WO2022267210A1 - 一种人工心脏瓣膜及其输送系统 - Google Patents

一种人工心脏瓣膜及其输送系统 Download PDF

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Publication number
WO2022267210A1
WO2022267210A1 PCT/CN2021/114546 CN2021114546W WO2022267210A1 WO 2022267210 A1 WO2022267210 A1 WO 2022267210A1 CN 2021114546 W CN2021114546 W CN 2021114546W WO 2022267210 A1 WO2022267210 A1 WO 2022267210A1
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WIPO (PCT)
Prior art keywords
stent
heart valve
delivery system
artificial heart
catheter
Prior art date
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PCT/CN2021/114546
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English (en)
French (fr)
Inventor
张海军
何东
刘祥
闻靖
Original Assignee
上海臻亿医疗科技有限公司
江苏臻亿医疗科技有限公司
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Publication date
Priority claimed from CN202121424835.1U external-priority patent/CN217138356U/zh
Priority claimed from CN202110709244.7A external-priority patent/CN113288518A/zh
Application filed by 上海臻亿医疗科技有限公司, 江苏臻亿医疗科技有限公司 filed Critical 上海臻亿医疗科技有限公司
Priority to EP21946694.3A priority Critical patent/EP4316426A1/en
Publication of WO2022267210A1 publication Critical patent/WO2022267210A1/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
    • A61F2/2412—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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the invention relates to the field of medical devices, in particular to an artificial heart valve and a delivery system thereof.
  • Heart valves are membrane-like structures that can open and close in the organs of humans or certain animals.
  • Each human heart has four valves, the aortic valve connecting the left ventricle to the aorta, the pulmonary valve connecting the right ventricle to the pulmonary artery, the mitral valve connecting the left atrium to the left ventricle, and the mitral valve connecting the right atrium to the right ventricle.
  • tricuspid valve These heart valves act as one-way valves, allowing blood to flow from one direction to the other and not back.
  • valvular heart disease has increased significantly.
  • traditional surgical treatment is still the first choice for patients with severe valvular disease, but for patients who are elderly, complicated with multiple organ diseases, have a history of thoracotomy, and have poor heart function, the risk of traditional surgery is high and death The rate is high, and some patients do not even have the chance of surgery.
  • the tricuspid valve has a structure similar to that of the mitral valve, including leaflets, annulus, chordae, papillary muscles, and myocardium.
  • Transcatheter tricuspid valve replacement/repair has the advantages of no need for thoracotomy, less trauma, and faster recovery of patients, and has attracted extensive attention from experts and scholars.
  • tricuspid valve designs are divided into two types: double-layer stent and single-layer stent.
  • double-layer stent it is often necessary to use a valve with a larger radius.
  • the valve with a larger radius will withstand greater blood pulsation pressure than a valve with a smaller radius during the cardiac cycle, and the force of the larger valve will affect the stent. Fatigue strength has a great influence.
  • single-layer stents are not easy to maintain the shape of the stent and the valve during the cardiac cycle.
  • the valve diameter of the double-layer stent is relatively small, and the functions of carrying artificial valve leaflets, anchoring, and sealing can be distributed to components of different layers, so as to achieve a better performance without affecting the normal operation of other structures of the heart.
  • the double-layer stent often faces the problem that the overall delivery size (Profile) is too large, and the delivery is difficult, resulting in a narrower range of applicable people and potential safety hazards during use.
  • Profile overall delivery size
  • the object of the present invention is to provide an artificial heart valve and its delivery system for solving the problems in the prior art.
  • the present invention provides an artificial heart valve
  • the artificial heart valve includes an outer stent and an inner stent
  • the outer stent and the inner stent are detachably connected, or the artificial heart valve is in use
  • the inner stent is placed inside the outer stent, and the inner stent is not connected to the outer stent
  • the outer stent includes an outer stent frame and a disposable valve leaflet arranged on the outer stent frame
  • the inner stent includes an inner The stent frame and the prosthetic valve leaflets placed in the stent frame.
  • the present invention also provides a delivery system for an artificial heart valve.
  • the delivery system includes a delivery sheath, a guide wire lumen sheathed in the delivery sheath and a stent catheter, and the stent catheter is configured to be suitable for use with the artificial heart valve connection.
  • the present invention also provides a heart valve replacement system, which includes the artificial heart valve and the delivery system.
  • an artificial heart valve and its delivery system of the present invention have the following beneficial effects:
  • the lower delivery system size can reduce the resulting delivery risk, improve the safety of implantation and the universality of size.
  • a lower profile can be adapted to more suitable people, such as people with relatively small femoral veins.
  • FIG. 1 is a schematic cross-sectional view of the artificial heart valve of the present invention.
  • Fig. 2 is a schematic cross-sectional view of the outer stent of the artificial heart valve of the present invention, in which the shadow is the projection of the skirt.
  • Fig. 3 is a schematic cross-sectional view of the inner stent of the artificial heart valve of the present invention.
  • Fig. 4-1 is a schematic cross-sectional view of a delivery system for the artificial heart valve of the present invention.
  • Fig. 4-2 is a schematic cross-sectional view of another delivery system for the artificial heart valve of the present invention.
  • FIGS 4-3 are schematic cross-sectional views of another delivery system for the artificial heart valve of the present invention.
  • FIGS 4-4 are schematic cross-sectional views showing another delivery system of the artificial heart valve of the present invention.
  • Fig. 5-1 is a schematic diagram showing the process of implanting a prosthetic heart valve using the delivery system shown in Fig. 4-1.
  • Fig. 5-2 is a schematic diagram showing the process of implanting a prosthetic heart valve using the delivery system shown in Fig. 4-2 and Fig. 4-3.
  • Fig. 5-3 is a schematic diagram showing the process of implanting a prosthetic heart valve using the delivery system shown in Fig. 4-2 and Fig. 4-4.
  • the present invention provides an artificial heart valve, which includes an outer stent 1 and an inner stent 2, the outer stent 1 and the inner stent 2 are detachably connected, or the artificial heart
  • the inner stent 2 is placed inside the outer stent 1, and the inner stent 2 is not connected to the outer stent 1.
  • the outer stent 1 includes an outer stent frame 11 and a primary
  • the inner stent 2 includes an inner stent frame 21 and an artificial valve leaflet 22 placed in the inner stent frame 21 .
  • the inner stent frame 21 is cylindrical.
  • the outer support 1 has a cylindrical space, so as to ensure that the inner support frame 21 can be sleeved therein.
  • the outer support frame 11 includes a flange part 111 , a main body part 112 and an ear part 113 connected in sequence.
  • the flange part 111 is placed in the atrium.
  • the flange part 111 and the grasping ear part 113 jointly clamp the native tissue to achieve the function of anchoring the valve.
  • the flange part 111 includes a first flange segment 111a, a second flange segment 111b and a third flange segment 111c connected in sequence.
  • the degree of the angle ⁇ between the second flange segment 111b and the horizontal direction is -10° ⁇ 55°. That is, in the outer support frame 11 , the degree between the second flange segment 111 b and the radial direction of the outer support frame 11 is -10° ⁇ 55°.
  • the main body 112 includes an inner wall 112a and an outer wall 112b, and the inner wall 112a and the outer wall 112b are connected end to end to form a closed structure.
  • the wall near the central axis of the artificial heart valve is the inner wall 112a
  • the wall far from the central axis of the artificial heart valve is the outer wall 112b.
  • the inner wall 112a is used to support the inner frame 2 .
  • the outer wall 112b can form a certain compression between the outer stent 1 and the native valve annulus, so that the outer stent 1 can form a radial anchoring force between the chambers.
  • the closed structure of the main body part 112 is hollow inside.
  • the ear part 113 includes a first ear segment 113a, a second ear segment 113b and a third ear segment 113c connected in sequence.
  • the degree of the angle ⁇ between the third grabbing ear section 113c and the vertical direction is -15° ⁇ 15°. That is, the angle between the third grabbing ear segment 113c and the axial direction of the outer support frame 11 is -15° ⁇ 15°.
  • the catch ear portion 113 can form a U-shaped space with the outer wall 112b.
  • the grasping ears 113 can hook the leaflets and pass between the chordae, so that the outer frame 1 does not rotate in the circumferential direction.
  • the outer bracket 1 is anchored between the atrioventricular chambers by the joint action of the flange part 111 , the main body part 112 and the grasping ear part 113 .
  • the disposable leaflet 12 is disposed on the inner wall 112a.
  • the disposable valve leaflet 12 is composed of a polymer braid.
  • the main function of the disposable valve leaflet 12 is to use the disposable valve leaflet 12 as a temporary artificial valve leaflet to prevent reflux during the process from the release of the outer stent 1 to the end of the release of the inner stent 2 .
  • the disposable leaflets 12 are filled between the inner and outer stents, which can increase the friction between the inner and outer stents, thereby increasing the anchoring force; the disposable leaflets 12 are filled between the inner and outer stents, reducing the gap between the inner and outer stents. leakage between cells; and contributes to endothelialization. If the disposable valve leaflet 12 is not provided, severe regurgitation will occur between the start of the release of the inner stent and the completion of the release of the inner stent when the artificial heart valve is implanted, which may easily cause heart failure.
  • the outer bracket 1 further includes an outer bracket skirt, and the outer bracket skirt is at least provided on the surface of the flange part 111 and the main body part 112 .
  • the skirt of the outer bracket covers the surface of the flange part 111 and the main body part 112 .
  • the outer bracket skirt can be of an integrated structure, that is, the same outer bracket skirt is arranged on the surface of the flange part 111 and the main body part 112 at the same time; the outer bracket skirt can also be a separate structure, that is, more than two outer brackets The skirts are respectively disposed on the surfaces of the flange portion 111 and the main body portion 112 .
  • the function of the skirt of the outer stent is to block the circulation between the chambers and assist endothelialization after the implantation of the outer stent 1 .
  • the outer stent 1 further includes an anchor 13 , and the anchor 13 is arranged on the outer stent frame 11 .
  • the anchor 13 is disposed on the inner wall 112 a of the outer stent frame 11 .
  • the specific location of the inner wall 112a is not specifically limited.
  • the anchor 13 is disposed at a middle position of the inner wall 112a.
  • the anchor 13 can be a protrusion integrally formed with the inner wall 112a, or an independent component fixedly connected to the inner wall 112a.
  • the material of the anchor 13 can be biocompatible metal or synthetic material, etc., which is not limited in the present invention.
  • the surface of the anchor piece 13 is uneven. The function of the unevenness is to provide anchoring position and anchoring force for the release of the inner stent 2 .
  • the disposable leaflet 12 is disposed below the anchor 13 .
  • Such an arrangement can ensure that a cavity is not easily formed after the implantation of the inner stent 2 and reduce the risk of thrombus; at the same time, it is convenient for sewing and helps to prevent leakage from the ventricle to the atrium.
  • the inner stent frame 21 includes a connected inflow section 211 and an outflow section 212 .
  • the inflow section 211 refers to a section for blood to flow into the inner stent 2 from the atrium
  • the outflow section 212 refers to a section for blood to flow out from the inner stent 2 through the leaflets to the ventricle.
  • the material of the inner stent frame 21 is selected from nickel-titanium alloy or cobalt-chromium alloy. Nickel-titanium can expand by itself, and cobalt-chromium needs to be expanded with balls.
  • the material of the artificial valve leaflet 22 is not particularly limited, and common or common materials in the prior art can be selected.
  • a biological tissue such as a chemically stable tissue from a heart valve of an animal such as a pig, or pericardial tissue of an animal such as bovine (bovine pericardium) or sheep (ovine pericardium) or porcine (porcine pericardium) is selected.
  • bovine pericardium bovine pericardium
  • sheep ovine pericardium
  • porcine porcine
  • horse equine pericardium
  • bovine pericardium preferably bovine pericardium tissue.
  • it can be made from small intestinal submucosal tissue.
  • synthetic materials may be selected. For example, expanded polytetrafluoroethylene or polyester.
  • synthetic materials also include thermoplastic polycarbonate urethanes, polyether urethanes, segmented polyether urethanes, silicone polyether urethanes, silicone-polycarbonate urethanes, and ultra-high molecular weight polyethylene.
  • Synthetic materials also include biocompatible polymers such as polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters , silicone polymers and/or oligomers, and/or polylactones and block copolymers using them.
  • an anticoagulant is provided on the surface of the artificial valve leaflet 22 .
  • anticoagulants include, but are not limited to, heparinized polymers.
  • the inner stent 2 further includes an inner stent skirt 23, and the position of the inner stent skirt 23 is not limited, as long as the skirt can block the flow between chambers. In one embodiment, the inner stent skirt 23 is disposed on the inner surface of the inner stent frame 21 .
  • the artificial valve leaflet 22 is connected to the inner stent skirt 23 .
  • the inner stent skirt 23 provides a place for the artificial leaflet 22 to cling to.
  • the material of the outer bracket skirt or the inner bracket skirt 23 in the present invention is not particularly limited, and common or common materials in the prior art can be selected. Knitted, woven, woven polyester fabric, PTFE, ePTFE and other materials can be selected.
  • the skirt of the outer stent or the skirt 23 of the inner stent mainly functions as a seal to prevent reflux or paravalvular leakage.
  • the materials of the outer bracket 1 and the inner bracket 2 in the present invention are not particularly limited, and common or common materials in the prior art can be selected, such as Nitinol, titanium alloy, cobalt-chromium alloy, MP35n, 316 stainless steel, L605, Phynox / Elgiloy, platinum chrome, or other biocompatible metal or laser-cut solid metal tubing as known to those skilled in the art.
  • selected from shape memory alloys Preferably, it may be selected from other elastically or plastically deformable materials, such as balloon expandable, or may be a shape memory alloy that transitions between a contracted delivery state and an expanded deployed state in response to temperature changes.
  • the stent may also be constructed from braided wire or other suitable material.
  • the detachable connection between the outer stent 1 and the inner stent 2 or no connection can make the outer stent 1 implanted in the body first, and then release the inner stent 2 after being stably anchored in the atrioventricular space; the inner stent 2 relies on its own grid structure, or Self-expanding, or ball expanding, fixed in the middle of the outer frame.
  • the detachable design of the inner and outer stents reduces the radial size of the delivery sheath in the delivery system, and can reduce the size of the first delivery system with a size above 35Fr to 28Fr; the second delivery system with a size above 35Fr or The size of the third delivery system is reduced to 24Fr, which can solve the delivery problem caused by the oversize of the double-layer stent delivery system in the prior art, and improve the safety of implantation and the universality of size.
  • the present invention also provides a delivery system for an artificial heart valve, which includes a delivery sheath 31, a guide wire lumen 32 and a stent sheathed in the delivery sheath 31 A catheter 33, the stent catheter 33 is configured to be suitable for being connected with the artificial heart valve.
  • the stent catheter 33 includes an outer stent catheter 331 and an inner stent catheter 332, and the outer stent catheter 331 and the inner stent catheter 332 are placed in the delivery sheath. 31, the outer stent conduit 331 and the inner stent conduit 332 are both tubular.
  • the material of the inner stent frame 21 is selected from nickel-titanium alloy.
  • the endo-stent frame 21 is self-expandable.
  • the cross-sectional area of the inner stent catheter 332 is larger than that of the outer stent catheter 331 .
  • the outer stent catheter 331 passes through the inner stent catheter 332 .
  • the inner stent catheter 332 is uniform in thickness.
  • One end of the inner stent conduit 332 is used to connect with the inner stent 2 .
  • One end of the outer stent conduit 331 is provided with a wide portion 33a. The wide portion 33a is used for connecting with the outer support 1 .
  • the steps of using this delivery system to implant an artificial heart valve are as follows: firstly, the inner and outer stents are respectively loaded on the inner stent catheter 332 and the outer stent catheter 331 and then implanted.
  • the delivery sheath 31 is sheathed backward; after the outer stent 1 is released, the guide wire lumen 32 moves back until it is close to the inner stent 2; the delivery system is adjusted so that the inner stent 2 and the outer stent 1.
  • Coaxial setting the delivery system can be used to assist coaxial
  • the delivery sheath 31 continues to release the inner stent 2 toward the retreat sheath; after the release is completed, the delivery sheath 31 is retracted, and the delivery system is withdrawn.
  • the delivery system also includes a bending control sheath 34 sleeved outside the delivery sheath 31, and the stent catheter 33 is Tubular, one end of the stent catheter 33 is provided with a wide portion 33a.
  • the wide portion 33a is used for connecting with the outer support 1 or the inner support 2 .
  • the material of the inner stent frame 21 is selected from nickel-titanium alloy.
  • the endo-stent frame 21 is self-expandable.
  • the steps of using this delivery system to implant an artificial heart valve are as follows: firstly load the inner and outer stents into two identical delivery systems.
  • the outer stent 1 is implanted first.
  • the delivery system passes through the bending control sheath 34 , and releases the outer stent 1 by moving the delivery sheath 31 backward between the chambers.
  • the delivery system is then withdrawn.
  • the delivery system loaded with the inner stent 2 is passed through the bending control sheath 34 , and the inner stent 2 is released into the cylindrical space of the outer stent 1 by moving the delivery sheath 31 backward in the atrioventricular compartment.
  • the delivery system further includes a bending control sheath 34 sheathed outside the delivery sheath 31, and the stent catheter 33 is in the shape of a balloon.
  • the stent catheter 33 is used to be placed in the inner stent 2 .
  • the material of the inner stent frame 21 is selected from cobalt-chromium alloy.
  • the inner stent frame 21 can be balloon expanded.
  • the steps of using this delivery system to implant an artificial heart valve are as follows: First, load the outer stent 1 into the delivery system shown in Figure 4-2, and load the inner stent 2 into the delivery system shown in Figure 4-2. In the delivery system shown in 4-4.
  • the outer stent 1 is implanted first.
  • the delivery system equipped with the inner stent 2 is passed through the bending control sheath 34, and the delivery sheath tube 31 is moved backward firstly between the chambers.
  • the present invention also provides a heart valve replacement system, which includes the artificial heart valve and the delivery system.
  • the present invention effectively overcomes various shortcomings in the prior art and has high industrial application value.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (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)
  • Prostheses (AREA)

Abstract

一种人工心脏瓣膜及其输送系统，人工心脏瓣膜包括外支架（1）和内支架（2），外支架（1）和内支架（2）可拆卸式连接，或人工心脏瓣膜使用状态下，内支架（2）置于外支架（1）内部，且内支架（2）与外支架（1）无连接，外支架（1）包括外支架框架（11）和设于外支架框架（11）上的一次性瓣叶（12），内支架（2）包括内支架框架（21）和置于内支架框架（21）中的人工瓣叶（22）。输送系统包括输送鞘管（31）、套设于输送鞘管（31）内的导丝腔（32）和支架导管（33），支架导管（33）被设置为适于与人工心脏瓣膜连接。人工心脏瓣膜及其输送系统降低了输送系统的输送尺寸，提高植入的安全性和尺寸的普适性。

Description

一种人工心脏瓣膜及其输送系统 技术领域
本发明涉及医疗器械领域，特别是涉及一种人工心脏瓣膜及其输送系统。
背景技术
心脏瓣膜是人或某些动物的器官里面可以开闭的膜状结构。每个人的心脏内都有四个瓣膜，即连结左心室和主动脉的主动脉瓣、连结右心室和肺动脉的肺动脉瓣、连结左心房和左心室的二尖瓣和连结右心房和右心室的三尖瓣。这些心脏瓣膜均起单向阀门作用，使血液只能从一个方向流向另一个方向而不能倒流。
随着社会经济的发展和人口的老龄化，瓣膜性心脏病的发病率明显增加，研究表明75岁以上的老年人群瓣膜性心脏病发病率高达13.3％。目前，采用传统外科手术治疗仍是重度瓣膜病变患者的首选治疗手段，但是对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者来说，传统外科手术的风险大、死亡率高，部分患者甚至没有手术的机会。三尖瓣作为右心脏的房室瓣，其结构与二尖瓣类似，包含瓣叶、瓣环、腱索、乳头肌及心肌。经导管三尖瓣的置换/修复术具有无需开胸、创伤小、患者恢复快等优点，受到了专家学者的广泛关注。
当前，三尖瓣瓣膜设计分为双层支架和单层支架两种。对于单层支架来说，往往需要配合使用较大半径的瓣膜，较大半径的瓣膜在心动周期中会比较小半径瓣膜承受更大的血液脉动压力，且较大的瓣膜受力会对支架的疲劳强度产生较大影响。此外，单层支架不容易维持支架及瓣膜在心动周期中的形态。双层支架的瓣膜直径相对较小，且可将承载人工瓣叶和承担锚固、密封等作用分配到不同层的构件上，从而达到既不影响心脏其他结构的正常运转，又能较好的发挥植入治疗功能的目的。但是，双层支架往往面临整体输送尺寸(Profile)过大的问题，输送难度大，导致适用人群的范围变小以及使用过程中存在安全隐患。
发明内容
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种人工心脏瓣膜及其输送系统，用于解决现有技术中的问题。
为实现上述目的及其他相关目的，本发明提供一种人工心脏瓣膜，所述人工心脏瓣膜包括外支架和内支架，所述外支架和内支架可拆卸式连接，或所述人工心脏瓣膜使用状态下，所述内支架置于外支架内部，且所述内支架与外支架无连接，所述外支架包括外支架框架和 设于外支架框架上的一次性瓣叶，所述内支架包括内支架框架和置于内支架框架中的人工瓣叶。
本发明还提供一种人工心脏瓣膜的输送系统，所述输送系统包括输送鞘管、套设于输送鞘管内的导丝腔和支架导管，所述支架导管被设置为适于与所述人工心脏瓣膜连接。
本发明还提供一种心脏瓣膜置换系统，所述心脏瓣膜置换系统包括所述人工心脏瓣膜和所述输送系统。
如上所述，本发明的一种人工心脏瓣膜及其输送系统，具有以下有益效果：
1.组装式支架在装载进输送系统时，无需像传统双层支架一样径向交叠，因此可以大幅度的降低输送系统尺寸(Profile)；
2.较低的输送系统尺寸(Profile)可以降低由此产生的输送风险，提高植入的安全性和尺寸的普适性。
3.较低的Profile可以适配更多的适用人群，如股静脉相对较小的人。
4.组装式支架在压握装载进输送系统内部后，相对于传统的双层支架刚度较小，便于支架通过迂曲血管，例如便于支架通过主动脉弓。
附图说明
图1显示为本发明的人工心脏瓣膜的剖面示意图。
图2显示为本发明的人工心脏瓣膜的外支架的剖面示意图，图中阴影为裙边的投影。
图3显示为本发明的人工心脏瓣膜的内支架的剖面示意图。
图4-1显示为本发明的人工心脏瓣膜的一种输送系统的剖面示意图。
图4-2显示为本发明的人工心脏瓣膜的另一种输送系统的剖面示意图。
图4-3显示为本发明的人工心脏瓣膜的另一种输送系统的剖面示意图。
图4-4显示为本发明的人工心脏瓣膜的另一种输送系统的剖面示意图。
图5-1显示为使用图4-1所示的输送系统的植入人工心脏瓣膜的过程示意图。
图5-2显示为使用图4-2和图4-3所示的输送系统的植入人工心脏瓣膜的过程示意图。
图5-3显示为使用图4-2和图4-4所示的输送系统的植入人工心脏瓣膜的过程示意图。
元件标号说明
1                      外支架
11                     外支架框架
111                    法兰部
111a                   第一法兰段
111b                   第二法兰段
111c                   第三法兰段
112                    主体部
112a                   内壁
112b                   外壁
113                    抓耳部
12                     一次性瓣叶
13                     锚固件
2                      内支架
21                     内支架框架
211                    流入段
212                    流出段
22                     人工瓣叶
23                     内支架裙边
31                     输送鞘管
32                     导丝腔
33                     支架导管
331                    外支架导管
332                    内支架导管
33a                    宽部
34                     控弯鞘
具体实施方式
以下由特定的具体实施例说明本发明的实施方式，熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。
请参阅图1至图5-3。须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明可实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整， 在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容能涵盖的范围内。同时，本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语，亦仅为便于叙述的明了，而非用以限定本发明可实施的范围，其相对关系的改变或调整，在无实质变更技术内容下，当亦视为本发明可实施的范畴。
如图1和2所示，本发明提供一种人工心脏瓣膜，所述人工心脏瓣膜包括外支架1和内支架2，所述外支架1和内支架2可拆卸式连接，或所述人工心脏瓣膜使用状态下，所述内支架2置于外支架1内部，且所述内支架2与外支架1无连接，所述外支架1包括外支架框架11和设于外支架框架11上的一次性瓣叶12，所述内支架2包括内支架框架21和置于内支架框架21中的人工瓣叶22。
在一种实施方式中，所述内支架框架21呈筒状。外支架1具有筒状空间，从而保证能将内支架框架21套设于其中。
在一种实施方式中，外支架框架11包括依次连接的法兰部111、主体部112和抓耳部113。
在所述人工心脏瓣膜植入体内后，所述法兰部111置于心房内。法兰部111与抓耳部113共同将原生组织夹持住，达到锚固瓣膜的作用。
在一种实施方式中，所述法兰部111包括依次连接的第一法兰段111a、第二法兰段111b和第三法兰段111c。
在一种实施方式中，当所述外支架框架11竖直放置时，第二法兰段111b和水平方向之间的角α的度数为-10°～55°。即所述外支架框架11中，第二法兰段111b与所述外支架框架11的径向之间的度数为-10°～55°。
在一种实施方式中，所述主体部112包括内壁112a和外壁112b，内壁112a和外壁112b首尾连接形成封闭结构。具体的，近人工心脏瓣膜中轴线的壁为内壁112a，远人工心脏瓣膜中轴线的壁为外壁112b。内壁112a用于支撑内支架2。外壁112b可以使外支架1与原生瓣环之间形成一定的挤压，使外支架1在房室间形成径向锚固力。
所述主体部112的封闭结构内部中空。
在一种实施方式中，所述抓耳部113包括依次连接的第一抓耳段113a、第二抓耳段113b和第三抓耳段113c。
在一种实施方式中，当所述外支架框架11竖直放置时，所述第三抓耳段113c和竖直方向之间的角β的度数为-15°～15°。即所述第三抓耳段113c与外支架框架11的轴向之间的角度为-15°～15°。
抓耳部113其他的角度不做具体限制，只要保证第三抓耳段113c与竖直方向的角度即可。 抓耳部113可与外壁112b形成U形空间。
抓耳部113能够钩住瓣叶，且从腱索之间穿过，使外支架1不发生周向旋转。
外支架1由法兰部111、主体部112和抓耳部113共同作用从而锚固于房室之间。
在一种实施方式中，所述一次性瓣叶12设于内壁112a上。
在一种实施方式中，一次性瓣叶12由高分子编织物组成。一次性瓣叶12主要的作用为从外支架1开始释放，到内支架2释放结束的过程中，一次性瓣叶12作为临时的人工瓣叶使用，防止出现反流。内支架2释放完之后，一次性瓣叶12填充在内外支架之间，能增加内外支架之间的摩擦力，从而增加锚固力；一次性瓣叶12填充在内外支架之间，减少内外支架之间的渗漏；并且有助于内皮化。如果不设置一次性瓣叶12，在人工心脏瓣膜植入时，内支架释放开始到内支架释放完成的过程之间产生剧烈的反流，容易造成心衰。
在一种实施方式中，所述外支架1还包括外支架裙边，所述外支架裙边至少设于法兰部111和主体部112表面。
所述外支架裙边包覆于法兰部111和主体部112表面。所述外支架裙边可以是一体结构的，即同一个外支架裙边同时设于法兰部111和主体部112表面；所述外支架裙边也可以是分离结构，即两个以上外支架裙边分别设于法兰部111和主体部112表面。
外支架裙边的作用在于外支架1植入后，阻断房室间的流通、辅助内皮化等。
在一种实施方式中，所述外支架1还包括锚固件13，所述锚固件13设于外支架框架11上。在一优选的实施方式中，所述锚固件13设于外支架框架11的内壁112a上。具体在内壁112a的何处不做具体限定。在一优选的实施方式中，所述锚固件13设于内壁112a的中间位置。
所述锚固件13可以为与内壁112a一体成型的突出物，或者为独立的构件固定连接在内壁112a上。所述锚固件13的材料可为生物相容的金属或合成材料等，对此本发明不做限制。在一优选的实施方式中，锚固件13表面凹凸不平。凸凹不平的作用在于为内支架2的释放提供锚固位置和锚固力。
所述一次性瓣叶12设于锚固件13的下方。这样的设置可以保证在内支架2植入之后不易形成空腔，降低血栓风险；同时方便缝制及有助于防止心室到心房的泄露。
所述内支架框架21包括相连接的流入段211和流出段212。所述流入段211是指用于血液从心房流进内支架2的一段，流出段212是指血液从内支架2中穿过瓣叶流出至心室的一段。
内支架框架21的材料选自镍钛合金或者钴铬合金。镍钛可以自膨胀，钴铬需要用球扩。
所述人工瓣叶22的材料不做特殊限制，可以选用现有技术中常见或通用的材料。在一种实施方式中，选择生物组织例如来自动物(如猪)的心脏瓣膜的化学性稳定的组织，或者是动物的心包组织例如牛(牛心包)或羊(羊心包)或猪(猪心包)或马(马心包)，优选牛心包组织。在另一种实施方式中，可以由小肠粘膜下组织制成。在其他的实施方式中，可以选择合成材料。例如，膨体聚四氟乙烯或聚酯。可选地，合成材料还包括热塑性聚碳酸酯聚氨酯、聚醚聚氨酯、分段聚醚聚氨酯、有机硅聚醚聚氨酯、有机硅-聚碳酸酯聚氨酯、以及超高分子量聚乙烯。合成材料还包括生物相容的聚合物，例如聚烯烃、弹性体、聚乙二醇、聚醚砜、聚砜、聚乙烯基吡咯烷酮、聚氯乙烯、其它的含氟聚合物、有机硅聚酯、硅氧烷聚合物和/或低聚物，和/或聚内酯以及使用它们的嵌段共聚物。
在一种实施方式中，人工瓣叶22表面设有抗凝剂。所述抗凝剂包括但不限于肝素化聚合物。
在一种实施方式中，所述内支架2还包括内支架裙边23，内支架裙边23的位置不做限制，只要裙边能满足阻断房室之间的流动即可。在一种实施方式中，内支架裙边23设于内支架框架21的内表面。
在一种实施方式中，人工瓣叶22与内支架裙边23连接。内支架裙边23为人工瓣叶22提供攀附的位置。
本发明中的外支架裙边或内支架裙边23的材料不做特殊限制，可以选用现有技术中常见或通用的材料。可选择针织、梭织、编织的聚酯织物，PTFE，ePTFE等材料。外支架裙边或内支架裙边23主要起密封的作用，防止反流或瓣周漏。
本发明中的外支架1和内支架2的材料不做特殊限制，可以选用现有技术中常见或通用的材料，如镍钛诺、钛合金、钴铬合金、MP35n、316不锈钢、L605、Phynox/Elgiloy、铂铬，或如本领域技术人员已知的其它生物相容性金属或激光切割的固体金属管。优选地，选自形状记忆合金。例如可以选自其他可弹性或可塑性变形的材料，如球囊可扩张的，或者可以是响应温度变化以在收缩递送状态和扩张展开状态之间转变的形状记忆合金。可选地，支架也可以由编织线或其它合适的材料构造。
外支架1和内支架2可拆卸式连接或无连接可以使得外支架1先植入体内，稳定的锚固于房室间后，再释放内支架2；内支架2依靠自身的网格结构，或自膨展开，或球扩展开，固定于外支架中间。这种内外支架可分离的设计降低了输送系统中输送鞘管的径向尺寸，可以将尺寸为35Fr以上的第一输送系统的尺寸降到28Fr；可以将尺寸为35Fr以上的第二输送系统或第三输送系统的尺寸降到24Fr，可以解决现有技术中双层支架输送系统尺寸过大而导 致的输送问题，提高植入的安全性和尺寸的普适性。
如图4-1至4-4所示，本发明还提供一种人工心脏瓣膜的输送系统，所述输送系统包括输送鞘管31、套设于输送鞘管31内的导丝腔32和支架导管33，所述支架导管33被设置为适于与所述人工心脏瓣膜连接。
在如图4-1所示的输送系统(第一输送系统)中，所述支架导管33包括外支架导管331和内支架导管332，所述外支架导管331和内支架导管332在输送鞘管31内前后顺序排列，所述外支架导管331和内支架导管332均为管状。此种实施方式中，内支架框架21的材料选自镍钛合金。内支架框架21可以自膨。
所述内支架导管332的截面积较外支架导管331的截面积大。所述外支架导管331穿设于内支架导管332内部。所述内支架导管332粗细均一。所述内支架导管332一端用于与内支架2连接。所述外支架导管331一端设有宽部33a。所述宽部33a用于与外支架1连接。
如图5-1所示，使用此种输送系统植入人工心脏瓣膜的步骤如下：首先将内外支架分别装载于内支架导管332和外支架导管331上后进行植入。植入过程中，释放外支架1时，输送鞘管31向后退鞘；释放完外支架1之后，导丝腔32向后退，直到靠近内支架2；调整输送系统，使内支架2与外支架1同轴设置(可利用输送系统辅助同轴)；输送鞘管31继续向后退鞘释放内支架2；释放完毕后，收输送鞘管31，撤离输送系统。
在如图4-2和图4-3所示的输送系统(第二输送系统)中，所述输送系统还包括套设于输送鞘管31外的控弯鞘34，所述支架导管33为管状，所述支架导管33一端设有宽部33a。所述宽部33a用于与外支架1或内支架2连接。
此种实施方式中，内支架框架21的材料选自镍钛合金。内支架框架21可以自膨。
如图5-2所示，使用此种输送系统植入人工心脏瓣膜的步骤如下：先将内外支架分别装载进两个相同的输送系统。植入时，先植入外支架1。输送系统从控弯鞘34中穿过，在房室间通过向后退输送鞘管31的方式将外支架1释放。然后撤出该输送系统。接下来将装载有内支架2的输送系统穿过控弯鞘34，在房室间同样通过向后退输送鞘管31的方式将内支架2释放到外支架1的筒状空间内。
在如图4-4所示的输送系统(第三输送系统)中，所述输送系统还包括套设于输送鞘管31外的控弯鞘34，所述支架导管33为球囊状。所述支架导管33用于置于内支架2内。
此种实施方式的输送系统中，内支架框架21的材料选自钴铬合金。内支架框架21可以进行球囊式扩张。
如图5-3所示，使用此种输送系统植入人工心脏瓣膜的步骤如下：先将外支架1分别装 载进如图4-2所示的输送系统中，将内支架2装载进如图4-4所示的输送系统中。植入时，先植入外支架1。然后，将装有内支架2的输送系统穿过控弯鞘34，在房室间，先向后退输送鞘管31。然后向支架导管33内充生理盐水，从而撑开内支架2，将内支架2固定于外支架1内壁112a的中心位置。
本发明还提供一种心脏瓣膜置换系统，所述心脏瓣膜置换系统包括所述人工心脏瓣膜和所述输送系统。
综上所述，本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。
上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。

Claims (13)

  1. 一种人工心脏瓣膜，其特征在于，所述人工心脏瓣膜包括外支架(1)和内支架(2)，所述外支架(1)和内支架(2)可拆卸式连接，或所述人工心脏瓣膜在使用状态下，所述内支架(2)位于外支架(1)内部，所述外支架(1)包括外支架框架(11)和设于外支架框架(11)上的一次性瓣叶(12)，所述内支架(2)包括内支架框架(21)和置于内支架框架(21)中的人工瓣叶(22)。
  2. 根据权利要求1所述的人工心脏瓣膜，其特征在于，外支架框架(11)包括依次连接的法兰部(111)、主体部(112)和抓耳部(113)；所述法兰部(111)包括依次连接的第一法兰段(111a)、第二法兰段(111b)和第三法兰段(111c)，当所述外支架框架(11)竖直放置时，第二法兰段(111b)和水平方向之间的角α的度数为-10°～55°；所述主体部(112)包括内壁(112a)和外壁(112b)，内壁(112a)和外壁(112b)首尾连接形成封闭结构；所述抓耳部(113)包括依次连接的第一抓耳段(113a)、第二抓耳段(113b)和第三抓耳段(113c)，当所述外支架框架(11)竖直放置时，所述第三抓耳段(113c)和竖直方向之间的角β的度数为-15°～15°。
  3. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述一次性瓣叶(12)设于内壁(112a)上。
  4. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述外支架(1)还包括外支架裙边，所述外支架裙边至少设于法兰部(111)和主体部(112)表面。
  5. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述外支架(1)还包括锚固件(13)，所述锚固件(13)设于外支架框架(11)上。
  6. 根据权利要求2所述的人工心脏瓣膜，其特征在于，所述锚固件(13)设于内壁(112a)上。
  7. 根据权利要求1所述的人工心脏瓣膜，其特征在于，所述内支架框架(21)分为流入段(211)和流出段(212)，所述内支架(2)还包括内支架裙边(23)，内支架裙边(23)设于内支架框架(21)的内表面。
  8. 根据权利要求7所述的人工心脏瓣膜，其特征在于，所述人工瓣叶(22)与内支架裙边(23)连接。
  9. 一种人工心脏瓣膜的输送系统，其特征在于，所述输送系统包括输送鞘管(31)、套设于输送鞘管(31)内的导丝腔(32)和支架导管(33)，所述支架导管(33)被设置为适于与权利要求1-8任一所述人工心脏瓣膜连接。
  10. 根据权利要求9所述的输送系统，其特征在于，所述支架导管(33)包括外支架导管(331) 和内支架导管(332)，所述外支架导管(331)穿设于内支架导管(332)并延伸出内支架导管(332)，所述内支架导管(332)一端用于与内支架(2)连接，所述外支架导管(331)一端设有宽部(33a)，所述宽部(33a)用于与外支架(1)连接，所述外支架导管(331)和内支架导管(332)均为管状。
  11. 根据权利要求9所述的输送系统，其特征在于，所述输送系统还包括套设于输送鞘管(31)外的控弯鞘(34)，所述支架导管(33)为管状，所述支架导管(33)一端设有宽部(33a)，所述宽部(33a)用于与外支架(1)或内支架(2)连接。
  12. 根据权利要求9所述的输送系统，其特征在于，所述输送系统还包括套设于输送鞘管(31)外的控弯鞘(34)，所述支架导管(33)为球囊状，所述支架导管(33)用于植入时设于内支架(2)内。
  13. 一种心脏瓣膜置换系统，其特征在于，所述心脏瓣膜置换系统包括权利要求1-8任一所述的人工心脏瓣膜和权利要求9-12任一所述的输送系统。
PCT/CN2021/114546 2021-06-25 2021-08-25 一种人工心脏瓣膜及其输送系统 WO2022267210A1 (zh)

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