WO2023051497A1 - 一种可避免流出道梗阻的置换系统 - Google Patents

一种可避免流出道梗阻的置换系统 Download PDF

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Publication number
WO2023051497A1
WO2023051497A1 PCT/CN2022/121577 CN2022121577W WO2023051497A1 WO 2023051497 A1 WO2023051497 A1 WO 2023051497A1 CN 2022121577 W CN2022121577 W CN 2022121577W WO 2023051497 A1 WO2023051497 A1 WO 2023051497A1
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Prior art keywords
arm
valve
clamping
leaflet
replacement system
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PCT/CN2022/121577
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English (en)
French (fr)
Inventor
吕世文
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宁波健世科技股份有限公司
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Publication of WO2023051497A1 publication Critical patent/WO2023051497A1/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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2457—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
    • A61F2/2466—Delivery devices therefor

Definitions

  • the present application relates to the field of medical devices, in particular to a replacement system that can avoid outflow tract obstruction.
  • both the mitral valve and the tricuspid valve have a special physiological structure, which makes it very difficult to accurately position and fix the product.
  • the specific anatomical position of the mitral valve in the heart and its complex anatomical structure bring great challenges to mitral valve replacement surgery.
  • the technique of locking the prosthesis of the mitral valve/tricuspid valve in the heart through surgery often utilizes the radial support force of the stent on the atrioventricular valve ring.
  • the disadvantage of this technique is that it is easy to cause compression on the tissue around the valve annulus, and it is easy to cause the impact of the stent and the compressed tissue on the outflow tract. From the perspective of the long-term use of the replacement valve, as the patient's use time goes by after the operation, the regurgitation will decrease, the ventricular and atrial pressure will decrease, and the heart structure will be reconstructed. The larger size of the stent will affect the reduction of the size of the valve ring. Affecting the internal structures of the heart is clearly an unwanted result.
  • Patent CN109789019A describes a heart valve docking coil and system from Edwards Lifesciences. In this patent publication, the leaflet and stent are tightly clamped together by wrapping the docking device on the outside of the leaflet.
  • mitral valve replacement prosthesis currently has at least the following technical pain points: 1.
  • the valve leaflet clamping mechanism has only one chance to capture the valve leaflet, and the angle of capturing the valve leaflet cannot be effectively adjusted, and the error tolerance rate is very low; 2.
  • the prosthesis After replacement, the anterior valve leaflet will block the left ventricular outflow tract; 3.
  • Large-scale stents radially support the native valve ring will affect the internal structure of the heart, resulting in a large number of complications; the industry urgently needs a new transcatheter heart valve replacement system , to solve the above and other technical problems.
  • a replacement system capable of avoiding outflow tract obstruction, comprising: a valve support, a valve clamping device cooperating with the valve support, and the valve clamping device is configured to clamp A clamping mechanism and a hoop for holding the native valve leaflet, the hoop is at least partially configured on the clamping mechanism, and the hoop can drive the native valve leaflet to move upward and tighten the valve support ;
  • the clamping mechanism includes a clamping arm, a control lever and a dismounting wire, wherein the clamping arm comprises a fixed arm and a capture arm, the capture arm is hinged on the fixed arm, and the control lever passes through the A detachment wire is detachably connected to the capture arm, and pulling back or pushing the control rod can cause the capture arm to open or close.
  • the capture arm is divided into a long arm and a short arm at the hinge point hinged with the fixed arm, and the control rod is detachably connected with the short arm through the dismounting wire; when the capture After the arm captures the native valve leaflet, the valve support enters the valve clamping mechanism and radially expands, and one end of the short arm abuts against the valve support so that the long arm fits against the fixed arm.
  • valve support After the capture arm captures the native valve leaflet, the valve support enters the valve clamping mechanism along the control rod, and the disassembly wire is removed to separate it from the clamping arm, the valve support After radial expansion, the valve support will abut against the short arm, and make the long arm abut against the fixed arm, and at the same time drive the hoop member, native valve leaflet and chordal tendon linkage, wherein the hoop The member is at least partly displaced upwards and drives the native valve leaflet and the chordae to be pulled upwards, and the hoop member tightens the valve support.
  • the replacement system further includes a controllable release device, the distal end of the controllable release device is detachably connected with the proximal end of the valve clamping mechanism, wherein, when capturing the native valve leaflet, Upon manipulation of the lever to move distally relative to the controllable release mechanism, the capture arms are opened to capture the native valve leaflets.
  • the hoop when the valve stent is radially expanded, the hoop is located between the chordae and the native valve leaflet, and the valve stent is radially expanded such that the hoop is at least partially covered. It is displaced upwards and pulls the native valve leaflets and chordae upward.
  • the short arm is provided with a connection hole, the distal end of the control rod is in a "concave" shape, and the short arm is at least partly set in the groove at the distal end of the control rod Inside, the detachment wire passes through the connection hole and is detachably connected with the capture arm.
  • the fixed arm is provided with a slot, and the axial length of the slot is greater than the axial length of the short arm, so that the turning angle of the long arm is greater than 180°.
  • the clamping arm includes a first clamping arm and a second clamping arm, and the first clamping arm and the second clamping arm capture and anchor the adjacent native leaflets respectively.
  • valve leaflets around the clamping arm can realize automatic opening and closing.
  • the valve support enters the valve clamping mechanism, the disassembly wire Withdraw from the connection hole, the control rod and the clamping arm are disassembled and separated, the valve support is in a state of radial expansion, and the radial expansion of the valve support causes the hoop to drive the body The valve leaflets are displaced upward and tighten the valve support.
  • valve support enters the valve clamping mechanism along the control rod.
  • the flap clamping mechanism also includes an elastic sheet for anchoring the native valve leaflet and a wire for controlling the opening and closing of the elastic sheet, the elastic sheet is fixed on the capture arm, and the wire is connected to the
  • the elastic pieces are detachably connected, and the elastic pieces are all provided with teeth, and the teeth can limit the relative position between the first clamping arm and the second clamping arm and the native leaflet, and the teeth are configured to bite and fix the Clipped native valve leaflets.
  • the proximal end of the valve clamp mechanism is provided with an atrium support section, and the atrium support section includes a plurality of support rods, and the length of the support rods in the front leaflet area is greater than that in the rear leaflet area. The length of the area's support rods.
  • the number of the support rods is three or four, which can not only play a strong supporting role, but also avoid excessive pulling on the original annulus and reduce the number of implants.
  • a method for operating a replacement system that can avoid outflow tract obstruction including: operating the outer sheath of the replacement system that can avoid outflow tract obstruction to enter the surgical site;
  • the outer sheath tube is gradually retracted to the proximal end relative to the control rod, gradually exposing the clamping mechanism in the constrained state in the outer sheath tube, and pulling back the control rod so that the capture arm opens and catches and clamps The corresponding native valve leaflets;
  • the outer sheath tube is completely withdrawn from the surgical site, and the control rod is left in place;
  • the valve stent delivery device is operated to enter the tubular valve stent along the control rod and reach between the Between the first clamping arm and the second clamping arm of the valve clamp mechanism, the disassembly wire is pulled out to separate it from the capture arm, and the control rod is withdrawn;
  • the valve support is radially expanded, and the valve support abut against the short arm and make the long arm abut against the fixed arm, thereby
  • the existing replacement system can clamp the valve leaflets through the valve clamping mechanism, after radially expanding the valve support, the wire loop drives the chordae and the native valve leaflets to lift up, which can avoid blocking the outflow tract, but the valve clamping mechanism
  • the structure is shaped by nickel-titanium metal.
  • the capturing arm When capturing the autogenous valve leaflet, its opening angle cannot be adjusted, and it cannot be recovered after opening, and the error tolerance rate is low; according to an embodiment of the application, the capturing arm is hinged on the fixed arm
  • the capture arm can be opened or closed by pushing or pulling back the control rod, so that the capture arm can precisely adjust its opening angle when capturing the native valve leaflet, and when the capture arm is hooked to the chordal tissue or its capture position
  • the control lever can be pushed to make the capture arm turn down, and the capture position can be readjusted, and after the valve leaflet is captured, the valve support can make the long arm lean against the fixed arm by abutting against the short arm.
  • This mechanical locking The method can effectively avoid stress fatigue, and is more conducive to the long-term implantation of the device, which has good clinical significance.
  • the hoop can not only pull the chordae and lift the valve leaflet, but also enable the valve stent to tighten the valve stent after radial expansion. It avoids the occlusion of the left ventricular outflow tract, and at the same time prevents the valve stent from radially supporting the native valve annulus, avoiding adverse effects on the shape of the native valve, and at the same time solves the two major technical problems of mitral valve replacement in related technologies Pain points with good clinical significance.
  • the short arm part when pre-installed, is pre-installed in the groove at the distal end of the control rod, which can save the loading space of the sheath tube and is more conducive to transvascular approach.
  • the fixed arm is provided with a groove, and the axial length of the groove is greater than the axial length of the short arm, so that the long arm can turn over an angle greater than 180°;
  • the atrial support section includes a plurality of support rods, and the length of the support rods in the front leaflet area is greater than the length of the support rods in the rear leaflet area; thus After implantation, the valve stent can be biased toward the posterior valve leaflet area, and the position of the outflow tract should be avoided as much as possible to avoid blocking the outflow tract.
  • FIGS 1a to 1c are schematic diagrams of the flap clamping device of the present application.
  • Figures 2a and 2b are overall schematic diagrams of the present application, wherein Figure 2b is a schematic diagram of a control rod.
  • 3a to 3e are schematic diagrams of the operation of the flap clamping mechanism of the present application.
  • FIGS. 4a to 4h are schematic diagrams of an operation of the present application.
  • 1-valve support 2-clamping device, 21-clamping mechanism, 211-clamping arm, 2111-fixing arm, 21111-slot, 2112-capturing arm, 21121-long arm, 21122-short arm, 2113- First clamping arm, 2114-second clamping arm, 212-control rod, 213-removal wire, 214-shrapnel, 2141-tooth, 215-wire, 22-clamp piece, 3-controllable release device, 4 - Atrial support segment, 41 - Support rod.
  • proximal end refers to the end close to the operator
  • distal end refers to the end away from the operator
  • a valve clamping mechanism 21 and a hoop member 22 configured to clamp the autologous leaflet
  • the hoop member 22 is at least partially configured on the valve clamping mechanism 21
  • the valve clamping mechanism 21 includes a clamping arm 211,
  • the capture arm 2112 is opened or closed to capture the native valve leaflet.
  • valve support 1 After the capture arm 2112 captures the native valve leaflet, the valve support 1 enters the valve clamping mechanism 21 along the control rod 212 and is removed. Disassemble the wire 213 to separate it from the clamping arm 211. After the valve support 1 is radially expanded, the valve support 1 will abut against the short arm 21122, and make the long arm 21121 abut against the fixed arm 2111, while Drive the hoop member 22, the autogenous valve leaflet and the chordal tendon linkage, wherein the hoop member 22 is at least partially displaced upwards and drives the autologous valve leaflet and the chord tendon to be pulled upward, and the hoop member 22 is clamped Tighten the valve support 1.
  • the replacement system further includes a controllable release device 3, as shown in FIG. , when capturing the native valve leaflet, the control rod 212 is operated to move distally relative to the controllable release device 3 , and the capturing arm 2112 is opened to capture the native valve leaflet.
  • the hoop member 22 when the valve stent 1 expands radially, the hoop member 22 is located between the chordae and the native valve leaflet, as shown in FIG. 4d , and the valve stent 1 expands radially so that The hoop member 22 is at least partly displaced upwards and drives the native leaflets and chordae to be pulled upwards.
  • the short arm 21122 is provided with a connection hole, and the distal end of the control rod 212 is in a “concave” shape, and the short arm 21122 is at least partially disposed on the distal end of the control rod 212
  • the detachment wire 213 is detachably connected with the catch arm 2112 through the connection hole, as shown in Fig. 2a and 2b.
  • the fixed arm 2111 is provided with a slot 21111, and the axial length of the slot 21111 is greater than the axial length of the short arm 21122, so that the turning angle of the long arm 21121 is greater than 180° °, as shown in Figure 1b.
  • the clamping arm 211 includes a first clamping arm 2113 and a second clamping arm 2114, as shown in Figures 1a and 4f, the first clamping arm 2113 and the second clamping arm 2114 Capture and anchor adjacent native valve leaflets separately.
  • valve leaflets around the clamping arm 211 can realize automatic opening and closing.
  • the disassembly wire 213 is withdrawn from the connecting hole, and the control rod 212 is disassembled and separated from the clamping arm 211.
  • the radial expansion of the valve stent 1 causes the hoop member 22 to drive the native leaflets to move upwards and tighten the valve stent 1 .
  • the flap clamping mechanism 21 further includes an elastic piece 214 for anchoring the native valve leaflet and a wire 215 for controlling the opening and closing of the elastic piece 214.
  • the elastic piece 214 is fixed on the capture arm 2112, and the The wire 215 is detachably connected to the elastic piece 214, and the elastic piece 214 is provided with teeth 2141, as shown in Figures 1b and 1c, the teeth 2141 can define the first clamping arm 2113 and the second clamping arm 2114 with the body The relative position between the valve leaflets, the teeth 2141 are configured to bite and fix the clamped native valve leaflets.
  • the proximal end of the valve clamping mechanism 21 is provided with an atrium support section 4, and the atrium support section 4 includes a plurality of support rods 41, and the length of the support rods 41 in the anterior leaflet region is greater than The length of the struts 41 in the posterior leaflet region.
  • the number of the support rods 41 is three or four, which can not only play a strong supporting role, but also avoid excessive pulling on the original annulus and reduce the number of implants.
  • a method for operating the replacement system that can avoid outflow tract obstruction is also provided, as shown in Figures 4a to 4h, including: operating the one The outer sheath tube of a replacement system that can avoid outflow tract obstruction enters the surgical site; the outer sheath tube is gradually retracted to the proximal end relative to the control rod 212, and the clamp in the restrained state in the outer sheath tube is gradually exposed. flap mechanism 21, and push the control rod 212 so that the catch arm 2112 opens and catches.

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

Abstract

一种可避免流出道梗阻的置换系统，抱箍件(22)能带动自体瓣叶向上移位并箍紧瓣膜支架(1)；夹瓣机构(21)包括夹持臂(211)、控制杆(212)以及拆卸丝(213)，夹持臂(211)包括固定臂(2111)和捕捉臂(2112)，捕捉臂(2112)铰接在固定臂(2111)上，控制杆(212)通过拆卸丝(213)与捕捉臂(2112)可拆卸连接。

Description

一种可避免流出道梗阻的置换系统
相关申请的交叉引用：本申请要求了2021年9月30日提交的，专利申请号为CN 202111164164.4的专利申请作为优先权，该申请所公开的内容在此参考引入。
技术领域
本申请涉及医疗器械领域，具体涉及一种可避免流出道梗阻的置换系统。
背景技术
从心脏结构来看，无论是二尖瓣还是三尖瓣，均具有特殊的生理结构，造成产品准确定位和固定非常困难。尤其是，二尖瓣在心内的特定解剖位置及其复杂的解剖结构，给二尖瓣置换手术带来极大的挑战。
相关技术中，通过手术将二尖瓣/三尖瓣的假体在心内锁定的技术，常利用支架对房室瓣环的径向支撑力。这种技术的缺点在于，容易对瓣环周围组织造成压迫，并且容易导致支架和压迫组织对流出道产生影响。从置换瓣膜的长期使用影响来看，随着手术后患者使用时间的推移，返流会减少，心室心房压下降，心脏结构进行重建，较大尺寸规格的支架会影响瓣环尺寸的缩小，从而影响心脏的内部结构，这显然是不想要的结果。
除此之外，锁定的技术也可通过预先在瓣叶处植入一个对接装置，通过支架在该对接装置内部撑开来固定在瓣叶处。专利CN109789019A描述了Edwards Lifesciences公司的一种心脏瓣膜对接线圈和系统。在该专利公开中，通过将对接装置缠绕在瓣叶外侧，将瓣叶和支架紧紧箍在一起。这种支架固定的方式优越性很突出，但是前叶较大箍在支架上，对左流出道血流得阻挡并未解决；而专利202111164164.4中虽然能利用抱箍件将自体瓣叶向上提拉，使其减少流出道的遮挡，但是带有抱箍件的夹瓣机构利用夹子的预设形态来捕捉并锚定瓣叶，这种方式使得捕捉瓣叶的机会只有一次，并且，如果夹子勾连到腱索时，夹子不能回复到伸直的状态，会导致手术的失败，该结构方案对术者的要求非常高。
综上所述，二尖瓣置换假体目前至少存在如下技术痛点：1.瓣叶夹持机构捕捉瓣叶只有一次机会，无法有效调节捕捉瓣叶的角度，容错率很低；2.假体置换后，前瓣叶会遮挡左室流出道；3.大规格的支架径向支撑自体瓣环会影响心脏内部结构，导致出现大量并发症；业内亟需一种新的经导管心脏瓣膜置换系统，来解决以上的和其它的技术问题。
发明内容
鉴于以上和其它构思，而提出了本申请。本申请的主要目的是克服相关技术的一些问题和不足。
根据本申请的一方面，公开了一种可避免流出道梗阻的置换系统，包括：瓣膜支架、与所述瓣膜支架协同操作的夹瓣固定装置，所述夹瓣固定装置被构造成用来夹持自体瓣叶的夹瓣机构和抱箍件，所述抱箍件至少部分被配置在所述夹瓣机构上，所述抱箍件能带动自体瓣叶向上移位并箍紧所述瓣膜支架；所述夹瓣机构包括夹持臂、控制杆以及拆卸丝，其中，所述夹持臂包括固定臂和捕捉臂，所述捕捉臂铰接在所述固定臂上，所述控制杆通过所述拆卸丝与所述捕捉臂可拆卸连接，并且，回拉或推动所述控制杆可使得所述捕捉臂张开或闭合。
作为本申请的进一步改进，所述捕捉臂以与固定臂铰接的铰接点被分为长臂和短臂，所述控制杆通过所述拆卸丝与所述短臂可拆卸连接；当所述捕捉臂捕捉到自体瓣叶后，所述瓣膜支架进入所述夹瓣机构内并径向扩张，并且，所述短臂的一端抵靠所述瓣膜支架使得所述长臂贴合所述固定臂。
作为本申请的进一步改进，所述捕捉臂捕捉到自体瓣叶后，所述瓣膜支架沿着控制杆进入夹瓣机构内，并且，撤掉拆卸丝使其与夹持臂分离，所述瓣膜支架径向扩张后，所述瓣膜支架会抵靠短臂，并使得所述长臂贴靠所述固定臂，同时带动所述抱箍件、自体瓣叶和腱索联动，其中，所述抱箍件至少部分被向上移位并带动自体瓣叶和腱索向上提拉，并且所述抱箍件箍紧所述瓣膜支架。
作为本申请的进一步改进，所述置换系统还包括可控释放装置，所述可控释放装置的远端与所述夹瓣机构的近端配合可拆卸连接，其中，在捕捉自体瓣叶时，操作所述控制杆使其相对所述可控释放装置向远端移动，所述捕捉臂被打开并捕捉自体瓣叶。
作为本申请的进一步改进，所述瓣膜支架在径向扩张时，所述抱箍件处于腱索与自体瓣叶之间，并且，所述瓣膜支架径向扩张使得所述抱箍件至少部分被向上移位并带动自体瓣叶和腱索向上提拉。
作为本申请的进一步改进，所述短臂设有连接孔，所述控制杆的远端为“凹”字型结构，并且，所述短臂至少部分设置在所述控制杆远端的凹槽内，所述拆卸丝穿过所述连接孔与所述捕捉臂可拆卸连接。
作为本申请的进一步改进，所述固定臂上设有槽，并且，所述槽的轴向长度大于所述短臂的轴向长度，使得所述长臂的可翻转角度大于180°。
作为本申请的进一步改进，所述夹持臂包括第一夹持臂和第二夹持臂，所述第一夹持臂和第二夹持臂分别捕捉和锚定相邻的自体瓣叶。
作为本申请的进一步改进，当所述捕捉臂捕捉自体瓣叶后，所述夹持臂周边的瓣叶可实现自主开闭，当所述瓣膜支架进入所述夹瓣机构内，所述拆卸丝从所述连接孔内撤离，所述控制杆与所述夹持臂被拆卸分离，所述瓣膜支架处于径向扩张的状态，所述瓣膜支架的径向扩张导致所述抱箍件能带动自体瓣叶向上移位并箍紧所述瓣膜支架。
作为本申请的进一步改进，在所述夹瓣机构捕捉自体瓣叶后，所述瓣膜支架沿着所述控制杆进入所述夹瓣机构内。
作为本申请的进一步改进，所述夹瓣机构还包括用于锚定自体瓣叶的弹片以及控制弹片开闭的线，所述弹片固定在所述捕捉臂上，并且，所述线与所述弹片可拆卸连接，所述弹片均设有齿，其齿可限定第一夹持臂和第二夹持臂与自体瓣叶之间的相对位置，所述齿构造成用于咬住和固定被夹持的自体瓣叶。
作为本申请的进一步改进，所述夹瓣机构的近端设有心房支撑段，所述心房支撑段包括多根支撑杆，并且，在前瓣叶区域的支撑杆的长度要大于在后瓣叶区域的支撑杆的长度。
作为本申请的进一步改进，所述支撑杆数量为三根或四根，既能起到有力的支撑作用，又能避免对原生瓣环造成过度的牵拉，减少植入物。
作为本申请的进一步改进，还提供了一种操作可避免流出道梗阻的置换系统的方法，包括：操作所述一种可避免流出道梗阻的置换系统的外鞘管进入手术部位；使所述外鞘管相对于控制杆向近端逐渐回撤，逐步地露出所述外鞘管内的在约束状态下的夹瓣机构，并回拉所述控制杆使得所述捕捉臂打开并捕捉、夹持相应的自体瓣叶；将所述外鞘管完全从手术部位撤出，并保留所述控制杆在原位；操作瓣膜支架输送装置将管状瓣膜支架沿所述控制杆进入并到达介于所述夹瓣机构的第一夹持臂和第二夹持臂之间，将拆卸丝拉出使其与捕捉臂分离，并撤出所述控制杆；径向扩张所述瓣膜支架，所述瓣膜支架抵靠所述短臂并使得所述长臂贴靠所述固定臂，由此展开和张紧栓系在所述夹瓣机构外周的抱箍件，其中，所述抱箍件的展开和张紧则沿着所述瓣膜支架的轴向方向逐步地提拉腱索以及自体瓣叶，直到所述抱箍件箍紧所述瓣膜支架和所述夹瓣机构，并最终实现自体瓣叶提拉以及回折；和撤出所述瓣膜支架输送装置。
与相关技术相比，本申请的优点和有益技术效果至少包含以下所列：
1.现有的置换系统虽然能通过夹瓣机构夹持瓣叶，利用瓣膜支架径向扩张后，让线环带动腱索及自体瓣叶上提，能避免流出道的遮挡，但是夹瓣机构的结构采用镍钛金属定型，在捕捉自体瓣叶时，无法调节其张开的角度，并且，在打开后无法回收，容错率较低；根据本申请的一实施例，捕捉臂铰接在固定臂上，通过推动或回拉控制杆可使得捕捉臂张开或闭合，使得捕捉臂在捕捉自体瓣叶时能精准调节其张开的角度，并且，当捕捉臂勾连到腱索组织或其捕捉位置不合适的时候，可以推动控制杆使得捕捉臂下翻，重新调整捕捉的位置，并且，在捕捉瓣叶后，瓣膜支架通过抵靠短臂使得长臂贴靠固定臂，这种机械式的锁定方式能有效避免应力疲劳，更有利于器械的长期植入，具有很好的临床意义。
2.区别于相关技术，根据本申请的一实施例，抱箍件既能牵拉腱索和提拉瓣叶，又能使得瓣膜支架在径向扩张后，抱箍件能箍紧瓣膜支架，避免了对左室流出道的遮挡，同时还能避免瓣膜支架径向支撑自体瓣环，避免对原生瓣膜的形态造成不利影响，同时解决了相关技术中关于二尖瓣置换术治疗 的两大技术痛点，具有很好的临床意义。
3.区别于相关技术，根据本申请的一实施例，在预装时，短臂部分是预装在控制杆远端的凹槽内，可以节省鞘管的装载空间，更有利于经血管的入路。
4.区别于相关技术，根据本申请的一实施例，固定臂上设有槽，并且，槽的槽的轴向长度大于短臂的轴向长度，使得长臂的可翻转角度大于180°；这样设计的好处在于：当夹持臂勾连到腱索或者捕捉位置不合适的时候，可以将夹持臂下翻，重新调整夹持臂的捕捉位置，有效提高手术的成功率。
5.区别于相关技术，本申请的一实施例中，心房支撑段包括多根支撑杆，并且，在前瓣叶区域的支撑杆的长度要大于在后瓣叶区域的支撑杆的长度；这样能使得瓣膜支架在植入后更偏向后瓣叶区域，尽可能的让出流出道的位置，避免对流出道产生遮挡。
附图说明
图1a～图1c为本申请夹瓣固定装置示意图。
图2a和2b为本申请整体示意图，其中图2b为控制杆示意图。
图3a～图3e为本申请夹瓣机构工作示意图。
图4a～图4h为本申请一种操作示意图。
附图中各数字所指代的特征名称如下：
1-瓣膜支架；2-夹瓣固定装置，21-夹瓣机构，211-夹持臂，2111-固定臂，21111-槽，2112-捕捉臂，21121-长臂，21122-短臂，2113-第一夹持臂，2114-第二夹持臂，212-控制杆，213-拆卸丝，214-弹片，2141-齿，215-线，22-抱箍件，3-可控释放装置，4-心房支撑段，41-支撑杆。
具体实施方式
本申请中，“近端”是指接近手术操作者的一端，“远端”是指远离手术操作者的一端。
实施例一：
如图1a～图1c所示，一种可避免流出道梗阻的置换系统，包括：瓣膜支架1、与所述瓣膜支架1协同操作的夹瓣固定装置2，所述夹瓣固定装置2被构造成用来夹持自体瓣叶的夹瓣机构21和抱箍件22，所述抱箍件22至少部分被配置在所述夹瓣机构21上，所述夹瓣机构21包括夹持臂211、控制杆212以及拆卸丝213，其中，所述夹持臂211包括固定臂2111和捕捉臂2112，所述捕捉臂2112铰接在所述固定臂2111上，并且，所述捕捉臂2112以与固定臂2111铰接的铰接点被分为长臂21121和短臂21122，所述控制杆212通过所述拆卸丝213与所述短臂21122可拆卸连接；并且，推动或回拉所述控制杆212可使得所述捕捉臂2112张开或闭合以实现捕捉自体瓣叶，在所述捕捉臂2112捕捉到自体瓣叶后，所述瓣膜支架1沿着控制杆212进入夹瓣机构21内，并且，撤掉拆卸丝213使其与夹持臂211分离，所述瓣膜支架1径向扩张后，所述瓣膜支架1会抵靠短臂21122，并使得所述长臂21121贴靠所述固定臂2111，同时带动所述抱箍件22、自体瓣叶和腱索联动，其中，所述抱箍件22至少部分被向上移位并带动自体瓣叶和腱索向上提拉，并且所述抱箍件22箍紧所述瓣膜支架1。
在本实施例中，所述置换系统还包括可控释放装置3，如图2a所示，所述可控释放装置3的远端与所述夹瓣机构21的近端配合可拆卸连接，其中，在捕捉自体瓣叶时，操作所述控制杆212使其相对所述可控释放装置3向远端移动，所述捕捉臂2112被打开并捕捉自体瓣叶。
在本实施例中，所述瓣膜支架1在径向扩张时，所述抱箍件22处于腱索与自体瓣叶之间，如图4d所示，并且，所述瓣膜支架1径向扩张使得所述抱箍件22至少部分被向上移位并带动自体瓣叶和腱索向上提拉。
在本实施例中，所述短臂21122设有连接孔，所述控制杆212的远端为“凹”字型结构，并且，所述短臂21122至少部分设置在所述控制杆212远端的凹槽21111内，所述拆卸丝213穿过所述连接孔与所述捕捉臂2112可拆卸连接，如图2a和2b所示。
在本实施例中，所述固定臂2111上设有槽21111，并且，所述槽21111的轴向长度大于所述短臂21122的轴向长度，使得所述长臂21121的可翻转角度大于180°，如图1b所示。
在本实施例中，所述夹持臂211包括第一夹持臂2113和第二夹持臂2114，如图1a和4f所示，所述第一夹持臂2113和第二夹持臂2114分别捕捉和锚定相邻的自体瓣叶。
在本实施例中，当所述捕捉臂2112捕捉自体瓣叶后，所述夹持臂211周边的瓣叶可实现自主开闭，当所述瓣膜支架1进入所述夹瓣机构21内，所述拆卸丝213从所述连接孔内撤离，所述控制杆212与所述夹持臂211被拆卸分离，如图3a～图3e所示，所述瓣膜支架1处于径向扩张的状态，所述瓣膜支架1的径向扩张导致所述抱箍件22带动自体瓣叶向上移位并箍紧所述瓣膜支架1。
在本实施例中，所述夹瓣机构21还包括用于锚定自体瓣叶的弹片214以及控制弹片214开闭的线215，所述弹片214固定在所述捕捉臂2112上，并且，所述线215与所述弹片214可拆卸连接，所述弹片214均设有齿2141，如图1b和1c所示，其齿2141可限定第一夹持臂2113和第二夹持臂2114与自体瓣叶之间的相对位置，所述齿2141构造成用于咬住和固定被夹持的自体瓣叶。
在本实施例中，所述夹瓣机构21的近端设有心房支撑段4，所述心房支撑段4包括多根支撑杆41，并且，在前瓣叶区域的支撑杆41的长度要大于在后瓣叶区域的支撑杆41的长度。
在本实施例中，所述支撑杆41数量为三根或四根，既能起到有力的支撑作用，又能避免对原生瓣环造成过度的牵拉，减少植入物。
在本实施例中，当所述置换系统用于二尖瓣治疗时，还提供了一种操作可避免流出道梗阻的置换系统的方法，如图4a～图4h所示包括：操作所述一种可避免流出道梗阻的置换系统的外鞘管进入手术部位；使所述外鞘管相对于控制杆212向近端逐渐回撤，逐步地露出所述外鞘管内的在约束状态下的夹瓣机构21，并推动所述控制杆212使得所述捕捉臂2112打开并捕捉。夹持相应的自体瓣叶；将所述外鞘管完全从手术部位撤出，并保留所述控制杆212在原位；操作瓣膜支架1输送装置将管状瓣膜支架1沿所述控制杆212进入并到达介于所述夹瓣机构21的第一夹持臂2113和第二夹持臂2114之间，将拆卸丝213拉出使其与捕捉臂2112分离，并撤出所述控制杆212；径向扩张所述瓣膜支架1，所述瓣膜支架1抵靠所述短臂21122并使得所述长臂21121贴靠所述固定臂2111，由此展开和张紧栓系在所述夹瓣机构21外周的抱箍件22，其中，所述抱箍件22的展开和张紧则沿着所述瓣膜支架1的轴向方向逐步地提拉腱索以及自体瓣叶，直到所述抱箍件22箍紧所述瓣膜支架1和所述夹瓣机构21，并最终实现自体瓣叶提拉以及回折；和撤出所述瓣膜支架1输送装置。
出于说明的目的而提出了对本申请的示例实施例的前文描述。前文描述并非意图是穷举的，也并非将本申请限于所公开的精确配置和/或构造，显然，根据上文的教导，本领域的技术人员可作出许多修改和变型而不偏离本申请。本申请的范围和等同物旨在由所附权利要求限定。

Claims (10)

  1. 一种可避免流出道梗阻的置换系统，包括：瓣膜支架、与所述瓣膜支架协同操作的夹瓣固定装置，所述夹瓣固定装置被构造成用来夹持自体瓣叶的夹瓣机构和抱箍件，所述抱箍件至少部分被配置在所述夹瓣机构上，所述抱箍件能带动自体瓣叶向上移位并箍紧所述瓣膜支架；其特征在于：所述夹瓣机构包括夹持臂、控制杆以及拆卸丝，其中，所述夹持臂包括固定臂和捕捉臂，所述捕捉臂铰接在所述固定臂上，所述控制杆通过所述拆卸丝与所述捕捉臂可拆卸连接，并且，回拉或推动所述控制杆可使得所述捕捉臂张开或闭合。
  2. 根据权利要求1所述的可避免流出道梗阻的置换系统，其特征在于：所述捕捉臂以与固定臂铰接的铰接点被分为长臂和短臂，所述控制杆通过所述拆卸丝与所述短臂可拆卸连接；当所述捕捉臂捕捉到自体瓣叶后，所述瓣膜支架进入所述夹瓣机构内并径向扩张，并且，所述短臂的一端抵靠所述瓣膜支架使得所述长臂贴合所述固定臂。
  3. 根据权利要求2所述的可避免流出道梗阻的置换系统，其特征在于：所述置换系统还包括可控释放装置，所述可控释放装置的远端与所述夹瓣机构的近端配合可拆卸连接，其中，在捕捉自体瓣叶时，操作所述控制杆使其相对所述可控释放装置向远端移动，所述捕捉臂被打开并捕捉自体瓣叶。
  4. 根据权利要求2所述的可避免流出道梗阻的置换系统，其特征在于：所述短臂设有连接孔，所述控制杆的远端为“凹”字型结构，并且，所述短臂至少部分设置在所述控制杆远端的凹槽内，所述拆卸丝穿过所述连接孔与所述捕捉臂可拆卸连接。
  5. 根据权利要求2所述的可避免流出道梗阻的置换系统，其特征在于：所述固定臂上设有槽，并且，所述槽的轴向长度大于所述短臂的轴向长度，使得所述长臂的可翻转角度大于180°。
  6. 根据权利要求4所述的可避免流出道梗阻的置换系统，其特征在于：所述夹持臂包括第一夹持臂和第二夹持臂，所述第一夹持臂和第二夹持臂分别捕捉和锚定相邻的自体瓣叶。
  7. 根据权利要求6所述的可避免流出道梗阻的置换系统，其特征在于：当所述捕捉臂捕捉自体瓣叶后，所述夹持臂周边的瓣叶可实现自主开闭，当所述瓣膜支架进入所述夹瓣机构内，所述拆卸丝从所述连接孔内撤离，所述控制杆与所述夹持臂被拆卸分离，所述瓣膜支架处于径向扩张的状态，所述瓣膜支架的径向扩张导致所述抱箍件能带动自体瓣叶向上移位并箍紧所述瓣膜支架。
  8. 根据权利要求2所述的可避免流出道梗阻的置换系统，其特征在于：在所述夹瓣机构捕捉自体瓣叶后，所述瓣膜支架沿着所述控制杆进入所述夹瓣机构内。
  9. 根据权利要求2所述的可避免流出道梗阻的置换系统，其特征在于：所述夹瓣机构还包括用于锚定自体瓣叶的弹片以及控制弹片开闭的线，所述弹片固定在所述捕捉臂上，并且，所述线与所述弹片可拆卸连接。
  10. 根据权利要求1所述的可避免流出道梗阻的置换系统，其特征在于：所述夹瓣机构的近端设有心房支撑段，所述心房支撑段包括多根支撑杆，并且，在前瓣叶区域的支撑杆的长度要大于在后瓣叶区域的支撑杆的长度。
PCT/CN2022/121577 2021-09-30 2022-09-27 一种可避免流出道梗阻的置换系统 WO2023051497A1 (zh)

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