WO2022037084A1 - 组织夹持件及瓣膜夹合装置 - Google Patents

组织夹持件及瓣膜夹合装置 Download PDF

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Publication number
WO2022037084A1
WO2022037084A1 PCT/CN2021/085736 CN2021085736W WO2022037084A1 WO 2022037084 A1 WO2022037084 A1 WO 2022037084A1 CN 2021085736 W CN2021085736 W CN 2021085736W WO 2022037084 A1 WO2022037084 A1 WO 2022037084A1
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WO
WIPO (PCT)
Prior art keywords
clamping
tissue
valve
width
arm
Prior art date
Application number
PCT/CN2021/085736
Other languages
English (en)
French (fr)
Inventor
张庭超
张伟伟
郑贤章
何贻伟
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202010854973.7A external-priority patent/CN111938869A/zh
Priority claimed from CN202021775358.9U external-priority patent/CN212996890U/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Priority to EP21857185.9A priority Critical patent/EP4201379A4/en
Publication of WO2022037084A1 publication Critical patent/WO2022037084A1/zh
Priority to US18/112,513 priority patent/US20230200995A1/en

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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
    • A61F2/246—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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Definitions

  • the present application relates to the field of interventional medical devices, and in particular, to a tissue clamping member and a valve clamping device provided with the tissue clamping member.
  • the mitral valve 1 is a one-way valve located between the left atrium 2 and the left ventricle 3 of the heart.
  • a normal healthy mitral valve 1 can control the flow of blood from the left atrium 2 to the left ventricle 3, while preventing blood from flowing from the left atrium 2 to the left ventricle 3.
  • Left ventricle 3 flows into left atrium 2.
  • the mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1b.
  • the anterior lobe 1a and the posterior lobe 1b are fixed to the papillary muscle of the left ventricle 3 through the chordae tendineae 4 .
  • mitral valve 1 when the leaflets of mitral valve 1 or their related structures change qualitatively or functionally, such as partial rupture of chordae tendineae 4, the anterior leaflet 1a and posterior leaflet 1b of mitral valve 1 are misaligned , thus, when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing the blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a pathophysiological change in the primary system, known as "mitral regurgitation" flow".
  • Surgical procedures such as edge-to-edge suturing are usually used to treat mitral regurgitation.
  • this type of surgery has disadvantages such as complex surgical procedure, high surgical cost, high degree of patient trauma, high risk of complications, long hospital stay, and painful recovery process for patients.
  • There is a minimally invasive treatment operation which is based on the principle of edge-to-edge operation of the valve.
  • the valve clamping device is delivered to the mitral valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve are clamped at the same time, so that the valve is clamped.
  • the leaves are drawn closer to each other, alleviating "mitral regurgitation".
  • the valve clamping device uses a pair of concave jaw arms and a tissue holder made of shape memory material to cooperate with each other to fix the leaflet of the mitral valve between the jaw arms and the tissue holder. That is, the forceps arm and the tissue holding member simultaneously grasp the anterior leaflet and the posterior leaflet of the mitral valve, so as to achieve the purpose of fixing the valve leaflet and reducing mitral valve regurgitation.
  • the tissue clamping member 3a includes a base 3a1 and clamping arms 3a2 disposed on opposite sides of the base 3a1.
  • Each clamping arm 3a2 is provided with an opening 3a3 to reduce the stress at the position and reduce the Small pulling force increases the resilience; however, this clamping arm 3a2 reduces its own fatigue resistance; if the clamping arm 3a2 does not have an opening 3a3, the clamping arm 3a2 is pulled up to fit the valve
  • the central axis of the clamping device requires a large pulling force, and has high requirements on the control wire and the proximal handle, which may easily lead to the breakage of the control wire.
  • the present application provides a tissue clamping member and a valve clamping device, which can not only improve the fatigue resistance of the tissue clamping member, but also reduce the stress when the tissue clamping member is in a folded state, so as to reduce the amount of tissue clamping.
  • the tension required to pull the piece up to the tucked state prevents the control wire from breaking.
  • the present application provides a tissue clamp, which includes a connecting frame and two clamping arms, the connecting frame includes two connecting pieces opposite to each other at intervals; the two clamping arms are respectively arranged in On the opposite sides of the two connecting pieces, each of the clamping arms extends to a side away from the other clamping arm, and each clamping arm includes a bending section connected to the corresponding connecting piece and a bending section connected to the corresponding connecting piece.
  • the bending section is far away from the clamping section of the corresponding connecting piece, and the width of the bending section is smaller than the width of the clamping section and smaller than the width of the connecting piece.
  • the present application also provides a valve clamping device, which includes a fixing base, a pair of forceps arms that are open and close relative to the fixing base, and a tissue clamping member, and the tissue clamping member is provided on the fixing base Between the clamp arms, the two clamp arms of the tissue clamp are respectively matched with one of the pair of clamp arms to clamp the valve leaflets.
  • Each clamping arm of the valve clamping device provided by the application has a bending section, and the width of the bending section is smaller than the width of the clamping section and smaller than the width of the connecting piece; thus not only can reduce the weight of the valve clamping device, but also It is beneficial to the rebound of the gripping arm, reducing the difficulty of gripping, improving the fatigue resistance of the tissue gripper, and reducing the tension required to pull the gripping arm up to fit the central axis through the control wire, reducing the burden on the control wire.
  • the reverse force can prevent the control wire from breaking, improve the fatigue resistance of the valve clamping device implanted in the human body for a long time, and improve the safety and effectiveness of the device.
  • Figure 1 is a schematic view of the mitral valve in a normal state.
  • Fig. 2 is a schematic diagram of the mitral valve with lesions.
  • Fig. 3 is a schematic three-dimensional structural diagram of a tissue holder in the prior art.
  • FIG. 4 is a schematic three-dimensional structural diagram of a valve clamping device provided in one embodiment of the present application.
  • FIG. 5 is a schematic three-dimensional structural diagram of the tissue clamping member and the fixing seat of the valve clamping device in FIG. 4 .
  • FIG. 6 is an exploded schematic diagram of the three-dimensional structure of the tissue holder and the fixing base in FIG. 5 .
  • FIG. 7 is a side view of the tissue gripper of FIG. 6 .
  • FIG. 8 is a top view of the tissue gripper of FIG. 6 .
  • FIG. 9 is a schematic structural diagram of another embodiment of the tissue holder in FIG. 7 .
  • FIG. 10 is a side view of the tissue gripper and mount of FIG. 5 .
  • FIG. 11 is an enlarged view of part XI in FIG. 10 .
  • FIG. 12 is a side view of the valve clamping device of FIG. 4 .
  • FIG. 13 is a diagram of one of the states of use of the valve clamping device in FIG. 4 .
  • FIG. 14 is a schematic structural diagram of a valve clamping device provided by another embodiment of the present application.
  • FIG. 15 is a schematic structural diagram of the clamping arm of the valve clamping device in FIG. 14 .
  • FIG. 16 is a statistical chart of the results of the fatigue test and the performance test of the tissue clamp for the valve clamping device of the present application.
  • proximal end refers to the end that is far away from the operator during the surgical operation
  • proximal end refers to the end that is close to the operator during the surgical operation
  • proximal end in this application is relative to the distal distance from the operator ( The distance between the surgeon and the surgeon is relatively short, and after the device is assembled, each of the components includes a proximal end and a distal end, wherein the proximal end of each component is closer to the operator than the distal end.
  • Axial refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs. The common terms used in the specification of the present application are only for the purpose of describing specific embodiments, and should not be construed as limitations of the present application.
  • an element when an element is referred to as being “fixed to” or “disposed on” another element, the element can be directly connected to the other element or indirectly connected to the other element through one or more connecting elements on a component.
  • an element When an element is referred to as being “connected to” another element, it can be directly connected to the other element or connected to the other element through one or more connecting elements.
  • the first embodiment of the present application provides a valve clamping device 100 , which includes a fixing base 20 , at least a pair of clamp arms 40 hinged with the fixing base 20 , and a clamp arm 40 connected to the fixing base 20 .
  • a tissue holding member 60 and a drive assembly 70 for driving the forceps arm 40 to open and close relative to the fixed seat 20; a pair of forceps arms 40 to open and close relative to the fixed seat 20, and the tissue holding member 60 is provided on the fixed seat 20 and the forceps arm
  • the tissue holding member 60 includes a connecting frame 62 and two holding arms 64 .
  • the proximal end of the valve clamping device 100 When in use, the proximal end of the valve clamping device 100 is releasably connected to the delivery device, and the two clamping arms 64 of the valve clamping device 100 are pulled up to the center axis of the abutment through the control wire, and the operator clamps the valve.
  • the device 100 is pushed to the patient's mitral valve, and then the valve clamping device 100 is remotely operated, so that the clamp arm 40 is opened relative to the fixed seat 20, and then the pulling force of the control wire on the two clamping arms 64 is released, and the mitral valve is clamped.
  • the anterior and posterior leaflets of the valve are respectively clamped by the clamp arms 40 and the corresponding clamping arms 64, so that the leaflets of the mitral valve are abutted together edge-to-edge, and then the delivery device is released and clamped with the valve
  • the connection between the devices 100, the valve clamping device 100 remains in the patient as an implant in order to keep the coapted position of the valve leaflets together, achieve "edge-to-edge repair" of the mitral valve, relieve the patient's mitral Valve regurgitation.
  • valve clamping device 100 and the delivery device can be delivered to the patient's body by using an existing guide device such as an adjustable sheath tube, a plastic sheath tube, and the like.
  • the connecting frame 62 includes a base plate 621 and two connecting pieces 623 disposed on opposite sides of the base plate 621; two clamping arms 64 are respectively disposed on the opposite sides of the two connecting pieces 623, A side extending away from the other clamping arm 64; each clamping arm 64 includes a bending section 641 connected to the corresponding connecting piece 623 and a clamping section 643 connected to the bending section 641 away from the corresponding connecting piece 623, The width of the bending section 641 is smaller than the width of the clamping section 643 and smaller than the width of the connecting piece 623; the two clamping arms 64 of the tissue clamping member 60 are respectively matched with one of the pair of clamp arms 40 to clamp the flap Leaflet 300 (shown in FIG. 13 ), ie, the gripping section 643 of each gripping arm 64 cooperates with one of the gripper arms 40 to grip a piece of leaflet 300 .
  • each clamping arm 64 of the valve clamping device 100 has a bending section 641, and the width of the bending section 641 is smaller than the width of the clamping section 643 and smaller than the width of the connecting piece 623; thus not only can reduce the valve
  • the weight of the clamping device 100 is beneficial to the rebound of the clamping arm 64, reduces the difficulty of clamping, improves the fatigue resistance of the tissue clamping member 60, and can also reduce the pulling up of the clamping arm 64 to the center axis of the fit through the control wire
  • the required pulling force reduces the reverse force borne by the control wire, prevents the control wire from breaking, can improve the fatigue resistance of the valve clamping device 100 implanted in the human body for a long time, and improve the safety and effectiveness of the device.
  • the valve clamping device 100 includes a pair of clamp arms 40 disposed opposite to each other, and each clamp arm 40 can be opened and closed relative to the fixing seat 20 .
  • Each clamp arm 40 includes a connection frame 42 and a clamping frame 44 connected to one end of the connection frame 42 away from the fixing base 20 .
  • the ends of the connection frames 42 of the two clamp arms 40 away from the clamping frame 44 are stacked on each other and then hinged to the fixing base. 20.
  • a leaflet accommodating space is formed between the clamping arm 64 and the forceps arm 40 .
  • each clamp arm 40 facing the clamping arm 64 is recessed inwardly to form a receiving groove 45, so that in the delivery state of the valve clamping device 100, the clamping arm 64 is at least partially accommodated in the receiving groove 45 of the clamp arm 40, In order to reduce the outer diameter and volume of the valve clamping device 100, it is convenient for delivery in the body.
  • the valve leaflet 300 is clamped in the receiving groove 45, which can increase the contact area between the clamp arm 40 and the valve leaflet 300, and enable the clamp arm 64 to hold the valve leaflet 300.
  • the 300 is pressed into the receiving groove 45 of the forceps arm 40 to increase the clamping force of the valve leaflet 300 .
  • each clamp arm 40 includes a rectangular connecting plate 442 and side plates 444 disposed on opposite sides of the connecting plate 442 .
  • the connecting plate 442 and the two side plates 444 enclose a receiving groove 45 .
  • the connecting plate 442 defines a number of material removal holes 446 along its length to reduce the weight of the clamp arm 40 .
  • One end of the side plate 444 adjacent to the fixing base 20 extends obliquely and is hinged on the fixing base 20 to form a connecting portion 42 of the clamp arm 40 , and the connecting portion 42 defines a pin hole for inserting a pin.
  • the clamp arm 40 is opened and closed relative to the fixed seat 20 through the drive assembly 70 .
  • the driving assembly 70 includes a driving shaft 72 passing through the fixing base 20 , a connecting base 74 disposed at the distal end of the driving shaft 72 , and a pair of connecting rods 76 movably connected to both sides of the connecting base 74 .
  • One end of each link 76 is connected to a corresponding one of the clamp arms 40, and the other end is connected to the connection seat 74 by pivoting, that is, each clamp arm 40 is connected to the connection of the driving assembly 70 through the connecting rod 76 on the corresponding side.
  • Seat 74 is distal.
  • the drive shaft 72 movably passes through the fixing base 20 and is connected to the connecting base 74 . When the drive shaft 72 slides relative to the fixed seat 20 in the axial direction, the connecting seat 74 moves in the axial direction to rotate the connecting rod 76 and drive the clamp arm 40 to open and close relative to the fixed seat 20 .
  • the fixing base 20 includes a rectangular fixing frame 21 , a connecting block 22 arranged at the proximal end of the fixing frame 21 , and bosses 23 arranged on opposite sides of the fixing frame 21 , and the fixing base 20 is axially arranged.
  • a through hole 24 is provided to penetrate through the connecting block 22 and the fixing frame 21 , and the through hole 24 is used for inserting the drive shaft 72 therethrough.
  • the opposite ends of the connecting block 22 are respectively provided with pin holes 26 .
  • the axis of the pin holes 26 is perpendicular to the axis line of the through hole 24 .
  • the fixing frame 21 is respectively provided with a first attaching curved surface 212 and a second attaching curved surface 214 on opposite sides of the connecting block 22 , wherein the first attaching curved surface 212 is closer to the connecting block 22 than the second attaching curved surface 214 .
  • the curvature radius of the attaching curved surface 212 is K1
  • the curvature radius of the second attaching surface 214 is K2.
  • the tissue gripper 60 is at least partially made of a shape memory material and has undergone a heat setting process so that the tissue gripper 60 has a natural expanded state and a collapsed state.
  • the shape memory material is first cut into the desired shape by laser cutting, and then placed in a mold for heat setting at about 550°C to make it have a specific shape. As shown in FIG.
  • the clamping arms 64 on both sides of the tissue clamping member 60 extend radially outward relative to the connecting frame 62; preferably, the clamping arms 64 extend obliquely toward the distal end so as to facilitate and
  • the clamp arms 40 cooperate to clamp the valve tissue, that is, the angle between the clamping arms 64 on both sides in the natural unfolded state should be slightly larger than the angle between the two clamp arms 40 to provide more stable clamping Therefore, there is a certain clamping force between the clamping arm 64 and the clamping arm 40 to clamp the valve leaflet located therebetween; specifically, the length direction of the clamping section 643 of each clamping arm 64
  • the included angle a between the axial direction of the fixing seat 20 is greater than the included angle between the clamping arm 40 and the axial direction of the fixing seat 20 when the clamp arm 40 corresponding to the clamping arm 64 is fully opened with respect to the fixing seat 20, so that each The free end of a clamping arm 64 and the corresponding clamping arm 40 are close to each other and have a certain clamping
  • the angle a between the length direction of the clamping segment 643 and the axial direction of the fixing seat 20 is in the range of 0-150 degrees, that is, the angle between the two clamping segments 643 is the largest Up to 300 degrees, preferably 160-200 degrees, in this embodiment, the angle between the two clamping segments 643 is greater than 180 degrees.
  • the tissue holding member 60 is entirely made of superelastic nickel-titanium alloy, so as to provide elastic force for the tissue holding member 60 to drive the holding arm 64 to move closer to the forceps arm 40 to hold the valve tissue and reduce production Process difficulty, simplify the process flow, and reduce production costs.
  • different parts of the clamping arm 64 can be made of different materials separately and then fixedly connected.
  • the gripping section 643 of the gripping arm 64 is made of stainless steel to improve the gripping force
  • the bending section 641 should have a bending function to provide the tissue gripper 60 with a natural unfolding state and a folded state that facilitates delivery. Therefore,
  • the bent section 641 is made of shape memory material.
  • each connecting piece 623 and the corresponding bending section 641 are connected by a bent fixing piece 625 , and the fixing piece 625 on each connecting piece 623 is bent toward the other connecting piece 625 .
  • the segment 641 is bent away from the other bent segment 641 .
  • Each connecting piece 623 is provided with a slot 6230 along its length direction, and the slot 6230 extends into the corresponding fixing piece 625 for cooperating and fixing with the fixing base 20 .
  • the shape of the card slot 6230 can be a rectangle, an ellipse, a prism or other shapes. In this embodiment, a rectangle is preferred for higher stability.
  • the base plate 621 , the two connecting pieces 623 and the two fixing pieces 625 enclose a connecting frame 62 with an open proximal end, the fixing seat 20 is accommodated in the inner cavity of the connecting frame 62 , and the drive shaft 72 is inserted through the opening of the proximal end of the connecting frame 62 . on the fixing base 20 and the connecting frame 62 .
  • the substrate 621 has a through hole 6210 , after the fixing seat 20 is accommodated in the inner cavity of the connecting frame 62 , the through hole 24 of the fixing seat 20 corresponds to the through hole 6210 of the substrate 621 , and the driving shaft 72 is inserted through the fixing seat 20 .
  • the through hole 24 and the through hole 6210 of the substrate 621 .
  • the fixing piece 625 should have a certain deformation ability to be clamped outside the fixing seat 20, so the fixing piece 625 should be made of shape memory material, and other parts of the connecting frame 62 can be made of relatively hard materials such as stainless steel. , thereby improving the connection strength. That is, the fixing piece 625 of the connecting frame 62 and the bending section 641 connected to it can be integrally formed with Nitinol, and the base plate 621 and the connecting piece 623 of the connecting frame 62 can be integrally formed with stainless steel and then welded or bonded to the fixing piece 625. , and each bending segment 641 is welded or bonded to the clamping segment 643 for fixing.
  • the bending section 641 includes a first end 6412 connected to the corresponding fixing piece 625 and a second end 6414 connected to the corresponding clamping section 643 , and the bending section 641 is a variable diameter structure That is, the width of the bent segment 641 at the first end 6412 is greater than the width of the bent segment 641 at the second end 6414 , and the width of the bent segment 641 gradually decreases from the first end 6412 to the second end 6414 .
  • the width of the first end 6412 of the bending section 641 is equal to the width of the fixing piece 625
  • the width of the second end 6414 of the bending section 641 is equal to the width of the clamping section 643
  • the first end of the bending section 641 is equal to the width of the clamping section 643 .
  • the reduction structure of the bending section 641 can effectively reduce the stress of the clamping arm 64 in the folded state, thereby reducing the risk of breakage of the control wire.
  • a hole is opened in the middle of the bending section, but microcracks are prone to appear at the opening position, and the microcracks are often difficult to observe, and the valve clamping device is implanted in the human body.
  • the state of long-term stress The micro-cracks near the opening position are prone to fatigue fracture. Therefore, in this embodiment, the stress is reduced by the variable diameter structure, and the risk of fatigue fracture caused by the opening is avoided at the same time.
  • the width ratio of the second end 6414 to the first end 6412 of the bent segment 641 ranges from 0.4 to 0.8; more preferably, the width ratio of the second end 6414 to the first end 6412 of the bent segment 641 ranges from 0.5 -0.65. If the ratio of the width of the second end 6414 to the first end 6412 is too large, that is, the width of the second end 6414 is too large, the stress of the bending section 641 in the retracted state of the clamping arms 64 is relatively large, and the required pulling force is relatively large.
  • the width ratio of the second end 6414 to the first end 6412 is too small, that is, the width of the second end 6414 is too small, the clamping force of the clamping arm 64 on the tissue will be affected , causing the clamping device 100 to slip off easily.
  • the clamping section 643 includes a clamping piece 6431 connected with the second end 6414 of the bending section 641, and two barbs 6433 connected with both sides of the clamping piece 6431.
  • the clamping piece The number of barbs 6433 on each side of 6431 is four.
  • each barb 6433 and the holding piece 6431 There is an angle between each barb 6433 and the holding piece 6431, and the angle ranges from 30 degrees to 85 degrees, preferably 45 degrees to 65 degrees. Too large or too small an angle will increase the difficulty of capturing the valve leaflets.
  • the included angle A between each barb 6433 and the clamping piece 6431 may be the same or different. In this embodiment, the included angle A between each barb 6433 and the clamping piece 6431 is 60 degrees.
  • each barb 6433 is in the range of 0.3 mm to 2.0 mm, preferably 0.5 mm to 1.2 mm.
  • the effective lengths of the barbs 6433 may or may not be the same.
  • the barbs in each row of barbs 6433 have the same extension length; specifically, the four barbs 6433 in the same bay on each side of the clamping piece 6431 extend from one end adjacent to the bending section 641 to the end
  • the included angle between the barbs in at least one row of barbs 6433 of each clamping segment 643 and the corresponding clamping segment 643 is along the clamping
  • the extension direction of the holding arm gradually increases, and the effective length of the barbs 6433 from one end adjacent to the bent section 641 to the end also gradually increases.
  • the number of barbs 6433 in each row is four, and the included angles between the barbs 6433 from one end to the end of the adjacent bending segment 641 and the clamping segment 643 are A1, A2, A3, and A4, respectively, and A1 ⁇ A2 ⁇ A3 ⁇ A4; the effective lengths of the barbs 6433 from one end of the adjacent bending section 641 to the end are L1, L2, L3, and L4, respectively, and L1 ⁇ L2 ⁇ L3 ⁇ L4.
  • the angle of A1 is 45 degrees, the angle of A2 is 50 degrees, the angle of A3 is 55 degrees, and the angle of A4 is 60 degrees;
  • the effective length of L1 is 0.4 mm, the effective length of L2 is 0.8 mm, and the effective length of L3 is 0.4 mm.
  • the effective length of the L4 is 1.0 mm and the effective length of the L4 is 1.2 mm. The reason for this setting is that due to the uneven thickness of the valve leaflets, the edge of the valve leaflet is the thinnest, and the thickness gradually increases to the point where the valve leaflet connects with the valve annulus.
  • each barb 6433 at different contact positions with the valve leaflet tissue is approximately the same, to ensure the clamping force of the clamping segment 643 to the valve leaflet, and not to pierce the valve leaflet, so as to adjust the angle of the barbs 6433 to Adapt to the force depth of leaflet tissue of different thicknesses.
  • the width of D2 is too narrow, the fatigue resistance and tensile strength of the valve clamping device 100 will be reduced; if D2 is too wide, it means that the weight of the valve clamping device 100 will increase, which will cause the valve clamping device 100 to be implanted. After falling under the valve for a long time, it is not only easy to slip off, but also may strain the target tissue or even lead to cardiac dysfunction; and, since the tissue holder 60 is made of shape memory alloy, if D2 is too wide, the bent section 641 will be caused The compressed leaflets are subjected to greater pressure during the expansion and contraction of the heart, resulting in excessive tissue damage.
  • the distal end of the fixing piece 625 is connected to the connecting frame 62
  • the proximal end of the fixing piece 625 is connected to the bending section 641
  • the fixing piece 625 is used to realize the mutual connection between the tissue clamping member 60 and the fixing seat 20 .
  • the function of buckling and fixing prevents the tissue holder 60 from being displaced or loosened relative to the fixing seat 20 under the unilateral force of the control wire, thereby ensuring the reliability of the tissue holder 60 in the process of capturing the valve.
  • the fixing piece 625 includes a first buckling position 6251 and a second buckling position 6253 .
  • the first buckling position 6251 is to prevent the connection frame 62 from moving up and down after it cooperates with the fixing seat 20 , that is, it plays the role of limiting the position of the proximal and distal ends; Move left and right, that is, play the role of left and right limit.
  • the radius of curvature of the proximal portion of the mount 20 is greater than the radius of curvature of the mount 625 .
  • the first buckling position 6251 is a curved piece corresponding to the first abutting curved surface 212 of the fixing base 20
  • the second buckling position 6523 is a curved piece corresponding to the second abutting curved surface 214 of the fixing base 20
  • the radius of curvature of the first engaging position 6251 is K3
  • the radius of curvature of the second engaging position 6523 is K4.
  • the radius of curvature K3 of the first buckling position 6251 is greater than the radius of curvature K1 of the first abutting curved surface 212 of the fixing seat 20
  • the radius of curvature K4 of the second buckling position 6253 is smaller than the radius of curvature of the second abutting curved surface 212 of the fixing seat 20 .
  • the fixing base 20 when the fixing base 20 is accommodated in the connecting frame 62 , the two bosses 23 of the fixing base 20 are respectively clamped into the two slots 6230 of the tissue holder 60 , so that the fixing base 20 and the tissue holding member 60 are engaged with each other, so as to prevent the tissue holding member 60 and the fixing seat 20 from moving back and forth, that is, it plays the role of front and rear limit.
  • the fixing seat 20 and the forceps arm 40 are respectively made of biocompatible metal materials such as stainless steel, cobalt alloy, cobalt-chromium alloy, titanium alloy or nickel-titanium alloy;
  • the driving component 70 is made of polyester, Silicone resin, stainless steel, cobalt alloy, cobalt chromium alloy or titanium alloy and other biocompatible polymer materials or metal materials.
  • the fixing base 20 , the clamp arm 40 and the driving assembly 70 are all made of stainless steel.
  • the clamp arm 40 when the drive assembly 70 drives the clamp arm 40 to open and close relative to the fixed base 20 , the clamp arm 40 can be opened and closed relative to the fixed base 20 in a wide range, and the angle between the two clamp arms 40 can be realized.
  • the maximum can reach 300 degrees, that is, after the forceps arm 40 is opened relative to the fixed seat 20, it can be turned downward to a certain extent, which is conducive to clamping the valve in motion, improving the success rate of clamping, and after clamping If the effect is found to be unsatisfactory, the valve leaflet can be released by flipping the forceps arm 40 downward and re-clamping.
  • the included angle between the two clamp arms 40 is preferably 0-240 degrees, more preferably 120-180 degrees.
  • a non-slip structure may be provided on the surface of the forceps arm 40 facing the clamping section 643 to enhance the frictional force when the forceps arm 40 is in contact with the valve leaflet 300 , thereby providing a stable clamping force and enabling The leaflet 300 is prevented from being damaged by the forceps arm 40 .
  • the anti-slip structure may be a protrusion or groove provided on the inner surface of the receiving groove 45 of the clamping frame 44 or a gasket made of a biocompatible material with a high friction coefficient attached to the inner surface of the receiving groove 45 .
  • active drugs may also be applied on the inner surface of the receiving groove 45 of the forceps arm 40 and/or each clamping segment 643 to promote the endothelial cells of the valve tissue on the inner surface of the forceps arm 40 and the clamping arm 64 to crawl cover and grow.
  • the two gripping segments 643 of the tissue gripping member 60 are also provided with control wires respectively, and the gripping segments 643 can be pulled up to fit the central axis by pulling or loosening the control wires for convenient transportation;
  • the pulling force on the clamping section 643 causes the clamping arm 64 to rebound and restore to its natural state due to its own elastic memory performance, and the clamping section 643 expands relative to the fixing seat 20 to press the valve leaflet 300 to the clamp arm 40 to clamp the valve leaflet 300.
  • the control wire may be a metal wire made of nickel-titanium alloy or the like, and since it has nothing to do with the improvement and creation of the present application, it will not be repeated here.
  • the following takes the mitral valve repair process as an example to illustrate the operation method of the valve clamping device of the present application, which mainly includes the following steps:
  • Step 1 The valve clamping device 100 is detachably connected to the distal end of the delivery device, and the control wire is pulled toward the proximal end to control the clamping arm 64 to retract relative to the fixed seat 20, so that the clamping section 643 of the clamping arm 64 is attached on the surface of the fixing base 20 . Then, the drive shaft 72 is moved proximally to drive the connecting rod 76 to drive the forceps arm 40 to close relative to the fixed seat 20, so that the valve clamping device 100 is in a fully retracted state, and both the tissue holding member 60 and the forceps arm 40 are close to the fixed seat 20 surface, keep the folded state unchanged.
  • the second step femoral vein puncture, using a trans-atrial septal route, through the flexible sheath to advance the distal end of the delivery device and the valve clamping device 100 from the left atrium, through the mitral valve to the left ventricle.
  • Step 3 Adjust the relative positions of the valve clamping device 100 and the mitral valve, so that the valve clamping device 100 is close to the anterior and posterior leaflets of the mitral valve.
  • the fourth step moving the drive shaft 72 toward the distal end, thereby driving the connecting rod 76 to drive the clamp arm 40 to open relative to the fixed seat 20 .
  • Step 5 withdraw the entire valve clamping device 100 toward the proximal end, so that the forceps arm 40 supports the valve leaflet on the left ventricle side.
  • Step 6 Release the control of each control wire to the corresponding clamping arm 64 to release the clamping arms 64 on both sides, and the clamping arms 64 on each side press the valve leaflet 300 on the atrial side and connect with the clamp arm on that side. 40 fits to hold the leaflets (as shown in Figure 13).
  • the seventh step move the drive shaft 72 toward the proximal end, and the drive shaft 72 drives the connecting rod to drive the clamp arm 40 to close relative to the fixed seat 20, until the valve clamping device 100 is fully retracted.
  • Step 9 Release the connection between the valve clamping device 100 and the delivery device and the control wire, and withdraw the delivery device and the control wire from the patient's body. Pulled toward each other to obtain a bi-ported mitral valve, edge-to-edge repair of the mitral valve is completed, and the valve clamping device 100 is indwelled in the patient.
  • the structure 100a of the valve clamping device provided in the second embodiment of the present application is similar to the structure of the valve clamping device 100 in the first embodiment, the difference is that: in the second embodiment
  • the structure of the clamp arm 64a is slightly different from that of the clamp arm 64 in the first embodiment.
  • a curved portion 645 is provided between the clamping segment 643 of each clamping arm 64a and the corresponding bending segment 641, and the curved portion 645 is bent toward the side away from the connecting frame 62, so that the valve clamping device 100a can be In a natural state, the clamping section 643 of the clamping arm 64 is substantially parallel to the clamping frame 44 of the clamp arm 40 .
  • the gap between the barbs 6433 and the clamping frame 44 of the forceps arm 40 is relatively uniform, and the barbs 6433 can simultaneously contact the valve leaflet 300 to improve the success of capturing the valve leaflet 300 rate and stability.
  • the same nickel-titanium alloy material and manufacturing process are respectively used to make three groups of clamping arms, wherein the first group is the tissue clamping member used in this application (the width and diameter of the embodiments A1-A4 in FIG. 16 ), and the second group It is the constant diameter (equal diameter and equal width) tissue clamps in the prior art (the equal width and constant diameter of the comparative examples B1-B4 in FIG. 16 ), and the third group is the equal width tissue clamps in the prior art.
  • a tissue holder with holes formed by laser cutting on the holder (the equal-width openings of Comparative Examples C1-C4 in Figure 16), the following performance tests were performed on several groups of tissue holders respectively, and the test results are shown in Figure 16. shown.
  • test equipment is the AWT-1000 artificial heart valve fatigue resistance tester of Shanghai Heart Valve Testing Equipment Co., Ltd. It is tested whether the tissue holder is fractured or cracked due to load during the fatigue test cycle. The test results are shown in Figure 16.
  • the fatigue resistance test parameters are as follows: cyclic tension (peak value): 0.80N ⁇ 0.30N, amplitude: 1mm, frequency: 50Hz, water bath temperature: 37°C ⁇ 0.5°C, cycle: ⁇ 400 million times.
  • the test equipment is the HY-0580 electronic universal tensile testing machine produced by Shanghai Hengyi Precision Instrument Co., Ltd.
  • the test method is as follows: connect the valve clamping device to the simple handle, respectively use two U-shaped control wires to pass through the control holes of the two free ends of each clamping arm, and the control wires pass through the proximal end of the simple handle, Fix the simple handle on the machine table of the tension machine, the moving end of the tension machine hooks the proximal end of the control wire, move the moving end at a constant speed of 4.5mm/min, and record the tissue clamps are retracted to the basic gripping section on both sides.
  • the force value in parallel, the test results are shown in Figure 16.
  • the fatigue resistance of control wires of three groups of tissue holders was tested.
  • the test equipment is the HY-0580 electronic universal tensile testing machine produced by Shanghai Hengyi Precision Instrument Co., Ltd.
  • the test method is as follows: connect the valve clamping device to the simple handle, respectively use two U-shaped control wires to pass through the control holes of the two free ends of each clamping arm, and the control wires pass through the proximal end of the simple handle,
  • the simple handle is fixed on the table of the tension machine, the moving end of the tension machine is hooked to the proximal end of the control wire, and the action of the tissue holder being closed and released under the control of the control wire is repeated, and the number of tests is 50 times.
  • After the test observe the control wire. If any of scratches, abrasions, cracks, and breaks occur, it is judged that the test has not passed.
  • the test results are shown in Figure 16.
  • the retracting force required to control the retraction of the tissue holder can be effectively reduced, which can not only ensure the fatigue resistance of the control wire, but also ensure the tissue holder itself. Fatigue resistance;
  • the tissue holder in the prior art is not provided with a variable diameter structure, and the required retraction when controlling the tissue holder is significantly larger. Although it can ensure the fatigue resistance of the tissue holder itself, it cannot guarantee the control wire. fatigue resistance;
  • the opening of the tissue holder in the prior art can reduce the retraction force required to control the retraction of the tissue holder and ensure the fatigue resistance of the control wire, but cannot guarantee the fatigue resistance of the tissue holder itself. .
  • the tissue holder of the present application has better fatigue resistance, requires less pulling force and retracting force, and lowers the risk of breakage of the control wire.
  • valve clamping device using the tissue clamping device of the present application can meet the load of 10 years of implantation as a medical device implant after clamping the two leaflets of the mitral valve.
  • the artificial mitral valve model was fixed with a valve clamping device to simulate the edge-to-edge treatment effect, and then the mitral valve model with the valve clamping device was placed in a fatigue testing machine that simulates the beating of the human left heart system.
  • carry out non-destructive fatigue test record the sliding of valve clamping device due to load and damage to valve leaflet during the fatigue test cycle.
  • Test equipment AWT-1000 artificial heart valve fatigue resistance test machine of Shanghai Heart Valve Testing Equipment Co., Ltd.
  • Test standard Test according to the method of "fatigue test” in ISO 5840 and GB12279-2008 “Cardiovascular Implant Prosthetic Heart Valve", cycle: ⁇ 400 million times, the test result is that the valve clamping device of this embodiment satisfies According to relevant requirements, the valve clamping device did not slide during the test period, and the valve clamping device did not cause damage to the valve leaflets.
  • valve clamping device as an example for alleviating or treating "mitral valve regurgitation”. It can be understood that, in other embodiments, the valve clamping device can also be used to alleviate or treat "tricuspid valve regurgitation", and its principle and structure are the same as those used in the embodiments of the present application to solve "mitral valve regurgitation”.
  • the principle and structure of the valve clamping device are basically the same, and it is only necessary to form multiple clamps by multiple sets of proximal clamps and distal clamps, and each clamp can clamp a valve leaflet respectively, which will not be repeated here. .

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Abstract

一种组织夹持件（60），其包括连接框（62）及两个夹持臂（64），连接框（62）包括间隔相对的两个连接片（623）；两个夹持臂（64）分别设于两个连接片（623）相对的侧边，每一夹持臂（64）向远离另一夹持臂（64）的一侧延伸，每一夹持臂（64）包括连接于对应的连接片（623）的折弯段（641）及连接于折弯段（641）远离对应的连接片（623）的夹持段（643），折弯段（641）的宽度小于夹持段（643）的宽度，并小于连接片（623）的宽度；不仅可以减轻瓣膜夹合装置（100）的重量，还可以减少通过控制丝将瓣膜夹合装置（100）的两个夹持臂（64）拉起至贴合中心轴所需的拉力，减少控制丝所承担的反向作用力，防止控制丝断裂，利于操作。还提供一种设有组织夹持件（60）的瓣膜夹合装置（100）。

Description

组织夹持件及瓣膜夹合装置 技术领域
本申请涉及介入类医疗器械领域，尤其涉及一种组织夹持件及设有组织夹持件的瓣膜夹合装置。
背景技术
请参阅图1，二尖瓣1是位于心脏左心房2与左心室3之间的单向阀，正常健康的二尖瓣1可以控制血液从左心房2流到左心室3，同时避免血液从左心室3流到左心房2。二尖瓣1包括一对瓣叶，称为前叶1a及后叶1b。前叶1a及后叶1b通过腱索4固定于左心室3的乳头肌上。正常情况下，心脏左心室3收缩时，前叶1a和后叶1b的边缘完全对合，避免血液从左心室3流到左心房2。请参阅图2，当二尖瓣1的瓣叶或其相关结构发生器质性改变或功能性改变时，如腱索4部分断裂，二尖瓣1的前叶1a和后叶1b对合不良，由此，当心脏左心室3收缩时，二尖瓣1不能完全关闭，导致血液从左心室3反流至左心房2，从而引起一系棑的病理生理改变，称为“二尖瓣反流”。
外科通常采用瓣膜缘对缘缝合术等手术方式治疗二尖瓣返流。但是这类外科手术存在手术过程复杂、手术成本高、病人创伤程度高、并发症风险高、住院时间长以及患者恢复过程痛苦等缺陷。现有一种微创治疗手术，其基于瓣膜的缘对缘手术原理，将瓣膜夹合装置通过介入导管输送至二尖瓣处，再同时夹持二尖瓣的前叶和后叶，从而将瓣叶拉近彼此，减轻“二尖瓣反流”。这种瓣膜夹合装置通过一对内凹的钳臂和一个由形状记忆材料制成的组织夹持件相互配合，将二尖瓣的瓣叶固定在钳臂和组织夹持件之间。即钳臂与组织夹持件同时抓持二尖瓣的前叶和后叶，从而达到固定瓣叶、减少二尖瓣返流的目的。
具体地，瓣膜夹合装置在输送状态时，组织夹持件通过细长的控制丝牵拉后贴合在瓣膜夹合装置的中心轴两侧，并通过细长的输送导管输送至二尖瓣附近，然后调整瓣膜夹合装置的位置，松开控制丝对组织夹持件的牵拉后，组织夹持件由于其自身的形状记忆性能而展开并将瓣叶压向钳臂中，从而与钳臂配合夹持瓣叶。请参阅图3，组织夹持件3a包括基座3a1及设于基座3a1相对两侧的夹持臂3a2，每一夹持臂3a2上设置开孔3a3，以减小该部位的应力，减小拉力，增加回弹力；然而，这种夹持臂3a2降低了其自身的耐疲劳性能；若夹持臂3a2上不开设开孔3a3，则所述夹持臂3a2被拉起至贴合瓣膜夹合装置的中心轴所需的拉力较大，对控制丝及近端手柄的要求较高，容易导致控制丝断裂。
发明内容
有鉴于此，本申请提供一种组织夹持件及瓣膜夹合装置，不仅能提高组织夹持件的耐疲劳性能且能减轻组织夹持件处于收拢状态时的应力，以减少将组织夹持件拉起至收拢状态所需的拉力，防止控制丝断裂。
为解决上述技术问题，本申请提供一种组织夹持件，其包括连接框及两个夹持臂，所述连接框包括间隔相对的两个连接片；所述两个夹持臂分别设于所述两个连接片相对的侧边，每一所述夹持臂向远离另一夹持臂的一侧延伸，每一夹持臂包括连接于对应的连接片的折弯段及连接于所述折弯段远离对应的连接片的夹持段，所述折弯段的宽度小于所述夹持段的宽度，并小于所述连接片的宽度。
本申请还提供一种瓣膜夹合装置，其包括固定座、与所述固定座之间相对开合的一对钳臂，以及组织夹持件，所述组织夹持件设于所述固定座与钳臂之间，所述组织夹持件的两个夹持臂分别与所述一对钳臂中的一者配合以夹持瓣叶。
本申请提供的瓣膜夹合装置的每一夹持臂具有折弯段，且折弯段的宽度小于夹持段的宽度，并小于连接片的宽度；从而不仅可以减轻瓣膜夹合装置的重量，利于夹持臂的回弹、降低夹持难度，提高组织夹持件的耐疲劳性能，还可以减少通过控制丝将夹持臂拉起至贴合中心轴所需的拉力，减少控制丝所承担的反向作用力，防止控制丝断裂，提高瓣膜夹合装置长期植入人体的耐疲劳性能，提高器械安全性和有效性。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是二尖瓣正常状态时的示意图。
图2是二尖瓣出现病变时的示意图。
图3是现有技术中的组织夹持件的立体结构示意图。
图4是本申请的其中一实施例提供的瓣膜夹合装置的立体结构示意图。
图5是图4中的瓣膜夹合装置的组织夹持件与固定座的立体结构示意图。
图6是图5中的组织夹持件与固定座的立体结构分解示意图。
图7是图6中的组织夹持件的侧视图。
图8是图6中的组织夹持件的俯视图。
图9是图7中的组织夹持件的另一实施方式的结构示意图。
图10是图5中的组织夹持件与固定座的侧视图。
图11是图10中XI部分的放大图。
图12是图4中的瓣膜夹合装置的侧视图。
图13是图4中的瓣膜夹合装置的其中一使用状态图。
图14是本申请的又一实施例提供的瓣膜夹合装置的结构示意图。
图15是图14中的瓣膜夹合装置的夹持臂的结构示意图。
图16是本申请瓣膜夹合装置进行疲劳测试及对组织夹持件性能测试的结果统计图表。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或者暗示所指的装置或者元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
为了更加清楚地描述导线锁定系统及导线锁定装置的结构，本申请所述的限定术语“近端”、“远端”及“轴向”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端；“近端”表示手术操作过程中靠近操作人员的一端；本申请中的所述近端相对于远端距离操作者(外科医生)的距离较近，装置组装后，其中的每个部件均包括近端与远端，其中每个部件的近端相对远端距离操作者较近。“轴向”指装置中轴线所在方向，径向为与中轴线垂直的方向。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施例的目的，并不能理解为对本申请的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件时，该元件可以直接地连接在另一个元件上，也可以通过一个或者多个连接元件间接地连接在另一个元件上。当一个元件被称为是“连接于”另一个元件，它可以是直接地连接到另一个元件上，或者通过一个或者多个连接元件连接到另一元件上。
请一并参阅图4-图6，本申请的第一实施例提供一种瓣膜夹合装置100，包括固定座20、与固定座20铰接的至少一对钳臂40、连接于固定座20的组织夹持件60，以及用于驱动钳臂40相对固定座20开合的驱动组件70；一对钳臂40相对于固定座20开合，组织夹持件60设于固定座20与钳臂40之间，以与钳臂40配合夹持瓣叶，组织夹持件60包括连接框62及两个夹持臂64。使用时，瓣膜夹合装置100的近端可释放地连接到输送装置，通过控制丝将瓣膜夹合装置100的两个夹持臂64拉起至贴合中心轴处，操作者将瓣膜夹合装置100推送至患者的二尖瓣处，然后远距离操作瓣膜夹合装置100，使得钳臂40相对于固定座20张开，再解除控制丝对两个夹持臂64的拉力，将二尖瓣的前叶和后叶分别被钳臂40与对应的夹持臂64夹持在一起，从而使二尖瓣的瓣叶被缘对缘地对合在一起，然后解脱输送装置与瓣膜夹合装置100之间的连接，瓣膜夹合装置100作为植入物留在患者体内，以便将瓣叶的对合位置保持在一起，实现二尖瓣的“缘对缘修复”，减轻患者的二尖瓣返流。
需要说明的是，瓣膜夹合装置100及输送装置可以采用现有的可调弯鞘管、塑形鞘管等导引装置输送至患者体内。
具体地，连接框62包括基板621及设置于基板621相对两侧的两个连接片623；两个 夹持臂64分别设于两个连接片623相对的侧边，每一夹持臂64向远离另一夹持臂64的一侧延伸；每一夹持臂64包括连接于对应的连接片623的折弯段641及连接于折弯段641远离对应的连接片623的夹持段643，折弯段641的宽度小于夹持段643的宽度，并小于连接片623的宽度；组织夹持件60的两个夹持臂64分别与一对钳臂40中的一者配合以夹持瓣叶300(如图13所示)，即每个夹持臂64的夹持段643分别与一个钳臂40配合以夹持一片瓣叶300。
本申请中，瓣膜夹合装置100的每一夹持臂64具有折弯段641，且折弯段641的宽度小于夹持段643的宽度，并小于连接片623的宽度；从而不仅可以减轻瓣膜夹合装置100的重量，利于夹持臂64的回弹、降低夹持难度，提高组织夹持件60的耐疲劳性能，还可以减少通过控制丝将夹持臂64拉起至贴合中心轴所需的拉力，减少控制丝所承担的反向作用力，防止控制丝断裂，能提高瓣膜夹合装置100长期植入人体的耐疲劳性能，提高器械安全性和有效性。
如图4所示，本实施例中，瓣膜夹合装置100包括相对设置的一对钳臂40，每一钳臂40可相对于固定座20开合。每一钳臂40包括连接框42以及连接于连接框42远离固定座20的一端的夹持框44，两个钳臂40的连接框42远离夹持框44的一端相互层叠后铰接于固定座20。夹持臂64与钳臂40之间形成瓣叶容纳空间。每一钳臂40面朝夹持臂64的表面向内凹陷形成收容槽45，从而在瓣膜夹合装置100的输送状态下，夹持臂64至少部分容纳在钳臂40的收容槽45中，以减少瓣膜夹合装置100的外径及体积，利于在体内进行输送。在钳臂40与夹持臂64配合夹持瓣叶300后，瓣叶300被夹持在收容槽45内可以增加钳臂40与瓣叶300的接触面积、并使得夹持臂64将瓣叶300压入钳臂40的收容槽45中，增加对瓣叶300的夹持力。
具体地，每一钳臂40包括矩形的连接板442及设置于连接板442相对两侧的侧板444，连接板442与两个侧板444围成收容槽45。连接板442沿其长度方向开设若干去料孔446，以减轻钳臂40的重量。侧板444邻近固定座20的一端倾斜延伸并铰接在固定座20上，形成钳臂40的连接部42，连接部42开设销钉孔，用于穿插销钉。
钳臂40通过驱动组件70实现相对于固定座20的开合。驱动组件70包括穿设于固定座20的驱动轴72、设于驱动轴72远端的连接座74，以及与连接座74两侧活动相连的一对连杆76。每一连杆76的一端与对应的一个钳臂40相连，另一端通过枢转连接于连接座74，即，每一钳臂40通过相应一侧的连杆76转动连接于驱动组件70的连接座74远端。驱动轴72活动地穿过固定座20后连接于连接座74。当驱动轴72相对于固定座20沿轴向滑动时，连接座74沿轴向移动使连杆76转动并带动钳臂40相对于固定座20开合。
如图6所示，固定座20包括呈矩形状的固定框21、设置于固定框21近端的连接块22，以及设置于固定框21相对两侧的凸台23，固定座20沿轴向设有贯穿连接块22及固定框21的通孔24，通孔24用于穿插驱动轴72。连接块22相对的两端分别设有销钉孔26，销钉孔26的轴心线与通孔24的轴心线相互垂直，销钉孔26用于与钳臂40的连接部42通过销钉相连。固定框21于连接块22相对的两侧分别设有第一贴接曲面212及第二贴接曲面 214，其中第一贴接曲面212较第二贴接曲面214更靠近连接块22，第一贴接曲面212的曲率半径为K1，第二贴接曲面214的曲率半径为K2。
组织夹持件60至少部分由形状记忆材料制成，且经过热定型处理，组织夹持件60具有自然展开状态及收拢状态。制作时，先通过激光切割的方式将形状记忆材料切割成需要的形状，然后放置在模具中在550℃左右经过热定型，使其具有特定形态。如图7所示，在自然状态下，组织夹持件60两侧的夹持臂64均相对于连接框62向外辐射延伸；优选地，夹持臂64倾斜地朝远端延伸以便于和钳臂40配合以夹持瓣膜组织，即，自然展开状态下的两侧的夹持臂64之间的夹角应略大于两个钳臂40之间的夹角，以提供更稳定的夹持力，从而保证夹持臂64与钳臂40之间具有一定的夹紧力，以夹紧位于二者之间的瓣叶；具体地，每一夹持臂64的夹持段643的长度方向与固定座20轴向之间的夹角a大于与夹持臂64对应的钳臂40相对于固定座20完全张开时的该钳臂40与固定座20轴向之间的夹角，从而使每一夹持臂64的自由端与对应的钳臂40相互靠近并具有一定的夹紧力，以提供更稳定的夹持力。具体的，自然状态下，夹持段643的长度方向与固定座20的轴向之间的夹角a的角度范围为0-150度，即，两个夹持段643之间的夹角最大可达300度，优选为160-200度，本实施例中，两个夹持段643之间的角度大于180度。
本实施例中，组织夹持件60整体由超弹性的镍钛合金制成，从而为组织夹持件60提供弹力以驱使夹持臂64向钳臂40靠拢以夹持瓣膜组织，并降低生产工艺难度，简化工艺流程，降低生产成本。
在其他实施例中，夹持臂64的不同部位可以采用不同材料单独制作后固定连接。例如，夹持臂64的夹持段643采用不锈钢材料制成以提高夹持力，折弯段641应具有折弯功能从而为组织夹持件60提供自然展开状态及利于输送的收拢状态，因此折弯段641由形状记忆材料制成。
本实施例中，每一连接片623与对应的折弯段641之间通过弯折的固定片625连接，每一连接片623上的固定片625朝向另一连接片625弯曲，每一折弯段641向远离另一折弯段641弯曲。每一连接片623沿其长度方向设有卡槽6230，卡槽6230延伸至对应的固定片625中，用于与固定座20配合固定。卡槽6230形状可以是矩形，椭圆形，棱形或其他形状，本实施例优选矩形，配合稳定性更高。基板621、两个连接片623及两个固定片625围成近端开放的连接框62，固定座20容置于连接框62的内腔，驱动轴72经由连接框62的近端开放处穿插于固定座20及连接框62。具体地，基板621开设通孔6210，固定座20容置于连接框62的内腔后，固定座20的通孔24与基板621的通孔6210对应，驱动轴72穿设于固定座20的通孔24及基板621的通孔6210。可以理解的是，固定片625应具有一定变形能力从而卡持在固定座20外部，因此固定片625应由形状记忆材料制成，连接框62的其他部位可以采用不锈钢等较硬质材料制成，从而提高连接强度。即，连接框62的固定片625及与其相连的折弯段641可以采用镍钛合金一体成型，连接框62的基板621及连接片623采用不锈钢一体成型后再与固定片625焊接或粘接固定，每一折弯段641再与夹持段643焊接或粘接固定。
如图6-图8所示，折弯段641包括连接于对应的固定片625的第一端6412，以及连接于对应的夹持段643的第二端6414，折弯段641为变径结构，即，折弯段641在第一端6412处的宽度大于折弯段641在第二端6414处的宽度，且折弯段641的宽度自第一端6412朝第二端6414逐渐减小。本实施例中，折弯段641的第一端6412的宽度等于固定片625的宽度，折弯段641的第二端6414的宽度等于夹持段643的宽度，折弯段641的第一端6412与第二端6414之间光滑过渡。由于瓣膜夹合装置100在手术过程中经常会出现需要反复开合，多次抓捕瓣叶的情形，若夹持臂64的回弹应力过大，则对控制丝的牵拉力要求更高，会增加控制丝断裂的风险。折弯段641采用变径结构能够有效减小夹持臂64在收拢状态时的应力，从而降低控制丝断裂的风险。另外，现有技术中，为了减小应力，在折弯段中间开孔，但是开孔位置容易出现微裂纹，而微裂纹往往难以观测，在瓣膜夹合装置植入人体体内长期受力的状态下，开孔位置附近的微裂纹容易出现疲劳断裂。因此，本实施例通过变径结构减小应力，同时避免开孔导致的疲劳断裂风险。
优选地，折弯段641的第二端6414与第一端6412的宽度比例范围为0.4-0.8；更优选地，折弯段641的第二端6414与第一端6412的宽度比例范围为0.5-0.65。若第二端6414与第一端6412的宽度比例过大，即，第二端6414的宽度过大，则折弯段641在夹持臂64收拢状态时的应力较大，所需的拉力较大且控制丝的断裂风险较高；若第二端6414与第一端6412的宽度比例过小，即，第二端6414的宽度过小，则会影响夹持臂64对组织的夹持力，导致夹合装置100容易滑脱。
如图5-图8所示，每一夹持臂64的夹持段643沿其长度方向设有至少一排倒刺6433，每一倒刺6433的末端设为圆角，以避免刺穿瓣叶。具体地，夹持段643包括与折弯段641的第二端6414相连的夹持片6431，以及与夹持片6431的两侧相连的两棑倒刺6433，本实施例中，夹持片6431的每一侧的一棑倒刺6433的数量为四个。
每一倒刺6433与夹持片6431之间具有角度，角度范围为30度-85度，优选45度-65度，角度过大或过小均会增加捕获瓣叶的难度。每根倒刺6433与夹持片6431之间的夹角A可以相同，也可以不同，本实施例中，每根倒刺6433与夹持片6431之间的夹角A均为60度。
每一倒刺6433的有效长度范围为0.3毫米-2.0毫米，优选为0.5毫米-1.2毫米。倒刺6433的有效长度可以相同或不相同。本实施例中，每排倒刺6433中的倒刺的延伸长度相同；具体地，夹持片6431的每一侧的同一棑的四个倒刺6433，自邻近折弯段641的一端向末端的有效长度分别为L1、L2、L3、L4，且L1＝L2＝L3＝L4；本实施例中，L1、L2、L3、L4的有效长度均为0.8毫米。
如图9所示，在组织夹持件60的另一实施方式中，每一夹持段643的至少一排倒刺6433中的倒刺与对应的夹持段643之间的夹角沿夹持臂的延伸方向逐渐增加，且自邻近折弯段641的一端向末端的倒刺6433的有效长度也逐渐增加。具体地，每排倒刺6433的数量为四个，自邻近折弯段641的一端向末端的倒刺6433与夹持段643之间的夹角分别为A1、A2、A3、A4，且A1≤A2≤A3≤A4；自邻近折弯段641的一端向末端的倒刺6433的 有效长度分别为L1、L2、L3、L4，且L1≤L2≤L3≤L4。本实施例中，A1的角度为45度、A2的角度为50度、A3的角度为55度及A4的角度为60度；L1的有效长度为0.4毫米、L2的有效长度为0.8毫米、L3的有效长度为1.0毫米、L4的有效长度为1.2毫米。这样设置的原因是，由于瓣叶的厚度不均匀，瓣叶边缘最薄，至瓣叶与瓣环相连处的厚度逐渐增加，根据瓣叶从瓣缘到瓣中逐渐增厚的解剖结构，为了保证每根倒刺6433与瓣叶组织不同接触位置处的受力深度大致相同，保证夹持段643对瓣叶的夹持力，并且不会刺穿瓣叶，从而调整倒刺6433的角度以适应不同厚度瓣叶组织的受力深度。
如图8所示，夹持段643的宽度D1(宽度D1＝夹持片6431的宽度+两侧倒刺6433的宽度)、折弯段641的第二端6414的宽度D2、与固定片625的宽度D3之比的范围为(1.5～2)：1：(1.5～2),即D1:D2:D3＝(1.5～2):1:(1.5～2)。本实施例中，夹持段643宽度D1：折弯段641的第二端6414的宽度D2：固定片625的宽度D3＝1.5:1:1.5。若D2宽度过窄，会导致瓣膜夹合装置100的耐疲劳性及抗拉强度降低；若D2过宽，意味着瓣膜夹合装置100的重量增大，将导致瓣膜夹合装置100在植入后长时间坠在瓣下，不仅容易滑脱，也可能拉伤目标组织甚或导致心功能失常；并且，由于组织夹持件60为形状记忆合金制成，若D2过宽将导致被折弯段641压紧的瓣叶在心脏扩张和收缩运动时受到较大的压力，进而导致过大的组织损伤。
如图10及图11所示，固定片625的远端与连接框62相连，固定片625的近端与折弯段641相连，固定片625用于实现组织夹持件60与固定座20相互扣合固定的作用，防止组织夹持件60在受到控制丝的单侧接力作用下，与固定座20发生相对移位或松动，从而保证组织夹持件60在捕获瓣膜过程中的可靠性。
本实施例中，固定片625包括第一扣合位6251和第二扣合位6253。第一扣合位6251是防止连接框62与固定座20配合后发生上下移动，即起到近远端限位的作用；第二扣合位6253是防止连接框62与固定座20配合后发生左右移动，即起到左右限位的作用。固定座20的近端部分的曲率半径大于固定处625的曲率半径。具体地，第一扣合位6251是与固定座20的第一贴接曲面212对应的弯曲片，第二扣合位6523是与固定座20的第二贴接曲面214对应的弯曲片，其中第一扣合位6251的曲率半径为K3，第二扣合位6523的曲率半径为K4。第一扣合位6251的曲率半径K3大于固定座20的第一贴接曲面212的曲率半径K1，第二扣合位6253的曲率半径K4小于固定座20的第二贴接曲面212的曲率半径K2，从而在第一贴接曲面212与第一扣合位6251之间保留有第一避让位P1，在第二贴接曲面214与第二扣合位6523之间保留有第二避让位P2，固定片625与固定框21的接触点刚好设置在第一避让位P1与第二避让位P2之间，以防止固定片625与固定座20的连接出现干涉，从而保证第一扣合位6251的稳定性，即保证近远端限位的稳定性。
如图5及图6所示，当固定座20容置于连接框62中时，固定座20的两个凸台23分别卡入组织夹持件60的两个卡槽6230中，使固定座20与组织夹持件60相互扣合，以防止组织夹持件60与固定座20发生前后移动，即起到前后限位的作用。
为保证植入后的安全性，固定座20及钳臂40分别由不锈钢、钴合金、钴铬合金、钛 合金或镍钛合金等生物相容性金属材料制成；驱动组件70由聚酯、硅树脂、不锈钢、钴合金、钴铬合金或钛合金等生物相容性高分子材料或金属材料制成。本实施例中，固定座20、钳臂40及驱动组件70均由不锈钢制成。
如图12所示，驱动组件70带动钳臂40相对于固定座20开合时，可以实现钳臂40相对于固定座20在较大范围内开合，两个钳臂40之间的夹角最大可达到300度，即，钳臂40相对于固定座20打开后，可以实现一定程度的向下翻转，从而有利于夹持处于运动中的瓣膜，提高夹持成功率，并且在夹持后如若发现效果不理想可以通过向下翻转钳臂40来松脱瓣叶，重新夹持。本实施例中，两个钳臂40之间的夹角范围优选为0-240度，更优为120-180度。
优选地，钳臂40朝向夹持段643的表面上可以设置防滑结构(图中未示)，以增强钳臂40与瓣叶300接触时的摩擦力，从而提供稳定的夹持力，并能够避免钳臂40对瓣叶300造成损伤。防滑结构可以是设置于夹持框44的收容槽45内表面的凸起、凹槽或贴设于收容槽45内表面的由摩擦系数较高的生物相容性材料制成的垫片。
优选的，钳臂40的收容槽45内表面和/或每一夹持段643上还可以施加活性药物，以促进瓣膜组织在钳臂40的内表面上及夹持臂64上的内皮细胞爬覆及生长。
需要说明的是，组织夹持件60的两个夹持段643还分别设置有控制丝，通过牵拉或放松控制丝可以将夹持段643拉起至贴合中心轴，方便输送；或者解除对夹持段643的拉力使夹持臂64由于自身弹性记忆性能回弹并恢复自然状态，夹持段643相对于固定座20展开，以将瓣叶300压向钳臂40而夹持瓣叶300。具体的，控制丝可以是镍钛合金等制成的金属丝，因与本申请的改进与创造无关，此处不做赘述。
以下以二尖瓣修复过程为例，说明本申请的瓣膜夹合装置的操作方法，主要包括以下步骤：
第一步：将瓣膜夹合装置100可拆卸连接至输送装置远端，朝近端拉紧控制丝以控制夹持臂64相对于固定座20收拢，使夹持臂64的夹持段643贴合在固定座20的表面上。然后向近端移动驱动轴72而带动连杆76驱动钳臂40相对于固定座20闭合，以使瓣膜夹合装置100处于完全收拢状态，组织夹持件60及钳臂40均贴近于固定座20的表面，保持收拢状态不变。
第二步：股静脉穿刺，采用经房间隔的路径，通过可调弯鞘管将输送装置的远端以及瓣膜夹合装置100从左心房推进，经过二尖瓣到达左心室。
第三步：调整瓣膜夹合装置100与二尖瓣的相对位置，使得瓣膜夹合装置100接近二尖瓣的前叶和后叶。
第四步：朝远端移动驱动轴72，从而带动连杆76驱动钳臂40相对于固定座20张开。
第五步：朝近端回撤整个瓣膜夹合装置100，使钳臂40在左心室一侧托住瓣叶。
第六步：解除每一控制丝对相应夹持臂64的控制，以释放两侧的夹持臂64，每侧的夹持臂64在心房侧压住瓣叶300并与该侧的钳臂40配合以夹持瓣叶(如图13所示)。
第七步：朝近端移动驱动轴72，驱动轴72带动连杆驱动钳臂40相对于固定座20闭 合，直至瓣膜夹合装置100完全收拢。
第九步：解除瓣膜夹合装置100与输送装置及控制丝之间的连接，将输送装置及控制丝撤出患者体外，此时，瓣膜夹合装置100将二尖瓣的前叶和后叶拉向彼此，得到双孔化的二尖瓣，完成二尖瓣的缘对缘修复，瓣膜夹合装置100留置于患者体内。
请参阅图14及图15，本申请第二实施例提供的瓣膜夹合装置的结构100a与第一实施例中的瓣膜夹合装置100的结构相似，不同之处在于：在第二实施例中夹持臂64a的结构与第一实施例中的夹持臂64的结构略有区别。具体地，每一夹持臂64a的夹持段643与对应的折弯段641之间设有弯曲部645，弯曲部645朝远离连接框62的一侧弯曲，以使瓣膜夹合装置100a在自然状态下夹持臂64的夹持段643与钳臂40的夹持框44大致平行。由此，夹持臂64a在捕获瓣叶时，倒刺6433与钳臂40的夹持框44的间隙比较均匀，倒刺6433可以同步接触到瓣叶300，以提高抓捕瓣叶300的成功率和稳定性。
对组织夹持件进行性能测试及对瓣膜夹合装置进行疲劳测试。
组织夹持件性能测试
分别采用相同的镍钛合金材料及制作工艺制作三组夹持臂，其中第一组为本申请采用的组织夹持件(图16中实施例A1-A4的减宽变径)，第二组为现有技术中的不变径(等径等宽)组织夹持件(图16中的对比例B1-B4的等宽不变径)，第三组为现有技术中在等宽组织夹持件上通过激光切割形成开孔的组织夹持件(图16中的对比例C1-C4的等宽开孔)，分别对几组组织夹持件进行下述性能测试，测试结果如图16所示。
1.组织夹持件耐疲劳测试
测试组织夹持件自身的耐疲劳性能，测试设备为上海心瓣测试设备有限公司的AWT-1000型人工心脏瓣膜耐疲劳性能测试机。测试组织夹持件在疲劳测试周期内是否出现因负荷断裂或出现裂纹的情况，测试结果如图16所示。
耐疲劳试验参数如下：循环拉力(峰值)：0.80N±0.30N，振幅：1mm，频率：50Hz，水浴温度：37℃±0.5℃，周期：≥4亿次。
2.控制丝对组织夹持件的收拢力测试
测试相同的控制丝对三组组织夹持件的收拢力。测试设备为上海衡翼精密仪器有限公司生产的HY-0580型电子式万能拉力试验机。测试方法如下：将瓣膜夹合装置与简易手柄连接，分别用两根呈U形的控制丝穿过每个夹持臂的两个自由端的控制孔，控制丝从简易手柄的近端穿出，把简易手柄固定在拉力机的机台上，拉力机的移动端钩住控制丝的近端，以4.5mm/min速度的匀速移动移动端，记录组织夹持件收拢至两侧夹持段基本平行时的力值，测试结果如图16所示。
3.控制丝耐疲劳性能测试
测试三组组织夹持件的控制丝耐疲劳性能。测试设备为上海衡翼精密仪器有限公司生产的HY-0580型电子式万能拉力试验机。测试方法如下：将瓣膜夹合装置与简易手柄连接，分别用两根呈U形的控制丝穿过每个夹持臂的两个自由端的控制孔，控制丝从简易手柄的近端穿出，把简易手柄固定在拉力机的机台上，拉力机的移动端钩住控制丝的近端，重复 组织夹持件在控制丝控制下被收拢和释放的动作，测试次数为50次。测试后观察控制丝，若出现划伤、磨损、裂纹、断裂任意一种情况，则判定为未通过测试，测试结果如图16所示。
从图16所示的测试结果可知：
1).本申请通过在组织夹持件上设置变径结构，可以有效降低控制组织夹持件收拢所需要的收拢力，既能保证控制丝的耐疲劳性能，又能保证组织夹持件自身耐疲劳性能；
2).现有技术的组织夹持件未设置变径结构，控制组织夹持件收拢时所需要的收拢明显较大，虽能保证组织夹持件自身的耐疲劳性能，但不能保证控制丝的耐疲劳性能；
3).现有技术的组织夹持件开设开孔，尽管可以降低控制组织夹持件收拢所需要的收拢力，保证控制丝的耐疲劳性能，但不能保证组织夹持件自身的耐疲劳性能。
综上可知，本申请的组织夹持件与现有技术相比，具有较好的耐疲劳性能，所需要的牵拉力及收拢力较小，控制丝出现断裂的风险更低。
瓣膜夹合装置疲劳测试
通过疲劳测试验证采用本申请的组织夹持件的瓣膜夹合装置在夹持二尖瓣的两片瓣叶后是否能够满足作为医疗器械植入件植入10年载荷使用。测试前，先用瓣膜夹合装置固定人工二尖瓣模型，模拟缘对缘治疗效果，然后把带有瓣膜夹合装置的二尖瓣模型放置在模拟人体心脏左心系统跳动的疲劳测试机里，进行非破坏性疲劳测试，记录疲劳测试周期内瓣膜夹合装置因负荷产生的滑动及对瓣叶损伤情况。
测试设备：上海心瓣测试设备有限公司的AWT-1000型人工心脏瓣膜耐疲劳性能测试机。
测试标准：按照ISO 5840及GB12279—2008《心血管植入物人工心脏瓣膜》中关于“疲劳试验”的方法进行测试，周期：≥4亿次，测试结果是本实施例的瓣膜夹合装置满足相关要求，试验周期内未发生瓣膜夹合装置滑动，瓣膜夹合装置未对瓣叶造成损伤。
需要说明的是，以上内容均是以瓣膜夹合装置用于减轻或治疗“二尖瓣反流”为例进行描述的。可以理解的是，在其他实施例中，瓣膜夹合装置也可以用于减轻或治疗“三尖瓣反流”，其原理及结构与本申请实施例中用于解决“二尖瓣反流”的瓣膜夹合装置的原理及结构大致相同，只需通过多组近端夹片和远端夹片构成多个夹钳，每个夹钳分别夹合一片瓣叶即可，此处不做赘述。
需要说明的是，在不脱离本申请实施例原理的前提下，以上各个实施例中的具体技术方案可以相互适用，在这里不做赘述。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (15)

  1. 一种组织夹持件，其特征在于，包括：
    连接框，所述连接框包括间隔相对的两个连接片；
    两个夹持臂，所述两个夹持臂分别设于所述两个连接片相对的侧边，每一所述夹持臂向远离另一夹持臂的一侧延伸，每一所述夹持臂包括连接于对应的连接片的折弯段及连接于所述折弯段远离对应的连接片的夹持段，所述折弯段的宽度小于所述夹持段的宽度，并小于所述连接片的宽度。
  2. 如权利要求1所述的组织夹持件，其特征在于，每一连接片与对应的折弯段之间通过弯折的固定片连接，每一连接片上的固定片朝向另一连接片弯曲，每一折弯段向远离另一折弯段弯曲。
  3. 如权利要求2所述的组织夹持件，其特征在于，所述折弯段包括连接于对应的固定片的第一端，以及连接于对应的夹持段的第二端，所述折弯段在所述第一端处的宽度大于所述折弯段在第二端处的宽度。
  4. 如权利要求3所述的组织夹持件，其特征在于，所述折弯段的宽度自所述第一端朝第二端逐渐减小。
  5. 如权利要求3所述的组织夹持件，其特征在于，所述折弯段的第一端的宽度等于固定片的宽度，所述折弯段的第二端的宽度等于夹持段的宽度，所述折弯段的第一端与第二端之间光滑过渡。
  6. 如权利要求1所述的组织夹持件，其特征在于，每一夹持臂的夹持段沿其长度方向设有至少一排倒刺。
  7. 如权利要求6所述的组织夹持件，其特征在于，每一所述倒刺的末端设为圆角。
  8. 如权利要求6所述的组织夹持件，其特征在于，所述至少一排倒刺中的倒刺的延伸长度沿所述夹持臂的延伸方向逐渐增加。
  9. 如权利要求6所述的组织夹持件，其特征在于，所述至少一排倒刺中的倒刺与对应的夹持段之间的夹角沿所述夹持臂的延伸方向逐渐增加。
  10. 如权利要求1所述的组织夹持件，其特征在于，每一夹持臂的夹持段与对应的折弯段之间设有弯曲部，所述弯曲部朝远离所述连接框的一侧弯曲。
  11. 如权利要求1所述的组织夹持件，其特征在于，所述组织夹持件至少部分由形状记忆材料制成，所述组织夹持件具有自然展开状态及收拢状态。
  12. 如权利要求11所述的组织夹持件，其特征在于，所述折弯段由形状记忆材料制成，所述组织夹持件在自然状态下，两个夹持臂的夹持段之间的角度大于180度。
  13. 一种瓣膜夹合装置，其特征在于，包括固定座、与固定座之间相对开合的一对钳臂，以及如权利要求1-12中任意一项所述的组织夹持件，所述组织夹持件设于所述固定座与所述钳臂之间，所述组织夹持件的两个夹持臂分别与所述一对钳臂中的一者配合以夹持瓣叶。
  14. 如权利要求13所述的瓣膜夹合装置，其特征在于，所述固定座容置于连接框中， 所述连接框的至少一连接片设有卡槽，所述固定座设有卡扣于所述卡槽的凸起。
  15. 如权利要求14所述的瓣膜夹合装置，其特征在于，每一连接片与对应的折弯段之间通过弯折的固定片连接，所述固定座的近端部分的曲率半径大于所述固定片的曲率半径。
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