CN114681128A - Annuloplasty ring delivery device and annuloplasty system - Google Patents
Annuloplasty ring delivery device and annuloplasty system Download PDFInfo
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- CN114681128A CN114681128A CN202011593343.5A CN202011593343A CN114681128A CN 114681128 A CN114681128 A CN 114681128A CN 202011593343 A CN202011593343 A CN 202011593343A CN 114681128 A CN114681128 A CN 114681128A
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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
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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
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
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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
- A61F2/2466—Delivery devices therefor
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Abstract
本发明公开了一种瓣膜成形环输送装置和瓣环成形术系统。瓣膜成形环输送装置包括容置件和引线组件。容置件沿轴向设有用于容置瓣膜成形环的容置腔,容置件相对的两侧沿轴向设有连通容置槽的通槽。引线组件包括分线件和至少一个两端连通的导管,分线件包括沿轴向贯通的主腔和多个径向连通主腔的分线孔。容置件可拆卸地容置于主腔中,每一导管活动贯穿于分线孔中。本发明实施例提供的瓣膜成形环输送装置,导管贯穿于分线件的分线孔中同时通过通槽穿过容置腔中的瓣膜成形环,将已经缝入原生瓣环的缝合线穿过导管,撤出导管后可将原生瓣环上的多个缝合线耦合到瓣膜成形环上,操作简便,方便快捷。同时,可以确保缝合线穿设在瓣膜成形环上的合适位置。
The invention discloses an annuloplasty ring delivery device and an annuloplasty system. The annuloplasty ring delivery device includes a receiver and a lead assembly. The accommodating part is axially provided with an accommodating cavity for accommodating the annuloplasty ring, and two opposite sides of the accommodating part are axially provided with through grooves communicating with the accommodating grooves. The lead wire assembly includes a wire splitting piece and at least one conduit communicating with both ends. The wire splitting piece comprises a main cavity passing through in the axial direction and a plurality of wire branching holes communicating with the main cavity in a radial direction. The accommodating piece is detachably accommodated in the main cavity, and each conduit movably passes through the branching hole. In the annuloplasty ring delivery device provided by the embodiment of the present invention, the catheter is inserted into the shunting hole of the shunting member and simultaneously passes through the annuloplasty ring in the accommodating cavity through the through slot, and the suture that has been sewn into the original annulus is passed through The catheter, after withdrawing the catheter, can couple multiple sutures on the original valve annulus to the annuloplasty ring, and the operation is simple, convenient and fast. At the same time, the proper position of the suture thread on the annuloplasty ring can be ensured.
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种瓣膜成形环输送装置和瓣环成形术系统。The present invention relates to the technical field of medical devices, and in particular, to an annuloplasty ring delivery device and an annuloplasty system.
背景技术Background technique
二尖瓣关闭不全是当今最常见的心脏瓣膜疾病之一,主要病因是风湿性心脏病、二尖瓣粘液样变性、心脏缺血性疾病、心肌病变等,导致二尖瓣结构中瓣环、瓣叶、腱索以及乳头肌发生病变,导致二尖瓣的瓣叶不能完全关闭。Mitral valve insufficiency is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, mitral valve myxoid degeneration, cardiac ischemic disease, cardiomyopathy, etc. The leaflets, chordae tendineae, and papillary muscles develop lesions that prevent the leaflets of the mitral valve from closing completely.
二尖瓣环缩术,亦称为二尖瓣瓣环成形术,属于二尖瓣外科修复的基础术式之一,其通过缩小二尖瓣瓣环,加强二尖瓣的对合,能够有效减少二尖瓣反流,同时又保持二尖瓣结构的生理完整性。例如,在瓣环上植入人工瓣环,然后用无创缝线沿瓣叶附着部做间断U形缝合,再通过收紧缝线从而调整瓣环的尺寸,实现缩环效果。Mitral valve annulus reduction, also known as mitral valve annuloplasty, is one of the basic procedures for mitral valve surgical repair. Reduce mitral regurgitation while maintaining the physiological integrity of the mitral valve structure. For example, an artificial valve annulus is implanted on the valve annulus, and then discontinuous U-shaped sutures are made along the attachment portion of the valve leaflets with non-invasive sutures, and then the size of the valve annulus is adjusted by tightening the sutures to achieve the effect of shrinking the ring.
现有技术公开了采用介入式二尖瓣瓣环成形术治疗二尖瓣关闭不全的器械,其利用介入器械在二尖瓣的瓣环上施加多个缝合线,然后将多个缝合线耦合到瓣膜成形环上,再将瓣膜成形环沿缝合线下滑穿过通道而到达二尖瓣。目前,可通过带环形部的引线器将缝合线一一耦合到瓣膜成形环上,但是操作繁琐且不便,而且医生仅能凭经验确定每个缝合线耦合到瓣膜成形环上的位置,无法确保缝合线的位置合适。The prior art discloses an apparatus for the treatment of mitral regurgitation using interventional mitral annuloplasty, which utilizes the interventional instrument to apply a plurality of sutures to the annulus of the mitral valve, and then couple the plurality of sutures to the annulus of the mitral valve. On the annuloplasty ring, the annuloplasty ring is then slid down the suture through the channel to reach the mitral valve. At present, the sutures can be coupled to the annuloplasty ring one by one through a wire guide with a loop, but the operation is cumbersome and inconvenient, and doctors can only empirically determine the position where each suture is coupled to the annuloplasty ring. The position of the suture is appropriate.
发明内容SUMMARY OF THE INVENTION
为了解决方便快捷将多个缝合线耦合到瓣膜成形环上的技术问题,本发明提供了一种瓣膜成形环输送装置和瓣环成形术系统。In order to solve the technical problem of conveniently and quickly coupling multiple sutures to the annuloplasty ring, the present invention provides an annuloplasty ring delivery device and an annuloplasty system.
第一方面,本发明提供了一种瓣膜成形环输送装置,包括:In a first aspect, the present invention provides an annuloplasty ring delivery device, comprising:
容置件,所述容置件沿轴向设有容置腔,所述容置件相对的两侧沿轴向设有通槽,所述通槽连通所述容置腔,所述容置腔用于容置瓣膜成形环;和an accommodating piece, the accommodating piece is provided with an accommodating cavity in the axial direction, and the two opposite sides of the accommodating piece are provided with a through groove in the axial direction, the through groove communicates with the accommodating cavity, and the accommodating part a cavity for receiving the annuloplasty ring; and
引线组件,所述引线组件包括分线件和至少一个两端连通的导管,所述分线件包括沿轴向贯通的主腔和多个径向连通所述主腔的分线孔,所述容置件可拆卸地容置于所述主腔中,每一所述导管活动贯穿于所述分线孔中。A lead assembly, the lead assembly includes a branch piece and at least one conduit communicating with both ends, the branch piece includes a main cavity passing through in the axial direction and a plurality of branch holes communicating with the main cavity in a radial direction, the The accommodating part is detachably accommodated in the main cavity, and each of the conduits movably passes through the branching hole.
第二方面,本发明提供了一种瓣环成形术系统,包括瓣膜成形环和上述的瓣膜成形环输送装置,所述瓣膜成形环容置于所述容置件的容置腔中。In a second aspect, the present invention provides an annuloplasty system, comprising an annuloplasty ring and the aforementioned annuloplasty ring delivery device, wherein the annuloplasty ring is accommodated in a accommodating cavity of the accommodating member.
本发明实施例提供的上述技术方案与现有技术相比,至少具有如下优点:Compared with the prior art, the above technical solutions provided by the embodiments of the present invention have at least the following advantages:
本发明实施例提供的瓣膜成形环输送装置和瓣环成形术系统,瓣膜成形环容置于容置件的容置腔中,容置件再容置于引线组件的分线件的主腔中,然后将导管贯穿于分线件的分线孔中,导管同时通过通槽穿过容置腔中的瓣膜成形环,当操作者将已经缝入原生瓣环的缝合线穿过导管,撤出导管后可使缝合线穿设在瓣膜成形环上,从而将原生瓣环上的多个缝合线耦合到瓣膜成形环上,操作简便,方便快捷。同时,由于缝合线经由分线件的分线孔穿设在瓣膜成形环上,可以确保缝合线穿设在瓣膜成形环上的合适位置且相邻缝合线的间距均匀。In the annuloplasty ring delivery device and the annuloplasty system provided by the embodiments of the present invention, the annuloplasty ring is accommodated in the accommodating cavity of the accommodating member, and the accommodating member is then accommodated in the main cavity of the wire splitter of the lead assembly , and then pass the catheter through the shunt hole of the shunt, and the catheter passes through the annuloplasty ring in the accommodating cavity through the through slot at the same time. When the operator passes the suture that has been sewn into the original valve ring through the catheter, withdraw After the catheter, the sutures can be threaded on the annuloplasty ring, so that multiple sutures on the original valve annulus can be coupled to the annuloplasty ring, and the operation is simple, convenient and quick. At the same time, since the suture is threaded on the annuloplasty ring through the shunt hole of the shunt, it can be ensured that the suture is threaded at a proper position on the annuloplasty ring and the distance between adjacent sutures is uniform.
附图说明Description of drawings
此处的附图被并入说明书中并构成本说明书的一部分,示出了符合本发明的实施例,并与说明书一起用于解释本发明的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description serve to explain the principles of the invention.
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,对于本领域普通技术人员而言,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. In other words, on the premise of no creative labor, other drawings can also be obtained from these drawings.
附图中:In the attached picture:
图1是本发明实施例提供的瓣膜成形环输送装置的结构示意图;Fig. 1 is the structural schematic diagram of the annuloplasty ring delivery device provided by the embodiment of the present invention;
图2是本发明实施例提供的瓣膜成形环输送装置的另一结构示意图;2 is another structural schematic diagram of the annuloplasty ring delivery device provided by an embodiment of the present invention;
图3是本发明实施例提供的容置件和鞘管的结构示意图;3 is a schematic structural diagram of a container and a sheath provided in an embodiment of the present invention;
图4至图7是本发明实施例提供的引线组件的结构示意图;4 to 7 are schematic structural diagrams of lead assemblies provided by embodiments of the present invention;
图8是本发明实施例提供的瓣膜成形环在自然状态的结构示意图;8 is a schematic structural diagram of an annuloplasty ring in a natural state provided by an embodiment of the present invention;
图9是本发明实施例提供的瓣膜成形环在放置入容置件的结构示意图;FIG. 9 is a schematic structural diagram of the annuloplasty ring provided in an embodiment of the present invention placed in a accommodating member;
图10至图13是本发明实施例提供的容置件的结构示意图;10 to 13 are schematic structural diagrams of a accommodating member provided by an embodiment of the present invention;
图14是本发明实施例提供的瓣膜成形环输送装置的结构示意图;14 is a schematic structural diagram of the annuloplasty ring delivery device provided by an embodiment of the present invention;
图15是本发明实施例提供的容置件与推送件的剖视图;15 is a cross-sectional view of the accommodating member and the pushing member provided by an embodiment of the present invention;
图16至图19是本发明实施例提供的瓣膜成形环输送装置的操作示意图;16 to 19 are schematic views of the operation of the annuloplasty ring delivery device provided by the embodiments of the present invention;
图20是本发明实施例提供的二尖瓣原生瓣环示意图;FIG. 20 is a schematic diagram of a native mitral valve annulus according to an embodiment of the present invention;
图21是本发明实施例提供的介入锁结器械锁结示意图。Fig. 21 is a schematic diagram of the locking of the interventional locking device provided by the embodiment of the present invention.
具体实施方式Detailed ways
为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图详细说明本发明的具体实施方式。以下描述中,需要理解的是,“前”、“后”、“上”、“下”、“左”、“右”、“纵”、“横”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“头”、“尾”等指示的方位或位置关系为基于附图所示的方位或位置关系、以特定的方位构造和操作,仅是为了便于描述本技术方案,而不是指示所指的装置或元件必须具有特定的方位,因此不能理解为对本发明的限制。In order to have a clearer understanding of the technical features, objects and effects of the present invention, the specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, it should be understood that "front", "rear", "upper", "lower", "left", "right", "vertical", "horizontal", "vertical", "horizontal", The orientation or positional relationship indicated by "top", "bottom", "inner", "outer", "head", "tail", etc. is constructed and operated in a specific orientation based on the orientation or positional relationship shown in the drawings, It is only for the convenience of describing the technical solution, rather than indicating that the referred device or element must have a specific orientation, so it should not be construed as a limitation on the present invention.
还需要说明的是,除非另有明确的规定和限定,“安装”、“相连”、“连接”、“固定”、“设置”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,或成一体;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。当一个元件被称为在另一元件“上”或“下”时,该元件能够“直接地”或“间接地”位于另一元件之上,或者也可能存在一个或更多个居间元件。术语“第一”、“第二”、“第三”等仅是为了便于描述本技术方案,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量,由此,限定有“第一”、“第二”、“第三”等的特征可以明示或者隐含地包括一个或者更多个该特征。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。It should also be noted that, unless otherwise expressly specified and limited, terms such as "installation", "connection", "connection", "fixation" and "setup" should be understood in a broad sense, for example, it may be a fixed connection, or a It can be a detachable connection or integrated; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication between the two elements or the interaction relationship between the two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element, or one or more intervening elements may also be present. The terms "first", "second", "third", etc. are only for the convenience of describing the technical solution, and should not be understood as indicating or implying relative importance or implying the number of indicated technical features, thus, Features defined as "first", "second", "third" etc. may expressly or implicitly include one or more of that feature. 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.
以下描述中,为了说明而不是为了限定,提出了诸如特定系统结构、技术之类的具体细节,以便透彻理解本发明实施例。然而,本领域的技术人员应当清楚,在没有这些具体细节的其它实施例中也可以实现本发明。在其它情况中,省略对众所周知的系统、装置、电路以及方法的详细说明,以免不必要的细节妨碍本发明的描述。In the following description, for the purpose of illustration rather than limitation, specific details such as specific system structures and technologies are set forth in order to provide a thorough understanding of the embodiments of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.
在本发明的描述中,需要说明的是,在介入医疗器械领域,近端是指距离操作者较近的一端,而远端是指距离操作者较远的一端;轴向是指平行于医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便,并不能理解为对本发明的限制。In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther away from the operator; the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the instrument. The above definitions are only for the convenience of expression, and should not be construed as limiting the present invention.
参考图1至图21,依据本发明一实施例的瓣环成形术系统包括瓣膜成形环3和瓣膜成形环输送装置1。瓣膜成形环输送装置1用于将已经缝入心脏原生瓣环4上的多个缝合线2耦合到瓣膜成形环3上,并通过微创的介入路径沿着多个缝合线2将瓣膜成形环3输送至心房内。瓣膜成形环输送装置1可用于二尖瓣瓣环成形术和三尖瓣瓣环成形术中输送瓣膜成形环3,微创介入,不需要心脏停跳即可植入瓣膜成形环3。瓣膜成形环输送装置1包括容置件10、引线组件20、推送件30、操控组件40和鞘管50。Referring to FIGS. 1 to 21 , an annuloplasty system according to an embodiment of the present invention includes an
参考图1至图11,容置件10沿轴向设有容置腔11,容置件10相对的两侧沿轴向设有通槽12,通槽12连通容置腔11,容置腔11用于容置瓣膜成形环3。引线组件20包括分线件21和至少一个两端连通的导管22。分线件21包括沿轴向贯通的主腔214和多个径向连通主腔214的分线孔213。容置件10可拆卸地容置于主腔214中,导管22活动贯穿于分线孔213中。1 to 11 , the
上述瓣膜成形环输送装置1中,瓣膜成形环3容置于容置件10的容置腔11中,容置件10再容置于引线组件20的分线件21的主腔214中,然后将导管22贯穿于分线件21的分线孔213中,导管22同时通过通槽12穿过容置腔11中的瓣膜成形环3,当操作者将已经缝入原生瓣环4的缝合线2穿过导管22,撤出导管22后可使缝合线2穿设在瓣膜成形环3上,从而将原生瓣环4上的多个缝合线2耦合到瓣膜成形环3上,操作简便,方便快捷。同时,由于缝合线2经由分线件21的分线孔213穿设在瓣膜成形环3上,可以确保缝合线2穿设在瓣膜成形环3上的合适位置且相邻缝合线的间距均匀。In the above-mentioned annuloplasty
可以理解,引线组件20可以包括一个导管22或多个导管22。导管22可活动地贯穿于分线件21的分线孔213中,由于内置有瓣膜成形环3的容置件10容置于分线件21的主腔214中,导管22可自分线孔213的一端穿入,然后从容置件10一侧的通槽12中穿入到容置腔11中,并穿过位于容置腔11中的瓣膜成形环3,再从容置件10另一侧的通槽12中穿出,最后自分线孔213的另一端穿出。导管22贯穿分线孔213的同时通过通槽12穿过容置腔11中的瓣膜成形环3。因此,操作者将已经缝入原生瓣环4的缝合线2穿过导管22,然后撤出导管22即可将缝合线2保留穿设于容置腔11中的瓣膜成形环3上。使用可撤离的导管22引导缝合线2穿入瓣膜成形环3,操作简便,还可以缩短手术时间,提高手术效率。It will be appreciated that
瓣膜成形环3置于分线件21的主腔214中后,缝合线2经由分线孔213穿设在瓣膜成形环3上,缝合线2在瓣膜成形环3上的位置由分线孔213与瓣膜成形环3的相对位置决定。由于分线件21上的多个分线孔213位置固定,可以确保缝合线2穿设在瓣膜成形环3上的合适位置且相邻缝合线2之间的距离均匀,从而保证瓣膜成形环3受力后均匀收缩。After the
参考图12和图13,瓣膜成形环3由形状记忆材料制成,瓣膜成形环3处于自然状态时呈C字形,即,瓣膜成形环3具有自然状态及输送状态,在自然状态时其两端开放,呈C形;在容置于输送装置时,呈平直形状的输送状态。瓣膜成形环3具有超弹性,具体可选用硅胶、镍钛合金等可植入且具备合适弹性性能的材料。如图13所示,瓣膜成形环3由于其超弹性的性能,可呈现平直状态容置于容置件10中。将瓣膜成形环3呈平直状态放置于瓣膜成形环输送装置1中,可最大程度地减少瓣膜成形环输送装置1的外形尺寸,有利于减小创口,进而可以减小手术因创口过大而产生的风险。当然,在风险可接受的范围内,也可以将瓣膜成形环3设置为其他的形状并容置于瓣膜成形环输送装置1中,例如螺旋状。如图12所示,当瓣膜成形环输送装置1到达心房内时,可将瓣膜成形环3自容置件10中推出使瓣膜成形环3恢复至自然状态,呈C字形。瓣膜成形环3在自然状态下的形状尺寸与原生瓣环4的形状尺寸相同或接近,在原生瓣环4及瓣膜成形环3上穿设缝合线2后,通过锁结缩环,可将患者异常的原生瓣环4恢复至正常状态。12 and 13 , the
参考图4至图7,引线组件20包括分线件21、导管22和引线件23。分线件21包括可拆卸对合的第一盖体211和第二盖体212。第一盖体211和第二盖体212盖合后形成沿轴向贯通的主腔214和多个径向连通主腔214的分线孔213。这样,可拆卸对合的第一盖体211和第二盖体212方便容置件10容置于分线件21的主腔214中。Referring to FIGS. 4 to 7 , the
参考图4,分线件21还包括锁定旋钮215,第一盖体211与第二盖体212相对应的位置分别设置有锁定孔216。在容置件10容置于分线件21的主腔214后,锁定旋钮215可以依次穿过位于第一盖体211和第二盖体212上的锁定孔216,将第一盖体211和第二盖体212锁紧,从而将容置件10固定在分线件21的主腔214中。在一具体实施方式中,第一盖体211和第二盖体212分别对应设置有两个锁定孔216。以第一盖体211为例,两个锁定孔216中的一个锁定孔216设置在第一盖体211的近端,另一个锁定孔216设置在第一盖体211的远端,且两个锁定孔216分别设置在主腔214的轴向两侧。这样可以提高第一盖体211和第二盖体212盖合的稳定性,进而提高分线件21的稳固性,便于操作。当然,在另一具体实施方式中,第一盖体211和第二盖体212可通过卡扣卡合的方式将容置件10固定在分线件21的主腔214中。Referring to FIG. 4 , the
具体地,分线孔213的数量为多个,沿分线件21的轴向间隔设置。在一具体实施方式中,分线孔213的数量为16个,沿分线件21的轴向均匀间隔分布,这样可通过16个分线孔分别将已经缝入原生瓣环4的16个缝合线2间隔均匀地耦合到瓣膜成形环3上,确保缝合线2穿设在瓣膜成形环3上合适的位置。当然,引线组件20可以配置具有不同数量分线孔213的分线件21,可根据缝入原生瓣环4的缝合线2数量,选择具有相同数量分线孔213的分线件21。Specifically, the number of the branching
当瓣膜成形环3由硅胶等软性形状记忆材料制成时,瓣膜成形环3可不设置穿线孔。在一具体实施方式中,首先将瓣膜成形环3容置于容置腔11中,然后通过第一盖体211和第二盖体212盖合固定容置件10,再将导管22贯穿于分线孔213中,导管22在贯穿分线孔213的同时可穿透瓣膜成形环3,在瓣膜成形环3上形成穿线孔腔。此时,将缝合线2穿引过导管22,然后将导管22沿着缝合线2的游离端撤出,即可将缝合线2耦合到瓣膜成形环3上。When the
当瓣膜成形环3由镍钛合金等形状记忆材料制成时,瓣膜成形环3可对应多个分线孔213设置多个穿线孔,容置件10容置于分线件21的主腔214中时,瓣膜成形环3的穿线孔与分线孔213一一连通。在这种情况下,首先将瓣膜成形环3容置于容置腔11中,然后将多个导管22分别穿设在瓣膜成形环3的多个穿线孔中,再通过第一盖体211和第二盖体212盖合固定容置件10和多个导管22。此时,将缝合线2穿引过导管22,然后将导管22沿着缝合线2的游离端撤出,即可将缝合线2耦合到瓣膜成形环3上。When the
分线件21可选用高分子材料或者金属材料制成。为便于观察分线件21的内部情况,优选为透明的高分子材料,例如聚甲基丙烯酸甲酯(polymethyl methacrylate,简称PMMA)、聚碳酸酯(poly-carbonate,简称PC)等高分子材料。导管22可选用具有一定支撑性的高分子材料制成,例如聚醚醚酮(poly-ether-ether-ketone,简称PEEK)、聚酰亚胺(Polyimide,简称PI)等高分子材料。The
参考图5,引线组件20还包括引线件23,引线件23活动贯穿于导管22中。引线件23包括杆状部231和设于杆状部231一端的环形部232。缝合线2可穿过环形部232,杆状部231用于带动缝合线2穿过导管22。可以理解,在导管22贯穿于分线孔213中并穿设瓣膜成形环3后,可将引线件23活动于贯穿导管22中,然后将缝合线2穿过引线件23的环形部232,拉动杆状部231的另一端,导引缝合线2穿引过导管22,再将导管22沿着缝合线2的游离端撤出,这样缝合线2可穿设于瓣膜成形环3上,此时完成缝合线2的引线。Referring to FIG. 5 , the
环形部232可为一金属环,具体可由具有弹性的金属丝制成,优选为具有超弹性性质的镍钛合金丝。杆状部231可为一直杆,具体可由304不锈钢或者镍钛合金等制成。The
参考图8至图11,容置件10包括容置腔11和通槽12,容置件10的远端设有开口,开口连接容置腔11和通槽12。这样,在将多个缝合线2耦合到瓣膜成形环3后,可将瓣膜成形环3自容置件10的开口推出,缝合线2也可随着瓣膜成形环3沿着通槽12从开口推出。容置件10为圆柱状结构,其远端设有开口10a,近端设有连接腔,用于连接鞘管50。当然,容置件10也可为其他形状的柱状结构。容置件10可选用刚性较强的金属材料或高分子材料制成,如304不锈钢、聚醚醚酮等。Referring to FIGS. 8 to 11 , the accommodating
参考图14和图15,瓣膜成形环输送装置1还包括推送件30,推送件30的远端可移动地容置于容置腔11中。这样,在将多个缝合线2耦合到瓣膜成形环3上后,可通过推送件30将瓣膜成形环3推出容置腔11外。Referring to FIGS. 14 and 15 , the annuloplasty
具体地,推送件30包括推送杆31和与推送杆31远端固定连接的推送块32。推送杆31与推送块32固定连接,固定连接的方式包括焊接、粘接或者扣合等连接方式。推送块32可活动地容置于容置腔11中,推送块32沿径向的截面面积大于推送杆31沿径向的截面面积。这样,可增大推送块32与瓣膜成形环3的接触面积,从而提高将瓣膜成形环3推送出容置腔11的稳定性。进一步地,推送块32和推送杆31可为一体成型结构,从而可以更为稳定地将瓣膜成形环3推送出容置腔11外。推送杆31和推送块32可以选用刚性较强的金属材料或者高分子材料制成,例如304不锈钢、或者聚醚醚酮。Specifically, the
参考图14和图15,瓣膜成形环输送装置1还包括鞘管50,鞘管50为具有内腔的管状结构。鞘管50用于收纳推送件30。鞘管50与容置件10的近端固定连接,具体地,鞘管50与容置件10近端的连接腔固定连接,固定连接的方式为焊接、粘接或者扣合等方式。鞘管50的内腔连通容置腔11,推送件30可移动地容置于鞘管50的内腔及容置腔11中。这样,便于可以较为平稳的推动推送件30,使推送件30推动瓣膜成形环3脱离容置件10。鞘管50可以选用刚性较强的金属材料或者高分子材料制成,例如304不锈钢、或者聚醚醚酮。14 and 15, the annuloplasty
继续参考图14,瓣膜成形环输送装置1还包括操控组件40,操控组件40包括手柄42和设置于手柄42上的操作件41。手柄42与鞘管50的近端固定连接,操作件41连接推送件30的近端并用于控制推送件30的轴向移动。这样,可通过操控操作件41带动推送件30轴向移动,从而将瓣膜成形环3推出容置件10外。Continuing to refer to FIG. 14 , the annuloplasty
具体地,操作件41包括旋钮和滑块,滑块位于手柄42的内腔中,旋钮与手柄42同轴设置。滑块与推送件30的近端固定连接,即与推送杆31的近端固定连接滑块。滑块的周侧设置外螺纹,旋钮上设置有于外螺纹配对的内螺纹。通过旋转旋钮驱动滑块沿轴向运动,从而通过旋钮的转动控制推送件30沿轴向运动。当然,操作件41也可以仅包括旋钮,通过旋钮直接与推送杆31螺纹连接,通过旋钮转动从而带动推送杆31沿轴向运动。操控组件40整体可以由强度较大的高分子材料制成,例如丙烯腈-丁二烯-苯乙烯塑料(AcrylonitrileButadiene Styrene plastic,简称为ABS)、聚丙烯(Polypropylene,简称PP)等。Specifically, the operating
参考图16至图19,本发明实施例提供的瓣膜成形环输送装置1的操作过程具体如下所示。Referring to FIG. 16 to FIG. 19 , the operation process of the annuloplasty
首先,将瓣膜成形环3置于容置件10内并将容置件放置于分线件21的主腔214固定,导管22贯穿分线件21的分线孔213穿插在瓣膜成形环3上。First, the
然后,将已经缝合在原生瓣环4上的缝合线2的游离端穿过引线件23的环形部232,通过引线件23将缝合线2的游离端穿引过导管22,从而完成缝合线2穿设在瓣膜成形环3上。Then, the free end of the
具体地,可根据引线组件20上标注的序号依次完成每个缝合线2的穿线。参考图20,引线组件20的远端第一个分线孔213的位置,对应的是原生瓣环4中右纤维三角的位置。缝合线2在瓣膜成形环3上的顺序依次是右纤维三角、P3、P2、P1、左纤维三角。这样,将瓣膜成形环3的相应位置与原生瓣环4的位置一一对应,才能带动原生瓣环4的组织起到缩环作用。在图20中,AV表示aortic valve主动脉瓣、CS表示coronary sinus冠状窦、ALC表示左纤维三角、PMC表示右纤维三角、A1/A2/A3,P1/P2/P3分别表示瓣膜成形环3上的位置。本发明实施例中的原生瓣环4为二尖瓣原生瓣环。Specifically, the threading of each
最后,多个缝合线2均穿设在瓣膜成形环后,撤出导管22,解锁分线件的第一盖体211和第二盖体212,将第一盖体211和第二盖体212分离并撤出。Finally, after a plurality of
参考图16,图示为撤出引线组件20后的状态,每个缝合线2均穿过瓣膜成形环输送装置1内的瓣膜成形环3,缝合线2的另一端缝合在患者的原生瓣环4上。Referring to FIG. 16, it is shown the state after the
参考图17和图18,瓣膜成形环输送装置1的远端沿着已经穿设好的缝合线2,通过心脏的微创口,进入心脏内的目标位置如左心房。瓣膜成形环输送装置1进入目标位置后,通过驱动操作件41,将瓣膜成形环3推出,此时瓣膜成形环3与缝合线2将同时从瓣膜成形环输送装置1推出。Referring to FIGS. 17 and 18 , the distal end of the annuloplasty
参考图19,瓣膜成形环3完全推出瓣膜成形环输送装置1的容置腔11并释放,瓣膜成形环3由于具有形状记忆功能恢复至自然状态,与原生瓣环4的外形结构对齐,即瓣膜成形环3与原生瓣环4的P1、P2、P3位置对齐。Referring to FIG. 19 , the
参考图20和图21,通过介入锁结器械5,将瓣膜成形环3与原生瓣环4贴合并将邻近的缝合线2两两依次锁结,从而完成瓣膜成形环3的植入并达到缩环效果。由于介入锁结器械5在介入医疗领域比较常见,此处不做详述。20 and 21, through the intervention of the
可以理解的,以上实施例仅表达了本发明的优选实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制;应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,可以对上述技术特点进行自由组合,还可以做出若干变形和改进,这些都属于本发明的保护范围;因此,凡跟本发明权利要求范围所做的等同变换与修饰,均应属于本发明权利要求的涵盖范围。It can be understood that the above examples only represent the preferred embodiments of the present invention, and their descriptions are more specific and detailed, but should not be construed as a limitation on the scope of the patent of the present invention; In other words, without departing from the concept of the present invention, the above-mentioned technical features can be freely combined, and some deformations and improvements can be made, and these all belong to the protection scope of the present invention; All equivalent transformations and modifications made shall fall within the scope of the claims of the present invention.
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| CN202011593343.5A Active CN114681128B (en) | 2020-12-29 | 2020-12-29 | Annuloplasty ring delivery device and annuloplasty system |
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| CN111374799A (en) * | 2018-12-29 | 2020-07-07 | 杭州德晋医疗科技有限公司 | A single-window guided valve ring retraction system |
| CN215384905U (en) * | 2020-12-29 | 2022-01-04 | 杭州德晋医疗科技有限公司 | Annuloplasty ring delivery device and annuloplasty system |
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| US20090177277A1 (en) * | 2001-12-21 | 2009-07-09 | Simcha Milo | Implantation system for annuloplasty rings |
| US20070078514A1 (en) * | 2005-09-30 | 2007-04-05 | Ryan Timothy R | Method of implanting an annuloplasty prosthesis |
| US20070083259A1 (en) * | 2005-10-11 | 2007-04-12 | Medtronic Vascular, Inc. | Annuloplasty device having shape-adjusting tension filaments |
| US20080262609A1 (en) * | 2006-12-05 | 2008-10-23 | Valtech Cardio, Ltd. | Segmented ring placement |
| US20120022644A1 (en) * | 2008-12-22 | 2012-01-26 | Valtech Cardio, Ltd. | Partially-adjustable annuloplasty structure |
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| CN111374799A (en) * | 2018-12-29 | 2020-07-07 | 杭州德晋医疗科技有限公司 | A single-window guided valve ring retraction system |
| CN215384905U (en) * | 2020-12-29 | 2022-01-04 | 杭州德晋医疗科技有限公司 | Annuloplasty ring delivery device and annuloplasty system |
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| CN114681128B (en) | 2025-07-11 |
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