WO2020048325A1 - 一种医疗器械置入装置 - Google Patents

一种医疗器械置入装置 Download PDF

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Publication number
WO2020048325A1
WO2020048325A1 PCT/CN2019/102165 CN2019102165W WO2020048325A1 WO 2020048325 A1 WO2020048325 A1 WO 2020048325A1 CN 2019102165 W CN2019102165 W CN 2019102165W WO 2020048325 A1 WO2020048325 A1 WO 2020048325A1
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WO
WIPO (PCT)
Prior art keywords
tube
handle
inner tube
medical device
outer tube
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
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PCT/CN2019/102165
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English (en)
French (fr)
Inventor
李玉茜
刘环
冷德嵘
赵永雪
李常青
刘春俊
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Micro Tech Nanjing Co Ltd
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Micro Tech Nanjing Co Ltd
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Publication date
Application filed by Micro Tech Nanjing Co Ltd filed Critical Micro Tech Nanjing Co Ltd
Priority to EP19858546.5A priority Critical patent/EP3848007B1/en
Priority to US17/272,448 priority patent/US11969370B2/en
Publication of WO2020048325A1 publication Critical patent/WO2020048325A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument

Definitions

  • the invention relates to a medical device, in particular to a medical device insertion device.
  • the traditional Y-bracket placement device needs to retract the front handle to make the Y-branch branch extend, then release the bracket branch by releasing the binding line, and then unscrew the positioning lock, and then continue to retract the front handle to release the bracket completely.
  • the operation process is cumbersome and the operation takes a long time; the knot of the binding line will cause some damage to the erosive tissue; the release of the pulling line requires a certain force and it is easy to cause the stent to shift and cause the operation to fail; the binding line needs sufficient resistance Pull the strength, otherwise there will be a case where the binding line breaks during the operation and the instrument fails; the binding line needs to be buckled during the binding of the brace, otherwise the operation line will fail to loosen and the operation will fail.
  • the object of the present invention is to design a medical device insertion device, which is suitable for medical devices with branches, such as a Y-shaped stent.
  • a medical device insertion device which is suitable for medical devices with branches, such as a Y-shaped stent.
  • the invention provides a medical instrument insertion device, which includes an outer tube connected to a first part of a handle and extending from a proximal end to a distal end; a middle tube, a middle tube provided in the outer tube, and a second tube connected to the handle.
  • Inner tube the inner tube allows the inner tube to pass through, the inner tube is connected to the third part of the handle, the inner tube and the outer tube can move relative to each other; the outer tube is at least two, and the distal end of the inner tube is fixedly connected to the outer tube respectively
  • a medical device which is arranged around the inner tube and can be partially contained in the outer tube; the third part of the handle is manipulated so that the inner tube moves relative to the outer tube to release the medical device.
  • the outer sleeve includes a portion for fixing the inner tube and a portion for fixing the medical device.
  • the inner tube includes a first inner tube and a second inner tube distributed side by side, and the distal ends of the inner tube are respectively connected to the outer tube.
  • the lengths of the first inner tube and the second inner tube are the same or different.
  • the inner tube has a distal bifurcation structure and is connected to the outer tube respectively.
  • the medical instrument insertion device of the present invention is a stent.
  • the middle tube is connected to the second part of the handle through a booster tube.
  • the booster tube is made of metal.
  • a positioning lock is provided between the first part of the handle and the second part of the handle.
  • the first part of the handle is retracted proximally, and some medical devices are released from the outer tube; then the third part of the handle is pushed to the distal end, and the medical device is detached from the outer tube; finally Withdraw the first part of the handle and release the medical device.
  • FIG. 1 is a schematic diagram of a medical device insertion device according to the present invention.
  • FIG. 2 is an enlarged view of a distal end of the medical device insertion device of the present invention.
  • FIG. 3 is a cross-sectional view of an outer sleeve of the medical device insertion device shown in FIG. 1.
  • FIG. 4 is a schematic diagram of a Y-shaped bracket used with a medical device insertion device.
  • FIG. 5-7 are schematic diagrams of the process of inserting a medical device into the medical device insertion device of the present invention.
  • Outer casing 1 inner tube 2, middle tube 3, outer tube 4, booster tube 5, handle 6, front handle piece 7, rear handle piece 8, adjusting handle 9, safety lock 10, first outer tube 11, second Outer sleeve 12, developing member 13, positioning lock 14, first inner tube 15, second inner tube 16, distal inner hole 21, middle inner hole 22, proximal inner hole 23, stent main branch 30, stent branch 31, 32.
  • the invention provides a medical instrument insertion device, which includes an outer tube connected to a first part of the handle, that is, a front handle piece, which extends from the proximal end to the distal end; a middle tube, which is provided with a middle tube in the outer tube, and the middle tube is connected to The second part of the handle is the rear handle; the inner tube, the middle tube allows the inner tube to pass through, and the third part of the handle is the adjustment handle, the inner tube and the outer tube can move relatively; the outer tube, at least two, The distal end of the inner tube is fixedly connected to the outer tube, respectively; medical instruments are arranged around the inner tube and can be partially contained in the outer tube.
  • the third part of the handle is manipulated to make the inner tube move relative to the outer tube and release the medical device.
  • the outer tube includes a part that fixes the inner tube and a part that fixes the medical device, and the part that fixes the inner tube and the part that fixes the medical device may have the same structure or different structures.
  • the inner tube includes a first inner tube and a second inner tube distributed side by side, and the distal ends of the inner tube are respectively connected to the outer tube.
  • the inner tube is fixed in the middle hole of the outer tube.
  • the medical device part is arranged between the inner tube and the outer tube.
  • the lengths of the first inner tube and the second inner tube are the same or different.
  • the inner tube may also have a lumen at the proximal end and a bifurcated structure at the distal end, and the ends of the bifurcated structure are respectively connected with the outer sleeve.
  • the medical device insertion device of the present invention is a stent, and the medical device may also be a medical catheter.
  • the middle tube is connected to the second part of the handle through a booster tube; the proximal end of the middle tube is fixedly connected to the booster tube and then connected to the handle.
  • the middle tube can also be directly connected to the handle at the proximal end.
  • the booster tube is made of metal, including medical stainless steel.
  • a positioning lock is provided between the first part of the handle and the second part of the handle.
  • the first part of the handle is retracted to the proximal end, and part of the medical instruments is released from the outer tube. Specifically, the branch part of the medical instrument assembled in the outer tube is detached from the outer tube; The third part of the handle is pushed distally, and the medical device is detached from the outer tube. Specifically, the medical device assembled in the outer tube is detached from the outer tube. Finally, the first part of the handle is retracted, and the main branch of the medical device is removed from the outer tube. Exit and complete release placement.
  • the present invention provides a medical device insertion device including an outer tube 1, an inner tube 2, a middle tube 3, an outer tube 4, a booster tube 5, and a handle 6, wherein the handle 6 It includes three parts, specifically the front handle part 7, the rear handle part 8, and the adjustment handle 9.
  • the outer casing 1 may be two or more, including at least a first outer casing 11 and a second outer casing 12; the first outer casing 11 and the second outer casing 12 may be a one-stage structure, a two-stage structure, or a three-stage structure.
  • Type structure for fixing the inner tube 2 and accommodating the structure of the medical device Preferably, as shown in FIG. 3, a hollow three-stage structure includes a distal inner hole 21, a middle inner hole 22, and a proximal inner hole 23; wherein the medical guide wire can extend from the proximal end to the distal end through the distal inner hole. 21. Guide the medical device insertion device to the desired position.
  • the inner tube 2 can be fixed in the middle hole 22.
  • the distal hole 21 and the middle hole 22 can be designed separately as two parts, or they can be integrated parts.
  • the compression bracket branches 31 and 32 are fixed in the inner end hole 23.
  • the inner tube 2 includes a first inner tube 15 and a second inner tube 16; the first outer tube 11 and the second outer tube 12 respectively wrap and fix a distal end of an inner tube 2, the first outer tube 11 and the second outer tube 12 is located on the outer side of the distal end of the inner tube 2, and the distal end surface of the outer tube 1 and the side wall of the outer tube 1 form a curved structure with a certain arc to avoid damage to the human cavity during use; the first inner tube 15 and The second inner tubes 16 are arranged side by side, and the inside can be respectively passed through medical guide wires.
  • the distal ends are respectively wrapped by the first outer sleeve 11 and the second outer sleeve 12, and the proximal end is connected to the adjustment handle 9 through the rear handle member 8.
  • the first The inner tube 15 and the second inner tube 16 are hollow structures, and a guide wire can be passed through the inner tube.
  • the inner tube 2 may also be designed as a distal bifurcation structure, and the distal bifurcation structure part is connected to the first outer sleeve 11 and the second outer sleeve 12 respectively.
  • the middle tube 3 covers at least part of the inner tube 2 and its distal end is in contact with the proximal end of the stent main branch 30 to limit the position of the stent.
  • the proximal end of the middle tube 3 may be designed to be connected to the rear handle 8 or the middle tube 3
  • the proximal end is connected to the booster tube 5.
  • the booster tube 5 is a hollow structure.
  • the distal end of the booster tube 5 is fixedly connected to the proximal end of the middle tube 3. It is a metal material that helps to release the force transmission of the medical device.
  • the proximal end of the booster tube 5 is connected to the rear handle 8 ; Because the middle tube 3 is made of polymer plastic, it is relatively soft, and the booster tube 5 is made of metal, such as medical stainless steel.
  • the middle tube 3 has good flexibility and bending when entering the human body cavity, and the booster tube 5 helps to transmit force during the insertion and release of the medical device; it is arranged on the outer wall of the distal portion of the middle tube 3
  • a developing element 13 which can be embedded on the outer wall of the middle tube 3 or placed on the outer surface of the middle tube 3 in other ways, which is helpful for the positioning and release of medical instruments during the operation.
  • the outer tube 4 is located outside the middle tube 3 and covers at least part of the middle tube 3 and is movable relative to the inner tube 2; the proximal end of the outer tube 4 is connected to the front handle 7 and can surround soft materials on the outside of the outer tube 4. It can reduce the irritation to the human cavity during the operation, especially when cornering.
  • the handle 6 is located at the proximal end of the medical instrument insertion device and includes a front handle piece 7, a rear handle piece 8, and an adjustment handle 9.
  • the front handle part 7 is located at the distal end of the handle 6 and is connected to the proximal end of the outer tube 4.
  • the proximal end of the front handle part 7 is provided with a safety lock 10, which is composed of a locking screw and a locking nut.
  • the front handle piece 7 is fixed on the booster tube 5 in a tightening manner, and plays a positioning role.
  • the rear handle member 8 is located between the front handle member 7 and the adjustment handle 9 and is connected to the proximal end of the booster tube 5.
  • the adjusting handle 9 is located at the proximal end of the medical instrument insertion device and is connected to the proximal end of the inner tube 2.
  • a positioning lock 14 is provided between the front handle piece 7 and the rear handle piece 8 and covers the booster tube 5.
  • the outer sleeve 1 can be used to compress the stent.
  • the stent can include a stent main branch 30 and stent branches 31 and 32.
  • the two stent branches 31 and 32 can be the same length or different lengths, as shown in FIG. 4
  • the two branches 31 and 32 of the stent are respectively sleeved on the first inner tube 15 and the second inner tube. 16 so as to be compressed into the first outer sleeve 11 and the second outer sleeve 12, respectively, the stent branches 31, 32 will be defined in the proximal inner hole 23 of the outer sleeve 1.
  • the medical device insertion device of the present invention includes, but is not limited to, a self-expandable stent that can be delivered, and other medical devices that can be released from the insertion device by retracting the outer tube 4 relative to the inner tube 2.
  • the insertion process of the medical device insertion device of the present invention is as follows: first, the distal ends of the two stent branches 31 and 32 of the stent are compressed into the outer sleeve 1 respectively, and then the main body stent 30 is covered. On the inner tube 2, the positioning lock 14 is locked to fix it on the booster tube 5. After the outer tube 4 covers the main bracket 30 and the branches 31 and 32 of the bracket, the safety lock 10 is tightened, and the bracket assembly is completed. When the positioning lock 14 is fixed, its position is close to the security lock 10, which can remind the doctor that when the front handle 7 is retracted to the positioning lock 14, the stent branches 31, 32 have been released from the outer tube 4.

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Abstract

一种医疗器械置入装置，包括：外管（4），连接到手柄（6）的第一部分，从近端向远端延伸；中管（3），外管（4）内设有中管（3），中管（3）连接到手柄（6）的第二部分；内管（2），中管（3）内允许内管（2）通过，内管（2）连接到手柄（6）的第三部分，内管（2）与外管（4）可相对移动；外套管（1），至少为两个，内管（2）的远端分别与外套管（1）固定连接；医疗器械，设置在内管（2）周围，并且可部分容纳在外套管（1）中，操纵手柄（6）的第三部分，释放医疗器械。释放时，向近端回撤手柄（6）第一部分，部分医疗器械从外管（4）中释放；然后向远端推动手柄（6）第三部分，医疗器械从外套管（1）中脱离；最后再回撤手柄（6）第一部分，医疗器械释放置入。

Description

一种医疗器械置入装置 技术领域
本发明涉及一种医疗器械，特别是一种医疗器械置入装置。
背景技术
对于患晚期肺癌所致腔道狭窄的患者，纵隔及食管肿瘤造成管腔外压性狭窄的患者，以及年龄大、全身状况不佳不能耐受手术的肿瘤患者而言，Y型支架的出现很好的解决了腔道狭窄及支架移位的并发症。
传统的Y型支架置入装置，需要先回撤前手柄使Y型支架分支伸出，然后分别通过松开捆绑线释放支架分支，再旋开定位锁，继续回撤前手柄使支架完全释放。操作过程繁琐，手术耗时比较长；捆绑线的结扣对糜烂性的组织会造成一定的损伤；拉线释放时因需要一定的力还容易使得支架移位造成手术失败；捆绑线需要足够的抗拉强度，否则会有术中捆绑线断裂造成器械失效的情况出现；捆绑支架时捆绑线需要节节活扣，否则术中会出现捆绑线无法松扣而造成手术失败。
因此迫切需要一种操作简便且能有效释放支架的置入装置，从而克服传统支架置入装置难于操作且耗时长的问题，以及捆绑线带来的一系列安全隐患。
发明内容
本发明的目的，是设计一种医疗器械置入装置，适用于具有分支的医疗器械，如Y型支架。通过约束医疗器械产品的远端，达到以医疗器械远端进行定位的效果；操作更加简便，从而缩短手术时间的同时减小对于肿瘤组织的损伤，减轻病人的痛苦；并且减少器械失效的几率。
本发明提供了一种医疗器械置入装置，包括：外管，连接到手柄的第一部分，从近端向远端延伸；中管，外管内设有中管，中管连接到手柄的第二部分；内管，中管内允许内管通过，内管连接到手柄的第三部分，内管与外管可相对移动；外套管，至少为两个，内管的远端分别与外套管固定连接；医疗器械，设置在内管周围，并且可部分容纳在外套管中，操纵手柄的第三部分，使得内管相对于外管移动，释放医疗器械。
本发明的医疗器械置入装置，外套管包括固定内管的部分和固定医疗器械的部分。
本发明的医疗器械置入装置，内管包括并排分布的第一内管和第二内管，内管远端末端分别与外套管相连接。
本发明的医疗器械置入装置，第一内管和第二内管的长度相同或不同。
本发明的医疗器械置入装置，内管具有远端分叉结构，分别与外套管相连接。
本发明的医疗器械置入装置，医疗器械为支架。
本发明的医疗器械置入装置，中管通过助推管与手柄的第二部分相连接。
本发明的医疗器械置入装置，助推管为金属材质。
本发明的医疗器械置入装置，手柄的第一部分和手柄的第二部分之间设有定位锁。
本发明的医疗器械置入装置的使用方法，向近端回撤手柄第一部分，部分医疗器械从外管中释放；然后向远端推动手柄第三部分，医疗器械从外套管中脱离；最后再回撤手柄第一部分，医疗器械释放置入。
附图说明
图1为本发明的医疗器械置入装置示意图。
图2为本发明的医疗器械置入装置远端放大图。
图3为图1所示的医疗器械置入装置的外套管剖面图。
图4为配合医疗器械置入装置使用的Y型支架示意图。
图5-7为本发明医疗器械置入装置置入医疗器械过程示意图。
附图标号说明
外套管1，内管2，中管3，外管4，助推管5，手柄6，前手柄件7，后手柄件8，调节手柄9，安全锁10，第一外套管11，第二外套管12，显影件13，定位锁14，第一内管15，第二内管16，远端内孔21，中段内孔22，近端内孔23，支架主支30，支架分支31、32。
具体实施方式
以下结合附图对本发明技术方案进行详细说明。应当理解，此处所描述的具体实施方式仅用以解释本发明，并不用于限定本发明。本申请的范围并不受这些实施方式的限定，乃以申请专利的范围为准。而为提供更清楚的描述及使熟悉该项技艺者能理解本申请的申请内容，图示内各部分并不一定依照其相对 的尺寸而绘图，某些尺寸与其他相关尺度的比例会被凸显而显得夸张，且不相关或不重要的细节部分亦未完全绘出，以求图示的简洁。
本发明提供了一种医疗器械置入装置，包括：外管，连接到手柄的第一部分即前手柄件，从近端向远端延伸；中管，外管内设有中管，中管连接到手柄的第二部分即后手柄件；内管，中管内允许内管通过，内管连接到手柄的第三部分即调节手柄，内管与外管可相对移动；外套管，至少为两个，内管的远端分别与外套管固定连接；医疗器械，设置在内管周围，并且可部分容纳在外套管中，操纵手柄的第三部分，使得内管相对于外管移动，释放医疗器械。
本发明的医疗器械置入装置，外套管包括固定内管的部分和固定医疗器械的部分，固定内管的部分和固定医疗器械的部分可以是同一个结构，也可以是不同的结构。
本发明的医疗器械置入装置，内管包括并排分布的第一内管和第二内管，内管远端末端分别与外套管相连接，优选的，内管固定在外套管的中段内孔内；医疗器械部分设置在内管和外套管之间。
本发明的医疗器械置入装置，第一内管和第二内管的长度相同或不同。
本发明的医疗器械置入装置，内管还可以是具有近端为一个管腔而远端为分叉结构，其分叉结构末端分别与外套管相连接。
本发明的医疗器械置入装置，医疗器械为支架，医疗器械还可以是医用导管。
本发明的医疗器械置入装置，中管通过助推管与手柄的第二部分相连接；中管的近端与助推管固定连接后再连接到手柄。中管也可以近端直接连接手柄。
本发明的医疗器械置入装置，助推管为金属材质，包括医用不锈钢。
本发明的医疗器械置入装置，手柄的第一部分和手柄的第二部分之间设有定位锁。
本发明的医疗器械置入装置的使用方法，向近端回撤手柄第一部分，部分医疗器械从外管中释放，具体为装配在外管中的医疗器械的分支部分从外管中脱离；然后向远端推动手柄第三部分，医疗器械从外套管中脱离，具体为装配在外套管中的医疗器械从外套管中脱离；最后再回撤手柄第一部分，医疗器械的主支从外管中被退出，完成释放置入。
如图1至图4所示，本发明提供了一种医疗器械置入装置，包括外套管1、内管2、中管3、外管4、助推管5、和手柄6，其中手柄6包括三个部分，具体为前手柄件7，后手柄件8，调节手柄9。
其中外套管1可以为两个或多个，至少包括第一外套管11和第二外套管12；第一外套管11和第二外套管12可以为一段式结构，两段式结构或三段式结构，用来固定内管2以及容纳医疗器械结构。优选的，如图3所示为中空三段式结构，包括远端内孔21、中段内孔22和近端内孔23；其中医用导丝可以从近端向远端延伸通过远端内孔21，引导医疗器械置入装置到达所需位置，中段内孔22内可固定内管2，远端内孔21和中段内孔22可以单独设计成两个部件，也可以为一体的部件，近端内孔23内固定压缩支架分支31、32。
内管2包括第一内管15和第二内管16；第一外套管11和第二外套管12中各自包裹固定一根内管2的远端，第一外套管11和第二外套管12位于内管2的远端外侧，且外套管1的远端端面与其侧壁连接处形成具有一定弧度的弯角结构，避免在使用过程中对人体腔道的损伤；第一内管15和第二内管16并排分布，内部可以分别通过医用导丝，其远端分别被第一外套管11和第二外套管12包裹，近端通过后手柄件8与调节手柄9相连接，第一内管15和第二内管16为中空结构，内部可以通过导丝。另外，内管2也可以设计为远端分叉结构，远端分叉结构部分分别与第一外套管11和第二外套管12相连接。
中管3至少覆盖部分内管2，其远端与支架主支30的近端相抵接，限制支架的位置，中管3的近端可以设计为与后手柄件8相连接，或中管3近端与助推管5相连接。助推管5为中空结构，其远端与中管3近端固定连接，其为金属材质，有助于释放医疗器械时力的传递，助推管5的近端与后手柄件8相连接；因为中管3由高分子塑料制成，比较柔软，而助推管5为金属材质，如医用不锈钢。所以使得中管3进入人体腔道时候具有好的柔性和弯曲性，而助推管5有助于在医疗器械置入及释放过程中力的传递；在中管3的远端部外壁上设置有显影件13，显影件13可以嵌在中管3外壁上或者其它方式置于中管3外表面，有助于医疗器械在手术过程中的定位与释放。
外管4位于中管3的外侧，覆盖至少部分中管3，且可相对于内管2移动；外管4的近端与前手柄件7相连接，在外管4外侧可环绕软性材料，在手术中尤其是过弯时可以减少对人体腔道产生的刺激。
手柄6位于医疗器械置入装置的近端，包括前手柄件7、后手柄件8和调节手柄9。前手柄件7位于手柄6的远端且与外管4近端相连接；前手柄件7的近端设有一个安全锁10，安全锁10由锁紧螺杆和锁紧螺帽组成，可通过旋紧的方式将前手柄件7固定在助推管5上，起到定位作用。后手柄件8位于前手柄件7和调节手柄9之间，与助推管5的近端连接。调节手柄9位于医疗器械置入装置的近端，其与内管2的近端末端相连。前手柄件7和后手柄件8之间设有定位锁14，覆盖在助推管5上。
外套管1可以用于压缩支架，支架可包括支架主支30和支架分支31、32，两个支架分支31、32可以长度相同也可以长度不相同，如图4所示支架的两个支架分支31、32长度是不一致时，因为第一内管15和第二内管16的长度不一致，所以将支架的两个分支31、32分别针对性的套在第一内管15和第二内管16上，从而分别压缩进第一外套管11和第二外套管12中，支架分支31、32将被限定在外套管1的近端内孔23内。
本发明的医疗器械置入装置，包括但不限于可输送自膨式支架，还可以输送通过相对于内管2回撤外管4可从置入装置释放的其它医疗器械。
如图5-7所示，本发明医疗器械置入装置的置入过程为：首先将支架两个支架分支31、32的远端分别压缩装入外套管1中，然后将主体支架30覆于内管2上，锁紧定位锁14使其固定在助推管5上，在使得外管4覆盖支架主支30和支架分支31、32后旋紧安全锁10，支架装配完成。其中定位锁14固定时其位置靠近安全锁10，该位置可以提示医生，当回撤前手柄件7至定位锁14时，支架分支31、32已经被释放出外管4。
使用时，先将两根医用导丝分别从内管2中穿过，在医用导丝的引导下医疗器械置入装置到达病灶位置，此时安全锁10和定位锁14均为锁紧状态；旋开医疗器械置入装置的安全锁10，固定后手柄件8和调节手柄9，回撤前手柄件7从而带动外管4后撤，使得装配在外管4中的支架分支31、32输出外管4，当支架的两个分支31、32夹角顶住隆突时，旋紧安全锁10；然后固定前手柄件7和后手柄件8，向前推动调节手柄9，调节手柄9带动内管2向远端移动，从而带动外套管1向远端推移把支架分支31、32的远端从外套管1中脱离出来；此时分支的分叉处会抵住人体的腔道，旋开安全锁10和定位锁14，固定后手柄件8并回撤前手柄件7使支架主支30部分被推出外管4，从而完成医疗器械释 放过程。
以上所述仅是本发明的优选实施例而已，并非对本发明做任何形式上的限制，虽然本发明已以优选实施例揭露如上，然而并非用以限定本发明，任何熟悉本专业的技术人员，在不脱离本发明技术方案的范围内，当可利用上述揭示的技术内容作出些许更动或修饰为等同变化的等效实施例，但凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (10)

  1. 一种医疗器械置入装置，其特征在于，包括：外管，连接到手柄的第一部分，从近端向远端延伸；中管，所述外管内设有所述中管，所述中管连接到手柄的第二部分；内管，所述中管内允许所述内管通过，所述内管连接到手柄的第三部分，所述内管与所述外管可相对移动；外套管，至少为两个，所述内管的远端分别与所述外套管固定连接；医疗器械，设置在所述内管周围，并且可部分容纳在所述外套管中，操纵所述手柄的第三部分，使得所述内管相对于所述外管移动，释放医疗器械。
  2. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述外套管包括固定所述内管的部分和固定所述医疗器械的部分。
  3. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述内管具有远端分叉结构，分别与外套管相连接。
  4. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述内管包括并排分布的第一内管和第二内管，所述内管远端末端分别与外套管相连接。
  5. 根据权利要求4所述的医疗器械置入装置，其特征在于，所述第一内管和第二内管的长度相同或不同。
  6. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述医疗器械为支架。
  7. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述中管通过助推管与所述手柄的第二部分相连接。
  8. 根据权利要求7所述的医疗器械置入装置，其特征在于，所述助推管为金属材质。
  9. 根据权利要求1所述的医疗器械置入装置，其特征在于，所述手柄的第一部分和所述手柄的第二部分之间设有定位锁。
  10. 一种医疗器械置入装置的使用方法，其特征在于，向近端回撤手柄第一部分，部分医疗器械从外管中释放；然后向远端推动手柄第三部分，所述医疗器械从外套管中脱离；最后再回撤所述手柄第一部分，所述医疗器械释放置入。
PCT/CN2019/102165 2018-09-03 2019-08-23 一种医疗器械置入装置 Ceased WO2020048325A1 (zh)

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