WO2023125162A1 - 瓣膜夹合器及瓣膜夹合系统 - Google Patents

瓣膜夹合器及瓣膜夹合系统 Download PDF

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Publication number
WO2023125162A1
WO2023125162A1 PCT/CN2022/140425 CN2022140425W WO2023125162A1 WO 2023125162 A1 WO2023125162 A1 WO 2023125162A1 CN 2022140425 W CN2022140425 W CN 2022140425W WO 2023125162 A1 WO2023125162 A1 WO 2023125162A1
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WO
WIPO (PCT)
Prior art keywords
valve
fixed base
clip
control
arm
Prior art date
Application number
PCT/CN2022/140425
Other languages
English (en)
French (fr)
Inventor
邢怒安
黄辉
Original Assignee
瀚芯医疗科技(深圳)有限公司
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Publication of WO2023125162A1 publication Critical patent/WO2023125162A1/zh

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Classifications

    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61F2/02—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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2463—Implants forming part of the valve leaflets
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02E—REDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E30/00—Energy generation of nuclear origin
    • Y02E30/30—Nuclear fission reactors

Definitions

  • the present application relates to the technical field of medical devices, in particular to a valve clamp and a valve clamp system.
  • Mitral valve insufficiency is one of the most common valvular diseases today, the main reasons are mitral valve ring dilatation, chordal insufficiency, mitral valve mucus degeneration, valve leaflet prolapse, rheumatic heart valve disease, ischemic disease wait.
  • Direct mitral valvuloplasty and artificial valve replacement are the most effective methods for the treatment of mitral valve insufficiency, but because the operation requires extracorporeal circulation technical support, the trauma to the human body is relatively large, and there are many complications for elderly patients. disease patients, there are quite high morbidity and mortality. Therefore, in recent years, medical personnel and scientific researchers from various countries have carried out the exploration of transcatheter mitral valve repair technology. The efficacy of mitral valve clamping is the most reliable.
  • the mitral valve clamp sends an implantable clip to the vicinity of the mitral valve through atrial septal puncture, and clamps and fixes the free edges of the front and rear valve leaflets, so that the valve leaflets fit well at the end of systole and reduce regurgitation.
  • One of the objectives of the embodiments of the present application is to provide a valve clamping device and a valve clamping system.
  • a valve clamp comprising:
  • At least one pair of tong arms the proximal ends of at least one pair of tong arms are connected to the fixed base, at least one pair of tong arms can be opened and closed relative to the fixed base;
  • each clip positioned between the fixed base and each arm;
  • the drive assembly includes a drive shaft connected to the fixed base.
  • the drive shaft moves along its own axial direction to drive the forceps arm to open and close relative to the fixed base.
  • the proximal end of the drive shaft is used to detachably connect to the delivery device, which is used for the delivery device.
  • the device is used to deliver the valve clamp and control the drive shaft to move along its own axial direction, and control the opening and closing of the clips relative to the fixed base, so that each clip cooperates with its corresponding forceps arm to clamp the valve.
  • the valve clamp further includes a blocking body, the blocking body includes a connecting portion and an elastic balloon, the proximal end of the elastic balloon is connected to the distal end of the fixed base through the connecting portion, and the distal end of the elastic balloon is suspended in the air. .
  • the obstructing body is ultrasonically detectable.
  • the valve clamp further includes a wire guide, the wire guide is arranged at the far end of the fixed base, a wire passing hole is provided on the wire guide, and the control wire in the delivery device is movably threaded in the wire passing hole and Connected to the far end of the clip, the control wire is used to control the opening and closing of the clip relative to the fixed base.
  • the wire guide is located on the central axis of the fixed base, and the wire guide includes a support rod connected to the fixed base and at least one threading ring arranged at the far end of the support rod, each threading ring is provided with a Cable hole.
  • the clamp arm includes a connecting arm and a clamping arm connected to the end of the connecting arm away from the fixed base, the end of the connecting arm away from the clamping arm is hinged to the fixed base, and each clamping arm is connected to its corresponding clamping arm.
  • the leaflet accommodation space is formed between the blades;
  • the drive assembly also includes a lock base and connecting rods with the same number as the clamp arms.
  • the lock base is movably sleeved on the drive shaft and connected to the distal end of the clip.
  • a connecting rod is arranged between them, and the two ends of each connecting rod are respectively connected between the lock seat and the connecting arm and the clamping arm of the corresponding clamp arm.
  • a valve clipping system comprising:
  • the delivery device the distal end of the delivery device is detachably connected to the valve clamp, and the delivery device is used to deliver the valve clamp and control the axial movement of the drive shaft along itself, and control the opening and closing of the clip relative to the fixed base, so as to Each clip cooperates with its corresponding forceps arm to grip the valve.
  • the delivery device comprises:
  • the control handle is arranged at the proximal end of the delivery sheath;
  • a control rod is movably threaded inside the delivery sheath, the distal end of the control rod is detachably connected to the drive shaft, and the proximal end of the control rod is connected to the control handle;
  • At least one control line is movably threaded inside the delivery sheath, the control line is threaded at the far end of the clip, and the two ends of the control line are connected to the control handle.
  • the delivery device further includes two wire guides.
  • the two guide wires are arranged at the distal end of the delivery sheath and are symmetrical to the central axis of the delivery sheath.
  • the connecting rods between the far ends of the coils are each provided with a threading hole.
  • the number of control wires is the same as the number of clips, and each control wire is connected with threading holes on two wire guides and a distal end of a clip.
  • valve clamp connects the proximal ends of at least one pair of forceps arms with the fixed base, and the clips with the same number as the forceps arms are located between the fixed base and each forceps.
  • the drive assembly drives the fixed base to drive the proximal movement of the forceps arm to drive the forceps arm to open and close relative to the fixed base, and cooperates with the delivery device to control the opening and closing of the clips relative to the fixed base, so that each clamp
  • the valve clip cooperates with the corresponding forceps arm to clamp the valve, and the valve clamp can be sent from the left ventricle to the vicinity of the mitral valve through the apex of the heart.
  • valve clamp can be sent from the left ventricle to the vicinity of the mitral valve through the delivery device, and then the front and rear valve leaflets can be clamped and fixed by the valve clamp .
  • FIG. 1 is a schematic structural view of a valve clamp provided in an embodiment of the present application
  • Fig. 2 is a schematic side view of the valve clamp shown in Fig. 1, with both the clamp arms and the clips folded relative to the fixed base;
  • Fig. 3 is a schematic side view of the clamp arm of the valve clamp shown in Fig. 1 unfolded relative to the fixed base, and the clips folded relative to the fixed base;
  • Fig. 4 is a schematic side view of the valve clamp shown in Fig. 1 where both the forceps arms and the clips are deployed relative to the fixed base;
  • Fig. 5 is a schematic top view of a partial structure of the valve clamp shown in Fig. 1;
  • Fig. 6 is a schematic diagram of the valve clamp provided by the embodiment of the present application inserted into the heart through the delivery device through the apex;
  • Fig. 7 is a schematic diagram of the valve clamp provided by the embodiment of the present application clamping the leaflets of the mitral valve under the control of the delivery device;
  • Fig. 8 is a schematic diagram showing that the valve clamp provided by the embodiment of the present application is separated from the delivery device under the control of the delivery device;
  • Fig. 9 is a schematic structural view of another valve clamp provided in the embodiment of the present application.
  • Fig. 10 is a schematic structural view of another valve clamp provided in the embodiment of the present application.
  • Fig. 11 is a schematic top view of part of the structure of Fig. 10;
  • Fig. 12 is a schematic structural view of another valve clamp provided by the embodiment of the present application.
  • Fig. 13 is a schematic structural view of the valve clamping system provided by the embodiment of the present application.
  • Fig. 14 is a schematic structural view of the valve clamping device of the valve clamping system provided by the embodiment of the present application after being separated from the delivery device;
  • Fig. 15 is a schematic diagram of the connection of another wire guide, clip and control wire of the delivery device in the valve clamping system provided by the embodiment of the present application;
  • Fig. 16 is a schematic top view of the wire guide, clips and control wires of the delivery device shown in Fig. 15 .
  • proximal end the end close to the operator
  • distal end any medical device is defined according to this principle.
  • front refers to a direction away from the operator
  • rear refers to a direction toward the operator.
  • an embodiment of the present application provides a valve clamp, as shown in FIGS.
  • the proximal ends of at least one pair of clamp arms 200 are connected to the fixed base 100, at least one pair of clamp arms 200 can be opened and closed relative to the fixed base 100; each clip 300 is located between the fixed base 100 and each clamp arm 200 ;
  • the drive assembly 400 includes a drive shaft 410 connected to the fixed base 100, the drive shaft 410 moves along its own axial direction to drive the forceps arm 200 to open and close relative to the fixed base 100, and the proximal end of the drive shaft 410 is used for detachable Connect the delivery device 20, the delivery device 20 is used to deliver the valve clamp 10 and control the drive shaft 410 to move along its own axial direction, and control the opening and closing of the clips 300 relative to the fixed base 100, so that each clip 300 is connected to the fixed base 100 Corresponding forceps arms 200 cooperate to grip the valve.
  • the valve clamp 10 connects the proximal ends of at least one pair of forceps arms 200 to the fixed base 100, and the clips 300 with the same number as the forceps arms 200 are located between the fixed base 100 and each forceps arm 200.
  • the drive assembly 400 drives the fixed base 100 to drive the proximal movement of the forceps arm 200 to drive the forceps arm 200 to open and close relative to the fixed base 100, and cooperates with the delivery device 20 to control the opening and closing of the clip 300 relative to the fixed base 100. close together, so that each clip 300 cooperates with its corresponding forceps arm 200 to clamp the valve.
  • valve clamp 10 Using the valve clamp 10, it can be sent from the left ventricle to the vicinity of the mitral valve through the apex of the heart.
  • the operation entrance is very close to the valve, and the delivery path Short and straight, the delivery device 20 does not need to be bent, easy to adjust and control, less time-consuming, easier to operate, and less demanding on the doctor's operating skills.
  • valve clamp 10 can be sent from the left ventricle to the vicinity of the mitral valve through a small chest incision and apical puncture, there is no need for digital subtraction angiography (DSA). angiography) to reduce the harm to doctors and patients.
  • DSA digital subtraction angiography
  • the two clips 300 are made of materials with shape memory function, and superelastic nickel-titanium alloy can be selected.
  • the natural state of the two clips 300 is to expand relative to the fixed base 100, and the distal end (that is, the free end) of the clips 300 is controlled by the delivery device 20 to be closed relative to the fixed base 100 for easy delivery.
  • the free end of the clip 300 is released, and the clip 300 rebounds due to its own elastic memory performance and returns to its natural state, so as to press the valve leaflet to the corresponding forceps arm 200 to realize Clamping of leaflets.
  • the two tong arms 200 correspond to the two clips 300 to form two tongs, and the two tongs are symmetrically arranged with respect to the fixed base 100 .
  • the valve clamp 10 is delivered to the patient's mitral valve through the delivery device 20, and the two clamps can respectively clamp the anterior leaflet and the posterior leaflet of the mitral valve to reduce the valve leaflet gap, and leave it as an implant patient's body to relieve or treat "mitral regurgitation" in the patient.
  • the valve clamp 10 has at least three configurations, which are respectively the first configuration in which the forceps arms 200 and the clips 300 are fully folded, the second configuration in which the clamp arms 200 are fully expanded and the clips 300 are fully retracted, and the clamp arms 200 and clips are fully folded.
  • the first form is the form when the valve clamp 10 is delivered; as shown in FIG.
  • the clip composed of the flaps 300 is open), in this state, by adjusting the valve clamp 10, the folded clips 300 pass through the gap between the anterior leaflet and the posterior leaflet and are positioned at an appropriate position above the leaflet to place the mitral
  • the anterior leaflet and the posterior leaflet of the valve are respectively placed in the two clamps; as shown in Figure 4, the third state is that after the delivery device 20 releases the control on the distal end of the clip 300, the clip 300 unfolds due to its own elastic memory performance, and Press the valve leaflet to the corresponding forceps arm 200 to realize the clamping of the valve leaflet (that is, the closed state of the clamp composed of the forceps arm 200 and the clip piece 300 ).
  • valve clamp 10 When using the valve clamp 10 to treat mitral valve insufficiency, as shown in FIGS.
  • the small incision and the apical puncture port are sent from the left ventricle LV to the vicinity of the mitral valve MV, and the delivery device 20 controls the drive assembly 400 to drive the forceps arm 200 to expand to form the above-mentioned second state, and adjust the position of the valve clamp 10 to make the mitral valve
  • the anterior leaflet and the posterior leaflet of the valve MV are respectively placed in the two clamps, and the control of the clip 300 is released by the delivery device 20, so that the clip 300 is freely expanded to form the above-mentioned third state, so that the two clips of the valve clip 10
  • the clamp clamps the anterior leaflet and the posterior leaflet of the mitral valve MV to reduce the leaflet gap, and then controls the delivery device 20 so that its distal end is separated from the valve clamp 10, withdraws the delivery device 20, and closes the valve clamp. 10 remains in the patient's body as an implant to relieve or
  • the valve clamp 10 further includes a blocking body 500, the blocking body 500 includes a connecting portion 510 and an elastic balloon 520, and the proximal end of the elastic balloon 520 is connected to the The distal end of the base 100 is fixed, and the distal end of the elastic balloon 520 is suspended.
  • the blocking body 500 By setting the blocking body 500 at the distal end of the fixed base 100, during the operation, the blocking body 500 is placed between the front and rear leaflets of the mitral valve for positioning, so that the valve clip 10 is always positioned in the middle of the mitral valve .
  • the elastic balloon 520 After the valve clamp 10 is closed, the elastic balloon 520 is filled between the anterior leaflet and the posterior leaflet of the clamped mitral valve, and is pressed against the forceps arm 200, so it also has the following advantages: (1) elastic ball The sac 520 has a buffering effect on the pulsating leaflets, so that the pulling degree of the valve leaflets by the valve clamp 10 can be adjusted to avoid damage to the leaflets; (2) the elastic balloon 520 can be squeezed following the pulsation of the leaflets Compression deformation, the generated elastic force pushes the part of the valve leaflet close to the elastic balloon 520 away from the fixed base 100, so that the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the tension
  • the obstructing body 500 is ultrasonically detectable.
  • the valve clip 10 can be easily identified and accurately positioned under ultrasound.
  • the blocking body 500 may be made of or implanted with a material detectable under ultrasound.
  • the valve clamp 10 further includes a wire guide 600, the wire guide 600 is arranged at the distal end of the fixed base 100, and the wire guide 600 is provided with a wire passing hole,
  • the control wire 1000 in the delivery device 20 is movably threaded in the wire hole and connected to the distal end of the clip 300 , and the control wire 1000 is used to control the opening and closing of the clip 300 relative to the fixed base 100 .
  • the wire guide 600 By disposing the guide wire 600 at the distal end of the fixed base 100 , the wire guide 600 cooperates with the control wire 1000 in the delivery device 20 to better control the clip 300 .
  • the wire guide 600 is located on the central axis of the fixed base 100 , the wire guide 600 includes a support rod 610 connected to the fixed base 100 and a There is at least one threading ring 620 at the far end of 610, and each threading ring 620 is provided with a thread passing hole.
  • the wire guide 600 is arranged on the central axis of the fixed base 100.
  • the resultant force of the pulling force acting on the clip 300 passes through the wire guide. 600 acts on the central axis of the delivery device 20, so that the torque generated by the resultant force on the valve clamp 10 is zero, thereby avoiding the bending of the delivery sheath 700 of the delivery device 20 and causing the valve clamp 10 to swing and shift, which facilitates the operation It is beneficial to shorten the operation time and improve the operation efficiency.
  • control lines 1000 is usually the same as the number of clips 300, and the activities of each control line 1000 and each clip 300 One-to-one corresponding piercing connection, so that the clip 300 can be pulled up and down at the same time or independently.
  • each control wire 1000 can It is separately threaded in the corresponding wire hole, which can avoid the friction between the wires and the wires to cause the control wire 1000 to be stuck and entangled.
  • the pliers arm 200 includes a connecting arm 210 and a clamping arm 220 connected to the end of the connecting arm 210 away from the fixed base 100 , and the connecting arm 210 is far away from the clamping arm.
  • One end of 220 is hinged to the fixed base 100, and a leaflet accommodation space is formed between each clamping arm 220 and its corresponding clip 300;
  • the driving assembly 400 also includes a lock seat 420 and the same number of connecting rods 430 as the forceps arm 200,
  • the lock base 420 is movably sleeved on the drive shaft 410 and connected to the distal end of the clip 300.
  • a connecting rod 430 is arranged between each pliers arm 200 and the lock base 420, and the two ends of each connecting rod 430 are respectively connected to the lock base. 420 and between the connecting arm 210 and the clamping arm 220 of the corresponding clamp arm 200 .
  • the fixed base 100, forceps arm 200, lock seat 420, connecting rod 430 and drive shaft 410 can be made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy .
  • the embodiment of the present application also provides a valve clamping system, as shown in FIG. 13 , the valve clamping system includes the above-mentioned valve clamping device 10 and delivery device 20 .
  • the distal end of the delivery device 20 is detachably connected to the valve clamp 10, the delivery device 20 is used to deliver the valve clamp 10 and controls the drive shaft 410 to move along its own axial direction, and controls the clip 300 relative to the fixed base 100 Open and close, so that each clip 300 cooperates with its corresponding forceps arm 200 to clamp the valve.
  • valve clamp 10 Due to the use of the valve clamp 10 described above, the valve clamp system correspondingly also has the advantages and benefits brought by the valve clamp 10 described above, which will not be repeated here.
  • the delivery device 20 includes a delivery sheath 700 , a control handle, a control rod 900 and at least one control wire 1000 , and the control handle 800 is arranged on the delivery sheath 700
  • Proximal end the control rod 900 is movably installed inside the delivery sheath 700, the distal end of the control rod 900 is detachably connected to the drive shaft 410, and the proximal end of the control rod 900 is connected to the control handle 800; at least one control wire 1000
  • the control wire 1000 is threaded through the distal end of the clip 300 , and the two ends of the control wire 1000 are connected to the control handle 800 .
  • the control rod 900 includes a hollow tube 910 movably threaded in the delivery sheath 700 and an insertion rod 920 movably threaded in the hollow tube 910.
  • the distal end of the insertion rod 920 is provided with a thread groove
  • the drive assembly 400 also includes a sleeve 440 fixedly connected to the proximal end of the lock seat 420, the drive shaft 410 is movably inserted in the sleeve 440, the distal end of the drive shaft 410 is fixedly connected to the fixed base 100, and the drive shaft 410 is pushed and pulled 410 to move it axially relative to the sleeve 440 to expand and retract the pliers arm 200 relative to the fixed base 100 .
  • the proximal end of the sleeve 440 and the distal end of the hollow tube 910 are respectively formed with a limit groove and a limit flange that can be engaged with each other.
  • the axial direction of the tube 910 is locked, and the control handle 800 is used to push the insertion rod 920 forward, so that the distal end of the insertion rod 920 extends into the sleeve 440, so that the sleeve 440 and the hollow tube 910 can be moved along the radial direction of the insertion rod 920.
  • control wire 1000 is selected from nickel-titanium wire, stainless steel wire or high-strength polymer wire.
  • the delivery device 20 further includes two guide guides 2000 , and the two guide guides 2000 are arranged at the far end of the delivery sheath 700 .
  • the end is symmetrical with respect to the central axis of the delivery sheath 700.
  • the guide wire 2000 includes a threading coil 2200 and a connecting rod 2100 connected between the threading coil 2200 and the distal end of the delivery sheath 700.
  • Each threading coil 2200 is provided with a threading coil 2200. hole.
  • the two wire guides 2000 are arranged symmetrically with respect to the central axis of the delivery sheath 700.
  • the control line 1000 is used to control the folding of the clip 300 relative to the fixed base 100
  • the resultant force of the pulling force acting on the clip 300 acts through the two wire guides 2000. on the central axis of the delivery sheath tube 700, so that the moment generated by the resultant force on the valve clamp 10 is zero, thereby preventing the delivery sheath tube 700 from bending and causing the valve clamp 10 to swing and shift, which is convenient for surgical operation and is conducive to shortening operation time and improve operation efficiency.
  • Fig. 15-Fig. The threading hole on the 2000 is threaded and connected with the far end of a clip 300 .
  • the number of control lines 1000 is set to be the same as the number of clips 300, and each control line 1000 is connected to the movable end of each clip 300 in one-to-one correspondence, so that the clips 300 can be pulled up and down at the same time or independently Pull up and down.
  • control line 1000 and the clip 300 correspondingly connected with the control line 1000 Take a control line 1000 and the clip 300 correspondingly connected with the control line 1000 as an example to illustrate the connection mode between the control line 1000, the wire guide 2000 and the clip 300, one end of the control line 1000 is connected with the control handle 800, and the control
  • the active end of the thread 1000 is passed through the delivery sheath 700 to the distal end of the delivery sheath 700, and then passes through the threading hole on a guide wire guide 2000, the through hole at the movable end of the clip 300 and the opening on the other guide guide 2000 in sequence. After the threading hole passes through the interior of the delivery sheath 700 to the distal end of the delivery sheath 700 and is connected to the control handle 800 .
  • the number of threading coils 2200 in each thread guide 2000 may be one.
  • the number of threading coils 2200 in each thread guide 2000 can also be as many as the number of clips 300, so that one end of each control line 1000 can be threaded separately In the threading coil 2200 corresponding to the thread guide 2000, this can avoid thread-to-thread friction, causing the control thread 1000 to be stuck and entangled.
  • the interior of the delivery sheath 700 is provided with a plurality of mutually isolated holes along the axial direction, so that each control wire 1000 can be threaded independently in a hole, thereby avoiding entanglement and jamming caused by friction between the wires.
  • valve clamp and valve clamping system provided by this embodiment has at least the following beneficial technical effects:
  • the valve clamp connects the proximal ends of at least one pair of forceps arms to the fixed base, the clips with the same number as the forceps arms are located between the fixed base and each forceps arm, and the drive assembly drives the fixed base to drive the forceps arms
  • the proximal movement to drive the forceps arm to open and close relative to the fixed base, and cooperate with the delivery device to control the opening and closing of the clips relative to the fixed base, so that each clip cooperates with its corresponding forceps arm to clamp the valve.
  • the valve clamp can be sent from the left ventricle to the vicinity of the mitral valve through the apex of the heart, the surgical entrance is very close to the valve, the delivery path is short and straight, the delivery device does not need to be bent, easy to adjust and control, takes less time, and the operation is easier , The doctor's operating skills are not required.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
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Abstract

一种瓣膜夹合器（10）及瓣膜夹合系统，该瓣膜夹合器（10）中至少一对钳臂（200）的近端与固定基座（100）连接，至少一对钳臂（200）能够相对于固定基座（100）开合；每一夹片（300）位于固定基座（100）与每一钳臂（200）之间；驱动组件（400）包括与固定基座（100）连接的驱动轴（410），驱动轴（410）沿自身的轴向移动以带动钳臂（200）相对于固定基座（100）开合。使用该瓣膜夹合器（10）可以经心尖从左心室送至二尖瓣附近，手术入口距离瓣膜很近，输送路径短且直，输送装置无需调弯，易于调整和控制，耗时较短，手术操作较容易，对医生的操作技巧要求不高。

Description

瓣膜夹合器及瓣膜夹合系统
本申请要求于2021年12月28日在中国专利局提交的、申请号为202111627769.2、发明名称为“瓣膜夹合器及瓣膜夹合系统”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，具体涉及一种瓣膜夹合器及瓣膜夹合系统。
 背景技术
二尖瓣关闭不全是当今最常见的瓣膜病变之一，主要原因有二尖瓣环扩张、腱索功能不全、二尖瓣粘液变性、瓣叶脱垂、风湿性心瓣膜病、缺血性病变等。二尖瓣直视成形术及人工瓣膜置换术是治疗二尖瓣关闭不全的最有效方法，但是由于手术需要体外循环技术支持，给人体带来的创伤比较大，对高龄患者和有较多合并症患者，有相当高的并发症和死亡率。因此，近年各国的医务人员和科研人员进行了经导管二尖瓣修复技术的探索，主要的介入治疗方式有瓣环成形术、负压抽吸缝合技术及二尖瓣钳夹术等，其中以二尖瓣钳夹术疗效最为可靠。二尖瓣钳夹通过房间隔穿刺将一个可植入的夹子送至二尖瓣附近，将前后瓣叶的游离缘进行钳夹固定，使瓣叶在收缩末期对合良好，减少返流。
 技术问题
本申请实施例的目的之一在于：提供一种瓣膜夹合器及瓣膜夹合系统。
 技术解决方案
本申请实施例采用的技术方案是：
第一方面，提供了一种瓣膜夹合器，包括：
固定基座；
至少一对钳臂，至少一对钳臂的近端与固定基座连接，至少一对钳臂能够相对于固定基座开合；
与钳臂数量相同的夹片，每一夹片位于固定基座与每一钳臂之间；以及
驱动组件，包括与固定基座连接的驱动轴，驱动轴沿自身的轴向移动以带动钳臂相对于固定基座开合，驱动轴的近端用于可拆卸地连接输送装置，输送装置用于输送瓣膜夹合器并控制驱动轴沿自身的轴向移动，以及控制夹片相对于固定基座开合，以使每一夹片与其对应的钳臂配合以夹持瓣膜。
在一个实施例中，瓣膜夹合器还包括阻塞体，阻塞体包括连接部和弹性球囊，弹性球囊的近端通过连接部连接于固定基座的远端，弹性球囊的远端悬空。
在一个实施例中，阻塞体具有超声可探测性。
在一个实施例中，瓣膜夹合器还包括导线件，导线件设置于固定基座的远端，导线件上设置有过线孔，输送装置中的控制线活动穿设于过线孔内并连接于夹片的远端，控制线用于控制夹片相对于固定基座开合。
在一个实施例中，导线件位于固定基座的中心轴线上，导线件包括与固定基座连接的支撑杆和设置于支撑杆的远端的至少一个穿线环，每一穿线环上均设置一过线孔。
在一个实施例中，钳臂包括连接臂以及连接于连接臂远离固定基座的一端的夹持臂，连接臂远离夹持臂的一端铰接于固定基座，每一夹持臂与其对应的夹片之间形成瓣叶容纳空间；驱动组件还包括锁座以及与钳臂数量相同的连杆，锁座活动套设于驱动轴上并连接于夹片的远端，每一钳臂与锁座之间设置一连杆，各连杆的两端分别连接于锁座和与其对应的钳臂的连接臂与夹持臂之间。
第二方面，提供一种瓣膜夹合系统，包括：
上述的瓣膜夹合器；以及
输送装置，输送装置的远端可拆卸地连接瓣膜夹合器，输送装置用于输送瓣膜夹合器并控制驱动轴沿自身的轴向移动，以及控制夹片相对于固定基座开合，以使每一夹片与其对应的钳臂配合以夹持瓣膜。
在一个实施例中，输送装置包括：
输送鞘管；
操控手柄，设置于输送鞘管的近端；
控制杆，活动穿设于输送鞘管的内部，控制杆的远端可拆卸地连接于驱动轴，控制杆的近端连接于操控手柄；以及
至少一根控制线，活动穿设于输送鞘管的内部，控制线穿设于夹片的远端，控制线的两末端连接于操控手柄。
在一个实施例中，输送装置还包括两个导线器，两导线器设置于输送鞘管的远端并关于输送鞘管的中心轴线对称，导线器包括穿线圈和连接于穿线圈与输送鞘管的远端之间的连接杆，每一穿线圈上均设置有一穿线孔。
在一个实施例中，控制线的数量与夹片的数量相同，每一控制线与两导线器上的穿线孔和一夹片的远端穿设连接。
 有益效果
本申请实施例提供的瓣膜夹合器的有益效果在于：瓣膜夹合器通过将至少一对钳臂的近端与固定基座连接，与钳臂数量相同的夹片位于固定基座与各钳臂之间，通过驱动组件驱动固定基座带动钳臂的近端运动，以带动钳臂相对于固定基座开合，配合输送装置控制夹片相对于固定基座开合，以使每一夹片与其对应的钳臂配合以夹持瓣膜，使用该瓣膜夹合器可以经心尖从左心室送至二尖瓣附近。
本申请实施例提供的瓣膜夹合系统的有益效果在于：通过输送装置可将瓣膜夹合器经心尖从左心室送至二尖瓣附近，再利用瓣膜夹合器将前后瓣叶进行钳夹固定。
 附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例或示范性技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，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它的附图。
图1是本申请实施例提供的瓣膜夹合器的结构示意图；
图2是图1示出的瓣膜夹合器的钳臂和夹片均相对于固定基座收拢的侧视示意图；
图3是图1示出的瓣膜夹合器的钳臂相对于固定基座展开，夹片相对于固定基座收拢后的侧视示意图；
图4是图1示出的瓣膜夹合器的钳臂和夹片均相对于固定基座展开的侧视示意图；
图5是图1示出的瓣膜夹合器的部分结构俯视示意图；
图6是本申请实施例提供的瓣膜夹合器通过输送装置经心尖插入心脏的示意图；
图7是本申请实施例提供的瓣膜夹合器在输送装置的操控下夹合二尖瓣的瓣叶的示意图；
图8是本申请实施例提供的瓣膜夹合器在输送装置的操控下与输送装置分离的示意图；
图9是本申请实施例提供的另一种瓣膜夹合器的结构示意图；
图10是本申请实施例提供的又一种瓣膜夹合器的结构示意图；
图11是图10的部分结构俯视示意图；
图12是本申请实施例提供的再一种瓣膜夹合器的结构示意图；
图13是本申请实施例提供的瓣膜夹合系统的结构示意图；
图14是本申请实施例提供的瓣膜夹合系统的瓣膜夹合器与输送装置分离后的结构示意图；
图15是本申请实施例提供的瓣膜夹合系统中输送装置的另一导线器与夹片和控制线的连接示意图；
图16是图15示出的输送装置的导线器与夹片和控制线的俯视示意图。
 本发明的实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本申请。
需说明的是，当部件被称为“固定于”或“设置于”另一个部件，它可以直接在另一个部件上或者间接在该另一个部件上。当一个部件被称为是“连接于”另一个部件，它可以是直接或者间接连接至该另一个部件上。术语“上”、“下”、“左”、“右”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，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，对于本领域的普通技术人员而言，可以根据具体情况理解上述术语的具体含义。术语“第一”、“第二”仅用于便于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明技术特征的数量。“多个”的含义是两个或两个以上，除非另有明确具体的限定。
需要说明的是，在介入式医疗器械中，将靠近手术操作者的一端称为“近端”，将远离手术操作者的一端称为“远端”，并依据此原理定义医疗器械中的任一部件的“近端”和“远端”。此外，本文中所述的“前”是指远离操作者的方向，“后”是指指向操作者的方向。
为了说明本申请所提供的技术方案，以下结合具体附图及实施例进行详细说明。
根据本申请的一个方面，本申请的实施例提供了一种瓣膜夹合器，如图1-图4所示，该瓣膜夹合器10包括固定基座100、钳臂200、与钳臂200数量相同的夹片300以及驱动组件400。至少一对钳臂200的近端与固定基座100连接，至少一对钳臂200能够相对于固定基座100开合；每一夹片300位于固定基座100与每一钳臂200之间；驱动组件400包括与固定基座100连接的驱动轴410，驱动轴410沿自身的轴向移动以带动钳臂200相对于固定基座100开合，驱动轴410的近端用于可拆卸地连接输送装置20，输送装置20用于输送瓣膜夹合器10并控制驱动轴410沿自身的轴向移动，以及控制夹片300相对于固定基座100开合，以使每一夹片300与其对应的钳臂200配合以夹持瓣膜。
传统瓣膜夹合器多为经股静脉穿刺，从上腔静脉穿过房间隔进入左心房，从左心房往下送至二尖瓣附近。由于此路径比较长且迂曲，通常需要多向可调弯的输送装置来配合使用，同时对房间隔穿刺位置要求较高，操作比较复杂，耗时较久，对医生的操作技巧要求较高。
在本申请实施例中，瓣膜夹合器10通过将至少一对钳臂200的近端与固定基座100连接，与钳臂200数量相同的夹片300位于固定基座100与各钳臂200之间，通过驱动组件400驱动固定基座100带动钳臂200的近端运动，以带动钳臂200相对于固定基座100开合，配合输送装置20控制夹片300相对于固定基座100开合，以使每一夹片300与其对应的钳臂200配合以夹持瓣膜，使用该瓣膜夹合器10可以经心尖从左心室送至二尖瓣附近，手术入口距离瓣膜很近，输送路径短且直，输送装置20无需调弯，易于调整和控制，耗时较短，手术操作较容易，对医生的操作技巧要求不高。
此外，可以理解的是，由于该瓣膜夹合器10可以由胸部小切口和心尖穿刺口从左心室送至二尖瓣附近，因此无需数字减影血管造影（Digital subtraction angiography）配合使用，减少对医生和患者的危害。
本实施例中，钳臂200与夹片300的数量均为两个，其中，两个夹片300均由具有形状记忆功能的材料制成，可选超弹性的镍钛合金。可以理解的是，两夹片300的自然状态为相对于固定基座100展开，通过输送装置20控制夹片300的远端（即自由端）相对于固定基座100收拢以便于输送，而在解除对夹片300的远端的控制后，夹片300的自由端被释放，夹片300由于自身弹性记忆性能回弹并恢复自然状态，以将瓣叶压向与其对应的钳臂200，实现对瓣叶的夹持。两个钳臂200与两个夹片300一一对应以构成两个夹钳，且两个夹钳关于固定基座100轴对称设置。通过输送装置20将瓣膜夹合器10输送至患者的二尖瓣处，两个夹钳可分别夹持二尖瓣的前叶和后叶以减小瓣叶间隙，并作为植入物留在患者的体内，以减轻或治疗患者的“二尖瓣反流”。
该瓣膜夹合器10至少具有三种形态，分别为钳臂200和夹片300均完全收拢的第一形态、钳臂200完全展开且夹片300完全收拢的第二形态以及钳臂200和夹片300均完全展开的第三形态。如图2所示，第一形态为瓣膜夹合器10被输送时的形态；如图3所示，第二形态为钳臂200被驱动组件400驱动而展开的状态（即钳臂200与夹片300组成的夹钳打开的状态），此状态下通过调整瓣膜夹合器10，使收拢的夹片300穿过前叶和后叶之间的间隙并位于瓣叶上方适当位置以将二尖瓣的前叶和后叶分别置于两夹钳中；如图4所示，第三状态为输送装置20解除对夹片300远端的控制后，夹片300由于自身弹性记忆性能展开，以将瓣叶压向与其对应的钳臂200，实现对瓣叶的夹持（即钳臂200与夹片300组成的夹钳闭合的状态）。
使用该瓣膜夹合器10治疗二尖瓣关闭不全时，如图6-图8所示，将瓣膜夹合器10设置在输送装置20的远端并使其处于上述的第一状态，经胸部小切口和心尖穿刺口从左心室LV送至二尖瓣MV附近，通过输送装置20控制驱动组件400带动钳臂200展开以形成上述的第二状态，调整瓣膜夹合器10的位置使二尖瓣MV的前叶和后叶分别置于两夹钳中，通过输送装置20解除对夹片300的控制使夹片300自由展开以形成上述的第三状态，使得瓣膜夹合器10的两个夹钳分别夹持二尖瓣MV的前叶和后叶以减小瓣叶间隙，然后控制输送装置20使其远端与瓣膜夹合器10分离，撤出输送装置20，将瓣膜夹合器10作为植入物留在患者的体内，以减轻或治疗患者的“二尖瓣反流”。
在一种实施例中，如图9所示，瓣膜夹合器10还包括阻塞体500，阻塞体500包括连接部510和弹性球囊520，弹性球囊520的近端通过连接部510连接于固定基座100的远端，弹性球囊520的远端悬空。
通过在固定基座100的远端设置阻塞体500，在手术过程中，阻塞体500放置在二尖瓣的前后叶间起定位作用，使瓣膜夹合器10始终定位在二尖瓣的中间位置。当瓣膜夹合器10闭合后，弹性球囊520填充于被夹持的二尖瓣的前叶和后叶之间，且抵顶于钳臂200，因此还具有以下优点：(1)弹性球囊520对于搏动的瓣叶具有缓冲作用，从而实现瓣膜夹合器10对瓣叶的牵拉程度可调节，以避免损伤瓣叶；(2)弹性球囊520可以跟随瓣叶的搏动而被挤压变形，产生的弹力将瓣叶靠近弹性球囊520的部分向远离固定基座100的方向推动，使得二尖瓣的前叶和后叶之间的夹合角度小于钳臂200之间的张开角度，能够减少瓣膜夹合器10对瓣叶的牵拉，使得瓣膜夹合器10对瓣叶的牵拉程度始终保持在合理范围内；(3)弹性球囊520可以缓冲血流对瓣膜夹合器10内部的直接冲刷，避免瓣膜夹合器10受到血液的连续冲刷而脱落，还可以避免血液在瓣膜夹合器的夹持部之间的死角处淤积形成血栓。
在一些具体的实施例中，阻塞体500具有超声可探测性。
通过将阻塞体500设置为具有超声可探测性，使瓣膜夹合器10在超声下易被识别并准确定位。
具体来说，阻塞体500可采用或植入超声下可探测的材料制成。
在一种实施例中，如图10-图12所示，瓣膜夹合器10还包括导线件600，导线件600设置于固定基座100的远端，导线件600上设置有过线孔，输送装置20中的控制线1000活动穿设于过线孔内并连接于夹片300的远端，控制线1000用于控制夹片300相对于固定基座100开合。
通过在固定基座100的远端设置导线件600，导线件600配合输送装置20中的控制线1000以对夹片300更好地进行控制。
在一种具体的实施例中，如图10-图12所示，导线件600位于固定基座100的中心轴线上，导线件600包括与固定基座100连接的支撑杆610和设置于支撑杆610的远端的至少一个穿线环620，每一穿线环620上均设置一过线孔。
将导线件600设置于固定基座100的中心轴线上，在通过穿设于过线孔内的控制线1000拉动夹片300的活动端时，作用在夹片300上的拉力的合力通过导线件600作用于输送装置20的中心轴线上，使得该合力对瓣膜夹合器10产生的力矩为零，从而避免输送装置20的输送鞘管700弯曲导致瓣膜夹合器10发生摆动移位，方便手术操作，有利于缩短手术时间、提高手术效率。
此外，由此设计，当支撑杆610的远端设置一个穿线环620时，如图10-图11所示，可以只需要一根穿设于过线孔的控制线1000与所有的夹片300自由端穿设连接便可实现所有夹片300的同时拉起和放下。
需要说明的是，在现实情况下，为在手术中操作更加灵活便捷，适用不同的使用需求，控制线1000的数量通常与夹片300的数量相同，各控制线1000与各夹片300的活动端一一对应穿设连接，由此可实现夹片300同时被拉起和放下或独立拉起和放下，当支撑杆610的远端连接一个穿线环620时，所有的控制线1000均穿设在一个过线孔内，线与线之间的摩擦容易导致控制线1000缠绕或卡顿；当支撑杆610的远端连接与控制线1000数量相同的穿线环620时，每根控制线1000可以单独穿设在相应的过线孔内，这样可以避免线与线摩擦导致控制线1000卡顿和缠绕。
在一些具体的实施例中，如图1-图12所示，钳臂200包括连接臂210以及连接于连接臂210远离固定基座100的一端的夹持臂220，连接臂210远离夹持臂220的一端铰接于固定基座100，每一夹持臂220与其对应的夹片300之间形成瓣叶容纳空间；驱动组件400还包括锁座420以及与钳臂200数量相同的连杆430，锁座420活动套设于驱动轴410上并连接于夹片300的远端，每一钳臂200与锁座420之间设置一连杆430，各连杆430的两端分别连接于锁座420和与其对应的钳臂200的连接臂210与夹持臂220之间。
为保证植入后的安全性，固定基座100、钳臂200、锁座420、连杆430和驱动轴410可由不锈钢、钴合金、钴铬合金或钛合金等生物相容性金属材料制成。
根据本申请的另一个方面，本申请的实施例还提供了一种瓣膜夹合系统，如图13所示，该瓣膜夹合系统包括上述的瓣膜夹合器10以及输送装置20。输送装置20的远端可拆卸地连接瓣膜夹合器10，输送装置20用于输送瓣膜夹合器10并控制驱动轴410沿自身的轴向移动，以及控制夹片300相对于固定基座100开合，以使每一夹片300与其对应的钳臂200配合以夹持瓣膜。
由于采用了上述的瓣膜夹合器10，该瓣膜夹合系统相应地也具备上述瓣膜夹合器10所带来的有点和好处，在此不再赘述。
在一种实施例中，如图13-图14所示，该输送装置20包括输送鞘管700、控制手柄、控制杆900以及至少一根控制线1000，操控手柄800设置于输送鞘管700的近端；控制杆900活动穿设于输送鞘管700的内部，控制杆900的远端可拆卸地连接于驱动轴410，控制杆900的近端连接于操控手柄800；至少一根控制线1000活动穿设于输送鞘管700的内部，控制线1000穿设于夹片300的远端，控制线1000的两末端连接于操控手柄800。
具体来说，控制杆900包括活动穿设于输送鞘管700内的空心管910和活动穿设于所述空心管910内的插杆920，插杆920的远端设置有螺纹槽，相应地，驱动组件400还包括与锁座420的近端固定连接的套管440，驱动轴410活动穿设于套管440内，驱动轴410的远端与固定基座100固接，通过推拉驱动轴410使其相对于套管440沿轴向运动以使钳臂200相对于固定基座100展开和收拢。套管440的近端及空心管910的远端分别形成有可配合卡接的限位槽及限位凸缘，套管440与空心管910对合后限位槽与限位凸缘沿空心管910的轴向相卡持，利用操控手柄800前推插杆920，使插杆920的远端伸入套管440内，可使套管440与空心管910沿插杆920的径向被锁定，转动插杆920，使插杆920的前端与驱动轴410螺接，从而实现控制杆900与驱动轴410的连接固定，通过操控手柄800推拉插杆920可控制钳臂200的开合，通过操控手柄800转动空心管910可调整瓣膜夹合器10转动；当瓣膜夹合器10夹持二尖瓣的前叶和后叶后，利用操控手柄800转动插杆920使其与驱动轴410解除螺接，然后通过操控手柄800回拉插杆920，使插杆920的远端从套管440内撤出，可使限位槽与限位凸缘沿空心管910的径向分离以解除空心管910与套管440的连接，从而实现控制杆900与驱动轴410的分离。
其中，控制线1000选自镍钛丝、不锈钢丝或高强度的高分子线。
在一种具体的实施例中，如图1-图5和图9、图15-图16所示，输送装置20还包括两个导线器2000，两导线器2000设置于输送鞘管700的远端并关于输送鞘管700的中心轴线对称，导线器2000包括穿线圈2200和连接于穿线圈2200与输送鞘管700的远端之间的连接杆2100，每一穿线圈2200上均设置有一穿线孔。
将两导线器2000关于输送鞘管700的中心轴线对称设置，在通过控制线1000控制夹片300相对于固定基座100收拢时，作用在夹片300上的拉力的合力通过两导线器2000作用于输送鞘管700的中心轴线上，使得该合力对瓣膜夹合器10产生的力矩为零，从而避免输送鞘管700弯曲导致瓣膜夹合器10发生摆动移位，方便手术操作，有利于缩短手术时间、提高手术效率。
在一种更加具体的实施例中，如图1-图5和图9、图15-图16所示，控制线1000的数量与夹片300的数量相同，每一控制线1000与两导线器2000上的穿线孔和一夹片300的远端穿设连接。
将控制线1000的数量设置为与夹片300的数量相同，各控制线1000与各夹片300的活动端一一对应穿设连接，由此可实现夹片300同时被拉起和放下或独立拉起和放下。
以一根控制线1000和与该控制线1000对应连接的夹片300为例阐述控制线1000、导线器2000与夹片300之间的连接方式，控制线1000的一端与操控手柄800连接，控制线1000的活动端经输送鞘管700内部穿设至输送鞘管700的远端，然后依次穿过一导线器2000上的穿线孔、夹片300活动端的通孔和另一导线器2000上的穿线孔后经输送鞘管700内部穿设至输送鞘管700的远端并于操控手柄800连接。
具体来说，如图1-图5和图9所示，每一个导线器2000中的穿线圈2200的数量可以是一个。当然，如图15-图16所示，每一个导线器2000中的穿线圈2200的数量也可以是与夹片300数量相同的多个，如此，可以使得每根控制线1000的一端单独穿设在导线器2000相应的穿线圈2200中，这样可以避免线与线摩擦，导致控制线1000卡顿和缠绕。
输送鞘管700的内部沿轴向设置有多个相互隔离的孔腔，以使每根控制线1000独立穿设于一孔腔内，从而避免线与线之间的摩擦导致缠绕和卡顿。
综上，实施本实施例提供的瓣膜夹合器及瓣膜夹合系统，至少具有以下有益技术效果：
该瓣膜夹合器通过将至少一对钳臂的近端与固定基座连接，与钳臂数量相同的夹片位于固定基座与各钳臂之间，通过驱动组件驱动固定基座带动钳臂的近端运动，以带动钳臂相对于固定基座开合，配合输送装置控制夹片相对于固定基座开合，以使每一夹片与其对应的钳臂配合以夹持瓣膜，使用该瓣膜夹合器可以经心尖从左心室送至二尖瓣附近，手术入口距离瓣膜很近，输送路径短且直，输送装置无需调弯，易于调整和控制，耗时较短，手术操作较容易，对医生的操作技巧要求不高。
以上仅为本申请的可选实施例而已，并不用于限制本申请。对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的权利要求范围之内。

Claims (10)

  1. 瓣膜夹合器，其特征在于，包括：
    固定基座；
    至少一对钳臂，所述至少一对钳臂的近端与所述固定基座连接，所述至少一对钳臂能够相对于所述固定基座开合；
    与所述钳臂数量相同的夹片，每一所述夹片位于所述固定基座与每一所述钳臂之间；以及
    驱动组件，包括与所述固定基座连接的驱动轴，所述驱动轴沿自身的轴向移动以带动所述钳臂相对于所述固定基座开合，所述驱动轴的近端用于可拆卸地连接输送装置，所述输送装置用于输送所述瓣膜夹合器并控制所述驱动轴沿自身的轴向移动，以及控制所述夹片相对于所述固定基座开合，以使每一所述夹片与其对应的所述钳臂配合以夹持瓣膜。
  2. 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阻塞体，所述阻塞体包括连接部和弹性球囊，所述弹性球囊的近端通过所述连接部连接于所述固定基座的远端，所述弹性球囊的远端悬空。
  3. 根据权利要求2所述的瓣膜夹合器，其特征在于，所述阻塞体具有超声可探测性。
  4. 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导线件，所述导线件设置于所述固定基座的远端，所述导线件上设置有过线孔，所述输送装置中的控制线活动穿设于所述过线孔内并连接于所述夹片的远端，所述控制线用于控制所述夹片相对于所述固定基座开合。
  5. 根据权利要求4所述的瓣膜夹合器，其特征在于，所述导线件位于所述固定基座的中心轴线上，所述导线件包括与所述固定基座连接的支撑杆和设置于所述支撑杆的远端的至少一个穿线环，每一所述穿线环上均设置一所述过线孔。
  6. 根据权利要求1-5任一项所述的瓣膜夹合器，其特征在于，所述钳臂包括连接臂以及连接于所述连接臂远离所述固定基座的一端的夹持臂，所述连接臂远离所述夹持臂的一端铰接于所述固定基座，每一所述夹持臂与其对应的所述夹片之间形成瓣叶容纳空间；所述驱动组件还包括锁座以及与所述钳臂数量相同的连杆，所述锁座活动套设于所述驱动轴上并连接于所述夹片的远端，每一所述钳臂与所述锁座之间设置一所述连杆，各所述连杆的两端分别连接于所述锁座和与其对应的所述钳臂的所述连接臂与所述夹持臂之间。
  7. 瓣膜夹合系统，其特征在于，包括：
    如权利要求1-6任一项所述的瓣膜夹合器；以及
    输送装置，所述输送装置的远端可拆卸地连接所述瓣膜夹合器，所述输送装置用于输送所述瓣膜夹合器并控制所述驱动轴沿自身的轴向移动，以及控制所述夹片相对于所述固定基座开合，以使每一所述夹片与其对应的所述钳臂配合以夹持瓣膜。
  8. 根据权利要求7所述的瓣膜夹合系统，其特征在于，所述输送装置包括：
    输送鞘管；
    操控手柄，设置于所述输送鞘管的近端；
    控制杆，活动穿设于所述输送鞘管的内部，所述控制杆的远端可拆卸地连接于所述驱动轴，所述控制杆的近端连接于所述操控手柄；以及
    至少一根控制线，活动穿设于所述输送鞘管的内部，所述控制线穿设于所述夹片的远端，所述控制线的两末端连接于所述操控手柄。
  9. 根据权利要求8所述的瓣膜夹合系统，其特征在于，所述输送装置还包括两个导线器，两所述导线器设置于所述输送鞘管的远端并关于所述输送鞘管的中心轴线对称，所述导线器包括穿线圈和连接于所述穿线圈与所述输送鞘管的远端之间的连接杆，每一所述穿线圈上均设置有一穿线孔。
  10. 根据权利要求9所述的瓣膜夹合系统，其特征在于，所述控制线的数量与所述夹片的数量相同，每一所述控制线与两所述导线器上的穿线孔和一所述夹片的远端穿设连接。
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