WO2021082821A1 - 可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统 - Google Patents

可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统 Download PDF

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Publication number
WO2021082821A1
WO2021082821A1 PCT/CN2020/117248 CN2020117248W WO2021082821A1 WO 2021082821 A1 WO2021082821 A1 WO 2021082821A1 CN 2020117248 W CN2020117248 W CN 2020117248W WO 2021082821 A1 WO2021082821 A1 WO 2021082821A1
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WO
WIPO (PCT)
Prior art keywords
valve
probe
clamp
detection
indicator
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Application number
PCT/CN2020/117248
Other languages
English (en)
French (fr)
Inventor
张庭超
王泽涛
张伟伟
郑贤章
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN201921863424.5U external-priority patent/CN212346813U/zh
Priority claimed from CN201911057746.5A external-priority patent/CN112741711A/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021082821A1 publication Critical patent/WO2021082821A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • This application relates to the field of medical devices, and in particular to a valve clamp and a valve clamp system capable of detecting the clamping state of the valve.
  • Mitral valve 1 is a one-way valve located between the left atrium 2 and left ventricle 3 of the heart.
  • a normal and healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3, while preventing blood from flowing from The left ventricle 3 flows to the left atrium 2.
  • the mitral valve 1 includes a pair of leaflets, called the anterior leaflet 1a and the posterior leaflet 1b.
  • the anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through the chordae 4.
  • valve edge-to-edge surgery There is a minimally invasive surgical operation, which is based on the principle of valve edge-to-edge surgery.
  • the valve clamp is pushed to the mitral valve through a pushing device, and then the anterior leaflet and the mitral valve are clamped by the relative opening of the clamp.
  • the posterior leaflets draw the leaflets closer to each other, reducing mitral regurgitation. Because the anterior and posterior leaflets of the mitral valve are always in a state of large and powerful opening and closing activities, it is difficult to clamp. Even if they are clamped, there may be problems with an unstable clamping position.
  • valve The leaflets may be only partially clamped, which may result in unsatisfactory clamping position of the anterior and posterior leaflets of the mitral valve or the only partially clamped leaflets will eventually slip from the clamp, and the operation can only be repeated.
  • the valve clamp in the prior art generally detects the clamping state of the valve leaflet based on the visibility of the detection element or the current integrity of the sensor and the detection circuit.
  • the position judgment of the detection element under color Doppler ultrasound will interfere with the judgment of the position of the detection element, and the doctor cannot intuitively evaluate the clamping effect of the valve leaflet.
  • the detection element is generally small, and the actual imaging effect is poor. Therefore, the operation time is long and the efficiency is low.
  • the detection element or sensor caused the implanted valve clamp to become an electromechanical device instead of a pure mechanical device, which reduces the safety of the device, and requires external equipment to detect the clamping state of the valve leaflets, which increases the cost of surgery. Moreover, the operation process is cumbersome, the operation time is long, and the efficiency is low.
  • the present application provides a valve clamp and a valve clamp system that can detect the clamping state of the valve.
  • the operation is simple, which is beneficial to reduce the operation time and improve the operation efficiency.
  • the present application provides a valve clamp capable of detecting the clamping state of a valve, including a clamp main body and a detection assembly;
  • the clamp main body includes a push rod, and a proximal clamp that can be radiated and expanded relative to the push rod And a distal clip, a valve accommodating space is formed between the proximal clip and the distal clip, and the proximal clip and the distal clip cooperate to clamp in the valve accommodating space
  • the detection assembly includes a probe and a traction wire used to drive the probe to move, the traction wire can drive the probe to be inserted into the valve accommodation space to detect the valve accommodation space
  • the clamping state of the valve tissue includes a probe and a traction wire used to drive the probe to move, the traction wire can drive the probe to be inserted into the valve accommodation space to detect the valve accommodation space.
  • the present application also provides a valve clamping system, including a valve clamping device capable of detecting the clamping state of the valve and a pushing device for conveying the valve clamping device. After being delivered to the patient and clamping the leaflets, the clamping state of the valve tissue can be detected.
  • the valve clamp and valve clamping system provided by the present application move the probe by pulling the ribbon so that the probe is inserted into the valve accommodating space to detect the clamping state of the valve tissue in the valve accommodating space, and the operation is simple, thereby It can reduce operation time and improve operation efficiency; and there is no need to use electromechanical devices, so the safety is high.
  • Figure 1 is a schematic diagram of the mitral valve in a normal state.
  • Figure 2 is a schematic diagram of mitral valve disease.
  • Fig. 3 is a schematic diagram of the three-dimensional structure of the valve clamp provided in the first embodiment of the present application for clamping valve tissue in an opened state.
  • Fig. 4 is an enlarged schematic diagram of the IV part in Fig. 3 with the fixing seat and the traction wire removed.
  • FIG. 5 is a schematic diagram of FIG. 3 from another perspective.
  • FIG. 6 is a schematic diagram of the three-dimensional structure of the proximal clip in FIG. 3.
  • Fig. 7 is a schematic diagram of the state of use of the valve clamp in Fig. 3.
  • Fig. 8 is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflet is clamped by the valve clamp in Fig. 7.
  • Fig. 9 is a schematic diagram of the mitral valve in diastole after the valve leaflet is clamped by the valve clamp in Fig. 7.
  • FIG. 10 is a three-dimensional schematic diagram of a part of the structure of the detection assembly in FIG. 3.
  • Fig. 11 is a schematic front view of an extracorporeal control device.
  • Fig. 12 is a schematic diagram of the internal structure of the extracorporeal control device in Fig. 11 after the upper shell is removed.
  • Fig. 13 is a schematic diagram of the position of the pulling member of the extracorporeal control device when the probes of the valve clamp are in different positions.
  • FIG. 14 is a three-dimensional structure diagram of a partial structure of a valve clamping system provided by one of the embodiments of the present application.
  • Fig. 15 is a schematic cross-sectional view of Fig. 14.
  • FIGS 16 to 19 are schematic diagrams of the use process of the valve clamp.
  • 20 is a schematic diagram of the internal structure of the extracorporeal control device of the valve clamp provided by the second embodiment of the present application after the upper shell is removed.
  • 21 is a schematic diagram of the three-dimensional structure of the valve clamp provided by the third embodiment of the present application.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the medical treatment.
  • the direction of the connection between the center of the distal end and the center of the proximal end of the instrument is only for the convenience of presentation, and cannot be construed as a limitation on the application.
  • the first embodiment of the present application provides a valve clamp 100, which includes a clamp body for clamping a valve and a detection component for detecting the clamping state of the valve.
  • the clip body includes a push rod 10, a proximal clip 20 that can be radiatedly expanded relative to the push rod 10, and a distal clip 30.
  • a valve containing space is formed between the proximal clip 20 and the distal clip 30.
  • the proximal clip 20 and the distal clip 30 cooperate to clamp the valve tissue 40 in the valve receiving space.
  • the detection assembly includes a probe 50 and a traction wire 60 for driving the probe 50 to move.
  • the traction wire 60 can drive the probe 50 to be inserted into the valve accommodating space to detect the clamping state of the valve tissue 40 in the valve accommodating space.
  • the operator when the valve clamp 100 is used to clamp the valve tissue 40, the operator only needs to pull the traction wire 60 to drive the probe 50 to move, so that the probe 50 is inserted into the valve accommodation space, and the clamping of the valve tissue 40 can be detected.
  • the operation time is reduced and the operation efficiency is improved due to the holding state and simple operation; and there is no need to use electromechanical devices, so the safety is high.
  • the push rod 10 is made of biocompatible polymer materials or metal materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel with higher hardness.
  • a cobalt-chromium alloy both the proximal clip 20 and the distal clip 30 are made of biocompatible metal materials selected from stainless steel, cobalt alloys, cobalt-chromium alloys, titanium alloys, or nickel-titanium alloys.
  • the proximal clip 20 is made of an elastic material with a shape memory function
  • the distal clip 30 is made of a rigid material with higher hardness to ensure that the two can be clamped and fixed.
  • Valve tissue 40 In this embodiment, the proximal clip 20 is made of Nitinol, and the distal clip 30 is made of stainless steel or cobalt-chromium alloy.
  • proximal clips 20 and two distal clips 30 there are two proximal clips 20 and two distal clips 30 respectively.
  • the two proximal clips 20 and the two distal clips 30 are matched in a one-to-one correspondence to clamp the mitral valve respectively.
  • the anterior and posterior leaflets make the mitral valve align, thereby reducing or treating "mitral valve regurgitation.”
  • the two sets of detection components are respectively used to detect the clamping state of the anterior leaflet and the posterior leaflet of the mitral valve.
  • the push rod 10 is a rod body or a tube body.
  • the push rod 10 is a round rod body.
  • the proximal end of the push rod 10 is provided with a stud 11 with an external thread, and the stud 11 is used to connect with the mandrel (not shown in the figure) of the pushing device.
  • the distal end of the push rod 10 is provided with a connecting seat 13, and the connecting seat 13 includes two opposite first planes and two connecting surfaces connecting the first planes.
  • the two connecting surfaces include a curved surface at the distal end and a curved surface at the proximal end.
  • the second plane connected with the smooth transition of the curved surface.
  • the opposite ends of the connecting seat 13 are respectively provided with pin holes (not shown in the figure) that penetrate the two first planes.
  • the cross-sectional size of the connecting seat 13 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 13 is any structure such as a hemisphere, a spherical crown, or a bullet shape, so that the valve can be clamped.
  • the device 100 is easier to push in the body.
  • the main body of the clipper also includes a fixing seat 70, which includes a first seat body 71 and a second seat body 72 connected to the distal end of the first seat body 71.
  • the first seat body 71 and the second seat body 72 are transitionally connected by a third seat body 73, and the three can be an integrated structure or a non-integrated structure. In this embodiment, it is an integrated structure.
  • the proximal end of the first base body 71 is provided with two rectangular clamping holes 711, and the clamping holes 711 are used to connect with the connecting rod (not shown in the figure) of the pushing device.
  • the second seat 72 is provided with a receiving cavity 75 penetrating the two opposite sides of the second seat 72.
  • One inner wall of the receiving cavity 75 is provided with a boss 751.
  • the proximal surface of the boss 751 is an inclined surface.
  • a steel sheet 753 and a deformed elastic sheet 755 abutting on the proximal surface of the steel sheet 753 are arranged in the 75.
  • One end of the steel sheet 753 abuts on the slope of the boss 751.
  • the steel sheet 753 It is arranged obliquely in the accommodating cavity 75.
  • Two opposite outer sides of the distal end of the second seat body 72 are respectively provided with connecting holes (not shown in the figure) for rotatably connecting with the distal end clip 30.
  • the fixing seat 70 is provided with a through passage 77 extending through the first seat body 71, the second seat body 72 and the third seat body 73 along the axial direction, and the push rod 10 penetrates into the fixing seat 70 from the distal end of the fixing seat 70.
  • the piercing channel 77 can move along the axial direction.
  • the steel sheet 753 and the deformed elastic sheet 755 are provided with corresponding through holes along the axial direction, and the area of the through holes is slightly larger than the cross-sectional area of the push rod 10.
  • the push rod 10 passes through the steel sheet 753 and the deformed elastic sheet 755. Under the elastic force of the deformed elastic sheet 755, the steel sheet 753 is inclined at a certain angle with the push rod 10 and contacts the edge of the through hole.
  • the steel sheet 753 generates friction to prevent the push rod 10 from moving relative to the fixed seat 70, so that the push rod 10 and the fixed seat 70 are connected Locked state.
  • the fixing base 70, the steel sheet 753, and the deformable shrapnel 755 are all made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy, or nickel-titanium alloy.
  • the fixing seat 70 and the steel sheet 753 are made of high-hardness stainless steel or cobalt-chromium alloy
  • the deformable elastic sheet 755 is made of elastic nickel-titanium alloy.
  • the two opposite sides of the fixing seat 70 are respectively provided with a control member (not shown in the figure) for controlling the steel sheet 753.
  • the control member is preferably a wire made of nickel-titanium alloy, and the control member is attached to the fixing seat.
  • the distal end of the control member is bent toward the axial direction of the fixing seat 70 and is received in the accommodating cavity 75.
  • the distal end of the control member has two branches, one of which abuts on the distal plane of the boss 751, and the other abuts on the distal surface of the steel sheet 753 and is close to the steel sheet 753 away from the boss 751.
  • the branch can drive the end of the steel sheet 753 away from the boss 751 so that the steel sheet 753 abuts against the inclined surface of the boss 751.
  • One end is the support point and rotates in the proximal direction until the axis of the steel sheet 753 and the push rod 10 is 90 degrees.
  • the through hole of the steel sheet 753 is coaxial with the axis of the push rod 10, and the push rod 10 and the fixed seat 70 The locked state of the connection between the two is released, and the push rod 10 can move in the axial direction.
  • the two proximal clips 20 are arranged outside the distal end of the fixing base 70 and are arranged axisymmetrically with respect to the fixing base 70.
  • Each proximal clip 20 includes a connecting end 21 and a free end 22 that are oppositely disposed.
  • the connecting ends 21 of the two proximal clips 20 are connected as a whole through a connecting frame 23, and the connecting frame 23 is sleeved on the distal end of the second seat 72 to realize the connection and fixing of the two proximal clips 20.
  • the seat 70 is relatively fixed. Wherein, a through hole (not marked in the figure) for the push rod 10 is opened in the middle of the connecting frame 23.
  • the connecting end 21 of the proximal clip 20 may be directly fixed to the distal end of the second base 72 by welding or the like.
  • the proximal clip 20 is at least partially made of an elastic material with a shape memory function, and is heat-set. In a natural state, the proximal clip 20 extends radially outward relative to the fixing base 70 so as to cooperate with the distal clip 30 to clamp the valve tissue 40.
  • the proximal clip 20 is cut from a nickel-titanium alloy and placed in a shaping mold, and then the shaping mold is placed in an electrically heated circulating air box furnace, and the shaping heat treatment is performed at 300-650°C, taken out and Quickly put it into purified water to cool, and remove the shaping mold to obtain the shaped proximal clip 20.
  • the entire proximal clip 20 is made of super-elastic Nitinol
  • the connecting frame 23 is also made of Nitinol and is integrally formed with the proximal clip 20 to reduce the difficulty of the production process. Simplify the process and reduce production costs.
  • the connecting frame 23 can also be made of rigid stainless steel, and then welded to the proximal clip 20 to improve the strength of the connection between the connecting frame 23 and the second base 72.
  • the free end 22 of the proximal clip 20 is provided with an adjustment wire hole 24 for connecting the adjustment wire (not shown in the figure) of the pushing device, and the free end 22 of the proximal clip 20 can extend outside the patient's body through The adjustment line is controlled.
  • the free end 22 of the proximal clip 20 is tightened by the adjustment wire and fits against the surface of the fixing seat 70, and after the control of the adjustment wire on the free end 22 is released, the proximal clip 20 is released , The proximal clip 20 rebounds and returns to its natural state due to its own elastic memory performance, so as to press the valve tissue 40 toward the distal clip 30.
  • the included angle between the two proximal clips 20 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 30 to provide a more stable clamping force, that is, the proximal clip
  • the included angle between the sheet 20 and the fixing seat 70 is greater than or equal to the included angle between the distal clip 30 and the fixing seat 70 when the distal end clip 30 corresponding to the side is fully opened relative to the fixing seat 70, so as to ensure close proximity.
  • the angle between the length direction of the free end 22 and the axial direction of the fixing seat 70 ranges from 0 to 150 degrees, that is, the angle between the two proximal clips 20 is the largest. It can reach 300 degrees, and the opening angle range between the two proximal clips 20 is preferably 0-240 degrees, more preferably 160-200 degrees.
  • the proximal clip 20 also includes a first surface facing the distal clip 30, and a clamping reinforcement member is provided on the first surface to increase the proximal clip 20 and the valve tissue clamped in the valve accommodation space.
  • the friction force between 40 increases the clamping force of the valve clamp 100 to the valve tissue 40.
  • the clamping reinforcement is two rows of barbs 25 arranged at intervals on opposite sides of the first surface.
  • the barbs 25 can be formed on the proximal clip 20 by an integral molding method, or the barbs 25 can be formed of the same or different material as the proximal clip 20 and then connected to the first surface of the proximal clip 20 .
  • the angle between the extending direction of the barb 25 and the first surface is less than or equal to 90 degrees, preferably 30-60 degrees, so as to enhance the clamping force of the valve clamp 100 on the valve tissue 40.
  • the clamping reinforcement may be a structure such as ribs, bosses, or other irregularly distributed protrusions protruding on the first surface, and may also be a rough surface at least partially covering the first surface to improve The clamping force of the valve tissue 40.
  • the region where the connecting end 21 of the proximal clip 20 is located on the movement path of the probe 50 is correspondingly provided with a long through hole 26 to facilitate the probe 50 to pass through. It is understandable that other areas of the proximal clip 20 can also be provided with at least one opening 27.
  • the through holes 26 and the openings 27 can reduce the weight of the proximal clip 20, thereby avoiding the excessive weight of the valve clip 100 for a long time. Falling below the valve leaflets can cause slippage or damage the valve leaflets, and it is also conducive to the creeping and growth of endothelial cells.
  • each distal end clip 30 is respectively connected to the fixing base 70 rotatably, and respectively correspond to the two proximal end clips 20 one-to-one.
  • Each distal end clip 30 includes a connecting section 31 located at the distal end and a clamping section 32 connected to the proximal end of the connecting section 31.
  • the connecting section 31 includes two oppositely spaced connecting pieces
  • the clamping section 32 includes a clamping piece.
  • the two connecting pieces are located on opposite sides of the clamping piece.
  • a hollow area is enclosed between the space, so that the probe 50 can be inserted into the hollow area, and at the same time, it is beneficial to reduce the overall weight of the valve clamp 100.
  • the main body of the clipper also includes two connecting rods 15 arranged opposite to each other.
  • the end of the connecting section 31 of each distal end clip 30 away from the corresponding clamping section 32 is rotatably connected to the distal end of the second seat 72 of the fixing seat 70; the end of the connecting section 31 close to the clamping section 32 is rotatably connected to
  • the proximal end of the connecting rod 15 on the corresponding side and the distal end of the connecting rod 15 are rotatably connected to the connecting seat 13.
  • the rotation connection is realized by a corresponding rotation pin or a rotation bolt.
  • the steel sheet 753 is pulled proximally by the control member to make the axis of the steel sheet 753 and the push rod 10 to be 90 degrees, and the locking state of the connection between the push rod 10 and the fixing seat 30 can be released.
  • the push rod 10 can move relative to the fixed seat 70 in the axial direction.
  • the connecting seat 13 drives the connecting rod 15 to move.
  • the distal clip 30 can rotate around the center of the connection position with the fixing seat 70 (that is, the center of the connecting hole of the second seat body 72) to open and close relative to the fixing seat 70.
  • the distal clip 30 when the connecting rod 15 drives the distal clip 30 to open and close relative to the fixing base 70, the distal clip 30 can be opened and closed relative to the fixing base 70 in a relatively large range.
  • the maximum included angle can reach 300 degrees, that is, after the distal clip 30 is opened relative to the fixing seat 70, it can be turned down to a certain extent, thereby facilitating the clamping of the valve tissue 40 that is constantly in motion, and improving the clamping success rate .
  • the angle between the two distal clips 30 is preferably 0-240 degrees, more preferably 120-180 degrees.
  • the push rod 10 moves axially in the proximal direction, and the distal clip 30 is driven relative to the fixing seat through the connecting rod 15 70 is closed until the distal clip 30 is completely closed relative to the fixing seat 70, so that the valve clip 100 is in a closed state, and then the control of the steel plate 753 by the control member is released, and the elastic force of the deformed spring plate 755 and the boss 751 Under the action of pushing, the steel piece 753 inclines and contacts the push rod 10 at a certain angle, and the connection between the push rod 10 and the fixing seat 70 is locked to prevent the distal clip 30 from opening relative to the fixing seat 70 and being in a closed state.
  • the valve clamp 100 falls below the valve leaflets.
  • the second surface of the distal clip 30 facing the proximal clip 20 may also be provided with barbs, protrusions, grooves, gaskets and other clamping and anti-slip structures (not shown in the figure).
  • the second surface may be a flat surface or a curved surface.
  • the second surface is set as a curved surface to increase the contact area and clamping area between the distal clip 30 and the valve tissue 40, thereby providing a stable clamping force.
  • the second surface of the curved surface forms a receiving groove.
  • active drugs may be applied to the second surface of the distal clip 30, or at least one opening may be opened to promote the crawling and growth of endothelial cells of the valve tissue 40 on the inner surface of the distal clip 30; Furthermore, opening the opening can also reduce the overall weight of the valve clamp 100, thereby preventing the overweight valve clamp 100 from falling under the leaflets for a long time to cause slippage or damage the leaflets.
  • the axial length of the distal clip 30, that is, the distance between the connecting section 31 and the clamping section 32, should be greater than or equal to 4 mm, preferably 6-10 mm, so as to prevent the excessively long distal clip 30 from becoming too long.
  • Many anterior leaflets and posterior leaflets are clamped together, resulting in that when the valve clamp 100 is closed, the two leaflets are forcibly pulled toward each other and fixed together.
  • too many leaflets are Restriction of movement can lead to serious consequences such as abnormal mitral valve function or leaflet tearing; it can also avoid that the too short distal clip 30 can only clamp a small part of the valve leaflets, making the leaflets easy to slide out, and the effect of clamping and fixing Poor.
  • the width of the distal clip 30, that is, the length of the direction perpendicular to the axial direction of the distal clip 30, should be greater than or equal to 2 mm, preferably 4-6 mm, to avoid a narrow distal clip 30 affects the clamping effect, and at the same time prevents the excessively wide distal clip 30 from affecting the movement of the valve leaflet or damaging the valve leaflet. .
  • valve clamp 100 provided in this embodiment can be used to reduce or treat "mitral valve regurgitation." Specifically, please refer to FIGS. 7 to 9 together, and place the valve clamp 100 at the position where the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve cannot align normally, so that the corresponding set of proximal clips 20 And the distal clip 30 clamps the edge of the anterior leaflet 1a of the mitral valve, and another set of corresponding proximal clip 20 and the distal clip 30 clamp the edge of the posterior leaflet 1b of the mitral valve to The positions of the anterior lobe 1a and the posterior lobe 1b that cannot be normally aligned are clamped together. The direction of the arrow shown in Figs.
  • FIG 8 and 9 is the direction of blood flow.
  • the anterior leaflets 1a and posterior leaflets 1b are closed, the area A of the mitral valve opening becomes smaller or the mitral valve can be completely closed, and only a small amount of blood flows back into the mitral valve opening The left atrium, which can reduce or treat "Mitral regurgitation.”
  • the anterior leaflets 1a and the posterior leaflets 1b are only aligned at the position B where the valve clamp 100 is clamped, and the other positions of the anterior leaflets 1a and the posterior leaflets 1b are still in normal diastole, so that Blood can enter the left ventricle from the left atrium to ensure the normal circulation of blood.
  • the valve clamp 100 is provided with a detection Components, the detection component includes a probe 50 and a pulling wire 60 for driving the probe 50 to move.
  • the detection component includes a probe 50 and a pulling wire 60 for driving the probe 50 to move.
  • the two sets of detection components are arranged symmetrically about the push rod 10 and are located in the space surrounded by the two opposite connecting rods 15 of the valve clamp 100, that is, the detection components are arranged in The inside of the valve clamp 100 does not increase the overall size of the valve clamp 100.
  • the traction wire 60 extends outside the patient's body to facilitate the operation of the operator.
  • the traction wire 60 can drive the probe 50 to move in the proximal direction, so that the probe 50 can be inserted into the valve housing space.
  • the needle of the probe 50 abuts against the valve tissue 40 in the valve accommodation space.
  • the probe 50 is located in the first position, that is, it is determined that the position in the valve accommodation space is The valve tissue 40 is clamped in place; in other embodiments, after the probe 50 moves toward the proximal end, the needle of the probe 50 does not abut the valve tissue 40 in the valve receiving space and passes through the valve receiving space.
  • the probe 50 is located at the second position, that is, it is determined that the valve tissue 40 in the valve accommodation space is not clamped in place.
  • the improper clamping of the valve tissue 40 means that the proximal clip 20 and the distal clip 30 do not clamp the valve tissue 40 or that only a small part of the valve tissue 40 is clamped.
  • the probe 50 on the right abuts against the distal side of the right valve tissue 40 (posterior leaflet), and the right valve tissue 40 is clamped in place; the probe 50 on the left Passing through the valve accommodating space and partially protruding from the proximal clip 20, it means that the left valve tissue 40 (anterior leaflet) is not clamped in place, specifically, the left valve tissue 40 is only partially clamped.
  • the probe 50 is made of at least one polymer material among silica gel, polyetheramide, polycarbonate, polyoxymethylene, polyurethane, and polyvinyl chloride, or is made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, cobalt alloy, Made of any metal material in titanium alloy.
  • the probe 50 is made of stainless steel to improve the support of the probe 50 and improve the detection effect.
  • the traction wire 60 is a wire or tube made of a metal material or a polymer material, the metal material is selected from stainless steel, nickel-titanium, cobalt-chromium alloy, etc., and the polymer material is selected from at least one of PET, PTFE, or PP.
  • the traction wire 60 is made of a stainless steel wire with a certain hardness, so that the operator can either pull the traction wire 60 in the proximal direction or push the traction wire 60 in the distal direction, so as to drive the probe.
  • the needle 50 reciprocates to detect the clamping state of the valve tissue 40 in the valve accommodating space multiple times.
  • the detection assembly further includes a detection rail 81, and the traction wire 60 drives the probe 50 to move along the extension direction of the detection rail 81.
  • a pair of detection rails 81 are arranged on the second plane of the connection base 13, the distal end of the detection rail 81 is fixedly connected to the connection base 13, the proximal end of the detection rail 81 is opened, and the extension direction of the detection rail 81 is consistent with the push rod.
  • the axial direction of 10 is the same.
  • the traction wire 60 drives the probe 50 to move along the axial direction of the push rod 10.
  • the detection rail 81 and the connecting seat 13 may be an integral structure, or may be a non-integral structure connected by detachable or non-detachable means such as welding, bonding, crimping, or screwing.
  • the detection rail 81 and the connecting seat 13 are an integral structure.
  • the detection guide 81 is made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy, preferably stainless steel or cobalt-chromium with higher hardness.
  • the alloy is used to avoid deformation of the detection rail 81, which is beneficial to ensure the consistency of the trajectory of the probe 50 when reciprocating along the extension direction of the detection rail 81.
  • the detection assembly further includes a detection base 83, the detection base 83 is movably sleeved outside the detection guide 81, the distal end of the traction wire 60 is connected to the detection base 83, and the probe 50 is set On the detection base 83, the traction wire 60 drives the detection base 83 to move along the extension direction of the detection rail 81 to drive the probe 50 to move.
  • the traction wire 60 is movably inserted in the detection base 83 and is detachably connected to the detection base 83, so that the traction wire 60 can be removed from the patient's body after the operation is completed.
  • the detection assembly further includes a positioning member 85.
  • the proximal end of the positioning member 85 is connected to the probe 50, and the distal end of the positioning member 85 is connected to the detection base 83, ie, the probe The needle 50 is set on the detection base 83 through the positioning member 85.
  • the detection base 83 is approximately a rectangular parallelepiped, an arc-shaped avoiding groove 831 is defined at one end of the detection base 83 close to the push rod 10, and a rectangular accommodating groove 833 is defined at an end of the detection base 83 away from the push rod 10.
  • the positioning member 85 includes a cylindrical section and a block section connected to the distal end of the cylindrical section.
  • the block section of the positioning member 85 is arranged in the accommodating groove 833 and is fixed at a preset angle with the detection base 83, and the cylindrical section of the positioning member 85 is provided with an accommodating hole for accommodating and fixing the distal end of the probe 50, so that The probe 50 is set on the detection base 83 through the positioning member 85.
  • the proximal end surface of the cylindrical section of the positioning member 85 and the distal end surface of the probe 50 may be directly butted and fixed by welding.
  • the push rod 10 is partially contained in the avoidance groove 831, which is beneficial to reduce the side of the detection base 83 away from the push rod 10 relative to the push rod 10.
  • the distance between the axis of the valve clamper 100 is smaller than the distance between the connecting rod 15 located on the outside of the detection base 83 and the axis of the push rod 10, thereby reducing the outer diameter of the valve clamp 100; and, the avoiding groove 831 It can also play a role of guiding sliding to assist the detection base 83 to move along the axial direction of the push rod 10.
  • the block section of the positioning member 85 is fixed in the accommodating groove 833 of the detection base 83 at a preset angle, so that the included angle between the axial direction of the positioning member 85 and the axial direction of the push rod 10 is fixed, that is, the probe 50
  • the included angle between the axial direction and the axial direction of the push rod 10 is fixed.
  • the angle between the axial direction of the probe 50 and the axial direction of the push rod 10 should be within a certain range. Specifically, the included angle between the axial direction of the probe 50 and the axial direction of the push rod 10 is less than or equal to 90 degrees, preferably 45-70 degrees.
  • the detection base 83 and the positioning member 85 are made of at least one polymer material among polyoxymethylene, polycarbonate, polyurethane, polyetheramide, and polyvinyl chloride, or made of stainless steel or nickel titanium. Alloy, cobalt-chromium alloy, cobalt alloy, and titanium alloy are made of any metal material, preferably stainless steel or cobalt-chromium alloy with higher hardness.
  • the detection assembly may not include or only include any one or more or all of the detection rail 81, the detection base 83 and the positioning member 85, As long as it is ensured that the traction wire 60 can drive the probe 50 to move, so that the probe 50 can be inserted into the valve accommodation space.
  • the probe 50 is directly welded and fixed to the distal end of the traction wire 60, and the angle between the axial direction of the probe 50 and the axial direction of the push rod 10 is less than or equal to 90 degrees, when the operator pulls the traction wire 60
  • the traction wire 60 drives the probe 50 to be inserted into the valve accommodating space, thereby detecting the clamping state of the valve tissue 40 in the valve accommodating space.
  • the valve clamp 100 further includes an extracorporeal control device 90.
  • the extracorporeal control device 90 includes at least one traction member 91, at least one traction member 91 and a proximal end of a traction wire 60 extending outside the patient's body It is connected so that the operator holds at least one traction member 91 to control the movement of the traction wire 60, and then drives the probe 50 to move to detect the clamping state of the valve tissue 40.
  • there are two traction members 91 and the two traction members 91 are respectively connected to the traction wires 60 of the two sets of detection components, and each traction member 91 can independently control the movement of the probe 50 of the corresponding set of detection components. , So that the corresponding detection components can be controlled by different traction members 91 to detect the clamping state of the anterior leaflet and the posterior leaflet of the mitral valve.
  • the extracorporeal control device 90 further includes an indicator 92 and an indicator piece 93 arranged at the bottom of the indicator 92, for indicating the position of the probe 50 after the traction member 91 controls the movement of the probe 50, so that the operator can directly follow The position of the probe 50 determines the clamping state of the valve tissue 40.
  • the indicator 92 is arranged between the traction member 91 and the traction wire 60.
  • the indicator sheet 93 includes a first indicator area 931 and a second indicator area 932 located at the proximal end of the first indicator area 931. In the initial state, that is, when the probe 50 is not moving, the indicator 92 is located at the distal end of the first indicator area 931.
  • the moving indicator 92 is located in different areas of the indicator piece 93. Referring to FIG. 13, when the probe 50 moves to the first position, the indicator 92 is located in the first indicator area 931 of the indicator piece 93; when the probe 50 moves to the second position, the indicator 92 is located on the indicator piece 93 Within the second indication area 932. The operator can determine the position of the probe 50 based on the position of the indicator 92 in the area of the indicator sheet 93, and further determine the clamping state of the valve tissue 40 based on the position of the probe 50.
  • the indicator sheet 93 may be provided with a third indicator area, which is located at the distal end of the first indicator area 931.
  • the indicator 92 is located in the third indicator area to indicate the probe. 50 initial position.
  • the indicator piece 93 may also be provided with a fourth indicator area, the fourth indicator area is located at the proximal end of the second indicator area 932, and when the probe 50 moves to completely pass through the valve accommodation space, the indicator member 92 is located at the fourth indicator area.
  • the indication area is used to indicate the limit position of the probe 50 to prevent the operator from excessively pulling the traction member 91 in the proximal direction to cause the traction wire 60 to drive the detection base 83 to detach from the open proximal end of the detection guide 81.
  • the extracorporeal control device 90 further includes an axially telescopic telescopic member 94, the distal end of the indicator member 92 is connected to the traction wire 60, and the proximal end of the indicator member 92 is connected to the traction member through the telescopic member 94.
  • Piece 91 When the probe 50 moves to abut against the valve tissue 40, the valve tissue 40 prevents the probe 50 from moving. If the operator continues to pull the traction member 91 proximally due to inertia, at this time, the telescopic member 94 is deformed and a certain deformation occurs. The distance keeps the positions of the probe 50 and the indicator 91 unchanged, and prevents the probe 50 from continuing to move toward the proximal end and damaging the valve tissue 40.
  • the telescopic member 94 is selected from a spring tube, a spring, or an elastic element made of a single or mixed elastic material, or a plurality of laminated sleeves, wherein at least one sleeve is superimposed with an elastic element such as a spring.
  • the telescopic member 94 is a spring.
  • connection between the traction member 91, the telescopic member 94, the indicator member 92, and the traction wire 60 can be realized by any connection method such as welding, bonding, crimping, or screwing.
  • the external control device 90 also includes an upper shell 95 and a lower shell 96 that can be aligned.
  • the indicator 92, the indicator piece 93 and the telescopic member 94 are disposed on the upper shell 95 and the lower shell.
  • the upper housing 95 is provided with an opening for the indicator piece 93 to be exposed, so that the operator can intuitively see through the opening that the indicator member 92 moves with the traction member 91 when the indicator member 91 is located in the indicator
  • the position on the sheet 93 is used to determine the position of the probe 50, and the clamping state of the valve tissue 40 is further determined according to the position of the probe 50.
  • the indicator piece 93 is provided on the lower housing 96 and located at the bottom of the indicator 92 by any connection method such as welding, bonding, crimping, or screwing; the upper housing 95 and the lower housing 96 are also at opposite ends.
  • a through hole is provided for the traction wire 60 and the traction member 91 to pass through, which will not be repeated here.
  • the traction wire 60 is driven by the traction member 91 to move to drive the probe 50 to move, so as to detect the clamping state of the valve tissue 40, and can pass through the indicator 92 and indicator piece 93 outside the body.
  • the indication function intuitively reflects the detection results to the operator, avoids defects that require multiple ultrasound or angiography to confirm, reduces the harm to the patient, and at the same time makes the operation simple, which can effectively shorten the operation time and improve the operation efficiency.
  • the present application also provides a valve clamping system.
  • the valve clamping system includes a pushing device and the aforementioned valve clamping device 100.
  • the valve clamping device 100 can be delivered to a predetermined treatment through the pushing device. The position, such as the mitral valve, and adjust the relative position between the valve clamp 100 and the treatment site.
  • the pushing device includes an operating handle and a pushing component. The proximal end of the pushing component is connected with the operating handle, and the distal end of the pushing component is detachably connected with the valve clamp 100.
  • the operating handle since the operating handle is placed outside the patient's body for remote operation, the operating handle can be assembled with the aforementioned extracorporeal control device 90 as a whole, or the extracorporeal control device 90 can be directly used as the operating handle of the valve clamping system.
  • the pushing assembly includes a mandrel 210, a liner 220 and a pushing tube 230 movably and coaxially sleeved together from the inside to the outside, and the liner 220 is located between the mandrel 210 and the pushing tube 230.
  • the operator can drive the mandrel 210, the liner 220, and the push tube 230 to move or rotate relative to each other by operating the handle or the extracorporeal control device 90, respectively.
  • the mandrel 210 is detachably connected to the push rod 10 for driving the push rod 10 to slide along the axial direction of the fixing seat 70 to drive the distal end clip 30 to open and close relative to the fixing seat 70.
  • the mandrel 210 is a round rod body with an internal threaded hole 211 at the distal end, and the internal threaded hole 211 is used for screwing with the stud 11 at the proximal end of the push rod 10, thereby connecting the pushing assembly with the valve clamp
  • the combiner 100 is connected to drive the mandrel 210 to move through an operating handle or an external control device 90 to realize the axial movement of the push rod 10 along the fixing seat 70.
  • a pair of elastic connecting rods 231 are arranged axisymmetrically at the distal end of the push tube 230, the proximal end of each connecting rod 231 is connected to the distal end of the push tube 230, and the distal end of each connecting rod 231 is inclined to the axis of the push tube 230
  • each connecting rod 231 gradually shrinks from the proximal end to the distal end toward the axial direction of the push tube 230, and the distal ends of the two axisymmetrically arranged connecting rods 231 are close to each other.
  • the distal end of the connecting rod 231 receives a thrust outward along the radial direction of the push tube 230, the distal end of the connecting rod 231 expands outward.
  • each connecting rod 231 is protrudingly provided with a buckle 235, which is used for buckling into the buckling hole 711 of the fixing base 70 to realize the connection between the push tube 230 and the fixing base 70.
  • the lining tube 220 is a round tube body or a tube body with a taper at the distal end.
  • the lining tube 220 moves from the proximal end of the pushing tube 230 to the distal direction until the lining tube 220 is located at the distal end of the connecting rod 231, the lining tube 220 outwards Pushing the distal end of the connecting rod 231 causes the buckle 235 to move outward to be inserted into the hole 711, thereby realizing the connection between the push tube 230 and the fixing seat 70.
  • the connecting rod 231 at the distal end of the push tube 230 is first inserted into the penetration channel 77 from the proximal end of the fixing seat 70, so that the connecting rod 231 is farther away.
  • the buckle 235 at the end faces the hole 711 of the fixing seat 70; then the liner 220 sleeved in the push tube 230 is driven to move distally, and the liner 220 pushes the distal end of the connecting rod 231 outward, and the connecting rod 231 is far away
  • the buckle 235 at the end is snapped into the corresponding snap hole 711, so that the fixing seat 70 and the push tube 230 are in a connected state; finally, the mandrel 210, which is driven and sleeved in the liner 220, passes through the fixing seat 70 closely and is connected to the fixing seat 70.
  • the seat 70 is connected to the push rod 10 in the locked state, and the mandrel 210 is rotated to make the mandrel 210 and the push rod 10 threadedly connected.
  • the mandrel 210 can drive the push rod 10 to freely slide along the axial direction of the fixing base 70.
  • the pushing device further includes the aforementioned adjustment wire for fixing the free end 22 of the proximal clip 20 to the surface of the fixing seat 70.
  • the regulating wire can be made of metal or polymer materials such as PTFE.
  • the pusher assembly and the valve clamp 100 can be delivered into the patient's body by using the existing adjustable curved sheath, and the adjustment wire and traction wire 60 can also be inserted in the adjustable curved sheath and extend in the opposite direction. To the patient's body, I will not repeat it here.
  • the following takes the mitral valve repair process as an example to illustrate the operation method of the valve clamping system of the present application, which mainly includes the following steps:
  • the first step use the adjustment wire to tie the free end 22 of the proximal clip 20 to the surface of the fixing seat 70, and then connect the pusher assembly to the valve clip 100; then move the mandrel 210 to the proximal end to drive the push
  • the rod 10 slides to the distal end in the axial direction, driving the distal clip 30 to close relative to the fixing seat 70, so that the valve clamp 100 is in a fully retracted state.
  • the proximal clip 20 and the distal clip 30 are both It is close to the surface of the fixing seat 70 and keeps the folded state unchanged.
  • the second step using an interventional route such as transatrial septum, the valve clamp 100 connected to it is advanced from the left atrium through the pushing component, and then reaches the left ventricle through the mitral valve.
  • an interventional route such as transatrial septum
  • the third step adjust the relative position of the valve clamp 100 and the mitral valve through the push tube 230 so that the valve clamp 100 is close to the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve, as shown in FIG. 16.
  • Step 4 Move the mandrel 210 to the proximal end by operating the handle, thereby driving the push rod 10 to slide proximally to drive the distal clip 30 to open relative to the fixing seat 70, and adjust the direction of the valve clip 100 so that The distal clip 30 is perpendicular to the occlusal line of the mitral valve.
  • Step 5 Withdraw the entire valve clamp 100 proximally, so that the distal clamp 30 supports the valve leaflets on the left ventricle side, as shown in FIG. 17.
  • Step 6 Release the restraint of the adjustment wire on the proximal clip 20, the proximal clip 20 rebounds and expands relative to the fixing seat 70, so that the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve are respectively clamped in the corresponding Between the proximal clip 20 and the distal clip 30, as shown in FIG. 18.
  • Step 7 Operate the two traction members 91 outside the body respectively to control the movement of the two sets of detection components to detect the clamping state of the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve. Specifically, as described above, pull the traction member 91 toward the proximal end to drive the probe 50 to move toward the proximal end, and the probe 50 is inserted into the valve accommodation space. When the valve leaflets are clamped in place, the valve leaflets will bear against the probe 50.
  • the indicator 92 is located in the first indicator area 931 of the indicator piece 93; when the leaflet is not clamped in place, the probe 50 will pass through the valve accommodation space, and the indicator 92 is located on the first indicator area 931 of the indicator piece 93. 2. Indicating area 932; the operator judges whether it is necessary to pull up the proximal clip again through the adjustment wire to re-grasp the valve leaflets according to the indicating function of the indicator 92 and the indicator piece 93, and detect the mitral valve again after grasping again The clamping state of the leaflets until the leaflets are clamped in place.
  • Step 8 Move the mandrel 210 to the distal end again, and the mandrel 210 drives the push rod 10 to axially slide to the distal end, thereby driving the distal clip 30 to close relative to the fixing seat 70 until the valve clip 100 is completely retracted. As shown in Figure 19.
  • Step 9 Control the rotation of the mandrel 210 by operating the handle to release the threaded connection between the mandrel 210 and the push rod 10, and then withdraw the liner 220 and the mandrel 210 to the proximal end until the connecting rod 231 of the push tube 230
  • the buckle 235 is unlocked and separated from the hole 711 of the fixing seat 70, and the valve clamp 100 is completely separated from the pushing assembly.
  • the pushing component is withdrawn from the patient's body, and the valve clamp 100 is left in the patient's body to complete the edge-to-edge repair of the mitral valve.
  • valve clamping system of the present application can also transport the valve clamping device 100 to the mitral valve through a path such as the apex of the heart.
  • the operator in the process of clamping the valve leaflets by the valve clamp 100, the operator can detect the clamping state of the valve leaflets in time through the detection assembly, and intuitively know the detection result through the external control device, and the operation operation Simple, conducive to shorten the operation time and improve the efficiency of the operation.
  • the structure of the valve clamp provided by the second embodiment of the present application is similar to the structure of the valve clamp 100 of the first embodiment, except that: in the second embodiment, the valve clamp
  • the external control device 90b only includes one traction member 91b, which is used to simultaneously control the movement of the probes of the two different detection assemblies to detect the clamping state of the anterior and posterior mitral valve leaflets at the same time, so that the surgical operation It is simpler and reduces the operation time.
  • the structure of the valve clamp 100c provided by the third embodiment of the present application is similar to the structure of the valve clamp 100 of the first embodiment, except that: in the third embodiment, the valve clamps
  • the detection component of the device 100c includes a probe 50, a traction wire 60, and a hollow detection rail 87.
  • the detection rail 87 is arranged on the outer wall of the push rod 10c.
  • the detection guide 87 extends outward and radiates toward the distal direction relative to the push rod 10c.
  • the probe 50 is welded to the distal end of the traction wire 60, and the probe 50 can follow the traction wire 60 to move along the extension direction of the detection rail 87 to extend or receive in the detection rail 87.
  • the push rod 10c has two long holes (not shown in the figure) extending along the axial direction of the push rod 10c in axial symmetry, and each long hole penetrates the push rod.
  • the proximal openings of the two elongated holes are respectively located on opposite sides of the stud 11, and the distal openings of the two elongated holes are respectively provided on the outer wall of the distal end of the push rod 10c and located at the proximal clip 20 above.
  • a pair of detection rails 87 are arranged axisymmetrically on the outer wall of the push rod 10c by welding connection, and the proximal nozzle of each detection rail 87 is butted with the distal opening of the corresponding side of the long hole, and the pair of detection rails 87 are respectively Correspondingly communicate with the two long holes inside the push rod 10c.
  • Two sets of welding wires 60 and probes 50 are respectively movably inserted into the corresponding long holes and the detection rail 87 on opposite sides of the push rod 10c, and the probe 50 is located in the detection rail 87 as a whole.
  • the traction wire 60 drives the probe 50 to move in the detection rail 87 along the extension direction of the detection rail 87 to extend or retract into the detection rail 87.
  • the probe 50 extends out of the detection rail 87, the probe 50 approaches the proximal clip 20 and passes through the elongated through hole 26 of the proximal clip 20 to be inserted into the valve accommodating space to detect the clamping state of the valve tissue 40 .
  • the detection rail 87 is arranged on the outer wall of the push rod 10c at a predetermined angle.
  • the predetermined angle is the angle between the extension direction of the detection rail 87 and the axial direction of the push rod 10c, and the angle is less than or equal to 90 degrees, preferably 45-70 degrees.
  • the detection rail 87 is made of at least one elastic polymer material or metal material, preferably a polymer material mixed with a nickel-titanium woven mesh, so it has certain elasticity. Due to the elasticity of the detection rail 87, when the valve clamp 100c is folded, the detection rail 87 can be contracted between the push rod 10c and the proximal clip 20; and when the valve clamp 100c is opened, the detection rail 87 can expand and unfold itself At this time, the detection rail 87 is facing the elongated through hole 26 of the proximal clip 20.
  • the difference from the first embodiment is that the first indicator area 931 of the indicator sheet 93 is located at the first Two indicates the proximal side of the area 932.
  • the push rod 10c may not have a long hole
  • the detection guide 87 is fixed on the outer surface of the push rod 10c
  • the detection guide 87 is located between the push rod 10c and the proximal clip 20
  • the traction wire 60 is movably passed through
  • the probe 50 is driven to extend or retract into the detection rail 87 in the detection rail 87, and can also be used to detect the clamping state of the valve tissue 40, which will not be repeated here.
  • valve clamps to reduce or treat "mitral regurgitation” as an example. It is understandable that in other embodiments, the valve clamp can also be used to reduce or treat "tricuspid regurgitation", and its principle and structure are the same as those used in the embodiments of this application to solve “mitral regurgitation”. The principle and structure of the valve clamp are roughly the same. It only needs to clamp a leaflet through multiple sets of proximal and distal clamps, which will not be repeated here.
  • valve clamp provided in the present application can also be applied to other minimally invasive surgical operations that require more than three sheet-shaped valve tissues to be clamped together.

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Abstract

本申请提供一种可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统。瓣膜夹合系统包括推送装置及瓣膜夹合器。瓣膜夹合器包括夹合器主体及探测组件。夹合器主体包括推杆、可相对于推杆辐射展开的近端夹片及远端夹片，近端夹片与远端夹片之间形成瓣膜容纳空间，近端夹片与远端夹片配合以夹紧位于瓣膜容纳空间内的瓣膜组织。探测组件包括探针及用于驱动探针移动的牵引丝，牵引丝能带动探针插入瓣膜容纳空间内，以探测瓣膜容纳空间内的瓣膜组织的夹持状态。本申请中，通过牵引丝带动探针移动，使探针插入瓣膜容纳空间，即可探测瓣膜容纳空间内的瓣膜组织的夹持状态，操作简单，有利于减少手术时间、提高手术效率。

Description

可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统 技术领域
本申请涉及医疗器械领域，尤其涉及一种可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统。
背景技术
请参阅图1，二尖瓣1是位于心脏左心房2与左心室3之间的单向阀，正常健康的二尖瓣1可以控制血液从左心房2流到左心室3，同时避免血液从左心室3流到左心房2。二尖瓣1包括一对瓣叶，称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的乳头肌上。正常情况下，心脏左心室3收缩时，前叶1a和后叶1b的边缘完全对合，避免血液从左心室3流到左心房2。请参阅图2，当二尖瓣1的瓣叶或其相关结构发生器质性改变或功能性改变时，如腱索4部分断裂，二尖瓣1的前叶1a和后叶1b对合不良，由此，当心脏左心室3收缩时，二尖瓣1不能完全关闭，导致血液从左心室3返流至左心房2，从而引起一系列的病理生理改变，称为“二尖瓣返流”。
现有一种微创治疗手术，其基于瓣膜的缘对缘手术原理，将瓣膜夹钳通过推送装置推送至二尖瓣处，再通过夹钳的相对开合同时夹持二尖瓣的前叶和后叶，从而将瓣叶拉近彼此，减轻二尖瓣返流。由于二尖瓣的前叶和后叶始终处于大幅度、大力度的开合活动状态，夹持难度较大，即使被夹持住了，也可能存在夹持位置不牢靠的问题，例如，瓣叶可能只被部分夹持，这可能导致二尖瓣的前叶和后叶夹合位置不理想或者仅被部分夹持的瓣叶最终从夹钳中滑移，只能重复进行手术操作。
现有技术中的瓣膜夹钳，一般基于探测元件显影性或者通过传感器和探测电路的电流完整性来检测瓣叶夹持状态。然而，基于探测元件显影性来检测瓣叶夹持状态时，由于瓣膜夹钳的零件多为金属，在彩超下会干扰对探测元件的位置判断，医生无法直观的评估瓣叶的夹持效果，且探测元件一般很小，实际的显影效果较差，因此，手术时间长、效率低；而通过传感器和探测电路的电流完整性来检测瓣叶夹持状态时，需要在瓣膜夹钳上安装导电的探测元件或者传感器，导致植入的瓣膜夹钳变成了机电装置，而不是单纯的机械装置，降低装置的安全性，并且需要借助外接设备才能检测瓣叶的夹持状态，提高手术成本，且操作过程繁琐，手术时间长、效率低。
发明内容
有鉴于此，本申请提供一种可探测瓣膜夹持状态的瓣膜夹合器及瓣膜夹合系统，操作简单，有利于减少手术时间、提高手术效率。
本申请提供一种可探测瓣膜夹持状态的瓣膜夹合器，包括夹合器主体及探测组件；所述夹合器主体包括推杆、可相对于所述推杆辐射展开的近端夹片及远端夹片，所述近端夹片与所述远端夹片之间形成瓣膜容纳空间，所述近端夹片与所述远端夹片配合以夹紧位于所述瓣膜容纳空间内的瓣膜组织；所述探测组件包括探针及用于驱动所述探针移动的牵引丝，所述牵引丝能带动所述探针插入所述瓣膜容纳空间内，以探测所述瓣膜容纳空间内的瓣膜组织的夹持状态。
本申请还提供一种瓣膜夹合系统，包括可探测瓣膜夹持状态的瓣膜夹合器及用于输送所述瓣膜夹合器的推送装置，在通过所述推送装置将所述瓣膜夹合器输送至患者体内并夹持瓣叶后，可以探测瓣膜组织的夹持状态。
本申请提供的瓣膜夹合器及瓣膜夹合系统，通过牵引丝带动探针移动，使探针插入瓣膜容纳空间内，即可探测瓣膜容纳空间内的瓣膜组织的夹持状态，操作简单，从而能够减少手术时间、提高手术效率；并且无需使用机电装置，因此安全性较高。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是二尖瓣正常状态时的示意图。
图2是二尖瓣出现病变时的示意图。
图3是本申请第一实施例提供的瓣膜夹合器张开状态下夹持瓣膜组织的立体结构示意图。
图4是图3中的IV部分去除固定座及牵引丝后的放大示意图。
图5是图3的另一视角的示意图。
图6是图3中的近端夹片的立体结构示意图。
图7是图3中的瓣膜夹合器的使用状态示意图。
图8是图7中的瓣膜夹合器夹持瓣叶后，心脏收缩时二尖瓣示意图。
图9是图7中的瓣膜夹合器夹持瓣叶后，心脏舒张时二尖瓣示意图。
图10是图3中的探测组件的部分结构的立体结构示意图。
图11是体外控制装置的正面示意图。
图12是图11中的体外控制装置去除上壳后的内部结构示意图。
图13是瓣膜夹合器的探针位于不同位置时体外控制装置的牵引件的位置示意图。
图14是本申请其中一实施例提供的瓣膜夹合系统的部分结构的立体结构示意图。
图15是图14的截面示意图。
图16至图19是瓣膜夹合器的使用过程示意图。
图20是本申请第二实施例提供的瓣膜夹合器的体外控制装置去除上壳后的内部结构示意图。
图21是本申请第三实施例提供的瓣膜夹合器的立体结构示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。
请参阅图3至图5，本申请的第一实施例提供一种瓣膜夹合器100，包括用于夹持瓣膜 的夹合器主体及用于探测瓣膜夹持状态的探测组件。具体的，夹合器主体包括推杆10、可相对于推杆10辐射展开的近端夹片20及远端夹片30，近端夹片20与远端夹片30之间形成瓣膜容纳空间，近端夹片20与远端夹片30配合以夹紧位于瓣膜容纳空间内的瓣膜组织40。探测组件包括探针50及用于驱动探针50移动的牵引丝60，牵引丝60能带动探针50插入瓣膜容纳空间内，以探测瓣膜容纳空间内的瓣膜组织40的夹持状态。本申请中，利用瓣膜夹合器100夹持瓣膜组织40时，操作者只需拉动牵引丝60以带动探针50移动，使得探针50插入瓣膜容纳空间内，即可探测瓣膜组织40的夹持状态，操作简单，从而能够减少手术时间、提高手术效率；并且无需使用机电装置，因此安全性较高。
为保证植入后的安全性，推杆10由聚酯、硅树脂、不锈钢、钴合金、钴铬合金或钛合金等生物相容性高分子材料或金属材料制成，优选硬度较高的不锈钢或钴铬合金；近端夹片20及远端夹片30均由生物相容性金属材料制成，所述金属材料选自不锈钢、钴合金、钴铬合金、钛合金或镍钛合金等常用的植入用金属材料，优选的，近端夹片20由具有形状记忆功能的弹性材料制成，远端夹片30由硬度较高的刚性材料制成，以保证二者配合能够夹紧固定瓣膜组织40。本实施例中，近端夹片20由镍钛合金制成，远端夹片30由不锈钢或钴铬合金制成。
本实施例中，近端夹片20及远端夹片30的数量分别有两个，两个近端夹片20与两个远端夹片30一一对应配合，以分别夹紧二尖瓣的前叶和后叶而使二尖瓣对合，从而减轻或治疗“二尖瓣返流”。
本实施例中，探测组件设置有两组，两组探测组件分别用于探测二尖瓣的前叶和后叶的夹持状态。
具体的，请一并参阅图3至图5，推杆10为杆体或管体。本实施例中，推杆10为圆杆体。推杆10的近端设有带外螺纹的螺柱11，螺柱11用于与推送装置的芯轴(图中未示)连接。推杆10的远端设有连接座13，连接座13包括相对的两个第一平面及两个连接第一平面的连接面，两个连接面包括位于远端的曲面及位于近端、且与曲面光滑过渡相接的第二平面。连接座13相对的两端分别开设有贯通两个第一平面的销钉孔(图中未示)。其中，连接座13的平行于第二平面方向的截面尺寸由近端至远端逐渐减小，即连接座13的形状为半球体、球冠或弹头形等任一结构，以使瓣膜夹合器100更容易在体内进行推送。
请一并参阅图3和图5，夹合器主体还包括固定座70，固定座70包括第一座体71及连接于第一座体71远端的第二座体72，第一座体71与第二座体72之间通过一第三座体73过渡连接，三者可以是一体结构或非一体结构。本实施例中为一体结构。
本实施例中，第一座体71的近端设置有两个矩形卡孔711，卡孔711用于与推送装置的连接杆(图中未示)连接。第二座体72开设有贯通第二座体72相对的两侧的容置腔75，容置腔75的一侧内壁设置有凸台751，凸台751的近端面为斜面，容置腔75内设置有钢片753及抵顶于钢片753近端面上的变形弹片755，钢片753的一端抵接于凸台751的斜面上，在变形弹片755的弹力作用下，钢片753倾斜设置于容置腔75内。第二座体72的远端相对的两外侧分别开设有用于与远端夹片30转动连接的连接孔(图中未示)。
进一步的，固定座70沿轴向开设有贯通第一座体71、第二座体72及第三座体73的穿设通道77，推杆10自固定座70的远端穿入固定座70的穿设通道77内并可沿轴向移动。其中，钢片753及变形弹片755沿轴向开设有相应的通孔，且通孔的面积略大于推杆10的横截面的面积，当推杆10穿设于穿设通道77内时，推杆10穿过设置于容置腔75内的钢片753及变形弹片755的通孔。
可以理解的是，推杆10穿过钢片753及变形弹片755，在变形弹片755的弹力作用下，钢片753倾斜后与推杆10呈一定夹角且在通孔边缘接触，当推杆10沿轴向移动时，推杆 10与固定座70之间存在相对运动的趋势，钢片753产生摩擦力以阻止推杆10相对于固定座70移动，使得推杆10与固定座70处于连接锁定状态。
其中，为保证植入后的安全性，固定座70、钢片753及变形弹片755均由不锈钢、钴合金、钴铬合金、钛合金或镍钛合金等生物相容性金属材料制成。优选的，固定座70及钢片753由硬度较高的不锈钢或钴铬合金制成，变形弹片755由具有弹性的镍钛合金制成。
需要说明的是，固定座70相对的两侧还分别设置有用于控制钢片753的控制件(图中未示)，控制件优选为镍钛合金制成的金属丝，控制件贴合于固定座70，控制件的远端朝向固定座70的轴线方向弯折而收容于容置腔75内。具体的，控制件的远端具有两分支，其中一分支抵接于凸台751的远端平面上，另一分支抵接于钢片753的远端面上且靠近钢片753远离凸台751的一端。当向近端方向拉动控制件抵接于钢片753的远端面上的分支时，该分支能带动钢片753远离凸台751的一端以钢片753抵接于凸台751的斜面上的一端为支撑点而向近端方向转动，直至钢片753与推杆10的轴线呈90度，此时，钢片753的通孔与推杆10的轴线同轴，推杆10与固定座70之间的连接锁定状态解除，推杆10可沿轴向移动。
请一并参阅图3和图6，本实施例中，两个近端夹片20设置于固定座70的远端外部，且相对于固定座70轴对称设置。每一近端夹片20包括相对设置的连接端21及自由端22。两个近端夹片20的连接端21通过一连接框23连接为一体，连接框23套设于第二座体72的远端，以实现两个近端夹片20的连接端21与固定座70的相对固定。其中，连接框23的中部开设有供推杆10穿过的通孔(图中未标示)。
在其他实施例中，近端夹片20的连接端21可以直接通过焊接等方式固定于第二座体72的远端。
近端夹片20至少部分由具有形状记忆功能的弹性材料制成，且经过热定型处理。在自然状态下，近端夹片20相对于固定座70向外辐射延伸，以便于和远端夹片30配合以夹持瓣膜组织40。本实施例中，近端夹片20由镍钛合金切割后放置到定型模具中，再将定型模具放入电加热式循环空气箱式炉，于300-650℃条件下进行定型热处理，取出并迅速放入到纯化水中冷却，拆除定型模具得到定型好的近端夹片20。具体的，本实施例中，近端夹片20整体由超弹性的镍钛合金制成，连接框23也采用镍钛合金制成并与近端夹片20一体成型，以降低生产工艺难度，简化工艺流程，降低生产成本。在其他实施例中，连接框23也可以采用刚性的不锈钢制成，再与近端夹片20焊接，以提高连接框23与第二座体72的连接强度。
需要说明的是，近端夹片20的自由端22开设有用于连接推送装置的调节线(图中未示)的调节线孔24，近端夹片20的自由端22可以通过延伸至患者体外的调节线进行控制。在输送状态下，近端夹片20的自由端22被调节线拉紧并贴合于固定座70的表面，而在放开调节线对自由端22的控制后，近端夹片20被释放，近端夹片20由于自身弹性记忆性能而回弹并恢复自然状态，以将瓣膜组织40压向远端夹片30。优选的，自然展开状态下的两个近端夹片20之间的夹角应略大于两个远端夹片30之间的夹角，以提供更稳定的夹持力，即，近端夹片20与固定座70之间的夹角大于或等于与该侧对应的远端夹片30相对于固定座70完全张开时的远端夹片30与固定座70之间的夹角，从而保证近端夹片20与远端夹片30之间具有一定的夹紧力，以夹紧位于近端夹片20与远端夹片30之间的瓣膜组织40。具体的，本实施例中，自由端22的长度方向与固定座70的轴向之间的夹角的角度范围为0-150度，即，两个近端夹片20之间的夹角最大可达300度，两个近端夹片20之间的打开角度范围优选为0-240度，更优为160-200度。
进一步的，近端夹片20还包括朝向远端夹片30的第一表面，第一表面上设有夹持增 强件，以增加近端夹片20与夹持于瓣膜容纳空间内的瓣膜组织40之间的摩擦力，提高瓣膜夹合器100对瓣膜组织40的夹持力。具体的，本实施例中，夹持增强件为设置于第一表面相对的两侧的两列间隔设置的倒刺25。倒刺25可以采用一体成型方式在近端夹片20上形成，也可以采用与近端夹片20相同或不同的材料形成倒刺25再将其连接于近端夹片20的第一表面上。倒刺25的延伸方向与第一表面之间的夹角小于或等于90度，优选为30-60度，以增强瓣膜夹合器100对瓣膜组织40的夹持力。
在其他实施例中，夹持增强件可以是凸设于第一表面的凸棱、凸台或其它不规则分布的凸起等结构，还可以是至少部分覆盖第一表面的粗糙表面，以提高对瓣膜组织40的夹持力。
其中，近端夹片20的连接端21位于探针50移动路径上的区域对应开设有长条形通孔26，以便于探针50穿过。可以理解的是，近端夹片20的其他区域也可以开设至少一开孔27，通孔26及开孔27能够减轻近端夹片20的重量，从而避免过重的瓣膜夹合器100长期坠在瓣叶下方产生滑脱或损伤瓣叶，同时也有利于内皮细胞爬覆和生长。
请一并参阅图3和图5，本实施例中，两个远端夹片30分别与固定座70转动连接，且分别与两个近端夹片20一一对应。每一远端夹片30包括位于远端的连接段31以及连接于连接段31近端的夹持段32。本实施例中，连接段31包括间隔相对的两个连接片，夹持段32包括一夹持片，两个连接片分别位于夹持片相对的两侧，两个连接片与夹持片之间围成镂空区域，以便于探针50插入所述镂空区域，同时有利于减轻瓣膜夹合器100的整体重量。
本实施例中，夹合器主体还包括相对设置的两个连杆15。每一远端夹片30的连接段31远离对应的夹持段32的一端转动连接于固定座70的第二座体72的远端；连接段31靠近夹持段32的端部转动连接于相应一侧的连杆15的近端，连杆15的远端转动连接于连接座13上。其中，所述转动连接均通过相应的转动销钉或转动螺栓来实现。
具体的，如前所述，通过控制件向近端拉动钢片753，使钢片753与推杆10的轴线呈90度，推杆10与固定座30之间的连接锁定状态即可解除，推杆10可沿轴向相对于固定座70运动，由此，固定座70与推杆10远端的连接座13相对运动，连接座13带动连杆15运动，在连杆15的拉动下，远端夹片30可围绕与固定座70的连接位置的中心(即第二座体72的连接孔的中心)转动而相对于固定座70开合，当近端夹片20被释放并由于其自身弹性记忆功能而自由展开后，近端夹片20可向对应的远端夹片30靠拢，以夹紧瓣膜容纳空间内的瓣膜组织40。
其中，连杆15带动远端夹片30相对于固定座70开合时，可以实现远端夹片30相对于固定座70在较大范围内开合，两个远端夹片30之间的夹角最大可达到300度，即，远端夹片30相对于固定座70打开后，可以实现一定程度的向下翻转，从而方便夹持不断处于运动中的瓣膜组织40，提高夹持成功率。本实施例中，两个远端夹片30之间的夹角范围优选为0-240度，更优为120-180度。
可以理解的是，当近端夹片20与远端夹片30夹紧瓣膜组织40后，推杆10沿轴向向近端方向运动，通过连杆15带动远端夹片30相对于固定座70合拢，直至远端夹片30相对于固定座70完全闭合，使瓣膜夹合器100处于收拢状态，然后释放控制件对钢片753的控制，在变形弹片755的弹力作用及凸台751的抵推作用下，钢片753倾斜并与推杆10呈一定夹角接触，推杆10与固定座70之间的连接锁定，以避免远端夹片30相对于固定座70打开，收拢状态的瓣膜夹合器100坠于瓣叶下方。
优选的，远端夹片30朝向近端夹片20的第二表面上也可以设置倒刺、凸起、凹槽、垫片等夹持防滑结构(图中未示)。
其中，第二表面可以是平面，也可以是曲面。优选的，第二表面设置为曲面，以增加远端夹片30与瓣膜组织40的接触面积及夹持面积，从而提供稳定的夹持力。而且，曲面的第二表面形成一收容槽，近端夹片20向远端夹片30靠拢时，近端夹片20的第一表面上的倒刺25能够收容于收容槽内，以压紧位于瓣叶容纳空间内的瓣膜组织40，并且能够尽量缩小瓣膜夹合器100收拢时的体积，利于在体内进行输送。
进一步优选的，远端夹片30的第二表面上还可以施加活性药物，或者开设至少一个开孔，以促进瓣膜组织40在远端夹片30的内表面上的内皮细胞爬覆及生长；再者，开设开孔还可以减轻瓣膜夹合器100的整体重量，从而避免过重的瓣膜夹合器100长期坠在瓣叶下方产生滑脱或损伤瓣叶。
本申请中，远端夹片30的轴向长度，即连接段31至夹持段32的距离，应大于或等于4mm，优选为6-10mm，以避免过长的远端夹片30将过多的前叶和后叶夹在一起，导致瓣膜夹合器100收拢时，两个瓣叶被强行拉向彼此并固定在一起，在心脏跳动和瓣叶运动的时候，过多的瓣叶被限制运动，导致二尖瓣功能异常或瓣叶撕裂等严重后果；也可避免过短的远端夹片30只能夹持小部分的瓣叶，使得瓣叶容易滑出，夹合固定效果较差。本申请中，远端夹片30的宽度，即与远端夹片30的轴向方向垂直的方向的长度，应大于或等于2mm，优选为4-6mm，以避免过窄的远端夹片30影响夹持效果，同时也避免过宽的远端夹片30影响瓣叶运动或损伤瓣叶。。
如前所述，本实施例提供的瓣膜夹合器100能够用于减轻或治疗“二尖瓣返流”。具体的，请一并参阅图7至图9，将瓣膜夹合器100置于二尖瓣的前叶1a及后叶1b的不能正常对合的位置，使得对应的一组近端夹片20及远端夹片30夹持二尖瓣的前叶1a边缘，另一组对应的近端夹片20及远端夹片30夹持二尖瓣的后叶1b边缘，以将二尖瓣的前叶1a及后叶1b的不能正常对合的位置夹持在一起，图8和图9中所示箭头方向为血流方向。如图8所示，当心脏收缩时，前叶1a与后叶1b收拢，二尖瓣开口的面积A变小或者二尖瓣能完全闭合，只有少量血液从二尖瓣的开口处返流进入左心房，从而可减轻或治疗“二尖瓣返流”。如图9所示，当心脏舒张时，前叶1a及后叶1b仅在瓣膜夹合器100夹合的位置B对合在一起，前叶1a及后叶1b其它的位置仍然正常舒张，使得血液能够从左心房进入左心室，从而保证血液的正常流通。
请一并参阅图3、图5及图10，为了探测瓣膜夹合器100夹合二尖瓣的过程中前叶和后叶的夹持状态，本申请中，瓣膜夹合器100设置有探测组件，探测组件包括探针50及用于驱动探针50移动的牵引丝60。本实施例中，探测组件设置有两组，两组探测组件关于推杆10轴对称设置，且位于瓣膜夹合器100相对设置的两个连杆15围拢的空间内，即，探测组件设置于瓣膜夹合器100的内部，从而不会增加瓣膜夹合器100的整体尺寸。
其中，牵引丝60延伸至患者体外以便于操作者操作，当操作者向近端方向拉动牵引丝60时，牵引丝60能带动探针50朝近端方向移动，以使探针50插入瓣膜容纳空间。
在一些实施例中，探针50朝近端移动后，探针50的针头抵顶于瓣膜容纳空间内的瓣膜组织40，此时，探针50位于第一位置，即判定瓣膜容纳空间内的瓣膜组织40夹持到位；在另一些实施例中，探针50朝近端移动后，探针50的针头未抵顶到瓣膜容纳空间内的瓣膜组织40而穿过瓣膜容纳空间，此时，探针50位于第二位置，即判定瓣膜容纳空间内的瓣膜组织40夹持不到位。其中，瓣膜组织40夹持不到位是指近端夹片20与远端夹片30未夹持瓣膜组织40或瓣膜组织40只有小部分被夹持。如图5所示，本实施例中，右侧的探针50抵顶于右侧瓣膜组织40(后叶)的远端一侧，右侧瓣膜组织40夹持到位；左侧的探针50则穿过瓣膜容纳空间并部分伸出于近端夹片20，也即表明，左侧瓣膜组织40(前叶)夹持不到位，具体为左侧瓣膜组织40只被部分夹持。
其中，探针50由硅胶、聚醚酰胺、聚碳酸酯、聚甲醛、聚氨酯、聚氯乙烯中的至少一种高分子材料制成，或者由不锈钢、镍钛合金、钴铬合金、钴合金、钛合金中的任一种金属材料制成。优选的，本实施例中，探针50由不锈钢制成，以提高探针50的支撑性，提高探测效果。
其中，牵引丝60为金属材料或高分子材料制成的线材或者管材，金属材料选自不锈钢、镍钛、钴铬合金等，高分子材料选自PET、PTFE或PP中的至少一种。优选的，本实施例中，牵引丝60由具有一定硬度的不锈钢丝制成，使得操作者既可以向近端方向拉动牵引丝60，也可以向远端方向推送牵引丝60，从而能够带动探针50往复移动，以用于多次探测瓣膜容纳空间内的瓣膜组织40的夹持状态。
如图3所示，本实施例中，探测组件还包括探测导轨81，牵引丝60带动探针50沿探测导轨81的延伸方向移动。具体的，一对探测导轨81设置于连接座13的第二平面上，探测导轨81的远端固定连接于连接座13，探测导轨81的近端开放设置，探测导轨81的延伸方向与推杆10的轴向相同。也即是说，牵引丝60带动探针50沿推杆10的轴向移动。
其中，探测导轨81与连接座13可以是一体结构，也可以是通过焊接、粘结、压接或螺接等可拆卸或不可拆卸方式连接的非一体结构。本实施例中，探测导轨81与连接座13为一体结构。
其中，为保证植入后的安全性，探测导轨81由不锈钢、钴合金、钴铬合金、钛合金或镍钛合金等生物相容性金属材料制成，优选为硬度较高的不锈钢或钴铬合金，以避免探测导轨81变形，有利于保证探针50沿探测导轨81的延伸方向往复移动时的轨迹一致性。
请参阅图5，本实施例中，探测组件还包括探测基座83，探测基座83活动地套设于探测导轨81外，牵引丝60的远端连接于探测基座83，探针50设置于探测基座83上，牵引丝60带动探测基座83沿探测导轨81的延伸方向移动以带动探针50移动。其中，牵引丝60活动地穿设于探测基座83中而与探测基座83可拆卸连接，以便于在手术完成后将牵引丝60从患者体内抽离。
进一步的，请一并参阅图10，本实施例中，探测组件还包括定位件85，定位件85的近端与探针50连接，定位件85的远端与探测基座83连接，即探针50通过定位件85设置于探测基座83上。
具体的，探测基座83大致呈长方体，探测基座83靠近推杆10的一端开设弧形的避让槽831，探测基座83背离推杆10的一端开设矩形的容置槽833。定位件85包括圆柱段及连接于圆柱段远端的方块段。定位件85的方块段设置于容置槽833内并与探测基座83以预设角度固定，定位件85的圆柱段设置容置孔，用于容置并固定探针50的远端，使得探针50通过定位件85设置于探测基座83上。在其他实施例中，定位件85的圆柱段的近端面与探针50的远端面可以直接对接并焊接固定。
定位件85的方块段与容置槽833靠近避让槽831的壁面之间留有间隙，探测导轨81穿设于该间隙中，使得探测基座83可在牵引丝60的带动下沿探测导轨81的延伸方向移动，定位件85跟随探测基座83移动以带动探针50移动。
需要说明的是，探测基座83沿探测导轨81的延伸方向移动时，推杆10部分收容于避让槽831内，有利于减小探测基座83背离推杆10的一侧相对于推杆10的轴心线的距离，使得位于探测基座83外侧的连杆15相对于推杆10的轴心线的距离较小，从而减小瓣膜夹合器100的外径尺寸；并且，避让槽831还能够起到导滑的作用，以辅助探测基座83沿推杆10的轴向移动。
定位件85的方块段以预设角度固定于探测基座83的容置槽833内，使得定位件85的轴向与推杆10的轴向之间的夹角固定，也即探针50的轴向与推杆10的轴向之间的夹角固 定。本申请中，为保证探针50朝近端移动后，探针50能准确插入瓣膜容纳空间内，并在瓣膜组织40夹持不到位时自近端夹片20的长条形通孔26穿出，探针50的轴向与推杆10的轴向之间的夹角应在一定范围内。具体的，探针50的轴向与推杆10的轴向之间的夹角小于或等于90度，优选为45-70度。
其中，为保证安全性，探测基座83及定位件85均由聚甲醛、聚碳酸酯、聚氨酯、聚醚酰胺、聚氯乙烯中的至少一种高分子材料制成，或者由不锈钢、镍钛合金、钴铬合金、钴合金、钛合金中的任一种金属材料制成，优选为硬度较高的不锈钢或钴铬合金。
可以理解的是，本申请中，除探针50及牵引丝60外，探测组件可以不包括或仅包括探测导轨81、探测基座83及定位件85中的任一种或多种或所有，只要保证牵引丝60能带动探针50移动，使探针50能够插入瓣膜容纳空间即可。例如，在其他实施例中，探针50直接焊接固定于牵引丝60的远端，探针50的轴向与推杆10的轴向夹角小于或等于90度，当操作者拉动牵引丝60朝近端方向沿着一定的轨迹移动时，牵引丝60带动探针50插入瓣膜容纳空间内，从而探测瓣膜容纳空间内的瓣膜组织40的夹持状态。
请一并参阅图11至图13，瓣膜夹合器100还包括体外控制装置90，体外控制装置90包括至少一牵引件91，至少一牵引件91与延伸至患者体外的牵引丝60的近端连接，以便于操作者手持至少一牵引件91控制牵引丝60移动，进而带动探针50移动以探测瓣膜组织40的夹持状态。本实施例中，牵引件91设置为两个，两个牵引件91分别与两组探测组件的牵引丝60对应连接，每一牵引件91可独立控制对应的一组探测组件的探针50移动，使得可分别通过不同的牵引件91控制对应的探测组件来进行探测二尖瓣的前叶和后叶的夹持状态。
优选的，体外控制装置90还包括指示件92及设置于指示件92底部的指示片93，用于指示牵引件91控制探针50移动后探针50所处的位置，使操作者可直接根据探针50的位置判定瓣膜组织40的夹持状态。
具体的，如图12所示，指示件92设置于牵引件91与牵引丝60之间，牵引件91带动牵引丝60移动以控制探针50移动时，指示件92可同步移动。本实施例中，指示片93包括第一指示区域931及位于第一指示区域931近端的第二指示区域932。在初始状态下，即探针50未移动时，指示件92位于第一指示区域931的远端，当牵引件91带动牵引丝60移动以控制探针50朝近端移动至不同位置时，同步移动的指示件92位于指示片93的不同区域内。请参阅图13，当探针50移动至第一位置时，指示件92位于指示片93的第一指示区域931内；当探针50移动至第二位置时，指示件92位于指示片93的第二指示区域932内。操作者根据指示件92位于指示片93的区域位置，即可判断探针50所处的位置，从而进一步根据探针50的位置判定瓣膜组织40的夹持状态。
在其他实施例中，指示片93可以设置第三指示区域，第三指示区域位于第一指示区域931的远端，探针50未移动时，指示件92位于第三指示区域，以指示探针50的初始位置。
在其他实施例中，指示片93还可以设置第四指示区域，第四指示区域位于第二指示区域932的近端，探针50移动至完全穿过瓣膜容纳空间时，指示件92位于第四指示区域，以指示探针50的极限位置，避免操作者向近端方向过度拉动牵引件91导致牵引丝60带动探测基座83自探测导轨81开放设置的近端脱离。
进一步优选的，如图12所示，体外控制装置90还包括可轴向伸缩的伸缩件94，指示件92的远端连接于牵引丝60，指示件92的近端通过伸缩件94连接于牵引件91。当探针50移动至抵顶于瓣膜组织40时，瓣膜组织40阻止探针50移动，若操作者由于惯性继续向近端拉动牵引件91，此时，伸缩件94发生形变并产生一定的形变距离，使得探针50及指示件91的位置不变，避免探针50继续朝近端移动而损伤瓣膜组织40。
其中，伸缩件94选自弹簧管、弹簧或者由弹性材料单一制成或混合制成的弹性元件，或者层叠的多个套管，其中至少一个套管中叠加弹簧等弹性元件。本实施例中，伸缩件94为弹簧。
需要说明的是，牵引件91、伸缩件94、指示件92及牵引丝60之间的连接可以通过焊接、粘结、压接或螺接等任一连接方式实现。
请一并参阅图11及图12，体外控制装置90还包括可对合的上壳体95及下壳体96，指示件92、指示片93以及伸缩件94设置于上壳体95与下壳体96对合形成的收容空间内，上壳体95开设供指示片93外露的开口，使得操作者可透过所述开口直观地看到指示件92随牵引件91移动时指示件91位于指示片93上的位置，以判断探针50的位置，并进一步根据探针50的位置判断瓣膜组织40的夹持状态。
其中，指示片93通过焊接、粘结、压接或螺接等任一连接方式设置于下壳体96上并位于指示件92的底部；上壳体95与下壳体96相对的两端还相应开设有供牵引丝60及牵引件91穿出的通孔，此处不做赘述。
本申请提供的瓣膜夹合器100，通过牵引件91带动牵引丝60移动以带动探针50移动，即可探测瓣膜组织40的夹持状态，并且能通过体外的指示件92及指示片93的指示作用将探测结果直观反映给操作者，避免了需要多次超声或造影才能确认的缺陷，减少对患者的伤害，同时使手术操作变得简单，可以有效缩短手术时间、提高手术效率。
请参阅图14及图15，本申请还提供一种瓣膜夹合系统，瓣膜夹合系统包括推送装置及前述的瓣膜夹合器100，通过推送装置可将瓣膜夹合器100输送至预定的治疗位点，例如二尖瓣处，并调整瓣膜夹合器100与治疗位点之间的相对位置。推送装置包括操作手柄及推送组件，推送组件的近端与操作手柄连接，推送组件的远端与瓣膜夹合器100之间可拆卸连接。可以理解的是，由于操作手柄是置于患者体外进行远程操作，因此可以将操作手柄与前述的体外控制装置90组装为一个整体，或者直接将体外控制装置90作为瓣膜夹合系统的操作手柄。
推送组件包括由内至外活动地同轴套装在一起的芯轴210、衬管220及推送管230，衬管220位于芯轴210与推送管230之间。操作者通过操作手柄或体外控制装置90能够分别驱动芯轴210、衬管220以及推送管230进行相对移动或旋转。
芯轴210与推杆10可拆卸连接，用于驱动推杆10沿固定座70的轴向滑动，以带动远端夹片30相对于固定座70开合。具体的，本实施例中，芯轴210为远端开设有内螺纹孔211的圆杆体，内螺纹孔211用于与推杆10近端的螺柱11螺接，从而将推送组件与瓣膜夹合器100连接，以通过操作手柄或体外控制装置90驱动芯轴210移动，从而实现推杆10沿固定座70的轴向移动。
推送管230的远端轴对称设置有一对具有弹性的连接杆231，每一连接杆231的近端连接于推送管230的远端，每一连接杆231的远端向推送管230的轴线倾斜，也即是说，在自然状态下，每一连接杆231自近端向远端逐渐向推送管230的轴向收拢，轴对称设置的两个连接杆231的远端相互靠近。当连接杆231的远端受到沿推送管230的径向向外的推力时，连接杆231的远端向外扩张。每一连接杆231的远端的外壁凸设有卡扣235，卡扣235用于卡入固定座70的卡孔711内以实现推送管230与固定座70的连接。
衬管220为圆管体或远端具有锥度的管体，当衬管220自推送管230的近端向远端方向移动至衬管220位于连接杆231的远端时，衬管220向外顶推连接杆231的远端，使得卡扣235向外移动以卡入卡孔711内，从而实现推送管230与固定座70的连接。
具体的，本实施例中，将推送组件与瓣膜夹合器100进行连接时，首先将推送管230远端的连接杆231自固定座70的近端插入穿设通道77，使连接杆231远端的卡扣235正 对固定座70的卡孔711；然后驱动套装于推送管230内的衬管220向远端移动，衬管220向外抵推连接杆231的远端，连接杆231远端的卡扣235卡入对应的卡孔711内，使得固定座70与推送管230处于连接状态；最后，驱动套装于衬管220内的芯轴210靠近穿设于固定座70内且与固定座70处于连接锁定状态的推杆10，旋转芯轴210，使芯轴210与推杆10螺纹连接。当推杆10与固定座70的连接锁定状态解除后，芯轴210即可驱动推杆10沿固定座70的轴向自由滑动。
进一步的，推送装置还包括前述的调节线，用于将近端夹片20的自由端22固定贴合于固定座70的表面。其中，调节线可由金属或者PTFE等高分子材料制成。
需要说明的是，推送组件及瓣膜夹合器100可以采用现有的可调弯鞘管输送至患者体内，调节线及牵引丝60等也可以穿设于可调弯鞘管中而反向延伸至患者体外，此处不做赘述。
以下以二尖瓣的瓣膜修复过程为例，说明本申请的瓣膜夹合系统的操作方法，主要包括以下步骤：
第一步：利用调节线将近端夹片20的自由端22束缚在固定座70的表面上，再将推送组件与瓣膜夹合器100进行连接；然后向近端移动芯轴210而带动推杆10沿轴向向远端滑动，驱动远端夹片30相对于固定座70闭合，以使瓣膜夹合器100处于完全收拢状态，此时，近端夹片20及远端夹片30均贴近于固定座70的表面，保持收拢状态不变。
第二步：采用经房间隔等介入路径，通过推送组件将与其相连的瓣膜夹合器100从左心房推进，经过二尖瓣到达左心室。
第三步：通过推送管230调整瓣膜夹合器100与二尖瓣的相对位置，使得瓣膜夹合器100接近二尖瓣的前叶1a和后叶1b，如图16所示。
第四步：通过操作手柄向近端移动芯轴210，从而带动推杆10向近端滑动，以驱动远端夹片30相对于固定座70张开，调整瓣膜夹合器100的方向，使得远端夹片30垂直于二尖瓣的对合线。
第五步：向近端回撤整个瓣膜夹合器100，使远端夹片30在左心室一侧托住瓣叶，如图17所示。
第六步：释放调节线对近端夹片20的束缚，近端夹片20回弹而相对于固定座70张开，使得二尖瓣的前叶1a和后叶1b分别被夹持在对应的近端夹片20及远端夹片30之间，如图18所示。
第七步：分别操作体外的两个牵引件91，用于控制两组探测组件移动，以探测二尖瓣的前叶1a和后叶1b的夹持状态。具体的，如前所述，向近端拉动牵引件91以带动探针50朝近端移动，探针50插入瓣膜容纳空间内，当瓣叶夹持到位时，瓣叶会顶住探针50阻止其继续朝近端移动，指示件92位于指示片93的第一指示区域931；当瓣叶夹持不到位时，探针50会穿过瓣膜容纳空间，指示件92位于指示片93的第二指示区域932；操作者根据指示件92与指示片93的指示作用，判断是否需要再次通过调节线拉起近端夹片以重新抓取瓣叶，并在再次抓取后再次探测二尖瓣的瓣叶的夹持状态，直至瓣叶夹持到位。
第八步：再次向远端移动芯轴210，芯轴210带动推杆10向远端轴向滑动，从而驱动远端夹片30相对于固定座70闭合，直至瓣膜夹合器100完全收拢，如图19所示。
第九步：通过操作手柄控制芯轴210旋转，解除芯轴210与推杆10之间的螺纹连接，再向近端回撤衬管220和芯轴210，直至推送管230的连接杆231的卡扣235与固定座70的卡孔711解锁分离，瓣膜夹合器100与推送组件完全分离。最后，将推送组件撤出患者体外，瓣膜夹合器100留置于患者体内，完成二尖瓣的缘对缘修复。
可以理解的是，本申请的瓣膜夹合系统也可采用经心尖等路径输送瓣膜夹合器100至 二尖瓣处。
本申请的瓣膜夹合系统，在瓣膜夹合器100夹合瓣叶的过程中，操作者可以通过探测组件及时探测瓣叶的夹持状态，并通过体外控制装置直观地获知探测结果，手术操作简单，有利于缩短手术时间、提高手术效率。
请参阅图20，本申请第二实施例提供的瓣膜夹合器的结构与第一实施例的瓣膜夹合器100的结构相似，不同之处在于：在第二实施例中，瓣膜夹合器的体外控制装置90b仅包括一个牵引件91b，牵引件91b用于同时控制两组不同的探测组件的探针移动，以同时探测二尖瓣的前叶和后叶的夹持状态，使得手术操作更为简单，减少手术时间。
请参阅图21，本申请第三实施例提供的瓣膜夹合器100c的结构与第一实施例的瓣膜夹合器100的结构相似，不同之处在于：在第三实施例中，瓣膜夹合器100c的探测组件包括探针50、牵引丝60及中空的探测导轨87，探测导轨87设置于推杆10c的外壁管，探测导轨87相对于推杆10c向外并朝远端方向辐射延伸，探针50焊接于牵引丝60的远端，探针50可跟随牵引丝60沿探测导轨87的延伸方向移动以伸出或收入探测导轨87中。
具体的，如图21所示，本实施例中，推杆10c的内部轴对称开设有两个沿推杆10c的轴向延伸的长孔(图中未示)，每一长孔贯通推杆10c的近端面，两个长孔的近端开口分别位于螺柱11相对的两侧，两个长孔的远端开口则分别设置于推杆10c的远端外壁、且位于近端夹片20的上方。一对探测导轨87通过焊接的连接方式轴对称设置于推杆10c的外壁，且每一探测导轨87的近端管口与相应一侧的长孔的远端开口对接，一对探测导轨87分别与推杆10c内部的两个长孔对应连通。两组焊接为一体的牵引丝60及探针50分别活动地穿设于推杆10c相对的两侧对应连通的长孔及探测导轨87中，探针50整体位于探测导轨87中。操作者通过牵引件91带动牵引丝60在长孔及探测导轨87中移动时，牵引丝60带动探针50在探测导轨87中沿探测导轨87的延伸方向移动以伸出或收入探测导轨87中。当探针50伸出探测导轨87时，探针50靠近近端夹片20并穿过近端夹片20的长条形通孔26以插入瓣膜容纳空间，以探测瓣膜组织40的夹持状态。
其中，为保证探针50伸出探测导轨87后探针50能正对于近端夹片20的长条形通孔26，探测导轨87以预定角度设置于推杆10c的外壁。所述预定角度为探测导轨87的延伸方向与推杆10c的轴向之间的夹角，该角度小于或等于90度，优选为45-70度。
其中，探测导轨87由至少一种具有弹性的高分子材料或金属材料制成，优选为高分子材料与镍钛编织网混合制成，因此具有一定弹性。由于探测导轨87具有弹性，当瓣膜夹合器100c收拢时，探测导轨87能收缩于推杆10c和近端夹片20之间；而当瓣膜夹合器100c张开时，探测导轨87能自膨胀展开，此时，探测导轨87正对着近端夹片20的长条形通孔26。
需要说明的是，在第三实施例中，探针50朝向瓣膜容纳空间移动的方向为朝向远端移动，因此，与第一实施例不同的是：指示片93的第一指示区域931位于第二指示区域932的近端一侧。
在其他实施例中，推杆10c可以不开设长孔，探测导轨87固定于推杆10c的外表面，探测导轨87位于推杆10c和近端夹片20之间，牵引丝60活动地穿设于探测导轨87中以带动探针50伸出或收入探测导轨87中，同样可用于探测瓣膜组织40的夹持状态，此处不做赘述。
需要说明的是，以上内容均是以瓣膜夹合器用于减轻或治疗“二尖瓣返流”为例进行描述的。可以理解的是，在其他实施例中，瓣膜夹合器也可以用于减轻或治疗“三尖瓣返流”，其原理及结构与本申请实施例中用于解决“二尖瓣返流”的瓣膜夹合器的原理及结构大致相同，只需通过多组近端夹片和远端夹片分别夹合一片瓣叶即可，此处不做赘述。
显然，在其他实施例中，本申请提供的瓣膜夹合器还可以应用于需要将三个以上片状的瓣膜组织夹合在一起的其他微创外科手术中。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (19)

  1. 一种可探测瓣膜夹持状态的瓣膜夹合器，其特征在于，包括：
    夹合器主体，所述夹合器主体包括推杆及可相对于所述推杆辐射展开的近端夹片及远端夹片，所述近端夹片与所述远端夹片之间形成瓣膜容纳空间，所述近端夹片与所述远端夹片配合以夹紧位于所述瓣膜容纳空间内的瓣膜组织；
    探测组件，所述探测组件包括探针及用于驱动所述探针移动的牵引丝，所述牵引丝能带动所述探针插入所述瓣膜容纳空间内，以探测所述瓣膜容纳空间内的瓣膜组织的夹持状态。
  2. 如权利要求1所述的瓣膜夹合器，其特征在于，所述探针的针头抵顶于所述瓣膜容纳空间内的瓣膜组织时，所述探针位于第一位置，所述瓣膜容纳空间内的瓣膜组织夹持到位；所述探针的针头未抵顶到所述瓣膜容纳空间内的瓣膜组织而穿过所述瓣膜容纳空间时，所述探针位于第二位置，所述瓣膜容纳空间内的瓣膜组织夹持不到位。
  3. 如权利要求1或2所述的瓣膜夹合器，其特征在于，所述探测组件还包括探测导轨，所述牵引丝带动所述探针沿所述探测导轨的延伸方向移动。
  4. 如权利要求3所述的瓣膜夹合器，其特征在于，所述推杆的远端设置连接座，所述探测导轨的远端连接于所述连接座，所述探测导轨的近端开放设置，所述探测导轨的延伸方向与所述推杆的轴向相同。
  5. 如权利要求4所述的瓣膜夹合器，其特征在于，所述探测组件还包括探测基座，所述探测基座活动地套设于所述探测导轨外，所述牵引丝的远端连接于所述探测基座，所述探针设置于所述探测基座上，所述牵引丝带动所述探测基座沿所述探测导轨的延伸方向移动以带动所述探针移动。
  6. 如权利要求5所述的瓣膜夹合器，其特征在于，所述探测组件还包括定位件，所述定位件的近端与所述探针连接，所述定位件的远端与所述探测基座连接。
  7. 如权利要求6所述的瓣膜夹合器，其特征在于，所述定位件的轴向与所述推杆的轴向之间的夹角小于或等于90度。
  8. 如权利要求6所述的瓣膜夹合器，其特征在于，所述定位件的近端设置容置孔，所述探针的远端插接于所述容置孔中。
  9. 如权利要求6所述的瓣膜夹合器，其特征在于，所述定位件的近端面与所述探针的远端面对接，并通过焊接固定。
  10. 如权利要求6至9任一项所述的瓣膜夹合器，其特征在于，所述定位件由聚甲醛、聚碳酸酯、聚氨酯、聚醚酰胺、聚氯乙烯中的一种或两种以上的高分子材料制成，或者由不锈钢、镍钛合金、钴铬合金、钴合金、钛合金中的任一种金属材料制成。
  11. 如权利要求3所述的瓣膜夹合器，其特征在于，所述探测导轨设置于所述推杆的外壁管，所述探测导轨相对于所述推杆向外并朝远端方向辐射延伸，所述探测导轨的延伸方向与所述推杆的轴向之间的夹角小于或等于90度。
  12. 如权利要求11所述的瓣膜夹合器，其特征在于，所述推杆的内部设置长孔，所述探测导轨连通于所述长孔，所述牵引丝活动地穿设于所述长孔及所述探测导轨中，所述探针连接于所述牵引丝的远端，所述探针可跟随所述牵引丝沿所述探测导轨的延伸方向移动以伸出或收入所述探测导轨中。
  13. 如权利要求1或2所述的瓣膜夹合器，其特征在于，所述瓣膜夹合器还包括体外控制装置，所述体外控制装置包括至少一牵引件，至少一所述牵引件与所述牵引丝的近端连接，至少一所述牵引件用于供操作者手持控制所述牵引丝及所述探针移动。
  14. 如权利要求13所述的瓣膜夹合器，其特征在于，所述体外控制装置还包括指示件及设置于所述指示件底部的指示片，所述指示件设置于所述牵引件与所述牵引丝之间，所述指示片至少包括第一指示区域与第二指示区域；当所述牵引件带动所述牵引丝移动使所述探针移动至所述第一位置时，所述指示件位于所述指示片的第一指示区域内；当所述牵引件带动所述牵引丝移动使所述探针移动至所述第二位置时，所述指示件位于所述指示片的第二指示区域内。
  15. 如权利要求14所述的瓣膜夹合器，其特征在于，所述体外控制装置还包括可沿轴向伸缩的伸缩件，所述指示件的远端连接于所述牵引丝，所述指示件的近端通过所述伸缩件连接于所述牵引件。
  16. 如权利要求15所述的瓣膜夹合器，其特征在于，所述体外控制装置还包括可对合的上壳体及下壳体，所述指示件、所述指示片以及所述伸缩件设置于所述上壳体与所述下壳体对合形成的收容空间内，所述上壳体开设供所述指示片外露的开口。
  17. 如权利要求1所述的瓣膜夹合器，其特征在于，所述探针由硅胶、聚醚酰胺、聚碳酸酯、聚甲醛、聚氨酯、聚氯乙烯中的至少一种高分子材料制成，或者由不锈钢、镍钛合金、钴铬合金、钴合金、钛合金中的任一种金属材料制成。
  18. 如权利要求1所述的瓣膜夹合器，其特征在于，所述牵引丝为金属材料或高分子材料制成的线材或者管材，所述金属材料选自不锈钢、镍钛合金或钴铬合金，所述高分子材料选自PET、PTFE或PP中的至少一种。
  19. 一种瓣膜夹合系统，其特征在于，包括权利要求1至18任一项所述的瓣膜夹合器，还包括用于输送所述瓣膜夹合器的推送装置。
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