WO2023138565A1 - 一种带可驱动夹持件的瓣膜假体 - Google Patents

一种带可驱动夹持件的瓣膜假体 Download PDF

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Publication number
WO2023138565A1
WO2023138565A1 PCT/CN2023/072556 CN2023072556W WO2023138565A1 WO 2023138565 A1 WO2023138565 A1 WO 2023138565A1 CN 2023072556 W CN2023072556 W CN 2023072556W WO 2023138565 A1 WO2023138565 A1 WO 2023138565A1
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WIPO (PCT)
Prior art keywords
clamping
fixed
valve
section
support
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PCT/CN2023/072556
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English (en)
French (fr)
Inventor
潘文志
周达新
葛均波
Original Assignee
复旦大学附属中山医院
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Publication of WO2023138565A1 publication Critical patent/WO2023138565A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/243—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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath

Definitions

  • the invention relates to the technical field of valve prosthesis, in particular to a valve prosthesis with a drivable clamping part.
  • the atrioventricular valve is attached to the atrium and the periphery of the ventricle, and is connected to the papillary muscle by the chordae, which prevents the blood from the ventricle from flowing back to the atrium, and acts as a single valve. It includes the mitral and tricuspid valves.
  • tricuspid regurgitation is a common heart disease. Severe mitral regurgitation can cause dilation of the left ventricle, eventually leading to left ventricular systolic failure and heart failure, as well as dilation of the left atrium, atrial fibrillation, and pulmonary hypertension.
  • Severe tricuspid regurgitation can lead to a decrease in cardiac output and systemic circulation congestion, which is a signal of poor prognosis in many heart diseases and is closely related to the prognosis of patients.
  • Surgery is currently the most important treatment for micuspid regurgitation, but it has the disadvantages of large trauma, many complications, and high mortality.
  • transcatheter valve replacement has become a hot spot in the research and development of cardiac interventional therapy devices due to its low trauma and high safety.
  • the embodiment of the present invention provides a valve prosthesis with a drivable clamping part, which is used to solve the problems existing in the prior art of how to stably anchor, reduce the delivery size and prolong the service life of the valve.
  • a valve prosthesis with a drivable clamping part comprising: a bracket, a clamping part, a driving part and a biological valve tissue.
  • the biological valve tissue is sutured in the bracket.
  • the clamping part includes a fixed segment body and a clamping segment body.
  • the fixed segment body is fixed on the bracket.
  • the segments form an included angle of 0-90°, and a number of barbs are provided on the end wall of the clamping segment close to the bracket.
  • the support includes a functional support and a fixed support.
  • the functional support is a cylindrical structure
  • the fixed support is composed of a cylindrical fixed end, an inverted conical disk and an inverted conical connecting piece.
  • the upper end of the cylindrical fixed end is connected to the lower end of the inverted conical disk.
  • the axial centerlines of the fixed brackets are on the same line, and the cross-section of the functional bracket is smaller than that of the fixed bracket.
  • the functional support and the cylindrical fixed end are connected by an inverted tapered plate and an inverted tapered connecting piece, and are made of shape memory metal, which has shape memory.
  • the composite structure can be straightened into a single-layer structure in series (from the proximal end to the distal end, there are functional stents, inverted tapered connecting pieces, inverted tapered disks, and cylindrical fixed ends), so as to reduce the delivery size of the stent, so as to realize the possibility of transvascular delivery; and return to the above-mentioned working state in natural conditions.
  • the longitudinal section of the cylindrical fixed end is wide at the top and narrow at the bottom, that is, the diameter of the cross section of the upper end is larger than the diameter of the cross section of the lower end.
  • the upper end of the functional bracket contains connecting parts to realize detachable connection with the delivery system.
  • the connecting parts adopt nuts, hooks, ring structures and the like.
  • the fixed section body includes two fixed sections
  • the clamping section body includes two clamping sections and a bridging piece.
  • the clamping piece is composed of two fixing sections, two clamping sections and a bridging piece to form a W-shaped structure.
  • One end of the two clamping sections is connected by a bridge piece to form an inverted V-shaped structure.
  • the two fixed sections are symmetrically arranged on both sides of the two clamping sections and connected to the other end of the clamping section. sewn on the cylindrical fixed end, and the clamping section fits on the outer peripheral wall of the cylindrical fixed end, the The driving part is connected with the bridge.
  • the clamping piece is made of memory material, there are 2-3 clamping pieces, and the clamping piece is equiangularly distributed along the outer circumference of the cylindrical fixed end.
  • both the functional support and the fixed support are composed of a plurality of diamond-shaped lattice units, and biological valve tissue is sutured in the functional support.
  • the functional bracket and the fixed bracket are made of memory alloy tubes after cutting or braiding and then heat-set.
  • the functional bracket and the fixing bracket can be made by integral cutting or braiding, or can be made by sewing, hinged or welding.
  • the outer surfaces of the functional support and the fixed support are covered with a film, and the film is a polymer film.
  • the driving component adopts a wire rope.
  • the biological valve tissue is a valve leaflet of biological tissue, and the biological valve tissue includes bovine pericardium or porcine pericardium.
  • the biological valve tissue is composed of three independent valves or integrally formed three valves.
  • the inner diameter of the functional stent is smaller than that of the fixed stent, thereby reducing the area of the biological valve sewn into the functional stent, thereby reducing the stress on the biological valve and prolonging its service life;
  • the clamping part can be actively operated by the driver, and compared with other inventions, the clamping part is passively deformed, which can better control the movement of the clamping part, so that the valve can be captured more easily, making the operation simpler and feasible;
  • the clamping part contains barbs, which can stably fix the valve; Wide at the top and narrow at the bottom, it has little impact on the outflow tract and heart function, and the long-term prognosis of the patient is good;
  • the valve prosthesis can be implanted through blood vessels, and the trauma is small.
  • Fig. 1 is a structural schematic diagram of the natural state of a valve prosthesis with a drivable clamping member according to the present invention
  • Fig. 2 is the structural representation of clamping part
  • Fig. 3 is a structural schematic diagram of a valve prosthesis with a drivable clamping member after the clamping section is driven;
  • Fig. 4 is a schematic diagram of the operation process of the valve prosthesis of the present invention.
  • a valve prosthesis with a drivable clamping part includes: a bracket, a clamping part 3, a driving part 4 and a biological valve tissue 5.
  • the biological valve tissue 5 is sutured in the bracket.
  • the clamping part 3 includes a fixed segment body and a clamping segment body.
  • the fixed segment body is fixed on the bracket. Move in the direction away from the bracket and form an angle of 0-90° between the clamping segment and the fixed segment.
  • a number of barbs 321 are provided on the end wall of the clamping segment close to the bracket.
  • the clamping part 3 is in a natural state, as shown in FIG. 1 , the clamping segment body is close to the peripheral wall of the bracket, and can be pulled toward the ventricle side by the driving part 4 so as to form a certain angle with the fixed segment body.
  • the driving part 4 is connected to the free end of the clamping segment body, and the clamping segment body in the clamping part 3 can be made to swing by pulling the driving part 4 .
  • the support adopts a double-layer support, that is, the support includes a functional support 1 and a fixed support 2.
  • the functional support 1 is a cylindrical structure.
  • the upper end of the disk 21 is connected, and the lower end of the inverted tapered connecting piece 23 is connected with the lower end of the functional support 1.
  • the functional support 1 and the fixed support 2 are on the same axial center line, and the cross section of the functional support 1 is smaller than the fixed support 2.
  • a double-layer stent is used, and the inner diameter of the functional stent 1 is smaller than that of the fixed stent 2, thereby reducing the area of the biological valve sewn into the functional stent 1, thereby reducing the stress on the biological valve and prolonging its service life.
  • the functional support and the cylindrical fixed end are connected by an inverted tapered plate and an inverted tapered connecting piece, and are made of shape memory metal, which has shape memory.
  • the composite structure can be straightened into a single-layer structure in series (from the proximal end to the distal end, there are functional stents, inverted tapered connecting pieces, inverted tapered disks, and cylindrical fixed ends), so as to reduce the delivery size of the stent, so as to realize the possibility of transvascular delivery; and return to the above-mentioned working state in natural conditions.
  • the longitudinal section of the cylindrical fixing end is wide at the top and narrow at the bottom, that is, the diameter of the cross-section of the upper end is larger than that of the cross-section of the lower end, thereby reducing the risk of ventricular outflow tract obstruction.
  • the upper end of the functional bracket contains connecting parts to realize detachable connection with the delivery system.
  • the connecting parts adopt nuts, hooks, ring structures and the like.
  • the fixed segment body includes two fixed segments 31, and the clamping segment body includes two Clamping section 32 and bridging piece 322, described clamping piece 3 is formed W-shaped structure by two fixed sections 31, two clamping sections 32 and bridging piece 322, and one end of two described clamping sections 32 is connected by bridging piece 322 to form inverted V-shaped structure, two described fixing sections 31 are symmetrically arranged on two sides of two clamping sections 32 and are connected with the other end of clamping section 32, described clamping section 32 is provided with barb 321 on the side wall facing fixed section 31, described fixing section 31 A threading hole 311 is opened on the top, the fixing section 31 is sewn on the cylindrical fixed end 22 through the threading hole 311, and the clamping section 32 is attached to the outer circumference of the cylindrical fixed end 22, and the driving part 4 is connected to the bridge piece 322.
  • the clamping part 3 can be actively operated by the driving part 4.
  • the clamping part 3 is passively deformed, which can better control the movement of the clamping part 3, so that the valve can be captured more easily, making the operation simpler and feasible;
  • the clamping part 3 contains barbs 321, which can stably fix the valve;
  • the use of the clamping part 3 to fix the valve does not rely on radial support force, which has little impact on the outflow tract, has little impact on heart function, and has a good long-term prognosis for patients;
  • the valve prosthesis can be implanted through blood vessels with less trauma.
  • the clamping member 3 is made of memory material, there are 2-3 clamping members 3, and the clamping members 3 are equiangularly distributed along the outer circumference of the cylindrical fixed end 22 .
  • the clamping piece is connected to the fixed section of the fixed bracket, which is W-shaped in its natural state and made of heat-set memory metal, as shown in FIG. 2 , including a fixed section 31 and a clamping section 32 .
  • the clamping section 32 includes a barb 321 facing the fixing bracket, and a bridge 322 connected with the driving part.
  • the fixing section 31 contains threading holes through which sutures can be threaded to connect the fixing section to the outer periphery of the fixing bracket. In a natural state, the clamping section 32 fits on the peripheral wall of the fixing bracket. During the operation, the clamping section 31 can be driven to swing by the driving component, forming an included angle with the fixing section 32 .
  • both the functional support 1 and the fixed support 2 are composed of a plurality of rhombic lattice units, and the biological valve tissue 5 is sutured inside the functional support 1 .
  • the functional support 1 and the fixed support 2 are made of memory alloy tubes after cutting or braiding and then heat-set.
  • the functional support 1 and the fixed bracket 2 can be made by integral cutting or braiding, or can be made by sewing, hinged or welding.
  • the outer surfaces of the functional support 1 and the fixed support 2 are covered with a film, and the film is a polymer film.
  • the covering film is made of PET film, which can effectively improve the sealing performance of the functional stent 1 and the fixed stent 2, and make the functional stent 1 and the fixed stent 2 better endothelialized.
  • the driving part 4 adopts a wire rope.
  • the driving part is a part that can drive and manipulate the clamping part of the clamping part to swing, preferably
  • the choice is the cord. It runs in a delivery tube just below the valve prosthesis and extends outside the body. By pulling the driving part, the clamping section of the clamping part can swing downwards and outwards, forming an angle or even perpendicular to the fixed section, as shown in FIG. 3 .
  • the biological valve tissue 5 is a valve leaflet of biological tissue, and the biological valve tissue includes bovine pericardium or porcine pericardium.
  • the biological valve tissue 5 is composed of three independent valves or three integrally formed valves.
  • the clamping section When the clip is in a natural state, as shown in Figure 1, the clamping section is close to the peripheral wall of the stent and can be pulled toward the ventricle side by the driving part to form a certain angle with the fixed section.
  • the driving part is connected to the free end of the clamping part, and the clamping part in the clamping part can be made to swing by pulling the driving part.
  • the clamping part can be actively operated by the driving part.
  • the clamping part is passively deformed, which can better control the movement of the clamping part, so that the valve can be captured more easily, making the operation simpler and feasible;
  • the clamping part is connected to the fixing section of the fixing bracket, which is W-shaped in its natural state and made of heat-set memory metal, as shown in FIG. 2 , including a fixing section 31 and a clamping section 32 .
  • the clamping section 32 includes a barb 321 facing the fixing bracket, and a bridge 322 connected with the driving part.
  • the fixing section 31 contains threading holes through which sutures can be threaded to connect the fixing section to the outer periphery of the fixing bracket. In a natural state, the fixing section 31 and the clamping section 32 are on a plane. During the operation, the clamping section 31 can be driven to swing by the driving component, forming an included angle with the fixing section 32 .
  • the driving component is a component capable of driving the clamping section of the manipulation clamp to swing, and is preferably a wire rope. It runs in a delivery tube just below the valve prosthesis and extends outside the body. By pulling the driving part, the clamping section of the clamping part can swing downwards and outwards, forming an angle or even perpendicular to the fixed section, as shown in FIG. 3 .
  • the present invention adopts a double-layer bracket, and the inner diameter of the functional bracket is smaller than that of the fixed bracket, so as to reduce the area of the biological valve orifice sewn in the functional bracket, thereby reducing the stress on the biological valve and prolonging its service life.
  • FIG. 4 The operation steps of the valve prosthesis according to the present invention are shown in Figure 4: 1 Load the valve into the delivery sheath, at this time, the clamping part of the clamping part is pulled downward and overlapped with the fixed part and put into the delivery sleeve together, and sent to the atrium through the venous system to reach the ventricle across the mitral valve or tricuspid valve; 4The valve prosthesis is lifted up as a whole, so that the clipping section hooks the captured leaflet, loosens the driving part, so that the leaflet is driven to the valve prosthesis, and continues to withdraw the delivery sheath tube, so that the valve prosthesis gradually expands and forms a clamping force between the clamping parts to clamp the valve leaflet, so that the valve prosthesis is fixed on the valve leaflet; 5 Continue to withdraw the delivery sheath tube upward, so that the valve prosthesis The body is completely protruded from the sheath, and fixed and released at the mitral and tricuspid valves of the human body.

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

Abstract

本发明实施例公开了一种带可驱动夹持件的瓣膜假体，包括：支架、夹持件、驱动部件及生物瓣组织，生物瓣组织缝合于支架内，夹持件包括固定段体和夹合段体，固定段体固定于支架上，夹合段体与固定段体连接并贴合在支架外周上，夹合段体的自由端与驱动部件连接，且通过牵拉驱动部件可使夹合段体向背离支架的方向移动并使夹合段体与固定段体形成夹角0-90°，夹合段体靠近支架的一端壁上设有若干倒刺。本发明采用双层支架，功能支架内径小于固定支架，从而减少缝在功能支架内生物瓣口面积，继而减少生物瓣所受的应力，延长其使用寿命；此外，夹持件可由驱动件主动操作，便于捕获瓣膜，使得手术更简单可行；另外，夹持件含有倒刺，能稳固的固定瓣膜。

Description

一种带可驱动夹持件的瓣膜假体 技术领域
本发明涉及瓣膜假体技术领域，尤其涉及一种带可驱动夹持件的瓣膜假体。
背景技术
房室瓣是附于心房、心室口周缘片状，借腱索连于乳头肌，有阻止心室的血液流回心房的作用，起到单项阀门的作用。它包括二尖瓣和三尖瓣。二、三尖瓣反流是常见的心脏疾病。严重二尖瓣反流会引起左室扩大，最终导致左心收缩功能衰竭障碍及心衰，以及左心房扩大、房颤和肺动脉高压。严重的三尖瓣反流可以导致心排量的下降以及体循环淤血，是很多心脏疾病预后不良的信号，与患者预后密切相关。外科手术是目前二三尖瓣反流最主要的治疗手段，但具有创伤大、并发症多、死亡率高等缺陷。近10年来，经导管瓣膜置换由于创伤性小、安全性高成为目前心脏介入治疗器械研发热点。
目前，国内外同行已设计、研发多款房室瓣置换器械，但绝大多处于探索阶段，相当部分设计已被证明不具可行性。目前本领域人员仍致力于研发具有临床手术操作可行性、且安全有效的经导管房室瓣膜。
如何稳固锚定、降低输送尺寸、延长瓣膜寿命是经导管房室瓣膜设计最大的难点。现有锚定方式主要有以及几种类型：1)以径向支撑、微小倒刺插入二尖瓣叶固定，如专利CN 105101911 A和CN 107028685 A公开的美敦力intrepid瓣膜；专利CN 106175987 A、CN 105520792 A以及CN 103153232 A公开的纽脉mithos瓣膜，但这种设计由于是径向支撑，瓣口面积非常大会导致瓣膜容易衰败，若增加内支架、采用双层支架来缩小瓣口面积，势必增加了输送尺寸，难以实现经血管植入。2)采用预定型的倒钩夹持固定，如专利CN 105188611 B公开的爱德华Fortis瓣膜；专利CN 107735053B、CN 111970995 A及US10376363公开的爱德华Evoque瓣膜；专利CN 108578016 A公开的赛诺瓣膜，上述已公开的结构虽然对径向力支撑以来较小，但支架仍偏大，瓣口面积仍较大，瓣膜容易衰败，存在流出道梗阻的风险，并且在临床操作实践中，夹持件伸出输送系统之后，难以同时捕获多个瓣叶，导致手术困难；3)采用连接到心尖或者室间隔的线索牵拉瓣膜固定，如专利CN 105682609 A和CN 107405195 A公开的雅培tendyne瓣膜；专利CN 104055603B和CN106618798B公开的健世Lux-Valve，此种瓣膜虽然较稳固固定瓣膜，但创伤较大，产生心尖或者室间隔伤口，操作也较复杂；4)采用心房球形结构固定，如专利CN 112107392 A、CN 108156805 B及CN 110678149 A公开的瓣膜，此种结构设计，心房腔内植入大量附属结构，影响心房功 能，过多植入物导致血栓风险大；5)先植入瓣下环，再植入瓣膜，如专利CN106470641 B和CN 108283534 B公开的Highlife瓣膜，这种设计瓣环植入操作难度大，需要分步植入瓣膜，手术难度极大。
故针对上述问题亟需一种可解决稳固锚定、降低输送尺寸、延长瓣膜寿命的问题的瓣膜假体。
发明内容
本发明实施例提供一种带可驱动夹持件的瓣膜假体，用以解决现有技术中存在的如何稳固锚定、降低输送尺寸及延长瓣膜寿命的问题。
本发明实施例方法包括：
一种带可驱动夹持件的瓣膜假体，包括：支架、夹持件、驱动部件及生物瓣组织，所述生物瓣组织缝合于支架内，所述夹持件包括固定段体和夹合段体，所述固定段体固定于支架上，所述夹合段体与固定段体连接并贴合在支架外周壁上，所述夹合段体的自由端与驱动部件连接，且通过牵拉驱动部件可使夹合段体向背离支架的方向移动并使夹合段体与固定段体形成夹角0-90°，所述夹合段体靠近支架的一端壁上设有若干倒刺。
进一步的，所述支架包括功能支架和固定支架，在自然工作状态，所述功能支架为圆筒状结构，所述固定支架由筒状固定端、倒锥形盘片及倒锥形连接片构成，所述筒状固定端上端与倒锥形盘片下端连接，所述倒锥形连接片设于倒锥形盘片内，且所述倒锥形连接片的上端与倒锥形盘片的上端连接，所述倒锥形连接片的下端与功能支架下端连接，所述功能支架与固定支架轴向中心线在同一条线上，且所述功能支架横截面小于固定支架。
所述的功能支架和筒状固定端，通过倒锥形盘片及倒锥形连接片相连接，由形态记忆金属制成，具有形态记忆性。在输送状态，该复合结构可以被拉直成串联的单层结构(从近端到远端依次为功能支架、倒锥形连接片、倒锥形盘片、筒状固定端)，以降低支架的输送尺寸，从而实现经血管输送的可能；而在自然情况恢复成上述的工作状态。
优选的，所述筒状固定端的纵截面为上宽下窄，即上端横截面直径大于下端横截面的直径。所述的功能支架上端含有连接部件，以实现和输送系统可拆卸的连接。所述连接部件采用螺帽、挂钩、圆环结构等。
进一步的，所述固定段体包括两个固定段，所述夹合段体包括两个夹合段和桥接件，所述夹持件由两个固定段、两个夹合段及桥接件构成W型结构，两个所述夹合段的一端通过桥接件连接构成倒V型结构，两个所述固定段对称设于两个夹合段两侧并与夹合段另一端连接，所述夹合段朝向固定段的一侧壁上设有倒刺，所述固定段上开设有穿线孔，所述固定段通过穿线孔缝合在筒状固定端上，且所述夹合段贴合在筒状固定端外周壁上，所述 驱动部件与桥接件连接。
进一步的，所述夹持件采用记忆性材料，所述夹持件设有2-3个，且所述夹持件沿筒状固定端外周等角度分布。
进一步的，所述功能支架和固定支架均由多个菱形格单元构成，且所述功能支架内缝合有生物瓣组织。
进一步的，所述功能支架和固定支架由记忆合金管切割或者编织后热定型制成，所述功能支架和固定支架可通过一体切割或者编织制成，也可通过缝合、铰接或焊接连接制成。
进一步的，所述功能支架和固定支架的外表面均覆盖有覆膜，所述覆膜为高分子膜。
进一步的，所述驱动部件采用线绳。
进一步的，所述生物瓣组织为生物组织瓣叶，所述生物瓣组织包括牛心包或猪心包。
进一步的，所述生物瓣组织由三片独立瓣膜或一体成型的三片瓣膜组成。
本发明综上所述目前亟需。实施例有益效果如下：采用双层支架，功能支架内径小于固定支架，从而减少缝在功能支架内生物瓣口面积，继而减少生物瓣所受的应力，延长其使用寿命；夹持件可由驱动件主动操作，相对于其他发明夹持件均是被动变形可以更好控制夹持件的运动，从而可以更容易的捕获瓣膜，使得手术更简单可行；夹持件含有倒刺，能稳固的固定瓣膜；采用夹持件固定瓣膜而不依靠径向支撑力，且筒状固定端上宽下窄，对流出道影响小，对于心功能影响小，患者远期预后好；瓣膜假体可以经血管植入，创伤小。
附图说明
为了更清楚地说明本发明实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简要介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域的普通技术人员来讲，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为本发明所述一种带可驱动夹持件的瓣膜假体的自然状态的结构示意图；
图2为夹持件的结构示意图；
图3为本发明所述一种带可驱动夹持件的瓣膜假体的夹合段被驱动后的结构示意图；
图4为本发明所述瓣膜假体手术过程示意图。
1-功能支架、2-固定支架、3-夹持件、4-驱动部件、5-生物瓣组织、21-倒锥形盘片、22-筒状固定端、23-倒锥形连接片、31-固定段、311-穿线孔、32-夹合段、321-倒刺、322-桥接件。
具体实施方式
为了使本发明的目的、技术方案和优点更加清楚，下面将结合附图对本发明作进一步地详细描述，显然，所描述的实施例仅仅是本发明一部份实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本发明保护的范围。
如图1-图3所示，一种带可驱动夹持件的瓣膜假体，包括：支架、夹持件3、驱动部件4及生物瓣组织5，所述生物瓣组织5缝合于支架内，所述夹持件3包括固定段体和夹合段体，所述固定段体固定于支架上，所述夹合段体与固定段体连接并贴合在支架外周壁上，所述夹合段体的自由端与驱动部件4连接，且通过牵拉驱动部件4可使夹合段体向背离支架的方向移动并使夹合段体与固定段体形成夹角0-90°，所述夹合段体靠近支架的一端壁上设有若干倒刺321。
在上述技术方案中，夹持件3在自然状态下，如图1所示，夹合段体贴近支架的外周壁，可被驱动部件4拉向心室侧从而与固定段体成一定夹角，在本技术方案中，驱动部件4连接于夹合段体的自由端，通过牵拉驱动部件4可以使得夹持件3中的夹合段体摆动。
为了延长瓣膜假体的使用寿命，所述支架采用双层支架，即所述支架包括功能支架1和固定支架2，所述功能支架1为圆筒状结构，所述固定支架2由筒状固定端22、倒锥形盘片21及倒锥形连接片23构成，所述筒状固定端22上端与倒锥形盘片21下端连接，所述倒锥形连接片23设于倒锥形盘片21内，且所述倒锥形连接片23的上端与倒锥形盘片21的上端连接，所述倒锥形连接片23的下端与功能支架1下端连接，所述功能支架1与固定支架2轴向中心线在同一条线上，且所述功能支架1横截面小于固定支架2。
在上述技术方案中，采用双层支架，功能支架1内径小于固定支架2，从而减少缝在功能支架1内生物瓣口面积，继而减少生物瓣所受的应力，延长其使用寿命。
所述的功能支架和筒状固定端，通过倒锥形盘片及倒锥形连接片相连接，由形态记忆金属制成，具有形态记忆性。在输送状态，该复合结构可以被拉直成串联的单层结构(从近端到远端依次为功能支架、倒锥形连接片、倒锥形盘片、筒状固定端)，以降低支架的输送尺寸，从而实现经血管输送的可能；而在自然情况恢复成上述的工作状态。
优选的，所述筒状固定端的纵截面为上宽下窄，即上端横截面直径大于下端横截面的直径，从而减少心室流出道梗阻风险。所述的功能支架上端含有连接部件，以实现和输送系统可拆卸的连接。所述连接部件采用螺帽、挂钩、圆环结构等。
作为上述技术方案的优选，所述固定段体包括两个固定段31，所述夹合段体包括两个 夹合段32和桥接件322，所述夹持件3由两个固定段31、两个夹合段32及桥接件322构成W型结构，两个所述夹合段32的一端通过桥接件322连接构成倒V型结构，两个所述固定段31对称设于两个夹合段32两侧并与夹合段32另一端连接，所述夹合段32朝向固定段31的一侧壁上设有倒刺321，所述固定段31上开设有穿线孔311，所述固定段31通过穿线孔311缝合在筒状固定端22上，且所述夹合段32贴合在筒状固定端22外周上，所述驱动部件4与桥接件322连接。
在上述技术方案中，夹持件3可由驱动部件4主动操作，相对于其他发明夹持件3均是被动变形可以更好控制夹持件3的运动，从而可以更容易的捕获瓣膜，使得手术更简单可行；夹持件3含有倒刺321，能稳固的固定瓣膜；采用夹持件3固定瓣膜而不依靠径向支撑力，对流出道影响小，对于心功能影响小，患者远期预后好；瓣膜假体可以经血管植入，创伤小。
作为上述技术方案的优选，所述夹持件3采用记忆性材料，所述夹持件3设有2-3个，且所述夹持件3沿筒状固定端22外周等角度分布。
在上述技术方案中，所述夹持件连接于固定支架的固定段，自然状态为W形，为记忆金属热定型而成，如图2，包括固定段31及夹合段32。所述的夹合段32含有面向固定支架的倒刺321，以及与驱动部件相连的桥接件322。所述的固定段31含有穿线孔，可穿过缝线，将固定段缝合连接于固定支架的外周上。自然状态下，夹合段32贴合在固定支架外周壁上。在手术过程中，夹合段31可被驱动部件驱动发生摆动，与固定段32形成夹角。
另外，所述的夹持件为2-3个，沿固定支架外周间隔分布，当用于二尖瓣置换时为2个，当用于三尖瓣置换时为3个。
作为上述技术方案的优选，所述功能支架1和固定支架2均由多个菱形格单元构成，且所述功能支架1内缝合有生物瓣组织5。
作为上述技术方案的优选，所述功能支架1和固定支架2由记忆合金管切割或者编织后热定型制成，所述功能支架1和固定支架2可通过一体切割或者编织制成，也可通过缝合、铰接或焊接连接制成。
作为上述技术方案的优选，所述功能支架1和固定支架2的外表面均覆盖有覆膜，所述覆膜为高分子膜。
在上述技术方案中，覆膜采用PET覆膜，可有效提高功能支架1和固定支架2的密封性，并使得功能支架1和固定支架2更好的内皮化。
作为上述技术方案的优选，所述驱动部件4采用线绳。
在上述技术方案中，所述驱动部件，为能驱动操纵夹持件夹合段发生摆动的部件，优 选的为线绳。其走行于在瓣膜假体正下方的输送管内并延长至体外。通过牵拉驱动部件，可以使得夹持部件的夹合段向下向外摆动，与固定段行成夹角乃至垂直，如图3所示。
所述生物瓣组织5为生物组织瓣叶，所述生物瓣组织包括牛心包或猪心包。
所述生物瓣组织5由三片独立瓣膜或一体成型的三片瓣膜组成。
本发明的实施原理如下：
夹持件在自然状态下，如图1所示，夹合段贴近支架的外周壁，可被驱动部件拉向心室侧从而与固定段成一定夹角，在本技术方案中，驱动部件连接于夹持件的自由端，通过牵拉驱动部件可以使得夹持件中的夹合段摆动。夹持件可由驱动部件主动操作，相对于其他发明夹持件均是被动变形可以更好控制夹持件的运动，从而可以更容易的捕获瓣膜，使得手术更简单可行；夹持件含有倒刺，能稳固的固定瓣膜；采用夹持件固定瓣膜而不依靠径向支撑力，对流出道影响小，对于心功能影响小，患者远期预后好；瓣膜假体可以经血管植入，创伤小。
另外，所述的夹持件连接于固定支架的固定段，自然状态为W形，为记忆金属热定型而成，如图2，包括固定段31及夹合段32。所述的夹合段32含有面向固定支架的倒刺321，以及与驱动部件相连的桥接件322。所述的固定段31含有穿线孔，可穿过缝线，将固定段缝合连接于固定支架的外周上。自然状态下，固定段31及夹合段32处于一个平面上。在手术过程中，夹合段31可被驱动部件驱动发生摆动，与固定段32形成夹角。另外，所述的夹持件为2-3个，沿固定支架外周间隔分布，当用于二尖瓣置换时为2个，当用于三尖瓣置换时为3个。
此外，所述的驱动部件，为能驱动操纵夹持件夹合段发生摆动的部件，优选的为线绳。其走行于在瓣膜假体正下方的输送管内并延长至体外。通过牵拉驱动部件，可以使得夹持部件的夹合段向下向外摆动，与固定段行成夹角乃至垂直，如图3所示。
本发明采用双层支架，功能支架内径小于固定支架，从而减少缝在功能支架内生物瓣口面积，继而减少生物瓣所受的应力，延长其使用寿命。
本发明所述瓣膜假体手术步骤如图4所示：①将瓣膜装载输送鞘管内，此时夹持件夹合段被拉向下方与固定段重叠一起装进输送套管，通过静脉系统送到心房再跨越二尖瓣或三尖瓣到达心室；②将输送鞘管向上撤使得瓣膜假体夹持件夹合段及筒状固定段从鞘管内释放；③拉动驱动部件，使得瓣膜假体夹持件夹合段向外向下摆动与固定段呈约90度的夹角；④整体向上提起瓣膜假体，使得夹合段勾住捕获瓣叶，放松驱动部件，使得瓣叶被驱动带向瓣膜假体，并继续向上撤输送鞘管，使得瓣膜假体逐渐膨胀展开与夹持件之间形成夹合力夹持瓣叶，从而使得瓣膜假体被固定在瓣叶；⑤继续向上撤输送鞘管，使得瓣膜假 体完全从鞘管内脱出，固定释放于人体二尖瓣、三尖瓣处。
尽管已描述了本发明的优选实施例，但本领域内的技术人员一旦得知了基本创造性概念，则可对这些实施例作出另外的变更和修改。所以，所附权利要求意欲解释为包括优选实施例以及落入本发明范围的所有变更和修改。
显然，本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (10)

  1. 一种带可驱动夹持件的瓣膜假体，其特征在于，包括：支架、夹持件、驱动部件及生物瓣组织，所述生物瓣组织缝合于支架内，所述夹持件包括固定段体和夹合段体，所述固定段体固定于支架上，所述夹合段体与固定段体连接并贴合在支架外周壁上，所述夹合段体的自由端与驱动部件连接，且通过牵拉驱动部件可使夹合段体向背离支架的方向移动并使夹合段体与固定段体形成夹角0-90°，所述夹合段体靠近支架的一端壁上设有若干倒刺。
  2. 根据权利要求1所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述支架包括功能支架和固定支架，所述功能支架为圆筒状结构，所述固定支架由筒状固定端、倒锥形盘片及倒锥形连接片构成，所述筒状固定端上端与倒锥形盘片下端连接，所述倒锥形连接片设于倒锥形盘片内，且所述倒锥形连接片的上端与倒锥形盘片的上端连接，所述倒锥形连接片的下端与功能支架下端连接，所述功能支架与固定支架轴向中心线在同一条线上，且所述功能支架横截面小于固定支架。
  3. 根据权利要求2所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述筒状固定端的纵截面为上宽下窄，即所述筒状固定端的上端横截面直径大于下端横截面的直径；所述功能支架上端设有便于与输送系统可拆卸连接的连接部件。
  4. 根据权利要求2所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述固定段体包括两个固定段，所述夹合段体包括两个夹合段和桥接件，所述夹持件由两个固定段、两个夹合段及桥接件构成W型结构，两个所述夹合段的一端通过桥接件连接构成倒V型结构，两个所述固定段对称设于两个夹合段两侧并与夹合段另一端连接，所述夹合段朝向固定段的一侧壁上设有倒刺，所述固定段上开设有穿线孔，所述固定段通过穿线孔缝合在筒状固定端上，且所述夹合段贴合在筒状固定端外周壁上，所述驱动部件与桥接件连接。
  5. 根据权利要求4所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述夹持件采用记忆性材料，所述夹持件设有2-3个，且所述夹持件沿筒状固定端外周等角度分布。
  6. 根据权利要求2所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述功能支架和固定支架均由多个菱形格单元构成，且所述功能支架内缝合有生物瓣组织。
  7. 根据权利要求6所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述功能支架和固定支架由记忆合金管切割或者编织后热定型制成，所述功能支架和固定支架可通过一体切割或者编织制成，也可通过缝合、铰接或焊接连接制成。
  8. 根据权利要求7所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述功能支 架和固定支架的外表面均覆盖有覆膜，所述覆膜为高分子膜。
  9. 根据权利要求1所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述驱动部件采用线绳。
  10. 根据权利要求1所述的一种带可驱动夹持件的瓣膜假体，其特征在于，所述生物瓣组织为生物组织瓣叶，所述生物瓣组织包括牛心包或猪心包，且所述生物瓣组织由三片独立瓣膜或一体成型的三片瓣膜组成。
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CN115553977B (zh) * 2022-10-14 2024-08-23 上海诠昕医疗科技有限公司 一种假体瓣膜系统

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