CN105662654A - Coronary artery protecting device - Google Patents

Coronary artery protecting device Download PDF

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Publication number
CN105662654A
CN105662654A CN 201610105080 CN201610105080A CN105662654A CN 105662654 A CN105662654 A CN 105662654A CN 201610105080 CN201610105080 CN 201610105080 CN 201610105080 A CN201610105080 A CN 201610105080A CN 105662654 A CN105662654 A CN 105662654A
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CN
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coronary
spacer member
member
coronary artery
protection device
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CN 201610105080
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Chinese (zh)
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潘文志
周达新
程蕾蕾
葛均波
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复旦大学附属中山医院
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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
    • 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
    • A61F2210/0061Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable

Abstract

The invention discloses a coronary artery protecting device which comprises an isolating part and a fixing part. The isolating part is used for isolating a potential obstacle from a coronary artery opening, and the fixing part is used for fixing the position of the isolating part. The device is provided with a grid structure, the grid structure is implanted into the joint portion of the ascending aorta and coronary artery through the peripheral arterial path, the grid structure is implanted before transcatheter aortic valve replacement, smoothness of blood flow in the coronary artery during the transcatheter aortic valve replacement operation and after the operation can be guaranteed, coronary occlusion complications is avoided, and therefore transcatheter aortic valve replacement can be achieved for an aortic valve disease patient whose ascending aorta root anatomical structure does not meet the current standard.

Description

一种冠状动脉保护装置 Coronary one kind of protection device

技术领域 FIELD

[0001]本发明涉及一种冠状动脉保护装置,尤其涉及一种用于经导管转动脉瓣置换术的冠状动脉保护装置。 [0001] The present invention relates to a coronary protection device, in particular it relates to a protective device for coronary artery via a catheter transfected aortic valve replacement surgery.

背景技术 Background technique

[0002]经导管主动脉辦置换术(TAVR,transcatheter aortic valve replacement)是目前心血管介入的热门新技术,该技术是通过外周动脉送入介入导管,通过介入导管将压缩的人工心脏瓣膜输送至主动脉瓣区打开,从而完成人工瓣膜置入,恢复瓣膜功能的,是一种微创的置入人工心脏瓣膜的方式。 [0002] transcatheter aortic do replacement (TAVR, transcatheter aortic valve replacement) is the hot new technology of cardiovascular intervention, the technology is fed by peripheral arterial interventional catheter, interventional catheter through the compression of the artificial heart valve delivery to aortic valve area open, thus completing the prosthetic valve implantation, restore valve function, heart valve prosthesis is placed in a minimally invasive manner. 该技术的侵入性小于开心手术,因而大大降低了心脏外科手术的风险,患者的术后恢复时间也大大缩短,目前在国际上已成为主动脉瓣狭窄患者的一线治疗方案。 This invasive technique is less than open heart surgery, thus greatly reducing the risk of cardiac surgery, postoperative patient recovery time is also greatly reduced, currently in the international community has become a first-line treatment of patients with aortic stenosis. TAVR前景目前被普遍看好,预计到2025年,全球每年完成TAVR手术量将达30万例左右。 TAVR is generally optimistic about the prospects for the current, 2025, to complete the global TAVR surgery will reach about 300,000 cases per year.

[0003]但是,该技术目前仍是一种高危的手术,可导致致命的并发症。 [0003] However, this technology is still a high-risk surgery, can lead to fatal complications. 冠状动脉堵塞是其中一种死亡率极高的并发症,可引起急性心肌梗死、心源性休克而致死。 Coronary artery blockage is one kind of high mortality complications can cause acute myocardial infarction, cardiogenic shock and death. 其主要机制是自体主动脉脉瓣膜上翻堵住冠状动脉开口。 The main mechanism is the tenderness of the valve body from turning on the active opening blocked coronary arteries. 此外,瓣膜支架放置过高,使得介入瓣膜裙边挡住冠脉开口,也可引起冠脉阻塞及心肌梗死。 In addition, valve stent is placed too high, so that the valve skirt blocking the coronary intervention, may cause myocardial infarction and coronary artery occlusion. 因此,TAVR术前应评估主动脉根部的解剖结构,包括瓦氏窦宽度(应比瓣膜型号大3mm以上)、瓦氏窦高度(应>15mm)以及冠状动脉高度(应〉12mm)。 Thus, patients should be evaluated before TAVR anatomy of the aortic root including the Valsalva sinus width (the valve should be greater than 3mm or more models), Valsalva sinus height (to be> 15mm), and coronary artery height (should be> 12mm). 但是如果按照此标准进行病例筛选,将有1/4的病例被排除在外而无法接受TAVR手术。 But if the cases screened in accordance with this standard, there will be a quarter of cases are excluded and can not accept TAVR surgery. 此外,即使完全按照此标准进行TAVR手术,仍有少数病例可能发生冠脉堵塞。 In addition, even if completely TAVR procedure in accordance with this standard, there are still a few cases of coronary artery blockage may occur. 因此,研发用于TAVR术冠状动脉保护的装置,使得诸多的主动脉根部条件不符合条件患者也能行TAVR术,具有巨大社会效益和市场需求。 Thus, the development of coronary protection means TAVR surgery for many conditions such that the aortic root is not eligible patients can do it TAVR surgery, and having a great social demand.

发明内容 SUMMARY

[0004]有鉴于现有技术的上述缺陷,本发明所要解决的技术问题是如何为TAVR术提供冠状动脉的保护,避免TAVR引起冠状动脉堵塞的风险。 [0004] In view of the above drawbacks of the prior art, the present invention is to solve the technical problem is how to provide protection for the coronary artery surgery TAVR avoid causing TAVR risk of coronary blockage.

[0005]为实现上述目的,本发明提供了一种冠状动脉保护装置,该装置也是经外周动脉途径植入升主动脉和冠状动脉的结合处的,在经导管主动脉瓣置换之前植入,可保障TAVR术中和术后冠状动脉血流的通畅,避免冠状动脉闭塞并发症的发生,使得升主动脉根部解剖结构不符合目前标准的主动脉瓣疾病患者实现经导管主动脉瓣的置换。 [0005] To achieve the above object, the present invention provides a coronary protection device that is implanted in the outer peripheral artery via the junction of the ascending aorta and coronary arteries, before implantation transcatheter aortic valve replacement, can protect TAVR surgery and postoperative patency of coronary flow, coronary occlusion avoid complications, making the anatomy of the root of the ascending aorta does not meet current standards to achieve replacement in patients with aortic valve disease transcatheter aortic valve.

[0006]本发明提供的冠状动脉保护装置包括用于将潜在的阻挡物与冠状动脉开口隔离的隔离部件和用于固定该隔离部件位置的固定部件,该隔离部件与该固定部件相互连接在一起;该隔离部件的工作位置为升主动脉根部与冠状动脉的结合处。 [0006] Coronary protection device according to the present invention comprises a potential barrier for the isolation member for isolating the coronary ostium and a spacer member for fixing the position of the fixing member, the spacer member connected to each other with the fixed member ; operating position of the spacer member is the root of the ascending aorta and the coronary artery junction. 其中,所述潜在的阻挡物可以是上翻的自体主动脉脉瓣膜、介入瓣膜裙边或其它任何可能会造成冠状动脉堵塞的物件。 Wherein said potential barrier may be turned on autologous aortic pulse valve, a valve skirt or any other intervening objects may cause blockage of the coronary artery.

[0007]该冠状动脉保护装置可在径向扩张的第一形态和径向收缩的第二形态之间变换;其中,所述第一形态为该装置被植入人体升主动脉根部与冠状动脉结合处的预定位置后的工作形态,所述第二形态为该装置被经导管输送时的输送形态。 [0007] The coronary protection means switchable between a first configuration and a second configuration of the radially expandable radially contracted; wherein the device is implanted aortic root and coronary arteries for the first aspect after a predetermined operational configuration at the binding position, the device is conveyed via catheter delivery configuration when the second form for.

[0008]进一步,所述第二形态为细条状,使之能够装载于一定内径的长条状输送鞘管内,从体外沿着人体动脉送到升主动脉根部。 [0008] Further, the second form is a thin strip, so that it can be mounted on a certain inner diameter of the elongated inner sheath of the delivery, to the arteries from outside the body along the aortic root.

[0009]优选地,该隔离部件具有网格结构,不会影响血液的流动;进一步优选地,该隔离部件为管状,血液能从周围流入该隔离部件的内腔;更进一步,该管状隔离部件的工作状态为沿升主动脉的轴向排布。 [0009] Preferably, the spacer member having a lattice structure, does not affect the flow of blood; more preferably, the spacer member is a tubular lumen into the surrounding blood from the spacer member; Still further, the tubular spacer member operating state along an axial arrangement of the ascending aorta.

[0010]优选地,该固定部件的工作位置为冠状动脉内,该固定部件通过与冠状动脉壁之间的静摩擦力来固定该冠状动脉保护装置的位置,以防止整个装置移位脱落;进一步优选地,该固定部件为具有网格结构的管状;在这种情况下,其第一形态的截面直径应适合冠状动脉的内径,以比冠状动脉内径略大为佳,通常优选为2-5mm;优选地,该固定部件的长度为2-6cm,所述长度也即该固定部件进入冠状动脉的深度。 [0010] Preferably, the working position of the fixing member is within a coronary artery, the fixing member to fix the position of the protection device through the coronary static friction force between the wall of the coronary artery, to prevent the displacement of the entire device off; more preferably , the fixing member is a tubular mesh structure; in this case, a first aspect of the cross-sectional diameter should be suitable for the inner diameter of the coronary artery, to slightly better than the inner diameter of the coronary artery, usually preferably 2-5 mm; preferably, the length of the fixing member is 2-6cm, i.e. the length of the fixing member into the depth of the coronary artery.

[0011]优选地,所述管状为圆管状或椭圆管状,该结构具有较强的支撑力,不易变形;对于隔离部件,当介入瓣膜被植入升主动脉中后会对该隔离部件产生压迫作用,较强的支撑力能保持管体内血流的通畅;对于固定部件,较强的支撑力可产生更好的摩擦作用从而更牢固地固定,且也能保持管体内血流的通畅。 [0011] Preferably, the circular tubular tubular tubular or oval, the structure has a strong supporting force, easily deformed; For isolation member, when the valve is implanted in the ascending aorta intervention will produce compression of the spacer member action, strong supporting force of the tubular body to maintain the patency of blood flow; respect to the fixed member, a strong supporting force can produce better friction to more firmly fixed, and the tubular body can maintain patency of the blood flow.

[0012]优选地,所述网格结构为菱形网格结构,该结构可进一步提高支撑力;构成隔离部件网格结构的网格线可以比固定部件的网格线略粗,因为隔离部件需要更强的支撑力。 [0012] Preferably, the grid structure is diamond-shaped grid structure, the structure may further increase the support force; gridline grid structure constituting a spacer member may be a little thicker than the grid wire fixing member, because the spacer member needs stronger support force.

[0013] 优选地,所述隔离部件的直径为4-8mm,所述隔离部件的长度为5-15cm。 Diameter [0013] Preferably, the spacer member is 4-8mm, the length of the spacer member is 5-15cm.

[0014]在本发明的一种优选实施方式中,所述隔离部件与所述固定部件为一体化的管状,中间具有弯折角,即该冠状动脉保护装置在第一形态时自身会形成一个弯折角,该弯折角的范围优选为60°〜150°,进一步该弯折角为圆角,不具有尖锐而容易造成机械损害的外轮廓。 [0014] In a preferred embodiment of the present invention, the spacer member is a tubular member with said stationary integrated, having a bending angle of the intermediate, i.e., the coronary artery first aspect protection device itself will form a bend angular, the bent angle is preferably in the range of 60 ° ~150 °, the angle of bend is more rounded outer contour having no sharp and likely to cause mechanical damage.

[0015]升主动脉壁连有左冠状动脉和右冠状动脉,在本发明的一种优选实施方式中,所述隔离部件的工作位置从冠状动脉的开口处向上延伸,贴靠升主动脉根部一侧(左或右)的内壁,且其高度高于即将植入的介入瓣膜的高度,于是就在该侧的升主动脉至冠状动脉开口之间架设了一条血液流通的通道,可保证冠状动脉血流的畅通。 [0015] connected with a wall of the ascending aorta right coronary artery and the left coronary artery, in a preferred embodiment of the present invention, the spacer member operative position extending upwardly from the opening of the coronary arteries, aortic root against the inner wall of one side (left or right), and a height higher than the height of the intervention valve is about to implant, in the ascending aorta so that an erected side to the blood flow passage between the coronary artery, coronary ensure arterial smooth blood flow.

[0016]优选地,该隔离部件的第一形态的远心端开口较大,容易进入导管和导丝,有利于日后的冠状动脉介入治疗;该隔离部件的第一形态的近心端截面直径可等于或大于固定部件的最大截面直径。 [0016] Preferably, the distal end of the spacer member of the first aspect of the larger opening, and easy access to the catheter guidewire facilitate future coronary intervention; the proximal end of the cross-sectional diameter of the first aspect of the spacer member It may be equal to or greater than the maximum cross-sectional diameter of the fixing member. 在本发明的一种优选实施方式中,该隔离部件的形状优选为沿管状的轴向向远心端逐渐增大的喇叭状。 In a preferred embodiment of the present invention, the shape of the spacer member is preferably a tubular axial direction to the distal end of the horn gradually increases.

[0017]左冠状动脉和右冠状动脉为心脏提供血流,保障心脏的供血、供氧,所述固定部件由升主动脉壁上的左/右冠状动脉开口处进入左/右冠状动脉内。 [0017] The left coronary artery and right coronary arteries provide the heart blood flow, protect the heart blood, oxygen, the fixing member by the wall of the ascending aorta of the left / right coronary artery into the opening of the left / right coronary artery. 由于左、右冠状动脉的结构会有小差异,因此本发明的固定部件的形态可按左/右冠状动脉的走形设计,径向截面的直径略大于冠状动脉的内径;进一步隔离部件也可按左/右冠状动脉与升主动脉之间的走形设计;更进一步,本发明的冠状动脉保护装置可根据个体差异作个性化设计,以满足不同人群的不同的需求。 Due to the structure of the left and right coronary arteries will be a small difference, and therefore forms the fixed member of the present invention may be the inner diameter of the left / right coronary artery take-shaped design, the diameter slightly larger than the radial cross-section of a coronary artery; spacer member may be further take-shaped design between the left / right coronary artery and the ascending aorta; Still further, coronary protection device of the invention can be individually designed according to individual differences, in order to meet different needs of different groups.

[0018]本发明所述“远心端”是指所述装置被植入升主动脉根部与冠状动脉的结合处预定位置后远离心脏的一端,“近心端”是指所述装置被植入升主动脉根部与冠状动脉的结合处预定位置后靠近心脏的一端。 [0018] The present invention, "distal end" refers to the rise of the device is implanted at a predetermined binding position remote from the aortic root and coronary heart end, "proximal end" is meant that the device was implanted after the lift at a predetermined position of the binding of the aortic root and coronary heart near one end.

[0019]优选地,所述冠状动脉保护装置的总长为10-20cm。 [0019] Preferably, the total length of the protective device is a coronary 10-20cm.

[0020]优选地,所述冠状动脉保护装置由一体化3D打印制成。 [0020] Preferably, the printing apparatus is made of a coronary protective integrated 3D.

[0021]在本发明的一种优选实施方式中,所述冠状动脉保护装置由自膨胀材料构成,在体外可以压缩成条状的第二形态,在体内释放后可以自动恢复到第一形状。 [0021] In a preferred embodiment of the present invention, the protective device is composed of coronary self-expanding material, may be compressed into a second in vitro strip form, it can be automatically restored to the first shape upon release in vivo. 在本发明的另一种优选实施方式中,该装置也可以球囊扩张原理进行释放,装置在体外压缩成条状的第二形态,负载在球囊外面,到达体内后扩张球囊释放装置,使得装置恢复到第一形态。 In another preferred embodiment of the present invention, the device may be balloon expandable principle release, a second means compressed into a strip shape in vitro, the load on the outside of the balloon, the dilatation balloon means reaching the in vivo release, so that the apparatus returns to the first aspect.

[0022]优选地,所述冠状动脉保护装置由金属材料制成;进一步优选为具有温度记忆的镍钛合金材料。 [0022] Preferably, the coronary protective means made of metallic material; even more preferably a temperature of nickel-titanium alloy material having a memory.

[0023]在本发明的一个优选实施例中,所述冠状动脉保护装置为一体化的圆管,具有网格结构,可在径向扩张的第一形态和径向收缩的第二形态之间变换,其第一形态具有弯折角,该弯折角的一侧为隔离部件,用于将潜在的阻挡物与冠状动脉开口隔离,该弯折角的另一侧为固定部件,用于固定该隔离部件的位置,所述一体化的圆管的第一形态接近于人体升主动脉根部和冠状动脉结合处的解剖结构。 [0023] In a preferred embodiment of the present invention, the protective device is a coronary integrated pipe, a mesh structure, between the second form of the first aspect of collapsible radial and radially expandable transformation, which forms a first angle having a bend, the bend angle of the side spacer member, a potential barrier for the isolated coronary artery, the other side of the bend angle of the fixing member, for fixing the spacer member position, a first aspect of the integrated pipe body close to the root of the ascending aorta and the coronary anatomy at the junction.

[0024]本发明是根据心脏解剖特征和经导管主动脉瓣置换技术原理而发明的:经导管主动脉瓣置换时,所植入的介入瓣膜充分扩张后,可能使得自体的主动脉瓣膜被挤压上翻,堵塞冠状动脉开口,介入瓣膜的裙边也可能堵塞冠状动脉开口,该保护装置被植入后,可在介入瓣膜的外侧的升主动脉至冠状动脉开口之间撑开一条隧道,保证血流由升主动脉流入冠状动脉;另一方面,保护装置的形态符合主动脉根部解剖特点,能良好的固定而不脱位;本装置位于自体瓣环之上、介入瓣膜之外,故不会影响介入瓣膜的功能和固定作用,不会导致瓣周漏和瓣膜反流。 [0024] The present invention is based on the anatomical feature of the heart and aortic valve replacement transcatheter techniques and principles of the invention: when the aortic valve is replaced with a catheter, the implanted valve intervention full expansion, so that the aortic valve may be extruded autologous turn on the pressure, coronary artery blockage, the valve skirt intervention clogged coronary artery is also possible, after the protective device is implanted, the outer valve may be involved in the ascending aorta between the coronary arteries to the expansion of a tunnel opening, to ensure that blood flows from the coronary artery ascending aorta; on the other hand, the protection device forms a root anatomy of the aortic compliance, good fixing without dislocation can; this means positioned above the body from the annulus, the valve outside intervention, it is not intervention will affect the function of the valve and fixed effect, does not cause PVL and valvular regurgitation.

[0025]本发明具有以下有益技术效果: [0025] The present invention has the following beneficial technical effects:

[0026]①操作作简单:本发明的体内植入过程与目前的冠脉支架植入过程相同,手术操作相对简单。 [0026] ① operation as simple: the process of the present invention implanted in the same current coronary stent implantation procedure, the surgical procedure is relatively simple.

[0027]②制作简单、成熟:本发明的基本材料可采用常规的冠脉、血管支架材料,制作方法也可采用目前常规的支架制作方法,故制作相对简单、成熟。 [0027] ② simple production, maturation: the basic material of the present invention can be conventional coronary graft material, current production methods may also be employed conventional stent manufacturing method, making it relatively simple and mature.

[0028]③安全性高:该装置植入时和植入后,都不影响冠状动脉的供血,不影响人体瓣膜或者介入瓣膜的功能。 [0028] ③ safe: after implanting the implant and means, not affect the blood supply to the coronary arteries, does not affect human intervention or valve function of the valve.

[0029]④不影响冠脉介入治疗:隔离部件的开口较大,成喇叭状,容易进入导丝和导管,万一患者日后发生冠状动脉病变,不影响其介入治疗。 [0029] ④ not affect coronary intervention: the larger spacer member opening, flared, easy access to the guide wire and catheter, patients with coronary artery disease later case, does not affect its intervention.

[0030]以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明,以充分地了解本发明的目的、特征和效果。 [0030] Hereinafter, in conjunction with the accompanying drawings of the inventive concept, the specific structure and technical effect produced is further described to fully understand the objects, features and advantages of the present invention.

附图说明 BRIEF DESCRIPTION

[0031]图1是本发明的一个较佳实施例的第一形态立体结构示意图; [0031] FIG. 1 is a perspective schematic structural view of a preferred embodiment of the first aspect of the embodiment of the present invention;

[0032]图2是图1中较佳实施例的立体俯视图; [0032] FIG. 2 is a perspective plan view of a preferred embodiment;

[0033]图3是本发明的工作位置解剖结构示意图。 [0033] FIG. 3 is a schematic view of the working position of the anatomical structure of the present invention.

具体实施方式 detailed description

[0034]如图1所示为本发明的一个较佳实施例的第一形态的结构示意图。 Schematic structural diagram of a preferred embodiment of the first aspect of the embodiment [0034] of the present invention as shown in FIG. 该冠状动脉保护装置为具有网格结构的管状,包括隔离部件I和固定部件2,该装置的各部件之间可采用常规的连接方式连接,也可以采用一体成型的方式制作而成。 The coronary tubular protective device having a grid structure comprising spacer member 2 and the fixing member I, can be used between the various components of the apparatus of the conventional connection mode, forming one embodiment may be adopted made.

[0035]本实施例中,隔离部件I与固定部件2为一体化的圆管,其第一形态如图中所示类似于字母L型,该圆管具有菱形的网格结构,隔离部件I与固定部件2之间形成弯折的圆角α,α的大小以隔离部件I的中轴线和固定部件2的中轴线的夹角来确定,优选为60°〜150° ;隔离部件I的网格线比固定部件2的网格线略粗,可以提供更大的支撑力。 [0035] In this embodiment, the spacer member and the fixed member I for the integration of tube 2, a first type shape resembling the letter L as shown in FIG., The tube having a rhombic mesh structure, spacer member I α fillet is formed between the fixed member 2 and is bent, the size of the angle α of the member I to isolate the fixing member 2 and the axis of the central axis is determined, preferably 60 ° ~150 °; mesh spacer member I ruled line is slightly thicker than the fixing member 2 of the grid lines, can provide greater support force.

[0036]本发明的结构不只局限于L型管状,任意能实现隔离和固定功能的结构都是可行的,如T型管状、I型管状等;本发明的网格形状也不唯一,任意能满足血流流通和收缩扩张要求的形状都是可行的。 [0036] The structure of the present invention is not limited to the L-shaped tube, and the spacer structure can be realized in any fixed function are possible, such as T-tube, tube and other type I; a grid shape is not unique to the present invention, can be any expansion and contraction of blood flow to meet the flow requirements of shape are possible.

[0037]如图2所示,本实施例的隔离部件I为喇叭状的圆管,沿管状的轴向向远心端逐渐增大,其工作位置如图3所示,贴靠升主动脉根部的内壁,自冠状动脉开口向上排布;固定部件的工作位置在冠状动脉内。 [0037] 2, the spacer member of the present embodiment is trumpet-shaped tube I is gradually increased along the distal end to the heart of the tubular axial direction in its operating position shown in Figure 3, against the ascending aorta the inner wall of the root, are arranged upwardly from the coronary artery; operating position fixing member in the coronary arteries. 当介入瓣膜3植入后会对该隔离部件I产生径向的压迫作用,本实施例中的隔离部件I则具有较强的支撑力,能保持管体内血流的通畅,使血流能顺利地流入冠状动脉内。 When the valve 3 intervention implant I will produce a radial compression effect of the spacer member, the spacer member in the embodiment I of the present embodiment has a strong supporting force, the tubular body to maintain patency of blood flow, smooth blood flow flow into the coronary arteries.

[0038]本发明的外部轮廓线与升主动脉根部及冠状动脉近段的走形一致。 [0038] The outer contour line of the present invention and the proximal aortic root and coronary out of shape consistent. 本发明可以根据需要设计成左冠状动脉型和右冠状动脉型两种类型,固定部件的长度为2-6cm,内径与比人体左右冠状动脉的内径稍大,支撑力可接近目前现有的冠脉支架,以免损伤冠状动脉,且可根据个体差异设计个性化参数,以符合不同人体不同冠状动脉内径的需求。 The present invention may be designed to the right coronary artery and the left coronary artery type of two types, the fixing member is needed 2-6cm length, inner diameter than an inner diameter slightly larger than the left and right coronary body, the supporting force of the currently available crown accessible pulse bracket, so as not to damage the coronary arteries, and can be personalized according to individual differences in design parameters, to meet the different needs of different coronary artery diameter of the human body.

[0039]隔离部件的长度为5-15cm,近心端直径可等于或者大于固定部件的直径,远心端的直径逐渐扩大,呈喇叭状开口。 Length [0039] The spacer member is 5-15cm, the diameter of the proximal end of the fixing member may be equal to or greater in diameter, the diameter of the distal end gradually enlarged, flared opening. 隔离部件的径向支撑力较大,可以对抗介入瓣膜的压迫,在介入瓣膜压迫下,仍可保持圆管状或椭圆管状形态,保证隔离部件内有管腔空间连向固定部件。 Spacer member radially larger supporting force, can intervene against compression valve, the intervention of the valve under compression, can be maintained or elliptical tubular round tubular shape to ensure the space within the lumen spacer member connected to the fixing member.

[0040]本实施例装置的第一形态整体上接近L型,但是,隔离部件I和固定部件2之间由平滑的圆角过渡,一体连接,无锐角,以免植入时损伤人体组织,且该圆角的角度依据冠状动脉和升主动脉的夹角设计,使得本实施例装置植入人体后能自然贴合于升主动脉内壁。 [0040] The first aspect of the present embodiment of the apparatus as a whole nearly embodiment L-shaped, however, spacer member and the fixing member I between the two, integrally connected by a smooth rounded transition, no acute angle, so as not to damage when implanted in human tissue, and the rounded angles based on the angle between the ascending aorta and coronary arteries design, so that this embodiment of the apparatus implanted in the body can naturally fit the inner wall of the ascending aorta.

[0041]该装置可在扩张的第一形态和收缩的第二形态之间变换,第一形态为该装置被植入人体升主动脉根部与冠状动脉结合处的预定位置后的工作形态,第二形态为该装置被经导管输送时的输送形态。 [0041] The device may be expandable between a first configuration and a second configuration contraction conversion, a first aspect the working device is implanted configuration after human aortic root and the coronary artery junction predetermined position for the first bimodal device is conveyed by the delivery configuration when the catheter for. 本实施例采用自膨胀或者球囊扩张膨胀的原理,在体外,该装置可以被压迫成条状,放置于输送系统中,到达主动脉根部预定位置后,通过自膨胀或者球囊扩张,可以恢复到原始设计的形态且具有较高的硬度,并通过固定部件的作用牢牢固定于升主动脉根部的预定位置中。 This embodiment uses the principle of the self-expanding or balloon expandable, in vitro, the apparatus may be oppressed into strips, placed in the delivery system, the aortic root reaches a predetermined position, the self-expanding or balloon can be recovered to the original design shape and has a high hardness, and by the action of the fixing member is firmly fixed to a predetermined position of the lift in the aortic root.

[0042]本实施例的冠状动脉保护装置的制作方法优选为激光雕刻技术,但该制备方法不唯一,在其它的优选实施方式中也可以采用一体成型的3D打印技术制作。 Preferably coronary protection device manufacturing method of the embodiment [0042] This laser engraving technique, but the production method is not unique, in other preferred embodiments the 3D printing technology to produce integrally formed may be used.

[0043]本发明的冠状动脉保护装置在实际植入时可采用以下步骤: [0043] Coronary protection device according to the present invention can be implanted in the actual steps of:

[0044] (I)在体外,使用压迫器械,将所述装置迫成细条状后,再将其置入输送系统的鞘管中; [0044] (I) in vitro using a compression device, after the device is forced into a thin strip, which is then placed in a sheath of the delivery system;

[0045] (2)将导丝从升主动脉路径插入冠状动脉中,沿着导丝将装有装置的输送鞘管送至冠状动脉内; [0045] (2) from the guide wire into the ascending aorta path coronary arteries, along with the guidewire to the coronary delivery sheath means;

[0046] (3)后撤输送鞘管,打开装置; [0046] (3) the delivery sheath retreat, the opening means;

[0047] (4)完全释放装置,退出输送系统。 [0047] (4) complete release means to exit the delivery system.

[0048] 上述植入步骤以及植入后不会影响患者自身的主动脉瓣功能,也不影响冠脉血流,植入后不影响介入瓣膜的功能,同时又能在介入瓣膜植入后起到保护冠状动脉的作用,避免冠状动脉开口被堵塞。 [0048] above the implantation procedure and post-implantation does not affect the patient's own aortic valve function, does not affect coronary blood flow, does not affect the function of the valve intervention after implantation, while newcomer in the intervention valve implantation to protect the coronary artery, the coronary openings to avoid clogging.

[0049]以上详细描述了本发明的较佳具体实施例。 [0049] The above detailed description of particular preferred embodiments of the present invention. 应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。 It should be understood by those of ordinary skill in the art without creative work can make many modifications and variations of the inventive concept. 因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。 Therefore, any person skilled in the art under this inventive concept on the basis of prior art technical solutions through logical analysis, reasoning or limited experiments can be obtained, are to be within the scope defined by the claims in.

Claims (10)

  1. 1.一种冠状动脉保护装置,其特征在于所述装置包括用于将潜在的阻挡物与冠状动脉开口隔离的隔离部件和用于固定所述隔离部件位置的固定部件,所述隔离部件与所述固定部件相互连接在一起;所述隔离部件的工作位置为升主动脉根部与冠状动脉的结合处;所述冠状动脉保护装置可在径向扩张的第一形态和径向收缩的第二形态之间变换。 A coronary protection device, characterized in that said means comprises a potential barrier for isolating the opening coronary spacer member and said spacer member for fixing the position of the fixing member, the spacer member and the the second aspect coronary retractable protection means in a first form and the radially expanded; and said fixing member are connected to each other; said spacer member operating position of the aortic root and coronary artery junction between transformation.
  2. 2.如权利要求1所述的冠状动脉保护装置,其特征在于所述隔离部件具有网格结构。 Coronary protection device as claimed in claim 1, wherein said spacer member has a mesh structure.
  3. 3.如权利要求1所述的冠状动脉保护装置,其特征在于所述隔离部件为管状。 Coronary protection device according to claim 1, wherein said spacer member is tubular.
  4. 4.如权利要求1所述的冠状动脉保护装置,其特征在于所述固定部件的工作位置为冠状动脉内,并通过与冠状动脉壁之间的静摩擦力来固定防止脱落。 4. The protection device of claim coronary claim 1, characterized in that the working position of the fixing member is within a coronary artery, and by the static friction force between the fixed and prevented from coming off the wall of the coronary artery.
  5. 5.如权利要求4所述的冠状动脉保护装置,其特征在于所述固定部件为具有网格结构的管状。 5. The protective device such as coronary according to claim 4, wherein said fixing member is a tubular mesh structure.
  6. 6.如权利要求1所述的冠状动脉保护装置,其特征在于所述隔离部件的形状为沿管状的轴向向远心端逐渐增大的喇叭状。 Coronary protection device as claimed in claim 1, wherein said spacer member in the axial direction of the tubular shape is increased gradually toward the distal end of the horn.
  7. 7.如权利要求1所述的冠状动脉保护装置,其特征在于所述隔离部件与所述固定部件为一体化的管状,中间具有弯折角。 7. The protection device of claim coronary claim 1, wherein said spacer member is a tubular member with said stationary integrated, having an intermediate angle of bend.
  8. 8.如权利要求1-7任意一项所述的冠状动脉保护装置,其特征在于所述装置由自膨胀材料构成。 Coronary protection device according to any one of claims 1-7, characterized in that said means comprises a self-expanding material.
  9. 9.如权利要求1-7任意一项所述的冠状动脉保护装置,其特征在于所述装置以球囊扩张原理实现缩放。 9. The protective device of any one of the coronary arteries of claims 1-7, characterized in that said expandable means to implement the principle of scaling balloon.
  10. 10.一种冠状动脉保护装置,其特征在于所述装置为一体化的圆管,具有网格结构,所述冠状动脉保护装置可在径向扩张的第一形态和径向收缩的第二形态之间变换,其第一形态具有弯折角,所述弯折角的一侧为隔离部件,用于将潜在的阻挡物与冠状动脉开口隔离,所述弯折角的另一侧为固定部件,用于固定所述隔离部件的位置,所述一体化的圆管的第一形态接近于人体升主动脉根部和冠状动脉结合处的解剖结构。 A coronary protection device, characterized in that said integrated device is a tube, having a mesh structure, the second aspect coronary retractable protection means in a first form and the radially expanded transformation between that of the first aspect having a bend angle, the bend angle is a side spacer member, for the other side of the potential barrier and isolated coronary artery, the angular bend is a fixed member, for fixing the position of the spacer member, a first aspect of the integrated pipe body close to the root of the ascending aorta and the coronary anatomy at the junction.
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