CN105997235A - A bronchial thermoplasty system - Google Patents

A bronchial thermoplasty system Download PDF

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Publication number
CN105997235A
CN105997235A CN201610298459.3A CN201610298459A CN105997235A CN 105997235 A CN105997235 A CN 105997235A CN 201610298459 A CN201610298459 A CN 201610298459A CN 105997235 A CN105997235 A CN 105997235A
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China
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sub
needle
radio frequency
working
bronchial
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CN201610298459.3A
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Chinese (zh)
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秦杰
汪虔
孔凡斌
何俊德
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上海安臻医疗科技有限公司
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Priority to CN201610298459.3A priority Critical patent/CN105997235A/en
Publication of CN105997235A publication Critical patent/CN105997235A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor

Abstract

The invention provides a bronchial thermoplasty system which comprises a bronchial thermoplasty catheter and a bronchial thermoplasty radio frequency therapy instrument. The bronchial thermoplasty catheter comprises a working end, an outer sleeve tube and a handle. The working end comprises an end cap, working sub-needles, a support base and a radio frequency sub-needle. One end of each working sub-needle and one end of the radio frequency sub-needle are fixed to the end cap; the other end of each working sub-needle is fixed to the support base. The other end of the radio frequency sub-needle is connected with the handle after passing through the support base. The radio frequency sub-needle can slide on the support base. The two ends of each working sub-needle are electrically connected with the radio frequency sub-needle. The number of the working sub-needles is 3-6 and the radio frequency sub-needle is surrounded by the working sub-needles. The working sub-needles are made of nickel-titanium alloy and the radio frequency sub-needle is made of stainless steel or copper; the outer sleeve tube is a three-cavity tube. The bronchial thermoplasty system can display failure information in real time and has a large screen, and has the advantages of adjustable therapy time and adjustable power. The sub-needles are not liable to deform, and the adjustable bending angle of the catheter is larger; the working principle is simple and the operation is convenient.

Description

支气管热成形系统 Bronchial thermoforming system

技术领域 FIELD

[0001]本发明涉及一种医疗器械,尤其涉及一种支气管热成形系统。 [0001] The present invention relates to a medical instrument, particularly to a thermoforming bronchial system.

背景技术 Background technique

[0002]射频是指无线电频率,但它不属于无线电通信中波段的划分,因为在这样的频率范围内辐射性能很低,故通讯设备中较少采用,面对生物体的作用主要是热效应。 [0002] RF radio frequency means, but it does not belong to divided band radio communication, such as in the low frequency range radiating performance, it is less employed in communications equipment, mainly the face of an organism thermal effect. 当射频的电流频率高到一定值时(MOOkHz),引起组织内带电荷的离子运动即摩擦生热(60〜100°C)。 When the high frequency RF current to a certain value (MOOkHz), causing movement of charged ions within the organization, the frictional heat (60~100 ° C). 射频消融设备常用的频率为200〜500kHz,输出功率根据不同的消融组织来确定,对于支气管来说一般为20W左右。 Common device for the frequency of the RF ablation 200~500kHz, determined depending on the output power of the ablated tissue, bronchial is generally about 20W.

[0003]支气管热成形术,是一种创新的哮喘治疗技术,通过支气管镜导入端帽,利用射频能量(或热量)打薄气道壁上增生的气道平滑肌(ASM),从而降低气道在哮喘症状发作时的收缩幅度,并降低发作的频率与严重程度。 [0003] Bronchial thermal angioplasty, asthma is an innovative technology, introduced through the bronchoscope end cap, using radio frequency energy (or heat) airway wall thinning of airway smooth muscle proliferation (the ASM), thereby reducing the airway contraction amplitude at the onset of symptoms of asthma, and reduce the frequency and severity of attacks. 它专门针对18岁及以上采用糖皮质激素和长效的β-受体激动剂治疗没有得到良好控制并且能够耐受支气管的镜检查的重度持续性哮喘患者。 It specifically glucocorticoid receptor agonist β- and long-lasting treatment for over 18 years and are not well controlled and severe persistent asthma microscope capable of withstanding bronchi.

[0004]目前该领域的产品主要是波士顿科技公司生产的Alair系列产品。 [0004] At present, the main product areas are Boston Scientific's Alair series production. Alair系列产品的支气管热成形导管在使用过程中易发生子针变形从而影响使用寿命,影响手术治疗效果,并且不能作用于直径小于3mm的气道,子针的工作面较小,以及导管可调控的折弯角度较小。 Bronchial hot forming catheter products Alair prone to affect the service life of the sub-needle deformed, affect surgical outcomes during use, and can not act on airway diameter of less than 3mm, the smaller face of the sub-needle, and the catheter may be regulated smaller bending angle. 支气管热成形导管又叫做射频消融导管。 Bronchial thermoforming radiofrequency catheter ablation catheter also known.

[0005]现有系统工作时间不可调,为固定消融时间;现有系统出现故障无故障信息;现有系统显示窗口太小,不能有效显示,显示的信息有限,只显示消融次数(有效和无效)。 [0005] Working time is not adjusted prior systems, ablation is a fixed time; fault information prior system has no fault; conventional window display system is too small to effectively display information displayed is limited, only frequency ablation (active and inactive ).

发明内容 SUMMARY

[0006]有鉴于现有技术的上述缺陷,本发明提供的一种支气管热成形系统,包括支气管热成形导管和支气管热成形射频治疗仪,支气管热成形导管包括工作端、外套管和手柄;工作端包括端帽、工作子针、支撑座和射频子针;工作子针和射频子针的一端均固定在端帽处;工作子针的另一端固定在支撑座处;射频子针的另一端穿过支撑座与手柄连接;射频子针能够在支撑座上滑动;工作子针的两端均与射频子针电连接;工作子针的数量是3-6根,将射频子针包围着中间;工作子针为镍钛合金;射频子针为不锈钢或者铜;工作端具有第一形状和第二形状,在第一形状下,工作子针合拢,工作端被设置为适于在气管或者支气管中移动;在第二形状下,工作子针撑开,使得工作子针适于将射频子针传导的能量以热量的方式作用于气管或者支气管;第一形状和第二形状的切换通 [0006] In view of the aforementioned drawbacks of the prior art A system of the present invention bronchial thermoforming provided, including bronchial catheter and bronchial thermoforming thermoforming radio frequency treatment instrument, including bronchial thermoforming working end of the catheter, the outer sleeve and handle; work end comprises an end cap, the work of the sub-needle, a support seat and a radio frequency sub-needle; working sub-needle and the end of radio frequency sub-needles are fixed to the end cap of the; other working sub-needle end fixed to the supporting base at; the other end of the radio frequency sub-needle through the support base connected to the handle; radio frequency sub-needle can slide in the support base; working ends are connected to the sub-needle electrical radio frequency sub-needle; the number of working needles sub-root 3-6, RF intermediate sub-needle surrounded ; working sub-needle is nitinol; radio frequency sub-needle is a stainless steel or copper; working end having a first shape and a second shape, the first shape at the working sub-needle collapsed, working end adapted to be disposed in the trachea or bronchi move; in the second shape, the expansion work of the sub-needle, the needle is adapted so that the working sub-sub-needle radiofrequency energy acts to heat conducting manner to the trachea or bronchus; switching on the first and second shapes 过滑动射频子针改变端帽和支撑座之间的距离进行调整;外套管为三腔管,包括管壁和由管壁围合而成的三个空腔,分别命名为第一空腔、第二空腔和第三空腔;外套管的一端与支撑座连接,另一端与手柄连接;射频子针在支撑座和手柄之间的区段被设置在第一空腔、第二空腔或者第三空腔中。 Sliding the needle over the radio frequency sub varying the distance between the end cap and the support seat adjustment; three outer cannula lumen, the wall comprising a wall and three cavities encircled respectively named a first cavity, third cavity and the second cavity; end of the outer sleeve and the supporting base and the other end connected to the handle; radio frequency sub-section between the needle and the handle support base is disposed in the first cavity, the second cavity or the third cavity.

[0007]进一步地,工作端还包括热电偶;热电偶呈线形,包括第一端部和第二端部;热电偶的第一端部设置在任意一根工作子针上,第二端部穿过支撑座与支气管热成形导管的手柄连接;热电偶除第一端部外,其表面包被有绝缘层;第一端部的长度为0.3-0.7mm。 [0007] Further, the working end further comprises a thermocouple; linearly thermocouple comprising a first end and a second end; the first end portion of the thermocouple is disposed on any one sub-needle work, the second end portion through the support base and bronchial thermoforming handle connecting conduit; thermocouple addition to the first end of the outer surface thereof coated with an insulating layer; length of the first end portion of 0.3-0.7mm. 优选地,第一端部的长度为0.5mm。 Preferably, the length of the first end portion is 0.5mm.

[0008]进一步地,从第一端部到支撑座的这段热电偶贴合在任意一根工作子针的内表面。 [0008] Further, from the first end to the support base of this thermocouple attached to the inner surface of the work at any one of the sub-needle.

[0009]优选地,工作子针的数量是4根。 [0009] Preferably, the number of working needles are four sub.

[00Ί0] 进一步地,工作子针的长度是30±0.1mm,宽是0.36mm,厚度是0.1mm;射频子针的直径是0.25 ±0.05mm。 [00Ί0] Further, the length of the working sub-needle is 30 ± 0.1mm, a width of 0.36mm, a thickness of 0.1mm; diameter radio frequency sub-needle is 0.25 ± 0.05mm.

[0011 ]进一步地,工作端还包括膜,膜的壁厚是0.01 ± 0.005mm,膜是PET热缩套管;膜包被在工作子针的两端;工作子针上未被膜包被的长度是5-6_。 [0011] Further, the working end further comprises a film, the film thickness is 0.01 ± 0.005mm, PET film is heat-shrinkable sleeve; film coating work ends in the sub-needle; sub-needle is not working on the film-coated length 5-6_.

[0012]进一步地,端帽的材料是聚醚醚酮(PEEK)。 [0012] Further, the end cap material is a polyether ether ketone (PEEK). 相比于其他材料,如丙烯腈-丁二烯-苯乙烯(ABS)、树脂类来说,从硬度、强度和耐温性综合比较,发现PEEK更好。 Compared to other materials, such as acrylonitrile - butadiene - styrene (ABS), resins, the comprehensive comparison of hardness, strength and temperature resistance, PEEK found better.

[0013] 进一步地,工作端的工作直径范围为1.5-13mm。 [0013] Further, the working end of the working diameter range 1.5-13mm. 工作直径范围是指在工作子针合拢时达到的最小工作直径为1.5_;在工作子针撑开时达到的最大工作直径为13_。 It refers to the smallest diameter of the working range of working diameters up collapses during operation of the sub-needle 1.5_; maximum working diameter attained during operation of the sub-needle 13_ distraction.

[0014]进一步地,工作子针的靠近端帽的那一端与射频子针通过导电胶水电连接。 [0014] Further, that end of the radio frequency sub-sub-needle near the needle working end cap connected by the conductive adhesive hydropower.

[0015]另一方面,外套管的三个腔室的横截面均为圆形,第一空腔横截面的直径为0.37-0.47mm ;第二空腔横截面的直径为0.30-0.40mm ;第三空腔横截面的直径为0.25-0.35mm。 [0015] On the other hand, the cross section of the overtube three chambers are circular, the cross section of the first cavity having a diameter of 0.37-0.47mm; second cavity cross-sectional diameter of 0.30-0.40mm; diameter of the third cavity cross section of 0.25-0.35mm. 优选地,第一空腔横截面的直径为0.45mm,该尺寸的公差范围为:+0.02mm/-0.08mm;第二空腔横截面的直径为0.38mm,该尺寸的公差范围为:+0.02mm/-0.08mm;第三空腔横截面的直径为0.30mm,该尺寸的公差范围为:±0.05mm。 Preferably, the diameter of the first cavity cross section of 0.45 mm, the tolerance range of dimensions: + 0.02mm / -0.08mm; diameter of the second cavity cross section of 0.38mm, the dimension of the tolerance range: + 0.02mm / -0.08mm; diameter of the third cavity cross section of 0.30mm, the dimension of the tolerance range: ± 0.05mm.

[0016]进一步地,外套管的横截面为圆形,其外径为1.1-1.2mm。 [0016] Further, the cross section of the outer sleeve is circular, an outer diameter of 1.1-1.2mm. 优选地,外套管的外径为I.Imm0 Preferably, the outer diameter, the outer tube is I.Imm0

[0017]进一步地,外套管的管壁采用带有BaSO4的Pebax材料。 [0017] Further, the outer wall of the tube using a Pebax material having a BaSO4. 优选地,外套管的管壁采用Pebax(嵌段聚醚酰胺弹性体)材料,且在Pebax材料中添加有占质量百分比20%的BaS04。 Preferably, the outer wall of the tube using Pebax (polyether block amide elastomer) material, and the material has added to the account Pebax 20% by mass of BaS04.

[0018]进一步地,支气管热成形射频治疗仪包括显示屏,所述显示屏的有效显示区域的长度为82〜85mm,宽度为40〜43mm。 [0018] Further, bronchial thermoforming radio frequency treatment instrument includes a display screen, a length of the effective display region of the display screen is 82~85mm, width 40~43mm. 优选地,所述显示屏的有效显示区域尺寸是83.1 X41.Smnin Preferably, the effective display region of the display screen size is 83.1 X41.Smnin

[0019]进一步地,支气管热成形射频治疗仪还包括时间调整按钮。 [0019] Further, bronchial thermoforming radio frequency treatment instrument further comprises a time adjustment button.

[0020]进一步地,支气管热成形射频治疗仪还包括功率调节按钮。 [0020] Further, bronchial thermoforming radio frequency treatment instrument further comprises a power control button.

[0021]进一步地,支气管热成形射频治疗仪还包括与之配套的软件;所述软件根据不同的故障显示不同的错误代码或者故障信息。 [0021] Further, bronchial thermoforming apparatus further includes a radiofrequency accompanying software; the software displays an error code different depending on the failure information or fault. 比如支气管热成形导管未接插到位,则所述软件会发出指令使得显示屏上显示“No Handel” ;脚踏开关未连接或者连接不到位会显示“NoFootSwitch” ;支气管热成形系统5V供压出错会显示“Fault 33”等。 Such as bronchial ductus thermoforming plug in place, the software will send an instruction so that the display "No Handel" on a display screen; foot switch is not connected or not connected is displayed in place "NoFootSwitch"; thermoforming bronchial system 5V supply pressure error displays "Fault 33" and so on. 由于显示屏较大,且本发明的所述软件设定了该显示屏除了显示消融次数外,还会实时显示实际消融的温度,实时显示阻抗,实时显示消融时间等有效信息。 Due to the larger display, and the software of the present invention, in addition to setting the screen display frequency ablation, the ablation will display the actual temperature in real time, real-time display impedance, ablation time information effective real-time display and the like.

[0022]进一步地,支气管热成形射频治疗仪可以提供的输出功率包括18W±20% ;支气管热成形射频治疗仪可以提供的频率包括480KHz±10%;支气管热成形射频治疗仪可以提供的稳定温度包括65°C ±3°C。 [0022] Further, bronchial thermoforming output power of the radio frequency treatment instrument may include 18W ± 20%; frequency of the radio frequency treatment instrument may include 480KHz ± 10% bronchial thermoforming; stable temperature radio frequency treatment instrument may be provided bronchial thermoforming including 65 ° C ± 3 ° C.

[0023]优选地,支气管热成形射频治疗仪可以提供的输出功率包括18W;支气管热成形射频治疗仪可以提供的频率包括480KHZ;支气管热成形射频治疗仪可以提供的稳定温度包括65°C。 [0023] Preferably, bronchial thermoforming output radio frequency treatment instrument may include 18W; frequency radio frequency treatment instrument may include thermoforming 480KHZ bronchus; stable temperature radio frequency treatment instrument may include thermoforming bronchus 65 ° C.

[0024]本发明通过调整射频子针在支撑座上的滑动情况调整工作端的工作直径,实现工作端第一形状和第二形状之间的切换。 [0024] Switching between the working end of the first and second shapes of the present invention, by adjusting the radio frequency sub-needle adjustment end in the case of the slide supporting base diameter work achieved. 采用镍钛合金制备的工作子针,有利于充分使用镍钛合金的记忆性能,可确保在每一次撑开的位置都能均匀和适度。 Working prepared using the sub-needle nitinol, conducive to the full use of the memory properties of nickel titanium alloy, it ensures that every position can be stretched uniformly and moderately. 镍钛合金制作的工作子针的设计,由于所用材料耐热性、韧性较好,多次闭合和撑开不易发生形变,有利于提升使用次数。 Nickel-titanium alloy sub-needle design work, since the heat-resistant material, good toughness, and repeatedly closing the expansion deformation hardly occurs conducive to improve the frequency of use. 4根工作子针的设计,有利于既能使得工作子针能够有效接触到需要处理的工作面;又能使得第一形状下的工作端的工作直径足够小,有利于进入气管或者支气管进行操作。 4 sub-needle design work, such work is conducive to both the sub-face contact with the needle can be efficiently need of treatment; but that the working diameter of the work at the first end of the shape is small enough, into the trachea or bronchi facilitate operation.

[0025]现有技术的同类产品的外套管为单腔或者双腔。 Similar products [0025] The prior art single lumen or overtube lumen. 若为双腔时,分别用于放置射频子针和热电偶。 If the dual-chamber, respectively, for placing the radio frequency sub-needle, and a thermocouple. 而本发明所涉及的用于射频消融导管的外套管有三个空腔,使得其可以剩下一个空腔让其空置,这样有利于增加该外套管的柔韧性,使得可调整的折弯角度更广。 For radio frequency ablation catheter while the overtube according to the present invention has three cavities, one cavity such that it can be left vacant allowed, this will help increase the flexibility of the outer tube, so that the adjustable bending angle more wide. 本发明所涉及的用于射频消融导管的外套管能达到60°的可调整折弯角度;而一般的两个空腔的外套管只能达到75°。 For radio frequency ablation catheter overtube according to the present invention it is to achieve an adjustable bending angle of 60 °; and the general two cavities overtube can reach 75 °. 在管壁中添加了BaSO4,使得管材具有可显影性。 BaSO4 is added in the pipe wall, so that the pipe has developability. Pebax材料的优点是最轻的工程热塑性弹性体;低温下良好和稳定一致的性能;反复形变下没有机械性能的损失,并且抗疲劳;良好的回弹和弹性恢复;精确的尺寸稳定性;以及优秀的加工性能。 Pebax material advantage is the lightest engineering thermoplastic elastomer; stable at low temperatures and good consistent performance; without loss of mechanical properties under cyclic deformation and fatigue; good elastic recovery and resilience; exact dimensional stability; and excellent processing performance.

[0026]支气管热成形射频治疗仪的时间调整按钮,有利于医生在操作过程中可以根据实际需要对治疗时间进行调整,以达到最佳治疗效果。 [0026] Bronchial thermoforming radio frequency treatment instrument time adjustment button, help doctors during operation can be adjusted according to actual needs of the treatment time to achieve the optimal therapeutic effect. 此外,显示屏的尺寸大,有利于显示更多有效信息。 In addition, the screen size, is conducive to display more useful information.

[0027]以下将结合附图对本发明的构思、具体结构及产生的技术效果作进一步说明,以充分地了解本发明的目的、特征和效果。 [0027] Here will be further described in conjunction with the accompanying drawings of the concepts of the present invention, the specific configuration and technical effects as produced, in order to fully understand the objects, features and advantages of the present invention.

附图说明 BRIEF DESCRIPTION

[0028]图1是本发明所涉及的支气管热成形系统的一个具体实施方式的结构示意图。 [0028] FIG. 1 is a structural diagram of the present invention relates to a thermal bronchial forming system of a specific embodiment.

[0029]图2是本发明所涉及的支气管热成形导管的一个具体实施方式的示意图。 [0029] FIG. 2 is a schematic diagram of the present invention relates to heat bronchial shaped conduit embodiment of a particular embodiment.

[0030]图3是本发明所涉及的工作端的一个具体实施方式的截面示意图。 [0030] FIG. 3 is a cross-sectional view of a specific embodiment of the working end of the embodiment according to the present invention.

[0031 ]图4是本发明所涉及的外套管的一个具体实施方式的示意图。 [0031] FIG. 4 is a schematic diagram of a specific embodiment of the overtube embodiment of the present invention.

具体实施方式 Detailed ways

[0032]结合附图对本发明做进一步的说明。 [0032] The accompanying drawings further illustrate the present invention. 应该理解为这不是对本发明的限制,在本发明上做的常规变化也应属于本发明的保护范畴。 It should be understood that the invention is not a limitation, of the present invention, in the routine variations should also be done within the protection scope of the invention. 本发明所用到的材料均可以从市场上购买获得。 The materials are used in the present invention can be purchased from the market.

[0033]如图1所示,本发明所涉及的支气管热成形系统包括支气管热成形导管A和支气管热成形射频治疗仪B。 [0033] As shown, the present invention relates to a thermoforming system comprises bronchial bronchus and bronchial A pipe thermoforming thermoforming radio frequency treatment instrument B. 支气管热成形导管A通过插头301连接在支气管热成形射频治疗仪B上。 A thermoforming bronchial conduit connected to the bronchus thermoforming B radio frequency treatment instrument 301 through the plug. 支气管热成形射频治疗仪B包括显示屏,该显示屏的有效显示区域尺寸是83.1 X41.5_。 Bronchial thermoforming B radio frequency treatment instrument includes a display screen, the effective display region of the display screen size is 83.1 X41.5_. 支气管热成形射频治疗仪还可以包括时间调整按钮和功率调节按钮。 Bronchial thermoforming apparatus may further include a radio frequency ablation time adjustment and power adjustment buttons buttons.

[0034]如图2所示,本发明所涉及的支气管热成形导管,包括工作端100、外套管200和手柄300。 [0034] As shown, the present invention relates to heat bronchial forming catheter 2, comprising a working end 100, the outer sleeve 200 and the handle 300. 手柄300包括插头301。 Handle 300 includes a plug 301. 支气管热成形射频治疗仪上设置有与插头匹配的插座。 The plug socket is provided with a matching radio frequency therapy device bronchial thermoforming.

[0035]如图3所示,本发明所涉及的工作端包括端帽1、工作子针2、支撑座4、射频子针3、膜和热电偶6 ο工作子针2—共有4根,图1为截面图只显示了两根工作子针2。 [0035] As shown, the present invention relates to a working end 3 includes an end cap 1, the work of the sub-needle 2, the support base 4, radio frequency sub-needle 3, and a film thermocouple 6 ο total working sub-needle 4 2-, FIG. 1 is a sectional view shows only two sub-working needles 2. 工作子针2也可以有3根、5根或者6根。 Work sub-needle 2 may also have three, five or six. 射频子针3是被4根工作子针2包围的,其一端与工作子针2的一端一样固定在端帽I上,另一端穿过支撑座4与支气管热成形导管的手柄连接(图中未示出)。 3 is a radio frequency sub-needle 2 surrounded by four sub-needle work, one end of the working end of the sub-needle 2 is fixed to the end cap as I, and the other end passing through the support base 4 and bronchial thermoforming handle connecting conduit (FIG. not shown). 工作子针2的另一端固定在支撑座4上。 Another working sub-needle 2 is fixed to the end of the support base 4. 工作子针2的两端和射频子针3通过导电胶水连接。 Working ends and radio frequency sub-sub pin 2, pin 3 connected by a conductive glue. 工作子针2的长度是30 ± 0.1mm,宽是0.36mm,厚度是0.1mm。 Length of the working sub-needle 2 is 30 ± 0.1mm, a width of 0.36mm, a thickness of 0.1mm. 射频子针3的直径是0.25 土 RF sub-diameter needle 3 is 0.25 soil

0.05mm。 0.05mm. 端帽的材料是PEEK;工作子针的材料是镍钛合金;射频子针的材料是不锈钢或者铜。 PEEK material is an end cap; sub-work material is a nickel titanium alloy needle; radio frequency sub-needle material is stainless steel or copper.

[0036]膜包被在工作子针2的两端;工作子针2上未被膜包被的长度是5.5±0.5mm。 [0036] The film coating work ends in the sub-needle 2; working sub-needle 2 is not coated film length 5.5 ± 0.5mm. 膜的壁厚是0.01 ± 0.005mm,膜是PET热缩套管。 The film thickness is 0.01 ± 0.005mm, PET film is a heat shrinkable tube.

[0037]本发明所涉及的工作端的工作直径范围为1.5_13mm。 The working range of the working end the diameter [0037] The present invention relates to 1.5_13mm.

[0038]射频子针3可以在支撑座4上滑动,改变端帽I与支撑座4之间的距离,实现工作子针2的闭合和撑开,即使得用于支气管热成形导管的工作端的第一形状和第二形状的切换。 [0038] radio frequency sub-needle 3 can slide on the support 4, the distance I between the end cap 4 and the supporting base changes, the sub-work to achieve the closure needle 2 and softened, thermoforming even have a bronchial catheter working end the first and second shapes handover.

[0039]热电偶6包括第一端部5和第二端部。 [0039] Thermocouple 6 includes a first end and a second end portion 5. 第二端部穿过支撑座4与支气管热成形导管的手柄连接(图中未示出)。 A second end portion through the support base 4 handle connecting conduit formed with bronchial heat (not shown). 从第一端部5到支撑座4之间的这段热电偶内贴于其中一根工作子针2的内壁。 From the first end portion of the period between the thermocouple 45 attached to the support base in which the inner wall of a working sub-needle 2. 当工作子针2撑开时,第一端部5位于靠近其贴合的那根工作子针2的凸起的位置。 When operating the sub-needle 2 is softened, the first end portion 5 is located close to its bonding position of the needle sub Flanagan work projections 2. 热电偶6的表面有绝缘层,但是在第一端部5的位置处其表面剥除了绝缘层,这样有利于感知工作子针2的热量。 Thermocouple surface of the insulating layer 6, but at the first end portion 5 of a surface of the insulating layer stripping, it is a good perception of heat from the working sub-needle 2. 第一端部5的长度为0.5_,不过其长度范围可以为0.2-1.0_。 Length of the first end portion 5 of 0.5_, but its length may 0.2-1.0_.

[0040]如图4所示,本发明所涉及的外套管包括管壁201和由管壁201围合而成的三个空腔。 [0040] As shown, the present invention relates to the overtube 4 comprises three wall 201 and wall 201 enclosed by the cavity formed. 这三个空腔的横截面均为圆形,分别命名为第一空腔211、第二空腔212和第三空腔213。 A cross section of three circular cavities are respectively named a first cavity 211, second cavity 212 and the third cavity 213. 其中第一空腔211的横截面的直径为0.45_,不过其直径范围也可以为0.37-0.47mm。 Wherein the diameter of the cross section of the first cavity 211 is 0.45_, but it may be a diameter in the range 0.37-0.47mm. 第二空腔212的横截面的直径为0.38mm,不过其直径范围也可以为0.30-0.40mm。 The cross-sectional diameter of the second cavity 212 is 0.38mm, but it may be a diameter in the range 0.30-0.40mm. 第三空腔213的横截面的直径为0.33mm,不过其直径范围也可以为0.25-0.35mm。 The diameter of the cross section of the third cavity 213 is 0.33mm, but it may be a diameter in the range 0.25-0.35mm. 该外套管的横截面为圆形,该外套管的外径为1.1_,不过其外径范围也可以为1.1-1.2mm。 Cross section of the outer tube is circular, the outer diameter of the outer tube is 1.1_, but it may be a diameter range 1.1-1.2mm. 三个空腔中每个空腔装哪个配件主要是根据装配件的尺寸来决定,合适的空腔更有利于工艺的操作。 Three cavities each cavity installed accessories which are mainly based on assembly to decide the size of the cavity is more conducive to proper operation of the process. 一般来说,第一空腔21是用来装射频子针;第二空腔22或者第三空腔23装热电偶。 In general, the first cavity 21 is used to hold the radio frequency sub-needle; second cavity 22 or the third cavity 23 thermocouples.

[0041 ]此外,管壁201采用带有BaSO4的Pebax材料。 [0041] Further, use of Pebax material having a wall 201 of BaSO4. 尤其是管壁201采用添加有占质量百分比20%的BaSO4的Pebax材料。 In particular, the wall 201 using the accounting added with 20% by mass of BaSO4 as Pebax material.

[0042] 再则,管壁上还可以设置有螺纹。 [0042] Furthermore, it is also provided with a thread on the tube wall.

[0043]外套管200的一端与支撑座4连接,另一端与手柄300连接。 [0043] One end of the outer sleeve 4 is connected with the support base 200, a handle 300 connected to the other end. 射频子针3在支撑座200和手柄300之间的区段,以及热电偶6在支撑座200和手柄300之间的区段,分别被设置在外套管200的两个空腔中,剩下一个空腔空置(图中未示出)。 Radio frequency sub-section 3 between the support pin 200 and the handle base 300, and a section between the thermocouple 6 and the support base 200 of handle 300, are provided in the outer sleeve 200 of the two cavities, rest a vacant cavity (not shown).

[0044]本发明所涉及的支气管热成形系统的原理是:支气管热成形射频治疗仪产生的能量通过射频子针传导给工作子针,使得后者产生热量对需治疗的组织进行治疗。 [0044] The principles of the bronchial system of the present invention is heat formed are: bronchial radio frequency treatment instrument thermoformed energy generated is conducted to the needle work by radio frequency sub-sub-needle, such that the latter generates heat treated tissue to be treated. 热电偶能够实时探测和传递工作子针所产生的热量。 Thermocouples detect in real time and transfer the heat generated by the work of the sub-needle.

[0045]多根工作子针通过手柄控制射频子针来实现对工作子针的撑开和收拢动作,该动作可调整工作子针的有效工作直径来贴合被治疗面,进而可以适应不同大小的气管或者支气管腔道的治疗。 [0045] The plurality of sub-needle working to realize the expansion and operation of the work sub-retracted needle control handle through the radio frequency sub-needle, can adjust the effective working diameter of the work operation of the sub-needle bonded to the surface to be treated, and thus can adapt to different sizes treatment of trachea or bronchi cavity. 支气管热成形射频治疗仪的时间调整按钮可以设定不同的治疗时间;支气管热成形射频治疗仪的显示屏能够对信息进行显示,比如热电偶探测到的实时温度,支气管热成形射频治疗仪产生的电流大小、输出功率等。 Time radio frequency treatment instrument bronchial thermoforming adjustment button can set different treatment times; bronchial thermoforming radio frequency treatment instrument display capable of displaying information, such as a thermocouple temperature detected in real time, bronchial thermoforming generated radio frequency treatment instrument magnitude of the current, output power.

[0046] 实施例1 [0046] Example 1

[0047]如图1-4所示,本实施例中的支气管热成形系统的各部件及连接关系同上所述。 [0047] shown in Figure 1-4, in the present embodiment the heat bronchial embodiment and the connection relationship of the components forming the system described above. 这里仅对上述不确定的具体参数做详细限定,以便了解用于性能比较测试的本发明所涉及的支气管热成形导管具体的情况。 Here only specific parameters defined above uncertain detail, in order to understand a specific case of bronchial catheter of the present invention, the thermal performance comparison test involved molding. 射频子针的材料是不锈钢。 Radio frequency sub-needle material is stainless steel. 工作子针2—共有4根,图3为截面图只显示了两根工作子针2。 Sub total work needle 2- 4, FIG. 3 is a sectional view shows only two sub-working needles 2. 工作子针2的长度是30±0.1mm,宽是0.36mm,厚度是0.1mm。 Length of the working sub-needle 2 is 30 ± 0.1mm, a width of 0.36mm, a thickness of 0.1mm. 射频子针3的直径是0.25 ±0.05mm。 Diameter radio frequency sub-needle 3 is 0.25 ± 0.05mm. 工作子针2上未被膜包被的长度是5.5 ±0.5mm。 Work sub-needle 2 is not coated film length 5.5 ± 0.5mm. 膜的壁厚是0.01 ±0.005mm,膜是PET热缩套管。 The film thickness is 0.01 ± 0.005mm, PET film is a heat shrinkable tube. 工作端的工作直径范围为1.5-13mm。 The working end of the working diameter range 1.5-13mm. 热电偶6的第一端部5的长度为0.5mm。 The length of the first thermocouple 6 end portion 5 is 0.5mm. 外套管200的第一空腔211的横截面的直径为0.45mm,第二空腔212的横截面的直径为0.38mm,第三空腔213的横截面的直径为0.33mm。 The cross-sectional diameter of the outer sleeve 200 of the first cavity 211 is 0.45mm, the diameter of the cross section of the second cavity 212 is 0.38mm, the diameter of the cross section of the third cavity 213 is 0.33mm. 外套管200的横截面为圆形,该外套管200的外径为1.1mm。 The cross-section of the outer sleeve 200 is circular, the outer diameter of the outer sleeve 200 is 1.1mm. 管壁201采用添加有占质量百分比20%的BaSO4的Pebax材料。 Wall 201 using account added with 20% by mass of BaSO4 as Pebax material.

[0048] 射频子针3在支撑座200和手柄300之间的区段,以及热电偶6在支撑座200和手柄300之间的区段,分别被设置在外套管200的第一空腔211和第二空腔212中,第三空腔213空置(图中未示出)。 [0048] The radio frequency sub-section 3 between the support pin 200 and the handle base 300, and a section between the thermocouple 6 and the support base 200 of handle 300, are provided a first cavity 200 of the outer sleeve 211 and a second cavity 212, a third vacant chamber 213 (not shown).

[0049]性能比较测试1:工作子针收起和撑开的不发生有效形变的次数 The number of sub-needles working distraction stowed and effective deformation does not occur: [0049] Performance Comparison Test 1

[0050]对象:波士顿科技有限公司生产的Alair导管,以及实施例1所述的支气管热成形导管。 [0050] Object: Boston Technology Co Alair catheter, as well as bronchial thermally shaped conduit in Example 1.

[0051]结果:波士顿科技有限公司生产的Alair导管的工作子针在使用80次左右即无法使用,影响手术治疗的有效性和充分性。 [0051] Results: Boston Scientific Ltd working sub-needle production Alair catheter in use about 80 times that is not available, affect the validity and adequacy of surgical treatment.

[0052] 一般来说,每一次手术大概要消融70-80个点,因此需要工作子针多次撑开和收起,其次数应大于等于需要消融的点的个数。 [0052] In general, each time the ablation surgery probably 70-80 points, requiring multiple working distraction and retract the sub-needle, which often need to be greater than or equal to the number of points of ablation. 实施例1所述的支气管热成形导管的工作子针有效使用次数(即工作子针收起和撑开的不发生有效形变的次数)大于100次,这对手术中预留一定的冗余量进而确保手术过程的安全性,充分性和有效性。 Sub Working Example needle bronchial thermally shaped conduit 1, the effective use of frequency (i.e., number of operations of the sub-needle stowed and effective deformation of the expansion does not occur) is greater than 100, which reserve a certain amount of redundancy to surgery thus ensuring the safety of surgical procedures, adequacy and effectiveness.

[0053]性能比较测试2:装载有射频子针和热电偶的外套管的可调整的折弯角度检测 [0053] Performance Comparison Test 2: loaded with overtube bending angle adjustable RF detection sub-needle and a thermocouple

[0054]对象:波士顿科技有限公司生产的Alair导管,以及实施例1所述的支气管热成形导管。 [0054] Object: Boston Technology Co Alair catheter, as well as bronchial thermally shaped conduit in Example 1.

[0055]结果:波士顿科技有限公司生产的Alair导管的可调整的折弯角度是:>75°。 [0055] Results: Boston Technology Co Alair catheter folding angle is adjustable:> 75 °. 实施例I所述的支气管热成形导管的可调整的折弯角度是:多60°。 Example I thermoforming the catheter bronchial folding angle is adjustable: over 60 °.

[0056]以上详细描述了本发明的较佳具体实施例。 [0056] The above detailed description of particular preferred embodiments of the present invention. 应当理解,本领域的普通技术人员无需创造性劳动就可以根据本发明的构思作出诸多修改和变化。 It should be understood by those of ordinary skill in the art without creative work can make many modifications and variations of the inventive concept. 因此,凡本技术领域中技术人员依本发明的构思在现有技术的基础上通过逻辑分析、推理或者有限的实验可以得到的技术方案,皆应在由权利要求书所确定的保护范围内。 Therefore, any person skilled in the art under this inventive concept on the basis of prior art technical solutions through logical analysis, reasoning or limited experiments can be obtained, are to be within the scope defined by the claims in.

Claims (10)

1.一种支气管热成形系统,包括支气管热成形射频治疗仪和与所述支气管热成形射频治疗仪电连接的支气管热成形导管,其特征在于,所述支气管热成形导管包括工作端、外套管和手柄;所述工作端包括端帽、工作子针、支撑座和射频子针;所述工作子针和所述射频子针的一端均固定在所述端帽处;所述工作子针的另一端固定在所述支撑座处;所述射频子针的另一端穿过所述支撑座与所述手柄连接;所述射频子针能够在所述支撑座上滑动;所述工作子针的两端均与所述射频子针电连接;所述工作子针的数量是3-6根,将所述射频子针包围着中间;所述工作子针为镍钛合金;所述射频子针为不锈钢或者铜;所述工作端具有第一形状和第二形状,在所述第一形状下,所述工作子针合拢,所述工作端被设置为适于在气管或者支气管中移动;在所述第二形状下,所述工作子 A thermoforming bronchial system, including bronchial thermoforming radio frequency treatment instrument of the bronchial and bronchial heat and hot forming radio frequency treatment instrument electrical connector forming the conduit, wherein the conduit comprises bronchial thermoforming working end, the outer sleeve and a handle; the working end includes an end cap, the work of the sub-needle, and radio frequency sub-needle support base; sub-needle and the working end of the radio frequency sub-needles are fixed at the end cap; the working sub-needle the other end is fixed at a supporting base; the other terminal of the radio frequency needle through the support base is connected to the handle; the needle is in the radio frequency sub-slide supporting base; the working sub-needle both ends connected electrically to the radio frequency sub-needle; the number of said sub-needle is a working root 3-6, the radio frequency intermediate sub-needle surrounds; the working sub-needle is nitinol; the radio frequency sub-needle stainless steel or copper; the working end having a first shape and a second shape, said first shape, said sub-needle work together and the working end is adapted to move the set to the trachea or bronchi; in the the said second shape, and the sub-work 撑开,使得所述工作子针适于将所述射频子针传导的能量以热量的方式作用于气管或者支气管;所述第一形状和所述第二形状的切换通过滑动所述射频子针改变所述端帽和所述支撑座之间的距离进行调整; 所述外套管为三腔管,包括管壁和由所述管壁围合而成的三个空腔,分别命名为第一空腔、第二空腔和第三空腔; 所述外套管的一端与所述支撑座连接,另一端与所述手柄连接;所述射频子针在所述支撑座和所述手柄之间的区段被设置在所述第一空腔、第二空腔或者第三空腔中。 Distraction, so that the working sub-sub-needle is adapted to the radio frequency energy to the needle action of heat conducting manner to the trachea or bronchus; the first shape and the second shape is switched by sliding the radio frequency sub-needle changing the distance between the end cap and said support seat is adjusted; the outer tube is a triple lumen tube comprising a wall and three cavities formed by said enclosed wall, a first named cavity, the second cavity and the third cavity; end of the outer tube and the support base and the other end connected to the handle; between the support seat and the handle of the pin sub-RF the first section is disposed in the cavity, the second cavity or the third cavity.
2.如权利要求1所述的支气管热成形系统,其特征在于,所述工作端还包括热电偶;所述热电偶呈线形,包括第一端部和第二端部;所述热电偶的第一端部设置在任意一根所述工作子针上,所述第二端部穿过所述支撑座与支气管热成形导管的手柄连接;所述热电偶除所述第一端部外,其表面包被有绝缘层;所述第一端部的长度为0.3-0.7mm。 2. thermoforming bronchial system according to claim 1, wherein the working end further comprises a thermocouple; linearly said thermocouple comprising a first end and a second end portion; said thermocouple the first end portion is provided on any one of said sub-needle work, said second end portion through the support base and bronchial thermoforming handle connecting conduit; the thermocouples other than the first outer end portion, a surface coated with an insulating layer; length of the first end portion of 0.3-0.7mm.
3.如权利要求1所述的支气管热成形系统,其特征在于,所述工作子针的长度是30±0.1mm,宽是0.36mm,厚度是0.1mm;所述射频子针的直径是0.25±0.05mm。 3. The system of claim bronchial thermoforming as claimed in claim 1, wherein the working length of the sub-needle is 30 ± 0.1mm, a width of 0.36mm, a thickness of 0.1mm; diameter of the radio frequency sub-needle 0.25 ± 0.05mm.
4.如权利要求3所述的支气管热成形系统,其特征在于,所述工作端还包括膜,所述膜的壁厚是0.0I ± 0.005mm,所述膜是PET热缩套管;所述膜包被在所述工作子针的两端;所述工作子针上未被所述膜包被的长度是5-6_。 4. The system of claim bronchial thermoforming as claimed in claim 3, wherein the working end further includes a wall thickness of a membrane that is 0.0I ± 0.005mm, the PET film is a heat-shrinkable sleeve; the the membrane was coated at both ends of said sub-needle work; not on the working of said sub-needle coated film length 5-6_.
5.如权利要求1所述的支气管热成形系统,其特征在于,所述端帽的材料是PEEK。 5. The system of claim bronchial thermoforming as claimed in claim 1, wherein said end cap material is PEEK.
6.如权利要求1所述的支气管热成形系统,其特征在于,所述工作端的工作直径范围为1.5~13mm η 6. The system of claim bronchial thermoforming as claimed in claim 1, characterized in that the working diameter of said working end is 1.5 ~ 13mm η
7.如权利要求1所述的支气管热成形系统,其特征在于,所述三个腔室的横截面均为圆形,所述第一空腔横截面的直径为0.37-0.47mm;所述第二空腔横截面的直径为0.30-0.40mm;所述第三空腔横截面的直径为0.25-0.35mm;所述外套管的横截面为圆形,其外径为I.1-1.2mmο 7. The system of claim bronchial thermoforming as claimed in claim 1, characterized in that the cross section of the three chambers are circular, the diameter of the cross section of the first cavity 0.37-0.47mm; the diameter of the second cavity cross section of 0.30-0.40mm; third cavity diameter of the cross section of 0.25-0.35mm; outer cross-section of the pipe is circular, an outer diameter of I.1-1.2 mmο
8.如权利要求1所述的支气管热成形系统,其特征在于,所述管壁采用带有BaSO4的Pebax材料。 8. The system of claim bronchial thermoforming as claimed in claim 1, wherein the tube wall using a Pebax material having a BaSO4.
9.如权利要求1所述的支气管热成形系统,其特征在于,所述支气管热成形射频治疗仪包括显示屏;所述显示屏的有效显示区域的长度为82〜85mm,宽度为40〜43mm。 9. The system of claim bronchial thermoforming as claimed in claim 1, wherein said heat bronchial shaped radio frequency treatment instrument includes a display screen; the length of the effective display region of the display screen is 82~85mm, width 40~43mm .
10.如权利要求1-9任一项所述的支气管热成形系统,其特征在于,所述支气管热成形射频治疗仪可以提供的输出功率包括18W±20%;所述支气管热成形射频治疗仪可以提供的频率包括480KHz± 10% ;所述支气管热成形射频治疗仪可以提供的稳定温度包括65°C 土3。 10. A thermoforming bronchial system according to any one of claims 1-9, wherein said radio frequency output power bronchial thermal treatment device may include forming 18W ± 20%; radio frequency treatment instrument of the bronchial thermoforming frequency may include 480KHz ± 10%; the bronchial thermoforming temperature stable radio frequency treatment instrument may include 65 ° C soil 3. . .
CN201610298459.3A 2016-05-06 2016-05-06 A bronchial thermoplasty system CN105997235A (en)

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