WO2019148450A1

WO2019148450A1 - Clipping device

Info

Publication number: WO2019148450A1
Application number: PCT/CN2018/075121
Authority: WO
Inventors: 时百明; 程永华
Original assignee: 杭州安杰思医学科技有限公司
Priority date: 2018-02-02
Filing date: 2018-02-02
Publication date: 2019-08-08

Abstract

A clipping device, comprising: a mandrel (220), a sheath tube (2) and a clip (1), the sheath tube (2) being provided with a channel, the mandrel (220) being provided in the channel of the sheath tube (2), the mandrel (220) being connected to the clip (1); the clip (1) comprising at least two clip arms (10A, 10B), and when the clip (1) is closed, the region between the two clip arms (10A, 10B) form a clipping region, the clipping region comprising a first clipping region (101) and a second clipping region (102), the first clipping region (101) having a minimum clipping distance as a first distance (K1), the second clipping region (102) having a minimum clipping distance as a second distance (K2), the first distance (K1) being less than the second distance (K2), the first clipping region (101) being located at a proximal end of the second clipping region (102), alternatively, the first clipping region (101) being located at a distal end of the second clipping region (102). The device can realize wound surface closure for hemostasis and perforation closure for suture, and can also ensure the clipping force of the clip (1) so as to prevent tissue from falling off.

Description

Clamping device

Technical field

The invention belongs to the field of medical instruments, and in particular relates to a clipping device.

Background technique

At present, 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. For example, gastrointestinal bleeding is often caused by illness or accidental injury or after endoscopic treatment, which can be very dangerous if left untreated. 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. For example, the patent No. 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.

However, 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.

Summary of the invention

Based on this, 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.

Its technical solutions are as follows:

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, and 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.

In one embodiment, 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. Or 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.

In one of the embodiments, the first clamping portion is provided with a notch.

In one of the embodiments, the notch is rounded, and the notch is smoothly transitioned with the first clamping portion.

In one of the embodiments, the gap is at least two.

In one of the embodiments, 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.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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.

In one embodiment, 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 beneficial effects of the invention are:

1. 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.

Wherein the 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.

2. 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. Alternatively, 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. For example, 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 clip located at the distal end of the first clamping portion constitute a second clamping zone.

Or 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.

Preferably, 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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;

Or 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;

Or 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;

Or 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, and the third spacing is greater than the second spacing, so that the clamping zone constitutes "narrow-width- a wider structure;

Alternatively, 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, and the third spacing is smaller than the second spacing, so that the clamping zone constitutes "narrow-width" The structure of "".

9. 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. When the clip is clamped, the teeth of the two clips are engaged. The teeth can better engage the tissue and prevent the tissue from falling out of the clip.

Here, the term "proximal" and "distal" as used herein 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. The "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.

DRAWINGS

1 is an overall structural view of a clip device according to an embodiment of the present invention;

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;

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;

Figure 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.

Description of the reference signs:

1. Clip; 10A, first clamp arm, 10B, second clamp arm, 11A, first clip; 101, first clamping zone, 102, second clamping zone, 103, third clamping zone, 11B a second clamping piece; 111A, a first clamping portion of the first clamping piece; 111B, a first clamping portion of the second clamping piece; 112A, a second clamping portion of the first clamping piece; 112B, a second clamping member a second clamping portion of the sheet; 113A, a pinch of the first clip; 113B, a pinch of the second clip; 114A, a notch of the first clip; 114B, a notch of the second clip; , 210, storage tube, 211, blocking portion, 220, mandrel; 3, control portion; K1, first spacing, K2, second spacing, K3, third spacing, K4, fourth spacing.

Detailed ways

The present invention will be further described in detail below, but embodiments of the invention are not limited thereto.

Embodiment 1

As shown in FIG. 1 and FIG. 2, 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. There is a passage, and the passage of the storage tube 210 communicates with the passage of the sheath tube 2, and the mandrel 220 is inserted into the passage of the sheath tube 2 and the storage tube 210, and the mandrel 220 is connected to the clip 1. 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. When 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.

In the present embodiment, 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. However, it is not limited to the embodiment, and three or more clip arms may be included. 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.

As shown in FIGS. 3 to 7, when the clip 1 is clamped without clamping the human tissue, 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. As shown in FIG. 4, 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. For the first clip 11A, 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; for the second clip 11B, 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.

As shown in Figures 3, 6, and 7, 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. When the clip 1 is clamped, 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.

As shown in Figs. 12 and 13, the first clamp 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:

As shown in Fig. 12(a), 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.

As shown in FIG. 12(b), referring to the up-and-down direction shown in the screen of FIG. 12(b), 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 10B are vertically symmetrical and asymmetrical left and right.

As shown in Fig. 13 (a), the 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.

As shown in Fig. 13 (b), the 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.

As shown in FIGS. 13(c) and (g), 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.

As shown in FIG. 13(d), 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.

As shown in Fig. 13 (e), 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.

As shown in Fig. 13 (f), 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. For the cross section of the first clamp arm 10A, 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.

In the present embodiment, referring to the up, down, left and right directions shown in the screen of FIG. 13, 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. .

In the present embodiment, as shown in FIGS. 12 and 13, 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. In other embodiments, 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.

Preferably, 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.

Accordingly, 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. In contrast, in the present embodiment, 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. .

In this embodiment, the 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.

Embodiment 2

The difference between the second embodiment and the first embodiment is:

As shown in FIG. 8, 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.

Embodiment 3

The difference between the third embodiment and the first embodiment is:

As shown in FIG. 9, 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.

Similar to the measuring method of the first clamping zone and the second clamping zone, 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.

Not limited to the embodiment, 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;

Alternatively, 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;

Alternatively, 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, and the third spacing K3 is greater than the second spacing K2, so that the clamping zone Forming a "narrow-wide-wider" structure;

Alternatively, 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, and the third spacing K3 is smaller than the second spacing K2, so that the clamping zone It constitutes a "narrow-wide-medium" structure.

Embodiment 4

The difference between the fourth embodiment and the first embodiment is:

As shown in FIG. 10, 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. As shown in FIG. 10, 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. The above "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.

Not limited to the above-mentioned scheme of FIG. 10, as shown in FIG. 11, 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.

Embodiment 5

The difference between the fifth embodiment and the first embodiment is:

As shown in FIG. 16, 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 When the region 101 holds the tissue, 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.

The technical features of the above embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, It is considered to be the range described in this specification.

The above embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

A clamping device, comprising: a mandrel, a sheath, and a clip, wherein the sheath is provided with a passage, the mandrel is disposed in a passage of the sheath, the mandrel and the a clip connection, the clip comprising at least two clamp arms, the region between the two clamp arms forming a clamping region when the clip is clamped, the clamping region comprising a first clamping zone and a second clamp a tight zone, a minimum clamping pitch of the first clamping zone is a first spacing, a minimum clamping spacing of the second clamping zone is a second spacing, and the first spacing is smaller than the second spacing;

Wherein the 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 clip device according to claim 1, wherein at least one of said clip arms includes a clip, and said clip is provided with a first clamping portion toward a side of said first clamping portion. The area between the first clamping portion and the remaining of the clamping arms constitutes the first clamping zone.

Or 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 clip device according to claim 2, wherein the first clamping portion is provided with a notch.
The clip device according to claim 3, wherein the notch is rounded, and the notch and the first clamping portion are smoothly transitioned.
The clip device of claim 4 wherein said notches are at least two.
The clip device according to claim 4, wherein at least two of said clips are provided with said first clamping portion and said notch, said notch having the same position on at least two of said clips Or not the same.
The clamping device according to claim 1, wherein the clamping region further comprises a third clamping zone, wherein the minimum clamping pitch of the third clamping zone is a third spacing, the third spacing Greater than the first spacing; wherein:

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 Said 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 less than the Second spacing.
The clamping device according to claim 1, wherein the clamping arm has a U-shaped cross section;

Or the cross section of the clamp arm is C-shaped;

Or the cross section of the clip arm is a 3-shaped shape;

Or the cross section of the clip 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 facing the first clamping region;

Or, the cross section of the clip arm is bow-shaped.
The clamping device according to any one of claims 1 to 8, wherein the first clamping zone has a length of 0.1 mm to 20 mm, and 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, and the second spacing K2 is 0.3 mm to 3 mm;

Alternatively, 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 clip device according to any one of claims 1 to 8, further comprising a housing tube and a control unit, wherein the control unit is in contact with the mandrel and the proximal end of the sheath tube, and the housing The tube is in contact 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 .