WO2017162126A1 - 肺内标记物 - Google Patents

肺内标记物 Download PDF

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Publication number
WO2017162126A1
WO2017162126A1 PCT/CN2017/077423 CN2017077423W WO2017162126A1 WO 2017162126 A1 WO2017162126 A1 WO 2017162126A1 CN 2017077423 W CN2017077423 W CN 2017077423W WO 2017162126 A1 WO2017162126 A1 WO 2017162126A1
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WO
WIPO (PCT)
Prior art keywords
self
intrapulmonary
marker
expanding structure
lesion
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PCT/CN2017/077423
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English (en)
French (fr)
Inventor
赫捷
孙非
王永胜
刘世信
訾振军
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Broncus Medical China Co Ltd
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Broncus Medical China Co Ltd
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Application filed by Broncus Medical China Co Ltd filed Critical Broncus Medical China Co Ltd
Priority to EP17769403.1A priority Critical patent/EP3434220A4/en
Priority to JP2019500717A priority patent/JP2019520922A/ja
Publication of WO2017162126A1 publication Critical patent/WO2017162126A1/zh
Priority to US16/138,372 priority patent/US11207151B2/en
Anticipated expiration legal-status Critical
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    • 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
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00809—Lung operations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3912—Body cavities
    • 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
    • A61B2090/3962—Markers, e.g. radio-opaque or breast lesions markers palpable

Definitions

  • the invention relates to the field of medical devices, in particular to an intrapulmonary marker.
  • the object of the present invention is to overcome the defects of the prior art and provide an intrapulmonary marker, which solves the problem that the existing surgery relies on expanding the scope of resection to ensure the radical treatment of the lesion, and seriously reduces the quality of life of the patient and reduces the postoperative life of the patient. Problems such as life expectancy.
  • the present invention relates to an intrapulmonary marker for marking a lesion site of the lung, the intrapulmonary marker comprising a self-expanding structure that is radially expandable upon release from the compression device to effect labeling.
  • the intrapulmonary marker of the present invention adopts a self-expanding structure, and when a lesion is found in a lung examination, it can be transported to a lesion position by a compression device (such as a general-purpose catheter or a dedicated delivery device), and can be released after being expanded at the lesion position. It is fixed in situ, which can help doctors to accurately and quickly locate the lesion with the finger, shorten the operation time, reduce the scope of resection, improve the quality of life after surgery, and avoid the risk of reducing the life expectancy of the patient.
  • a compression device such as a general-purpose catheter or a dedicated delivery device
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure is woven from a memory alloy.
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure has a convex convex lens shape.
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure has a biconvex convex lens shape.
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure is provided with a cuff end away from the distal end surface of the release opening of the compression device.
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure is provided with a cuff end near the proximal end face of the release opening of the compression device.
  • a further improvement of the intrapulmonary marker of the present invention is that the self-expanding structure is spherical.
  • Fig. 1 is a top perspective view showing the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention after expansion.
  • Fig. 2 is a schematic view showing the structure of the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention before expansion.
  • Figure 3 is a side elevational view of the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention after inflation.
  • Figure 4 is a top plan view of the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention after expansion.
  • Fig. 5 is a bottom perspective view showing the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention after inflation.
  • Fig. 6 is a schematic view showing the structure of the self-expanding structure of the second embodiment of the intrapulmonary marker of the present invention after expansion.
  • Fig. 7 is a schematic view showing the structure of the self-expanding structure of the third embodiment of the intrapulmonary marker of the present invention after expansion.
  • Fig. 8 is a view showing the state in which the intrapulmonary marker of the present invention realizes the marking function in the lungs.
  • the present invention provides an intrapulmonary marker for marking the location of a lesion in the lung, which facilitates the doctor to quickly find the location of the lesion during surgery.
  • Lung internal standard of the present invention The record is an elastic self-expanding structure made of a memory alloy. With the elasticity of the self-expanding structure, when the marker is transported by a compression device (such as a universal catheter or a dedicated delivery device), the marker is strip-shaped. After being sent to the lungs, the catheter is pushed out. Since the memory alloy has the property of restoring the original shape, and the density of the lung tissue is extremely small, the self-expanding structure self-expands to the original shape, thereby being pinched in the lesion position, thereby playing the identification. The role.
  • the structure of the intrapulmonary marker of the present invention will now be described with reference to the accompanying drawings.
  • FIG. 1 there is shown a top perspective view of the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention after expansion.
  • the intrapulmonary markers of the present invention will now be described with reference to Fig. 1.
  • the intrapulmonary markers of the present invention are used to mark the location of lesions in the lungs, such as tumors, nodules, etc., and the markers in the lungs include self-expansion after release from the compression device to achieve self-indication.
  • the self-expanding structure 12 has a memory function, and after being detached from the release port of the compression device, the original shape is restored after the restraining force (ie, external pressure) is released, and the original shape is restored by the expansion of the self-expanding structure 12, thereby making the marker It is pinched in the lesion of the lungs, which plays a role in labeling.
  • the self-expanding structure 12 is woven from a memory alloy, and the self-expanding structure 12 is mesh-shaped.
  • the mesh-shaped self-expanding structure 12 has a certain deformability, and can be changed into a small volume when the force is restrained, thereby facilitating transportation. When the restraint is released, it becomes a large volume and is clamped to the lesion site fixed in the lungs.
  • the memory alloy may be a nickel-titanium memory alloy or a rubber material having elasticity.
  • the self-expanding structure 12 has a biconvex convex lens shape.
  • the self-expanding structure 12 may also be in the shape of a single convex convex lens, and the shape of the self-expanding structure 12 may also be spherical, tapered, or the like.
  • the self-expanding structure 12 is in the shape of a biconvex convex lens after expansion, and the self-expanding structure 12 includes two closing ends 11, and the two closing ends 11 are formed opposite each other. On both sides of the self-expanding structure 12.
  • the closing end 11 is columnar.
  • the self-expanding structure 12 includes a proximal end surface adjacent to the release opening of the compression device and a distal end surface remote from the release opening of the compression device. The proximal end surface and the distal end surface are oppositely disposed.
  • the two closing ends 11 are disposed near End face and distal end face.
  • FIG. 2 there is shown a schematic view of the structure of the self-expanding structure of the first embodiment of the intrapulmonary marker of the present invention before expansion, and the self-expanding structure of the intrapulmonary marker of the present invention will be described below with reference to Fig. 2.
  • the self-expanding structure 12 has a strip shape before expansion, and the self-expanding structure 12 of the strip shape can be conveniently transported to the affected part of the patient, and can be pushed to the affected part by a universal catheter or a special delivery device.
  • the self-expanding structure 12 has elasticity.
  • the markers in the lungs are connected to the special delivery device through the cuff end 11 and are sent to the lesions of the lungs through a dedicated delivery device to release the connection between the dedicated delivery device and the cuff end 11, so that the markers in the lungs are sent to the lungs.
  • the self-expanding structure 12 of the marker in the lung expands to the original state after being released from the constraint, and is thus pinched in the lesion position of the lung, thereby playing a marking role.
  • FIG. 6 there is shown a schematic view of the self-expanding structure of the second embodiment of the intrapulmonary marker of the present invention after expansion.
  • a second embodiment of the intrapulmonary marker of the present invention will be described with reference to Fig. 6.
  • the structure of the intrapulmonary marker is different from that of the first embodiment in that the self-expanding structure 12 has a convex convex lens shape after expansion, and the self-expanding structure 12 includes a cuff.
  • the end 11, the closing end 11 is disposed at a distal end face of the release opening away from the compression device.
  • the proximal end surface of the self-expanding structure 12 opposite to the distal end surface where the cuff end 11 is located is planar, and the self-expanding structure 12 has a strip shape before expansion to facilitate transportation.
  • the self-expanding structure 12 has a memory function and can be restored to the original state after the constraint is released, so that when the lung marker is transported to the lung lesion position, the self-expanding structure 12 automatically expands back to the convex convex lens shape, and is It is clamped in the lung lesions.
  • the doctor performs the operation, it is convenient to find the lesion location of the patient through the markers in the lungs, which provides convenience for the operation.
  • the intrapulmonary marker includes a self-expanding structure 12 in the shape of a sphere, which is a mesh-like sphere in an expanded state.
  • the nickel-titanium memory alloy is used to woven into a mesh body, and then the shape is shaped, and the shape of the shape is an original shape, which may be a spherical shape, or a convex convex lens shape or a double convex shape.
  • the shape of the convex lens may also be a taper or other shape.
  • a self-expanding structure is formed, and then the end of the woven mesh body is closed to form a closing end, and the closing end may be one or For two, this forms a marker in the lungs.
  • the intrapulmonary markers of the present invention can share a dedicated delivery device with the occluder (used to block defects in the heart or blood vessels), when loading, Applying force to the self-expanding structure Shrinked into a strip, placed in the conveyor, constrained by the conveyor to still have a strip shape, the special conveyor is lowered to the patient's lung lesions, and then the marker is ejected through the structure inside the conveyor The sheath, the self-expanding structure is sandwiched near the lesions in the lungs, which serves as a marker. As shown in Fig. 8, a schematic diagram showing a state in which markers in the lung are marked at the lesion position of the lung is shown.
  • the surgeon can use his fingers to explore the surface of the lungs, and the position of the foreign body of the lung tissue is felt by the change of the pressure on the surface of the finger, thereby rapidly locating the lesion and clarifying the minimum resection range.
  • minimally invasive resection not only the operation time is shortened, the recovery time of the patient is shortened, and the quality of life after surgery is greatly improved.

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Abstract

一种肺内标记物，用于标记肺部的病变位置，所述肺内标记物包括从压缩装置释放后可径向自行膨胀从而实现标记的自膨胀结构。所述肺内标记物由于采用自膨胀结构，在进行肺部检查发现病变位置时，即可通过导管或输送器运送至病变位置，在病变位置膨胀后被肺实质挤压固定，这样在外科手术时，医生可快速定位病变位置，缩短手术时间，减小切除范围，提高病人术后生存质量。

Description

肺内标记物 技术领域
本发明涉及医疗器械领域，特指一种肺内标记物。
背景技术
随着中国工业化的进程，环境污染，生活压力，抽烟等不良生活习惯，均会显著增加肺部疾病，特别是肺癌的发病几率。随着影像设备的进步，如低剂量螺旋CT扫描的推广使用，有越来越多的无任何症状的人会被检查出早期肺癌或性质不明结节。针对这些早期病变，外科手术根治是最佳治疗方法。然而早期病变不仅尺寸小，密度有时也非常接近正常肺组织，大部分无法在术中准确发现病变位置。外科手术仅能依靠扩大范围切除，来保证对病变的根治。这种手术方法会严重降低患者的术后生存质量，甚至降低患者的术后预期寿命。因此一种更加有效，安全的肺部结节定位手段是临床迫切需求的。
发明内容
本发明的目的在于克服现有技术的缺陷，提供一种肺内标记物，解决现有外科手术依靠扩大切除范围来保证对病变的根治而存在的严重降低患者术后生活质量和降低患者术后预期寿命等问题。
实现上述目的的技术方案是：
本发明一种肺内标记物，用于标记肺部的病变位置，所述肺内标记物包括从压缩装置释放后可径向自行膨胀从而实现标记的自膨胀结构。
本发明的肺内标记物，由于采用自膨胀结构，在进行肺部检查发现病变位置时，即可通过压缩装置(如通用导管或专用输送器械)运送至病变位置，在病变位置释放膨胀后可固定在原位，这样在外科手术时，可以帮助医生用手指感觉精确快速定位病变位置，缩短手术时间，减小切除范围，提高病人术后生存质量，避免了降低病人术后预期寿命的风险。
本发明肺内标记物的进一步改进在于，所述自膨胀结构由记忆合金编织而成。
本发明肺内标记物的进一步改进在于，所述自膨胀结构呈平凸的凸透镜形。
本发明肺内标记物的进一步改进在于，所述自膨胀结构呈双凸的凸透镜形。
本发明肺内标记物的进一步改进在于，所述自膨胀结构远离所述压缩装置的释放口的远端端面设有一个收口端。
本发明肺内标记物的进一步改进在于，所述自膨胀结构靠近所述压缩装置的释放口的近端端面设有一个收口端。
本发明肺内标记物的进一步改进在于，所述自膨胀结构为球形。
附图说明
图1为本发明肺内标记物的第一实施例的自膨胀结构在膨胀后的俯视立体结构示意图。
图2为本发明肺内标记物的第一实施例的自膨胀结构在膨胀前的结构示意图。
图3为本发明肺内标记物的第一实施例的自膨胀结构在膨胀后的侧视图。
图4为本发明肺内标记物的第一实施例的自膨胀结构在膨胀后的俯视图。
图5为本发明肺内标记物的第一实施例的自膨胀结构在膨胀后的仰视立体结构示意图。
图6为本发明肺内标记物的第二实施例的自膨胀结构在膨胀后的结构示意图。
图7为本发明肺内标记物的第三实施例的自膨胀结构在膨胀后的结构示意图。
图8为本发明肺内标记物在肺部实现标记功能的状态示意图。
具体实施方式
下面结合附图和具体实施例对本发明作进一步说明。
本发明提供了一种肺内标记物，用于标记肺部的病变位置，能够方便医生在外科手术时快速找到病变位置。本发明的肺内标 记物为采用记忆合金制成的具有弹性的自膨胀结构，利用该自膨胀结构的弹性，在通过压缩装置(如通用导管或专用输送器械)运送标记物时，该标记物呈条状，在送到肺部后被推出导管，由于记忆合金具有恢复原始形状的性能，同时肺组织的密度极小，使得自膨胀结构自行膨胀至原始形状，从而被夹在了病变的位置，进而起到了标识的作用。下面结合附图对本发明肺内标记物的结构进行说明。
参阅图1，显示了本发明肺内标记物的第一实施例的自膨胀结构在膨胀后的俯视立体结构示意图。下面结合图1，对本发明肺内标记物进行说明。
如图1所示，本发明肺内标记物用于标记肺部的病变位置，比如肿瘤、结节等位置，该肺内标记物包括从压缩装置释放后可径向自行膨胀从而实现标记的自膨胀结构12。该自膨胀结构12具有记忆功能，能够在从压缩装置的释放口脱离后，在束缚力(即外部压力)解除后恢复原始形状，通过自膨胀结构12膨胀后恢复原始形状，进而使得该标记物被夹在肺部的病变处，从而起到了标识作用。
较佳地，自膨胀结构12由记忆合金编织而成，自膨胀结构12为网状，该网状的自膨胀结构12具有一定的变形能力，受力约束时可变成小体积进而方便运送，在解除约束时可变成大体积进而被夹住固定在肺部的病变位置。记忆合金可以为镍钛记忆合金，也可以是具有弹性的橡胶材质。
自膨胀结构12呈双凸的凸透镜形。自膨胀结构12还可以呈单凸的凸透镜形，自膨胀结构12的形状还可为球形、锥形等。
结合图3至图5所示，在第一实施例中，自膨胀结构12在膨胀后呈双凸的凸透镜形，该自膨胀结构12包括两个收口端11，两个收口端11相对的形成于自膨胀结构12的两侧。收口端11呈柱状。自膨胀结构12包括靠近压缩装置的释放口的近端端面和远离压缩装置的释放口的远端端面，该近端端面和远端端面相对设置，较佳地，两个收口端11设置在近端端面和远端端面。
参阅图2，显示了本发明肺内标记物的第一实施例的自膨胀结构在膨胀前的结构示意图，下面结合图2，对本发明肺内标记物的自膨胀结构进行说明。
如图2所示，自膨胀结构12在膨胀前呈条形状，该条形状的自膨胀结构12能够方便运送到病人的患部处，通过通用导管或者专用输送器械即可推送至患处。该自膨胀结构12具有弹性。
肺内标记物通过收口端11与专用输送器械连接，通过专用输送器械被送到肺部的病变处，解除专用输送器械与收口端11的连接，这样使得肺内标记物被送至肺部的病变位置，肺内标记物的自膨胀结构12在解除了约束后，就会膨胀至原始状态，进而被夹在肺部的病变位置，起到了标记作用。
参阅图6，显示了本发明肺内标记物的第二实施例的自膨胀结构在膨胀后的结构示意图。下面结合图6，对本发明肺内标记物的第二实施例进行说明。
如图6所示，在第二实施例中，肺内标记物的结构与第一实施例的区别在于，自膨胀结构12在膨胀后呈平凸的凸透镜形，该自膨胀结构12包括一个收口端11，该收口端11设于远离压缩装置的释放口的远端端面。自膨胀结构12与收口端11所在的远端端面相对的近端端面为平面状，自膨胀结构12在膨胀前呈条形状，以方便运送。自膨胀结构12具有记忆功能，能够在解除约束后恢复至原始状态，所以使得肺内标记物在被运送到肺部病变位置时，自膨胀结构12自动膨胀变回平凸的凸透镜形，进而被夹固在肺部病变处，在医生进行手术时，可以很方便的通过肺内标记物找到病人的病变位置，为手术提供了方便。
如图7所述，在第三实施例中，肺内标记物包括呈球形状的自膨胀结构12，该肺内标记物在膨胀后的状态为网状的球体。
下面对本发明的肺内标记物的制作和使用过程进行说明。
以镍钛记忆合金为例进行说明，利用镍钛记忆合金编织成网状体，进而进行塑型，塑型的形状为原始形状，可以为球形，也可以为平凸的凸透镜形或者双凸的凸透镜形，还可以是锥形或其他形状，塑型后就形成了自膨胀结构，然后在对编织的网状体的端部进行收口就形成了收口端，该收口端可以为一个，也可以为两个，这样就形成了肺内标记物。
在运送肺内标记物时，采用专用输送器械进行运送，本发明的肺内标记物可以与封堵器(用于封堵心脏或血管内的缺损)共用一个专用输送器械，在进行装载时，将自膨胀结构施力使其压 缩为条形，放入到输送器内，通过输送器的约束使其仍呈条形状，该专用输送器被下放到病人的肺部病变处，然后经输送器内结构将标记物顶出输送鞘管，自膨胀结构被夹在了肺部的病变附近，这样就起到了标识作用。如图8所示，显示了肺内标记物在肺部的病变位置进行标记的状态示意图。在进行外科手术时，外科大夫可以用手指从肺表面摸索，靠手指表面压力的变化感觉出与肺组织不同的异物所在位置，从而快速定位病变，明确最小切除范围。微创切除后，不仅手术时间缩短，病人康复时间缩短，同时术后生活质量也会大大提高。
以上结合附图实施例对本发明进行了详细说明，本领域中普通技术人员可根据上述说明对本发明做出种种变化例。因而，实施例中的某些细节不应构成对本发明的限定，本发明将以所附权利要求书界定的范围作为本发明的保护范围。

Claims (7)

  1. 一种肺内标记物，用于标记肺部的病变位置，其特征在于，所述肺内标记物包括从压缩装置释放后可径向自行膨胀从而实现标记的自膨胀结构。
  2. 如权利要求1所述的肺内标记物，其特征在于，所述自膨胀结构由记忆合金编织而成。
  3. 如权利要求1或2所述的肺内标记物，其特征在于，所述自膨胀结构呈平凸的凸透镜形。
  4. 如权利要求1或2所述的肺内标记物，其特征在于，所述自膨胀结构呈双凸的凸透镜形。
  5. 如权利要求4所述的肺内标记物，其特征在于，所述自膨胀结构远离所述压缩装置的释放口的远端端面设有一个收口端。
  6. 如权利要求5所述的肺内标记物，其特征在于，所述自膨胀结构靠近所述压缩装置的释放口的近端端面设有一个收口端。
  7. 如权利要求2所述的肺内标记物，其特征在于，所述自膨胀结构为球形。
PCT/CN2017/077423 2016-03-23 2017-03-21 肺内标记物 Ceased WO2017162126A1 (zh)

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