WO2008034341A1 - Stent creux pouvant transporter une source ultra-miniaturisée de particules radioactives - Google Patents

Stent creux pouvant transporter une source ultra-miniaturisée de particules radioactives Download PDF

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Publication number
WO2008034341A1
WO2008034341A1 PCT/CN2007/002623 CN2007002623W WO2008034341A1 WO 2008034341 A1 WO2008034341 A1 WO 2008034341A1 CN 2007002623 W CN2007002623 W CN 2007002623W WO 2008034341 A1 WO2008034341 A1 WO 2008034341A1
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WO
WIPO (PCT)
Prior art keywords
drainage tube
source
particle
micro
tube
Prior art date
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PCT/CN2007/002623
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English (en)
French (fr)
Inventor
Zhaoshen Li
Yan Liu
Zheng Lu
Original Assignee
The Second Military Medical University
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Publication date
Priority to US12/442,332 priority Critical patent/US20100030127A1/en
Application filed by The Second Military Medical University filed Critical The Second Military Medical University
Priority to EP07800840A priority patent/EP2070493A1/en
Publication of WO2008034341A1 publication Critical patent/WO2008034341A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/008—Implant devices for drainage of body fluids from one part of the body to another pre-shaped, for use in the urethral or ureteral tract
    • 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
    • A61F2002/041—Bile ducts
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0095—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof radioactive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1014—Intracavitary radiation therapy
    • A61N2005/1018—Intracavitary radiation therapy with multiple channels for guiding radioactive sources
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1027—Interstitial radiation therapy

Definitions

  • Pipe bracket capable of carrying a source of micro-radioactive particles
  • the invention relates to the technical field of medical instruments, and is a pipeline bracket capable of carrying a source of micro-radioactive particles, and is mainly used for internal irradiation treatment of advanced pancreatic cancer or cholangiocarcinoma and has the function of bow and blood flow.
  • Pancreatic cancer and cholangiocarcinoma are a group of digestive tract malignancies with serious conditions, low cure rate and poor prognosis. Most of them are in the advanced stage and often cannot be surgically removed. Tumors often compress the pancreatic ducts and bile ducts, causing stenosis or obstruction. For the narrowing or obstruction of the pipeline, it is currently mainly used to insert a stent with drainage function under the endoscope to relieve the clinical symptoms. Mainly divided into two types of plastic brackets and metal brackets.
  • the plastic tube bracket commonly used in clinical practice is composed of a drainage bar and a facing barb disposed on the outer side of both ends of the drainage tube.
  • the tube stent is placed in the affected part by a duodenoscope.
  • the drainage tube is supported in a narrow or obstructed area.
  • Bile or pancreatic juice can be drained through the intraductal drainage chamber; barbs at both ends are used to fix the position of the stent, which prevents the stent from being inserted into the intestinal lumen. Slippage prevents the stent from fully entering the pancreatic duct or bile duct.
  • the bracket can be removed and replaced periodically to keep the lead.
  • Metal stents are widely used in the treatment of benign and malignant stenosis in human lumens. It is a metal mesh structure, which is mainly fixed to the affected part by self-expansion. Some scholars have used chemical plating to uniformly plate radionuclides on metal stents to produce radioactive metal stents of different strengths for the prevention and treatment of luminal restenosis caused by proliferation of blood vessels or bile duct endothelial cells after implantation of the stent. Some researchers have attached a radionuclide film containing radionuclide ' ⁇ 6 ⁇ ' to the surface of a metal stent for the treatment of esophageal cancer or biliary restenosis after implantation of the internal stent.
  • the radioactive stent produced by the above method can not meet the clinical treatment requirements for the treatment of malignant tumor diseases, and the following defects exist.
  • Trap The production and processing process is complex and difficult to store; the dose rate is single, and the stent cannot be customized according to the size of the patient's tumor; it is difficult to industrialize.
  • micro-radioactive particle sources for efficacy determination.
  • the medical micro-radioactive particles are short rod-shaped solid radiation prepared by encapsulating a radionuclide in a titanium alloy casing. 5 ⁇ , ⁇ 0 ⁇
  • the most commonly used particles are iodine ( 125 ⁇ ), palladium ( 1Q3 Pd) particles, and the like. It can be placed in the vicinity of the tumor or implanted in the sputum by the implant device, and has the characteristics of high local dose of the therapeutic target, low normal surrounding tissue, safe, reliable and easy protection.
  • the commonly used implantation method is percutaneous implantation or surgical implantation through an injection needle (or an implanter equipped with an injection needle), which has the disadvantages of complicated operation, large trauma, and unfavorable rehabilitation of the patient, and cannot be implanted. Take out, can not adjust the treatment plan according to the effect.
  • the affected part of the pancreatic duct or bile duct is placed through the duodenoscope. It is easy to operate, minimally invasive, and has both drainage and local continuous irradiation of the surrounding tumor. It can also be removed or periodically as needed. replace.
  • the production and processing process is simple, and the stent can be customized according to the position and size of the tumor; the dose optimization calculation can conveniently adjust the local radiotherapy dose of the stent, avoiding the disadvantage of single dose rate, and the conformability of the tumor target area is good.
  • the present invention proposes a pipe bracket capable of carrying a source of micro-radioactive particles, which can be used for fixing the position of the bracket by the drainage tube of the tubular structure and the opposite ends of the drainage tube, preventing the fixed part of the stent from being moved, and draining
  • the lumen of the tube is a drainage lumen for draining pancreatic juice or bile, characterized in that a particle channel is arranged in the wall of the drainage tube, and the inner diameter of the particle 'sub-channel is matched with the outer diameter of the source of the micro-radioactive particles placed.
  • the invention further provides a pipeline bracket capable of carrying a source of micro-radioactive particles, which can be used for fixing the position of the bracket by the opposite ends of the drainage tube and the drainage tube, and is composed of a fixing portion for preventing displacement of the stent, and the lumen of the drainage tube is used for draining pancreatic juice or bile.
  • the drainage chamber is characterized in that a particle groove is arranged on the wall of the drainage tube, and the size of the particle groove matches the outer diameter of the micro-radioactive particle source placed. And depending on the need for treatment, choose whether to close the particle groove after placing the radioactive particles.
  • the drainage tube of the above tubular structure is made of plastic material.
  • the cross-section of the draft tube of the above tubular structure is of any regular or irregular shape.
  • the fixing portions provided at both ends of the above-mentioned drainage tube are composed of opposite barbs, and the barbs can be used to fix the position of the bracket and prevent the bracket from being displaced.
  • the particle channel provided in the wall of the drainage tube is parallel and equal in length to the drainage tube, and the inner diameter of the channel matches the outer diameter of the micro-radioactive particle source placed, and different types of radionuclide sources are placed in the particle channel.
  • the radionuclide source is embedded in the wall of the stent.
  • the particle channel provided in the wall of the above-mentioned drainage tube can be used for the treatment of the radioactive particles, and whether or not a certain material is used, the cavity between two or more adjacent particles in the particle channel is selected. Partially closed.
  • the above-mentioned tube stent can be selected according to the thickness of the bile duct and the pancreatic duct. Different particle diameters can be designed according to the location of the cancerous tumor, and various types of micro-nuclear sources can be placed and fixed.
  • the above-mentioned drainage tube is provided with an irradiation window outside the tube wall of the micro-radioactive particle source, and the size, shape and spacing of the irradiation window are determined by the shape or intensity of the radiation source, and the size and micro-radioactivity of the irradiation window
  • the matching of the particle source is that the length and width of the irradiation window are slightly smaller than the source of the micro-radioactive particles, which is convenient for observing the position of the source of the radioactive particles in the tube wall.
  • the source of the placed micro-radioactive particles is not allowed to escape from the irradiation window. It can make the radionuclide safely fixed on the wall of the stent, and minimize the shielding of the radionuclide by the wall of the stent to exert the best radiation treatment effect.
  • the above irradiation window can be selected according to the requirements of radiotherapy, after placing the radioactive particles, whether to apply a material material to cover or fill the irradiation window.
  • the tube bracket can be designed into different specifications. For example, different outer diameters can be selected according to the thickness of the bile duct and the pancreatic duct.
  • One, two or more particle channels can be designed according to the location of the cancerous tumor for placement and fixation.
  • One, two or more irradiation windows are designed according to the needs of the radiotherapy. The size, shape and spacing of the irradiation window may also vary depending on the shape or intensity of the radiation source. It can also be placed directly on the particle groove structure of the irradiation window or tube wall according to the shape of the micro-radio-nuclear source, without setting the particle channel structure.
  • the invention has the advantages of low cost, simple structure and convenient use, and can not only dilate the bile duct or the pancreatic duct, but also can place the micro-radioactive particle source around the cancer under minimally invasive, and perform continuous and effective radiotherapy for the cancer. It can also be removed or replaced at the right time when needed, which is conducive to patient treatment and rehabilitation.
  • the present invention can also be used to treat cancerous tumors by placing them in other places by endoscopy or other means. BRIEF DESCRIPTION OF THE DRAWINGS
  • Figure 1 is a schematic view of the overall structure of the present invention
  • Figure 2 is a schematic longitudinal sectional view of the present invention
  • Figure 3 is a schematic view of Embodiment 3 of the present invention
  • Figure 4 is a schematic view of Embodiment 4 of the present invention.
  • Figure 5 is a schematic view of Embodiment 5 of the present invention.
  • the present invention consists of a drainage tube 1 and opposing barbs 2 disposed at opposite ends of the drainage tube.
  • the inner tube of the drainage tube 1 is a drainage chamber 1.1, and a particle channel 1.2 is arranged in the surrounding tube wall, and its diameter matches the outer diameter of the micro-radiative particle source.
  • the outer side wall of the particle channel 1.2 is provided with an irradiation window 1.3.
  • the irradiation window 1.3 is slightly shorter in length and width than the source of micro-radioactive particles.
  • the treatment plan select the appropriate micro-radioactive particle source and the corresponding standard type of pipe bracket, and place the micro-particles into the particle channel 1.2 of the stent one by one and fix it to the irradiation window 1.3.
  • the stent is placed into the bile duct or pancreatic duct through the endoscope as usual, and the position of the stent is adjusted under fluoroscopy so that the source of the micro-radioactive particles is located near the lesion area.
  • Barbs 2 help to fix the position of the bracket.
  • Example 1 A pancreatic duct that can carry a source of micro-radioactive particles
  • the length of the drainage tube of the present invention is 54.4 mm, the outer diameter is 3.2 mm, the diameter of the drainage chamber is 1.8 mm, and one particle channel is provided in the tube wall.
  • the particle channel inner diameter is 0.8 hidden.
  • the outer side wall of the particle channel is provided with three irradiation windows, and the length, width and height are divided into 4.4X0.7X0.2(ram), and the adjacent irradiation and window center interval are 10.0 ⁇ .
  • the irradiation windows on both sides are 15.0 paintings from both ends of the drainage tube.
  • the length of the two barbs is 7mm, and the roots are 5 hidden from the ends of the drainage tube.
  • the micro-radioactive particle source has a length of 4.5 mm and a diameter of 0.8 ⁇ .
  • the single particle activity is 0.5raCi.
  • This design of a 50Gy pancreatic duct stent carrying a radioactive 1251 particle source has been successfully performed by endoscopic stent placement. Into the pig pancreatic duct, and confirmed that the stent is safe and effective.
  • Example 2 A bile duct stent capable of carrying a source of microradioactive particles
  • the length of the drainage tube of the present invention is 69.4, the outer diameter is 3.6 ⁇ , the diameter of the drainage chamber is 1.5 ram, and two particle channels are symmetrically arranged in the tube wall.
  • the particle channel inner diameter is 0.8 ⁇ .
  • the distance between the head end irradiation window and the start end of the drainage tube is 25.0, and the distance between the end irradiation window and the end of the drainage tube is 15.0. Both barbs are 7mm in length and the roots are 5mm from the ends of the bracket.
  • the source of the miniature radioactive particles is 4.5mm in length and 0.8 in diameter.
  • Single particle activity 0.6mCio
  • This bile duct stent with a therapeutic dose of 150Gy carrying a radioactive 1251 particle source has been successfully placed into the porcine bile duct by endoscopic stenting and has proven to be safe and effective.
  • the material of the pipe holder can be different, that is, by using the shielding effect of the radiation of the source, whether or not the irradiation window is set as needed.
  • the following examples 3 and 4 are detailed:
  • a pipe bracket made of a low-shielding material such as polyethylene plastic can have a wide range of radiation without a radiation window 1.3, and has little effect on the radiation effect, and is suitable for a wide range of tumors. Or after setting the irradiation window 1.3, in order to prevent the radiation source from falling off, the irradiation window is covered or filled with a low shielding material 1.4.
  • a high-shielding material or a radiopaque material, is required to provide a radiation window 1.3 suitable for localized tumor irradiation to avoid exposure to other normal tissues that do not require irradiation.
  • a radiation window 1.3 suitable for localized tumor irradiation to avoid exposure to other normal tissues that do not require irradiation.
  • use 'low shielding material 1.4 The irradiation window is covered or filled.
  • the particle groove is provided on the wall of the drainage tube 1.
  • the particle groove is 1.5.
  • the size of the particle groove is matched with the outer diameter of the placed micro-radioactive particle source, and the source is fixed in the groove to reach the source.

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Description

一种可承载微型放射性粒子源的管道支架
技术领域
本发明涉及医疗器械技术领域， 是一种可承载微型放射性粒子源的 管道支架， 主要用于中晚期胰腺癌或胆管癌的内照射治疗并具备弓 I流功 能。
技术背景
胰腺癌和胆管癌是一组病情凶险、 治愈率低、 预后极差的消化道恶 性肿瘤， 多数发现时已属中晚期， 往往无法手术切除。 肿瘤常常会压迫 胰管、 胆管， 造成狭窄或阻塞。 对于管道狭窄或阻塞， 目前主要釆用内 镜下置入具备引流功能的管道支架来缓解临床症状。 主要分为塑料支架 和金属支架两大类型。
临床常用的塑料管道支架由引流管和引流管两端外侧所设的相向 的倒刺组成。 通过十二指肠镜将管道支架置入患部， 引流管支撑在狭窄 或阻塞区域， 胆汁或胰液可通过管内引流腔进行引流； 两端倒刺用于固 定支架位置， 既可防止支架向肠腔滑脱， 又可防止支架完全进入胰管或 胆管内。 支架可定期取出更换， 以保持引流通畅。
金属支架广泛应用于人体管腔内良、 恶性狭窄的治疗。 为金属网状 结构， 主要通过自膨作用支撑固定于患部。 有学者采用化学电镀方式将 放射性核素均匀电镀于金属支架上， 制成不同强度的放射性金属支架， 用于防治植入内支架后由血管或胆管内皮细胞增生造成的管腔再狭窄。 有学者将含放射性核素 'Β6Ηο的 polyurethane膜粘附在金属支架表面， 用于治疗食管癌或胆管内植入内支架后管腔再狭窄。采用上述方式生产 的放射性支架治疗恶性肿瘤疾病， 无法满足临床治疗要求， 存在如下缺 陷： 生产加工工艺复杂， 不易保存； 剂量率单一， 无法根据患者肿瘤 大小定制支架； 很难行成产业化。
对于胰腺癌和胆管癌的治疗， 目前临床上己有用微型放射性粒子源 进行局部放疗， 疗效确定。 医用微型放射性粒子是将放射性核素封装在 钛合金外壳内制成的短杆状固体放射^ 。 目前常用的粒子有碘 （125ι)、 钯（1Q3Pd)粒子等， 临床常用规格为长度 4. 5瞧， 直径 0. 8隱。 可通过植 入装置， 将其置于肿瘤附近或植入癉体内进行照射， 具有治疗靶点局部 剂量高， 周围正常组织受量低以及安全、 可靠、 易防护等特点。 目前常 用的植入方式为通过注射针 （或配有注射针的植入器） 经皮植入或通过 手术植入， 存在操作复杂、 创伤大、 不利于患者康复等缺点， 且植入后 无法取出， 不能根据疗效及时调整治疗方案。
发明内容
本发明的目的是提供一种可承载微型放射性粒子源的管道支架。 通 过十二指肠镜置入胰管或胆管内的患部， 不仅置入时操作方便， 创伤极 小， 而且既具有引流作用， 又可对周围肿瘤进行局部持续照射， 还可根 据需要取出或定期更换。.生产加工工艺简单， 可根据肿瘤的位置及大小 定制支架； 通过剂量优化计算， 方便调整支架局部放疗剂量， 避免了剂 量率单一的缺点， .对肿瘤靶区的适形性较好。 ' . 为解决上述技术问题， 本 明提出一种可承载微型放射性粒子源的 管道支架， 由管状结构的引流管和引流管两端相向可用于固定支架位 置， 防止支架移 的固定部组成， 引流管内腔为用 引流胰液或胆汁的 引流腔， 其特征在于所述引流管管壁内设有粒子孔道， 粒'子孔道内径与 所放置的微型放射性粒子源外径匹配。 本发明又提出一种可承载微型放射性粒子源的管道支架， 由引流 管和引流管两端相向可用于固定支架位置， 防止支架移位的固定部组 成， 引流管内腔为用以引流胰液或胆汁的引流腔， 其特征在于所述引流 管管壁上设有粒子凹槽， 粒子凹槽尺寸与所放置的微型放射性粒子源外 径匹配。 并根据治疗需要， 选择是否在放置放射性粒子后将粒子凹槽封 闭。
上述管状结构的引流管是塑料材质。
上述管状结构的引流管横截面是任意规则或不规则形状。
上述引流管两端所设的固定部是由相向的倒刺组成， 倒刺可用于固 定支架位置， 防止支架移位。
上述引流管管壁内所设有的粒子孔道与引流管平行、 等长， 孔道内 径与所放置的微型放射性粒子源外径匹配， 是在所述粒子孔道内放置不 同类型的放射性核素源， 使放射性核素源嵌入支架的管壁内。
上述引流管管壁内所设有的粒子孔道， 在放置放射性粒子过程中， 可根裾治疗需要， 选择是否采用某种材料， 将粒子孔道内两个或多个相 邻粒子之间的空腔部分封闭。
上述管道支架可根据胆管和胰管粗细的不同可选择不同外径， 根据 癌瘤分布的部位不同可设计若干条粒子孔道，.用以放置、 固定各种类型 的微型放射性核素源。
上述的引流管放置微型放射性粒子源的管壁外部设有辐照窗口， 所 述辐照窗口的大小、 形状和间距由辐射源形状或强度大小而定， 所述辐 照窗口的大小与微型放射性粒子源的匹配是辐照窗口的长度和宽度略 小于微型放射性粒子源， 既方便观察放射性粒子源在管壁内的位置， 也 使所放置微型放射性粒子源不会从辐照窗口处脱出。 可以使放射性核 素可以安全固定在支架管壁上， 并尽可能减少支架管壁对放射性核素的 屏蔽， 发挥最佳放射治疗效果？
上述辐照窗口， 可根据放射治疗要求， 在放置放射性粒子后， 选择 是否应用某种材质材料将辐照窗口覆盖住或填平。
本管道支架可设计成不同规格型号， 如根据胆管和胰管粗细的不同 可选择不同外径， 根据癌瘤分布的部位不同可设计 1条、 2条或多条粒 子孔道， 用以放置、 固定各种类型的微型放射性核素源。 根据放疗需要 设计 1个、 2个或多个辐照窗口， 辐照窗口的大小、 形状和间距也可因 辐射源形状或强度大小而不同。.也可根据微型 ¾射性核素源的形状， 将 其直接放置固定于辐照窗口或管壁上的粒子凹槽结构， 而不设置粒子孔 道结构。 使用时选择柑应的规格型号， 先将微型放射性粒子源置于本支 架的设计位置， 再按常规将支架通过十二指肠镜置入胆管或胰管的相应 位置即可。
本发明成本低廉、 结构简单、 使用方便， 既能扩张胆管或胰管起引 流作用， 又能在微创下将微型放射性粒子源置于癌瘤周围， 对癌瘤进行 近距离持续有效的放疗， 还能在需要时适时取出或更换， 有利于患者治 疗和康复。
本发明也可通过内窥镜或其它途径置入其它部位， 对癌瘤进行放 疗。 . 附图说明
图 1是本发明整体结构示意图；
图 2是本发明纵剖面结构示意图； 图 3是本发明实施例 3的示意图；
图 4是本发明实施例 4的示意图；
图 5是本发明实施例 5的示意图。
具体实施方式
现结合附图和实施例对本发明的实施方式作详细描述。
本发明由引流管 1和引流管两端所设相向的倒刺 2组成。 引流管 1 内腔为引流腔 1.1， 周围管壁内设有粒子孔道 1.2， 其直径与微型放射 性粒子源外径匹配。 粒子孔道 1.2的外侧壁设有辐照窗口 1.3。 辐照窗 口 1.3长度和宽度略小于微型放射性粒子源。
使用时， 根据治疗方案， 选择适当的微型放射性粒子源和相应规格 型号的管道支架， 逐一将微型粒子置入支架的粒子孔道 1.2并使其固定 于辐照窗口 1.3。
再按常规通过内镜将支架置入胆管或胰管内， 于 X线透视下调整支 架位置， 使微型放射性粒子源位于病变区域附近。 倒刺 2可帮助固定支 架位置。
实施例 1. 一种可承载微型放射性粒子源的胰管亥架
本发明引流管的长度为 54.4mm， 外径为 3.2mm， 引流腔直径为 1.8mm, 管壁内设有 1条粒子孔道。粒子孔道内径为 0.8隱。 粒子孔道的 外侧壁设有 3个辐照窗口， 长宽高分为 4.4X0.7X0.2(ram) , 相邻辐照、 窗口中心间隔 10.0隠。 两侧辐照窗口距引流管两端均为 15.0画。 两根 倒刺长度均为 7mm， 其根部距引流管两端各 5隱。 微型放射性粒子源长 度 4.5mm,直径 0.8瞧。单个粒子活度 0.5raCi。这种设计治疗剂量为 50Gy 的承载放射性 1251 粒子源的胰管支架已成功通过内镜下支架置入术置 入猪胰管内， 并证实此支架安全有效。
实施例 2. —种可承载微型放射性粒子源的胆管支架
本发明引流管的长度为 69.4讓， 外径为 3.6誦， 引流腔直径为 1.5ram, 管壁内设有左右对称的 2条粒子孔道。 粒子孔道内径为 0.8瞧。 每条粒子孔道的外侧壁均设有 6 个辐照窗口， 长宽高分为 4.4X0.7 X 0.2(國） ， 相邻辐照窗口中心间隔 5.0脑。头端辐照窗口距引流管起始端 距离为 25.0隱， 尾端辐照窗口距引流管末端距离为 15.0議。 两根倒刺 长度均为 7mm，其根部距'支架两端各 5mm。微型放射性粒子源长度 4.5mm, 直径 0.8隱。 单个粒子活度 0.6mCio 这种设计治疗剂量为 150Gy的承载 放射性 1251 粒子源的胆管支架已成功通过内镜下支架置入术置入猪胆 管内， 并证实此支架安全有效。
可依据患者的肿瘤情况， 照射目的的不同， 利用管道支架材质的不 同， 即利用放射源射线的屏蔽作用的不同， 选择是否根据需要设置辐照 窗口。 如下实施例 3和 4详述：
实施例 3:
如图 3所示， 采用低屏蔽材料， 例如聚乙烯塑料制成的管道支架， 可在不设置辐射窗口 1.3的情况下， 射线照射范围广， 对辐射效果影响 不大， 适用于广泛的肿瘤。 或在设置辐照窗口 1.3后， 为防治放射源脱 落， 采用低屏蔽材料 1.4将辐照窗口覆盖住或填平。
实施例 4:
如图 4所示， 采用高屏蔽材料， 或不透射线的材料， 需设置辐射窗 口 1.3， 适用于局部的肿瘤照射， 以避免照射其它无需照射的正常组织。 或在设置辐照窗口 1.3后， 为防治放射源脱落， 采用'低屏蔽材料 1.4将 辐照窗口覆盖住或填平。
实施例 5:
可在引流管 1管壁上设有粒子凹槽 1. 5， 粒子凹槽 1. 5尺寸与所放 置的微型放射性粒子源外径匹配， 放射源固定在该凹槽内， 以达到将放 射源固定在管壁上的目的。 或在设置粒子凹槽.1. 5后， 为防治放射源脱 落， 采用低屏蔽材料 1. 4将粒子凹槽 1. 5覆盖住或填平。
虽然以上描述了本发明的具体实施方式， 但是本领域技术人员应当 理解， 这些仅是举例说明，·可以对这些实施方式作出多种变更或修改， 而不背离本发明的原理和实质。 本发明的范围仅由所附权利要求书限 定。

Claims

权 利 要 求
1、 一种可承载微型放射性粒子源的管道支架， 由管状结构的引流管 (1) 和引流管两端相向可用于固定支架位置， 防止支架移位的固定 部（2)组成，引流管（1)内腔为用以引流胰液或胆汁的引流腔（1.1)， 其特征在于所述引流管 （1) 管壁内设有粒子孔道 （1.2)， 粒子孔道 (1.2) 内径与所¾ (置的微型放射性粒子源外径匹配。
2、 一种可承载微型放射性粒子源的管道支架， 由引流管（1)和引流 管两端相向可用于固定支架位置， 防止支架移位的固定部（2)组成， 引流管 （1) 内腔为用以引流胰液或胆汁的引流腔 （1.1)， 其特征在 于所述引流管 （1) 管壁上设有粒子凹槽（1.4)， 粒子凹槽（1.4)尺 寸与所放置的微型放射性粒子源外径匹配。 .
3、 按权利要求 1或 2所述的管道支架， 其特征在于所述管状结构的 引流管 （1) 是塑料材质。
4、 按权利要求 1或 2所述的管道支架， 其特征在于所述管状结构的 引流管 （1) 横截面是任意规则或不规则形状。
5、 按权利要求 1或 2所述的管道支架， 其特征在于在所述的引流管 (1) 放置微型放射性粒子源的管壁外部设有辐照窗口， 所述辐照窗 口的大小、形状和间距由辐射源形状或强度大小而定， 所述辐照窗口 的大小与微型放射性粒子源的匹配是辐照窗口的长度和宽度略小于 微型放射性粒子源，以使所放置微型放射性粒子源不会从辐照窗口处 脱出。
6、 按权利要求 1或 2所述的管道支架， 其特征在于所述固定部 （2)
7、 按权利要求 1所述的管道支架， 其特征在于所述引流管（1)管壁 内所设有的粒子孔道 （1.2) 与引流管 （1) 平行。
8、 按权利要求 1所述的管道支架， 其特征在于所述引流管（1)管壁 内所设有的粒子孔道 （1.2) 与引流管 （1) 等长。
9、 按权利要求 1所述的管道支架， 其特征在于所述粒子孔道 （1.2) 内径与所放置的微型放射性粒子源外径匹配， 是在所述粒子孔道
(1.2) 内放置不同类型的放射性核素源， 使放射性核素源嵌入支架 的管壁内。
10、按权利要求 1所述的管道支架， 其特征在于可根据治疗需要， 所 述粒子孔道 （1.2) 内的两个或多个相邻粒子之间的空腔部分是封闭 的。
11、按权利要求 1所述的管道支架， 其特征在于所述粒子孔道（1.2) 根据胆管和胰管粗细的不同可选择不同外径，根据癌瘤分布的部位不 同可设计若干条粒子孔道， 用以放置、 固定各种类型的微型放射性核 素源。
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