CN114903658A - Locking structure and external anchor of left ventricular volume reducing device - Google Patents
Locking structure and external anchor of left ventricular volume reducing device Download PDFInfo
- Publication number
- CN114903658A CN114903658A CN202210725630.XA CN202210725630A CN114903658A CN 114903658 A CN114903658 A CN 114903658A CN 202210725630 A CN202210725630 A CN 202210725630A CN 114903658 A CN114903658 A CN 114903658A
- Authority
- CN
- China
- Prior art keywords
- locking
- locking structure
- rod
- left ventricular
- transmission
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Images
Classifications
-
- 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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
本发明公开了一种锁定结构、外锚及左心室减容装置,所述锁定结构具有所述锁定结构具有一锁紧单元,所述锁紧单元具有:一可抵压于系杆上的锁定件,所述锁定件为一锁块;一可压紧所述锁定件于所述系杆上的压挤件,所述压挤件为一传动杆,所述传动杆的一端连接有传动轴,所述传动轴的两端穿设在所述锁块中部两相对的侧端,通过传动杆推拉所述锁块来实现锁定与解锁。本发明通过在锁定结构进行结构改进,进一步降低外锚从系杆上滑落的风险,并通过解锁锁定结构来取回外锚;而且锁定结构与系杆在同一方向操作锁定与解锁,非常便利。
The invention discloses a locking structure, an external anchor and a left ventricle volume reducing device. The locking structure has the locking structure and a locking unit, and the locking unit has: a lock that can be pressed against a tie rod The locking piece is a lock block; a pressing piece that can compress the locking piece on the tie rod, the pressing piece is a transmission rod, and one end of the transmission rod is connected with a transmission shaft , the two ends of the transmission shaft pass through the two opposite side ends of the middle part of the lock block, and the lock block is pushed and pulled by the transmission rod to achieve locking and unlocking. The invention further reduces the risk of the outer anchor slipping from the tie rod by improving the structure in the locking structure, and retrieves the outer anchor by unlocking the locking structure; and the locking structure and the tie rod operate in the same direction to lock and unlock, which is very convenient.
Description
技术领域technical field
本发明属于医疗器械技术领域,具体涉及一种左心室减容装置的锁定结构及外锚。The invention belongs to the technical field of medical devices, and in particular relates to a locking structure and an external anchor of a left ventricular volume reducing device.
背景技术Background technique
左心室室壁瘤(Left ventricular aneurysm,LVA)是心肌梗死后的常见并发症。是因为左心室由于心肌梗塞以后,导致部分心室肌缺血坏死。由于坏死的心室肌失去收缩功能,患者在心脏收缩时,这部分坏死的心肌就会向外突出,从而导致室壁瘤的发生。由于心脏的补偿效应,心脏持续性增大一定体积,继而产生心衰,肺淤血等情况。Left ventricular aneurysm (LVA) is a common complication after myocardial infarction. It is because the left ventricle is avascular necrosis of part of the ventricular myocardium after myocardial infarction. Since the necrotic ventricular myocardium loses its contractile function, when the heart contracts, this part of the necrotic myocardium will protrude outward, resulting in the occurrence of ventricular aneurysm. Due to the compensatory effect of the heart, the heart continues to increase in a certain volume, resulting in heart failure and pulmonary congestion.
左心室减容是一种经导管心室增强系统,可用于解决心肌梗死后缺血性心肌病患者的瘢痕组织问题。左心室减容装置将多对锚(分内锚和外锚)送入体内。它们可以钳住左心室,可以通过体表小切口允许其他手术器械进入心脏。这种极小创伤性的系统也可以用于传统的开胸手术实现心室修复。现有技术中,内外锚结合在一起的原理是通过内外锚之间的系杆连接,系杆的一端固定在内锚上,系杆的另一端被外锚的锁定结构锁紧。同时现有技术中控制外锚锁紧与解离的控制方向与系杆垂直,需要专用的器械从系杆垂直的方向与锁紧结构配合,不仅增加了手术的难度,极不方便,同时也需要对患者采取更加侵入性的措施,不利于患者健康。因此,有必要研制一种集成度更高、稳定性更好的外锚(特别是锁定结构)来解决上述问题。Left ventricular volume reduction is a transcatheter ventricular augmentation system that can be used to address scar tissue in patients with ischemic cardiomyopathy after myocardial infarction. The left ventricular volume reduction device delivers multiple pairs of anchors (inner and outer anchors) into the body. They clamp the left ventricle and allow other surgical instruments to enter the heart through small incisions in the body surface. This minimally invasive system can also be used for ventricular repair in traditional thoracotomy. In the prior art, the principle of combining the inner and outer anchors is to connect the inner and outer anchors through tie rods, one end of the tie rod is fixed on the inner anchor, and the other end of the tie rod is locked by the locking structure of the outer anchor. At the same time, in the prior art, the control direction for controlling the locking and disengagement of the external anchor is perpendicular to the tie rod, and special instruments are required to cooperate with the locking structure from the vertical direction of the tie rod, which not only increases the difficulty of the operation, but also is extremely inconvenient. More invasive measures are required for the patient, which is not good for the patient's health. Therefore, it is necessary to develop an external anchor (especially a locking structure) with higher integration and better stability to solve the above problems.
发明内容SUMMARY OF THE INVENTION
本发明目的之一在于提供一种结构完全不同的用于左心室减容装置的锁定结构。One of the objectives of the present invention is to provide a locking structure for a left ventricular volume reducing device with a completely different structure.
本发明的用于左心室减容装置的锁定结构具有一锁紧单元,所述锁紧单元具有:The locking structure for the left ventricular volume reduction device of the present invention has a locking unit, and the locking unit has:
一可抵压于系杆上的锁定件,所述锁定件为一锁块;a locking piece that can be pressed against the tie rod, and the locking piece is a lock block;
一可压紧所述锁定件于所述系杆上的压挤件,所述压挤件为一传动杆,所述传动杆的一端连接有传动轴,所述传动轴的两端穿设在所述锁块中部两相对的侧端,通过传动杆推拉所述锁块来实现锁定与解锁。A pressing piece that can compress the locking piece on the tie rod, the pressing piece is a transmission rod, one end of the transmission rod is connected with a transmission shaft, and both ends of the transmission shaft pass through the The two opposite side ends of the middle part of the lock block are locked and unlocked by pushing and pulling the lock block through a transmission rod.
较佳地是,Preferably,
所述锁块的一侧内设有定位轴,所述定位轴与所述传动轴平行,通过所述传动杆推拉所述锁块,以所述定位轴为轴心,推动所述锁块的另一侧面挤压至所述系杆的表面来实现锁定。One side of the lock block is provided with a positioning shaft, and the positioning shaft is parallel to the transmission shaft. The other side is pressed against the surface of the tie rod to achieve locking.
较佳地是,所述锁定结构还具有一外壳,所述外壳内置有所述锁紧单元:Preferably, the locking structure further has a casing, and the casing is built with the locking unit:
所述外壳的两相对的第一壳壁上分别具有定位轴支撑孔,所述定位轴的两端分别固定在所述定位轴支撑孔内;Two opposite first shell walls of the outer casing are respectively provided with positioning shaft support holes, and both ends of the positioning shaft are respectively fixed in the positioning shaft support holes;
所述外壳的一第二壳壁上具有传动杆孔,所述传动杆的另一端穿设在所述传动杆孔内。A second shell wall of the casing is provided with a transmission rod hole, and the other end of the transmission rod is penetrated in the transmission rod hole.
较佳地是,Preferably,
所述锁块的中部具有一中空的传动腔,所述传动杆的一端位于所述传动腔内,所述传动杆一端的传动轴的两端穿设在所述锁块的传动腔的两相对侧壁内。The middle of the lock block has a hollow transmission cavity, one end of the transmission rod is located in the transmission cavity, and the two ends of the transmission shaft at one end of the transmission rod pass through the two opposite sides of the transmission cavity of the lock block. inside the side wall.
较佳地是,Preferably,
所述传动杆的一端为圆柱杆,所述传动轴设在所述圆柱杆的一端上;One end of the transmission rod is a cylindrical rod, and the transmission shaft is arranged on one end of the cylindrical rod;
所述传动杆的另一端为螺杆,所述螺杆的一端螺纹连接在所述圆柱杆的另一端内,所述螺杆的另一端设在外壳的第二壳壁的传动杆孔内。The other end of the transmission rod is a screw rod, one end of the screw rod is screwed into the other end of the cylindrical rod, and the other end of the screw rod is arranged in the transmission rod hole of the second shell wall of the casing.
较佳地是,Preferably,
所述圆柱杆的另一段的侧面设有直角梯形的凹槽。The side surface of the other section of the cylindrical rod is provided with a right-angled trapezoid groove.
较佳地是,Preferably,
所述圆柱杆的一端的底面被设置成所述传动轴同轴向的圆柱侧表面形式的弧面。The bottom surface of one end of the cylindrical rod is set as an arc surface in the form of a cylindrical side surface coaxial with the transmission shaft.
较佳地是,Preferably,
所述锁紧单元具有限位所述锁块的一U型限位槽,固定在所述外壳内,所述锁块的另一侧限位于所述U型限位槽内。The locking unit has a U-shaped limiting groove for limiting the locking block, which is fixed in the housing, and the other side of the locking block is limited to be located in the U-shaped limiting groove.
较佳地是,所述外壳的两相对的第二壳壁即与所述传动杆孔同一壳壁上于所述锁定件锁定所述系杆的对应位置处分别具有系杆孔。Preferably, two opposite second shell walls of the housing, that is, the same shell wall as the transmission rod hole, respectively have tie rod holes at corresponding positions where the locking member locks the tie rod.
本发明的另一目的是提供一种用于左心室减容装置的外锚,具有:Another object of the present invention is to provide an external anchor for a left ventricular volume reduction device, having:
一扁长方体形的外锚主体;an outer anchor body in the shape of a flat cuboid;
一锁定结构,其特征在于:所述锁定结构为本发明所述的用于左心室减容装置的锁定结构,所述锁定结构固定设置在所述外锚主体的一侧面的中心位置。A locking structure is characterized in that: the locking structure is the locking structure for the left ventricular volume reducing device according to the present invention, and the locking structure is fixedly arranged at the center of one side surface of the outer anchor body.
较佳地是,所述外锚主体具有:Preferably, the outer anchor body has:
一可抵靠于左心室外壁上的接触面;和a contact surface against the outer wall of the left ventricle; and
一与所述接触面相背的非接触面,所述锁定结构固定在所述非接触面的中心位置。A non-contact surface is opposite to the contact surface, and the locking structure is fixed at the center of the non-contact surface.
较佳地是,所述外锚主体的中心位置具有一贯通的锁孔,所述锁孔供穿设所述系杆,所述锁定结构的外壳的第二壳壁固设在所述外锚主体的锁孔位置。Preferably, the central position of the outer anchor body has a through lock hole, the lock hole is used for passing the tie rod, and the second shell wall of the outer shell of the locking structure is fixed on the outer anchor. The keyhole position of the main body.
本发明还有一目的在于提供一种左心室减容装置,其包括:Another object of the present invention is to provide a left ventricular volume reduction device, which includes:
一系杆;a tie rod;
一内锚,穿设于所述系杆头端;an inner anchor, pierced through the head end of the tie rod;
一外锚,穿设于所述系杆上的近段,其特征在于所述外锚为本发明所述的用于左心室减容装置的外锚。An external anchor, which is inserted into the proximal section of the tie rod, is characterized in that the external anchor is the external anchor for the left ventricular volume reduction device according to the present invention.
较佳地是,所述系杆具有依次连接的方形连接段、引导段和针头段,所述内锚穿设在所述方形连接段的头端,所述外锚穿设在所述方形连接段的近段。Preferably, the tie rod has a square connecting section, a guiding section and a needle section connected in sequence, the inner anchor is pierced through the head end of the square connecting section, and the outer anchor is pierced through the square connecting section. the nearest segment of the segment.
较佳地是,所述方形连接段的头端具有绞合孔,所述绞合孔可穿设在所述内锚上的系杆轴上。Preferably, the head end of the square connecting section has a twisted hole, and the twisted hole can pass through the tie rod shaft on the inner anchor.
较佳地是,所述引导段和所述针头段轴向中心分别具有相互连通的导丝通道。Preferably, the guide section and the needle section have guide wire channels communicating with each other in the axial center respectively.
较佳地是,所述引导段靠近所述方形连接段的头端具有供导丝穿入所述导丝通道的引导孔。Preferably, the guide section near the head end of the square connecting section has a guide hole for the guide wire to pass through the guide wire channel.
较佳地是,所述内锚具有:Preferably, the inner anchor has:
一可抵靠于右心室室间隔上的接触面;和a contact surface against the right ventricular septum; and
一与所述接触面相背的非接触面,其特征在于,所述非接触面的至少一侧边朝向所述非接触面的中部方向延伸出一与所述非接触面大体平行的倒钩,所述倒钩与所述非接触面之间的空间形成一可给圈套器提供导向的导向腔。A non-contact surface opposite to the contact surface, characterized in that at least one side of the non-contact surface extends toward the middle of the non-contact surface with a barb that is substantially parallel to the non-contact surface, The space between the barbs and the non-contact surface forms a guide cavity that provides guidance for the snare.
较佳地是,所述非接触面的两相对侧边分别朝向所述非接触面的中部方向各自延伸出与所述非接触面大体平行的所述倒钩。Preferably, the two opposite sides of the non-contact surface respectively extend toward the middle of the non-contact surface with the barbs that are substantially parallel to the non-contact surface.
较佳地是,所述非接触面的两相对侧边的两个倒钩之间相距一定间距,所述间距形成供所述圈套器进入所述导向腔的倒钩开口。Preferably, there is a certain distance between the two barbs on the two opposite sides of the non-contact surface, and the distance forms a barb opening for the snare to enter the guide cavity.
较佳地是,所述导向腔的终点止于所述内锚的侧端中心。Preferably, the end point of the guide cavity ends at the center of the side end of the inner anchor.
较佳地是,所述倒钩靠近所述导向腔的终点处具有突出于所述导向腔的用于提示导向终点的导向凸点。Preferably, the barb near the end point of the guide cavity has a guide bump protruding from the guide cavity for indicating the end point of the guide.
较佳地是,所述倒钩的形状为U型。Preferably, the barb is U-shaped.
较佳地是,所述内锚的主体为长方体形。Preferably, the main body of the inner anchor is in the shape of a rectangular parallelepiped.
较佳地是,所述内锚的轴向中心具有供导丝穿过的导丝腔。Preferably, the axial center of the inner anchor has a guide wire lumen for the guide wire to pass through.
较佳地是,所述内锚的侧端为球形端面。Preferably, the side end of the inner anchor is a spherical end surface.
较佳地是,所述内锚的接触面沿着轴向具有一用于容纳及限位系杆的系杆凹槽。Preferably, the contact surface of the inner anchor has a tie rod groove along the axial direction for accommodating and limiting the tie rod.
较佳地是,所述内锚的接触面中部具有分别位于所述系杆凹槽两侧的铰合部和横跨所述系杆凹槽的用于穿设所述系杆的系杆轴,所述系杆轴的两端分别固定在所述铰合部的中部。Preferably, the middle part of the contact surface of the inner anchor has hinge parts located on both sides of the tie rod groove and a tie rod shaft for passing the tie rod across the tie rod groove. , the two ends of the tie rod shaft are respectively fixed in the middle of the hinge part.
较佳地是,所述内锚的横截面为工字型。Preferably, the cross section of the inner anchor is I-shaped.
本发明的积极进步效果在于:The positive progressive effect of the present invention is:
1.本发明通过在锁定结构进行结构改进,提供了一种全新的锁定结构,降低外锚从系杆上滑落的风险,并通过解锁锁定结构,来取回外锚。1. The present invention provides a new locking structure by improving the structure of the locking structure, reducing the risk of the outer anchor slipping off the tie rod, and by unlocking the locking structure, the outer anchor can be retrieved.
2.本发明的控制外锚锁紧与解离的控制方向与系杆在同一方向,大大降低了操作锁紧与解锁的难度。2. The control direction for controlling the locking and disengagement of the outer anchor of the present invention is in the same direction as the tie rod, which greatly reduces the difficulty of operating locking and unlocking.
3.本发明通过在外锚上设置具有齿形面的锁定结构,通过齿形面提高外锚与系杆的抓力,从而提高外锚在体内脱落的风险。3. In the present invention, a locking structure with a toothed surface is provided on the outer anchor, and the toothed surface improves the gripping force between the outer anchor and the tie rod, thereby increasing the risk of the outer anchor falling off in the body.
4.本发明通过在内锚的非接触面设置倒钩,可以挂靠圈套器,从而在手术失败或者后续需要取出内锚时,只需要用圈套器挂设在内锚上的倒钩从而从输送鞘管里将内锚拉出体外,而不需要进行开胸手术,具有二次介入回收的功能,增加手术的容错率,减轻患者经济负担,避免开心手术等高风险手术,造福患者。4. In the present invention, by setting the barbs on the non-contact surface of the inner anchor, the snare can be attached, so that when the operation fails or the inner anchor needs to be taken out later, only the barbs on the inner anchor need to be hung with the snare, so as to prevent the delivery from being transported. The inner anchor is pulled out of the body in the sheath without thoracotomy. It has the function of secondary intervention and recovery, which increases the fault tolerance rate of the operation, reduces the economic burden of the patient, avoids high-risk operations such as open-heart surgery, and benefits the patient.
附图说明Description of drawings
图1为本发明的左心室减容装置的立体结构示意图;Fig. 1 is the three-dimensional structure schematic diagram of the left ventricular volume reduction device of the present invention;
图2为本发明的系杆10的结构示意图;FIG. 2 is a schematic structural diagram of the
图3A~3D为本发明可回收内锚的结构示意图;3A-3D are schematic structural diagrams of the retrievable inner anchor of the present invention;
图3E为本发明可回收内锚的回收过程示意图;3E is a schematic diagram of the recovery process of the recyclable inner anchor of the present invention;
图4A~4F为本发明锁定结构的结构示意图;4A to 4F are schematic structural diagrams of the locking structure of the present invention;
图5A~5D为本发明的左心室减容装置植入过程结构示意图。5A-5D are schematic structural diagrams of the implantation process of the left ventricular volume reducing device of the present invention.
具体实施方式Detailed ways
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体图示进一步阐述本发明。In order to make it easy to understand the technical means, creation features, achieved goals and effects of the present invention, the present invention will be further described below with reference to specific drawings.
在介入医疗器械领域,定义“远端”为手术过程中远离操作者的一端,定义“近端”为手术过程中靠近操作者的一端。In the field of interventional medical devices, the "distal end" is defined as the end away from the operator during the operation, and the "proximal end" is defined as the end close to the operator during the operation.
在本发明中,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,也可以是成一体;可以是机械连接,也可以是电连接,也可以是通讯连接;可以是直接连接,也可以通过中间媒介的间接连接,可以是两个元件内部的连通或两个元件的相互作用关系,除非另有明确的限定。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。In the present invention, unless otherwise expressly specified and limited, the terms "installed", "connected", "connected", "fixed" and other terms should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection , it can also be integrated; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal connection of two components or two components. interactions, unless otherwise expressly defined. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
本发明所指的锁释件是指在输送装置中可以对锁定结构上锁也可以对锁定结构解锁的装置。The lock-release member referred to in the present invention refers to a device that can lock and unlock the locking structure in the conveying device.
如图1所示,本发明的左心室减容装置包括系杆10、内锚20和外锚30,内锚20可铰接在系杆10的远端;外锚30穿设在系杆10上。本发明提供的左心室减容装置将内外锚嵌入心室壁,缝合多余的瘢痕组织,以帮助心脏恢复其先前的形状和功能。As shown in FIG. 1 , the left ventricular volume reduction device of the present invention includes a
本发明的系杆可以是现有技术中普通的系杆,如图4A所示的直杆;也可以是三截式,如图2所述,系杆10从远端至近端具有方形的连接段11、引导段12和针头段13,方形连接段11、引导段12与针头段13按远端到近端的顺序一体成型。近端的针头段13由不锈钢等高硬度金属或者高分子材料制成。连接段11的远端具有绞合孔111。引导段12和针头13段轴向中心分别具有相互连通的导丝通道。引导段12靠近连接段11的头端具有供导丝穿入导丝通道的引导孔121。系杆10可以由不锈钢、铂铱合金、PEEK等高分子材质制成。The tie rod of the present invention can be a common tie rod in the prior art, such as a straight rod as shown in FIG. 4A; it can also be a three-section type, as shown in FIG. 2, the
本发明的内锚可以是现有技术中任何结构形式的内锚,只要能设置于心脏的右心室室间隔上即可。但是为了在心脏减容装置的植入手术失败后或者患者后期需要取出左心室减容装置,而减少胸前开腔的手术风险,本发明图3A~3E提供一种示例的可回收内锚20。可回收内锚20的主体大致为长方体形,具有两面,一面是接触面21,一面是非接触面22。接触面21是指植入后贴合在心脏右心室室间隔的一面;非接触面22是指植入后不会贴在心脏上的一面,也即与接触面21相背向的一面。内锚20的轴向中心具有导丝腔213,在手术输送内锚时供导丝穿过,导丝腔23的截面可以是方形,圆形,其他任意形状的中空内腔,只要能够使得导丝能够穿过即可,较佳地是圆形通孔。内锚20的侧端可以为任意光滑的曲面形状,较佳地为球形端面,球形端面有利于内锚21顺利进入输送鞘管,减少输送阻力。接触面21可抵靠于右心室室间隔上。接触面21可以如现有技术一样没有系杆凹槽,在输送内锚过程中,系杆10紧贴于接触面21。为了减小输送鞘管的大小,比较好的方式是接触面21沿着轴向设置系杆凹槽211,在输送内锚的过程中,系杆10容纳在系杆凹槽211内,减小内锚与系杆在输送过程中的体积;同时系杆凹槽211也给系杆10进行限位,系杆10束缚在系杆凹槽211内,规范系杆10的运动,避免对心脏组织造成损伤。系杆10可以枢接在接触面21的中部,比较好的方式是不可拆卸的方式,例如在接触面21中部具有分别位于系杆凹槽211两侧的铰合部212和横跨系杆凹槽211的用于穿设系杆10的系杆轴213,系杆轴213的两端分别固定在铰合部212的中部,铰合部212作为系杆轴213两端的支撑点,系杆轴213无法从铰合部212上取下,系杆10的绞合孔111穿设在内锚20上的系杆轴213上。The internal anchor of the present invention can be any structural form of the internal anchor in the prior art, as long as it can be arranged on the right ventricular septum of the heart. However, in order to reduce the surgical risk of prethoracic opening after the implantation of the cardiac volume reduction device fails or the patient needs to remove the left ventricular volume reduction device at a later stage, FIGS. 3A to 3E of the present invention provide an exemplary recoverable
可回收内锚20的非接触面22背向接触面21。非接触面22的至少一侧边朝向非接触面22的中部方向延伸出一与非接触面22大体平行的倒钩221,利于圈套器91对内锚20的捕捉。比较好的方式是,非接触面22的两相对侧边分别朝向非接触面22的中部方向各自延伸出与非接触面22大体平行的倒钩221,两侧都有倒钩更加有利于圈套器91对内锚20的捕捉。非接触面22的两侧边都延伸出倒钩221,如此使得内锚的横截面为工字型,工字型截面有利于圈套器91带动内锚20撤出时圈套器钢丝堆积在内锚工字型横截面的腔内,减少撤出内锚20的阻力。倒钩221可以是长板状,但是倒钩的形状可以采用U型,减少内锚20在体内的内皮化附着生长,有利于后续回收。倒钩221与非接触面22之间的空间形成可给圈套器91提供导向的导向腔222。可回收内锚20在内锚一侧设置可以供圈套器91钩拉的倒钩221,从而从输送鞘管内拉回内锚20来完成内锚20的回收,而不再需要另外进行开心手术取内锚。在非接触面22的两相对侧边都延伸出有倒钩221的情况下,非接触面22的两相对侧边的两个倒钩221之间相距一定间距,也就是两个倒钩221没有对接上,此时间距就形成可以捕捉圈套器91进入导向腔222的倒钩开口223。此时导向腔222从倒钩开口223处为起点一直沿着内锚的非接触面22平行的直线方向延伸,当延伸至快要到达但是还没有到达内锚20的侧端位置,此时导向腔222开始向内锚20轴心方向弯折延伸,最终导向腔222止于内锚20侧端轴心的,也即导向腔222终止于轴向中心的导丝腔23。如此设置可以使得在回收内锚时挂设在导向腔222内的圈套器91捕捉内锚20时处于内锚20的中心位置,利于圈套器91的运动指引,圈套器捕捉内锚20时处于内锚20的中心位置有利于内锚20进入输送鞘管。而且倒钩221靠近导向腔222的终点处具有突出于导向腔222的用于提示导向终点的导向凸点224。当圈套器91运动至此位置时,结合外部影像仪,完成圈套器对内锚20的捕捉,可进行撤出圈套器91的相应操作。本示例的内锚20整体可以一体成型。内锚材料可以为不锈钢、钛、镍钛合金等生物相容性和韧性较好的金属材料中一种或者多种组合制成。还可以对内锚的接触面或者整个内锚覆盖聚酯涂层或者进行表面涂层处理,涂层从而可对内锚与心脏组织之间的接触进行缓冲,同时能够增加内皮化的速度,减轻相应炎症反应。The
本发明的外锚可以是现有技术中任意结构的外锚,用于排除左心室瘢痕结构。如图4A~4B所示,其中一种结构形式的外锚如外锚30,大体为扁平的长方体形状,具有一外锚主体30a,外锚主体也同样具有两面,接触面和非接触面,接触面可抵靠于左心室外壁上的,非接触面与接触面相背。在外锚主体30a的中心位置具有贯通的锁孔(图未示),锁孔供穿设系杆10。外锚材料可以为不锈钢、钛、镍钛合金、钴铬合金、铂铱合金等生物相容性和韧性较好的金属材料中一种或者多种组合制成,还可以对外锚的接触面或者整个外锚主体覆盖聚酯涂层或者进行表面涂层处理,涂层结构对外锚与心脏组织之间的接触进行缓冲,同时能够增加内皮化的速度,减轻相应炎症反应。The external anchor of the present invention can be any external anchor in the prior art, and is used to exclude left ventricular scar structures. As shown in Figures 4A-4B, one of the external anchors, such as the
本发明为了加强外锚30锁合于系杆10上的牢固度,在外锚主体30a的锁孔位置处于非接触面上设置有锁定结构,本发明的锁定结构可以是任意能将外锚30与系杆10相互紧紧锁紧的结构。本发明示例的锁定结构至少具有锁定件和压挤件,较佳的情况下还可以有复位件,或者还可以进一步有凸轮,还可以进一步有外壳。锁定件、压挤件、复位件、外壳等结构可以多种多样,只要是能够将锁定件锁在系杆上的结构都是可行的,凡是能够将锁定件压挤在系杆10上的压挤件也都是可行的,复位件是可以将锁定件从系杆上解除锁定关系,对锁定件释放出来的结构都是可行的。In the present invention, in order to enhance the firmness of the
本发明示例的一种锁定结构具有锁紧单元和外壳,本发明的锁紧单元可以是现有技术中的锁紧单元,也可以是本申请人在先专利申请中的锁紧单元,参见申请CN2022104104038及CN2022104103800,该专利申请具有锁定件、压挤件、一对复位件和凸轮。本发明专利申请包括上述专利申请的全部技术内容。A locking structure exemplified in the present invention has a locking unit and a housing. The locking unit of the present invention may be a locking unit in the prior art, or may be a locking unit in the applicant's prior patent application, see the application CN2022104104038 and CN2022104103800, the patent application has a locking piece, a pressing piece, a pair of restoring pieces and a cam. The patent application of the present invention includes all the technical contents of the above patent application.
如图4A~4F所示,本发明还示例一种结构简单的与系杆10在同一方向进行控制的锁定结构,该锁定结构也可以进行解锁来进行回收外锚和内锚,本示例的锁定结构还由于与系杆10是在同一方向进行操作,所以非常方便进行锁定与解锁操作。本发明的锁定结构也具有锁紧单元,锁紧单元具有:一可抵压于系杆10上的锁定件、一可压紧锁定件于系杆10上的压挤件以及外壳。As shown in FIGS. 4A to 4F , the present invention also exemplifies a locking structure with a simple structure that is controlled in the same direction as the
在本示例中,锁定件为一锁块31,大致为方块体形状,一侧面被设置成光滑的圆柱体侧表面的弧形,其他三侧面仍然为平面形状;相对于设置成弧形侧面的另一侧面为可挤压系杆10的锁定面311,锁定面311例如可以设置成齿形面(图未示),可以将系杆10咬合得更结实。锁块31于弧形侧面的一侧内部设置有定位轴312,定位轴312的两端设置在外壳的两相对的第一壳壁上。锁块31可以绕着定位轴312转动,从而将锁定面311推向系杆10的表面上进行挤压锁定。在锁块31中部靠近一侧处被镂空出一传动腔313。In this example, the locking member is a
在本示例中,压挤件为传动杆32。传动杆32的一端连接有传动轴321。传动轴321与定位轴312平行,传动杆32的一端位于传动腔313内,传动轴321设在锁块31中部的中空的传动腔313内,传动轴321的两端穿设在传动腔313两相对侧壁内,通过传动杆32推拉锁块31,以定位轴312为轴心,锁块31旋转,使得锁块31的锁定面311推向系杆10的表面来实现锁定,反之拉传动杆32使得锁块31的锁定面311从系杆10表面解离开来进行解锁。具体地,传动杆32的一端为圆柱杆322,传动轴321设在圆柱杆322的一端上。圆柱杆322的另一段的侧面设有直角梯形的凹槽324,便于锁块31的容纳与旋转。圆柱杆322的一端的底面被设置成传动轴321同轴向的圆柱侧表面形式的弧面,便于圆柱杆322在传动腔313内容纳与旋转。传动杆32的另一端为螺杆323,螺杆323的一端螺纹连接在圆柱杆322的另一端内,螺杆323的另一端设在外壳的第二壳壁的传动杆孔内。In this example, the extrusion is the
在本示例中,外壳33一方形的盒体,外壳33内置有锁紧单元。外壳33的两相对的第一壳壁上分别具有定位轴支撑孔331,锁块31的定位轴312的两端分别固定在定位轴支撑孔331内。外壳33的一第二壳壁上具有传动杆孔332,传动杆32的螺杆323另一端穿设在传动杆孔332内。外壳33的两相对的第二壳壁于锁定件锁定系杆10的对应位置处分别具有系杆孔333。系杆孔333与传动孔332在同一侧壁,因而便于操作锁定与解锁。整个锁定结构借用具有系杆孔333但没有传动孔332那侧的第二壳壁固定连接在外锚本体30非接触面的中心位置的锁孔处。In this example, the
在本示例中,还具有限位锁块31的U型限位槽34,限位槽34固定在外壳33内,限位槽34的形状大致是两侧板和一底板围成的一U型槽,限位槽34两侧的槽口对准外壳33的系杆孔333,以便于系杆10穿过。锁块31的具有锁定面311的另一侧限位于U型限位槽34内。In this example, there is also a
如图5A~5D所示,本发明的左心室减容装置的植入过程如下:As shown in Figures 5A-5D, the implantation process of the left ventricular volume reduction device of the present invention is as follows:
利用系杆10上的近端针头段13或者其他穿刺件完成左心室瘢痕部位和室间隔部位的穿刺,进入穿刺鞘管,建立右心室和心外膜区域之间的通道,撤出穿刺鞘管中的扩张器,顺着穿刺鞘管进入J型导丝92,利用进入输送装置的圈套器91完成对J型导丝92的捕捉,保持圈套器91对J型导丝92紧缚状态,撤出圈套器91,将J型导丝92拉入输送装置90内腔,进而出输送装置近端。Use the
调整穿刺鞘管,使穿刺鞘管远端进入输送装置90远端内腔,在体外将J型导丝92进入系杆10上的近端针头段13,顺着J型导丝92进入连接内锚之系杆10,保持J型导丝92不动,推送系杆10,使得系杆近端依次进入输送装置90内腔、穿刺鞘管远端内腔、输送装置90远端、右心室、左心室、心外膜区域。当系杆10近端出心外膜时,可撤出J型导丝92,拉动系杆10即可完成内锚20的进入。Adjust the puncture sheath so that the distal end of the puncture sheath enters the lumen of the distal end of the
通过影像仪透视确认内锚20的位置,当内锚20接近右心室室间隔位置时,撤出穿刺鞘管远端至左心室,同时回撤输送装置90,使得内锚20在右心室室间隔位置得以释放。Confirm the position of the
在方形连接段11与引导段12连接处剪断方形连接段11,调整外锚30锁定结构,使其处于释放状态,顺着方形连接段11进入外锚30,保证外锚30接触面与心外膜区域的瘢痕组织接触。Cut the
缩短内锚与外锚之间的距离,同时保持心脏合适的压缩力,不可过大也不可过小,最佳力为1~6N,操作外部锁释件,锁定锁定结构,剪断多余方形连接段11,完成左心室减容装置的植入。结合患者心脏的解剖结构和实际需求,重复以上步骤,可植入多对锚,一般为2~4对。Shorten the distance between the inner anchor and the outer anchor, while maintaining the proper compression force of the heart, neither too large nor too small, the optimal force is 1-6N, operate the external locking and release parts, lock the locking structure, and cut off the excess
当手术失败或患者需移除左心室减容装置等情况时,顺着右颈静脉进入输送装置90,撤出输送装置90中的扩张器,顺着输送装置90进入圈套器91,借助影像仪的支持,利用圈套器捕捉内锚20上的倒钩开口223,顺利捕捉内锚20的倒钩221,收紧圈套器91,当圈套器91接触到导向凸点224,影像仪提示圈套器完成对内锚的捕捉,利用外部锁释件解除外锚30对系杆10的锁定,保持圈套器对内锚20的紧缚状态,撤出圈套器的同时完成内锚20进入输送装置90,撤出输送装置90,即可完成内锚20的介入回收。When the operation fails or the patient needs to remove the left ventricular volume reduction device, enter the
本发明提供的左心室减容装置以外科左胸前微创切口和介入右侧颈内静脉为手术入路,在心脏不停跳的状态下,利用导丝在心脏中来回穿梭“铺设轨道”后,像束紧口袋一样,将两个锚定器精准置于室壁瘤边缘,一左一右、一内一外、两面夹击,使室壁瘤折叠夹闭,将左心室瘢痕部位和右心室折叠在一起,将系列锚嵌入心室壁,缝合多余的瘢痕组织,以帮助心脏恢复其先前的形状和功能,患者左心室重新塑造至接近正常的形状与尺寸,重塑心室,帮助改善心脏功能,患者症状和生活质量。本发明的左心室减容装置具有可回收介入的功能,避免手术过程中或者术后患者需移除该左心室减容装置等情况时采取开心手术,可回收的方式减少了手术对患者的二次伤害,减轻患者及其家属的经济负担。The left ventricular volume reduction device provided by the present invention uses a surgical minimally invasive incision in the left chest and intervention of the right internal jugular vein as the surgical approach, and uses a guide wire to shuttle back and forth in the heart to "lay a track" when the heart is not beating Then, like tightening the pockets, place the two anchors on the edge of the aneurysm precisely, pinching the left and the right, the inside and the outside, and both sides, so that the aneurysm is folded and clamped, and the left ventricular scar and the right The ventricles are folded together, serial anchors are embedded in the ventricle wall, excess scar tissue is sutured to help the heart return to its previous shape and function, the patient's left ventricle is reshaped to a near-normal shape and size, remodeling the ventricle to help improve heart function , patient symptoms and quality of life. The left ventricular volume reduction device of the present invention has the function of retrievable intervention, which avoids open-heart surgery when the patient needs to remove the left ventricular volume reduction device during the operation or after the operation. secondary injury and reduce the financial burden on patients and their families.
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。The foregoing has shown and described the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above-mentioned embodiments, and the descriptions in the above-mentioned embodiments and the description are only to illustrate the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have Various changes and modifications fall within the scope of the claimed invention. The claimed scope of the present invention is defined by the appended claims and their equivalents.
Claims (12)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210725630.XA CN114903658B (en) | 2022-06-24 | 2022-06-24 | Locking structure and external anchor of left ventricular volume reduction device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210725630.XA CN114903658B (en) | 2022-06-24 | 2022-06-24 | Locking structure and external anchor of left ventricular volume reduction device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN114903658A true CN114903658A (en) | 2022-08-16 |
| CN114903658B CN114903658B (en) | 2025-06-24 |
Family
ID=82771973
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210725630.XA Active CN114903658B (en) | 2022-06-24 | 2022-06-24 | Locking structure and external anchor of left ventricular volume reduction device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114903658B (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104739460A (en) * | 2015-01-28 | 2015-07-01 | 深圳市科奕顿生物医疗科技有限公司 | Left ventricle volume reduction device |
| US20200078000A1 (en) * | 2017-04-05 | 2020-03-12 | Opus Medical Therapies, LLC | Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods |
| WO2020086427A1 (en) * | 2018-10-22 | 2020-04-30 | Opus Medical Therapies, LLC | Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods |
| CN112190294A (en) * | 2020-08-27 | 2021-01-08 | 周元军 | Myocardial anchoring device |
| CN113491598A (en) * | 2020-03-18 | 2021-10-12 | 杭州德晋医疗科技有限公司 | Knot-locking anchoring device and through-conduit knot-locking anchoring system |
| CN217960422U (en) * | 2022-06-24 | 2022-12-06 | 启晨(上海)医疗器械有限公司 | Locking structure and external anchor of left ventricular volume reduction device |
-
2022
- 2022-06-24 CN CN202210725630.XA patent/CN114903658B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104739460A (en) * | 2015-01-28 | 2015-07-01 | 深圳市科奕顿生物医疗科技有限公司 | Left ventricle volume reduction device |
| US20200078000A1 (en) * | 2017-04-05 | 2020-03-12 | Opus Medical Therapies, LLC | Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods |
| WO2020086427A1 (en) * | 2018-10-22 | 2020-04-30 | Opus Medical Therapies, LLC | Transcatheter anchoring assembly for a mitral valve, a mitral valve, and related methods |
| CN113491598A (en) * | 2020-03-18 | 2021-10-12 | 杭州德晋医疗科技有限公司 | Knot-locking anchoring device and through-conduit knot-locking anchoring system |
| CN112190294A (en) * | 2020-08-27 | 2021-01-08 | 周元军 | Myocardial anchoring device |
| CN217960422U (en) * | 2022-06-24 | 2022-12-06 | 启晨(上海)医疗器械有限公司 | Locking structure and external anchor of left ventricular volume reduction device |
Also Published As
| Publication number | Publication date |
|---|---|
| CN114903658B (en) | 2025-06-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN111870398B (en) | Valve clamp | |
| CN211723546U (en) | A valve clamp and its clamping system | |
| US10219904B2 (en) | Cardiac implant migration inhibiting systems | |
| CN111772874B (en) | A valve clamp and a clamping system thereof | |
| EP3547962B1 (en) | Cinch and post for tricuspid valve repair | |
| CN217960422U (en) | Locking structure and external anchor of left ventricular volume reduction device | |
| CN213098536U (en) | Valve clamping device | |
| CN115024863A (en) | Anchor assembly, implant, transcatheter retraction system and use thereof | |
| CN114681163B (en) | Left ventricle volume reducing device | |
| CN115024865A (en) | Locking structure and external anchor of left ventricle volume reduction device | |
| US20230210664A1 (en) | Valve clamping device with locking mechanism and valve repair system | |
| CN114569288B (en) | Valve clamp and valve repair system | |
| CN114903658A (en) | Locking structure and external anchor of left ventricular volume reducing device | |
| CN114681165A (en) | Locking structure and external anchor for left ventricle volume reduction device | |
| CN219109843U (en) | Tie rod and external anchor of left ventricular volume reduction device | |
| CN218247498U (en) | Locking structure of left ventricular volume reducing device | |
| CN113288517A (en) | Valve closing apparatus | |
| WO2021135907A1 (en) | Guided valve suturing device and valve suturing system | |
| CN114681164B (en) | Recyclable inner anchor for left ventricular volume reduction device and left ventricular volume reduction device | |
| CN115089348B (en) | Left Ventricular Volume Reduction Delivery System | |
| CN117918906A (en) | Implant delivery system | |
| CN217338990U (en) | Locking structure and external anchor for left ventricle volume reduction device | |
| CN217338991U (en) | Locking structure and external anchor for left ventricle volume reduction device | |
| CN217338988U (en) | Locking structure and external anchor for left ventricle volume reduction device | |
| CN217338989U (en) | Locking structure and external anchor for left ventricle volume reduction device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP03 | Change of name, title or address | ||
| CP03 | Change of name, title or address |
Address after: 519040, No. 111 Yao Guan Road, Sanzao Town, Jinwan District, Zhuhai City, Guangdong Province Patentee after: Qichen Fuxin Medical Technology (Zhuhai) Co.,Ltd. Country or region after: China Patentee after: Chenxing (Nantong) Medical Instrument Co.,Ltd. Address before: Room 106, building 1, 2555 xiupu Road, Pudong New Area, Shanghai 201315 Patentee before: Qichen (Shanghai) medical equipment Co.,Ltd. Country or region before: China Patentee before: Chenxing (Nantong) Medical Instrument Co.,Ltd. |