrusion, when the actuator is applied When the driving force toward the proximal end is greater than the threshold, the positioning pin enters the second area from the first area.
The medical device that can be opened and closed repeatedly according to claim 4, wherein the locking protrusion is located on the inner wall of the sliding groove close to the side of the clamping leg to close the anastomosis line.
The medical device that can be opened and closed repeatedly according to claim 4, wherein the locking projection has a hole-shaped portion, and when the locking projection is pressed by the positioning pin, the hole-shaped portion Deformation, and then the positioning pin enters the second zone.
The medical device that can be opened and closed repeatedly according to claim 2, wherein the clamping legs are integrally formed with a clamping part configured to clamp tissue at the distal end and a movable part that can be housed in the clamping seat. The chute is located in the movable part.
The medical device that can be opened and closed repeatedly according to claim 1, wherein the releasable connecting member is nearly cylindrical, and at least one slot extending from the distal end to the proximal end is provided on the side wall to form the The expandable structure, so that when the expansion actuating member moves proximally and abuts against the side wall, the slot expands, and the distal end of the releasable connecting member is moved by the clip The outer wall of the proximal end of the seat is detached, releasing the clamp seat.
The medical device that can be opened and closed repeatedly according to claim 8, wherein 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.
The reopenable and closable medical device according to claim 1, wherein the releasable connection member comprises: the substantially tubular releasable connecting member is formed by at least two expansion sheets extending in the axial direction and spaced apart from each other. Expansion structure; 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 when the distal end of the expansion piece receives the proximal end of the expansion actuation component, The positioning ring surrounding the outer wall of the expansion sheet base can be expanded outward to release the clamp base.
The medical device that can be opened and closed repeatedly according to claim 10, wherein the outer wall of the distal end of the expansion piece is provided with an expansion groove extending in the circumferential direction to accommodate the elastic return surrounding the expandable structure. Shrinking ring.
The medical device that can be opened and closed repeatedly according to claim 10, wherein the distal end of the expansion piece base is provided with a card slot fixedly combined with the distal end of the expansion piece, and the expansion piece and the expansion piece base A continuous fixing groove extending in the axial direction is provided on the outer wall of the seat to accommodate the positioning ring.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the expandable structure is made of an elastically deformable material and can be restored after removing the compressive force.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the expansion actuating member is an inverted part that is sheathed at the distal end of the control wire and gradually decreases from far to near in the axial direction. A frustum structure, the inner wall of the expandable structure in the release connecting part is provided with an expansion boss,

When the control wire moves to the proximal end, the expansion actuating component is driven to move to the proximal end and abuts against the expansion boss to drive the expandable structure to expand radially on the distal side.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the expansion actuation component is a slider structure sheathed at the distal end of the control wire, and the slider structure is spherical Or cylindrical; the inner wall of the expandable structure in the release connecting member is in the shape of a funnel whose distance from the central axis gradually decreases from far to near,

When the control wire moves to the proximal end, the expansion actuating component is driven to move proximally and abuts against the inner wall of the expandable structure to drive the distal end of the expandable structure to expand radially.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the proximal end of each clamping leg is pivotally connected by an actuating pin, and the distal end of the control wire 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 the clamping leg is actuated to open or close through the cam structure.
The medical device that can be repeatedly opened and closed according to any one of claims 1-12, wherein the proximal end of the clamp leg has a hook, and in the locked and closed state, the clamp is locked with the locking boss on the inner wall of the proximal end of the clamp base. Together.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the distal end of the control wire has a step structure, and when the control wire moves toward the proximal end, the step structure and the The distal end surface of the expansion actuation member abuts to drive the expansion actuation member to move proximally.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein a transition tube is provided between the proximal end of the releasable connecting member and the distal end of the outer sleeve, and the transition tube is provided with There is a return spring which is engaged with the expansion actuation part and provides elastic force for resetting the expansion actuation part.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the control wire has at least two regions, and the distal end of the control wire is wound by a multi-strand steel wire. The end is made of single-strand steel wire.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the distal end of the releasable connecting member has a snap key, and the outer wall of the proximal end of the clip base is provided with a snap in the circumferential direction. In a natural state, the engaging key is located in the engaging groove to realize the engagement of the clip base and the releasable connecting member, and the engaging key is preferably perpendicular to the central axis of the releasable connecting member extend.
The medical device that can be opened and closed repeatedly according to any one of claims 1-12, wherein the outer tube has a double-layer structure formed by a gap between the outer tube and the inner tube, and the inner tube is of low friction The coefficient is made of polymer material.