WO2022174635A1 - 瓣叶捕捞装置、系统及装配方法 - Google Patents

瓣叶捕捞装置、系统及装配方法 Download PDF

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Publication number
WO2022174635A1
WO2022174635A1 PCT/CN2021/131388 CN2021131388W WO2022174635A1 WO 2022174635 A1 WO2022174635 A1 WO 2022174635A1 CN 2021131388 W CN2021131388 W CN 2021131388W WO 2022174635 A1 WO2022174635 A1 WO 2022174635A1
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WO
WIPO (PCT)
Prior art keywords
proximal
distal
coil
joint
main body
Prior art date
Application number
PCT/CN2021/131388
Other languages
English (en)
French (fr)
Inventor
王海山
虞奇峰
秦涛
Original Assignee
上海纽脉医疗科技股份有限公司
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Application filed by 上海纽脉医疗科技股份有限公司 filed Critical 上海纽脉医疗科技股份有限公司
Priority to US18/547,157 priority Critical patent/US11890195B1/en
Publication of WO2022174635A1 publication Critical patent/WO2022174635A1/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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • 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
    • 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 present application relates to the technical field of medical devices, and in particular, to a valve leaflet fishing device, system and assembly method.
  • Mitral valve disease is a common heart valve disease, and patients with mitral valve disease are also the largest group in heart valve surgery, accounting for about 60%. Mitral valve interventional therapy provides good treatment options, including transcatheter mitral valve repair and transcatheter mitral valve replacement. Among them, transcatheter mitral valve replacement is the mainstream development direction at present, and countries around the world have invested a lot in research and development of transcatheter mitral valve replacement. Transcatheter mitral valve replacement requires the mitral valve leaflet to be soft, and with the continuous change of the cardiac cycle and the condition, the mitral valve leaflet cannot provide radial support for the valve stent. valve-in-the-ring technique.
  • the existing problem is that the currently used valve-in-the-ring technology needs to arrange the leaflet fishing ring in a suitable position around the mitral valve leaflet before the artificial valve is implanted, so as to provide a certain support force for the mitral valve leaflet, It also provides radial support force for the subsequent implanted artificial valve.
  • the leaflet fishing ring cannot be accurately arranged in a suitable position, and the operation of the valve-in-ring technique is difficult and the operation takes a long time. Therefore, how to accurately arrange the leaflet fishing ring at a suitable position to reduce the difficulty of delivery of the valve leaflet fishing ring and shorten the operation time has become an urgent technical problem to be solved.
  • the purpose of one or more embodiments of this specification is to provide a valve leaflet fishing device, system and manufacturing method, which can accurately arrange the valve leaflet fishing device in a suitable position, reduce the difficulty of delivering the valve leaflet fishing ring, and shorten the operation time .
  • a valve leaflet fishing device comprising: a wire body configured in a helical shape, including a distal coil, an intermediate coil and a proximal coil arranged in sequence, the distal coil being arranged on the wire body
  • the distal end of the coil is arranged at the proximal end of the wire body, wherein the inner diameter of the coil of the proximal end and the inner diameter of the coil of the distal end are both larger than the inner diameter of the spiral of the intermediate coil
  • the proximal joint comprises a proximal joint main body part, a proximal clamping claw and a proximal clamping part, the proximal clamping claw is arranged at one end of the proximal joint main body part, and the proximal clamping part is arranged At the other end of the proximal joint main body, the proximal joint is provided with a proximal through hole penetrating from the proximal clamping portion to the proximal
  • a valve leaflet fishing system comprising a delivery device and the valve leaflet fishing device as described above, the delivery device comprising a pusher, the delivery device being provided with a distal release portion and penetrating the distal end
  • the delivery through hole of the end release part, the proximal end clipping part is clipped with the releasable part, the delivery through hole is aligned with the proximal end through hole, and the pusher passes through the delivery through hole and
  • the proximal through hole is abutted on the proximal end of the proximal coil.
  • a method for assembling a valve leaflet fishing device which is suitable for the valve leaflet fishing device including a wire body, and the wire body includes a distal coil, an intermediate coil and a proximal coil arranged in sequence, and the proximal end
  • the method includes: applying the wire to the wire The body is subjected to heat setting treatment, and the wire body is constructed into a helical shape, so that the inner helical diameter of the proximal coil and the inner helical diameter of the distal coil are both larger than the inner helical diameter of the intermediate coil; heat the proximal joint
  • the shaping process is performed to realize that the proximal jaws of the proximal joint are in a closed state; the proximal joint is placed in ice water to realize
  • valve leaflet fishing device provided by the present application includes a wire body and a proximal joint, and the wire body is configured in a helical shape, and the helical wire body includes sequentially arranged distal end joints.
  • the distal coil captures the valve leaflets, and the middle coil wraps around the heart valve leaflets, which can provide sufficient radial support for the implanted valve stent.
  • the proximal coil is stuck on the left atrium side, preventing the valve stent from being implanted.
  • An unexpected situation occurs in which the leaflet capture device is impacted by blood flow and falls into the ventricle.
  • the distal coil is disposed at the distal end of the wire body
  • the proximal coil is disposed at the proximal end of the wire body
  • the proximal end of the proximal coil is fixed to the proximal connector.
  • the proximal joint includes a main body part of the proximal joint, a proximal claw and a proximal clamping part, the proximal clamping claw is arranged at one end of the main body part of the proximal joint, and the proximal clamping part is arranged at the other end of the main body part of the proximal joint , the proximal joint is provided with a proximal through hole that penetrates from the proximal clamping part to the proximal claw through the proximal joint main body part, and the proximal end of the proximal coil is clamped in the proximal joint main body part after being fixed to the proximal joint main body part.
  • the proximal through hole communicates with the proximal end of the proximal coil, and after the proximal engaging portion is engaged with the releasable portion of the delivery device, the pusher of the delivery device is pushed against the proximal through hole through the proximal through hole.
  • the proximal end of the end coil can fix the valve leaflet fishing device to the delivery device, so that the valve leaflet fishing device can be accurately arranged in a proper position, reducing the difficulty of delivering the valve leaflet fishing ring and shortening the operation time.
  • FIG. 1 is a schematic structural diagram of a valve leaflet fishing device according to an embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional view of the leaflet fishing device shown in FIG. 1 arranged around the heart valve leaflets.
  • FIG. 3 is a partially enlarged schematic view of the leaflet fishing device shown in FIG. 2 at a position.
  • FIG. 4 is a schematic structural diagram of the valve leaflet fishing device shown in FIG. 3 after implanting a valve stent.
  • FIG. 5 is a schematic structural diagram of a proximal joint in another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 6 is a schematic structural diagram of a proximal sleeve in another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 7 is a schematic view of the structure of the valve leaflet fishing device shown in FIG. 6 where the midline body is fixed to the proximal sleeve.
  • FIG. 8 is a schematic cross-sectional view of the leaflet fishing device shown in FIG. 7 along line B-B.
  • FIG. 9 is a schematic structural diagram of the proximal sleeve fixed to the proximal joint in the valve leaflet fishing device shown in FIG. 7 .
  • FIG. 10 is a schematic structural diagram of the proximal-end claws in yet another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 11 is a schematic structural diagram of a proximal-end claw spread in yet another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 12 is a schematic structural diagram of a proximal clamping part in another valve leaflet fishing device and a releasable part in a delivery device according to an embodiment of the present invention.
  • FIG. 13 is a schematic structural diagram of the proximal-end clamping part in the valve leaflet fishing device shown in FIG. 12 and the releasable clamping part in the delivery device after clamping.
  • FIG. 14 is a schematic structural diagram of another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 15 is a schematic cross-sectional view along A-A of the leaflet fishing device shown in FIG. 14 .
  • FIG. 16 is a schematic structural diagram of a shape memory alloy piece in another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 17 is a schematic structural diagram of a shape memory alloy piece in another valve leaflet fishing device provided by an embodiment of the present invention.
  • FIG. 18 is a schematic structural diagram of a distal sleeve of a distal joint in yet another valve leaflet fishing device provided by an embodiment of the present invention.
  • Fig. 19 is a schematic view of the structure of the valve leaflet fishing device shown in Fig. 18 where the centerline body is fixed in the distal sleeve.
  • FIG. 20 is a schematic cross-sectional view along B-B of the leaflet fishing device shown in FIG. 19 .
  • FIG. 21 is a schematic view of the structure of the valve leaflet fishing device shown in FIG. 19 where the distal sleeve is fixed to the distal joint.
  • FIG. 1 a schematic diagram of a leaflet fishing device according to an embodiment of the present invention is shown. It can be seen that in the valve leaflet fishing device provided by the embodiment of the present invention, the wire body is configured in a spiral shape, the cross section of the wire body can be configured as a circle, and the diameter of the wire body can be set according to the physiological structure of the actual patient's heart valve leaflets.
  • the wire body includes a distal coil, a middle coil and a proximal coil arranged in sequence, and the inner helical diameter of the distal coil and the inner helical diameter of the proximal coil are larger than that of the middle coil, and the wire located in the middle coil
  • the body occupies most of the wire body, and is tightly coiled with a small gap between each other.
  • the purpose of this design is to arrange the valve leaflet fishing device around the heart valve leaflet before the valve stent is implanted in the patient. When the valve is positioned, the opening size of the heart valve leaflets is limited, and the middle coil plays a better supporting role for the valve stent when the valve stent is placed between the valve leaflets.
  • the inner diameter of the spiral here refers to the inner diameter of the spiral coil formed by the spiral coil of the wire body.
  • proximal end mentioned in the present application refers to the part close to the operator during the operation as the proximal end
  • distal end refers to the part away from the operator during the operation as the distal end
  • FIG. 1 it is a schematic structural diagram of a valve leaflet fishing device provided by an embodiment of the present invention.
  • the valve leaflet fishing device includes a wire body 1 and joints at both ends of the wire body 1.
  • the joints here include a proximal joint 12 and a distal joint 11.
  • the joint close to the operator is the proximal joint 12.
  • the joint away from the operator is the distal joint 11.
  • the wire body 1 is configured in a helical shape, including a distal coil 10 , an intermediate coil 20 and a proximal coil 30 arranged in sequence, the distal coil 10 is disposed at the distal end of the wire body 1 , and the proximal coil 30 Set at the proximal end of the wire body 1, as shown in FIG. 1, the helical inner diameter of the proximal coil 30 and the helical inner diameter of the distal coil 10 are both larger than the helical inner diameter of the intermediate coil 20, as shown in FIG.
  • the helical inner diameter is tapered, and as previously described, such a configuration facilitates the distal coil capture of the leaflets as they close together when delivering the leaflet capture device around the heart valve leaflets.
  • the helical inner diameter of the distal coil can be set at 30mm to 40mm.
  • the opening of the distal coil of this size is large enough to facilitate fishing, but the opening is not too large to avoid abutting on the inner wall of the heart. Appear.
  • the inner diameters of the spirals of the middle coils 20 are substantially the same, the adjacent coils in the middle coils 20 are closely arranged, and the middle coils 20 occupy most of the wire body 1 .
  • the middle coil 20 When the middle coil 20 is wrapped around the heart valve leaflet, it can provide sufficient radial support for the implanted valve stent, while the inner diameter of the proximal coil needs to be larger, so that the proximal coil is stuck on the left atrium side, preventing the Before the valve stent was implanted, the valve leaflet trapping device was hit by blood flow and fell into the ventricle unexpectedly. Therefore, the inner diameter of the coil at the proximal end was slightly larger than the diameter of the mitral valve annulus. The inner diameter of the coil at the proximal end can be determined according to The size of the valve annulus of different patients should be set accordingly, which can generally be 45mm to 60mm. This numerical range does not constitute a limitation to the technical solution of the present application. It is understandable that the numerical reference range of the helical inner diameter of the distal coil does not constitute a limitation to the technical solution of the present application. Program limitations.
  • the leaflet fishing ring is pre-arranged around the mitral valve leaflets, especially the middle coil 20 is used to reduce the tension of the mitral valve leaflets.
  • the inner diameter of the valve leaflet fishing ring can be made smaller than the outer diameter of the opened valve stent 5 .
  • the wire body 1 may include a shape memory alloy member 13, which can maintain a lasting support force for the valve stent 5, so that the patient will not be affected by the valve disease for a long time.
  • a shape memory alloy member 13 which can maintain a lasting support force for the valve stent 5, so that the patient will not be affected by the valve disease for a long time.
  • the proximal coil 30 is located in the upper left atrium, and the black circle in the figure is the section 130 of the shape memory alloy piece 13 , it can be seen that the intermediate coils 20 are closely arranged between adjacent coils when they are arranged in a proper position.
  • the shape memory alloy piece 13 Since the shape memory alloy piece 13 is subjected to a high temperature heat setting process, after the wire body 1 is implanted around the heart valve leaflet 4, the shape memory alloy piece 13 can be arranged according to the previously heat-set shape.
  • the proximal joint 12 includes a proximal joint main body 120, a proximal claw 121, and a proximal clamping portion 122.
  • the proximal claw 121 is disposed at one end of the proximal joint main body 120, and the proximal clamping
  • the connecting portion 122 is disposed at the other end of the proximal joint main body portion 120 , and the proximal joint 12 is provided with a proximal through hole 123 penetrating from the proximal engaging portion 122 to the proximal claw 121 through the proximal joint main body portion 120 .
  • the proximal end portion of the end coil 30 is clamped in the proximal end claw 121 after being fixed to the proximal end joint main body portion 120, wherein the proximal end through hole 123 is connected to the proximal end portion of the proximal end coil 30, and the proximal end is clamped.
  • the part 122 is used for snapping with the releasable part 90 of the delivery device 9 (see FIGS. 12 and 13 ), and the pusher 91 of the delivery device 9 pushes against the proximal end of the proximal coil 30 via the proximal through hole 123 .
  • the valve leaflet catching device is fixed to the delivery device 9 , and the pusher 91 can limit the valve leaflet catching device along the lengthwise extending direction of the pusher 91 .
  • the releasable part 90 of the delivery device 9 is snapped with the proximal end clipping part 122 of the valve leaflet fishing device, and the pusher 91 is pushed outward on the delivery device 9, The pusher 91 is pushed through the proximal through hole 123 against the proximal end of the proximal coil 30 .
  • the pusher 91 is pulled backward, so that the pusher 912 leaves the proximal through hole 123 and is perpendicular to the length of the pusher 91 relative to the pusher 91 .
  • the proximal snap portion 122 moves the releasable portion 90 such that the leaflet capture device is separated from the delivery device 9 .
  • the valve leaflet fishing device provided by the embodiments of the present invention further includes a distal joint 11 , and the distal joint 11 includes a distal joint main body 110 , a distal claw 111 and a guide head 112, the distal clamping claw 111 is arranged at one end of the distal main body portion, the guide head 112 is arranged at the other end of the distal main body portion, and the distal end portion of the distal coil 10 is clamped after being fixed to the distal joint main body portion 110 in the distal claw 111 .
  • the outer contour of the guide head 112 can be rounded, so that after the valve leaflet fishing device enters the human blood vessel, it can smoothly avoid the human tissue and enter the heart.
  • the distal claw 111 and the proximal claw 121 achieve the same technical effect that the end of the wire body 1 is clamped after the end of the wire body 1 is fixed on the main body of the joint, which improves the reliability of the fixing of the wire body 1 and the joint. sex.
  • the wire body 1 includes a shape memory alloy member 13 extending along the length direction of the wire body 1 and a shape memory alloy clad in the shape memory alloy.
  • the outer packaging layer 7 of the member 13, the distal end of the shape memory alloy member 13 is fixed to the distal joint main body portion 110, the proximal end portion of the shape memory alloy member 13 is fixed to the proximal joint main body portion 120, and the proximal clamping claw 121 and the distal jaw 111 are clamped on the packaging layer 7 .
  • the shape memory alloy piece 13 may be a nickel-titanium wire or the like.
  • the cross-sectional size of the shape memory alloy piece 133 located on the distal coil 10 is smaller than that of the shape memory alloy piece located on the middle coil 20
  • the cross-sectional dimensions of 132 and the cross-sectional dimensions of the shape memory alloy piece 131 located on the proximal coil 30 and the cross-sectional dimension 130 of the shape memory alloy piece 133 located on the distal coil 10 are from the distal end of the distal coil 10 to the distal coil.
  • the proximal end of 10 gradually increases until it is the same size as the interface of shape memory alloy piece 132 on intermediate coil 20 .
  • the diameter of the shape memory alloy piece 131 located on the proximal coil 30 and the diameter of the shape memory alloy piece 13 located on the middle coil 20 can be kept the same, not less than 0.7 mm.
  • the diameter of the shape memory alloy piece 133 located on the distal coil 10 gradually increases from the distal end of the distal coil 10 to the proximal end of the distal coil 10, so that the distal end of the distal coil 10 has better compliance, and can Moves better in blood vessels.
  • the diameter of the distal end of the shape memory alloy piece 133 located at the distal end coil 10 is not less than 0.3 mm, and the maximum value of the proximal end diameter of the shape memory alloy piece 133 located at the distal end coil 10 can be the same as that of the shape memory alloy piece located on the proximal end coil 30.
  • the diameter of the piece 131 is the same as the diameter of the shape memory alloy piece 132 located on the intermediate coil 20 .
  • At least the packaging layer 7 located on the distal coil 10 includes a mesh that is sequentially wrapped on the outside of the shape memory alloy piece 13 The end of the mesh metal layer 710 is fixed to the shape memory alloy member 13, and the cross-sectional size of the distal coil 10, the cross-sectional size of the intermediate coil 20 and the cross-sectional size of the proximal coil 30 are the same .
  • Both ends of the mesh metal layer 710 may be welded on the shape memory alloy member 13 respectively, and the mesh metal layer 710 may be woven from circular nickel-titanium wire, stainless steel wire or platinum wire.
  • the mesh metal layer 710 may be provided only on the distal coil 10 , or may be provided throughout the wire body 1 . If all metal braided layers are provided on the wire body 1 , it can be ensured that the cross-sectional dimensions of the distal coil 10 , the cross-sectional dimensions of the intermediate coil 20 and the cross-sectional dimensions of the proximal coil 30 are the same.
  • the mesh metal layer 710 can cover the entire wire body 1 , and both ends of the mesh metal layer 710 are welded on the shape memory alloy member 13 , which increases the friction between the leaflet fishing ring and the valve stent 5 .
  • the membrane layer 71 includes an ePTFE layer 711 and a PET layer 70 that are sequentially wrapped on the mesh metal layer 710 .
  • the layer 70 is stitched to the ePTFE layer 711 by a suture thread which is inserted through the mesh metal layer 710 .
  • the ePTFE layer 711 and the PET layer 70 are sequentially wrapped on the shape memory alloy piece 13 .
  • the suture used for suturing between the ePTFE layer 711 and the PET layer 70 can be inserted into the gap in the mesh metal layer 710 , so that the suture is stuck in the mesh metal layer 710 In this way, the ePTFE layer 711 and the PET layer 70 can be better fixed.
  • the cross-sectional size of the distal coil 10 the cross-sectional size of the intermediate coil 20, and the cross-sectional size of the proximal coil 30 are the same, and the mesh metal layer 710 is only provided on the distal coil 10, the foaming process of the ePTFE layer 711 is better accomplish.
  • the proximal jaw 121 and the distal jaw 111 can clamp both ends of the membrane layer 71 including the ePTFE layer 711 and the PET layer 70 .
  • the packaging layer includes a reticulated metal layer and a film layer sequentially wrapped around the outside of the shape memory alloy piece, the film layer includes an ePTFE layer and a PET layer sequentially wrapped around the outside of the reticulated metal layer, and the ePTFE layer is close to the metal layer.
  • the end portion and the proximal end portion of the PET layer are squeezed into the proximal fitting groove under the pressure of the proximal claw, and the distal end portion of the ePTFE layer and the distal end portion of the PET layer are clamped at the distal end. Under the pressure of the claw, it is squeezed into the distal assembly groove and clamped.
  • the ePTFE membrane material has a microporous structure, excellent endothelialization, excellent toughness, and high biocompatibility.
  • the valve annulus fishing device is straight before it is implanted into the human body. When the valve leaflet fishing device enters the human heart, it begins to restore the heat-set shape as the temperature rises (as shown in Figure 1), and returns to a spiral while fishing the valve leaflets. shape. When the two ends of the ePTFE layer 711 are clamped by the distal claw 111 and the proximal claw 121, they will be subjected to axial tension. Therefore, the ePTFE layer 711 needs to have at least 7% elongation according to the working conditions during design.
  • the ePTFE membrane layer 71 has a unique structure consisting of a large number of solid nodes interconnected by a matrix of fine fibers. The distance between the nodes is called the node distance IND, which is an index of the expansion amount of the ePTFE layer 711.
  • the IND of the ePTFE layer 711 used in the embodiment of the present invention is 5 micrometers to 100 micrometers.
  • the proximal joint main body 120 and the distal joint main body 110 are configured to be tubular, and the proximal claw 121 is directed toward the proximal joint main body.
  • the axial retraction of the portion 120 causes the distal jaws 111 to retract toward the axis of the distal joint main body portion 110 .
  • the state of the proximal end clamping claw 121 in FIG. 10 is the state before the valve leaflet fishing device is implanted into the human heart, and the distal end and the proximal end of the wire body 1 can be clamped tightly.
  • the ePTFE layer and the PET layer are squeezed into the proximal assembly groove 1200 under the pressure of the proximal clamping claw to be clamped.
  • the proximal clamping portion 122 includes a proximal clamping groove 1221 and a proximal clamping body 1220, and a proximal through hole 123 From the proximal clip body 1220 to the proximal joint body portion 120, the proximal clip body 1220 and the proximal joint main body portion 120 are integrally formed, and the groove between the proximal clip body 1220 and the proximal joint main body portion 120 forms the proximal end
  • the card slot 1221 is used for engaging with the releasable card slot 900 formed on the delivery device 9 .
  • the valve leaflet fishing device is fixed to the delivery device 9 through the design of the proximal through hole 123 , the proximal clip body 1220 , and the proximal clip slot 1221 .
  • the proximal end sleeve 14 is fixed inside the proximal joint main body 120 , and the wire body
  • the distal end of the shape memory alloy piece 13 in 1 is fixed to the inside of the distal sleeve 15 .
  • the material of the proximal joint main body 120 and the proximal sleeve 14 can be nickel-titanium alloy, and after the shape memory alloy piece 13 is welded into the proximal sleeve 14, the proximal sleeve 14 can be welded to the tubular proximal end.
  • the inside of the joint body portion 120 is the inside of the joint body portion 120 .
  • the distal end sleeve 15 is fixed inside the distal joint main body 110
  • the proximal end of the shape memory alloy piece 13 is fixed inside the proximal sleeve 14
  • the proximal through hole 123 includes the lumen 141 of the proximal sleeve 14
  • the shape memory alloy piece 13 can be welded into the distal sleeve 15 , and then the distal sleeve 15 can be welded inside the tubular distal joint main body 110 .
  • the material of the distal joint 11 is a shape memory alloy
  • the side wall of the distal sleeve 15 is provided with a distal penetration groove 150
  • the distal end of the shape memory alloy piece 13 is welded to the edge of the distal penetration groove 150
  • the distal end fitting groove 1100 is provided on the side wall of the distal joint main body 110
  • the distal sleeve 15 is welded to at least the distal end fitting edge of slot 1100.
  • the distal penetration groove 150 and the distal fitting groove 1100 in the figures facilitate the fixing of the shape memory alloy member 13 to the interior of the distal joint body portion 110 .
  • the material of the proximal joint 12 is a shape memory alloy
  • the side of the proximal sleeve 14 is A proximal end penetration groove 140 is provided on the wall
  • the proximal end of the shape memory alloy piece 13 is welded to the edge of the proximal end penetration groove 140
  • a proximal end fitting groove 1200 is provided on the side wall of the proximal joint main body 120.
  • the sleeve 14 is welded to at least the edge of the proximal fitting slot 1200 . Therefore, the clamping force of the proximal claw 121 on the end of the wire body 1 can be increased while ensuring that the shape memory alloy piece 13 is firmly fixed in the proximal joint main body 120 .
  • the materials of the proximal claws 121 and the distal claws 111 are shape memory alloys, and the distal claws 111 include discrete settings A plurality of distal claw bodies 1110 at one end of the distal joint main body portion 110, and the plurality of distal claw bodies 1110 extend from the distal joint main body portion 110 in a direction away from the distal joint main body portion 110 and gradually close together until multiple The distal ends 1114 of the two distal jaw bodies 1110 are brought together.
  • the distal ends 1114 of the plurality of distal claws 111 in FIG. 21 are not close together, while the proximal ends 1214 of the proximal claw 121 shown in FIG. Apply a strong grip.
  • the proximal claw 121 includes a plurality of proximal claw bodies 1210 discretely provided at one end of the proximal joint main body 120 , and The plurality of proximal claw bodies 1210 extend from the proximal joint body portion 120 in a direction away from the proximal joint main body portion 120 and gradually close together until the proximal ends 1214 of the plurality of proximal claw bodies 1210 are closed together.
  • each distal claw body 1110 of the plurality of distal claw bodies 1110 includes a distal base body 1111 and a distal bifurcation portion 1112, the distal bifurcation portion 1112 includes a first distal branch 1113 and a second distal branch 1115, the distal base 1111 is circumferentially disposed along the nozzle of the distal joint main body portion 110, and the distal bifurcation portion 1112 is distal
  • the end base 1111 extends in a direction away from the distal joint body portion 110 , and the end of the first distal branch 1113 of each distal claw body 1110 is connected to the second distal branch 1115 of the adjacent distal claw body 1110 .
  • This structure can realize that the distal clamping claw 111 provides the clamping force at the distal end 1114 to concentrate on one point, the clamping force is large, the closing effect is good, and the end of the wire body 1 can be reliably clamped.
  • the ePTFE layer and the PET layer are squeezed into the distal assembly groove 1100 under the pressure of the distal body 1110 and clamped.
  • each proximal claw body 1210 of the plurality of proximal claw bodies 1210 includes a proximal base body 1211 and a proximal bifurcated portion 1212, the proximal bifurcated portion 1212 includes a first proximal branch 1213 and a second proximal branch 1215, the proximal base 1211 is circumferentially disposed along the orifice of the distal joint body portion 110, and the proximal end
  • the bifurcated portion 1212 extends from the proximal base body 1211 in a direction away from the proximal joint body portion 120 , and the end of the first proximal branch 1213 of each proximal claw body 1210 is connected to the first proximal end claw body 1210 of the adjacent proximal claw body 1210 .
  • the ends of the two proximal branches 1215 such a structure has a better effect when they are closed together, and there will be no uneven close together.
  • the proximal claw body 1210 is divided into a proximal base body 1211 and a proximal bifurcated portion 1212.
  • the proximal bifurcated portion 1212 can be stretched to a larger angle, which is convenient for the wire body 1 installation.
  • the proximal bifurcated portion 1212 can form a larger clamping force at the proximal end 1214 , and can reliably hold the end of the wire body 1 .
  • the valve leaflet fishing device provided by the embodiments of the present invention further includes a developing ring 8 , and the developing ring 8 is sheathed outside the intermediate coil 20 , outside and near the distal bifurcation portion 1112 .
  • the imaging ring 8 is arranged at the distal bifurcation part 1112 and the proximal bifurcation part 1212.
  • the position of the imaging ring 8 can be collected for the operator's reference, and on the other hand, the imaging ring 8 can be stuck at the distal bifurcation part. 1112 and the proximal bifurcation portion 1212, improve the force of the distal bifurcation portion 1112 and the proximal bifurcation portion 1212 to hold the ePTFE layer 711 and the PET layer 70.
  • the valve leaflet fishing device includes a wire body and a proximal joint, the wire body is configured in a helical shape, and the helical wire body includes a distal coil, an intermediate coil and a proximal coil arranged in sequence, wherein Both the helical inner diameter of the proximal coil and the helical inner diameter of the distal coil are larger than the inner helical diameter of the middle coil.
  • Such a structure facilitates the distal coil to capture the valve leaflet when the valve leaflet capture device is delivered around the heart valve leaflet, and the middle coil wraps around the valve leaflet.
  • the middle coil wraps around the valve leaflet.
  • the heart valve leaflet it can provide enough radial support force to the implanted valve stent.
  • the proximal coil is stuck on the left atrium side to prevent the valve leaflet fishing device from being impacted by blood flow before the valve stent is implanted.
  • An unexpected condition of the ventricle occurs.
  • the distal coil is disposed at the distal end of the wire body
  • the proximal coil is disposed at the proximal end of the wire body
  • the proximal end of the proximal coil is fixed to the proximal connector.
  • the proximal joint includes a main body part of the proximal joint, a proximal claw and a proximal clamping part, the proximal clamping claw is arranged at one end of the main body part of the proximal joint, and the proximal clamping part is arranged at the other end of the main body part of the proximal joint , the proximal joint is provided with a proximal through hole that penetrates from the proximal clamping part to the proximal claw through the proximal joint main body part, and the proximal end of the proximal coil is clamped in the proximal joint main body part after being fixed to the proximal joint main body part.
  • the proximal through hole communicates with the proximal end of the proximal coil, and after the proximal engaging portion is engaged with the releasable portion of the delivery device, the pusher of the delivery device is pushed against the proximal through hole through the proximal through hole.
  • the proximal end of the end coil can fix the valve leaflet fishing device to the delivery device, so that the valve leaflet fishing device can be accurately arranged in a proper position, reducing the difficulty of delivering the valve leaflet fishing ring and shortening the operation time.
  • the valve leaflet fishing system includes: a delivery device 9 and the valve leaflet fishing device as described above, the delivery device 9 includes a pusher 91, the delivery device 9 is provided with a releasable part 90 and a delivery through hole penetrating the releasable part 90, The proximal clamping part 122 is clamped with the releasable part 90 , the delivery through hole is aligned with the proximal through hole 123 , and the pusher 91 is pushed against the proximal end of the proximal coil through the delivery through hole and the proximal through hole 123 .
  • the releasable clip groove 900 of the releasable part 90 is snapped with the proximal clip body 1220 of the valve leaflet fishing device, and the releasable clip body 910 of the releasable part 90 is clipped. It is engaged with the proximal slot 1221 of the valve leaflet fishing device, and the delivery device 9 pushes the pusher 91 outward, so that the pusher 91 passes through the delivery through hole and the proximal through hole, so as to push the pusher 91 against the proximal end of the wire. end. After the leaflet fishing device is delivered to the preset position of the human body, the pusher 91 is pulled backward so that the pusher 91 leaves the proximal through hole, so that the leaflet fishing device is separated from the delivery device 9 .
  • the valve leaflet fishing device includes a wire body and a proximal joint, the wire body is configured in a helical shape, and the helical wire body includes a distal coil, an intermediate coil and a proximal coil arranged in sequence, wherein Both the helical inner diameter of the proximal coil and the helical inner diameter of the distal coil are larger than the inner helical diameter of the middle coil.
  • Such a structure facilitates the distal coil to capture the valve leaflet when the valve leaflet capture device is delivered around the heart valve leaflet, and the middle coil wraps around the valve leaflet.
  • the middle coil wraps around the valve leaflet.
  • the heart valve leaflet it can provide enough radial support force to the implanted valve stent.
  • the proximal coil is stuck on the left atrium side to prevent the valve leaflet fishing device from being impacted by blood flow before the valve stent is implanted.
  • An unexpected condition of the ventricle occurs.
  • the distal coil is disposed at the distal end of the wire body
  • the proximal coil is disposed at the proximal end of the wire body
  • the proximal end of the proximal coil is fixed to the proximal connector.
  • the proximal joint includes a main body part of the proximal joint, a proximal claw and a proximal clamping part, the proximal clamping claw is arranged at one end of the main body part of the proximal joint, and the proximal clamping part is arranged at the other end of the main body part of the proximal joint , the proximal joint is provided with a proximal through hole that penetrates from the proximal clamping part to the proximal claw through the proximal joint main body part, and the proximal end of the proximal coil is clamped in the proximal joint main body part after being fixed to the proximal joint main body part.
  • the proximal through hole communicates with the proximal end of the proximal coil, and after the proximal engaging portion is engaged with the releasable portion of the delivery device, the pusher of the delivery device is pushed against the proximal through hole through the proximal through hole.
  • the proximal end of the end coil can fix the valve leaflet fishing device to the delivery device, so that the valve leaflet fishing device can be accurately arranged in a proper position, reducing the difficulty of delivering the valve leaflet fishing ring and shortening the operation time.
  • the embodiments of the present invention provide steps of an assembling method for a valve leaflet fishing device according to an embodiment.
  • the assembling method of the valve leaflet fishing device is suitable for the valve leaflet fishing device comprising a wire body, the wire body comprising a distal coil, an intermediate coil and a proximal coil arranged in sequence, the proximal coil is arranged at the proximal end of the wire body, and the distal end coil is arranged at the proximal end of the wire body.
  • the assembling method of the valve leaflet fishing device provided by the embodiment of the present invention includes:
  • Step 10 heat-setting the wire body to construct the wire body into a helical shape, so that both the helical inner diameter of the proximal coil and the helical inner diameter of the distal coil are larger than the helical inner diameter of the middle coil;
  • the wire body can be in such a heat-set shape, which is beneficial to the capture of the valve leaflets and the subsequent provision of valve stents. Strong support.
  • Step 20 heat-setting the proximal joint to realize that the proximal claws of the proximal joint are in a close state
  • Both the proximal joint and the distal joint need to be heat-set at high temperature, so that the proximal jaws of the proximal joint and the distal jaws of the distal joint are in a close state (see FIG. 10 ). In this way, after the valve leaflet fishing device is implanted into the human body, the proximal jaw and the distal jaw remain close together.
  • Step 30 Place the proximal joint in ice water to realize the proximal jaw is in the open state
  • Step 40 placing the proximal end of the proximal coil inside the proximal jaw, and placing the shape memory alloy piece in the proximal end of the proximal coil inside the proximal joint main body;
  • the proximal joint and the wire body is taken as an example, in which the shape memory alloy piece is taken as an example of a nickel-titanium wire, and the same reference can be made to the distal joint.
  • Step 50 Keep the positional relationship between the proximal connector and the proximal coil in the ice water, and take it out of the ice water at room temperature, so that the proximal jaws are restored to a closed state, so that the proximal end of the proximal coil is clamped to the proximal jaws Inside;
  • the proximal connector and the proximal coil keep the relative positional relationship in the ice water and take it out of the ice water and place it at room temperature. As the temperature rises, the proximal jaws begin to recover to the close state of the previous heat setting. At this time, the ePTFE layer and the The PET layer is squeezed into the proximal fitting groove 1200 and/or the distal fitting groove 1100 under the pressure of the proximal clamping claw to be clamped.
  • Step 60 welding the shape memory alloy piece to the proximal joint, and making the proximal through hole communicate with the proximal end of the proximal coil;
  • Step 70 Put the developing ring on the outside of the proximal jaw.
  • the developing ring is then sleeved on the outside of the proximal-end clamping claw to effectively prevent the proximal-end clamping claw from being stretched under the action of other external forces.
  • the valve leaflet fishing device includes a wire body and a proximal joint, the wire body is configured in a helical shape, and the helical wire body includes a distal coil, an intermediate coil and a proximal coil arranged in sequence, wherein Both the helical inner diameter of the proximal coil and the helical inner diameter of the distal coil are larger than the inner helical diameter of the middle coil.
  • Such a structure facilitates the distal coil to capture the valve leaflet when the valve leaflet capture device is delivered around the heart valve leaflet, and the middle coil wraps around the valve leaflet.
  • the middle coil wraps around the valve leaflet.
  • the heart valve leaflet it can provide enough radial support force to the implanted valve stent.
  • the proximal coil is stuck on the left atrium side to prevent the valve leaflet fishing device from being impacted by blood flow before the valve stent is implanted.
  • An unexpected condition of the ventricle occurs.
  • the distal coil is disposed at the distal end of the wire body
  • the proximal coil is disposed at the proximal end of the wire body
  • the proximal end of the proximal coil is fixed to the proximal connector.
  • the proximal joint includes a main body part of the proximal joint, a proximal claw and a proximal clamping part, the proximal clamping claw is arranged at one end of the main body part of the proximal joint, and the proximal clamping part is arranged at the other end of the main body part of the proximal joint , the proximal joint is provided with a proximal through hole that penetrates from the proximal clamping part to the proximal claw through the proximal joint main body part, and the proximal end of the proximal coil is clamped in the proximal joint main body part after being fixed to the proximal joint main body part.
  • the proximal through hole communicates with the proximal end of the proximal coil, and after the proximal engaging portion is engaged with the releasable portion of the delivery device, the pusher of the delivery device is pushed against the proximal through hole through the proximal through hole.
  • the proximal end of the end coil can fix the valve leaflet fishing device to the delivery device, so that the valve leaflet fishing device can be accurately arranged in a proper position, reducing the difficulty of delivering the valve leaflet fishing ring and shortening the operation time.

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Abstract

一种瓣叶捕捞装置、系统及装配方法。该瓣叶捕捞装置，包括：线体（1），构造为螺旋状，包括顺次设置的远端线圈（10）、中间线圈（20）和近端线圈（30），近端接头（12），近端接头（12）包括近端接头主体部（120）、近端卡爪（121）和近端卡接部（122），近端卡爪（121）设置在近端接头主体部（120）的一端，近端卡接部（122）设置在近端接头主体部（120）的另一端，近端接头（12）设置有自近端卡接部（122）经由近端接头主体部（120）贯通至近端卡爪（121）的近端通孔（123），近端线圈（30）的近端端部在固定至近端接头主体部（120）后卡持于近端卡爪（121）内，其中近端通孔（123）连通至近端线圈（30）的近端端部，近端卡接部（122）用于与递送装置（9）的可释放部（90）卡接，递送装置（9）的推送件（91）经由近端通孔（123）顶在近端线圈（30）的近端端部。可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。

Description

瓣叶捕捞装置、系统及装配方法 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种瓣叶捕捞装置、系统及装配方法。
背景技术
二尖瓣病变是常见的心脏瓣膜病，二尖瓣病变患者也是心脏瓣膜外科最大的群体，占到60％左右。二尖瓣介入治疗提供了很好的治疗方案，二尖瓣介入治疗包括经导管二尖瓣修复术和经导管行二尖瓣置换术。其中，经导管二尖瓣置换术是目前较为主流的发展方向，目前世界各国对经导管二尖瓣置换术投入较大研发。经导管行二尖瓣置换术需要面对的二尖瓣叶质地软，且随着心动周期及病情的不断变化，二尖瓣叶无法为瓣膜支架提供径向支撑力，这样的问题目前通常采用环中瓣技术来解决。
存在的问题是，目前所使用的环中瓣技术，需要在人工瓣膜植入之前，将瓣叶捕捞环布置在二尖瓣叶周围合适的位置，从而为二尖瓣叶提供一定的支撑力，更是为后续植入的人工瓣膜提供径向支撑力。但是心脏结构复杂导致不能将瓣叶捕捞环准确地布置在合适的位置，出现环中瓣技术的操作难度较大，手术耗时较长。因此如何将瓣叶捕捞环准确地布置在合适的位置降低瓣叶捕捞环递送的难度，缩短手术时间成为亟需解决的技术问题。
发明内容
本说明书一个或多个实施例的目的是提供一种瓣叶捕捞装置、系统及制造方法，可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。
为解决上述技术问题，本说明书一个或多个实施例是这样实现的：
第一方面，提出了一种瓣叶捕捞装置，包括：线体，构造为螺旋状，包括顺次设置的远端线圈、中间线圈和近端线圈，所述远端线圈设置于所述线体的远端，所述近端线圈设置于所述线体的近端，其中所述近端线圈的螺旋内径和所述远端线圈的螺旋内径均大于所述中间线圈的螺旋内径；近端接头，所述近端接头包括近端接头主体部、近端卡爪和近端卡接部，所述近端卡爪设置在所述近端接头主体部的一端，所述近端卡接部设置在所述近端接头主体部的另一端，所述近端接头设置有自所述近端卡接部经由近端接头主体部贯通至所述近端卡爪的近端通孔，所述近端线圈的近端端部在固定至所述近端接头主体部后卡持于所述近端卡爪内，其中所述近端通孔连通至所述近端线圈的所述近端端部，所述近端卡接部用于与递送装置的可释放部卡接，所述递送装置的推送件经由所述近端通孔顶在所述近端线圈的近端端部。
第二方面，提出了一种瓣叶捕捞系统，包括递送装置和如上文所述的瓣叶捕捞装置，所述递送装置包括推送件，所述递送装置设置有远端释放部和贯通所述远端释放部的递送通孔，所述近端卡接部与所述可释放部卡接，所述递送通孔与所述近端通孔对准，所述推送件经由所述递送通孔和所述近端通孔后顶在所述近端线圈的近端端部。
第三方面，提出了一种瓣叶捕捞装置的装配方法，适用于瓣叶捕捞装置包括线体，所述线体包括顺次设置的远端线圈、中间线圈和近端线圈，所述近端线圈设置于所述线体的近端，所述远端线圈设置于所述线体的远端，所述近端接头的材料为形状记忆合金的场景，所述方法，包括：对所述线体进行热定型处理，将所述线体构造为螺旋状，实现所述近端线圈的螺旋内径和所述远端线圈的螺旋内径均大于所述中间线圈的螺旋内径；对近端接头进行热定型处理，实现所述近端接头的近端卡爪处于并拢状态；将所述近端接头置于冰水中实现所述近端卡爪处于撑开状态；将所述近端线圈的近端端部置于所述近端卡爪的内部，并且使得位于所述近端线圈的近端端部中的形状记忆合金件置于所述近端接头主体部的内部；将所述近端接头和所述近端线圈保持冰水中的位置关系从冰水中取出处于常温下，使得所述近端卡爪恢 复并拢状态，实现所述近端线圈的近端端部卡持于所述近端卡爪内；将所述形状记忆合金件焊接至所述近端接头，并且使得近端通孔连通至所述近端线圈的所述近端端部；将显影环套在所述近端卡爪的外部。
由以上本说明书一个或多个实施例提供的技术方案可见，本申请提供的瓣叶捕捞装置包括线体和近端接头，线体构造为螺旋状，螺旋状的线体包括顺次设置的远端线圈、中间线圈和近端线圈，其中近端线圈的螺旋内径和远端线圈的螺旋内径均大于中间线圈的螺旋内径，这样的结构在将瓣叶捕捞装置递送至心脏瓣叶周围时，便于远端线圈捕获瓣叶，中间线圈包绕在心脏瓣叶周围，可以对植入的瓣膜支架提供足够的径向支撑力，此时的近端线圈卡在左心房侧，防止瓣膜支架植入前瓣叶捕捞装置被血流冲击掉落在心室的意外情况出现。顾名思义，远端线圈设置于线体的远端，近端线圈设置于线体的近端，近端线圈的近端端部固定至近端接头。近端接头包括近端接头主体部、近端卡爪和近端卡接部，近端卡爪设置在近端接头主体部的一端，近端卡接部设置在近端接头主体部的另一端，近端接头设置有自近端卡接部经由近端接头主体部贯通至近端卡爪的近端通孔，近端线圈的近端端部在固定至近端接头主体部后卡持于近端卡爪内，其中近端通孔连通至近端线圈的近端端部，近端卡接部与递送装置的可释放部卡接后递送装置的推送件经由近端通孔顶在近端线圈的近端端部，从而可以将瓣叶捕捞装置固定至递送装置上，从而可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。
附图说明
为了更清楚地说明本说明书一个或多个实施例或现有技术中的技术方案，下面将对一个或多个实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本说明书中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。
图1是本发明实施例提供的一种瓣叶捕捞装置的结构示意图。
图2是图1所示瓣叶捕捞装置布置在心脏瓣叶周围的剖面示意图。
图3是图2所示瓣叶捕捞装置的a处的局部放大示意图。
图4是图3所示瓣叶捕捞装置在植入瓣膜支架后的结构示意图。
图5是本发明实施例提供的另一种瓣叶捕捞装置中近端接头的结构示意图。
图6是本发明实施例提供的又一种瓣叶捕捞装置中近端套管的结构示意图。
图7是图6所示瓣叶捕捞装置中线体固定至近端套管中的结构示意图。
图8是图7所示瓣叶捕捞装置沿B-B线的截面示意图。
图9是图7所示瓣叶捕捞装置中近端套管固定至近端接头中的结构示意图。
图10是本发明实施例提供的又一种瓣叶捕捞装置中近端卡爪并拢的结构示意图。
图11是本发明实施例提供的又一种瓣叶捕捞装置中近端卡爪撑开的结构示意图。
图12是本发明实施例提供的又一种瓣叶捕捞装置中近端卡接部和递送装置中可释放部卡接的结构示意图。
图13是图12所示瓣叶捕捞装置中近端卡接部和递送装置中可释放卡接部卡接后的结构示意图。
图14是本发明实施例提供的又一种瓣叶捕捞装置的结构示意图。
图15是图14所示瓣叶捕捞装置中沿A-A的截面示意图。
图16是本发明实施例提供的又一种瓣叶捕捞装置中形状记忆合金件的结构示意图。
图17是本发明实施例提供的又一种瓣叶捕捞装置中形状记忆合金件的结构示意图。
图18是本发明实施例提供的又一种瓣叶捕捞装置中远端接头的远端套管的结构示意图。
图19是图18所示瓣叶捕捞装置中线体固定在远端套管中的结构示意图。
图20是图19所示瓣叶捕捞装置沿B-B的截面示意图。
图21是图19所示瓣叶捕捞装置中远端套管固定至远端接头中的结构示意图。
1-线体；10-远端线圈；11-远端接头；12-近端接头；20-中间线圈；30-近端线圈；4-心脏瓣叶；13-形状记忆合金件；130-形状记忆合金件的截面；131-位于近端线圈上的形状记忆合金件；132-位于中间线圈上的形状记忆合金件；133-位于远端线圈上的形状记忆合金件；5-瓣膜支架；120-近端接头主体部；121-近端卡爪；122-近端卡接部；123-近端通孔；1220-近端卡体；1221-近端卡槽；1200-近端装配槽；1210-近端爪体；1211-近端基体；1212-近端分叉部；1213-第一近端分支；1215-第二近端分支；1214-近末端；14-近端套管；140-近端贯穿槽；141-近端套管的内腔；9-递送装置；90-可释放部；900-可释放卡槽；910-可释放卡体；91-推送件；8-显影环；7-包装层；70-PET层；71-膜层；710-网状金属层；711-ePTFE层；110-远端接头主体部；111-远端卡爪；112-导向头；15-远端套管；150-远端贯穿槽；151-远端套管的内腔；1100-远端装配槽；1110-远端爪体；1111-远端基体；1112-远端分叉部；1113-第一远端分支；1115-第二远端分支；1114-远末端。
具体实施方式
为了使本技术领域的人员更好地理解本说明书中的技术方案，下面将结合本说明书一个或多个实施例中的附图，对本说明书一个或多个实施例中的技术方案进行清楚、完整地描述，显然，所描述的一个或多个实施例仅仅是本说明书一部分实施例，而不是全部的实施例。基于本说明书中的一个或多个实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都应当属于本文件的保护范围。
参照图1所示为本发明实施例所涉及的瓣叶捕捞装置的示意图。可见，在本发明实施例提供的瓣叶捕捞装置中，线体构造为螺旋状，线体的横截面可以构造为圆形，线体的直径可以根据实际患者心脏瓣叶的生理结构进行设置。从图中可以看出线体包括顺次设置的远端线圈、中间线圈和近端线圈，并且远端线圈的螺旋内径和近端线圈的螺旋内径大于中间线圈的螺旋内径，另外位于中间线圈的线体占用了绝大部分的线体，并且紧密盘绕，相互之间的间隙较小，这样设计的目的是在将瓣膜支架植入患者体内前，将瓣叶捕捞装置布置在心脏瓣叶周围的合适位置时，限制心脏瓣叶的张开尺寸，在瓣膜支架放入瓣叶之间时中间线圈对瓣膜支架起到较好的支撑作用。这里的螺旋内径是说的线体螺旋盘绕形成的螺旋圈的内径。
需要说明的是，本申请提到的近端是在手术操作过程中靠近操作者的一部分为近端，远端是在手术操作过程远离手术操作者的一部分为远端。
实施例一
参照图1所示，为本发明实施例提供的瓣叶捕捞装置的结构示意图。该瓣叶捕捞装置，包括线体1和位于线体1两端部的接头，这里的接头包括近端接头12和远端接头11，如上文所述，靠近手术操作者的接头为近端接头12，远离操作者的接头为远端接头11。
如图1所示，线体1构造为螺旋状，包括顺次设置的远端线圈10、中间线圈20和近端线圈30，远端线圈10设置于线体1的远端，近端线圈30设置于线体1的近端，正如图1中所示，近端线圈30的螺旋内径和远端线圈10的螺旋内径均大于中间线圈20的螺旋内径，如图1所示远端线圈30的螺旋内径是渐变的，正如前面所述，这样的结构在将瓣叶捕捞装置递送至心脏瓣叶周围时，便于远端线圈在瓣叶并拢时捕获瓣叶。远端线圈的螺旋内径可以设置在30mm～40mm，该尺寸的设置在捕捞瓣叶时是的远端线圈的开口足够大易于捕捞，但是开口又不会太大避免抵靠在心脏内壁上的情况出现。中间线圈20的螺旋内径大体相同，中间线圈20中的相邻线圈排列较为紧密，中间线圈20占据线体1的绝大部分。当中间线圈20包绕在心脏瓣叶周围时，可以对植入的瓣膜支架提供足够的径向支撑力，而近端线圈的螺旋内径需要大一些，使得近端线圈卡在左心房侧，防止瓣膜支架植入前瓣叶捕捞装置被血流冲击掉落在心室的意外情况出现，因此近端线圈的螺旋内径略大于二尖瓣环的直径尺寸，近端线圈的螺旋内径的具体大小可根据不同病人的瓣环尺寸进行相应设置，一般可以在45mm～60mm，该数值范围不构成对本申请技术方案的限制，可以理解地，上述远端线圈的螺旋内径的数值参考范围也不构成对本申请技术方案的限制。
参照图2、3和图4所示，在植入瓣膜支架5之前，将瓣叶捕捞环预先布置到二尖瓣瓣叶的周围，特别是利用中间线圈20来缩小二尖瓣瓣叶的张开尺寸，再将瓣膜支架5植入在二尖瓣瓣叶之间时，可以使得瓣叶捕捞环的内径比撑开的瓣膜支架5的外径要小。当瓣膜支架5撑开后会受到瓣叶捕捞环施加的一个径向支撑力，使瓣膜支架5不容易发生轴向移位，保证瓣膜支架5可靠固定。线体1可以包括形状记忆合金件13，可以保持持久地为瓣膜支架5提供支撑力，利于患者长期不受到瓣膜病变带来的影响。如图2、图3和图4所示，瓣叶捕捞环布置在二尖瓣瓣叶周围后，近端线圈30位于上方的左心房，图中黑色的圆圈为形状记忆合金件13的截面130，可见中间线圈20在布置到合适的位置时相邻线圈之间紧密排布。
由于形状记忆合金件13经过高温热定型处理工艺，在将线体1植入到心脏瓣叶4周围后，形状记忆合金件13可以按照之前热定型的形状进行布置。
参照图5所示，近端接头12包括近端接头主体部120、近端卡爪121和近端卡接部122，近端卡爪121设置在近端接头主体部120的一端，近端卡接部122设置在近端接头主体部120的另一端，近端接头12设置有自近端卡接部122经由近端接头主体部120贯通至近端卡爪121的近端通孔123，近端线圈30的近端端部在固定至近端接头主体部120后卡持于近端卡爪121内，其中近端通孔123连通至近端线圈30的近端端部，近端卡接部122用于与递送装置9的可释放部90卡接(参见图12和图13)，递送装置9的推送件91经由近端通孔123顶在近端线圈30的近端端部。从而将瓣叶捕捞装置固定于递送装置9，推送件91可以沿着推送件91的长度延伸方向上对瓣叶捕捞装置进行限位。
在递送本发明所提供的瓣叶捕捞装置之前，将递送装置9的可释放部90与瓣叶捕捞装置的近端卡接部122相卡接，在递送装置9上向外推动推送件91，使得推送件91穿过近端通孔123顶在近端线圈30的近端端部。递送装置9通过递送导管将瓣叶捕捞装置递送至人体的预设位置后，向后拉动推送件91，使得推送件912离开近端通孔123，在垂直于推送件91的长度方向上相对于近端卡接部122移动可释放部90，使得瓣叶捕捞装置与递送装置9相分离。
参照图21所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，还包括远端接头11，远端接头11包括远端接头主体部110、远端卡爪111和导向头112，远端卡爪111设置在远端主体部的一端，导向头112设置在远端主体部的另一端，远端线圈10的远端端部在固定至远端接头主体部110后卡持于远端卡爪111内。
导向头112的外轮廓可以圆润一下，这样在瓣叶捕捞装置进入到人体血管后可以顺利地躲避人体组织，进入到心脏内部。远端卡爪111和近端卡爪121实现相同的技术效果是在将线体1的端部固定在接头主体部后卡紧线体1的端部，提高了线体1与接头固定的可靠性。
参照图14和图15所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，线体1包括沿线体1的长度方向延伸的形状记忆合金件13和包覆于形状记忆合金件13外部的包装层7，形状记忆合金件13的远端端部固定至远端接头主体部110，形状记忆合金件13的近端端部固定至近端接头主体部120，近端卡爪121和远端卡爪111卡持在包装层7上。
可以看出，在将形状记忆合金件13的远端端部和近端端部分别固定至远端接头主体部110和近端接头主体部120后，远端卡爪111和近端卡爪121分别卡持在线体1的包装层7上。形状记忆合金件13可以是镍钛丝等。
参见图16所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置中，位于远端线圈10上的形状记忆合金件133的截面尺寸小于位于中间线圈20上的形状记忆合金件132的截面尺寸和位于近端线圈30上的形状记忆合金件131的截面尺寸，并且位于远端线圈10上的形状记忆合金件133的截面130尺寸自远端线圈10的远端至远端线圈10的近端逐渐增大直至与位于中间线圈20上的形状记忆合金件132的界面尺寸相同。
位于近端线圈30上的形状记忆合金件131的直径和位于中间线圈20上的形状记忆合金件13的直径可以保持一致，不小于0.7mm。位于远端线圈10上的形状记忆合金件133的直径从远端线圈10的远端到远端线圈10的近端逐渐变大，使得远端线圈10的远端具有更好的 顺应性，可以较好地在血管中移动。位于远端线圈10的形状记忆合金件133的远端直径不小于0.3mm，位于远端线圈10的形状记忆合金件133的近端直径的最大值可以跟位于近端线圈30上的形状记忆合金件131的直径和位于中间线圈20上的形状记忆合金件132的直径相同。
参照图14和图15所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，至少位于远端线圈10上的包装层7包括顺次包裹在形状记忆合金件13外部的网状金属层710和膜层71，网状金属层710的端部固定至形状记忆合金件13上，并且远端线圈10的截面尺寸、中间线圈20的截面尺寸和近端线圈30的截面尺寸相同。
网状金属层710的两端可以分别焊接在形状记忆合金件13上，网状金属层710可以是由圆形的镍钛丝、不锈钢丝或者铂丝编织而成。网状金属层710可以仅是设置在远端线圈10上，也可以在线体1通体设置。如果线体1上全部设置金属编制层，可以保证远端线圈10的截面尺寸、中间线圈20的截面尺寸和近端线圈30的截面尺寸相同。网状金属层710可以包覆在整个线体1上，网状金属层710的两端焊接在形状记忆合金件13上，这样增加了瓣叶捕捞环跟瓣膜支架5之间的摩擦力。
参照图14和图15所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，膜层71包括顺次包裹在网状金属层710上的ePTFE层711和PET层70，PET层70通过缝合线缝合至ePTFE层711上，缝合线穿插在网状金属层710上。对于没有金属编制层的线圈，ePTFE层711和PET层70顺次包裹在形状记忆合金件13上。
在固定ePTFE层711、PET层70时，用于缝合ePTFE层711和PET层70之间的缝合线可以穿插在网状金属层710中的缝隙中，从而将缝合线卡在网状金属层710中，这样可以更好地固定ePTFE层711和PET层70。在远端线圈10的截面尺寸、中间线圈20的截面尺寸和近端线圈30的截面尺寸相同时，网状金属层710仅设置在远端线圈10上，那么ePTFE层711的发泡加工更好实现。
正如前面提到的，近端卡爪121和远端卡爪111可以将膜层71包括ePTFE层711和PET层70的两端卡住。包装层包括顺次包裹在所述形状记忆合金件外部的网状金属层和膜层，所述膜层包括顺次包裹在网状金属层外部的ePTFE层和PET层，所述ePTFE层的近端端部和PET层的近端端部在近端卡爪的压力作用下被挤入近段装配槽内卡紧，ePTFE层的远端端部和PET层的远端端部在远端卡爪的压力作用下被挤入远端装配槽内卡紧。
ePTFE膜材料为微孔结构，内皮化出众，韧性极佳，具有很高的生物相容性。瓣环捕捞装置在植入人体之前是直的，当瓣叶捕捞装置进入人体心脏以后，随着温度升高开始恢复热定型的形状(如图1所示)，一边捕捞瓣叶一边恢复成螺旋状。ePTFE层711的两端在被远端卡爪111和近端卡爪121卡紧的情况下，会受到轴向张力，因此在设计时根据工况条件ePTFE层711需要至少有7％的延伸率，本申请采用远端卡爪111和近端卡爪121卡紧ePTFE层711的效果亦在于此，可以给予具有延伸性的ePTFE层711进行限位。ePTFE膜层71的结构独特，由大量通过细纤维矩阵相互连接在一起的固体节点构成。节点之间的间距称为节点间距IND，是ePTFE层711膨胀量的指标，本发明实施例采用的ePTFE层711的IND为5微米～100微米。
参照图10所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，近端接头主体部120和远端接头主体部110构造为管状，近端卡爪121向近端接头主体部120的轴向收拢，远端卡爪111向远端接头主体部110的轴线收拢。
图10中近端卡爪121的状态即为将瓣叶捕捞装置植入人体心脏之前的状态，可以将线体1的远端和近端卡紧。在装配时，ePTFE层和PET层在近端卡爪的压力作用下被挤入近端装配槽1200内卡紧。
参照图5和图12所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，近端卡接部122包括近端卡槽1221和近端卡体1220，近端通孔123自近端卡体1220贯穿至近端接头主体部120，近端卡体1220与近端接头主体部120一体成型，近端卡体1220和近端接头主体部120之间的凹槽形成近端卡槽1221，用于与递送装置9上形成的可释放卡槽900卡接。通过近端通孔123和近端卡体1220、近端卡槽1221的设计将瓣叶捕捞装置固定至递送装置9 上。
在一些实施例中，本发明实施例提供的瓣叶捕捞装置，参照图6、图7、图8和图9所示，近端接头主体部120的内部固定有近端套管14，线体1内的形状记忆合金件13的远端端部固定至远端套管15的内部。近端接头主体部120和近端套管14的材料可以是镍钛合金，可以将形状记忆合金件13焊接至近端套管14内后，再将近端套管14焊接在管状的近端接头主体部120的内部。
参照图18、图19、图20和图21所示，远端接头主体部110的内部固定有远端套管15，形状记忆合金件13的近端端部固定至近端套管14的内部，近端通孔123包括近端套管14的内腔141。同样可以实现形状记忆合金件13焊接至远端套管15内，再将远端套管15焊接在管状的远端接头主体部110的内部。
参照图21所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，远端接头11的材料为形状记忆合金，远端套管15的侧壁上设置有远端贯穿槽150，形状记忆合金件13的远端端部焊接至远端贯穿槽150的边缘，远端接头主体部110的侧壁上设置有远端装配槽1100，远端套管15至少焊接至远端装配槽1100的边缘。图中的远端贯穿槽150和远端装配槽1100方便将形状记忆合金件13固定至远端接头主体部110的内部。也可以直接将形状记忆合金件13焊接至远端接头主体部110的内部，但是这样导致远端接头主体部110的内径较小，相应的远端卡爪111的尺寸较小，尺寸较小的远端卡爪111发生的形变量(并拢和撑开)较小，对应地远端卡爪111的咬合力降低，影响远端卡爪111对线体1端部的卡紧力。
参照图9、图10和图11所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，近端接头12的材料为形状记忆合金，同样地，近端套管14的侧壁上设置有近端贯穿槽140，形状记忆合金件13的近端端部焊接至近端贯穿槽140的边缘，近端接头主体部120的侧壁上设置有近端装配槽1200，近端套管14至少焊接至近端装配槽1200的边缘。从而可以确保形状记忆合金件13牢固地固定至近端接头主体部120内的情况下增大近端卡爪121对线体1端部的卡紧力。
参照图21所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，至少近端卡爪121和远端卡爪111的材料为形状记忆合金，远端卡爪111包括离散设置在远端接头主体部110的一端的多个远端爪体1110，并且多个远端爪体1110自远端接头主体部110沿远离远端接头主体部110的方向延伸并且逐渐并拢，直至多个远端爪体1110的远末端1114并拢在一起。图21中多个远端卡爪111的远末端1114并未并拢在一起，而图10所示的近端卡爪121的近末端1214是并拢在一起的，这样可以对线体1的端部施加较强的抓紧力。
参照图10所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，近端卡爪121包括离散设置在近端接头主体部120的一端的多个近端爪体1210，并且多个近端爪体1210自近端接头主体部120沿远离近端接头主体部120的方向延伸并且逐渐并拢，直至多个近端爪体1210的近末端1214并拢在一起。
参照图21所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，多个远端爪体1110中的每一个远端爪体1110包括远端基体1111和远端分叉部1112，远端分叉部1112包括第一远端分支1113和第二远端分支1115，远端基体1111沿着远端接头主体部110的管口周向设置，远端分叉部1112自远端基体1111沿远离远端接头主体部110的方向延伸，每一个远端爪体1110的第一远端分支1113的端部连接至相邻的远端爪体1110的第二远端分支1115的端部。这种结构可以实现远端卡爪111在远末端1114提供卡紧力集中在一个点上，卡紧力较大，并拢效果好，可以可靠地卡持住线体1的端部。在进行装配时，ePTFE层和PET层在远端主体1110的压力作用下被挤入远端装配槽1100内卡紧。
参照图9、图10、图11所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，多个近端爪体1210中的每一个近端爪体1210包括近端基体1211和近端分叉部1212，近端分叉部1212包括第一近端分支1213和第二近端分支1215，近端基体1211沿着远端接头主体部110的管口周向设置，近端分叉部1212自近端基体1211沿远离近端接头主体部120的 方向延伸，每一个近端爪体1210的第一近端分支1213的端部连接至相邻的近端爪体1210的第二近端分支1215的端部，这样的结构在并拢时具有较好的并拢效果，不会出现并拢参差不齐的情况。将近端爪体1210分为近端基体1211和近端分叉部1212，近端爪体1210如图11所示撑开时近端分叉部1212可以撑开更大的角度，便于线体1的安装。近端爪体1210如图10所示并拢时近端分叉部1212可以在近末端1214形成较大的卡紧力，可以可靠地卡持住线体1的端部。
参照图14所示，在一些实施例中，本发明实施例提供的瓣叶捕捞装置，还包括显影环8，显影环8套装在中间线圈20的外部、远端分叉部1112的外部和近端分叉部1212的外部。将显影环8布置在远端分叉部1112和近端分叉部1212，一方面可以采集显影环8所在的位置供手术操作者参考，另一方面显影环8可以卡住远端分叉部1112和近端分叉部1212，提高远端分叉部1112和近端分叉部1212卡持ePTFE层711和PET层70的作用力。
通过上述技术方案，本申请提供的瓣叶捕捞装置包括线体和近端接头，线体构造为螺旋状，螺旋状的线体包括顺次设置的远端线圈、中间线圈和近端线圈，其中近端线圈的螺旋内径和远端线圈的螺旋内径均大于中间线圈的螺旋内径，这样的结构在将瓣叶捕捞装置递送至心脏瓣叶周围时，便于远端线圈捕获瓣叶，中间线圈包绕在心脏瓣叶周围，可以对植入的瓣膜支架提供足够的径向支撑力，此时的近端线圈卡在左心房侧，防止瓣膜支架植入前瓣叶捕捞装置被血流冲击掉落在心室的意外情况出现。顾名思义，远端线圈设置于线体的远端，近端线圈设置于线体的近端，近端线圈的近端端部固定至近端接头。近端接头包括近端接头主体部、近端卡爪和近端卡接部，近端卡爪设置在近端接头主体部的一端，近端卡接部设置在近端接头主体部的另一端，近端接头设置有自近端卡接部经由近端接头主体部贯通至近端卡爪的近端通孔，近端线圈的近端端部在固定至近端接头主体部后卡持于近端卡爪内，其中近端通孔连通至近端线圈的近端端部，近端卡接部与递送装置的可释放部卡接后递送装置的推送件经由近端通孔顶在近端线圈的近端端部，从而可以将瓣叶捕捞装置固定至递送装置上，从而可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。
实施例二
参照图12和图13所示，本发明实施例提供的一种瓣叶捕捞系统的结构示意图。该瓣叶捕捞系统，包括：递送装置9和如上文所述的瓣叶捕捞装置，递送装置9包括推送件91，递送装置9设置有可释放部90和贯通可释放部90的递送通孔，近端卡接部122与可释放部90卡接，递送通孔与近端通孔123对准，推送件91经由递送通孔和近端通孔123后顶在近端线圈的近端端部。
在递送本发明所提供的瓣叶捕捞装置之前，将可释放部90的可释放卡槽900与瓣叶捕捞装置的近端卡体1220相卡接，将可释放部90的可释放卡体910与瓣叶捕捞装置的近端卡槽1221相卡接，递送装置9向外推动推送件91，使得推送件91穿过递送通孔和近端通孔，从而将推送件91顶在线体的近端端部。在将瓣叶捕捞装置递送至人体的预设位置后，向后拉动推送件91，使得推送件91离开近端通孔，使得瓣叶捕捞装置与递送装置9相分离。
通过上述技术方案，本申请提供的瓣叶捕捞装置包括线体和近端接头，线体构造为螺旋状，螺旋状的线体包括顺次设置的远端线圈、中间线圈和近端线圈，其中近端线圈的螺旋内径和远端线圈的螺旋内径均大于中间线圈的螺旋内径，这样的结构在将瓣叶捕捞装置递送至心脏瓣叶周围时，便于远端线圈捕获瓣叶，中间线圈包绕在心脏瓣叶周围，可以对植入的瓣膜支架提供足够的径向支撑力，此时的近端线圈卡在左心房侧，防止瓣膜支架植入前瓣叶捕捞装置被血流冲击掉落在心室的意外情况出现。顾名思义，远端线圈设置于线体的远端，近端线圈设置于线体的近端，近端线圈的近端端部固定至近端接头。近端接头包括近端接头主体部、近端卡爪和近端卡接部，近端卡爪设置在近端接头主体部的一端，近端卡接部设置在近端接头主体部的另一端，近端接头设置有自近端卡接部经由近端接头主体部贯通至近端卡爪的近端通孔，近端线圈的近端端部在固定至近端接头主体部后卡持于近端卡爪内，其中近 端通孔连通至近端线圈的近端端部，近端卡接部与递送装置的可释放部卡接后递送装置的推送件经由近端通孔顶在近端线圈的近端端部，从而可以将瓣叶捕捞装置固定至递送装置上，从而可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。
实施例三
本发明实施例提供的一个实施例的瓣叶捕捞装置的装配方法的步骤。该瓣叶捕捞装置的装配方法，适用于瓣叶捕捞装置包括线体，线体包括顺次设置的远端线圈、中间线圈和近端线圈，近端线圈设置于线体的近端，远端线圈设置于线体的远端，近端接头的材料为形状记忆合金的场景，本发明实施例提供的瓣叶捕捞装置的装配方法，包括：
步骤10：对线体进行热定型处理，将线体构造为螺旋状，实现近端线圈的螺旋内径和远端线圈的螺旋内径均大于中间线圈的螺旋内径；
正如前面提到的，将线体在热定型处理成的形状在将瓣叶捕捞装置植入人体心脏后，线体可以成为这样热定型的形状，利于对瓣叶的捕捞以及后续为瓣膜支架提供有力的支撑力。
步骤20：对近端接头进行热定型处理，实现近端接头的近端卡爪处于并拢状态；
不论近端接头还是远端接头都需要做高温热定型处理，使得近端接头的近端卡爪和远端接头的远端卡爪处于并拢状态(参见图10所示)。这样在瓣叶捕捞装置植入人体后，近端卡爪和远端卡爪保持并拢状态。
步骤30：将近端接头置于冰水中实现近端卡爪处于撑开状态；
装配时，将近端接头和远端接头置于冰水中，处于冰水中的近端接头和远端接头，近端卡爪和远端卡爪处于撑开状态，参见图11所示。
步骤40：将近端线圈的近端端部置于近端卡爪的内部，并且使得位于近端线圈的近端端部中的形状记忆合金件置于近端接头主体部的内部；
这里仅以近端接头和线体的装配为例，其中形状记忆合金件以镍钛丝为例，远端接头的可以做相同参考。一方面将已经将镍钛丝的近端端部焊接在近端套管后的近端套管放在近端接头主体部内，另一方面将ePTFE层和PET层塞在近端卡爪的内部。
步骤50：将近端接头和近端线圈保持冰水中的位置关系从冰水中取出处于常温下，使得近端卡爪恢复并拢状态，实现近端线圈的近端端部卡持于近端卡爪内；
将近端接头和近端线圈保持冰水中的相对位置关系从冰水中取出，置于常温下，随着温度的升高，近端卡爪开始恢复之前热定型的并拢状态，此时ePTFE层和PET层在近端卡爪的压力作用下被挤入近端装配槽1200和/或远端装配槽1100内卡紧。
步骤60：将形状记忆合金件焊接至近端接头，并且使得近端通孔连通至近端线圈的近端端部；
将镍钛丝焊接在近端接头中，如果是存在近端套管的情况，此时只需要将近端套管焊接在近端接头主体部的内部，并且使得近端通孔炼制至近端线圈的近端端部，确保后续推送件可以顶在近端线圈的近端端部。
步骤70：将显影环套在近端卡爪的外部。
再将显影环套在近端卡爪的外部，有效防止近端卡爪在其他外力作用下被撑开的情况出现。
通过上述技术方案，本申请提供的瓣叶捕捞装置包括线体和近端接头，线体构造为螺旋状，螺旋状的线体包括顺次设置的远端线圈、中间线圈和近端线圈，其中近端线圈的螺旋内径和远端线圈的螺旋内径均大于中间线圈的螺旋内径，这样的结构在将瓣叶捕捞装置递送至心脏瓣叶周围时，便于远端线圈捕获瓣叶，中间线圈包绕在心脏瓣叶周围，可以对植入的瓣膜支架提供足够的径向支撑力，此时的近端线圈卡在左心房侧，防止瓣膜支架植入前瓣叶捕捞装置被血流冲击掉落在心室的意外情况出现。顾名思义，远端线圈设置于线体的远端，近端线圈设置于线体的近端，近端线圈的近端端部固定至近端接头。近端接头包括近端接头主体部、近端卡爪和近端卡接部，近端卡爪设置在近端接头主体部的一端，近端卡接部设置在 近端接头主体部的另一端，近端接头设置有自近端卡接部经由近端接头主体部贯通至近端卡爪的近端通孔，近端线圈的近端端部在固定至近端接头主体部后卡持于近端卡爪内，其中近端通孔连通至近端线圈的近端端部，近端卡接部与递送装置的可释放部卡接后递送装置的推送件经由近端通孔顶在近端线圈的近端端部，从而可以将瓣叶捕捞装置固定至递送装置上，从而可以将瓣叶捕捞装置准确地布置在合适的位置，降低瓣叶捕捞环递送的难度，缩短手术时间。
总之，以上所述仅为本说明书的较佳实施例而已，并非用于限定本说明书的保护范围。凡在本说明书的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本说明书的保护范围之内。
还需要说明的是，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、商品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、商品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、商品或者设备中还存在另外的相同要素。
本说明书中的各个实施例均采用递进的方式描述，各个实施例之间相同相似的部分互相参见即可，每个实施例重点说明的都是与其他实施例的不同之处。尤其，对于系统实施例而言，由于其基本相似于方法实施例，所以描述的比较简单，相关之处参见方法实施例的部分说明即可。
上述对本说明书特定实施例进行了描述。其它实施例在所附权利要求书的范围内。在一些情况下，在权利要求书中记载的动作或步骤可以按照不同于实施例中的顺序来执行并且仍然可以实现期望的结果。另外，在附图中描绘的过程不一定要求示出的特定顺序或者连续顺序才能实现期望的结果。在某些实施方式中，多任务处理和并行处理也是可以的或者可能是有利的。

Claims (17)

  1. 一种瓣叶捕捞装置，包括：
    线体，构造为螺旋状，包括顺次设置的远端线圈、中间线圈和近端线圈，所述远端线圈设置于所述线体的远端，所述近端线圈设置于所述线体的近端，其中所述近端线圈的螺旋内径和所述远端线圈的螺旋内径均大于所述中间线圈的螺旋内径；
    近端接头，所述近端接头包括近端接头主体部、近端卡爪和近端卡接部，所述近端卡爪设置在所述近端接头主体部的一端，所述近端卡接部设置在所述近端接头主体部的另一端，所述近端接头设置有自所述近端卡接部经由近端接头主体部贯通至所述近端卡爪的近端通孔，所述近端线圈的近端端部在固定至所述近端接头主体部后卡持于所述近端卡爪内，其中所述近端通孔连通至所述近端线圈的所述近端端部，所述近端卡接部用于与递送装置的可释放部卡接，所述递送装置的推送件经由所述近端通孔顶在所述近端线圈的近端端部。
  2. 如权利要求1所述的瓣叶捕捞装置，还包括远端接头，所述远端接头包括远端接头主体部、远端卡爪和导向头，所述远端卡爪设置在所述远端主体部的一端，所述导向头设置在所述远端主体部的另一端，所述远端线圈的远端端部在固定至所述远端接头主体部后卡持于所述远端卡爪内。
  3. 如权利要求2所述的瓣叶捕捞装置，所述线体包括沿所述线体的长度方向延伸的形状记忆合金件和包覆于所述形状记忆合金件外部的包装层，所述形状记忆合金件的远端端部固定至所述远端接头主体部，所述形状记忆合金件的近端端部固定至所述近端接头主体部，所述近端卡爪和所述远端卡爪卡持在所述包装层上。
  4. 如权利要求3所述的瓣叶捕捞装置，位于所述远端线圈上的所述形状记忆合金件的截面尺寸自所述远端线圈的远端至所述远端线圈的近端逐渐增大，直至与位于所述中间线圈上的所述形状记忆合金件的截面尺寸保持一致，位于所述近端线圈上的所述形状记忆合金件的截面尺寸与位于所述中间线圈上的所述形状记忆合金件的截面尺寸保持一致。
  5. 如权利要求3所述的瓣叶捕捞装置，所述包装层包括顺次包裹在所述形状记忆合金件外部的网状金属层和膜层，所述网状金属层的端部固定至所述形状记忆合金件上，并且所述远端线圈的截面尺寸、所述中间线圈的截面尺寸和所述近端线圈的截面尺寸相同。
  6. 如权利要求5所述的瓣叶捕捞装置，所述膜层包括顺次包裹在所述网状金属层外部的ePTFE层和PET层，所述PET层通过缝合线缝合至所述ePTFE层上，所述缝合线穿插在所述网状金属层上。
  7. 如权利要求2至6中任一项所述的瓣叶捕捞装置，所述近端接头主体部和所述远端接头主体部构造为管状，所述近端卡爪向所述近端接头主体部的轴向收拢，所述远端卡爪向所述远端接头主体部的轴线收拢。
  8. 如权利要求7所述的瓣叶捕捞装置，所述近端卡接部包括近端卡槽和近端卡体，所述近端通孔自所述近端卡体贯穿至所述近端接头主体部，所述近端卡体与所述近端接头主体部一体成型，所述近端卡体和所述近端接头主体部之间的凹槽形成所述近端卡槽，用于与所述递送装置上形成的可释放卡槽卡接。
  9. 如权利要求8所述的瓣叶捕捞装置，所述近端接头主体部的内部固定有近端套管，所述远端接头主体部的内部固定有远端套管，所述线体内的形状记忆合金件的远端端部固定至所述远端套管的内部，所述形状记忆合金件的近端端部固定至所述近端套管的内部，所述近端通孔包括所述近端套管的内腔。
  10. 如权利要求9所述的瓣叶捕捞装置，所述近端接头的材料和所述远端接头的材料均为形状记忆合金，所述远端套管的侧壁上设置有远端贯穿槽，所述形状记忆合金件的远端端部焊接至所述远端贯穿槽的边缘，所述远端接头主体部的侧壁上设置有远端装配槽，所述远端套管至少焊接至所述远端装配槽的边缘；和/或，所述近端套管的侧壁上设置有近端贯 穿槽，所述形状记忆合金件的近端端部焊接至所述近端贯穿槽的边缘，所述近端接头主体部的侧壁上设置有近端装配槽，所述近端套管至少焊接至所述近端装配槽的边缘。
  11. 如权利要求10所述的瓣叶捕捞装置，所述ePTFE层的近端端部和所述PET层的近端端部在所述近端卡爪的压力作用下被挤入所述近段装配槽内卡紧，和/或所述ePTFE层的远端端部和所述PET层的远端端部在所述远端卡爪的压力作用下被挤入所述远端装配槽内卡紧。
  12. 如权利要求8所述的瓣叶捕捞装置，至少所述近端卡爪和所述远端卡爪的材料为形状记忆合金，所述远端卡爪包括离散设置在所述远端接头主体部的一端的多个远端爪体，并且所述多个远端爪体自所述远端接头主体部沿远离所述远端接头主体部的方向延伸并且逐渐并拢，直至所述多个远端爪体的远末端并拢在一起；和/或，所述近端卡爪包括离散设置在所述近端接头主体部的一端的多个近端爪体，并且所述多个近端爪体自所述近端接头主体部沿远离所述近端接头主体部的方向延伸并且逐渐并拢，直至所述多个近端爪体的近末端并拢在一起。
  13. 如权利要求12所述的瓣叶捕捞装置，所述多个远端爪体中的每一个远端爪体包括远端基体和远端分叉部，所述远端分叉部包括第一远端分支和第二远端分支，所述远端基体沿着所述远端接头主体部的管口周向设置，所述远端分叉部自所述远端基体沿远离所述远端接头主体部的方向延伸，所述每一个远端爪体的所述第一远端分支的端部连接至相邻的远端爪体的所述第二远端分支的端部；和/或，所述多个近端爪体中的每一个近端爪体包括近端基体和近端分叉部，所述近端分叉部包括第一近端分支和第二近端分支，所述近端基体沿着所述远端接头主体部的管口周向设置，所述近端分叉部自所述近端基体沿远离所述近端接头主体部的方向延伸，所述每一个近端爪体的所述第一近端分支的端部连接至相邻的近端爪体的所述第二近端分支的端部。
  14. 如权利要求13所述的瓣叶捕捞装置，还包括显影环，所述显影环套装在中间线圈的外部、所述远端分叉部的外部和所述近端分叉部的外部。
  15. 一种瓣叶捕捞系统，包括递送装置和如权利要求1至14中任一项所述的瓣叶捕捞装置，所述递送装置包括推送件，所述递送装置设置有可释放部和贯通所述可释放部的递送通孔，所述近端卡接部与所述可释放部卡接，所述递送通孔与所述近端通孔对准，所述推送件在经由所述递送通孔和所述近端通孔后顶在所述近端线圈的近端端部。
  16. 一种瓣叶捕捞装置的装配方法，适用于瓣叶捕捞装置包括线体，所述线体包括顺次设置的远端线圈、中间线圈和近端线圈，所述近端线圈设置于所述线体的近端，所述远端线圈设置于所述线体的远端，所述近端接头的材料为形状记忆合金的场景，所述方法，包括：
    对所述线体进行热定型处理，将所述线体构造为螺旋状，实现所述近端线圈的螺旋内径和所述远端线圈的螺旋内径均大于所述中间线圈的螺旋内径；
    对近端接头进行热定型处理，实现所述近端接头的近端卡爪处于并拢状态；
    将所述近端接头置于冰水中实现所述近端卡爪处于撑开状态；
    将所述近端线圈的近端端部置于所述近端卡爪的内部，并且使得位于所述近端线圈的近端端部中的形状记忆合金件置于所述近端接头主体部的内部；
    将所述近端接头和所述近端线圈保持冰水中的位置关系从冰水中取出处于常温下，使得所述近端卡爪恢复并拢状态，实现所述近端线圈的近端端部卡持于所述近端卡爪内；
    将所述形状记忆合金件焊接至所述近端接头，并且使得近端通孔连通至所述近端线圈的所述近端端部；
    将显影环套在所述近端卡爪的外部。
  17. 如权利要求16所述的装配方法，所述近端接头主体部为管状，将所述形状记忆合金件焊接至所述近端接头，并且使得近端通孔连通至所述近端线圈的所述近端端部，具体包括：
    将所述形状记忆合金件焊接至近端套管的内部；
    将所述近端套管套装于所述近端接头主体部的内部；
    将所述近端套管焊接至所述近端接头主体部上，并且使得所述近端套管与所述近端接头主体部同轴设置，实现所述近端套管的内腔作为所述近端通孔的一段。
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