CN105726167A - Involved artificial heart valve prosthesis - Google Patents

Involved artificial heart valve prosthesis Download PDF

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Publication number
CN105726167A
CN105726167A CN201610074784.1A CN201610074784A CN105726167A CN 105726167 A CN105726167 A CN 105726167A CN 201610074784 A CN201610074784 A CN 201610074784A CN 105726167 A CN105726167 A CN 105726167A
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CN
China
Prior art keywords
sub
support
heart valve
stent
prosthetic heart
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CN201610074784.1A
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Chinese (zh)
Inventor
虞奇峰
秦涛
杨剑
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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Priority to CN201610074784.1A priority Critical patent/CN105726167A/en
Publication of CN105726167A publication Critical patent/CN105726167A/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
    • 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
    • A61F2/2412Heart 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

Abstract

The invention provides an involved artificial heart valve prosthesis.A support of the involved artificial heart valve prosthesis sequentially comprises a first sub-support, a second sub-support and a third sub-support connected in sequence.The first sub-support is a net pipe in a cone frustum shape, the second sub-support is a cylindrical net pipe, and the third sub-support is a trumpet-shaped net pipe.The maximum pipe diameter of the first sub-support is the same as the pipe diameter of the second sub-support.The minimum pipe diameter of the third sub-support is the same as that pipe diameter of the second sub-support.Due to the fact that the first sub-support is designed as the net pipe in the cone frustum shape, compared with an existing support designed as a cylindrical net pipe, the length of the support is reduced through the structure of the first sub-support, and harm caused by the fact that a too long part of the support punctures into the surrounding heart tissue to the heart is avoided.In addition, due to the fact that barbs with a locating function are arranged on the first sub-support, it is avoided that the involved artificial heart valve prosthesis shifts after being released; meanwhile, the structure is matched with the surrounding tissue, a blocking structure can be conveniently formed through membranae tectoria, perivalvular leakage can be avoided, and the success rate of an operation is increased.

Description

_种介入式人工心脏瓣膜 _ Invasive species of artificial heart valves

技术领域 FIELD

[0001 ]本发明涉及医疗器械技术领域,特别涉及一种介入式人工心脏瓣膜。 [0001] The present invention relates to the field of medical devices, particularly to an 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,经导管输送介入式人工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 delivery invasive cardiac 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介入式人工心脏瓣膜,以解决现有介入式人工心脏瓣膜为了满足工作需求,支架与天然瓣膜的生理结构吻合程度不够,容易发生位移和瓣周漏;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,影响手术操作的问题。 [0007] The object of the present invention is to provide an invasive prosthetic heart valve, in order to solve the conventional invasive prosthetic heart valve in order to meet operational requirements, the degree of fit of the structural support and physiological native valve not prone to displacement and circumferential lobe leakage; stent structure can be easily compression cardiac outflow tract; support structure is too large for too long, heart injury; developing unreasonable design point, the operator issues impact.

[0008]为解决上述技术问题,本发明提供一种介入式人工心脏瓣膜,所述介入式人工心脏瓣膜包括: [0008] To solve the above problems, the present invention provides an invasive prosthetic heart valve, the interventional prosthetic heart valve comprising:

[0009]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, [0009] The stent, the leaflet provided inside the stent and a coating disposed on the wall of the holder body; wherein,

[0010]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,所述第一子支架为圆锥台状网管,所述第二子支架为圆柱状网管,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,所述第一子支架和/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,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。 [0010] The bracket comprises a first sub-bracket connected sequentially, the second and third sub-sub-bracket holder, the holder first sub-network frusto-conical shape, the second sub-network stent is cylindrical, the flared stent third sub-network; the same diameter of the first sub-maximum diameter of the second stent submount, the submount third smallest diameter of the second tube submount the same diameter, the first sub-support and / or the second sub-body wall is provided with a barb holder, the free end of the barb in the direction away from the free end of the first sub-mount are inclined, the provided with a developing point on the carriage on the third film on the third sub-sub-carrier and / or the.

[0011]可选的,在所述的介入式人工心脏瓣膜中,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, in the invasive prosthetic heart valve, the body wall of the first sub-body wall bracket with respect to the second sub mount are inclined 10 degrees ~ 60 degrees.

[0012]可选的,在所述的介入式人工心脏瓣膜中,所述倒刺的自由端与第一子支架或所述第二子支架的体壁之间的角度为20度〜80度,所述倒刺的长度为3mm〜10mm。 [0012] Optionally, in the invasive prosthetic heart valve, the angle between the body wall of the barb free end of the first stent or the second sub-sub-bracket 20 degrees ~ 80 degrees the length of barbs 3mm~10mm.

[0013]可选的,在所述的介入式人工心脏瓣膜中,还包括输送连接部件,所述输送连接部件设置于所述第一子支架的自由端。 [0013] Optionally, in the invasive prosthetic heart valve, the connector further comprising conveying means, the conveying means is provided to connect the first submount free end.

[0014]可选的,在所述的介入式人工心脏瓣膜中,所述输送连接部件的数量至少为3个。 Quantity [0014] Optionally, in the invasive prosthetic heart valve, the delivery connection member is at least three.

[0015]可选的,在所述的介入式人工心脏瓣膜中,所述显影点的数量为2个。 [0015] Optionally, in the invasive prosthetic heart valve, the number of the developing point is two.

[0016]可选的,在所述的介入式人工心脏瓣膜中,所述瓣叶的数量为至少两片。 [0016] Optionally, in the invasive prosthetic heart valve, the leaflet of the number is at least two.

[0017]可选的,在所述的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。 [0017] Optionally, in the invasive prosthetic heart valve, the leaflet is a biological tissue, tissue engineered valves, or valve produced polymer material.

[0018]可选的,在所述的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。 [0018] Optionally, in the invasive prosthetic heart valve, the first submount or the holder is provided with a second sub-leaflet suture holes, suture holes through which the leaflet flap leaf sewn on the support.

[0019]可选的,在所述的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。 [0019] Optionally, in the invasive prosthetic heart valve, the material of the stent is a nitinol, the coating film is made of PET, e-PTFE, pericardium one or more .

[0020]在本发明所提供的介入式人工心脏瓣膜中,所述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,第一子支架为圆锥台状网管,第二子支架为圆柱状网管,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。 [0020] In invasive prosthetic heart valve according to the present invention provided herein, the invasive prosthetic heart valve comprising a stent, the stent disposed on the inner side of the flap member and arranged covered in a wall of the stent, the stent comprising a first sequentially connected a sub-bracket, the second bracket and the third sub-sub-frame, the first sub-network stent frusto-conical shape, the second sub-network stent is cylindrical, flared stent third sub-network; the maximum diameter of the first submount the same diameter and the same as the second submount, the submount third diameter and the second diameter of the smallest sub-holder. 通过将第一子支架设计为圆锥台状网管,且第一子支架的最大管径与第二子支架的管径相同,与现有的介入式人工心脏瓣膜中支架设计为圆柱状网管相比,本发明中第一子支架的结构缩短了支架的长度,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,由于支架结构与天然瓣膜的生理结构相吻合,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。 Compared stent designs by first sub network frusto-conical shape, and the maximum diameter of the first submount and a second submount same diameter, the conventional type of prosthetic heart valve involvement in a cylindrical shape stent design NM , the first sub-structure of the present invention, the stent shortens the length of the stent, the stent is too long to avoid damage due to the penetration of tissue around the heart caused by heart, improve the success rate of surgery; on the other hand, since the support structure and the native valve consistent physical structure, the stent of the first sub-body or the wall of the second sub-holder is provided with a barb, the barb is implanted to a particular location in the heart valve can be inserted into the tissue surrounding the valve, functions paravalvular leakage and shift positioning effect hardly occurs, so that the invasive prosthetic heart valve after release; the other hand, the position of the point of the present invention is provided based on developing more reasonable, to meet the needs of the operation.

附图说明 BRIEF DESCRIPTION

[0021]图1是本发明一实施例中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; [0021] FIG. 1 is a schematic view of the embodiment of in situ invasive mitral prosthetic heart valve implantation into a heart embodiment of the present invention;

[0022]图2是本发明一实施例中介入式人工心脏瓣膜的支架的主视图; [0022] FIG. 2 is a front view of the embodiment invasive prosthetic heart valve stent to an embodiment of the present invention;

[0023]图2a是图2的俯视图; [0023] FIG 2a is a plan view of FIG 2;

[0024]图3是本发明一实施例中介入式人工心脏瓣膜的支架覆膜后的主视图; [0024] FIG. 3 is a front view of the embodiment invasive prosthetic heart valve stent embodiment of the present invention, a coating film;

[0025 ]图3a是图3的支架的内部缝合有瓣叶后的俯视图。 [0025] FIG. 3a is an internal stent of Figure 3 is a plan view of the stitching leaflet.

[0026]图中:支架I;瓣叶2;覆膜3;第一子支架10;第二子支架11;第三子支架12;倒刺4;输送连接部件5;显影点6;瓣叶缝合孔110。 [0026] FIG: scaffold I; leaflet 2; 3 film; a first submount 10; a second sub-holder 11; third sub-frame 12; barbs 4; 5 delivery connection member; a developing point 6; leaflet suture holes 110.

具体实施方式 Detailed ways

[0027]以下结合附图和具体实施例对本发明提出的介入式人工心脏瓣膜作进一步详细说明。 [0027] The following specific examples and invasive prosthetic heart valve made according to the present invention will be described in further detail in conjunction with the 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.

[0028]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。 [0028] Before the present invention is specifically described, in this first described the main principle idea of ​​the present invention. 对于微创介入治疗来说,本发明所述介入式人工心脏瓣膜的支架可沿径向伸缩,在安装输送时,便于将支架收紧装入体积有限的输送装置中,当从输送装置中释放后又能迅速撑开,便于与目标组织紧密贴合,形成充足的血流通道;所述第三子支架的结构与天然瓣膜的生理结构相吻合(尤其与二尖瓣周围组织的天然生理结构相吻合),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;所述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,使得心脏瓣膜释放后不易发生移位和瓣周漏,所述第三子支架植入瓣膜位置后作为血液的进血口,第一子支架作为血液的出血口。 For minimally invasive treatment, the present invention is the invasive prosthetic heart valve stent can be radially retractable, when the transport installation, to facilitate tightening the stent delivery device loaded in a limited volume, when released from the delivery device after able to quickly softened to facilitate close contact with the target tissue, adequate blood flow passageway formed; the third sub-structure and physical structure of the native valve stent coincide (in particular native mitral surrounding tissue physiology coincide), has a certain self positioning function, facilitates quick and accurate positioning of the release, after the release of the stent and the blood flow passageway in close contact, displacement hardly occurs, while the complex structure and the surrounding tissue to facilitate closure film forming structure, easily displaced and after the barb PVL after heart valve is implanted to a particular position can be inserted into the tissue surrounding the valve, play the role of positioning, such that the heart valve is released, the second; facilitates avoidance valvular leak after three position valve stent into the blood as the blood inlet, a first submount as blood bleeding port. 由于所述第三子支架结构部的直径大于所述第二子支架的直径,当因心脏舒张时天然板环组织可对第三子支架部起到阻挡作用防止瓣膜向心室内滑落,而当心脏收缩时,由于倒刺的作用又可阻止瓣膜移动,因此该结构的支架,可以更有效地防止瓣膜释放后在血流压力和冲刷下发生移位,瓣膜释放后使用寿命更长,对周围组织的伤害小。 Since the diameter of the support structure portion is greater than the diameter of the second sub third submount, because when the ring plate diastolic native tissue may be acts as a barrier to prevent the portion of the third sub-stent-valve to the heart chamber slide, and when systolic, but also to prevent the action of the barbs move the valve, so that the stent structure can be more effectively prevented from occurring at a displacement of blood pressure and the flushing valve is released, the longer life of the valve is released, the surrounding little damage tissue.

[0029]图1为本发明的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。 [0029] FIG. 1 of the present invention invasive prosthetic heart valve implanted in the schematic view of the mitral valve of the heart in situ. 图2是本发明介入式人工心脏瓣膜的支架的主视图。 FIG 2 is a front view of the present invention invasive prosthetic heart valve stent. 图3为本发明一实施例中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 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为圆锥台状网管,所述第二子支架11为圆柱状网管,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, as shown in FIGS. 3, invasive prosthetic heart valve according to the present invention includes 3a: a stent, the stent disposed on the inner side I of the leaflet 2 is provided on the holder and the coating of the body wall 3 I ; 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 frusto-conical shape, the second submount 11 NM cylindrical, the third sub-network flared stent 12; maximum diameter of the first submount 10 with the second diameter is the same submount 11, the third tube 12 of the minimum submount diameter the same as the diameter 11 of the second submount.

[0030]请参考图2及图2a,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 and FIG. 2a, 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,第二子支架11与原始网管的管径相同,也就是无需变形处理,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 shaping process is divided into three segments, the second bracket 11 has the same sub-network the original diameter, that is, without deformation process, the first sub-bracket 10 is the original NM end edge along a radial contraction of the original network, reference numeral 2 showing a portion of the shape shown in FIG 10, the body wall of the body wall where the first sub-bracket 10 relative to the bracket 11 of the second sub-inclined an angle Θ is 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20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 20 degrees ~ 80 degrees, preferably 60 degrees. 所述倒刺的长度为3mm〜10_。 The length of barbs 3mm~10_. 应用时,倒刺4刺入瓣膜周围的组织,起到定位介入式人工心脏瓣膜的作用。 When applied, the barbs penetrate the tissue valve 4 around, play positioning invasive artificial 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,本实施例中的介入式人工心脏瓣膜可沿其径向伸缩,在安装输送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, in the present embodiment interventional telescopic embodiment prosthetic heart valve in its radial direction, when the mounting conveyor invasive prosthetic heart valve, in order to facilitate close contact with the target tissue, sufficient to form a blood flow passageway, the present invention, said second carrier and said third sub-sub-structures cooperating scaffold structure designed to coincide with the physical structure of the native valve (especially a mitral valve and surrounding tissue structures coincide natural physiologically) so that it has a certain self positioning function, facilitates quick and accurate positioning of the release, after the release of the stent and the blood flow passageway in close contact, displacement hardly occurs, while the complex structure and the surrounding tissue to facilitate closure structure coating formation, is advantageous to avoid Valvular leak.

[0033]实际应用时,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,释放介入式人工心脏瓣膜,此时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,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介入式人工心脏瓣膜移位,因此基于本发明的支架结构,可以更有效地防止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,延长了介入式人工心脏瓣膜释放后的使用寿命,降低了其对周围组织的伤害。 [0033] In practice, the invasive prosthetic heart valve delivery apparatus is accommodated implanted in a patient, when the target position is reached, releasing invasive prosthetic heart valve, artificial heart valve time involved would be a compressed state of the stent rapidly softened, as shown in FIG. 1 can be seen, after the release of invasive prosthetic heart valve is located in a first submount ventricle, atrium located in the third sub-bracket, the third sub-bracket into the blood as the blood inlet, a first submount as the blood bleeding port, since the diameter of the stent is greater than the third sub-sub-second stent diameter, the stent may be natural plate annulus tissue acts as a barrier to prevent invasive prosthetic heart valve when the result of the third sub-diastolic intraventricular to fall, and when the heart contracts, but also to prevent the action of barbs invasive prosthetic heart valve displacement, the present invention is thus based on the structure of the stent can be more effectively prevented after invasive prosthetic heart valve is released in the blood stream pressure and scouring displaced, extending the life of the artificial heart valve release intrusive, reducing the 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,瓣叶2的数量为至少两片。 As shown in [0034] Figure 3a, is known shape and position of the distribution flap 2, in this embodiment, the number of the leaflet 2 is at least two. 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。 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、图2a及图3,为了便于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] Further, please refer to FIGS. 2, 2a and 3, for convenience of 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 the number of said 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,三个显影点6沿支架的周向均匀设置。 Position [0036] Please refer to FIG. 2 and FIG. 3a, in order to meet the positioning and observation invasive prosthetic heart valve is provided with a coating on the developing point and / or the third sub-holder on said third sub-bracket 6, the developing number 6 points is three, three developing points 6 disposed along the circumferential direction of the stent uniform. 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)、铀金属(Pt)、钽金属(Ta)中的一种或多种。 The developing medium is a platinum-iridium alloy (Pt / Ir), uranium metal (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 improve the problems involved in the use of artificial heart valve supporting force, the supporting force is insufficient to avoid fracture of the stent results in .

[0039]综上,在本发明所提供的介入式人工心脏瓣膜中,所述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,第一子支架为圆锥台状网管,第二子支架为圆柱状网管,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 invasive prosthetic heart valve according to the present invention provided herein, the 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 stent frusto-conical shape, the second sub-network stent is cylindrical, flared stent third sub-network; a first submount the same diameter and the same largest diameter of the second submount, the submount third diameter and the second diameter of the smallest sub-holder. 通过将第一子支架设计为圆锥台状网管,且第一子支架的最大管径与第二子支架的管径相同,与现有的介入式人工心脏瓣膜中支架设计为圆柱状网管相比,本发明中第一子支架的结构缩短了支架的长度,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,由于支架结构与天然瓣膜的生理结构相吻合,所述第一子支架和/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,使得介入式人工心脏瓣膜释放后不易发生移位,同时瓣膜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;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。 Compared stent designs by first sub network frusto-conical shape, and the maximum diameter of the first submount and a second submount same diameter, the conventional type of prosthetic heart valve involvement in a cylindrical shape stent design NM , the first sub-structure of the present invention, the stent shortens the length of the stent, the stent is too long to avoid damage due to the penetration of tissue around the heart caused by heart, improve the success rate of surgery; on the other hand, since the support structure and the native valve consistent physical structure, the first sub-support and / or the wall of the second sub-body holder is provided with a barb, the barb is implanted into a particular position can be inserted into the tissue surrounding the valve in the heart valve, play the role of positioning, such that the invasive prosthetic heart valve releases easily displaced, while the valve and the surrounding tissue to facilitate mating closure structure coating formation, is advantageous to avoid paravalvular leak; on the other hand, based on the development of the present invention provided dot position is more reasonable, in line with 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,所述第一子支架为圆锥台状网管,所述第二子支架为圆柱状网管,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,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,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。 An invasive prosthetic heart valve, wherein, comprising: a bracket provided on the flap and is provided on the holder body covered wall of the inner bracket; and wherein said second bracket includes sequentially connected a sub-bracket, the second bracket and the third sub-sub-frame, the first sub-network stent frusto-conical shape, the second sub-network is a cylindrical holder, the flared stent third sub-network; the the maximum diameter the same as the first diameter of the second submount submount, the minimum diameter of the same diameter and the third sub-holder of the second submount, the submount or the first the free end of said second sub-body wall is provided with a barb holder, along the barb free end facing away from the first sub-mount are inclined, the third sub-carrier and / or the third sub- the coating on the stent is provided with a developing point.
2.如权利要求1所述的介入式人工心脏瓣膜,其特征在于,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。 2. The invasive prosthetic heart valve according to claim 1, characterized in that the body wall opposite the first sub-body wall bracket second sub mount are inclined 10 degrees ~ 60 degrees.
3.如权利要求1所述的介入式人工心脏瓣膜,其特征在于,所述倒刺的自由端与第一子支架或所述第二子支架的体壁之间的角度为20度〜80度,所述倒刺的长度为3mm〜10mm。 3. The invasive prosthetic heart valve according to claim 1, characterized in that the angle between the body wall of the barb free end of the first stent or the second sub-sub-bracket 20 degrees ~ 80 degree, the barb length 3mm~10mm.
4.如权利要求1所述的介入式人工心脏瓣膜,其特征在于,还包括输送连接部件,所述输送连接部件设置于所述第一子支架的自由端。 4. The invasive prosthetic heart valve according to claim 1, wherein the connecting member further comprises a delivery, the delivery connection of the first sub-member disposed to the free end of the stent.
5.如权利要求4所述的介入式人工心脏瓣膜,其特征在于,所述输送连接部件的数量至少为2个。 5. The invasive prosthetic heart valve according to claim 4, wherein the number of said delivery connection member is at least two.
6.如权利要求5所述的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。 6. The invasive prosthetic heart valve according to claim 5, characterized in that the number of points is three developing.
7.如权利要求1所述的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. The invasive prosthetic heart valve according to claim 1, wherein the number of the leaflet is at least two.
8.如权利要求7所述的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。 Invasive heart valve prosthesis as claimed in claim 7, 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. 1-8 in any invasive prosthetic heart valve of any one of the preceding claims, characterized in that the first submount is provided with a flap or the second suture hole submount through said valve leaves the leaflet suture hole in the suture holder.
10.如权利要求1-8中任一项所述的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 invasive prosthetic heart valve as claimed in any one of the preceding claims, characterized in that the material is a nitinol stent, the coating is made of PET, e-PTFE, pericardium of one or more.
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