CN116602802B - Implants and Implant Systems - Google Patents
Implants and Implant Systems Download PDFInfo
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- CN116602802B CN116602802B CN202310901178.2A CN202310901178A CN116602802B CN 116602802 B CN116602802 B CN 116602802B CN 202310901178 A CN202310901178 A CN 202310901178A CN 116602802 B CN116602802 B CN 116602802B
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
Abstract
Description
技术领域Technical field
本发明涉及介入医疗器械技术领域,特别地,涉及一种植入物及植入物系统。The present invention relates to the technical field of interventional medical devices, and in particular, to an implant and an implant system.
背景技术Background technique
心力衰竭(Heart Failure)是心室充盈和射血功能异常导致的临床综合征。心力衰竭的主要表现为呼吸困难、疲乏和液体潴留(肺淤血、体循环淤血及外周水肿)等。心力衰竭可分为三类,即射血分数降低的心力衰竭、射血分数轻度降低的心力衰竭和射血分数保留的心力衰竭。据2012-2015年中国心力衰竭流行病学调查显示,中国35岁以上的居民中,加权后心衰患病率为1.3%,约1370万。其中52.7%的患者为射血分数降低的心力衰竭,23.9%的患者为射血分数轻度降低的心力衰竭,23.4%的患者为射血分数保留的心力衰竭。在射血分数保留及射血分数降低的慢性心力衰竭患者中,持续的左心房压力升高是肺淤血的主要原因,90%的心衰患者因此入院治疗。Heart failure is a clinical syndrome caused by abnormal ventricular filling and ejection function. The main manifestations of heart failure are dyspnea, fatigue, and fluid retention (pulmonary congestion, systemic circulation congestion, and peripheral edema). Heart failure can be divided into three categories, namely heart failure with reduced ejection fraction, heart failure with mildly reduced ejection fraction, and heart failure with preserved ejection fraction. According to the 2012-2015 China Heart Failure Epidemiological Survey, the weighted prevalence rate of heart failure among Chinese residents over 35 years old was 1.3%, or approximately 13.7 million. Among them, 52.7% of the patients had heart failure with reduced ejection fraction, 23.9% of the patients had heart failure with mildly reduced ejection fraction, and 23.4% of the patients had heart failure with preserved ejection fraction. In patients with chronic heart failure with preserved or reduced ejection fraction, persistent elevation of left atrial pressure is the main cause of pulmonary congestion, and 90% of heart failure patients are hospitalized for this reason.
心房分流术是改善左心房高压的一种手段,其通过在房间隔造孔来引导左心房的血流向右心房分流,从而减轻左心房负荷。心房分流术分为植入物分流和非植入物分流。植入物分流需要将植入物固定在人工形成的房间隔孔中以保持孔洞不闭合。当前一般通过血管介入手段进行房间隔造孔和植入物固定。具体过程为,将器械或分流器容纳在导管中,将器械或分流器随导管经人体动脉或静脉送入心脏病变部位进行操作。由于血管直径有限,对应的导管直径也受限制,因此分流器需要先在导管内保持为压缩状态,送达目标部位时再从导管中脱出后自动或被动地膨胀至预定尺寸。Atrial shunting is a method to improve left atrial hypertension by creating a hole in the interatrial septum to guide blood flow from the left atrium to the right atrium, thereby reducing the load on the left atrium. Atrial shunts are divided into implant shunts and non-implant shunts. Implant shunting requires the implant to be anchored in an artificially created atrial septal hole to keep the hole open. Currently, atrial septal perforation and implant fixation are generally performed through vascular intervention. The specific process is to accommodate the device or shunt in the catheter, and then send the device or shunt along with the catheter to the heart disease site through the human artery or vein for operation. Since the diameter of blood vessels is limited, the diameter of the corresponding catheter is also limited. Therefore, the shunt needs to be kept in a compressed state in the catheter first, and then when it is delivered to the target site, it will be dislodged from the catheter and automatically or passively expand to a predetermined size.
除了上述心衰患者适用的分流器,对于心血管疾病患者,还存在其他适于设置在心内或血管中的支架类植入物,如某些患者心脏或血管中需要设置封堵器以完善心血管功能,血管狭窄患者可能要植入血管支架。然而,除了通过植入物治疗相关症状外,对患者心血管的血流动力学参数监测也是很有意义的。如,对于心衰患者,除了手术治疗外,对心房的压力监测也是很重要的健康管理手段。然而,如何将压力监测装置与这些支架类植入物相结合是本领域的一大技术难点。申请人发现,如将压力监测装置安装在支架内,由于支架通常都是由金属线材编织或管材切割而成的网状结构,网状结构会干扰甚至屏蔽压力监测装置的无线信号传输。如将压力监测装置沿轴向设置于支架的近端或远端,压力监测装置会增加整体结构长度,会阻碍血流正常流动,对支架端口的尺寸造成影响,产生远期狭窄的风险。In addition to the above-mentioned shunts suitable for patients with heart failure, for patients with cardiovascular disease, there are other stent implants suitable for placement in the heart or blood vessels. For example, some patients need to install occluders in the heart or blood vessels to improve their heart health. Vascular function, patients with vascular stenosis may need to have vascular stents implanted. However, in addition to treating related symptoms through implants, it is also of interest to monitor the patient's cardiovascular hemodynamic parameters. For example, for patients with heart failure, in addition to surgical treatment, atrial pressure monitoring is also an important health management method. However, how to combine pressure monitoring devices with these stent-like implants is a major technical difficulty in this field. The applicant found that if the pressure monitoring device is installed in a bracket, since the bracket is usually a mesh structure made of metal wires braided or cut from pipes, the mesh structure will interfere with or even block the wireless signal transmission of the pressure monitoring device. If the pressure monitoring device is installed axially at the proximal or distal end of the stent, the pressure monitoring device will increase the length of the overall structure, hinder the normal flow of blood flow, affect the size of the stent port, and create the risk of long-term stenosis.
发明内容Contents of the invention
有鉴于此,本公开提供一种植入物和植入物系统,以至少解决部分上述问题。In view of this, the present disclosure provides an implant and an implant system to solve at least some of the above problems.
第一方面,本公开提供一种植入物,用于植入生物体内的目标部位,包括支架、无线传感器和连接件。支架用于设置于目标部位以改善生物体的生理功能,支架包括由多个弹性曲线段形成的主体,多个弹性曲线段包括至少一个接合段,所述接合段设置于主体的预定区域并与至少一个所述弹性曲线段的一部分相连接;无线传感器包括检测元件和无线信号传输元件,检测元件用于获得目标生理参数,无线信号传输元件用于将检测元件获得的目标生理参数传输至生物体外部;连接件用于连接无线传感器和支架;连接件包括相连接的第一连接部和第二连接部,第一连接部连接无线传感器,第二连接部连接接合段,从而使得无线传感器在预定区域附着于支架的外周面。In a first aspect, the present disclosure provides an implant for implanting into a target site in a living body, including a stent, a wireless sensor and a connector. The stent is used to be placed at a target site to improve the physiological function of a living body. The stent includes a main body formed by a plurality of elastic curve segments. The plurality of elastic curve segments include at least one joint segment. The joint segment is disposed in a predetermined area of the main body and is connected with the main body. At least a part of the elastic curve segment is connected; the wireless sensor includes a detection element and a wireless signal transmission element, the detection element is used to obtain the target physiological parameters, and the wireless signal transmission element is used to transmit the target physiological parameters obtained by the detection element to the living body External; the connecting piece is used to connect the wireless sensor and the bracket; the connecting piece includes a connected first connecting part and a second connecting part, the first connecting part is connected to the wireless sensor, and the second connecting part is connected to the joint section, so that the wireless sensor is connected at a predetermined time The area is attached to the outer circumference of the stent.
在一种可能的实现方式中,第二连接部包括被夹持部,接合段插入第二连接部以夹持被夹持部;所述接合段与至少一个所述弹性曲线段的所述一部分一体成型,接合段通过自身的弹力迫使被夹持部贴靠在主体的外周面,和/或,接合段通过粘结剂使被夹持部贴靠在主体的外周面。In a possible implementation, the second connecting part includes a clamped part, and the engaging segment is inserted into the second connecting part to clamp the clamped part; the engaging segment and the part of at least one elastic curve segment Formed in one piece, the joint section forces the clamped part to abut against the outer peripheral surface of the main body through its own elasticity, and/or the joint section forces the clamped part to abut against the outer peripheral surface of the main body through adhesive.
结合上述可能的实现方式,在另一种可能的实现方式中,支架与无线传感器并排设置。Combined with the above possible implementation manner, in another possible implementation manner, the bracket and the wireless sensor are arranged side by side.
结合上述可能的实现方式,在另一种可能的实现方式中,第二连接部包括片材部,片材部具有边缘部分,边缘部分形成被夹持部,接合段以夹持边缘部分的形式与片材部连接。In combination with the above possible implementation, in another possible implementation, the second connection part includes a sheet part, the sheet part has an edge part, the edge part forms a clamped part, and the joint section is in the form of clamping the edge part Connected to the sheet part.
结合上述可能的实现方式,在另一种可能的实现方式中,边缘部分位于片材部的边缘区域或位于片材部上形成的开口的边缘区域。In conjunction with the above possible implementation, in another possible implementation, the edge portion is located in an edge area of the sheet portion or in an edge area of an opening formed on the sheet portion.
结合上述可能的实现方式,在另一种可能的实现方式中,连接件为环形套件,环形套件的一部分为第一连接部,环形套件的另一部分为第二连接部;片材部的边缘部分由环形套件的边缘部分形成,或者,环形套件设置有开口,片材部的边缘部分由开口的边缘部分形成。Combined with the above possible implementation manner, in another possible implementation manner, the connecting member is an annular sleeve, a part of the annular sleeve is the first connection part, and the other part of the annular sleeve is the second connection part; the edge part of the sheet part The edge portion of the sheet portion is formed by an edge portion of the annular sleeve, or the annular sleeve is provided with an opening.
结合上述可能的实现方式,在另一种可能的实现方式中,环形套件与无线信号传输元件在轴向上至少部分重叠,环形套件为非金属套管,非金属套管的横截面为封闭结构或非封闭结构,或者环形套件为金属套管,金属套管的横截面为非封闭结构。In combination with the above possible implementation, in another possible implementation, the annular set and the wireless signal transmission element at least partially overlap in the axial direction, the annular set is a non-metallic sleeve, and the cross-section of the non-metallic sleeve is a closed structure Or a non-closed structure, or the annular set is a metal sleeve, and the cross section of the metal sleeve is a non-closed structure.
结合上述可能的实现方式,在另一种可能的实现方式中,环形套件在轴向上完全覆盖无线传感器,在无线传感器的端面暴露出检测元件,检测元件用于检测压力。Combined with the above possible implementation, in another possible implementation, the annular sleeve completely covers the wireless sensor in the axial direction, and a detection element is exposed on the end face of the wireless sensor, and the detection element is used to detect pressure.
结合上述可能的实现方式,在另一种可能的实现方式中,弹性曲线段通过在周向和轴向延伸形成主体,且弹性曲线段至少包括波浪段,波浪段的一部分形成接合段。In combination with the above possible implementation, in another possible implementation, the elastic curve segment forms the main body by extending in the circumferential direction and the axial direction, and the elastic curve segment at least includes a wavy segment, and a part of the wavy segment forms a joint segment.
结合上述可能的实现方式,在另一种可能的实现方式中,波浪段的预定波谷部和/或波峰部形成接合段。In conjunction with the above possible implementation manner, in another possible implementation manner, the predetermined trough portion and/or crest portion of the wave segment forms a joint segment.
结合上述可能的实现方式,在另一种可能的实现方式中,接合段包括第一接合段和第二接合段,第二连接部包括被夹持部,第一接合段和第二接合段分别从两个相反方向夹持被夹持部。In combination with the above possible implementation, in another possible implementation, the joint section includes a first joint section and a second joint section, the second connection section includes a clamped section, and the first joint section and the second joint section respectively Clamp the clamped part from two opposite directions.
结合上述可能的实现方式,在另一种可能的实现方式中,所述弹性曲线段通过在周向和轴向延伸形成所述主体,且所述弹性曲线段至少包括波浪段,波浪段的预定部位具有迂回段,迂回段在中间是断开的并形成第一接合段和第二接合段,第一接合段和第二接合段包括弯曲并回折的末端,第一接合段和第二接合段各自弯曲并回折的末端互相嵌套配置。In combination with the above possible implementation, in another possible implementation, the elastic curve segment forms the main body by extending in the circumferential direction and the axial direction, and the elastic curve segment at least includes a wave segment, and the predetermined length of the wave segment The location has a circuitous section. The circuitous section is disconnected in the middle and forms a first joint section and a second joint section. The first joint section and the second joint section include ends that are bent and turned back. The first joint section and the second joint section The respective bent and folded ends are nested in each other.
结合上述可能的实现方式,在另一种可能的实现方式中,连接件为环形套件,环形套件的一部分为第一连接部,环形套件的另一部分为第二连接部;环形套件设置有在轴向具有预定间距的第一开口和第二开口,第一接合段和第二接合段分别经第一开口和第二开口插设于环形套件与无线传感器之间。In combination with the above possible implementation manner, in another possible implementation manner, the connecting member is an annular sleeve, a part of the annular sleeve is a first connection part, and the other part of the annular sleeve is a second connection part; the annular sleeve is provided with a shaft on the shaft Toward the first opening and the second opening having a predetermined distance, the first engaging section and the second engaging section are respectively inserted between the annular sleeve and the wireless sensor through the first opening and the second opening.
结合上述可能的实现方式,在另一种可能的实现方式中,支架为心房分流器,主体为用于分流的筒体,筒体由所述弹性曲线段以环形和/或螺旋形式延伸形成。In combination with the above possible implementation, in another possible implementation, the stent is an atrial shunt, and the main body is a barrel for shunting, and the barrel is formed by extending the elastic curve segment in an annular and/or spiral form.
结合上述可能的实现方式,在另一种可能的实现方式中,筒体为弹性曲线段形成的网状结构,筒体被设置能够在径向可回弹地变形且保持周长不变。In combination with the above possible implementation, in another possible implementation, the barrel is a network structure formed by elastic curve segments, and the barrel is configured to be able to resiliently deform in the radial direction while maintaining the same circumference.
结合上述可能的实现方式,在另一种可能的实现方式中,筒体被设置为能够在限制空间内被沿第一径向方向可回弹地压缩,并且/或者,筒体被设置为在限制空间内被沿第一径向方向压缩时的横截面形状呈C形。In conjunction with the above possible implementation, in another possible implementation, the barrel is configured to be resiliently compressed along the first radial direction within the restricted space, and/or the barrel is configured to be in The cross-sectional shape when compressed along the first radial direction in the restricted space is C-shaped.
结合上述可能的实现方式,在另一种可能的实现方式中,无线传感器与主体平行,并且/或者,无线传感器与主体外切地连接。In combination with the above possible implementation manner, in another possible implementation manner, the wireless sensor is parallel to the main body, and/or the wireless sensor is connected to the main body circumferentially.
结合上述可能的实现方式,在另一种可能的实现方式中,支架还包括夹持臂组,夹持臂组至少包括第一夹持臂和第二夹持臂,第一夹持臂和第二夹持臂沿主体的轴向间隔分布在主体外周,第一夹持臂和第二夹持臂各自形成凸出于主体的外周的悬臂。In combination with the above possible implementation manner, in another possible implementation manner, the bracket further includes a clamping arm group, the clamping arm group at least includes a first clamping arm and a second clamping arm, the first clamping arm and the third clamping arm. The two clamping arms are spaced along the axial direction of the main body and are distributed on the outer circumference of the main body. The first clamping arm and the second clamping arm each form a cantilever protruding from the outer circumference of the main body.
结合上述可能的实现方式,在另一种可能的实现方式中,第一夹持臂和/或第二夹持臂由弹性金属丝弯折形成,并且/或者,第一夹持臂和/或第二夹持臂具有由弹性金属丝向径向延伸预定距离后折回形成的U形或V形结构。In conjunction with the above possible implementation, in another possible implementation, the first clamping arm and/or the second clamping arm are formed by bending elastic metal wires, and/or the first clamping arm and/or The second clamping arm has a U-shaped or V-shaped structure formed by an elastic metal wire extending a predetermined distance in the radial direction and then folded back.
结合上述可能的实现方式,在另一种可能的实现方式中,构成第一夹持臂和/或第二夹持臂的弹性金属丝与所述第一夹持臂和/或第二夹持臂的基部所附着的筒体的弹性金属丝为同一根弹性金属丝,并且/或者,第一夹持臂和/或第二夹持臂与各自相邻的筒体的端部具有预定距离。In combination with the above possible implementation, in another possible implementation, the elastic metal wire constituting the first clamping arm and/or the second clamping arm is connected with the first clamping arm and/or the second clamping arm. The elastic metal wire of the barrel to which the base of the arm is attached is the same elastic metal wire, and/or the first clamping arm and/or the second clamping arm have a predetermined distance from the end of the respective adjacent barrel.
结合上述可能的实现方式,在另一种可能的实现方式中,第一夹持臂的自由端与第二夹持臂的自由端在轴向投影上重叠,第一夹持臂的固定端与第二夹持臂的固定端在轴向投影上错开。Combined with the above possible implementation, in another possible implementation, the free end of the first clamping arm and the free end of the second clamping arm overlap in axial projection, and the fixed end of the first clamping arm overlaps with the free end of the second clamping arm. The fixed ends of the second clamping arms are offset in axial projection.
结合上述可能的实现方式,在另一种可能的实现方式中,支架还包括覆膜,覆膜敷设于主体的内部和/或外部,当覆膜敷设于主体的外部时,覆膜具有暴露出接合段的缺口。In combination with the above possible implementation manner, in another possible implementation manner, the stent further includes a covering film, and the covering film is laid on the inside and/or outside of the main body. When the covering film is laid on the outside of the main body, the covering film has an exposed Notch in the joint section.
结合上述可能的实现方式,在另一种可能的实现方式中,连接件由高分子材料制成,并通过热缩工艺将无线传感器和支架相固定。Combined with the above possible implementation manner, in another possible implementation manner, the connecting piece is made of polymer material, and the wireless sensor and the bracket are fixed through a heat shrink process.
第二方面,提供一种植入物系统,包括输送导管和植入物。植入物为第一方面中任一说明的植入物,当植入物被设置在导管内时呈压缩状态,支架被压缩为截面呈C形的结构,被压缩后的支架的外表面至少部分包围无线传感器,植入物能够从导管中伸出。In a second aspect, an implant system is provided, including a delivery catheter and an implant. The implant is the implant described in any one of the first aspects. When the implant is placed in the catheter, it is in a compressed state. The stent is compressed into a C-shaped cross-section. The outer surface of the compressed stent is at least Partially surrounding the wireless sensor, the implant can extend out of the catheter.
在一种可能的实现方式中,还包括信号接收装置,信号接收装置用于接收植入物中无线传感器的信号。In a possible implementation, a signal receiving device is further included, and the signal receiving device is configured to receive signals from wireless sensors in the implant.
本公开提供的植入物,用于植入生物体内的目标部位。植入物包括支架、无线传感器和连接件。支架用于连接至目标部位以改善生物体的生理功能,支架包括由多个弹性曲线段形成的主体至少一个接合段,所述接合段设置于所述主体的预定区域并与至少一个所述弹性曲线段的一部分相连接;无线传感器包括检测元件和无线信号传输元件,检测元件用于获得目标生理参数,无线信号传输元件用于将检测元件获得的目标生理参数传输至生物体外部;连接件用于连接无线传感器和支架;连接件包括相连接的第一连接部和第二连接部,第一连接部连接无线传感器,第二连接部连接接合段,从而使得无线传感器在预定区域附着于支架的外周面。无线传感器设置在支架外周,使得支架本身不会屏蔽无线信号。进一步地,通过与弹性曲线段相连接的接合段与连接件配合将无线传感器固定至支架表面,连接结构简单可靠且紧凑。The implant provided by the present disclosure is used to be implanted into a target site in a living body. Implants include stents, wireless sensors and connectors. The stent is used to connect to a target site to improve the physiological function of a living body. The stent includes at least one joint section of a main body formed by a plurality of elastic curve sections. The joint section is arranged in a predetermined area of the main body and is connected with at least one of the elastic curve sections. A part of the curve segments are connected; the wireless sensor includes a detection element and a wireless signal transmission element, the detection element is used to obtain the target physiological parameters, and the wireless signal transmission element is used to transmit the target physiological parameters obtained by the detection element to the outside of the organism; the connector is used For connecting the wireless sensor and the bracket; the connecting piece includes a connected first connecting part and a second connecting part, the first connecting part is connected to the wireless sensor, and the second connecting part is connected to the joint section, so that the wireless sensor is attached to the bracket in a predetermined area Peripheral surface. The wireless sensors are set on the periphery of the bracket so that the bracket itself will not block wireless signals. Furthermore, the wireless sensor is fixed to the surface of the bracket through the joint section connected to the elastic curve section and the connecting piece, and the connection structure is simple, reliable and compact.
附图说明Description of the drawings
为了更清楚地说明本公开实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍。In order to explain the technical solutions of the embodiments of the present disclosure more clearly, the drawings required to be used in the embodiments will be briefly introduced below.
应当理解,以下附图仅示出了本公开的某些实施例,不应看作是对范围的限定。It should be understood that the following drawings illustrate only certain embodiments of the present disclosure and should not be considered limiting of scope.
还应当理解,在附图中使用相同或相似的附图标记来表示相同或相似的要素。It will also be understood that the same or similar reference numbers are used in the drawings to refer to the same or similar elements.
还应当理解,附图仅是示意性的,附图中的要素的尺寸和比例不一定精确。It should also be understood that the drawings are schematic only and that the dimensions and proportions of elements in the drawings are not necessarily precise.
图1是根据本公开一实施例的生物体内目标部位的结构示意图。Figure 1 is a schematic structural diagram of a target site in a living body according to an embodiment of the present disclosure.
图2是根据本公开一实施例的植入物的结构示意图。Figure 2 is a schematic structural diagram of an implant according to an embodiment of the present disclosure.
图3是图2中植入物隐去无线传感器后的结构示意图。Figure 3 is a schematic structural diagram of the implant in Figure 2 with the wireless sensor hidden.
图4是图2中连接件与支架的连接方式的局部放大示意图。FIG. 4 is a partially enlarged schematic view of the connection method between the connector and the bracket in FIG. 2 .
图5是图1中植入物的端面正视图。Figure 5 is an end elevational view of the implant of Figure 1 .
图6是根据本公开一实施例的位于输送管中植入物的压缩状态示意图。Figure 6 is a schematic diagram of the compressed state of the implant located in the delivery tube according to an embodiment of the present disclosure.
图7是图6中输送管和植入物的横截面示意图。Figure 7 is a schematic cross-sectional view of the delivery tube and implant of Figure 6.
图8是含有植入物的输送管到达目标部位时的示意图。Figure 8 is a schematic diagram of the delivery tube containing the implant reaching the target site.
图9是植入物从输送管中伸出一端和一些夹持臂时示意图。Figure 9 is a schematic view of the implant with one end extending from the delivery tube and some clamping arms.
图10是回撤输送管使植入物的夹持臂到达房间隔表面时的示意图。Figure 10 is a schematic view of the delivery tube being withdrawn so that the implant's clamping arm reaches the interatrial septal surface.
图11是撤去输送管使植入物安装至目标部位时的示意图。Figure 11 is a schematic diagram when the delivery tube is removed and the implant is installed at the target site.
图12是根据本公开另一个实施例的植入物的结构示意图。Figure 12 is a schematic structural diagram of an implant according to another embodiment of the present disclosure.
图13是图12中植入物另一角度的视图。Figure 13 is a view of the implant of Figure 12 from another angle.
图14是图12中连接件与主体中接合段的连接结构放大视图。Figure 14 is an enlarged view of the connection structure of the connecting piece and the main body in Figure 12.
图15是图12中植入物的主体和覆膜的结构示意图。Figure 15 is a schematic structural diagram of the main body and covering of the implant in Figure 12.
图16是根据本公开另一实施例的植入物中无线传感器、连接件与接合段的结构示意图。Figure 16 is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
图17是根据本公开另一实施例的植入物中无线传感器、连接件与接合段的结构示意图。Figure 17 is a schematic structural diagram of a wireless sensor, a connector and a joint section in an implant according to another embodiment of the present disclosure.
图18是根据本公开另一实施例的植入物中无线传感器、连接件与接合段的结构示意图。Figure 18 is a schematic structural diagram of a wireless sensor, a connecting piece and a joint section in an implant according to another embodiment of the present disclosure.
图19是根据本公开另一实施例的植入物中无线传感器、连接件与接合段的结构示意图。Figure 19 is a schematic structural diagram of a wireless sensor, a connecting piece and a joint section in an implant according to another embodiment of the present disclosure.
图20是一种可选实施方式中无线传感器、连接件与接合段的结构示意图。Figure 20 is a schematic structural diagram of a wireless sensor, connecting piece and joint section in an optional embodiment.
图21是一种可选实施方式中连接件结构示意图。Figure 21 is a schematic structural diagram of a connector in an optional embodiment.
图22a是一种可选实施方式中支架的纵剖截面形状示意图。Figure 22a is a schematic diagram of the longitudinal cross-sectional shape of a stent in an optional embodiment.
图22b是另一种可选实施方式中支架的纵剖截面形状示意图。Figure 22b is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment.
图22c是另一种可选实施方式中支架的纵剖截面形状示意图。Figure 22c is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment.
图22d是另一种可选实施方式中支架的纵剖截面形状示意图。Figure 22d is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment.
图22e是另一种可选实施方式中支架的纵剖截面形状示意图。Figure 22e is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment.
具体实施方式Detailed ways
下面结合附图,对本公开的实施例进行示例性地描述。应当理解,本公开的实现方式可以有多种,不应被解释为限于这里阐述的实施例,这里阐述的实施例仅是为了更加透彻和完整地理解本公开。The embodiments of the present disclosure are exemplarily described below with reference to the accompanying drawings. It should be understood that the present disclosure may be implemented in various ways and should not be construed as being limited to the embodiments set forth here. The embodiments set forth here are only for a more thorough and complete understanding of the present disclosure.
应当理解,本公开使用的术语“包括”及其变形是开放性包括,即“包括但不限于”。术语“根据”是“至少部分地根据”。It should be understood that the term "include" and its variations used in this disclosure are open-ended inclusion, that is, "including but not limited to." The term "based on" means "based at least in part on."
应当理解,虽然术语“第一”或“第二”等可能在本公开中用来描述各种元素,但这些元素不被这些术语所限定,这些术语只是用来将一个元素与另一个元素区分开。It will be understood that, although the terms "first" or "second" and the like may be used to describe various elements in this disclosure, these elements are not limited by these terms, which are only used to distinguish one element from another element. open.
本公开实施例提供一种植入物,用于植入生物体内,以改善生物体的生理功能,同时获取目标生理参数。植入物包括支架、无线传感器和连接件。支架用于设置于目标部位以改善生物体的生理功能。支架可以是分流器、封堵器或血管支架等网状结构体。支架至少包括由多根弹性曲线段形成的主体。此处的“弹性曲线段”是指具有弹性且整体上呈现曲线的线材段,但在“弹性曲线段”的局部区域仍然可以呈现出直线形态,多根弹性曲线段也可以由同一根线材或多根不同线材形成,例如金属丝编织而成,本发明对此不做限制。无线传感器包括电性连接的检测元件和无线信号传输元件。检测元件用于获得目标生理参数。无线信号传输元件用于将检测元件获得的目标生理参数传输至生物体外部。连接件用于连接无线传感器和支架,并使得无线传感器设置于支架外并与支架的外周面相贴靠。通过如此布置,支架不会影响到无线传感器的信号传输,无线传感器也不会影响到支架两端的端口尺寸,特别是当支架是分流器时,支架的分流能力不会受到影响。Embodiments of the present disclosure provide an implant for implanting into a living body to improve the physiological functions of the living body and obtain target physiological parameters at the same time. Implants include stents, wireless sensors and connectors. The scaffold is used to be placed at a target site to improve the physiological function of the organism. The stent can be a mesh structure such as a shunt, an occluder or a vascular stent. The bracket at least includes a main body formed by a plurality of elastic curve segments. The "elastic curve segment" here refers to a wire segment that is elastic and presents a curve as a whole, but the local area of the "elastic curve segment" can still show a straight line shape, and multiple elastic curve segments can also be made of the same wire or It is formed by multiple different wires, such as braided metal wires, which is not limited by the present invention. Wireless sensors include electrically connected detection components and wireless signal transmission components. The detection element is used to obtain target physiological parameters. The wireless signal transmission element is used to transmit the target physiological parameters obtained by the detection element to the outside of the living body. The connecting piece is used to connect the wireless sensor and the bracket, so that the wireless sensor is arranged outside the bracket and abuts against the outer peripheral surface of the bracket. With such an arrangement, the bracket will not affect the signal transmission of the wireless sensor, and the wireless sensor will not affect the port size at both ends of the bracket. Especially when the bracket is a splitter, the splitting ability of the bracket will not be affected.
支架可以与无线传感器通过压接、粘接、缝合连接、焊接等多种方式进行固定。在本实施例中,支架与无线传感器通过特殊设计连接件进行固定,连接件包括相互连接的第一连接部和第二连接部,第一连接部连接无线传感器,第二连接部连接支架的弹性曲线段。具体地,所述支架还包括至少一个接合段,设置于主体的预定区域并与至少一个所述弹性曲线段的一部分相连接,接合段插入第二连接部以使连接件在预定区域附着于支架表面,无线传感器通过连接件保持在支架外周且与支架大致并排设置。通过与弹性曲线段相连接的接合段与连接件配合将无线传感器固定至支架表面,连接结构简单可靠且紧凑,且弹性曲线段本身为支架的一部分,不需要额外设置其他结构与连接件连接,不会显著增大植入物的径向尺寸,并进一步降低了产生血栓的风险。The bracket can be fixed with the wireless sensor through various methods such as crimping, bonding, suture connection, and welding. In this embodiment, the bracket and the wireless sensor are fixed through a specially designed connecting piece. The connecting piece includes a first connecting part and a second connecting part that are connected to each other. The first connecting part is connected to the wireless sensor, and the second connecting part is connected to the elasticity of the bracket. curve segment. Specifically, the bracket further includes at least one joint section, which is disposed in a predetermined area of the main body and connected to a part of at least one of the elastic curve sections, and the joint section is inserted into the second connecting portion to attach the connector to the bracket in the predetermined area. On the surface, the wireless sensor is held on the periphery of the bracket through the connecting piece and is arranged approximately side by side with the bracket. The wireless sensor is fixed to the surface of the bracket by cooperating with the joint section connected to the elastic curve section and the connector. The connection structure is simple, reliable and compact, and the elastic curve section itself is part of the bracket, and there is no need to set up other additional structures to connect with the connector. It does not significantly increase the radial size of the implant and further reduces the risk of thrombosis.
图1是根据本公开一实施例的生物体内目标部位m1的结构示意图。具体地,目标部位m1为位于左心房与右心房之间的房间隔m2上的孔。该孔可以是未闭合的卵圆孔,也可以是人工造孔。对于某些心衰患者,该孔可以降低左心房压力,缓解心衰症状。本公开实施例提供的支架为分流器,分流器可以设置在该孔中以维持该孔的形态,引导血液从左心房流向右心房。较佳地,无线传感器设置于分流器的外周面的中间位置,因此,当本实施例中的植入物被设置于房间隔m2上时,无线传感器与支架一同设置于目标部位m1内且与目标部位相贴靠。进一步地,无线传感器的两端可以设置两个检测元件,从而同时获取左心房和右心房的压力。Figure 1 is a schematic structural diagram of a target site m1 in a living body according to an embodiment of the present disclosure. Specifically, the target site m1 is a hole located on the interatrial septum m2 between the left atrium and the right atrium. The hole can be an unclosed foramen ovale or an artificial hole. In some patients with heart failure, the hole can reduce pressure in the left atrium and relieve heart failure symptoms. The stent provided by the embodiment of the present disclosure is a shunt, and the shunt can be disposed in the hole to maintain the shape of the hole and guide blood to flow from the left atrium to the right atrium. Preferably, the wireless sensor is disposed at the middle position of the outer circumferential surface of the shunt. Therefore, when the implant in this embodiment is disposed on the interatrial septum m2, the wireless sensor and the stent are disposed in the target site m1 together with The target parts are close to each other. Furthermore, two detection elements can be provided at both ends of the wireless sensor to simultaneously obtain the pressure of the left atrium and the right atrium.
参考图2至图5,图2至图5为根据本公开一实施例的植入物的结构示意图。本实施例中植入物包括支架100和无线传感器200。图2是根据本公开一实施例的植入物的结构示意图。图3是图2中植入物隐去无线传感器200后的结构示意图。图4是图2中连接件300与支架100的连接方式的局部放大示意图。图5是图1中植入物的端面正视图。Referring to FIGS. 2 to 5 , FIGS. 2 to 5 are schematic structural diagrams of an implant according to an embodiment of the present disclosure. In this embodiment, the implant includes a stent 100 and a wireless sensor 200 . Figure 2 is a schematic structural diagram of an implant according to an embodiment of the present disclosure. FIG. 3 is a schematic structural diagram of the implant in FIG. 2 with the wireless sensor 200 hidden. FIG. 4 is a partially enlarged schematic diagram of the connection method between the connector 300 and the bracket 100 in FIG. 2 . Figure 5 is an end elevational view of the implant of Figure 1 .
植入物包括支架100、无线传感器200和连接件300。支架100和无线传感器200并排设置,连接件300将二者连接为一体。应当理解,本发明中的“并排设置”并不局限于平行设置,包括支架100和无线传感器还可以是具有预定夹角的位置关系(但非垂直位置关系)。当然,较佳地,支架100和无线传感器200相平行地设置,并且如图5所示,当支架的主体为筒状结构,而无线传感器200也为筒状结构时,在接合段与连接件的作用下,无线传感器200与支架100呈现出外切的形态。如此设计,可以使得植入物在输送过程中可以具有更小的径向尺寸,便于被压握在输送装置内。The implant includes a stent 100, a wireless sensor 200, and a connector 300. The bracket 100 and the wireless sensor 200 are arranged side by side, and the connector 300 connects them as one body. It should be understood that the "side-by-side arrangement" in the present invention is not limited to a parallel arrangement. The bracket 100 and the wireless sensor may also have a positional relationship with a predetermined angle (but not a vertical positional relationship). Of course, preferably, the bracket 100 and the wireless sensor 200 are arranged in parallel, and as shown in Figure 5, when the main body of the bracket has a cylindrical structure and the wireless sensor 200 also has a cylindrical structure, the joint section and the connecting piece Under the action of , the wireless sensor 200 and the bracket 100 present an external shape. This design allows the implant to have a smaller radial size during delivery, making it easier to be pressed and held within the delivery device.
在本实施例中,支架100包括主体110、第一夹持臂112、第二夹持臂113和覆膜120。主体110为金属丝编织而成的筒状结构体,大致呈圆柱形。覆膜120敷设于主体110的内表面。第一夹持臂112和第二夹持臂113从主体110的表面沿径向向外延伸形成悬臂结构。第一夹持臂112和第二夹持臂113形成至少一个夹持臂组,二者用于分布在心房间隔m2的两侧以夹持心房间隔m2。主体110、第一夹持臂112和第二夹持臂113均由弹性曲线段101卷绕弯折形成。具体地,主体110分为上段筒和下段筒。第一夹持臂112和第二夹持臂113的数量均为3个。3个第一夹持臂112均布在上段筒的表面。3个第二夹持臂113均布在下段筒的表面。部分弹性曲线段101在轴向上呈波浪状延伸并同时在周向上延伸形成网状筒体;另一部分弹性曲线段101从网状筒体表面沿径向向外延伸后再折回至筒体表面形成U形的夹持臂。In this embodiment, the bracket 100 includes a main body 110 , a first clamping arm 112 , a second clamping arm 113 and a covering film 120 . The main body 110 is a cylindrical structure made of metal wires and is generally cylindrical. The coating 120 is laid on the inner surface of the main body 110 . The first clamping arm 112 and the second clamping arm 113 extend radially outward from the surface of the main body 110 to form a cantilever structure. The first clamping arm 112 and the second clamping arm 113 form at least one clamping arm group, and they are used to be distributed on both sides of the interatrial septum m2 to clamp the interatrial septum m2. The main body 110 , the first clamping arm 112 and the second clamping arm 113 are all formed by winding and bending elastic curve segments 101 . Specifically, the main body 110 is divided into an upper cylinder and a lower cylinder. The number of the first clamping arms 112 and the second clamping arms 113 is both three. The three first clamping arms 112 are evenly distributed on the surface of the upper barrel. The three second clamping arms 113 are evenly distributed on the surface of the lower barrel. Part of the elastic curve segment 101 extends in a wavy shape in the axial direction and extends in the circumferential direction to form a mesh cylinder; the other part of the elastic curve segment 101 extends radially outward from the surface of the mesh cylinder and then folds back to the surface of the cylinder. Form a U-shaped clamping arm.
一些可选实施例中,主体110也可以由金属切割而成。第一夹持臂112和第二夹持臂113各自的数量也可以大于3个或小于3个,例如2个,只要能够实现夹持功能即可。弹性曲线段101也可以呈现其他的形态,本发明对此不做限制。In some optional embodiments, the main body 110 may also be cut from metal. The number of each of the first clamping arms 112 and the second clamping arms 113 may also be greater than 3 or less than 3, such as 2, as long as the clamping function can be achieved. The elastic curve segment 101 can also take on other forms, which is not limited by the present invention.
进一步地,3个第一夹持臂112和3个第二夹持臂113形成三个夹持臂组。每个夹持臂组的第一夹持臂112和第二夹持臂113在轴向上间隔分布。第一夹持臂112与主体110的第一端(图2中的上端)具有预定间距。第二夹持臂113与主体110的第二端(图2中的下端)具有预定间距。第一夹持臂112的自由端与第二夹持臂113的自由端在轴向投影上重叠,第一夹持臂112的固定端与第二夹持臂113的固定端在轴向投影上错开,从而实现更大的夹持面积(第一夹持臂112与第二夹持臂113共同形成的夹持区域的面积),获得更好的夹持效果。其中,第一夹持臂112的固定端与第二夹持臂113的固定端为第一夹持臂112与第二夹持臂113同主体110连接的那端。上段筒和下段筒同轴分布,二者之间可以通过覆膜120和/或弹性曲线段相连接。下段筒的弹性曲线段在初始阶段在周向以环形形式延伸,一圈后以螺旋形式向上延伸。上段筒的弹性曲线段在初始阶段在周向以螺旋形式向上延伸,最后一圈以环形形式延伸。上述实施方式中,夹持臂轴向距离为3mm。轴向距离可选范围为大于0mm且小于等于3mm。上述实施方式中,构成夹持臂的弹性金属丝与夹持臂基部所附着的筒体的弹性金属丝为同一根弹性金属丝。在一些可选实施方式中,夹持臂可以为单独的U形或V形零件,通过焊接方式焊接至筒体的弹性曲线段上。Further, three first clamping arms 112 and three second clamping arms 113 form three clamping arm groups. The first clamping arm 112 and the second clamping arm 113 of each clamping arm group are spaced apart in the axial direction. The first clamping arm 112 has a predetermined distance from the first end (upper end in FIG. 2 ) of the main body 110 . The second clamping arm 113 has a predetermined distance from the second end (lower end in FIG. 2 ) of the main body 110 . The free end of the first clamping arm 112 and the free end of the second clamping arm 113 overlap in the axial projection, and the fixed end of the first clamping arm 112 and the fixed end of the second clamping arm 113 overlap in the axial projection. By staggering, a larger clamping area (the area of the clamping area formed by the first clamping arm 112 and the second clamping arm 113 together) is achieved, and a better clamping effect is obtained. The fixed end of the first clamping arm 112 and the fixed end of the second clamping arm 113 are the ends where the first clamping arm 112 and the second clamping arm 113 are connected to the main body 110 . The upper cylinder and the lower cylinder are coaxially distributed, and the two can be connected through the coating 120 and/or the elastic curve segment. The elastic curve section of the lower barrel extends in an annular form in the circumferential direction at the initial stage, and extends upward in a spiral form after one circle. The elastic curve section of the upper barrel extends upward in a spiral form in the circumferential direction in the initial stage, and extends in an annular form in the final circle. In the above embodiment, the axial distance of the clamping arms is 3 mm. The optional range of axial distance is greater than 0mm and less than or equal to 3mm. In the above embodiment, the elastic metal wire constituting the clamping arm and the elastic metal wire of the cylinder attached to the base of the clamping arm are the same elastic metal wire. In some optional embodiments, the clamping arm can be a separate U-shaped or V-shaped part that is welded to the elastic curve section of the barrel.
本实施例中的夹持臂设计不同于现有技术中腰形或法兰盘结构的锚定设计,既能够有效减少分流装置在腔体内的体积及与锚定点的接触面积,避免对血流产生不利影响,又能够稳固地将主体锚定于目标部位中。The clamping arm design in this embodiment is different from the waist-shaped or flange structure anchoring design in the prior art. It can effectively reduce the volume of the shunt device in the cavity and the contact area with the anchor point, and avoid causing damage to the blood flow. It has no adverse effects and can firmly anchor the subject in the target part.
本实施例中,覆膜120的长度等于上段筒和下端筒的长度之和,由于覆膜120为筒状结构,有一定的强度,其敷设在主体110内/外表面时也可以加强主体110的强度及上段筒和下端筒之间的连接强度,同时可以维持弹性曲线段的预设形态,从而保持主体110的形态。覆膜120使筒体内腔光滑,防止房间隔组织增生堵塞筒腔,维持筒腔畅通。覆膜120的材料可以为高分子材料或生物材料,不限于涤纶、聚四氟乙烯、动物心包等。覆膜120的表面可以设置涂层以提高表面光洁度,以提高远期通畅率。在一些可选实施例中,覆膜120还可以设置在主体110的外表面。在另一些可选实施例中,主体110的内表面和外表面均可以设置一层覆膜120。覆膜120的另一个有益效果是产生绝缘作用,其可以在一定程度上隔离主体110和无线传感器200,避免信号干扰。覆膜120与主体110之间可以通过热压或缝合的方式连接。图中为更清楚地区分覆膜120和主体110,刻意放大了覆膜120的厚度尺寸且将覆膜120绘示在主体110的内表面,实际厚度比所示意的尺寸更小。In this embodiment, the length of the coating 120 is equal to the sum of the lengths of the upper tube and the lower tube. Since the coating 120 has a cylindrical structure and has a certain strength, it can also strengthen the main body 110 when it is laid on the inner/outer surface of the main body 110 The strength and the connection strength between the upper tube and the lower tube can maintain the preset shape of the elastic curve segment, thereby maintaining the shape of the main body 110. The coating 120 makes the inner cavity of the cylinder smooth, prevents the proliferation of interatrial septal tissue from clogging the cylinder cavity, and keeps the cylinder cavity smooth. The material of the coating 120 can be polymer material or biological material, and is not limited to polyester, polytetrafluoroethylene, animal pericardium, etc. A coating can be provided on the surface of the coating 120 to improve surface smoothness and improve long-term patency. In some optional embodiments, the coating 120 can also be disposed on the outer surface of the main body 110 . In other optional embodiments, a layer of coating 120 may be provided on both the inner surface and the outer surface of the main body 110 . Another beneficial effect of the coating 120 is to produce an insulation effect, which can isolate the main body 110 and the wireless sensor 200 to a certain extent to avoid signal interference. The covering film 120 and the main body 110 may be connected by heat pressing or sewing. In order to distinguish the coating 120 and the main body 110 more clearly in the figure, the thickness of the coating 120 is deliberately enlarged and the coating 120 is shown on the inner surface of the main body 110. The actual thickness is smaller than the illustrated size.
本领域的技术人员可以理解,虽然在本实施例中,上述支架100与无线传感器200通过连接件300相连接,但在其他实施例中,上述支架100也可以作为一个独立的分流器使用。Those skilled in the art can understand that although in this embodiment, the above-mentioned bracket 100 and the wireless sensor 200 are connected through the connector 300, in other embodiments, the above-mentioned bracket 100 can also be used as an independent shunt.
本实施例中,接合段包括第一接合段和第二接合段,分别与两个弹性曲线段的各自的一部分一体成型,换句话说,第一接合段由弹性曲线段的一部分自然延伸形成,第二接合段由另一个弹性曲线段的一部分自然延伸形成。请结合图3及图4,在主体110的中部,下段筒的弹性曲线段的初始段(上方)形成第一接合段114,上段筒的弹性曲线段的末端段(下方)形成第二接合段115。In this embodiment, the joint section includes a first joint section and a second joint section, which are integrally formed with respective parts of the two elastic curve sections. In other words, the first joint section is formed by a natural extension of a part of the elastic curve section. The second joint section is formed by a natural extension of a part of another elastic curve section. Please refer to Figures 3 and 4. In the middle of the main body 110, the initial section (upper) of the elastic curve section of the lower tube forms the first joint section 114, and the end section (lower) of the elastic curve section of the upper tube forms the second joint section. 115.
请参考图2,无线传感器200包括检测元件210和无线信号传输元件220。检测元件210可以为压力检测元件,可以测量例如血流的压力。检测元件210设置在无线传感器200的一端,用于监测左心房的压力。无线信号传输元件220用于将检测元件210收集的信号通过电磁波的形式传输至人体外。检测元件210和无线信号传输元件220被密封结构封装为一体。在其他实施例中,两个检测元件210还可以设置在无线传感器200的两个端部,从而检测左心房和右心房的压力,无线信号传输元件220设置于两个检测元件210之间。Referring to FIG. 2 , the wireless sensor 200 includes a detection element 210 and a wireless signal transmission element 220 . The detection element 210 may be a pressure detection element that can measure, for example, the pressure of blood flow. The detection element 210 is disposed at one end of the wireless sensor 200 for monitoring the pressure of the left atrium. The wireless signal transmission element 220 is used to transmit the signals collected by the detection element 210 to the outside of the human body in the form of electromagnetic waves. The detection element 210 and the wireless signal transmission element 220 are integrated by a sealing structure. In other embodiments, two detection elements 210 can also be disposed at both ends of the wireless sensor 200 to detect the pressure of the left atrium and the right atrium, and the wireless signal transmission element 220 is disposed between the two detection elements 210 .
请参考图3及图4,本实施例中,连接件300为环形套件,环形套件的局部段略向外凸出形成第二连接部320,除第二连接部320的其他部分为第一连接部310。第二连接部320向外凸出的形态,可以是在连接件300将支架100和无线传感器200连接后被二者牵拉形成,也可以是在制造时设置的永久性的凸起。第一连接部310绕设于无线传感器200的中部。第二连接部320整体为薄片结构,包括一个片材部321。片材部321大致呈矩形。片材部321具有两个平行的边缘,即与环形套件的轴线垂直的上边缘和下边缘。上边缘和与其相邻的至少部分区域形成一个边缘部分322,下边缘和与其相邻的至少部分区域形成另一个边缘部分322。两个边缘部分322用于被第一接合段114和第二接合段115夹持,即,两个边缘部分322形成被夹持部323。Please refer to Figures 3 and 4. In this embodiment, the connecting member 300 is an annular set. A partial section of the annular set slightly protrudes outward to form a second connecting part 320. The other parts except the second connecting part 320 are first connections. Department 310. The outward protruding shape of the second connecting portion 320 may be formed by pulling the bracket 100 and the wireless sensor 200 after the connector 300 connects the bracket 100 and the wireless sensor 200, or may be a permanent protrusion provided during manufacturing. The first connection part 310 is arranged around the middle part of the wireless sensor 200 . The second connecting part 320 is a sheet structure as a whole, including a sheet part 321 . The sheet portion 321 has a substantially rectangular shape. The sheet portion 321 has two parallel edges, an upper edge and a lower edge perpendicular to the axis of the annular sleeve. The upper edge and at least part of the area adjacent thereto form one edge part 322 , and the lower edge and at least part of the area adjacent thereto form another edge part 322 . The two edge portions 322 are used to be clamped by the first engaging section 114 and the second engaging section 115 , that is, the two edge portions 322 form a clamped portion 323 .
本实施中环形套件的宽度(轴向方向的尺寸)较小,而第一接合段114和第二接合段115长度较大,因此第一接合段114和第二接合段115各自都会夹持两个边缘部分322,即,第一接合段114和第二接合段115夹持了片材部321的整个轴向方向的区域。在一些可选实施例中,片材部321的轴向尺寸较大,并且/或者,第一接合段114和/或第二接合段115的长度较小,第一接合段114可以仅夹持下边缘对应的边缘部分322,而第二接合段115仅夹持上边缘对应的边缘部分322。相对于连接件整体尺寸而言,第二连接部320凸出的高度很小。在一些可选实施例中,第一连接部也可以是一个完整的筒状结构,第二连接部320可视为贴合第一连接部310的外轮廓设置,使得第二连接部320和第一连接部310在径向的尺寸不会显著增大。此处所称的贴合,可以是两个相邻表面彼此接触(但可以被外力分开,如被接合段插入而分开),也可以是两个相邻表面具有很小的距离,从而可供第一接合段插入。In this implementation, the width (dimension in the axial direction) of the annular set is small, and the length of the first joint section 114 and the second joint section 115 is large, so the first joint section 114 and the second joint section 115 each clamp two The two edge portions 322 , that is, the first joint section 114 and the second joint section 115 sandwich the entire axial direction area of the sheet portion 321 . In some optional embodiments, the axial dimension of the sheet portion 321 is larger, and/or the length of the first joint section 114 and/or the second joint section 115 is smaller, and the first joint section 114 can only clamp The lower edge corresponds to the edge portion 322 , while the second joint section 115 only clamps the upper edge corresponding to the edge portion 322 . Relative to the overall size of the connector, the protruding height of the second connecting portion 320 is very small. In some optional embodiments, the first connecting part can also be a complete cylindrical structure, and the second connecting part 320 can be regarded as being arranged to fit the outer contour of the first connecting part 310, so that the second connecting part 320 and the The size of a connecting portion 310 in the radial direction does not increase significantly. The so-called "fitting" here can be that two adjacent surfaces are in contact with each other (but can be separated by external forces, such as being separated by the insertion of a joint segment), or that the two adjacent surfaces have a small distance so that they can be used for the third time. A joint segment is inserted.
通过上述连接方式,连接件300的第二连接部320被夹持在第一接合段114、第二接合段115与覆膜120之间,相当于将第二连接部320压在主体110表面;支架100与无线传感器200平行且外切地连接在一起。并且,第一接合段114和第二接合段115也被夹持在无线传感器200与第二连接部320之间。这样的连接简单可靠,便于分流器这种微小部件的装配连接。且第一接合段114与第二接合段115的自由端的指向方向相反,还能防止第二连接部320沿轴向脱落。支架100表面的接合段夹持无线传感器200表面的片材结构的连接方式,连接结构在径向上的尺寸很小,因此可以允许无线传感器200与支架100紧密连接,不会造成植入物整体的径向尺寸过大。Through the above connection method, the second connecting part 320 of the connecting piece 300 is clamped between the first joining section 114, the second joining section 115 and the covering film 120, which is equivalent to pressing the second connecting part 320 against the surface of the main body 110; The bracket 100 and the wireless sensor 200 are connected together in parallel and circumferentially. Moreover, the first joint section 114 and the second joint section 115 are also clamped between the wireless sensor 200 and the second connection part 320 . Such a connection is simple and reliable, and facilitates the assembly and connection of tiny components such as the shunt. Moreover, the free ends of the first joint section 114 and the second joint section 115 point in opposite directions, which can also prevent the second connecting part 320 from falling off in the axial direction. The joint section on the surface of the stent 100 clamps the sheet structure on the surface of the wireless sensor 200. The size of the connection structure in the radial direction is very small, which allows the wireless sensor 200 to be tightly connected to the stent 100 without causing damage to the overall implant. Radial dimensions are too large.
连接件300的形状并不局限于前述实施例中描写的结构,只要第一连接部310能够固定连接无线传感器200、第二连接部320贴合第一连接部310表面设置且能够被主体110的接合段夹持即可。因此,第一连接部310还可以为带有开口的环状结构,其可以箍住无线传感器200;或者是与无线传感器200形状适配的封闭或不封闭的盒状结构,其可以容纳无线传感器200;或者是用于与无线传感器200的被连接的部分相适配的结构,如具有卡扣、螺纹或粘接面等结构(当然,无线传感器本身需设置相对应的卡槽、螺纹或粘接面等配合结构);而第二连接部320则可以是能够被接合段夹持的拱形结构或悬臂结构等。The shape of the connector 300 is not limited to the structure described in the previous embodiments, as long as the first connector 310 can be fixedly connected to the wireless sensor 200 and the second connector 320 is disposed close to the surface of the first connector 310 and can be connected by the main body 110 . Just clamp the joint section. Therefore, the first connecting part 310 can also be a ring-shaped structure with an opening, which can hoop the wireless sensor 200; or a closed or unclosed box-shaped structure that is adapted to the shape of the wireless sensor 200, which can accommodate the wireless sensor. 200; or a structure adapted to the connected part of the wireless sensor 200, such as a buckle, thread or adhesive surface (of course, the wireless sensor itself needs to be provided with a corresponding slot, thread or adhesive). mating structures such as joints); and the second connecting portion 320 can be an arch structure or a cantilever structure that can be clamped by the joint section.
较佳地,连接件300为套管,其一部分为第一连接部,另一部分为第二连接部。当连接件300与无线信号传输元件220在轴向上至少部分重叠时,连接件300为非金属套管,所述非金属套管的横截面为封闭结构(例如,O形结构)或不封闭结构(例如C形结构),如此,可以避免连接件300本身对信号传输造成影响;或者所述环形套件为金属套管,所述金属套管的横截面为非封闭结构,同样可以避免连接件300本身对信号传输造成影响;当连接件300与无线信号传输元件220在轴向上完全不重叠时,则对此连接件300的材料不做限制。Preferably, the connecting member 300 is a sleeve, one part of which is the first connecting part and the other part is the second connecting part. When the connecting member 300 and the wireless signal transmission element 220 at least partially overlap in the axial direction, the connecting member 300 is a non-metallic sleeve, and the cross-section of the non-metallic sleeve is a closed structure (for example, an O-shaped structure) or not closed structure (such as a C-shaped structure), in this way, the impact of the connector 300 itself on signal transmission can be avoided; or the annular set is a metal sleeve, and the cross-section of the metal sleeve is a non-closed structure, which can also avoid the connector 300 300 itself affects signal transmission; when the connector 300 and the wireless signal transmission element 220 do not overlap at all in the axial direction, the material of the connector 300 is not limited.
参考图11,其中示出了安装至目标部位时的植入物。目标部位m1为连通左心房和右心房的孔。植入物整体插入孔中,并通过第一夹持臂112和第二夹持臂113夹持在房间隔组织上以防止植入物沿轴向脱出目标部位m1。检测元件210位于左心房中,能够检测左心房的血液压力。左心房收缩时,其中的血流除了进入左心室中,还会有一部分通过支架100的管腔进入右心房。无线传感器200并排设置在支架100的外部,因此无线传感器200不会对支架100的管腔内或两端的血流产生阻碍;而支架100没有包围无线传感器200,因此不会阻碍无线信号传输,无线传感器200能同支架100一起并排地安装在房间隔孔中,不会像传统的轴向串联方式那样过多占用心房空间。连接件300通过与支架100的接合段紧密连接,使得支架100和无线传感器200紧密地抵靠彼此,既能增强二者的连接强度,也可以减小二者的径向尺寸,有利于经血管介入植入的操作。Referring to Figure 11, the implant is shown when installed at the target site. The target site m1 is the hole connecting the left atrium and the right atrium. The implant is inserted into the hole as a whole, and is clamped on the interatrial septal tissue by the first clamping arm 112 and the second clamping arm 113 to prevent the implant from axially protruding from the target site m1. The detection element 210 is located in the left atrium and can detect the blood pressure of the left atrium. When the left atrium contracts, in addition to entering the left ventricle, part of the blood flow will also enter the right atrium through the lumen of the stent 100 . The wireless sensors 200 are arranged side by side outside the stent 100, so the wireless sensors 200 will not hinder the blood flow in the lumen of the stent 100 or at both ends; and the stent 100 does not surround the wireless sensors 200, so it will not hinder wireless signal transmission. The sensor 200 can be installed side by side in the atrial septal hole together with the stent 100, and will not occupy too much atrial space like the traditional axial series connection method. The connector 300 is tightly connected to the joint section of the stent 100, so that the stent 100 and the wireless sensor 200 are closely abutted against each other, which can not only enhance the connection strength of the two, but also reduce the radial size of the two, which is beneficial to the transvasculature. Interventional implantation procedures.
参考图6和图7。图7为根据前述实施例的植入物位于输送管中时的压缩状态示意图。图8为图7中输送管和植入物的横截面示意图。植入物的支架100由弹性曲线段101形成,因此其整体可以在外力压缩下变形并在撤去外力后恢复原来的形状。植入物与用于介入手术的输送管形成植入物系统。Refer to Figures 6 and 7. Figure 7 is a schematic diagram of the compressed state of the implant according to the previous embodiment when it is located in the delivery tube. Figure 8 is a schematic cross-sectional view of the delivery tube and implant of Figure 7. The stent 100 of the implant is formed by an elastic curve segment 101, so that the entire frame 100 can be deformed under external compression and return to its original shape after the external force is removed. The implant and the delivery tube used for interventional procedures form an implant system.
植入物中,弹性曲线段形成支架100的主体,使得支架100整体具有弹性。沿无线传感器200与支架100的中心连线方向将无线传感器200向支架100施加压力时,支架100可以被压缩,即支架100在限制空间内被沿第一径向方向可回弹地变形(在施力方向上的径向尺寸减小,垂直于施力方向的径向尺寸变大,此处的“第一径向方向”是指与施力方向一致的径向方向),无线传感器200可以部分嵌入支架100的凹陷区域。外力消失后支架100将恢复原形且恢复与无线传感器200的位置关系。在将植入物放入输送管400的过程中,输送管400的管壁对支架100和无线传感器200在沿无线传感器200与支架100的中心连线方向及垂直于该方向的方向均产生压力,使得支架100被沿第一径向方向压缩成横截面呈C形的状态,而无线传感器200则部分嵌入支架100的凹陷部分。并且,第一夹持臂112和第二夹持臂113被沿纵截面压倒以靠拢至支架100的表面,即第一夹持臂112和第二夹持臂113的自由端各自向支架100的两端的延伸方向靠拢。放入输送管400后的植入物,径向整体尺寸被压缩;因其压缩变形的形式是筒体被压扁,筒体的周长不变。而非通过轴向拉长来实现径向尺寸减小,使得植入物轴向尺寸没有明显变化。较短长度的植入物,更有利于输送管400的弯曲,有利于植入过程的便利性。In the implant, the elastic curve segment forms the main body of the stent 100, making the entire stent 100 elastic. When the wireless sensor 200 applies pressure to the bracket 100 along the center line connecting the wireless sensor 200 and the bracket 100, the bracket 100 can be compressed, that is, the bracket 100 is resiliently deformed along the first radial direction in the restricted space (in The radial size in the direction of force application decreases, and the radial size perpendicular to the direction of force application increases. The "first radial direction" here refers to the radial direction consistent with the direction of force application). The wireless sensor 200 can Partially embedded in the recessed area of the bracket 100 . After the external force disappears, the bracket 100 will return to its original shape and the positional relationship with the wireless sensor 200 will be restored. During the process of placing the implant into the delivery tube 400, the wall of the delivery tube 400 exerts pressure on the stent 100 and the wireless sensor 200 in both the direction along the center line connecting the wireless sensor 200 and the stent 100 and in the direction perpendicular to this direction. , so that the bracket 100 is compressed along the first radial direction into a C-shaped cross-section, and the wireless sensor 200 is partially embedded in the recessed portion of the bracket 100 . Moreover, the first clamping arm 112 and the second clamping arm 113 are pressed along the longitudinal section to be close to the surface of the bracket 100 , that is, the free ends of the first clamping arm 112 and the second clamping arm 113 are each directed toward the surface of the bracket 100 The extension directions of both ends are close together. After the implant is placed in the delivery tube 400, the overall radial size is compressed; because of the compression deformation, the cylinder is flattened and the circumference of the cylinder remains unchanged. Rather than achieving radial size reduction through axial elongation, the axial size of the implant does not change significantly. An implant with a shorter length is more conducive to the bending of the delivery tube 400 and is beneficial to the convenience of the implantation process.
一并参考图8至图10,其中示出了经介入导管将分流器植入目标部位的手术过程。图8是含有植入物的输送管400到达目标部位m1时的示意图。图9是植入物从输送管400中伸出一端和第一夹持臂112时示意图。图10是回撤输送管400使植入物的第一夹持臂112到达心房间隔m2的表面时的示意图。图11是撤去输送管400使植入物安装至目标部位m1时的示意图。Referring to FIGS. 8 to 10 together, the surgical process of implanting a shunt into a target site via an interventional catheter is shown. FIG. 8 is a schematic diagram of the delivery tube 400 containing the implant reaching the target site m1. FIG. 9 is a schematic diagram of the implant extending out from the delivery tube 400 and the first clamping arm 112 . Figure 10 is a schematic view of the delivery tube 400 being withdrawn so that the first clamping arm 112 of the implant reaches the surface of the interventricular septum m2. FIG. 11 is a schematic diagram when the delivery tube 400 is removed and the implant is installed in the target site m1.
含有植入物的输送管400的一端经人体较粗的血管进入右心房,并通过心房间隔m2的孔进入左心房。在该位置,通过回撤输送管或将植入物向外推出的方式使植入物的一端从输送管400末端伸出,并使第一夹持臂112展开为悬臂状态。第一夹持臂112展开后,植入物径向的整体尺寸大于心房间隔m2上的孔的直径。再回撤输送管,植入物随导管移动,直至第一夹持臂112与心房间隔m2接触。再继续回撤输送管400,由于心房间隔m2的阻挡,植入物将保持在该位置而不随输送管400回撤。植入物完全脱离输送管400后,第二夹持臂113也会展开,第二夹持臂113和第一夹持臂112将支架100和无线传感器200保持在心房间隔m2的孔中。且支架100沿径向恢复原形状,其管腔可供左心房的血流进入右心房。支架100就位后,无线传感器200的检测元件210可以实时监测左心房的血压并通过无线信号传输元件220将相关信息传输至外部接收设备。One end of the delivery tube 400 containing the implant enters the right atrium through a thick blood vessel of the human body, and enters the left atrium through the hole of the interatrial septum m2. In this position, one end of the implant is extended from the end of the delivery tube 400 by retracting the delivery tube or pushing the implant outward, and the first clamping arm 112 is deployed into a cantilevered state. After the first clamping arm 112 is deployed, the overall radial size of the implant is larger than the diameter of the hole in the interatrial septum m2. The delivery tube is then withdrawn, and the implant moves with the catheter until the first clamping arm 112 contacts the interatrial septum m2. If the delivery tube 400 continues to be withdrawn, due to the obstruction of the interatrial septum m2, the implant will remain in this position without retreating with the delivery tube 400. After the implant is completely separated from the delivery tube 400, the second clamping arm 113 will also be deployed, and the second clamping arm 113 and the first clamping arm 112 will retain the stent 100 and the wireless sensor 200 in the hole of the interatrial septum m2. And the stent 100 returns to its original shape along the radial direction, and its lumen allows blood flow from the left atrium to enter the right atrium. After the stent 100 is in place, the detection element 210 of the wireless sensor 200 can monitor the blood pressure of the left atrium in real time and transmit the relevant information to an external receiving device through the wireless signal transmission element 220 .
参考图12至图15。图12是根据本公开另一个实施例的植入物的结构示意图。图13是图12中植入物另一角度的视图。图14是图12中连接件与接合段的连接结构放大视图。图15是图12中植入物的主体的结构示意图。本实施例中的植入物与前述实施例中的植入物结构基本相同,如第一夹持臂112a、第二夹持臂113a和覆膜与第一夹持臂112、第二夹持臂113和覆膜120的构造相同,二者主要区别在于连接件的结构和对应的主体上的接合段的结构。为了便于说明连接件的结构,本实施例的示意图中隐去了传感器。Refer to Figures 12 to 15. Figure 12 is a schematic structural diagram of an implant according to another embodiment of the present disclosure. Figure 13 is a view of the implant of Figure 12 from another angle. Figure 14 is an enlarged view of the connection structure of the connecting piece and the joint section in Figure 12. Fig. 15 is a schematic structural diagram of the main body of the implant in Fig. 12. The structure of the implant in this embodiment is basically the same as that in the previous embodiment, such as the first clamping arm 112a, the second clamping arm 113a and the covering film The arm 113 and the covering film 120 have the same structure, and the main difference between them lies in the structure of the connecting piece and the structure of the corresponding joint section on the main body. In order to facilitate the explanation of the structure of the connector, the sensor is hidden in the schematic diagram of this embodiment.
本实施例中,弹性曲线段101a在周向和轴向延伸形成支架100a的主体,且弹性曲线段整体为波浪状弯曲,包括多个波浪段102a。其中,支架100a中部的一处波浪段102a的波谷部114a形成第一接合段,支架100a中部的另一处波浪段102a的波峰部115a形成第二接合段。波谷部114a和波峰部115a在轴向和周向所夹持的面积更大,其强度和夹持力更大,能形成更稳固的连接。In this embodiment, the elastic curve segment 101a extends in the circumferential direction and the axial direction to form the main body of the stent 100a, and the elastic curve segment is curved in a wavy shape as a whole, including a plurality of wavy segments 102a. Among them, the trough part 114a of one wavy section 102a in the middle of the bracket 100a forms a first joint section, and the crest part 115a of another wavy section 102a in the middle of the bracket 100a forms a second joint section. The trough portion 114a and the crest portion 115a clamp a larger area in the axial and circumferential directions, have greater strength and clamping force, and can form a more stable connection.
连接件300a为两端贯通的环形套件。本实施例中的环形套件的宽度(轴向尺寸)大于图2所示实施例中环形套件的宽度。环形套件包括两部分,一部分为截面呈半开放的三分之二圆环的套体,其形成第一连接部310a;另一部分为截面呈半开放的、大致矩形的套体,其形成第二连接部320a。当然,在其他实施方式中,也可以在二者交界处设置隔膜,将套体内分为两个腔。第一连接部310a围绕无线传感器设置。第二连接部320a用于供第一接合段114a(波谷部)和第二接合段115a(波峰部)夹持。第二连接部320a大致为矩形的薄膜片,其被第一接合段114a(波谷部)和第二接合段115a(波峰部)压在主体100a的表面。第二连接部320a也可以进一步与覆膜120a之间粘接或缝合以加强连接强度。The connecting piece 300a is a ring-shaped set with both ends penetrating. The width (axial dimension) of the annular sleeve in this embodiment is greater than the width of the annular sleeve in the embodiment shown in FIG. 2 . The annular sleeve includes two parts, one part is a sleeve body with a semi-open cross-section of two-thirds of a ring, which forms the first connecting part 310a; the other part is a semi-open, approximately rectangular sleeve body with a semi-open cross-section, which forms the second connecting part 310a. Connection part 320a. Of course, in other embodiments, a diaphragm may also be provided at the junction between the two to divide the sleeve body into two cavities. The first connection part 310a is provided around the wireless sensor. The second connecting portion 320a is used for clamping the first joint section 114a (trough portion) and the second joint section 115a (crest portion). The second connecting portion 320a is generally a rectangular film piece, which is pressed against the surface of the main body 100a by the first joining section 114a (trough portion) and the second joining section 115a (crest portion). The second connecting portion 320a can also be further bonded or sewn to the covering film 120a to enhance the connection strength.
参考图16,图16是根据本公开另一实施例的植入物中连接件300b与接合段114b的结构示意图。为了更清楚地表达连接件与接合段的连接关系,本实施例中仅示出了传感器200b、连接件300b和支架中的部分弹性曲线段结构,省略了其他结构。连接件300b为环形套件,由高分子材料形成。环形套件的一部分的上边缘和下边缘及其二者间的区域形成被夹持部,在本实施例中被夹持部即第二连接部。环形套件的另一部分为第一连接部,其围绕传感器200b的中部被固定。支架中的接合段114b为弹性曲线段弯折形成的倒V形结构,其从第二连接部的下边缘处插入第二连接部与传感器200b之间。接合段114b的长度大于连接件300b的轴向尺寸,因此接合段114b的一端从连接件300b与传感器200b之间延伸出。Referring to FIG. 16, FIG. 16 is a schematic structural diagram of the connecting member 300b and the joint section 114b in the implant according to another embodiment of the present disclosure. In order to express the connection relationship between the connecting piece and the joint section more clearly, this embodiment only shows part of the elastic curve segment structure in the sensor 200b, the connecting piece 300b and the bracket, and other structures are omitted. The connecting piece 300b is a ring-shaped set and is made of polymer material. The upper edge and lower edge of a part of the annular set and the area therebetween form a clamped portion, which in this embodiment is the second connecting portion. The other part of the annular sleeve is the first connection part, which is fixed around the middle of the sensor 200b. The joint section 114b in the bracket is an inverted V-shaped structure formed by bending an elastic curve section, and is inserted between the second connecting part and the sensor 200b from the lower edge of the second connecting part. The length of the engaging section 114b is greater than the axial dimension of the connecting piece 300b, so one end of the engaging section 114b extends from between the connecting piece 300b and the sensor 200b.
参考图17,图17中示出的传感器200b、连接件300b和接合段114b的结构与图16中所示结构基本相同,不同之处在于,接合段114b的顶端和两个基端通过缝合结构600缝合在分流器支架的覆膜上(图未示)。Referring to Figure 17, the structures of the sensor 200b, the connector 300b and the joint section 114b shown in Figure 17 are basically the same as those shown in Figure 16, except that the top end and the two base ends of the joint section 114b pass through a suture structure. 600 is sutured on the covering of the shunt stent (not shown).
参考图18,图18是根据本公开另一实施例的植入物中连接件与接合段的结构示意图。本实施例中,传感器200c由连接件300c箍住,连接件300c与第一接合段114c和第二接合段115c相连接。具体地,连接件300c的第二连接部上设置有两个缝状的开口324c,两个开口324c平行于连接件300c的边缘且在轴向上有预定距离。第一接合段114c为波谷部,第二接合段115c为波峰部,两者相对设置。第一接合段114c和第二接合段115c从两个开口324c插入至连接件300c与传感器200c之间。两个开口324c的各自的边缘与二者之间的区域为被夹持部。Referring to FIG. 18 , FIG. 18 is a schematic structural diagram of a connector and a joint section in an implant according to another embodiment of the present disclosure. In this embodiment, the sensor 200c is clamped by the connecting piece 300c, and the connecting piece 300c is connected to the first joint section 114c and the second joint section 115c. Specifically, two slit-shaped openings 324c are provided on the second connecting portion of the connecting piece 300c. The two openings 324c are parallel to the edge of the connecting piece 300c and have a predetermined distance in the axial direction. The first joint section 114c is a trough part, and the second joint section 115c is a crest part, and they are arranged oppositely. The first engaging section 114c and the second engaging section 115c are inserted between the connecting piece 300c and the sensor 200c from the two openings 324c. The respective edges of the two openings 324c and the area between them are the clamped parts.
参考图19,图19是根据本公开另一实施例的植入物中连接件与接合段的结构示意图。本实施例中的传感器200d及连接件300d与图17中所示的相应结构相同,区别在于,第一接合段114d和第二接合段115d不同。本实施例中的第一接合段114d和第二接合段115d与图3所示的接合段结构类似,但不同于单杆的接合段,在本实施例中,通过使得弹性曲线段在波浪段处断开,弹性曲线段的末端在其长度方向上延伸并回折而形成U形的接合段。并且两个末端回折形成的第一接合段114d和第二接合段114d在长度方向上重合、在径向方向上嵌入彼此。具体的制作过程,可以是两根金属丝各自弯折后嵌合在一起,也可以是同一根金属丝在绕制过程中设置一部分迂回段,将迂回段中部剪断或剪去一段,使迂回段形成两个带有U形结构的接合段。Referring to FIG. 19 , FIG. 19 is a schematic structural diagram of a connector and a joint section in an implant according to another embodiment of the present disclosure. The sensor 200d and the connecting piece 300d in this embodiment are the same as the corresponding structures shown in Figure 17, except that the first joint section 114d and the second joint section 115d are different. The first joint section 114d and the second joint section 115d in this embodiment are similar in structure to the joint section shown in Figure 3, but different from the joint section of a single rod. In this embodiment, by making the elastic curve section in the wave section The end of the elastic curve segment extends in the length direction and is folded back to form a U-shaped joint segment. And the first joint section 114d and the second joint section 114d formed by the two ends being folded overlap in the length direction and are embedded in each other in the radial direction. The specific manufacturing process can be that two metal wires are bent separately and then fitted together, or the same metal wire can be provided with a roundabout section during the winding process, and the middle of the roundabout section can be cut or a section is cut off to make the roundabout section Two joint sections with a U-shaped structure are formed.
参考图20,图20是一种可选实施方式中连接件300d与接合段的结构示意图。图20中所示的连接方式与图19中所示的连接方式类似,不同之处在于,第一接合段114d和第二接合段115d不是从连接件300d的边缘插入至连接件300d与传感器200d之间,而是从设置在连接件300d的两个开口324d中插入其中。两个开口324d均为矩形,二者在轴向具有预定距离。图19所示的连接方式中,位于连接件300d下方的第一接合段114d和第二接合段115d不能与支架上的覆膜连接,因此支架在该处的强度会较弱。而通过在连接件300d上设置开口324d,可以减少第一接合段114d和第二接合段114d被连接件300d覆盖的长度,从而使接合段具有更多的区域可以与覆膜连接,避免支架在该处的强度显著减弱。并且,由于第一接合段114d和第二接合段114d为U形的弯折结构,其有更大的面积去夹持连接件300d,与连接件之间的连接强度也可以进一步提高。在一些可选实施方式中,第一接合段114d和第二接合段114d与连接件300d之间还可以进一步设置粘胶连接。Referring to Figure 20, Figure 20 is a schematic structural diagram of the connecting piece 300d and the joint section in an optional embodiment. The connection method shown in Figure 20 is similar to the connection method shown in Figure 19, except that the first engaging section 114d and the second engaging section 115d are not inserted from the edge of the connecting piece 300d into the connecting piece 300d and the sensor 200d. between the two openings 324d provided in the connecting member 300d. Both openings 324d are rectangular and have a predetermined distance in the axial direction. In the connection method shown in Figure 19, the first joint section 114d and the second joint section 115d located below the connector 300d cannot be connected to the covering film on the bracket, so the strength of the bracket there will be weak. By arranging the opening 324d on the connecting piece 300d, the length of the first joining section 114d and the second joining section 114d covered by the connecting piece 300d can be reduced, so that the joining section has more area to be connected to the coating, and the stent is prevented from being The intensity there is significantly reduced. Moreover, since the first joint section 114d and the second joint section 114d are U-shaped bent structures, they have a larger area to clamp the connector 300d, and the connection strength with the connector can be further improved. In some optional embodiments, an adhesive connection may be further provided between the first joint section 114d, the second joint section 114d and the connecting piece 300d.
参考图21,其示出了一种可选实施方式中连接件30的结构示意图。连接件30包括第一连接部31和第二连接部32。本实施例中连接件30的结构与图2中所示连接件300的结构基本一致,不同之处在于,其轴向尺寸更大,这样能完全在轴向上包围无线传感器。这种设置可以使植入物表面整体较为光滑,减少孔或缝隙,减少血栓形成的几率。较佳地,连接件30为高分子材料制成,不仅可以防止其本身对信号传输造成的影响,还可以对无线传感器起到防护作用,避免在输送过程中,支架对无线传感器造成损伤。Referring to FIG. 21 , a schematic structural diagram of the connector 30 in an alternative embodiment is shown. The connecting piece 30 includes a first connecting part 31 and a second connecting part 32 . The structure of the connector 30 in this embodiment is basically the same as the structure of the connector 300 shown in FIG. 2 . The difference is that its axial size is larger, so that it can completely surround the wireless sensor in the axial direction. This arrangement can make the overall surface of the implant smoother, reduce holes or gaps, and reduce the chance of thrombosis. Preferably, the connector 30 is made of polymer material, which not only prevents its own influence on signal transmission, but also protects the wireless sensor from being damaged by the bracket during transportation.
为了更好地将无线传感器与支架相连接,上述这些实施例中的连接件都可以由热缩材料制成,在通过接合段与连接件连接后,通过热缩工艺使得接合段被牢固于连接件与无线传感器之间,从而实现无线传感器与支架的稳固连接。在上述这些实施例中,是以接合段与弹性曲线段一体成型为例,但是本领域的技术人员可以理解,在其他变换的实施例中,接合段也可以是与弹性曲线段不同的材质,例如弹性曲线段为金属丝,接合段为硬质塑料管或不锈钢片等等,接合段与弹性曲线段固定连接(例如焊接),也可以实现本发明的发明目的。但是,从加工工艺的便捷性和使用效果上,优选接合段与弹性曲线段一体成型的方式,不仅连接结构简单可靠且紧凑;且弹性曲线段本身为支架的一部分,不需要额外设置其他结构与连接件连接,不会显著增大植入物的径向尺寸,也可以完全避免由额外的接合段与弹性曲线段的连接牢固度或光滑度等产生的安全问题。In order to better connect the wireless sensor to the bracket, the connecting parts in the above embodiments can be made of heat-shrinkable materials. After being connected to the connecting parts through the joint section, the joint section is firmly connected to the connection through a heat-shrinking process. between the component and the wireless sensor, thereby achieving a stable connection between the wireless sensor and the bracket. In the above embodiments, the joint section and the elastic curve section are integrally formed as an example. However, those skilled in the art can understand that in other alternative embodiments, the joint section can also be made of a different material from the elastic curve section. For example, the elastic curve section is a metal wire, the joint section is a hard plastic pipe or a stainless steel sheet, etc., and the joint section and the elastic curve section are fixedly connected (for example, welded), and the object of the present invention can also be achieved. However, from the convenience of the processing technology and the use effect, it is preferred to form the joint section and the elastic curve section in one piece. Not only the connection structure is simple, reliable and compact; the elastic curve section itself is part of the bracket, and there is no need to set up other additional structures and The connector connection will not significantly increase the radial size of the implant, and can completely avoid safety issues caused by the connection firmness or smoothness of the additional joint section and the elastic curve section.
参考图22a至图22e,其中示出了支架的一些可选实施方式。Referring to Figures 22a to 22e, some alternative embodiments of a stent are shown.
图22a是一种可选实施方式中支架的纵剖截面形状示意图。本实施方式中,支架的中部的直径小于两端的直径,形成X形的纵剖面形状。图22b是另一种可选实施方式中支架的纵剖截面形状示意图。本实施方式中,支架的上段呈喇叭状,下段呈直筒状,形成Y形的纵剖面形状。图22c是另一种可选实施方式中支架的纵剖截面形状示意图。本实施方式中,支架的一端直径大于另一端的直径,且在轴向上筒体的直径呈线性变化,形成V形的纵剖面形状。图22d是另一种可选实施方式中支架的纵剖截面形状示意图,在该实施方式中,支架两端的直径与中部的直径不同,且两端的中心与中部的中心不同轴,支架具有K形的纵剖面形状。图22e是另一种可选实施方式中支架的纵剖截面形状示意图,在该实施方式中,支架整体呈Z状。Figure 22a is a schematic diagram of the longitudinal cross-sectional shape of a stent in an optional embodiment. In this embodiment, the diameter of the middle part of the stent is smaller than the diameter of both ends, forming an X-shaped longitudinal cross-section. Figure 22b is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment. In this embodiment, the upper section of the bracket is in the shape of a trumpet, and the lower section is in the shape of a straight tube, forming a Y-shaped longitudinal cross-section. Figure 22c is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment. In this embodiment, the diameter of one end of the stent is larger than the diameter of the other end, and the diameter of the cylinder changes linearly in the axial direction, forming a V-shaped longitudinal cross-section. Figure 22d is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment. In this embodiment, the diameters of the two ends of the stent are different from the diameter of the middle part, and the centers of the two ends are not axial with the centers of the middle part. The stent has K Shape of longitudinal section. Figure 22e is a schematic diagram of the longitudinal cross-sectional shape of the stent in another optional embodiment. In this embodiment, the stent is Z-shaped as a whole.
本公开还提供一种植入物系统。植入物系统包括输送导管和植入物。输送导管用于容纳压缩后的植入物,并将植入物经人工或自然腔室/管道送至目标部位。植入物可以包括支架和无线传感器,支架可以如前述实施例中用于心房分流术的分流器,也可以为封堵器或血管支架。植入物在输送导管内呈压缩状态。具体地,支架被压缩为截面呈C形,被压缩后的支架的外表面至少部分包围传感器,从而减小植入物的直径。在输送导管将植入物送达目标部位时,可以通过内导管将植入物从导管中推出。The present disclosure also provides an implant system. Implant systems include delivery catheters and implants. Delivery catheters are used to accommodate the compressed implant and deliver the implant to the target site through artificial or natural cavities/conduits. The implant may include a stent and a wireless sensor. The stent may be a shunt used for atrial shunting in the aforementioned embodiments, or may be an occluder or a vascular stent. The implant is compressed within the delivery catheter. Specifically, the stent is compressed into a C-shaped cross-section, and the outer surface of the compressed stent at least partially surrounds the sensor, thereby reducing the diameter of the implant. As the delivery catheter delivers the implant to the target site, the implant can be pushed out of the catheter through the inner catheter.
在一些可选实施例中,植入物系统还包括信号接收装置,信号接收装置用于接述植入物中无线传感器的信号,用于供医护人员实时跟踪生物体的生理参数变化情况。In some optional embodiments, the implant system also includes a signal receiving device. The signal receiving device is used to receive signals from wireless sensors in the implant, and is used for medical staff to track changes in physiological parameters of the living body in real time.
以上所述,仅为本公开的具体实施方式,但本公开的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本公开揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本公开的保护范围之内。因此,本公开的保护范围应以所述权利要求的保护范围为准。The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any person familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure. should be covered by the protection scope of this disclosure. Therefore, the protection scope of the present disclosure should be subject to the protection scope of the claims.
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| PCT/CN2024/106290 WO2025021004A1 (en) | 2023-07-21 | 2024-07-19 | Implant and implant system |
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