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CN221963695U - A flexible pjncture needle for mammary gland location - Google Patents

A flexible pjncture needle for mammary gland location Download PDF

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Publication number
CN221963695U
CN221963695U CN202420140508.0U CN202420140508U CN221963695U CN 221963695 U CN221963695 U CN 221963695U CN 202420140508 U CN202420140508 U CN 202420140508U CN 221963695 U CN221963695 U CN 221963695U
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wire
anchoring
positioning
needle
guide wire
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郭琪
马路遥
付永
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Nanjing Xinke Medical Instrument Co ltd
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Nanjing Xinke Medical Instrument Co ltd
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Abstract

The application relates to a flexible puncture needle for mammary gland positioning, which comprises a positioning wire assembly and a guide needle assembly, wherein the positioning wire assembly consists of a positioning hook and a positioning wire, the guide needle assembly comprises a puncture needle tube, a guide needle handle and a push rod, the puncture needle tube is sleeved outside the positioning wire assembly, the push rod is arranged in the puncture needle tube, the distal end of the push rod is abutted with the proximal end of the positioning hook and is used for pushing the positioning hook out of the puncture needle tube, the positioning wire is flexible, the positioning hook comprises a marking sleeve, a fixed guide wire, a depth prompt sleeve and an anchoring guide wire, the anchoring guide wire comprises a straight section and a bending section, the marking sleeve and the depth prompt sleeve are sleeved on the straight section of the anchoring guide wire, the marking sleeve is fixed at the proximal end of the bending section, the depth prompt sleeve is fixed at the proximal end part of the straight section, the fixed guide wire is used for fixing the anchoring guide wire in the marking sleeve, and the flexible puncture needle has good developing property and strong anchoring force.

Description

一种用于乳腺定位的柔性穿刺针A flexible puncture needle for breast positioning

技术领域Technical Field

本实用新型涉及医疗器械领域,具体涉及一种用于乳腺定位的柔性穿刺针。The utility model relates to the field of medical instruments, in particular to a flexible puncture needle for breast positioning.

背景技术Background Art

近年来,随着我国乳腺癌综合诊疗水平的进步,乳腺癌生存率逐年升高,通过乳腺癌的筛查提高了乳腺癌的早诊率。乳腺癌筛查是改善乳腺癌预后、降低乳腺癌死亡率的重要措施。在临床应用方面,乳腺病变往往由于病变小,临床医师触诊阴性,容易延误治疗,而且较小的乳腺病变不易寻找,也容易造成手术治疗的困难及病理取材假阴性的结果。针对这种情况乳腺定位针应运而生。乳腺定位针在超声或X光引导下进行病变穿刺,留置导丝于病变部位,引导外科医师对可疑恶性病变进行手术切除或病理取检。在影像学的指导下,穿刺定位术具有较高的安全性、准确性和临床应用价值,通过这种定位方法可切除微小乳腺良性病变,在乳腺癌早期诊断中,属于高水平的诊断手段。In recent years, with the improvement of comprehensive diagnosis and treatment of breast cancer in my country, the survival rate of breast cancer has increased year by year, and the early diagnosis rate of breast cancer has been improved through breast cancer screening. Breast cancer screening is an important measure to improve the prognosis of breast cancer and reduce the mortality rate of breast cancer. In clinical application, breast lesions are often small and clinical physicians are negative on palpation, which can easily delay treatment. In addition, smaller breast lesions are not easy to find, which can easily lead to difficulties in surgical treatment and false negative results in pathological sampling. In response to this situation, breast localization needles came into being. The breast localization needle performs lesion puncture under the guidance of ultrasound or X-ray, and leaves a guide wire at the lesion site to guide surgeons to perform surgical resection or pathological examination of suspected malignant lesions. Under the guidance of imaging, puncture localization has high safety, accuracy and clinical application value. This positioning method can remove small benign breast lesions. It is a high-level diagnostic method in the early diagnosis of breast cancer.

现有的穿刺针的锚定钩多为刚性材料制成,例如由双股不锈钢丝绞合制成,定位钩较宽,手术切口较大,且容易出现锚定力不足脱钩的现象,对人体造成二次伤害。在产品使用时,需将双股不锈钢丝制成的导丝收入到穿刺针管内,不锈钢丝不具备记忆功能,收入穿刺针管内后会导致导丝变形,锚定力下降。而且,现有技术中的定位丝也多为刚性,定位丝裸漏在体外给患者带来较大的疼痛感和心理压力。The anchor hooks of existing puncture needles are mostly made of rigid materials, such as twisted double-strand stainless steel wire. The positioning hook is wide, the surgical incision is large, and it is easy to get unhooked due to insufficient anchoring force, causing secondary damage to the human body. When the product is used, the guide wire made of double-strand stainless steel wire needs to be put into the puncture needle tube. The stainless steel wire does not have a memory function, and after being put into the puncture needle tube, the guide wire will be deformed and the anchoring force will decrease. Moreover, the positioning wires in the prior art are also mostly rigid, and the positioning wires exposed outside the body will cause great pain and psychological pressure on the patient.

专利CN 204863412U公开了一种新型的肺肿瘤定位针,包括穿刺针,所述穿刺针由穿刺针套管和穿刺针手柄组成,其还包括锚定定位针、定位线和推送装置,所述推送装置包括推管和推管手柄,所述推管被置于所述穿刺针套管内,所述推管的远端抵住所述锚定定位针的近端,所述锚定定位针的近端宽度大于或等于所述推管的外径,所述定位线的远端与所述锚定定位针的近端连接,所述定位线从所述推管的管腔内部延伸出所述推送装置外部,所述定位线的远端部分设置有多个不同颜色的色带,每个所述色带的长度在3mm至15mm之间。该技术使用镍钛合金作为锚定定位针(导丝)材料,解决了现有不锈钢导丝锚定力不足、使用时需收入穿刺针管内导致变形的问题。镍钛合金具有记忆功能,在使用时,锚定定位针可收入穿刺针管内,在释放后恢复形状,不影响锚定力。但是该产品的锚定针显影性差,而且色带在X光或超声下无法显影,不具备辅助定位功能,在使用时,多个不同颜色的色带易受到组织液或血液的污染,导致无法区分具体颜色,不能起到测量定位深度的功能,此外,色带在使用时有褪色风险,生物安全性差。Patent CN 204863412U discloses a new type of lung tumor localization needle, including a puncture needle, which is composed of a puncture needle sleeve and a puncture needle handle, and also includes an anchoring positioning needle, a positioning line and a pushing device, the pushing device includes a push tube and a push tube handle, the push tube is placed in the puncture needle sleeve, the distal end of the push tube is against the proximal end of the anchoring positioning needle, the proximal width of the anchoring positioning needle is greater than or equal to the outer diameter of the push tube, the distal end of the positioning line is connected to the proximal end of the anchoring positioning needle, the positioning line extends from the lumen of the push tube to the outside of the pushing device, and the distal part of the positioning line is provided with a plurality of ribbons of different colors, each of which has a length of 3mm to 15mm. This technology uses nickel-titanium alloy as the anchoring positioning needle (guide wire) material, which solves the problem that the existing stainless steel guide wire has insufficient anchoring force and needs to be put into the puncture needle tube when used, resulting in deformation. Nickel-titanium alloy has a memory function. When in use, the anchoring needle can be put into the puncture needle tube and restore its shape after release, which does not affect the anchoring force. However, the anchoring needle of this product has poor visualization, and the ribbon cannot be visualized under X-ray or ultrasound, and does not have an auxiliary positioning function. When in use, multiple ribbons of different colors are easily contaminated by tissue fluid or blood, resulting in the inability to distinguish specific colors and the inability to measure the positioning depth. In addition, the ribbon has the risk of fading during use, and has poor biological safety.

发明内容Summary of the invention

为了克服现有技术中的缺陷,本实用新型设计了一种显影性好、锚定力强的柔性穿刺针。In order to overcome the defects in the prior art, the utility model designs a flexible puncture needle with good developing property and strong anchoring force.

本申请的目的是通过以下技术方案来实现的:The purpose of this application is achieved through the following technical solutions:

一种用于乳腺定位的柔性穿刺针,包括定位丝组件和导引针组件,所述定位丝组件由定位钩和定位丝组成,所述定位钩的近端和所述定位丝的远端固定连接,所述导引针组件包括穿刺针管、导引针手柄和推杆,所述穿刺针管的近端与所述导引针手柄固定连接,所述穿刺针管套接在所述定位丝组件外,所述推杆被设置在所述穿刺针管内,所述推杆的远端与所述定位钩的近端抵接,用于将所述定位钩推出所述穿刺针管外,所述定位丝为柔性,所述定位钩包括标记套管、固定导丝、深度提示套管和锚定导丝,所述锚定导丝包括平直段和弯曲段,所述标记套管和所述深度提示套管被套接在所述锚定导丝的平直段,所述标记套管被固定在所述弯曲段的近端处,所述深度提示套管被固定在所述平直段的近端部分,所述固定导丝用于将所述锚定导丝固定在所述标记套管内。A flexible puncture needle for breast positioning, comprising a positioning wire assembly and a guide needle assembly, wherein the positioning wire assembly is composed of a positioning hook and a positioning wire, the proximal end of the positioning hook is fixedly connected to the distal end of the positioning wire, the guide needle assembly comprises a puncture needle tube, a guide needle handle and a push rod, the proximal end of the puncture needle tube is fixedly connected to the guide needle handle, the puncture needle tube is sleeved outside the positioning wire assembly, the push rod is arranged in the puncture needle tube, the distal end of the push rod abuts against the proximal end of the positioning hook, and is used for The positioning hook is pushed out of the puncture needle tube. The positioning wire is flexible. The positioning hook includes a marking sleeve, a fixed guide wire, a depth indication sleeve and an anchoring guide wire. The anchoring guide wire includes a straight section and a curved section. The marking sleeve and the depth indication sleeve are sleeved on the straight section of the anchoring guide wire. The marking sleeve is fixed at the proximal end of the curved section. The depth indication sleeve is fixed at the proximal end of the straight section. The fixed guide wire is used to fix the anchoring guide wire in the marking sleeve.

本申请的目的还可以通过以下技术方案来进一步实现:The purpose of this application can be further achieved through the following technical solutions:

在一个实施方式中,所述锚定导丝由一根形状记忆合金丝对折构成位于近端的折弯处和位于远端的两个游离端,对折后的所述锚定导丝的远端部分被热定型成为所述弯曲段,对折后的所述锚定导丝的近端部分为所述平直段。In one embodiment, the anchoring guide wire is formed by folding a shape memory alloy wire in half to form a bend at the proximal end and two free ends at the distal end. The distal end of the folded anchoring guide wire is heat-formed into the curved section, and the proximal end of the folded anchoring guide wire is divided into the straight section.

在一个优选的实施方式中,对折后的所述锚定导丝的所述弯曲段为两根对称的锚定钩丝。更优选的,In a preferred embodiment, the curved section of the anchoring guide wire after being folded in half is two symmetrical anchoring hook wires. More preferably,

在一个优选的实施方式中,所述定位丝在所述折弯处与所述锚定导丝通过打结或滴胶固定连接。In a preferred embodiment, the positioning wire is fixedly connected to the anchoring guide wire at the bend by knotting or glue dripping.

在一个优选的实施方式中,所述固定导丝被对折,对折后的所述固定导丝的近端与所述锚定导丝缠绕打结形成固定导丝结,对折后的所述固定导丝的远端插入所述标记套管内,并在所述标记套管的横截面上与所述锚定导丝呈十字形结构设置,所述固定导丝和所述锚定导丝与所述标记套管过盈配合连接。In a preferred embodiment, the fixed guide wire is folded in half, and the proximal end of the folded fixed guide wire is entangled and knotted with the anchoring guide wire to form a fixed guide wire knot, and the distal end of the folded fixed guide wire is inserted into the marking sleeve, and is arranged in a cross-shaped structure with the anchoring guide wire on the cross section of the marking sleeve, and the fixed guide wire and the anchoring guide wire are connected to the marking sleeve by interference fit.

在一个优选的实施方式中,所述固定导丝结所在的平面垂直于所述折弯处所在的平面。In a preferred embodiment, the plane where the fixed guide wire knot is located is perpendicular to the plane where the bend is located.

在一个优选的实施方式中,所述标记套管的长度为3-10mm,优选为5mm。In a preferred embodiment, the length of the marking sleeve is 3-10 mm, preferably 5 mm.

在一个实施方式中,在所述导引针组件的远端设置有卡扣。In one embodiment, a buckle is provided at the distal end of the introducer needle assembly.

在一个实施方式中,在所述导引针手柄上设置有按钮,所述按钮与推杆固定连接,通过移动所述按钮实现所述定位丝组件的释放。In one embodiment, a button is provided on the guide needle handle, and the button is fixedly connected to the push rod, and the positioning wire assembly is released by moving the button.

在一个实施方式中,所述推杆为中空设计,所述定位丝的近端穿过所述推杆的空腔并延伸到所述推杆的近端外。In one embodiment, the push rod is hollow in design, and the proximal end of the positioning wire passes through the cavity of the push rod and extends outside the proximal end of the push rod.

在一个优选的实施方式中,所述推杆的近端固定连接有推杆手柄。In a preferred embodiment, the proximal end of the push rod is fixedly connected to a push rod handle.

在一个实施方式中,在所述穿刺针管的远端设置有针尖,在所述穿刺针管的管体上设置有刻度线。In one embodiment, a needle tip is provided at the distal end of the puncture needle tube, and scale lines are provided on the tube body of the puncture needle tube.

同现有技术相比,本实用新型具有如下优点:Compared with the prior art, the utility model has the following advantages:

1、本申请的用于乳腺定位的柔性穿刺针设置有标记套管和深度提示套管,标记套管在X光和超声下具有显影功能,标记套管的长度低于市场上常见穿刺针标记套管长度,对患者带来的疼痛感和伤害较小;深度提示套管选用铂铱合金作为原材料,铂铱合金作为常用的心血管植入材料,具有生物亲和性好,在X光或超声下显影性能强的优点,医生在X光或超声下观察穿刺深度时可起到提示作用,方便医生寻找穿刺后定位钩的位置,此外,标记套管和深度提示套管是套接在所述锚定导丝的平直段外侧的,因此均可触摸,可辅助医生确定穿刺深度,或在切除病灶时进行提示。1. The flexible puncture needle for breast positioning of the present application is provided with a marking sleeve and a depth indication sleeve. The marking sleeve has a developing function under X-ray and ultrasound. The length of the marking sleeve is shorter than the length of the marking sleeve of common puncture needles on the market, which causes less pain and harm to patients. The depth indication sleeve uses platinum-iridium alloy as raw material. Platinum-iridium alloy, as a commonly used cardiovascular implant material, has the advantages of good bioaffinity and strong developing performance under X-ray or ultrasound. It can serve as a prompt when the doctor observes the puncture depth under X-ray or ultrasound, making it convenient for the doctor to find the position of the positioning hook after puncture. In addition, the marking sleeve and the depth indication sleeve are sleeved on the outside of the straight section of the anchoring guide wire, so they can be touched, which can assist the doctor in determining the puncture depth or provide prompts when removing the lesion.

2、本申请的用于乳腺定位的柔性穿刺针的固定导丝的两个游离端在标记套管内与锚定导丝的远端在所述标记套管的横截面上呈十字形结构,此时标记套管与固定导丝和锚定导丝过盈配合固定,锚定导丝不会在标记套管内偏转、移位,保证锚定钩丝对称设置,定位钩的锚定性能更优。2. The two free ends of the fixed guide wire of the flexible puncture needle for breast positioning of the present application form a cross-shaped structure in the marking sleeve and the distal end of the anchoring guide wire on the cross-section of the marking sleeve. At this time, the marking sleeve is fixed with the fixed guide wire and the anchoring guide wire by interference fit, and the anchoring guide wire will not deflect or shift in the marking sleeve, ensuring that the anchoring hook wire is symmetrically arranged, and the anchoring performance of the positioning hook is better.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1是本实用新型的用于乳腺定位的柔性穿刺针的整体结构示意图。FIG1 is a schematic diagram of the overall structure of the flexible puncture needle for breast positioning of the present invention.

图2是本实用新型的用于乳腺定位的柔性穿刺针的定位丝组件的结构示意图。FIG. 2 is a schematic structural diagram of a positioning wire assembly of a flexible puncture needle for breast positioning according to the present invention.

图3是本实用新型的定位丝组件中的定位钩的结构示意图。FIG. 3 is a schematic structural diagram of a positioning hook in a positioning wire assembly of the present invention.

图4是本实用新型的定位钩的左视图。FIG. 4 is a left side view of the positioning hook of the present utility model.

图5是本实用新型的用于乳腺定位的柔性穿刺针的导引针组件的结构示意图。FIG5 is a schematic structural diagram of the guide needle assembly of the flexible puncture needle for breast positioning of the present invention.

图6是本实用新型的导引针组件中的穿刺针管的结构示意图。FIG. 6 is a schematic structural diagram of the puncture needle tube in the guide needle assembly of the present invention.

图7是本实用新型的导引针组件中的推杆和推杆手柄的结构示意图。FIG. 7 is a schematic structural diagram of a push rod and a push rod handle in the guide needle assembly of the present invention.

具体实施方式DETAILED DESCRIPTION

以下结合附图和具体实施例对本申请的技术方案和由此带来的优点进行进一步详细描述。其中,附图中的部件并非一定是按比例进行绘制,其重点在于对本申请的构思进行举例说明。The technical solution of the present application and the advantages brought about by it are further described in detail below in conjunction with the accompanying drawings and specific embodiments. Among them, the components in the accompanying drawings are not necessarily drawn to scale, and the focus is on illustrating the concept of the present application.

本申请所述的“近端”是指接近手术操作者的一端,本申请所述的“远端”是指远离手术操作者的一端。The “proximal end” mentioned in the present application refers to the end close to the surgical operator, and the “distal end” mentioned in the present application refers to the end far away from the surgical operator.

如图1所示,一种用于乳腺定位的柔性穿刺针,包括定位丝组件1和导引针组件3,如图2所示,所述定位丝组件1由定位钩11和定位丝12组成,所述定位钩11的近端和所述定位丝12的远端固定连接,所述定位丝12为柔性。如图5所示,所述导引针组件3包括穿刺针管31、导引针手柄33和推杆34,所述穿刺针管31的近端与所述导引针手柄33固定连接。如图1所示,所述穿刺针管31套接在所述定位丝组件1外,所述推杆34被设置在所述穿刺针管31内,所述推杆34的远端与所述定位钩11的近端抵接,用于将所述定位钩11推出所述穿刺针管31外。如图3所示,所述定位钩11包括标记套管111、固定导丝112、深度提示套管113和锚定导丝114,所述定位钩11的长度优选为19.5-22mm,所述锚定导丝114包括平直段1141和弯曲段1142,所述标记套管111和所述深度提示套管113被套接在所述锚定导丝114的平直段1141,所述标记套管111被固定在所述弯曲段1142的近端处,所述深度提示套管113被固定在所述平直段1141的近端部分,所述固定导丝112用于将所述锚定导丝114固定在所述标记套管111内,使得所述锚定导丝114在所述标记套管111内位置固定不发生偏移。所述标记套管111优选为不锈钢制成。As shown in Figure 1, a flexible puncture needle for breast positioning includes a positioning wire assembly 1 and a guide needle assembly 3. As shown in Figure 2, the positioning wire assembly 1 is composed of a positioning hook 11 and a positioning wire 12. The proximal end of the positioning hook 11 is fixedly connected to the distal end of the positioning wire 12, and the positioning wire 12 is flexible. As shown in Figure 5, the guide needle assembly 3 includes a puncture needle tube 31, a guide needle handle 33 and a push rod 34. The proximal end of the puncture needle tube 31 is fixedly connected to the guide needle handle 33. As shown in Figure 1, the puncture needle tube 31 is sleeved outside the positioning wire assembly 1, and the push rod 34 is arranged in the puncture needle tube 31. The distal end of the push rod 34 abuts against the proximal end of the positioning hook 11, and is used to push the positioning hook 11 out of the puncture needle tube 31. As shown in FIG3 , the positioning hook 11 includes a marking sleeve 111, a fixed guide wire 112, a depth indication sleeve 113 and an anchoring guide wire 114. The length of the positioning hook 11 is preferably 19.5-22 mm. The anchoring guide wire 114 includes a straight section 1141 and a curved section 1142. The marking sleeve 111 and the depth indication sleeve 113 are sleeved on the straight section 1141 of the anchoring guide wire 114. The marking sleeve 111 is fixed at the proximal end of the curved section 1142. The depth indication sleeve 113 is fixed at the proximal end of the straight section 1141. The fixed guide wire 112 is used to fix the anchoring guide wire 114 in the marking sleeve 111, so that the anchoring guide wire 114 is fixed in the marking sleeve 111 without displacement. The marking sleeve 111 is preferably made of stainless steel.

所述锚定导丝114由一根形状记忆合金丝对折后构成位于近端的折弯处1143和位于远端的两个游离端,对折后的所述锚定导丝114露出标记套管111的部分被热定型成为所述弯曲段1142,对折后的所述锚定导丝114的近端部分为所述平直段1141。所述折弯处1143优选为圆弧形。在一个实施方式中,对折后的所述锚定导丝114的所述弯曲段1142为两根对称的锚定钩丝1144。优选的,两根锚定钩丝1144呈180度对称设置。所述锚定导丝114优选为镍钛丝,镍钛丝制成的锚定钩丝1144具有良好的记忆性,生物亲和性好,在未使用时候可以将定位钩11收入穿刺针管31内,保护定位钩11不受损伤,释放后的锚定钩丝1141可以迅速恢复,定位钩11的锚定力不受影响。在一个实施方式中,所述定位丝12在所述折弯处1143与所述锚定导丝114通过滴胶固定连接。在其他的实施方式中,打结或所述定位丝12在所述折弯处1143与所述锚定导丝114通过打结固定连接。The anchoring guide wire 114 is formed by folding a shape memory alloy wire in half to form a bend 1143 at the proximal end and two free ends at the distal end. The portion of the anchoring guide wire 114 exposed from the marking sleeve 111 after being folded in half is heat-formed into the curved section 1142, and the proximal portion of the anchoring guide wire 114 after being folded in half is divided into the straight section 1141. The bend 1143 is preferably in an arc shape. In one embodiment, the curved section 1142 of the anchoring guide wire 114 after being folded in half is two symmetrical anchoring hook wires 1144. Preferably, the two anchoring hook wires 1144 are symmetrically arranged at 180 degrees. The anchoring guide wire 114 is preferably a nickel-titanium wire. The anchoring hook wire 1144 made of nickel-titanium wire has good memory and good bioaffinity. When not in use, the positioning hook 11 can be put into the puncture needle tube 31 to protect the positioning hook 11 from damage. The anchoring hook wire 1141 can be quickly restored after release, and the anchoring force of the positioning hook 11 is not affected. In one embodiment, the positioning wire 12 is fixedly connected to the anchoring guide wire 114 at the bend 1143 by glue dripping. In other embodiments, a knot is tied or the positioning wire 12 is fixedly connected to the anchoring guide wire 114 at the bend 1143 by knotting.

如图3所示,所述固定导丝112被对折,对折后的所述固定导丝112的近端与所述锚定导丝114缠绕打结形成固定导丝结1121,如图4所示,对折后的所述固定导丝112的远端插入所述标记套管111内,并在所述标记套管111的横截面上与所述锚定导丝114呈十字形结构设置,所述固定导丝112和所述锚定导丝114与所述标记套管111过盈配合连接。优选的,对折后的所述固定导丝112的远端与所述标记套管111的远端平齐。在制作过程中,固定导丝112的远端插入标记套管111后,固定导丝112露出标记套管111远端的部分可以被剪掉,使得所述固定导丝112的远端与标记套管111的远端平齐。As shown in FIG3 , the fixed guide wire 112 is folded in half, and the proximal end of the folded fixed guide wire 112 is entangled and knotted with the anchoring guide wire 114 to form a fixed guide wire knot 1121. As shown in FIG4 , the distal end of the folded fixed guide wire 112 is inserted into the marking sleeve 111, and is arranged in a cross-shaped structure with the anchoring guide wire 114 on the cross section of the marking sleeve 111, and the fixed guide wire 112 and the anchoring guide wire 114 are connected to the marking sleeve 111 by interference fit. Preferably, the distal end of the folded fixed guide wire 112 is flush with the distal end of the marking sleeve 111. During the manufacturing process, after the distal end of the fixed guide wire 112 is inserted into the marking sleeve 111, the portion of the fixed guide wire 112 exposed at the distal end of the marking sleeve 111 can be cut off, so that the distal end of the fixed guide wire 112 is flush with the distal end of the marking sleeve 111.

在一个实施方式中,固定导丝结1121所在的面垂直于折弯处1143所在的面,使得固定导丝112更牢固地固定锚定导丝114。而且,固定导丝112的远端在标记套管112的横截面上与锚定导丝114呈十字形,使得锚定导丝114不会在标记套管111内偏转、移位,保证锚定钩丝1144处于180度对称位置,定位钩11的锚定性能更优。In one embodiment, the surface where the fixed wire knot 1121 is located is perpendicular to the surface where the bend 1143 is located, so that the fixed wire 112 more firmly fixes the anchoring wire 114. In addition, the distal end of the fixed wire 112 is in a cross shape with the anchoring wire 114 on the cross section of the marking sleeve 112, so that the anchoring wire 114 will not deflect or shift in the marking sleeve 111, ensuring that the anchoring hook wire 1144 is in a 180-degree symmetrical position, and the anchoring performance of the positioning hook 11 is better.

本实用新型的标记套管111在X光和超声下具有显影功能,所述标记套管的长度为3-10mm,优选为5mm。标记套管111长度低于市场上常见穿刺针标记套管长度,对患者带来的疼痛感和伤害较小。深度提示套管113的长度优选为3mm,选用铂铱合金作为原材料,铂铱合金作为常用的心血管植入材料,具有生物亲和性好,在X光或超声下显影性能强的优点,医生在X光或超声下观察穿刺深度时可起到提示作用,方便医生寻找穿刺后定位钩11的位置。而且,标记套管111和深度提示套管113是套接在所述锚定导丝的平直段外的,因此均可触摸,可辅助医生确定穿刺深度,或在切除病灶时进行提示。The marking sleeve 111 of the utility model has a developing function under X-ray and ultrasound, and the length of the marking sleeve is 3-10mm, preferably 5mm. The length of the marking sleeve 111 is lower than the length of the common puncture needle marking sleeve on the market, and the pain and harm caused to the patient are less. The length of the depth prompt sleeve 113 is preferably 3mm, and platinum-iridium alloy is selected as the raw material. Platinum-iridium alloy, as a commonly used cardiovascular implant material, has good bioaffinity and strong developing performance under X-ray or ultrasound. It can serve as a prompt when the doctor observes the puncture depth under X-ray or ultrasound, and it is convenient for the doctor to find the position of the positioning hook 11 after puncture. Moreover, the marking sleeve 111 and the depth prompt sleeve 113 are sleeved outside the straight section of the anchoring guide wire, so they can be touched, which can assist the doctor in determining the puncture depth, or provide prompts when removing the lesion.

本申请的定位丝12是柔性的,选用非吸收性聚丙烯缝合线作为原材料,缝合线作为常用的医疗耗材,具有良好的生物相容性,断裂强度高。定位丝12不做染色处理,对折后通过打结和/或滴胶的方式与定位钩11固定连接,因此,定位丝组件1的定位钩11(19.5-22mm)为刚性,定位丝12为柔性材料。在手术中,定位丝12对患者造成的疼痛感和紧张感较小,且定位丝12为非金属材料,在手术过程中不易传递热量产生局部升温的情况。在一个实施方式中,定位丝12通过打结的方式固定在锚定导丝114的折弯处1143后,还可以通过滴胶再次固定,防止打结位置松散。The positioning wire 12 of the present application is flexible, and non-absorbent polypropylene suture is selected as raw material. Suture, as a commonly used medical consumable, has good biocompatibility and high breaking strength. The positioning wire 12 is not dyed, and is fixedly connected with the positioning hook 11 by knotting and/or dripping glue after being folded in half. Therefore, the positioning hook 11 (19.5-22mm) of the positioning wire assembly 1 is rigid, and the positioning wire 12 is a flexible material. In surgery, the pain and tension caused by the positioning wire 12 to the patient are small, and the positioning wire 12 is a non-metallic material, which is not easy to transfer heat to produce local warming during surgery. In one embodiment, after the positioning wire 12 is fixed to the bend 1143 of the anchoring guide wire 114 by knotting, it can also be fixed again by dripping glue to prevent the knotting position from being loose.

如图5所示,在所述导引针手柄33上设置有按钮32,所述按钮32与推杆34固定连接,通过移动所述按钮32实现所述定位丝组件1的释放。在一个可选的实施方式中,所述导引针手柄33一体注塑成型。所述推杆34为中空设计,所述定位丝12的近端穿过所述推杆34的空腔并延伸到所述推杆34的近端外。如图7所示,所述推杆34的近端固定连接有推杆手柄341。所述推杆34与推杆手柄341可以通过粘接固定连接。所述推杆手柄341也可选择一体注塑成型,在使用时医生可通过推送推杆手柄341的尾端实现定位丝组件1的释放。因此,在使用中,操作者可通过推动按钮32或推杆手柄342向穿刺针管31的针尖311方向推送,具有双重推送结构。As shown in FIG5 , a button 32 is provided on the guide needle handle 33, and the button 32 is fixedly connected to the push rod 34, and the release of the positioning wire assembly 1 is achieved by moving the button 32. In an optional embodiment, the guide needle handle 33 is integrally injection molded. The push rod 34 is a hollow design, and the proximal end of the positioning wire 12 passes through the cavity of the push rod 34 and extends outside the proximal end of the push rod 34. As shown in FIG7 , the proximal end of the push rod 34 is fixedly connected with a push rod handle 341. The push rod 34 and the push rod handle 341 can be fixedly connected by bonding. The push rod handle 341 can also be integrally injection molded, and the doctor can release the positioning wire assembly 1 by pushing the tail end of the push rod handle 341 when in use. Therefore, in use, the operator can push the push rod handle 342 toward the needle tip 311 of the puncture needle tube 31, which has a double push structure.

如图6所示,在所述穿刺针管31的远端设置有针尖311,在所述穿刺针管31的管体上设置有刻度线312。如图5和图6所示,在所述导引针手柄33上设置有方向标记331,所述方向标记331与穿刺针管31的针尖311的方向一致,以便提示医生使用时的推送方向。As shown in Fig. 6, a needle tip 311 is provided at the distal end of the puncture needle tube 31, and a scale line 312 is provided on the tube body of the puncture needle tube 31. As shown in Fig. 5 and Fig. 6, a direction mark 331 is provided on the guide needle handle 33, and the direction mark 331 is consistent with the direction of the needle tip 311 of the puncture needle tube 31, so as to remind the doctor of the pushing direction when using.

在一个实施方式中,如图1所示,在所述导引针组件3的远端设置有卡扣2,在卡扣2未取下时,导引针组件3上按钮33或推杆手柄341无法向穿刺针管的针尖311方向推送。In one embodiment, as shown in FIG. 1 , a buckle 2 is provided at the distal end of the guide needle assembly 3 , and when the buckle 2 is not removed, the button 33 or the push rod handle 341 on the guide needle assembly 3 cannot be pushed toward the needle tip 311 of the puncture needle tube.

以上对本实用新型做了详尽的描述,其目的在于让熟悉此领域技术的人士能够了解本实用新型的内容并加以实施,并不能以此限制本实用新型的保护范围,凡根据本实用新型的精神实质所作的等效变化或修饰,都应涵盖在本实用新型的保护范围内。The above detailed description of the utility model is intended to enable people familiar with the technology in this field to understand the content of the utility model and implement it. It is not intended to limit the protection scope of the utility model. All equivalent changes or modifications made according to the spirit of the utility model should be included in the protection scope of the utility model.

Claims (10)

1. The utility model provides a flexible pjncture needle for mammary gland location, includes location silk subassembly and guide needle subassembly, the location silk subassembly comprises location hook and location silk, the proximal end of location hook with the distal end fixed connection of location silk, the guide needle subassembly includes puncture needle tube, guide needle handle and push rod, the proximal end of puncture needle tube with guide needle handle fixed connection, puncture needle tube cup joints outside the location silk subassembly, the push rod is set up in the puncture needle tube, the distal end of push rod with the proximal end butt of location hook is used for with the location hook is released outside the puncture needle tube, its characterized in that, the location hook is flexible, the location hook includes mark sleeve pipe, fixed seal wire, degree of depth suggestion sleeve pipe and anchor seal wire, the anchor seal wire includes straight section and curved section, mark sleeve pipe with the degree of depth suggestion sleeve pipe is cup jointed the straight section of anchor seal wire, mark sleeve pipe is fixed in the proximal end department of curved section, the degree of depth suggestion sleeve pipe is fixed in the proximal end section, be used for fixing the anchor seal wire in the anchor seal wire.
2. The flexible puncture needle for breast positioning according to claim 1, wherein the anchoring wire is formed by folding a shape memory alloy wire into a bent portion at a proximal end and two free ends at a distal end, a distal end portion of the folded anchoring wire is heat-set into the bent portion, and a proximal end portion of the folded anchoring wire is the flat portion.
3. The flexible penetration needle for breast positioning of claim 2, wherein said curved section of said anchoring guidewire after doubling back is two symmetrical anchoring hooks.
4. A flexible penetration needle for breast positioning according to claim 3, wherein two of said anchoring hooks are symmetrically disposed at 180 degrees.
5. The flexible puncture needle for breast positioning according to claim 2, wherein the fixing guide wire is folded in half, the proximal end of the fixing guide wire folded in half and the anchoring guide wire are wound and knotted to form a fixing guide wire knot, the distal end of the fixing guide wire folded in half is inserted into the marking sleeve and is arranged in a cross structure with the anchoring guide wire on the cross section of the marking sleeve, and the fixing guide wire and the anchoring guide wire are connected with the marking sleeve in an interference fit manner.
6. The flexible penetration needle for breast positioning of claim 5, wherein the plane of the fixed guide wire knot is perpendicular to the plane of the bend.
7. The flexible lance of claim 1 wherein the marker cannula is 3-10mm in length.
8. The flexible penetration needle for breast positioning of claim 1, wherein a catch is provided at the distal end of the introducer needle assembly.
9. The flexible penetration needle for breast positioning according to claim 1, wherein a button is provided on the introducer needle handle, the button being fixedly connected to a push rod, and the release of the wire assembly is accomplished by moving the button.
10. The flexible needle of claim 1, wherein the pushrod is hollow in design and the proximal end of the positioning wire extends through the cavity of the pushrod and out of the proximal end of the pushrod.
CN202420140508.0U 2024-01-19 2024-01-19 A flexible pjncture needle for mammary gland location Active CN221963695U (en)

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