WO2024065874A1 - 一种肺部病灶定位装置和方法 - Google Patents

一种肺部病灶定位装置和方法 Download PDF

Info

Publication number
WO2024065874A1
WO2024065874A1 PCT/CN2022/124544 CN2022124544W WO2024065874A1 WO 2024065874 A1 WO2024065874 A1 WO 2024065874A1 CN 2022124544 W CN2022124544 W CN 2022124544W WO 2024065874 A1 WO2024065874 A1 WO 2024065874A1
Authority
WO
WIPO (PCT)
Prior art keywords
positioning
needle
hook
pushing
lung
Prior art date
Application number
PCT/CN2022/124544
Other languages
English (en)
French (fr)
Inventor
金跃辉
周海燕
殷青
陈建彬
叶波
郑志春
吕依侣
许宽
陈瑭冰
王静
Original Assignee
上海契斯特医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海契斯特医疗器械有限公司 filed Critical 上海契斯特医疗器械有限公司
Publication of WO2024065874A1 publication Critical patent/WO2024065874A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/02—Arrangements for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/03—Computed tomography [CT]
    • A61B6/032—Transmission computed tomography [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3991—Markers, e.g. radio-opaque or breast lesions markers having specific anchoring means to fixate the marker to the tissue, e.g. hooks

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a device and method for locating lung lesions.
  • the location of small lung nodules larger than 1 cm can be determined by naked eye observation and finger palpation.
  • the failure rate of the positioning method through naked eye observation and finger palpation reaches more than 50%, and there is a risk of excessive surgical resection, increasing the risk of patient trauma.
  • preoperative positioning is generally achieved by percutaneous puncture under CT guidance to locate small lung nodules.
  • Common positioning materials include metal materials (hook wire, spiral wire, micro coil), and the commonly used product is a hook-wire with a positioning hook at the end, which can be fixed in the lung.
  • a wire designed for breast diseases is often used as a positioning needle.
  • the wire will be linked. The more firmly the wire is combined with the chest wall, the more likely it is that the positioning hook will shift or fall off.
  • the puncture needle matched with the wire has no needle core, which will aggravate the damage to the lung tissue during the puncture process and increase the incidence of pneumothorax and bleeding;
  • the patient after the wire is positioned, the patient will maintain a fixed position for a long time, which will cause discomfort, limb numbness, pain, etc. Therefore, the patient needs to be transferred to the operating room for surgery as soon as possible, which causes tight turnover in the operating room.
  • the Chinese invention patent specification discloses a new type of lung tumor localization needle. It includes a puncture needle, which is composed of a puncture needle sleeve and a puncture needle handle fixedly connected to the proximal end of the puncture needle sleeve.
  • the lung tumor localization needle 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 fixedly connected to the proximal end of the push tube.
  • the push tube is placed in the puncture needle sleeve, the distal end of the push tube abuts 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 end of the positioning line is provided with a plurality of ribbons of different colors, each of which has a length of 3mm to 15mm.
  • a protective device is provided at the proximal end of the puncture needle, and a U-shaped card slot is provided inside the protective device, and the U-shaped card slot can cooperate with the puncture needle handle.
  • An annular groove is provided at the proximal end of the protective device, and an annular snap ring is fixedly connected to the proximal end of the puncture needle. The annular groove and the annular snap ring are interference fit, and the friction force between the annular snap ring and the annular groove is greater than the dead weight of the protective device, that is, in the absence of external force, the protective device will not loosen from the puncture needle.
  • the operation steps of the new lung tumor localization needle are as follows:
  • the operator grasps the proximal end of the positioning wire with a grasping forceps or other surgical instruments, lifts the positioning wire, and observes the color of the ribbon left on the lung surface by the positioning wire to determine the depth of the lesion. Finally, the lesion is removed by wedge-shaped resection, and the lesion, anchoring positioning needle and positioning wire are removed together.
  • the lung tumor localization needle has the functions of determining the location of the lesion and measuring the depth of the lesion. It can not only lift up the lung or part of the lung to facilitate the surgeon to remove the lesion, but also measure the depth of the lesion during the operation.
  • the device has very high requirements for the operator, and the positioning operation must be successful at one time, that is, in the above-mentioned operation steps, the distal end of the lung tumor positioning needle is sent to the edge of the lesion, and the anchor positioning needle is pushed out of the puncture needle by the pushing device, and the anchor positioning needle must be inserted into the lesion. If a position deviation occurs during the operation so that the anchor positioning needle cannot accurately penetrate the lesion, the anchor positioning needle that has been pushed out of the puncture needle and is in a released and stretched state cannot be withdrawn, let alone a secondary repositioning. The anchor positioning needle that remains in the lungs after such a positioning error can only be removed through subsequent surgery, which will cause greater unnecessary trauma to the patient.
  • the positioning line is left inside the chest wall.
  • the lesion, anchoring positioning needle and positioning line need to be removed together after the lesion is removed. In other words, the positioning line cannot be seen outside the body.
  • the proximal end of the positioning line must be grasped by surgical instruments such as forceps, and the positioning line must be lifted to observe the color of the ribbon left on the lung surface by the positioning line to determine the depth of the lesion. In this process, how to find and grasp the positioning line left inside the chest wall is also difficult.
  • the positioning wire may break if it touches the electric knife during surgery, causing medical problems.
  • the purpose of the present invention is to provide a lung lesion positioning device and method, which mainly solves the technical problems existing in the above-mentioned prior art. It is a device that can repeatedly position multiple times until the positioning is successful. Even if the positioning is wrong, the positioning operation can be withdrawn and re-implemented without causing greater harm to the patient.
  • the present invention is achieved as follows:
  • a lung lesion positioning device comprises a positioning needle, a pushing mechanism, and a positioning mechanism, and is characterized in that it also comprises a handle and a clamping mechanism;
  • the positioning needle is used to puncture and establish a channel
  • the positioning mechanism is an integrally formed component with anchoring, shape memory, body surface fixation, and multiple recovery functions, and includes a positioning hook at the distal end, a coiled wire at the proximal end, and a guide wire in the middle connecting the positioning hook and the coiled wire;
  • the positioning hook is a single-loop or nearly single-loop circular ring structure with a hook tip at the distal end, and its circular ring surface is parallel to the axis in the stretched state;
  • the positioning hook is a relatively hard part of the positioning mechanism, providing anchoring force;
  • the guide wire and the coiled wire are relatively soft parts of the positioning mechanism;
  • the pushing mechanism is used to carry the positioning mechanism, and after the positioning needle is inserted, the positioning mechanism is pushed out or retracted from the channel established by the positioning needle;
  • the handle is used to clamp the positioning needle and the pushing mechanism and define the relative positions of the two;
  • the clamping mechanism is used to clamp the positioning mechanism and play a pulling role when the positioning mechanism is retracted into the positioning needle.
  • the lung lesion positioning device is characterized in that the positioning hook of the positioning mechanism is processed with an identification mark; the identification mark is size or color or color difference.
  • the lung lesion positioning device is characterized in that the outer diameter of the positioning hook at its maximum outer diameter is greater than the maximum outer diameter of the guide wire and the coil wire, and the connection between the positioning hook and the guide wire adopts a slope or arc surface for smooth transition.
  • the lung lesion positioning device is characterized in that the positioning mechanism is integrally formed of a memory metal material.
  • the lung lesion positioning device is characterized in that the needle tube of the positioning needle has scales on the outside.
  • the lung lesion positioning device is characterized in that the pushing mechanism comprises a pushing tube and a pushing head connected to the proximal end of the pushing tube, the pushing head comprises a channel connected to the pushing tube, and the channel is used to penetrate the positioning mechanism.
  • the lung lesion positioning device is characterized in that the push tube has scales on the outside.
  • the lung lesion positioning device is characterized in that the clamping mechanism is a clamping forceps.
  • a method for locating a lung lesion is characterized by being implemented using the lung lesion locating device as described above, and the specific steps are:
  • the operator punctures the chest wall with the positioning needle fixed in step B above, punctures into the lung, and delivers the distal end of the positioning needle to the edge of the lesion;
  • step D If the positioning hook does not accurately penetrate the lesion after step D, perform the following operations:
  • the clamping mechanism is used to clamp the positioning mechanism exposed outside the proximal end of the pushing mechanism; the pushing mechanism and the clamping mechanism are pulled toward the proximal end together, so that the positioning hook of the positioning mechanism is retracted into the positioning needle;
  • the present invention has the following advantages:
  • the anchoring component positioning hook
  • the specially designed positioning mechanism and pushing device of the device of the present invention are the key to implementing this operation.
  • the positioning mechanism of the present invention is flexible, and its marking part (coiled wire) can be left outside the body and firmly attached to the body surface by a patch, which can also reduce the fear and pain brought to the patient.
  • the positioning mechanism of the present invention will not break if it accidentally touches surgical instruments such as electric knife and electric hook during surgery.
  • the positioning hook of the positioning mechanism of the present invention can be pulled from a relatively deep part of the lung to a relatively surface of the lung during lung resection surgery without causing too much damage to the lung.
  • the positioning hook is marked with a color to indicate that it has reached the vicinity of the lung surface, which is convenient for doctors to operate. Otherwise, the positioning device may break in the lung when removing lung tissue, causing medical problems.
  • FIG. 1 is a schematic diagram of the structure of the present invention (excluding the clamping mechanism).
  • FIG. 2 is a schematic structural diagram of a positioning pin in the present invention.
  • FIG. 3 is a schematic structural diagram of the positioning mechanism in the present invention.
  • FIG. 4 is a schematic diagram of the structure of the pushing mechanism in the present invention.
  • FIG. 5 is a schematic structural diagram of the clamping mechanism of the present invention.
  • the present invention discloses a lung lesion positioning device, which includes a positioning needle 1 , a pushing mechanism 2 , and a positioning mechanism 4 .
  • the device is characterized in that it also includes a handle 3 and a clamping mechanism 5 .
  • the positioning needle 1 is used for puncturing and establishing a channel, and comprises a needle body 11 with a needle tip at the distal end and an end 12 connected to the needle body 11.
  • the needle tube of the positioning needle 1 has a scale outside, which is convenient for the operator to confirm the depth of the positioning needle 1 inserted into the human body.
  • the positioning mechanism 4 is an integrally formed component with anchoring, shape memory, body surface fixation, and multiple recovery functions, and includes a positioning hook 4.1 at the distal end, a coiled wire 4.3 at the proximal end, and a guide wire 4.2 located in the middle and connecting the positioning hook 4.1 and the coiled wire 4.3;
  • the positioning hook 4.1 is a circular ring structure with a hook tip at the distal end of a single turn or a nearly single turn, and its circular ring surface is parallel to the axis of 4.2 in the stretched state;
  • the positioning hook 4.1 is a relatively hard part of the positioning mechanism 4, providing anchoring force;
  • the guide wire 4.2 and the coiled wire 4.3 are relatively soft parts of the positioning mechanism 4.
  • the positioning hook 4.1 is a circular ring structure with a hook tip at the distal end of a single turn or a nearly single turn, and its circular ring surface is parallel to the axis of 4.2 in the stretched state, so as to facilitate the retraction of the distal positioning hook 4.1 into the positioning needle 1 through the pushing mechanism 2.
  • This shape encounters less resistance during retraction and will not cause significant damage to the positioned part.
  • the positioning hook 4.1 of the positioning mechanism 4 is processed with identification marks; the identification marks are size, color or color difference.
  • color processing can be used to pull the positioning hook from a relatively deep part of the lung to a relatively surface of the lung during lung resection surgery without causing too much damage to the lung.
  • the color marks that the positioning hook has reached the surface of the lung which is convenient for doctors to operate.
  • the outer diameter of the locating hook 4.1 at its maximum outer diameter is greater than the maximum outer diameters of the guide wire 4.2 and the coil wire 4.3.
  • the connection between the locating hook 4.1 and the guide wire 4.2 adopts a bevel or arc surface for a smooth transition, which is conducive to the recovery of the locating hook 4.1.
  • the positioning mechanism 4 is generally formed in one piece from a memory metal material.
  • the pushing mechanism 2 is used to carry the positioning mechanism 4, and after the positioning needle 1 is inserted, the positioning mechanism 4 is pushed out or retracted from the channel established by the positioning needle 1.
  • the pushing mechanism 2 comprises a pushing tube 21 and a pushing head 22 connected to the proximal end of the pushing tube 21, and the pushing head 22 has a channel connected to the pushing tube 21, and the channel is used to penetrate the positioning mechanism 4.
  • the pushing tube 21 has a scale on the outside, which is convenient for the doctor to confirm that the positioning hook 4.1 of the positioning mechanism 4 is completely retracted into the cavity of the positioning needle 1, and a secondary puncture operation can be performed.
  • the handle 3 is used to clamp the positioning needle 1 and the pushing mechanism 2 and define the relative positions of the two; in particular, by clamping the pushing head 22 of the pushing mechanism 2 and the end 12 of the positioning needle 1 .
  • the clamping mechanism 5 is used to clamp the positioning mechanism 4 and play a pulling role when the positioning mechanism 4 is retracted into the positioning needle 1.
  • the clamping mechanism 5 can be a clamping forceps, as shown in Figure 5.
  • the present invention also discloses a lung lesion localization method, which is implemented by using the lung lesion localization device as described above, and the specific steps are:
  • the operator punctures the chest wall with the positioning needle 1 fixed in step B above, punctures into the lung, and delivers the distal end of the positioning needle 1 to the edge of the lesion;
  • the operator releases the limit of the handle 3 on the clamping positioning needle 1 and the pushing mechanism 2, and pushes the positioning hook 4.1 of the positioning mechanism 4 out of the positioning needle 1 through the pushing mechanism 2, and the positioning hook 4.1 is inserted into the lesion;
  • the coiled wire 4.3 is in the shape of a pigtail, with a more compact structure, and is easier to stick to the body surface with a patch, which can also reduce the fear and pain brought to the patient.
  • the biggest difference between the device of the present invention and the existing device is that when the first positioning is inaccurate, a re-positioning operation is performed. Specifically, when the positioning hook 4.1 is not accurately inserted into the lesion after the step D operation, the following operations are performed:
  • the clamping mechanism 5 is used to clamp the positioning mechanism 4 exposed outside the proximal end of the pushing mechanism 2; the pushing mechanism 2 and the clamping mechanism 5 are pulled together toward the proximal direction, so that the positioning hook 4.1 of the positioning mechanism 4 is retracted into the positioning needle 1;

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Theoretical Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pulmonology (AREA)
  • Surgical Instruments (AREA)

Abstract

一种肺部病灶定位装置和方法。该装置包括定位针（1）、推送机构（2）、定位机构（4）、手柄（3）和夹持机构（5）；定位针（1）用于穿刺并建立通道；定位机构（4）包括位于远端的定位钩（4.1）、位于近端的盘丝（4.3）和导丝（4.2）；定位钩（4.1）是单圈或接近单圈的远端具有钩尖的圆环结构，其圆环面与拉伸状态时的轴线平行；定位钩（4.1）是定位机构（4）上相对较硬的部分，提供锚定力；导丝（4.2）和盘丝（4.3）是定位机构（4）上相对较软的部分；推送机构（2）用于携带定位机构（4），并穿入定位针（1）后从定位针（1）建立的通道将定位机构（4）推出或收回定位机构（4）；手柄（3）用于夹持定位针（1）和推送机构（2），并限定二者的相对位置；夹持机构（5）用于回收定位机构（4）入定位针（1）时夹持定位机构（4）并起拉驰作用。该装置是一种可以反复多次定位直至定位成功的装置，即便定位失误也可以撤回后重新实施定位操作，不会对患者造成较大伤害。

Description

一种肺部病灶定位装置和方法 技术领域
本发明涉及医疗器械技术领域，特别是一种肺部病灶定位装置和方法。
背景技术
随着影像诊断技术发展，使得早期肺部病变的发现变得越来越早，越来越容易，而需要外科治疗的肺小结节的检出率也越来越容易。目前尺寸大于1cm的肺小结节，能够通过肉眼观察和手指触诊的定位方法确定肺小结节的位置，但是当肺小结节的尺寸小于或等于1cm时，通过肉眼观察和手指触诊的定位方法失败率达到50％以上，并且存在手术切除范围过大，加大患者创伤的风险。
目前，术前定位一般通过CT引导下经皮穿刺实现肺小结节定位，常用定位材料包括金属材料(带钩金属丝、螺旋金属丝、微弹簧圈)，常用产品为末端带定位钩的金属丝(Hook-wire)，其定位钩能够固定在肺内，但一款为乳腺疾病设计的金属丝常被用作定位针，在肺小结节定位过程中，存在缺陷：第一，金属丝末端只有倒钩状的定位钩，且金属丝前端部分固定于胸壁，由于呼吸运动会导致金属丝的联动作用，金属丝与胸壁结合越牢固，越容易发生定位钩出现移位、脱落风险；第二，与金属丝配套的穿刺针没有针芯，在穿刺过程中会加重肺组织的损伤，增加气胸、出血的发生率；第三，金属丝定位后，患者长时间保持固定体位会引起不适，出现肢体麻木、疼痛等，因此需要尽快将患者转送手术室进行手术，这造成手术室周转紧张。
为此，中国发明专利说明书(CN105011989B)公开了一种新型的肺肿瘤定位针。它包括穿刺针，所述穿刺针由穿刺针套管和与所述穿刺针套管的近端固定连接的穿刺针手柄组成，所述肺肿瘤定位针还包括锚定定位针、定位线和 推送装置，所述推送装置包括推管和与所述推管的近端固定连接的推管手柄，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。另外，所述穿刺针的近端设置有一个保护装置，所述保护装置内部为一个U型卡槽，所述U型卡槽能够与所述穿刺针手柄配合。所述的保护装置的近端设置有环形卡槽，所述穿刺针的近端固定连接一个环形卡环，所述环形卡槽与所述环形卡环为过盈配合，所述环形卡环与所述环形卡槽配合的摩擦力大于所述保护装置的自重，即在无外力作用下，所述保护装置不会从所述穿刺针松脱。
该新型肺肿瘤定位针的操作步骤如下：
a)在CT引导下，操作者通过所述穿刺针穿刺胸壁，穿刺进入肺，最终将所述肺肿瘤定位针的远端送至病灶边缘；
b)操作者解除所述保护装置，通过所述推送装置将所述锚定定位针从所述穿刺针内推出，所述的锚定定位针扎入所述病灶；
c)操作者将所述推送装置从所述穿刺针内抽出；
d)操作者将所述穿刺针从肺中拔出到胸壁边缘，再将所述推送装置插入所述穿刺针内，将所述定位线从所述穿刺针内推出，推送至胸腔；
e)操作者将所述穿刺针从胸壁拔出，体表消毒，送入手术室。
f)在电视胸腔镜下，操作者通过抓钳等手术器械抓住定位线近端，提起定位线，并观察定位线留在肺表面的色带颜色，确定病灶深度。最终通过锲形切除将病灶切除，并将病灶和锚定定位针及定位线一起取出。
因此，该肺肿瘤定位针同时具备确定病灶定位和测量病灶深度功能，不仅能够将肺或者肺的部分提拉起来，方便术者对病灶进行切除，而且能在术中测量病灶的深度。
但是，在实际使用过程中，我们发现这种肺肿瘤定位针具有较大缺陷，具体是：
1、该装置对操作者的要求很高，定位操作必须一次性成功，即上述操作步骤中，肺肿瘤定位针的远端送至病灶边缘，通过所述推送装置将所述锚定定位针从所述穿刺针内推出，所述的锚定定位针必须扎入所述病灶。如果操作时产生位置偏差使锚定定位针无法准确扎入所述病灶，已经从穿刺针内推出的且呈释放撑开状态的锚定定位针是无法撤回的，更不用说去实施进行二次重新定位。对于这种定位失误后留在肺部的锚定定位针只能通过后续的手术取出，这样就会对患者造成更大的不必要的创伤。况且，患者原有的病灶仍然是需要手术，此时只能另外准备一套肺肿瘤定位针重复进行上述操作步骤，直至定位和手术成功，其又会额外增加手术成本和患者的经济负担。
因此，从这个层面上来看，我们需要实现一种可以实施多次定位的装置(即一次定位失误后，可以回收锚定定位针并进行重新定位)，且其操作过程中不会对患者造成较大伤害。
2、该装置在实施定位操作后，其定位线是留在胸壁内的，需要通过病灶切除后，将病灶和锚定定位针及定位线一起取出。也就是说，该定位线是无法在体外看到的，手术时必须通过抓钳等手术器械抓住定位线近端，提起定位线来观察定位线留在肺表面的色带颜色，确定病灶深度。在这个过程中，如何去找到和抓住留在胸壁内的定位线也有一定的操作难度。
3、该定位线在手术时碰到电刀会断裂，造成医疗问题。
发明内容
本发明的目的在于提供一种肺部病灶定位装置和方法，它主要解决上述现有技术所存在的技术问题，它是一种可以反复多次定位直至定位成功的装置，即便定位失误也可以撤回后重新实施定位操作，不会对患者造成较大伤害。
为解决上述技术问题，本发明是这样实现的：
一种肺部病灶定位装置，它包括定位针、推送机构、定位机构，其特征在于：它还包括手柄和夹持机构；
该定位针用于穿刺并建立通道；
该定位机构是一体形成的具有锚定、形状记忆、体表固定、多次回收作用部件，它包括位于远端的定位钩、位于近端的盘丝和位于中间的连接定位钩和盘丝的导丝；该定位钩是单圈或接近单圈的远端具有钩尖的圆环结构，其圆环面与拉伸状态时的轴线平行；该定位钩是定位机构上相对较硬的部分，提供锚定力；该导丝和盘丝是定位机构上相对较软的部分；
该推送机构用于携带定位机构，并穿入定位针后从定位针建立的通道将定位机构推出或收回定位机构；
该手柄用于夹持定位针和推送机构，并限定二者的相对位置；
该夹持机构用于回收定位机构入定位针时夹持定位机构并起拉驰作用。
所述的肺部病灶定位装置，其特征在于：该定位机构的定位钩进行识别标志处理；该识别标志是尺寸或颜色或色差。
所述的肺部病灶定位装置，其特征在于：该定位钩最大外径处的外径大于导丝和盘丝的最大外径，该定位钩与导丝的衔接处采用斜面或者弧面平缓过渡。
所述的肺部病灶定位装置，其特征在于：该定位机构是由记忆金属材料一体形成。
所述的肺部病灶定位装置，其特征在于：该定位针的针管外具有刻度。
所述的肺部病灶定位装置，其特征在于：该推送机构具有推送管和推送管近端连接的推头，该推头上具有与推送管连通的通道，该通道用于穿入定位机构。
所述的肺部病灶定位装置，其特征在于：该推送管外具有刻度。
所述的肺部病灶定位装置，其特征在于：该夹持机构为夹持钳。
一种肺部病灶定位方法，其特征在于：采用如上所述的肺部病灶定位装置进行实施，具体步骤是：
A、将该定位机构穿入定位针后再穿入推送机构中，并确保定位机构的定位钩位于入推送机构的远端、盘丝位于推送机构的近端外；
B、采用手柄夹持定位针和推送机构，并限定二者的相对位置；
C、在CT引导下，操作者将上述步骤B所固定后的定位针穿刺胸壁，穿刺进入肺，将定位针的远端送至病灶边缘；
D、操作者解除手柄对夹持定位针和推送机构的限位，通过推送机构将定位机构的定位钩从定位针内推出，定位钩扎入病灶；
E、操作者将推送机构和定位针从肺中拔出到胸壁外，此时，定位机构的定位钩仍处于扎入病灶的状态，定位机构的盘丝露出体表外；
F、用贴敷类物品将露出体表外的盘丝进行体表固定和隐藏。
所述的肺部病灶定位方法，其特征在于：
当步骤D操作后，定位钩并未准确扎入病灶，则实施如下操作：
采用夹持机构夹住露出于推送机构的近端外的定位机构；将推送机构连同夹持机构一同向近端方向拉驰，使定位机构的定位钩重新回收到定位针内；
重复实施上述步骤C-F。
本发明与现有技术相比，具有如下优点：
1、采用本发明的定位装置和定位方法，在一次定位不准的情况下，还可以实施收回锚定部件(定位钩)后再次定位，通过本发明装置特殊设计的定位机构和推送装置是可以实施该操作的关键。
2、相较于乳腺定位针，有一根硬质直金属伸出体表，给与患者恐惧和疼痛感。采用本发明的定位机构柔韧，其标识部(盘丝)可以留在体外，并采用敷贴类贴牢于体表，这样还能减少给患者带来的恐惧和疼痛。
3、本发明的定位机构，在手术中不经意间碰到电刀、电钩等手术器械不断裂。
4、本发明定位机构的定位钩可以在肺切除手术时从肺内相对深处拉至肺内相对表面，不造成肺太大伤害，有颜色标识出定位钩已至肺表面附近，方便医生操作；否则的话，在切除肺组织时可能造成定位装置断裂于肺内，造成医疗问题。
附图说明
图1是本发明的结构示意图(夹持机构除外)。
图2是本发明中定位针的结构示意图。
图3是本发明中定位机构的结构示意图。
图4是本发明中推送机构的结构示意图。
图5是本发明中夹持机构的结构示意图。
具体实施方式
请参阅图1，本发明公开了一种肺部病灶定位装置，它包括定位针1、推送机构2、定位机构4，其特征在于：它还包括手柄3和夹持机构5。
如图2所示，该定位针1用于穿刺并建立通道，它包括远端具有针尖的针 体11和连接针体11的端部12。该定位针1的针管外具有刻度，便于操作者确认定位针1插入人体的深度。
如图3所示，该定位机构4是一体形成的具有锚定、形状记忆、体表固定、多次回收作用部件，它包括位于远端的定位钩4.1、位于近端的盘丝4.3和位于中间的连接定位钩4.1和盘丝4.3的导丝4.2；该定位钩4.1是单圈或接近单圈的远端具有钩尖的圆环结构，其圆环面与拉伸状态时4.2的轴线平行；该定位钩4.1是定位机构4上相对较硬的部分，提供锚定力；该导丝4.2和盘丝4.3是定位机构4上相对较软的部分。其中：定位钩4.1是单圈或接近单圈的远端就够钩尖的圆环结构，其圆环面与拉伸状态时4.2的轴线平行，是便于将远端的定位钩4.1通过推送机构2收回到定位针1内，这种形状在收回时遇到的阻力较小，不会对被定位的部位产生较大伤害。
作为优选结构，该定位机构4的定位钩4.1进行进行识别标志处理；该识别标志是尺寸或颜色或色差。比如：颜色处理，可以在肺切除手术时从肺内相对深处拉至肺内相对表面，不造成肺太大伤害，有颜色标识出定位钩已至肺表面附近，方便医生操作。
作为优选结构，该定位钩4.1最大外径处的外径大于导丝4.2和盘丝4.3的最大外径，该定位钩4.1与导丝4.2的衔接处采用斜面或者弧面平缓过渡，有利于定位钩4.1的回收。
本发明中，该定位机构4一般是由记忆金属材料一体形成。
如图4所示，该推送机构2用于携带定位机构4，并穿入定位针1后从定位针1建立的通道将定位机构4推出或收回定位机构4。该推送机构2具有推送管21和推送管21近端连接的推头22，该推头22上具有与推送管21连通的通道，该通道用于穿入定位机构4。该推送管21外具有刻度，便于医生确 认定位机构4的定位钩4.1完全回收至定位针1的腔道内，可以进行二次穿刺操作。
该手柄3用于夹持定位针1和推送机构2，并限定二者的相对位置；特别是通过夹持推送机构2的推头22和定位针1的端部12。
该夹持机构5用于回收定位机构4入定位针1时夹持定位机构4并起拉驰作用。该夹持机构5可以采用夹持钳，如图5。
本发明还公开了一种肺部病灶定位方法，采用如上所述的肺部病灶定位装置进行实施，具体步骤是：
A、将该定位机构4穿入定位针1后再穿入推送机构2中，并确保定位机构4的定位钩4.1位于入推送机构2的远端、盘丝4.3位于推送机构2的近端外；
B、采用手柄3夹持定位针1和推送机构2，并限定二者的相对位置；
C、在CT引导下，操作者将上述步骤B所固定后的定位针1穿刺胸壁，穿刺进入肺，将定位针1的远端送至病灶边缘；
D、操作者解除手柄3对夹持定位针1和推送机构2的限位，通过推送机构2将定位机构4的定位钩4.1从定位针1内推出，定位钩4.1扎入病灶；
E、操作者将推送机构2和定位针1从肺中拔出到胸壁外，此时，定位机构4的定位钩4.1仍处于扎入病灶的状态，定位机构4的盘丝4.3露出体表外；
F、用贴敷类物品将露出体表外的盘丝4.3进行体表固定和隐藏，这个是与现有技术较大的不同，且较软的盘丝4.3使得体表用敷贴类，可完全隐藏掉，使得患者更加舒适；盘丝4.3为猪尾巴状，结构更小巧、更加容易用敷贴类贴牢于体表，这样还能减少给患者带来的恐惧和疼痛。
本发明装置与现有装置最大的不同点就是在一次定位不准时，进行再次定 位操作。具体的，当步骤D操作后，定位钩4.1并未准确扎入病灶，则实施如下操作：
采用夹持机构5夹住露出于推送机构2的近端外的定位机构4；将推送机构2连同夹持机构5一同向近端方向拉驰，使定位机构4的定位钩4.1重新回收到定位针1内；
重复实施上述步骤C-F。
综上所述仅为本发明的较佳实施例而已，并非用来限定本发明的实施范围。即凡依本发明申请专利范围的内容所作的等效变化与修饰，都应为本发明的技术范畴。

Claims (10)

  1. 一种肺部病灶定位装置，它包括定位针(1)、推送机构(2)、定位机构(4)，其特征在于：它还包括手柄(3)和夹持机构(5)；
    该定位针(1)用于穿刺并建立通道；
    该定位机构(4)是一体形成的具有锚定、形状记忆、体表固定、多次回收作用部件，它包括位于远端的定位钩(4.1)、位于近端的盘丝(4.3)和位于中间的连接定位钩(4.1)和盘丝(4.3)的导丝(4.2)；该定位钩(4.1)是单圈或接近单圈的远端具有钩尖的圆环结构，其圆环面与拉伸状态时(4.2)的轴线平行；该定位钩(4.1)是定位机构(4)上相对较硬的部分，提供锚定力；该导丝(4.2)和盘丝(4.3)是定位机构(4)上相对较软的部分；
    该推送机构(2)用于携带定位机构(4)，并穿入定位针(1)后从定位针(1)建立的通道将定位机构(4)推出或收回定位机构(4)；
    该手柄(3)用于夹持定位针(1)和推送机构(2)，并限定二者的相对位置；
    该夹持机构(5)用于回收定位机构(4)入定位针(1)时夹持定位机构(4)并起拉驰作用。
  2. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该定位机构(4)的定位钩(4.1)进行识别标志处理；该识别标志是尺寸或颜色或色差。
  3. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该定位钩(4.1)最大外径处的外径大于导丝(4.2)和盘丝(4.3)的最大外径，该定位钩(4.1)与导丝(4.2)的衔接处采用斜面或者弧面平缓过渡。
  4. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该定位机构(4)是由记忆金属材料一体形成。
  5. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该定位针(1)的针管外具有刻度。
  6. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该推送机构(2)具有推送管(21)和推送管(21)近端连接的推头(22)，该推头(22)上具有与推送管(21)连通的通道，该通道用于穿入定位机构(4)。
  7. 根据权利要求6所述的肺部病灶定位装置，其特征在于：该推送管(21)外具有刻度。
  8. 根据权利要求1所述的肺部病灶定位装置，其特征在于：该夹持机构(5)为夹持钳。
  9. 一种肺部病灶定位方法，其特征在于：采用如权利要求1或2或3或4或5或6或7或8所述的肺部病灶定位装置进行实施，具体步骤是：
    A、将该定位机构(4)穿入定位针(1)后再穿入推送机构(2)中，并确保定位机构(4)的定位钩(4.1)位于入推送机构(2)的远端、盘丝(4.3)位于推送机构(2)的近端外；
    B、采用手柄(3)夹持定位针(1)和推送机构(2)，并限定二者的相对位置；
    C、在CT引导下，操作者将上述步骤B所固定后的定位针(1)穿刺胸壁，穿刺进入肺，将定位针(1)的远端送至病灶边缘；
    D、操作者解除手柄(3)对夹持定位针(1)和推送机构(2)的限位，通过推送机构(2)将定位机构(4)的定位钩(4.1)从定位针(1)内推出，定位钩(4.1)扎入病灶；
    E、操作者将推送机构(2)和定位针(1)从肺中拔出到胸壁外，此时，定位机构(4)的定位钩(4.1)仍处于扎入病灶的状态，定位机构(4)的盘 丝(4.3)露出体表外；
    F、用贴敷类物品将露出体表外的盘丝(4.3)进行体表固定和隐藏。
  10. 根据权利要求9所述的肺部病灶定位方法，其特征在于：
    当步骤D操作后，定位钩(4.1)并未准确扎入病灶，则实施如下操作：
    采用夹持机构(5)夹住露出于推送机构(2)的近端外的定位机构(4)；将推送机构(2)连同夹持机构(5)一同向近端方向拉驰，使定位机构(4)的定位钩(4.1)重新回收到定位针(1)内；
    重复实施上述步骤C-F。
PCT/CN2022/124544 2022-09-30 2022-10-11 一种肺部病灶定位装置和方法 WO2024065874A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211205265.6 2022-09-30
CN202211205265.6A CN115530936A (zh) 2022-09-30 2022-09-30 一种肺部病灶定位装置和方法

Publications (1)

Publication Number Publication Date
WO2024065874A1 true WO2024065874A1 (zh) 2024-04-04

Family

ID=84731890

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/124544 WO2024065874A1 (zh) 2022-09-30 2022-10-11 一种肺部病灶定位装置和方法

Country Status (2)

Country Link
CN (1) CN115530936A (zh)
WO (1) WO2024065874A1 (zh)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6053925A (en) * 1998-02-27 2000-04-25 Barnhart; William H. Lesion localization device and method
CN204016436U (zh) * 2014-08-14 2014-12-17 王谦 一种肺小结节穿刺定位针
CN105011989A (zh) * 2015-08-14 2015-11-04 宁波胜杰康生物科技有限公司 一种新型的肺肿瘤定位针
US20180078328A1 (en) * 2016-09-16 2018-03-22 Regents Of The University Of Minnesota Pre-surgical pulmonary nodule localization systems and methods
US20190183600A1 (en) * 2017-11-22 2019-06-20 Laurent Fumex Device for anchoring and identifying multiple suspected lesions anchoring devices
CN113017792A (zh) * 2021-02-26 2021-06-25 德迈特医学技术（北京）有限公司 肺小结节穿刺定位装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6053925A (en) * 1998-02-27 2000-04-25 Barnhart; William H. Lesion localization device and method
CN204016436U (zh) * 2014-08-14 2014-12-17 王谦 一种肺小结节穿刺定位针
CN105011989A (zh) * 2015-08-14 2015-11-04 宁波胜杰康生物科技有限公司 一种新型的肺肿瘤定位针
US20180078328A1 (en) * 2016-09-16 2018-03-22 Regents Of The University Of Minnesota Pre-surgical pulmonary nodule localization systems and methods
US20190183600A1 (en) * 2017-11-22 2019-06-20 Laurent Fumex Device for anchoring and identifying multiple suspected lesions anchoring devices
CN113017792A (zh) * 2021-02-26 2021-06-25 德迈特医学技术（北京）有限公司 肺小结节穿刺定位装置

Also Published As

Publication number Publication date
CN115530936A (zh) 2022-12-30

Similar Documents

Publication Publication Date Title
US10792022B2 (en) Tissue sampling devices, systems and methods
US4790329A (en) Adjustable biopsy localization device
CN105011989B (zh) 一种新型的肺肿瘤定位针
US5221269A (en) Guide for localizing a nonpalpable breast lesion
CA2141023C (en) Percutaneous gastrostomy feeding tube applicator and method
JP5542771B2 (ja) 経皮的進入装置及び方法
US20100324573A1 (en) Surgical closure instrument and methods
WO1998046142A1 (en) Needle assembly and method for passing suture
WO1998046142A9 (en) Needle assembly and method for passing suture
CA3111301C (en) Stone extraction basket and double lumen end cap for stone extraction basket
WO2024065874A1 (zh) 一种肺部病灶定位装置和方法
CN211271051U (zh) 腹腔镜悬吊引导针
KR102115663B1 (ko) 복강경 수술용 병변 마킹 시스템
EP3038538A1 (en) Apparatus and method for fascial closure device for laparoscopic trocar port site and surgery
CN218419993U (zh) 一种用于乳腺定位的穿刺针
CN213190057U (zh) 一种用于内膜开窗的装置
CN214049003U (zh) 一种用于肺结节胸腔镜术前的定位针
CN217593004U (zh) 一种穿刺设备
CN109431619A (zh) 手术中的定位标记装置
CN215688521U (zh) 一种乳腺肿物定位装置
CN217338745U (zh) 一种经皮介入套件
CN219645793U (zh) 带可识别标识的腹壁缝合器
CN217907865U (zh) 一次性使用穿刺导入针
US20230285047A1 (en) Introduction device for the percutaneous introduction of drainage tubes, in particular thoracic drainage tubes
CN113855264A (zh) 一种穿刺定位递送装置和穿刺定位装置

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22960478

Country of ref document: EP

Kind code of ref document: A1