WO2014146557A1 - 一种支架以及具有该支架的安装稳固的人造瓣膜置换装置 - Google Patents

一种支架以及具有该支架的安装稳固的人造瓣膜置换装置 Download PDF

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Publication number
WO2014146557A1
WO2014146557A1 PCT/CN2014/073519 CN2014073519W WO2014146557A1 WO 2014146557 A1 WO2014146557 A1 WO 2014146557A1 CN 2014073519 W CN2014073519 W CN 2014073519W WO 2014146557 A1 WO2014146557 A1 WO 2014146557A1
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WIPO (PCT)
Prior art keywords
stent
head
fixing
bracket
replacement device
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/CN2014/073519
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English (en)
French (fr)
Inventor
雷荣军
张志飞
张启明
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.)
Venus Medtech Hangzhou Inc
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Venus Medtech Hangzhou Inc
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 Venus Medtech Hangzhou Inc filed Critical Venus Medtech Hangzhou Inc
Priority to EP14770011.6A priority Critical patent/EP2977026B1/en
Publication of WO2014146557A1 publication Critical patent/WO2014146557A1/zh
Priority to US14/856,872 priority patent/US10098763B2/en
Anticipated expiration legal-status Critical
Priority to US16/158,597 priority patent/US10806613B2/en
Priority to US17/073,371 priority patent/US11364133B2/en
Ceased legal-status Critical Current

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    • 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
    • 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
    • A61F2250/0037—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 height or in length
    • 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
    • A61F2250/0014—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
    • A61F2250/0051—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 tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
    • A61F2250/0052—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 tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts differing in bone ingrowth capacity

Definitions

  • the present invention relates to the field of medical device technology, and in particular, to a stent and a mounted artificial valve replacement device having the same.
  • heart valve mitral valve, tricuspid valve, aortic valve or pulmonary valve
  • mitral valve tricuspid valve, aortic valve or pulmonary valve
  • pulmonary valve aortic valve or pulmonary valve
  • the variation of heart valves can be divided into open insufficiency and insufficiency. Both of these conditions can cause an increase in cardiac load. Whether the heart can work normally under this load is the main basis for determining whether the heart valve should be replaced.
  • the artificial heart valve implanted by interventional surgery has less trauma to the human body, less invasiveness, and is more widely used.
  • the operation does not open the knife, and makes a small opening of a few millimeters in diameter in the skin of the patient, thereby accessing the vasculature of the human body, establishing a delivery channel, and then delivering the artificial heart valve or stent to the heart through a special delivery system. And replace the defective autologous valve.
  • the prior art artificial heart valve replacement device comprises a mesh stent made of a memory metal material and a unidirectional open trilobal valve sewed in the stent.
  • the stent is divided into aorta.
  • the stent 1, the valve stent 2 and the right ventricle flow tunnel stent 3 are three-part, and a "T"-shaped fixed ear 10 is distributed on the top edge of the stent.
  • the artificial valve replacement device is transported by the delivery system to the implantation site, and the delivery system fixes the valve replacement device to a stent fixation head having a streamlined guide head at the front end of the stent, and the core tube is fixed through the stent
  • the head is connected to the guiding head, and the core tube, the bracket fixing head and the guiding head together form a sheath core.
  • the artificial valve replacement device When the valve is implanted, the artificial valve replacement device is first engaged on the stent fixing head of the conveying device, and the sheath is sheathed
  • the outer part of the core maintains the compressed state of the stent
  • the sheath tube and the sheath core carry the artificial valve replacement device from the entrance of the blood vessel to the valve portion of the lesion, and then release the artificial valve replacement device, and the stent expands under the action of body temperature.
  • the blade of the human valve is pushed onto the vessel wall to complete the position, and then the sheath and sheath core are withdrawn.
  • the artificial valve replacement device Before the artificial valve replacement device is released, it must be firmly installed in the delivery system. If the artificial valve replacement device is accidentally removed, it will seriously threaten the patient's life safety.
  • FIG. 2 shows the structure of a conventional bracket fixing head.
  • the outer wall of the bracket fixing head is provided with a positioning groove 11 when the artificial valve replacement device is installed.
  • the fixed ear anastomosis of the bracket of the artificial valve replacement device is embedded in the positioning groove.
  • the thickness of the bracket fixing ear is generally 0.4 mm, and correspondingly, the positioning groove has a depth of 0.4 mm and a shallow depth.
  • the artificial valve replacement device can be sent to the implantation site due to the complicated vasculature of the delivery system, so when transporting When the system turns, the sheath bends and deforms, and the stent fixing ear easily slides out along the gap, causing the artificial valve replacement device to fall off.
  • the opening of the positioning groove is further provided with a chamfer 12, and the edge around the positioning groove is also provided.
  • the chamfer 13 which further promotes the shedding of the artificial valve replacement device.
  • the stent of the artificial valve replacement device is in a state of being collapsed when not in use, and is a dense tubular structure formed by laser cutting of a memory metal or a non-shape memory alloy, which is swelled in the human body and closely adheres to the blood vessel wall, and if the thickness is increased, Increasing the difficulty of processing will also affect the flexibility and expansion of the stent.
  • the present invention provides a bracket that can be stably mounted on a delivery system without affecting the normal use of the stent.
  • a bracket having a cylindrical structure, the top edge of the bracket being provided with a fixing ear having a neck connected to the top edge of the bracket and a head engaged with the bracket fixing head, the head A bent structure having an increased overall radial thickness.
  • the radial direction of the present invention refers to the radial direction of the stent, and since the stent is a cylindrical structure, the radial thickness refers to the thickness of the head along the radial direction of the stent.
  • the whole or part of the head is a bent structure. After the bent structure is used, the thickness of the head is increased as a whole, and preferably, the ratio of the radial thickness of the bent structure to the neck is 1.2 to 3:1.
  • the radial thickness of the neck can be regarded as the overall thickness of the fixed ear when there is no bending structure in the prior art, and the thickness of the head after bending is increased compared with the neck to prevent the effect.
  • the outer wall of the bracket fixing head is provided with a positioning groove.
  • the gap value is too large (for example: greater than 0.1mm), because the sheath of the stent is a thin-walled polymer material, when subjected to the radial pressing force of the fixed ear head, flexible deformation will occur, so that the sheath of the stent
  • the gap with the bracket fixing head is increased several times in the contact with the fixed ear, which causes the fixing ear to come out of the positioning groove; otherwise, the gap is too small, which will cause excessive axial resistance during loading and releasing of the bracket, which makes the operation difficult. . Therefore, the requirement of the precision of the fit between the stent fixing head and the sheath tube of the stent has become a major problem in the prior art.
  • the present invention adopts a bending structure for fixing the head of the ear, thereby increasing the radial thickness of the head and making it
  • the radial thickness is several times the value of the gap, so that the accuracy requirement for the gap can be greatly reduced, and it can be reliably ensured that the bracket fixing ear does not come out from the bracket fixing head without increasing the axial resistance, so that The bracket is securely mounted in the delivery system.
  • bent structure is formed by laser-engraved stents and does not affect the biological properties of the stent.
  • the form of the bend structure is varied.
  • the entirety of the head is a bent structure, as an alternative, the head is generally curved, with the arcuate depression facing the axis of the stent.
  • the thickness of the head refers to the difference in height between the middle and the ends of the arc in the radial direction.
  • the head is undulating as a whole.
  • the thickness of the head refers to the difference in height between the peak and the trough in the radial direction.
  • the undulating head should have at least two peaks.
  • the undulating crests and troughs are sequentially arranged along the circumference of the stent.
  • the ends of the head abutting the bottom of the positioning groove are trough portions.
  • the portion of the head is a bent structure, as an alternative, the sides of the head are bent toward each other.
  • the two sides of the head When bending, the two sides of the head may be bent toward the same side, or may be bent toward the opposite side.
  • the angle of the bend is usually 160 to 180 degrees, preferably 180 degrees.
  • the radial thickness of the fixed ear is equivalent to twice the thickness before the bend.
  • the top edge of the head is bent towards the neck.
  • the angle of the bend is usually 160 to 180 degrees, preferably 180 degrees.
  • the radial thickness of the fixed ear is equivalent to twice the thickness before the bend.
  • the fixing ear is T-shaped, and the top end of the neck of the fixing ear is connected to the center of the bottom edge of the head.
  • the number of fixed ears can be multiple and evenly distributed on the top edge of the stent.
  • the fixing ears are 2 to 4.
  • the top edges of the plurality of fixed ears are staggered along the projected position on the axis of the stent. That is, the heights of the top edges of the plurality of fixed ears are inconsistent, and the two are not the same, so that when the bracket is fixed to the conveying system, a plurality of fixing ears can be sequentially placed, firstly, the top edge is the highest. The fixed ear is in place first, and then all the fixed ears are placed in order according to the height of the top edge, which is more convenient.
  • the present invention also provides a securely mounted artificial valve replacement device constructed from the stent and a prosthetic valve secured to the stent.
  • the prosthetic valve is a prosthetic tricuspid valve, a prosthetic pulmonary valve, a prosthetic aortic valve, and the like.
  • the prosthetic valve can be sewn to the inner wall of the stent, or it can be fixed by other existing methods.
  • the bracket of the invention overcomes the problem that the bracket is easy to be detached from the bracket fixing head by providing a bending structure, and the bracket can be firmly mounted on the conveying system, and the safety is higher, and at the same time, the release of the bracket is not affected.
  • the bracket of the invention is designed and improved on the basis of the existing bracket, and is simple and convenient, and easy to operate.
  • FIG. 1 is a schematic structural view of a stent of a prior art artificial valve replacement device
  • FIG. 2 is a schematic structural view of a bracket fixing head in the prior art
  • Figure 3 is a cross-sectional view of the stent fixing head of Figure 2;
  • FIG. 4 is a schematic structural view of a stent of the artificial valve replacement device of the present invention.
  • Figure 5 is a schematic structural view of the first type of fixing ear of Figure 4.
  • Figure 6 is a schematic view of the fixing ear assembly of Figure 5 to the delivery system (one of which is coordinated);
  • Figure 7 is a schematic view of the fixed ear assembly of Figure 5 to the delivery system (another manner of cooperation);
  • Figure 8 is a schematic view showing the structure of the second fixing ear of Figure 4.
  • Figure 9 is a schematic view of the fixing ear assembly of Figure 8 to the delivery system (one of which is coordinated);
  • Figure 10 is a schematic view of the fixed ear assembly of Figure 8 to the delivery system (another manner of cooperation);
  • Figure 11 is a schematic view showing the structure of the third fixing ear of Figure 4.
  • Figure 12 is a schematic view showing the structure of the fourth fixing ear of Figure 4.
  • Figure 13 is a schematic exploded view of the artificial valve replacement device of the present invention before release of the stent.
  • the artificial valve replacement device of the present invention consists of a stent and a prosthetic valve fixed to the stent.
  • the artificial valve replacement device of the present invention will be described by taking the aortic stent as an example, but it should be noted that the artificial valve device of the present invention is not limited to the aortic stent, but may be a pulmonary artery stent, a tricuspid valve stent or the like.
  • the stent (aortic stent) is a mesh-like cylindrical structure composed of aortic stent 4, valve stent 5, and flow-channel stent 6 which are sequentially connected.
  • the stent is composed of a plurality of continuously distributed diamond-shaped cell grids, and three hollow regions are distributed on the side wall of the valve stent 5. Due to the angle problem, only the hollow region 9a and the hollow region 9b are seen in the figure, and the hollow region is used for opening the prosthetic valve.
  • the tops of the prosthetic valves are respectively accommodated by the adjacent four diamond-shaped unit meshes, that is, the veins inside the region are removed to form a hollowed-out region, which is convenient for processing and good overall strength.
  • the mesh structure of the bracket is not limited to the diamond shape, and may also have a regular or irregular ellipse, a circle, a rectangle, etc., which can satisfy the support force and compliance of the bracket.
  • the abutment of the aortic stent 4 is provided with a fixing ear 60 for cooperating with the positioning groove of the stent fixing head in the conveying device when being implanted in the human body.
  • the fixing ear 60 is T-shaped, the fixing ear 60 has a neck 601 and a head 602, the neck 601 is connected to the top edge of the aortic stent 4, the head 602 is engaged with the stent fixing head, and the top of the neck 601 of the fixing ear 60 is fixed. Connected to the center of the bottom edge of the head 602, the head 602 also has a bent structure that increases the overall radial thickness.
  • Figure 5 shows a first embodiment of the bent structure of the head of the fixing lug 60 of the present invention
  • the head 602 of the fixing lug 60 is integrally curved in an arc shape, and the arcuate recess is oriented toward the axis of the bracket, thus
  • the overall radial thickness H of the head 602 (the difference in height between the middle and the ends of the arc) is improved.
  • the depth can be adapted to the thickness of the fixed ear head, as shown in FIG. 6, so that even if the sheath tube is bent and deformed, the fixing ear does not easily come out of the positioning groove 8, thereby preventing the support from falling off. .
  • Figure 8 shows a second embodiment of the bending structure.
  • the head 602 of the fixing lug 60 is wavy as a whole, and the wave-shaped crests and troughs are sequentially arranged along the circumferential direction of the bracket, wherein the head 602 abuts. Both ends of the bottom of the positioning groove 8 are trough portions, so that the fixing lug 60 can be more securely fitted in the positioning groove 8 of the bracket fixing head 7.
  • Figures 9 and 10 show the mounted state of the head 602 of the undulating fixed lug 60 in the delivery system when the stent is installed.
  • a third embodiment of the bending structure of the head is that the head 602 of the fixing ear 60 is partially bent, and the two sides of the head 602 are bent toward each other, as shown in FIG. The same side is bent in the opposite direction, the bending angle is 180 degrees, and the thickness of the fixing ear 60 is equivalent to twice before the bending.
  • the two sides of the head are bent toward the opposite sides, and are roughly "S" shaped.
  • Fig. 12 shows a fourth embodiment of the bending structure of the head portion 602 of the present invention
  • the top edge of the head portion 602 is bent toward the neck portion 601
  • the angle of the bending is 180 degrees
  • the thickness of the fixing ear 60 is equivalent to Twice before bending, of course, the bending angle between 160 and 180 degrees can achieve better results.
  • the bending structure of the head 602 of the fixing ear 60 of the present invention is not limited to the above-mentioned several cases, and various modifications can be made.
  • the head 602 of the fixing ear 60 is two.
  • the side edges are only bent once. In fact, the two sides can also be bent twice or more, and the thickness of the multi-layer stack is 3 times or more before the unfolding.
  • the angle of bending or bending of the head can be adjusted according to actual conditions.
  • the fixing ears 60 are usually set to three, as shown in FIG. 13, which are a fixing ear 60a, a fixing ear 60b, and a fixing ear 60c, respectively.
  • the heights of the top edges of the three fixing ears 60 are inconsistent. It can be seen that the fixing ears 60b are significantly higher than the fixing ears 60a, and the fixing ears 60c are significantly higher than the fixing ears 60b.
  • the height H1 of the fixing ear 60c is the distance between the top edge of the aortic stent 4 and the top edge of the fixed ear fixing ear 60c.
  • the height of the fixing ear 60c is 7 mm
  • the height of the fixing ear 60b is 5 mm.
  • the height of the ear 60a is 2.8 mm
  • the height H2 of the bracket (not counting the fixed ear) is 55 mm.
  • the stent of the artificial valve replacement device is in a state of being closed when not in use, and is a dense tubular structure, which is generally formed by laser cutting of a tube of a memory metal material, and enters the human body and releases it at a body temperature.
  • the lower opening forms a fluffy cylindrical structure.
  • the structure of the artificial valve replacement device and the stent thereof is referred to as a structure in a state in which the human body is completely opened.

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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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

一种支架以及具有支架的安装稳固的人造瓣膜置换装置。支架为筒形结构，支架的顶沿设有固定耳（60），固定耳（60）具有与支架顶沿相连的颈部（601）以及与支架固定头卡合的头部（602），头部（602）具有提高整体径向厚度的折弯结构。人造瓣膜置换装置由支架和固定在支架上的假体瓣膜构成。支架通过设置折弯结构，克服了支架易脱出支架固定头的问题，同时，支架的释放也不会受到影响。

Description

一种支架以及具有该支架的安装稳固的人造瓣膜置换装置
本发明涉及医疗器械技术领域，尤其涉及一种支架以及具有该支架的安装稳固的人造瓣膜置换装置。
当病人自身的心脏瓣膜（二尖瓣、三尖瓣、主动脉瓣或肺动脉瓣）由于先天或后天疾病引发变异，造成瓣膜不能正常开闭时，会对健康生活乃至生命造成影响。心脏瓣膜的变异可分为开放不全和关闭不全，这两种情况都可以造成心脏负荷增大，心脏在此负荷下是否还能正常工作是决定人体心脏瓣膜是否应置换的主要依据。
通过介入手术植入人工心脏瓣膜对人体造成的创伤小，侵害性少，应用愈加广泛。该手术在不开刀的情况下，在患者的皮肤内做直径几毫米的小开口，由此通达人体的脉管系统，建立输送通道，再通过专门的输送系统将人工心脏瓣膜即支架输送至心脏并替代有缺陷的自体瓣膜。
现有技术中的人工心脏瓣膜置换装置，由记忆金属材料制成的网状支架，以及缝制在该支架内的可单向开放的三叶瓣膜构成，参见图1，该支架分为主动脉支架1、瓣膜支架2和右心室流进道支架3三部分，在支架的顶沿分布有“T”型的固定耳10。
手术时，人造瓣膜置换装置由输送系统输送到植入位点，输送系统是将造瓣膜置换装置固定在一个支架固定头上，该支架固定头前端带有流线型的引导头，芯管贯穿支架固定头与引导头相连，上述芯管、支架固定头和引导头共同构成了鞘芯，进行瓣膜植入时，首先将人造瓣膜置换装置卡合到输送装置的支架固定头上，鞘管套在鞘芯的外部，保持支架的压缩状态，鞘管、鞘芯携带着人造瓣膜置换装置从血管的入口处推送到病变的瓣膜部位，再释放人造瓣膜置换装置，其支架在体温的作用下会膨胀开，将人体瓣膜的叶片推压到血管壁上完成就位，然后再将鞘管和鞘芯抽出。
在人造瓣膜置换装置被释放以前，其必须稳固的安装在输送系统中，若人造瓣膜置换装置不慎脱出，就会严重威胁患者的生命安全。
在输送系统中，人造瓣膜置换装置固定安装在支架固定头上，图2示出了一种现有的支架固定头的结构，支架固定头的外壁开设有定位槽11，安装人造瓣膜置换装置时，人造瓣膜置换装置的支架的固定耳吻合的嵌入在该定位槽中，现有技术中，支架固定耳的厚度一般为0.4mm，相应的，该定位槽的深度也为0.4mm，深度较浅，由于支架固定头与鞘管的内壁之间会存在0.1~0.2mm左右的间隙，由于输送系统需经过曲折复杂的脉管系统才能将人造瓣膜置换装置送入到植入位点，因此当输送系统转弯时，鞘管弯曲变形，则支架固定耳很容易沿着间隙滑出，造成人造瓣膜置换装置的脱落。
此外，为顺利引导支架的固定耳进入定位槽以及便于手术过程中人造瓣膜置换装置的释放，如图3所示，定位槽的开口处还设有倒角12，定位槽周边的边缘也设有倒角13，这就更加促使人造瓣膜置换装置的脱落。
人造瓣膜置换装置的支架在未使用时是收拢的状态，是致密的管状结构，通过记忆金属或者非形状记忆合金经过激光切割加工而成，在人体内膨胀后紧贴血管壁，若增加厚度不仅增加加工难度，还会影响支架的柔顺性及膨胀性能。
本发明提供了一种支架，可稳固的安装在输送系统上，且不影响支架的正常使用。
一种支架，所述支架为筒形结构，该支架的顶沿设有固定耳，所述固定耳具有与支架顶沿相连的颈部以及与支架固定头卡合的头部，所述头部具有提高整体径向厚度的折弯结构。
若无特殊说明，本发明的径向指支架的径向，由于支架为筒形结构，所述径向厚度是指头部沿着支架的径向方向的厚度。
所述头部的整体或局部为折弯结构。采用折弯结构后，头部在整体上厚度会增加，作为优选，所述折弯结构与颈部的径向厚度之比为1.2~3:1。
颈部的径向厚度可以视为现有技术中无折弯结构时固定耳的整体厚度，头部折弯后厚度比较颈部增加可起到防脱作用。
支架固定头的外壁带有定位槽，支架安装时，固定耳的头部卡合在上述定位槽中，外部由支架的鞘管包围着，支架的鞘管与支架固定头之间是间隙配合，此间隙值过大（如：大于0.1mm），因支架的鞘管是薄壁高分子材料，当受到固定耳头部的径向挤压力时，将产生挠性变形，使支架的鞘管与支架固定头的间隙在与固定耳接触的局部增大数倍，导致固定耳脱出定位槽；反之间隙过小，将导致在支架装载和释放时产生过大的轴向阻力，造成手术操作困难。因此对于支架固定头与支架的鞘管之间的配合精度的要求，成为现有技术的主要难题，本发明采用固定耳的头部的折弯结构，提高了头部的径向厚度，使其径向厚度数倍于此间隙值，因此，可以大幅降低对此间隙的精度要求，且能可靠地保证在不增加轴向阻力的情况下，支架固定耳不会从支架固定头上脱出，使支架稳固的安装在输送系统中。
另外，该折弯结构由激光雕刻完成的支架进行再加工形成，也不会影响支架的生物学性能。
折弯结构的形式多种多样。当所述头部的整体为折弯结构时，作为一种选择方式，所述头部整体上为弧形，弧形的凹陷处朝向支架的轴线。
该处，头部的厚度指在径向上，弧形的中部与两端的高度差。
作为另一选择方式，所述头部整体上为波浪形。
该处，头部的厚度指在径向上，波峰与波谷的高度差。
所述波浪形的头部应至少具有两个波峰。
优选的，波浪形的波峰与波谷沿着支架的周向依次排布。
为使固定耳更加牢靠的嵌装在支架固定头的定位槽中，所述头部抵接定位槽底部的两端为波谷部分。
当所述头部的局部为折弯结构时，作为一种选择方式，所述头部的两侧边相向的折弯。
折弯时，头部的两侧边可以向同侧相向的弯折，也可以向异侧相向的弯折。
折弯的角度通常为160~180度，优选为180度。当折弯的角度为180度时，固定耳的径向厚度相当于折弯前的两倍。
作为另一选择方式，所述头部的顶沿朝向颈部的折弯。
折弯的角度通常为160~180度，优选为180度。当折弯的角度为180度时，固定耳的径向厚度相当于折弯前的两倍。
为便于折弯结构的加工，优选的，所述固定耳为T型，所述固定耳的颈部的顶端与头部底沿的中心处连接。
固定耳的数量可以为多个，均匀的分布在支架的顶沿。优选的，固定耳为2~4个。
优选的，多个固定耳的顶沿在支架的轴线上的投影位置交错分布。即多个固定耳的顶沿的高度是不一致的，且两两不相同，这样的话，在将支架固定到输送系统上的时候，可以依次将多个固定耳就位，首先是顶沿最高的固定耳先就位，然后按照顶沿高度由高到低依次将所有的固定耳就位，更加便利。
本发明还提供了一种安装稳固的人造瓣膜置换装置，由所述的支架和固定在支架上的假体瓣膜构成。
假体瓣膜为假体三尖瓣、假体肺动脉瓣、假体主动脉瓣等。
假体瓣膜可缝制在支架的内壁，也可以采用现有的其他方法进行固定。
本发明的支架通过设置折弯结构，克服了支架易脱出支架固定头的问题，支架可牢固的安装在输送系统上，安全性更高，同时，支架的释放也不会受到影响。
本发明的支架是在现有支架的基础上进行设计改进，简单方便，易于操作。
图1为现有技术中人造瓣膜置换装置的支架结构示意图；
图2为现有技术中支架固定头的结构示意图；
图3为图2中支架固定头的剖视图；
图4为本发明人造瓣膜置换装置的支架的结构示意图；
图5为图4中第一种固定耳的结构示意图；
图6为图5中固定耳装配到输送系统（其中一种配合方式）的示意图；
图7为图5中固定耳装配到输送系统（另一种配合方式）的示意图；
图8为图4中第二种固定耳的结构示意图；
图9为图8中固定耳装配到输送系统（其中一种配合方式）的示意图；
图10为图8中固定耳装配到输送系统（另一种配合方式）的示意图；
图11为图4中第三种固定耳的结构示意图；
图12为图4中第四种固定耳的结构示意图；
图13为本发明人造瓣膜置换装置的支架释放前的展开示意图。
下面结合附图进一步阐释本发明。
本发明人造瓣膜置换装置由支架和固定在支架上的假体瓣膜组成。
以主动脉支架为例说明本发明人造瓣膜置换装置的结构，但应注意本发明的人造瓣膜装置不仅限于主动脉支架，也可以为肺动脉支架、三尖瓣支架等等。
如图4所示，支架（主动脉支架）为由依次连接的主动脉支架4、瓣膜支架5和流进道支架6构成的网状的筒形结构。
支架由连续分布的多个菱形单元网格组成，在瓣膜支架5的侧壁分布有三个镂空区域，由于角度问题，图中仅见镂空区域9a和镂空区域9b，镂空区域用于在假体瓣膜开放时分别容纳假体瓣膜的顶端，由相邻的四个菱形单元网格合并构成，即去掉区域内部的脉络，形成镂空区域，这样的话不仅便于加工，而且整体强度好。
当然，支架的网格结构不仅限于菱形，也可呈有规律或者无规则的椭圆形、圆形、矩形等，满足支架的支撑力和顺应性即可。
主动脉支架4顶沿设有固定耳60，用于植入人体内时与输送装置中支架固定头的定位槽相配合。
固定耳60呈T型，固定耳60具有颈部601和头部602，颈部601与主动脉支架4顶沿相连，头部602与支架固定头卡合；固定耳60的颈部601的顶端与头部602底沿的中心处连接，该头部602还具有提高整体径向厚度的折弯结构。
图5显示了本发明中固定耳60的头部的折弯结构中第一种实施方式，固定耳60的头部602整体弯曲呈弧形，弧形的凹陷处朝向支架的轴线，这样，使得头部602整体径向厚度H（弧形的中部与两端的高度差）得到了提高。当固定耳与定位槽配合时，如图7所示，可以将支架固定头7的定位槽8的深度适度的加深（也可以不加深）后，使固定耳的头部与鞘管14的内壁紧密相贴在一起。当然，将定位槽8加深后，其深度可以与固定耳头部的厚度相适应，如图6所示，这样，即使鞘管弯曲变形，固定耳也不易脱出定位槽8，防止了支架的脱落。
即使定位槽的深度不变，由于头部602整体的径向厚度增加，使该径向厚度数倍于鞘管14与支架固定头7的间隙，仍可以大幅降低对此间隙的精度要求，对鞘管的精度要求也降低了一个数量级，加工工艺更简单易行。
图8显示了折弯结构中第二种实施方式，固定耳60的头部602整体上为波浪形，波浪形的波峰与波谷沿着支架的周向依次排布，其中，头部602抵接定位槽8底部的两端为波谷部分，这样可以使固定耳60更加牢靠的嵌装在支架固定头7的定位槽8内。图9和图10显示了支架安装时，该波浪形的固定耳60的头部602在输送系统中的安装状态。
头部的折弯结构的第三种实施方式为固定耳60的头部602局部折弯，头部602的两侧边相向的折弯，如图11所示，头部602的两侧边向同侧相向的进行弯折，折弯角度为180度，固定耳60的厚度相当于折弯前的两倍。
当然，头部的两侧边向异侧相向的进行弯折，大致呈“S”型。
图12示出了本发明中头部602的折弯结构的第四种实施方式，头部602的顶沿朝向颈部601折弯，折弯的角度为180度，固定耳60的厚度相当于折弯前的两倍，当然，折弯角度在160~180度之间均可达到较好的效果。
显然的，上述图11和图12示出的固定耳与定位槽配合时，也可以采用前述的配合方式（如第一种实施方式），这里不再做具体阐述。
值得注意的是，本发明的固定耳60的头部602的折弯结构并不仅限于上述列举的几种情况，可以做出多种变形，如图11中，固定耳60的头部602的两侧边仅弯折一次，其实该两侧边也可以弯折两次或更多，多层叠加的厚度为未折弯前的3倍或更多。
其次，折弯结构中，头部的弯折或弯曲的角度等均可以根据实际情况进行调整。
固定耳60通常设置为3个，如图13所示，分别为固定耳60a、固定耳60b和固定耳60c。这三个固定耳60的顶沿的高度是不一致的，图中可见，固定耳60b要明显高于固定耳60a，固定耳60c要明显高于固定耳60b。
固定耳60c的高度H1为主动脉支架4的顶沿与固定耳固定耳60c的顶沿之间的距离，本实施例中，固定耳60c的高度为7mm，固定耳60b的高度为5mm，固定耳60a的高度为2.8mm，支架高度H2（固定耳不计算在内）为55mm。
需要说明的是人造瓣膜置换装置的支架在未使用时是收拢的状态，是致密的管状结构，一般是通过记忆金属材料的管材经过激光切割加工而成，而进入人体并释放后会在体温作用下涨开形成蓬松的筒状结构，本发明中如果没有特殊说明，在描述人造瓣膜置换装置及其支架的结构时，均是指在人体内完全涨开状态下的结构。

Claims (10)

  1. 一种支架，所述支架为筒形结构，该支架的顶沿设有固定耳，其特征在于，所述固定耳具有与支架顶沿相连的颈部以及与支架固定头卡合的头部，所述头部具有提高整体径向厚度的折弯结构。
  2. 如权利要求1所述的支架，其特征在于，所述头部的整体或局部为折弯结构。
  3. 如权利要求2所述的支架，其特征在于，所述折弯结构与颈部的径向厚度之比为1.2~3：1。
  4. 如权利要求1~3任一项所述的支架，其特征在于，所述头部整体上为弧形，弧形的凹陷处朝向支架的轴线。
  5. 如权利要求1~3任一项所述的支架，其特征在于，所述头部整体上为波浪形。
  6. 如权利要求1~3任一项所述的支架，其特征在于，所述头部的两侧边相向折弯。
  7. 如权利要求6所述的支架，其特征在于，所述折弯的角度为160~180度。
  8. 如权利要求1~3任一项所述的支架，其特征在于，所述头部的顶沿朝向颈部折弯。
  9. 如权利要求8所述的支架，其特征在于，所述折弯的角度为160~180度。
  10. 一种安装稳固的人造瓣膜置换装置，由如权利要求1~9任一项所述的支架和固定在支架上的假体瓣膜构成。
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US20160000591A1 (en) 2016-01-07
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US10098763B2 (en) 2018-10-16
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US10806613B2 (en) 2020-10-20
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