WO2021249174A1 - 一种止血夹和保险机构 - Google Patents

一种止血夹和保险机构 Download PDF

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Publication number
WO2021249174A1
WO2021249174A1 PCT/CN2021/095591 CN2021095591W WO2021249174A1 WO 2021249174 A1 WO2021249174 A1 WO 2021249174A1 CN 2021095591 W CN2021095591 W CN 2021095591W WO 2021249174 A1 WO2021249174 A1 WO 2021249174A1
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WO
WIPO (PCT)
Prior art keywords
release
clip
proximal
distal
radial
Prior art date
Application number
PCT/CN2021/095591
Other languages
English (en)
French (fr)
Inventor
金鸿雁
李常青
沈正华
宋冉
马小军
胡洁
Original Assignee
南微医学科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202010537738.7A external-priority patent/CN111544075A/zh
Priority claimed from CN202021094622.2U external-priority patent/CN214157434U/zh
Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to DE112021001209.6T priority Critical patent/DE112021001209T5/de
Publication of WO2021249174A1 publication Critical patent/WO2021249174A1/zh

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

Definitions

  • the present disclosure relates to a hemostatic clip used in tissue closure for minimally invasive surgery, and belongs to the field of medical devices.
  • the existing hemostatic clip is fed through the endoscope clamp channel to stop bleeding or clip the wound. It mainly uses the clamp to mechanically compress the blood vessel and surrounding tissues to achieve the purpose of hemostasis and clip.
  • the principle of hemostasis is similar to that of surgical blood vessel suture or ligation. It is a mechanical method and does not cause coagulation, degeneration, and necrosis of mucosal tissue.
  • the local tissue inflammation process forms a granuloma, which falls off by itself and is excreted through the digestive tract. Endoscopic suture surgery has the advantages of less damage, fast hemostasis, low incidence of rebleeding, fewer complications, and definite curative effect.
  • the inventor of the present disclosure has noticed that the hemostatic clip used in the prior art has many technical problems, and there is a lot of room for improvement.
  • the proximal end of the clip is provided with elastic pieces A to achieve the locking of the clip assembly, and because the hemostatic clip is inevitably trapped between the two clips during the use of the hemostatic clip, the use of Due to the inaccurate positioning of the locked hemostatic clip clip body and the expansion of the release aperture, the control line is released in advance, which eventually leads to technical problems such as undesired premature fall off and tissue tearing of the clip before the locked state.
  • adding a pin at the distal end of the clip holder or presetting the distal end of the clip holder between the openings of the clip. Leave bulge and bend.
  • both of these two solutions increase process difficulty and production cost.
  • the clip Since the clip is already in a semi-locked state at this time, on the one hand, it cannot be opened to realize the reselection of the hemostasis position. On the other hand, it is more important to be a doctor.
  • the control wire When the control wire is pulled back again, it is difficult for the fixing seat to accurately guide the clip seat to the locking position of the hemostatic clip due to the detachment or semi-detachment of the clip seat.
  • the clip body excessively enters the clip seat and the control wire is difficult to release from the release hole And other technical problems, resulting in serious consequences such as tissue tearing and inability to release the clip.
  • the present disclosure proposes a hemostatic clip and an insurance mechanism for the hemostatic clip. .
  • the present disclosure provides a hemostatic clip with a handle on the proximal side, a clip assembly on the distal side, a sheath between the handle and the clip assembly, and a control wire in the sheath.
  • the distal end of the sheath has a fixed Seat
  • the control wire has a release portion at the distal end
  • the clip assembly may include:
  • a clamp body which has at least two clamp arms and a transition connecting portion connecting the proximal ends of the at least two clamp arms;
  • the transition connection part may have a release hole, and the release part located on the distal side of the control wire is releasably connected to the release hole,
  • the transitional connection portion may have a radial restricting portion to restrict the expansion of the release hole in the radial direction.
  • the hemostatic clip provided by the present disclosure at least solves the technical problems in the prior art that the clip is difficult to accurately lock and the release member is released in advance.
  • the radial restraint state transitions to the radially expandable state.
  • the transition connecting portion may have a U-shaped plate structure, and the radial restricting portion is located on at least one side of the U-shaped plate.
  • the release hole extends along the bending direction of the U-shaped plate, and the extent of the radial restricting portion extending along the side edge may at least partially overlap with the extent of the release hole.
  • the radial restricting portion may protrude radially from the side edge.
  • one side of the U-shaped plate may have one or more radially protruding radial restricting portions.
  • the radially protruding radial restricting portion may extend in the radial direction, or may be bent or curled toward the proximal side.
  • the proximal end of the clip base may have a notch capable of engaging with the radially protruding radial restricting portion.
  • the fixing seat may have a boss which can abut against the radial restricting portion.
  • the fixing seat may be provided with a safety mechanism, which can restrict the release portion on the distal side of the control wire from moving to the distal side.
  • the safety mechanism may have a through hole through which the control wire release portion can pass, and when the release portion penetrates into the through hole, the through hole can be radially deformed.
  • the proximal end of the release portion can abut against the distal end surface of the safety mechanism.
  • the inner wall of the through hole may have a protrusion that protrudes inward
  • the proximal side of the release portion may have a diameter-reducing portion whose radial width decreases from the proximal side to the distal side, and the diameter-reducing portion The proximal end can abut against the distal end surface of the protrusion.
  • the safety mechanism can be formed separately or integrally formed with the fixing base.
  • the present disclosure also provides a hemostatic clip with a handle on the proximal side, a clip assembly on the distal side, a sheath between the handle and the clip assembly, and a control wire in the sheath.
  • the distal end of the sheath has The fixing seat, the distal end of the control wire has a release part, wherein the clip assembly includes:
  • a clamp body which may have at least two clamp arms, and a transition connecting portion connecting the proximal ends of the at least two clamp arms;
  • the transition connection part may have a release hole, and the release part located on the distal side of the control wire is releasably connected to the release hole,
  • the hemostatic clip has:
  • the transitional connection portion may have a radial restricting portion.
  • the radially inward restriction is provided by the internal passage of the clip holder to restrict the expansion of the release hole in the radial direction, Transition until the radial restricting portion abuts against the fixing seat, thereby forming a mechanical feedback of the release position.
  • the proximal side of the fixing seat may be provided with a safety mechanism, and when the control wire moves to the distal side, the release portion on the distal side of the control wire abuts against the safety mechanism so that the safety mechanism provides Mechanical feedback of the thrust position that restricts the control line from moving distally.
  • the present disclosure has at least the following technical effects:
  • tissue is often embedded in the clamp assembly of the hemostatic clip, which may cause the clip to fall off or tear and other technical problems.
  • the inventor added a radial restriction at the proximal end of the clip.
  • the technical problem of early release of the control line has been subtly solved, ensuring that the clamp assembly will not be prematurely separated from the control line before being locked. Effective control to avoid technical problems such as tissue tearing and inaccurate clip positioning.
  • the present disclosure also provides an insurance institution, which is characterized in that the insurance institution may have:
  • the main body and
  • the safety mechanism can restrict the movement of the release portion on the distal side of the control wire to the distal side.
  • the insurance mechanism provided by the present disclosure at least solves the technical problems of tissue tearing and inability to release the clip due to the existence of the hemostatic clip in the prior art.
  • the through hole can be deformed at least in the radial direction.
  • the proximal end of the release portion can abut against the distal end surface of the safety mechanism.
  • the inner wall of the through hole may have a protrusion protruding inward, and the proximal end of the release portion may abut against the distal end surface of the protrusion.
  • the radial section shape of the protrusion may be selected from one or more of the following ways: straight line segment, bending line segment with at least one inflection point, circular arc line segment, and spiral line segment.
  • the tip side of the protrusion may have at least one inflection point, and the inflection point has an arc-shaped chamfer structure.
  • the outer periphery of the distal end surface of the insurance mechanism may be round or regular polygon with arc-shaped chamfers.
  • the proximal side of the release portion may have a diameter reducing portion whose radial width decreases from the proximal side to the distal side, and the proximal end of the diameter reducing portion can abut against the distal end surface of the safety mechanism .
  • the outer peripheral surface of the diameter reducing portion can be selected from the following manners: a tapered surface whose radial distance gradually decreases from the proximal side to the distal side, and a radial distance whose gradient decreases from the proximal side to the distal side.
  • the present disclosure also provides a hemostatic clip with an insurance mechanism, including:
  • At least two clamping arms At least two clamping arms
  • a clamp base, the clamp arm can move relative to the clamp base between an open configuration and a closed configuration
  • the proximal side of the fixing seat is provided with the above-mentioned safety mechanism.
  • the safety mechanism can be formed separately or integrally formed with the fixing base.
  • the proximal surface of the safety mechanism may have a sheath tube abutment portion supporting the distal surface of the sheath tube.
  • Figure 1 is a view of the clamp structure in the prior art
  • Figure 2 is an overall view of the hemostatic clip in the present disclosure
  • Figure 3 is a cross-sectional view of the hemostatic clip clip assembly of the present disclosure
  • Figure 4 is a three-dimensional view of the clip body in an expanded state in the present disclosure
  • Figure 5 is a three-dimensional view of the holder in the present disclosure.
  • Figure 6a is a three-dimensional view of the transition part in the present disclosure.
  • Figure 6b is a side view of the transitional connection in the present disclosure.
  • Figures 7a-7d are examples of alternative structures of the lugs (radial restraints) in the present disclosure.
  • FIG. 8 is a schematic diagram of the force of the clip assembly in the second mechanical feedback state of the present disclosure.
  • FIG. 9 is a schematic diagram of the force of the clip assembly in the first mechanical feedback state of the present disclosure.
  • Figure 10 is a schematic diagram of the structure of the clip assembly of the present disclosure in a released state
  • Figure 11a is a perspective view of an insurance mechanism in another embodiment of the present disclosure.
  • Figure 11b is a side view of the distal end of the insurance mechanism in the embodiment shown in Figure 11a of the present disclosure
  • Figure 12 is a perspective view of an insurance mechanism in another embodiment of the present disclosure.
  • FIG. 13 is a schematic diagram of a radial cross-section of an alternative form of the protruding portion of the insurance mechanism in the present disclosure
  • FIG. 14 is a schematic diagram of the radial end surface of the alternative form of the protruding portion of the insurance mechanism in the present disclosure
  • 15 is a schematic diagram of an alternative form of the outer peripheral contour of the distal end surface of the insurance mechanism in the present disclosure
  • Fig. 16a is a partial view of the control wire releasing part in the embodiment shown in Fig. 3 in the present disclosure
  • Figure 16b is a partial view of an alternative form of the control line release part in another embodiment of the present disclosure.
  • Figure 17 is a schematic diagram of an alternative form of the reducing portion of the releasing portion in the present disclosure.
  • Figure 18 is a partial view of an alternative form of the control line release part of the present disclosure.
  • 19 is a radial cross-sectional view of an alternative method of the radial restricting portion in yet another embodiment of the present disclosure.
  • Fig. 20 is a perspective view of a holder in another embodiment of the present disclosure.
  • the proximal end refers to the end close to the operator outside the body; the distal end refers to the end located in the tissue to be closed in the body; the axial direction refers to the direction along the longitudinal axis of the hemostatic clip control line; the radial refers to the direction perpendicular to the axial direction; Circumferential refers to the circumferential direction along the circumferential axis.
  • the hemostatic clip has a handle 600 located on the proximal side, a clip assembly on the distal side, a sheath 500 located between the handle 600 and the clip assembly 100, and a control wire 400 located in the sheath 500.
  • the sheath The distal end of the tube 500 has a fixing seat 300, and the distal end of the control wire 400 has a release portion 401.
  • the clip assembly includes: a clip body 100, which has two clip arms 101, and a transition connecting portion 102 that connects the proximal ends of the two clip arms 101; Channel, the proximal side of the clip base and the fixing base are releasably connected.
  • the clamp base 200 has a holder 201 on the proximal side, and the holder 300 has an open release chamber 302 toward the distal side.
  • the holder 201 has a clamping groove 3021 between the distal tail and the distal side wall of the release chamber 302 in a natural state.
  • a releasable snap connection When the clip body 100 is in the locked state, the proximal end of the holder 201 is forced to be biased radially outward, and the distal end of the holder 201 is formed by the side wall of the distal end of the release chamber 302.
  • the clamping groove 3021 is released, and the clip body 100 that is finally locked in the clip base 200 after clamping the tissue is released together with the clip base.
  • the transition connecting portion 102 has a release hole 105, and the release portion 401 on the distal side of the control wire 400 is releasably connected to the release hole 105.
  • the proximal end of the control wire 400 is fixedly connected to the slider structure in the handle, and the handle is moved longitudinally.
  • the slider structure in 600 drives the control line 400 to move longitudinally, thereby realizing the transformation of the elastic clip body 100 between the open and closed positions.
  • the control wire 400 continues to move to the proximal side, and the release end 4011 at the distal end of the control wire is released from the release hole 105.
  • a guide piece 104 is provided on the clamp arm 101 of the clamp body, correspondingly A guide groove 202 for accommodating the sliding of the guide piece 104 is provided on the side wall of the holder 200.
  • the transition connecting portion 102 has a U-shaped plate structure (the U-shaped plate structure in this embodiment includes all substantially U-shaped plate-shaped structures, such as V-shaped, ⁇ -shaped, ⁇ type, etc.), on the side 106 of the U-shaped plate, a protruding piece 103 (as a radial restricting part in this embodiment) is respectively arranged radially outward, and the release hole 105 is along the bending direction of the U-shaped plate.
  • the U-shaped plate structure in this embodiment includes all substantially U-shaped plate-shaped structures, such as V-shaped, ⁇ -shaped, ⁇ type, etc.
  • the extent of the protruding piece 103 along the side falls within the extent of the release hole 105, so that when the clip body 100 slides into the inner sliding channel of the clip seat 200, the radially protruding lug 103 can Play a role in restricting the radial expansion of the release hole 105.
  • This design can effectively prevent the release hole 105 from expanding radially due to the undesired entry of part of the tissue between the two clamp arms due to the back and forth drive of the control line, which results in the distal end of the control line when the clamp body 100 is not locked.
  • the release portion 401 is prematurely pulled out of the release hole 105, so that the purpose of clamping the tissue and effectively stopping bleeding cannot be achieved.
  • the premise is that the complexity of the clip structure is not increased too much.
  • the technical problem that the clip body is not locked and falls off due to the tissue being embedded in the clip body in the prior art is cleverly solved.
  • the edge of the protrusion 103 has an arc-shaped chamfer.
  • the radially protruding tab 103 in this embodiment can extend in the radial direction.
  • the tab 103 can have a proximal end.
  • the side (the side facing the handle) is bent or curled, such as the linear pre-bending structure shown in Figure 7a, the circular arc structure shown in Figure 7b, the spiral structure shown in Figure 7c, and the The straight line segment structure extending toward the proximal side in 7d, among which the pre-bending structure in Fig. 7a has better resistance to deformation and better radial confinement capability.
  • the structures with arc-shaped curved surfaces in Figs. 7b and 7c The sliding performance is excellent in the sliding process.
  • the straight line segment structure in Figure 7d is simpler and more practical in the processing process. According to the actual use environment and the holder structure, a suitable structure can be adopted to achieve the best technical effect.
  • the radial restricting part in the present disclosure refers to the part on the side of the transition joint at the proximal end of the clip body that can restrict the expansion of the release aperture.
  • the radial restricting part is designed as The outwardly convex structure is only a preferred embodiment in the present disclosure.
  • a safety mechanism 301 is provided on the proximal side of the fixing seat 300.
  • the safety mechanism 301 has a through hole through which the control wire release portion 401 can pass. When penetrating into the through hole, the through hole can be radially deformed.
  • the safety mechanism 301 functions to restrict the release portion 401 on the distal side of the control wire 400 from moving to the distal side.
  • the safety mechanism 301 has a main body with a through hole through which the release section 401 at the distal end of the control wire 400 passes.
  • the The through hole can be deformed radially.
  • the safety mechanism 301 has three inwardly protruding protrusions 3011 at equal intervals in the circumferential direction.
  • the protrusion 3011 is provided on the inner wall of the main body through hole of the safety mechanism 301; the proximal side of the release portion 401 of the control wire 400 has a diameter reducing portion whose radial width decreases from the proximal side to the distal side. 4012, as shown in Figure 6a.
  • the diameter reducing portion 4012 has a nearly truncated cone structure with a radial cross-sectional length gradually decreasing toward the distal side.
  • the diameter reducing part 4012 can abut against the distal end surface of the safety mechanism.
  • the through hole is deformed at least in the radial direction, and the proximal end of the diameter-reducing portion 4012 moves toward the proximal side and exceeds the proximal end surface of each protrusion 3011, so that the diameter-reducing portion 4012 and each protrusion 3011 are formed between Full and/or barb fit.
  • the diameter reducing portion can abut against the distal end surface of the safety mechanism.
  • the protrusion 3011 in the present disclosure has elasticity. During the specific operation, when the control wire is pulled to the proximal side, the distance between the vertices of the protrusions 3011 is enlarged and changed under the pressure of the reducing portion 4012 at the proximal end of the release portion 401.
  • the diameter portion 4012 After the diameter portion 4012 is pulled until its proximal end surface exceeds the proximal end surface of the protrusion 3011, if the control line is pushed to the distal end again, the maximum radial width of the proximal side of the diameter reducing portion 4012 is greater than that of the protrusions 3011.
  • the minimum radial distance between the top ends of the defined shape to realize that the proximal end of the release part can abut against the distal end surface of the safety mechanism
  • the diameter reducing part 4012 abuts the protruding part 3011, because the flexible control wire is provided to the variable during the pushing process
  • the pushing force of the diameter part to the distal side is difficult to resist the proximal contact force provided by the insurance mechanism to the reducing part, so that the control wire can no longer push the reducing part 4012 distally, and finally realize the safety mechanism 301 pairing Restrictions on the direction of movement of the control line.
  • the purpose of setting up the insurance mechanism is:
  • the doctor when the doctor repeatedly pulls and pushes the control line, it is difficult to accurately determine the locked state of the clip assembly.
  • the clip assembly When the clip assembly is in a semi-locked state that is not completely locked, Although the elastic clip body is not completely locked, it is difficult to expand again due to the large distance into the internal passage of the clip body.
  • the doctor wants to unfold the elastic clip body to reposition the hemostatic site, it is impossible to accurately judge the opening and closing of the clip at that time. Status, the control line will be pushed to the far end again, so that the clip holder is pushed out of the release chamber of the holder.
  • a safety mechanism 301 is added to the proximal end of the fixing base.
  • the clip When the control wire is pulled to the proximal end, the clip is already in a half-locked state, and it is established that the control wire can only be pulled to the proximal end and cannot be moved to the distal side again.
  • the safety mechanism of the one-way movement of the control line solves the technical problems in the prior art that the operator cannot accurately determine the opening and closing state of the clip, which causes the tissue to be torn and the clip body is difficult to release.
  • the tabs 103 on both sides of the transition connecting portion 102 at the proximal end of the clip body 100 In contact with the inner wall of the holder 201 at the proximal end of the clamp base, the elastic holder 201 applies a radially inward pressing force F3 to the protrusion 103.
  • the protrusion 103 applies a reaction force to the holder 201, thereby controlling When the wire gradually moves to the proximal side, the holder 201 is caused to be released from the release chamber 302 of the fixing seat 300.
  • the release end 4011 at the distal end of the control wire abuts against the wall of the release hole 105 at the proximal end of the clip body 100.
  • the release end 4011 provides a pressing force to the wall of the release hole in the direction of the arrow F2 in FIG. Expansion and deformation, so that at this stage, the clip body 100 continues to move to the proximal side along the internal passage of the clip seat under the control of the control wire, and the proximal side of the holder 201 gradually expands radially outward under the pressure of the fin 103.
  • the proximal end of the release portion 401 can abut against the distal end surface of the safety mechanism 301, when the control line moves to the proximal end, the proximal end surface of the reducing portion on the proximal side of the release portion 401 and the distal end surface of the safety mechanism Abut, provide the operator with a mechanical feedback of the abutment position at this time, the operator can know that the control line release part 401 has been in contact with the safety mechanism at this time, and if it is pulled to the proximal end, the safety mechanism will be activated; if you want to unfold the clip again , Reposition the site to be hemostatic, you can move the control line to the distal side again, it can be seen that the operator can clearly understand the shape of the hemostatic clip in the endoscope through mechanical feedback of this abutment position Knowing the relative positional relationship between the control wire release portion 401 and the safety mechanism 301, and then can accurately determine whether the clip can be reopened at this time.
  • the through hole inside the safety mechanism 301 is deformed at least in the radial direction, and the inner wall of the through hole has elastic protrusions.
  • the distance between the tips of the diameter-reducing portion 4012 is enlarged, and the proximal end surface of the reducing portion 4012 is pulled to exceed the proximal end surface of the protruding portion 3011.
  • the abutment function between 3011 enables the insurance mechanism 301 to provide the operator (such as a doctor) with a mechanical feedback of the thrust position that restricts the control line from moving to the distal side, prompts the operator to clamp the body state in time, and ensures that the control line can no longer be moved.
  • the diameter reducing portion 4012 is pushed out to the far side, and finally the restriction of the movement direction of the control wire by the safety mechanism 301 is realized.
  • the protrusions 103 on both sides of the transition connecting portion 102 at the proximal end of the clip body abut against the protrusions 3022 at the bottom of the fixing seat release chamber 302, and the protrusions 103 are removed from the clamping seat.
  • the internal passage 200 provides a radially inward restriction to limit the expansion of the release hole 105 in the radial direction.
  • the protrusion 103 exceeds the proximal surface of the holder 201 of the holder 200 and expands in the radial direction, the protrusion 103 is restricted.
  • a mechanical feedback of the release position is provided to the operator.
  • the operator can learn that the elastic clip body 100 is in the locked state under the mechanical feedback, and the clip assembly can be released from the fixing seat at this time.
  • the boss 3022 at the bottom of the release chamber 302 of the fixing seat provides a supporting force F4 toward the distal side to the tab 103, and at the same time the release end 4011
  • the wall of the release hole 105 is provided with a pressing force in the direction shown in F2 in FIG. Under the combined force of, the aperture of the release hole 105 expands and deforms, which provides a basis for the release end 4011 at the distal end of the control wire to be released from the release hole 105 smoothly.
  • this structure provides abutting support force opposite to the pulling force of the control wire to the radial restricting portion (such as the protrusion in this embodiment). It makes the release hole easier to deform and expand, reduces the difficulty of releasing the control line, and makes it easier to release the hemostatic clip.
  • the clamping arm 101 and the transition connecting portion 102 in the elastic clamping body are integrally formed, and according to actual processing requirements, the transition connecting portion 102 can be manufactured separately and connected to the clamping arm in a manner that can be foreseen by those skilled in the art.
  • the elastic clip body can be repeatedly changed in the expanded and contracted state.
  • the insurance mechanism 301 is a separate component, which is fixed between the fixing base 300 and the sheath 500 by bonding, welding, etc., and according to actual needs or from the viewpoint of simplifying the processing steps, the insurance mechanism 301 can be integrated It is formed on the proximal side of the fixing seat 300 and the end surface that abuts the sheath 500, so as to achieve the technical effect of simplifying the processing steps.
  • U-shaped elastic clip structure is only used as an example in this embodiment to schematically explain the principle of the insurance mechanism.
  • the insurance mechanism described in this disclosure can be applied to any type of clip structure in the field. , Such as 8-shaped elastic clip, pivotal (clip piece and clip seat are connected by a pivot) clip, etc.
  • Figures 11a and 11b show another embodiment according to the present disclosure. As shown in Figures 11a and 11b, this embodiment changes the structure of the insurance mechanism 301 in the embodiment shown in Figure 3.
  • the outer circumference of the distal end of the insurance mechanism 301 is a regular triangle, in order to insert the sheath with the fixing seat
  • the side wall of the channel of the tube is adapted, and the top corners of the triangle are curved and chamfered.
  • the center of the safety mechanism has a through hole 3013, and each radially protruding protrusion 3011 on the inner wall of the through hole 3013 has a bend that deflects toward the proximal side.
  • This structure can make the diameter reducing portion 4012 at the proximal end of the control wire release portion 401 When sliding to the distal side, it passes through the safety mechanism 301 more smoothly, and when the portion with the largest radial length of the reducing portion 4012 exceeds the proximal surface of the protruding portion 3011, it can provide a higher abutment force and prevent it to the greatest extent.
  • the control line moves to the far end again, so as to achieve a better insurance effect.
  • the proximal surface of the insurance mechanism 301 has sheath tube abutting portions 3012 arranged at equal intervals in the circumferential direction. When the insurance mechanism is independently processed, the insurance mechanism has a higher adaptability to the fixing seat and the sheath. , While still being able to obtain the technical effect of a solid connection between the holder and the sheath.
  • Fig. 12 shows yet another embodiment according to the present disclosure.
  • this embodiment changes the structure of the insurance mechanism 301 in the embodiment shown in Fig. 3.
  • the distal end of the safety mechanism has a circular structure, and six protrusions 3011 protruding radially inward are arranged on the inner peripheral wall of the safety mechanism 301 at equal intervals.
  • the protrusions extend radially, and the six protrusions Provides a more reliable limit ability, and better ensures the one-way movement of the control line.
  • the proximal surface of the safety mechanism 301 has a circular end surface that fits with the distal surface of the sheath, so that the proximal and distal surfaces of the safety mechanism 301 fully abut the sheath and the fixing seat, respectively, and the lifting device is stable and reliable.
  • the connection performance to ensure the effectiveness of insurance institutions.
  • a radial groove can be provided on the side wall of the through hole of the safety mechanism. It is also possible to obtain a technology that the through hole can be deformed in the radial direction when the release portion abuts and passes through the through hole. Effect.
  • FIGS. 13 to 15 show alternative structural examples as the structure of the protrusion 3011 in the present disclosure.
  • the radial section shape of the protrusion 3011 can be selected as a radially extending straight line segment as shown in part a in FIG. 13, and as shown in part b in FIG.
  • the arc-shaped line segment that is bent on the proximal side, as shown in Figure 13c, has a curved chamfer at the end of the line segment
  • the line segment as shown in part d in Figure 13 has an arc-shaped segment extending toward the proximal side, as shown in Figure 13
  • the end of the line segment shown in part e has an arc-shaped segment that curves to the distal side and the distal side in sequence, and the end of the line segment shown in part f in FIG.
  • the protrusion 3011 shown in part a in Fig. 13 is easy to process and shape; the friction force between the protrusion 3011 and the control line release part as shown in part b to part d in Fig. 13 is small, and the hand feels more during the pulling process. Smooth; part e to f in Figure 13, based on the special arc structure, so that the protrusion 3011 can provide better resistance to the release part to move to the distal side, and the safety performance is better.
  • the tip side of the protrusion 3011 has at least one inflection point, and the inflection point has an arc-shaped chamfer structure.
  • the inflection point has an arc-shaped chamfer structure.
  • this structure is simple to process and the connection with the main body of the insurance mechanism is more reliable and firm; as shown in part d in Figure 14, the distal end of the protrusion has two protruding vertices, The adaptation performance of the outer surface contour of the control line release part is higher, and the reliability of the use of the insurance mechanism is improved.
  • the outer periphery of the distal end surface of the safety mechanism 301 may be a quadrilateral as shown in part a in FIG. 15
  • the pentagon shown in part b in FIG. 15 is deformed by 8 as shown in part c in FIG. 15.
  • the polygonal structure preferably has an arc-shaped chamfer.
  • Figure 16b shows another embodiment according to the present disclosure.
  • this embodiment changes the structure of the diameter reducing portion 4012 at the proximal end of the control wire release portion in the embodiment shown in Fig. 3.
  • the diameter reducing part is a convex ring structure surrounding the outer surface of the control wire.
  • the control wire can no longer be directed due to the limiting effect of the convex ring.
  • the movement of the remote side realizes the function of restricting the unidirectional movement of the control line.
  • the release portion 401 at the distal end of the control wire is simple to process, and the effect of resisting the distal movement of the control wire again is good.
  • the diameter reducing part can also be transformed into a stepped surface with a gradient decreasing from the proximal side to the distal side in the radial distance, and a stepped surface with a radial distance decreasing from the proximal side to the distal side.
  • the concave-convex surface structure can also obtain a better technical effect of restricting the one-way movement of the control line.
  • FIG. 17 shows an exemplary embodiment as an alternative structure of the diameter reducing portion structure in the present disclosure.
  • the outer peripheral surface of the diameter reducing portion may be a stepped surface whose radial distance is reduced from the proximal side (from the position with the largest radial distance R1) to the distal side as shown in part a in FIG. 17, Or, as shown in Figure 17b, the wavy surface whose radial distance decreases from the proximal side (from the position with the largest radial distance Rl) to the distal side can also obtain a better technical effect of restricting the one-way movement of the control line .
  • the outer surface of the reducing structure may have unevenness known in the art to increase surface friction, such as serrations, protrusions, pits, and frosting. Surface structure.
  • the proximal end of the release portion may not have a diameter reducing portion whose radial width decreases toward the distal side.
  • the proximal end of the control wire release portion has substantially the same radial width.
  • FIG. 19 shows another embodiment according to the present disclosure.
  • this embodiment changes the structure of the radial restricting portion in the embodiment shown in FIG. 3.
  • the inner wall of the clip seat corresponding to the radially restricted portion on the side of the clip body transition portion 102 has a restricted diameter extending in the axial direction.
  • the structure in which the restricting portion radially expands in the process of moving in the axial direction For example, as shown in part a in Fig. 19, the inner wall of the holder corresponding to the movement path of the radial restricting portion has a thickened structure; or b in Fig.
  • corrugated structure there is a longitudinally extending corrugated structure on the inner wall of the clamp base corresponding to the movement path of the radial restricting portion.
  • the thickening structure or the corrugated structure can also function by the radial restricting portion provided at the proximal end of the clip body. To limit the release of the effect of the expansion of the aperture during the axial movement of the clamp.
  • FIG. 20 shows another embodiment according to the present disclosure.
  • this embodiment changes the structure of the holder holder 201 in the embodiment shown in FIG. 3.
  • a receiving tab 103 is provided at the end of the proximal holder 201 of the clamp base. ⁇ notches 203.
  • the inner restraint restricts the expansion of the release hole 105 in the radial direction, and transforms to a state where the protrusion 103 exceeds the proximal end surface of the holder 201 of the holder 200 to be radially expandable, and engages in the notch 203 at the end of the holder 201. Being firmly positioned, the clip will not be displaced in the radial or circumferential direction at this time, which improves the effectiveness and safety of the hemostatic clip during use.
  • the present disclosure provides a hemostatic clip and insurance mechanism.
  • the hemostatic clip has a handle on the proximal side, a clip assembly on the distal side, a sheath between the handle and the clip assembly, and a control wire in the sheath.
  • the distal end of the sheath has a fixing seat, and the control
  • the distal end of the wire has a release part
  • the clip assembly includes: a clip body; a clip seat, wherein the transition part of the clip body has a release hole, and the release part on the distal side of the control wire is releasably connected to the release hole.
  • the transition connecting portion has a radial restricting portion to restrict the expansion of the releasing hole in the radial direction.
  • hemostatic clip and safety mechanism of the present disclosure are reproducible and can be used in various minimally invasive surgeries that require hemostasis.

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Abstract

一种止血夹，具有位于近端侧的手柄（600），远端侧的夹子组件，以及位于手柄（600）和夹子组件间的鞘管（500）和位于鞘管（500）中的控制线（400），鞘管（500）远端具有固定座（300），控制线（400）远端具有释放部（401）。其中，夹子组件包括：夹体（100）和夹座（200），其中，夹体（100）的过渡连接部（102）具有释放孔（105），位于控制线（400）远端侧的释放部（401）可释放的与释放孔（105）连接，过渡连接部（102）具有径向限制部（103），以限制释放孔（105）在径向上的扩张。在不增加止血夹整体结构复杂程度的基础上，解决了控制线（400）提前释放的技术问题，确保在锁定前夹子组件不会与控制线（400）过早脱离，避免组织撕扯、夹子定位不准等技术问题。一种保险机构（301）和包括保险机构（301）的止血夹。保险机构（301）限制控制线（400）远端侧的释放部（401）向远端侧的移动。

Description

一种止血夹和保险机构
相关申请的交叉引用
本公开要求于2020年06月12日提交中国专利局的申请号为2020105377387、名称为“一种新型止血夹”的中国专利申请以及于2020年06月12日提交中国专利局的申请号为2020210946222、名称为“一种保险机构和具有保险机构的止血夹”的中国专利申请的优先权，其全部内容通过引用结合在本公开中。
技术领域
本公开涉及微创手术用组织闭合中使用的止血夹，属于医疗装置领域。
背景技术
现有的止血夹通过内窥镜钳道送入，对创面进行止血或夹闭操作，其主要通过钳夹机械压迫血管及周围组织达到止血夹闭的目的，止血原理与外科血管缝合或结扎相似，属于机械方法，不引起黏膜组织的凝固、变性、坏死。金属止血夹治疗后，局部组织炎症过程形成肉芽肿，自行脱落并经过消化道排出体外。内镜下缝合手术具有损伤小、止血速度快、再出血发生率低、并发症少、疗效确切等优点。
现有的止血夹除具备夹闭功能外，技术人员通过赋予止血夹可旋转、可重复开闭的性能实现对钳夹夹闭组织时角度的灵活调整，以及根据实际需要可以反复选择治疗部位以进行精确定位。为了实现重复开闭和旋转角度可调的需求，现有技术通常通过对夹座、夹体结构进行不断的优化调整，以解决实际使用中产生的众多需求。
发明内容
本公开的发明人注意到，现有技术中采用的止血夹存在诸多技术问题，有很大的改进空间。
具体地，如图1中所示的现有技术中，夹子近端通过设置弹片A实现夹子组件的锁定，而由于在止血夹使用过程中不可避免的有组织陷入两个夹片间，导致用于锁定的止血夹夹体存在定位不准以及释放孔径扩大的情况，进而导致控制线提前释放，最终引发夹子在锁定状态前出现不期望的提前脱落、撕扯组织等技术问题。为了解决在止血夹使用过程组织陷入两个夹片间的问题，在相关技术中存在下述两种设计：在夹座的远端增加销轴；或者夹座远端在夹片开口之间预留凸起并折弯。然而，这两种解决方案均增加了工艺难度和制作成本。
现有大部分类似结构的弹性夹子均存在类似问题，如何以较低的工艺难度和较少的制作成本避免由于组织陷入夹臂间导致夹子难以有效锁定、释放件提前释放等情况，是亟待解决的技术问题。
此外，现有技术中，当医生在反复拉动、推送控制线的过程中，很难精确判断夹子组件的锁定状态，当夹子组件处于还未完全锁定的半锁定状态时，弹性夹体虽然没有完全锁定但由于进入夹体内部通道的距离较大，已无法实现再次展开，而此时当医生希望展开弹性夹体重新定位止血部位时，由于无法准确判断夹子当时的开闭状态，会再次将控制线向远端推送，使得夹座由固定座的释放腔室中推出，由于此时夹子已经处于半锁定状态，一方面无法打开而实现重新选择止血位置，另一方面，更重要的，当医生 再次回拉控制线时，由于夹座的脱离或半脱离，导致固定座难以准确将夹座导向至止血夹锁定位置，此时，存在夹体过度进入夹座、控制线难以由释放孔中释放等技术问题，进而造成组织撕扯、无法释放夹子等严重的后果。
有鉴于此，本公开提出一种止血夹以及用于止血夹的保险机构。。
本公开提供一种止血夹，具有位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件可以包括：
夹体，其具有至少两个夹臂，以及将至少两个夹臂近端连接的过渡连接部；
夹座，具有能够约束所述夹体移动路径的内部通道，所述夹座近端侧与固定座可释放连接；
其中，所述过渡连接部可以具有释放孔，位于所述控制线远端侧的释放部可释放的与所述释放孔连接，
所述过渡连接部可以具有径向限制部，以限制所述释放孔在径向上的扩张。
通过本公开所提供的止血夹，至少解决了现有技术存在的钳夹难以精确锁定、释放件提前释放等技术问题，
优选地，所述径向限制部从远端向近端的轴向移动过程中，由径向约束状态过渡到径向可扩张状态。
优选地，所述过渡连接部可以具有U型板结构，所述径向限制部位于U型板的至少一个侧边上。
优选地，所述释放孔沿所述U型板弯曲方向延伸，所述径向限制部沿所述侧边延伸的范围至少部分可以与所述释放孔延伸范围重叠。
优选地，所述径向限制部可以径向凸出于所述侧边。
优选地，所述U型板的一个侧边上可以具有一个或多个径向凸出的所述径向限制部。
优选地，径向凸出的所述径向限制部可以沿径向方向延伸，或者可以朝向近端侧弯折或卷曲。
优选地，所述夹座近端可以具有可与径向凸出的所述径向限制部卡合的槽口。
优选地，所述固定座可以具有可与所述径向限制部抵接的凸台。
优选地，所述固定座可以设有保险机构，所述保险机构可以限制所述控制线远端侧的释放部向远端侧移动。
优选地，所述保险机构可以具有可供控制线释放部穿过的通孔，当释放部穿入所述通孔时，所述通孔可径向形变。
优选地，当所述释放部位于所述保险机构的远端时，所述释放部的近端可抵接在所述保险机构的远端端面。
优选地，所述通孔内壁可以具有向内凸出的突出部，所述释放部近端侧可以具有径向宽度由近端侧向远端侧减小的变径部，所述变径部近端可抵接在所述突出部的远端端面。
优选地，所述保险机构可以单独成型或与所述固定座一体形成。
本公开还提供一种止血夹，具有位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件包括：
夹体，其可以具有至少两个夹臂，以及将至少两个夹臂近端连接的过渡连接部；
夹座，具有能够约束所述夹体移动路径的内部通道，所述夹座近端侧与固定座可释放连接；
其中，所述过渡连接部可以具有释放孔，位于所述控制线远端侧的释放部可释放的与所述释放孔连接，
所述止血夹具有：
所述过渡连接部可以具有径向限制部，所述径向限制部向近端侧移动过程中，从由夹座内部通道提供径向向内约束以限制所述释放孔在径向上的扩张，过渡至所述径向限制部与固定座抵接，从而形成释放位置力学反馈。
优选地，所述固定座近端侧可以设有保险机构，当所述控制线向远端侧移动时，控制线远端侧的释放部与所述保险机构抵接以使所述保险机构提供限制所述控制线向远侧移动的止推位置力学反馈。
通过上述技术方案，本公开至少具有如下技术效果：
对于在实际夹持止血过程中止血夹的钳夹组件中往往会嵌入组织，进而导致夹子提前脱落或发生撕扯等技术问题，发明人在研发过程中通过在夹子近端增加径向限制部，在不过多增加夹子整体结构复杂程度的基础上，巧妙地解决了控制线提前释放的技术问题，确保在锁定前夹子组件不会与控制线过早脱离，提升在锁定状态前，控制线对夹子的有效控制，避免组织撕扯、夹子定位不准等技术问题。
本公开还提供一种保险机构，其特征在于，所述保险机构可以具有：
主体部，以及
位于所述主体部中供止血夹控制线远端侧释放部穿过的通孔，
其中，所述保险机构可以限制所述控制线远端侧的释放部向远端侧的移动。
通过本公开提供的保险机构，至少解决了现有技术存在的止血夹存在造成组织撕扯、无法释放夹子等技术问题。
优选地，当所述释放部穿入所述通孔时，所述通孔至少在径向上可发生形变。
优选地，当所述释放部位于所述保险机构的远端时，所述释放部的近端可抵接在所述保险机构的远端端面。
优选地，所述通孔内壁可以具有向内凸出的突出部，所述释放部近端可抵接在所述突出部的远端端面。
优选地，所述突出部径向切面形状可以选自以下方式的一种或多种：直线线段、具有至少一个拐点的弯折线段、圆弧线段、螺旋线段。
优选地，所述突出部顶端侧可以具有至少一个拐点，且所述拐点具有弧形倒角结构。
优选地，所述保险机构远端面外周可以呈圆形或者具有弧形倒角的正多边形。
优选地，所述释放部近端侧可以具有径向宽度由近端侧向远端侧减小的变径部，所述变径部的近端可抵接在所述保险机构的远端端面。
优选地，所述变径部的外周面可以选自以下方式：径向距离由近端侧向远端侧逐渐减小的锥面、径向距离由近端侧向远端侧梯度减小的台阶面、径向距离由近端侧向远端侧减小的凹凸面。
本公开还提供一种具有保险机构的止血夹，包括：
位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件可以包括：
至少两个夹臂；
夹座，所述夹臂能够相对所述夹座在打开构造和闭合构造间移动；
所述固定座近端侧设有如上所述的保险机构。
优选地，所述保险机构可以单独成型或与所述固定座一体形成。
优选地，所述保险机构近端面可以具有支撑鞘管远端面的鞘管抵接部。
通过在固定座上设置保险机构，避免了由于操作不当使得还未完全锁定的夹子组件提前由固定座中脱出，而控制线仍然未从释放孔中脱离这一情况下，存在操作过程中组织撕扯和夹子释放困难的技术问题。提升了治疗过程的安全性。
附图说明
图1是现有技术中钳夹结构视图；
图2是本公开中止血夹整体视图；
图3是本公开中止血夹夹子组件剖视图；
图4是本公开中扩张状态下夹体立体视图；
图5是本公开中夹座立体视图；
图6a是本公开中过渡连接部立体视图；
图6b是本公开中过渡连接部侧视图；
图7a-图7d是本公开中凸片(径向限制部)可替换结构示例；
图8是本公开第二力学反馈状态下夹子组件受力示意图；
图9是本公开第一力学反馈状态下夹子组件受力示意图；
图10是本公开夹子组件释放状态下结构示意图；
图11a是本公开又一实施例中保险机构立体视图；
图11b是本公开图11a所示实施例中保险机构远端侧侧视图；
图12是本公开的又一实施例中保险机构立体视图；
图13是本公开中保险机构突出部可替换形态径向剖面示意图；
图14是本公开中保险机构突出部可替换形态径向端面示意图；
图15是本公开中保险机构远端面外周轮廓可替换形态示意图；
图16a是本公开中图3所示实施例中控制线释放部局部视图；
图16b是本公开中又一实施例中控制线释放部可替换形式的局部视图；
图17是本公开中释放部变径部可替换形态示意图；
图18是本公开中控制线释放部可替换形式的局部视图；
图19是本公开中又一实施例中径向限制部替换方式径向截面视图；
图20是本公开中又一实施例中夹座立体视图。
附图标记说明：
100-夹体，101-夹臂，102-过渡连接部，103-凸片，104-导向片，105-释放孔，106-U型板侧边，200-夹座，201-保持件，202-导向槽，203-槽口，300-固定座，301-保险机构，3011-突出部，3012-鞘管抵接部，3013-通孔，302-释放腔室，3021-释放腔室侧壁卡槽，3022-释放腔室底部凸台，400-控制线，401-释放部，4011-释放端，4012-变径部，500-鞘管，600-手柄
具体实施方式
结合附图和具体实施例对本公开的技术内容作详细说明。
下面将结合实施例对本公开的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本公开，而不应视为限制本公开的范围。
对本公开中涉及的一些名词进行说明。近端是指靠近体外操作者的一端；远端是指位于体内待闭合组织的一端；轴向是指沿止血夹控制线纵轴延伸的方向；径向是指与轴向垂直方向延伸方向；周向是指沿环绕轴向的周向方向。
图2-5示出了根据本公开的示例性实施例。本实施例中，止血夹具有位于近端侧的手柄600，远端侧的夹子组件，以及位于手柄600和夹子组件100间的鞘管500和位于鞘管500中的控制线400，所述鞘管500远端具有固定座300，所述控制线400远端具有释放部401。其中，所述夹子组件包括：夹体100，其具有两个夹臂101，以及将两个夹臂101近端连接的过渡连接部102；夹座200，具有能够约束夹体100移动路径的内部通道，所述夹座近端侧与固定座可释放连接。夹座200近端侧具有保持件201，固定座300朝向远端侧具有开放的释放腔室302，该保持件201在自然状态下远端尾部与释放腔室302远端侧壁的卡槽3021可释放的卡合连接，当夹体100处于锁定状态后，该保持件201近端受力而被径向向外偏压，进而保持件201远端尾部由释放腔室302远端侧壁的卡槽3021中释放，最终锁定在夹座200中的夹持组织后的夹体100连同夹座一同释放。
其中，过渡连接部102具有释放孔105，位于控制线400远端侧的释放部401可释放的与该释放孔105连接，控制线400近端固定连接手柄中的滑块结构，通过纵向移动手柄600中的滑块结构带动控制线400纵向移动，进而实现弹性夹体100在打开和闭合位置间的变换。当夹子锁定后，控制线400继续 向近端侧移动，控制线远端的释放端4011由释放孔105中释放脱出。
为了防止夹体100在夹座内部通道中移动时，周向旋转错位，造成组织拉扯、难以锁定的技术问题，本实施例中，在夹体的夹臂101上设置导向片104，相对应地在夹座200侧壁上设置容纳导向片104滑动的导向槽202。当夹体100在夹座200内滑动时，导向片104沿导向槽202移动而不脱出，从而消除了夹体100周向旋转的可能，从而进一步避免组织撕扯和夹体难以锁定的技术问题。
如图6a-6b所示，本实施例中，过渡连接部102具有U型板结构(本实施例中U型板结构包含所有大体上呈U型的板状结构，如V型、︺型，ㄩ型等)，在该U型板侧边106上分别径向向外凸出设置一凸片103(本实施例中作为径向限制部)，释放孔105沿与所述U型板弯曲方向延伸，该凸片103沿侧边延伸的范围落入该释放孔105的延伸范围内，从而当夹体100滑入至夹座200的内部滑动通道中时，径向凸出的凸片103可以起到限制释放孔105径向扩张的作用。这一设计可以有效避免由于部分组织不期望地进入两个夹臂之间后，在控制线的来回带动下致使释放孔105径向扩张，导致在夹体100还未锁定时，控制线远端的释放部401过早的由释放孔105中脱出，从而不能达到夹紧组织、有效止血的目的。本公开中，通过在夹体100近端侧对应释放孔105径向扩张的方向上设置径向限制部(例如本实施例中的凸片103)，在不过多的增加夹子结构复杂程度的前提下，巧妙地解决了现有技术中由于组织嵌入夹体而导致的夹体未锁定即脱落的技术问题。为了减小凸片103在夹座内部过大的滑动摩擦力，改善止血夹使用时的手感，使得操作更加顺滑，凸片103边缘具有弧形倒角。
如图6b所示，本实施例中径向凸出的凸片103可以沿径向延伸，作为可替换的技术方案，作为示例，如图7a-7d所示，凸片103可以具有朝向近端侧(朝向手柄的一侧)的方向弯折或者卷曲的形状，例如图7a中所示的线性预折弯结构、图7b中所示的圆弧结构、图7c中所示的螺旋结构、图7d中朝向近端侧延伸的直线线段结构等，其中，图7a中的预折弯结构具有更优的抗形变性能，径向限制能力较好，图7b、7c中具有弧形曲面的结构在滑动过程中顺滑性能优异，图7d中的直线线段结构在加工过程中更简单实用，根据实际使用环境以及夹座结构，可以采用相适应的结构以实现最优的技术效果。
此处需要说明的是，本公开中径向限制部是指位于夹体近端的过渡连接部侧边上具有的能够限制释放孔径向扩展的部位，本实施例中将径向限制部位设计为向外凸起的结构仅是本公开中的优选实施例。
接下来对本公开中的保险机构进行详细描述。如图3和图8所示，作为止血夹优选结构，在固定座300近端侧设有保险机构301，所述保险机构301具有可供控制线释放部401穿过的通孔，当释放部穿入所述通孔时，所述通孔可径向形变。该保险机构301起到限制控制线400远端侧的释放部401向远端侧移动。
在示例性实施例中，所述保险机构301具有主体部，所述主体部具有供控制线400远端的释放部401穿过的通孔，当释放部穿入所述通孔时，所述通孔可径向形变。通过在固定座近端侧设置具有上述结构的保险机构301，可以起到限制控制线400上释放部401向远端侧的移动。
具体地说，在示例性实施例中，该保险机构301具有周向上等间距间隔的三个向内凸出的突出部3011。 在示例性实施例中，突出部3011设置在保险机构301的主体通孔内壁上；控制线400的释放部401近端侧具有径向宽度由近端侧向远端侧减小的变径部4012，如图6a所示。
在示例性实施例中，如图16a所示，该变径部4012具有径向截面长度向远端侧逐渐减小的近圆锥台结构。当所述变径部4012的近端位于保险机构的远端侧时，变径部能够与保险机构的远端端面相抵接，当控制线拉动变径部向近端移动并穿过保险机构通孔的过程中，通孔至少在径向发生形变，变径部4012近端端面向近端侧移动并超过各突出部3011近端端面，从而使得变径部4012与各突出部3011间形成过盈和/或倒刺配合。根据示例性实施例，当所述变径部4012近端侧的最大径向宽度Rl位置位于保险机构的远端侧时，变径部能够与保险机构的远端端面相抵接。在该示例性实施例中，变径部4012近端最大径向宽度Rl位置向近端侧移动并超过各突出部3011近端端面后，实现变径部4012与各突出部3011间形成过盈和/或倒刺配合。
本公开中突出部3011具有弹性，具体操作过程中，当控制线向近端侧拉动时，在释放部401近端的变径部4012压迫下，各突出部3011顶点间的间距被扩大，变径部4012被拉动至其近端端面超过突出部3011近端端面后，若再发生将控制线向远端推送的动作，由于变径部4012近端侧的最大径向宽度大于各突出部3011顶端间限定形状的最小径向间距(以实现释放部近端能够抵接在保险机构远端端面)，变径部4012与突出部3011抵接，由于挠性控制线在推送过程中提供给变径部的向远端侧的推送力难以抵抗由保险机构提供给变径部的向近端侧的抵接力，使得控制线无法再将变径部4012向远侧推出，最终实现保险机构301对控制线移动方向的限制。
设置该保险机构的目的在于：现有技术中，当医生在反复拉动、推送控制线的过程中，很难精确判断夹子组件的锁定状态，当夹子组件处于还未完全锁定的半锁定状态时，弹性夹体虽然没有完全锁定但由于进入夹体内部通道的距离较大，已难以实现再次展开，而此时当医生希望展开弹性夹体重新定位止血部位时，由于无法准确判断夹子当时的开闭状态，会再次将控制线向远端推送，使得夹座由固定座的释放腔室中推出，由于此时夹子已经处于半锁定状态，一方面无法打开而实现重新选择止血位置，另一方面，更重要的，当医生再次回拉控制线时，由于夹座的脱离或半脱离，导致固定座难以准确将夹座导向至止血夹锁定位置，此时，存在夹体过度进入夹座、控制线难以由释放孔中释放等技术问题，进而造成组织撕扯、难以释放夹子等严重的后果。本公开通过在固定座近端增设保险机构301，当控制线向近端拉动时，夹子已处于半锁定状态下后，建立了控制线只能向近端拉动而无法再次向远端侧移动的控制线单向移动的保险机制，从而解决了现有技术中由于操作者无法精确判断夹子开闭状态而造成组织撕扯、夹体难以释放的技术问题。
结合图8至图10，对本实施例中止血夹使用过程进行详述。
首先，如图8所示，当操作者以F1方向的拉力向近端拉动控制线以锁定并释放夹体100的过程中夹体100近端的过渡连接部102两侧边上的凸片103与夹座近端的保持件201内壁抵接，弹性保持件201向凸片103施加以径向向内的压迫力F3，相应的，凸片103向保持件201施加一反作用力，从而在控制 线逐步向近端侧移动时促使保持件201由固定座300的释放腔室302中释放。同时，控制线远端的释放端4011与夹体100近端的释放孔105孔壁抵接，如图8中所示，释放端4011径向长度大于释放孔105径向宽度，从而在控制线向近端移动时，释放端4011向释放孔孔壁提供如图8中F2箭头方向的压迫力，而此时，保持件201向凸片103提供的轴向支撑力不足以使得释放孔105孔径扩张变形，从而这一阶段，在控制线的带动下夹体100沿夹座内部通道继续向近端侧移动，保持件201的近端侧逐步在凸片103的压迫下径向向外扩张。
此阶段中，由于释放部401近端可抵接在保险机构301远端端面，当控制线向近端移动过程中，释放部401近端侧的变径部近端面与保险机构远端面抵接，此时向操作者提供一个抵接位置力学反馈，操作者能够获知此时控制线释放部401已经与保险机构接触，若再向近端拉动则会启动保险机制；若希望再次展开夹子、重新定位待止血部位，则可以将控制线重新向远端侧移动，可见，操作者通过这一抵接位置力学反馈，在不需要观察内镜中止血夹形态的情况下，就能够清楚的获知控制线释放部401和保险机构301的相对位置关系，进而可以准确的判断此时夹子是否还能重新打开。随后，当控制线继续向近端从移动时，在释放部401近端的变径部4012压迫下，保险机构301内部通孔至少在径向上发生形变，通孔内壁上具有弹性的各突出部的顶端间的间距被扩大，变径部4012被拉动至其近端端面超过突出部3011的近端端面，若再发生将控制线向远端侧推动的动作，由于变径部4012与突出部3011间的抵接作用，以使保险机构301提供给操作者(如医生)一个限制控制线向远侧移动的止推位置力学反馈，及时提示操作者夹体状态，并确保控制线无法再将变径部4012向远侧推出，最终实现保险机构301对控制线移动方向的限制。
接下来，如图9所示，此时，夹体近端的过渡连接部102两侧边上的凸片103与固定座释放腔室302底部凸台3022抵接，凸片103从由夹座200内部通道提供径向向内约束以限制释放孔105在径向上扩张的状态，变换至凸片103超过夹座200保持件201近端面而径向上可扩张的状态，凸片103被限位在夹体100近端面和固定座释放腔室302底部凸台3022之间，从而向操作者提供一个释放位置力学反馈。此时操作者在该力学反馈下可以获知弹性夹体100已处于锁定状态，夹子组件此时可以由固定座中释放。
当控制线向近端侧进一步以如图9中F1所示方向拉动过程中，固定座座释放腔室302底部凸台3022向凸片103提供一向远端侧的支撑力F4，同时释放端4011向释放孔105孔壁提供如图9中F2所示方向的压迫力，该压迫力F2具有沿图9中F2X和F2Y所示方向的径向和轴向上的压迫力分量，在F4和F2的合力作用下，释放孔105孔径扩张变形，提供了控制线远端的释放端4011能够顺利从释放孔105中释放脱出的基础。通过上述力学分析可以看出，通过在固定座内设置上述凸台3022，该结构向径向限制部(如本实施例中的凸片)提供与控制线拉力方向相反的抵接支撑力，可以使得释放孔更容易变形、扩张，降低控制线释放难度，使得释放止血夹更加容易。
最后，如图10所示，当控制线继续向近端拉动时，控制线远端的释放端4011由释放孔105中完全释放脱离，夹体100近端过渡连接部102两侧边上的凸片103被约束在夹座保持件201的近端面上，并 抵接压迫保持件201近端一直处于径向向外扩张的状态，进而保持件201远端彻底从释放腔室302侧壁卡槽3021中释放脱离，当向近端撤回鞘管时，即可实现释放处于锁定状态下的夹子组件，达到组织止血的目的。
本实施例中，弹性夹体中的夹臂101和过渡连接部102一体成型，而根据实际加工需要，过渡连接部102可以单独加工制造并通过本领域技术人员能够预知的方式与夹臂连接以实现弹性夹体在展开和收缩状态下反复变换。
此外，本实施例中保险机构301为单独部件，通过粘结、焊接等方式固定于固定座300和鞘管500之间，而根据实际需要或从简化加工步骤等方面考虑，保险机构301可以一体成型于固定座300近端侧、与鞘管500抵接的端面上，从而可以达到简化加工步骤的技术效果。
需要说明的是，本实施例中仅是采用U型弹性夹子结构作为示例，以对保险机构的作用原理进行示意性解释，本公开所记载的保险机构可以适用于本领域中任意类型的夹子结构，例如8字型弹性夹子、枢转型(夹片与夹座通过枢轴连接)夹子等。
图11a、图11b示出了根据本公开的又一实施例。如图11a、图11b所示，本实施例对图3所示实施例中保险机构301结构进行变换，在本实施例中，保险机构301远端面外周成正三角形，为了与固定座插接鞘管的通道侧壁适配，三角形各顶角做弧形倒角处理。保险机构中心具有通孔3013，位于通孔3013内壁上各径向凸出的突出部3011具有朝向近端侧偏转的折弯，这一结构可以使控制线释放部401近端的变径部4012向远端侧滑动时更顺滑地通过保险机构301，而当变径部4012具有最大径向长度的部分超过突出部3011近端面后，又能提供更高的抵接力，最大程度的阻止控制线再次向远端移动，从而实现更优的保险效果。本实施例中，保险机构301近端面具有周向等间距间隔设置的鞘管抵接部3012，当独立加工保险机构时，使得保险机构具有更高的与固定座、鞘管的适配性能，同时仍然能够获得固定座与鞘管稳固连接的技术效果。
图12示出了根据本公开的又一实施例。如图12所示，本实施例对图3所示实施例中保险机构301结构进行变换。在本实施例中，保险机构远端面具有圆形结构，6个径向向内凸出的突出部3011等间距间隔设置于保险机构301内周壁上，突出部径向延伸，6个突出部提供了更为可靠的限位能力，更好的确保控制线的单向移动。同时，保险机构301近端面具有与鞘管远端面适配的圆环形端面，从而保险机构301的近端面和远端面分别与鞘管、固定座充分抵接，提升设备稳定可靠的连接性能，进而确保保险机构的有效性。
当然，作为突出部的变形方式，可以在保险机构通孔侧壁上开设径向凹槽，同样能够获得在释放部抵接并穿过通孔的过程中，通孔在径向上可以变形的技术效果。
此外，本公开中突出部3011的结构也可以进行各种变换，图13至图15示出了作为本公开中突出部3011结构的可替换结构示例。
在图13所示的示例性实施例中，突出部3011径向切面形状选可以为如图13中的a部分所示的径 向延伸的直线线段，如图13中的b部分所示的向近端侧弯曲的弧形线段，如图13c所示的线段末端具有弯曲倒角，如图13中的d部分所示的线段末端具有向近端侧延伸的弧形段，如图13中的e部分所示的线段末端具有依次向远端侧和远端侧弯曲的弧形段，如图13中的f部分所示的线段末端具有两个拐点的螺旋线段。如图13中的a部分所示的突出部3011加工成型简单；如图13中的b部分至d部分所示的突出部3011与控制线释放部间摩擦作用力小，拉动过程中手感更为顺滑；如图13中的e部分至f部分，基于特殊的弧形结构，使得突出部3011能够提供更优的抵抗释放部向远端侧移动的能力，保险性能更优。
在图14所示的示例性实施例中，突出部3011顶端侧具有至少一个拐点，且所述拐点具有弧形倒角结构，具体的如图14中的a部分至c部分所示，突出部呈近似正四边形、等腰梯形和等边三角形，这种结构加工简单且与保险机构主体的连接更为可靠牢固；如图14中的d部分所示，突出部远端具有两个突出顶点，对于控制线释放部外表面轮廓的适配性能更高，提升保险机构使用的可靠性。
在图15所示的示例性实施例中，根据实际固定座容纳鞘管槽口的内部结构的适配性需求，保险机构301远端面外周可以为如图15中的a部分所示的四边形，图15中的b部分所示的五边形，如图15中的c部分所示的8变形，为了提高与弧形内壁的可靠接触，所述多边形结构优选具有弧形倒角。
图16b示出了根据本公开的又一实施例。如图16b所示，本实施例对图3所示实施例中控制线释放部近端的变径部4012结构进行变换。本实施例中变径部呈周向环绕控制线外表面的凸环结构，当凸环结构远端面超过保险机构301的近端面后，由于凸环的限位作用，控制线无法再向远端侧移动，实现了限制控制线单向移动的作用。该实施例中控制线远端的释放部401加工简单，抵抗控制线再次向远侧移动的效果好。
当然，在该实施例的基础上，变径部还可以变换为径向距离由近端侧向远端侧梯度减小的台阶面、径向距离由近端侧向远端侧减小的具有凹凸表面结构，同样能够获得较好的限制控制线单向移动的技术效果。
图17示出了作为本公开中变径部结构的可替换结构的示例性实施例。所述变径部的外周面，可以为如图17中的a部分所示的径向距离由近端侧(由具有最大径向距离Rl的位置)向远端侧梯度减小的台阶面，或者如图17b所示的径向距离由近端侧(由具有最大径向距离Rl的位置)向远端侧减小的波浪面，同样能够获得较好的限制控制线单向移动的技术效果。作为径向距离由近端侧向远端侧减小的波浪面的替换方式，变径结构外表面可以具有如锯齿、凸起、凹坑、磨砂等本领域已知的增加表面摩擦力的凹凸表面结构。
此外，作为可实施的方式，释放部近端也可以不具备径向宽度向远端侧减小的变径部，如图18所示，控制线释放部的近端侧呈径向宽度基本相同的圆柱结构，当保险机构接触释放部近端径向变化位置时，同样能够提供给操作者一个抵接位置力学反馈，此时，由于圆柱形径向宽度大于保险结构通孔孔径，释放部近端可抵接在保险机构远端面上，当继续向近端拉动控制线时，保险机构通孔被释放部近端侧的 圆柱形部分挤压而形变，并与圆柱形部分形成过盈配合，此时，由于保险机构与释放部圆柱形侧壁的过盈配合，使得挠性控制线难以抵抗向远端侧的推送力而形变，最终同样能够实现防止控制线再向远端侧推出的技术效果。
图19示出了根据本公开的又一实施例。如图19所示，本实施例对图3所示实施例中径向限制部结构进行变换。作为图3所示实施例中夹体近端侧凸片103结构的替换方式，在夹体过渡连接部102侧边上径向限制部位对应的夹座内壁上具有沿轴向延伸的、限制径向限制部在沿轴向移动过程中径向扩张的结构，例如图19中的a部分所示，与径向限制部移动路径对应的夹座内壁具有增厚结构；或者如图19中的b部分所示，在径向限制部移动路径对应的夹座内壁上具有纵向延伸的凸楞结构，上述增厚结构或者凸楞结构通过与夹体近端设置的径向限制部位作用，同样能够起到在夹子轴向移动过程中限制释放孔径向扩张的作用。
图20示出了根据本公开的又一实施例。如图20所示，本实施例对图3所示实施例中夹座保持件201结构进行变换。为了使图3所示实施例中凸片103更稳固地抵接于夹座近端面而不发生移位或滑脱，本实施例中，在夹座近端保持件201末端设置容纳凸片103的槽口203。当锁定夹体时，夹体近端过渡连接部102两侧边上的凸片103与固定座释放腔室302底部凸台3022抵接，凸片103从由夹座200内部通道提供径向向内约束以限制释放孔105在径向上的扩张的状态，变换至凸片103超过夹座200保持件201近端面而径向可扩张，并卡合在保持件201末端的槽口203中而被牢固定位，此时夹子无论在径向还是周向上均不会在发生位移，提升了止血夹在使用过程的有效性和安全性。
最后应说明的是：以上各实施例仅用以说明本公开的技术方案，而非对其限制；尽管参照前述各实施例对本公开进行了详细的说明，但本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本公开各实施例技术方案的范围。
工业实用性
本公开提供了一种止血夹和保险机构。止血夹，具有位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件包括：夹体；夹座，其中，夹体的过渡连接部具有释放孔，位于控制线远端侧的释放部可释放的与所述释放孔连接，所述过渡连接部具有径向限制部，以限制所述释放孔在径向上的扩张。在不增加夹子整体结构复杂程度的基础上，解决了控制线提前释放的技术问题，确保在锁定前夹子组件不会与控制线过早脱离，避免组织撕扯、夹子定位不准等技术问题。
此外，可以理解的是，本公开的止血夹和保险机构是可以重现的，并且可以用在需要进行止血的各种微创手术中。

Claims (28)

  1. 一种止血夹，具有位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件包括：
    夹体，其具有至少两个夹臂，以及将至少两个夹臂近端连接的过渡连接部；
    夹座，具有能够约束所述夹体移动路径的内部通道，所述夹座近端侧与固定座可释放连接；
    其中，所述过渡连接部具有释放孔，位于所述控制线远端侧的释放部可释放的与所述释放孔连接，
    其特征在于，
    所述过渡连接部具有径向限制部，以限制所述释放孔在径向上的扩张。
  2. 根据权利要求1所述的止血夹，其特征在于，所述径向限制部从远端向近端的轴向移动过程中，由径向约束状态过渡到径向可扩张状态。
  3. 根据权利要求1或2所述的止血夹，其特征在于，所述过渡连接部具有U型板结构，所述径向限制部位于U型板的至少一个侧边上。
  4. 根据权利要求3所述的止血夹，其特征在于，所述释放孔沿所述U型板弯曲方向延伸，所述径向限制部沿所述侧边延伸的范围至少部分与所述释放孔延伸范围重叠。
  5. 根据权利要求3或4所述的止血夹，其特征在于，所述径向限制部径向凸出于所述侧边。
  6. 根据权利要求5所述的止血夹，其特征在于，所述U型板的一个侧边上具有一个或多个径向凸出的所述径向限制部。
  7. 根据权利要求5或6所述的止血夹，其特征在于，径向凸出的所述径向限制部沿径向方向延伸，或者朝向近端侧弯折或卷曲。
  8. 根据权利要求5-7任一项所述的止血夹，其特征在于，所述夹座近端具有可与径向凸出的所述径向限制部卡合的槽口。
  9. 根据权利要求1-8任一项所述的止血夹，其特征在于，所述固定座具有可与所述径向限制部抵接的凸台。
  10. 根据权利要求1-9任一项所述的止血夹，其特征在于，所述固定座设有保险机构，所述保险机构限制所述控制线远端侧的释放部向远端侧移动。
  11. 根据权利要求10所述的止血夹，其特征在于，所述保险机构具有可供控制线释放部穿过的通孔，当释放部穿入所述通孔时，所述通孔可径向形变。
  12. 根据权利要求11所述的止血夹，其特征在于，当所述释放部位于所述保险机构的远端时，所述释放部的近端可抵接在所述保险机构的远端端面。
  13. 根据权利要求12所述的止血夹，其特征在于，所述通孔内壁具有向内凸出的突出部，所述释 放部近端侧具有径向宽度由近端侧向远端侧减小的变径部，所述变径部近端可抵接在所述突出部的远端端面。
  14. 根据权利要求10-13任一项所述的止血夹，其特征在于，所述保险机构单独成型或与所述固定座一体形成。
  15. 一种止血夹，具有位于近端侧的手柄，远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件包括：
    夹体，其具有至少两个夹臂，以及将至少两个夹臂近端连接的过渡连接部；
    夹座，具有能够约束所述夹体移动路径的内部通道，所述夹座近端侧与固定座可释放连接；
    其中，所述过渡连接部具有释放孔，位于所述控制线远端侧的释放部可释放的与所述释放孔连接，
    其特征在于，所述止血夹具有：
    所述过渡连接部具有径向限制部，所述径向限制部向近端侧移动过程中，从由夹座内部通道提供径向向内约束以限制所述释放孔在径向上的扩张，过渡至所述径向限制部与固定座抵接，从而形成释放位置力学反馈。
  16. 根据权利要求15所述的止血夹，其特征在于，所述固定座近端侧设有保险机构，当所述控制线向远端侧移动时，控制线远端侧的释放部与所述保险机构抵接以使所述保险机构提供限制所述控制线向远侧移动的止推位置力学反馈。
  17. 一种保险机构，其特征在于，所述保险机构具有：
    主体部，以及
    位于所述主体部中供止血夹控制线远端侧释放部穿过的通孔，
    其中，所述保险机构限制所述控制线远端侧的释放部向远端侧的移动。
  18. 根据权利要求17所述的保险机构，其特征在于，当所述释放部穿入所述通孔时，所述通孔至少在径向上可发生形变。
  19. 根据权利要求17或18所述的保险机构，其特征在于，当所述释放部位于所述保险机构的远端时，所述释放部的近端可抵接在所述保险机构的远端端面。
  20. 根据权利要求19所述的保险机构，其特征在于，所述通孔内壁具有向内凸出的突出部，所述释放部近端可抵接在所述突出部的远端端面。
  21. 根据权利要求20所述的保险机构，其特征在于，所述突出部径向切面形状选自以下方式的一种或多种：直线线段、具有至少一个拐点的弯折线段、圆弧线段、螺旋线段。
  22. 根据权利要求20所述的保险机构，其特征在于，所述突出部顶端侧具有至少一个拐点，且所述拐点具有弧形倒角结构。
  23. 根据权利要求17-22任一项所述的保险机构，其特征在于，所述保险机构远端面外周呈圆形或 者具有弧形倒角的正多边形。
  24. 根据权利要求17-22任一项所述的保险机构，其特征在于，所述释放部近端侧具有径向宽度由近端侧向远端侧减小的变径部，所述变径部的近端可抵接在所述保险机构的远端端面。
  25. 根据权利要求24所述的保险机构，其特征在于，所述变径部的外周面选自以下方式：径向距离由近端侧向远端侧逐渐减小的锥面、径向距离由近端侧向远端侧梯度减小的台阶面、径向距离由近端侧向远端侧减小的凹凸面。
  26. 一种具有保险机构的止血夹，包括：
    位于近端侧的手柄，位于远端侧的夹子组件，以及位于手柄和夹子组件间的鞘管和位于鞘管中的控制线，所述鞘管远端具有固定座，所述控制线远端具有释放部，其中，所述夹子组件包括：
    至少两个夹臂；
    夹座，所述夹臂能够相对所述夹座在打开构造和闭合构造间移动；
    其特征在于，
    所述固定座近端侧设有如权利要求17-25任一项所述的保险机构。
  27. 根据权利要求26所述的止血夹，其特征在于，所述保险机构单独成型或与所述固定座一体形成。
  28. 根据权利要求26或27所述的止血夹，其特征在于，所述保险机构近端面具有支撑鞘管远端面的鞘管抵接部。
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CN104546055A (zh) * 2013-10-25 2015-04-29 常州乐奥医疗科技有限公司 一种新型可重复闭合的消化道止血夹
CN110393564A (zh) * 2018-04-25 2019-11-01 杭州安杰思医学科技股份有限公司 夹持装置
WO2020095428A1 (ja) * 2018-11-09 2020-05-14 オリンパス株式会社 クリップユニットおよび内視鏡クリップ
CN110464410A (zh) * 2019-07-03 2019-11-19 安瑞医疗器械(杭州)有限公司 配合内窥镜使用的夹子装置及其夹持部
CN110613495A (zh) * 2019-10-29 2019-12-27 南微医学科技股份有限公司 一种医用止血夹
CN112790811A (zh) * 2019-11-13 2021-05-14 杭州安杰思医学科技股份有限公司 一种端部执行器械
CN111544075A (zh) * 2020-06-12 2020-08-18 南微医学科技股份有限公司 一种新型止血夹

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