CN105520792A - D-shaped invasive prosthetic heart valve - Google Patents

D-shaped invasive prosthetic heart valve Download PDF

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Publication number
CN105520792A
CN105520792A CN201610074782.2A CN201610074782A CN105520792A CN 105520792 A CN105520792 A CN 105520792A CN 201610074782 A CN201610074782 A CN 201610074782A CN 105520792 A CN105520792 A CN 105520792A
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China
Prior art keywords
sub
stent
heart valve
bracket
prosthetic heart
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CN201610074782.2A
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Chinese (zh)
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CN105520792B (en
Inventor
虞奇峰
秦涛
王海山
梁玉晨
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上海纽脉医疗科技有限公司
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Publication of CN105520792A publication Critical patent/CN105520792A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448D-shaped rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0034D-shaped

Abstract

The invention provides a D-shaped invasive prosthetic heart valve, which comprises a stent, valve leaflets on the inner side of the stent and a tectorial membrane on the body wall of the stent, wherein the stent includes a first sub stent, a second sub stent and a third sub stent which are sequentially connected; the first sub stent is a net tube, the second sub stent is a net tube with D-shaped cross section, and the third sub stent is a trumpet-shaped net tube; the maximum tube diameter of the first sub stent is equal to the tube diameter of the second sub stent; and the minimum tube diameter of the third sub stent is equal to the tube diameter of the second sub stent. Compared with an existing D-shaped invasive prosthetic heart valve that the stent is designed as a tubular structure with circular cross section, the D-shaped invasive prosthetic heart valve disclosed by the invention, by designing the second sub stent into the net tube with the D-shaped cross section and by forming the second sub stent in correspondence to the shape of an accommodating space surrounded by the protogenetic body wall of orthotopic mitral valve, can avoid the problem of other complications in patients due to compression on the outflow tract of heart when used, so that the success rate of an operation is improved.

Description

一种D形介入式人工心脏瓣膜 A D-shaped invasive heart valve prosthesis

技术领域 FIELD

[0001]本发明涉及医疗器械技术领域,特别涉及一种D形介入式人工心脏瓣膜。 [0001] The present invention relates to the technical field of medical devices, particularly to a D-invasive prosthetic heart valve.

背景技术 Background technique

[0002]心脏是人体非常重要的器官,为人体血液循环提供动力,心脏分为左右两部分,每一部分包含一个心室和心房,心室和心室之间及心房和心房之间通过室间隔和房间隔分割开,在房、室、动脉之间具有防止血液返流的瓣膜。 [0002] The heart is a very important organ of the human body to power blood circulation, the heart is divided into left and right parts, each containing between a ventricular and atrial, ventricular and atrial and ventricular and atrial septal and atrial septal through separated, with a valve to prevent regurgitation of blood between the atrium and ventricle, artery.

[0003] 二尖瓣位于左心房与左心室之间,如同一个单向阀门,保证血液由左心房向左心室方向流动并通过一定流量。 [0003] The mitral valve is located between the left atrium and the left ventricle, as a check valve to ensure flow of blood from the left atrium and the left ventricle through a certain flow direction. 二尖瓣复合体是一组功能和解剖结构复杂的装置,通常认为包括瓣环、瓣叶、腱索和乳头肌。 Mitral complex is a complex set of functional and anatomical structure of the device, generally considered to include an annulus, valve leaflets, chordae tendineae, and papillary muscles. 二尖瓣的功能取决于其生理结构的完整性。 Mitral valve function depends on the integrity of the physical structure. 正常的二尖瓣关闭时,两个瓣叶处在同一个平面且对合密切,能够完全阻挡心室血流的回流。 Normal mitral, two leaflets are in the same plane and of close fit can be completely blocked ventricular blood reflux. 要达到这样的效果,要求二尖瓣环大小合适、瓣叶结构完整、乳头肌收缩牵拉腱索发挥对瓣叶的支撑作用、左心室肌肉收缩产生的关闭力量适当、心室形态及功能正常。 To achieve this effect, the size of the mitral annulus requires a suitable, complete leaflet structure, papillary muscles pulling the chordae play a supporting role in the flap, the closing force of the left ventricle muscle contraction produced by appropriate, normal ventricular function and morphology. 这些因素中任何一个出现异常都可能导致二尖瓣反流(MR)。 Any of these factors could lead to abnormal mitral regurgitation (MR).

[0004]病因最常见为风湿性心脏瓣膜病,女性较多见。 [0004] The most common cause is rheumatic heart disease, more common in women. 其他常见病因包括二尖瓣脱垂、二尖瓣退行性变、二尖瓣环钙化、心肌缺血导致的乳头肌功能衰竭、左心室增大导致的功能性二尖瓣关闭不全、感染性心内膜炎、先天性畸形等。 Other common causes include mitral valve prolapse, mitral valve degeneration, mitral annular calcification, myocardial ischemia caused by papillary muscle failure, left ventricular enlargement functional mitral regurgitation caused by infection of the heart endometritis, congenital malformations. 外科瓣膜置换术手术创伤大,患者的恢复时间长,因此对老年患者常因高龄、体质弱、病变重或合并其它疾病而禁忌手术。 Surgical valve replacement surgeries and long recovery time of patients, so the elderly patients often due to age, physical weakness, disease, or combined with other heavy disease taboo surgery.

[0005]近年来,随着介入治疗技术的进步,经导管心脏瓣膜置换或者修复术得到了快速发展并应用于临床,取得了较为满意的效果。 [0005] In recent years, with the advancement of interventional therapy, transcatheter heart valve replacement or repair has been rapid development and clinical application, and achieved satisfactory results. 通过微创介入手术将介入式人工心脏瓣膜植入到心脏的原位二尖瓣中,以置换或修复损害的天然瓣膜进行相关工作。 Through minimally invasive surgery will involve the artificial heart valve implanted in the mitral valve of the heart in situ, to replace or repair the damage of the natural valve related work. 所述介入式人工心脏瓣膜主要包括支架,及设置于支架内部的瓣叶,手术过程无需开胸,因而创伤小、术后恢复快,针对那些目前常规治疗手段不能延长其生命或缓解其痛苦的心脏瓣膜狭窄患者,提供了一种新的解决办法。 The invasive heart valve prosthesis includes bracket, and the bracket is set inside the leaflet, the surgical process without thoracotomy, and therefore less trauma, quick recovery, can not extend its life for those who are currently or conventional treatments to alleviate their suffering heart valve stenosis, provides a new solution.

[0006]但由于介入治疗技术出现时间较短,应用时还面临着较多的问题。 [0006] However, because the intervention was relatively new technology, application Shihai faced with many problems. 例如一些介入式人工心脏瓣膜在使用时由于支撑力不足,容易断裂;支架与天然瓣膜的生理结构吻合程度不够,容易发生瓣周漏;支架结构容易压迫心脏流出道;支架结构过长过大,伤害心脏;显影点设计不合理,影响手术操作。 For example, some invasive heart valve prosthesis in use due to lack of supporting force, easy to break; physiological structure of the stent and not the degree of fit of the native valve, paravalvular leakage easily occurs; stent structure can be easily compression cardiac outflow tract; long support structure is too large, damage to the heart; developing points unreasonable design, affects the operation. 针对现有的介入式人工心脏瓣膜所存在的问题,本领域技术人员一直在寻找解决的方法。 For existing invasive artificial heart valve problems existing, skilled in the art have been looking for a solution.

发明内容 SUMMARY

[0007]本发明的目的在于提供一种D形介入式人工心脏瓣膜,以解决现有介入式人工心脏瓣膜应用时存在压迫心脏流出道的问题。 [0007] The object of the present invention is to provide a D-invasive prosthetic heart valve, in order to solve the problems of oppression of an existing cardiac outflow tract invasive prosthetic heart valve applications.

[0008]为解决上述技术问题,本发明提供一种D形介入式人工心脏瓣膜,所述介入式人工心脏瓣膜包括:支架、设置于所述支架内侧的瓣叶及设置于所述支架体壁上的覆膜;其中, [0008] To solve the above problems, the present invention provides a D-invasive prosthetic heart valve, the interventional prosthetic heart valve comprising: a stent disposed in the leaflet holder and the inner side is provided in the body wall bracket the film; wherein,

[0009]所述支架包括依次连接的第一子支架、第二子支架及第三子支架,所述第一子支架为网管,所述第二子支架为横截面为D形的网管,所述第三子支架呈喇叭状网管;所述第一子支架的最大管径与所述第二子支架的管径相同,所述第三子支架的最小管径与所述第二子支架的管径相同。 [0009] The bracket comprises a first sub-bracket connected sequentially, the second and third sub-sub-bracket holder, the holder of the first sub-network, the second submount D-shaped cross section of the network, the said third sub-network flared stent; maximum diameter of the same diameter of the first bracket and the second sub-sub-holder, the minimum diameter of the third sub-holder of the second sub-bracket the same diameter.

[0010]可选的,在所述的D形介入式人工心脏瓣膜中,所述第二子支架包括平直体壁及弧形体壁,所述平直体壁和所述弧形体壁相互连接围成横截面为D形的网管,所述第三子支架的体壁相对于所述第二子支架的平直体壁的倾斜角度大于所述第三子支架的体壁相对于所述第二子支架的弧形体壁的倾斜角度。 [0010] Optionally, the D-shaped invasive prosthetic heart valve, the second sub-body wall and the bracket comprises a flat arcuate body wall, said flat wall and the body wall of the arcuate interconnecting cross section surrounded by a D-shaped network, a third sub-body wall bracket with respect to the inclination angle of the body wall of the body wall of the second flat submount is greater than the third sub-bracket relative to the inclination angle of said arcuate wall of the second sub-body bracket.

[0011]可选的,在所述的D形介入式人工心脏瓣膜中,所述第一子支架为圆锥台状网管,所述第一子支架的体壁相对所述第二子支架的体壁倾斜10度〜60度。 [0011] Optionally, the D-shaped invasive prosthetic heart valve, the first sub-network stent frusto-conical shape, with respect to the second sub-body bracket of the first sub-body wall bracket 10 degrees ~ 60 degrees inclined wall.

[0012]可选的,在所述的D形介入式人工心脏瓣膜中,所述第一子支架或所述第二子支架的体壁上设置有倒刺,所述倒刺的自由端沿背离所述第一子支架的自由端的方向倾斜。 [0012] Optionally, the D-shaped invasive prosthetic heart valve, the first sub-body wall bracket or the bracket is provided with a second sub-barb, the barb free end along inclined away from the direction of the free end of the first sub-bracket.

[0013]可选的,在所述的D形介入式人工心脏瓣膜中,还包括显影点,所述显影点设置于所述第三子支架上和/或所述第三子支架上的覆膜上。 [0013] Alternatively, the D-shaped in invasive prosthetic heart valve further includes a developing point, the developing point disposed on the bracket cover to said third sub-carrier and / or the third sub- film.

[0014]可选的,在所述的D形介入式人工心脏瓣膜中,所述显影点的数量为3个,其中2个显影点设置于与所述第二子支架的平直体壁连接的所述第三子支架上,另外I个显影点设置于与所述第二子支架的弧形体壁连接的所述第三子支架的覆膜上。 [0014] Optionally, the D-shaped invasive prosthetic heart valve, the number of developing three points, of which two points provided on the developing body connected to the flat wall of the second sub-bracket on the third sub-frame, a developing additional points I disposed on the film-arc wall and the second bracket is connected to the third sub-sub-bracket.

[0015]可选的,在所述的D形介入式人工心脏瓣膜中,所述瓣叶的数量为至少两片。 [0015] Optionally, the D-shaped invasive prosthetic heart valve, the leaflet of the number is at least two.

[0016]可选的,在所述的D形介入式人工心脏瓣膜中,所述瓣叶为生物组织、高分子材料制备的瓣膜或组织工程瓣膜。 [0016] Optionally, the D-shaped invasive prosthetic heart valve, the leaflet is a biological tissue, tissue engineered valves, or valve produced polymer material.

[0017]可选的,在所述的D形介入式人工心脏瓣膜中,所述第一子支架或所述第二子支架上设置有瓣叶缝合孔,通过所述瓣叶缝合孔将所述瓣叶缝合于所述支架上。 [0017] Optionally, the D-shaped invasive prosthetic heart valve, said stent or said first sub-leaflet suture hole provided on the second sub-bracket, through the leaflet The suture hole said flap sutured on the stent.

[0018]可选的,在所述的D形介入式人工心脏瓣膜中,所述支架的材质为镍钛合金,所述覆膜的材质为PET、e-PTFE、心包材料中的一种或多种。 [0018] Optionally, the D-shaped invasive prosthetic heart valve, the material of the stent is a nitinol, the coating film is made of PET, e-PTFE, the material of one or pericardial variety.

[0019]在本发明所提供的D形介入式人工心脏瓣膜,所述D形介入式人工心脏瓣膜包括支架、设置于支架内侧的瓣叶及设置于支架体壁上的覆膜,支架包括依次连接的第一子支架、第二子支架及第三子支架,第一子支架为网管,第二子支架为横截面为D形的网管,第三子支架呈喇叭状网管;第一子支架的最大管径与第二子支架的管径相同,第三子支架的最小管径与第二子支架的管径相同。 [0019] In the present invention provides the D-intrusive prosthetic heart valve, the D-invasive prosthetic heart valve comprising a stent-graft, the stent disposed on the inner side of the flap and is provided on the wall of the holder body, the holder comprising sequentially the first sub-bracket connection bracket and a second sub third sub-frame, the first sub-network of the stent, the stent of the second sub-section D-shaped cross-network, the third sub-network flared stent; a first submount the same the same diameter and the maximum diameter of the second submount, the submount third diameter and the second diameter of the smallest sub-holder. 通过将第二子支架设计为横截面为D形的网管,与现有的D形介入式人工心脏瓣膜中支架设计为截面为圆形的管状相比,所述第二子支架的形状与原位二尖瓣的原生体壁围成的容置空间形状相吻合,从而在使用时避免其对心脏流出道的压迫造成患者出现其他的并发症的问题,提高了手术的成功率。 By comparison to the second sub stent design D-shaped in cross-section network, the conventional D-invasive prosthetic heart valve stent in a circular cross section designed as a tubular shape of the stent and the second sub-primary bit body wall native mitral valve accommodating space enclosed shape coincide, thus avoiding pressure on the heart outflow tract which cause problems in patients with other complications, improve the success rate of the procedure in use.

附图说明 BRIEF DESCRIPTION

[0020]图1是本发明一实施例中D形介入式人工心脏瓣膜植入到心脏的原位二尖瓣后的结构示意图; [0020] FIG. 1 is a schematic view of the embodiment D-situ mitral prosthetic heart valve implantation invasive to the heart of the present invention, an embodiment;

[0021]图2是本发明一实施例中D形介入式人工心脏瓣膜的支架的主视图; [0021] FIG. 2 is a front view of the embodiment D-invasive prosthetic heart valve stent to an embodiment of the present invention;

[0022]图3是本发明一实施例中D形介入式人工心脏瓣膜的支架覆膜后的主视图; [0022] FIG. 3 is a front view of the embodiment D-invasive prosthetic heart valve stent embodiment of the present invention, a coating film;

[0023 ]图3a是图3的支架的内部缝合有瓣叶后的俯视图。 [0023] FIG. 3a is an internal stent of Figure 3 is a plan view of the stitching leaflet.

[0024]图中:支架I;瓣叶2;覆膜3;第一子支架1;第二子支架11 ;瓣叶缝合孔110;平直体壁111;弧形体壁112;第三子支架12;倒刺4;输送连接部件5;显影点6。 [0024] FIG: scaffold I; leaflet 2; 3 film; a first sub-holder 1; a second sub-holder 11; leaflet suture hole 110; straight body wall 111; 112 arcuate body wall; third sub bracket 12; barbs 4; 5 delivery connection member; a developing point 6.

具体实施方式 Detailed ways

[0025]以下结合附图和具体实施例对本发明提出的D形介入式人工心脏瓣膜作进一步详细说明。 [0025] and in conjunction with the following specific embodiments of the present invention is made D-shaped invasive prosthetic heart valve will be further described in detail accompanying drawings. 根据下面说明和权利要求书,本发明的优点和特征将更清楚。 The following description and the appended claims, features and advantages of the present invention will be apparent. 需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。 It should be noted that the drawings are used in a very simplified form and are using a non-precise proportion, only to facilitate, assist clarity purpose of illustrating an embodiment of the present invention.

[0026]在具体说明本发明之前,在此先说明本发明之主要原理与思想。 [0026] Before the present invention is specifically described, in this first described the main principle idea of ​​the present invention. 针对现有的现有介入式人工心脏瓣膜应用时存在压迫心脏流出道的问题,本发明的发明人经过长期的实验验证发现,导致上述现象的原因在于,由于现有的介入式人工心脏瓣膜的支架结构为管状,由于容置介入式人工心脏瓣膜的空间的截面形状并非是圆形,而是D形,因此在支架为管状的介入式人工心脏瓣膜置入心脏的原位二尖瓣中后,会对容置空间平直的侧壁造成压迫,致使心脏的流出道变得狭窄。 For problems oppression cardiac outflow tract of an existing conventional invasive artificial heart valve application, the inventors of the present invention after long-term experiments found that cause the above behavior occurs because, due to the existing invasive artificial heart valve tubular stent structure, since the sectional shape of the accommodating space intervening artificial heart valve is not circular, but the D-shaped, so in situ after invasive mitral prosthetic heart valve implantation tubular stent of the heart , would accommodating space straight side walls caused by oppression, resulting in the outflow tract of the heart become narrow. 基于这一问题的发现,提出了本发明的技术方案,本发明的技术方案主要从支架的形状设计出发进行的。 Based on the discovery of this problem, a technique of the present invention, the main aspect of the present invention, starting from the shape of the stent design performed.

[0027]图1为本发明的D形介入式人工心脏瓣膜植入到心脏的原位二尖瓣后的结构示意图。 [0027] FIG 1 D-shape of the present invention invasive prosthetic heart valve implanted in the schematic view of the mitral valve of the heart in situ. 图2是本发明D形介入式人工心脏瓣膜的支架的主视图。 FIG 2 is a D-invasive present invention is a front view of a prosthetic heart valve stent. 图3为本发明一实施例中D形介入式人工心脏瓣膜的支架覆膜后的主视图。 FIG 3 a front view of the embodiment D-invasive prosthetic heart valve stent coating an embodiment of the present invention. 图3a为图3的支架的内部缝合有瓣叶后的俯视图。 FIG 3a is a plan view of the internal leaflet suture holder of Figure 3. 如图2、图3-图3a所示,本发明的D形介入式人工心脏瓣膜包括:支架1、设置于所述支架I内侧的瓣叶2及设置于所述支架I体壁上的覆膜3;其中,所述支架I包括依次连接的第一子支架10、第二子支架11及第三子支架12,所述第一子支架10为网管,所述第二子支架11为横截面为D形的网管,所述第三子支架12呈喇叭状网管;所述第一子支架10的最大管径与所述第二子支架11的管径相同,所述第三子支架12的最小管径与所述第二子支架11的管径相同。 2, FIG. 3 to FIG. 3a, D-shape of the present invention invasive prosthetic heart valve comprising: a stent, the stent disposed on the inner leaflet of I 2 and I is provided in said holder body wall overlying 3 film; wherein the bracket comprises a first sub-I in turn connected to the bracket 10, the bracket 11 and the second sub third sub-bracket 12, the bracket 10 of the first sub-network, the second sub-bracket 11 is a cross- D-shaped cross-section network, the third sub-carrier 12 flared network; maximum diameter of the first sub-bracket 10 and the second diameter is the same submount 11, the third sub-carrier 12 the minimum diameter and the second diameter 11 of the same submount.

[0028] 请参考图3,所述第二子支架包括平直体壁111及弧形体壁112,所述平直体壁111和所述弧形体壁112相互连接围成横截面为D形的网管,从而使得制备的D形介入式人工心脏瓣膜的结构形貌符合容置D形介入式人工心脏瓣膜的空间的截面形状,避免由于支架结构不合理造成对心脏流出道的压迫;其中,所述第三子支架的体壁相对于所述第二子支架的平直体壁111的倾斜角度大于所述第三子支架的体壁相对于所述第二子支架的弧形体壁112的倾斜角度,进一步顺应原生组织的形貌分布,避免第三子支架结构对心脏组织造成的损伤。 [0028] Please refer to FIG. 3, the second submount comprises a body wall 111 and an arcuate wall 112 flat member, said flat member and said arcuate wall 111 interconnecting the body wall 112 enclosed cross section D NM-shaped, D-shaped so that the preparation of invasive prosthetic heart valve structure or morphology compliance sectional shape of the space accommodating the D-invasive prosthetic heart valve, the support structure of unreasonable avoid pressure on the heart outflow tract; wherein , the third sub-body wall bracket with respect to the flat wall of the second sub-body bracket 111 is greater than the angle of inclination of the body wall relative to the third sub-holder of the second sub-arc wall bracket the inclination angle 112, and further conform to the topography of the distribution of the native tissue, the third sub-frame structure to avoid damage to the cardiac tissue caused. 实际应用时,D形介入式人工心脏瓣膜置入心脏的原位二尖瓣中后,第二子支架的平直体壁靠近心脏流出道一侧。 When practical, D-shaped invasive mitral prosthetic heart valve of the heart in situ after implantation, the body wall of the second flat submount side close to the heart outflow tract.

[0029]进一步地,这里将所述第一子支架为圆锥台状网管,从而减少整个支架的长度,避免植入心脏后,支架过长对心脏周围组织的伤害。 [0029] Further, where the first sub-network stent frusto-conical shape, thereby reducing the overall length of the stent, after implantation to avoid heart, long stents of damage to tissue surrounding the heart.

[0030]请参考图2,所述第一子支架10、第二子支架11及第三子支架12三者共轴,三者的区别在于形状不同。 [0030] Please refer to FIG 2, the first sub-bracket 10, the bracket 11 and the second sub third sub-frame 12 three coaxial, that the difference between the three different shapes. 实际制备支架时,是采用同一原始网管,将原始网管分为三段进行塑形工艺,制备第二子支架11时,将该段原始网管塑性为横截面为D型的网管,第一子支架10是将原始网管的一端的边缘沿原始网管的径向收缩,呈现出如图2中标号为10部分的形状,这里所述第一子支架10的体壁相对所述第二子支架11的体壁倾斜的角度Θ为10度〜60度,优选为30度。 When preparing the actual stent, the NMS is the use of the same original, the original network is divided into three segments shaping process, the preparation of the second sub-holder 11, the original network segment as the plastic cross-section D-type network, a first sub-bracket 10 is an end edge of the original network of the network of the original radially contracted, as shown in FIG. 2 showing a portion of the reference numeral 10 is a shape where the second sub-bracket 11 relative to the wall of the first sub-body stent 10 body wall angle of inclination Θ of 10 degrees ~ 60 degrees, preferably 30 degrees.

[0031]请参考图2及图3,在所述第一子支架10或所述第二子支架11的体壁上设置有倒刺4,所述倒刺4的自由端沿背离所述第一子支架10的自由端的方向倾斜,倒刺4与第一子支架10或所述第二子支架11的体壁之间的角度为10度〜80度,优选的60度。 [0031] Please refer to FIG. 2 and FIG. 3, the first sub-bracket 10 or the second sub-body wall 11 is provided with a barb holder 4, a direction away from the barb free end 4 of the a sub direction of the free end of the bracket 10 is inclined, the angle between the wall of the body 4 and the barbs of the first bracket 10 or the second sub-sub-bracket 11 is 10 degrees ~ 80 degrees, preferably 60 degrees. 所述倒刺的长度为3mm〜I Omm。 The barb length 3mm~I Omm. 应用时,倒刺4刺入瓣膜周围的组织,起到定位D形介入式人工心脏瓣膜的作用。 When applied, the barbs 4 inserted into the tissue surrounding the valve, the D-shaped positioning functions invasive prosthetic heart valve effect. 这里,倒刺4的数量为多个,多个所述倒刺4均匀分布在第一子支架10或第二子支架11的外周。 Here, the number 4 is a plurality of barbs, the plurality of barbs 4 evenly distributed periphery of the first bracket 10 or the second sub-sub-bracket 11.

[0032]具体的,本实施例中的D形介入式人工心脏瓣膜可沿其径向伸缩,在安装输送D形介入式人工心脏瓣膜时,为了便于与目标组织紧密贴合,以形成充足的血流通道,本发明将上述第二子支架和所述第三子支架的结构相配合的结构设计为与天然瓣膜的生理结构相吻合(尤其与二尖瓣的周围组织的天然生理结构相吻合),从而使其具有一定的自定位功能,便于快速准确地定位释放,且释放后支架紧密贴合血流通道,不易发生移位,同时该结构与周围组织配合便于覆膜形成封堵结构,有利于避免瓣周漏。 [0032] Specifically, the present embodiment of the embodiment D-invasive heart valve prosthesis in its radially retractable, when the D-shaped conveyor mounted invasive prosthetic heart valve, in order to facilitate close contact with the target tissue, sufficient to form blood flow passageway, the present invention said second bracket and the third sub-sub-structure scaffold structure designed to cooperate coincide with the physical structure of the native valve (especially a mitral valve and the surrounding tissue structure consistent natural physiologically ), so that it has a certain self-locating features for quick release of accurate positioning, and the close contact with the stent released after blood flow passageway, displacement hardly occurs, while the complex structure and the surrounding tissue to facilitate closure structure coating formation, It helps to avoid PVL.

[0033]实际应用时,D形介入式人工心脏瓣膜是容置于输送装置中植入患者体内,当到达目标位置时,释放D形介入式人工心脏瓣膜,此时D形介入式人工心脏瓣膜的支架会由压缩状态迅速撑开,如图1所示可知,D形介入式人工心脏瓣膜释放后第一子支架位于心室,第三子支架位于心房中,所述第三子支架作为血液的进血口,第一子支架作为血液的出血口,由于第三子支架的管径大于所述第二子支架的管径,当因心脏舒张时天然板环组织可对第三子支架起到阻挡作用防止D形介入式人工心脏瓣膜向心室内滑落,而当心脏收缩时,由于倒刺的作用又可阻止D形介入式人工心脏瓣膜向心房移动,因此基于本发明的支架结构,可以更有效地防止D形介入式人工心脏瓣膜释放后在血流压力和冲刷下发生移位,延长了D形介入式人工心脏瓣膜释放后的使用寿命,降低了其 [0033] The practical application, D-invasive prosthetic heart valve delivery apparatus is accommodated implanted in a patient, when the target position is reached, the release of D-invasive prosthetic heart valve, this time D-invasive prosthetic heart valve rapidly stretched by the stent in a compressed state, shown in FIG apparent 1, D form a first sub-invasive heart valve prosthesis after release bracket located ventricle, atrium located in the third sub-bracket, the third submount as blood blood inlet port, a first port sub-bracket as bleeding of blood, since the diameter of the stent is greater than the third sub-sub-second stent diameter, the native annulus tissue sheet may be holder for the third sub-diastolic functions because when barrier effect to prevent the D-shaped slide invasive prosthetic heart valve to the heart chamber when the heart contracts, but also to prevent the action of a D-shaped barbs invasive prosthetic heart valve is moved to the atrium, the present invention is thus based on the stent structure, it may be more effectively prevent displacement occurs at the pressure of blood flow and scour D-invasive prosthetic heart valve is released, extending the life of the D-invasive prosthetic heart valve is released, reducing their 周围组织的伤害。 Damage to surrounding tissue.

[0034]如图3a所示,可获知瓣叶2的分布位置及其形状,本实施例中,所述瓣叶2的数量为至少两片,所述瓣叶为生物组织(如猪心包、牛心包、猪心瓣、牛心瓣等)、高分子材料制备的瓣膜或组织工程瓣膜。 As shown in [0034] Figure 3a, is known shape and position of the distribution flap 2, in the present embodiment, the number of the leaflet 2 is at least two, the leaflet is a biological tissue (e.g., porcine pericardium, bovine pericardium, porcine heart valves, bovine heart valves, etc.), tissue engineered valves, or valve produced polymer material. 其中,所述瓣叶包括矩形部和与所述矩形部连接的弧形部,采用该形状的瓣叶便于配合缝合,且所得瓣膜的血流动力学效果好。 Wherein said leaflet includes an arcuate portion and a rectangular portion connected to said rectangular portion, this shape is adopted to facilitate mating leaflet suture, and good hemodynamic effects resulting valve. 其中,如图2所示,为了将瓣叶设置于所述支架中,本发明在所述第一子支架或所述第二子支架上设置有瓣叶缝合孔110,通过所述瓣叶缝合孔110将所述瓣叶缝合于所述支架上。 Wherein, as shown, disposed in the order of the leaflet holder, the present invention is disposed on the first sub-2 or the holder with a second submount leaflet suture holes 110, through the leaflet suture the hole 110 in the leaflet suture holder.

[0035]进一步地,请参考图2及图3,为了便于D形介入式人工心脏瓣膜在输送阶段与输送装置结合,在所述第一子支架的自由端设置有输送连接部件5,所述输送连接部件5的数量至少为2个。 [0035] Furthermore, refer to FIG. 2 and FIG. 3, for convenience of D-invasive prosthetic heart valve delivery means in combination with the feed phase, the connection member 5 is provided with a conveyor at the free end of the first sub-bracket, the number of delivery connection member 5 is at least two.

[0036]请参考图2及图3a,为了满足定位及观测D形介入式人工心脏瓣膜的位置,在所述第三子支架上和/或所述第三子支架上的覆膜上设置有显影点6,所述显影点6的数量为3个,其中2个显影点设置于与所述第二子支架的平直体壁连接的所述第三子支架上,另外I个显影点设置于与所述第二子支架的弧形体壁连接的所述第三子支架的覆膜上,3个显影点构成一个平面,在D形介入式人工心脏瓣膜置入心脏时到达于目标位置时,设置在平直体壁连接的所述第三子支架上的两个显影点在同一条直线上,观测显示为同一个点。 [0036] Please refer to FIG. 2 and FIG. 3a, in order to meet the positioning and observation of D-invasive prosthetic heart valve position, is provided on the film on the stand and / or on the third sub-holder has the third sub developing point 6, the developing amount is three points 6, wherein the developing two points disposed on said flat body connected to the wall of the second sub third sub stent scaffold, further developing the I point setting the arcuate member to the second wall and the sub-bracket is connected on the third sub-covered stents, three points constitute a development plane, when arriving at the target position D-invasive cardiac prosthetic heart valve implantation , the two points provided on the developing body of said flat wall connected to the third sub-holder in the same line, is shown as the same observation point. 具体的,若显影点6设置于第三子支架上,则所述第三子支架上的外壁上需设置有显影孔,所述显影孔中填充有显影介质;若显影点6设置于覆膜中,则在需要设置显影点6的位置的覆膜材料中添加显影介质。 Specifically, if the developing point 6 disposed on the third sub-frame, on the outer wall of the holder is provided with a developing third sub required hole, the hole is filled with developing a developing medium; if the coating film 6 is provided a developing point adding a developing medium, we need to set the position of the developing film material 6 points. 上述显影介质为铂铱合金(Pt/Ir)、铂金属(Pt)、钽金属(Ta)中的一种或多种。 The developing medium is a platinum-iridium alloy (Pt / Ir), platinum (Pt), tantalum (Ta) of one or more.

[0037]较佳的,所述支架的材质为镍钛合金,所述覆膜的材质为PET、e_PTFE、心包材料中的一种或多种。 [0037] Preferably, the material is a nitinol stent, the coating is made of PET, e_PTFE, pericardial one or more materials.

[0038]优选的,将所述第二子支架的圆柱状网管的网格形状设计为菱形,以提高D形介入式人工心脏瓣膜在使用中支撑力,避免出现由于支撑力不足导致支架的断裂的问题。 [0038] Preferably, the cylindrical shape of the mesh network of the second diamond submount designed to increase the support force D-invasive heart valve prosthesis in use, to avoid breakage due to the lack of supporting force cause the stent to appear The problem.

[0039]综上,在本发明所提供的D形介入式人工心脏瓣膜中,所述D形介入式人工心脏瓣膜包括支架、设置于支架内侧的瓣叶及设置于支架体壁上的覆膜,支架包括依次连接的第一子支架、第二子支架及第三子支架,第一子支架为网管,第二子支架为横截面为D形的网管,第三子支架呈喇叭状网管;第一子支架的最大管径与第二子支架的管径相同,第三子支架的最小管径与第二子支架的管径相同。 [0039] In summary, the present invention provides the D-intrusive prosthetic heart valve, the D-invasive prosthetic heart valve comprising a stent, the stent disposed on the inner side of the flap and arranged covered in a wall of the holder body , a first bracket support includes sub sequentially connected, a second and a third sub-sub-holder bracket, the bracket of the first sub-network, the second submount D-shaped cross section of the network, as a trumpet-shaped stent third sub-network; the same maximum diameter the same as the first diameter of the second sub-sub-holder bracket, the third sub-minimal stent diameter and a second diameter submount. 通过将第二子支架设计为横截面为D形的网管,与现有的D形介入式人工心脏瓣膜中支架设计为截面为圆形的管状相比,所述第二子支架的形状与原位二尖瓣的原生体壁围成的容置空间形状相吻合,从而在使用时避免其对心脏流出道的压迫造成患者出现其他的并发症的问题;另一方面,本发明中第一子支架设计为圆锥台状网管,缩短了支架总体长度,避免了由于支架过长刺入周围心脏组织对心脏造成的伤害,提高了手术的成功率;另一方面,由于所述第一子支架或所述第二子支架的体壁上设置有倒刺,倒刺在心脏瓣膜被植入到特定位置后能够刺入瓣膜周围的组织,起到定位作用,使得D形介入式人工心脏瓣膜释放后不易发生移位和瓣周漏;另一方面,基于本发明显影点设置的位置较为合理,符合手术的需求。 By comparison to the second sub stent design D-shaped in cross-section network, the conventional D-invasive prosthetic heart valve stent in a circular cross section designed as a tubular shape of the stent and the second sub-primary bit body wall native mitral valve accommodating space enclosed shape coincide, thus avoiding pressure on the heart outflow tract which cause problems in patients with other complications in use; another aspect, the present invention, a first sub- stent design network frusto-conical shape, shortening the overall length of the stent, the stent avoids long piercing tissue around the heart caused by damage to the heart, improve the success rate of surgery; on the other hand, since the first submount or after the body wall is provided with a second submount barbs, the barbs in the heart valve is implanted after a particular position can be inserted into the tissue surrounding the valve, play the role of positioning, so that the D-shaped release invasive prosthetic heart valve and shift paravalvular leakage hardly occurs; on the other hand, based on the set point position of the developing of the present invention is more reasonable, to meet the needs of the operation.

[0040]上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。 [0040] The above description is a description of the preferred embodiments of the present invention, and are not in any limiting the scope of the present invention, the art of the present invention of ordinary skill in the art to make according to the above disclosure of any change, modification, all fall within the scope of the claims .

Claims (10)

1.一种D形介入式人工心脏瓣膜,其特征在于,包括:支架、设置于所述支架内侧的瓣叶及设置于所述支架体壁上的覆膜;其中, 所述支架包括依次连接的第一子支架、第二子支架及第三子支架,所述第一子支架为网管,所述第二子支架为横截面为D形的网管,所述第三子支架呈喇叭状网管;所述第一子支架的最大管径与所述第二子支架的管径相同,所述第三子支架的最小管径与所述第二子支架的管径相同。 A D-invasive prosthetic heart valve, wherein, comprising: a bracket provided on the flap and is provided on the holder body covered wall inside the stent; wherein the stent comprises sequentially connected a first sub-frame, a second sub-bracket and the third sub-frame, the first sub-network is a stent, the stent is a second sub-section D-shaped cross-network, the third sub-network flared stent ; maximum diameter of the first bracket and the second sub-sub same stent diameter, the minimum diameter of the same diameter and the third sub-holder of the second submount.
2.如权利要求1所述的D形介入式人工心脏瓣膜,其特征在于,所述第二子支架包括平直体壁及弧形体壁,所述平直体壁和所述弧形体壁相互连接围成横截面为D形的网管,所述第三子支架的体壁相对于所述第二子支架的平直体壁的倾斜角度大于所述第三子支架的体壁相对于所述第二子支架的弧形体壁的倾斜角度。 2. D-1 according to claim invasive prosthetic heart valve, wherein the second sub-body wall bracket comprises a flat arcuate body wall and said flat wall and the said arcuate member the inclination angle of walls connected to one another enclose a D-shaped cross-section network, the third sub-body wall bracket with respect to the flat wall of the second sub-body is greater than the stent body wall bracket with respect to the third sub the arcuate angle of inclination of the body wall of the second submount.
3.如权利要求1所述的D形介入式人工心脏瓣膜,其特征在于,所述第一子支架为圆锥台状网管,所述第一子支架的体壁相对所述第二子支架的体壁倾斜10度〜60度。 3. D-1 according to claim invasive prosthetic heart valve, wherein the first sub-network stent frusto-conical shape, the first sub-body wall relative to said second bracket submount body wall is inclined 10 degrees ~ 60 degrees.
4.如权利要求1所述的D形介入式人工心脏瓣膜,其特征在于,所述第一子支架或所述第二子支架的体壁上设置有倒刺,所述倒刺的自由端沿背离所述第一子支架的自由端的方向倾斜。 4. The free end of the D-1 according to claim invasive prosthetic heart valve, characterized in that the first sub-body wall bracket or the bracket is provided with a second sub-barb, the barb along inclined away from the direction of the free end of the first submount.
5.如权利要求2所述的D形介入式人工心脏瓣膜,其特征在于,还包括显影点,所述显影点设置于所述第三子支架上和/或所述第三子支架上的覆膜上。 5. D-shape according to claim 2 invasive prosthetic heart valve, characterized by further comprising a developing point, the point is provided on developing the third sub-carrier and / or the third sub-bracket on the film.
6.如权利要求5所述的D形介入式人工心脏瓣膜,其特征在于,所述显影点的数量为3个,其中2个显影点设置于与所述第二子支架的平直体壁连接的所述第三子支架上,另外I个显影点设置于与所述第二子支架的弧形体壁连接的所述第三子支架的覆膜上。 5 6. D-shaped claim invasive prosthetic heart valve, wherein, the number of developing three points, of which two points provided on the developing body wall of the second flat submount the third sub-connection on the holder, a developing additional points I disposed on the film-shaped solid wall and the second bracket is connected to the third sub-sub-bracket.
7.如权利要求1所述的D形介入式人工心脏瓣膜,其特征在于,所述瓣叶的数量为至少两片。 7. D-1 according to claim invasive prosthetic heart valve, wherein the number of the leaflet is at least two.
8.如权利要求7所述的D形介入式人工心脏瓣膜,其特征在于,所述瓣叶为生物组织、高分子材料制备的瓣膜或组织工程瓣膜。 8. The D-shaped according to claim 7 invasive prosthetic heart valve, wherein said leaflet is a biological tissue, tissue engineered valves, or valve produced polymer material.
9.如权利要求1-8中任一项所述的D形介入式人工心脏瓣膜,其特征在于,所述第一子支架或所述第二子支架上设置有瓣叶缝合孔,通过所述瓣叶缝合孔将所述瓣叶缝合于所述支架上。 9. D-shaped claimed in any one of claims invasive prosthetic heart valve, characterized in that the first submount is provided with a flap or on the holder of the second sub suture hole through the said leaflet suture hole the suture in the leaflet holder.
10.如权利要求1-8中任一项所述的D形介入式人工心脏瓣膜,其特征在于,所述支架的材质为镍钛合金,所述覆膜的材质为PET、e-PTFE、心包材料中的一种或多种。 10 1-8 D-shaped as claimed in any one of claims invasive prosthetic heart valve, wherein the material is a nitinol stent, the coating is made of PET, e-PTFE, one or more of the pericardium.
CN201610074782.2A 2016-02-02 2016-02-02 A kind of D-shaped insertion type artificial cardiac valve CN105520792B (en)

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