WO2018053927A1 - 一种人工二尖瓣成形环 - Google Patents
一种人工二尖瓣成形环 Download PDFInfo
- Publication number
- WO2018053927A1 WO2018053927A1 PCT/CN2016/107271 CN2016107271W WO2018053927A1 WO 2018053927 A1 WO2018053927 A1 WO 2018053927A1 CN 2016107271 W CN2016107271 W CN 2016107271W WO 2018053927 A1 WO2018053927 A1 WO 2018053927A1
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- WIPO (PCT)
- Prior art keywords
- annuloplasty ring
- wire
- mitral annuloplasty
- artificial mitral
- coil
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A61F2/2448—D-shaped rings
Definitions
- the present invention relates to the field of medical device technology, and in particular to an artificial mitral valve forming ring.
- Mitral regurgitation is one of the most common valvular heart disease. With the aging of China's population, the incidence of mitral regurgitation has increased significantly. According to the etiology, mitral regurgitation can be divided into primary mitral regurgitation and secondary mitral regurgitation. For patients with mitral regurgitation, part of the blood will flow back into the left atrium when the left ventricle contracts. As a result, the heart works not only by pumping a regular volume of blood, but also by pumping extra blood back to the left atrium. More heavy. The increased workload burdens the left ventricle causing excessive fatigue and eventually consuming the heart. Severe mitral regurgitation is extremely damaging to the patient and can even lead to death in severe cases.
- Mitral valvuloplasty is the main method for the treatment of mitral regurgitation, and the surgical effect has been widely recognized internationally. Mitral valvuloplasty preserves the mitral valve leaflet and subvalvular structure, retaining the connection between the chordae papillary muscle and the left ventricle, which is conducive to diastolic ventricular shaping, thus protecting the left ventricular systolic function, and the operative mortality is low. The long-term effect is good.
- the artificial mitral annuloplasty ring is the core device of mitral valvuloplasty and an important guarantee for the quality of mitral valvuloplasty.
- cardiopulmonary bypass is required to operate under cardiac arrest.
- cardiac arrest is a non-physiological state.
- the surgical effect cannot be very accurate. Only when the heart recovers from beating can the quality of the mitral valve repair be evaluated by ultrasound. If the repair is not satisfactory, the cardiopulmonary bypass can be started again, and the heart can be cut again. Subsurgery increases the risk of surgery.
- the object of the present invention is to provide an artificial mitral annuloplasty ring to solve the problem that the existing artificial mitral annuloplasty ring is implanted, and the patient needs to have a high risk of secondary thoracotomy after recurrence, and the existing The mitral annuloplasty ring does not have the problem of size adjustment multiple times.
- the present invention provides an artificial mitral valve forming ring, the artificial mitral valve forming ring comprising: a wire, an adjusting member for adjusting the length of the wire, and an adjusting mitral valve forming ring diameter a sized support coil; the support coil is sleeved on the outside of the wire and together with the adjustment member forms a shape that matches the mitral annulus of the heart.
- the artificial mitral annuloplasty ring further comprising: a medical polyester fabric disposed outside the support coil.
- the adjustment member includes a reel for winding the wire, and a shaft member disposed in an axial direction of the reel.
- the reel is provided with a first through hole for fixing a wire.
- the adjustment member further includes a gasket for fastening the reel and a damping member for fastening the wound wire, the gasket and the
- the damper members are oppositely disposed at two ends of the reel, and the shims are provided with a second through hole exposing the shaft member.
- the adjustment component further includes a housing, and the spacer, the reel and the damping component are housed in the housing.
- the reel is provided with a cross-shaped groove, and the cross-shaped groove is located on a reel opposite to the rotating shaft member.
- the damping component is a rotary through piece, and the rotary through piece is embedded in the cross-shaped groove to fasten the wound wire.
- the inside of the housing is provided with a groove for accommodating the rotating through-stop piece, and the groove shape and the rotating through-stop piece are The shape is consistent.
- an interface for secondary adjustment is further included, and the interface is connected to the adjustment component.
- the shape of the support coil is two-pointed
- the D-shaped structure of the valve ring physiological structure is matched, including a longitudinally compressible coil and a longitudinal incompressible coil connected to the longitudinally compressible coil.
- the number of the longitudinally compressible coils is at least two, and the number of the longitudinal incompressible coils is plural, and the longitudinal incompressible coils Any two adjacent longitudinally compressible coils are connected to control the size of the artificial mitral annuloplasty ring at different locations.
- the state of the support coil changes with the change of the length of the guide wire; the wire becomes long, and the support coil exhibits an expanded state; the wire Shortening, the support coil assumes a tightened state.
- the support coil is made of titanium, nickel-titanium alloy, stainless steel, cobalt-chromium alloy or molybdenum-niobium alloy;
- the wire is made of titanium or nickel-titanium alloy.
- the artificial mitral annuloplasty ring includes a wire, an adjustment member for adjusting the length of the wire, and a support coil for adjusting the radial dimension of the mitral annuloplasty ring.
- the support coil is sleeved on the outer side of the wire and together with the adjustment component forms a shape that matches the mitral annulus of the heart.
- FIG. 1a is a schematic structural view 1 of a manual mitral annuloplasty ring according to a first embodiment of the present invention
- Figure 1b is a schematic view showing the structure of the support coil of Figure 1a with a polyester fabric sleeved on the outside;
- Figure 2a is a front elevational view of the adjusting member of the first embodiment of the present invention.
- Figure 2b is a plan view of the adjusting member in the first embodiment of the present invention.
- Figure 2c is an exploded view of the internal structure of the housing of the adjusting member when the damping member is a damper ring;
- FIGS. 2d to 2e are schematic structural views of a reel according to Embodiment 1 of the present invention.
- Figure 2f is a schematic structural view of a rotary through-stop sheet
- 2g is a schematic structural view of the inside of a part of the casing when the damping member is a rotating through-stop;
- Figure 3 is a schematic view showing the structure of the artificial mitral annuloplasty ring after contraction in Figure 1a;
- FIG 4 is a schematic structural view 2 of the artificial mitral annuloplasty ring in the first embodiment of the present invention.
- the invention discloses an artificial mitral annuloplasty ring capable of repairing a diseased mitral valve with a normal physiological shape and contour.
- FIG. 1a it is a schematic structural view of the artificial mitral annuloplasty ring of the present invention.
- the artificial mitral valve forming ring includes: a wire 1, an adjusting member 2 for adjusting the length of the wire 1, and a supporting coil 3 for adjusting a radial dimension of the mitral forming ring; the supporting coil 3 is sleeved on The outer side of the wire 1 and together with the adjustment member 2 form a shape that matches the mitral annulus of the heart.
- the shape and size of the artificial mitral annuloplasty ring are mechanically adjusted by the adjustment member 2, since the support coil 3 is used to maintain the shape of the artificial mitral annuloplasty ring, The size and shape of the artificial mitral annuloplasty ring is changed by adjusting the length of the wire 1 such that the support coil 3 assumes a tightened or expanded state.
- FIG. 1b is a schematic view showing the structure of the artificial mitral annuloplasty ring shown in FIG. 1a, after the medical polyester fabric 5 is sleeved on the outer side of the support coil of FIG. 1a, the medical polyester fabric 5 is distributed.
- a suture having a specific color-marking segment is used to meet the requirements of the marker suture fixation of the artificial mitral annuloplasty ring.
- the surface of the medical polyester fabric 5 is coated with polytetrafluoroethylene.
- the artificial mitral annuloplasty ring in this embodiment needs an external rotatable conveyor when the adjusting component is applied, and the rotatable conveyor interfaces with the adjusting component to provide a rotation effect. The force, and thus the adjustment member, changes the size and shape of the artificial mitral annuloplasty ring.
- the adjusting component 2 mainly comprises a housing 24 and a spacer 22, a reel 20 and a damping component which are arranged in the housing 24 from top to bottom.
- the spacer is provided with a second through hole 220 for exposing the rotating shaft component; in order to facilitate stable connection with the adjusting component when the rotatable conveyor is applied, please refer to FIG. 1b, in the housing 24 of the adjusting component A thread 25 is also provided thereon as an interface for subsequent connection to the rotatable conveyor.
- the adjusting component is further provided with a coil fixing thread 26, so that the supporting coils 3 on both sides of the adjusting component are embedded in the coil fixing thread 26, and the partial supporting coil 3 is defined. Make it a longitudinally incompressible coil.
- the reel 20 is used for winding the wire (the structure of the reel 20 can refer to FIG.
- the gasket for fastening the reel 20 22 is disposed opposite the damper member for fastening the wound wire at both ends of the reel 20 to increase the friction between the shims 22 and the damper member and the reel 20, the role of which is on the reel 20 tightening or expanding hinders the shape of the forming ring from deforming, effectively maintaining the size and shape required for the artificial mitral annuloplasty ring.
- the damping member is a damper ring 23.
- the adjusting member in order to rotate the reel 20, the adjusting member further includes a rotating shaft member 21 disposed in an axial direction of the reel 20, and the spacer 22 is provided with the exposed rotating shaft member
- the second through hole 220 of the second through hole 220 is used to adjust the length of the wire 1 to be adjusted by docking with the rotating shaft member 21 through the second through hole 220, and the outer side of the wire 1 is supported while the length of the wire 1 is changed.
- the coil 3 assumes an expanded state or a tightened state. Specifically, the state of the support coil 3 changes with the change of the length of the wire 1; the wire 1 becomes long, the support coil 3 assumes an expanded state; the wire 1 becomes short, and the support coil 3 presents Tightening state.
- the rotating shaft member 21 is a groove structure (as shown in FIG. 2c), and more preferably, the groove structure is a groove-shaped groove; the rotatable conveyor is matched with the rotating shaft member.
- One end of the protrusion is provided with a convex structure conforming to the groove structure. If the groove structure is a groove having a shape, the convex structure is a flat protrusion.
- the main body portion of the rotatable conveyor may be a flexible structure or a rigid structure material, preferably a flexible material, and the main body of the rotatable conveyor prepared by the flexible material facilitates passage adjustment by the conduit extension line.
- the shape and shape of the cusp forming ring can be bent as needed.
- the damping member includes, but is not limited to, a damper ring 23, and may also be a rotary passage piece 23'. Accordingly, in order to satisfy the function of the rotating through-stop piece 23' to fasten the wound wire on the reel 20, the structure of the reel 20 and the casing 24 are improved, as shown in Figs. 2d, 2e and 2g.
- the reel 20 is provided with a cross-shaped groove, and the cross-shaped groove is located on the reel 20 opposite to the rotating shaft member; the inside of the housing 24 is provided for accommodating the rotation.
- the groove shape coincides with the shape of the rotary through-stop piece 23'.
- the rotary through-stop piece 23' is embedded in the cross-shaped groove to fasten the wound wire; when it is necessary to adjust the formed size later, the rotating conveyor is externally connected to the adjusting member, and can be rotated.
- the conveyor is longitudinally downward in the central portion of the adjustment member so that the rotary passage piece 23' is disengaged from the cross-shaped groove to adjust the size of the forming ring.
- FIG. 3 is a schematic structural view of the artificial mitral annuloplasty ring of FIG. 1a after contraction.
- the support coil is in the form of a D-shaped structure that matches the physiological structure of the mitral annulus, including a longitudinally incompressible coil 30 and a longitudinally compressible connection to the longitudinally incompressible coil 30.
- the coil 31, the longitudinally incompressible coil 30 differs from the longitudinally compressible coil 31 in that the density of the braided filaments is different when the coils are prepared to achieve a longitudinally compressible or non-vertical compression of the coil.
- the longitudinally compressible coil 31 has a lower coil density than the longitudinally incompressible coil 30 and is spaced apart.
- the number of the longitudinally incompressible coils 30 is at least two, and the number of the longitudinally compressible coils is plural, by providing the longitudinally incompressible coils 30 and the longitudinally compressible coils 31 in the entire forming ring. Locations that are distributed to each other to control the size of the artificial mitral annuloplasty ring at different locations.
- the longitudinally incompressible coil 30 and the longitudinally compressible coil 31 exhibit only a longitudinally compressible coil 30 in a longitudinally compressed or stretched state during tightening or expansion of the artificial mitral annuloplasty ring.
- the longitudinally compressible coil 31 does not deform in the longitudinal direction.
- the position and the number of the longitudinally incompressible coils 30 and the longitudinally compressible coils 31 respectively distributed in the forming ring are not limited to the structure shown in FIG. 1a, and may also be as shown in FIG.
- the structure can be set according to the patient's condition and mechanical energy.
- the support coil 3 is not limited to two kinds of density coils, and may also include coils of other densities.
- the specific layout of the different density coils may be designed according to the needs of the patient, and the treatment effect of the mitral regurgitation is effectively improved.
- the material of the support coil 3 is nickel titanium alloy, copper zinc aluminum alloy, copper aluminum nickel alloy, iron manganese silicon alloy, iron nickel aluminum alloy or gold cadmium alloy.
- the wire is made of titanium, nickel titanium alloy, stainless steel, cobalt chromium alloy, molybdenum rhenium alloy, ultra high molecular weight polyethylene, carbon fiber or polyimide.
- the artificial mitral annuloplasty ring includes a wire for adjusting the length of the wire.
- An adjustment member a support coil for adjusting a radial dimension of the mitral annuloplasty ring; the support coil is sleeved on an outer side of the wire and together with the adjustment member to form a shape matching the mitral annulus of the heart.
Abstract
一种人工二尖瓣成形环，包括导线（1）、用于调节导线（1）长度的调节部件（2）、用于调节二尖瓣成形环径向尺寸的支撑线圈（3），支撑线圈（3）套接于导线（1）的外侧并与调节部件（2）共同构成与心脏二尖瓣环匹配的形状。通过常规的外科手术缝合方式植入，当患者心脏恢复跳动状态下，在人工二尖瓣成形环的调节部件（2）处外接可旋转输送器，调节部件（2）在可旋转输送器的旋转作用下调节导线（1）的长度进而使得二尖瓣成形环尺寸收缩或扩张，以准确调节人工二尖瓣成形环构成与心脏二尖瓣瓣环相匹配的形状，从而有效解决二尖瓣关闭不全问题。
Description
本发明涉及医疗器械技术领域，特别涉及一种人工二尖瓣成形环。
二尖瓣关闭不全是最常见的心脏瓣膜病之一。随着我国人口老龄化，二尖瓣关闭不全发病率明显增加。依据病因可将二尖瓣关闭不全分为原发性二尖瓣关闭不全和继发性二尖瓣关闭不全。对于二尖瓣关闭不全患者当左心室收缩时部分血液将会反流到左心房中，结果心脏由于不仅要泵送常规体积的血液，而且还要额外泵送回流到左心房内的血液而工作更沉重。所增加的工作负担对左心室造成过度的疲劳最终消耗心脏，严重二尖瓣关闭不全对患者危害极大并在严重时甚至导致死亡。
二尖瓣成形术是治疗二尖瓣关闭不全主要手段，手术效果已经得到国际广泛的认可。二尖瓣成形术保留了二尖瓣瓣叶及瓣下结构，保留了腱索乳头肌与左心室的连接，有利于舒张期心室塑形，因而保护了左心室收缩功能，手术死亡率低，远期效果好。
人工二尖瓣成形环是二尖瓣成形术的核心装置，也是体现二尖瓣成形手术质量的重要保证。在传统的外科手术中需要利用心肺转流术在心脏停跳下进行操作。但心脏停跳是非生理状态手术效果无法做到十分精确，只有当心脏恢复跳动后才可以通过超声技术评价二尖瓣修复质量，如修复不满意只能再次开始心肺转流、再次切开心脏二次手术，从而加大手术风险。
发明内容
本发明的目的在于提供一种人工二尖瓣成形环，以解决现有人工二尖瓣成形环植入后，患者术后复发需要高风险的二次开胸手术进行调整，且现有
二尖瓣成形环不可以多次进行尺寸调整的问题。
为解决上述技术问题，本发明提供一种人工二尖瓣成形环，所述人工二尖瓣成形环包括：导线、用于调节所述导线长度的调节部件、用于调节二尖瓣成形环径向尺寸的支撑线圈；所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。
可选的，在所述的人工二尖瓣成形环中，还包括：设置于所述支撑线圈外侧的医用聚酯织物。
可选的，在所述的人工二尖瓣成形环中，所述调节部件包括用于缠绕所述导线的卷轴、设置于所述卷轴的轴向方向上的转轴部件。
可选的，在所述的人工二尖瓣成形环中，所述卷轴上设置有用于固定导线的第一通孔。
可选的，在所述的人工二尖瓣成形环中，所述调节部件还包括用于紧固所述卷轴的垫片和用于紧固缠绕导线的阻尼部件，所述垫片和所述阻尼部件相对的设置于所述卷轴的两端，所述垫片上开设有外露所述转轴部件的第二通孔。
可选的，在所述的人工二尖瓣成形环中，所述调节部件还包括壳体，所述垫片、所述卷轴和所述阻尼部件均容置于所述壳体内。
可选的，在所述的人工二尖瓣成形环中，所述卷轴上设置有十字型凹槽，所述十字型凹槽位于与所述转轴部件相对一端的卷轴上。
可选的，在所述的人工二尖瓣成形环中，所述阻尼部件为旋转通止片，所述旋转通止片内嵌于所述十字型凹槽中以紧固缠绕导线。
可选的，在所述的人工二尖瓣成形环中，所述壳体的内部设置有用于容置所述旋转通止片的凹槽，所述凹槽形状与所述旋转通止片的形状相吻合。
可选的，在所述的人工二尖瓣成形环中，还包括用于二次调节的接口，所述接口与所述调节部件连接。
可选的，在所述的人工二尖瓣成形环中，所述支撑线圈的形态为与二尖
瓣瓣环生理结构相匹配的D型结构，包括纵向可压缩的线圈和与所述纵向可压缩的线圈连接的纵向不可压缩线圈。
可选的，在所述的人工二尖瓣成形环中，所述纵向可压缩的线圈的数量为至少两个，所述纵向不可压缩的线圈的数量为多个，所述纵向不可压缩的线圈连接任意相邻两个纵向可压缩线圈，以控制人工二尖瓣成形环在不同位置的尺寸。
可选的，在所述的人工二尖瓣成形环中，所述支撑线圈的状态随所述导丝长度的改变而改变；所述导线变长，所述支撑线圈呈现扩张状态；所述导线变短，所述支撑线圈呈现收紧状态。
可选的，在所述的人工二尖瓣成形环中，所述支撑线圈的材质为钛、镍钛合金、不锈钢、钴铬合金或钼铱合金；所述导线的材质为钛、镍钛合金、不锈钢、钴铬合金、钼铱合金、超高分子量聚乙烯、碳纤维或聚酰亚胺。
在本发明所提供的人工二尖瓣成形环中，所述人工二尖瓣成形环包括导线、用于调节所述导线长度的调节部件、用于调节二尖瓣成形环径向尺寸的支撑线圈；所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。通过常规的外科手术缝合方式植入，当患者心脏恢复跳动状态下，在人工二尖瓣成形环的调节部件出外接可旋转输送器，调节部件在可旋转输送器的旋转作用下调节导线的长度进而使得二尖瓣成形环尺寸收缩或扩张，以调节人工二尖瓣成形环构成与心脏二尖瓣瓣环相匹配的形状，从而有效解决二尖瓣关闭不全问题。
图1a是本发明实施例一中人工二尖瓣成形环的结构示意图一；
图1b是图1a中支撑线圈外侧套接有聚酯织物后的结构示意图；
图2a是本发明实施例一中调节部件的主视图；
图2b是本发明实施例一中调节部件的俯视图；
图2c是阻尼部件为阻尼圈时，调节部件的壳体内部结构的爆炸图；
图2d～图2e是本发明实施例一中卷轴的结构示意图；
图2f是旋转通止片的结构示意图；
图2g是阻尼部件为旋转通止片时，部分壳体内部的结构示意图；
图3是图1a中人工二尖瓣成形环收缩后的结构示意图；
图4是本发明实施例一中人工二尖瓣成形环的结构示意图二。
图中：导线1；调节部件2；卷轴20；第一通孔200；十字型凹槽201；转轴部件21；垫片22；第二通孔220；阻尼圈23；旋转通止片23’；壳体24；螺纹25；线圈固定螺纹26；支撑线圈3；纵向不可压缩的线圈30；纵向可压缩的线圈31；医用聚酯织物5。
以下结合附图和具体实施例对本发明提出的人工二尖瓣成形环作进一步详细说明。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。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。
本发明公开了一种可修复病变二尖瓣为正常生理形状和轮廓的人工二尖瓣成形环，请参考图1a，其为本发明的人工二尖瓣成形环的结构示意图。所述人工二尖瓣成形环包括：导线1、用于调节所述导线1长度的调节部件2、用于调节二尖瓣成形环径向尺寸的支撑线圈3；所述支撑线圈3套接于所述导线1的外侧并与所述调节部件2共同构成与心脏二尖瓣环匹配的形状。在人工二尖瓣成形环常规缝合手术方法植入后，通过调节部件2实现机械式调节人工二尖瓣成形环的形状及尺寸，由于支撑线圈3用于保持人工二尖瓣成形环的外形，通过调整导线1的长度从而使得支撑线圈3呈现收紧或扩张状态，进而改变人工二尖瓣成形环的尺寸和形状。
图1b是图1a所示的人工二尖瓣成形环的结构的基础上，在图1a中的支撑线圈外侧套接有医用聚酯织物5后的结构示意图，所述医用聚酯织物5上分布有特定颜色标记分段的缝合线，用于满足人工二尖瓣成形环的标记缝合固定的需求，优选的，所述医用聚酯织物5表面涂覆有聚四氟乙烯。如图1b所示，为了实现调节部件的调节，本实施例中的人工二尖瓣成形环在调节部件应用时需要外接可旋转输送器，所述可旋转输送器与调节部件对接，提供旋转作用力，进而控制调节部件改变人工二尖瓣成形环的尺寸和形状。
为了解决人工二尖瓣成形环植入后存在尺寸不合适，需要二次调节的问题，在所述人工二尖瓣成形环上还设置有用于二次调节的接口，所述接口与所述调节部件连接。
本实施例中，请参考图2a-图2c，所述调节部件2主要包括壳体24及封装于壳体24中自上而下分布的垫片22、卷轴20及阻尼部件。其中，所述垫片上开设有外露所述转轴部件的第二通孔220；为了便于可旋转输送器应用时与调节部件的稳定连接，请参考图1b，在所述调节部件的壳体24上还设置有螺纹25，以作为后续与可旋转输送器连接的接口。较佳的，请参考图2a及图2b，所述调节部件上还设置有线圈固定螺纹26，以使调节部件两侧的支撑线圈3嵌于所述线圈固定螺纹26中，限定局部支撑线圈3，使其成为纵向不可压缩的线圈。其中，所述卷轴20用于缠绕所述导线(所述卷轴20的结构可以参考图2c)，进而改变套接于支撑线圈3中导线1的长度；用于紧固所述卷轴20的垫片22和用于紧固缠绕导线的所述阻尼部件相对的设置于所述卷轴20的两端，以增大垫片22和阻尼部件与卷轴20之间的摩擦力，两者的作用是在卷轴20收紧或者扩张后阻碍成形环形状发生形变，有效的保持住人工二尖瓣成形环所需要的尺寸和形状。优选的，如图2c所示，所述阻尼部件为阻尼圈23。
请参考图2b，为了使得卷轴20转动，所述调节部件还包括设置于所述卷轴20的轴向方向上的转轴部件21，所述垫片22上开设有外露所述转轴部件
21的第二通孔220，后续调节导线1长度时采用的可旋转输送器通过贯穿第二通孔220与转轴部件21对接进行调节，在导线1长度改变的同时，导线1外侧套接的支撑线圈3呈现扩张状态或收紧状态。具体的，所述支撑线圈3的状态随所述导线1长度的改变而改变；所述导线1变长，所述支撑线圈3呈现扩张状态；所述导线1变短，所述支撑线圈3呈现收紧状态。
具体的，可旋转输送器与调节部件外接时，实际上所述可旋转输送器与调节部件的所述转轴部件匹配连接，从而便于后续可旋转输送器对调节部件的调节。优选的，所述转轴部件21为一凹槽结构(如图2c所示)，更优选的，所述凹槽结构为一字型凹槽；所述可旋转输送器与所述转轴部件匹配连接的一端设置有与所述凹槽结构相吻合的凸起结构，若所述凹槽结构为以一字型凹槽，此时所述凸起结构为一字型凸起。其中，所述可旋转输送器的主体部分可以是柔性的结构也可以是刚性结构的材料，优选为柔性材料，柔性材料制备的可旋转输送器的主体便于通过导管延长线构成的通道调节人工二尖瓣成形环的尺寸和形状，并且可根据需要弯曲输送。利用可旋转输送器驱动卷轴20逆时针旋转时，支撑线圈3呈现扩张状态；反之，收紧状态。卷轴20的旋转方向与支撑线圈3呈现的状态之间关系包括但不局限于上述情况，其具体对应关系，需要根据导线1与卷轴20缠绕的关系而定。为了较好的实现导线1与卷轴20的固定，所述卷轴20上设置有用于固定导线1的第一通孔200，所述导线1通过贯穿第一通孔200实现初步固定进而开展后续绕卷轴20缠绕。
作为阻尼部件另一优选的方案，如图2f所示：所述阻尼部件包括但不局限于阻尼圈23，也可以为旋转通止片23’。相应地，为了满足旋转通止片23’起到紧固卷轴20上已缠绕的导线的作用，所述卷轴20及壳体24的结构均进行了改进，如图2d、图2e及图2g所示，所述卷轴20上设置有十字型凹槽，所述十字型凹槽位于与所述转轴部件相对一端的卷轴20上；所述壳体24的内部设置有用于容置所述旋转通止片23’的凹槽(如图2g所示)，所述凹槽形
状与所述旋转通止片23’的形状相吻合。实际应用时，所述旋转通止片23’内嵌于所述十字型凹槽中以紧固缠绕导线后；在后续需要调节成型后尺寸时，在调节部件上外接可旋转输送器，可旋转输送器在调节部件的中心部分纵向向下，使得旋转通止片23’脱离十字型凹槽，方可进行成形环尺寸的调节。
请参考图1a及图3，图3为图1a的人工二尖瓣成形环收缩后的结构示意图。如图1a所示，所述支撑线圈的形态为与二尖瓣瓣环生理结构相匹配的D型结构，包括纵向不可压缩的线圈30和与所述纵向不可压缩的线圈30连接的纵向可压缩的线圈31，纵向不可压缩的线圈30与纵向可压缩的线圈31的区别在于两者线圈制备时编织丝缠绕的密度不同，以实现线圈在纵向可压缩或不可纵向压缩的性能。如图1a所示，所述纵向可压缩的线圈31的线圈密度比所述纵向不可压缩的线圈30的线圈密度低，且两者间隔连接。其中，所述纵向不可压缩的线圈30的数量为至少两个，所述纵向可压缩的线圈的数量为多个，通过设置纵向不可压缩的线圈30和纵向可压缩的线圈31在整个成形环中彼此分布的位置，以控制人工二尖瓣成形环在不同位置的尺寸。
请继续参考图1a，纵向不可压缩的线圈30和纵向可压缩的线圈31在人工二尖瓣成形环收紧或者扩张过程中仅纵向可压缩的线圈30在纵向上呈现压缩或伸展的状态，而纵向可压缩的线圈31在纵向上不产生形变。实际设计人工二尖瓣成形环时，纵向不可压缩的线圈30和纵向可压缩的线圈31在成形环中各自分布的位置及数量不局限于图1a所示的结构，也可以如图4所示的结构，具体可以根据患者的病情需要机械能设定。
此外，所述支撑线圈3中不局限于两种密度的线圈，也可包括其他密度的线圈，不同密度线圈具体布局可以根据患者的需求进行设计，有效的提高二尖瓣关闭不全治疗效果。
较佳的，所述支撑线圈3的材质为镍钛合金、铜锌铝合金、铜铝镍合金、铁锰硅合金、铁镍铝合金或金镉合金。所述导线的材质为钛、镍钛合金、不锈钢、钴铬合金、钼铱合金、超高分子量聚乙烯、碳纤维或聚酰亚胺。
综上，在本发明所提供的一种可修复病变二尖瓣为正常生理形状和轮廓的人工二尖瓣成形环中，所述人工二尖瓣成形环包括导线、用于调节所述导线长度的调节部件、用于调节二尖瓣成形环径向尺寸的支撑线圈；所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。通过常规的外科手术缝合方式植入，当患者心脏恢复跳动状态下，在人工二尖瓣成形环的调节部件出外接可旋转输送器，调节部件在可旋转输送器的旋转作用下调节导线的长度进而使得二尖瓣成形环尺寸收缩或扩张，以调节人工二尖瓣成形环构成与心脏二尖瓣瓣环相匹配的形状，从而有效解决二尖瓣关闭不全问题。
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。
Claims (14)
- 一种人工二尖瓣成形环，其特征在于，包括：导线、用于调节所述导线长度的调节部件、用于调节二尖瓣成形环径向尺寸的支撑线圈；所述支撑线圈套接于所述导线的外侧并与所述调节部件共同构成与心脏二尖瓣环匹配的形状。
- 如权利要求1所述的人工二尖瓣成形环，其特征在于，还包括：设置于所述支撑线圈外侧的医用聚酯织物。
- 如权利要求2所述的人工二尖瓣成形环，其特征在于，所述调节部件包括用于缠绕所述导线的卷轴、设置于所述卷轴的轴向方向上的转轴部件。
- 如权利要求3所述的人工二尖瓣成形环，其特征在于，所述卷轴上设置有用于固定导线的第一通孔。
- 如权利要求3所述的人工二尖瓣成形环，其特征在于，所述调节部件还包括用于紧固所述卷轴的垫片和用于紧固缠绕导线的阻尼部件，所述垫片和所述阻尼部件相对的设置于所述卷轴的两端，所述垫片上开设有外露所述转轴部件的第二通孔。
- 如权利要求5所述的人工二尖瓣成形环，其特征在于，所述调节部件还包括壳体，所述垫片、所述卷轴和所述阻尼部件均容置于所述壳体内。
- 如权利要求5所述的人工二尖瓣成形环，其特征在于，所述卷轴上设置有十字型凹槽，所述十字型凹槽位于与所述转轴部件相对一端的卷轴上。
- 如权利要求7所述的人工二尖瓣成形环，其特征在于，所述阻尼部件为旋转通止片，所述旋转通止片内嵌于所述十字型凹槽中以紧固缠绕导线。
- 如权利要求8所述的人工二尖瓣成形环，其特征在于，所述壳体的内部设置有用于容置所述旋转通止片的凹槽，所述凹槽形状与所述旋转通止片的形状相吻合。
- 如权利要求1所述的人工二尖瓣成形环，其特征在于，还包括用于 二次调节的接口，所述接口与所述调节部件连接。
- 如权利要求1所述的人工二尖瓣成形环，其特征在于，所述支撑线圈的形态为与二尖瓣瓣环生理结构相匹配的D型结构，包括纵向可压缩的线圈和与所述纵向可压缩的线圈连接的纵向不可压缩线圈。
- 如权利要求11所述的人工二尖瓣成形环，其特征在于，所述纵向可压缩的线圈的数量为至少两个，所述纵向不可压缩的线圈的数量为多个，所述纵向不可压缩的线圈连接任意相邻两个纵向可压缩线圈，以控制人工二尖瓣成形环在不同位置的尺寸。
- 如权利要求1所述的人工二尖瓣成形环，其特征在于，所述支撑线圈的状态随所述导丝长度的改变而改变；所述导线变长，所述支撑线圈呈现扩张状态；所述导线变短，所述支撑线圈呈现收紧状态。
- 如权利要求1～13中任一项所述的人工二尖瓣成形环，其特征在于，所述支撑线圈的材质为钛、镍钛合金、不锈钢、钴铬合金或钼铱合金；所述导线的材质为钛、镍钛合金、不锈钢、钴铬合金、钼铱合金、超高分子量聚乙烯、碳纤维或聚酰亚胺。
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| CN109646150A (zh) * | 2019-02-27 | 2019-04-19 | 复旦大学附属中山医院 | 一种可调节外植入式主动脉瓣成形环 |
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