WO2022188845A1 - 一种可回收的瓣膜夹合装置及系统 - Google Patents

一种可回收的瓣膜夹合装置及系统 Download PDF

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Publication number
WO2022188845A1
WO2022188845A1 PCT/CN2022/080246 CN2022080246W WO2022188845A1 WO 2022188845 A1 WO2022188845 A1 WO 2022188845A1 CN 2022080246 W CN2022080246 W CN 2022080246W WO 2022188845 A1 WO2022188845 A1 WO 2022188845A1
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WO
WIPO (PCT)
Prior art keywords
piece
rod
connecting piece
clamping
locking
Prior art date
Application number
PCT/CN2022/080246
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English (en)
French (fr)
Inventor
黄辉
Original Assignee
瀚芯医疗科技(深圳)有限公司
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Publication of WO2022188845A1 publication Critical patent/WO2022188845A1/zh

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    • 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
    • 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
    • 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
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • 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
    • A61F2/2466—Delivery devices therefor

Definitions

  • the invention relates to the field of medical devices, in particular to a retrievable valve clamping device and system.
  • Mitral regurgitation is one of the most common valvular diseases today. The main reasons are mitral annular dilatation, chordae insufficiency, mitral valve mucus degeneration, leaflet prolapse, rheumatic heart valve disease, ischemic disease Wait. Open mitral valvuloplasty and prosthetic valve replacement are the most effective methods for the treatment of mitral insufficiency, but since the operation requires the support of cardiopulmonary bypass, the trauma to the human body is relatively large. patients with schizophrenia have high morbidity and mortality.
  • Mitral valve clamping is the most reliable. Mitral valve clamp sends an implantable clip to the vicinity of the mitral valve through atrial septal puncture, and clamps the free edges of the anterior and posterior leaflets, so that the valve leaflets are well matched at the end of systole and reduce regurgitation, but The opening and closing angle of the clamping arm of the mitral valve clamp cannot be reversed by 180° to form a straight line, which makes the clamping arm always at an inverse angle to the valve leaflet and the chordae tendineae, which makes it easy to hang the chordae tendineae and cannot be recovered into the catheter.
  • a mitral valve clamp whose clamping arm can be opened and closed at a reversible angle, so that the clamping arm is not easy to hang on the chordae tendineae and can be easily recovered into the catheter.
  • the elastic material with the shape memory function is shaped, and the clamping arm completely relies on the elasticity of the material to provide the clamping force, which is not as reliable as the mechanical locking force.
  • the width of the clamp arm also affects the effect of the clamp. When the width of the clamp arm is too large, the delivery system will become larger, so that the larger puncture hole will cause more damage to the patient. When the width of the clamp arm is too small, the clamping area of the clamp is too small, and the clinical effect is poor.
  • the purpose of the present invention is to overcome the above-mentioned deficiencies of the prior art, and to provide a retrievable valve clamping device and system, which can not only ensure the stability of clamping and locking of the clamping arm, but also easily make the valve clamping device easy to use when recovery is required. Almost detached from the chordae tendineae for retrieval of the valve clamping device.
  • a retrievable valve clamping device comprising a clamping piece and a clamping arm, a valve accommodating space is formed between the clamping piece and the clamping arm, a locking assembly, a first connecting piece, a driving rod and a lower a hinge support, the distal end of the first connecting piece is provided with an upper hinge support;
  • the clamping arms include at least one set of outer clamping arms and a set of inner clamping arms, each set of the outer clamping arms includes two left-right symmetrically arranged outer clamping arms, and each set of the inner clamping arms.
  • the group includes two symmetrical inner clamp arms; the inner end of each inner clamp arm is rotatably connected to the upper hinge support, and the inner end of each outer clamp arm is connected to the lower hinge support A rotatable connection, the outer ends of the inner clamping arm and the outer clamping arm on the same side are rotatably connected, and the valve accommodating space is formed between the inner clamping arm and the clamping sheet;
  • the driving rod penetrates through the first connecting piece and the locking assembly and extends downward to be connected with the lower hinge support; thus, the clamping arm can be clamped by driving the driving rod to move up and down Or unfold, when the clip arm is at the maximum deployment angle, the angle between the inner clip arm and the outer clip arm is not less than 90°;
  • the locking assembly is fixedly connected to the distal end of the first connecting piece, and the locking assembly is used for locking the driving rod and thus restricting the up and down movement of the driving rod.
  • the inner clamping arm is connected to the upper hinge support through a first pin
  • the outer clamping arm is connected to the lower hinge support through a second pin
  • the inner clamping arm is connected to the lower hinge support through a second pin.
  • the arm and the outer clamp arm are connected by a third pin;
  • the inner clamp arm is a rigid structure, the outer clamp arm and the lower hinge support are integrally formed by elastic material, and the inner end of the inner clamp arm is supported by the upper hinge through a first pin seat connection;
  • the inner clamping arm, the outer clamping arm and the lower hinge support are integrally shaped by elastic materials.
  • the locking assembly includes a lock seat, a lock member, an elastic member and an unlocking member, the lock member and the elastic member are both arranged in the lock seat, and the lock seat is connected to the lock seat.
  • the first connecting piece is fixedly connected, and the driving rod penetrates the locking seat, the locking piece and the elastic piece;
  • the elastic piece is used to push the lock piece to keep it in a locked state, and the lock piece clamps the drive rod in the locked state;
  • the unlocking member is used to push the locking member and the elastic member to move to achieve unlocking.
  • the elastic member is compressed, and at this time, the driving rod is released from the clamping of the locking member.
  • the lock seat is in the shape of a square frame with a middle part running through it, and a blocking block protruding inward is provided on one side of the inner side wall of the lock seat;
  • the lock piece is a piece In the locked state, the elastic piece pushes the lock piece away from the card One side of the block moves downward, so that the locking piece remains in an inclined state to lock the driving rod;
  • the unlocking member is a closed-loop metal wire passing through the lock base, one side of the unlocking member is limited to the lower side of the blocking block, and the other side is located under the side of the locking member away from the blocking block. side, then, when the unlocking piece is pulled upwards, the unlocking piece will pull the locking piece and the elastic piece away from the blocking block and move upwards, so that the locking piece tends to be in a horizontal state, releasing the locking of the drive lever.
  • the lock seat is in the shape of a square frame with a middle part running through it, and a lock hinge support extending inward is provided on one side of the lock seat;
  • the lock seat is in the shape of a sheet , the middle part of the lock piece is hinged with the lock piece hinge support;
  • the elastic piece is arranged on the upper side of the lock piece; in the locked state, the elastic piece pushes the side of the lock piece to move downward , so that the lock piece keeps the inclined state and then locks the drive rod;
  • the unlocking piece is a closed-loop metal wire passing through the lock base, one side of the unlocking piece is limited to the lower side of the hinged support of the lock piece, and the other side is located at the hinged support of the lock piece away from the lock piece the lower side of one side of the seat, then when the unlocking member is pulled upwards, the unlocking member will pull the locking member and the elastic member away from the side of the hinged support of the locking member to move upwards, so that the The locking piece tends to be in a horizontal state, releasing the locking of the driving rod.
  • the lock seat is in the shape of a square frame with a middle part running through it;
  • the lock member includes two cylindrical bodies, and the two cylindrical bodies are respectively arranged on two sides of the driving rod.
  • the elastic piece pushes the two cylindrical bodies closer to each other, thereby clamping and locking the driving rod;
  • the unlocking member is a closed-loop metal wire passing through the lock base, and the two sides of the unlocking member are respectively restricted to the lower sides of the two cylindrical bodies. Then, when the unlocking member is pulled upward, the two The cylinders move upward while being separated from each other, releasing the locking of the drive rod.
  • extending portions extending outward are provided on both sides of the middle clamping section of the inner clamping arm, and the outer contour of the extending portions is arc-shaped and rounded.
  • a clipping system for a recoverable valve any of the above-mentioned recoverable valve clipping devices, further comprising a delivery device, the delivery device comprising a handle assembly and a tube body assembly, the proximal end of the tube body assembly is connected to the The handle assembly is connected, the distal end is connected with the first connecting piece, and the clamping piece and the clamping arm can be controlled to be clamped and unfolded through the handle assembly.
  • the tube body assembly includes a tube body, a fixed head, a second connector, a sliding rod and a control rod, and the fixed head is fixedly connected to the distal end of the tube body, so The second connecting piece is fixedly connected with the fixing head, and a corresponding buckling structure is arranged between the second connecting piece and the first connecting piece;
  • the distal end of the control rod is connected with a sliding rod, and the sliding rod is detachably connected with the proximal end of the driving rod; after the second connecting piece is fastened with the first connecting piece, the sliding rod can be driven
  • the control rod drives the sliding rod to move, thereby driving the sliding rod to connect with the driving rod.
  • the second connecting piece is tubular, and the sliding rod can freely extend and rotate through the inside of the second connecting piece;
  • the sliding rod and the driving rod are threadedly connected, and after the second connecting piece is fastened with the first connecting piece, the sliding rod is driven to extend into the first connecting piece, and then rotated.
  • the sliding rod can connect and fix the sliding rod and the driving rod, and at the same time lock the buckle structure.
  • the sliding rod is a hollow tube, the proximal end of the sliding rod extends into the tube body and is connected to the control rod, and the distal end extends downward to cover the The outer periphery of the second connector;
  • the side wall of the second connecting piece is provided with a convex block protruding outward for connecting with the fixed head, the middle part of the sliding rod is provided with a sliding groove for allowing the convex block to pass through, and the convex block is provided in the middle of the sliding rod.
  • the block is connected and fixed with the fixed head through the chute from the inside of the sliding rod;
  • the proximal end of the drive rod is provided with an outwardly protruding boss
  • the distal end of the sliding rod is provided with an L-shaped slot that allows the boss to slide in, and the width of the sliding slot is not less than the width of the
  • the width of the L-shaped card slot allows the sliding rod to rotate relative to the second connecting piece;
  • the first connecting piece and the second connecting piece are provided with corresponding slideways that allow the boss to slide.
  • the sliding rod is driven to move and rotate, so that the boss can be clamped in the L-shaped slot, and the buckle can be fastened at this time.
  • the structure is locked.
  • the buckle structure includes an elastic hook provided at the distal end of the second connecting piece and a button hole provided at the proximal end of the first connecting piece.
  • the button holes correspond to the elastic buckles, and in a natural state, the elastic buckles automatically shrink inwardly and disengage from the buckles with the buckle holes;
  • the delivery device further includes two first strings, the proximal ends of the first strings are connected to the handle assembly, and the distal ends pass through the tube assembly.
  • the inner part protrudes from the distal end of the tube body assembly and is connected with the clamping piece, and each of the first wire ropes is respectively connected with one of the clamping pieces, so that the first wire can be pulled by pulling the first wire rope. Pulling the clamping piece to clamp and contract, and loosening the first string can make the clamping piece freely unfold.
  • the delivery device further includes a second wire, the proximal end of the second wire is connected to the handle assembly, and the distal end passes through the inside of the tube body assembly and then passes through the tube body assembly.
  • the distal end of the tube assembly is extended and connected to the locking assembly, whereby the locking assembly can be unlocked by pulling the second wire, and the locking assembly can be freely locked by loosening the second wire.
  • the handle assembly includes a casing, a telescopic rod, a telescopic adjustment knob and a rotation adjustment knob, the telescopic adjustment knob is rotatably mounted on the proximal end of the casing, and the telescopic rod is installed.
  • the distal end extends into the casing and is slidably connected to the casing, and the proximal end extends out of the casing and passes through the telescopic adjustment knob, and the telescopic rod is threadedly connected to the telescopic adjustment knob;
  • the rotation adjustment knob is rotatably mounted on the proximal end of the telescopic rod, the telescopic rod is provided with a sliding hole allowing the proximal end of the control rod to pass through, and the proximal end of the control rod passes through the sliding hole and the The rotation adjustment knob is connected, so that rotating the rotation adjustment knob can drive the control rod to rotate; rotating the telescopic adjustment knob can drive the telescopic rod to telescopically move, thereby driving the control rod to telescopically move.
  • the handle assembly includes two first pull rods, and each of the first pull rods is respectively connected to a first wire rope, which can be achieved by pulling the first pull rods. Pull the first cord.
  • the handle assembly includes a second pull rod, the second pull rod is connected with the second wire, and the second wire can be pulled by pulling the second pull rod.
  • the present invention has the following beneficial effects: the present invention provides a retrievable valve clamping device and system.
  • the clamping device adopts a mechanical locking structure. After the clamping arms are clamped, a stable and reliable locking force can be provided and the clamping device is reduced The risk of falling off; the inner clamping arm of the valve clamping device can be reversed. When the valve clamping device needs to be retracted, the clamping arm can be driven to fully unfold, and the inner clamping arm facing the clamping sheet will not reverse. The angle hooks the chordae so that the clamp arm can be easily detached from the chordae plexus for retrieval.
  • Fig. 1 is the anatomical structure diagram of human heart
  • FIG. 2 is a schematic diagram of the overall structure of the retrievable valve clamping device of the present invention.
  • FIG. 3 is a schematic structural diagram of the retrievable valve clamping device of the present invention when it is clamped;
  • FIG. 4 is a schematic structural diagram of the retrievable valve clamping device of the present invention when it is unfolded at a certain angle;
  • FIG. 5 is a schematic structural diagram of the retrievable valve clamping device of the present invention when it is fully deployed
  • FIG. 6 is a schematic diagram of the retrievable valve clamping device of the present invention opened at a certain angle at the mitral valve leaflet;
  • Fig. 7 is the partial enlarged schematic diagram of Fig. 6;
  • FIG. 8 is a schematic view of the fully deployed mitral valve leaflet of the retrievable valve clamping device of the present invention.
  • Fig. 9 is the partial enlarged schematic diagram of Fig. 8.
  • Fig. a1 is the structural schematic diagram when the embodiment a of the present invention is unfolded at a certain angle
  • Fig. a2 is the structural representation when the embodiment a of the present invention is fully unfolded
  • Figure b1 is a schematic structural diagram of Embodiment b of the present invention when unfolded at a certain angle;
  • Figure b2 is a schematic structural diagram of Embodiment b of the present invention when it is fully expanded;
  • FIG. 10 is a schematic structural diagram of the locking assembly of the present invention when it is locked
  • FIG. 11 is a schematic structural diagram of the locking assembly of the present invention when it is unlocked
  • Figure c1 is a schematic structural diagram of Embodiment c of the present invention when it is locked;
  • Figure c2 is a schematic structural diagram of Embodiment c of the present invention when it is unlocked;
  • Figure d1 is a schematic structural diagram of Embodiment d of the present invention when it is locked;
  • Fig. d2 is the structural schematic diagram when the embodiment d of the present invention is unlocked
  • Fig. 12 is the side view structure schematic diagram of the clamp arm of the present invention.
  • FIG. 13 is a schematic structural diagram of the conveying device of the present invention.
  • FIG. 14 is a schematic diagram of the exploded structure of the tubular body assembly and the valve clamping device of the present invention.
  • 15 is a schematic structural diagram of the connection between the first connector and the second connector of the present invention.
  • Figure e1 is a schematic diagram of the exploded structure of the tubular body assembly and the valve clamping device according to the embodiment e of the present invention
  • Figure e2 is a schematic structural diagram of the connection between the first connector and the second connector according to the embodiment e of the present invention.
  • FIG. e3 is a schematic structural diagram of the unlocked structure after the first connector and the second connector are buckled according to the embodiment e of the present invention
  • Figure f1 is a schematic structural diagram of the connection between the first connector and the second connector according to Embodiment f of the present invention.
  • Fig. f2 is a schematic diagram of the exploded structure of the first connector and the second connector according to the embodiment f of the present invention
  • 16 is a schematic structural diagram of the connection between the tubular body assembly of the present invention and the valve clamping device;
  • FIG. 17 is a schematic diagram of the overall structure of the handle assembly of the present invention.
  • FIG. 18 is a schematic cross-sectional view of the handle assembly of the present invention.
  • a retrievable valve clamping device includes a clamping piece 1 and a clamping arm 2, and a valve accommodating space 11 is formed between the clamping piece 1 and the clamping arm 2, then, when clamping the valve leaflets LF , the two valve leaflets LF extend into the two valve accommodating spaces 11 respectively, the valve leaflets LF can be clamped by the clamping sheet 1 and the clamping arm 2, and the valve clamping device also includes a locking component 3, a first connecting piece 5 , the drive rod 4 and the lower hinge support 41, the distal end of the first connecting piece 5 is provided with an upper hinge support 51;
  • the clamp arm 2 includes at least one group of outer clamp arm groups and one group of inner clamp arm groups (preferably one group, when multiple groups are required, multiple groups of outer clamp arm groups and inner clamp arm groups are arranged side by side), and each group of outer clamp arms is arranged side by side.
  • the arm group includes two left-right symmetrical outer clamping arms 22, and each inner clamping arm group includes two left-right symmetrical inner clamping arms 21; the inner end of each inner clamping arm 21 and the upper hinge support 51 can be Rotationally connected, the inner end of each outer clamping arm 22 is rotatably connected to the lower hinge support 41, the inner clamping arm 21 and the outer end of the outer clamping arm 22 on the same side are rotatably connected, and the inner clamping arm 21 and the clamping piece 1 A valve accommodating space 11 is formed between them; it should be noted that the "inner end and outer end” here are judged based on the central axis of the driving rod, and the ends of the inner and outer clamping arms close to the central axis of the driving rod are the inner side. end, the end away from the central axis of the driving rod is the outer end, and the result shown in Figure 2 can be referred to;
  • the driving rod 4 penetrates through the first connecting piece 5 and the locking assembly 3 and extends downward to connect with the lower hinge support 41; thus, the clamping arm 2 can be clamped or unfolded by driving the driving rod 4 to move up and down, and the clamping arm 2 At the maximum deployment angle, the angle between the inner clamp arm 21 and the outer clamp arm 22 (the angle between the inner clamp arm 21 and the outer clamp arm 22 towards the direction of the drive rod 4) is not less than 90°.
  • the inner clamp arm 21 There will be no reverse angle on the side facing the clamping piece to hook the chordae tendineae, which can ensure that the valve clamping device can be easily disengaged from the chordae tendineae; preferably, the angle between the inner clamping arm 21 and the outer clamping arm 22 Above 120°, preferably above 160°;
  • the locking assembly 3 is fixedly connected to the distal end of the first connecting piece 5 (in the description of the present invention, the distal end refers to the end away from the operator, and the proximal end refers to the end close to the operator), and the locking assembly 3 is used to lock the drive rod 4 further restricts the up and down movement of the drive rod 4 .
  • the unfolding angle of the clamping arm 2 can be changed.
  • the clamp arm is in the clamped state, at this time, the drive rod 4 pulls the lower hinge support 41 to move up to the highest position, and the angle between the inner clamp arm 21 and the outer clamp arm 22 is close to 0;
  • Fig. 4 In the middle, the driving rod 4 pushes the lower hinge support 41 to move downward, and a certain angle is unfolded between the inner clip arm 21 and the outer clip arm 22, and the inner clip arm 21 is pulled down to unfold;
  • the clip arm 2 is in the In the maximum deployment state, the drive rod 4 pushes the lower hinge support 41 to move down to the lowest position, and the angle between the legs of the inner clamp arm 21 and the outer clamp arm 22 approaches 180°.
  • the valve clamping device is delivered through the left atrium LA to the middle position of the mitral valve MV vertically through the delivery device, and the delivery device is controlled to control the clip at this time.
  • the valve leaflet is extended into the valve accommodating space 11, and the clip arm 2 is used to clamp the valve leaflet, and the opening and closing angle of the clip arm 2 is adjusted so that the mitral valve reaches Best closed state.
  • valve clamping device When the valve clamping device needs to be taken out after the treatment is completed, referring to FIG. 7 , since the clip arm will hang on the chordae CT after the clip arm is opened, and the opened clip arm 2 cannot be taken out upward under the blocking of the mitral valve MV. For this reason, referring to FIGS. 8-9, when the valve clamping device of the present invention is taken out, the lower hinge support 41 can be pushed down by the driving rod 4, so that the clamping arm 2 is turned over and fully unfolded.
  • the entire valve clamping device is The width of the clip arm 2 reaches the minimum value, and there is no angle between the clip arm 2 and the valve leaflets and chordae tendineae, so that it can be easily escaped from the chordae tendineae plexus and pulled out freely, thus realizing the retrievability of the valve clipping device.
  • the inner clip arm 21 is connected to the upper hinge support 51 through the first pin 23
  • the outer clip arm 22 is connected to the lower hinge support through the second pin 24 .
  • 41 connection, the inner clamping arm 21 and the outer clamping arm 22 are connected by the third pin 23; each component is connected by rotation through the pin, thus the free rotation of the inner clamping arm 21 and the outer clamping arm 2 can be realized, and the present invention can be realized function.
  • the clip arm connection structure of the present invention also has other possible implementations.
  • Example a and Example b are listed as supplementary descriptions, but it should be noted that the protection scope of the present invention is not limited to this. , and the embodiments obtained by conventional transformation means all belong to the protection scope of the present invention.
  • the inner clamp arm 21 is a rigid structure
  • the outer clamp arm 22 and the lower hinge support 41 are integrally shaped by elastic materials
  • the inner end of the inner clamp arm 22 is connected to the upper hinge support 51 through a first pin connection;
  • the elastic material is preferably a nickel-titanium alloy material.
  • the inner clamp arm 21, the outer clamp arm 22 and the lower hinge support 41 are integrally shaped by elastic materials.
  • the elastic material is preferably a nickel-titanium alloy material.
  • the locking assembly 3 includes a lock base 31, a lock piece 32, an elastic piece 33 and an unlocking piece 34, and the lock piece 32 and the elastic piece 33 are both arranged in the lock base 31,
  • the lock seat 31 is fixedly connected with the first connector 5, and the connection method is not limited to: welding, riveting, screw connection, and bonding, and laser welding is preferred here;
  • the driving rod 4 penetrates the lock seat 31, the lock member 32 and the elastic member 33;
  • the elastic piece 33 is used to push the lock piece 32 to keep it in the locked state, and the lock piece 32 clamps the driving rod 4 in the locked state;
  • the unlocking member 34 is used to push the locking member 32 and the elastic member 33 to move to achieve unlocking.
  • the elastic member 33 is compressed, and at this time, the driving rod 4 is released from the clamping of the locking member 32 .
  • the lock seat 31 is in the shape of a square frame with the middle part penetrating, and a blocking block 311 protruding inward is provided on one side of the inner side wall of the lock seat 31;
  • the lock piece 32 is a piece In the locked state, the elastic member 33 pushes the side of the locking member 32 away from the blocking block 311 and moves downwards. , so that the locking piece 32 keeps the inclined state and then locks the driving rod 4 ; by locking the driving rod 4 , the opening and closing angle of the clamping arm 2 is locked.
  • the material of the lock member 32 is a cemented carbide suitable for implantation, such as cobalt-based alloy, titanium alloy, and cobalt-chromium alloy is preferred here, and the material of the elastic member 33 is an elastic material suitable for implantation, such as nickel-titanium alloy, 316L Stainless steel, here preferably Nitinol;
  • the unlocking member 34 is a closed-loop metal wire passing through the lock base 31.
  • One side of the unlocking member 34 is limited to the lower side of the locking block 311, and the other side is located on the lower side of the side of the locking member 32 away from the locking block 311. Then, pull up.
  • the side of the unlocking member 34 restricted by the blocking block 311 does not move. Unlock the drive lever 4 .
  • the unlocking principle is that a through hole with a diameter larger than that of the drive rod 4 is opened on the lock piece 32. When the lock piece 32 is in an inclined state, the lock piece 32 will clamp both sides of the drive rod 4, thereby removing the drive rod 4. After clamping, when the lock member 32 is in a horizontal state, the through hole with a larger diameter in the lock member 32 cannot restrict the drive rod 4, thereby realizing unlocking.
  • the locking assembly structure of the present invention has other possible implementations, and the embodiment c and the embodiment d are listed here for supplementary description, but it should be noted that the protection scope of the present invention is not limited to this, The embodiments obtained by conventional transformation means all belong to the protection scope of the present invention.
  • the lock seat 31 is in the shape of a square frame with the middle part running through, and a lock hinge support 312 extending inward is provided on one side of the lock seat 31;
  • the hinge support 312 is hinged;
  • the elastic member 33 is arranged on the upper side of the lock member 32; in the locked state, the elastic member 33 moves downward against the side of the push lock member 32, so that the lock member 32 keeps the inclined state and then locks the driving rod 4
  • the lock hinge support 312 is located on one side of the drive rod 4, and only one side of the lock 32 is connected to the lock hinge support 312 through a hinge;
  • the unlocking member 34 is a closed-loop metal wire passing through the lock base 31 , one side of the unlocking member 34 is limited to the lower side of the lock member hinge support 312 , and the other side is located under the side of the lock member 32 away from the lock member hinge support 312 . Then, when the unlocking member 34 is pulled upward, the unlocking member 34 will move the side of the locking member 32 and the elastic member 33 away from the hinged support 312 of the locking member upwards, so that the locking member 32 tends to be in a horizontal state, releasing the lock on the driving rod 4 . lock.
  • the lock seat 131 is in the shape of a square frame with the middle part penetrating;
  • the lock member includes two columnar bodies 321, the two columnar bodies 321 are respectively arranged on both sides of the driving rod 4, and the elastic member 33 is arranged on the two columnar bodies The upper side of the body 321; in the locked state, the elastic member 33 pushes the two cylindrical bodies 321 closer to each other, thereby clamping and locking the driving rod 4;
  • the unlocking member 34 is a closed-loop metal wire passing through the lock base 31 , and the two sides of the unlocking member 34 are respectively restricted to the lower sides of the two cylindrical bodies 321 . Then, when the unlocking member 34 is pulled upward, the two cylindrical bodies 321 move upwards at the same time as each other. Disengage and unlock the drive lever 4 .
  • extending portions 211 extending outward are provided on both sides of the middle clamping section of the inner clamping arm 21 , and the outer contour of the extending portions 211 is arc-shaped and rounded.
  • the extension part 211 increases the area of the valve clamping device to clamp the valve leaflet to reduce regurgitation.
  • the width dimension A of the extension part 211 affects the clamping area of the valve leaflet. The range is set as: 0.2 ⁇ 5mm.
  • the outer contour of the extension part 32 is arc-shaped and rounded so as not to damage the valve.
  • a clamping system of a retrievable valve including the above-mentioned retrievable valve clamping device, also includes a delivery device, with reference to FIG.
  • the handle assembly 7 is connected, and the distal end is connected with the first connecting piece 5 , and the clamping piece 1 and the clamping arm 2 can be controlled to be clamped and unfolded through the handle assembly 7 .
  • the pipe body assembly 6 includes a pipe body 61 , a fixed head 62 , a second connecting piece 63 , a sliding rod 64 and a control rod 65 , and the fixed head 62 is fixedly connected to the distal end of the pipe body 61 .
  • the second connector 63 is fixedly connected with the fixing head 62, and a corresponding buckle structure is provided between the second connector 63 and the first connector 5;
  • the distal end of the control rod 65 is connected with the sliding rod 64, and the sliding rod 64 is detachably connected with the proximal end of the driving rod; when the second connecting piece 63 is engaged with the first connecting piece 5, the control rod 65 can be driven to drive the sliding rod 64 Therefore, the sliding rod 64 is driven to be connected with the driving rod 4 .
  • the snap-fit structure is locked.
  • the second connecting member 63 is tubular, and the sliding rod 64 can freely extend and rotate through the interior of the second connecting member 63;
  • the sliding rod 64 is threadedly connected with the driving rod 4. After the second connecting piece 63 is engaged with the first connecting piece 5, the driving sliding rod 64 extends into the first connecting piece 5, and then the sliding rod 64 is rotated to remove the sliding rod 64 is connected and fixed with the driving rod 4, and at the same time locks the buckle structure.
  • the locking principle can be understood with reference to Fig. 15. When the first connecting member 5 and the second connecting member 6 are buckled, the two connecting members cannot move up and down relative to each other, but can only move left and right. 4, thereby restricting the left and right movement between the two connecting pieces, thereby ensuring that the two connecting pieces are locked and cannot be disengaged.
  • connection and fixing structure of the first connector and the second connector of the present invention can be implemented in other ways.
  • the embodiment e and the embodiment f are listed for supplementary description, but it should be noted that this The protection scope of the invention is not limited to this, and the embodiments obtained by conventional transformation means all belong to the protection scope of the present invention.
  • the sliding rod 64 is a hollow tubular shape, and the proximal end of the sliding rod 64 extends into the tube body 61 and is connected to the control rod 65.
  • the sliding rod 64 can be driven to move up and down and rotate through the control rod 65, and the distal end extends the sleeve downward. on the periphery of the second connector 63;
  • the side wall of the second connecting member 63 is provided with a protrusion 631 protruding outward for connecting with the fixing head 62 , and a sliding groove 641 is provided in the middle of the sliding rod 64 to allow the protrusion 631 to pass through.
  • the inside of the rod 64 is connected and fixed with the fixed head 62 through the chute 641;
  • the proximal end of the drive rod 4 is provided with a boss 42 protruding outward
  • the distal end of the sliding rod 64 is provided with an L-shaped slot 642 that allows the boss 42 to slide in, and the width of the slot 641 is not smaller than the L-shaped slot.
  • the driving rod 4 can slide between the first connecting piece 5 and the second connecting piece 63; then, when the boss 42 is snapped into the L-shaped slot 642, the sliding rod 64 moves up and down It will drive the driving rod 4 to move up and down, when the driving rod 4 moves up and down, the boss 42 will move up and down along the slideway 52;
  • the sliding rod 64 is driven to move and rotate, so that the boss 42 can be clamped in the L-shaped slot 642, and the fastening structure can be locked at this time.
  • the snap-fit structure includes an elastic hook 632 provided at the distal end of the second connecting member 63 and a button hole 53 provided at the proximal end of the first connecting member 5.
  • the button hole 53 corresponds to the elastic hook 32.
  • the elastic buckle 632 automatically shrinks inwardly and disengages from the buckle hole 53;
  • the delivery device further includes two first strings 66 .
  • the distal end of the tube body assembly 6 protrudes and is connected to the clamping piece 1 , and each first wire 66 is connected to a clamping piece 1 respectively, so that the clamping piece 1 can be pulled to be clamped and contracted by pulling the first wire 66 , loosening the first wire 66 can make the clamping piece 1 unfold freely. Therefore, when clamping the leaflets, the clamping arm 2 needs to be unfolded.
  • the clamping piece 1 itself is elastic, it will be automatically unfolded, so at this time, it is necessary to pull the clamping piece 1 through the first wire 66 to make it merge, so as to It is ensured that the valve accommodating space 11 is bottomed out, so that the valve leaflets can freely extend into the valve accommodating space 11 .
  • the delivery device further includes a second wire 67 .
  • the proximal end of the second wire 67 is connected to the handle assembly 7 , and the distal end passes through the interior of the tube assembly 6 from the distal end of the tube assembly 6 . Extends and connects with the locking assembly 3, whereby the locking assembly 3 can be unlocked by pulling the second wire 67, and the locking assembly 3 can be freely locked by loosening the second wire 67.
  • the second wire 67 is connected to the unlocking member 34 of the locking assembly 3 , and the unlocking member 34 can be pulled to unlock by pulling the second wire 67 .
  • the first wire rope 66 and the second wire rope 67 need to have good flexibility, bending resistance, tensile resistance, and wear resistance.
  • the wire rope can be multi-strand stainless steel Molecular weight polyethylene braided rope, multi-strand nickel-titanium wire rope, and ultra-high molecular weight polyethylene braided rope is preferred here.
  • the handle assembly 7 includes a casing 71 , a telescopic rod 72 , a telescopic adjustment knob 73 and a rotation adjustment knob 74 , and the telescopic adjustment knob 73 is mounted on the proximal end of the casing 71 ,
  • the distal end of the telescopic rod 72 extends into the casing 71 and is slidably connected to the casing 71, and its proximal end extends out of the casing 71 and passes through the telescopic adjustment knob 73, and the telescopic rod 72 is threadedly connected to the telescopic adjustment knob 73; Rotate the telescopic adjustment knob 73 to push the telescopic rod 72 to move up and down;
  • the rotation adjustment knob 74 is rotatably mounted on the proximal end of the telescopic rod 72 .
  • the telescopic rod 72 is provided with a sliding hole 721 allowing the proximal end of the control rod 65 to pass through, and the proximal end of the control rod 65 is connected to the rotation adjustment knob 74 through the sliding hole 721 Therefore, rotating the rotary adjusting knob 74 can drive the control rod 65 to rotate; rotating the telescopic adjusting knob 73 can drive the telescopic rod 72 to telescopically move, thereby driving the control rod 65 to telescopically move.
  • a locking pin 75 for locking the rotation adjustment knob 74 is provided on one side of the telescopic rod 72.
  • the rotation adjustment knob 74 cannot be rotated, which can be avoided at this time.
  • the rotary adjustment knob 74 rotates freely; when the rotation adjustment knob 74 needs to be rotated, it is only necessary to loosen the locking nail 75 to operate.
  • a guide block 76 for limiting the control rod 65 is also provided in the housing 71 .
  • the guide block has a guide hole for allowing the control rod 65 to pass through, so as to ensure the stable movement and rotation of the control rod 65 .
  • the handle assembly 7 includes two first pull rods 77 , and each first pull rod 77 is respectively connected with a first wire 66 , and the first wire 66 can be pulled by pulling the first pull rod 77 .
  • the handle assembly 7 includes a second pull rod 78 , the second pull rod 78 is connected with the second wire 67 , and the second wire 67 can be pulled by pulling the second pull rod 78 .

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Abstract

一种可回收的瓣膜夹合装置及系统，该瓣膜夹合装置包括夹持片（1）、夹臂（2）、锁定组件（3）、第一连接件（5）、驱动杆（4）和下铰支座（41），第一连接件（5）的远端设有上铰支座（51）；夹臂（2）包括内夹臂（21）和外夹臂（22），内夹臂（21）的内侧端与上铰支座（51）可转动连接，外夹臂（22）的内侧端与下铰支座（41）可转动连接，同一侧的内夹臂（21）和外夹臂（22）的外侧端可转动连接；驱动杆（4）贯穿穿过第一连接件（5）以及锁定组件（3）并往下延伸与下铰支座（41）连接；从而，通过驱动驱动杆（4）上下移动令夹臂夹合或展开，夹臂处于最大展开角时，内夹臂（21）和外夹臂（22）之间的夹角不小于160°。该可回收的瓣膜夹合装置及系统既能够保证夹臂夹合锁定稳定，在需要回收时，又能够使瓣膜夹合装置轻松从腱索丛中摆脱，以此实现对瓣膜夹合装置的回收。

Description

一种可回收的瓣膜夹合装置及系统 技术领域
本发明涉及医疗器械领域，尤其是涉及一种可回收的瓣膜夹合装置及系统。
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，但二尖瓣钳夹的夹臂的开合角度无法完成180°的反转形成直线，这使得夹臂始终与瓣叶以及腱索呈逆角，导致容易挂腱索且不能回收至导管中。另外有一个二尖瓣钳夹其夹臂可以开合角度可反转，使得其夹臂不易挂腱索，并能轻松回收至导管中，但由于其夹臂及其夹臂连接部都是由具有形状记忆功能的弹性材料定型而成，夹臂夹合时完全依赖该材料的弹性来提供夹合力，这种夹合锁定力不如机械式的锁定力牢靠。另外该夹臂的宽度尺寸也影响着所述钳夹的效果，当所述夹臂宽度过大时会导致所述输送系统变大，从而使所述穿刺孔变大对病人的损伤更大，当夹臂宽度过小时所述夹钳的夹合面积过小，临床效果差。
发明内容
本发明的目的在于克服上述现有技术之不足，提供一种可回收的瓣膜夹合装置及系统，既能够保证夹臂夹合锁定里稳定，在需要回收时，又能够轻松使瓣膜夹合装置轻松从腱索丛中摆脱，以此实现对瓣膜夹合装置的回收。
本发明的目的通过以下技术方案予以实现：
一种可回收的瓣膜夹合装置，包括夹持片和夹臂，所述夹持片和所述夹臂之间形成有瓣膜容纳空间，还包括锁定组件、第一连接件、驱动杆和下铰支座，所述第一连接件的远端设有上铰支座；
所述夹臂包括有至少一组外夹臂组和一组内夹臂组，每一组所述外夹臂组包 括有两个左右对称设置的外夹臂，每一组所述内夹臂组包括有两个左右对称的内夹臂；每一所述内夹臂的内侧端与所述上铰支座可转动连接，每一所述外夹臂的内侧端与所述下铰支座可转动连接，同一侧的所述内夹臂和所述外夹臂的外侧端可转动连接，所述内夹臂和所述夹持片之间形成所述瓣膜容纳空间；
所述驱动杆贯穿穿过所述第一连接件以及所述锁定组件并往下延伸与所述下铰支座连接；从而，通过驱动所述驱动杆上下移动可实现令所述夹臂夹合或展开，所述夹臂处于最大展开角时，所述内夹臂和所述外夹臂之间的夹角不小于90°；
所述锁定组件固定连接于所述第一连接件的远端，所述锁定组件用于锁定所述驱动杆进而限制所述驱动杆的上下移动。
进一步的，上述瓣膜夹合装置中，所述内夹臂通过第一销钉与所述上铰支座连接，所述外夹臂通过第二销钉与所述下铰支座连接，所述内夹臂和外夹臂之间通过第三销钉连接；
或，所述内夹臂为刚性结构，所述外夹臂与所述下铰支座为一体由弹性材料定型而成，所述内夹臂的内侧端通过第一销钉与所述上铰支座连接；
或，所述内夹臂、外夹臂和下铰支座为一体由弹性材料定型而成。
进一步的，上述瓣膜夹合装置中，所述锁定组件包括锁座、锁件、弹性件和解锁件，所述锁件和弹性件均设于所述锁座内，所述锁座与所述第一连接件固定连接，所述驱动杆贯穿所述锁座、锁件和弹性件；
所述弹性件用于抵推所述锁件使其保持锁定状态，锁定状态时所述锁件卡紧所述驱动杆；
所述解锁件用于推动所述锁件和所述弹性件移动实现解锁，解锁时所述弹性件被压缩，此时所述驱动杆脱离所述锁件的卡紧。
作为上述瓣膜夹合装置的一种实施方式，所述锁座为中部贯穿的方型框状，所述锁座的内侧壁一侧设有一向内凸起的卡块；所述锁件为片状，所述锁件的一侧卡在所述卡块上侧；所述弹性件设于所述锁件上侧；在锁定状态下，所述弹性件抵推所述锁件远离所述卡块的一侧向下移动，使得所述锁件保持倾斜状态进而将所述驱动杆锁紧；
所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件一侧被限制在所述卡块下侧，另一侧位于所述锁件远离所述卡块的一侧的下侧，则，向上拉动所述解锁件时，所述解锁件将拉动所述锁件和所述弹性件远离所述卡块的一侧向上移动，使得所述锁件趋于水平状态，解除对所述驱动杆的锁定。
作为上述瓣膜夹合装置的一种实施方式，所述锁座为中部贯穿的方型框状， 所述锁座一侧设有一向内延伸的锁件铰支座；所述锁件为片状，所述锁件的中部与所述锁件铰支座铰接；所述弹性件设于所述锁件上侧；在锁定状态下，所述弹性件抵推所述锁件一侧向下移动，使得所述锁件保持倾斜状态进而将所述驱动杆锁紧；
所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件一侧被限制在所述锁件铰支座下侧，另一侧位于所述锁件远离所述锁件铰支座的一侧的下侧，则，向上拉动所述解锁件时，所述解锁件将拉动所述锁件和所述弹性件远离所述锁件铰支座的一侧向上移动，使得所述锁件趋于水平状态，解除对所述驱动杆的锁定。
作为上述瓣膜夹合装置的一种实施方式，所述锁座为中部贯穿的方型框状；所述锁件包括两个柱状体，两个所述柱状体分别设在所述驱动杆的两侧，所述弹性件设于两个所述柱状体上侧；在锁定状态下，所述弹性件抵推两个所述柱状体彼此靠拢，从而将所述驱动杆夹紧锁紧；
所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件的两侧分别被限制在两个所述柱状体下侧，则，向上拉动所述解锁件时，两个所述柱状体向上移动同时彼此分离，解除对所述驱动杆的锁定。
进一步的，上述瓣膜夹合装置中，所述内夹臂的中部夹合段处两侧设有往外伸出的延伸部，所述延伸部的外轮廓呈弧形圆角。
一种可回收瓣膜的夹合系统，上述任意一种可回收的瓣膜夹合装置，还包括输送装置，所述输送装置包括手柄组件和管体组件，所述管体组件的近端与所述手柄组件连接，远端与所述第一连接件连接，通过所述手柄组件可控制所述夹持片以及所述夹臂的夹合与展开。
进一步的，上述瓣膜的夹合系统中，所述管体组件包括管体、固定头、第二连接件、滑杆和控制杆，所述固定头固定连接于所述管体的远端，所述第二连接件与所述固定头固定连接，所述第二连接件和所述第一连接件之间设有相对应的扣合结构；
所述控制杆的远端与滑杆连接，所述滑杆与所述驱动杆的近端可拆卸连接；当所述第二连接件与所述第一连接件扣合后，可驱动所述控制杆带动所述滑杆运动，从而驱动所述滑杆与所述驱动杆连接，当所述滑杆与所述驱动杆连接固定时，所述扣合结构被锁定。
作为上述瓣膜的夹合系统的一种实施方式，所述第二连接件为管状，所述滑杆可穿过所述第二连接件内部自由伸出和旋转；
所述滑杆与所述驱动杆之间螺纹连接，当所述第二连接件与所述第一连接件 扣合后，驱动所述滑杆伸入所述第一连接件内，再转动所述滑杆可将所述滑杆与所述驱动杆连接固定，同时将所述扣合结构锁定。
作为上述瓣膜的夹合系统的一种实施方式，所述滑杆为中空的管状，所述滑杆近端延伸入所述管体内与所述控制杆连接，远端往下延伸套在所述第二连接件外周；
所述第二连接件的侧壁设有向外凸出的用于与所述固定头连接的凸块，所述滑杆的中部开设有允许所述凸块穿过的滑槽，所述凸块从所述滑杆内部穿过所述滑槽与所述固定头连接固定；
所述驱动杆的近端设有一向外凸出的凸台，所述滑杆的远端开设有允许所述凸台滑入的L型卡槽，且所述滑槽的宽度不小于所述L型卡槽的宽度，从而允许所述滑杆相对所述第二连接件转动；所述第一连接件和第二连接件均开设有对应的允许所述凸台滑动的滑道，所述第一连接件和第二连接件扣合后，所述驱动杆可在所述第一连接件和第二连接件之间滑动；
在将所述第一连接件和第二连接件扣合后，驱动所述滑杆移动和转动，可使所述凸台卡紧在所述L型卡槽内，此时可将所述扣合结构锁紧。
作为上述瓣膜的夹合系统的一种实施方式，所述扣合结构包括设在所述第二连接件远端的弹性扣钩和设在所述第一连接件近端的扣孔，所述扣孔与所述弹性扣钩对应，在自然状态下，所述弹性扣钩自动向内收缩脱离与所述扣孔的扣合；
则，在将所述第一连接件和第二连接件连接时，将所述弹性扣钩插入所述第一连接件内，再驱动所述滑杆伸入所述第一连接件内与所述驱动杆连接，此时所述滑杆抵推所述弹性扣钩向外转动与所述扣孔扣合，进而实现将所述扣合结构锁定。
进一步的，上述瓣膜的夹合系统中，所述输送装置还包括有两根第一线绳，所述第一线绳的近端与所述手柄组件连接，远端穿过所述管体组件内部后从所述管体组件的远端伸出并且与所述夹持片连接，每一所述第一线绳分别连接一个所述夹持片，以此通过拉动所述第一线绳可拉动所述夹持片夹合收缩，放松所述第一线绳可使所述夹持片自由展开。
进一步的，上述瓣膜的夹合系统中，所述输送装置还包括有第二线绳，所述第二线绳的近端与所述手柄组件连接，远端穿过所述管体组件内部后从所述管体组件的远端伸出并且与所述锁定组件连接，以此通过拉动所述第二线绳可使所述锁定组件解锁，放松所述第二线绳可使所述锁定组件自由锁定。
进一步的，上述瓣膜的夹合系统中，所述手柄组件包括壳体、伸缩杆、伸缩调节旋钮和旋转调节旋钮，所述伸缩调节旋钮转动安装于所述壳体的近端，所述 伸缩杆远端伸入所述壳体内与所述壳体滑动连接且其近端伸出所述壳体外并穿过所述伸缩调节旋钮，所述伸缩杆与所述伸缩调节旋钮螺纹连接；
所述旋转调节旋钮转动安装于伸缩杆近端，所述伸缩杆内开有允许所述控制杆的近端穿过的滑孔，所述控制杆的近端穿过所述滑孔与所述旋转调节旋钮连接，从而，转动所述旋转调节旋钮可带动所述控制杆转动；旋转所述伸缩调节旋钮可带动所述伸缩杆伸缩移动，进而带动所述控制杆伸缩移动。
进一步的，上述瓣膜的夹合系统中，所述手柄组件包括有两个第一拉杆，每一所述第一拉杆分别连接一根所述第一线绳，通过拉动所述第一拉杆可实现拉动所述第一线绳。
进一步的，上述瓣膜的夹合系统中，所述手柄组件包括有第二拉杆，所述第二拉杆与所述第二线绳连接，通过拉动所述第二拉杆可实现拉动所述第二线绳。
本发明具有如下有益效果：本发明提供了一种可回收的瓣膜夹合装置及系统，该夹合装置采用机械式锁定结构，夹臂夹合后能提供稳定牢靠的锁定力，降低夹合装置脱落的风险；该瓣膜夹合装置的内夹臂可反转，在需要将瓣膜夹合装置回收时，可驱动夹臂完全展开，此时内夹臂朝向夹持片的一侧不会有逆角勾住腱索，从而使得夹臂能够轻松从腱索丛中摆脱实现回收。
附图说明
图1为人体心脏的解剖结构图；
图2为本发明的可回收的瓣膜夹合装置的整体结构示意图；
图3为本发明的可回收的瓣膜夹合装置夹合时的结构示意图；
图4为本发明的可回收的瓣膜夹合装置展开一定角度时的结构示意图；
图5为本发明的可回收的瓣膜夹合装置完全展开时的结构示意图；
图6为本发明的可回收的瓣膜夹合装置在二尖瓣瓣叶处打开一定角度的示意图；
图7为图6的局部放大示意图；
图8为本发明的可回收的瓣膜夹合装置在二尖瓣瓣叶处完全展开的示意图；
图9为图8的局部放大示意图；
图a1为本发明的实施例a展开一定角度时的结构示意图；
图a2为本发明的实施例a完全展开时的结构示意图；
图b1为本发明的实施例b展开一定角度时的结构示意图；
图b2为本发明的实施例b完全展开时的结构示意图；
图10为本发明的锁定组件锁定时的结构示意图；
图11为本发明的锁定组件解锁时的结构示意图；
图c1为本发明的实施例c锁定时的结构示意图；
图c2为本发明的实施例c解锁时的结构示意图；
图d1为本发明的实施例d锁定时的结构示意图；
图d2为本发明的实施例d解锁时的结构示意图；
图12为本发明的夹臂的侧视结构示意图；
图13为本发明的输送装置的结构示意图；
图14为本发明的管体组件与瓣膜夹合装置的分解结构示意图；
图15为本发明的第一连接件和第二连接件连接的结构示意图；
图e1为本发明的实施例e的管体组件与瓣膜夹合装置的分解结构示意图；
图e2为本发明的实施例e的第一连接件和第二连接件连接的结构示意图；
图e3为本发明的实施例e的第一连接件和第二连接件扣合后未锁定的结构示意图；
图f1为本发明的实施例f的第一连接件和第二连接件连接的结构示意图；
图f2为本发明的实施例f的第一连接件和第二连接件的分解结构示意图；
图16为本发明的管体组件与瓣膜夹合装置连接的结构示意图；
图17为本发明的手柄组件的整体结构示意图；
图18为本发明的手柄组件的剖视示意图。
图中具体结构说明：LA左心房、LF瓣叶、MV二尖瓣、LV左心室、CT腱索、1夹持片、11瓣膜容纳空间、2夹臂、21内夹臂、211延伸部、22外夹臂、23第一销钉、24第二销钉、25第三销钉、3锁定组件、31锁座、311卡块、312锁件铰支座、32锁件、321柱状体、33弹性件、34解锁件、4驱动杆、41下铰支座、42凸台、5第一连接件、51上铰支座、52滑道、53扣孔、6管体组件、61管体、62固定头、63第二连接件、631凸块、632弹性扣钩、64滑杆、641滑槽、642L型卡槽、65控制杆、66第一线绳、67第二线绳、7手柄组件、71壳体、72伸缩杆、721滑孔、73伸缩调节旋钮、74旋转调节旋钮、75锁止钉、76导向块、77第一拉杆、78第二拉杆。
具体实施方式
下面结合附图给出的实施例对本发明作进一步详细说明。
参照图2，一种可回收的瓣膜夹合装置，包括夹持片1和夹臂2，夹持片1和夹臂2之间形成有瓣膜容纳空间11，则，在夹合瓣叶LF时，两片瓣叶LF分别伸入两个瓣膜容纳空间11中，通过夹持片1和夹臂2可将瓣叶LF夹紧，该瓣膜夹合装置还包括锁定组件3、第一连接件5、驱动杆4和下铰支座41，第一连接 件5的远端设有上铰支座51；
夹臂2包括有至少一组外夹臂组和一组内夹臂组(优选为一组，需要多组时，多组外夹臂组和内夹臂组并排设置)，每一组外夹臂组包括有两个左右对称设置的外夹臂22，每一组内夹臂组包括有两个左右对称的内夹臂21；每一内夹臂21的内侧端与上铰支座51可转动连接，每一外夹臂22的内侧端与下铰支座41可转动连接，同一侧的内夹臂21和外夹臂22的外侧端可转动连接，内夹臂21和夹持片1之间形成瓣膜容纳空间11；需要说明的是，在此处的“内侧端、外侧端”是以驱动杆的中轴线为基准判断，内、外夹臂靠近驱动杆的中轴线的一端为内侧端，远离驱动杆的中轴线的一端为外侧端，可参照图2所示结果；
驱动杆4贯穿穿过第一连接件5以及锁定组件3并往下延伸与下铰支座41连接；从而，通过驱动驱动杆4上下移动可实现令夹臂2夹合或展开，夹臂2处于最大展开角时，内夹臂21和外夹臂22之间的夹角(内夹臂21和外夹臂22朝向驱动杆4方向的夹角)不小于90°，此时内夹臂21朝向夹持片的一侧不会有逆角勾住腱索，即可保证瓣膜夹合装置可以轻松从腱索之间脱离；优选的，内夹臂21和外夹臂22之间的夹角在120°以上，最好在160°以上；
锁定组件3固定连接于第一连接件5的远端(本发明的描述中，远端指远离手术操作者的一端，近端指靠近手术操作者的一端)，锁定组件3用于锁定驱动杆4进而限制驱动杆4的上下移动。
具体的，参照图3-5，通过控制驱动杆4的伸出长度推动下铰支座41上下移动，即可改变夹臂2的展开角度。图3中，夹臂处于夹合状态，此时驱动杆4拉动下铰支座41向上移动到最高点位置，内夹臂21和外夹臂22之间的夹角趋近于0；图4中，驱动杆4推动下铰支座41向下移动，此时内夹臂21和外夹臂22之间展开一定角度，内夹臂21被向下拉动展开；图5中，夹臂2处于最大展开状态，此时驱动杆4推动下铰支座41向下移动到最低点位置，内夹臂21和外夹臂22支脚的夹角趋近于180°。
关于本发明的发明目的，参照图6-9，在图6中，通过输送装置将瓣膜夹合装置输送穿过左心房LA垂直送至二尖瓣MV的中间位置，此时操控输送装置控制夹持片1和夹臂2的展开角度后使瓣叶伸入瓣膜容纳空间11中，利用夹持片1和夹臂2夹紧瓣叶，调节夹臂2的开合角度，使二尖瓣达到最佳的关闭状态。
当完成治疗需要将瓣膜夹合装置取出时，参照图7，由于夹臂张开后会挂住腱索CT，且在二尖瓣MV的阻挡下张开后的夹臂2无法向上取出。为此，参照图8-9，本发明的瓣膜夹合装置在取出时，可通过驱动杆4向下推动下铰支座41，使夹臂2翻转后完全展开，此时整个瓣膜夹合装置的宽度达到最小值，夹臂2 和瓣叶以及腱索之间没有夹角，从而可轻松从腱索丛中摆脱，自由向上拉出，由此实现了瓣膜夹合装置的可回收性。
关于本发明的夹臂2连接结构的实施方式，参照图3-5，内夹臂21通过第一销钉23与上铰支座51连接，外夹臂22通过第二销钉24与下铰支座41连接，内夹臂21和外夹臂22之间通过第三销钉23连接；通过销钉将各部件进行转动连接，由此可实现内夹臂21和外夹臂2的自由转动，实现本发明的功能。
在上述实施例外，本发明的夹臂连接结构还有其他可实施方式，此处列举实施例a和实施例b以作补充说明，但需要说明的是，本发明的保护范围并不局限于此，通过常规的变换手段以获得的实施方案，均属于本发明的保护范畴。
实施例a.
参照图a1-a2，内夹臂21为刚性结构，外夹臂22与下铰支座41为一体由弹性材料定型而成，内夹臂22的内侧端通过第一销钉与上铰支座51连接；其中，弹性材料优选镍钛合金材料。
实施例b.
参照图b1-b2，内夹臂21、外夹臂22和下铰支座41为一体由弹性材料定型而成。其中，弹性材料优选镍钛合金材料。
关于本发明的锁定组件的结构，参照图10-11，锁定组件3包括锁座31、锁件32、弹性件33和解锁件34，锁件32和弹性件33均设于锁座31内，锁座31与第一连接件5固定连接，其连接方式不限于：焊接、铆接、螺纹连接、粘接，在此优选激光焊接；驱动杆4贯穿锁座31、锁件32和弹性件33；
弹性件33用于抵推锁件32使其保持锁定状态，锁定状态时锁件32卡紧驱动杆4；
解锁件34用于推动锁件32和弹性件33移动实现解锁，解锁时弹性件33被压缩，此时驱动杆4脱离锁件32的卡紧。
具体的，作为本发明的一种较佳实施方式，锁座31为中部贯穿的方型框状，锁座31的内侧壁一侧设有一向内凸起的卡块311；锁件32为片状，锁件32的一侧卡在卡块311上侧；弹性件33设于锁件32上侧；在锁定状态下，弹性件33抵推锁件32远离卡块311的一侧向下移动，使得锁件32保持倾斜状态进而将驱动杆4锁紧；通过锁紧驱动杆4进而锁紧夹臂2的开合角度。其中，锁件32材料为适于植入的硬质合金，如钴基合金、钛合金，在此优选钴铬合金，弹性件33材料为适于植入的弹性材料，如镍钛合金、316L不锈钢，在此优选镍钛合金；
解锁件34为穿过锁座31的闭环金属丝，解锁件34一侧被限制在卡块311 下侧，另一侧位于锁件32远离卡块311的一侧的下侧，则，向上拉动解锁件34时，解锁件34被卡块311限制的一侧不动，解锁件34将拉动锁件32和弹性件33远离卡块311的一侧向上移动，使得锁件32趋于水平状态，解除对驱动杆4的锁定。其解锁原理为，在锁件32上开有孔径比驱动杆4直径大的通孔，当锁件32处于倾斜状态时，锁件32将卡住驱动杆4的两侧，从而将驱动杆4卡紧，当锁件32处于水平状态时，此时锁件32内孔径较大的通孔无法对驱动杆4形成限制，由此实现解锁。
在上述实施例外，本发明的锁定组件结构还有其他可实施方式，此处列举实施例c和实施例d以作补充说明，但需要说明的是，本发明的保护范围并不局限于此，通过常规的变换手段以获得的实施方案，均属于本发明的保护范畴。
实施例c.
参照图c1-c2，锁座31为中部贯穿的方型框状，锁座31一侧设有一向内延伸的锁件铰支座312；锁件32为片状，锁件32的中部与锁件铰支座312铰接；弹性件33设于锁件32上侧；在锁定状态下，弹性件33抵推锁件32一侧向下移动，使得锁件32保持倾斜状态进而将驱动杆4锁紧；具体的，锁件铰支座312位于驱动杆4的一侧，锁件32只有一侧通过铰链与锁件铰支座312连接；
解锁件34为穿过锁座31的闭环金属丝，解锁件34一侧被限制在锁件铰支座312下侧，另一侧位于锁件32远离锁件铰支座312的一侧的下侧，则，向上拉动解锁件34时，解锁件34将拉动锁件32和弹性件33远离锁件铰支座312的一侧向上移动，使得锁件32趋于水平状态，解除对驱动杆4的锁定。
实施例d.
参照图d1-d2，锁座131为中部贯穿的方型框状；锁件包括两个柱状体321，两个柱状体321分别设在驱动杆4的两侧，弹性件33设于两个柱状体321上侧；在锁定状态下，弹性件33抵推两个柱状体321彼此靠拢，从而将驱动杆4夹紧锁紧；
解锁件34为穿过锁座31的闭环金属丝，解锁件34的两侧分别被限制在两个柱状体321下侧，则，向上拉动解锁件34时，两个柱状体321向上移动同时彼此分离，解除对驱动杆4的锁定。
参照图12，本发明中，内夹臂21的中部夹合段处两侧设有往外伸出的延伸部211，延伸部211的外轮廓呈弧形圆角。延伸部211增加了瓣膜夹合装置夹合瓣叶的面积从而减少反流，延伸部211的宽度尺寸A影响着瓣叶夹合面积，为保证延伸部211的有益效果，优选将宽度尺寸A的范围定为：0.2～5mm。延伸部32的外轮廓呈弧形圆角不会损伤瓣膜。
一种可回收瓣膜的夹合系统，包括上述的可回收的瓣膜夹合装置，还包括输送装置，参照图13，输送装置包括手柄组件7和管体组件6，管体组件6的近端与手柄组件7连接，远端与第一连接件5连接，通过手柄组件7可控制夹持片1以及夹臂2的夹合与展开。
进一步的，本发明中，参照图14，管体组件6包括管体61、固定头62、第二连接件63、滑杆64和控制杆65，固定头62固定连接于管体61的远端，第二连接件63与固定头62固定连接，第二连接件63和第一连接件5之间设有相对应的扣合结构；
控制杆65的远端与滑杆64连接，滑杆64与驱动杆的近端可拆卸连接；当第二连接件63与第一连接件5扣合后，可驱动控制杆65带动滑杆64运动，从而驱动滑杆64与驱动杆4连接，当滑杆64与驱动杆4连接固定时，扣合结构被锁定。
具体的，作为本发明的一种较佳实施方式，参照图14-15，第二连接件63为管状，滑杆64可穿过第二连接件63内部自由伸出和旋转；
滑杆64与驱动杆4之间螺纹连接，当第二连接件63与第一连接件5扣合后，驱动滑杆64伸入第一连接件5内，再转动滑杆64可将滑杆64与驱动杆4连接固定，同时将扣合结构锁定。锁定原理可参照图15理解，当第一连接件5和第二连接件6扣合后，两个连接件之间无法相对上下运动，只能左右运动，二由于内部有滑杆64和驱动杆4的限制，从而限制了两个连接件之间的左右移动，进而保证两个连接件被锁紧无法脱离。
在上述实施例外，本发明的第一连接件和第二连接件的连接固定结构还有其他可实施方式，此处列举实施例e和实施例f以作补充说明，但需要说明的是，本发明的保护范围并不局限于此，通过常规的变换手段以获得的实施方案，均属于本发明的保护范畴。
实施例e.
参照图e1-e3，滑杆64为中空的管状，滑杆64近端延伸入管体61内与控制杆65连接，通过控制杆65可驱动滑杆64上下移动以及转动，远端往下延伸套在第二连接件63外周；
第二连接件63的侧壁设有向外凸出的用于与固定头62连接的凸块631，滑杆64的中部开设有允许凸块631穿过的滑槽641，凸块631从滑杆64内部穿过滑槽641与固定头62连接固定；
驱动杆4的近端设有一向外凸出的凸台42，滑杆64的远端开设有允许凸台42滑入的L型卡槽642，且滑槽641的宽度不小于L型卡槽642的宽度，从而允 许滑杆64相对第二连接件63转动；第一连接件5和第二连接件63均开设有对应的允许凸台42滑动的滑道52，第一连接件5和第二连接件63扣合后，驱动杆4可在第一连接件5和第二连接件63之间滑动；则，当凸台42卡入L型卡槽642内后，滑杆64的上下移动将带动驱动杆4的上下移动，驱动杆4上下移动时，凸台42将沿滑道52上下移动；
在将第一连接件5和第二连接件63扣合后，驱动滑杆64移动和转动，可使凸台42卡紧在L型卡槽642内，此时可将扣合结构锁紧。
实施例f.
参照图f1-f2，扣合结构包括设在第二连接件63远端的弹性扣钩632和设在第一连接件5近端的扣孔53，扣孔53与弹性扣钩32对应，在自然状态下，弹性扣钩632自动向内收缩脱离与扣孔53的扣合；
则，在将第一连接件5和第二连接件63连接时，将弹性扣钩632插入第一连接件5内，再驱动滑杆64伸入第一连接件5内与驱动杆4连接，此时滑杆64抵推弹性扣钩632向外转动与扣孔53扣合，进而实现将扣合结构锁定。在需要分离时，只需将滑杆64与驱动杆4分离后，将滑杆64向上拉动，使弹性扣钩632自动向内回缩，即可实现分离。
在本发明的输送装置中，参照图16，输送装置还包括有两根第一线绳66，第一线绳66的近端与手柄组件7连接，远端穿过管体组件6内部后从管体组件6的远端伸出并且与夹持片1连接，每一第一线绳66分别连接一个夹持片1，以此通过拉动第一线绳66可拉动夹持片1夹合收缩，放松第一线绳66可使夹持片1自由展开。以此，在夹合瓣叶时，需要将夹臂2展开，由于夹持片1本身有弹性会自动展开，所以此时需要通过第一线绳66拉动夹持片1使其合并，以此保证瓣膜容纳空间11交底，从而使得瓣叶能够自由伸入到瓣膜容纳空间11内。
为了能够控制锁定组件的锁定状态，输送装置还包括有第二线绳67，第二线绳67的近端与手柄组件7连接，远端穿过管体组件6内部后从管体组件6的远端伸出并且与锁定组件3连接，以此通过拉动第二线绳67可使锁定组件3解锁，放松第二线绳67可使锁定组件3自由锁定。具体的，第二线绳67与锁定组件3的解锁件34连接，通过拉动第二线绳67即可拉动解锁件34实现解锁。
第一线绳66和第二线绳67需要有较好的柔顺性、抗折性、抗拉性、耐磨性，为满足线绳的上述性能，线绳可以为多股不锈钢丝绳、超高分子量聚乙烯编织绳、多股镍钛丝绳，在此优选超高分子量聚乙烯编织绳。
在本发明的手柄组件中，参照图17-18，手柄组件7包括壳体71、伸缩杆72、伸缩调节旋钮73和旋转调节旋钮74，伸缩调节旋钮转动73安装于壳体71 的近端，伸缩杆72远端伸入壳体71内与壳体71滑动连接且其近端伸出壳体71外并穿过伸缩调节旋钮73，伸缩杆72与伸缩调节旋钮73螺纹连接；由此，通过转动伸缩调节旋钮73即可推动伸缩杆72的上下移动；
旋转调节旋钮74转动安装于伸缩杆72近端，伸缩杆72内开有允许控制杆65的近端穿过的滑孔721，控制杆65的近端穿过滑孔721与旋转调节旋钮74连接，从而，转动旋转调节旋钮74可带动控制杆65转动；旋转伸缩调节旋钮73可带动伸缩杆72伸缩移动，进而带动控制杆65伸缩移动。
进一步的，在伸缩杆72的一侧设有用于将旋转调节旋钮74锁定的锁止钉75，旋入锁止钉75顶紧旋转调节旋钮74时，旋转调节旋钮74无法转动，此时可避免旋转调节旋钮74自由转动；在需要转动旋转调节旋钮74时，只需松开锁止钉75即可进行操作。
在壳体71内还设有用于对控制杆65进行限位的导向块76，导向块内部开有允许控制杆65穿过的导向孔，以此能保证控制杆65的稳定移动和转动。
进一步的，手柄组件7包括有两个第一拉杆77，每一第一拉杆77分别连接一根第一线绳66，通过拉动第一拉杆77可实现拉动第一线绳66。
进一步的，手柄组件7包括有第二拉杆78，第二拉杆78与第二线绳67连接，通过拉动第二拉杆78可实现拉动第二线绳67。
以上者，仅为本发明的较佳实施例而已，当不能以此限定本发明实施的范围，即但凡依本发明申请专利范围及发明说明内容所作的简单的等效变化与修饰，皆仍属本发明专利涵盖的范围内。

Claims (17)

  1. 一种可回收的瓣膜夹合装置，包括夹持片和夹臂，所述夹持片和所述夹臂之间形成有瓣膜容纳空间，其特征在于：还包括锁定组件、第一连接件、驱动杆和下铰支座，所述第一连接件的远端设有上铰支座；
    所述夹臂包括有至少一组外夹臂组和一组内夹臂组，每一组所述外夹臂组包括有两个左右对称设置的外夹臂，每一组所述内夹臂组包括有两个左右对称的内夹臂；每一所述内夹臂的内侧端与所述上铰支座可转动连接，每一所述外夹臂的内侧端与所述下铰支座可转动连接，同一侧的所述内夹臂和所述外夹臂的外侧端可转动连接，所述内夹臂和所述夹持片之间形成所述瓣膜容纳空间；
    所述驱动杆贯穿穿过所述第一连接件以及所述锁定组件并往下延伸与所述下铰支座连接；从而，通过驱动所述驱动杆上下移动可实现令所述夹臂夹合或展开，所述夹臂处于最大展开角时，所述内夹臂和所述外夹臂之间的夹角不小于90°；
    所述锁定组件固定连接于所述第一连接件的远端，所述锁定组件用于锁定所述驱动杆进而限制所述驱动杆的上下移动。
  2. 如权利要求1所述的一种可回收的瓣膜夹合装置，其特征在于：所述内夹臂通过第一销钉与所述上铰支座连接，所述外夹臂通过第二销钉与所述下铰支座连接，所述内夹臂和外夹臂之间通过第三销钉连接；
    或，所述内夹臂为刚性结构，所述外夹臂与所述下铰支座为一体由弹性材料定型而成，所述内夹臂的内侧端通过第一销钉与所述上铰支座连接；
    或，所述内夹臂、外夹臂和下铰支座为一体由弹性材料定型而成。
  3. 如权利要求1或2所述的一种可回收的瓣膜夹合装置，其特征在于：所述锁定组件包括锁座、锁件、弹性件和解锁件，所述锁件和弹性件均设于所述锁座内，所述锁座与所述第一连接件固定连接，所述驱动杆贯穿所述锁座、锁件和弹性件；
    所述弹性件用于抵推所述锁件使其保持锁定状态，锁定状态时所述锁件卡紧所述驱动杆；
    所述解锁件用于推动所述锁件和所述弹性件移动实现解锁，解锁时所述弹性件被压缩，此时所述驱动杆脱离所述锁件的卡紧。
  4. 如权利要求3所述的一种可回收的瓣膜夹合装置，其特征在于：所述锁座为中部贯穿的方型框状，所述锁座的内侧壁一侧设有一向内凸起的卡块；所述锁件为片状，所述锁件的一侧卡在所述卡块上侧；所述弹性件设于所述锁件上侧；在锁定状态下，所述弹性件抵推所述锁件远离所述卡块的一侧向下移动，使得所述锁件保持倾斜状态进而将所述驱动杆锁紧；
    所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件一侧被限制在所述卡块下侧，另一侧位于所述锁件远离所述卡块的一侧的下侧，则，向上拉动所述解锁件时，所述解锁件将拉动所述锁件和所述弹性件远离所述卡块的一侧向上移动，使得所述锁件趋于水平状态，解除对所述驱动杆的锁定。
  5. 如权利要求3所述的一种可回收的瓣膜夹合装置，其特征在于：所述锁座为中部贯穿的方型框状，所述锁座一侧设有一向内延伸的锁件铰支座；所述锁件为片状，所述锁件的中部与所述锁件铰支座铰接；所述弹性件设于所述锁件上侧；在锁定状态下，所述弹性件抵推所述锁件一侧向下移动，使得所述锁件保持倾斜状态进而将所述驱动杆锁紧；
    所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件一侧被限制在所述锁件铰支座下侧，另一侧位于所述锁件远离所述锁件铰支座的一侧的下侧，则，向上拉动所述解锁件时，所述解锁件将拉动所述锁件和所述弹性件远离所述锁件铰支座的一侧向上移动，使得所述锁件趋于水平状态，解除对所述驱动杆的锁定。
  6. 如权利要求3所述的一种可回收的瓣膜夹合装置，其特征在于：所述锁座为中部贯穿的方型框状；所述锁件包括两个柱状体，两个所述柱状体分别设在所述驱动杆的两侧，所述弹性件设于两个所述柱状体上侧；在锁定状态下，所述弹性件抵推两个所述柱状体彼此靠拢，从而将所述驱动杆夹紧锁紧；
    所述解锁件为穿过所述锁座的闭环金属丝，所述解锁件的两侧分别被限制在两个所述柱状体下侧，则，向上拉动所述解锁件时，两个所述柱状体向上移动同时彼此分离，解除对所述驱动杆的锁定。
  7. 如权利要求1所述的一种可回收的瓣膜夹合装置，其特征在于：所述内夹臂的中部夹合段处两侧设有往外伸出的延伸部，所述延伸部的外轮廓呈弧形圆角。
  8. 一种可回收瓣膜的夹合系统，其特征在于：包括权利要求1-7任意一种可回收的瓣膜夹合装置，还包括输送装置，所述输送装置包括手柄组件和管体组件，所述管体组件的近端与所述手柄组件连接，远端与所述第一连接件连接，通过所述手柄组件可控制所述夹持片以及所述夹臂的夹合与展开。
  9. 如权利要求8所述的一种可回收瓣膜的夹合系统，其特征在于：所述管体组件包括管体、固定头、第二连接件、滑杆和控制杆，所述固定头固定连接于所述管体的远端，所述第二连接件与所述固定头固定连接，所述第二连接件和所述第一连接件之间设有相对应的扣合结构；
    所述控制杆的远端与滑杆连接，所述滑杆与所述驱动杆的近端可拆卸连接；当所述第二连接件与所述第一连接件扣合后，可驱动所述控制杆带动所述滑杆运 动，从而驱动所述滑杆与所述驱动杆连接，当所述滑杆与所述驱动杆连接固定时，所述扣合结构被锁定。
  10. 如权利要求9所述的一种可回收瓣膜的夹合系统，其特征在于：所述第二连接件为管状，所述滑杆可穿过所述第二连接件内部自由伸出和旋转；
    所述滑杆与所述驱动杆之间螺纹连接，当所述第二连接件与所述第一连接件扣合后，驱动所述滑杆伸入所述第一连接件内，再转动所述滑杆可将所述滑杆与所述驱动杆连接固定，同时将所述扣合结构锁定。
  11. 如权利要求9所述的一种可回收瓣膜的夹合系统，其特征在于：所述滑杆为中空的管状，所述滑杆近端延伸入所述管体内与所述控制杆连接，远端往下延伸套在所述第二连接件外周；
    所述第二连接件的侧壁设有向外凸出的用于与所述固定头连接的凸块，所述滑杆的中部开设有允许所述凸块穿过的滑槽，所述凸块从所述滑杆内部穿过所述滑槽与所述固定头连接固定；
    所述驱动杆的近端设有一向外凸出的凸台，所述滑杆的远端开设有允许所述凸台滑入的L型卡槽，且所述滑槽的宽度不小于所述L型卡槽的宽度，从而允许所述滑杆相对所述第二连接件转动；所述第一连接件和第二连接件均开设有对应的允许所述凸台滑动的滑道，所述第一连接件和第二连接件扣合后，所述驱动杆可在所述第一连接件和第二连接件之间滑动；
    在将所述第一连接件和第二连接件扣合后，驱动所述滑杆移动和转动，可使所述凸台卡紧在所述L型卡槽内，此时可将所述扣合结构锁紧。
  12. 如权利要求9所述的一种可回收瓣膜的夹合系统，其特征在于：所述扣合结构包括设在所述第二连接件远端的弹性扣钩和设在所述第一连接件近端的扣孔，所述扣孔与所述弹性扣钩对应，在自然状态下，所述弹性扣钩自动向内收缩脱离与所述扣孔的扣合；
    则，在将所述第一连接件和第二连接件连接时，将所述弹性扣钩插入所述第一连接件内，再驱动所述滑杆伸入所述第一连接件内与所述驱动杆连接，此时所述滑杆抵推所述弹性扣钩向外转动与所述扣孔扣合，进而实现将所述扣合结构锁定。
  13. 如权利要求8所述的一种可回收瓣膜的夹合系统，其特征在于：所述输送装置还包括有两根第一线绳，所述第一线绳的近端与所述手柄组件连接，远端穿过所述管体组件内部后从所述管体组件的远端伸出并且与所述夹持片连接，每一所述第一线绳分别连接一个所述夹持片，以此通过拉动所述第一线绳可拉动所述夹持片夹合收缩，放松所述第一线绳可使所述夹持片自由展开。
  14. 如权利要求8所述的一种可回收瓣膜的夹合系统，其特征在于：所述输送装置还包括有第二线绳，所述第二线绳的近端与所述手柄组件连接，远端穿过所述管体组件内部后从所述管体组件的远端伸出并且与所述锁定组件连接，以此通过拉动所述第二线绳可使所述锁定组件解锁，放松所述第二线绳可使所述锁定组件自由锁定。
  15. 如权利要求9所述的一种可回收瓣膜的夹合系统，其特征在于：所述手柄组件包括壳体、伸缩杆、伸缩调节旋钮和旋转调节旋钮，所述伸缩调节旋钮转动安装于所述壳体的近端，所述伸缩杆远端伸入所述壳体内与所述壳体滑动连接且其近端伸出所述壳体外并穿过所述伸缩调节旋钮，所述伸缩杆与所述伸缩调节旋钮螺纹连接；
    所述旋转调节旋钮转动安装于伸缩杆近端，所述伸缩杆内开有允许所述控制杆的近端穿过的滑孔，所述控制杆的近端穿过所述滑孔与所述旋转调节旋钮连接，从而，转动所述旋转调节旋钮可带动所述控制杆转动；旋转所述伸缩调节旋钮可带动所述伸缩杆伸缩移动，进而带动所述控制杆伸缩移动。
  16. 如权利要求13所述的一种可回收瓣膜的夹合系统，其特征在于：所述手柄组件包括有两个第一拉杆，每一所述第一拉杆分别连接一根所述第一线绳，通过拉动所述第一拉杆可实现拉动所述第一线绳。
  17. 如权利要求14所述的一种可回收瓣膜的夹合系统，其特征在于：所述手柄组件包括有第二拉杆，所述第二拉杆与所述第二线绳连接，通过拉动所述第二拉杆可实现拉动所述第二线绳。
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