WO2021082482A1 - 一种医用止血夹 - Google Patents

一种医用止血夹 Download PDF

Info

Publication number
WO2021082482A1
WO2021082482A1 PCT/CN2020/098131 CN2020098131W WO2021082482A1 WO 2021082482 A1 WO2021082482 A1 WO 2021082482A1 CN 2020098131 W CN2020098131 W CN 2020098131W WO 2021082482 A1 WO2021082482 A1 WO 2021082482A1
Authority
WO
WIPO (PCT)
Prior art keywords
clip
control wire
sheath
distal
control
Prior art date
Application number
PCT/CN2020/098131
Other languages
English (en)
French (fr)
Inventor
茅爱武
邹晓平
唐志
范茗侨
解欢
宋冉
李常青
李宁
奚杰峰
金鸿雁
韦建宇
刘春俊
Original Assignee
南微医学科技股份有限公司
Priority date (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 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Publication of WO2021082482A1 publication Critical patent/WO2021082482A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/083—Clips, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/10—Surgical instruments, devices or methods, e.g. tourniquets for applying or removing wound clamps, e.g. containing only one clamp or staple; Wound clamp magazines
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding

Definitions

  • This application relates to a medical hemostatic clip, which belongs to a medical device used in the human body.
  • Endoscopes have been born for more than 50 years and have gone through the stage from disease diagnosis to disease treatment.
  • the treatment of specific diseases has been very effective and reliable, and has been widely used.
  • the stomach and intestines of organisms often cause bleeding, mucosal damage, or even perforation due to various diseases, accidental injuries, or injuries during endoscopic diagnosis and treatment.
  • Active bleeding is usually treated by drug spraying, high-frequency electrosurgical burning, or mechanical compression with hemostatic clips to stop bleeding.
  • mechanical compression of hemostatic clamps is more reliable for the treatment of active bleeding caused by non-varices, and has been generally recognized by doctors and patients.
  • endoscopic hemostasis technology hemostatic clamps are used for activities under endoscopy. Sexual bleeding treatment has become the first choice.
  • the current hemostatic clip commonly used in clinical surgery is mostly a single hair clip. There is only one clip in a set of hemostatic clip assembly, and it can only be released once. After the clip is released, the hemostatic clip needs to be removed from the endoscope. If the wound is large or bleeding points When multiple clips are needed to close the tissue, it is necessary to repeatedly replace the hemostatic clip assembly and repeat positioning, which not only greatly increases the workload of the doctor's operation and increases the treatment cost, but also takes a lot of time to repeatedly insert and extract the hemostatic clip assembly , There may even be the possibility of causing massive bleeding in the patient’s digestive tract. Therefore, the current hair clip has been gradually recognized based on its advantages of being able to release the clip multiple times after one insertion.
  • Prior art WO2006098994A1 discloses a continuous hair clip.
  • the disadvantage of the continuous hair clip is that multiple clips are connected end to end in sequence, and the control wire is only connected to the nearest clip.
  • the connection strength between the rear clips needs to be gradually increased. If the most distal clip If the release is not successful, the clip at the back end is likely to fail due to excessive tension. At this time, the entire set of hemostatic clip components need to be replaced. This situation will not only cause delays in the operation time but also increase the cost of the patient.
  • the most distal clip is released, the rear-end clip bears a certain force, so the performance of the clip will be damaged, which will cause the stability and reliability of each clip to be inconsistent and affect the treatment effect.
  • the prior art CN107280723A discloses a continuous hair clip.
  • the shortcomings of the continuous hair clip are that the design structure of the hemostatic clip cannot realize the repeated opening and closing of the clip, and the flexible rotation of the clip cannot be realized.
  • the prior art CN107106181A discloses a continuous hair clip.
  • the disadvantage of the continuous hair clip is that the structure of the continuous hair clip also cannot achieve repeated opening of the clip. When the clip slips off the tissue to be clamped, The distal clip cannot be deployed again, but can only be released, and the clip at the back is reloaded, which increases the cost of the operation.
  • the present application provides a medical hemostatic clip that can be repeatedly opened and closed, and can be flexibly rotated and accurately adjusted, which at least includes the following structure:
  • the clip assembly includes at least one clip arranged in an axial direction
  • a control wire which connects the clip components in series along the axial direction, and controls the opening or closing of the most distal clip by moving the control wire.
  • the clip includes a clip body and a clip seat, and the distal end of the control wire is connected to the The clip body of the most distal clip can be releasably connected;
  • a handle located at the proximal end of the control line and configured to control the forward and backward movement of the control line;
  • control wire extends along the sheath lumen, and the clip assembly is located on the distal side of the sheath lumen;
  • the distal end of the sheath has a limiting component, the proximal side of the limiting component has a limiting space facing the axial direction of the sheath, and at least a part of the most distal clip is releasably limited by the limiting component Located in the limited space.
  • the distal end of the limiting component has a limiting boss provided in a circumferential direction to form the limiting space on the proximal side of the limiting boss, and the outer peripheral wall of the clip base of the most distal clip is provided There is a biasing mechanism, and the biasing mechanism is releasably limited in the limiting space on the proximal side of the limiting boss.
  • the limiting boss extends toward the axial direction of the sheath, and when the radial expansion force received by the convex surface of the limiting boss is greater than a threshold, the limiting boss radially expands and releases the The most distal clip is described.
  • the sheath includes an inner sheath and an outer sheath sleeved on the outside of the inner sheath, the limiting component is located at the distal end of the outer sheath, and the proximal side of the limiting boss and the inner sheath The distal end of the sheath constitutes the limiting space configured to limit the most distal clip.
  • control wire includes a first control wire on the distal side and a second control wire on the proximal side, and the proximal end of the first control wire is movably connected to the distal end of the second control wire; wherein , The proximal end of the first control wire has a rotation control component that controls the rotation of the first control wire relative to the second control wire.
  • the present application also provides a medical hemostatic clip that can be repeatedly opened and closed, and can be flexibly rotated and accurately adjusted at an angle, which at least includes the following structure:
  • the clip assembly includes at least one clip arranged in an axial direction
  • the control wire connects the clip assembly in series along the axial direction, and controls the opening or closing of the most distal clip by moving the control wire.
  • the clip includes a clip body and a clip seat, and the distal end of the control wire is connected to the most distal clip.
  • the clip body of the distal clip can be releasably connected;
  • a handle located at the proximal end of the control line and configured to control the forward and backward movement of the control line;
  • control wire extends along the sheath lumen, and the clip assembly is located on the distal side of the sheath lumen;
  • the control wire includes a first control wire on the distal side and a second control wire on the proximal side.
  • the proximal end of the first control wire is movably connected to the distal end of the second control wire; wherein, the The proximal end of the first control wire is provided with a rotation control component that controls the rotation of the first control wire relative to the second control wire.
  • the rotation control assembly includes an end knob located at the proximal free end of the first control line, and a first limiting block and a second limiting block located near the first control line and spaced apart, the first limiting block
  • the position block and the second limit block are configured to limit the displacement of the second control line relative to the first control line in the axial direction.
  • the sheath includes an inner sheath and an outer sheath sheathed outside the inner sheath, the limiting component is located at the distal end of the outer sheath, and the proximal side of the limiting component is connected to the inner sheath A limiting space configured to limit the most distal clip is formed between the distal ends of the tubes.
  • the inner sheath includes a first inner sheath at the distal end that is configured to accommodate a plurality of the clips, and a second inner sheath at the proximal end that accommodates the control wire, and both ends are fixedly connected, so The clip is limited in the first inner sheath in the initial state.
  • the rotation control assembly is located at the proximal end of the inner sheath, and the connection between the rotation control assembly and the inner sheath is any one of the following (1) or (2):
  • the inner sheath is provided with a knob sliding groove, when the control wire slides back and forth, the rotation control assembly is located in the knob sliding groove and moves axially;
  • the inner sheath is provided with an extension hole of the rotation control assembly, and the proximal free end of the first control wire is movably extended from the extension hole.
  • the outer sheath and the inner sheath can move relatively, and the proximal end of the outer sheath is movably connected to the outer wall of the proximal end of the inner sheath through a movable stopper.
  • the structure of the movable limiter is any one of the following (1) or (2):
  • the proximal end of the movable restricting member is fixedly connected with the outer wall of the inner sheath, the distal end has a restricting track, and the proximal end of the outer sheath is axially restricted to move along the restricting track;
  • the proximal end of the outer sheath tube is provided with a positioning member provided with a sliding channel
  • the proximal end of the movable limiting member is fixedly connected to the outer wall of the inner sheath tube with a fixed connection part
  • the fixed connection part is provided with a distal end
  • the positioning sliding rod extends through the sliding channel and the distal end of the positioning sliding rod is limited in the positioning member.
  • the proximal end of the clip body in each of the clips has a release hole
  • the distal end of the control wire has a release component releasably connected to the release hole.
  • the tension on the control wire is greater than a threshold, the release The component escapes from the release hole.
  • the device of the present application realizes the repeated opening and closing of the clip through the structural design of the limit component.
  • the clip can be repeatedly opened and closed at least five times, which is convenient for multiple pre-clamping and repeated positioning. It is beneficial to place the hemostatic clamp at the most appropriate position to achieve the best hemostasis effect and avoid reloading a new clamp due to improper clamping.
  • the doctor can insert the hemostatic clip device at one time, and under the condition that multiple hemostatic clips can be released to fully hemostatically clamp the lesion, it is ensured that the release process of each clip is stable and reliable, and there will be no clip clamping failure. Invalid release process caused by success.
  • the continuous hair clip of the present application has a simple and reasonable structure, simple and convenient operation, stable and reliable release.
  • flexible rotation and adjustment of the angle can be realized during use, so that the doctor can quickly and accurately adjust the angle of the clip and the lesion , To better clamp the lesion.
  • the clip is arranged in the delivery device, which greatly shortens the length of the clip, makes it simpler and more reliable, has a shorter structure, and is more suitable for passing through curved endoscopic forceps, providing clinicians with a It can be widely used in devices of various parts of the digestive tract.
  • Figure 1 is an overall view of the hemostatic clip device in Example 1 of the present application.
  • Example 2 is a side view of the distal end of the hemostatic clip device in Example 1 of the present application;
  • FIG 3 is an assembly view of the distal end clip of the hemostatic clip device in Example 1 of the present application.
  • Example 4 is a view of the unfolded state of the distal end clip of the hemostatic clip device in Example 1 of the present application;
  • Example 5 is a separate view of the unfolded state of the distal end clip of the hemostatic clip device in Example 1 of the present application;
  • Example 6 is an exploded view of the unfolded state of the distal end clip of the hemostatic clip device in Example 1 of the present application;
  • Figure 8 is a view of the hemostatic clip device in Example 1 of the present application without a clip loaded
  • Figure 9 is a view of the connection between the outer sheath and the inner sheath of the hemostatic clip device in Example 1 of the present application;
  • Example 10 are respectively an axial cross-sectional view and a three-dimensional view of the limiting component of the hemostatic clip device in Example 1 of the present application;
  • Example 11 is a schematic diagram of the release process of the most distal clip in Example 1 of the present application.
  • Figure 12 is a view of the connection between the outer sheath and the inner sheath of the hemostatic clip device in Example 2 of the present application;
  • FIG. 13 is a schematic diagram of the release process of the most distal clip in Embodiment 3 of the present application.
  • FIG. 17 is an axial cross-sectional view of the limiting component in Embodiment 7 of the present application.
  • the proximal end refers to the end close to the operator outside the body; the distal end refers to the end located in the body to be closed; the axial direction refers to the direction along the longitudinal axis of the hemostatic clip control line; the radial refers to the direction perpendicular to the axial direction; Circumferential refers to the circumferential direction along the circumferential axis.
  • the first embodiment of the medical hemostatic clip in the present application wherein the hemostatic clip is a continuous hair clip (as shown in Figure 1), and includes two or more clips 1 arranged in the axial direction.
  • a clip assembly (not shown in the figure), a control line 2 that connects each clip 1 in the clip assembly in an axial direction and can control the opening or closing of the most distal clip.
  • the clip 1 includes a clip body (not shown in the figure). Mark) and a clip base 14.
  • the distal end of the control wire 2 is releasably connected to the clip body of the most distal clip 11; the burst clip also includes a proximal end of the control wire 2 and is configured to control the
  • the control wire 2 moves back and forth along the axial direction of the handle 3, and the sheath 4, the control wire 2 extends along the inner cavity of the sheath 4, and the proximal end of the control wire is fixedly connected to the slider 31 on the handle 3.
  • the clip assembly is located on the distal side of the inner cavity of the sheath.
  • the sheath 4 includes an inner sheath (as shown in FIG.
  • the inner sheath includes a first inner sheath 42 at the distal end and a second inner sheath 43 at the proximal end) and a sheath
  • the outer sheath 41 outside the inner sheath, the distal end of the outer sheath 41 has a limiting component 5 protruding from the distal end of the first inner sheath 42, and the most distal clip 11 is releasably held
  • the limiting component 5 is limited to the distal end of the sheath.
  • the control wire 2 is driven to slide back and forth by moving the slider 31 on the handle 3 back and forth, so that the most distal clip 11 is opened or closed.
  • the force of the proximal end of the control wire is greater than a threshold (that is, it can be When the force of the clip to enter the locked position), the clip body in the clip at the farthest end of the clip 11 is locked in the clip base 14, and the control line continues to be pulled to the proximal end.
  • a threshold that is, it is, it is possible to realize that the release component can escape from the release channel
  • the proximal end of the limiting component 5 is fixedly connected to the distal end of the outer sheath 41, and the distal end has a number of limiting protrusions 51 arranged in a circumferential direction, each of the limiting protrusions
  • the convex surface of the platform 51 faces the axial direction of the sheath tube.
  • a biasing mechanism 15 is provided on the outer peripheral wall of the clip base 14 of the most distal clip 11, and the biasing mechanism 15 is releasably limited to the limiting boss 51 and the first inner sheath 42. In the space formed between the ends. Specifically, the biasing mechanism 51 on the clip base 14 is pre-formed into an outwardly expanded form.
  • the limiting component 5 and the distal end of the outer sheath can also be an integral structure, and those skilled in the art can make changes according to actual needs, and they are all within the protection scope of the present application.
  • Embodiment 1 realizes the repeatable opening and closing of the clip by adopting the structure of the limiting component 5, and the clip can be repeatedly opened and closed at least five times, which is convenient for multiple pre-clamping and repeated positioning. It is beneficial to place the hemostatic clamp at the most appropriate position to achieve the best hemostasis effect and avoid reloading a new clamp due to improper clamping.
  • the doctor can insert the hemostatic clip device at one time, and under the condition that multiple hemostatic clips can be released to fully hemostatically clamp the lesion, it is ensured that the release process of each clip is stable and reliable, and there will be no clip clamping failure. Invalid release process caused by success.
  • a rotation control assembly 6 is provided at the proximal end.
  • the second inner sheath 43 extends proximally and is fixedly connected to the distal end of the handle, and the area where the proximal end extends beyond the outer sheath 41 is provided with a rotation control assembly 6;
  • the control line in the first embodiment includes the distal end The first control wire 21 on the side and the second control wire 22 on the proximal side, the proximal end of the first control wire 21 is movably connected to the distal end of the second control wire 22; wherein, the rotation control assembly 6 is fixedly connected to the proximal end of the first control wire 21, and the first control wire 21 is controlled to rotate relative to the second control wire by rotating the rotation control assembly 6.
  • the rotation control assembly 6 includes an end knob 61 located near the free end of the first control wire 21, and a first limiting block 62 and a second limiting block 63 located near the first control wire 21 and spaced apart.
  • the first limiting block 62 and the second limiting block 63 are configured to limit the displacement of the second control wire 22 relative to the first control wire 21 in the longitudinal direction.
  • the second inner sheath 43 has an extension hole of the first control wire 21 (not shown in the figure).
  • a first limiting block 62 and a second limiting block 63 are fixed at intervals on the proximal side of the first control line 21, and the distal end of the second control line 22 has a channel structure (not shown in the figure), and the end of the first control line 21
  • the pore structure passes through and extends from the extension hole on the second inner sheath 43, so as to realize the movable connection of the first control line 21 and the second control line 22, and the second control line can be freely relative to the first control line.
  • the moving distance is limited between the first limit block 62 and the second limit block 63.
  • the proximal end of the second control wire 22 is fixedly connected with the slider 31 on the handle 3.
  • the sliding slider 31 drives the second control wire 22 to slide back and forth
  • the distal end of the second control wire 22 abuts and pushes the first limit block 62, thereby driving the first control
  • the line 21 moves forward; when the second control line 22 moves to the proximal end, the distal end of the second control line abuts and pulls the second limiting block 63, and the end of the second control line 22 drags the first control line 21 closer End mobile.
  • first control wire 21 Since the first control wire 21 is movably extended from the extension hole on the second inner sheath tube 43, when the first control wire 21 moves back and forth in the axial direction, the free end of the first control wire 21 is not covered by the sheath.
  • the constraints of pipes and other parts realize the effective movement of the control line in the axial direction.
  • the rotating control assembly by additionally designing the rotating control assembly near the operating end of the doctor, it overcomes the technical defect that the rotation of the clip can only be controlled by the nurse operating the handle end in the prior art, and realizes that the first operating position of the doctor can be adjusted arbitrarily at the distal end.
  • the rotation angle of the control wire 21 further adjusts the technical effect of the clip angle, and the position of the rotation control assembly extending out of the sheath can be flexibly adjusted according to the position of the doctor in the actual operation, which greatly improves the flexibility of the operation during the operation.
  • the doctor can adjust the rotation angle of the clip arm by rotating the end knob 61 according to the actual lesion position and shape, without the need to rotate the entirety to stop bleeding There is no need to adjust the operating position of the nurse during the operation.
  • it can reduce the friction of the human body cavity tissue of the sheath arm, reduce the damage of the instrument to the human body, and improve the safety of the instrument; Flexibility, enhance the convenience of operation.
  • the extension hole in the above-mentioned embodiment 1 is transformed into an axially extending knob provided on the second inner sheath 43
  • the second limiting block 63 is located inside the knob sliding groove and is fixedly connected with the first control line 21, and the rotation control assembly is located in the sliding groove to axially limit the movement.
  • the first control line can be relative to the second control line under the premise of ensuring that the second control line can drive the first control line to move back and forth.
  • the wire rotates freely, and any achievable connection mode should be within the protection scope of this application.
  • the outer sheath 41 and the second inner sheath 43 in Embodiment 1 can move relatively, and the outer sheath 41
  • the proximal end is movably connected to the outer wall of the proximal end of the second inner sheath 43 through the movable limiting member 7.
  • the proximal end of the movable limiter 7 has a fixed connecting portion 71 which is fixedly connected to the outer wall of the inner sheath tube.
  • the fixed connecting portion 71 is provided with a positioning sliding rod 72 extending to the distal end.
  • the outer The proximal end of the sheath 41 has a positioning member 44, the positioning member 44 is provided with a sliding channel 45, the positioning sliding rod 72 extends distally through the sliding channel 45, and a protrusion is provided at the distal end of the positioning sliding rod 72 So that the positioning member 44 does not come out of the distal end of the positioning slide rod, the positioning member 44 on the outer sheath 41 can move in a limited position between the flange structure of the positioning slide rod 72 and the fixed connecting portion 71, and the maximum movement is The displacement is that the limiting boss 51 on the limiting component 5 is pulled to the outer side of the distal end of the inner sheath, so that the required distance of the outer sheath moving between the clip released state corresponds to that.
  • the method of the positioning sliding rod 72 and the sliding channel 45 in the first embodiment is changed.
  • the movable limit The member has a limiting track structure, the proximal end of the movable limiting member is fixedly connected to the outer wall of the inner sheath, and the structure provided with the limiting track extends along the longitudinal axis at the distal end. Accordingly, the distal end of the outer sheath
  • the limit sliding block adapted to the track can slide axially along the limit track, which can also realize the movable limit connection of the outer sheath 41 and the inner sheath.
  • any existing manner that can realize the movable limit connection of the outer sheath 41 and the inner sheath falls within the protection scope of the present application.
  • Each clip 1 includes a clip body (not shown in the figure) and a clip base 14 sleeved on the proximal end of the clip body, wherein the distal end of the clip body is a pair of oppositely arranged clip arms 13, the proximal end of which is housed in the clip base.
  • the clamp arm can be opened or closed; the proximal end of the clamp body has a release channel 19, and the distal end of the control wire 2 has a release assembly 23 releasably connected to the release channel 19, When the pulling force received by the control wire 2 is greater than a threshold, the release assembly 23 is released from the release hole 19.
  • the threshold refers to the maximum pulling force received by the control wire at the moment of release, which is radially expanded and elastically by the release hole. The deformation characteristics of the release component 23 at the distal end of the control line are determined.
  • the axial cross-section of the release component is nearly “I" shape
  • the release channel 19 is locked in the "I” shape groove in the unextended state
  • the release channel 19 is in the shape of a releasable long strip and a circle. Any structure that can achieve the above technical effects, such as a shape or an ellipse.
  • the clip body is an integrally formed near "U"-shaped clip.
  • the distal end of the clip body has a pair of axially symmetrical clamping arms 13, and the proximal end has a distal end configured to pass through the control line 2
  • the release hole 19 at the end and the elastic piece 16 on the distal side of the release hole 19 are arranged symmetrically in the radial direction.
  • the elastic piece can be compressed when subjected to a radial biasing force.
  • the clamp base 14 is cylindrical.
  • the distal side wall of the clamp base 14 is axially symmetrically provided with a biasing mechanism 15 which is an elastic member that can be biased radially.
  • the proximal side wall of the clamp base 14 is provided with a spring slide groove 17
  • the elastic piece 16 at the proximal end of the clip body slides back and forth in the elastic piece chute 17, so as to provide structural support for the clip to be opened and closed repeatedly; in addition, there is a locking groove at the proximal end of the elastic piece chute 17 18.
  • the clip assembly can be roughly divided into the most distal clip 11 (as shown in Figure 2) and the unloaded clip located at the proximal end of the first inner sheath (as shown in Figure 8), where the The inner sheath includes a first inner sheath 42 at the distal end that is configured to accommodate a number of the clips, and a second inner sheath 43 at the proximal end that accommodates the control wire.
  • the ends of the two are fixedly connected (as shown in Figure 2). (Shown), the clip is limited in the first inner sheath 42 in the initial state.
  • the release assembly at the distal end of the control wire can be releasably connected to the release channel 19 at the tail end of the clip body.
  • the unloaded clip is located at the proximal end of the most distal clip 11, and the proximal end of the clip arm is housed in the channel of the clip base 14.
  • the control wire sequentially connects the unloaded clips in series, that is, the control wire passes through the release channel at the tail of the closest clip. It is transmitted from the two clamp arms of the clamp, and then each unloaded clamp is connected in series in the same way.
  • each clamp There is no connection between each clamp and the control line, and the control line will not affect the shape and shape of each unloaded clamp during the movement process. performance.
  • the control wire moves to the proximal end until the release component at the distal end of the control wire opens and closes with the release channel of the tail of the distal most clip at this time, so as to realize the loading of the new clip.
  • the loading process from the release of the clip to the new clip will not affect the subsequent unloaded clip, ensuring the stability of the clip performance without being affected by the process of clip release and loading.
  • the connection between the outer sheath and the inner sheath in Example 1 is changed.
  • the proximal end of the outer sheath 41 and the outer wall of the second inner sheath 43 are directly and fixedly connected by the fixed connecting portion 71. Accordingly, the movement of the control wire can be used to control the release during the release process.
  • the specific operation process can refer to the operation mode of using the control wire to release the clip in Embodiment 1, which will not be repeated here.
  • the outer sheath 41 and the inner sheath in the fourth embodiment are replaced with a relatively movable manner.
  • the outer sheath 41 can also be moved.
  • the release assembly is also detached from the release channel of the most distal clip 11 first, and then along As shown by the dotted line in Fig. 13, by pulling the outer sheath proximally, the convex surface inside the limiting boss 51 is radially expanded by the radial and axial compression of the first inner sheath and then pulled to the first inner sheath.
  • the outer circumference of the distal end of the tube, and the most distal clip 11 is released. It can be seen that based on Embodiment 1 and Embodiment 3, the release of the clip can be achieved in two ways in this application, and the operation is more flexible. In the actual operation, the doctor can choose an appropriate operation method according to different parts and shapes of the operation.
  • the limit component structure in embodiment 1 is transformed, and the limit boss 51 with 4 circumferential distributions in embodiment 1 is replaced with the limit boss 51 with 3 circumferential distributions.
  • Each of the limiting bosses 51 forms a notch 52, and the depth and width of the notch define the extent of deformation of the limiting boss 51 to expand outwardly under compression.
  • You can control the radial expansion tension and deformation range of the limit boss by changing the number of limit bosses, and you can flexibly choose the appropriate limit component form according to the actual surgical scene. Of course, according to the actual size and application scenarios. Correspondingly increase or decrease the number of limit bosses to obtain the most effective release effect.
  • the restriction assembly structure in Embodiment 1 is changed.
  • the restriction assembly is formed integrally with the outer sheath 41, and the restriction assembly 5 extends from the end of the outer sheath to the distal end.
  • Symmetrical shrapnel the shrapnel is bent in the axial direction to form a limiting boss 51 structure, two symmetrically arranged two limiting bosses 51 and the distal surface of the inner sheath 42 form a space that limits the most distal clip.
  • the elastic sheet is compressed by the biasing mechanism on the outer peripheral surface of the clip and expands outward.
  • the structure in this embodiment is simple, and the release process is easy to control.
  • the structure of the limiting component in Embodiment 1 is changed.
  • the limiting component is formed integrally with the outer sheath 41, and the limiting component 5 extends from the end of the outer sheath to the distal end.
  • Cylindrical structure, the distal end of the cylindrical structure is circumferentially distributed with shrapnel bent in the axial direction to form a limiting boss 51, and the circumferentially distributed bending-shaped limiting boss 51 and the distal surface of the inner sheath 42
  • the space constitutes a space that limits the most distal clip.
  • the elastic piece bent inward is compressed by the biasing mechanism on the outer peripheral surface of the clip and expands outward.
  • the structure in this embodiment is simple, and the release process is easy to control.
  • the inner and outer sheath structures in Embodiment 1 are changed.
  • a single sheath structure is adopted.
  • the distal end of the sheath 4 has a limiting component 5, and the proximal end of the limiting component 5 is
  • the side has a limiting space facing the axial direction of the sheath, and at least a part of the most distal clip 11 is releasably limited in the limiting space by the limiting component 5.
  • the limiting space is defined by a number of axially-arranged limiting bosses 51 and a limiting portion 53 protruding inward from the proximal end of the limiting component 5.
  • a biasing mechanism 15 (combined with the most distal clip structure shown in FIGS. 2-3) is provided on the outer peripheral wall, and the biasing mechanism 15 is releasably limited between the limiting boss 51 and the limiting portion 53 Within the limit space formed.
  • the sheath 4 and the limiting component 5 may be integrally formed, or they may be separately manufactured and assembled according to actual assembly and manufacturing requirements.

Landscapes

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

Abstract

一种医用止血夹，至少包括如下结构：夹子组件；控制线(2)，沿轴向将夹子组件串接，并通过移动控制线(2)控制最远端夹子(11)的打开或闭合；手柄(3)，配置成控制控制线(2)的前后移动；鞘管(4)；鞘管(4)远端具有限位组件(5)，限位组件(5)近端侧具有朝向鞘管(4)轴向方向的限位空间，最远端夹子(11)的至少一部分可释放地被限位组件(5)限位于限位空间内。该医用止血夹具有可重复开闭和可旋转等技术效果。

Description

一种医用止血夹
相关申请的交叉引用
本申请要求于2019年10月29日提交中国专利局的申请号为CN201911035842.X、名称为“一种医用止血夹”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医用止血夹，属于人体内使用的医用装置。
背景技术
内窥镜诞生50多年来，经历了从疾病诊断到疾病治疗的阶段，对特定疾病的治疗已经十分有效和可靠，得到广泛应用。生物体的胃、肠道经常会因各种疾病、意外损伤或内镜诊疗术中损伤导致出血或黏膜损伤，甚至穿孔。对于活动性出血一般进行药物喷洒、高频电刀灼烧、或是止血夹机械压迫止血等方法进行治疗。其中止血夹机械压迫止血对于非静脉曲张造成的活动性出血治疗效果较为可靠，并且也已经得到医生和患者的普遍认可，且随着内镜下止血技术的发展，内镜下应用止血夹进行活动性出血治疗已成为首选。
现有临床手术常用止血夹多为单发夹，一套止血夹组件中仅有一发夹子，也只能释放一次，夹子被释放后止血夹需要从内镜中抽出，如果创面大或出血点多，需要使用多个夹子闭合组织时，就需要反复更换止血夹组件，反复定位，不仅极大的增加医生手术的工作量，增加治疗成本，而且重复插入、抽出止血夹组件会花费大量的时间，甚至会出现导致患者消化道大量出血的可能。因此，目前连发夹基于其可以实现一次插入可以多次释放夹子的优点，得到了逐步认可。
同时，临床应用止血夹进行治疗过程中，医生需要针对病灶组织位置、形态及状态等对止血夹的角度做出精确的调整，并且灵活、快速地调整夹子的角度以便更好的对病灶进行夹闭。快速、准确、灵活的调整止血夹旋转角度，对消化道病灶闭合十分重要，也是医生在实际手术中迫切需要的。同样，由于人体腔道的正常蠕动，夹子闭合到一半时，待夹持的组织容易从夹子中滑脱，此时需要重新张开夹子，进行二次夹持，因此，需要夹子具有可重复开闭的性能。此外，通过控制线能够有效地将远端夹子释放又不影响其他夹子形态、性能也是连发夹子需要改进的一个重要方向。
现有技术WO2006098994A1公开了一种连发夹子，该连发夹子的不足之处在于，多个夹子依次首尾连接，控制线仅与最近端夹子连接，当向最远端夹子施加拉力以释放远端夹子时，需要通过其后的各个夹子来传递力，为了有效将力传递给远端夹子并保证在后夹子间不断开，在后夹子间连接强度就需要逐渐增加，若最远端夹子没有成功释放，则后端的夹子极可能因拉力过大而失效，此时就需要更换整套止血夹组件，这种情况不仅会导致手术时间延误而且加大增加患者成本。此外，在释放最远端夹子时后端夹子均承受了一定的力，因此夹子的性能会受到一些损伤，这样会导致每个夹子的稳定性、可靠性不一致，影响治疗效果。
现有技术CN107280723A公开了一种连发夹子，该连发夹子的不足之处在于该止血夹的设计结构无法实现夹子的重复开闭，也无法实现夹子的灵活转动，在实际治疗过程中，医生很难调整夹子与病灶的角度，当组织脱出后只能释放远端夹子，采用后面的夹子重新夹持组织，而很难使用同一夹子进行重复定位，增加了手术成本和手术难度。
现有技术CN107106181A公开了一种连发夹子，该连发夹子的不足之处在于该连发夹 子的结构同样无法实现夹的重复张开，当夹子从待夹持的组织滑脱时，远端夹子就无法再次展开，只能释放掉，重新加载在后的夹子，增加了手术成本。
可见现有连发夹子结构中存在一定设计缺陷，导致夹子或是无法重复开闭，或是无法灵活调整角度，亦或夹子释放过程中，后面待释放夹子会受到远端夹子释放的影响而导致夹子性能的下降。
有鉴于此，特提出本申请。
发明内容
基于现有技术存在的不能重复开闭并且角度调整不灵活等技术问题，本申请提供一种可重复开闭，可灵活旋转准确调整角度的医用止血夹，至少包括如下结构：
夹子组件，包括至少一个沿轴向排列的夹子；
控制线，沿轴向将所述夹子组件串接，并通过移动所述控制线控制最远端夹子的打开或闭合，所述夹子包括夹体和夹座，所述控制线远端与所述最远端夹子的夹体可释放连接；
手柄，位于所述控制线近端，配置成控制所述控制线的前后移动；
鞘管，所述控制线沿所述鞘管内腔延伸，所述夹子组件位于所述鞘管内腔的远端侧；
所述鞘管远端具有限位组件，所述限位组件近端侧具有朝向鞘管轴向方向的限位空间，所述最远端夹子的至少一部分可释放地被所述限位组件限位于所述限位空间内。
优选地，所述限位组件远端具有周向设置的限位凸台以在该限位凸台的近端侧形成所述限位空间，所述最远端夹子的夹座外周壁上设有偏压机构，所述偏压机构被可释放地限位于所述限位凸台近端侧的限位空间内。
优选地，所述限位凸台朝向鞘管轴向方向延伸，当所述限位凸台的凸出面受到的径向扩张力大于一阈值时，所述限位凸台径向扩张并释放所述最远端夹子。
优选地，所述鞘管包括内鞘管和套设于所述内鞘管外侧的外鞘管，所述限位组件位于外鞘管远端，且所述限位凸台近端侧与内鞘管远端间构成配置成限位所述最远端夹子的所述限位空间。
优选地，所述控制线包括远端侧的第一控制线以及与近端侧的第二控制线，所述第一控制线的近端与所述第二控制线的远端活动连接；其中，所述第一控制线近端具有控制所述第一控制线相对于所述第二控制线转动的旋转控制组件。
本申请还提供一种可重复开闭，可灵活旋转准确调整角度的医用止血夹，至少包括如下结构：
夹子组件，包括至少一个沿轴向排列的夹子；
控制线，沿轴向将所述夹子组件串接，通过移动所述控制线控制最远端夹子的打开或闭合，所述夹子包括夹体和夹座，所述控制线远端与所述最远端夹子的夹体可释放连接；
手柄，位于所述控制线近端，配置成控制所述控制线的前后移动；
鞘管，所述控制线沿所述鞘管内腔延伸，所述夹子组件位于所述鞘管内腔的远端侧；
所述控制线包括远端侧的第一控制线以及与近端侧的第二控制线，所述第一控制线的近端与所述第二控制线的远端活动连接；其中，所述第一控制线近端设有控制所述第一控 制线相对于所述第二控制线转动的旋转控制组件。
优选地，旋转控制组件包括位于第一控制线近侧自由端的末端旋钮，以及位于所述第一控制线近侧且间隔设置的第一限位块和第二限位块，所述第一限位块和所述第二限位块配置成限制所述第二控制线相对于所述第一控制线在轴向上的位移。
优选地，所述鞘管包括内鞘管和套设于所述内鞘管外侧的外鞘管，所述限位组件位于外鞘管远端，且所述限位组件近端侧与内鞘管远端间构成配置成限位所述最远端夹子的限位空间。优选地，所述内鞘管包括位于远端的配置成容纳若干所述夹子的第一内鞘管以及位于近端的容纳所述控制线的第二内鞘管，两者末端固定连接，所述夹子初始状态下为限位在所述第一内鞘管中。
优选地，所述旋转控制组件位于所述内鞘管近端部，所述旋转控制组件与所述内鞘管的连接方式如下述(1)或(2)中的任意一种：
(1)内鞘管上具有旋钮滑槽，当控制线前后滑动时，所述旋转控制组件位于旋钮滑槽内轴向限位移动；
(2)内鞘管上具有所述旋转控制组件的伸出孔，所述第一控制线近侧自由端可移动地由所述伸出孔伸出。
优选地，所述外鞘管与所述内鞘管能够相对移动，所述外鞘管近端通过活动限位件活动连接至内鞘管近端部外壁。
优选地，所述活动限位件的结构如下述(1)或(2)中的任意一种：
(1)所述活动限位件近端与内鞘管外壁固定连接，远端具有限位轨道，所述外鞘管近端沿所述限位轨道轴向限位移动；
(2)所述外鞘管近端具有设有滑动通道的定位件，所述活动限位件近端与内鞘管外壁固定连接的固定连接部，所述固定连接部上设有向远端延伸穿过所述滑动通道的定位滑杆且所述定位滑杆远端限位于所述定位件中。
优选地，每个所述夹子中夹体近端具有释放孔道，所述控制线远端具有与所述释放孔道可释放连接的释放组件，当控制线受到的拉力大于一阈值时，所述释放组件由所述释放孔道中脱出。
通过上述技术方案，本申请具有如下技术效果：
首先，相对现有技术，本申请的装置通过限位组件的结构设计，本申请实现了夹子的重复开闭，夹子可至少反复开闭五次以上，方便多次重新预夹持重复定位，以利于将止血夹持放置在最适当的位置，达到最佳止血效果，避免了由于不适当的夹持而重新加载新的夹子。临床使用中，医生可以一次插入该止血夹装置，在能够释放多个止血夹对病灶部位进行充分止血夹持的情况下，保证每个夹子的释放过程都稳定可靠，不会存在夹子夹持不成功导致的无效释放过程。
其次，本申请的连发夹子结构简单合理，操作简单方便，释放稳定可靠，通过旋转控制组件设计，可以实现在使用过程中灵活旋转调整角度，使医生可以迅速准确的调整夹子和病灶的角度，更好的对病灶进行夹闭。
此外，本申请将夹子设置在输送装置内，这样大大缩短了夹子的长度，使其更简单并且更可靠，结构更短小，更适合通过弯曲的内窥镜钳道，为临床医生提供了一种可广泛适用于消化道各个部位的装置。
附图说明
图1是本申请实施例1中止血夹装置整体视图；
图2是本申请实施例1中止血夹装置远端侧视图；
图3是本申请实施例1中止血夹装置远端夹子装配视图；
图4是本申请实施例1中止血夹装置远端夹子展开状态视图；
图5是本申请实施例1中止血夹装置远端夹子展开状态单独视图；
图6是本申请实施例1中止血夹装置远端夹子展开状态爆炸图；
图7是本申请实施例1中远端夹子闭合状态单独视图；
图8是本申请实施例1中止血夹装置未加载夹子视图；
图9是本申请实施例1中止血夹装置外鞘管与内鞘管连接处视图；
图10分别是本申请实施例1中止血夹装置限位组件轴向截面图和立体视图；
图11是本申请实施例1中最远端夹子的释放过程示意图；
图12是本申请实施例2中止血夹装置外鞘管与内鞘管连接处视图；
图13是本申请实施例3中最远端夹子的释放过程示意图；
图14分别是本申请实施例4中限位组件轴向截面图和立体视图；
图15是本申请实施例5中限位组件轴向截面图；
图16是本申请实施例6中限位组件轴向截面图；
图17是本申请实施例7中限位组件轴向截面图。
附图标记说明：
1-夹子，11-最远端夹子，12-未加载夹子，13-夹臂，14-夹座，15-偏压机构，16-弹片，17-弹片滑槽，18-锁止槽，19-释放孔道，2-控制线，21-第一控制线，22-第二控制线，23-释放组件，3-手柄，31-滑块，4-鞘管，41-外鞘管，42-第一内鞘管，43-第二内鞘管，44-定位件，45-滑动通道，5-限位组件，51-限位凸台，52-槽口，53-限位部，6-旋转控制组件，61-末端旋钮，62-第一限位块，63-第二限位块，7-活动限位件，71-固定连接部，72-定位滑杆
具体实施方式
结合附图和具体实施例对本申请的技术内容作详细说明。
下面将结合实施例对本申请的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本申请，而不应视为限制本申请的范围。
对本申请中涉及的一些名词进行说明。近端是指靠近体外操作者的一端；远端是指位于体内待闭合组织的一端；轴向是指沿止血夹控制线纵轴延伸的方向；径向是指与轴向垂直方向延伸方向；周向是指沿环绕轴向的圆周方向。
实施例1
如图1-10所示的本申请中医用止血夹的第一实施例，其中该止血夹为连发夹子(如图1所示)，具有包括两个以上沿轴向排列的夹子1的夹子组件(图中未标示)，沿轴向将所述夹子组件中各个夹子1串接并能够控制最远端夹子的打开或闭合的控制线2，所述夹子1包括夹体(图中未标示)和夹座14，所述控制线2的远端与所述最远端夹子11的夹体可释放连接；连发夹子还包括位于所述控制线2的近端并配置成控制所述控制线2沿轴向前后移动的手柄3，以及鞘管4，所述控制线2沿所述鞘管4内腔延伸，控制线近端与手柄3上的滑块31固定连接，所述夹子组件位于所述鞘管内腔的远端侧。其中，本实施例中优选所述鞘管4包括内鞘管(如图2所示，内鞘管包括远端的第一内鞘管42和近端的第二内鞘管43)和套设于所述内鞘管外侧的外鞘管41，所述外鞘管41远端具有突出于第一内鞘管42远端的限位组件5，所述最远端夹子11可释放地被所述限位组件5限位于鞘管的远端。实际操作过程中，通过前后移动手柄3上的滑块31而带动控制线2的前后滑动，进而使得最远端夹子11打开或者闭合，当控制线向近端拉动的力大于一阈值(即能够实现夹子进入到锁止位置的力)时最远端夹子11夹子中的夹体被锁止在夹座14内，继续向近端拉动控制线，当控制线向近端拉动的力大于一阈值(即能够实现释放组件由所述释放孔道脱出)时，夹子与释放组件分离。如图11所示，沿虚线方向移动控制线2，控制线远端部推动最远端夹子11向远端移动进而全部由所述鞘管4远端脱出，从而实现最远端夹子11的释放。
接下来对本实施例中限位组件5的具体结构作进一步说明。如图3-4和图10所示，该限位组件5近端与外鞘管41的远端固定连接，远端具有周向排布的若干限位凸台51，各所述限位凸台51的凸出面朝向鞘管轴向方向。如图10所示，该实施例1中具有4个周向分布的限位凸台51，各个限位凸台51件形成槽口52，槽口深度和宽度限定了限位凸台51受压而向外扩张的形变幅度。所述最远端夹子11的夹座14外周壁上设有偏压机构15，所述偏压机构15被可释放地限位于所述限位凸台51和所述第一内鞘管42远端间构成的空间内。具体而言，夹座14上的偏压机构51预先成型为向外扩张的形态，当最远端夹子11由第一内鞘管42内腔中向远端推送至加载状态下时，原本被第一内鞘管内壁弹性约束的偏压机构15不再受到约束而向外扩张；偏压机构15的近端抵接与内鞘管42远端面，偏压机构15的外侧面抵接于限位凸台51内侧的凸出面，进而使得偏压机构15被可释放地限位于所述限位凸台51和所述第一内鞘管42远端间构成的空间内。此时，由于夹座14被限位，当前后滑动控制线2时，夹子可以在夹座内前后滑动，进而实现夹臂可重复地打开或闭合。
在释放夹子的过程中，首先向近端拉动控制线2并使最远端夹子11处于锁止状态，继续向近端拉动控制线2并使释放组件从所述释放孔道脱出，然后如图11所示，通过向远端推动控制线2，在控制线远端抵接夹体近端后，夹体受到控制线2的推动向远端移动并带动夹座14一并向远端移动，当偏压机构15抵压限位凸台51内侧的凸出面的力大于一阈值时，限位凸台51径向扩张并释放最远端夹子11。
此外，本实施例中，限位组件5和外鞘管远端也可以为一体成型结构，本领域技术人员可以根据实际需要进行变换，均在本申请的保护范围内。
通过对实施例1的描述可以看出，本申请通过采用限位组件5结构实现了夹子的可重复开闭，夹子可至少反复开闭五次以上，方便多次重新预夹持重复定位，以利于将止血夹持放置在最适当的位置，达到最佳止血效果，避免了由于不适当的夹持而重新加载新的夹子。临床使用中，医生可以一次插入该止血夹装置，在能够释放多个止血夹对病灶部位进行充分止血夹持的情况下，保证每个夹子的释放过程都稳定可靠，不会存在夹子夹持不成功导致的无效释放过程。
为了实现夹子近操作者端的可旋转操作，本实施例1中在近端设置旋转控制组件6，接下来对具体结构和操作方式作进一步说明。如图9所示，第二内鞘管43向近端延伸与手 柄远端固定连接，其近端延伸出外鞘管41的区域设有旋转控制组件6；本实施例1中控制线包括远端侧的第一控制线21以及与近端侧的第二控制线22，所述第一控制线21的近端与所述第二控制线22的远端活动连接；其中，所述旋转控制组件6固定连接于第一控制线21近端，通过旋转该旋转控制组件6控制所述第一控制线21相对于所述第二控制线转动。旋转控制组件6包括位于第一控制线21近侧自由端的末端旋钮61，以及位于所述第一控制线21近侧且间隔设置的第一限位块62和第二限位块63，所述第一限位块62和所述第二限位块63配置成限制所述第二控制线22相对于所述第一控制线21在纵轴方向上的位移。
对本实施例1中驱动第一控制线21转动的具体结构和实施方式具体进行详述，第二内鞘管43上具有第一控制线21的伸出孔(图中未标示)。第一控制线21近端侧间隔固定有第一限位块62和第二限位块63，第二控制线22远端具有孔道结构(图中未标示)，第一控制线21末端由该孔道结构穿过并由第二内鞘管43上的伸出孔中伸出，从而实现第一控制线21与第二控制线22的活动连接，第二控制线相对于第一控制线可自由移动距离被限制在第一限位块62和第二限位块63间。第二控制线22近端与手柄3上的滑块31固定连接。当滑动滑块31时带动第二控制线22前后滑动，在第二控制线22向远端移动时，第二控制线22远端抵接并推动第一限位块62，进而带动第一控制线21向前移动；在第二控制线22向近端移动时，第二控制线远端抵接并拉动第二限位块63，第二控制线22末端拖动第一控制线21向近端移动。由于第一控制线21可移动地由第二内鞘管43上的伸出孔中伸出，故当第一控制线21沿轴向前后移动时，第一控制线21末端自由端不受鞘管等部件的约束，实现控制线在轴向上的有效移动。
本申请通过在靠近医生操作端额外设计以旋转控制组件，克服了现有技术中仅能通过护士操作手柄端控制夹子旋转的技术缺陷，实现了医生操作位置处同样能够任意调整远端的第一控制线21的旋转角度进而调整夹子角度的技术效果，而且可以根据实际手术中医生位置灵活调整旋转控制组件伸出鞘管位置，极大提升了手术中操作灵活性。实际操作过程中，当最远端夹子11加载后，在夹臂打开状态下，医生可以根据实际病灶位置和形态等，通过旋转末端旋钮61来调整夹臂的旋转角度，而不需要整体转动止血夹，也不需要调整护士手术中的操作位置，这样一方面能够减少鞘管臂人体腔体组织的摩擦，降低器械对人体的损伤，提高器械的使用安全性；另一方面大大提高角度调整的灵活性，提升操作的便捷性。
作为对本实施例1于第二内鞘管43上设置伸出孔的一种替换结构，将上述实施例1中伸出孔变换为在第二内鞘管43上设置的一轴向延伸的旋钮滑槽，第二限位块63位于该旋钮滑槽内侧并与第一控制线21固定连接，所述旋转控制组件位于滑槽内轴向限位移动。当滑动滑块31时带动第二控制线22前后滑动，在第二控制线22向远端移动时，第二控制线22远端抵接并推动第一限位块62，进而带动第一控制线21向前移动；在第二控制线22向近端移动时，第二控制线22末端拖动第一控制线21向近端移动。由于第一控制线21可移动地由第二内鞘管43上的旋钮滑槽中伸出，故当第一控制线21沿轴向前后移动时，第一控制线21末端自由端不受鞘管等部件的约束，实现控制线在轴向上的有效移动。
此外，对于实施例1中第一控制线和第二控制线连接方式，以能够实现在确保第二控制线能够带动第一控制线前后移动的前提下，第一控制线能够相对于第二控制线自由转动，任意可实现的连接方式均应在本申请的保护范围内。
接下来对外鞘管和内鞘管的连接方式做进一步说明，如图9所示，实施例1中所述外鞘管41与第二内鞘管43能够相对移动，所述外鞘管41的近端通过活动限位件7活动连接至第二内鞘管43近端部外壁。所述活动限位件7近端具有一固定连接部71与内鞘管外壁 固定连接，由该固定连接部71上设有向远端延伸设有定位滑杆72，相对应的，所述外鞘管41近端具有定位件44，定位件44上设有滑动通道45，所述定位滑杆72向远端延伸穿过所述滑动通道45，且在该定位滑杆72的远端设置凸缘以使所述定位件44不会由定位滑杆远端脱出，则外鞘管41上的定位件44可以在定位滑杆72凸缘结构和固定连接部71间限位移动，移动的最大位移为限位组件5上的限位凸台51拉至内鞘管的远端外侧，以使夹子释放状态间所需外鞘管移动距离相对应。
作为对本实施例1外鞘管和内鞘管活动连接方式的一种替换结构，将实施例1中定位滑杆72和滑动通道45配合移动的方式进行变换，具体而言，所述活动限位件具有限位轨道结构，活动限位件的近端与内鞘管外壁固定连接，设置限位轨道的结构沿纵轴向远端延伸，相应地所述外鞘管远端具有与该限位轨道适配的限位滑块并可沿所述限位轨道轴向滑动，同样能够实现外鞘管41与内鞘管的活动限位连接。当然除了本申请所述的连接方式外，任何能够实现外鞘管41与内鞘管的活动限位连接的现有方式均属于本申请的保护范围内。
如图3-7所示，以最远端夹子为代表，对本申请优选的夹子结构进行进一步说明。每个所述夹子1包括夹体(图中未标示)和套设于夹体近端的夹座14，其中夹体远端为一对相对设置的夹臂13，其近端收纳在夹座通道内并在夹座14内壁的偏压作用下，夹臂可以打开或闭合；夹体近端具有释放孔道19，控制线2远端具有与所述释放孔道19可释放连接的释放组件23，当控制线2受到的拉力大于一阈值时，所述释放组件23由所述释放孔道19中脱出，所述阈值指的是释放瞬间控制线受到的最大拉力，其由释放孔道径向扩张弹性以及控制线远端的释放组件23形变特性决定。本实施例中释放组件轴向截面呈近“工”字型，释放孔道19在未脱出状态下卡合于“工”字型的凹槽内，释放孔道19呈可释放的长条形、圆形或椭圆形等任意可实现上述技术效果的结构。
进一步，如图4-6所示，夹体为一体成型的近“U”型夹，夹体远端具有轴向对称的一对夹臂13，近端部具有配置成穿过控制线2远端的释放孔道19，以及径向对称设置与释放孔道19远端侧的弹片16，弹片在受到径向偏压力时可以被压缩。夹座14呈圆筒状，夹座14远端侧壁轴向对称设有偏压机构15，偏压机构为可径向偏压的弹性件，夹座14近端侧壁开设弹片滑槽17，当夹子1未被锁止时，夹体近端的弹片16在弹片滑槽17内前后滑动，从而为夹子能够可重复开闭提供结构支持；此外在弹片滑槽17近端具有锁止槽18，当控制线向近端拉动并使得弹片16进入到锁止槽18中时，夹子被锁止。
结合图2和图8对夹子组件整体结构和释放以及加载过程做进一步说明。对于本实施例1中，夹子组件可以大致划分为最远端夹子11(如图2所示)和位于第一内鞘管近端的未加载夹子(如图8所示)，其中，所述内鞘管包括位于远端的配置成容纳若干所述夹子的第一内鞘管42以及位于近端的容纳所述控制线的第二内鞘管43，两者末端固定连接(如图2所示)，所述夹子初始状态下为限位在所述第一内鞘管42中。当最远端夹子11加载后位于第一内鞘管的最远端，控制线远端的释放组件与夹体尾端的释放孔道19可释放连接。未加载夹子位于最远端夹子11的近端，夹臂近端收纳于夹座14通道内，控制线依次将各个未加载夹子串接，即控制线由最近端的夹子尾部的释放孔道穿过并由夹子的两夹臂间传出，随后顺次将各个未加载夹子以相同方式串接，各个夹子与控制线间没有连接，进而控制线在移动过程中不会影响各个未加载夹子的形态和性能。当释放最远端夹子11后，控制线向近端移动，直至控制线远端的释放组件与此时最远端夹子的尾部的释放孔道开合，实现新夹子的加载。从夹子释放到新夹子的加载过程，不会影响在后未加载夹子，确保夹子性能的稳定，而不受夹子释放和加载等过程的影响。
实施例2
如图12所示，对实施例1中的外鞘管与内鞘管连接进行变换。本实施例2中，所述外 鞘管41近端与所述第二内鞘管43的外壁直接通过固定连接部71固定连接，相应地，在释放过程中可以单一使用控制线的移动来控制最远端夹子11的释放，具体操作过程可以参见实施例1中利用控制线释放夹子的操作方式，此不赘述。
实施例3
如图13所示，基于实施例1的基本结构，作为替换方式，本实施例4中外鞘管41和内鞘管间替换为可相对移动的方式。在释放最远端夹子11的过程中还可以采用移动外鞘管41的方式，具体而言，在释放夹子的过程中，同样是先使释放组件从最远端夹子11释放孔道脱离，然后沿图13中虚线方向所示，通过向近端拉动外鞘管，限位凸台51内侧的凸出面受第一内鞘管径向和轴向的压迫径向扩张后被拉至第一内鞘管远端端部的外周，并释放最远端夹子11。可见，基于实施例1和本实施例3，本申请中可以通过两种方式实现夹子的释放，操作更加灵活，在实际操作过程中医生可以根据手术的不同部位和形态选择适当的操作方式。
实施例4
如图14所示，对实施例1中的限位组件结构进行变换，将实施例1中具有4个周向分布的限位凸台51替换为具有3个周向分布的限位凸台51，各个限位凸台51件形成槽口52，槽口深度和宽度限定了限位凸台51受压而向外扩张的形变幅度。可以通过变换限位凸台的数量，控制限位凸台的径向扩张的张力和形变范围，可以根据实际手术场景灵活选择适当的限位组件形态，当然，根据实际尺寸和应用场景等需求可以相应增减限位凸台数量，以获得最有的释放效果。
实施例5
如图15所示，对实施例1中的限位组件结构进行变换，本实施例中限位组件与外鞘管41一体形成，限位组件5是由外鞘管端部向远端延伸的对称弹片，弹片向轴向方向折弯构成限位凸台51结构，两个对称设置的两个限位凸台51与内鞘管42远端面间构成了限制最远端夹子的空间。夹子释放过程中，弹片受夹子外周表面偏压机构压迫而向外扩展。通过调整弹片材质，可以实现限位凸台51向外扩张的形变幅度。该实施例中的结构简单，释放过程容易控制。
实施例6
如图16所示，对实施例1中的限位组件结构进行变换，本实施例中限位组件与外鞘管41一体形成，限位组件5是由外鞘管端部向远端延伸的筒形结构，筒形结构远端周向分布有向轴向方向折弯的弹片，进而构成限位凸台51，周向分布的折弯形限位凸台51与内鞘管42远端面间构成了限制最远端夹子的空间。夹子释放过程中，向内折弯的弹片受夹子外周表面偏压机构压迫而向外扩展。通过调整弹片材质，可以实现限位凸台51向外扩张的形变幅度。该实施例中的结构简单，释放过程容易控制。
实施例7
如图17所示，对实施例1中的内外鞘管结构进行变换，本实施例中采用单一鞘管结构，所述鞘管4远端具有限位组件5，所述限位组件5近端侧具有朝向鞘管轴向方向的限位空间，所述最远端夹子11的至少一部分可释放地被所述限位组件5限位于限位空间内。本实施例中，限位空间是由若干轴向布置的限位凸台51和限位组件5近端部向内侧突出的限位部53限定而成，所述最远端夹子11的夹座14外周壁上设有偏压机构15(结合图2-3所示最远端夹子结构)，所述偏压机构15被可释放地限位于所述限位凸台51和限位部53间形成的限位空间内。释放过程中，首先向近端拉动控制线2并使最远端夹子11处于锁止状态， 继续向近端拉动控制线2并使释放组件从所述释放孔道脱出，然后通过向远端推动控制线2，在控制线远端抵接夹体近端后，夹体受到控制线2的推动向远端移动并带动夹座14一并向远端移动，当偏压机构15抵压限位凸台51内侧的凸出面的力大于一阈值时，限位凸台51径向扩张并释放最远端夹子11。
本实施例中，所述鞘管4和所述限位组件5可以一体形成，也可以根据实际装配制造需要，分别制造后组装而成。
最后应说明的是：以上各实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述各实施例对本申请进行了详细的说明，但本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的范围。

Claims (12)

  1. 一种医用止血夹，至少包括如下结构：
    夹子组件，包括至少一个沿轴向排列的夹子；
    控制线，沿轴向将所述夹子组件串接，并通过移动所述控制线控制最远端夹子的打开或闭合，所述夹子包括夹体和夹座，所述控制线远端与所述最远端夹子的夹体可释放连接；
    手柄，位于所述控制线近端，配置成控制所述控制线的前后移动；
    鞘管，所述控制线沿所述鞘管内腔延伸，所述夹子组件位于所述鞘管内腔的远端侧；
    所述鞘管远端具有限位组件，所述限位组件近端侧具有朝向鞘管轴向方向的限位空间，所述最远端夹子的至少一部分可释放地被所述限位组件限位于所述限位空间内。
  2. 根据权利要求1所述的医用止血夹，其特征在于：
    所述限位组件远端具有周向设置的限位凸台以在该限位凸台的近端侧形成所述限位空间，所述最远端夹子的夹座外周壁上设有偏压机构，所述偏压机构被可释放地限位于所述限位凸台近端侧的限位空间内。
  3. 根据权利要求2所述的医用止血夹，其特征在于：
    所述限位凸台朝向鞘管轴向方向延伸，当所述限位凸台的凸出面受到的径向扩张力大于一阈值时，所述限位凸台径向扩张并释放所述最远端夹子。
  4. 根据权利要求2所述的医用止血夹，其特征在于：
    所述鞘管包括内鞘管和套设于所述内鞘管外侧的外鞘管，所述限位组件位于外鞘管远端，且所述限位凸台近端侧与内鞘管远端间构成配置成限位所述最远端夹子的所述限位空间。
  5. 根据权利要求1所述的医用止血夹，其特征在于：
    所述控制线包括远端侧的第一控制线以及与近端侧的第二控制线，所述第一控制线的近端与所述第二控制线的远端活动连接；其中，所述第一控制线近端具有控制所述第一控制线相对于所述第二控制线转动的旋转控制组件。
  6. 一种医用止血夹，至少包括如下结构：
    夹子组件，包括至少一个沿轴向排列的夹子；
    控制线，沿轴向将所述夹子组件串接，通过移动所述控制线控制最远端夹子的打开或闭合，所述夹子包括夹体和夹座，所述控制线远端与所述最远端夹子的夹体可释放连接；
    手柄，位于所述控制线近端，配置成控制所述控制线的前后移动；
    鞘管，所述控制线沿所述鞘管内腔延伸，所述夹子组件位于所述鞘管内腔的远端侧；
    所述控制线包括远端侧的第一控制线以及与近端侧的第二控制线，所述第一控制线的近端与所述第二控制线的远端活动连接；其中，所述第一控制线近端设有控制所述第一控制线相对于所述第二控制线转动的旋转控制组件。
  7. 根据权利要求6所述的医用止血夹，其特征在于：
    旋转控制组件包括位于第一控制线近侧自由端的末端旋钮，以及位于所述第一控制线 近侧且间隔设置的第一限位块和第二限位块，所述第一限位块和所述第二限位块配置成限制所述第二控制线相对于所述第一控制线在轴向上的位移。
  8. 根据权利要求7所述的医用止血夹，其特征在于：
    所述鞘管包括内鞘管和套设于所述内鞘管外侧的外鞘管，所述限位组件位于外鞘管远端，且所述限位组件近端侧与内鞘管远端间构成配置成限位所述最远端夹子的限位空间。
  9. 根据权利要求8所述的医用止血夹，其特征在于：
    所述旋转控制组件位于所述内鞘管近端部，所述旋转控制组件与所述内鞘管的连接方式如下述(1)或(2)中的任意一种：
    (1)内鞘管上具有旋钮滑槽，当控制线前后滑动时，所述旋转控制组件位于旋钮滑槽内轴向限位移动；
    (2)内鞘管上具有所述旋转控制组件的伸出孔，所述第一控制线近侧自由端可移动地由所述伸出孔伸出。
  10. 根据权利要求4、8-9任一项所述的医用止血夹，其特征在于：
    所述外鞘管与所述内鞘管能够相对移动，所述外鞘管近端通过活动限位件活动连接至内鞘管近端部外壁。
  11. 根据权利要求10所述的医用止血夹，其特征在于：
    所述活动限位件的结构如下述(1)或(2)中的任意一种：
    (1)所述活动限位件近端与内鞘管外壁固定连接，远端具有限位轨道，所述外鞘管近端沿所述限位轨道轴向限位移动；
    (2)所述外鞘管近端具有设有滑动通道的定位件，所述活动限位件近端与内鞘管外壁固定连接的固定连接部，所述固定连接部上设有向远端延伸穿过所述滑动通道的定位滑杆且所述定位滑杆远端限位于所述定位件中。
  12. 根据权利要求1-9任一项所述的医用止血夹，其特征在于：
    每个所述夹子中夹体近端具有释放孔道，所述控制线远端具有与所述释放孔道可释放连接的释放组件，当控制线受到的拉力大于一阈值时，所述释放组件由所述释放孔道中脱出。
PCT/CN2020/098131 2019-10-29 2020-06-24 一种医用止血夹 WO2021082482A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201911035842.XA CN110613495A (zh) 2019-10-29 2019-10-29 一种医用止血夹
CN201911035842.X 2019-10-29

Publications (1)

Publication Number Publication Date
WO2021082482A1 true WO2021082482A1 (zh) 2021-05-06

Family

ID=68926913

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/098131 WO2021082482A1 (zh) 2019-10-29 2020-06-24 一种医用止血夹

Country Status (2)

Country Link
CN (1) CN110613495A (zh)
WO (1) WO2021082482A1 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115444491A (zh) * 2022-10-11 2022-12-09 常州市久虹医疗器械有限公司 夹闭组件及内窥镜用止血装置
CN117338369A (zh) * 2023-11-23 2024-01-05 桐庐优视医疗器械有限公司 一种医用施夹钳

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110613495A (zh) * 2019-10-29 2019-12-27 南微医学科技股份有限公司 一种医用止血夹
CN112545605A (zh) * 2020-04-07 2021-03-26 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 一种多头止血夹
CN111449715B (zh) * 2020-04-07 2021-01-05 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 一种可控易用多止血夹夹持器
CN111388048B (zh) * 2020-04-13 2021-02-02 河南省中医院（河南中医药大学第二附属医院） 便携式外周血管用止血器
WO2021249174A1 (zh) * 2020-06-12 2021-12-16 南微医学科技股份有限公司 一种止血夹和保险机构
CN115444492A (zh) * 2022-10-24 2022-12-09 苏州法兰克曼医疗器械有限公司 一种内窥镜下止血夹闭装置
CN116035708B (zh) * 2023-02-28 2023-07-04 北京云力境安科技有限公司 一种手术器械
CN116898539B (zh) * 2023-04-25 2024-01-30 河北康誉医疗器械有限公司 组合式导管鞘组

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6814742B2 (en) * 2000-10-16 2004-11-09 Olympus Corporation Physiological tissue clipping apparatus, clipping method and clip unit mounting method
US20050107809A1 (en) * 2003-11-07 2005-05-19 Eric Litscher Endoscopic hemostatic clipping apparatus
CN202477780U (zh) * 2012-01-20 2012-10-10 东南大学 一种夹子控制单元及与其配合使用的夹子单元
CN106028974A (zh) * 2014-03-14 2016-10-12 波士顿科学国际有限公司 用于夹钳组织的方法和装置
CN108013914A (zh) * 2017-12-29 2018-05-11 安瑞医疗器械(杭州)有限公司 一种内镜下使用的改进型止血夹及其夹钳部
CN108784775A (zh) * 2018-08-28 2018-11-13 诸暨市鹏天医疗器械有限公司 多连发组织夹
CN208524957U (zh) * 2017-12-18 2019-02-22 常州贺利氏微创医疗器械有限公司 止血夹
CN109833074A (zh) * 2019-02-20 2019-06-04 江苏格里特医疗科技有限公司 一种可旋转止血夹
CN110613495A (zh) * 2019-10-29 2019-12-27 南微医学科技股份有限公司 一种医用止血夹
CN211270957U (zh) * 2019-10-29 2020-08-18 南微医学科技股份有限公司 一种医用止血夹

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6814742B2 (en) * 2000-10-16 2004-11-09 Olympus Corporation Physiological tissue clipping apparatus, clipping method and clip unit mounting method
US20050107809A1 (en) * 2003-11-07 2005-05-19 Eric Litscher Endoscopic hemostatic clipping apparatus
CN202477780U (zh) * 2012-01-20 2012-10-10 东南大学 一种夹子控制单元及与其配合使用的夹子单元
CN106028974A (zh) * 2014-03-14 2016-10-12 波士顿科学国际有限公司 用于夹钳组织的方法和装置
CN208524957U (zh) * 2017-12-18 2019-02-22 常州贺利氏微创医疗器械有限公司 止血夹
CN108013914A (zh) * 2017-12-29 2018-05-11 安瑞医疗器械(杭州)有限公司 一种内镜下使用的改进型止血夹及其夹钳部
CN108784775A (zh) * 2018-08-28 2018-11-13 诸暨市鹏天医疗器械有限公司 多连发组织夹
CN109833074A (zh) * 2019-02-20 2019-06-04 江苏格里特医疗科技有限公司 一种可旋转止血夹
CN110613495A (zh) * 2019-10-29 2019-12-27 南微医学科技股份有限公司 一种医用止血夹
CN211270957U (zh) * 2019-10-29 2020-08-18 南微医学科技股份有限公司 一种医用止血夹

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115444491A (zh) * 2022-10-11 2022-12-09 常州市久虹医疗器械有限公司 夹闭组件及内窥镜用止血装置
CN115444491B (zh) * 2022-10-11 2024-01-30 常州市久虹医疗器械有限公司 夹闭组件及内窥镜用止血装置
CN117338369A (zh) * 2023-11-23 2024-01-05 桐庐优视医疗器械有限公司 一种医用施夹钳
CN117338369B (zh) * 2023-11-23 2024-04-02 桐庐优视医疗器械有限公司 一种医用施夹钳

Also Published As

Publication number Publication date
CN110613495A (zh) 2019-12-27

Similar Documents

Publication Publication Date Title
WO2021082482A1 (zh) 一种医用止血夹
JP5172209B2 (ja) 内視鏡胃制限法および装置
EP1187559B1 (en) Gerd treatment apparatus
US7635374B2 (en) Endoscopic full thickness resection using surgical compression clips
US8685043B2 (en) Apparatus and method for compressing body tissue
JP4300033B2 (ja) 管腔内胃底皺襞形成術装置および関連方法
US20110054498A1 (en) Endoscopic compression clip and system and method for use thereof
ES2334131T3 (es) Aplicador y anillo de anastomosis.
US7648514B1 (en) Deep endoscopic staple and stapler
US20100331862A1 (en) Tissue compression using surgical clips
WO2020186838A1 (zh) 一种医用止血夹
BR112015013158B1 (pt) Aparelho
BR112015013062B1 (pt) Aparelho para grampear tecido
BRPI0404237B1 (pt) Instrumento cirúrgico para implantar um dispositivo anastomótico
US7799040B2 (en) Device for plicating and fastening gastric tissue
JP2008514244A (ja) 独立して作動する脚部を有する内視鏡装置
CN211270957U (zh) 一种医用止血夹
US20210022740A1 (en) Devices, systems, and methods for closing a wound
US11801041B2 (en) Handle and cartridge system for medical interventions
WO2008081436A2 (en) Tissue compression using surgical clips
US11213292B2 (en) Endoscopic hemostasis closure device and delivery system
JP4167686B2 (ja) 改良された陥入および吻合装置
JP4166785B2 (ja) 管内吻合装置
JP2022525717A (ja) 組織クリップ装置、組織クリップシステム、およびクリップ装置の操作方法
BR112020012176A2 (pt) conjunto de alça e grampeador incluindo o mesmo

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20881401

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20881401

Country of ref document: EP

Kind code of ref document: A1