WO2021027589A1 - Recoverable valve clamp and valve clamp recovery system - Google Patents

Recoverable valve clamp and valve clamp recovery system Download PDF

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Publication number
WO2021027589A1
WO2021027589A1 PCT/CN2020/105970 CN2020105970W WO2021027589A1 WO 2021027589 A1 WO2021027589 A1 WO 2021027589A1 CN 2020105970 W CN2020105970 W CN 2020105970W WO 2021027589 A1 WO2021027589 A1 WO 2021027589A1
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WO
WIPO (PCT)
Prior art keywords
valve
valve clamp
clamp
clip
recovery
Prior art date
Application number
PCT/CN2020/105970
Other languages
French (fr)
Chinese (zh)
Inventor
张庭超
张伟伟
郑贤章
王泽涛
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.)
Filing date
Publication date
Priority claimed from CN201921301623.7U external-priority patent/CN211243911U/en
Priority claimed from CN201910742196.4A external-priority patent/CN112386367A/en
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 WO2021027589A1 publication Critical patent/WO2021027589A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts

Definitions

  • This application relates to the field of medical equipment, and in particular to a recyclable valve clamp and a valve clamp recovery system.
  • 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 clamp is delivered to the mitral valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve are clamped by the relative opening of the clamp.
  • the leaf makes the anterior leaflet and the posterior leaflet of the mitral valve fixed, thereby achieving the purpose of narrowing the leaflet gap and reducing mitral valve regurgitation.
  • patients who have undergone minimally invasive treatment and surgical implantation of valve clamps may survive for several years due to ventricular enlargement, rheumatic mitral valve, inflammatory valve disease, severe valve calcification, and clamp compression to stimulate valve tissue proliferation.
  • valve stenosis or poor alignment results in valve stenosis or poor alignment, and then regurgitation or stenosis occurs again.
  • a second repair is required.
  • the implanted valve clamp and the valve tissue fixed together by the valve clamp must be removed.
  • the valve clamp of the prior art cannot be removed from the patient's body through an interventional catheter, and can only be removed by surgical operation, which is costly and difficult, and some patients cannot tolerate the surgical operation, and the risk is high.
  • the present application provides a retrievable valve clamp and a valve clamp recovery system. After the valve clamp is implanted in a patient, the valve clamp can pass through the valve clamp recovery system as needed Recovered in an interventional manner, the surgical procedure is simple, and the patient is less damaged, which is beneficial for secondary repair.
  • the present application provides a retrievable valve clamp, including a main body and a retrieving portion provided at the distal end of the main portion.
  • the retrieving portion is used to connect with a capturing device for retrieving through interventional methods.
  • the valve clamp is used to connect with a capturing device for retrieving through interventional methods.
  • the present application also provides a valve clamp recovery system for recovering the aforementioned valve clamp.
  • the valve clamp recovery system includes a capture device and a cutting device. The distal end of the capture device is connected to the valve clamp.
  • the recovery part of the combiner is detachably connected; the cutting device is used to cut the contact position of the valve with the valve clipper to cut off the valve clipper, and the capture device can capture the valve clipper.
  • valve clamp and valve clamp recovery system provided by the present application, by providing a recovery part at the distal end of the valve clamp, after the valve clamp is implanted in the patient's body, the valve can be passed through as needed
  • the clip recovery system is recovered in an interventional manner, the recovery process is simple, and the patient is less damaged, which is conducive to secondary repair.
  • 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 structural diagram of the valve clamp provided in the first embodiment of the present application in a closed state.
  • Fig. 4 is a three-dimensional structural diagram of the valve clamp in Fig. 3 from another perspective.
  • Fig. 5 is a schematic structural diagram of the valve clamp in Fig. 3 in an opened state.
  • Fig. 6 is a three-dimensional schematic diagram of the connecting seat of the valve clamp in Fig. 5.
  • Fig. 7 is a schematic diagram of the connection between the proximal end clip of the valve clamp in Fig. 5 and the fixing seat.
  • FIG. 8 is a schematic diagram of the three-dimensional structure of the fixing seat in FIG. 7.
  • Fig. 9 is a schematic diagram of the valve clamp in Fig. 3 after being implanted into the mitral valve.
  • Fig. 10 is a partial enlarged schematic diagram of part XI in Fig. 9.
  • Fig. 11 is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflets are clamped by the valve clamp in Fig. 9.
  • Fig. 12 is a schematic diagram of the mitral valve in diastole after the valve clamp in Fig. 9 clamps the valve leaflets.
  • Fig. 13 is a schematic diagram of the capture device to be connected to the valve clamp in Fig. 3.
  • Fig. 14 is a schematic diagram of a valve clamp recovery system provided by one embodiment of the present application.
  • Fig. 15 is a schematic diagram of an intervention channel in one embodiment of the valve clamp recovery system in Fig. 14.
  • Fig. 16 is a schematic diagram of an intervention channel of another embodiment of the valve clip recovery system in Fig. 14.
  • Fig. 17 is a schematic diagram of docking the capture device in Fig. 16 with the valve clamp.
  • Fig. 18 is a schematic diagram of the cutting device in Fig. 16 cutting off the valve clamp.
  • Fig. 19 is a schematic diagram of a valve clamp and a capture device provided by the second embodiment of the present application.
  • Fig. 20 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 19.
  • Fig. 21 is a schematic diagram of a valve clamp and a capture device provided by the third embodiment of the present application.
  • Fig. 22 is a schematic structural view of the connecting seat of the valve clamp in Fig. 21.
  • Fig. 23 is a schematic diagram of a valve clamp and a capture device provided by the fourth embodiment of the present application.
  • Fig. 24 is a schematic diagram of a valve clamp and a capture device provided by a fifth embodiment of the present application.
  • Fig. 25 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 24.
  • Fig. 26 is a schematic diagram of a valve clamp and a capture device provided by a sixth embodiment of the present application.
  • Fig. 27 is a schematic diagram of a valve clamp and a capture device provided by a seventh embodiment of the present application.
  • Fig. 28 is a schematic diagram of another embodiment of the recovery part of the valve clamp in Fig. 27.
  • connection should be understood in a broad sense.
  • it may be a fixed connection or a Disassembly connection, or integral connection; it can be directly connected or indirectly connected through an intermediate medium.
  • connection should be understood in a broad sense.
  • it may be a fixed connection or a Disassembly connection, or integral connection; it can be directly connected or indirectly connected through an intermediate medium.
  • 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 distal center and the proximal center of the instrument is only for the convenience of presentation, and cannot be understood as a limitation of the application.
  • the present application provides a retrievable valve clamp 100, including a main body 130 and a retrieving portion 150 disposed at the distal end of the main portion 130, the retrieving portion 150 is used to connect with the capture device to pass The valve clamp 100 is recovered in an interventional manner.
  • the main body 130 includes a connecting seat 10 at the distal end, a push rod 20 connected to the connecting seat 10, a fixing seat 30 sleeved on the outside of the push rod 20, and two proximal parts radiatingly deployed relative to the push rod 20.
  • the two proximal clips 40 and the two distal clips 50 are all arranged axisymmetrically with respect to the push rod 20, and the proximal clips 40 and the distal clips 50 correspond one-to-one.
  • proximal clip 40 One end of the proximal clip 40 is fixedly connected to the fixing base 30, the proximal clip 40 is arranged between the distal clip 50 and the fixing base 30, and the opposite end of the proximal clip 40 can be farther away due to its own elastic force.
  • the end clip 50 closes together, and a valve accommodating space 45 is formed between the corresponding proximal clip 40 and the distal clip 50.
  • One end of the distal end clip 50 is rotatably connected to the fixing base 30, and the distal end clip 50 is movably connected to the connection base 10 through a connecting rod 60. When the push rod 20 moves in the axial direction relative to the fixed seat 30, the connecting seat 10 moves relative to the fixed seat 30.
  • the distal clip 50 opens and closes relative to the fixed seat 30.
  • the proximal clip 40 on the seat 30 is close to the distal clip 50, it can cooperate with the distal clip 50 to clamp the valve located in the valve receiving space 45.
  • valve clamp 100 can be pushed to the mitral valve of the patient through the pushing device, and then the valve clamp can be operated remotely
  • the combiner 100 clamps the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge-to-edge, the operator can release the pushing device and the valve clamp 100
  • the connection between the valve clamper 100 is released from the distal end of the propulsion device and remains in the patient's body as an implant, thereby reducing or treating "mitral valve regurgitation".
  • the pushing device includes an adjustment wire for controlling the release of the proximal clip 40, a pushing assembly for driving the axial movement of the push rod 20 and a detachable connection with the valve clamp 100, and a pushing assembly connected to the pushing assembly
  • the operation handle at the proximal end will not be repeated here.
  • the proximal clip 40 and the distal clip 50 are made of biocompatible metal materials, and the metal materials are selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel. Commonly used metal materials for implants such as titanium alloys.
  • the proximal clip 40 is made of an elastic material with a shape memory function
  • the distal clip 50 is made of a rigid material to ensure that the two can clamp and fix the valve.
  • the proximal clip 40 is made of super-elastic Nitinol
  • the distal clip 50 is made of stainless steel or cobalt-chromium alloy with higher hardness.
  • the recovery part 150 can be used according to the patient’s condition or the need for secondary repair. It is connected with the capture device to recover the valve clamp 100 in an interventional manner.
  • the recovery process is simple, and the damage to the patient is small, which is beneficial for secondary repair.
  • the connecting base 10 and the push rod 20 may be an integral structure or a non-integral structure.
  • the connecting seat 10 and the push rod 20 are of a non-integral structure.
  • the push rod 20 is a round rod body, the distal end of the push rod 20 is provided with an external thread, and the push rod 20 is screwed and fixed with the connecting seat 10.
  • the push rod 20 may be connected to the connection base 10 by other detachable or non-detachable connection methods such as snapping.
  • the connecting seat 10 includes two opposite first surfaces 11 and two connecting surfaces connecting the two first surfaces 11.
  • the two connecting surfaces include a second surface 12 at the distal end and a second surface 12 at the proximal end.
  • the third surface 13 is smoothly connected to the second surface 12, wherein the first surface 11 and the third surface 13 are flat surfaces, and the second surface 12 is a curved surface.
  • the opposite ends of the connecting seat 10 are respectively provided with pin holes 14 penetrating through the two first surfaces 11 for connecting the connecting rod 60, and the third surface 13 of the connecting seat 10 is provided with a connection for connecting with the push rod 20 in the axial direction.
  • the hole 15 is provided with an internal thread corresponding to the external thread of the distal end of the push rod 20 in the connecting hole 15.
  • the cross-sectional size of the connecting seat 10 in the direction parallel to the third surface 13 gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 10 can be a hemisphere, a spherical crown, a bullet shape, etc., so that the valve can be clamped.
  • the device 100 is easier to push in the patient.
  • the outer surfaces of the connecting seat 10 and the push rod 20 are smooth to avoid damage to the valve or hook chordae.
  • the connecting seat 10 and the push rod 20 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy.
  • the fixing base 30 includes a first base 31 and a second base 32 connected to the distal end of the first base 31.
  • the first base 31 and the second base 31 The seat bodies 32 are transitionally connected to each other through a third seat body 33.
  • the first seat body 31, the second seat body 32, and the third seat body 33 may be an integral structure or a non-integral structure.
  • the first seat body 31, the second seat body 32 and the third seat body 33 are an integral structure.
  • the first seat body 31 has a cylindrical structure, and the cross section of any position in the axial direction of the first seat body 31 is a square; the two opposite outer sides of the second seat body 32 are respectively provided with convex bumps 321.
  • the second seat body 32 is also provided with an accommodating cavity 34.
  • One inner wall of the accommodating cavity 34 is provided with a boss 341.
  • the proximal surface of the boss 341 is an inclined surface.
  • the accommodating cavity 34 is provided with a steel sheet 343 and
  • the deformed elastic piece 345 abuts on the proximal surface of the steel piece 343, one end of the steel piece 343 abuts on the inclined surface of the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 is inclinedly arranged in the accommodating cavity 34
  • the third seat body 33 is roughly in a trapezoidal block structure, and two opposite outer sides of the third seat body 33 are respectively provided with connecting blocks 331 for rotating connection with the distal end clip 50, and the third seat body 33 is in the axial direction
  • the cross-section of any position is square, and its cross-sectional area gradually increases from the proximal end to the distal end.
  • the fixing seat 30 is provided with a through passage 35 passing through the first seat body 31, the second seat body 32 and the third seat body 33 along the axial direction.
  • the fixing seat 30 is sleeved on the outside of the push rod 20, the pushing The rod 20 is received in the through channel 35.
  • the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345 arranged in the accommodating cavity 34.
  • the steel sheet 343 and the deformed elastic sheet 345 are provided with corresponding through holes. The area of the hole is slightly larger than the cross-sectional area of the push rod 20.
  • the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345.
  • the steel sheet 343 Under the elastic force of the deformed elastic sheet 345, the steel sheet 343 is inclined to form a certain angle with the push rod 20 and contact at the edge of the through hole.
  • the steel sheet 343 generates friction to prevent the push rod 20 from moving relative to the fixed base 30.
  • the fixing seat 30 is made of a biocompatible metal material, and the metal material is selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel titanium alloy and other commonly used implantation metals
  • the material is preferably stainless steel or cobalt-chromium alloy with higher hardness.
  • the steel sheet 343 and the deformed elastic sheet 345 are also made of biocompatible materials.
  • the steel sheet 343 is preferably made of stainless steel or cobalt-chromium alloy with higher hardness
  • the deformed elastic sheet 345 is made of elastic Nitinol.
  • the fixing seat 30 may also have other structures, which will not be repeated here.
  • control members 36 are metal wires made of Nitinol, etc., and the control members 36 are attached to the fixing base 30.
  • the distal end of the control member 36 is bent toward the axial direction of the fixing base 30 and is received in the accommodating cavity 34.
  • the distal end of the control member 36 has two branches, one of which abuts on the distal plane of the boss 341, and the other abuts on the distal surface of the steel sheet 343 and is close to the steel sheet 343 away from the boss.
  • the branch can drive the end of the steel sheet 343 away from the boss 341 and the steel sheet 343 abuts against the slope of the boss 341
  • One end of the steel sheet 343 is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees.
  • the through hole of the steel sheet 343 is coaxial with the axis of the push rod 20, and the push rod 20 and the fixed seat The locked state of the connection between 30 is released, and the push rod 20 can move in the axial direction.
  • the two control members 36 respectively provided on the two opposite sides of the fixing base 30 may be an integral structure or a non-integral structure.
  • the two control members 36 are an integral structure.
  • the same metal wire can be formed by passing through the bottom of the containing cavity 34 and then bending.
  • the proximal clip 40 includes a connecting end 41 and a free end 42 that are oppositely disposed, and the connecting end 41 is fixed on the fixing base 30.
  • the connecting ends 41 of the two proximal clips 40 are connected as a whole through a connecting frame 43.
  • the connecting frame 43 has a through hole for the push rod 20 to pass through.
  • the two opposite sides of the connecting frame 43 are also provided with The rectangular hole through which the protrusion 321 on the second seat body 32 passes, the connecting frame 43 is sleeved on the second seat body 32 and the third seat body 33 to realize that the connecting ends 41 of the two proximal clips 40 are opposite to each other.
  • the fixing base 30 is fixed.
  • the connecting end 41 of the proximal clip 40 may be directly fixed to the fixing base 30 by welding or other connection methods.
  • the proximal clip 40 is at least partially made of an elastic material with a shape memory function, and has been heat-set. In a natural state, the proximal clip 40 is in an unfolded U shape, that is, the proximal clip 40 and the fixing seat 30 are arranged at an angle so as to cooperate with the distal clip 50 to clamp the valve.
  • the angle between the extending directions of the two sides of the proximal clip 40 ranges from 0 to 200 degrees.
  • the proximal clip 40 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 It is quickly put into purified water to cool, and the shaping mold is removed to obtain the shaped proximal clip 40.
  • the entire proximal clip 40 is made of super-elastic nickel-titanium alloy, so as to provide elastic force for the proximal clip 40 to drive the proximal clip 40 to the distal clip 50 to clamp the valve.
  • the connecting frame 43 is also made of elastic nickel-titanium alloy, so that the connecting frame 43 can be sleeved on the second seat body 32 and the third seat body 33.
  • the connecting end 41 of the proximal clip 40 is made of an elastic material
  • the free end 42 of the proximal clip 40 can be made of an inelastic material such as aluminum alloy.
  • the proximal end is driven by the elastic force of the connecting end 41.
  • the clip 40 moves closer to the distal clip 50.
  • the free end 42 of the proximal clip 40 that extends outward and radiating toward the proximal end relative to the push rod 20 can be controlled by an adjustment line.
  • the adjustment wire is tightened and fits on the surface of the fixing seat 30, and after releasing the adjustment wire to control the free end 42, the proximal clip 40 rebounds due to its own elastic memory performance, and the proximal clip 40 recovers Natural state, and press the valve toward the distal clip 50.
  • the included angle between the extension directions of the two sides of the proximal clip 40 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 50 to provide a more stable clamping force, that is,
  • the angle between the extending direction of each side of the proximal clip 40 and the fixing seat 30 is greater than or equal to the distance between the distal clip 50 and the fixing seat 30 when the distal clip 50 corresponding to the side is expanded to the maximum state Therefore, it is ensured that there is a certain clamping force between the distal clip 50 and the proximal clip 40 to clamp the valve between the distal clip 50 and the proximal clip 40.
  • the proximal clip 40 includes a first surface facing the valve accommodating space 45.
  • a clamping reinforcement is provided on the first surface to increase the gap between the proximal clip 40 and the valve clamped in the valve accommodating space 45.
  • the friction force increases the clamping force of the valve clamp 100 on the valve.
  • the clamping reinforcement is two rows of barbs 46 arranged at intervals on opposite sides of the first surface.
  • the barbs 46 can be formed on the proximal clip 40 by an integral molding method, or the barbs 46 can be formed of the same or different material as the proximal clip 40 and then connected to the first surface of the proximal clip 40 For example, a nickel-titanium metal wire or a nickel-titanium metal rod can be fixed on the first surface through a sleeve.
  • the root of the barb 46 is connected to the proximal clip 40, and the end of the barb 46 opposite to the root is a dangling end. In a natural deployment state, the dangling end of the barb 46 faces the distal clip 50.
  • the angle between the extending direction of the barb 46 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clamp 100 on the valve. Further, the suspended end of each barb 46 is a smooth curved surface, so as to avoid damage to the valve tissue.
  • the number of barbs 46 may be one, two, or other reasonable numbers.
  • the clamping reinforcement may be a structure such as a rib, a boss 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 on the valve.
  • the proximal clip 40 is provided with a plurality of openings to reduce the weight of the proximal clip 40 and prevent the excessively heavy valve clip 100 from falling under the leaflets for a long time to cause slippage or damage to the leaflets. Conducive to the crawling and growth of endothelial cells.
  • the distal end clip 50 includes a connecting section 51 at the distal end and a clamping section 52 connected to the proximal end of the connecting section 51.
  • the distal end of the connecting section 51 is rotatably connected to the connecting block 331 of the fixing base 30.
  • the proximal end of the connecting section 51 is rotatably connected to the proximal end of the connecting rod 60 on the corresponding side, and the distal end of the connecting rod 60 is rotatably connected to the connecting seat 10.
  • the rotation connections are all realized by corresponding rotation pins. Obviously, in other embodiments, the rotation pin can be replaced by a bolt.
  • the end of the steel sheet 343 away from the boss 341 can be driven, and the steel sheet 343 abuts against the inclined surface of the boss 341.
  • One end is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees, the connection lock state between the push rod 20 and the fixed seat 30 is released, and the push rod 20 can be axially relative to the fixed seat As a result, the fixing seat 30 and the connecting seat 10 move relative to each other.
  • the distal end clip 50 can rotate around the rotating pin on the connecting block 331 and open and close relative to the fixed seat 30.
  • the proximal clip 40 can move closer to the distal clip 50 to clamp the valve in the valve accommodation space 45. Further, after the proximal clip 40 and the distal clip 50 clamp the valve, the connecting seat 10 moves in the axial direction toward the proximal end until the valve clip 100 is in the retracted state, and then releases the control member 36 to the steel plate Under the control of the end of the 343 away from the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 contacts the push rod 20 at a certain angle, and the connection between the push rod 20 and the fixing seat 30 is locked to avoid the distal end
  • the clip 50 is opened relative to the fixing seat 30, and the valve clip 100 in the collapsed state falls below the leaflets.
  • the second surface of the distal clip 50 facing the valve accommodating space 45 can also be provided with a structure similar to the clamping reinforcement of the proximal clip 40, or apply active drugs and provide multiple openings.
  • the second surface is set as a curved surface to increase the contact area and clamping area between the distal end clip 50 and the valve, thereby providing a stable clamping force.
  • the second surface of the curved surface forms a receiving groove, and when the proximal clip 40 is close to the distal clip 50, the barbs 46 on the first surface of the proximal clip 40 can be received in the receiving groove to compress
  • the valve is located in the valve leaflet containing space 45, and the volume of the valve clamp 100 when the valve clamp 100 is folded is reduced as much as possible, which is conducive to delivery in the body.
  • the distal clip 50 has a certain size specification. Specifically, the length of the distal clip 50 must be within a certain range. When the length of the distal clip 50 is too long, the distal clip 50 tends to clamp too many anterior and posterior leaflets together. When the compositor 100 is closed, the two leaflets are forcibly pulled toward each other and fixed together.
  • the axial length of the distal end clip 50 should be greater than or equal to 4 mm, preferably 6-10 mm.
  • the width of the distal clip 50 is also limited to a certain extent, so as to prevent the width of the distal clip 50 from being too narrow and causing damage to the valve leaflets, and also to avoid the valve clip 100 when the width of the distal clip 50 is too wide. The effect on valve leaflet movement.
  • the width of the distal clip 50 that is, the length of the direction perpendicular to the axial direction of the distal clip 50, should be greater than or equal to 2 mm, preferably 4-6 mm.
  • the valve clamp 100 provided in this embodiment can be used to reduce or treat "mitral valve regurgitation". Specifically, please refer to Figures 9 to 12 together. 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 a distal clip 50 and a proximal end One side of the clip 40 clamps the edge of the anterior leaflet 1a of the mitral valve, and the other distal clip 50 and one side of the proximal clip 40 clamp the edge of the posterior leaflet 1b of the mitral valve, so that the mitral valve
  • the positions of the anterior lobe 1a and the posterior lobe 1b that cannot be normally aligned are clamped together, and the arrow direction shown in Fig. 11 and Fig.
  • FIG. 12 is the blood flow direction.
  • the anterior leaflet 1a and the posterior leaflet 1b are folded, and the positions where the anterior leaflet 1a and the posterior leaflet 1b cannot align properly are partially or completely folded together.
  • the area of the mitral valve opening is A
  • the mitral valve becomes smaller or the mitral valve can be completely closed only a small amount of blood regurgitates from the opening of the mitral valve into the left atrium, which can reduce or treat "mitral valve regurgitation.”
  • the anterior leaflet 1a and the posterior leaflet 1b are only aligned at the position B where the valve clamp 100 is clamped.
  • the other positions of the anterior leaflet 1a and the posterior leaflet 1b are still in normal diastole. This allows blood to enter the left ventricle from the left atrium, thereby ensuring the normal circulation of blood.
  • the distal end of the main body 130 of the valve clamp 100 is provided with a recovery part 150, which is used for capturing
  • the device 210 is connected to recover the valve clamp 100 by intervention.
  • each connecting rod 60 is provided with a recovery part 150, and the recovery part 150 is a groove provided on the outer surface of each connecting rod 60.
  • the connecting rod 60 includes a connecting portion 62 rotatably connected to the distal clip 50, an extension bar 64 extending obliquely from the distal end of the connecting portion 62 in the direction of the centerline of the valve clamp 100, and the extension bar 64.
  • the tab 66 outside the distal end.
  • the extension bar 64 and the protrusion 66 enclose the groove.
  • the groove is located at the distal end of the outer side of the connecting rod 60, and the distance from the surface of the proximal end of the groove to the centerline of the valve clamp 100 is greater than the surface of the distal end of the groove to the valve clamp 100 The distance between the centerline of the valve clamper 100 and the centerline of the valve clamper 100 are thus formed.
  • the capture device 210 includes a capture catheter 212 with a certain axial length and a capture device 214 disposed at the distal end of the capture catheter 212.
  • the capture device 214 is used to detachably connect with the recovery part 150 to capture the valve clip. ⁇ 100 ⁇ Combination 100.
  • the catcher 214 is a gooseneck snare, and the gooseneck snare is sleeved on the grooves of two opposite connecting rods 60, so that the recovery part 150 is connected to the catching device 210, thereby The valve clamp 100 is captured, and when the valve clamp 100 is cut from the valve, it can be recovered.
  • the minimum outer diameter of the valve clamp 100 at the groove is the same as the outer diameter of the valve clamp 100 adjacent to the distal end of the groove.
  • the range of diameter ratio is 0.5-0.95.
  • the recovery portion 150 may be a protrusion protruding from the outer surface of each connecting rod 60. Specifically, the distance between the protrusion and the outer surface of the connecting rod 60 is from the proximal end to the distal end. The direction gradually decreases, and the gooseneck snare of the capture device 210 is sleeved on the protrusions of the two connecting rods 60 arranged opposite to each other to connect with the recovery part 150.
  • the maximum outer diameter of the valve clamp 100 at the protrusion is the same as the proximal part of the valve clamp 100 adjacent to the protrusion
  • the range of the ratio of the outer diameter is 1.05-1.25.
  • the valve clamp 100 further includes an isolation portion 170, which is disposed between the main body portion 130 and the recovery portion 150, and the recovery portion 150 and the isolation portion 170 are at least partially applied anti-cell
  • the proliferation drug coating or the isolation layer is used to prevent the recovery part 150 from being completely covered by endothelial cells, so as to ensure that the capturing device 210 can be connected with the recovery part 150 to facilitate the recovery of the valve clamp 100.
  • the isolation portion 170 is disposed on the outer side surface and the opposite sides of each connecting rod 60 adjacent to the proximal end of the recovery portion 150, that is, the distal end of the connecting portion 62 adjacent to the extension bar 64.
  • the entire area of the isolation portion 170 is coated with an anti-cell proliferation drug, and the anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives.
  • the coverage area of the spacer 170 extending in the axial direction is 5-10 mm.
  • the entire area of the isolation portion 170 may be covered with an isolation layer to prevent endothelial growth.
  • the isolation layer is a sleeve or coating made of a biocompatible polymer material, and the polymer material is selected from PET. , At least one of polyester, silicone, PTFE, silica gel or urethane.
  • the isolation portion 170 may only apply an anti-cell proliferation drug coating or a coating isolation layer on a part of the area, for example, only when the isolation portion 170 is located on the outer side of each link 60 adjacent to the proximal end of the recovery portion 150 Anti-cell proliferation drug coating or coating isolation layer is applied to some areas of, as long as it can prevent endothelial cells from completely crawling over the recovery part 150.
  • the recovery part 150 may also be coated with an anti-cell proliferation drug coating or coated with an isolation layer to prevent endothelial cells from completely crawling over the recovery part 150.
  • the portion of the connecting seat 10 of the valve clamp 100 adjacent to the distal end of the recovery portion 150 may also be provided as the isolation portion 170.
  • the thickness of the anti-cell proliferation drug coating or isolation layer should avoid affecting the overall outer diameter of the valve clamp 100 to facilitate the delivery of the valve clamp 100 in the patient.
  • the present application also provides a valve clamp recovery system 200 for recovering the aforementioned valve clamp 100.
  • the valve clamp recovery system 200 includes a capturing device 210 and a cutting device 230.
  • the cutting device 230 is used to cut the position where the valve contacts the valve clamp 100 to cut the valve clamp 100.
  • the capture device 210 is detachably connected to the recovery part 150 of the valve clamp 100 through the capture device 214 at the distal end to capture the valve clamp 100.
  • the catcher 214 is a gooseneck snare
  • the recovery part 150 of the valve clamp 100 is a groove provided on the outer surface of each connecting rod 60
  • the gooseneck snare is sleeved in the groove
  • the valve clamp 100 is captured inside.
  • the catcher 214 may be a three-leaf snare, a vascular foreign body catcher, a ligator, a claw, a magnetic joint, and other forms.
  • the cutting method of the cutting device 230 adopts at least one of mechanical cutting or electric knife cutting.
  • the electric knife is selected from at least one of radio frequency electric knife, high frequency electric knife, ultrasonic scalpel, plasma scalpel, laser scalpel, or cryogenic scalpel.
  • the method of mechanical cutting refers to direct cutting with surgical instruments, such as inverted scissors or separately provided lancets, biopsy forceps, etc.
  • a mechanical cutting method is adopted, and the distal end of the cutting device 230 is provided with two blades 231 that can be opposed to each other.
  • the blade 231 is made of metal material and has visual properties to facilitate the operator to observe and cut the valve in real time.
  • the outer peripheral surface of the distal end of the cutting device 230 may be provided with a conductive portion in the circumferential direction, and the conductive portion is conductive on the surface in contact with the valve, so as to realize the electrosurgical cutting of the valve.
  • the conductive part includes a bare metal or metal electrode.
  • the outer surface of the remaining part of the cutting device 230 except for the conductive part is insulated. The method of insulation may be to coat an insulating coating or provide an insulator.
  • the cutting device 230 may also be provided with a temperature sensor electrically connected to the conductive part. The temperature sensor contacts the valve to indicate the local temperature of the part where the valve contacts the conductive part, thereby Prevent damage caused by excessively high local temperature of the valve.
  • the distal end of the cutting device 230 is provided with at least one developing part, and the operator can adjust the position of the distal end of the cutting device 230 according to the position of the developing part, so as to accurately cut the position where the valve contacts the valve clamp 100.
  • the developing part can be in the form of developing wire, developing dot or developing film.
  • the developing part is made of developing materials with strong corrosion resistance and good biocompatibility, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys or composites of these metals.
  • the developing part is a nickel-titanium alloy metal sheet containing tantalum, and the metal sheet is attached to the distal tube body of the cutting device 230.
  • the valve clamp recovery system 200 further includes a removal device 250 for removing the resected valve clamp 100 outside the patient's body.
  • the removal device 250 includes a positioning member 251, and the positioning member 251 is movably disposed at the distal end of the removal device 250.
  • the positioning member 251 includes an elastic frame that can be radially contracted and expanded. When the positioning member 251 extends from the distal end of the removal device 250, the elastic frame expands and expands and supports under the valve to reduce the pulsation amplitude of the valve, thereby This facilitates the removal of the valve by the removal device 230.
  • the positioning member 251 can be used to accommodate the valve clamp 100 after resection, and the valve clamp 100 can be accommodated in the removal device 250 along with the positioning member 251.
  • the radial dimension of the elastic frame of the positioning member 251 gradually decreases from the distal opening to the proximal direction, that is, the positioning member 251 is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the positioning member 251 is cup-shaped.
  • an adjustment mechanism is provided at the distal opening of the positioning member 251, and the adjustment mechanism includes at least one control wire, and the at least one control wire is used to adjust the radial size of the distal opening of the positioning member 251.
  • the control wire passes through different positions of the distal end of the positioning member 251 in the circumferential direction at the same time, and the size of the distal opening of the positioning member 251 is adjusted by controlling the length of the control wire passing through the different positions of the positioning member 251 in the circumferential direction.
  • the operator can tighten the control wire to tighten the distal opening of the positioning member 251 to wrap the valve clamp 100 To prevent the valve clamp 100 from falling off, so as to facilitate the recovery of the valve clamp 100.
  • the capture device 210 is movably disposed in the removal device 250, and can be extended from the distal opening of the positioning member 251 to capture the valve clamp 100. After the valve clamp 100 is captured, the capture device 210 When retracted into the removal device 250, at this time, the distal opening of the positioning member 251 is tightened to prevent the valve clamp 100 from falling off.
  • the valve clip recovery system 200 further includes a guiding device 270 and an adjustable bend sheath 290.
  • the guide device 270 can be movably arranged in the adjustable bend sheath 290 or used alternately in turn.
  • the guiding device 270 and the adjustable curved sheath 290 are used to establish an intervention channel from outside the patient to the inside of the body.
  • the guiding device 270 includes a puncture guide wire (not shown in the figure) and a conical dilator. After the channel is established and the puncture guide wire reaches the vicinity of the valve, the operator can control the end of the puncture guide wire to enter the left atrium, cross the valve clamp 100, and extend back to the patient's body, and then the puncture guide wire can be clamped to the valve.
  • the device 100 applies a pulling force to reduce the undulation amplitude of the valve clamp 100, thereby facilitating the connection of the capturing device 210 and the recovery part 150 of the valve clamp 100.
  • adjustable curved sheath 290, dilator and puncture guide wire are similar in structure to the existing adjustable curved sheath, dilator and puncture guide wire, and will not be described here.
  • At least one of the capturing device 210, the cutting device 230, and the removal device 250 can be delivered to the mitral valve of the patient through the corresponding interventional channel by adopting the adjustable curved sheath 290 of corresponding specifications.
  • FIGS. 15 and 16 together illustrate different intervention channels of the valve clip recovery system 200 of the present application. As shown in FIG.
  • the capturing device 210 is inserted into the removal device 250 and reaches the mitral valve through the apex-left ventricle path through the adjustable curved sheath 290a, and the resection device 230 passes through the The bending sheath 290b reaches the mitral valve through the path of femoral vein-right atrium-atrial septum-left atrium-mitral valve. As shown in FIG.
  • the capture device 210 and the removal device 250 can reach the mitral valve through the path of the femoral artery-aortic arch-aortic valve-left ventricle through the adjustable curved sheath 290a, and The resection device 230 can reach the mitral valve via the jugular vein-atrial septum-left atrium through the adjustable curved sheath 290b.
  • the capture device 210, the cutting device 230, and the removal device 250 can use the same path to reach the mitral valve, so as to avoid injury to the patient from multiple punctures.
  • the valve holder recovery system 200 further includes a detection device, which is movably inserted in the adjustable bend sheath 290 and can extend from the distal end of the adjustable bend sheath 290 And enter the left atrium for real-time feedback of the pressure value in the heart, so as to confirm the "Mitral regurgitation" situation in time and determine whether the resection is complete.
  • the detection device may be a pressure sensor.
  • the first step using the guiding device 270 and the adjustable curved sheath 290 of corresponding specifications to establish an intervention channel for the recovery device (ie, the capturing device 210 and the removing device 250) and the cutting device 230, respectively.
  • the intervention path of the recovery device is to enter the left ventricle through the aortic arch, and the intervention path of the cutting device 230 is to enter the left atrium through the atrial septum;
  • Step 2 Withdraw the guiding device 270, push the removing device 250 and the capturing device 210 put on together into the left ventricle through the adjustable curved sheath 290a, and push the cutting device 230 into the left ventricle through the adjustable curved sheath 290b
  • the atrium as shown in Figure 16;
  • Step 3 Connect the catcher 214 at the distal end of the catching device 210 to the recovery part 150 of the valve clamper 100 to catch the valve clamper 100 and maintain the catching state, as shown in FIG. 17;
  • Step 4 Use the two blades 231 of the cutting device 230 to respectively cut the attachment points of the valve clamp 100 on the anterior and posterior leaflets, thereby cutting the valve clamp 100 from the valve, as shown in FIG. 18;
  • Step 5 Withdraw the capture device 210 into the removal device 250, so as to receive the resected valve clamp 100 into the removal device 250;
  • Step 6 Withdraw the cutting device 230, the removal device 250, the capture device 210 and the valve clamp 100 contained in the removal device 250 through the corresponding adjustable curved sheath 290; finally withdraw the adjustable curved sheath 290, complete the operation.
  • the end of the puncture guide wire of the guiding device 270 can also be passed over the valve clamp 100 and extend back to the outside of the patient. Therefore, a pulling force is applied to the valve clamp 100 through the puncture guide wire to reduce the undulation amplitude of the valve clamp 100 following the pulsation of the valve leaflets, thereby facilitating the capture device 210 and the recovery part 150 of the valve clamp 100 The docking.
  • the operator can withdraw the cutting device 230, the removal device 250, the capture device 210, and the valve clamp 100, and then temporarily place the adjustable bend sheath 290 in the patient's body to pass the intervention
  • the channel undergoes secondary interventional repair operations, such as implantation of artificial heart valves.
  • the capture device 210, the cutting device 230, the removal device 250, the guiding device 270, and the adjustable bend sheath 290 have operating handles close to the operator, and the operator can control the corresponding device through the corresponding operating handles. Actions such as catching, cutting, and bending are not detailed here.
  • the structure of the valve clamp 100b provided by the second embodiment of the present application is similar to the structure of the valve clamp 100 of the first embodiment. The difference is that: in the second embodiment Wherein, the recovery portion 150b is disposed on the connection base 10b. Specifically, the recovery portion 150b is at least one hook protruding from at least one first surface 11 of the connection base 10b. In this embodiment, a hook is protrudingly provided on each first surface 11 of the connecting base 10b.
  • the operator can put the catcher 214 of the catching device 210 on a hook to realize unilateral catching, or The catcher 214 is sleeved on the two hooks to realize simultaneous catching on both sides.
  • the catcher 214 is a gooseneck snare.
  • the shape of the hook includes, but is not limited to, a right-angle hook, a half-circle hook and the like.
  • the hook is a right-angle hook.
  • the hook and the connecting seat 10b may be an integral structure or a non-integral structure.
  • the hook and the connecting seat 10b are integrally formed.
  • the hook may be separately formed and fixed to the first surface 11 of the connection base 10b by welding or the like.
  • the two hooks are arranged symmetrically about the central axis of the connecting seat 10b.
  • the grasping force received by the valve adapter 100b is always on the center of mass line, so that the valve clamp 100b can enter the removal device more easily, and the operation efficiency is improved.
  • the distance that the hook protrudes from the first surface 11 of the connecting seat 10b should avoid affecting the overall outer diameter of the valve clamp 100b, so as to facilitate delivery in the patient.
  • the isolation portion 170b of the valve clamp 100b is disposed on the connecting seat 10b.
  • the isolating portion 170b may be provided only on the first surface 11 of the connecting base 10b, or may be provided on the entire connecting base 10b, that is, the isolating portion 170b is provided at least at the portion of the connecting base 10b adjacent to the hook.
  • the isolation portion 170b is disposed on the outer surface of the entire connecting base 10b.
  • 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 100b of the second embodiment. The difference is that: in the third embodiment Among them, the recovery portion 150c is a through hole opened in the connecting seat 10c and passing through the two first surfaces 11.
  • the catcher 214c of the catching device 210c is a pair of claws, and the valve clamp 100c is recovered by inserting a pair of claws into both ends of the through hole.
  • the through hole is opened in the middle position of the connecting seat 10c, so that the grasping force received by the valve adaptor 100c is always on its center of mass line, so that the valve clamp 100c can enter the removal device more easily, and the operation efficiency is improved.
  • the connecting seat 10c is provided with a through hole, which can also reduce the weight of the valve clamp 100c, so as to prevent the excessively heavy valve clamp 100c from falling under the valve for a long time and straining the valve.
  • the proximal ends of a pair of jaws are staggered.
  • the recovery portion 150c may be at least one blind hole opened on at least one first surface 11 of the connecting seat 10c, and the claw of the capturing device 210c is inserted into the blind hole to recover the valve clamp. ⁇ 100c.
  • the two opposite first surfaces 11 of the connecting seat 10c are respectively provided with a blind hole, and the two blind holes are arranged symmetrically with respect to the central axis of the connecting seat 10c, so that the grasping force received by the valve adapter 100c is always at its The centroid line.
  • an auxiliary member for assisting the connection of the claws of the capture device 210c may be arranged in the blind hole.
  • the auxiliary member may be a magnetic sheet, which can attract the claw to prevent the claw from falling out of the blind hole.
  • the structure of the valve clamp 100d provided in the fourth embodiment of the present application is similar to the structure of the valve clamp 100b of the second embodiment, except that: in the fourth embodiment, the recovery part 150d It is at least one barb or at least one ring body disposed on the second surface 12 of the connecting seat 10d.
  • the recovery portion 150d is a barb protruding outward with respect to the second surface 12, and the catcher 214d of the catching device 210d is a catching ring, and the catching ring of the catching device 210d is hooked on the barb To recover the valve clamp 100d.
  • the shape of the barb includes, but is not limited to, a right-angled hook, a half-circle hook, etc.
  • the barb is a half-circle hook.
  • the barb is arranged at the axial position of the valve clamp 100d.
  • the catch ring of the capturing device 210d is hooked on the barb, the catching force received by the valve adapter 100d is always on its centroid line, making the valve clamp
  • the combiner 100d is easier to enter the removal device, which improves the efficiency of the operation.
  • the number of barbs may be two, and the catch ring of the catch device 210d is hooked on the two barbs at the same time, so that when the catch ring of the catch device 210d falls off one of the barbs, The catching ring is still hooked on the other barb to ensure that the catching device 210d remains connected to the recovery part 150d of the valve clamp 100d.
  • the two barbs are arranged symmetrically with respect to the connecting seat 10d, so that the grasping force received by the valve clipper 100d is always on its center of mass line.
  • the recovery part 150d may be at least one circular body made of biocompatible metal or polymer material, and the capture device 214d of the capture device 210d is correspondingly set as a claw. The claw is inserted into at least one annular body to recover the valve clamp 100d.
  • the structure of the valve clamp 100e provided by the fifth embodiment of the present application is similar to the structure of the valve clamp 100d of the fourth embodiment, except that: in the fifth embodiment Among them, the recovery portion 150e is a connecting hole opened on the second surface 12 of the connecting seat 10e, and a connecting piece for docking with the capturing device 210e is provided in the connecting hole.
  • the connecting hole is a blind hole 153e opened in the middle of the second surface 12, and a magnetic member is arranged in the blind hole 153e.
  • the capture device of the capture device 210e is a magnetic conduit connector 214e. The magnetic catheter connector 214e is docked in the connecting hole to realize the magnetic docking of the capture device 210e and the valve clamp 100e.
  • the magnetic member may be a magnetic gasket arranged in the blind hole 153e.
  • a threaded member is provided in the center of the blind hole 153e for screwing and fixing with the capturing device 210e.
  • the threaded member is a threaded hole 155e opened in the inner bottom of the connecting hole, the distal end of the capture device 210e is provided with a threaded joint 216e, and the threaded joint 216e is movably arranged in the magnetic catheter joint 214e.
  • the threaded connector 216e can be extended out of the magnetic conduit connector 214e and screwed to the threaded hole 155e in the blind hole 153e, thereby connecting the capture device 210e is screwed and locked with the valve clamp 100e.
  • the threaded member may be a stud protruding from the connecting hole, and the distal end of the capturing device 210e is provided with a connecting tube with internal threads.
  • the connecting tube is movably arranged in the magnetic catheter joint and can be extended. Screwed with the stud in the connecting hole.
  • the magnetic catheter connector 214e may be provided at the distal end of the removal device 250e, or the threaded connector 216e may be provided at the distal end of the removal device 250e.
  • the connecting hole may only be provided with a magnetic member or a screw member.
  • the structure of the valve clamp 100f provided by the sixth embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the sixth embodiment, the main body A through groove for connecting with the claw 214f of the capture device 210f is provided at the distal end of the valve.
  • the through groove extends in a direction perpendicular to the axial direction of the valve clamp 100f, and the through groove forms a recovery portion 15Of.
  • the connecting section 51f of each distal clip 50f is hollowed out, and the connecting section 51f of each distal clip 50f includes two connecting pieces, and each connecting piece is opened from the distal end to the proximal end.
  • the extended sliding groove, the two distal clips 50f are located on the same side of the connecting seat 10f, the two connecting pieces are stacked on each other, and the sliding grooves of the two connecting pieces are connected, and one end of a first pin passes through the two distal clips in turn
  • the piece 50f is located at the sliding grooves on the two connecting pieces on the same side of the connecting seat 10f, passes through the pin holes on the connecting seat 10f, and finally is inserted into the two distal clips 50f on the opposite side of the connecting seat 10f.
  • the distal ends of the connecting sections 51f of the two distal clips 50f are movably connected to the connecting seat 10f through the same first pin; the connecting section 51f of each distal clip 50f
  • the proximal end is provided with pin holes, the opposite ends of the fixing base 30f are provided with corresponding fixing holes, and the two second pins respectively pass through the pin holes on the two distal clips 50f and are inserted into the corresponding fixing holes on the fixing base 30f.
  • the proximal ends of the connecting sections 51f of the two distal end clips 50f are respectively rotatably connected to the opposite ends of the fixing base 30f.
  • the connecting seat 10f, the fixing seat 30f, and the two distal clips 50f are located between the two sets of connecting pieces on the opposite sides of the connecting seat 10f and the fixing seat 30f to form the through groove, and the through groove penetrates
  • the claws 214f of the capturing device 210f can be inserted into the through groove and abut against the third surface 13 of the connecting seat 10f to recover the valve clamp 100f.
  • the isolation portion 170f of the valve clamp 100f is provided at the distal end of the clamping section 52f of the distal end clip 50f.
  • the structure of the valve clamp 100g provided by the seventh embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the seventh embodiment, the valve clamp The combiner 100g includes two relatively superimposable V-shaped clamping members, wherein both of the clamping members are fixed on the fixing base 30g, the distal end of the fixing base 30g is provided with a recovery part 150g, and the catcher 214g of the capturing device 210g Connect with the recovery part 150g to recover 100g of the valve clamp.
  • the recovery part 150g is a groove opened in the circumferential direction at the distal end of the fixing seat 30g, and the catcher 214g is a gooseneck snare, and the valve clamp is recovered by socketing the snare in the groove 100g.
  • the recovery portion 150g' may be a hook, barb or ring protruding from the distal end of the fixing base 30g', or may be opened on the fixing base 30g'
  • the blind holes, through holes or connecting holes on the surface will not be repeated here.
  • the isolation portion 170g of the valve clamp 100g is provided at least at the portion of the fixing seat 30g adjacent to the recovery portion 150g. In this embodiment, the isolation portion 170g is provided On the outer surface of the entire fixing base 30g.
  • valve clamp is used to reduce or treat "mitral regurgitation”. 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 to solve "mitral regurgitation” in the embodiments of this application.
  • the principle and structure of the valve clamp is roughly the same. It only needs to form multiple clamps by multiple sets of proximal and distal clamps, and each clamp can clamp a leaflet separately, 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 pieces of valve tissue to be clamped together.

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Abstract

A recoverable valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), which comprises a main body part (130) and a recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') arranged at the distal end of the main body part (130). The recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') is arranged at the distal end of the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), so that after the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') is implanted in the body of a patient, same may be recovered in an interventional manner by means of a valve clamp recovery system (200) as needed. Further provided is a valve clamp recovery system (200) used for recovering the recoverable valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'), the valve clamp recovery system (200) comprising a capturing device (210, 210c, 210d, 210e, 210f, 210g, 210g') and a cutting device (230). The cutting device (230) is used to cut the position at which a valve and the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') come into contact so as to remove the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'); and the distal end of the capturing device (210, 210c, 210d, 210e, 210f, 210g, 210g') is detachably connected to the recovery part (150, 150b, 150c, 150d, 150e, 150f, 150g, 150g') of the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g') so as to capture the valve clamp (100, 100b, 100c, 100d, 100e, 100f, 100g, 100g'). The recovery process is simple, the damage to the patient is slight, and the process is advantageous for secondary repair.

Description

可回收的瓣膜夹合器及瓣膜夹合器回收***Recoverable valve clamp and valve clamp recovery system 技术领域Technical field
本申请涉及医疗器械领域，尤其涉及一种可回收的瓣膜夹合器及瓣膜夹合器回收***。This application relates to the field of medical equipment, and in particular to a recyclable valve clamp and a valve clamp recovery system.
背景技术Background technique
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***肌上。在正常情况下，心脏左心室收缩时，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”。Please refer to Figure 1. 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. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior lobe 1a and the posterior lobe 1b are completely aligned to prevent blood from flowing from the left ventricle 3 to the left atrium 2. Please refer to Figure 2. When the mitral valve leaflet or its related structure changes qualitatively or functionally, such as partial rupture of the chordae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly aligned. Therefore, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, causing a series of pathophysiological changes called "Mitral Regurgitation" .
现有一种微创治疗手术，基于瓣膜的缘对缘手术原理，将瓣膜夹钳通过介入导管输送至二尖瓣处，再通过夹钳的相对开合同时夹住二尖瓣的前叶和后叶，使得二尖瓣的前叶与后叶固定，从而达到缩小瓣叶间隙、减少二尖瓣返流的目的。但是，通过微创治疗手术植入瓣膜夹钳的患者，在生存数年后，可能由于心室扩大、风湿性二尖瓣、炎性瓣膜疾病、瓣膜重度钙化、夹钳压迫刺激瓣膜组织增生等原因导致瓣膜狭窄或对合不良，继而再次发生返流或狭窄，此时，就需要进行二次修复。在二次修复前，必须移除已植入的瓣膜夹钳及通过瓣膜夹钳固定在一起的瓣膜组织。然而，现有技术的瓣膜夹钳无法通过介入导管从患者体内移除，只能通过外科手术来切除，手术成本高、难度大，且部分患者无法耐受外科手术，风险高。There is a minimally invasive surgical operation. Based on the principle of valve edge-to-edge surgery, the valve clamp is delivered to the mitral valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve are clamped by the relative opening of the clamp. The leaf makes the anterior leaflet and the posterior leaflet of the mitral valve fixed, thereby achieving the purpose of narrowing the leaflet gap and reducing mitral valve regurgitation. However, patients who have undergone minimally invasive treatment and surgical implantation of valve clamps may survive for several years due to ventricular enlargement, rheumatic mitral valve, inflammatory valve disease, severe valve calcification, and clamp compression to stimulate valve tissue proliferation. This results in valve stenosis or poor alignment, and then regurgitation or stenosis occurs again. At this time, a second repair is required. Before the second repair, the implanted valve clamp and the valve tissue fixed together by the valve clamp must be removed. However, the valve clamp of the prior art cannot be removed from the patient's body through an interventional catheter, and can only be removed by surgical operation, which is costly and difficult, and some patients cannot tolerate the surgical operation, and the risk is high.
发明内容Summary of the invention
有鉴于此，本申请提供一种可回收的瓣膜夹合器及瓣膜夹合器回收***，所述瓣膜夹合器在植入患者体内后，可根据需要而通过所述瓣膜夹合器回收***以介入方式进行回收，手术流程简便，对患者损伤小，有利于二次修复。In view of this, the present application provides a retrievable valve clamp and a valve clamp recovery system. After the valve clamp is implanted in a patient, the valve clamp can pass through the valve clamp recovery system as needed Recovered in an interventional manner, the surgical procedure is simple, and the patient is less damaged, which is beneficial for secondary repair.
为解决上述技术问题，本申请提供一种可回收的瓣膜夹合器，包括主体部及设置于所述主体部远端的回收部，所述回收部用于与捕获装置连接以通过介入方式回收所述瓣膜夹合器。In order to solve the above technical problems, the present application provides a retrievable valve clamp, including a main body and a retrieving portion provided at the distal end of the main portion. The retrieving portion is used to connect with a capturing device for retrieving through interventional methods. The valve clamp.
本申请还提供一种瓣膜夹合器回收***，用于回收前述的瓣膜夹合器，所述瓣膜夹合器回收***包括捕获装置及切割装置，所述捕获装置的远端与所述瓣膜夹合器的回收部可拆卸连接；所述切割装置用于切割瓣膜与所述瓣膜夹合器接触的位置，以切除所述瓣膜夹合器，所述捕获装置能捕获所述瓣膜夹合器。The present application also provides a valve clamp recovery system for recovering the aforementioned valve clamp. The valve clamp recovery system includes a capture device and a cutting device. The distal end of the capture device is connected to the valve clamp. The recovery part of the combiner is detachably connected; the cutting device is used to cut the contact position of the valve with the valve clipper to cut off the valve clipper, and the capture device can capture the valve clipper.
本申请提供的瓣膜夹合器及瓣膜夹合器回收***，通过在瓣膜夹合器的远端设置回收部，在所述瓣膜夹合器植入患者体内后，可根据需要而通过所述瓣膜夹合器回收***以介入方式进行回收，回收过程简便，对患者损伤小，有利于二次修复。The valve clamp and valve clamp recovery system provided by the present application, by providing a recovery part at the distal end of the valve clamp, after the valve clamp is implanted in the patient's body, the valve can be passed through as needed The clip recovery system is recovered in an interventional manner, the recovery process is simple, and the patient is less damaged, which is conducive to secondary repair.
附图说明Description of the drawings
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。In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.
图1是二尖瓣正常状态时的示意图。Figure 1 is a schematic diagram of the mitral valve in a normal state.
图2是二尖瓣出现病变时的示意图。Figure 2 is a schematic diagram of mitral valve disease.
图3是本申请第一实施例提供的瓣膜夹合器闭合状态时的结构示意图。Fig. 3 is a schematic structural diagram of the valve clamp provided in the first embodiment of the present application in a closed state.
图4是图3中的瓣膜夹合器的另一视角的立体结构示意图。Fig. 4 is a three-dimensional structural diagram of the valve clamp in Fig. 3 from another perspective.
图5是图3中的瓣膜夹合器的张开状态时的结构示意图。Fig. 5 is a schematic structural diagram of the valve clamp in Fig. 3 in an opened state.
图6是图5中的瓣膜夹合器的连接座的立体结构示意图。Fig. 6 is a three-dimensional schematic diagram of the connecting seat of the valve clamp in Fig. 5.
图7是图5中的瓣膜夹合器的近端夹片与固定座的连接示意图。Fig. 7 is a schematic diagram of the connection between the proximal end clip of the valve clamp in Fig. 5 and the fixing seat.
图8是图7中的固定座的立体结构示意图。FIG. 8 is a schematic diagram of the three-dimensional structure of the fixing seat in FIG. 7.
图9是图3中的瓣膜夹合器植入二尖瓣后的示意图。Fig. 9 is a schematic diagram of the valve clamp in Fig. 3 after being implanted into the mitral valve.
图10是图9中XI部分的局部放大示意图。Fig. 10 is a partial enlarged schematic diagram of part XI in Fig. 9.
图11是图9中的瓣膜夹合器夹合瓣叶后，心脏收缩时二尖瓣示意图。Fig. 11 is a schematic diagram of the mitral valve when the heart is contracted after the valve leaflets are clamped by the valve clamp in Fig. 9.
图12是图9中的瓣膜夹合器夹合瓣叶后，心脏舒张时二尖瓣示意图。Fig. 12 is a schematic diagram of the mitral valve in diastole after the valve clamp in Fig. 9 clamps the valve leaflets.
图13是捕获装置将与图3中的瓣膜夹合器连接的示意图。Fig. 13 is a schematic diagram of the capture device to be connected to the valve clamp in Fig. 3.
图14是本申请其中一实施例提供的瓣膜夹合器回收***的示意图。Fig. 14 is a schematic diagram of a valve clamp recovery system provided by one embodiment of the present application.
图15是图14中的瓣膜夹合器回收***的其中一实施例中的介入通道的示意图。Fig. 15 is a schematic diagram of an intervention channel in one embodiment of the valve clamp recovery system in Fig. 14.
图16是图14中的瓣膜夹合器回收***的另一实施例的介入通道的示意图。Fig. 16 is a schematic diagram of an intervention channel of another embodiment of the valve clip recovery system in Fig. 14.
图17是图16中的捕获装置与瓣膜夹合器对接的示意图。Fig. 17 is a schematic diagram of docking the capture device in Fig. 16 with the valve clamp.
图18是图16中的切割装置切除瓣膜夹合器的示意图。Fig. 18 is a schematic diagram of the cutting device in Fig. 16 cutting off the valve clamp.
图19是本申请第二实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 19 is a schematic diagram of a valve clamp and a capture device provided by the second embodiment of the present application.
图20是图19中的瓣膜夹合器的连接座的结构示意图。Fig. 20 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 19.
图21是本申请第三实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 21 is a schematic diagram of a valve clamp and a capture device provided by the third embodiment of the present application.
图22是图21中的瓣膜夹合器的连接座的结构示意图。Fig. 22 is a schematic structural view of the connecting seat of the valve clamp in Fig. 21.
图23是本申请第四实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 23 is a schematic diagram of a valve clamp and a capture device provided by the fourth embodiment of the present application.
图24是本申请第五实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 24 is a schematic diagram of a valve clamp and a capture device provided by a fifth embodiment of the present application.
图25是图24中的瓣膜夹合器的连接座的结构示意图。Fig. 25 is a structural schematic diagram of the connecting seat of the valve clamp in Fig. 24.
图26是本申请第六实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 26 is a schematic diagram of a valve clamp and a capture device provided by a sixth embodiment of the present application.
图27是本申请第七实施例提供的瓣膜夹合器与捕获装置的示意图。Fig. 27 is a schematic diagram of a valve clamp and a capture device provided by a seventh embodiment of the present application.
图28是图27中的瓣膜夹合器的回收部的另一种实施方式的示意图。Fig. 28 is a schematic diagram of another embodiment of the recovery part of the valve clamp in Fig. 27.
具体实施方式detailed description
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。The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.
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。In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for It is convenient to describe the application and simplify the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore cannot be understood as a limitation of the application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance.
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”等应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以是通过中间媒介间接相连。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection", "connection", etc. should be understood in a broad sense. For example, it may be a fixed connection or a Disassembly connection, or integral connection; it can be directly connected or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in this application can be understood under specific circumstances.
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。In the description of this application, it should be noted that in the field of interventional medical devices, 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 distal center and the proximal center of the instrument. The above definition is only for the convenience of presentation, and cannot be understood as a limitation of the application.
请参阅图3至图5，本申请提供一种可回收的瓣膜夹合器100，包括主体部130及设置于主体部130远端的回收部150，回收部150用于与捕获装置连接以通过介入方式回收瓣膜夹合器100。3 to 5, the present application provides a retrievable valve clamp 100, including a main body 130 and a retrieving portion 150 disposed at the distal end of the main portion 130, the retrieving portion 150 is used to connect with the capture device to pass The valve clamp 100 is recovered in an interventional manner.
本实施例中，主体部130包括位于远端的连接座10、与连接座10相连的推杆20、套设于推杆20外部的固定座30、相对于推杆20辐射展开的两个近端夹片40和两个远端夹片50，以及两个相对设置的连杆60。具体的，两个近端夹片40与两个远端夹片50均关于推杆20轴对称设置，近端夹片40与远端夹片50一一对应。近端夹片40的一端固定连接于固定座30上，近端夹片40设置于远端夹片50及固定座30之间，近端夹片40相对的另一端由于其自身弹力可向远端夹片50靠拢，对应的近端夹片40与远端夹片50之间形成瓣膜容纳空间45。远端夹片50的一端转动连接于固定座30上，远端夹片50并通过一连杆60与连接座10活动连接。当推杆20相对于固定座30沿轴向运动时，连接座10相对于固定座30运动，在连杆60的拉动下，远端夹片50相对于固定座30开合，当固定于固定座30上的近端夹片40向远端夹片50靠拢时，即可与远端夹片50配合，以夹紧位于瓣膜容纳空间45内的瓣膜。In this embodiment, the main body 130 includes a connecting seat 10 at the distal end, a push rod 20 connected to the connecting seat 10, a fixing seat 30 sleeved on the outside of the push rod 20, and two proximal parts radiatingly deployed relative to the push rod 20. An end clip 40 and two distal clips 50, and two opposite connecting rods 60. Specifically, the two proximal clips 40 and the two distal clips 50 are all arranged axisymmetrically with respect to the push rod 20, and the proximal clips 40 and the distal clips 50 correspond one-to-one. One end of the proximal clip 40 is fixedly connected to the fixing base 30, the proximal clip 40 is arranged between the distal clip 50 and the fixing base 30, and the opposite end of the proximal clip 40 can be farther away due to its own elastic force. The end clip 50 closes together, and a valve accommodating space 45 is formed between the corresponding proximal clip 40 and the distal clip 50. One end of the distal end clip 50 is rotatably connected to the fixing base 30, and the distal end clip 50 is movably connected to the connection base 10 through a connecting rod 60. When the push rod 20 moves in the axial direction relative to the fixed seat 30, the connecting seat 10 moves relative to the fixed seat 30. Under the pulling of the connecting rod 60, the distal clip 50 opens and closes relative to the fixed seat 30. When the proximal clip 40 on the seat 30 is close to the distal clip 50, it can cooperate with the distal clip 50 to clamp the valve located in the valve receiving space 45.
具体的，将瓣膜夹合器100的近端可拆卸地连接到相应的推送装置上，则可通过该推送装置将瓣膜夹合器100推送至患者的二尖瓣处，然后远距离操作瓣膜夹合器100，将二尖瓣的前叶和后叶夹持在一起，一旦二尖瓣的瓣叶被缘对缘地对合在一起，操作者即可解脱该推送装置与瓣膜夹合器100之间的连接，使得瓣膜夹合器100自推送装置的远端解脱，并作为植入物留在患者体内，从而减轻或治疗“二尖瓣返流”。Specifically, if the proximal end of the valve clamp 100 is detachably connected to the corresponding pushing device, the valve clamp 100 can be pushed to the mitral valve of the patient through the pushing device, and then the valve clamp can be operated remotely The combiner 100 clamps the anterior and posterior leaflets of the mitral valve together. Once the leaflets of the mitral valve are aligned edge-to-edge, the operator can release the pushing device and the valve clamp 100 The connection between the valve clamper 100 is released from the distal end of the propulsion device and remains in the patient's body as an implant, thereby reducing or treating "mitral valve regurgitation".
其中，所述推送装置包括用于控制近端夹片40释放的调节线、用于驱动推杆20轴向运动及用于与瓣膜夹合器100可拆卸连接的推送组件，以及连接于推送组件近端的操作手柄，此处不做赘述。Wherein, the pushing device includes an adjustment wire for controlling the release of the proximal clip 40, a pushing assembly for driving the axial movement of the push rod 20 and a detachable connection with the valve clamp 100, and a pushing assembly connected to the pushing assembly The operation handle at the proximal end will not be repeated here.
其中，为保证植入后的安全性，近端夹片40及远端夹片50均由生物相容性金属材料制成，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。具体的，近端夹片40由具有形状记忆功能的弹性材料制成，远端夹片50由刚性材料制成，以保证二者配合能够夹紧固定瓣膜。本实施例中，近端夹片40由具有超弹性的镍钛合金制成，远端夹片50由硬度较高的不锈钢或钴铬合金制成。Among them, in order to ensure the safety after implantation, the proximal clip 40 and the distal clip 50 are made of biocompatible metal materials, and the metal materials are selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel. Commonly used metal materials for implants such as titanium alloys. Specifically, the proximal clip 40 is made of an elastic material with a shape memory function, and the distal clip 50 is made of a rigid material to ensure that the two can clamp and fix the valve. In this embodiment, the proximal clip 40 is made of super-elastic Nitinol, and the distal clip 50 is made of stainless steel or cobalt-chromium alloy with higher hardness.
本申请中，通过在瓣膜夹合器100的主体部130的远端设置回收部150，在瓣膜夹合器100植入患者体内后，可根据患者病情或二次修复的需要，通过回收部150与捕获装置进行连接，从而以介入方式将瓣膜夹合器100进行回收，回收过程简便，对患者损伤小，有利于二次修复。In this application, by providing the recovery part 150 at the distal end of the main body 130 of the valve clamp 100, after the valve clamp 100 is implanted in the patient, the recovery part 150 can be used according to the patient’s condition or the need for secondary repair. It is connected with the capture device to recover the valve clamp 100 in an interventional manner. The recovery process is simple, and the damage to the patient is small, which is beneficial for secondary repair.
具体的，请一并参阅图5和图6，连接座10与推杆20可以是一体结构，也可以是非一体结构。本实施例中，连接座10与推杆20为非一体结构。本实施例中，推杆20为圆杆体，推杆20的远端设置有外螺纹，推杆20与连接座10螺接固定。在其他实施例中，推杆20可以通过卡合等其他可拆卸或不可拆卸的连接方式与连接座10进行连接。本实施例中，连接座10包括相对的两个第一表面11及连接两个第一表面11的两个连接面，两个连接面包括位于远端的第二表面12及位于近端、且与第二表面12光滑过渡相接的第三表面13，其中，第一表面11及第三表面13为平面，第二表面12为曲面。连接座10相对的两端分别开设有贯通两个第一表面11的销钉孔14用于连接连杆60，连接座10的第三表面13的中心轴向开设有用于与推杆20连接的连接孔15，连接孔15内设置有与推杆20远端的外螺纹相对应的内螺纹。Specifically, please refer to FIG. 5 and FIG. 6 together. The connecting base 10 and the push rod 20 may be an integral structure or a non-integral structure. In this embodiment, the connecting seat 10 and the push rod 20 are of a non-integral structure. In this embodiment, the push rod 20 is a round rod body, the distal end of the push rod 20 is provided with an external thread, and the push rod 20 is screwed and fixed with the connecting seat 10. In other embodiments, the push rod 20 may be connected to the connection base 10 by other detachable or non-detachable connection methods such as snapping. In this embodiment, the connecting seat 10 includes two opposite first surfaces 11 and two connecting surfaces connecting the two first surfaces 11. The two connecting surfaces include a second surface 12 at the distal end and a second surface 12 at the proximal end. The third surface 13 is smoothly connected to the second surface 12, wherein the first surface 11 and the third surface 13 are flat surfaces, and the second surface 12 is a curved surface. The opposite ends of the connecting seat 10 are respectively provided with pin holes 14 penetrating through the two first surfaces 11 for connecting the connecting rod 60, and the third surface 13 of the connecting seat 10 is provided with a connection for connecting with the push rod 20 in the axial direction. The hole 15 is provided with an internal thread corresponding to the external thread of the distal end of the push rod 20 in the connecting hole 15.
其中，连接座10的平行于第三表面13方向的截面尺寸由近端至远端逐渐减小，即连接座10的形状可以为半球体、球冠、弹头形等结构，以使瓣膜夹合器100更容易在患者体内进行推送。Wherein, the cross-sectional size of the connecting seat 10 in the direction parallel to the third surface 13 gradually decreases from the proximal end to the distal end, that is, the shape of the connecting seat 10 can be a hemisphere, a spherical crown, a bullet shape, etc., so that the valve can be clamped. The device 100 is easier to push in the patient.
其中，连接座10及推杆20的外表面光滑，以避免损伤瓣膜或钩挂腱索。Wherein, the outer surfaces of the connecting seat 10 and the push rod 20 are smooth to avoid damage to the valve or hook chordae.
其中，连接座10及推杆20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材料制成，优选为不锈钢或钴铬合金。Wherein, the connecting seat 10 and the push rod 20 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel or cobalt-chromium alloy.
请一并参阅图5、图7及图8，固定座30包括第一座体31及连接于第一座体31远端的第二座体32，具体的，第一座体31与第二座体32之间通过一第三座体33过渡连接。其中，第一座体31、第二座体32及第三座体33可以是一体结构，也可以是非一体结构。本实施例中，第一座体31、第二座体32及第三座体33为一体结构。Please refer to Figures 5, 7 and 8, the fixing base 30 includes a first base 31 and a second base 32 connected to the distal end of the first base 31. Specifically, the first base 31 and the second base 31 The seat bodies 32 are transitionally connected to each other through a third seat body 33. Among them, the first seat body 31, the second seat body 32, and the third seat body 33 may be an integral structure or a non-integral structure. In this embodiment, the first seat body 31, the second seat body 32 and the third seat body 33 are an integral structure.
本实施例中，第一座体31为柱体结构，第一座体31的轴向方向上的任一位置的横截面为方形；第二座体32相对的两外侧分别凸设有凸块321，第二座体32还开设有容置腔34，容置腔34的一侧内壁设置有凸台341，凸台341的近端面为斜面，容置腔34内设置有钢片343及抵接于钢片343近端面上的变形弹片345，钢片343的一端抵接于凸台341的斜面上，在变形弹片345的弹力作用下，钢片343倾斜设置于容置腔34内；第三座体33大致呈梯形块结构，第三座体33相对的两外侧分别凸设用于与远端夹片50转动连接的连接块331，第三座体33的轴向方向上的任一位置的横截面为方形，且其横截面面积自近端向远端逐渐增大。In this embodiment, the first seat body 31 has a cylindrical structure, and the cross section of any position in the axial direction of the first seat body 31 is a square; the two opposite outer sides of the second seat body 32 are respectively provided with convex bumps 321. The second seat body 32 is also provided with an accommodating cavity 34. One inner wall of the accommodating cavity 34 is provided with a boss 341. The proximal surface of the boss 341 is an inclined surface. The accommodating cavity 34 is provided with a steel sheet 343 and The deformed elastic piece 345 abuts on the proximal surface of the steel piece 343, one end of the steel piece 343 abuts on the inclined surface of the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 is inclinedly arranged in the accommodating cavity 34 The third seat body 33 is roughly in a trapezoidal block structure, and two opposite outer sides of the third seat body 33 are respectively provided with connecting blocks 331 for rotating connection with the distal end clip 50, and the third seat body 33 is in the axial direction The cross-section of any position is square, and its cross-sectional area gradually increases from the proximal end to the distal end.
进一步的，固定座30沿轴向开设有贯通第一座体31、第二座体32及第三座体33的穿设通道35，当固定座30套设于推杆20的外部时，推杆20收容于穿设通道35内。其中，推杆20收容于穿设通道35内时，推杆20穿过设置于容置腔34内的钢片343及变形弹片345，钢片343及变形弹片345开设有相应的通孔，通孔的面积略大于推杆20的横截面面积。Further, the fixing seat 30 is provided with a through passage 35 passing through the first seat body 31, the second seat body 32 and the third seat body 33 along the axial direction. When the fixing seat 30 is sleeved on the outside of the push rod 20, the pushing The rod 20 is received in the through channel 35. Wherein, when the push rod 20 is accommodated in the through passage 35, the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345 arranged in the accommodating cavity 34. The steel sheet 343 and the deformed elastic sheet 345 are provided with corresponding through holes. The area of the hole is slightly larger than the cross-sectional area of the push rod 20.
可以理解的是，推杆20穿过钢片343及变形弹片345，在变形弹片345的弹力作用下，钢片343倾斜后与推杆20呈一定夹角且在通孔边缘接触，当推杆20与固定座30之间存在相对运动的趋势时，钢片343产生摩擦力而阻止推杆20相对于固定座30移动。It is understandable that the push rod 20 passes through the steel sheet 343 and the deformed elastic sheet 345. Under the elastic force of the deformed elastic sheet 345, the steel sheet 343 is inclined to form a certain angle with the push rod 20 and contact at the edge of the through hole. When there is a tendency of relative movement between the 20 and the fixed base 30, the steel sheet 343 generates friction to prevent the push rod 20 from moving relative to the fixed base 30.
其中，为保证植入后的安全性，固定座30由生物相容性金属材料制成，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，优选为硬度较高的不锈钢或钴铬 合金。Among them, in order to ensure the safety after implantation, the fixing seat 30 is made of a biocompatible metal material, and the metal material is selected from stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel titanium alloy and other commonly used implantation metals The material is preferably stainless steel or cobalt-chromium alloy with higher hardness.
其中，钢片343及变形弹片345同样由生物相容性的材料制成，钢片343优选为硬度较高的不锈钢或钴铬合金制成，变形弹片345由具有弹性的镍钛合金制成。Among them, the steel sheet 343 and the deformed elastic sheet 345 are also made of biocompatible materials. The steel sheet 343 is preferably made of stainless steel or cobalt-chromium alloy with higher hardness, and the deformed elastic sheet 345 is made of elastic Nitinol.
可以理解的是，此处仅给出了固定座30的一种实施例，实际上，固定座30还可以是其它结构，此处不做赘述。It is understandable that only one embodiment of the fixing seat 30 is given here. In fact, the fixing seat 30 may also have other structures, which will not be repeated here.
进一步的，如图8中所示，固定座30相对的两侧还分别设置有控制件36，控制件36为镍钛合金等制成的金属丝，控制件36贴合于固定座30上，控制件36的远端朝向固定座30的轴线方向弯折而收容于容置腔34内。具体的，控制件36的远端具有两分支，其中一分支抵接于凸台341的远端平面上，另一分支抵接于钢片343的远端面上且靠近钢片343远离凸台341的一端。当向近端方向拉动控制件36抵接于钢片343的远端面上的分支时，该分支能带动钢片343远离凸台341的一端以钢片343抵接于凸台341的斜面上的一端为支撑点而向近端方向转动，直至钢片343与推杆20的轴线呈90度，此时，钢片343的通孔与推杆20的轴线同轴，推杆20与固定座30之间的连接锁定状态解除，推杆20可沿轴向运动。Further, as shown in FIG. 8, two opposite sides of the fixing base 30 are respectively provided with control members 36. The control members 36 are metal wires made of Nitinol, etc., and the control members 36 are attached to the fixing base 30. The distal end of the control member 36 is bent toward the axial direction of the fixing base 30 and is received in the accommodating cavity 34. Specifically, the distal end of the control member 36 has two branches, one of which abuts on the distal plane of the boss 341, and the other abuts on the distal surface of the steel sheet 343 and is close to the steel sheet 343 away from the boss. One end of 341. When the control member 36 is pulled in the proximal direction to abut against the branch on the distal surface of the steel sheet 343, the branch can drive the end of the steel sheet 343 away from the boss 341 and the steel sheet 343 abuts against the slope of the boss 341 One end of the steel sheet 343 is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees. At this time, the through hole of the steel sheet 343 is coaxial with the axis of the push rod 20, and the push rod 20 and the fixed seat The locked state of the connection between 30 is released, and the push rod 20 can move in the axial direction.
其中，分别设置于固定座30相对的两侧的两个控制件36可以是一体结构，也可以是非一体结构。本实施例中，两个控制件36为一体结构，具体的，可由同一根金属丝穿过容置腔34的底部后弯折形成。Wherein, the two control members 36 respectively provided on the two opposite sides of the fixing base 30 may be an integral structure or a non-integral structure. In this embodiment, the two control members 36 are an integral structure. Specifically, the same metal wire can be formed by passing through the bottom of the containing cavity 34 and then bending.
请一并参阅图5及图7，近端夹片40包括相对设置的连接端41及自由端42，连接端41固定于固定座30上。本实施例中，两个近端夹片40的连接端41通过连接框43连接为一体，连接框43开设供推杆20穿过的通孔，连接框43相对的两侧还分别开设有供第二座体32上的凸块321穿过的矩形孔，连接框43套接于第二座体32与第三座体33上，以实现两个近端夹片40的连接端41相对于固定座30固定。在其他实施例中，近端夹片40的连接端41可以直接以焊接等连接方式固定于固定座30上。Please refer to FIGS. 5 and 7 together. The proximal clip 40 includes a connecting end 41 and a free end 42 that are oppositely disposed, and the connecting end 41 is fixed on the fixing base 30. In this embodiment, the connecting ends 41 of the two proximal clips 40 are connected as a whole through a connecting frame 43. The connecting frame 43 has a through hole for the push rod 20 to pass through. The two opposite sides of the connecting frame 43 are also provided with The rectangular hole through which the protrusion 321 on the second seat body 32 passes, the connecting frame 43 is sleeved on the second seat body 32 and the third seat body 33 to realize that the connecting ends 41 of the two proximal clips 40 are opposite to each other. The fixing base 30 is fixed. In other embodiments, the connecting end 41 of the proximal clip 40 may be directly fixed to the fixing base 30 by welding or other connection methods.
其中，近端夹片40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40呈展开的U形，即，近端夹片40与固定座30之间呈角度设置，以便于和远端夹片50配合以夹持瓣膜。近端夹片40的两侧延伸方向之间的夹角范围为0-200度。本实施例中，近端夹片40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40。本实施例中，近端夹片40整体由超弹性的镍钛合金制成，从而为近端夹片40提供弹力以驱使近端夹片40向远端夹片50靠拢以夹持瓣膜。此外，本实施例中，连接框43也采用弹性的镍钛合金制成，以便于将连接框43套接于第二座体32和第三座体33上。Wherein, the proximal clip 40 is at least partially made of an elastic material with a shape memory function, and has been heat-set. In a natural state, the proximal clip 40 is in an unfolded U shape, that is, the proximal clip 40 and the fixing seat 30 are arranged at an angle so as to cooperate with the distal clip 50 to clamp the valve. The angle between the extending directions of the two sides of the proximal clip 40 ranges from 0 to 200 degrees. In this embodiment, the proximal clip 40 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 It is quickly put into purified water to cool, and the shaping mold is removed to obtain the shaped proximal clip 40. In this embodiment, the entire proximal clip 40 is made of super-elastic nickel-titanium alloy, so as to provide elastic force for the proximal clip 40 to drive the proximal clip 40 to the distal clip 50 to clamp the valve. In addition, in this embodiment, the connecting frame 43 is also made of elastic nickel-titanium alloy, so that the connecting frame 43 can be sleeved on the second seat body 32 and the third seat body 33.
在其他实施例中，近端夹片40的连接端41由弹性材料制成，近端夹片40的自由端42可以由铝合金等非弹性材料制成，通过连接端41的弹力驱使近端夹片40向远端夹片50靠拢。In other embodiments, the connecting end 41 of the proximal clip 40 is made of an elastic material, and the free end 42 of the proximal clip 40 can be made of an inelastic material such as aluminum alloy. The proximal end is driven by the elastic force of the connecting end 41. The clip 40 moves closer to the distal clip 50.
需要说明的是，相对于推杆20向外并朝近端辐射延伸的近端夹片40的自由端42可以通过调节线进行控制，在输送状态下，使得近端夹片40的自由端42被调节线拉紧并贴合于固定座30的表面上，而在放开调节线对自由端42的控制后，近端夹片40由于自身弹性记忆性能而回弹，近端夹片40恢复自然状态，并将瓣膜压向远端夹片50。优选地，自然展开状态下的近端夹片40的两侧延伸方向之间的夹角应略大于两个远端夹片50之间的夹角，以提供更稳定的夹持力，即，近端夹片40的每侧延伸方向与固定座30之间的夹角大于或等于与该侧对应的远端夹片50张开至最大状态时的远端夹片50与固定座30之间的夹角，从而保证远端夹片50与近端夹片40之间具有一定的夹紧力，以夹紧位于远端夹片50与近端夹片40之间的瓣膜。It should be noted that the free end 42 of the proximal clip 40 that extends outward and radiating toward the proximal end relative to the push rod 20 can be controlled by an adjustment line. In the conveying state, the free end 42 of the proximal clip 40 The adjustment wire is tightened and fits on the surface of the fixing seat 30, and after releasing the adjustment wire to control the free end 42, the proximal clip 40 rebounds due to its own elastic memory performance, and the proximal clip 40 recovers Natural state, and press the valve toward the distal clip 50. Preferably, the included angle between the extension directions of the two sides of the proximal clip 40 in the natural unfolded state should be slightly larger than the included angle between the two distal clips 50 to provide a more stable clamping force, that is, The angle between the extending direction of each side of the proximal clip 40 and the fixing seat 30 is greater than or equal to the distance between the distal clip 50 and the fixing seat 30 when the distal clip 50 corresponding to the side is expanded to the maximum state Therefore, it is ensured that there is a certain clamping force between the distal clip 50 and the proximal clip 40 to clamp the valve between the distal clip 50 and the proximal clip 40.
进一步的，近端夹片40包括朝向瓣膜容纳空间45的第一表面，第一表面上设有夹持增强件，以增加近端夹片40与夹持于瓣膜容纳空间45内的瓣膜之间的摩擦力，提高瓣膜夹合器100对瓣膜的夹持力。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46。倒刺46可以采用一体成型方式在近端夹片40上形成，也可以采用与近端夹片40相同或不同的材料形成倒刺46再将其连接于近端夹片40的第一表面上，例如，可将镍钛金属丝或镍钛金属杆通过套筒固定于第一表面上。倒刺46的根部与近端夹片40相连，倒刺46的与其根部相对的一端为悬空端，在自然展开状态下，倒刺46的悬空端朝向远端夹片50。倒刺46的延伸方向与第一表面之间的夹角小于或等于90度，以增强瓣膜夹合器100对瓣膜的夹持力。进一步的，每根倒刺46的悬空端为光滑的弧形面，从而避免损伤瓣膜组织。Further, the proximal clip 40 includes a first surface facing the valve accommodating space 45. A clamping reinforcement is provided on the first surface to increase the gap between the proximal clip 40 and the valve clamped in the valve accommodating space 45. The friction force increases the clamping force of the valve clamp 100 on the valve. Specifically, in this embodiment, the clamping reinforcement is two rows of barbs 46 arranged at intervals on opposite sides of the first surface. The barbs 46 can be formed on the proximal clip 40 by an integral molding method, or the barbs 46 can be formed of the same or different material as the proximal clip 40 and then connected to the first surface of the proximal clip 40 For example, a nickel-titanium metal wire or a nickel-titanium metal rod can be fixed on the first surface through a sleeve. The root of the barb 46 is connected to the proximal clip 40, and the end of the barb 46 opposite to the root is a dangling end. In a natural deployment state, the dangling end of the barb 46 faces the distal clip 50. The angle between the extending direction of the barb 46 and the first surface is less than or equal to 90 degrees, so as to enhance the clamping force of the valve clamp 100 on the valve. Further, the suspended end of each barb 46 is a smooth curved surface, so as to avoid damage to the valve tissue.
在其他实施例中，倒刺46的数量可以是1根、2根或其他合理数量。In other embodiments, the number of barbs 46 may be one, two, or other reasonable numbers.
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，以提高对瓣膜的夹持力。In other embodiments, the clamping reinforcement may be a structure such as a rib, a boss 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 on the valve.
其中，近端夹片40上开设有多个开孔，以减轻近端夹片40的重量，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。Among them, the proximal clip 40 is provided with a plurality of openings to reduce the weight of the proximal clip 40 and prevent the excessively heavy valve clip 100 from falling under the leaflets for a long time to cause slippage or damage to the leaflets. Conducive to the crawling and growth of endothelial cells.
请参阅图5，远端夹片50包括位于远端的连接段51以及连接于连接段51近端的夹持段52，连接段51的远端转动连接于固定座30的连接块331上，连接段51的近端转动连接于相应一侧的连杆60的近端，连杆60的远端转动连接于连接座10上。本实施例中，所述转动连接均通过相应的转动销钉来实现。显然，在其他实施例中，转动销钉可以用螺栓代替。5, the distal end clip 50 includes a connecting section 51 at the distal end and a clamping section 52 connected to the proximal end of the connecting section 51. The distal end of the connecting section 51 is rotatably connected to the connecting block 331 of the fixing base 30. The proximal end of the connecting section 51 is rotatably connected to the proximal end of the connecting rod 60 on the corresponding side, and the distal end of the connecting rod 60 is rotatably connected to the connecting seat 10. In this embodiment, the rotation connections are all realized by corresponding rotation pins. Obviously, in other embodiments, the rotation pin can be replaced by a bolt.
如前所述，通过拉动控制件36抵接于钢片343的远端面上的分支，则可带动钢片343远离凸台341的一端以钢片343抵接于凸台341的斜面上的一端为支撑点向近端方向转动，直至钢片343与推杆20的轴线呈90度，推杆20与固定座30之间的连接锁定状态解除，推杆20可沿轴向相对于固定座30运动，由此，固定座30与连接座10相对运动，在连杆60的拉动下，远端夹片50可围绕连接块331上的转动销钉转动而相对于固定座30开合，当近端夹片40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40可向远端夹片50靠拢，以夹紧瓣膜容纳空间45内的瓣膜。进一步的，当近端夹片40与远端夹片50夹紧瓣膜后，连接座10沿轴向向近端方向运动，直至瓣膜夹合器100处于收拢状态，然后释放控制件36对钢片343远离凸台341的一端的控制，在变形弹片345的弹力作用下，钢片343与推杆20接触并呈一定夹角，推杆20与固定座30之间的连接锁定，以避免远端夹片50相对于固定座30打开，收拢状态的瓣膜夹合器100坠于瓣叶下方。As mentioned above, by pulling the control member 36 to abut against the branch on the distal end of the steel sheet 343, the end of the steel sheet 343 away from the boss 341 can be driven, and the steel sheet 343 abuts against the inclined surface of the boss 341. One end is the support point and rotates in the proximal direction until the axis of the steel sheet 343 and the push rod 20 is 90 degrees, the connection lock state between the push rod 20 and the fixed seat 30 is released, and the push rod 20 can be axially relative to the fixed seat As a result, the fixing seat 30 and the connecting seat 10 move relative to each other. Under the pulling of the connecting rod 60, the distal end clip 50 can rotate around the rotating pin on the connecting block 331 and open and close relative to the fixed seat 30. After the end clip 40 is released and expands freely due to its own elastic memory function, the proximal clip 40 can move closer to the distal clip 50 to clamp the valve in the valve accommodation space 45. Further, after the proximal clip 40 and the distal clip 50 clamp the valve, the connecting seat 10 moves in the axial direction toward the proximal end until the valve clip 100 is in the retracted state, and then releases the control member 36 to the steel plate Under the control of the end of the 343 away from the boss 341, under the elastic force of the deformed elastic piece 345, the steel piece 343 contacts the push rod 20 at a certain angle, and the connection between the push rod 20 and the fixing seat 30 is locked to avoid the distal end The clip 50 is opened relative to the fixing seat 30, and the valve clip 100 in the collapsed state falls below the leaflets.
优选的，远端夹片50朝向瓣膜容纳空间45的第二表面上也可以设置与近端夹片40的夹持增强件类似的结构，或施加活性药物、设置多个开口。Preferably, the second surface of the distal clip 50 facing the valve accommodating space 45 can also be provided with a structure similar to the clamping reinforcement of the proximal clip 40, or apply active drugs and provide multiple openings.
优选的，第二表面设置为曲面，以增加远端夹片50与瓣膜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40向远端夹片50靠拢时，近端夹片40的第一表面上的倒刺46能够收容于收容槽内，以压紧位于瓣叶容纳空间45内的瓣膜，并且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。Preferably, the second surface is set as a curved surface to increase the contact area and clamping area between the distal end clip 50 and the valve, thereby providing a stable clamping force. Moreover, the second surface of the curved surface forms a receiving groove, and when the proximal clip 40 is close to the distal clip 50, the barbs 46 on the first surface of the proximal clip 40 can be received in the receiving groove to compress The valve is located in the valve leaflet containing space 45, and the volume of the valve clamp 100 when the valve clamp 100 is folded is reduced as much as possible, which is conducive to delivery in the body.
需要说明的是，为了保证稳定的夹持力并与瓣叶的大小相对应，远端夹片50具有一定的尺寸规定。具体的，远端夹片50的长度必须在一定范围内，当远端夹片50的长度过长时，远端夹片50易将过多的前叶和后叶夹在一起，当瓣膜夹合器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，由于过多的瓣叶被限制运动，不仅容易导致二尖瓣功能异常，还可能导致瓣叶撕裂等严重后果；当远端夹片50过短时，瓣膜夹合器100只能夹住小部分的瓣叶，使得瓣叶容易滑出，夹合固定效果较差。本申请实施例中，远端夹片50的轴向长度，即连接段51至夹持段52的距离，应大于或等于4mm，优选为6-10mm。并且，远端夹片50的宽度也有一定的限制，以避免远端夹片50的宽度过窄而对瓣叶产生伤害，同时也避免远端夹片50的宽度过宽时瓣膜夹合器100对瓣叶运动的影响。远端夹片50的宽度，即与远端夹片50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。It should be noted that, in order to ensure a stable clamping force and correspond to the size of the valve leaflet, the distal clip 50 has a certain size specification. Specifically, the length of the distal clip 50 must be within a certain range. When the length of the distal clip 50 is too long, the distal clip 50 tends to clamp too many anterior and posterior leaflets together. When the compositor 100 is closed, the two leaflets are forcibly pulled toward each other and fixed together. When the heart beats and the leaflets move, the movement of too many leaflets is restricted, which not only easily leads to abnormal mitral valve function, but also It may cause serious consequences such as tearing of the valve leaflets; when the distal clip 50 is too short, the valve clamp 100 can only clamp a small portion of the valve leaflets, making the leaflets easy to slide out, and the clamping and fixing effect is poor. In the embodiment of the present application, the axial length of the distal end clip 50, that is, the distance from the connecting section 51 to the clamping section 52, should be greater than or equal to 4 mm, preferably 6-10 mm. In addition, the width of the distal clip 50 is also limited to a certain extent, so as to prevent the width of the distal clip 50 from being too narrow and causing damage to the valve leaflets, and also to avoid the valve clip 100 when the width of the distal clip 50 is too wide. The effect on valve leaflet movement. The width of the distal clip 50, that is, the length of the direction perpendicular to the axial direction of the distal clip 50, should be greater than or equal to 2 mm, preferably 4-6 mm.
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9至图12，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，使得一个远端夹片50及近端夹片40的一侧夹持二尖瓣的前叶1a边缘，另一个远端夹片50及近端夹片40的一侧夹持二尖瓣的后叶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11和图12中所示箭头方向为血流方向。如图11中所示，当心脏收缩时，前叶1a与后叶1b收拢，且前叶1a与后叶1b不能正常对合的位置部分或全部位置收拢在一起，二尖瓣开口的面积A变小或二尖瓣能完全闭合，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12中所示，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。The valve clamp 100 provided in this embodiment can be used to reduce or treat "mitral valve regurgitation". Specifically, please refer to Figures 9 to 12 together. 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 a distal clip 50 and a proximal end One side of the clip 40 clamps the edge of the anterior leaflet 1a of the mitral valve, and the other distal clip 50 and one side of the proximal clip 40 clamp the edge of the posterior leaflet 1b of the mitral valve, so that the mitral valve The positions of the anterior lobe 1a and the posterior lobe 1b that cannot be normally aligned are clamped together, and the arrow direction shown in Fig. 11 and Fig. 12 is the blood flow direction. As shown in Figure 11, when the heart contracts, the anterior leaflet 1a and the posterior leaflet 1b are folded, and the positions where the anterior leaflet 1a and the posterior leaflet 1b cannot align properly are partially or completely folded together. The area of the mitral valve opening is A When the mitral valve becomes smaller or the mitral valve can be completely closed, only a small amount of blood regurgitates from the opening of the mitral valve into the left atrium, which can reduce or treat "mitral valve regurgitation." As shown in Figure 12, when the heart is in diastole, the anterior leaflet 1a and the posterior leaflet 1b are only aligned at the position B where the valve clamp 100 is clamped. The other positions of the anterior leaflet 1a and the posterior leaflet 1b are still in normal diastole. This allows blood to enter the left ventricle from the left atrium, thereby ensuring the normal circulation of blood.
请一并参阅图3及图13，本申请中，为便于对二尖瓣进行二次修复，瓣膜夹合器100的主体部130的远端设置有回收部150，回收部150用于与捕获装置210连接以通过介入方式回收瓣膜夹合器100。Please refer to FIGS. 3 and 13 together. In this application, in order to facilitate the secondary repair of the mitral valve, the distal end of the main body 130 of the valve clamp 100 is provided with a recovery part 150, which is used for capturing The device 210 is connected to recover the valve clamp 100 by intervention.
本实施例中，每一连杆60的远端设置回收部150，回收部150为设置于每一连杆60的外侧面 的凹槽。具体的，连杆60包括转动连接于远端夹片50的连接部62、自连接部62的远端向瓣膜夹合器100的中心线方向倾斜延伸的延伸条64，以及设置于延伸条64远端外侧的凸片66。延伸条64与凸片66围成所述凹槽。具体的，凹槽位于连杆60的外侧面的远端，所述凹槽近端的表面至瓣膜夹合器100的中心线的距离大于所述凹槽远端的表面至瓣膜夹合器100的中心线的距离，从而形成远端向瓣膜夹合器100的中心线倾斜的凹槽。In this embodiment, the distal end of each connecting rod 60 is provided with a recovery part 150, and the recovery part 150 is a groove provided on the outer surface of each connecting rod 60. Specifically, the connecting rod 60 includes a connecting portion 62 rotatably connected to the distal clip 50, an extension bar 64 extending obliquely from the distal end of the connecting portion 62 in the direction of the centerline of the valve clamp 100, and the extension bar 64. The tab 66 outside the distal end. The extension bar 64 and the protrusion 66 enclose the groove. Specifically, the groove is located at the distal end of the outer side of the connecting rod 60, and the distance from the surface of the proximal end of the groove to the centerline of the valve clamp 100 is greater than the surface of the distal end of the groove to the valve clamp 100 The distance between the centerline of the valve clamper 100 and the centerline of the valve clamper 100 are thus formed.
如图13中所示，捕获装置210包括具有一定轴向长度的捕获导管212及设置于捕获导管212远端的捕获器214，捕获器214用于与回收部150可拆卸连接，以捕获瓣膜夹合器100。具体的，本实施例中，捕获器214为鹅颈圈套器，通过将鹅颈圈套器套接于相对设置的两个连杆60的凹槽上，使得回收部150与捕获装置210连接，从而捕获瓣膜夹合器100，当瓣膜夹合器100从瓣膜上切除后，即可将其回收。As shown in FIG. 13, the capture device 210 includes a capture catheter 212 with a certain axial length and a capture device 214 disposed at the distal end of the capture catheter 212. The capture device 214 is used to detachably connect with the recovery part 150 to capture the valve clip.合器100。 Combination 100. Specifically, in this embodiment, the catcher 214 is a gooseneck snare, and the gooseneck snare is sleeved on the grooves of two opposite connecting rods 60, so that the recovery part 150 is connected to the catching device 210, thereby The valve clamp 100 is captured, and when the valve clamp 100 is cut from the valve, it can be recovered.
为使鹅颈圈套器能稳定地套接于凹槽内而不脱落，优选的，瓣膜夹合器100在凹槽处的最小外径与瓣膜夹合器100邻近凹槽的远端部分的外径之比的范围为0.5-0.95。In order to enable the gooseneck snare to be stably sleeved in the groove without falling off, preferably, the minimum outer diameter of the valve clamp 100 at the groove is the same as the outer diameter of the valve clamp 100 adjacent to the distal end of the groove. The range of diameter ratio is 0.5-0.95.
在其他实施例中，回收部150可以是凸设于每一连杆60的外侧面的凸起，具体的，凸起相对于连杆60的外侧面向外凸起的距离自近端向远端方向逐渐减小，捕获装置210的鹅颈圈套器套接于相对设置的两个连杆60的凸起上而与回收部150连接。同样的，为使鹅颈圈套器稳定地套接于凹槽内而不脱落，优选的，瓣膜夹合器100在凸起处的最大外径与瓣膜夹合器100邻近凸起的近端部位的外径之比的范围为1.05-1.25。In other embodiments, the recovery portion 150 may be a protrusion protruding from the outer surface of each connecting rod 60. Specifically, the distance between the protrusion and the outer surface of the connecting rod 60 is from the proximal end to the distal end. The direction gradually decreases, and the gooseneck snare of the capture device 210 is sleeved on the protrusions of the two connecting rods 60 arranged opposite to each other to connect with the recovery part 150. Similarly, in order for the gooseneck snare to be stably sleeved in the groove without falling off, preferably, the maximum outer diameter of the valve clamp 100 at the protrusion is the same as the proximal part of the valve clamp 100 adjacent to the protrusion The range of the ratio of the outer diameter is 1.05-1.25.
进一步的，请参阅图3和图4，瓣膜夹合器100还包括隔离部170，隔离部170设置于主体部130与回收部150之间，回收部150及隔离部170上至少部分施加抗细胞增殖药物涂层或包覆隔离层，以避免回收部150被内皮细胞完全爬覆，从而保证捕获装置210能与回收部150连接，以便于回收瓣膜夹合器100。Further, referring to FIGS. 3 and 4, the valve clamp 100 further includes an isolation portion 170, which is disposed between the main body portion 130 and the recovery portion 150, and the recovery portion 150 and the isolation portion 170 are at least partially applied anti-cell The proliferation drug coating or the isolation layer is used to prevent the recovery part 150 from being completely covered by endothelial cells, so as to ensure that the capturing device 210 can be connected with the recovery part 150 to facilitate the recovery of the valve clamp 100.
具体的，本实施例中，隔离部170设置于每一连杆60的外侧面及相对的两侧面邻近回收部150的近端的部分，即连接部62远端邻近延伸条64的部分。隔离部170的整个区域施加抗细胞增殖药物涂层，抗细胞增殖药物选自雷帕霉素及其衍生物、紫杉醇及其衍生物中的至少一种。Specifically, in this embodiment, the isolation portion 170 is disposed on the outer side surface and the opposite sides of each connecting rod 60 adjacent to the proximal end of the recovery portion 150, that is, the distal end of the connecting portion 62 adjacent to the extension bar 64. The entire area of the isolation portion 170 is coated with an anti-cell proliferation drug, and the anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives.
其中，隔离部170沿轴向延伸的覆盖范围为5-10mm。Wherein, the coverage area of the spacer 170 extending in the axial direction is 5-10 mm.
在其他实施例中，隔离部170的整个区域可以包覆隔离层以防止内皮增长，所述隔离层为生物相容性的高分子材料制成的套管或涂层，高分子材料选自PET、聚酯、硅树脂、PTFE、硅胶或尿烷中的至少一种。In other embodiments, the entire area of the isolation portion 170 may be covered with an isolation layer to prevent endothelial growth. The isolation layer is a sleeve or coating made of a biocompatible polymer material, and the polymer material is selected from PET. , At least one of polyester, silicone, PTFE, silica gel or urethane.
在其他实施例中，隔离部170可以只在部分区域施加抗细胞增殖药物涂层或包覆隔离层，例如，只在隔离部170位于每一连杆60的外侧面邻近回收部150的近端的部分区域施加抗细胞增殖药物涂层或包覆隔离层，只要能阻止内皮细胞完全爬覆回收部150即可。In other embodiments, the isolation portion 170 may only apply an anti-cell proliferation drug coating or a coating isolation layer on a part of the area, for example, only when the isolation portion 170 is located on the outer side of each link 60 adjacent to the proximal end of the recovery portion 150 Anti-cell proliferation drug coating or coating isolation layer is applied to some areas of, as long as it can prevent endothelial cells from completely crawling over the recovery part 150.
在其他实施例中，回收部150也可以施加抗细胞增殖药物涂层或包覆隔离层以阻止内皮细胞完全爬覆回收部150。In other embodiments, the recovery part 150 may also be coated with an anti-cell proliferation drug coating or coated with an isolation layer to prevent endothelial cells from completely crawling over the recovery part 150.
在其他实施例中，瓣膜夹合器100的连接座10邻近回收部150的远端的部分也可以设置为隔离部170。In other embodiments, the portion of the connecting seat 10 of the valve clamp 100 adjacent to the distal end of the recovery portion 150 may also be provided as the isolation portion 170.
可以理解的是，抗细胞增殖药物涂层或隔离层的厚度应避免影响瓣膜夹合器100的整体外径，以利于瓣膜夹合器100在患者体内输送。It is understandable that the thickness of the anti-cell proliferation drug coating or isolation layer should avoid affecting the overall outer diameter of the valve clamp 100 to facilitate the delivery of the valve clamp 100 in the patient.
请一并参阅图13及图14，本申请还提供一种瓣膜夹合器回收***200，用于回收前述的瓣膜夹合器100。具体的，瓣膜夹合器回收***200包括捕获装置210及切割装置230。切割装置230用于切割瓣膜与瓣膜夹合器100接触的位置，以切除瓣膜夹合器100。如前所述，捕获装置210通过远端的捕获器214与瓣膜夹合器100的回收部150可拆卸连接，以捕获瓣膜夹合器100。具体的，本实施例中，捕获器214为鹅颈圈套器，瓣膜夹合器100的回收部150为设置于每一连杆60的外侧面的凹槽，鹅颈圈套器套接于凹槽内而捕获瓣膜夹合器100。在其他实施例中，捕获器214可以是三叶圈套器、血管异物抓捕器、套扎器、卡爪、磁性接头等其他形式。Please refer to FIGS. 13 and 14 together. The present application also provides a valve clamp recovery system 200 for recovering the aforementioned valve clamp 100. Specifically, the valve clamp recovery system 200 includes a capturing device 210 and a cutting device 230. The cutting device 230 is used to cut the position where the valve contacts the valve clamp 100 to cut the valve clamp 100. As described above, the capture device 210 is detachably connected to the recovery part 150 of the valve clamp 100 through the capture device 214 at the distal end to capture the valve clamp 100. Specifically, in this embodiment, the catcher 214 is a gooseneck snare, the recovery part 150 of the valve clamp 100 is a groove provided on the outer surface of each connecting rod 60, and the gooseneck snare is sleeved in the groove The valve clamp 100 is captured inside. In other embodiments, the catcher 214 may be a three-leaf snare, a vascular foreign body catcher, a ligator, a claw, a magnetic joint, and other forms.
其中，切割装置230的切割方式采用机械切割或电刀切割中的至少一种。电刀选自射频电刀、高频电刀、超声手术刀、等离子手术刀、激光手术刀或低温冷冻手术刀中的至少一种。Wherein, the cutting method of the cutting device 230 adopts at least one of mechanical cutting or electric knife cutting. The electric knife is selected from at least one of radio frequency electric knife, high frequency electric knife, ultrasonic scalpel, plasma scalpel, laser scalpel, or cryogenic scalpel.
其中，机械切割的方式是指采用外科手术器械直接切割，例如对合的剪刀式或单独设置的柳叶刀、活检钳等形式。本实施例中，采用机械切割方式，切割装置230的远端设置有可相对对合的两个刀刃231。刀刃231为金属材料制成，具有可显影性，以利于操作者实时观察并切割瓣膜。Among them, the method of mechanical cutting refers to direct cutting with surgical instruments, such as inverted scissors or separately provided lancets, biopsy forceps, etc. In this embodiment, a mechanical cutting method is adopted, and the distal end of the cutting device 230 is provided with two blades 231 that can be opposed to each other. The blade 231 is made of metal material and has visual properties to facilitate the operator to observe and cut the valve in real time.
在其他实施例中，切割装置230的远端的外周面可以周向设置导电部，导电部在与瓣膜接触的表面导电，以实现电刀切割瓣膜。具体的，以射频电刀为例，导电部包括裸露的金属或金属电极。为了保证安全性，切割装置230除导电部以外的其余部分的外表面绝缘，绝缘的方式可以是涂覆绝缘涂层或设置绝缘体。为了进一步保证安全性，当采用电刀切割的方式时，切割装置230还可以设置与导电部电连接的温度传感器，温度传感器与瓣膜接触以指示瓣膜与导电部接触的部分的局部温度，从而可防止瓣膜局部温度过高造成损伤。In other embodiments, the outer peripheral surface of the distal end of the cutting device 230 may be provided with a conductive portion in the circumferential direction, and the conductive portion is conductive on the surface in contact with the valve, so as to realize the electrosurgical cutting of the valve. Specifically, taking the radio frequency electrosurgical unit as an example, the conductive part includes a bare metal or metal electrode. In order to ensure safety, the outer surface of the remaining part of the cutting device 230 except for the conductive part is insulated. The method of insulation may be to coat an insulating coating or provide an insulator. In order to further ensure safety, when the electrosurgical cutting method is adopted, the cutting device 230 may also be provided with a temperature sensor electrically connected to the conductive part. The temperature sensor contacts the valve to indicate the local temperature of the part where the valve contacts the conductive part, thereby Prevent damage caused by excessively high local temperature of the valve.
优选的，切割装置230的远端设置至少一显影部，操作者可以根据显影部的位置调整切割装置230的远端位置，从而准确切割在瓣膜与瓣膜夹合器100接触的位置。Preferably, the distal end of the cutting device 230 is provided with at least one developing part, and the operator can adjust the position of the distal end of the cutting device 230 according to the position of the developing part, so as to accurately cut the position where the valve contacts the valve clamp 100.
其中，显影部可以是显影丝、显影点或显影片等形式。显影部采用耐腐蚀强、生物相容性好的显影材料制成，例如金、铂、钽、锇、铼、钨、铱、铑等材料或这些金属的合金或复合物。本实施例中，显影部是含钽的镍钛合金金属片，该金属片贴设于切割装置230远端管体上。Among them, the developing part can be in the form of developing wire, developing dot or developing film. The developing part is made of developing materials with strong corrosion resistance and good biocompatibility, such as gold, platinum, tantalum, osmium, rhenium, tungsten, iridium, rhodium and other materials or alloys or composites of these metals. In this embodiment, the developing part is a nickel-titanium alloy metal sheet containing tantalum, and the metal sheet is attached to the distal tube body of the cutting device 230.
如图14中所示，瓣膜夹合器回收***200还包括移除装置250，移除装置250用于将被切除的瓣膜夹合器100移除至患者体外。具体的，移除装置250包括定位件251，定位件251活动地设置于移除装置250的远端。定位件251包括可径向收缩及膨胀的弹性框架，当定位件251从移除装置250的远端伸出后，弹性框架膨胀展开并承托在瓣膜下方，以减小瓣膜的搏动幅度，从而利于切除装置230对瓣膜的切除。而且，定位件251可以用于容纳切除后的瓣膜夹合器100，并使瓣膜夹合器100随定位件251收容至移除装置250中。As shown in FIG. 14, the valve clamp recovery system 200 further includes a removal device 250 for removing the resected valve clamp 100 outside the patient's body. Specifically, the removal device 250 includes a positioning member 251, and the positioning member 251 is movably disposed at the distal end of the removal device 250. The positioning member 251 includes an elastic frame that can be radially contracted and expanded. When the positioning member 251 extends from the distal end of the removal device 250, the elastic frame expands and expands and supports under the valve to reduce the pulsation amplitude of the valve, thereby This facilitates the removal of the valve by the removal device 230. Moreover, the positioning member 251 can be used to accommodate the valve clamp 100 after resection, and the valve clamp 100 can be accommodated in the removal device 250 along with the positioning member 251.
其中，定位件251的弹性框架的径向尺寸自远端开口处向近端方向逐渐减小，即，定位件251为杯形、笼形或漏斗形。本实施例中，定位件251呈杯形。Wherein, the radial dimension of the elastic frame of the positioning member 251 gradually decreases from the distal opening to the proximal direction, that is, the positioning member 251 is cup-shaped, cage-shaped or funnel-shaped. In this embodiment, the positioning member 251 is cup-shaped.
进一步的，定位件251的远端开口设置调节机构，该调节机构包括至少一根控制线，至少一根控制线用于调节定位件251的远端开口的径向尺寸。具体的，控制线同时穿过定位件251的远端周向上的不同位置，通过控制穿过定位件251周向不同位置的控制线的长度以调节定位件251的远端开口的尺寸，由此，当切除后的瓣膜夹合器100和瓣膜组织落入杯形的定位件251中，操作者可通过拉紧控制线，使得定位件251的远端开口收紧而将瓣膜夹合器100包裹住，防止瓣膜夹合器100脱落，以利于将瓣膜夹合器100回收。Further, an adjustment mechanism is provided at the distal opening of the positioning member 251, and the adjustment mechanism includes at least one control wire, and the at least one control wire is used to adjust the radial size of the distal opening of the positioning member 251. Specifically, the control wire passes through different positions of the distal end of the positioning member 251 in the circumferential direction at the same time, and the size of the distal opening of the positioning member 251 is adjusted by controlling the length of the control wire passing through the different positions of the positioning member 251 in the circumferential direction. When the resected valve clamp 100 and valve tissue fall into the cup-shaped positioning member 251, the operator can tighten the control wire to tighten the distal opening of the positioning member 251 to wrap the valve clamp 100 To prevent the valve clamp 100 from falling off, so as to facilitate the recovery of the valve clamp 100.
需要说明的是，捕获装置210活动地设置于移除装置250中，并可由定位件251的远端开口伸出以捕获瓣膜夹合器100，在捕获瓣膜夹合器100后，捕获装置210后撤收入移除装置250中，此时，定位件251的远端开口收紧，以防止瓣膜夹合器100脱落。It should be noted that the capture device 210 is movably disposed in the removal device 250, and can be extended from the distal opening of the positioning member 251 to capture the valve clamp 100. After the valve clamp 100 is captured, the capture device 210 When retracted into the removal device 250, at this time, the distal opening of the positioning member 251 is tightened to prevent the valve clamp 100 from falling off.
进一步的，如图14中所示，瓣膜夹合器回收***200还包括引导装置270及可调弯鞘管290，引导装置270可以活动地设置于可调弯鞘管290中也可以依次交替使用，引导装置270及可调弯鞘管290用于建立从患者体外到体内的介入通道。Further, as shown in FIG. 14, the valve clip recovery system 200 further includes a guiding device 270 and an adjustable bend sheath 290. The guide device 270 can be movably arranged in the adjustable bend sheath 290 or used alternately in turn. , The guiding device 270 and the adjustable curved sheath 290 are used to establish an intervention channel from outside the patient to the inside of the body.
其中，引导装置270包括穿刺导丝(图中未示)和圆锥状的扩张器。当建立通道后，穿刺导丝到达瓣膜附近后，操作者可控制穿刺导丝的末端进入左心房越过瓣膜夹合器100，并反向延伸至患者体外，即可通过穿刺导丝向瓣膜夹合器100施加拉力，以减小瓣膜夹合器100的起伏幅度，从而利于捕获装置210与瓣膜夹合器100的回收部150的连接。The guiding device 270 includes a puncture guide wire (not shown in the figure) and a conical dilator. After the channel is established and the puncture guide wire reaches the vicinity of the valve, the operator can control the end of the puncture guide wire to enter the left atrium, cross the valve clamp 100, and extend back to the patient's body, and then the puncture guide wire can be clamped to the valve The device 100 applies a pulling force to reduce the undulation amplitude of the valve clamp 100, thereby facilitating the connection of the capturing device 210 and the recovery part 150 of the valve clamp 100.
其中，可调弯鞘管290、扩张器及穿刺导丝与现有的可调弯鞘管、扩张器及穿刺导丝的结构类似，此处不做赘述。Among them, the adjustable curved sheath 290, dilator and puncture guide wire are similar in structure to the existing adjustable curved sheath, dilator and puncture guide wire, and will not be described here.
可以理解的是，采用相应规格的可调弯鞘管290即可通过相应的介入通道将捕获装置210、切割装置230及移除装置250中的至少一种输送至患者的二尖瓣处。具体的，请一并参阅图15和图16，示意出了本申请的瓣膜夹合器回收***200的不同介入通道。如图15中所示，本实施例中，捕获装置210穿设于移除装置250中并通过可调弯鞘管290a经心尖-左心室的路径到达二尖瓣处，而切除装置230通过可调弯鞘管290b经股静脉-右心房-房间隔-左心房-二尖瓣的路径到达二尖瓣处。如图16中所示，在其他实施例中，捕获装置210及移除装置250可以通过可调弯鞘管290a经股动脉-主动脉弓-主动脉瓣-左心室的路径到达二尖瓣处，而切除装置230可以通过可调弯鞘管290b经颈静脉-房间隔-左心房的途径到达二尖瓣处。It is understandable that at least one of the capturing device 210, the cutting device 230, and the removal device 250 can be delivered to the mitral valve of the patient through the corresponding interventional channel by adopting the adjustable curved sheath 290 of corresponding specifications. Specifically, please refer to FIGS. 15 and 16 together, which illustrate different intervention channels of the valve clip recovery system 200 of the present application. As shown in FIG. 15, in this embodiment, the capturing device 210 is inserted into the removal device 250 and reaches the mitral valve through the apex-left ventricle path through the adjustable curved sheath 290a, and the resection device 230 passes through the The bending sheath 290b reaches the mitral valve through the path of femoral vein-right atrium-atrial septum-left atrium-mitral valve. As shown in FIG. 16, in other embodiments, the capture device 210 and the removal device 250 can reach the mitral valve through the path of the femoral artery-aortic arch-aortic valve-left ventricle through the adjustable curved sheath 290a, and The resection device 230 can reach the mitral valve via the jugular vein-atrial septum-left atrium through the adjustable curved sheath 290b.
当然，在其他实施例中，捕获装置210、切割装置230及移除装置250可以采用相同的路径到达二尖瓣处，从而避免多次穿刺对患者的损伤。Of course, in other embodiments, the capture device 210, the cutting device 230, and the removal device 250 can use the same path to reach the mitral valve, so as to avoid injury to the patient from multiple punctures.
优选的，在一些实施例中，瓣膜夹合器回收***200还包括检测装置，检测装置活动地穿设于可调弯鞘管290中，且可自可调弯鞘管290的远端伸出并进入左心房，以用于实时反馈心脏内的压 力值，从而及时确认“二尖瓣返流”的情况，判断切除是否完成。具体的，检测装置可以是压力传感器。Preferably, in some embodiments, the valve holder recovery system 200 further includes a detection device, which is movably inserted in the adjustable bend sheath 290 and can extend from the distal end of the adjustable bend sheath 290 And enter the left atrium for real-time feedback of the pressure value in the heart, so as to confirm the "Mitral regurgitation" situation in time and determine whether the resection is complete. Specifically, the detection device may be a pressure sensor.
以下以本申请第一实施例的瓣膜夹合器100的回收过程为例，说明本申请提供的瓣膜夹合器回收***200的使用步骤，如图16至图18所示：The following takes the recovery process of the valve clamp 100 of the first embodiment of the present application as an example to illustrate the use steps of the valve clamp recovery system 200 provided in the present application, as shown in FIGS. 16 to 18:
第一步：利用引导装置270和相应规格的可调弯鞘管290分别为回收装置(即捕获装置210及移除装置250)和切割装置230建立介入通道。回收装置的介入路径为经主动脉弓进入左心室，切割装置230的介入路径为经房间隔进入左心房；The first step: using the guiding device 270 and the adjustable curved sheath 290 of corresponding specifications to establish an intervention channel for the recovery device (ie, the capturing device 210 and the removing device 250) and the cutting device 230, respectively. The intervention path of the recovery device is to enter the left ventricle through the aortic arch, and the intervention path of the cutting device 230 is to enter the left atrium through the atrial septum;
第二步：撤出引导装置270，将穿装在一起的移除装置250和捕获装置210通过可调弯鞘管290a推送进入左心室，将切割装置230通过可调弯鞘管290b推送进入左心房，如图16中所示；Step 2: Withdraw the guiding device 270, push the removing device 250 and the capturing device 210 put on together into the left ventricle through the adjustable curved sheath 290a, and push the cutting device 230 into the left ventricle through the adjustable curved sheath 290b The atrium, as shown in Figure 16;
第三步：通过捕获装置210远端的捕获器214与瓣膜夹合器100的回收部150对接，以抓捕瓣膜夹合器100，并保持抓捕状态，如图17中所示；Step 3: Connect the catcher 214 at the distal end of the catching device 210 to the recovery part 150 of the valve clamper 100 to catch the valve clamper 100 and maintain the catching state, as shown in FIG. 17;
第四步：用切割装置230的两个刀刃231分别切割瓣膜夹合器100在前叶和后叶上的附着连接点，从而自瓣膜上切除瓣膜夹合器100，如图18中所示；Step 4: Use the two blades 231 of the cutting device 230 to respectively cut the attachment points of the valve clamp 100 on the anterior and posterior leaflets, thereby cutting the valve clamp 100 from the valve, as shown in FIG. 18;
第五步：将捕获装置210后撤进入移除装置250中，以将被切除的瓣膜夹合器100收入到移除装置250中；Step 5: Withdraw the capture device 210 into the removal device 250, so as to receive the resected valve clamp 100 into the removal device 250;
第六步：通过相应的可调弯鞘管290撤出切割装置230、移除装置250和收容在移除装置250中的捕获装置210及瓣膜夹合器100；最后撤出可调弯鞘管290，完成手术。Step 6: Withdraw the cutting device 230, the removal device 250, the capture device 210 and the valve clamp 100 contained in the removal device 250 through the corresponding adjustable curved sheath 290; finally withdraw the adjustable curved sheath 290, complete the operation.
可选地，第一步完成后，还可以将引导装置270的穿刺导丝的末端越过瓣膜夹合器100，并反向延伸至患者体外。由此，通过穿刺导丝在瓣膜夹合器100上施加拉力，以减小随着瓣叶搏动的瓣膜夹合器100的起伏幅度，从而利于捕获装置210与瓣膜夹合器100的回收部150的对接。Optionally, after the first step is completed, the end of the puncture guide wire of the guiding device 270 can also be passed over the valve clamp 100 and extend back to the outside of the patient. Therefore, a pulling force is applied to the valve clamp 100 through the puncture guide wire to reduce the undulation amplitude of the valve clamp 100 following the pulsation of the valve leaflets, thereby facilitating the capture device 210 and the recovery part 150 of the valve clamp 100 The docking.
在第五步完成后，操作者可以在撤出切割装置230、移除装置250、捕获装置210及瓣膜夹合器100后，将可调弯鞘管290暂时留置在患者体内，从而通过该介入通道进行二次介入修复手术，例如植入人工心脏瓣膜。After the fifth step is completed, the operator can withdraw the cutting device 230, the removal device 250, the capture device 210, and the valve clamp 100, and then temporarily place the adjustable bend sheath 290 in the patient's body to pass the intervention The channel undergoes secondary interventional repair operations, such as implantation of artificial heart valves.
需要说明的是，捕获装置210、切割装置230、移除装置250、引导装置270及可调弯鞘管290分别具有靠近操作者的操作手柄，操作者通过相应的操作手柄以控制相应的装置实现抓捕、切割、调弯等动作，具体的，此处不做赘述。It should be noted that the capture device 210, the cutting device 230, the removal device 250, the guiding device 270, and the adjustable bend sheath 290 have operating handles close to the operator, and the operator can control the corresponding device through the corresponding operating handles. Actions such as catching, cutting, and bending are not detailed here.
请一并参阅图19及图20，本申请第二实施例提供的瓣膜夹合器100b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，回收部150b设置于连接座10b上，具体的，回收部150b为凸设于连接座10b的至少一第一表面11上的至少一挂钩。本实施例中，连接座10b的每一第一表面11上均凸设有一挂钩。在回收瓣膜夹合器100b时，根据瓣膜夹合器100b的位置及内皮爬覆情况，操作者可以将捕获装置210的捕获器214套接于一个挂钩上以实现单侧抓捕，也可以将捕获器214套接于两个挂钩上以实现双侧同时抓捕。本实施例中，捕获器214为鹅颈圈套器。Please refer to FIGS. 19 and 20 together. The structure of the valve clamp 100b provided by the second embodiment of the present application is similar to the structure of the valve clamp 100 of the first embodiment. The difference is that: in the second embodiment Wherein, the recovery portion 150b is disposed on the connection base 10b. Specifically, the recovery portion 150b is at least one hook protruding from at least one first surface 11 of the connection base 10b. In this embodiment, a hook is protrudingly provided on each first surface 11 of the connecting base 10b. When recovering the valve clamp 100b, according to the position of the valve clamp 100b and the condition of endothelial creeping, the operator can put the catcher 214 of the catching device 210 on a hook to realize unilateral catching, or The catcher 214 is sleeved on the two hooks to realize simultaneous catching on both sides. In this embodiment, the catcher 214 is a gooseneck snare.
其中，挂钩的形状包括但不限于直角钩、半圆环钩等。本实施例中，挂钩为直角钩。Among them, the shape of the hook includes, but is not limited to, a right-angle hook, a half-circle hook and the like. In this embodiment, the hook is a right-angle hook.
其中，挂钩与连接座10b可以是一体结构，也可以是非一体结构。本实施例中，挂钩与连接座10b是一体成型的。在其他实施例中，挂钩可以单独成型并通过焊接等方式固定于连接座10b的第一表面11。Wherein, the hook and the connecting seat 10b may be an integral structure or a non-integral structure. In this embodiment, the hook and the connecting seat 10b are integrally formed. In other embodiments, the hook may be separately formed and fixed to the first surface 11 of the connection base 10b by welding or the like.
进一步优选的，本实施例中，两个挂钩关于连接座10b的中心轴呈对称设置。当捕获装置210的圈套器套接于两个挂钩上时，瓣膜接合器100b受到的抓捕力始终在其质心线上，使得瓣膜夹合器100b更容易进入移除装置中，提高手术效率。Further preferably, in this embodiment, the two hooks are arranged symmetrically about the central axis of the connecting seat 10b. When the snare of the capture device 210 is sleeved on the two hooks, the grasping force received by the valve adapter 100b is always on the center of mass line, so that the valve clamp 100b can enter the removal device more easily, and the operation efficiency is improved.
可以理解的是，挂钩相对于连接座10b的第一表面11向外凸出的距离应避免影响瓣膜夹合器100b的整体外径，以利于在患者体内输送。It can be understood that the distance that the hook protrudes from the first surface 11 of the connecting seat 10b should avoid affecting the overall outer diameter of the valve clamp 100b, so as to facilitate delivery in the patient.
进一步的，与第一实施例不同的是，在第二实施例中，瓣膜夹合器100b的隔离部170b设置于连接座10b上。具体的，隔离部170b可以只设置于连接座10b的第一表面11，也可以设置于整个连接座10b，即，隔离部170b至少设置于连接座10b邻近挂钩的部分。本实施例中，隔离部170b设置于整个连接座10b的外表面上。Further, different from the first embodiment, in the second embodiment, the isolation portion 170b of the valve clamp 100b is disposed on the connecting seat 10b. Specifically, the isolating portion 170b may be provided only on the first surface 11 of the connecting base 10b, or may be provided on the entire connecting base 10b, that is, the isolating portion 170b is provided at least at the portion of the connecting base 10b adjacent to the hook. In this embodiment, the isolation portion 170b is disposed on the outer surface of the entire connecting base 10b.
请一并参阅图21及图22，本申请第三实施例提供的瓣膜夹合器100c的结构与第二实施例的瓣膜夹合器100b的结构相似，不同之处在于：在第三实施例中，回收部150c为开设于连接座10c并穿通两个第一表面11的通孔。本实施例中，捕获装置210c的捕获器214c为一对卡爪，通过将一 对卡爪***通孔的两端以回收瓣膜夹合器100c。优选的，通孔开设于连接座10c的中间位置，以使瓣膜接合器100c受到的抓捕力始终在其质心线上，使得瓣膜夹合器100c更容易进入移除装置中，提高手术效率。此外，本实施例中，连接座10c开设通孔，还能够减轻瓣膜夹合器100c的重量，以避免过重的瓣膜夹合器100c长时间坠于瓣膜下方将瓣膜拉伤。Please refer to FIG. 21 and FIG. 22 together. 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 100b of the second embodiment. The difference is that: in the third embodiment Among them, the recovery portion 150c is a through hole opened in the connecting seat 10c and passing through the two first surfaces 11. In this embodiment, the catcher 214c of the catching device 210c is a pair of claws, and the valve clamp 100c is recovered by inserting a pair of claws into both ends of the through hole. Preferably, the through hole is opened in the middle position of the connecting seat 10c, so that the grasping force received by the valve adaptor 100c is always on its center of mass line, so that the valve clamp 100c can enter the removal device more easily, and the operation efficiency is improved. In addition, in this embodiment, the connecting seat 10c is provided with a through hole, which can also reduce the weight of the valve clamp 100c, so as to prevent the excessively heavy valve clamp 100c from falling under the valve for a long time and straining the valve.
其中，为了减小捕获装置210c的外径，一对卡爪的近端交错设置。Wherein, in order to reduce the outer diameter of the capturing device 210c, the proximal ends of a pair of jaws are staggered.
可以理解的是，在其他实施例中，回收部150c可以是开设于连接座10c的至少一第一表面11上的至少一盲孔，捕获装置210c的卡爪***盲孔内以回收瓣膜夹合器100c。优选的，连接座10c相对的两个第一表面11分别开设一盲孔，且两个盲孔关于连接座10c的中心轴呈对称设置，以使瓣膜接合器100c受到的抓捕力始终在其质心线上。进一步的，盲孔内可以设置用于辅助连接捕获装置210c的卡爪的辅助件，具体的，辅助件可以是磁吸片，磁性片能吸附卡爪以防止卡爪从盲孔中脱落。It can be understood that, in other embodiments, the recovery portion 150c may be at least one blind hole opened on at least one first surface 11 of the connecting seat 10c, and the claw of the capturing device 210c is inserted into the blind hole to recover the valve clamp.器100c. Preferably, the two opposite first surfaces 11 of the connecting seat 10c are respectively provided with a blind hole, and the two blind holes are arranged symmetrically with respect to the central axis of the connecting seat 10c, so that the grasping force received by the valve adapter 100c is always at its The centroid line. Further, an auxiliary member for assisting the connection of the claws of the capture device 210c may be arranged in the blind hole. Specifically, the auxiliary member may be a magnetic sheet, which can attract the claw to prevent the claw from falling out of the blind hole.
请参阅图23，本申请第四实施例提供的瓣膜夹合器100d的结构与第二实施例的瓣膜夹合器100b的结构相似，不同之处在于：在第四实施例中，回收部150d为设置于连接座10d的第二表面12上的至少一倒钩或至少一环状体。本实施例中，回收部150d为相对于第二表面12向外凸起的一倒钩，捕获装置210d的捕获器214d是抓捕环，通过将捕获装置210d的抓捕环勾挂于倒钩上以回收瓣膜夹合器100d。Referring to FIG. 23, the structure of the valve clamp 100d provided in the fourth embodiment of the present application is similar to the structure of the valve clamp 100b of the second embodiment, except that: in the fourth embodiment, the recovery part 150d It is at least one barb or at least one ring body disposed on the second surface 12 of the connecting seat 10d. In this embodiment, the recovery portion 150d is a barb protruding outward with respect to the second surface 12, and the catcher 214d of the catching device 210d is a catching ring, and the catching ring of the catching device 210d is hooked on the barb To recover the valve clamp 100d.
其中，倒钩的形状包括但不限于直角钩、半圆环钩等。本实施例中，倒钩为半圆环钩。Among them, the shape of the barb includes, but is not limited to, a right-angled hook, a half-circle hook, etc. In this embodiment, the barb is a half-circle hook.
其中，倒钩设置于瓣膜夹合器100d的轴线位置，当捕获装置210d的抓捕环勾挂于倒钩上时，瓣膜接合器100d受到的抓捕力始终在其质心线上，使得瓣膜夹合器100d更容易进入移除装置中，提高手术效率。Wherein, the barb is arranged at the axial position of the valve clamp 100d. When the catch ring of the capturing device 210d is hooked on the barb, the catching force received by the valve adapter 100d is always on its centroid line, making the valve clamp The combiner 100d is easier to enter the removal device, which improves the efficiency of the operation.
在其他实施例中，倒钩可以设置为两个，捕获装置210d的抓捕环同时勾挂于两个倒钩上，从而，当捕获装置210d的抓捕环从其中一个倒钩上脱落时，抓捕环仍勾挂于另一个倒钩上，以保证捕获装置210d与瓣膜夹合器100d的回收部150d保持连接。同样的，两个倒钩关于连接座10d对称设置，以使瓣膜夹合器100d受到的抓捕力始终在其质心线上。In other embodiments, the number of barbs may be two, and the catch ring of the catch device 210d is hooked on the two barbs at the same time, so that when the catch ring of the catch device 210d falls off one of the barbs, The catching ring is still hooked on the other barb to ensure that the catching device 210d remains connected to the recovery part 150d of the valve clamp 100d. Similarly, the two barbs are arranged symmetrically with respect to the connecting seat 10d, so that the grasping force received by the valve clipper 100d is always on its center of mass line.
在其他实施例中，回收部150d可以是至少一个生物相容性的金属或高分子材料制成的环状体，捕获装置210d的捕获器214d相应的设置为卡爪，通过将捕获装置210d的卡爪***至少一环状体内以回收瓣膜夹合器100d。In other embodiments, the recovery part 150d may be at least one circular body made of biocompatible metal or polymer material, and the capture device 214d of the capture device 210d is correspondingly set as a claw. The claw is inserted into at least one annular body to recover the valve clamp 100d.
请一并参阅图24及图25，本申请第五实施例提供的瓣膜夹合器100e的结构与第四实施例的瓣膜夹合器100d的结构相似，不同之处在于：在第五实施例中，回收部150e为开设于连接座10e的第二表面12上的连接孔，连接孔内设置有用于与捕获装置210e对接的连接件。本实施例中，连接孔为开设于第二表面12中间位置的盲孔153e，盲孔153e内设置有磁性件。本实施例中，捕获装置210e的捕获器为磁性导管接头214e。将磁性导管接头214e对接于连接孔内，即可实现捕获装置210e与瓣膜夹合器100e的磁力对接。Please refer to FIGS. 24 and 25 together. The structure of the valve clamp 100e provided by the fifth embodiment of the present application is similar to the structure of the valve clamp 100d of the fourth embodiment, except that: in the fifth embodiment Among them, the recovery portion 150e is a connecting hole opened on the second surface 12 of the connecting seat 10e, and a connecting piece for docking with the capturing device 210e is provided in the connecting hole. In this embodiment, the connecting hole is a blind hole 153e opened in the middle of the second surface 12, and a magnetic member is arranged in the blind hole 153e. In this embodiment, the capture device of the capture device 210e is a magnetic conduit connector 214e. The magnetic catheter connector 214e is docked in the connecting hole to realize the magnetic docking of the capture device 210e and the valve clamp 100e.
其中，磁性件可以是设置于盲孔153e内的磁性垫片。Wherein, the magnetic member may be a magnetic gasket arranged in the blind hole 153e.
进一步的，为了提高连接可靠性，在盲孔153e的中心设置螺纹件，用于与捕获装置210e螺接固定。本实施例中，螺纹件为开设于连接孔内底的螺纹孔155e，捕获装置210e的远端设置有螺纹接头216e，螺纹接头216e活动地设置于磁性导管接头214e中。当捕获装置210e的磁性导管接头214e与连接座10e上的盲孔153e磁性对接后，可将螺纹接头216e伸出磁性导管接头214e并与盲孔153e内的螺纹孔155e螺接，从而将捕获装置210e与瓣膜夹合器100e螺接并锁定。Further, in order to improve connection reliability, a threaded member is provided in the center of the blind hole 153e for screwing and fixing with the capturing device 210e. In this embodiment, the threaded member is a threaded hole 155e opened in the inner bottom of the connecting hole, the distal end of the capture device 210e is provided with a threaded joint 216e, and the threaded joint 216e is movably arranged in the magnetic catheter joint 214e. After the magnetic conduit connector 214e of the capture device 210e is magnetically connected to the blind hole 153e on the connecting seat 10e, the threaded connector 216e can be extended out of the magnetic conduit connector 214e and screwed to the threaded hole 155e in the blind hole 153e, thereby connecting the capture device 210e is screwed and locked with the valve clamp 100e.
在其他实施例中，螺纹件可以是凸设于连接孔内的螺柱，捕获装置210e的远端设置带内螺纹的连接管，该连接管活动地设置于磁性导管接头中并可伸出而与连接孔内的螺柱螺接。In other embodiments, the threaded member may be a stud protruding from the connecting hole, and the distal end of the capturing device 210e is provided with a connecting tube with internal threads. The connecting tube is movably arranged in the magnetic catheter joint and can be extended. Screwed with the stud in the connecting hole.
在其他实施例中，磁性导管接头214e可以设置于移除装置250e的远端，或螺纹接头216e设置于移除装置250e的远端。In other embodiments, the magnetic catheter connector 214e may be provided at the distal end of the removal device 250e, or the threaded connector 216e may be provided at the distal end of the removal device 250e.
当然，在其他实施例中，连接孔可以只设置磁性件或螺纹件。Of course, in other embodiments, the connecting hole may only be provided with a magnetic member or a screw member.
请参阅图26，本申请第六实施例提供的瓣膜夹合器100f的结构与第一实施例的瓣膜夹合器100的结构基本相似，不同之处在于：在第六实施例中，主体部的远端设置有用于与捕获装置210f的卡爪214f连接的通槽，通槽沿垂直于瓣膜夹合器100f的轴向的方向延伸，通槽形成回收部150f。Referring to FIG. 26, the structure of the valve clamp 100f provided by the sixth embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the sixth embodiment, the main body A through groove for connecting with the claw 214f of the capture device 210f is provided at the distal end of the valve. The through groove extends in a direction perpendicular to the axial direction of the valve clamp 100f, and the through groove forms a recovery portion 15Of.
具体的，本实施例中，每一远端夹片50f的连接段51f镂空，每一远端夹片50f的连接段51f包括两个连接片，每一连接片开设自远端向近端方向延伸的滑槽，两个远端夹片50f位于连接座10f 同一侧的两个连接片相互层叠，且两个连接片的滑槽连通，一个第一销钉的一端依次穿过两个远端夹片50f位于连接座10f同一侧的两个连接片上的滑槽，再穿过连接座10f上的销钉孔，最后插接于两个远端夹片50f位于连接座10f相对的另一侧的两个连接片上的滑槽中，从而将两个远端夹片50f的连接段51f的远端通过同一个第一销钉活动连接于连接座10f上；每一远端夹片50f的连接段51f的近端开设销钉孔，固定座30f相对的两端开设相应的固定孔，两个第二销钉分别穿过两个远端夹片50f上的销钉孔而插接于固定座30f上相应的固定孔内，从而将两个远端夹片50f的连接段51f的近端分别转动连接于固定座30f相对的两端。此时，连接座10f、固定座30f与两个远端夹片50f位于连接座10f及固定座30f相对的两侧的两组连接片之间即围成所述通槽，所述通槽贯通瓣膜夹合器100f相对的两侧，捕获装置210f的卡爪214f能够***通槽内并抵接于连接座10f的第三表面13上，以回收瓣膜夹合器100f。Specifically, in this embodiment, the connecting section 51f of each distal clip 50f is hollowed out, and the connecting section 51f of each distal clip 50f includes two connecting pieces, and each connecting piece is opened from the distal end to the proximal end. The extended sliding groove, the two distal clips 50f are located on the same side of the connecting seat 10f, the two connecting pieces are stacked on each other, and the sliding grooves of the two connecting pieces are connected, and one end of a first pin passes through the two distal clips in turn The piece 50f is located at the sliding grooves on the two connecting pieces on the same side of the connecting seat 10f, passes through the pin holes on the connecting seat 10f, and finally is inserted into the two distal clips 50f on the opposite side of the connecting seat 10f. In the sliding grooves on the two connecting pieces, the distal ends of the connecting sections 51f of the two distal clips 50f are movably connected to the connecting seat 10f through the same first pin; the connecting section 51f of each distal clip 50f The proximal end is provided with pin holes, the opposite ends of the fixing base 30f are provided with corresponding fixing holes, and the two second pins respectively pass through the pin holes on the two distal clips 50f and are inserted into the corresponding fixing holes on the fixing base 30f. In this way, the proximal ends of the connecting sections 51f of the two distal end clips 50f are respectively rotatably connected to the opposite ends of the fixing base 30f. At this time, the connecting seat 10f, the fixing seat 30f, and the two distal clips 50f are located between the two sets of connecting pieces on the opposite sides of the connecting seat 10f and the fixing seat 30f to form the through groove, and the through groove penetrates On opposite sides of the valve clamp 100f, the claws 214f of the capturing device 210f can be inserted into the through groove and abut against the third surface 13 of the connecting seat 10f to recover the valve clamp 100f.
进一步的，与第一实施例不同的是，在第六实施例中，瓣膜夹合器100f的隔离部170f设置于远端夹片50f的夹持段52f的远端。Further, different from the first embodiment, in the sixth embodiment, the isolation portion 170f of the valve clamp 100f is provided at the distal end of the clamping section 52f of the distal end clip 50f.
请参阅图27，本申请第七实施例提供的瓣膜夹合器100g的结构与第一实施例的瓣膜夹合器100的结构基本相似，不同之处在于：在第七实施例中，瓣膜夹合器100g包括两个可相对叠合的V型夹持件，其中，两个夹持件均固定在固定座30g上，固定座30g的远端设置回收部150g，捕获装置210g的捕获器214g与回收部150g连接以回收瓣膜夹合器100g。Please refer to FIG. 27, the structure of the valve clamp 100g provided by the seventh embodiment of the present application is basically similar to the structure of the valve clamp 100 of the first embodiment, except that: in the seventh embodiment, the valve clamp The combiner 100g includes two relatively superimposable V-shaped clamping members, wherein both of the clamping members are fixed on the fixing base 30g, the distal end of the fixing base 30g is provided with a recovery part 150g, and the catcher 214g of the capturing device 210g Connect with the recovery part 150g to recover 100g of the valve clamp.
具体的，本实施例中，回收部150g为周向开设于固定座30g远端的凹槽，捕获器214g为鹅颈圈套器，通过将圈套器套接于凹槽内以回收瓣膜夹合器100g。Specifically, in this embodiment, the recovery part 150g is a groove opened in the circumferential direction at the distal end of the fixing seat 30g, and the catcher 214g is a gooseneck snare, and the valve clamp is recovered by socketing the snare in the groove 100g.
请参阅图28，可以理解的是，在其他实施例中，回收部150g'可以是凸设于固定座30g'远端的挂钩、倒钩或环状体，也可以是开设于固定座30g'表面上的盲孔、通孔或连接孔，此处不再赘述。Referring to FIG. 28, it can be understood that, in other embodiments, the recovery portion 150g' may be a hook, barb or ring protruding from the distal end of the fixing base 30g', or may be opened on the fixing base 30g' The blind holes, through holes or connecting holes on the surface will not be repeated here.
进一步的，与第一实施例不同的是，在第七实施例中，瓣膜夹合器100g的隔离部170g至少设置于固定座30g邻近回收部150g的部分，本实施例中，隔离部170g设置于整个固定座30g的外表面。Further, different from the first embodiment, in the seventh embodiment, the isolation portion 170g of the valve clamp 100g is provided at least at the portion of the fixing seat 30g adjacent to the recovery portion 150g. In this embodiment, the isolation portion 170g is provided On the outer surface of the entire fixing base 30g.
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构成多个夹钳，每个夹钳分别夹合一片瓣叶即可，此处不做赘述。It should be noted that the above content is described with an example in which a valve clamp is used to reduce or treat "mitral regurgitation". 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 to solve "mitral regurgitation" in the embodiments of this application. The principle and structure of the valve clamp is roughly the same. It only needs to form multiple clamps by multiple sets of proximal and distal clamps, and each clamp can clamp a leaflet separately, which will not be repeated here. .
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。Obviously, in other embodiments, the valve clamp provided in the present application can also be applied to other minimally invasive surgical operations that require more than three pieces of valve tissue to be clamped together.
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。The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims (27)

  1. 一种可回收的瓣膜夹合器，其特征在于，包括主体部及设置于所述主体部远端的回收部，所述回收部用于与捕获装置连接以通过介入方式回收所述瓣膜夹合器。A recoverable valve clamp, which is characterized in that it comprises a main body and a recovery part arranged at the distal end of the main body, and the recovery part is used to connect with a capturing device to recover the valve clamp by intervention Device.
  2. 根据权利要求1所述的瓣膜夹合器，其特征在于，所述主体部包括两个相对设置的连杆，每一所述连杆的远端设置所述回收部，所述回收部为设置于每一所述连杆的外侧面的凹槽或凸设于每一所述连杆的外侧面的凸起。The valve clamp according to claim 1, wherein the main body portion includes two oppositely arranged connecting rods, the distal end of each connecting rod is provided with the recovery part, and the recovery part is arranged A groove on the outer surface of each connecting rod or a protrusion protruding from the outer surface of each connecting rod.
  3. 根据权利要求2所述的瓣膜夹合器，其特征在于，所述瓣膜夹合器在所述凹槽处的最小外径与所述瓣膜夹合器邻近所述凹槽的远端部位的外径之比的范围为0.5-0.95；所述瓣膜夹合器在所述凸起处的最大外径与所述瓣膜夹合器邻近所述凸起的近端部位的外径之比的范围为1.05-1.25。The valve clamp of claim 2, wherein the minimum outer diameter of the valve clamp at the groove is the same as the outer diameter of the valve clamp near the distal end of the groove The range of the diameter ratio is 0.5-0.95; the range of the ratio of the maximum outer diameter of the valve clamp at the protrusion to the outer diameter of the proximal part of the valve clamp adjacent to the protrusion is 1.05-1.25.
  4. 根据权利要求1所述的瓣膜夹合器，其特征在于，所述主体部包括位于远端的连接座，所述回收部设置于所述连接座，所述连接座包括相对的两个第一表面及位于远端的第二表面。The valve clamp according to claim 1, wherein the main body part includes a connecting seat at a distal end, the recovery part is disposed on the connecting seat, and the connecting seat includes two opposite first The surface and the second surface at the distal end.
  5. 根据权利要求4所述的瓣膜夹合器，其特征在于，所述回收部为凸设于至少一所述第一表面或所述第二表面的至少一挂钩、倒钩或环状体。The valve clamp of claim 4, wherein the recovery part is at least one hook, barb or ring protruding on at least one of the first surface or the second surface.
  6. 根据权利要求4所述的瓣膜夹合器，其特征在于，所述回收部为开设于至少一所述第一表面或所述第二表面的至少一盲孔或通孔。The valve clamp of claim 4, wherein the recovery part is at least one blind hole or a through hole opened on at least one of the first surface or the second surface.
  7. 根据权利要求6所述的瓣膜夹合器，其特征在于，所述通孔穿通两个所述第一表面。The valve clamp of claim 6, wherein the through hole penetrates through the two first surfaces.
  8. 根据权利要求6所述的瓣膜夹合器，其特征在于，所述盲孔为开设于所述第二表面的连接孔，所述连接孔内设置用于与所述捕获装置对接的连接件。The valve clamp according to claim 6, wherein the blind hole is a connecting hole opened on the second surface, and a connecting piece for docking with the capturing device is provided in the connecting hole.
  9. 根据权利要求8所述的瓣膜夹合器，其特征在于，所述连接件包括磁性件和/或螺纹件。The valve clamp according to claim 8, wherein the connecting member comprises a magnetic member and/or a screw member.
  10. 根据权利要求5或6所述的瓣膜夹合器，其特征在于，所述回收部的数量为两个，两个所述回收部关于所述连接座的中心轴呈对称设置。The valve clamp according to claim 5 or 6, wherein the number of the recovery parts is two, and the two recovery parts are symmetrically arranged with respect to the central axis of the connecting seat.
  11. 根据权利要求1所述的瓣膜夹合器，其特征在于，所述主体部的远端设置用于与所述捕获装置连接的通槽，所述通槽沿垂直于所述瓣膜夹合器的轴向的方向延伸，所述通槽形成所述回收部。The valve clamp according to claim 1, wherein the distal end of the main body portion is provided with a through groove for connecting with the capture device, and the through groove extends along a vertical direction of the valve clamp. Extending in the axial direction, the through groove forms the recovery part.
  12. 根据权利要求1所述的瓣膜夹合器，其特征在于，所述瓣膜夹合器还包括隔离部，所述隔离部设置于所述主体部与所述回收部之间，所述回收部及所述隔离部上至少部分施加抗细胞增殖药物涂层或包覆隔离层。The valve clamp according to claim 1, wherein the valve clamp further comprises an isolation part, the isolation part is provided between the main body part and the recovery part, the recovery part and An anti-cell proliferation drug coating or a covering isolation layer is at least partially applied to the isolation portion.
  13. 根据权利要求12所述的瓣膜夹合器，其特征在于，所述抗细胞增殖药物选自雷帕霉素及其衍生物、紫杉醇及其衍生物中的至少一种；所述隔离层为生物相容性的高分子材料制成的套管或涂层，所述高分子材料选自PET、聚酯、硅树脂、PTFE、硅胶或尿烷中的至少一种。The valve clamp of claim 12, wherein the anti-cell proliferation drug is selected from at least one of rapamycin and its derivatives, paclitaxel and its derivatives; the isolation layer is a biological A sleeve or coating made of a compatible polymer material, the polymer material is selected from at least one of PET, polyester, silicone, PTFE, silica gel or urethane.
  14. 一种瓣膜夹合器回收***，用于回收权利要求1至13任一项所述的瓣膜夹合器，其特征在于，所述瓣膜夹合器回收***包括捕获装置及切割装置；所述切割装置用于切割瓣膜与所述瓣膜夹合器接触的位置，以切除所述瓣膜夹合器；所述捕获装置的远端与所述瓣膜夹合器的回收部可拆卸连接，以捕获所述瓣膜夹合器。A valve clamp recovery system for recovering the valve clamp according to any one of claims 1 to 13, wherein the valve clamp recovery system includes a capturing device and a cutting device; the cutting The device is used to cut the contact position of the valve and the valve clamp to remove the valve clamp; the distal end of the capture device is detachably connected with the recovery part of the valve clamp to capture the Valve clamp.
  15. 根据权利要求14所述的瓣膜夹合器回收***，其特征在于，所述捕获装置包括捕获导管及设置于所述捕获导管远端的捕获器，所述捕获器用于与所述回收部可拆卸连接。The valve clip recovery system according to claim 14, wherein the capture device comprises a capture catheter and a capture device arranged at the distal end of the capture catheter, and the capture device is used to be detachable from the recovery part connection.
  16. 根据权利要求15所述的瓣膜夹合器回收***，其特征在于，所述捕获器为圈套器、抓捕环、卡爪、磁性接头、螺纹接头中的至少一种。The valve clamp recovery system according to claim 15, wherein the catcher is at least one of a snare, a catch ring, a claw, a magnetic joint, and a threaded joint.
  17. 根据权利要求14所述的瓣膜夹合器回收***，其特征在于，所述切割装置设置至少一显影部，至少一所述显影部设置于所述切割装置的远端。The valve clip recovery system according to claim 14, wherein the cutting device is provided with at least one developing part, and at least one developing part is arranged at the distal end of the cutting device.
  18. 根据权利要求14所述的瓣膜夹合器回收***，其特征在于，所述切割装置的切割方式选自机械切割或电刀切割中的至少一种。The valve clip recovery system according to claim 14, wherein the cutting method of the cutting device is selected from at least one of mechanical cutting or electrosurgical cutting.
  19. 根据权利要求18所述的瓣膜夹合器回收***，其特征在于，所述电刀选自射频电刀、高频电刀、超声手术刀、等离子手术刀、激光手术刀或低温冷冻手术刀中的至少一种。The valve clamp recovery system according to claim 18, wherein the electrosurgical knife is selected from radio frequency electrosurgical knife, high frequency electrosurgical knife, ultrasonic scalpel, plasma scalpel, laser scalpel, or cryogenic scalpel At least one of.
  20. 根据权利要求19所述的瓣膜夹合器回收***，其特征在于，所述切割装置的远端的外周面周向设置导电部，所述导电部在与所述瓣膜接触的表面导电，以电刀切割所述瓣膜。The valve clamp recovery system according to claim 19, wherein the outer peripheral surface of the distal end of the cutting device is provided with a conductive part in the circumferential direction, and the conductive part conducts electricity on the surface in contact with the valve. The knife cuts the valve.
  21. 根据权利要求20所述的瓣膜夹合器回收***，其特征在于，所述切割装置还包括与所述导电部电连接的温度传感器，所述温度传感器与所述瓣膜接触；所述温度传感器用于指示所述瓣膜与所述导电部接触的部分的温度。The valve clamp recovery system according to claim 20, wherein the cutting device further comprises a temperature sensor electrically connected to the conductive part, the temperature sensor being in contact with the valve; the temperature sensor is used for To indicate the temperature of the part of the valve in contact with the conductive part.
  22. 根据权利要求14所述的瓣膜夹合器回收***，其特征在于，所述瓣膜夹合器回收***还 包括移除装置，所述移除装置用于将被切除的所述瓣膜夹合器移除至患者体外。The valve clip recovery system according to claim 14, wherein the valve clip recovery system further comprises a removal device, the removal device is used to move the removed valve clip Except to the patient's body.
  23. 根据权利要求22所述的瓣膜夹合器回收***，其特征在于，所述移除装置包括定位件，所述定位件活动地设置于所述移除装置的远端，所述定位件用于承托所述瓣膜以减小所述瓣膜的搏动幅度。The valve clip recovery system according to claim 22, wherein the removal device comprises a positioning member, the positioning member is movably arranged at the distal end of the removal device, and the positioning member is used for The valve is supported to reduce the pulsation amplitude of the valve.
  24. 根据权利要求23所述的瓣膜夹合器回收***，其特征在于，所述定位件包括可径向收缩及膨胀的弹性框架，当所述定位件从所述移除装置的远端伸出后，所述弹性框架膨胀展开并承托在所述瓣膜下方。The valve clip recovery system according to claim 23, wherein the positioning member comprises an elastic frame that can be radially contracted and expanded, and when the positioning member extends from the distal end of the removal device , The elastic frame is expanded and expanded and supported under the valve.
  25. 根据权利要求24所述的瓣膜夹合器回收***，其特征在于，所述弹性框架的径向尺寸自远端开口处向近端方向逐渐减小。The valve clip recovery system according to claim 24, wherein the radial dimension of the elastic frame gradually decreases from the distal opening to the proximal direction.
  26. 根据权利要求23所述的瓣膜夹合器回收***，其特征在于，所述定位件的远端开口设置调节机构，所述调节机构包括至少一根控制线，至少一根所述控制线用于调节所述定位件的远端开口的径向尺寸。The valve clip recovery system according to claim 23, wherein the distal opening of the positioning member is provided with an adjustment mechanism, and the adjustment mechanism includes at least one control wire, and at least one of the control wires is used for Adjust the radial size of the distal opening of the positioning member.
  27. 根据权利要求14所述的瓣膜夹合器回收***，其特征在于，所述瓣膜夹合器回收***还包括引导装置，所述引导装置用于接近所述瓣膜夹合器，并在越过所述瓣膜夹合器后反向延伸以减小所述瓣膜夹合器的起伏幅度。The valve clip recovery system according to claim 14, wherein the valve clip recovery system further comprises a guiding device, the guiding device is used to approach the valve clip and pass over the The valve clamp is extended backward to reduce the undulation amplitude of the valve clamp.
PCT/CN2020/105970 2019-08-12 2020-07-30 Recoverable valve clamp and valve clamp recovery system WO2021027589A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201921301623.7 2019-08-12
CN201910742196.4 2019-08-12
CN201921301623.7U CN211243911U (en) 2019-08-12 2019-08-12 Recoverable valve clamping device and valve clamping device recovery system
CN201910742196.4A CN112386367A (en) 2019-08-12 2019-08-12 Recoverable valve clamping device and valve clamping device recovery system

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CN101547651A (en) * 2006-12-04 2009-09-30 伊西康内外科公司 Device for endoluminally or laparoscopically grasping and excising a tissue sample from areas in a patient's body
CN106420113A (en) * 2011-09-13 2017-02-22 艾博特心脏血管***公司 Independent gripper
CN106175986A (en) * 2016-07-26 2016-12-07 复旦大学附属中山医院 A kind of valve clamping machine
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