WO2014127750A1 - 心脏瓣膜假体 - Google Patents

心脏瓣膜假体 Download PDF

Info

Publication number
WO2014127750A1
WO2014127750A1 PCT/CN2014/072489 CN2014072489W WO2014127750A1 WO 2014127750 A1 WO2014127750 A1 WO 2014127750A1 CN 2014072489 W CN2014072489 W CN 2014072489W WO 2014127750 A1 WO2014127750 A1 WO 2014127750A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
heart valve
valve
inflow channel
channel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2014/072489
Other languages
English (en)
French (fr)
Inventor
陈国明
李�雨
黄峰
黄磊
韩建超
段轶豪
陈韶辉
罗七一
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Microport Medical Group Co Ltd
Original Assignee
Shanghai Microport Medical Group Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Microport Medical Group Co Ltd filed Critical Shanghai Microport Medical Group Co Ltd
Priority to US14/769,991 priority Critical patent/US20160000559A1/en
Priority to EP14754475.3A priority patent/EP2959866B1/en
Publication of WO2014127750A1 publication Critical patent/WO2014127750A1/zh
Anticipated expiration legal-status Critical
Priority to US16/160,857 priority patent/US10918479B2/en
Ceased legal-status Critical Current

Links

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
    • 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
    • A61F2/2412—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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/0078—Quadric-shaped hyperboloidal
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • 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
    • A61F2250/0036—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 thickness

Definitions

  • the present invention generally relates to a heart valve prosthesis that can be replaced with a heart valve without a knife. More specifically, the present invention relates to a valve prosthesis stent that is capable of accurately conforming to the positioning of the cardiac anatomy, thereby making it less prone to displacement and preventing paravalvular leakage. Background technique
  • aortic valve disease has become one of the common cardiovascular diseases.
  • the incidence rate in China is 2%-5%, and it ranks third in Europe and the United States after coronary heart disease and hypertension.
  • Thousands of patients benefit from surgical aortic valve replacement every year, but even in developed countries, there are still a large number of patients with severe aortic valve disease due to advanced disease, advanced age, and multiple comorbidities.
  • the inability to undergo surgical treatment, the emergence of percutaneous artificial aortic valve products and the continuous improvement of product performance have undoubtedly brought the gospel to these patients and provided an effective treatment.
  • Aortic valve disease can be caused by congenital defects, natural aging processes, infection or scar formation. Over time, calcification may deposit around the aortic valve, leading to aortic stenosis and/or valvular insufficiency causing "aortic regurgitation.”
  • Patients with aortic valve disease are mainly characterized by angina pectoris, syncope, and heart failure, which severely degrade the patient's quality of life, significantly shorten the survival time, and must be effectively treated.
  • the percutaneous artificial aortic valve products have been continuously updated and improved.
  • the representative products currently used in clinical practice are Edwards valve stent system and CoreValve valve stent system.
  • Edwards-SAPIEN bio-valve made of bovine pericardium, sutured on a stainless steel (or cobalt-chromium) stent, using a balloon-expanded stent to position the valve at the annulus, without the need to transport the sheath, can be antegrade, retrograde Or by apical approach, the valves available for clinical use are available in 23mm and 26mm diameters.
  • An example of such an aortic valve is described in the patent application WO 2009/149462 A2.
  • the Edwards-SAPIEN aortic valve system has undergone a large number of clinical trials and has obtained very good results.
  • the CoreValve Valve System is another clinically successful valve stent that was first used in humans in 2005 and has been successful.
  • the artificial valve mainly made of three-leaf pig pericardium is sutured on a nickel-titanium self-expanding stent, which is currently available in 26mm, 29mm and 31mm specifications.
  • An example of such a valve system is given in U.S. Patent Publication No. US 201 1/0172765 A1.
  • the CoreValve valve stent is made of nickel-titanium memory alloy. The upper part of the stent is used to anchor the ascending aorta above the sinus sinus.
  • the radial support force is low.
  • the central part of the stent is sewn with leaflets, and its geometry is concave. Coronary blood flow is unobstructed; the lower part of the stent is placed and fixed at the aortic annulus, and its radial support is strong.
  • the latest clinical studies have confirmed that the implantation of the CoreValve valve system not only has good hemodynamic effects, but also a 30-day mortality rate of 8%, indicating an ideal safety.
  • the CoreValve valve stent can be adjusted to a certain extent when released, and cannot be adjusted after release. If the positioning is found to be biased or the stent is not properly sized after implantation, it may cause serious complications and threaten the patient's life. In addition, via clinical feedback, CoreValve Valvular stents often have a long rupture into the ventricle to disrupt the conduction bundle and displacement after implantation.
  • the present invention is directed to solving one or more of the other technical problems mentioned above and in the prior art. Summary of the invention
  • Another object of the present invention is to provide a heart valve body in which the valve can be firmly positioned so as not to be easily displaced.
  • the present invention provides a stent for a heart valve prosthesis for supporting a heart valve and including an inflow channel, an outflow channel, and a transition region between the inflow channel and the outflow channel along a longitudinal axis, the stent There is a deployed collapsed configuration and a deployed expanded configuration, wherein in the expanded configuration, the inflow channel has a concave structure that matches the native structure of the annulus.
  • the stent is self-expanding and comprises a plurality of structural units in the form of a grid.
  • the inflow channel employs a larger structural unit at the recessed structure than the other portions of the inflow channel.
  • the stent in the deployed configuration, tapers from the inflow channel to the transition region and then expands toward the outflow channel.
  • the ends of the inflow channel and the outflow channel are slightly retracted to form a cuff.
  • the inflow channel circumferential direction comprises 12 structural units
  • the outflow channel circumferential direction comprises 6 structural units.
  • the bracket takes a structural unit having a larger rod width than the outflow channel and the transition region in the inflow channel region.
  • the transitional fillet at the concave structure has a value of R4-R6, a concave depth of l-2 mm, and the concave structure is positioned at a distance of 1-2 bands from the proximal end of the stent 1. At the office.
  • the bracket is made of a nickel titanium alloy.
  • the present invention also provides a heart valve prosthesis for heart valve replacement comprising a heart valve and a stent as described above.
  • the heart valve is a trilobal valve that is sewn from a three-lobed one-way open valve consisting of an anti-calcification pig pericardium.
  • the heart valve is sutured to the stent by a medical suture made of polyethylene terephthalate.
  • the valve stent positioning area realizes the automatic positioning of the valve support by adopting the concave structure, thereby improving the accuracy of the positioning of the stent and reducing the difficulty of the operation.
  • the stent inflow channel adopts a wedge-shaped structure, which effectively prevents the clogging of the coronary artery mouth, thereby strictly controlling the stent inflow extension.
  • the length of the ventricle is such that the stent is prevented from extending into the ventricle and causing serious complications such as conduction beam blockage.
  • FIG. 1 is a perspective view of an exemplary heart valve prosthesis in accordance with the present invention
  • FIG. 2 is an end view of the heart valve prosthesis of FIG. 1;
  • Figure 3 is a perspective view showing the delivery configuration of the heart valve prosthesis of the present invention in a partially released manner
  • the present invention generally relates to a heart valve prosthesis having a self-expanding stent that supports a heart valve.
  • the self-expanding stent has a proximal region, a middle region, and a distal region that are distributed along the longitudinal direction.
  • the proximal region refers to the region corresponding to the inflow tract of the valve prosthesis
  • the distal region refers to the region corresponding to the outflow tract of the valve prosthesis.
  • the valve prosthesis includes a stent 1 and an aortic valve 3.
  • the valve 3 is fixed to the inner surface of the stent 1 by, for example, suturing.
  • the stent 1 has a collapsed configuration for implantation into the delivery process and a deployment deployment configuration that conforms to the native structure of the heart upon implantation, and Figure 1 illustrates such an exemplary deployment deployment configuration.
  • the bracket 1 as a whole includes a grid-like structural unit and has a longitudinal direction. Specifically, the bracket 1 has a flared lattice structure and is divided into an outflow passage 6, a transition region 7, and an inflow passage 8 from top to bottom in the longitudinal direction.
  • the inflow channel 8 corresponds to the portion of the prosthesis where blood flows into the prosthesis during valve operation and extends into the left ventricle after implantation.
  • the outflow tract 6 corresponds to the portion of the prosthesis where the blood flows out of the prosthesis during valve operation and is attached to the ascending aorta after implantation.
  • the inflow channel 8 to the transition region 7 tapers and is expanded towards the outflow channel 6.
  • the positioning diameter of the inflow channel 8 may be in the range of 21 mm to 30 mm, for example, 30 mm; the diameter of the outflow channel 6 may be in the range of 38 mm to 43 mm, for example, 43 mm, for different specifications of the bracket.
  • the stent outflow channel 6 has a mesh structure composed of 6 cells in a circumferential direction, and the mesh unit area is about 0.8 to 1.6 cm 2 .
  • adjacent grid cell areas may be about 0.8 cm 2 and about 1.3 cm 2 , respectively .
  • the angle between adjacent poles is 60. ⁇ 120. More preferably, it is 60. ⁇ 5. .
  • valve stent transition region 7 is shown joining a larger diameter outflow channel 6 and a smaller diameter inflow channel 8, the circumferential grid structure being 6 grids of the outflow channel 6
  • the element transitions to 12 grid cells of the inflow channel 8, with an angle between adjacent poles of 50. ⁇ 5 °, grid area is about 0.7cm 2 .
  • the inflow channel 8 of the stent 1 has the most dense grid cells in the circumferential direction.
  • the stent inflow channel 8 is composed of 12 grid cells in the circumferential direction, and the mesh area is about 0.5 to 0.8 cm 2 .
  • the angle between adjacent poles is 30° ⁇ 65. .
  • the inflow region 8 is placed in the annulus of the aorta.
  • the inflow channel 8 is provided with a concave structure (shown by arrow 9 in the figure) that automatically conforms to the native structure of the annulus to closely fit the native annulus structure to achieve accurate positioning.
  • this shape can achieve self-positioning of the valve stent, reducing the difficulty of valve positioning and improving compared to the existing valve prosthesis without the concave structure.
  • the accuracy of the positioning Moreover, the shape matching itself provides a radially strong support force to ensure that the valve support fits snugly around the annulus and provides space for the valve to work, while effectively preventing displacement of the valve and the displacement of the valve support.
  • a larger grid unit can be used in the concave structure, and the value of the transition fillet can be in the range of R4-R6, the depth of the recess can be 1-2 mm, and the concave structure It can be positioned at 1-2 bands from the proximal end of the stent 1.
  • the concave structure matches the shape of the native annulus such that the valve prosthesis of the present invention has a self-positioning function.
  • the concave structure is important for repositioning and recycling of the stent.
  • the concave portion cooperates with the native annulus structure after deployment, for example, when the stent is inflow into the tract portion, even when released from the delivery sheath together with the transition region, the inflow portion, especially within it, has been released
  • the concave structure is restored to near its fully deployed deployed shape and will therefore naturally abut against the aortic annulus by virtue of its contour.
  • the medical staff can check the positioning by, for example, various imaging techniques.
  • the position of the delivery is found to be unsatisfactory, or the valve size is not suitable, it cannot fit perfectly with the annulus, and the tension of the release portion still does not hinder the The portion that has been released is recovered into the delivery sheath, enabling repositioning or replacement of the valve for delivery.
  • the deployment deployment configuration described above can be obtained by applying to a metal alloy material using techniques known in the art.
  • the preferred self-expanding structure of the stent 1 can be laser engraved through a metal alloy tube and subjected to a series of heat treatment processes (eg, shaping, grinding, Polishing, etc.) is molded into the desired shape to achieve the desired superelasticity and memory function.
  • the metal alloy tube may be a shape memory material such as a nickel titanium alloy.
  • the aortic valve 3 is fixed in the stent inflow channel 8.
  • the valve 3 is a three-lobed valve which is made by a three-leaf one-way open valve composed of an anti-calcification pig pericardium, which is first sutured in the valve by a medical suture 5
  • the skirts 4 on the stent inflow channel 8 are sewn together and secured to the stent inflow channel 8. Due to the anti-calcification treatment before suturing, the calcification rate of the valve 3 in the body is significantly reduced, and the fatigue life is significantly prolonged.
  • the skirt 4 can be polyethylene terephthalate (PET) or an anti-calcified pig pericardium.
  • the stent 1 is preferably made of a memory metal-nickel-titanium alloy having a superelastic property
  • the medical suture 5 is preferably made of polyethylene terephthalate (PTFE).
  • both the inflow channel 8 and the outflow channel 6 of the stent 1 of the present invention are slightly retracted to form a "close" 11 design, and the viewing angle can be 8 ° ⁇ 12. In the range of 10°, it is more preferable to prevent the metal stent from damaging the internal tissues when the left ventricle and the aortic inner wall are fitted (shown more clearly in Fig. 4).
  • FIG. 4 shows a schematic view of the valve prosthesis according to the present invention after implantation, from which it can be more clearly seen that the valve stent of the present invention is designed by adopting a concave design conforming to the native annulus structure at the stent inflow channel positioning. It can be closely attached to the annulus, so it can be accurately positioned, and at the same time, it can prevent displacement and circumferential leakage after implantation.
  • the inflow channel adopts a relatively large grid unit in the concave structure, it can effectively avoid the sudden sputum of large granular calcification at the patient's annulus, and the mesh unit is too dense to be deformed with the abrupt contour.
  • the wall is not tight, causing paravalvular leakage.
  • this large mesh design has a more obvious advantage.
  • the starting end of the inflow channel region of the bracket is a large taper design, and the larger rod width W design of the inflow channel region ensures that the segment has a strong supporting force, thereby achieving a stable fixing position of the bracket. This further enhances the resistance to displacement after stent implantation.
  • the stent of the present invention structurally achieves accurate positioning of the valve, the length of the valve stent into the left ventricle can be strictly controlled, for example, the concave structure is proximally Setting 1-2 bands is enough.
  • the stent of the present invention also prevents coronary artery blood flow from being blocked by the implantation of the valve stent by employing a suitable full skirt height H.
  • valve stent transition zone and outflow tract are designed with an open (large mesh) design that allows the stent to conform to the native structure with different axes of the annulus and the ascending aorta, ensuring that the valve will function properly.
  • the outflow tract extends into the ascending aorta and has good adherence.
  • the artificial aortic valve stent is loaded into the sheath 10 at the front end of the valve delivery device (not shown);
  • the delivery sheath 10 loaded with the artificial aortic valve stent is delivered along the guide wire to the active valve annulus, partially releasing the valve stent, and Figure 3 shows the stent in a partially released state;

Landscapes

  • 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

一种用于心脏瓣膜假体的支架（1）和包括该支架（1）的用于心脏瓣膜置换的心脏瓣膜假体，所述支架（1）用于支承心脏瓣膜（3）并沿着纵向轴线包括流入道（8）、流出道（6）以及位于流入道（8）和流出道（6）之间的过渡区域（7），所述支架（1）具有输送的收缩构型和部署的展开构型。在展开构型，流入道（8）具有与瓣环原生结构匹配的内凹结构。通过该内凹结构，所述支架（1）能够实现自定位功能，并且在植入后贴合紧密，防止移位以及周漏的发生。

Description

心脏瓣膜假体 技术领域
本发明总体涉及一种不用开刀即可进行心脏瓣膜替换的心脏瓣 膜假体。 更具体地， 本发明涉及一种能够准确紧密贴合心脏解剖结构 定位、 从而不易发生位移并防止瓣周漏的瓣膜假体支架。 背景技术
随着全球老龄化社会的到来， 主动脉瓣膜病变已成为常见的心血 管疾病之一。在我国国内的发病率为 2%-5%， 而在欧美国家位于冠心 病和高血压病之后， 居第三位。 每年有成千上万的患者能从外科主动 脉瓣膜置换术中获益， 但即使在发达国家， 仍有大量严重主动脉瓣膜 病变的患者因为疾病晚期、 高龄以及存在多种合并症等原因而不能接 受外科手术治疗， 经皮人工主动脉瓣产品的出现和产品性能的不断完 善， 无疑为这部分病人带来了福音， 提供了一种有效的治疗方法。
主动脉瓣膜疾病可由先天性缺陷、 自然老化过程、 感染或瘢痕的 形成而引起。 随着时间的推移， 钙化物可能在主动脉瓣周围沉积， 导 致主动脉瓣狭窄和 /或瓣膜关闭不全引起 "主动脉返流" 。 主动脉瓣膜 疾病的患者病症主要表现在心绞痛、 晕厥和心衰， 使病人的生活质量 严重下降， 存活时间明显缩短， 必须进行有效的治疗。
2002年 Cribier等首先报道了第一例人体经导管主动脉瓣膜置换 病例， 此后， 国内外众多学者、 医生均开展了经导管主动脉瓣膜置换 ( TAVR )的基础和临床研究， 并取得了较好的临床效果， 研究表明： 对于无法进行外科换瓣或外科换瓣手术存在高风险的患者， 这项新技 术是安全有效的。 与外科手术相比， 经皮主动脉瓣膜置换术无需开胸 及体外循环支持， 是一种创伤小、 并发症少、 术后康复快、 患者痛苦 小、 容易接受的治疗方法。 尽管进行 TAVR手术的多为高风险患者， 但术后 30天存活率高于 90%， 术后患者血流动力学指标得到了明显 的改善。 经皮人工主动脉瓣产品经过不断的更新改良， 目前应用于临床的 代表性产品有 Edwards瓣膜支架系统和 CoreValve瓣膜支架系统两大 类。 Edwards-SAPIEN生物瓣， 由牛心包制成， 缝合组装在不锈钢（或 钴铬合金） 支架上， 使用球嚢扩张支架实现瓣膜在瓣环处的定位， 无 需输送鞘管， 可采用顺行、 逆行或经心尖途径的方法置入， 可供临床 应用的瓣膜有直径 23mm 和 26mm 两种规格。 专利申请 WO 2009/149462A2 中描述了这种主动脉瓣膜的例子。 Edwards-SAPIEN 主动脉瓣系统已经进行大量的临床实验， 得到了非常理想的研究结 果。 CoreValve 瓣膜系统是另一个在临床上成功使用的瓣膜支架， 于 2005年首次应用于人体并获成功。其主要由三叶式猪心包制成的人工 瓣膜缝合在镍钛合金自膨式支架上， 这种支架目前有 26mm、 29mm 和 31mm三种规格。 美国专利公开文献 US 201 1/0172765A1中给出了 这种瓣膜系统的例子。 CoreValve 瓣膜支架由镍钛记忆合金制成， 支 架上部用于锚定在瓦氏窦上方的升主动脉， 其径向支撑力较低； 支架 中部缝制有瓣叶， 其几何形状内凹， 使冠状动脉血流不受阻挡； 支架 下部用于置入固定于主动脉瓣环处， 其径向支撑力强。 最新的临床研 究证实， 植入 CoreValve瓣膜系统不仅有良好的血流动力学效果， 而 且 30天死亡率为 8%， 显示了比较理想的安全性。
然而， 目前已上市的主动脉瓣膜产品仍然存在着一些弊端和不够 合理的地方。 对于经皮主动脉瓣置换 （TAVI ) 手术而言， 瓣膜支架 的定位是否准确直接关系着手术的成败。人体主动脉瓣膜区域的原生 结构复杂， 瓣叶上方有左右冠状动脉开口， 下方有左心室室间隔传导 束支， 右侧毗邻二尖瓣， 如果定位不准确很可能造成冠状动脉开口的 堵塞、 传导束阻滞等致命的并发症。 就两种代表性的瓣膜系统 ( Edwards 和 CoreValve ) 来说， 两种产品都不可回收和重新定位。 Edwards瓣膜支架由球嚢迅速膨胀扩张释放， 一旦定位没有调整的余 地； CoreValve 瓣膜支架部分释放时可做一定程度的调整， 释放后也 无法调整。 如植入后发现定位存在偏差或支架规格不当， 易引起位移 发生严重的并发症， 威胁病人生命。 此外， 经临床反馈， CoreValve 瓣膜支架时常有伸入心室过长破坏传导束支和植入后发生位移的情 况
本发明旨在解决上面提到以及现有技术中存在的一个或多个其 他技术问题。 发明内容
本发明的一个目的在于提供一种心脏瓣膜假体，其中瓣膜支架能 够准确与瓣环紧密贴合， 从而防止发生瓣周漏。
本发明的另一目的在于提供一种瓣膜能够牢固定位从而不容易 发生位移的心脏瓣月 K叚体。
本发明的又一目的在于提供一种心脏瓣膜假体，其能够解决瓣膜 支架伸入左心室过长因而易发生左束支受阻的问题。
本发明的又一目的在于提供一种心脏瓣膜假体，其能够解决瓣膜 设计缺陷或定位不准确引起的冠状动脉口血流受阻的问题。
本发明的目的还在于提供一种心脏瓣膜假体，其能够解决植入时 由于成像误差不能准确定位等的诸多问题。
相应地， 本发明提供一种用于心脏瓣膜假体的支架， 其用于支承 心脏瓣膜并沿着纵向轴线包括流入道、 流出道以及位于流入道和流出 道之间的过渡区域， 所述支架具有输送的收缩构型和部署的展开构 型，其中，在展开构型， 流入道具有与瓣环原生结构匹配的内凹结构。
根据一种实施方式， 所述支架是自膨胀式的， 并包括网格形式的 多个结构单元。
才艮据一种实施方式， 所述流入道在所述内凹结构处采用与流入道 其它部分相比更大的结构单元。
根据一种实施方式， 在所述展开构型， 所述支架从所述流入道到 所述过渡区域呈锥形， 继而朝着流出道扩张。
才艮据一种实施方式， 所述流入道和所述流出道的端部略 ί内缩呈 收口设计。
才艮据一种实施方式， 所述流入道周向包括 12个结构单元， 所述 流出道周向包括 6个结构单元。
才艮据一种实施方式， 所述支架在流入道区域采取具有比在流出道 和过渡区域更大的杆宽的结构单元。
才艮据一种实施方式，所述内凹结构处的过渡圆角的取值为 R4-R6, 内凹深度为 l-2mm， 且内凹结构定位在距支架 1近端 1-2个波段处。
根据一种实施方式， 所述支架采用镍钛合金制成。
本发明还提供一种用于心脏瓣膜置换的心脏瓣膜假体， 其包括心 脏瓣膜和上述的支架。
根据一种实施方式， 所述心脏瓣膜为三叶式瓣膜， 其由经过防钙 化处理的猪心包组成的三叶单向开放的瓣膜缝制而成。
根据一种实施方式， 所述心脏瓣膜通过利用聚对苯二曱酸乙二醇 酯制成的医用缝合线缝合到所述支架。
根据本发明的瓣膜支架定位区通过采用内凹结构实现了瓣膜支 架的自动定位， 从而提高了支架定位的准确性、 降低了手术的难度。 支架完全释放前， 如发现定位失当或支架规格不合适可实现支架的回 收和重定位操作； 同时， 支架流入道采用楔形结构， 有效防止了冠状 动脉口的堵塞， 从而能够严格控制支架流入道伸入心室的长度， 避免 支架伸入心室过长而导致传导束阻滞等严重的并发症。 附图说明
通过以下结合附图对仅是示例性而非限制性的实施方式的描述， 本发明的上述和其它特征和优点将变得更加清楚：
图 1是根据本发明的一种示例性心脏瓣膜假体的透视图； 图 2是图 1所示的心脏瓣膜假体的端视图；
图 3是示出了本发明的心脏瓣膜假体处于部分释放的输送构型的 透视图； 以及
图 4是描述部署在患者体内的本发明的心脏瓣膜假体的侧视图。 具体实施方式 下面结合具体实施方式， 进一步阐述本发明。 本发明总体涉及一 种心脏瓣膜假体， 其具有支承心脏瓣膜的自膨胀式支架。 自膨胀式支 架具有沿着纵向方向分布的近侧区域、 中间区域和远侧区域。 在描述 本发明的支架时， 近侧区域指的是与瓣膜假体的流入道对应的区域， 相应地， 远侧区域指的是与瓣膜假体的流出道对应的区域。
图 1示出了根据本发明一种示例性实施方式的心脏瓣膜假体， 具 体为一种介入式人工主动脉瓣膜假体， 用于置换发生病变的主动脉 瓣。 该瓣膜假体包括支架 1和主动脉瓣膜 3。 瓣膜 3通过例如缝合固 定到支架 1的内表面。 支架 1具有用于植入输送过程的收缩构型和植 入时与心脏原生结构符合的部署展开构型， 图 1示出了这种示例性的 部署展开构型。
如图 1的部署展开构型所示， 支架 1整体上包括网格状结构单元 并具有纵向方向。 具体地， 支架 1呈喇叭形网格结构， 沿纵向自上而 下分为流出道 6、 过渡区域 7和流入道 8。 流入道 8对应在瓣膜操作 时血液流入假体的假体部分， 在植入后伸入左心室。 流出道 6对应在 瓣膜操作时血液流出假体的假体部分， 在植入后附着于升主动脉。
从图 1可看到， 在根据本发明的支架 1中， 流入道 8至过渡区域 7呈锥形， 并且又朝着流出道 6扩张。 居一种实施方式， 流入道 8 的定位直径可以在 21mm~30mm的范围内， 例如为 30mm; 流出道 6 的直径可以在 38mm~43mm的范围内， 例如为 43mm， 以用于不同规 格的支架， 从而匹配不同尺寸的原生解剖结构。 具体地， 支架流出道 6周向由 6个单元格组成的网状结构， 网格单元面积约为 0.8~1.6cm2。 例如，相邻网格单元面积可分别为大约 0.8cm2和大约 1.3cm2。相邻波 杆之间的夹角为 60。 ~120。 ， 更优选为 60。 ± 5。 。 流出道 6的头端 平均布置两个挂耳 2，用于牵引支架进入输送器鞘管或推送瓣膜出鞘。 瓣膜假体植入后， 流出道 6伸入升主动脉与升主动脉内壁相贴合， 并 能校准瓣膜支架平行于血流方向。
继续参照图 1， 所示的瓣膜支架过渡区域 7连接直径较大的流出 道 6和直径较小的流入道 8， 周向网格结构由流出道 6的 6个网格单 元过渡到流入道 8的 12个网格单元，相邻波杆之间的夹角为 50。 ± 5 ° ， 网格面积约为 0.7cm2。
支架 1的流入道 8在周向上具有最密集的网格单元， 在图示的实 施方式中， 支架流入道 8周向由 12个网格单元组成， 网格面积约为 0.5~0.8cm2, 相邻波杆之间的夹角为 30° ~ 65。 。 在瓣膜假体植入后， 该流入区域 8放置在主动脉才 部的瓣环中。 特别地， 居本发明， 流 入道 8设有自动顺应瓣环原生结构的内凹结构（图中的箭头 9所示位 置） ， 以与原生瓣环结构紧密贴合并实现准确定位。 通过部署展开构 型时流入道 8的这种内凹结构， 与不具有该内凹结构的现有瓣膜假体 相比， 这种外形可实现瓣膜支架的自定位， 降低瓣膜定位的难度和提 高定位的准确性。 并且， 形状的匹配本身就能提供径向上强的支撑力 以保证瓣膜支架与瓣环周向紧密贴合， 并能够为瓣膜工作提供空间， 同时有效防止瓣周漏和瓣膜支架受力发生位移。
才艮据一种优选实施方式， 该内凹结构处可采用较大的网格单元， 过渡圆角的取值可在 R4-R6的范围， 内凹深度可为 l-2mm，且内凹结 构可定位在距支架 1近端 1-2个波段处。 可以理解， 该内凹结构通过 与原生瓣环的形状匹配， 使得本发明的瓣膜假体具有自定位功能。 此 夕卜， 该内凹结构对于支架的重新定位和回收具有重要意义。 具体地， 由于在部署后， 该内凹部分与原生瓣环结构配合， 例如在将支架流入 道部分、 甚至连同过渡区域一起从输送鞘管释放时， 已经释放的流入 道部分、 特别是其内凹结构即恢复到接近其完全部署展开形状， 因此 将借助其轮廓与主动脉瓣环自然贴靠。 在此过程中医护人员可通过例 如各种影像学技术检查定位情况， 如发现输送的位置不理想， 或者瓣 膜规格不合适， 不能与瓣环完美贴合， 这时释放部分的张力仍不妨碍 将该已经释放的部分回收到输送鞘管中， 使得能够重新定位或者更换 瓣膜后再次输送。
上述的部署展开构造可通过使用本领域已知的技术施加在金属 合金材料上来获得。 例如， 支架 1的优选自膨胀式结构可通过金属合 金管材经激光雕刻而成， 并经一系列热处理工艺 （例如定型、 研磨、 抛光等）成型为所需的形状， 达到所需的超弹性和记忆功能。 所述金 属合金管材可以是诸如镍钛合金等形状记忆材料。
主动脉瓣膜 3固定在支架流入道 8中。 如图 2的端视图所示， 瓣 膜 3为三叶式瓣膜， 其由经过防钙化处理的猪心包组成的三叶单向开 放的瓣膜缝制而成， 通过医用缝合线 5与首先缝合在瓣膜支架流入道 8上的裙边 4缝合在一起而固定于支架流入道 8。 由于在缝合前经过 防钙化处理， 瓣膜 3在体内钙化速度明显下降， 疲劳寿命明显延长。 裙边 4可以为聚对苯二曱酸乙二醇酯 （PET ) 或经过防钙化处理的猪 心包膜。
如上所述， 支架 1优选采用具有超弹性质的记忆金属一镍钛合金 制成， 而医用缝合线 5优选用聚对苯二曱酸乙二醇酯 （PTFE ) 制成。
如图 1所示， 居本发明的支架 1的流入道 8和流出道 6两端均 略微内缩呈 "收口" 11设计， 视图夹角可在 8° ~ 12。 的范围内， 更 优选为 10° ，以防止在贴合左心室和主动脉内壁时金属支架对体内组 织造成损伤 （图 4中更清楚显示） 。
根据本发明的心脏瓣膜假体可以实现许多优点。 图 4显示了根据 本发明的瓣膜假体植入后的示意图， 从该图可更清楚看到， 通过在支 架流入道定位处采用顺应原生瓣环结构的内凹形设计， 本发明的瓣膜 支架能够实现与瓣环紧密贴合， 因此能够准确定位， 并同时能防止植 入后发生移位和发生周漏。 同时， 由于流入道在内凹结构处采用相对 较大的网格单元， 能够有效回避因患者瓣环处存在大颗粒钙化物的突 兀而网格单元又过密不易随突兀轮廓变形而导致支架贴壁不严， 造成 瓣周漏的现象， 与流入道周向采用 15个网格单元的传统支架设计相 比， 这种大网格设计的内凹结构具有更显而易见的好处。
如上所述， 支架流入道区域采用的起始端为大头的锥度设计， 加 上流入道区域的较大杆宽 W设计确保了该区段具有强支撑力， 从而 实现支架的稳固定位。 这进一步增强了支架植入后的抗移位能力。
由于本发明的支架在结构上实现了瓣膜的准确定位， 因而可对瓣 膜支架伸入左心室的长度进行了严格控制， 例如使得内凹结构近侧再 设置 1-2个波段就已足够。
除了流入道的锥度设计， 本发明的支架还通过采用合适的全裙边 高度 H， 使冠状动脉口不因瓣膜支架的植入而阻碍冠状动脉血流的畅 通。
另外， 瓣膜支架过渡区和流出道采用开放式（大网格）设计， 能 够使支架在瓣环与升主动脉不同轴的情况下顺应原生结构， 保证瓣膜 能够正常工作。 流出道伸入升主动脉， 并具有良好的贴壁性。
以下以主动脉瓣膜为例描述 ^据本发明的心脏瓣膜假体植入到 患者体内的一般步骤。
1、 居食道超声心动检查或 CT测量病人主动脉瓣环尺寸， 并据 此选择合适规格的介入式人工主动脉瓣膜；
2、 在水水中， 将人工主动脉瓣膜支架装载进瓣膜输送器 （未显 示） 前端的鞘管 10中；
3、 在病人全身麻醉 （或局部麻醉） 状态下， 穿刺股动脉， 置入 输送器鞘管 10， 经输送器鞘管将导丝（未显示）经腹主动脉、 胸主动 脉， 过主动脉瓣至左心室， 建立轨道；
4、将装载有人工主动脉瓣膜支架的输送鞘管 10沿导丝送至主动 脉瓣环处，部分释放瓣膜支架，图 3显示了处于部分释放状态的支架；
5、 影像学检查瓣膜支架的定位情况， 如发现位置不理想， 可调 整位置， 待调整到理想位置时， 释放瓣膜支架使其膨胀， 达到置换主 动脉瓣膜的目的。 主动脉 ^部造影， 评价有无动脉瓣返流；
6、 沿导丝轨道退出鞘管 10， 退出导丝；
7、 根据食道超声心动图及再次造影结果确定人造瓣膜植入的位 置和效果， 然后， 缝合血管穿刺口， 手术完成。
阅读了本发明讲授的内容之后， 本领域技术人员可以对本发明作改动 或修改， 这些等同形式同样落于本申请所附权利要求书所限定的范 围。

Claims

权利要求书
1. 一种用于心脏瓣膜假体的支架， 其用于支承心脏瓣膜并沿着 纵向轴线包括流入道、 流出道以及位于流入道和流出道之间的过渡区 域， 所述支架具有输送的收缩构型和部署的展开构型，
其特征在于，
在所述展开构型， 所述流入道具有与瓣环原生结构匹配的内凹结 构。
2. 根据权利要求 1所述的支架， 其特征在于， 所述支架是自膨胀 式的， 并包括网格形式的多个结构单元。
3. 根据权利要求 2所述的支架， 其特征在于， 所述流入道在所述 内凹结构处采用与流入道其它部分相比更大的结构单元。
4. 根据权利要求 1-3中任一项所述的支架， 其特征在于， 在所述 展开构型， 所述支架从所述流入道到所述过渡区域呈锥形， 继而朝着 流出道扩张。
5. 根据权利要求 1-3中任一项所述的支架， 其特征在于， 所述流 入道和所述流出道的端部略 ί内缩呈收口设计。
6. 根据权利要求 1-2所述的支架， 其特征在于， 所述流入道周向 包括 12个结构单元， 所述流出道周向包括 6个结构单元。
7. 根据权利要求 1-3所述的支架， 其特征在于， 所述支架在流入 道区域采取具有比在流出道和过渡区域更大的杆宽的结构单元。
8. 根据权利要求 1-3所述的支架， 其特征在于， 所述内凹结构处 的过渡圆角的取值为 R4-R6 , 内凹深度为 l-2mm， 且内凹结构定位在 距支架 1近端 1-2个波段处。
9. 根据权利要求 1-3所述的支架， 其特征在于， 所述支架采用镍 钛合金制成。
10. 一种用于心脏瓣膜置换的心脏瓣膜假体， 包括：
心脏瓣 和
根据权利要求 1-9任一项所述的支架。
11. 居权利要求 10所述的心脏瓣膜假体， 其特征在于， 所述心 脏瓣膜为三叶式瓣膜， 其由经过防钙化处理的猪心包组成的三叶单向 开放的瓣膜缝制而成。
12. 居权利要求 10所述的心脏瓣膜假体， 其特征在于， 所述心 脏瓣膜通过利用聚对苯二曱酸乙二醇酯制成的医用缝合线缝合到所 述支架。
PCT/CN2014/072489 2013-02-25 2014-02-25 心脏瓣膜假体 Ceased WO2014127750A1 (zh)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US14/769,991 US20160000559A1 (en) 2013-02-25 2014-02-25 Heart valve prosthesis
EP14754475.3A EP2959866B1 (en) 2013-02-25 2014-02-25 Heart valve prosthesis
US16/160,857 US10918479B2 (en) 2013-02-25 2018-10-15 Heart valve prosthesis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310064011.1 2013-02-25
CN201310064011.1A CN104000672B (zh) 2013-02-25 2013-02-25 心脏瓣膜假体

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US14/769,991 A-371-Of-International US20160000559A1 (en) 2013-02-25 2014-02-25 Heart valve prosthesis
US16/160,857 Continuation-In-Part US10918479B2 (en) 2013-02-25 2018-10-15 Heart valve prosthesis

Publications (1)

Publication Number Publication Date
WO2014127750A1 true WO2014127750A1 (zh) 2014-08-28

Family

ID=51361774

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2014/072489 Ceased WO2014127750A1 (zh) 2013-02-25 2014-02-25 心脏瓣膜假体

Country Status (4)

Country Link
US (1) US20160000559A1 (zh)
EP (1) EP2959866B1 (zh)
CN (1) CN104000672B (zh)
WO (1) WO2014127750A1 (zh)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3275404A4 (en) * 2015-03-26 2018-10-31 Venus MedTech (HangZhou), Inc. Use of safe valve scaffold and valve replacement device with valve scaffold
CN109009568A (zh) * 2017-06-09 2018-12-18 上海微创心通医疗科技有限公司 二尖瓣瓣膜假体、三尖瓣瓣膜假体及其支架
CN109793596A (zh) * 2017-11-17 2019-05-24 上海微创心通医疗科技有限公司 瓣膜支架、瓣膜假体和输送装置
EP3043745B1 (en) 2013-09-12 2020-10-21 St. Jude Medical, Cardiology Division, Inc. Stent designs for prosthetic heart valves

Families Citing this family (54)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9554897B2 (en) 2011-04-28 2017-01-31 Neovasc Tiara Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US9308087B2 (en) 2011-04-28 2016-04-12 Neovasc Tiara Inc. Sequentially deployed transcatheter mitral valve prosthesis
US9375311B2 (en) * 2013-05-03 2016-06-28 Medtronic, Inc. Prosthetic valves and associated appartuses, systems and methods
CN104758091B (zh) * 2015-04-20 2018-09-21 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜的支架及其制备方法
US10631984B2 (en) 2015-12-15 2020-04-28 Neovasc Tiara Inc. Transseptal delivery system
EP4183372A1 (en) 2016-01-29 2023-05-24 Neovasc Tiara Inc. Prosthetic valve for avoiding obstruction of outflow
CN105726167A (zh) * 2016-02-02 2016-07-06 上海纽脉医疗科技有限公司 一种介入式人工心脏瓣膜
US10363130B2 (en) * 2016-02-05 2019-07-30 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US9974649B2 (en) * 2016-03-24 2018-05-22 Medtronic Vascular, Inc. Stented prosthetic heart valve having wrap and methods of delivery and deployment
US10321994B2 (en) 2016-05-13 2019-06-18 St. Jude Medical, Cardiology Division, Inc. Heart valve with stent having varying cell densities
CA3041455A1 (en) 2016-10-19 2018-05-03 Piotr Chodor Stent of aortic valve implanted transcatheterly
EP3541462A4 (en) 2016-11-21 2020-06-17 Neovasc Tiara Inc. METHODS AND SYSTEMS FOR THE QUICK RETURN OF A TRANSCATHETER HEART VALVE RELEASE SYSTEM
EP3402441B1 (en) * 2016-12-15 2026-02-11 Meril Life Sciences Pvt Ltd Prosthetic valve
US10653523B2 (en) 2017-01-19 2020-05-19 4C Medical Technologies, Inc. Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves
US10561495B2 (en) 2017-01-24 2020-02-18 4C Medical Technologies, Inc. Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve
US12029647B2 (en) 2017-03-07 2024-07-09 4C Medical Technologies, Inc. Systems, methods and devices for prosthetic heart valve with single valve leaflet
CN107088112A (zh) * 2017-05-18 2017-08-25 金仕生物科技（常熟）有限公司 一种经导管主动脉瓣膜
US12036113B2 (en) 2017-06-14 2024-07-16 4C Medical Technologies, Inc. Delivery of heart chamber prosthetic valve implant
CN109394393A (zh) * 2017-08-18 2019-03-01 上海微创心通医疗科技有限公司 心脏瓣膜假体
CN111263622A (zh) 2017-08-25 2020-06-09 内奥瓦斯克迪亚拉公司 顺序展开的经导管二尖瓣假体
CN109498213A (zh) * 2017-09-14 2019-03-22 上海微创心通医疗科技有限公司 一种瓣膜支架和瓣膜假体
US20190091013A1 (en) * 2017-09-22 2019-03-28 St. Jude Medical, Cardiology Division, Inc. Prosthetic Heart Valve with Atraumatic Aortic Portion
CN109966023B (zh) * 2017-12-28 2024-09-27 上海微创心通医疗科技有限公司 心脏瓣膜假体及其支架
CN110013359A (zh) * 2018-01-07 2019-07-16 苏州杰成医疗科技有限公司 心脏瓣膜假体和制造膜的方法
CN110101486B (zh) * 2018-02-01 2024-02-27 上海微创心通医疗科技有限公司 心脏瓣膜假体及其输送器
CN110193095B (zh) * 2018-02-27 2021-11-05 上海微创心通医疗科技有限公司 一种干态生物组织材料及其制备方法
CN108542554B (zh) * 2018-03-05 2021-07-02 沛嘉医疗科技(苏州)有限公司 经导管心脏主动脉瓣膜支架
US11857441B2 (en) 2018-09-04 2024-01-02 4C Medical Technologies, Inc. Stent loading device
CN111035473B (zh) * 2018-10-15 2025-06-27 上海微创心通医疗科技有限公司 一种人工心脏瓣膜假体及其支架
CN111053629B (zh) * 2018-10-17 2025-09-19 上海微创心通医疗科技有限公司 一种心脏瓣膜支架及其假体
EP3876870B1 (en) 2018-11-08 2023-12-20 Neovasc Tiara Inc. Ventricular deployment of a transcatheter mitral valve prosthesis
JP2022517423A (ja) * 2019-01-17 2022-03-08 エドワーズ ライフサイエンシーズ コーポレイション 人工弁用のフレーム
US12544226B2 (en) 2019-02-14 2026-02-10 4C Medical Technologies, Inc. Hydrophilic skirt for paravalvular leak mitigation and fit and apposition optimization for prosthetic heart valve implants
AU2020233892A1 (en) 2019-03-08 2021-11-04 Neovasc Tiara Inc. Retrievable prosthesis delivery system
WO2020210652A1 (en) 2019-04-10 2020-10-15 Neovasc Tiara Inc. Prosthetic valve with natural blood flow
US11452628B2 (en) 2019-04-15 2022-09-27 4C Medical Technologies, Inc. Loading systems for collapsible prosthetic heart valve devices and methods thereof
US11779742B2 (en) 2019-05-20 2023-10-10 Neovasc Tiara Inc. Introducer with hemostasis mechanism
US11311376B2 (en) 2019-06-20 2022-04-26 Neovase Tiara Inc. Low profile prosthetic mitral valve
CN114364341A (zh) * 2019-09-27 2022-04-15 爱德华兹生命科学公司 改进的假体心脏瓣膜支架
CN112641536A (zh) * 2019-10-12 2021-04-13 上海微创心通医疗科技有限公司 一种心脏瓣膜支架及其假体
US12133797B2 (en) 2020-01-31 2024-11-05 4C Medical Technologies, Inc. Prosthetic heart valve delivery system: paddle attachment feature
US11931253B2 (en) 2020-01-31 2024-03-19 4C Medical Technologies, Inc. Prosthetic heart valve delivery system: ball-slide attachment
US12053375B2 (en) 2020-03-05 2024-08-06 4C Medical Technologies, Inc. Prosthetic mitral valve with improved atrial and/or annular apposition and paravalvular leakage mitigation
US11992403B2 (en) 2020-03-06 2024-05-28 4C Medical Technologies, Inc. Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells
CN114469446B (zh) * 2020-11-13 2025-02-21 上海微创心通医疗科技有限公司 瓣膜支架和瓣膜假体
CN114469445B (zh) * 2020-11-13 2025-02-21 上海微创心通医疗科技有限公司 瓣膜支架和瓣膜假体
EP4046601B1 (en) * 2021-02-18 2026-04-01 P+F Products + Features GmbH Mitral stent
CN113197709A (zh) 2021-06-17 2021-08-03 上海臻亿医疗科技有限公司 植入物的输送装置及植入物的输送系统
CN113331999B (zh) 2021-07-07 2025-02-07 上海臻亿医疗科技有限公司 瓣膜假体
CN114681158B (zh) * 2022-03-10 2024-10-15 上海汇禾医疗科技股份有限公司 自适应医疗定位器械
US12594164B1 (en) 2022-09-01 2026-04-07 4C Medical Technologies, Inc. Prosthetic heart valve for natural blood flow
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
US20240366366A1 (en) 2023-03-24 2024-11-07 4C Medical Technologies, Inc. Implant delivery
CN117481870A (zh) * 2023-12-01 2024-02-02 江苏臻亿医疗科技有限公司 瓣膜支架及人工瓣膜

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060259136A1 (en) * 2005-05-13 2006-11-16 Corevalve Sa Heart valve prosthesis and methods of manufacture and use
WO2009149462A2 (en) 2008-06-06 2009-12-10 Edwards Lifesciences Corporation Low profile transcatheter heart valve
CN101953729A (zh) * 2010-04-19 2011-01-26 杭州启明医疗器械有限公司 一种使用安全的人造瓣膜置换装置及支架
CN102113921A (zh) * 2009-12-30 2011-07-06 微创医疗器械(上海)有限公司 一种介入式心脏瓣膜
US20120053685A1 (en) * 2010-08-31 2012-03-01 Biotronik Ag Medical valve implant for implantation in an animal body and/or human body
CN102481189A (zh) * 2009-06-05 2012-05-30 美敦力Ats医药股份有限公司 带有具有凹入着陆区域的锚固结构的心瓣膜
CN102764169A (zh) * 2012-04-19 2012-11-07 杭州启明医疗器械有限公司 人工心脏瓣膜及其瓣膜支架
CN203280540U (zh) * 2013-02-25 2013-11-13 上海微创医疗器械（集团）有限公司 心脏瓣膜假体及用于其的支架

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2909177A (en) * 1957-11-29 1959-10-20 Ethicon Inc Surgical suture and method for dyeing
US6273911B1 (en) * 1999-04-22 2001-08-14 Advanced Cardiovascular Systems, Inc. Variable strength stent
CN2902226Y (zh) * 2005-11-09 2007-05-23 王蓉珍 人工心脏支架瓣膜
EP3398560B8 (en) * 2005-12-22 2024-01-10 Boston Scientific Medical Device Limited Systems for surgery and stent valves for replacement
EP3449875B1 (en) * 2008-01-24 2025-10-15 Medtronic, Inc. Stents for prosthetic heart valves
US8652202B2 (en) * 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
AU2010311811B2 (en) * 2009-11-02 2015-09-17 Symetis Sa Aortic bioprosthesis and systems for delivery thereof
US9480557B2 (en) * 2010-03-25 2016-11-01 Medtronic, Inc. Stents for prosthetic heart valves
US8623079B2 (en) * 2010-04-23 2014-01-07 Medtronic, Inc. Stents for prosthetic heart valves
US10617517B2 (en) * 2013-01-14 2020-04-14 Medtronic CV Luxembourg S.a.r.l. Valve prosthesis frames

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060259136A1 (en) * 2005-05-13 2006-11-16 Corevalve Sa Heart valve prosthesis and methods of manufacture and use
US20110172765A1 (en) 2005-05-13 2011-07-14 Medtronic Corevalve Llc Heart Valve Prosthesis and Methods of Manufacture and Use
WO2009149462A2 (en) 2008-06-06 2009-12-10 Edwards Lifesciences Corporation Low profile transcatheter heart valve
CN102481189A (zh) * 2009-06-05 2012-05-30 美敦力Ats医药股份有限公司 带有具有凹入着陆区域的锚固结构的心瓣膜
CN102113921A (zh) * 2009-12-30 2011-07-06 微创医疗器械(上海)有限公司 一种介入式心脏瓣膜
CN101953729A (zh) * 2010-04-19 2011-01-26 杭州启明医疗器械有限公司 一种使用安全的人造瓣膜置换装置及支架
US20120053685A1 (en) * 2010-08-31 2012-03-01 Biotronik Ag Medical valve implant for implantation in an animal body and/or human body
CN102764169A (zh) * 2012-04-19 2012-11-07 杭州启明医疗器械有限公司 人工心脏瓣膜及其瓣膜支架
CN203280540U (zh) * 2013-02-25 2013-11-13 上海微创医疗器械（集团）有限公司 心脏瓣膜假体及用于其的支架

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2959866A4

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3043745B1 (en) 2013-09-12 2020-10-21 St. Jude Medical, Cardiology Division, Inc. Stent designs for prosthetic heart valves
US12156809B2 (en) 2013-09-12 2024-12-03 St. Jude Medical, Cardiology Division, Inc. Stent designs for prosthetic heart valves
EP3275404A4 (en) * 2015-03-26 2018-10-31 Venus MedTech (HangZhou), Inc. Use of safe valve scaffold and valve replacement device with valve scaffold
RU2703649C2 (ru) * 2015-03-26 2019-10-21 Венус Медтех (Ханчжоу), Инк. Стент клапана и устройство для замены клапана с таким стентом
US10537427B2 (en) 2015-03-26 2020-01-21 Venus Medtech (Hangzhou) Inc. Valve stent used safely and valve replacement device having the same
EP3957278A1 (en) * 2015-03-26 2022-02-23 Venus MedTech (HangZhou), Inc. Valve stent and valve replacement device
CN109009568A (zh) * 2017-06-09 2018-12-18 上海微创心通医疗科技有限公司 二尖瓣瓣膜假体、三尖瓣瓣膜假体及其支架
CN109009568B (zh) * 2017-06-09 2023-10-31 上海微创心通医疗科技有限公司 二尖瓣瓣膜假体、三尖瓣瓣膜假体及其支架
CN109793596A (zh) * 2017-11-17 2019-05-24 上海微创心通医疗科技有限公司 瓣膜支架、瓣膜假体和输送装置
CN109793596B (zh) * 2017-11-17 2025-03-28 上海微创心通医疗科技有限公司 瓣膜支架、瓣膜假体和输送装置

Also Published As

Publication number Publication date
EP2959866B1 (en) 2022-11-09
EP2959866A4 (en) 2016-03-02
CN104000672B (zh) 2016-06-15
EP2959866A1 (en) 2015-12-30
CN104000672A (zh) 2014-08-27
US20160000559A1 (en) 2016-01-07

Similar Documents

Publication Publication Date Title
WO2014127750A1 (zh) 心脏瓣膜假体
US12364593B2 (en) Valve prostheses having an integral centering mechanism and methods of use thereof
US11833038B2 (en) Valve prosthesis and method for delivery
JP6990722B2 (ja) 僧帽弁プロテーゼ
CN108366856B (zh) 用于心脏瓣膜假体的经导管植入的递送系统
CN108366857B (zh) 具有作为用于自扩张假体的联接机构和展开机构的可收缩线材的递送系统
CN112336498B (zh) 二尖瓣瓣膜组件
US9339274B2 (en) Paravalvular leak occlusion device for self-expanding heart valves
US10117743B2 (en) Hybrid orientation paravalvular sealing stent
CN203280540U (zh) 心脏瓣膜假体及用于其的支架
EP4406514A2 (en) Aortic bioprosthesis and systems for delivery thereof
US20070282436A1 (en) Stent-valve and deployment catheter for use therewith
WO2019062366A1 (zh) 心脏瓣膜假体
WO2019033989A1 (zh) 心脏瓣膜假体
US10918479B2 (en) Heart valve prosthesis
JP7407482B2 (ja) 構造がフィットする経カテーテル大動脈弁植え込み装置
CN114727872B (zh) 包括缩短补偿器以提高定位精度的瓣膜递送系统
CN115701956A (zh) 具有改进经导管心脏瓣膜定位的分裂远侧尖端的递送系统
HK1244868B (zh) 二尖瓣假体
HK1244868A1 (zh) 二尖瓣假体

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14754475

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 14769991

Country of ref document: US

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 2014754475

Country of ref document: EP