A medical device that can be opened and closed repeatedly

Abstract

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 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

Technical Field

[0001] The invention relates to a device for closing tissues, belonging to a medical device used in human body. Background Art

[0002] Among the existing medical devices used for tissue closure in the human body, releasable tissue closure clips are commonly used devices, which deliver the clip body to the position to be closed in the human body through a delivery device, close the clip through an actuating line, and through self-locking or other locking clip bodies, the clip body is retained in the body after clamping the tissue and closing and locking, thereby achieving tissue closure. How to achieve a quick and effective release process is the key point for the safe and effective use of such devices, and it is also the difficulty of structural improvement.

[0003] The existing patent CN103989500A discloses that the clamp assembly includes a clamp assembly and a clamp seat, and the release components connected to the clamp seat include a transition cap, a connector, a buckle, a claw and other components. The sleeve structure between the components is relatively complex, and the claw needs to be precisely matched with the hole at the proximal end of the clamp seat, and the assembly manufacturing process is relatively difficult. The document EP1328199B1 discloses a variety of ways in which the outer sheath tube of the locking clamp arm and the connecting tube can be releasably connected, and in the various ways adopted, there is sliding friction between the connecting tube and the outer sheath tube during the release process, that is, when the connecting tube is separated from the outer sheath tube, the connecting tube needs to overcome the friction between it and the outer sheath tube to achieve release. This separation principle leads to poor smoothness in the process of closing the clamp assembly, and the operator needs to exert greater pulling force to achieve the release of the clamp during the release process. Correspondingly, there will be greater difficulties in the assembly process.

[0004] In view of this, the present invention is proposed. Summary of the invention

[0005] Based on the technical problems existing in the prior art, such as the structure is relatively complex and difficult to assemble, or the hand feeling is not smooth enough and the operation is inconvenient, the present invention provides a tissue closure device that can be repeatedly opened and closed with a simple structure and a better hand feeling, comprising:

[0006] A closing clamp having at least two clamping legs whose distal ends can be opened or closed; a clamp seat, the proximal ends of the clamping legs being pivotally connected to the clamp seat via a positioning pin; a control line, the distal end of which is connected to the proximal ends of the clamping legs to drive the closing clamp to open or close; an outer sleeve, which is sleeved on the outside of the control line; an actuator, which is fixedly connected to the proximal end of the control line and drives the control line to move by moving the actuator; and also includes a releasable connecting component, which has a generally tubular structure and a radially expandable structure on its distal side, the distal end of the expandable structure being 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.

[0007] Furthermore, the closing clamp has two clamping legs arranged opposite to each other, and the proximal end of each clamping leg has a sliding groove for accommodating the positioning pin shaft, and the sliding groove has at least a first zone at the proximal end and a second zone at the distal end, and the first zone and the second zone have a certain angle, thereby defining: when the positioning pin shaft moves in the first zone, the two clamping legs can be repeatedly opened or closed, and when the positioning pin shaft 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 shaft, and when the driving force applied by the actuator toward the proximal end is greater than the threshold value, the positioning pin shaft enters the second zone from the first zone.

[0008] Furthermore, 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.

[0009] Furthermore, 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.

[0010] Furthermore, the locking protrusion is located on the inner wall of the slide groove close to the closed anastomosis line of the clamping legs.

[0011] Furthermore, 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.

[0012] Furthermore, the clamping leg is integrally formed, and has a clamping portion at the distal end for clamping tissue and a movable portion that can be received in the clamping seat, and the slide groove is located at the movable portion.

[0013] Furthermore, the releasable connecting component is nearly cylindrical, and at least one groove extending from the distal end to the proximal end is provided on the side wall to form the expandable structure, so that when the expansion actuator moves proximally and abuts against the side wall, the groove expands, and then the distal end of the releasable connecting component is detached from the proximal outer wall of the clamp seat, releasing the clamp seat.

[0014] Furthermore, four slots extending from the distal end to the proximal end are preferably formed at equal intervals on the side wall of the releasable connecting component.

[0015] Furthermore, the releasable connecting component includes: a roughly 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 when the distal end of the expansion piece is subjected to the proximal pressure force of the expansion actuator component, it can expand outward around the positioning ring of the outer wall of the expansion piece base, thereby releasing the clamp seat.

[0016] Furthermore, an outer wall on the distal end side 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.

[0017] Furthermore, a slot fixedly coupled to the distal end of the expansion piece is provided at the distal end of the expansion piece, and a continuous fixing groove extending axially is provided on the outer walls of the expansion piece and the expansion piece base to accommodate the positioning ring.

[0018] Furthermore, the expandable structure is made of an elastic deformable material and can recover after the compressive force is removed.

[0019] Furthermore, the expansion actuation component is an inverted cone structure which is sleeved on the distal end of the control line and gradually decreases axially from far to near. The inner wall of the expandable structure in the release connection component is provided with an expansion boss. 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 side of the expandable structure to expand radially.

[0020] Furthermore, 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 release connection component is funnel-shaped, and the distance from the central axis gradually decreases from far to near. 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 side of the expandable structure to expand radially.

[0021] Furthermore, 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.

[0022] Furthermore, the proximal end of the clamp leg has a hook, which is engaged with a locking boss on the inner wall of the proximal end of the clamp seat in a locked and closed state.

[0023] Furthermore, 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 actuation component to drive the expansion actuation component to move toward the proximal end.

[0024] Furthermore, a transition tube is provided between the proximal end of the releasable connection component and the distal end of the outer sleeve, and a return spring is provided in the transition tube, which engages with the expansion actuation component and provides elastic force to return the expansion actuation component.

[0025] Furthermore, 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.

[0026] Furthermore, 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. In a natural state, the snap-fit ​​key is located in the snap-fit ​​groove to achieve engagement between the clamp seat and the releasable connecting component, and the snap-fit ​​key preferably extends perpendicularly to the central axis of the releasable connecting component.

[0027] Furthermore, the outer sleeve has a double-layer structure formed by an outer tube and an inner tube being overlapped with each other, and the inner tube is made of a polymer material with a low friction coefficient.

[0028] Based on the above technical solution, the present invention has the following advantages:

[0029] 1. The releasable connection structure of the existing clamp assembly is optimized. The components for releasing the repeatable opening and closing device described in the present invention only include a radially expandable releasable connection component and an expansion actuating component sleeved on the far end of the control line. The structure is simpler and the corresponding assembly process is more convenient.

[0030] 2. In the present invention, during the release process of the clamp seat, there is no sliding friction between the clamp seat and the releasable connecting component. When the releasable connecting component is radially expanded under the drive of the expansion actuator component, the clamp seat is immediately released. The whole process does not need to overcome the blockage caused by sliding friction, and has a better operating feel.

[0031] 3. Based on the release structure of the present invention, the clamp assembly has the advantages of smooth feel and reliable locking of the pivotally connected clamp arm structure, as well as the advantages of simple structure and low release resistance of the radial release structure. Compared with the prior art, the present invention effectively solves the problem of actuating and locking the two clips under the pivotal connection. Compared with the existing U-shaped clamps that rely on their own elastic bending (such as the elastic biased clamp assemblies produced by Olympus and Boston Scientific), how to achieve a series of key operations such as actuation, clamping, locking, and release of the two pivotally connected clips is a technical point that is difficult to design and overcome in this field. The present invention cleverly solves the problem through the radial release structure and realizes the rapid and smooth release of the clamp assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 is an overall view of the re-openable and re-closable closing device in the first embodiment;

[0033] Figure 2 A stereoscopic view of the distal end of a closure device that can be opened and closed repeatedly;

[0034] Figure 3 A three-dimensional view of a releasable connecting component;

[0035] Figure 4 It is a side view of the closed clamp;

[0036] Figure 5 This is an enlarged view of the closed clip slide section;

[0037] Figure 6 This is an enlarged view of the proximal end of the clamp seat in the closed clamp locked state;

[0038] Figure 7 It is a side view of the legs being clamped;

[0039] Figure 8 It is a side view of the closed clip in the open state;

[0040] Fig. 9 This is a partial enlarged view of the part connected to the control line when the closing clip is in the open state;

[0041] Fig.10 A three-dimensional view of the clamp seat;

[0042] Fig.11 A partial cross-sectional view of a transition pipe of a closure device that can be opened and closed repeatedly;

[0043] Fig.12 A perspective view of the distal end of the re-openable and re-closable closure device in the second embodiment;

[0044] Fig.13 A stereoscopic view of the distal end of the releasable connecting component of the re-openable and re-closable closing device in the second embodiment in an expanded state;

[0045] Fig.14 An enlarged view of the distal end of the releasable connecting component in the second embodiment;

[0046] Fig.15 A stereoscopic view of the distal end of the releasable connecting component in the second embodiment in an expanded state;

[0047] Fig.16 It is a schematic diagram of the assembly of the control wire and the expansion actuation component;

[0048] Fig.17 It is a schematic diagram of the connection between the control line and the expansion actuation component;

[0049] Fig.18 It is a schematic diagram of the connection between the control line and the expansion actuation component;

[0050] Fig.19 It is a schematic diagram of the connection between the control line and the expansion actuator component.

[0051] Description of reference numerals:

[0052] 1-closing clamp, 11-clamping leg, 12-clamping portion, 13-movable portion, 14-first zone, 15-second zone, 16-locking protrusion, 17-hole-shaped portion, 18-clamping leg tail hole, 19-hooking, 2-clamping seat, 21-positioning pin, 22-actuating pin, 23-positioning pin hole, 24-U-shaped notch, 25-guide groove, 26-engaging groove, 27-locking boss, 3-releasable connecting component, 31-expandable structure, 32-slot, 33-engaging key, 3'-releasable Connecting component, 31'-expansion piece, 32'-expansion piece base, 33'-expansion groove, 34'-ring, 35'-positioning ring, 36'-fixing groove, 37'-clamping key, 4-outer sleeve, 41-transition tube, 42-reset 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 actuating component, 56-proximal guide part, 57-distal surface, 6-handle, 7-actuator DETAILED DESCRIPTION

[0053] The technical contents of the present invention are described in detail with reference to the accompanying drawings and specific embodiments.

[0054] The embodiments of the present invention will be described in detail below with reference to examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be construed as limiting the scope of the present invention.

[0055] Some terms involved in the present invention are explained. The proximal end refers to a section close to the operator outside the body; the distal end refers to an end of the tissue to be closed inside the body; the axial direction refers to the longitudinal direction extending along the control line; the radial direction refers to the direction extending perpendicular to the axial direction; the circumferential direction refers to the circumferential direction around the axial direction; the locked state, each clamp leg is in a closed state and is irreversibly locked by the clamp seat; the threshold value refers to the value of the force when the releasable connecting component is separated from the clamp seat after the closing clamp is in the locked closed state; the closed anastomosis line, the longitudinal center line of each clamp leg in the closed anastomosis state.

[0056] Figure 1-11 The first embodiment of the present invention is shown, wherein: Figure 1 FIG. 2 is an overall view of the re-openable and re-closable tissue closure device of the first embodiment. Figure 1 As shown, the tissue closure device that can be repeatedly opened and closed comprises: a closing clamp 1, which has two clamp legs 11 whose distal ends can be relatively opened or closed; a clamp seat 2, the proximal ends of the clamp legs 11 are pivotally connected to the clamp seat 2 through a positioning pin shaft 21 fixed to the distal end of the clamp seat 2, and when the closing clamp 1 is in a closed state, the proximal ends of the clamp legs 11 are received in the clamp seat 2; a control line 5, the distal end of which is pivotally connected to the proximal ends of the clamp legs 11 through an actuating pin shaft 22, and then the closing clamp 1 is driven to open or close by pulling the control line 5; an outer sleeve 4, which is sleeved on the outside of the control line 5, and is used to protect the control line and A support for the axial movement of the control line, wherein the distal end side of the outer sleeve can rotate relative to the proximal end side, and the proximal end side is connected to the handle; an actuator 7, which is fixedly connected to the proximal end of the control line 5, and drives the control line 5 to move by moving the actuator 7 axially back and forth; a handle 6, which is fixedly connected to the proximal end of the outer sleeve 4, and limits the displacement of the actuator 7 along the axis, wherein the proximal end of the control line 5 has a step tube to engage with the step of the inner wall of the distal end of the handle, and the outer shape of the step tube at the proximal end of the control line is a non-circular special-shaped structure to achieve the transmission of the rotational torque applied by the handle.

[0057] like Figure 2-3As shown in Figures 11, the re-openable and reclosable tissue closure device further comprises a releasable connecting component 3, which has a generally tubular structure, the proximal end of which is connected to the outer sleeve 4, and the distal end of which has a radially expandable structure 31, the distal end of which is engaged with the outer wall of the proximal end of the clamp seat 2; the distal end of the control line 5 is provided with an expansion actuation component 55, when the control line 5 is pulled toward the proximal end, the expansion actuation component 55 abuts against the inner wall of the expandable structure 31 and provides a driving force for the radial expansion of the expandable structure 31, and drives the distal end of the expandable structure 31 to expand radially, thereby releasing the clamp seat 2. The expandable structure 31 is made of an elastically deformable material, so that the shape can be restored after the compressive force provided by the expansion actuation component 55 is removed. In addition, in this embodiment, the distal end of the releasable connecting component 3 has a snap key 33, and the proximal outer wall of the clamp seat 2 is provided with a snap groove 26 along the circumferential direction. In the natural state, the snap key 33 is located in the snap groove 26 to realize the engagement between the clamp seat 2 and the releasable connecting component 3. The snap key 33 preferably extends vertically to the central axis of the releasable connecting component 3.

[0058] In this embodiment, during operation, when the actuator 7 of the control line 5 sliding on the upper limit of the handle 6 moves backward relative to the core rod of the handle 6, the outer sleeve 4 is fixed on the core rod of the handle 6 and plays a role in supporting the control line 5 backward, so as to force the distal end of the control line 5 to break or deform, or the proximal actuating pin 22 to deform or break, so that when the distal end of the control line is separated from the actuating pin 22, the lateral pressure force generated by the expansion actuating component 55 when the control line 5 moves backward is used to open the expandable structure 31. At this time, the snap-in key 33 at the distal end of the expandable structure 31 is separated from the snap-in groove 26 circumferentially arranged on the outer wall of the proximal end of the clamp seat, so that the closing clip 1 is separated from the releasable connecting component 3, and then retained in the body. During operation, when the handle 6 rotates, the torque generated can be transmitted forward through the control line 5. Since the snap-in groove 26 on the proximal outer wall of the clamp seat 2 is in clearance with the snap-in key 33 at the distal end of the expandable structure 31, the axial direction cannot move forward and backward, but the rotational movement around the axial direction can be achieved.

[0059] Based on the above design, the operator only needs to pull the control line 5 toward the proximal end to put the closing clip 1 in a locked closed state, and when the pulling force is greater than a threshold, the expandable structure 31 is compressed and expanded by the expansion actuating component 55, and the clamp seat can be released. Not only is the structure simple, but there is no sliding friction in the entire release process, and the operation feels smoother, which greatly improves the user's convenience. Compared with the existing self-closing clip release structure, the biggest improvement and innovation of the present invention is that it effectively combines the radial expansion release structure with the clip assembly connected by the pivot, which not only retains the advantages of the simple structure and fast release of the radial expansion release component, but also retains the advantages of the pivot-combined clip assembly such as frictionless and smooth feel. Specifically, in the prior art, the clamp assembly can be divided into a self-closing clamp made of metal material (such as patent document EP1328199B1) and a pivotally connected clamp similar to the structure of a biopsy forceps (such as patent document CN103989500A). The former relies on the elastic memory effect of the clamp itself to be in a normally closed state when not subject to external force. Therefore, there is no need to consider the release process and the linkage between the clamp closure when designing the release structure. However, this type of clamp has defects such as uncontrollable holding force caused by self-closing and difficulty in designing the opening clamp structure. The pivotally connected clamp has a design difficulty because the connection between the pivot structure and the control line is a design difficulty. The conventional solution of technical personnel in this field is to design the clamp seat or outer sleeve of the fixed clamp assembly as a cylindrical structure with a fixed clamping channel to meet the relatively stable open or closed position of the clamp assembly. However, it is difficult to imagine and difficult to achieve that the clamp seat or outer sleeve that plays a fixing and limiting role is designed to be radially deformable. The researchers and developers of the present invention have continuously explored and experimented during the tests, and innovatively combined the radial expansion support and the pivotally connected clamp assembly. Through the above-mentioned specific structural design method, a tissue closure device that can be opened and closed repeatedly with simple structure and better operating feel is realized.

[0060] Next, based on Figure 2-3 The specific structure of the releasable connection component 3 in this embodiment is further described. The releasable connection component 3 is a cylindrical structure with a central channel, and four slots 32 extending from the distal end to the proximal end are evenly spaced on its side wall, thereby forming an expandable structure 31 that can expand outward on the distal side, so that when the expansion actuator 55 moves toward the proximal end and abuts against the inner side wall of the expandable structure 31, the slot 32 is expanded under the driving force of the pressure force, and the snap-in key 33 on the distal side of the expandable structure 31 is disengaged from the snap-in groove 26 on the proximal outer wall of the clamp seat, thereby releasing the clamp seat. 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 achieve the expansion of the expandable structure 31.

[0061] based on Figure 4-9The specific structure of the closing clamp 1 and the clamp seat 2 in the first embodiment is described. In the present invention, the closing clamp 1 preferably has two clamp legs 11 arranged opposite to each other, and the proximal end of each clamp leg 11 has a slide groove for accommodating the positioning pin 21, and the slide groove has a first area 14 at the proximal end and a second area 15 at the distal end. The first area 14 and the second area 15 have an angle, and the size of the angle is designed to control the maximum opening angle between the clamp legs. The first and second areas define that when the positioning pin 21 moves in the first area 14, the two clamp legs 11 can be repeatedly opened or closed, and when the positioning pin 21 enters the second area 15, the two clamp legs 11 form a locked closed state. Among them, the intersection of the first area 14 and the second area 15 has a locking protrusion 16, so that the inner diameter of the slide groove here is smaller than the diameter of the positioning pin 21. When the driving force applied by the actuator 7 toward the proximal end 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 area 14. In this embodiment, the center line of the first area 14 moves away from the clamp leg closure anastomosis line from the proximal end to the distal end, and the center line of the second area 15 is parallel to the clamp leg closure anastomosis line A, so that when the positioning pin 21 moves in the first area 14, the two clamp legs 11 can be repeatedly opened or closed, and when entering the second area 15, the two clamp legs can be tightly closed. In this embodiment, Figure 7 As shown, the locking protrusion 16 is located on the inner wall of the slide groove near the side of the clamp leg closing anastomosis line A, and the locking protrusion 16 has a hole-shaped portion 17. When the locking protrusion 16 is pressed by the positioning pin shaft 21, the hole-shaped portion 17 is compressed and deformed, the inner diameter of the slide groove at the inflection point increases, and the positioning pin shaft 21 enters the second area 15.

[0062] In addition, the clamping legs 11 are preferably an integrally formed structure, which has a clamping portion 12 at the distal end for clamping tissue and a movable portion 13 that can be received in the clamp seat 2, and the slide groove is located at the movable portion 13. Each clamping leg 11 has a clamping leg tail hole 18 at the proximal end, and the actuating pin 22 passes through the clamping leg tail hole 18, so that each clamping leg is pivotally connected through the actuating pin 22, and at the same time, the control line 5 has a closed hole structure 54 at the distal end, and the closed hole structure 54 is also pivotally connected to the actuating pin 22, and then the two clamping legs 11 are driven to open or close relative to each other in the process of pulling the control line 5 through the cam structure at the tail of the clamping leg. Among them, the closed hole structure 54 at the distal end of the control line 5 can also be replaced by a hook structure. In the process of locking the closed clamp 1, the hook structure or the closed hole structure 54 at the distal end of the control line 5 breaks or deforms to achieve separation from the actuating pin 22, or the actuating pin 22 deforms or breaks and then separates from the distal structure of the control line 5. In addition, the clamp leg tail hole 18 at the clamp leg tail end may be circular or oblong to achieve pivotal connection.

[0063] like Figure 6As shown, the proximal ends of the two clamping legs 11 of the closing clamp 1 are provided with hooks 19. After the control line moves toward the proximal end to drive the two clamping legs to close, the hooks 19 engage with the locking bosses 27 on the proximal inner wall of the clamp seat 2, thereby forming a locked closed state, and the clamping legs 11 cannot be opened again.

[0064] In this embodiment, in order to make the control line 5 better transmit torque and the front end have a compliant performance so as to smoothly pass through the endoscope channel, the control line 5 can be composed of multiple segments, wherein the distal end 51 is wound by multiple strands of steel wire, and the proximal end 53 is made of a single strand of steel wire and has a 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 at both ends. Further, the outer sleeve 4 is provided with a polymer plastic tube for controlling the gap and reducing friction. Preferably, the outer sleeve 4 has a double-layer structure formed by overlapping the gap between the outer tube and the inner tube, and the inner tube is made of a polymer material with a low friction coefficient.

[0065] like Fig.10 The specific structure of the clamp seat shown is that the clamp seat 2 has a U-shaped structure, which has a U-shaped groove 24 for accommodating the clamp leg 11 and a positioning pin shaft hole 23 for fixing the distal pin shaft, the proximal inner wall has a guide groove 25 for constraining the actuating pin shaft 22, and the proximal end outer wall has a snap-fit ​​groove 26 that can be detachably engaged with the snap-fit ​​key 33 on the distal side of the expandable structure 31.

[0066] like Fig.11 The preferred outer sleeve structure shown in the figure has a transition tube 41 between the proximal end of the releasable connection component 3 and the distal end of the outer sleeve 4. A reset spring 42 is provided in the transition tube 41, and the reset spring can be fixedly engaged or abutted with the proximal end surface of the expansion actuation component 55 sleeved on the outside of the control line 5, with the purpose of providing elastic force to reset the expansion actuation component 55 to the distal end, so as to ensure that after eliminating the pulling force of the control line to the proximal end, the expansion actuation component 55 is restored to the distal end of the releasable connection component 3 under the action of the reset spring, thereby eliminating the compressive force that causes the expandable structure 31 to expand outward, and the expandable structure 31 is restored to its original natural state by its own elasticity. By adopting the reset spring, the releasable connection component 3 can be restored to its initial state in the shortest time.

[0067] like Figure 12-15In the second embodiment shown, the structure of the releasable connection component 3 in the first embodiment is changed. In this embodiment, the releasable connection component 3' comprises: a substantially tubular expandable structure formed by four expansion pieces 31' extending in the axial direction and arranged at intervals from each other; and an expansion piece base 32', wherein the proximal end of each expansion piece 31' is fixedly engaged with the distal end of the expansion piece base 32', so that when the distal end of the expansion piece 31' is pressed toward the proximal end by the expansion actuation component 55, the positioning ring 35' around the outer wall of the expansion piece base 32' can be expanded outward, thereby releasing the clamp seat 2. The outer wall of the distal end of the expansion piece 31' is provided with a circumferentially extending 33' to accommodate an elastically retractable annular member 34' surrounding the expandable structure. The distal end of the expansion piece base 32' is provided with a slot fixedly coupled to 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 axially extending fixing groove 36' to accommodate the positioning ring 35'. At the same time, the distal side outer wall of the expansion piece 31' is provided with a circumferentially extending expansion groove 33' to accommodate an elastically retractable ring member 34' surrounding the expandable structure.

[0068] In this embodiment, during operation, when the control line 5 moves backward, the expansion actuating component 55 generates a lateral compressive force. At this time, the proximal end of the expansion piece 31' is tightly connected to the expansion base 32' under the tightening action of the positioning ring 35', and the distal end of each expansion piece 31' is subjected to the lateral compressive force, the elastically retractable annular member 34' expands, and each expansion piece 31' expands outward with the positioning ring 35' as the axis, thereby realizing the separation of the closing clip 1 and the releasable connecting component 3', so that the closing clip 1 is retained in the body.

[0069] like Figure 16-17 In the configuration structure diagram of the control line 5 and the expansion actuation component 55 shown in the figure, the expansion actuation component 55 is an inverted cone structure which is sleeved on the distal end of the control line 5 and gradually decreases in axial direction from far to near. The inner wall of the expandable structure 31 in the releasable connection component 3 is provided with an expansion boss 38. When the control line 5 moves toward the proximal end, the expansion actuation component 55 is driven to move toward the proximal end and abut against the expansion boss 38 to drive the expansion of the distal side of the expandable structure 31 to expand radially. In addition, the distal end of the control line 5 has a step structure. When the control line 5 moves toward the proximal end, the step structure abuts against the distal end surface of the expansion actuation component 55 to drive the expansion actuation component 55 to move toward the proximal end.

[0070] like Figure 18-19 In the configuration structure diagram of another preferred control line 5 and expansion actuator component 55 shown in the figure, the structure of the expansion actuator component 55 can be replaced with a cylindrical or spherical shape, and the inner wall of the expandable structure 31 in the releasable connecting component 3 is in a funnel shape with the distance from the central axis gradually decreasing from far to near. When the control line 5 moves toward the proximal end, it drives the expansion actuator component 55 to move toward the proximal end and abut against the inner wall of the expandable structure 31 to drive the distal side of the expandable structure 31 to expand radially.

[0071] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A medical device that can be opened and closed repeatedly, include: A closing clamp having at least two clamp legs whose distal ends can be opened or closed; A clamp seat, the proximal end of the clamp leg is pivotally connected to the clamp seat via a positioning pin; 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; An outer sleeve, sleeved on the outside of the control line; an actuator fixedly connected to the proximal end of the control line, and driving the control line to move by moving the actuator; Features: 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; 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; 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; 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. The re-openable and re-closable medical device according to claim 1, Features: The closing clamp has two clamp legs arranged opposite to each other, and the proximal end of each clamp leg has a slide groove for accommodating the positioning pin shaft, and the slide groove has at least a first area at the proximal end and a second area at the distal end, and 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, 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. The re-openable and re-closable medical device according to claim 2, Features: 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. The re-openable and re-closable medical device according to claim 2, Features: A locking protrusion is provided on the inner wall of the slide groove at the intersection of the first zone and the second zone. 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. The re-openable and re-closable medical device according to claim 4, Features: The locking protrusion is located on the inner wall of the slide groove close to the closed anastomosis line of the clamping legs.

6. The re-openable and re-closable medical device according to claim 4, Features: The locking protrusion has a hole-shaped portion. 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. The re-openable and re-closable medical device according to claim 2, Features: The clamping leg is integrally formed, and comprises a clamping portion at the distal end for clamping tissue and a movable portion that can be received in the clamping seat, and the slide groove is located at the movable portion.

8. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The expandable structure is made of elastically deformable material and can recover after the compressive force is removed.

9. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The expansion actuation component is an inverted cone 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; 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. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: 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 the distance from the central axis gradually decreasing from far to near; 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. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The proximal ends of the clamping legs are pivotally connected via an actuating pin, and 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. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The proximal end of the clamp leg is provided with a hook, which is engaged with a locking boss on the inner wall of the proximal end of the clamp seat in a locked and closed state.

13. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The distal end of the control line has a step structure. When the control line moves toward the proximal end, the step structure abuts against the distal end surface of the expansion actuation component to drive the expansion actuation component to move toward the proximal end.

14. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: A transition tube is provided between the proximal end of the releasable connection component and the distal end of the outer sleeve. A return spring is provided in the transition tube, which engages with the expansion actuation component and provides elastic force for returning the expansion actuation component to its original position.

15. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The control line has at least two regions, the distal end of the control line is wound with multiple steel wires, and the proximal end is made of a single steel wire.

16. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The distal end of the releasable connecting component has a snap-in key, and the proximal outer wall of the clamp seat is provided with a snap-in groove along the circumferential direction. In a natural state, the snap-in key is located in the snap-in groove to achieve engagement between the clamp seat and the releasable connecting component.

17. The reclosable medical device according to claim 16, Features: The snap-fit ​​key extends perpendicularly toward the central axis of the releasable connection component.

18. The re-openable and re-closable medical device according to any one of claims 1 to 7, Features: The outer sleeve has a double-layer structure formed by overlapping an outer tube and an inner tube, and the inner tube is made of a polymer material with a low friction coefficient.

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