CN114052991B - Lung volume reduction device and method of use thereof - Google Patents
Lung volume reduction device and method of use thereof Download PDFInfo
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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
- A61F2/2476—Valves implantable in the body not otherwise provided for
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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
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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
- A61F2002/046—Tracheae
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract
本发明属于医疗器械技术领域,具体涉及一种肺减容装置及其使用方法。其中,肺减容装置,包括一支撑结构,可伸缩,具有压握状态和膨胀状态;还包括一单向阀结构,可伸缩,具有压握状态和膨胀状态;单向阀结构与支撑结构连接,单向阀结构的最大外径小于支撑结构的外径,单向阀结构位于支撑机构的外部或内部;单向阀结构包括:一可闭合件,远端与支撑结构连通,近端受到气流冲击时可闭合,以阻止外部气流自近端穿过且允许肺部残余的气流自远端穿过可闭合件。本发明通过支撑结构的径向支撑力将单向阀结构固定在气道中的目标位置上,可闭合件能使得肺气泡中囤积的多余气体排出肺部的同时阻止新的气体进入病患部位,从而达到肺减容手术的目的。
The present invention belongs to the field of medical device technology, and specifically relates to a lung volume reduction device and a method of using the same. The lung volume reduction device includes a support structure that is retractable and has a gripping state and an expanded state; it also includes a one-way valve structure that is retractable and has a gripping state and an expanded state; the one-way valve structure is connected to the support structure, the maximum outer diameter of the one-way valve structure is smaller than the outer diameter of the support structure, and the one-way valve structure is located outside or inside the support structure; the one-way valve structure includes: a closable component, the distal end of which is connected to the support structure, and the proximal end can be closed when impacted by airflow to prevent external airflow from passing through the proximal end and allow residual airflow in the lungs to pass through the closable component from the distal end. The present invention fixes the one-way valve structure at the target position in the airway through the radial support force of the support structure, and the closable component can allow the excess gas accumulated in the alveoli to be discharged from the lungs while preventing new gas from entering the patient's area, thereby achieving the purpose of lung volume reduction surgery.
Description
技术领域Technical Field
本发明属于医疗器械技术领域,具体涉及一种肺减容装置及其使用方法。The present invention belongs to the technical field of medical devices, and in particular relates to a lung volume reduction device and a method of using the same.
背景技术Background technique
肺是人体重要的呼吸器官,也是造血器官,位于胸腔,实现机体与外界环境之间的气体交换,以维持人体的生命活动。The lungs are important respiratory organs and hematopoietic organs in the human body. They are located in the chest cavity and realize gas exchange between the body and the external environment to maintain human life activities.
慢性阻塞性肺疾病(Chronic obstructive pulmonary disease,COPD)是一种以持续性的气流受限为特征的阻塞性肺疾病。其主要特征是呼吸短促、咳嗽和咳痰,常被误认为感冒或气喘,因此超过八成确诊时已经是中重度。COPD是一种进行性疾病,病情会随时间逐渐恶化,最后连走路、穿衣等日常活动都难以进行。疾病具不可逆性,研究显示肺阻塞病人急性发作住院的死亡率为4%,而病人出院后一年的死亡率高达22%。Chronic obstructive pulmonary disease (COPD) is an obstructive lung disease characterized by persistent airflow limitation. Its main features are shortness of breath, cough and sputum, which are often mistaken for colds or asthma, so more than 80% of cases are already moderate to severe when diagnosed. COPD is a progressive disease that gradually worsens over time, and eventually even daily activities such as walking and dressing become difficult to carry out. The disease is irreversible, and studies have shown that the mortality rate of patients with acute pulmonary obstruction in hospital is 4%, while the mortality rate one year after discharge is as high as 22%.
肺减容术(LVRS)作为姑息治疗COPD的一种手段,最早由OttoC.等教授在1959年提出,1990年代中期才开始正式运用于临床。然而由于与体循环血管壁相比,肺气管壁壁更加脆弱,特别是肺动脉,手术中容易发生撕破,甚至产生严重的空气栓塞,并引起其他并发症,如心脏骤停等。因此有必要开辟一种更柔和的肺减容装置及使用方法。Lung volume reduction surgery (LVRS) was first proposed by Professor Otto C. in 1959 as a palliative treatment for COPD, and was officially used in clinical practice in the mid-1990s. However, compared with the walls of systemic blood vessels, the walls of the pulmonary trachea are more fragile, especially the pulmonary artery, which is prone to tearing during surgery, even causing severe air embolism and other complications such as cardiac arrest. Therefore, it is necessary to develop a gentler lung volume reduction device and method of use.
发明内容Summary of the invention
本发明针对现有技术中的肺减容装置不适用于脆弱的肺气管壁壁,容易发生撕破的技术问题,目的在于提供一种肺减容装置及其使用方法。The present invention aims to provide a lung volume reduction device and a method for using the device in view of the technical problem that the lung volume reduction device in the prior art is not suitable for the fragile lung tracheal wall and is easily torn.
一种肺减容装置,包括一支撑结构,可伸缩,具有压握状态和膨胀状态;A lung volume reduction device comprises a support structure, which is retractable and has a compressed and gripped state and an expanded state;
还包括一单向阀结构,可伸缩,具有压握状态和膨胀状态;It also includes a one-way valve structure, which is retractable and has a compressed state and an expanded state;
所述单向阀结构与所述支撑结构连接,所述单向阀结构的最大外径小于所述支撑结构的外径,所述单向阀结构位于所述支撑机构的外部或内部。The one-way valve structure is connected to the supporting structure, the maximum outer diameter of the one-way valve structure is smaller than the outer diameter of the supporting structure, and the one-way valve structure is located outside or inside the supporting structure.
所述单向阀结构包括:The one-way valve structure comprises:
一可闭合件,远端与所述支撑结构连通,近端受到气流冲击时可闭合,以阻止外部气流自近端穿过且允许肺部残余的气流自远端穿过所述可闭合件。A closable component, the distal end of which is in communication with the support structure, and the proximal end of which can be closed when impacted by airflow, so as to prevent external airflow from passing through the proximal end and allow residual airflow in the lungs to pass through the closable component from the distal end.
作为优选方案,所述支撑结构为自膨式支撑结构或球扩式支撑结构。As a preferred solution, the support structure is a self-expanding support structure or a ball-expanding support structure.
作为优选方案,所述可闭合件的近端端面为倾斜面,所述倾斜面与水平面之间的倾斜角度为10°-20°。As a preferred solution, the proximal end surface of the closable component is an inclined surface, and the inclination angle between the inclined surface and the horizontal plane is 10°-20°.
作为优选方案,所述单向阀结构还包括:As a preferred solution, the one-way valve structure further includes:
一导向架,呈镂空的圆柱体结构,内部设置有所述可闭合件,并与所述可闭合件的至少部分固定连接;a guide frame, which is a hollow cylindrical structure, in which the closable component is arranged and is fixedly connected to at least a part of the closable component;
若干连接杆,近端与所述导向架的远端连接,远端与所述支撑结构的近端连接。A plurality of connecting rods, the proximal end of which is connected to the distal end of the guide frame, and the distal end of which is connected to the proximal end of the supporting structure.
作为优选方案,所述导向架与所述支撑结构同轴。As a preferred solution, the guide frame is coaxial with the support structure.
作为优选方案,所述导向架的远端位于所述支撑结构的近端内侧,以充分利用空间,减少轴向长度。As a preferred solution, the distal end of the guide frame is located inside the proximal end of the support structure to fully utilize the space and reduce the axial length.
作为优选方案,所述导向架包括多个导向支架,所述导向支架为倒V字型结构,多个所述导向支架的近端依次圆滑连接围成中空环状结构的所述导向架。As a preferred solution, the guide frame includes a plurality of guide frames, each of which is an inverted V-shaped structure, and the proximal ends of the plurality of guide frames are smoothly connected in sequence to form the guide frame with a hollow ring structure.
作为优选方案,所述肺减容装置还包括:As a preferred embodiment, the lung volume reduction device further comprises:
至少一个输送器连接部,设置于至少一个所述导向支架的近端,轴向长度小于所述导向支架的轴向长度;At least one conveyor connection portion is disposed at the proximal end of at least one of the guide brackets and has an axial length that is smaller than the axial length of the guide bracket;
所述输送器连接部上设置有与外部输送器可拆卸连接的螺纹孔或卡合部。The conveyor connecting portion is provided with a threaded hole or a clamping portion which is detachably connected to an external conveyor.
作为优选方案,所述连接杆倾斜设置,所述连接杆的长度方向与所述导向架的中心轴之间的倾斜夹角为α,75°≥α≥30°,α可以为35°、40°、45°、50°、55°、60°、65°、70°等。As a preferred embodiment, the connecting rod is arranged at an angle, and the inclination angle between the length direction of the connecting rod and the central axis of the guide frame is α, 75°≥α≥30°, α can be 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, etc.
作为优选方案,所述连接杆以所述导向架的中心轴为中心绕周向均匀设置成一圈,多个所述连接杆为中心对称分布。As a preferred solution, the connecting rods are evenly arranged in a circle around the central axis of the guide frame, and a plurality of the connecting rods are symmetrically distributed around the center.
作为优选方案,所述连接杆的数量为2-8根。As a preferred solution, the number of the connecting rods is 2-8.
作为优选方案,所述可闭合件优选为瓣叶结构,所述瓣叶结构包括若干片瓣叶,若干片所述瓣叶依次连接形成外圆周为圆环结构的瓣膜体,所述瓣膜体与所述导向架的内侧壁固定连接,所述瓣膜体的中部可单向开合。As a preferred embodiment, the closable part is preferably a leaflet structure, which includes a plurality of leaflets, which are connected in sequence to form a valve body with an outer circumference of a circular ring structure, and the valve body is fixedly connected to the inner wall of the guide frame, and the middle part of the valve body can be opened and closed in one direction.
作为优选方案,所述瓣叶为采用生物材料和/或高分子材料制成的瓣叶;As a preferred solution, the leaflets are made of biological materials and/or polymer materials;
所述瓣叶厚度为0.1mm-1mm,如0.2mm、0.8mm,优选为0.3-0.6mm,如0.4mm、0.5mm。The thickness of the leaflet is 0.1mm-1mm, such as 0.2mm, 0.8mm, preferably 0.3-0.6mm, such as 0.4mm, 0.5mm.
作为优选方案,所述支撑结构的内径大于所述单向阀结构的最大内径。As a preferred solution, the inner diameter of the support structure is larger than the maximum inner diameter of the one-way valve structure.
作为优选方案,所述支撑结构可以包括:As a preferred solution, the support structure may include:
至少一层多孔结构,具有多个第一支撑体,所述第一支撑体为四边形结构,多个所述第一支撑体依次固定连接围成中空环状的所述多孔结构;At least one layer of porous structure, having a plurality of first supports, wherein the first supports are quadrilateral structures, and the plurality of first supports are sequentially fixedly connected to form the porous structure in a hollow ring shape;
一支撑连接结构,呈中空环状结构,远端与所述多孔结构轴向邻接,近端与所述单向阀结构连接。A supporting connection structure is a hollow annular structure, the distal end of which is axially adjacent to the porous structure, and the proximal end is connected to the one-way valve structure.
作为优选方案,所述第一支撑体为菱形,所述第一支撑体包括:As a preferred solution, the first support body is rhombus-shaped, and the first support body comprises:
一支撑上部,呈倒V字型结构,两条相邻边长相等;A supporting upper part, in the shape of an inverted V, with two adjacent sides of equal length;
一支撑下部,呈V字型结构,远端与所述支撑上部的近端连接,两条相邻边长相等。A support lower part is in a V-shaped structure, the distal end of which is connected to the proximal end of the support upper part, and the two adjacent sides are equal in length.
作为优选方案,所述第一支撑体的远端外侧、所述第一支撑体的远端内侧、所述第一支撑体的近端内侧均为圆弧形或椭圆弧形。As a preferred solution, the distal outer side of the first support body, the distal inner side of the first support body, and the proximal inner side of the first support body are all in the shape of a circular arc or an elliptical arc.
作为优选方案,所述支撑连接结构具有多个第二支撑体,所述第二支撑体为波浪形、V字型、W字型或倒Z字型结构,多个所述第二支撑体依次圆滑连接围成中空环状的所述支撑连接结构。As a preferred embodiment, the supporting connection structure has a plurality of second supporting bodies, which are wavy, V-shaped, W-shaped or inverted Z-shaped structures, and the plurality of second supporting bodies are smoothly connected in sequence to form the supporting connection structure which is in a hollow ring shape.
作为优选方案,相邻两个所述第二支撑体连接处具有间隔段,以避免相邻的两个第二支撑体在压握时被过度压握。As a preferred solution, a spacer is provided at the connection between two adjacent second supporting bodies to prevent the two adjacent second supporting bodies from being over-crimped during crimping.
作为优选方案,所述第二支撑体的近端外侧、所述第二支撑体的近端内侧均为圆弧形或椭圆弧形。As a preferred solution, the outer side of the proximal end of the second support body and the inner side of the proximal end of the second support body are both in the shape of a circular arc or an elliptical arc.
作为优选方案,所述支撑结构还可以包括至少一排支撑端,所述支撑端包括:As a preferred solution, the support structure may further include at least one row of support ends, and the support ends include:
若干支撑框架单元,相互连接,为陀螺形的中空框架单元,具有第一凸起部和第二凸起部,所述第一凸起部沿所述支撑结构的轴向方向朝向远端方向凸出,所述第二凸起部沿所述支撑结构的轴向方向朝向近端方向凸出;A plurality of supporting frame units are interconnected and are gyro-shaped hollow frame units, having a first protrusion and a second protrusion, wherein the first protrusion protrudes toward the distal direction along the axial direction of the supporting structure, and the second protrusion protrudes toward the proximal direction along the axial direction of the supporting structure;
若干支撑连接区域,为相邻的两个所述支撑框架单元相互连接的区域。A plurality of supporting connection areas are areas where two adjacent supporting frame units are connected to each other.
作为优选方案,所述支撑框架单元还具有:As a preferred solution, the support frame unit further comprises:
一第一连接部,位于所述第一凸起部和对应的所述支撑连接区域之间;a first connection portion, located between the first protrusion and the corresponding support connection area;
一第二连接部,位于所述第二凸起部和对应的所述支撑连接区域之间;a second connection portion, located between the second protrusion and the corresponding support connection area;
所述支撑连接区域沿所述支撑结构周向上的宽度大于所述第一连接部和所述第二连接部沿所述支撑结构周向上的宽度的平均值的两倍。The width of the supporting connection area along the circumferential direction of the supporting structure is greater than twice the average value of the widths of the first connecting portion and the second connecting portion along the circumferential direction of the supporting structure.
作为优选方案,所述支撑连接区域沿所述支撑结构轴向上的长度为所述第一连接部和所述第二连接部沿所述支撑结构周向上的宽度的平均值的一倍至三倍。As a preferred solution, the length of the supporting connection area along the axial direction of the supporting structure is one to three times the average value of the widths of the first connecting portion and the second connecting portion along the circumferential direction of the supporting structure.
作为优选方案,相邻两个所述支撑连接区域之间的距离与所述第一凸起部和所述第二凸起部之间的距离的比值为0.8-1。As a preferred solution, the ratio of the distance between two adjacent supporting connection areas to the distance between the first protruding portion and the second protruding portion is 0.8-1.
所述第一凸起部的远端内侧、所述第一凸起部的远端外侧、所述第二凸起部的近端内侧均为圆弧形或椭圆弧形。The distal inner side of the first protrusion, the distal outer side of the first protrusion, and the proximal inner side of the second protrusion are all in the shape of a circular arc or an elliptical arc.
作为优选方案,所述支撑结构可以采用网状的中空环形结构,所述支撑结构中沿周向网格可以为单层或多层,一层的所述网格数量为3-30个,优选为8-16个。As a preferred solution, the support structure may adopt a mesh-like hollow annular structure, and the grids along the circumferential direction in the support structure may be single-layer or multi-layer, and the number of grids in one layer is 3-30, preferably 8-16.
作为优选方案,所述支撑结构是由切割、焊接或编织中的一种或多种方式形成网状的中空环形结构。As a preferred solution, the support structure is a hollow annular structure formed into a mesh by one or more methods of cutting, welding or weaving.
作为优选方案,当所述支撑结构为自膨式支撑结构时,所述支撑结构优选采用自膨胀记忆合金;As a preferred solution, when the support structure is a self-expanding support structure, the support structure preferably uses a self-expanding memory alloy;
当所述支撑结构为球扩式支撑结构时,所述支撑结构优选采用钴铬合金。When the support structure is a ball expansion type support structure, the support structure is preferably made of cobalt-chromium alloy.
作为优选方案,所述支撑结构的壁厚为0.1mm-1mm,如0.8mm、0.9mm,优选为0.2mm-0.6mm,如0.3mm、0.4mm、0.5mm等。As a preferred solution, the wall thickness of the support structure is 0.1 mm-1 mm, such as 0.8 mm, 0.9 mm, preferably 0.2 mm-0.6 mm, such as 0.3 mm, 0.4 mm, 0.5 mm, etc.
作为优选方案,所述支撑结构的直径为5mm-20mm,优选为6mm-15mm,更优先为7mm-10mm;As a preferred solution, the diameter of the support structure is 5 mm-20 mm, preferably 6 mm-15 mm, more preferably 7 mm-10 mm;
所述导向架的直径为1mm-6mm,优选为2mm-5mm,更优选为3mm-4mm;The diameter of the guide frame is 1 mm-6 mm, preferably 2 mm-5 mm, and more preferably 3 mm-4 mm;
所述肺减容装置的总高为6mm-15mm。The total height of the lung volume reduction device is 6 mm-15 mm.
作为优选方案,所述肺减容装置还包括:As a preferred embodiment, the lung volume reduction device further comprises:
一密封膜,位于所述支撑结构内侧,与所述可闭合件为一体结构。A sealing film is located inside the supporting structure and is an integral structure with the closable component.
作为优选方案,所述肺减容装置还包括:As a preferred embodiment, the lung volume reduction device further comprises:
一覆膜,至少位于所述支撑结构的外侧,外侧面上设有药物涂层。A covering film is at least located on the outer side of the supporting structure, and a drug coating is provided on the outer side.
作为优选方案,所述药物涂层为抗炎症药物,具体为地塞米松(DXM)、甲基强的松龙或双磷酸盐脂质体中的至少一种抗炎症药物。As a preferred embodiment, the drug coating is an anti-inflammatory drug, specifically at least one anti-inflammatory drug selected from dexamethasone (DXM), methylprednisolone or bisphosphonate liposomes.
作为优选方案,所述密封膜和所述覆膜的材料均为硅胶、PET、聚氨酯、PTFE或e-PTFE中的一种或多种;As a preferred embodiment, the sealing film and the covering film are made of one or more of silicone, PET, polyurethane, PTFE or e-PTFE;
所述密封膜和所述覆膜的厚度均为0.01mm-1mm。The thickness of the sealing film and the covering film are both 0.01 mm-1 mm.
作为优选方案,所述肺减容装置还包括:As a preferred embodiment, the lung volume reduction device further comprises:
至少一锚定结构,为尖刺形状设置于所述支撑结构的外侧面上。At least one anchoring structure is in the shape of a spike and is arranged on the outer side of the supporting structure.
作为优选方案,所述锚定结构的材料为高分子材料、生物组织或金属中的一种或多种。As a preferred solution, the material of the anchoring structure is one or more of polymer materials, biological tissues or metals.
作为优选方案,所述锚定结构与所述支撑结构一体制成。As a preferred solution, the anchoring structure and the supporting structure are made integrally.
一种肺减容装置的使用方法,采用本发明所述肺减容装置,包括如下步骤:A method for using a lung volume reduction device, using the lung volume reduction device of the present invention, comprises the following steps:
S1,将所述肺减容装置收于输送装置的管腔内,并使所述输送装置通过支气管镜的工作通道至目标位置;S1, placing the lung volume reduction device in the lumen of a delivery device, and passing the delivery device through a working channel of a bronchoscope to a target position;
S2,将所述肺减容装置的支撑结构释放紧贴于支气管管壁;S2, releasing the support structure of the lung volume reduction device to fit closely to the bronchial wall;
S3,将所述肺减容装置的单向阀结构释放;S3, releasing the one-way valve structure of the lung volume reduction device;
S4,撤离输送装置。S4, evacuate the conveying device.
作为优选方案,在步骤S1之前还包括:As a preferred solution, before step S1, the method further includes:
S0,将支气管镜通过气管进入气管内部到达目标位置;S0, insert the bronchoscope through the trachea into the trachea to the target location;
在步骤S4之后还包括:After step S4, the method further includes:
S5,调整所述支气管镜至其余病患位置,重复步骤S1-S4直至所有肺减容装置释放完毕;S5, adjusting the bronchoscope to the position of other patients, and repeating steps S1-S4 until all lung volume reduction devices are released;
S6,从体内撤出支气管镜。S6, withdraw the bronchoscope from the body.
本发明的积极进步效果在于:本发明采用肺减容装置及其使用方法,通过支撑结构的径向支撑力将单向阀结构固定在气道中的目标位置上,通过导向架保护可闭合件发挥效能。可闭合件能使得肺气泡中囤积的多余气体排出肺部的同时阻止新的气体进入病患部位,从而达到肺减容手术的目的。The positive and progressive effect of the present invention is that the present invention adopts a lung volume reduction device and a method of using the same, fixes the one-way valve structure at a target position in the airway through the radial support force of the support structure, and protects the closable component through the guide frame. The closable component can allow the excess gas accumulated in the alveoli to be discharged from the lungs while preventing new gas from entering the affected area, thereby achieving the purpose of lung volume reduction surgery.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为本发明带密封膜和覆膜时的一种整体结构示意图;FIG1 is a schematic diagram of an overall structure of the present invention with a sealing film and a coating;
图2为本发明带密封膜的一种结构示意图;FIG2 is a schematic diagram of a structure with a sealing film according to the present invention;
图3为图2的一侧结构示意图;FIG3 is a schematic diagram of the structure of one side of FIG2 ;
图4为本发明不带密封膜和覆膜时的一种整体结构示意图;FIG4 is a schematic diagram of an overall structure of the present invention without a sealing film and a covering film;
图5为图4的一侧结构示意图;FIG5 is a schematic diagram of the structure of one side of FIG4;
图6为图5的A处放大示意图;FIG6 is an enlarged schematic diagram of point A in FIG5 ;
图7为图4的另一侧结构示意图;FIG7 is a schematic structural diagram of another side of FIG4 ;
图8为图4的俯视图;FIG8 is a top view of FIG4;
图9为本发明密封膜和可闭合件的一种结构示意图;FIG9 is a schematic diagram of a structure of a sealing film and a closable member of the present invention;
图10为本发明的一种应用示意图。FIG. 10 is a schematic diagram of an application of the present invention.
具体实施方式Detailed ways
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体图示进一步阐述本发明。In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further described below with reference to specific illustrations.
参照图1至图9,一种肺减容装置,包括支撑结构100、单向阀结构200、至少一个输送器连接部300、密封膜400、覆膜500和至少一锚定结构。1 to 9 , a lung volume reduction device includes a support structure 100 , a one-way valve structure 200 , at least one conveyor connection portion 300 , a sealing membrane 400 , a covering membrane 500 , and at least one anchoring structure.
支撑结构100为可伸缩,支撑结构100具有压握状态和膨胀状态。支撑结构100的内径大于单向阀结构200的最大内径。支撑结构100用于支撑整个肺减容装置,支撑结构100的外侧壁贴合在肺支气管壁上,支撑结构100部分可根据支气管的大小调节其直径大小,以更好贴合并固定在肺支气管上。The support structure 100 is retractable and has a compressed state and an expanded state. The inner diameter of the support structure 100 is greater than the maximum inner diameter of the one-way valve structure 200. The support structure 100 is used to support the entire lung volume reduction device, and the outer wall of the support structure 100 fits on the wall of the lung bronchus. The diameter of the support structure 100 can be adjusted according to the size of the bronchus to better fit and fix on the lung bronchus.
支撑结构100可以为自膨式支撑结构或球扩式支撑结构。当支撑结构为球扩式支撑结构时,由于支撑结构不具有自膨胀的特点,因此在输送器上还设置有与支撑结构100配合的球囊。初始状态下,支撑结构100套设在球囊上进行压握,当球囊内没有注入介质时,球囊为收缩状态,与支撑结构100一起收束在外部输送装置的管腔内并输送至目标位置。然后向球囊内注入介质,在撑开球囊过程中使支撑结构100逐渐呈膨胀状态,进而实现单向阀结构200呈膨胀状态。球囊内注入的介质可以是生理盐水或者生理盐水和造影剂的混合液体,造影剂的注入,可以通过外部显影设备时时观察支撑结构100的形状,以判断支撑结构100的膨胀效果。当支撑结构100为自膨式支撑结构时,可以不用增设球囊,但是为了更好的支撑,也可以设置球囊以实现支撑结构100更好的呈现膨胀状态的整体形状,以更好的支撑整个肺减容装置。The support structure 100 can be a self-expanding support structure or a ball-expanding support structure. When the support structure is a ball-expanding support structure, since the support structure does not have the characteristic of self-expansion, a balloon that cooperates with the support structure 100 is also provided on the conveyor. In the initial state, the support structure 100 is sleeved on the balloon for compression and gripping. When no medium is injected into the balloon, the balloon is in a contracted state and is gathered together with the support structure 100 in the lumen of the external conveying device and conveyed to the target position. Then, a medium is injected into the balloon, and the support structure 100 is gradually expanded in the process of expanding the balloon, thereby realizing that the one-way valve structure 200 is in an expanded state. The medium injected into the balloon can be saline or a mixed liquid of saline and contrast agent. During the injection of the contrast agent, the shape of the support structure 100 can be observed from time to time by an external developing device to judge the expansion effect of the support structure 100. When the support structure 100 is a self-expanding support structure, there is no need to add a balloon. However, for better support, a balloon can also be provided to enable the support structure 100 to better present the overall shape of the expanded state, so as to better support the entire lung volume reduction device.
当支撑结构100为自膨式支撑结构时,支撑结构100优选采用自膨胀记忆合金,如镍钛、镍钛基、铜基、铁基等形状记忆合金。当支撑结构100为球扩式支撑结构时,支撑结构100优选采用钴铬合金。When the support structure 100 is a self-expanding support structure, the support structure 100 preferably uses a self-expanding memory alloy, such as nickel-titanium, nickel-titanium-based, copper-based, iron-based, etc. When the support structure 100 is a ball-expanding support structure, the support structure 100 preferably uses a cobalt-chromium alloy.
参照图1至图7,支撑结构100可以包括至少一层多孔结构110和支撑连接结构120。1 to 7 , the support structure 100 may include at least one layer of a porous structure 110 and a support connection structure 120 .
多孔结构110具有多个第一支撑体111,如图5和图6中所示,第一支撑体111为四边形结构,多个第一支撑体111依次固定连接围成中空环状的多孔结构110。第一支撑体111优选为菱形,第一支撑体111包括支撑上部1111和支撑下部1112。支撑上部1111呈倒V字型结构,支撑上部1111的两条相邻边长相等,支撑下部1112呈V字型结构,支撑下部1112的远端与支撑上部1111的近端连接,支撑下部1112两条相邻边长相等。第一支撑体111的远端外侧、第一支撑体111的远端内侧、第一支撑体111的近端内侧均为圆弧形或椭圆弧形,该圆弧形或椭圆弧形的弧度为130°-150°,可以是130°、140°或150°。致使在第一支撑体111的的远端内侧和第一支撑体111的的近端内侧的两条相邻边形成外扩部,该外扩部的外扩角度b为10°-30°。The porous structure 110 has a plurality of first supports 111. As shown in FIG. 5 and FIG. 6, the first supports 111 are quadrilateral structures, and the plurality of first supports 111 are sequentially fixedly connected to form a hollow ring-shaped porous structure 110. The first supports 111 are preferably rhombus-shaped, and the first supports 111 include an upper support portion 1111 and a lower support portion 1112. The upper support portion 1111 is an inverted V-shaped structure, and the two adjacent sides of the upper support portion 1111 are equal in length. The lower support portion 1112 is a V-shaped structure, and the distal end of the lower support portion 1112 is connected to the proximal end of the upper support portion 1111, and the two adjacent sides of the lower support portion 1112 are equal in length. The distal outer side of the first support body 111, the distal inner side of the first support body 111, and the proximal inner side of the first support body 111 are all circular arc or elliptical arc, and the arc of the circular arc or elliptical arc is 130°-150°, and can be 130°, 140° or 150°. As a result, two adjacent sides on the distal inner side of the first support body 111 and the proximal inner side of the first support body 111 form an outward expansion portion, and the outward expansion angle b of the outward expansion portion is 10°-30°.
支撑连接结构120呈中空环状结构,支撑连接结构120的远端与多孔结构110轴向邻接,支撑连接结构120的近端与单向阀结构200连接。支撑连接结构120具有多个第二支撑体121,第二支撑体121为波浪形、V字型、W字型或倒Z字型结构,多个第二支撑体121依次圆滑连接围成中空环状的支撑连接结构120。相邻两个第二支撑体121连接处具有间隔段122,以避免相邻的两个第二支撑体121在压握时被过度压握。第二支撑体121的近端外侧、第二支撑体121的近端内侧均为圆弧形或椭圆弧形,该圆弧形或椭圆弧形的形状与第一支撑体111上的相同,致使在第二支撑体121的近端内侧的两条相邻边形成相同的外扩部。The support connection structure 120 is a hollow annular structure, the distal end of the support connection structure 120 is axially adjacent to the porous structure 110, and the proximal end of the support connection structure 120 is connected to the one-way valve structure 200. The support connection structure 120 has a plurality of second support bodies 121, and the second support bodies 121 are wavy, V-shaped, W-shaped or inverted Z-shaped structures. The plurality of second support bodies 121 are smoothly connected in sequence to form a hollow annular support connection structure 120. There is a spacing section 122 at the connection between two adjacent second support bodies 121 to prevent the two adjacent second support bodies 121 from being over-gripped when being gripped. The outer side of the proximal end of the second support body 121 and the inner side of the proximal end of the second support body 121 are both circular arc or elliptical arc, and the shape of the circular arc or elliptical arc is the same as that of the first support body 111, so that the two adjacent sides on the inner side of the proximal end of the second support body 121 form the same outward expansion portion.
参照图1至图7,本发明的支撑结构100优选包括一层多孔结构110和一圈支撑连接结构120。多孔结构110中包括八个菱形的第一支撑体111,支撑连接结构120中包括八个V字型的第二支撑体121,第二支撑体121的远端与第一支撑体111的近端连接,连接处均具有间隔段122。1 to 7 , the support structure 100 of the present invention preferably includes a layer of porous structure 110 and a circle of support connection structure 120. The porous structure 110 includes eight rhombus-shaped first support bodies 111, and the support connection structure 120 includes eight V-shaped second support bodies 121, and the distal ends of the second support bodies 121 are connected to the proximal ends of the first support bodies 111, and the connection portions have spacer segments 122.
支撑结构100还可以包括至少一排支撑端,根据支撑结构100的轴向长度需求,可以设置有多排轴向邻接的支撑端。支撑端包括若干支撑框架单元和若干支撑连接区域。The support structure 100 may further include at least one row of support ends, and multiple rows of axially adjacent support ends may be provided according to the axial length requirements of the support structure 100. The support end includes a plurality of support frame units and a plurality of support connection areas.
若干支撑框架单元相互连接,支撑框架单元为陀螺形的中空框架单元,支撑框架单元具有第一凸起部和第二凸起部,第一凸起部沿支撑结构100的轴向方向朝向远端方向凸出,第二凸起部沿支撑结构100的轴向方向朝向近端方向凸出。支撑框架单元还具有第一连接部和第二连接部。第一连接部位于第一凸起部和对应的支撑连接区域之间。第二连接部位于第二凸起部和对应的支撑连接区域之间。支撑连接区域沿支撑结构100周向上的宽度大于第一连接部和第二连接部沿支撑结构100周向上的宽度的平均值的两倍。Several support frame units are connected to each other. The support frame units are gyro-shaped hollow frame units. The support frame units have a first protrusion and a second protrusion. The first protrusion protrudes toward the distal direction along the axial direction of the support structure 100, and the second protrusion protrudes toward the proximal direction along the axial direction of the support structure 100. The support frame unit also has a first connection portion and a second connection portion. The first connection portion is located between the first protrusion and the corresponding support connection area. The second connection portion is located between the second protrusion and the corresponding support connection area. The width of the support connection area along the circumference of the support structure 100 is greater than twice the average value of the width of the first connection portion and the second connection portion along the circumference of the support structure 100.
支撑连接区域为相邻的两个支撑框架单元相互连接的区域。支撑连接区域沿支撑结构100轴向上的长度为第一连接部和第二连接部沿支撑结构100周向上的宽度的平均值的一倍至三倍。相邻两个支撑连接区域之间的距离与第一凸起部和第二凸起部之间的距离的比值为0.8-1。第一凸起部的远端内侧、第一凸起部的远端外侧、第二凸起部的近端内侧均为圆弧形或椭圆弧形。The support connection area is the area where two adjacent support frame units are connected to each other. The length of the support connection area along the axial direction of the support structure 100 is one to three times the average value of the width of the first connection part and the second connection part along the circumferential direction of the support structure 100. The ratio of the distance between two adjacent support connection areas to the distance between the first protrusion and the second protrusion is 0.8-1. The distal inner side of the first protrusion, the distal outer side of the first protrusion, and the proximal inner side of the second protrusion are all circular arc or elliptical arc.
支撑结构100还可以采用网状的中空环形结构,支撑结构100中沿周向网格可以为单层或多层,一层的网格数量为3-30个,优选为8-16个。支撑结构100是由切割、焊接或编织中的一种或多种方式形成网状的中空环形结构。其中网格的形状不限,可以为方框状、Z形状、菱形状等。The support structure 100 may also adopt a mesh-like hollow annular structure, and the grids in the support structure 100 along the circumferential direction may be single-layer or multi-layer, and the number of grids in one layer is 3-30, preferably 8-16. The support structure 100 is a mesh-like hollow annular structure formed by one or more methods of cutting, welding or weaving. The shape of the grid is not limited, and may be a square frame, a Z shape, a diamond shape, etc.
参照图1至图5、图7至图9,单向阀结构200可伸缩,单向阀结构200具有压握状态和膨胀状态。单向阀结构200包括可闭合件210、导向架220和若干连接杆230。单向阀结构200的大小可不因支气管的大小进行变化,以便于简化单向阀结构200,特别是可闭合件210的制作,提高可闭合件210的稳定性。1 to 5 and 7 to 9, the one-way valve structure 200 is retractable and has a compression state and an expansion state. The one-way valve structure 200 includes a closable member 210, a guide frame 220, and a plurality of connecting rods 230. The size of the one-way valve structure 200 does not change with the size of the bronchus, so as to simplify the one-way valve structure 200, especially the production of the closable member 210, and improve the stability of the closable member 210.
可闭合件210的远端与支撑结构100连通,可闭合件210的近端受到气流冲击时可闭合,以阻止外部气流自近端穿过且允许肺部残余的气流自远端穿过可闭合件210。当可闭合件210膨胀打开时,其横截面可以为圆形或椭圆形等形状。如图2和图9中所示,可闭合件210的近端端面为倾斜面,倾斜面与水平面之间的倾斜角度c为10°-20°,该水平面是与支撑结构100的轴向垂直的径向所在的水平面。可闭合件210优选为瓣叶结构,瓣叶结构包括若干片瓣叶,若干片瓣叶依次连接形成外圆周为圆环结构的瓣膜体,瓣膜体与导向架220的内侧壁固定连接,瓣膜体的中部可单向开合。瓣叶为采用生物材料和/或高分子材料制成的瓣叶,瓣叶厚度为0.1mm-1mm,如0.2mm、0.8mm,优选为0.3-0.6mm,如0.4mm、0.5mm。The distal end of the closable member 210 is connected to the support structure 100, and the proximal end of the closable member 210 can be closed when impacted by airflow to prevent external airflow from passing through the proximal end and allow residual airflow in the lungs to pass through the closable member 210 from the distal end. When the closable member 210 is expanded and opened, its cross section can be circular or elliptical. As shown in Figures 2 and 9, the proximal end face of the closable member 210 is an inclined surface, and the inclination angle c between the inclined surface and the horizontal plane is 10°-20°. The horizontal plane is the horizontal plane where the radial direction perpendicular to the axial direction of the support structure 100 is located. The closable member 210 is preferably a leaflet structure, which includes a plurality of leaflets, which are sequentially connected to form a valve body with an outer circumference of a circular ring structure, and the valve body is fixedly connected to the inner side wall of the guide frame 220, and the middle part of the valve body can be opened and closed in one direction. The leaflets are made of biological materials and/or polymer materials, and the thickness of the leaflets is 0.1mm-1mm, such as 0.2mm, 0.8mm, preferably 0.3-0.6mm, such as 0.4mm, 0.5mm.
导向架220呈镂空的圆柱体结构,导向架220优选采用自膨式记忆合金制成。导向架220的内部设置有可闭合件210,导向架220与可闭合件210的至少部分固定连接。导向架220优选与支撑结构100同轴。导向架220的远端位于支撑结构100的近端内侧,以充分利用空间,在满足导向架220和支撑结构100轴向长度的基础上,尽量减少肺减容装置的轴向长度。优选,导向架220的远端位于支撑结构100的支撑连接结构120的内侧。导向架220包括多个导向支架221,导向支架221为倒V字型结构,多个导向支架221的近端依次圆滑连接围成中空环状结构的导向架220。优选的,导向支架221的远端内侧和外侧均为圆滑过渡面。The guide frame 220 is a hollow cylindrical structure, and the guide frame 220 is preferably made of a self-expanding memory alloy. A closable member 210 is arranged inside the guide frame 220, and the guide frame 220 is fixedly connected to at least part of the closable member 210. The guide frame 220 is preferably coaxial with the support structure 100. The distal end of the guide frame 220 is located inside the proximal end of the support structure 100 to make full use of the space, and on the basis of meeting the axial length of the guide frame 220 and the support structure 100, the axial length of the lung volume reduction device is minimized. Preferably, the distal end of the guide frame 220 is located inside the support connection structure 120 of the support structure 100. The guide frame 220 includes a plurality of guide brackets 221, and the guide bracket 221 is an inverted V-shaped structure. The proximal ends of the plurality of guide brackets 221 are sequentially and smoothly connected to form a guide bracket 220 with a hollow annular structure. Preferably, the inner and outer sides of the distal ends of the guide bracket 221 are both smooth transition surfaces.
连接杆230用于连接导向架220和支撑结构100,连接杆230优选采用自膨式记忆合金制成。连接杆230的近端与导向架220的远端连接,连接杆230的远端与支撑结构100的近端连接。优选,连接杆230、导向架220和支撑结构100为一体制成。连接杆230的数量为2-8根,优选的连接杆230的个数与导向支架221的个数相同,每个连接杆230的近端与导向支架221的远端波峰连接,连接杆230的远端与支撑连接结构120的远端波峰连接。连接杆230倾斜设置,如图7中所示,连接杆230的长度方向与导向架220的中心轴之间的倾斜夹角为α,75°≥α≥30°,α可以为35°、40°、45°、50°、55°、60°、65°、70°等。连接杆230以导向架220的中心轴为中心绕周向均匀设置成一圈,多个连接杆230为中心对称分布。The connecting rod 230 is used to connect the guide frame 220 and the support structure 100. The connecting rod 230 is preferably made of self-expanding memory alloy. The proximal end of the connecting rod 230 is connected to the distal end of the guide frame 220, and the distal end of the connecting rod 230 is connected to the proximal end of the support structure 100. Preferably, the connecting rod 230, the guide frame 220 and the support structure 100 are made as one piece. The number of connecting rods 230 is 2-8, and the number of connecting rods 230 is preferably the same as the number of guide brackets 221. The proximal end of each connecting rod 230 is connected to the distal crest of the guide bracket 221, and the distal end of the connecting rod 230 is connected to the distal crest of the support connection structure 120. The connecting rod 230 is tilted, as shown in FIG7 , the tilt angle between the length direction of the connecting rod 230 and the central axis of the guide frame 220 is α, 75°≥α≥30°, α can be 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, etc. The connecting rod 230 is evenly arranged in a circle around the central axis of the guide frame 220, and a plurality of connecting rods 230 are symmetrically distributed around the center.
本发明的一种优选结构为:支撑结构100的壁厚为强度和韧性性能最佳的0.1mm-1mm,如0.8mm、0.9mm,优选为0.2mm-0.6mm,如0.3mm、0.4mm、0.5mm等。支撑结构100的直径为5mm-20mm,优选为6mm-15mm,更优先为7mm-10mm。导向架220的壁厚为0.1mm-1mm,优选为0.2mm-0.6mm。导向架220的直径为1mm-6mm,优选为2mm-5mm,更优选为3mm-4mm。肺减容装置的总高为6mm-15mm。A preferred structure of the present invention is: the wall thickness of the support structure 100 is 0.1mm-1mm, such as 0.8mm, 0.9mm, preferably 0.2mm-0.6mm, such as 0.3mm, 0.4mm, 0.5mm, etc., which has the best strength and toughness performance. The diameter of the support structure 100 is 5mm-20mm, preferably 6mm-15mm, and more preferably 7mm-10mm. The wall thickness of the guide frame 220 is 0.1mm-1mm, preferably 0.2mm-0.6mm. The diameter of the guide frame 220 is 1mm-6mm, preferably 2mm-5mm, and more preferably 3mm-4mm. The total height of the lung volume reduction device is 6mm-15mm.
在支撑结构100、导向架220或连接杆230上可设置有具有不透射线的指示件,该指示件的设计可便于手术中和术后检查的装置定位。A radiopaque indicator may be provided on the support structure 100 , the guide frame 220 , or the connecting rod 230 . The design of the indicator may facilitate the positioning of the device for intraoperative and postoperative inspection.
输送器连接部300设置于导向支架221的近端,输送器连接部300的轴向长度小于导向支架221的轴向长度。输送器连接部300可以为一个或多个,如图1、图2、图4和图5所示,输送器连接部300为两个,两个输送器连接部300对称设置。输送器连接部300用于连接肺减容装置和外部输送器,输送器连接部300上设置有与外部输送器可拆卸连接的螺纹孔或卡合部。The conveyor connection part 300 is arranged at the proximal end of the guide bracket 221, and the axial length of the conveyor connection part 300 is less than the axial length of the guide bracket 221. The conveyor connection part 300 can be one or more, as shown in Figures 1, 2, 4 and 5, there are two conveyor connection parts 300, and the two conveyor connection parts 300 are symmetrically arranged. The conveyor connection part 300 is used to connect the lung volume reduction device and the external conveyor, and the conveyor connection part 300 is provided with a threaded hole or a clamping part that is detachably connected to the external conveyor.
参照图2和图3,密封膜400位于支撑结构100内侧,密封膜400与可闭合件210为一体结构。2 and 3 , the sealing film 400 is located inside the supporting structure 100 , and the sealing film 400 and the closable member 210 are an integral structure.
参照图1,覆膜500至少位于支撑结构100的外侧,优选肺减容装置的表面均设置有覆膜500。在覆膜500的外侧面上设有药物涂层。药物涂层为抗炎症药物,具体为地塞米松(DXM)、甲基强的松龙或双磷酸盐脂质体中的至少一种抗炎症药物。1 , the coating 500 is at least located on the outside of the support structure 100, and preferably the surface of the lung volume reduction device is provided with the coating 500. A drug coating is provided on the outer surface of the coating 500. The drug coating is an anti-inflammatory drug, specifically at least one anti-inflammatory drug selected from dexamethasone (DXM), methylprednisolone or bisphosphonate liposomes.
密封膜400和覆膜500的材料均为硅胶、PET、聚氨酯、PTFE或e-PTFE中的一种或多种。密封膜400和覆膜500的厚度均为0.01mm-1mm。当密封膜400和覆膜500均采用PTFE时,可以采用高温下内外的相互粘合连接。当密封膜400和覆膜500均采用硅胶时,可直接将液态的硅胶粘连在肺减容装置上之后再固化,不需要缝合,既不会破坏密封膜400和覆膜500的完整性,又能保证结合度。The materials of the sealing film 400 and the covering film 500 are one or more of silicone, PET, polyurethane, PTFE or e-PTFE. The thickness of the sealing film 400 and the covering film 500 is 0.01mm-1mm. When the sealing film 400 and the covering film 500 are both made of PTFE, they can be connected by mutual bonding inside and outside at high temperature. When the sealing film 400 and the covering film 500 are both made of silicone, the liquid silicone can be directly adhered to the lung volume reduction device and then solidified without suturing, which will not damage the integrity of the sealing film 400 and the covering film 500 and can ensure the bonding degree.
锚定结构为尖刺形状设置于支撑结构100的外侧面上。锚定结构的材料为高分子材料、生物组织或金属中的一种或多种。锚定结构优选与支撑结构100一体制成。The anchoring structure is in the shape of a spike and is disposed on the outer surface of the support structure 100. The material of the anchoring structure is one or more of a polymer material, a biological tissue or a metal. The anchoring structure is preferably made integrally with the support structure 100.
本发明还提供一种肺减容装置的使用方法,采用本发明肺减容装置600,包括如下步骤:The present invention further provides a method for using a lung volume reduction device, using the lung volume reduction device 600 of the present invention, comprising the following steps:
S0,将支气管镜通过气管进入气管内部到达目标位置;S0, insert the bronchoscope through the trachea into the trachea to the target location;
本步骤中的支气管镜可以为现有的任意支气管镜。The bronchoscope in this step can be any existing bronchoscope.
S1,将肺减容装置600收于输送装置的管腔内,并使输送装置通过支气管镜的工作通道至目标位置;S1, placing the lung volume reduction device 600 in the lumen of the delivery device, and passing the delivery device through the working channel of the bronchoscope to the target position;
S2,将肺减容装置600的支撑结构100释放紧贴于支气管700管壁;S2, releasing the support structure 100 of the lung volume reduction device 600 so that it is closely attached to the wall of the bronchus 700;
本步骤中,在释放支撑结构100时,可以允许支撑结构100的轴向与支气管700的轴向不平行,即允许支撑结构100的轴向与支气管700的轴向具有预设夹角,该预设夹角应不大于30°为佳。In this step, when the support structure 100 is released, the axial direction of the support structure 100 can be allowed to be non-parallel to the axial direction of the bronchus 700, that is, the axial direction of the support structure 100 and the axial direction of the bronchus 700 are allowed to have a preset angle, and the preset angle should preferably be no greater than 30°.
S3,将肺减容装置600的单向阀结构200释放;S3, releasing the one-way valve structure 200 of the lung volume reduction device 600;
S4,撤离输送装置。S4, evacuate the conveying device.
S5,调整支气管镜至其余病患位置,重复步骤S1-S4直至所有肺减容装置600释放完毕;S5, adjust the bronchoscope to the position of other patients, and repeat steps S1-S4 until all lung volume reduction devices 600 are released;
S6,从体内撤出支气管镜。S6, withdraw the bronchoscope from the body.
参照图10,本发明肺减容装置600至于支气管700内后,肺减容装置600的近端受到气流冲击时可闭合,以阻止外部气流自近端穿过,如图10中的箭头所示,允许肺部残余的气流自远端穿过肺减容装置600。肺减容装置600的支撑结构100由于自身可伸缩的径向支撑力固定在支气管700的气道内部,由于支撑结构100表面附有覆膜500,使得支撑结构100对人体造成的伤害降至最小;导向架220负责保护可闭合件210,从而保障装置发挥效能,延长装置使用时间。10 , after the lung volume reduction device 600 of the present invention is placed in the bronchus 700, the proximal end of the lung volume reduction device 600 can be closed when impacted by airflow to prevent external airflow from passing through the proximal end, as shown by the arrow in FIG10 , allowing the residual airflow in the lung to pass through the lung volume reduction device 600 from the distal end. The support structure 100 of the lung volume reduction device 600 is fixed inside the airway of the bronchus 700 due to its own retractable radial support force, and the support structure 100 is covered with a film 500 on the surface, so that the damage caused by the support structure 100 to the human body is minimized; the guide frame 220 is responsible for protecting the closable component 210, thereby ensuring the effectiveness of the device and extending the use time of the device.
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.
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