WO2019148450A1 - Dispositif d'agrafage - Google Patents

Dispositif d'agrafage Download PDF

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Publication number
WO2019148450A1
WO2019148450A1 PCT/CN2018/075121 CN2018075121W WO2019148450A1 WO 2019148450 A1 WO2019148450 A1 WO 2019148450A1 CN 2018075121 W CN2018075121 W CN 2018075121W WO 2019148450 A1 WO2019148450 A1 WO 2019148450A1
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WO
WIPO (PCT)
Prior art keywords
clamping
clip
zone
spacing
clamping zone
Prior art date
Application number
PCT/CN2018/075121
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English (en)
Chinese (zh)
Inventor
时百明
程永华
Original Assignee
杭州安杰思医学科技有限公司
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
Application filed by 杭州安杰思医学科技有限公司 filed Critical 杭州安杰思医学科技有限公司
Priority to PCT/CN2018/075121 priority Critical patent/WO2019148450A1/fr
Publication of WO2019148450A1 publication Critical patent/WO2019148450A1/fr

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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
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a clipping device.
  • the treatment of internal hemorrhage in the clinic usually adopts the endoscopic ligation device to stop bleeding, and the purpose of hemostasis is achieved by grasping and clamping the bleeding site.
  • endoscopic ligation device hemostasis is used to treat gastrointestinal bleeding and wound or perforation closure, which has the advantages of small trauma, fast hemostasis and less complications.
  • CN201280042482.6, CN201280042522.7 and the like have disclosed a living tissue ligation device, which enters the human body through the endoscopic forceps, grasps and clamps the bleeding site of the digestive tract, and achieves the purpose of stopping bleeding. It is suitable for acute non-variceal hemorrhage, especially hemorrhagic lesions with bare blood vessels or small arteries. With the development and advancement of surgical techniques, especially the development of ESD and EMR in early digestive tract early cancer technology, the damage to the digestive tract is becoming more and more serious. Some operations such as POM, full-thickness resection, and Notes surgery will be actively manufactured. "Perforation" or injury to treat some conditions.
  • the clamping force of the conventional ligation device is not sufficient, or the conventional ligation device may not be able to clamp the tissue depending on the clamping force of the jaw when the tissue is loose, or the ligation device may fall off in advance to cause hemostasis, and may cause re-bleeding, which needs to be repeated.
  • Treatment or surgical treatment Existing modifications to the ligation device generally increase the clamping force of the ligation device, but if the clamping force of the ligation device jaw is excessively increased, there may be a perforation of the ligation site due to excessive clamping force of the jaws. Secondary bleeding.
  • the present invention overcomes the defects of the prior art, and provides a clamping device, which can take into consideration the function of closing the wound to stop bleeding and close the perforation, and at the same time ensure the clamping force of the clip and prevent the tissue from falling off.
  • a clamping device comprising: a mandrel, a sheath, and a clip, the sheath being provided with a passage, the mandrel being disposed in a passage of the sheath, the mandrel being connected to the clip,
  • the clip includes at least two clamp arms, and when the clip is clamped, the area between the two clamp arms constitutes a clamping area, and the clamping area includes a first clamping zone and a second clamping zone.
  • the minimum clamping distance of the first clamping zone is a first spacing
  • the minimum clamping spacing of the second clamping zone is a second spacing
  • the first spacing is smaller than the second spacing; wherein the first spacing A clamping zone is located at a proximal end of the second clamping zone; or the first clamping zone is located at a distal end of the second clamping zone.
  • At least one of the clip arms includes a clip, the clip being provided with a first clamping portion toward a side of the first clamping zone, the first clamping portion and the rest The area between the clamp arms constitutes the first clamping zone.
  • at least one of the clamping arms includes a clip, the clip is provided with a second clamping portion toward a side of the second clamping zone, and the second clamping portion and the remaining clamping arms The intervening area constitutes the second clamping zone.
  • the first clamping portion is provided with a notch.
  • the notch is rounded, and the notch is smoothly transitioned with the first clamping portion.
  • the gap is at least two.
  • At least two of the clips are provided with the first clamping portion and the notch, the notches being identical or different in position on at least two of the clips.
  • the clamping region further includes a third clamping zone, the minimum clamping pitch of the third clamping zone is a third spacing, and the third spacing is greater than the first spacing;
  • the first clamping zone is located at a proximal end of the second clamping zone, the third clamping zone is located at a proximal end of the first clamping zone, and the third spacing is greater than, less than, or equal to The second spacing; or the third clamping zone is located between the first clamping zone and the second clamping zone, and the third spacing is greater than or less than the second spacing; or
  • the first clamping zone is located at a distal end of the second clamping zone, the third clamping zone is located at a proximal end of the second clamping zone, and the third spacing is greater or smaller than the second spacing.
  • the clamping arm has a U-shaped cross section; or the clamping arm has a C-shaped cross section; or the clamping arm has a cross-section of a 3-shape; or, the clip
  • the cross section of the arm is an arc or a straight line, and the middle portion of the arc or the straight type is provided with a convex portion, the convex portion faces the first clamping region; or, the cross section of the clamping arm is Bow type.
  • the first clamping zone has a length of 0.1 mm to 20 mm, the first spacing K1 is 0.1 mm to 1.2 mm; or the second clamping zone has a length of 0.01 mm to 20 mm, the second spacing K2 is 0.3 mm to 3 mm; or, the third clamping zone has a length of 0 mm to 10 mm, and the third spacing K3 is 0.3 mm to 3 mm.
  • the clipping device further includes a receiving tube, a control portion that interfaces with the mandrel, the proximal end of the sheath tube, and the receiving tube is docked with the distal end of the sheath tube
  • the receiving tube is provided with a passage, the mandrel is disposed in the passage of the receiving tube, and the clip may be wholly or partially received in the passage of the receiving tube.
  • the clamping region includes a first clamping zone and a second clamping zone, the minimum clamping pitch of the first clamping zone is a first spacing, and the minimum clamping spacing of the second clamping zone is a second pitch, the first pitch being smaller than the second pitch.
  • a second clamping zone with a larger clamping pitch is used for ligation, and a second clamping zone with a larger clamping spacing allows more space at the distal end of the clip to hold more tissue, thereby completing the ligation function
  • the first clamping zone with a smaller clamping spacing is used for hemostasis, and the smaller clamping gap allows the loose tissue in the first clamping zone to be subjected to a greater clamping force, thereby completing the hemostatic function; a clip of the invention
  • the first clamping zone for ligation and the second clamping zone for hemostasis are distinguished, and one clip is compatible with the hemostatic effect and the ligation effect.
  • first clamping zone is located at a proximal end of the second clamping zone; or the first clamping zone is located at a distal end of the second clamping zone.
  • the positional relationship between the first clamping zone and the second clamping zone can be designed according to requirements, so that the clamping device can adapt to different surgical requirements to ensure the ligation and hemostasis effects.
  • the clip includes at least two clip arms, and when the clip includes two clip arms, the gripping pitch refers to the spacing between the two clip arms in the cross section of the gripping region. When the clip includes more than two clip arms, the gripping pitch refers to the minimum width of the section of the gripping region.
  • At least one of the clips includes a clip, the clip being provided with a first clamping portion on a side of the other clip, between the first clamping portion and the other of the clips The area constitutes the first clamping zone.
  • the first clamping portion is formed by providing the first clamping portion, and the first clamping portion can be formed by bending the edge of the clip, or the first clamping portion can be connected to the clip by welding bonding or other connection.
  • the first clip and the first clamping portion may be integrally formed at the same time as the first clip is manufactured, or the first clamping portion may be manufactured in other manners.
  • the clip includes two clips, which are respectively referred to as a first clip and a second clip (the first and the second are only used for the sake of simplicity, and may represent any clip, and the order and orientation of the clip are not limited).
  • the first clip may be provided with a first clamping portion, the first clamping portion protrudes relative to the second clamping piece to the other clamping piece, and the second clamping piece does not have the first clamping portion, the first clamping piece a first clamping zone between the clamping portion and the second clamping piece, a second clamping zone formed between the portion of the first clamping piece at the distal end of the first clamping portion and the second clamping piece; or: a clip is provided with a first clamping portion, and the second clamping piece is also provided with a first clamping portion, and the first clamping portion of the first clamping piece and the first clamping portion of the second clamping piece form a first The clamping zone, the portion of the first clip located at the distal end of the first clamping portion and the portion of the second
  • At least one of the clip arms includes a clip, the clip being provided with a second clamping portion toward a side of the second clamping region, the second clamping portion and the remaining of the clamping arms
  • the intervening area constitutes the second clamping zone.
  • the manufacturing method of the second clamping portion is the same as or different from that of the first clamping portion.
  • the clip is simultaneously provided with a first clamping portion and a second clamping portion, the height of the first clamping portion is greater than the height of the second clamping portion, that is, the first clamping portion is opposite to the first clamping portion
  • the farthest distance from which the sheet protrudes is greater than the farthest distance the second clamping portion protrudes from the first clip such that the first pitch is smaller than the second pitch.
  • the first clamping portion and the second clamping portion are not limited to be configured such that the first spacing is smaller than the second spacing, and the clip may be bent or otherwise formed to form the first clamping zone and the second clamping zone. As long as the first spacing is less than the second spacing.
  • the first clamping portion is provided with a notch, and the notch can increase the friction between the human body tissue and the first clamping portion, and consolidate the clamping effect of the clamping device.
  • the notch is rounded, and the notch and the first clamping portion are smoothly transitioned to avoid damage to the tissue caused by the notch and the first clamping portion, especially when the clamping force of the clip is large, the notch, the first
  • the smooth contact surface between the clamping portion and the tissue can effectively avoid tissue damage or secondary bleeding caused by excessive local force.
  • the gap is at least two, and the plurality of notches can further increase the contact surface between the tissue and the clip, and relieve the local stress of the tissue from being excessive.
  • At least two of the clips are respectively provided with the first clamping portion, and the notches are symmetrically disposed or asymmetrically disposed.
  • Symmetrical arrangement means that the first clamping portion on the first clamping piece and the first clamping portion on the second clamping piece are symmetrically arranged, with the center line between the first clip and the second clamping piece being the axis of symmetry, first The notch on the clip and the notch on the second clip are symmetrically arranged.
  • the above "symmetry” means symmetry or approximately symmetry, and since the manufacturing error is always present, a slight asymmetry deviation due to manufacturing error is allowed.
  • the symmetrically arranged notches can cause a pressing force of "loose, tight, loose, tight" at the first clamping zone to increase the friction and consolidate the clamping effect.
  • the "asymmetric setting" is relative to the "symmetric setting" described above, and the notch is not arranged symmetrically, and the tissue can be distracted by the pressing force of the clamping to alleviate the tissue stress.
  • the clamping region further includes a third clamping zone, wherein the third clamping zone has a minimum clamping pitch of a third spacing, and the third spacing is greater than the first spacing.
  • the third clamping zone is located at a proximal end of the first clamping zone, and the third spacing may be greater than, equal to, or less than the second spacing, so that the clamping region constitutes a "wide-narrow-wide" structure, and The third clamping zone can provide a certain retracting space at the proximal end of the first clamping zone to prevent the tissue from opening the clip;
  • the third clamping zone is located between the first clamping zone and the second clamping zone, and the third spacing is greater than the second spacing, so that the clamping zone forms a "wide-wider-narrow" structure;
  • the third clamping zone is located between the first clamping zone and the second clamping zone, and the third spacing is smaller than the second spacing, so that the clamping zone constitutes a "wide-medium-narrow" structure;
  • first clamping zone is located at the distal end of the second clamping zone
  • third clamping zone is located at the proximal end of the second clamping zone
  • third spacing is greater than the second spacing, so that the clamping zone constitutes "narrow-width- a wider structure
  • the first clamping zone is located at the distal end of the second clamping zone
  • the third clamping zone is located at the proximal end of the second clamping zone
  • the third spacing is smaller than the second spacing
  • the clip device further includes a receiving tube and a control portion, the control portion is in abutment with the mandrel and the proximal end of the sheath tube, and the control portion is configured to control a positional relationship between the mandrel and the sheath tube, and the mandrel can be controlled Sliding proximally or distally relative to the sheath.
  • the receiving tube is in abutment with the distal end of the sheath tube, the receiving tube is provided with a passage, the mandrel is disposed in the passage of the receiving tube, and when the control portion controls the proximal movement of the core in the axial direction, the clip Gradually closed, the clips may be wholly or partially received in the passage of the receiving tube.
  • the clip is provided with a pinion located at a distal end of the second clamping zone.
  • a pinion located at a distal end of the second clamping zone.
  • proximal and distal refers to the direction along the length of the sheath (or the axis of the sheath) or the direction in which the sheath extends into the human body, facing the operator.
  • the side is “proximal”, the side facing the body for treatment is “distal”; the “proximal” includes the proximal end and a portion near the proximal end, the “distal” includes the distal end and the distal end A part near the end face.
  • proximal or distal part of a certain part means that the side of the certain part facing the operator is the “near end” of a certain part, and the side of the part that is oriented toward the human body for treatment is
  • the "distal end" of a certain part, the “proximal end” of a certain part includes a proximal end face of the part and a part near the proximal end face, and the “distal end” of the certain part includes the end face and the distal end of the part. A part near the end face.
  • FIG. 1 is an overall structural view of a clip device according to an embodiment of the present invention
  • FIG. 2 is a partial cross-sectional view of the distal end of the clip device according to the embodiment of the present invention.
  • Figure 3 is a structural view 1 of the embodiment of the present invention when the clip is closed;
  • FIG. 4 is a structural view of a clamping region according to an embodiment of the present invention.
  • Figure 5 is a structural view 2 of the embodiment of the present invention when the clip is closed;
  • Figure 6 is a cross-sectional view taken along line A-A of Figure 5;
  • Figure 7 is a cross-sectional view taken along line B-B of Figure 5;
  • Figure 8 is a block diagram showing the structure of the clip according to the second embodiment of the present invention.
  • FIG. 9 is a block diagram showing the structure of the clip of the embodiment of the present invention.
  • Figure 10 is a block diagram showing the structure of a clip according to an embodiment of the present invention.
  • Figure 11 is a block diagram showing the structure of a clip according to an embodiment of the present invention.
  • Figure 12 is a first schematic view showing a cross section of a clip according to an embodiment of the present invention.
  • Figure 13 is a second schematic view showing a cross section of a clip according to an embodiment of the present invention.
  • Figure 14 is a first schematic view showing the size of a clip according to an embodiment of the present invention.
  • Figure 15 is a second schematic view showing the size of a clip according to an embodiment of the present invention.
  • Figure 16 is a schematic view showing the dimensions of a clip according to an embodiment of the present invention.
  • the clamping device includes a clip 1, a sheath tube 2, a receiving tube 210, and a control portion 3.
  • the sheath tube 2 is provided with a channel, and the receiving tube 210 is docked with the distal end of the sheath tube 2, and the receiving tube 210 is provided.
  • the control unit 3 abuts the mandrel 220 and the proximal end of the sheath tube 2, and the control unit 3 controls the positional relationship of the mandrel 220 with respect to the sheath tube 2, and can control the mandrel 220 to be proximal or distal with respect to the sheath tube 2. Slide the end.
  • the control unit 3 controls the movement of the mandrel 220 to the proximal end, the clip 1 is gradually closed, and the clip 1 can be entirely or partially housed in the passage of the storage tube 210.
  • the distal end of the receiving tube 210 is provided with a blocking portion 211 that prevents the clip 1 from coming off the distal end of the receiving tube 210.
  • the clip 1 includes two clamping arms, a first clamping arm 10A and a second clamping arm 10B (the first and second are only used for the sake of simplicity, and may represent any clamping arm, and the order and orientation of the clamping arms are not limited.
  • the first clamping zone 101 and the second clamping zone 102 are formed between the two clamping arms.
  • the first clamp arm 10A includes a first clip 11A, a first clamp portion 111A and a second clamp portion 112A provided on the first clip 11A, and a clip 113A provided on the first clip 11A.
  • the second clamp arm 10B includes a second clip 11B, a first clamp portion 111B and a second clamp portion 112B provided on the second clip 11B, and a clip tooth 113B provided on the second clip 11B.
  • the area between the first clamp arm 10A and the second clamp arm 10B constitutes a clamping area, and the clamping area includes the first The clamping zone 101 and the second clamping zone 102, the first clamping zone 101 is located at the proximal end of the second clamping zone 102, and the minimum clamping pitch of the first clamping zone 101 is the first spacing K1, the second clamping The minimum clamping pitch of the zone 102 is the second spacing K2, and the first spacing K1 is smaller than the second spacing K2.
  • the first clamping zone 101 and the second clamping zone 102 may be located in the receiving tube 210 or outside the receiving tube 210.
  • the area between the first clip 11A and the second clip 11B constitutes a clamping area comprising a first clamping zone 101 and a second clamping zone 102.
  • the shaded portions are a first clamping zone 101 and a second clamping zone 102, respectively, and the first clamping zone 101 is in communication with the second clamping zone 102.
  • the first clip 11A is provided with a convex first clamping portion 111A toward the side of the second clamping piece 11B, and the second clamping piece 11B is provided with a convex first clamping portion facing one side of the first clamping piece 11A.
  • 111B a region between the first clamping portion 111A of the first clip 11A and the first clamping portion 111B of the second clip 11B constitutes the first clamping region 101.
  • the first clip 11A is provided with a convex second clamping portion 112A toward the side of the second clip 11B, and the second clamping portion 112A is located at the distal end of the first clamping portion 111A.
  • the second clip 11B is provided with a convex second clamping portion 112B toward the side of the first clip 11A, and the second clamping portion 112B is located at the distal end of the first clamping portion 111B.
  • the area between the second clamping portion 112A of the first clip 11A and the second clamping portion 112B of the second clip 11B constitutes the second clamping zone 102.
  • the height of the first clamping portions 111A, 111B is greater than the height of the second clamping portions 112A, 112B.
  • the farthest distance that the first clamping portion 111A protrudes from the first clip 11A is greater than the farthest distance that the second clamping portion 112A protrudes from the first clip 11A;
  • the farthest distance that the first clamping portion 111B protrudes from the second clip 11B is greater than the farthest distance that the second clamping portion 112B protrudes from the second clip 11B; thus the first spacing K1 is smaller than the second spacing. K2.
  • the first clamping portion 111A, 111B, the second clamping portion 112A, 112B may be formed by bending the edges of the first clip 11A and the second clip 11B, or by welding bonding or other connection means in the first clip.
  • the first clamping portion 111A, 111B, the second clamping portion 112A, 112B is connected to the piece 11A and the second clamping piece 11B, or the first clamping piece 11A and the second clamping piece 11B are simultaneously manufactured.
  • the tightening portions 111A, 111B and the second clamping portions 112A, 112B are integrally molded, or the first clamping portions 111A, 111B and the second clamping portions 112A, 112B are manufactured by other means.
  • the first clamping zone 101 is located at the proximal end of the second clamping zone 102, and the first spacing K1 is smaller than the second spacing K2.
  • the second clamping zone 102 having a larger clamping pitch is used for ligation, and the second clamping zone 102 having a larger clamping pitch allows more space at the distal end of the clip to hold more tissue, thereby completing The ligation function;
  • the first clamping zone 101 having a smaller clamping pitch is used for hemostasis, and the smaller clamping gap causes the loose tissue in the first clamping zone 101 to be subjected to a larger clamping force, thereby completing the hemostatic function;
  • a clip 1 of the present invention distinguishes a first clamping zone 101 for ligation and a second clamping zone 102 for hemostasis, and a clip 1 is compatible with a hemostatic effect and a ligation effect.
  • the round transition between the first clamping portions 111A, 111B and the second clamping portions 112A, 112B avoids damage to the tissue.
  • the distal end of the clip is further provided with clip teeth 113A, 113B, and the clip teeth 113A, 113B are located at the distal end of the second clamping zone 102.
  • the teeth 113A, 113B of the two clips are engaged.
  • the teeth 113A, 113B can better engage the tissue and prevent tissue from falling out of the clip 1.
  • the first clamping arm 10A and the second clamp arm 10B are referred to in the cross-sectional configuration of the A-A cross-sectional view of Fig. 5.
  • the first clamping arm 10A includes a first clip 11A and a first clamping portion 111A disposed on the first clamping piece 11A
  • the second clamping arm 10B includes a second clamping piece 11B, and a first portion disposed on the second clamping piece 11B. Clamping portion 111B.
  • the cross section of the first clamping arm 10A and the second clamping arm 10B in the first clamping zone 101 can take various forms. among them:
  • the first clamp arm 10A and the second clamp arm 10B are asymmetrical in cross section in the vertical and horizontal directions shown in Fig. 12(a), but are center-symmetrical.
  • the entire cross section of the first clamp arm 10A is a C-shaped shape with a slit, the C-shaped opening faces upward toward the clamping region, and the left end of the first clamping piece 111A is provided with a first clamping portion, so that the C of the first clamping arm 10A
  • the right side of the type has a slit; similarly, the second clamp arm 10B has a C-shaped cross section with a slit, the C-shaped opening faces downward toward the clamping region, and the second clip 11B has the first right side.
  • the clamping portion 111B has a slit on the left side of the C-shape of the second clamp arm 10B; the gap is disposed such that the first clamp arm 10A and the second clamp arm 10B are vertically asymmetric and centrally symmetrical.
  • the cross-sections of the first clamp arm 10A and the second clamp arm 10B are vertically symmetrical and asymmetrical left and right; the first clamp arm 10A
  • the cross section is a C-shaped shape with a slit, the opening of the C-shape is directed upward toward the clamping region, and the first clamping portion 111A is provided on the right side of the first clamping piece 11A, so that the left side of the C-shape of the first clamping arm 10A has
  • the second clamp arm 10B has a cross section of a C-shaped shape with a slit, the C-shaped opening faces downward toward the clamping region, and the right end of the second clamping piece 11B is provided with a first clamping portion 111B, so that the second clamping arm
  • the left side of the C type of 10B has a slit; the gap is arranged such that the first clamp arm 10A and the second clamp arm
  • first clamp arm 10A and the second clamp arm 10B are symmetrical in cross section.
  • the first clamp arm 10A has a U-shaped cross section, the U-shaped opening faces upward toward the clamping region;
  • the second clamp arm 10B has a U-shaped cross section, and the U-shaped opening faces downward toward the clamping region.
  • a first clamping portion 111A is disposed on each side of the first clip 11A, and a first clamping portion 111B is disposed on each side of the second clamping arm 10B.
  • first clamp arm 10A and the second clamp arm 10B are symmetrical in cross section.
  • the first clamp arm 10A has a C-shaped cross section, the C-shaped opening faces upward toward the clamping region;
  • the second clamp arm 10B has a C-shaped cross section, and the C-shaped opening faces downward toward the clamping region.
  • a first clamping portion 111A is disposed on each side of the first clip 11A, and a first clamping portion 111B is disposed on each side of the second clamping arm 10B.
  • the first clip 11A has a straight cross section, and the linear portion is located near the middle portion with a convex portion, and the convex portion is the first clamping portion 111A, the first clip.
  • the tight portion 111A faces upward toward the clamping region;
  • the second clip 11B has a straight cross section, and the linear portion is located near the middle portion with a convex portion, the convex portion is the first clamping portion 111B, and the first clamping portion 111B is oriented Lower facing the clamping area.
  • the first clip 11A has an arc shape in cross section, and a convex portion is provided at a position near the middle portion of the arc shape, the convex portion is a first clamping portion 111A, and the first clamping portion 111A is upward. Facing the clamping region; the cross section of the second clip 11BB is an arc shape, and the position of the arc near the middle portion is provided with a convex portion, the convex portion is the first clamping portion 111B, and the first clamping portion 111B is clamped downward. region.
  • the first clamp arm 10A and the second clamp arm 10B have a three-dimensional cross section.
  • the cross section of the first clamp arm 10A is a zigzag shape rotated 90 degrees clockwise; the cross section of the first clip 11B is a 3-shape rotated 90 degrees counterclockwise.
  • the first clamp arm 10A and the second clamp arm 10B are arched in cross section, and the arcuate profile is enclosed by an arc and a straight line.
  • the straight line of the bow shape faces upward toward the clamping region; for the cross section of the second clamp arm 10B, the straight line of the bow shape faces downward toward the clamping region.
  • the cross section shown in FIG. 13 is symmetrical downward, but is not limited to this embodiment, and various cross-sectional structures as shown in FIG. 13 may be employed, but the upper and lower asymmetry may be employed. .
  • the clamping arm includes a clip and a first clamping portion and a second clamping portion disposed on the clamping piece.
  • the cross section of the clamping arm distinguishes the first clamping piece and the first clamping piece. a clamping portion, a second clamping piece, and a first clamping portion on the second clamping piece, but not limited to the embodiment.
  • the horizontal position shown in FIGS. 12 and 13 can be used at any position on the clamping arm.
  • the cross-sectional structure, the overall cross section of the clamp arm is as shown in Figs. 12 and 13, and the clip and the first clamping portion are not distinguished.
  • the clip 1 is closed without gripping the tissue, as shown in Figures 14 and 15:
  • the length C1 of the first clamping zone is 0.1 mm to 20 mm; preferably, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 8 mm, 10 mm, 15 mm, 18 mm, or the like can be employed.
  • the first pitch K1 is 0.1 mm to 1.2 mm; preferably, 0.2 mm, 0.5 mm, 0.7 mm, 1 mm, 1.1 mm, or the like can be employed.
  • the height H1 of the first clamping portions 111A, 111B is 0.1 mm to 2 mm, and preferably 0.5 mm, 1 mm, 1.5 mm, 1.8 mm, or the like can be employed.
  • the length C1 of the second clamping zone is from 0.01 mm to 20 mm, and preferably, 0.05 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 8 mm, 10 mm, 15 mm, 18 mm, or the like can be used.
  • the second pitch K2 is 0.3 mm to 3 mm; preferably, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, or the like can be employed.
  • the height H2 of the second clamping portion is 0.1 mm to 1.5 mm, and preferably 0.2 mm, 0.5 mm, 0.8 mm, 1 mm, 1.2 mm, or the like can be employed.
  • the length of the first clamping portions 111A, 111B is 0.1 mm to 20 mm, and preferably 0.2 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 8 mm, 10 mm, 15 mm, 18 mm, or the like can be employed.
  • the length of the second clamping portion is 0 mm to 20 mm, and preferably 0.2 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 8 mm, 10 mm, 15 mm, 18 mm, or the like can be used.
  • the suture ligating device disclosed in the patents No. CN201621344652.8 and US Pat. No. 15,597,967 has a suture or barb structure on the clip, but causes the ligature of the clip 1 device to concentrate on the clip teeth 113A, 113B and the suture during the clamping process. Or at the barb structure, the clip is unevenly loaded and the clip 1 device is unstable in ligation.
  • the first clamping zone 101 and the second clamping zone 102 are disposed at two different intervals, which can avoid the bite and tear tissue of the sharp teeth, and at the same time ensure the necessary clamping force to achieve hemostasis and ligation. .
  • first clamping portion and the second clamping portion are formed by providing the first clamping portion and the second clamping portion on the clip, but the invention is not limited to the embodiment, and in other embodiments, The first clamping zone and the second clamping zone are formed by bending the clamping arms.
  • the second clip 11B is provided with a convex first clamping portion 111B toward the side of the first clip 11A.
  • the first clip 11A is not provided with the first clamping portion 111A, and the second clip
  • the area between the first clamping portion 111B of the 11B and the first clip 11A constitutes the first clamping zone 101.
  • the second clip 11B is provided with a convex second clamping portion 112B toward the side of the first clip 11A, and the second clamping portion 112B is located at the distal end of the first clamping portion 111B.
  • the first clip 11A is not provided with the second clamping portion 112A.
  • the area between the second clamping portion 112B of the second clip 11B and the first clip 11A constitutes the second clamping zone 102.
  • the clamping region further includes a third clamping zone 103, the third clamping zone 103 is located at the proximal end of the first clamping zone 101, and the minimum clamping spacing of the third clamping zone 103 is the third spacing.
  • K3 the third pitch K3 is greater than the first pitch K1.
  • the third pitch K3 may be greater than, equal to, or less than the second pitch K2 such that the clamping region constitutes a "wide-narrow-wide" configuration.
  • the third clamping zone 103 can provide a certain relief space at the proximal end of the first clamping zone 101 to prevent tissue from opening the clip 1.
  • the third clamping zone 103 may be located in the receiving tube 210 or may be located outside the receiving tube 210.
  • the length of the third clamping zone is 0 mm to 10 mm, preferably 0.01 mm, 0.1 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1mm, 2mm, 5mm, 8mm, etc.
  • the third pitch K3 is 0 mm to 3 mm, and preferably 0.01 mm, 0.1 mm, 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, or the like can be used.
  • the third clamping zone 103 is located between the first clamping zone 101 and the second clamping zone 102, and the third spacing K3 is greater than the second spacing K2, so that the clamping area constitutes "wide" a wider-narrower structure;
  • the third clamping zone 103 is located between the first clamping zone 101 and the second clamping zone 102, and the third spacing K3 is smaller than the second spacing K2, so that the clamping region constitutes a "wide-medium-narrow" structure;
  • the first clamping zone 101 is located at the distal end of the second clamping zone 102
  • the third clamping zone 103 is located at the proximal end of the second clamping zone 102
  • the third spacing K3 is greater than the second spacing K2, so that the clamping zone Forming a "narrow-wide-wider" structure
  • the first clamping zone 101 is located at the distal end of the second clamping zone 102
  • the third clamping zone 103 is located at the proximal end of the second clamping zone 102
  • the third spacing K3 is smaller than the second spacing K2, so that the clamping zone It constitutes a "narrow-wide-medium" structure.
  • the first clamping portion 111A of the first clip 11A is provided with a notch 114A.
  • the notch 114A can increase the friction between the human body tissue and the first clamping portion 111A, and consolidate the clamping effect of the clamping device. .
  • the first clamping portion 111B of the second clip 11B is provided with a notch 114B.
  • the notch 114B can increase the friction between the human body tissue and the first clamping portion 111B, and consolidate the clamping effect of the clamping device.
  • the notches 114A, 114B are at least two, and the plurality of notches 114A, 114B can further increase the contact surface of the tissue with the clip 1 to alleviate excessive local stress of the tissue.
  • the notches 114A, 114B are symmetrically disposed (not limited thereto, and may be asymmetrically disposed) symmetrically, and the "symmetric arrangement" means that the center line between the first clip 11A and the second clip 11B is The symmetry axis, the first clamping portion 111A on the first clip 11A and the first clamping portion 111B on the second clip 11B are symmetrically disposed, and the notch 114A on the first clip 11A and the notch on the second clip 11B The 114B is symmetrically arranged.
  • symmetry means symmetry or approximation to symmetry. Since manufacturing errors are always present, a slight asymmetry deviation due to manufacturing errors is allowed.
  • the symmetrically arranged notches 114A, 114B can cause a pressing force of "loose, tight, loose, tight" at the first clamping zone 101 to increase the friction and consolidate the clamping effect.
  • the notches 114A, 114B are rounded, the notches 114A, 114B and the first clamping portions 111A, 111B smoothly transition, avoiding the notches 114A, 114B, the first clamping portion 111A 111B causes damage to the tissue, especially when the clamping force of the clip 1 is large, the contact surfaces between the notches 114A, 114B and the first clamping portions 111A, 111B and the tissue can effectively avoid excessive local force. Tissue damage or secondary bleeding.
  • the maximum clamping distance between the notches 114A, 114B is a fourth spacing K4, the fourth spacing K4 is greater than the first spacing K1, and the fourth spacing K4 may be greater than, equal to, or less than the second spacing K2.
  • the first clamping zone 101 is located at the distal end of the second clamping zone 102.
  • the clamp arm 10A includes a clip 11A, and a first clamping portion 111A and a second clamping portion 112A provided on the clip 11A, and the first clamping portion 111A is located at the distal end of the second clamping portion 112A.
  • the clamp arm 10B includes a clip 11B, and a first clamping portion 111B and a second clamping portion 112B provided on the clip 11B, and the first clamping portion 111B is located at the distal end of the second clamping portion 112B.
  • the minimum clamping distance of the first clamping zone 101 (ie the first spacing K1) is smaller than the minimum clamping spacing of the second clamping zone 102 (ie the second spacing K2), the first clamping having a smaller first spacing
  • the tissue is subjected to a large clamping force and can be used for hemostasis; when the second clamping region 102 having a larger second spacing holds the tissue, the tissue can be ligated to consolidate the hemostatic effect.

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

Abstract

La présente invention concerne un dispositif d'agrafage, comprenant : un mandrin (220), un tube de gaine (2) et une agrafe (1), le tube de gaine (2) étant pourvu d'un canal, le mandrin (220) étant disposé dans le canal du tube de gaine (2), le mandrin (220) étant relié à l'agrafe (1) ; l'agrafe (1) comprenant au moins deux bras d'agrafe (10A, 10B), et lorsque l'agrafe (1) est fermée, la région entre les deux bras d'agrafe (10A, 10B) formant une région d'agrafage, la région d'agrafage comprenant une première région d'agrafage (101) et une deuxième région d'agrafage (102), la première région d'agrafage (101) ayant une distance d'agrafage minimale en tant que première distance (K1), la deuxième région d'agrafage (102) ayant une distance d'agrafage minimale en tant que deuxième distance (K2), la première distance (K1) étant inférieure à la deuxième distance (K2), la première région d'agrafage (101) étant située à une extrémité proximale de la deuxième région d'agrafage (102), en variante, la première région d'agrafage (101) étant située à une extrémité distale de la deuxième région d'agrafage (102). Le dispositif peut réaliser une fermeture de surface de plaie pour une hémostase et une fermeture de perforation pour une suture, et peut également assurer la force d'agrafage de l'agrafe (1) de façon à empêcher le tissu de tomber.
PCT/CN2018/075121 2018-02-02 2018-02-02 Dispositif d'agrafage WO2019148450A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2018/075121 WO2019148450A1 (fr) 2018-02-02 2018-02-02 Dispositif d'agrafage

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2018/075121 WO2019148450A1 (fr) 2018-02-02 2018-02-02 Dispositif d'agrafage

Publications (1)

Publication Number Publication Date
WO2019148450A1 true WO2019148450A1 (fr) 2019-08-08

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060155308A1 (en) * 2005-01-11 2006-07-13 Griego John A Multiple clip deployment magazine
CN202960641U (zh) * 2011-11-11 2013-06-05 朱俭 一种活组织结扎装置
CN104490449A (zh) * 2014-12-25 2015-04-08 江苏安特尔医疗科技有限公司 止血夹施夹***
CN204671214U (zh) * 2015-05-15 2015-09-30 江苏唯德康医疗科技有限公司 夹片式重复开合止血夹
US20150282813A1 (en) * 2003-11-07 2015-10-08 Boston Scientific Scimed, Inc. Endoscopic Hemostatic Clipping Apparatus
WO2017201188A1 (fr) * 2016-05-18 2017-11-23 Boston Scientific Scimed, Inc. Pince large pour hémostase

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150282813A1 (en) * 2003-11-07 2015-10-08 Boston Scientific Scimed, Inc. Endoscopic Hemostatic Clipping Apparatus
US20060155308A1 (en) * 2005-01-11 2006-07-13 Griego John A Multiple clip deployment magazine
CN202960641U (zh) * 2011-11-11 2013-06-05 朱俭 一种活组织结扎装置
CN104490449A (zh) * 2014-12-25 2015-04-08 江苏安特尔医疗科技有限公司 止血夹施夹***
CN204671214U (zh) * 2015-05-15 2015-09-30 江苏唯德康医疗科技有限公司 夹片式重复开合止血夹
WO2017201188A1 (fr) * 2016-05-18 2017-11-23 Boston Scientific Scimed, Inc. Pince large pour hémostase

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