WO2022188477A1 - 经导管心脏瓣膜输送系统 - Google Patents

经导管心脏瓣膜输送系统 Download PDF

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Publication number
WO2022188477A1
WO2022188477A1 PCT/CN2021/134832 CN2021134832W WO2022188477A1 WO 2022188477 A1 WO2022188477 A1 WO 2022188477A1 CN 2021134832 W CN2021134832 W CN 2021134832W WO 2022188477 A1 WO2022188477 A1 WO 2022188477A1
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WO
WIPO (PCT)
Prior art keywords
outer tube
valve
delivery system
release end
valve prosthesis
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PCT/CN2021/134832
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English (en)
French (fr)
Inventor
钟生平
靳永富
孟春旺
张波
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金仕生物科技（常熟）有限公司
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Application filed by 金仕生物科技（常熟）有限公司 filed Critical 金仕生物科技（常熟）有限公司
Publication of WO2022188477A1 publication Critical patent/WO2022188477A1/zh
Priority to US18/463,363 priority Critical patent/US20230414353A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the present application is in the technical field of cardiac implantation medical devices, and in particular, relates to a transcatheter heart valve delivery system.
  • Transcatheter Valve Replacement is a minimally invasive valve replacement surgery, which refers to placing the assembled valve into the valve through a catheter to replace the original valve and complete the valve replacement in function.
  • the specific implantation process of TVR is: first compress the artificial valve into a set of transcatheter delivery system, and then use the delivery system to move the valve through peripheral blood vessels (such as femoral artery, femoral vein, subclavian artery, abdominal aorta, etc.) or the apex of the heart.
  • peripheral blood vessels such as femoral artery, femoral vein, subclavian artery, abdominal aorta, etc.
  • TVR Delivered to the root of the valve and released, fixed in the valve annulus, and replaced by a prosthetic valve, TVR has become the main treatment for patients with valvular stenosis who cannot tolerate surgery or are at high surgical risk.
  • the outer tube of the delivery system is generally designed to have a distal end face that is perpendicular to the axis and is flush with the axis, because the corresponding valve end face is designed to be a flush end face, while the transcatheter implanted mitral valve emerging in recent years Valves and tricuspid valves often have an irregular release end face, and if an ordinary delivery system perpendicular to the axis of the outer tube is used for delivery and implantation, the beams of the valve stent will jump out one after another during the release process of the valve in the body, and the valve It will dangle during the release process, very unstable, and the surgeon will not be able to control its implantation position, which will bring great difficulties or risks to the operation. There is thus a need to design matching transcatheter heart valve delivery systems.
  • the present application relates to a transcatheter heart valve delivery system to solve the above-mentioned problem that the existing delivery system cannot match the mitral valve valve or the tricuspid valve valve.
  • transcatheter heart valve delivery system which includes:
  • valve prosthesis the valve prosthesis includes a valve release end, and the end face of the valve release end is a non-perpendicular surface to the axis of the valve prosthesis;
  • the outer tube includes an outer tube release end, and the end face of the outer tube release end is a non-perpendicular surface to the axis of the outer tube;
  • the inner tube is retractably penetrated in the outer tube, and a space for accommodating the valve prosthesis is maintained between the inner tube and the outer tube; when the proximal end of the valve prosthesis is stored
  • the shape of the end face of the valve releasing end is the same as or similar to the end face shape of the releasing end of the outer tube.
  • the angle difference between the end surface of the valve release end and the end surface of the outer tube release end and the direction perpendicular to the axis of the outer tube is between 0 and 60 degrees, so as to realize that the valve prosthesis is released in the middle circumference. Release to sync.
  • the requirement of controllable and successive release during the release of the valve prosthesis can be achieved by adjusting the shape of the release end of the outer tube.
  • the release end of the outer tube is a plane or a curved surface that is not perpendicular to the axis of the outer tube.
  • a conical head is also included, the conical head is fixedly connected to the end of the inner tube, and the shape of the contact part of the conical head and the outer tube is the same as that of the outer tube.
  • the shape of the outer tube release end of the tube is consistent to form an abutment surface.
  • the butting surface of the conical head and the distal outer tube is an outer tube release surface, and this surface of the conical head is in the same shape as the release end of the outer tube.
  • the diameters of the outer tube and the conical head are equal at the mutually butting positions, so that the outer surface of the outer tube and the outer surface of the conical head smoothly transition.
  • the outer tube includes a tube wall with at least one layer.
  • the end face edge of the releasing end of the valve prosthesis can be rounded at various positions.
  • the direction is separated from the release end of the delivery system at the same time, so as to ensure the simultaneous deployment of various parts of the proximal end of the valve prosthesis, ensure the positional accuracy of the valve prosthesis in the human body after deployment, and avoid the valve prosthesis in the prior art.
  • the release end is preferentially deployed locally, resulting in the overall deviation of the valve prosthesis.
  • the shape of the release end of the outer tube can also be designed according to the shape of the release end of the valve, so as to meet the specific requirements of successive release of each beam of the valve frame.
  • the end surface of the release end of the outer tube a surface that is not perpendicular to the axis of the outer tube, when the outer tube is rotated, images of different shapes can be obtained from the side of the outer tube, so that the angle of the outer tube can be directly determined. and position, as angular orientation markers during implantation.
  • FIG. 1 is a schematic structural diagram of a transcatheter heart valve delivery system provided by an embodiment of the application;
  • FIG. 2 is a partial enlarged view of a transcatheter heart valve delivery system provided by an embodiment of the application;
  • FIG. 3 is a state diagram of the valve prosthesis after deployment.
  • connection can be a fixed connection, a detachable connection, or an integral Connection, or electrical connection; either directly or indirectly through an intermediary.
  • the valve is an important organ in the process of human blood circulation, which is used to passively open or close to ensure the circulation of blood in one direction. When there is a problem with the valve, it needs to be treated in time, otherwise it is easy to be life-threatening.
  • the patient underwent valve replacement surgery, in which a prosthetic valve was used to replace the native valve. Usually, valve replacement surgery is performed in the heart, and the accuracy of the surgery is very high, especially the positioning accuracy of the release position of the valve.
  • Valve replacement surgery usually relies on a delivery system specially used to deliver valve prostheses.
  • the valve prosthesis is first compressed and stored in the delivery system, and the valve prosthesis is transported to a preset position in the human body through the delivery system, and then can be passed through the delivery system.
  • the control mechanism makes the valve prosthesis gradually release from the release end of the delivery system, and the valve prosthesis can be released from the release end of the delivery system.
  • the valve release end of the valve prosthesis is separated from the release end of the delivery system, the valve prosthesis is completely released. , and fully expand the valve prosthesis at a preset position automatically or through balloon expansion, realizing the replacement of the native valve in the human body.
  • the end faces at the exit of the release end of the existing delivery system are all planes perpendicular to the axis of the outer tube of the delivery system, and this delivery system is only applicable to the valve prosthetic valve whose end face of the release end of the valve is a plane perpendicular to the axis.
  • valve release end of such valve prosthesis 3 is often designed to be non-perpendicular to the axis, and the end face of the release end of the corresponding delivery system should also match the valve release end 31 .
  • this type of valve prosthesis 3 is detached from the release end of the existing delivery system, since the end face at the release end of the existing delivery system is flat, the valve release end 31 of the valve prosthesis 3 has a part of the edge that is first in contact with the delivery system.
  • the valve release end 31 of the valve prosthesis 3 still has some edges that are not separated from the outlet of the delivery system; the valve release end 31 of the valve prosthesis 3 is first separated from the delivery system.
  • the edge will be automatically unfolded first, However, the edges that are not separated from the delivery system are still constrained by the delivery system and cannot be deployed, which results in that the valve release end 31 of the valve prosthesis 3 cannot be unfolded at the same time when it is separated from the delivery system, which is easy to cause the valve prosthesis 3 It is difficult to ensure the positional accuracy of the valve prosthesis 3 in the human body if it is offset to the side that is deployed first, which will cause safety hazards to human health.
  • the present application provides a transcatheter heart valve delivery system, which includes an outer tube 1 , an inner tube 2 and a valve prosthesis 3 .
  • the valve prosthesis 3 includes a valve releasing end 31
  • the end surface of the valve releasing end 31 is a surface that is not perpendicular to the axis of the valve prosthesis 3 .
  • the outer tube 1 includes an outer tube release end 11, and the end face of the outer tube release end 11 is a non-perpendicular surface to the axis of the outer tube 1.
  • the delivery system can be hand-held by medical staff.
  • the release end 11 of the outer tube is the end away from the medical staff.
  • the inner tube 2 is retractably inserted into the outer tube 1, and a space for accommodating the valve prosthesis 3 is maintained between the inner tube 2 and the outer tube 1.
  • the inner tube 2 and the outer tube 1 are coaxially arranged, and the inner tube A space for accommodating the valve prosthesis 3 is formed between the outer wall of 2 and the inner wall of the outer tube 1 .
  • valve release end 31 of the valve prosthesis 3 When the valve release end 31 of the valve prosthesis 3 is accommodated in the above-mentioned space, the shape of the end face of the valve release end 31 of the valve prosthesis 3 is consistent with or similar to the end face shape of the outer tube release end 11 of the outer tube 1 , wherein the valve prosthesis
  • the valve release end 31 of the body 3 refers to the end close to the medical staff.
  • the valve prosthesis 3 can be made of memory metal, and its overall volume after compression becomes smaller, so that it can be accommodated in the space formed between the outer tube 1 and the inner tube 2. At this time, the valve prosthesis 3 has The shape of the end surface of the valve releasing end 31 is the same as the shape of the end surface of the outer tube releasing end 11 of the outer tube 1 .
  • the shape of the end surface of the valve release end 31 of the valve prosthesis 3 is different from the The shape of the end surface of the outer tube release end 11 of the outer tube 1 is the same, so that all positions of the end surface edge of the valve release end 31 of the valve prosthesis 3 can be separated from the outer tube release end 11 of the delivery system at the same time, so as to ensure the valve prosthesis.
  • the various parts of the valve release end 31 are unfolded synchronously, which ensures the positional accuracy of the valve prosthesis 3 in the human body after deployment, and avoids the false valve caused by the partial preferential deployment of the valve release end 31 of the valve prosthesis 3 in the prior art.
  • Body 3 overall offset problem. It can be understood that, in order to enable the transcatheter heart valve delivery system to match valve prostheses 3 with different end face shapes, in order to achieve the purpose of releasing the valve prosthesis 3 in the sequence required by the design, the end face shape of the outer tube release end 11 can be It is designed according to the structural shape of the valve release end 31 of the valve prosthesis 3 to be delivered.
  • the valve prosthesis in the process of delivering the valve prosthesis 3 to the preset position in the human body through the delivery system, if the angle of deployment of the valve prosthesis 3 is deviated, the valve prosthesis needs to be adjusted by rotating the delivery system.
  • the end surface of the outer tube releasing end 11 of the existing outer tube 1 is a plane perpendicular to the axis of the outer tube 1 , and it is difficult to identify the rotation angle of the outer tube 1 in the lateral direction of the outer tube 1 .
  • end-face ultrasound technology or X-ray scanning technology is generally used to assist in judging the angle of the valve prosthesis 3 .
  • a developing point is generally set on the valve prosthesis 3, and the developing point can be made of metal material.
  • the angle of the valve prosthesis 3 is determined.
  • the metal material of the developing point is usually a precious metal material.
  • the end face of the outer tube release end 11 of the outer tube 1 is a plane or curved surface that is not perpendicular to the axis of the outer tube 1, such as an inclined surface, a special-shaped surface, etc.
  • Different shapes of images can be obtained in the lateral direction of the device, so that the angle and position of the outer tube 1 can be directly determined without setting developing points on the outer tube 1, which facilitates the operation and the preparation of the outer tube 1.
  • the angle difference between the end surface of the valve releasing end 31 and the end surface of the outer tube releasing end 11 and the direction perpendicular to the axis of the outer tube 1 is between 0-60 degrees. Within the range of the angle difference, it can be ensured that the end face of the valve release end 31 is effectively fitted with the end face of the outer tube release end 11 .
  • the conical head 4 can be fixed on the end of the inner tube 2, so as to pass the conical head 4 for the transcatheter heart valve.
  • the movement of the conveyor system provides guidance.
  • the contact surface of the conical head 4 and the outer pipe 1 should be as close as possible to avoid the gap formed by the mismatch between the conical head 4 and the outer pipe 1 during the movement of the conveying system. Damage to human tissue, or hinder movement. For this reason, the surface of the conical head 4 in contact with the outer tube 1 should also be designed as an end surface structure consistent with the release end 11 of the outer tube.
  • the end face of the tapered head 4 is also a non-perpendicular face to the axis, and the tapered head 4 is in close contact with the end face of the outer tube release end 11 of the outer tube 1 .
  • the end face of the tapered head 4 can be closely matched with the end face of the release end 11 of the outer tube, so as to seal the valve prosthesis 3 in the outer tube 1 and the inner tube 2 in the space between.
  • the inner tube 2 can be controlled to move relative to the outer tube 1, so that the tapered head 4 is gradually moved away from the release end 11 of the outer tube along with the inner tube 2.
  • valve The prosthesis 3 moves synchronously with the inner tube 2, so that with the inner tube 2 gradually protruding from the release end 11 of the outer tube, when the valve release end 31 of the valve prosthesis 3 is completely separated from the outer tube release end 11, the valve prosthesis 3 can be It is fully deployed and can be separated from the inner tube 2 to complete the valve replacement operation.
  • the shape of the end surface of the conical head 4 is consistent with the shape of the end surface of the outer tube releasing end 11 in order to make the conical head 4 and the outer tube releasing end 11 meet without a gap.
  • the diameters of the outer tube 1 and the conical head 4 are equal at the position where they meet each other, so that the outer surface of the outer tube 1 and the outer surface of the conical head 4 smoothly transition. That is, when the end face of the conical head 4 is aligned with the end face of the release end 11 of the outer tube, the side wall of the conical head 4 and the side wall of the outer tube 1 can form a smooth transition side wall, which is conducive to moving in the body and avoids cause damage to the human body.
  • the outer tube 1 may include at least one layer of tube wall, that is, the tube wall of the outer tube 1 may have only one layer, or may have two, three or more layers. In this embodiment, the tube wall of the outer tube 1 has only one layer.
  • the transcatheter heart valve delivery system may also include a handle assembly 5, and the handle assembly 5 is connected with the inner tube 2, and the medical staff can hold the handle assembly 5. Movement of the inner tube 2 and movement of the transcatheter heart valve delivery system as a whole is controlled.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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

一种经导管心脏瓣膜输送系统，其包括瓣膜假体(3)、外管(1)和内管(2)。瓣膜假体(3)包括瓣膜释放端(31)，瓣膜释放端(31)端面与瓣膜轴线不垂直；外管(1)包括外管释放端(11)，外管释放端(11)端面与瓣膜释放端(31)端面相拟合，两者分别与垂直于外管轴线方向的角度差允许在0到60度之间；内管(2)可伸缩地穿设于外管(1)内，内管(2)与外管(1)之间装有瓣膜假体(3)。瓣膜假体(3)在释放时同时与输送系统分离，从而保证瓣膜假体(3)近端的各处部位同步展开，或按设计顺序释放，保证了瓣膜假体(3)展开后在人体内的位置精度。此外，由于外管释放端(11)的端面与外管轴的不垂直，在外管(1)转动时，从外管(1)的侧向可以获得不同形状的影像，从而可以直接判断出外管(1)的角度和位置，可作为瓣膜安装定向标记。

Description

经导管心脏瓣膜输送系统 技术领域
本申请心脏植入医疗器械技术领域，尤其涉及一种经导管心脏瓣膜输送系统。
背景技术
经导管瓣置换术(Transcatheter Valve Replacement，简称：TVR)是一种微创瓣膜置换手术，指将组装好的瓣膜经导管置入瓣膜，替代原有瓣膜，在功能上完成瓣膜置换。TVR具体的植入过程为：先将人工瓣膜压缩进入一套经导管输送系统中，再利用输送系统通过外周血管(例如股动脉、股静脉、锁骨下动脉活动腹主动脉等)或心尖将瓣膜输送到瓣膜根部并释放，固定在瓣环中，通过人工瓣膜对原生瓣膜进行置换，TVR已成为无法耐受的外科手术或外科手术高危的瓣膜病狭窄患者的主要治疗手段。
目前，输送系统设计的外管一般均是具有与轴垂直且平齐的远端端面，皆因对应的瓣膜端面设计为平齐的端面，而近些年兴起的经导管植入的二尖瓣瓣膜和三尖瓣瓣膜，其结构常为不规则释放端面，而如果用普通的与外管轴线垂直的输送系统进行输送植入，会在瓣膜在体内释放过程中瓣膜支架各梁陆续跳出，瓣膜会在释放的过程中晃来晃去，很不稳定，术者将无法控制其植入位置，给手术带来很大的困难或风险。因而需要设计匹配的经导管心脏瓣膜输送系统。
申请内容
本申请涉及一种经导管心脏瓣膜输送系统，以解决上述现有的输送系统无法匹配二尖瓣瓣膜或三尖瓣瓣膜的问题。
本申请的目的是提供一种经导管心脏瓣膜输送系统，其中，包括：
瓣膜假体，所述瓣膜假体包括瓣膜释放端，所述瓣膜释放端的端面为与所述瓣膜假体的轴线非垂直的面；
外管，所述外管包括外管释放端，所述外管释放端的端面为与所述外管的轴线非垂直的面；
内管，所述内管可伸缩地穿设于所述外管内，且所述内管与所述外管之间保持有用于收纳瓣膜假体的空间；当所述瓣膜假体的近端收纳于所述空间中时，所述瓣膜释放端的端面形状与所述外管释放端的端面形状一致或相近。
在一种可能实现方式中，所述瓣膜释放端的端面、所述外管释放端的端面分别与垂直于外管轴线方向的角度差在0-60度之间，以实现瓣膜假体在释放中周向同步释放。
在一种可能实现方式中，可通过调整外管释放端的形状，实现瓣膜假体释放过程中的可控陆续释放的要求。
在一种可能实现方式中，所述外管释放端为与所述外管的轴线不垂直的平面或曲面。
在一种可能的实现方式中，还包括锥形头，所述锥形头固接于所述内管的端部， 所述锥形头与所述外管相接触部位的形状与所述外管的所述外管释放端的形状相一致，形成对合面。
在一种可能的实现方式中，在收入状态，所述锥形头与远端外管对接面为外管释放面，则锥形头的此面与所述外管释放端形状一致。
在一种可能的实现方式中，所述外管和所述锥形头在相互对合位置处的直径相等，以使所述外管的外侧面与所述锥形头的外侧面平滑过渡。
在一种可能的实现方式中，所述外管包括有至少一层的管壁。
本申请提供的技术方案可以达到以下有益效果：
本申请提供的经导管心脏瓣膜输送系统，通过使瓣膜假体的近端的端面形状与外管的远端的端面形状相同或相近，从而可以使瓣膜假体释放端的端面边缘的各处位置圆周方向同时与输送系统的释放端分离，从而可以保证瓣膜假体近端的各处部位同步展开，保证了瓣膜假体展开后在人体内的位置精度，避免了现有技术中因瓣膜假体的释放端局部优先展开而造成瓣膜假体整体偏移的问题。当然，也可以根据瓣膜释放端的形状，设计外管释放端的形状，以实现瓣膜瓣架各梁的陆续释放的特定要求。此外，通过使外管释放端的端面为不垂直于外管轴线的面，由此，在外管转动时，从外管的侧向可以获得不同形状的影像，从而可以直接判断出外管转过的角度和位置，作为植入过程中的角度定位标记。
应当理解的是，以上的一般描述和后文的细节描述仅是示例性的，并不能限制本申请。
附图说明
图1为本申请实施例提供的经导管心脏瓣膜输送系统的结构示意图；
图2为本申请实施例提供的经导管心脏瓣膜输送系统的局部放大图；
图3为瓣膜假体展开后的状态图。
附图标记：
1-外管；
11-外管释放端；
2-内管；
3-瓣膜假体；
31-瓣膜释放端；
4-锥形头；
5-手柄组件。
此处的附图被并入说明书中并构成本说明书的一部分，示出了符合本申请的实施例，并与说明书一起用于解释本申请的原理。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本申请，并不用于限定本申请。
在本申请的描述中，除非另有明确的规定和限定，术语“第一”、“第二”仅用于描述的目的，而不能理解为指示或暗示相对重要性；除非另有规定或说明，术语“多个”是指两个或两个以上；术语“连接”、“固定”等均应做广义理解，例如，“连接”可以是固定连接，也可以是可拆卸连接，或一体地连接，或电连接；可以是直接相连，也可以通过中间媒介间接相连。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
本说明书的描述中，需要理解的是，本申请实施例所描述的“上”、“下”等方位词是以附图所示的角度来进行描述的，不应理解为对本申请实施例的限定。此外，在上下文中，还需要理解的是，当提到一个元件连接在另一个元件“上”或者“下”时，其不仅能够直接连接在另一个元件“上”或者“下”，也可以通过中间元件间接连接在另一个元件“上”或者“下”。
瓣膜是人体血液循环过程中的一个重要器官，用于被动地打开或关闭，以保证血液向一个方向循环流动。当瓣膜出现问题时需要及时进行治疗，否则容易出现生命危险。患者通过瓣膜置换手术，采用人工瓣膜代替原生瓣膜。通常情况下，瓣膜置换手术在心脏内进行，对于手术的精准度要求非常高，尤其是对于瓣膜的释放位置的定位精度要求。
瓣膜置换手术通常需要依靠一种专门用于输送瓣膜假体的输送系统，瓣膜假体先被压缩收纳于输送系统中，通过输送系统将瓣膜假体运送至人体内预设位置处，然后可以通过控制机构使瓣膜假体从输送系统的释放端逐渐释放，瓣膜假体上可以从输送系统的释放端释放出，当瓣膜假体的瓣膜释放端脱离输送系统的释放端时，瓣膜假体完全释放，并在预设位置处自动或通过球囊扩张将瓣膜假体完全展开，实现了对人体内原生瓣膜的置换。
但是，需要说明的是，现有输送系统的释放端出口处的端面均为与输送系统的外管轴线垂直的平面，这种输送系统仅适用于瓣膜释放端的端面为与轴垂直平面的瓣膜假体，即当瓣膜假体的瓣膜释放端与输送系统的释放端处分离的瞬间，瓣膜假体的瓣膜释放端的边缘可以同时与输送系统的释放端处分离，以保证瓣膜假体展开过程中的位置精度。
然而，对于二尖瓣、三尖瓣等介入瓣膜，这类瓣膜假体3的释放端经常设计成与轴线非垂直的面，相应的输送系统的释放端的端面也应与瓣膜释放端31相匹配。当这类瓣膜假体3从现有输送系统的释放端处脱离时，由于现有输送系统的释放端处的端面为平面，导致瓣膜假体3的瓣膜释放端31存在部分边缘先与输送系统的释放端分离，而瓣膜假体3的瓣膜释放端31仍存在部分边缘未与输送系统的出口处分离；瓣膜假体3的瓣膜释放端31先与输送系统分离的边缘处会优先自动展开，而未与输送系统分离的边缘处仍然会受到输送系统的约束而不能展开，这便导致瓣膜假体3的瓣膜释放端31在与输送系统分离时不能够同时展开，而易造成瓣膜假体3向先展开的一侧偏移，难以保证瓣膜假体3在人体内的位置精度，对人身健康造成安全隐患。
鉴于此，如图1至图3所示，本申请提供了一种经导管心脏瓣膜输送系统，其包括外管1、内管2和瓣膜假体3。其中，瓣膜假体3包括瓣膜释放端31，瓣膜释放端31的端面为与瓣膜假体3的轴线非垂直的面。外管1包括外管释放端11，该外管释放 端11的端面为与外管1的轴线非垂直的面，使用时，该输送系统可以通过医护人员手持操作。该外管释放端11为远离医护人员的一端。
此外，内管2可伸缩地穿设于外管1内，且内管2与外管1之间保持有用于收纳瓣膜假体3的空间，内管2和外管1同轴设置，内管2的外壁与外管1的内壁间形成用于收纳瓣膜假体3的空间。
当瓣膜假体3的瓣膜释放端31收纳于上述空间中时，瓣膜假体3的瓣膜释放端31的端面形状与外管1的外管释放端11的端面形状一致或相近，其中，瓣膜假体3的瓣膜释放端31是指靠近医护人员的一端。该瓣膜假体3可以采用记忆金属制备而成，其在压缩后的整体体积变小，从而可以收纳于上述外管1与内管2之间形成的空间中，此时，瓣膜假体3的瓣膜释放端31的端面形状与外管1的外管释放端11的端面形状相同。
本实施例中，当瓣膜假体3的具有与轴线不垂直端面的瓣膜释放端31从输送系统的外管释放端11出口处脱离时，由于瓣膜假体3的瓣膜释放端31的端面形状与外管1的外管释放端11的端面形状相同，从而可以使瓣膜假体3瓣膜释放端31的端面边缘的各处位置同时与输送系统的外管释放端11分离，从而可以保证瓣膜假体3瓣膜释放端31的各处部位同步展开，保证了瓣膜假体3展开后在人体内的位置精度，避免了现有技术中因瓣膜假体3的瓣膜释放端31局部优先展开而造成瓣膜假体3整体偏移的问题。可以理解的是，为了使该经导管心脏瓣膜输送系统能够匹配具有不同端面形状的瓣膜假体3，以实现根据设计要求的顺序释放瓣膜假体3的目的，外管释放端11的端面形状可以根据待输送的瓣膜假体3的瓣膜释放端31结构形状而进行设计。
此外，需要说明的是，在通过输送系统将瓣膜假体3输送至人体内的预设位置处的过程中，如果瓣膜假体3展开的角度有偏差，则需要通过转动输送系统来调整瓣膜假体3的展开角度。而现有的外管1的外管释放端11的端面为垂直于外管1轴线的平面，在外管1的侧向难以识别出外管1转动的角度。现有一般采用端面超声技术或X光扫描技术来辅助判断瓣膜假体3的角度。为了便于超声或X光对外管1角度的识别，一般在瓣膜假体3上设置有显影点，该显影点可以为金属材质，当超声或X光照射到显影点时，可以根据显影点的位置判断出瓣膜假体3的角度。显影点的金属材料通常为贵金属材料。
而本申请中，外管1的外管释放端11的端面为与外管1的轴线不垂直的平面或曲面，如斜面、异形面等，由此，在外管1转动时，从外管1的侧向可以获得不同形状的影像，从而可以直接判断出外管1转过的角度和位置，而无需在外管1上设置显影点，方便了操作及外管1的制备。
具体地，瓣膜释放端31的端面、外管释放端11的端面分别与垂直于外管1轴线方向的角度差在0-60度之间。在该角度差值范围内，可以保证瓣膜释放端31的端面与外管释放端11的端面有效拟合。
可以理解的是，为了便于该经导管心脏瓣膜输送系统进入人体静脉以及人体内移动，锥形头4可以固接于内管2的端部，以通过该锥形头4为该经导管心脏瓣膜输送系统的移动提供导向。
需要说明的是，锥形头4与外管1相接的面应尽可能的密合一致，以在输送系统 移动过程中，不会因锥形头4与外管1不匹配而形成的间隙损伤人体组织，或导致运动受阻。为此，锥形头4与外管1接触的面，也应设计为与外管释放端11相一致的端面结构。
其中，如图1和图2所示，锥形头4的端面也要为与轴非垂直的面，锥形头4与外管1的外管释放端11的端面密合。在将瓣膜假体3输送至人体内的设定位置之前，锥形头4的端面可以与外管释放端11的端面紧密对合，以将瓣膜假体3封闭于外管1和内管2之间的空间中。而当输送系统达到人体内的预设位置处时，可以控制内管2相对于外管1运动，以使锥形头4随内管2逐渐远离外管释放端11，在此过程中，瓣膜假体3随内管2同步移动，以随着内管2逐渐伸出于外管释放端11，当瓣膜假体3的瓣膜释放端31完全脱离外管释放端11时，瓣膜假体3可以完全展开，并能够与内管2分离，完成瓣膜置换操作。
具体地，为了使锥形头4和外管释放端11对合位置处无缝隙，锥形头4的端面的形状与外管释放端11的端面形状一致。
进一步地，外管1和锥形头4在相互对合位置处的直径相等，以使外管1的外侧面与锥形头4的外侧面平滑过渡。即当锥形头4的端面与外管释放端11的端面对合后，锥形头4的侧壁和外管1的侧壁可以形成平滑过渡的侧壁，有利于在体内移动，避免对人体造成损伤。
此外，外管1可以包括有至少一层的管壁，即外管1的管壁可以只有一层，也可以有两层、三层或者更多层。本实施例中，外管1的管壁仅有一层。
可以理解的是，有些设计可能需要陆续释放瓣膜的释放端各瓣架梁，适当设计本申请所提的外管释放端11的结构，可实现预设计释放顺序。
可以理解的是，为了便于控制内管2在外管1内的运动，该经导管心脏瓣膜输送系统还可以包括手柄组件5，手柄组件5与内管2相连，医护人员可以通过手持手柄组件5来控制内管2的移动以及该经导管心脏瓣膜输送系统整体的移动。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。

Claims (5)

  1. 一种经导管心脏瓣膜输送系统，其特征在于，包括：
    瓣膜假体(3)，所述瓣膜假体(3)包括瓣膜释放端(31)，所述瓣膜释放端(31)的端面为与所述瓣膜假体(3)的轴线非垂直的面；
    外管(1)，所述外管(1)包括外管释放端(11)，所述外管释放端(11)的端面为与所述外管(1)的轴线非垂直的面；
    内管(2)，所述内管(2)可伸缩地穿设于所述外管(1)内，且所述内管(2)与所述外管(1)之间保持有用于收纳瓣膜假体(3)的空间；当所述瓣膜假体(3)收纳于所述空间中时，所述瓣膜假体(3)的所述瓣膜释放端(31)的端面形状与所述外管(1)的所述外管释放端(11)的端面形状一致或相近。
  2. 根据权利要求1所述的经导管心脏瓣膜输送系统，其特征在于，所述瓣膜释放端(31)的端面、所述外管释放端(11)的端面分别与垂直于所述外管(1)轴线方向的角度差在0-60度之间。
  3. 根据权利要求1或2所述的经导管心脏瓣膜输送系统，其特征在于，所述外管释放端(11)的端面为与所述外管(1)的轴线不垂直的平面或曲面。
  4. 根据权利要求1所述的经导管心脏瓣膜输送系统，其特征在于，还包括锥形头(4)，所述锥形头(4)固接于所述内管(2)的端部，所述锥形头(4)与所述外管(1)相接触部位的形状与所述外管(1)的所述外管释放端(11)的形状相一致，形成对合面。
  5. 根据权利要求1所述的经导管心脏瓣膜输送系统，其特征在于，所述外管(1)包括有至少一层的管壁。
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