CN116269832A - A High Visibility Pulmonary Nodule Locating Needle - Google Patents
A High Visibility Pulmonary Nodule Locating Needle Download PDFInfo
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- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种高可视性肺结节定位针。The invention relates to the technical field of medical devices, in particular to a high-visibility pulmonary nodule locating needle.
背景技术Background technique
肺结节是肺内直径不超过3厘米的病变,其中小于10mm的病变定义为肺小结节。肺小结节由于肺小结节体积小、实性成分少,医生在外科切除过程中难以通过触摸及目视明确病灶所在位置。为避免过度损伤正常肺组织,常通过术前CT引导下标记肺结节所在位置的办法,提升手术效率并降低正常肺组织的损伤。现有的肺结节标记方法如下:Pulmonary nodules are lesions with a diameter of no more than 3 cm in the lung, and lesions smaller than 10 mm are defined as small pulmonary nodules. Pulmonary nodules Due to the small size and few solid components of pulmonary nodules, it is difficult for doctors to determine the location of the lesion through touch and vision during surgical resection. In order to avoid excessive damage to normal lung tissue, the location of pulmonary nodules is often marked under the guidance of preoperative CT to improve surgical efficiency and reduce damage to normal lung tissue. The existing pulmonary nodule labeling methods are as follows:
经皮穿肺打染色剂:其使用方法为经CT引导将穿刺针穿入肺组织并到达肺结节所在位置后,注射染色剂,利用染色剂对肺组织的染色,进而拔出穿刺针。在随后的术中实现对肺结节所在位置的标定。该方法缺点在于:染色剂弥散快,必须在手术开始前短时间内内进行标记,否则染料弥散范围过大失去了进行肺结节精准标记的价值;临床可用的现有染色剂刺激性大,患者发生胸膜反应及疼痛的比例高。Percutaneous lung puncture with dyeing agent: the method of use is to insert the puncture needle into the lung tissue under the guidance of CT and reach the location of the pulmonary nodule, inject the dye, use the dye to stain the lung tissue, and then pull out the puncture needle. The location of the pulmonary nodule can be demarcated in the subsequent operation. The disadvantages of this method are: the dye diffuses quickly and must be marked within a short time before the operation, otherwise the dye diffuses too much and loses the value of accurate labeling of pulmonary nodules; the existing clinically available dyes are highly irritating, The proportion of patients with pleural reaction and pain was high.
经皮穿肺放置非专用的乳腺定位钩:与前述弹簧圈方法相同,植入物为乳腺定位钩,该定位钩钩头放置于结节处,尾端粗金属丝留存于体外,其在做乳腺定位时由于不经过胸腔,所以即便金属丝很粗,也并不会引起患者较大反应,但在做肺结节定位时,该金属丝在患者肺呼吸运动过程中会反复牵扯胸膜,导致患者疼痛等不适较为明显。该方法缺点在于:刺激性大,患者疼痛明显;锚定力弱,易脱钩,无法满足肺结节定位需求;穿刺系统过粗(不小于20G),气胸、出血等并发症发生率高;定位钩植入后仅能通过外科手术取出,对于植入后考虑临时取消外科手术的患者无法实现定位钩的微创取出。Percutaneous placement of a non-specific breast positioning hook through the lung: the same as the aforementioned spring coil method, the implant is a breast positioning hook. Because breast positioning does not pass through the chest cavity, even if the metal wire is very thick, it will not cause a large reaction in the patient. However, when positioning lung nodules, the metal wire will repeatedly involve the pleura during the patient's lung breathing movement, resulting in The patient's pain and other discomfort are more obvious. The disadvantages of this method are: strong irritation and obvious pain for patients; weak anchoring force and easy decoupling, which cannot meet the needs of pulmonary nodule positioning; the puncture system is too thick (not less than 20G), and the incidence of complications such as pneumothorax and bleeding is high; positioning After the hook is implanted, it can only be removed by surgery, and the minimally invasive removal of the positioning hook cannot be achieved for patients who consider temporarily canceling the surgery after implantation.
经皮穿肺放置弹簧圈类肺结节定位钩:其使用方法为经CT引导将穿刺针穿入肺组织并到达肺结节所在位置后,将弹簧圈前段经穿刺针置入肺内结节所在位置,并在拔出穿刺针过程中尽可能将尾端置于胸膜腔。该方法缺点在于:弹簧圈质地仍多偏软,触感提升有限;弹簧圈锚定力弱,容易出现脱落;穿刺系统过粗(不小于20G),气胸、出血等并发症发生率高;定位钩植入后仅能通过外科手术取出,对于植入后考虑临时取消外科手术的患者无法实现定位钩的微创取出。Percutaneous lung placement of coil-like lung nodule positioning hook: the method of use is to penetrate the puncture needle into the lung tissue and reach the location of the lung nodule under the guidance of CT, and then insert the front part of the coil into the pulmonary nodule through the puncture needle position, and place the tail as far as possible in the pleural cavity during needle withdrawal. The disadvantages of this method are: the texture of the coil is still soft, and the tactile improvement is limited; the anchoring force of the coil is weak, and it is easy to fall off; the puncture system is too thick (not less than 20G), and the incidence of complications such as pneumothorax and bleeding is high; the positioning hook After implantation, it can only be taken out by surgical operation, and the minimally invasive removal of the positioning hook cannot be realized for patients who consider temporarily canceling the surgical operation after implantation.
经皮穿肺放置锚线型肺结节定位针:与前述弹簧圈方法相同,植入物为肺结节专用定位器,该定位钩钩头放置于结节处,尾端为高分子丝线,丝线留存于胸膜腔或胸壁内,术中医生可通过观察尾线的位置以及牵拉锚线对结节位置进行判断。该方法缺点在于:高分子线CT下不显影,脱钩后难以通过CT或X线寻找;穿刺系统过粗(不小于20G),气胸、出血等并发症发生率高;金属锚钩与高分子线需通过连接机构进行连接,易分离脱线(术中一旦脱线,锚只有靠X线或CT定位方式进行外科探查取出,而锚线由于X线不可见,则仅能靠反复翻找进行异物取出);定位钩植入后仅能通过外科手术取出,对于植入后考虑临时取消外科手术的患者无法实现定位钩的微创取出。Percutaneous placement of anchor-type pulmonary nodule positioning needle through the lung: the same as the aforementioned coil method, the implant is a special locator for pulmonary nodules. The silk thread remains in the pleural cavity or chest wall. During the operation, the doctor can judge the location of the nodule by observing the position of the tail thread and pulling the anchor thread. The disadvantages of this method are: the polymer wire does not develop under CT, and it is difficult to find it through CT or X-ray after decoupling; the puncture system is too thick (not less than 20G), and the incidence of complications such as pneumothorax and bleeding is high; It needs to be connected through a connecting mechanism, and it is easy to separate and disconnect the thread (once the thread is disconnected during the operation, the anchor can only be removed by surgical exploration by means of X-ray or CT positioning, while the anchor thread cannot be seen by X-ray, and the foreign body can only be detected by repeated rummaging. After the positioning hook is implanted, it can only be removed by surgery, and the minimally invasive removal of the positioning hook cannot be achieved for patients who consider temporarily canceling the surgery after implantation.
发明内容Contents of the invention
为解决现有技术的不足,本发明提出一种高可视性肺结节定位针,通过将核心结构定位钩设计为单线变径的结构,与以往的定位方式相比,可降低定位钩全程的最大直径,使得定位针放入更细的穿刺针,可降低气胸、出血等手术并发症的发生率;可提升锚部与线部的连接强度,降低锚与线脱离的情况发生;定位钩全程为金属丝,可实现X线或CT下全程显影,为定位精准度判定以及术中探查提供便利;线段丝径变细,刚性降低、柔性增大,可降低患者对金属异物的疼痛及胸膜反应等不适;在定位钩植入后,由于尾端为与锚段平滑过渡的金属单丝,可以定位钩尾端金属丝作为支撑,再次植入穿刺针并将定位钩在肺内拉回穿刺针针内腔,实现对定位钩的微创回收。In order to solve the deficiencies of the prior art, the present invention proposes a high-visibility pulmonary nodule locating needle. By designing the core structure locating hook as a structure with a single-wire variable diameter, compared with the previous locating methods, the whole process of locating hook can be reduced. The maximum diameter allows the positioning needle to be placed into a thinner puncture needle, which can reduce the incidence of surgical complications such as pneumothorax and bleeding; it can improve the connection strength between the anchor part and the thread part, and reduce the occurrence of the anchor and thread detachment; the positioning hook The whole process is made of metal wire, which can realize the whole process of imaging under X-ray or CT, and provides convenience for the determination of positioning accuracy and intraoperative exploration; the diameter of the wire segment is thinner, the rigidity is reduced, and the flexibility is increased, which can reduce the patient’s pain and pleura due to metal foreign bodies Discomfort such as reactions; after the positioning hook is implanted, because the tail end is a metal monofilament with a smooth transition with the anchor segment, the metal wire at the tail end of the positioning hook can be used as a support, and the puncture needle is re-implanted and the positioning hook is pulled back into the lung for puncture The inner cavity of the needle realizes the minimally invasive recovery of the positioning hook.
为实现以上目的,本发明所采用的技术方案包括:For realizing the above object, the technical scheme adopted in the present invention comprises:
一种高可视性肺结节定位针,包括:所述定位针由内而外设置有定位钩、推送杆和穿刺针;A high-visibility pulmonary nodule positioning needle, comprising: the positioning needle is provided with a positioning hook, a push rod and a puncture needle from the inside to the outside;
所述穿刺针的头部设有穿刺部,尾部固定连接有辅助圈;The head of the puncture needle is provided with a puncture part, and the tail is fixedly connected with an auxiliary ring;
所述推送杆的尾部固定连接有推柄;The tail of the push rod is fixedly connected with a push handle;
所述推柄设置有开孔;The push handle is provided with an opening;
所述定位钩包括线段部和锚段部,所述锚段部的直径大于所述线段部的直径;The positioning hook includes a line segment and an anchor segment, and the diameter of the anchor segment is larger than the diameter of the line segment;
所述线段部与所述锚段部为一体连接结构,所述线段部的一端与所述锚段部之间平滑过渡;The line section and the anchor section are integrally connected, and one end of the line section is smoothly transitioned to the anchor section;
所述线段部通过所述开孔位于所述推送杆内部,所述锚段部露出于所述推送杆的前端位于穿刺针内部;The wire segment is located inside the push rod through the opening, and the anchor segment exposed at the front end of the push rod is located inside the puncture needle;
所述推送杆向下移动,推出所述锚段部于穿刺针外部。The pushing rod moves downwards to push out the anchor section to the outside of the puncture needle.
进一步地,所述穿刺针为金属材质。Further, the puncture needle is made of metal.
进一步地,所述定位钩的材质为记忆金属丝。Further, the material of the positioning hook is a memory metal wire.
进一步地,所述线段部的直径区间为0.05-0.67mm;所述锚段部的直径区间为0.15-1.50mm。Further, the diameter interval of the line section is 0.05-0.67mm; the diameter interval of the anchor section is 0.15-1.50mm.
进一步地,所述锚段部的形态包括螺旋弹簧状。Further, the shape of the anchor section includes a helical spring shape.
本发明的有益效果为:The beneficial effects of the present invention are:
本发明通过将核心结构定位钩设计为单线变径的结构,与以往的定位方式相比,可降低定位钩全程的最大直径,使得定位针放入更细的穿刺针,可降低气胸、出血等手术并发症的发生率;可提升锚部与线部的连接强度,降低锚与线脱离的情况发生;定位钩全程为金属丝,可实现X线或CT下全程显影,为定位精准度判定以及术中探查提供便利;线段丝径变细,刚性降低、柔性增大,可降低患者对金属异物的疼痛及胸膜反应等不适;在定位钩植入后,由于尾端为与锚段平滑过渡的金属单丝,可以定位钩尾端金属丝作为支撑,再次植入穿刺针并将定位钩在肺内拉回穿刺针针内腔,实现对定位钩的微创回收。In the present invention, the positioning hook of the core structure is designed as a single-wire diameter-changing structure. Compared with the previous positioning method, the maximum diameter of the positioning hook in the whole process can be reduced, so that the positioning needle can be placed into a thinner puncture needle, which can reduce pneumothorax, bleeding, etc. The incidence of surgical complications; the connection strength between the anchor part and the line part can be improved, and the occurrence of the anchor and line detachment can be reduced; the whole positioning hook is made of metal wire, which can realize the whole process of development under X-ray or CT, which is used for positioning accuracy judgment and It provides convenience for intraoperative exploration; the wire diameter becomes thinner, the rigidity is reduced, and the flexibility is increased, which can reduce the patient's pain and pleural reaction to the metal foreign body. Metal monofilament, the metal wire at the tail end of the positioning hook can be used as a support, and the puncture needle is implanted again and the positioning hook is pulled back into the inner cavity of the puncture needle in the lung, so as to realize the minimally invasive recovery of the positioning hook.
附图说明Description of drawings
图1为本发明优选实施例高可视性肺结节定位针未推出状态结构正视图。Fig. 1 is a front view of the structure of the highly visible pulmonary nodule locating needle in the preferred embodiment of the present invention when it is not pushed out.
图2为本发明优选实施例高可视性肺结节定位针未推出状态结构侧视图。Fig. 2 is a side view of the structure of the highly visible pulmonary nodule locating needle in the preferred embodiment of the present invention when it is not pushed out.
图3为本发明优选实施例高可视性肺结节定位针推出状态结构正视图。Fig. 3 is a front view of the structure of the high-visibility pulmonary nodule locating needle in the push-out state of the preferred embodiment of the present invention.
图4为本发明优选实施例高可视性肺结节定位针推出状态结构侧视图。Fig. 4 is a side view of the structure of the high-visibility pulmonary nodule locating needle in the push-out state of the preferred embodiment of the present invention.
图5为本发明优选实施例定位钩结构正视图。Fig. 5 is a front view of the positioning hook structure of the preferred embodiment of the present invention.
图6为本发明优选实施例定位钩结构侧视图。Fig. 6 is a side view of the positioning hook structure of the preferred embodiment of the present invention.
附图编号说明:1定位钩、1-1线段部、1-2锚段部、2推送杆、2-1推柄、2-2开孔、3穿刺针、3-1穿刺部、3-2辅助圈。Description of the accompanying drawings: 1 positioning hook, 1-1 line segment, 1-2 anchor segment, 2 push rod, 2-1 push handle, 2-2 opening, 3 puncture needle, 3-1 puncture part, 3- 2 auxiliary circles.
具体实施方式Detailed ways
为了更清楚的理解本发明的内容,将结合附图和实施例详细说明。In order to understand the content of the present invention more clearly, it will be described in detail with reference to the drawings and embodiments.
在本发明的描述中,需要理解的是,术语“中心”、“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明创造和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明创造的限制。In describing the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", " The orientations or positional relationships indicated by "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the invention. and simplified descriptions, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the invention.
术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以通过具体情况理解上述术语在本发明创造中的具体含义。The terms "installation", "connection" and "connection" should be understood in a broad sense, for example, it can be fixed connection, detachable connection, or integral connection; it can be mechanical connection or electrical connection; it can be direct It can also be connected indirectly through an intermediary, or it can be the internal communication of two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention based on specific situations.
本发明涉及图1至图6所示的一种高可视性肺结节定位针,所述定位针由内而外设置有定位钩1、推送杆2和穿刺针3;The present invention relates to a high-visibility pulmonary nodule locating needle shown in Fig. 1 to Fig. 6, the locating needle is provided with a locating
所述穿刺针3的头部设有穿刺部3-1,尾部固定连接有辅助圈3-2;The head of the
所述推送杆2的尾部固定连接有推柄2-1;The tail of the
所述推柄2-1设置有开孔2-2;The push handle 2-1 is provided with an opening 2-2;
所述定位钩1包括线段部1-1和锚段部1-2,所述锚段部1-2的直径大于所述线段部1-1的直径;The
所述线段部1-1与所述锚段部1-2为一体连接结构,所述线段部1-1的一端与所述锚段部1-2之间平滑过渡;The line section 1-1 and the anchor section 1-2 are integrally connected, and one end of the line section 1-1 is smoothly transitioned to the anchor section 1-2;
所述线段部1-1通过所述开孔2-2位于所述推送杆内部,所述锚段部1-2露出于所述推送杆2的前端位于穿刺针3内部;The line section 1-1 is located inside the push rod through the opening 2-2, and the anchor section 1-2 is exposed at the front end of the
所述推送杆2向下移动,推出所述锚段部1-2于穿刺针外部。The pushing
具体而言,在本申请实施例中,穿刺针3采用金属材质,穿刺针3外径区间为2.0-0.1mm,优选地,外径为0.8mm、内径为0.6mm;穿刺针3含辅助圈3-2的长度为7.0-20.0cm,优选长度为12cm。Specifically, in the embodiment of the present application, the
穿刺针3及推送杆2尾端均连接了由高分子材料制成的、便于握持的辅助圈3-2。推送杆2外径小于穿刺针3内径,推送杆2内径大于定位钩1线段部1-1直径、小于定位钩1锚段部1-2直径,因此定位钩1线段部1-1位于推送杆2内,定位钩1锚段部1-2在释放前位于推送杆2前方穿刺针3内。The tail end of the
定位钩采用记忆金属丝(如镍钛合金丝)加工制成,其锚段部采用粗线,直径在0.15-1.50mm,优选直径为0.30mm,线段部采用细线,直径在0.05-0.67mm,优选直径为0.12mm,中间为平滑过渡。The positioning hook is made of memory metal wire (such as nickel-titanium alloy wire). The anchor section is made of thick wire with a diameter of 0.15-1.50mm, preferably 0.30mm in diameter. The line section is made of thin wire with a diameter of 0.05-0.67mm , the preferred diameter is 0.12mm, with a smooth transition in the middle.
锚段部形态多变,本实施例采用多排螺旋弹簧状结构,其所盘成的螺旋弹簧直径为4.0mm,亦可为单根丝所构成的其他形态。为保证穿刺针在植入过程中不会误推推送杆2导致定位钩1误释放,应在推送杆2及穿刺针3的尾端高分子辅助圈部分加装可随时拆卸的相对位置卡控装置。The shape of the anchor segment is changeable. This embodiment adopts a multi-row coil spring-like structure, and the diameter of the coiled spring is 4.0mm, and it can also be other shapes formed by a single wire. In order to ensure that the puncture needle will not mistakenly push the
如图3至图4所示,本定位针在CT引导下到达肺结节所在区域后,通过推送杆2可将定位钩1推出并释放于肺组织内,通过拔出穿刺针3及推送杆2,将定位钩线段部1-1留存于肺外。实现了在X线及CT下定位钩1(含锚段部与线线段部)的100%显影;实现了在保持锚段部肺内高锚定力的情况下,利用变径的方式,实现了线段的高柔顺性;同时锚段部与线段部为同一根记忆金属线加工而成,因此连接强度高,不易分离、脱线。此外,由于采用定位钩结构简单,采用单线制成,因此可采用更细的穿刺针进行植入,降低了穿刺相关并发症,并在必要时可实现对定位钩的微创回收。As shown in Figure 3 to Figure 4, after the positioning needle reaches the area where the pulmonary nodule is located under the guidance of CT, the
如图5至图6所示的本发明核心结构定位钩1采用单线变径的设计,与以往的定位方式相比,可降低定位钩全程的最大直径,使得定位针放入更细的穿刺针,可降低气胸、出血等手术并发症的发生率;(可提升锚部与线部的连接强度,降低锚与线脱离的情况发生;定位钩全程为金属丝,可实现X线或CT下全程显影,为定位精准度判定以及术中探查提供便利;线段部径变细,刚性降低、柔性增大,可降低患者对金属异物的疼痛及胸膜反应等不适;在定位钩植入后,由于尾端为与锚段平滑过渡的金属单丝,可以定位钩尾端金属丝作为支撑,再次植入穿刺针并将定位钩在肺内拉回穿刺针针内腔,实现对定位钩的微创回收。As shown in Figures 5 to 6, the
Claims (5)
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