技术领域technical field
本发明涉及一种用于前列腺肿瘤冷冻消融术中尿道可控保温的装置，尤其是一种基于实时分段测量的尿道组织的温度智能调控加热功率，降低/避免冷冻消融术中低温对尿道组织造成损伤，同时尽可能减小冷冻消融范围对尿道组织造成的不良影响，即在保护尿道组织的前提下获取最大冷冻消融范围。The present invention relates to a device for controllable heat preservation of the urethra in cryoablation of prostate tumors, in particular to an intelligent regulation and heating power of the temperature of urethral tissue based on real-time segmental measurement, reducing/avoiding the impact of low temperature on urethra tissue in cryoablation Cause damage while minimizing the adverse effects of the cryoablation range on the urethral tissue, that is, to obtain the maximum cryoablation range under the premise of protecting the urethra tissue.
背景技术Background technique
2010年，恶性肿瘤已经成为世界上致死率最高的疾病。如不及时采取有效手段，预计2030年全世界将有2600万新增病例，死亡人数达到1700万人。因只有大约20%左右的肿瘤患者能够接受外科切除手术，冷冻消融、射频消融、微波、激光热疗等肿瘤微创治疗技术正成为当代临床医学发展的前沿，冷冻消融（TargetedCryoablationOfProstateCancer，TCAP）是其中一种具有代表意义的技术，主要通过低温器械，有控制地使病灶组织经历降温、冻结、复温过程，从而造成肿瘤细胞的不可逆损伤甚至坏死。冷冻消融对肿瘤细胞的杀伤机制是：细胞脱水和皱缩；细胞内冰晶形成的机械损伤；细胞电解质毒性浓缩和pH值改变；细胞膜蛋白质成分变性；血流淤积和微血栓形成；以及免疫效应等。冷冻消融不仅手术创伤小，而且具有定位精确、止血镇痛、术后并发症少、安全性高等优点，深受广大医生与患者的好评与青睐。In 2010, malignant tumor has become the disease with the highest death rate in the world. If effective measures are not taken in time, it is estimated that there will be 26 million new cases and 17 million deaths in the world by 2030. Because only about 20% of tumor patients can receive surgical resection, minimally invasive tumor treatment technologies such as cryoablation, radiofrequency ablation, microwave, and laser hyperthermia are becoming the forefront of contemporary clinical medical development, and cryoablation (Targeted CryoablationOfProstateCancer, TCAP) is one of them. A representative technology mainly uses low-temperature equipment to control the lesion tissue to undergo cooling, freezing, and rewarming processes, thereby causing irreversible damage or even necrosis of tumor cells. The killing mechanisms of cryoablation on tumor cells are: cell dehydration and shrinkage; mechanical damage caused by intracellular ice crystal formation; toxic concentration of cell electrolytes and changes in pH value; denaturation of protein components in cell membranes; blood stasis and microthrombosis; and immune effects, etc. . Cryoablation is not only less traumatic, but also has the advantages of precise positioning, hemostasis and pain relief, fewer postoperative complications, and high safety. It is highly praised and favored by doctors and patients.
尽管TCAP是一种微创技术，但在冷冻消融在治疗前列腺癌症中依然存在阻碍，冷冻坏死组织脱落后易引起急性或迟发性下尿路梗阻、引起有关尿失禁、性功能障碍、尿道直肠瘘等并发症。TCAP在早期应用阶段，甚至由于并发症高发生率，曾被迫停滞发展数年。近年来，随着尿道温热循环、测温探针等保护装置、影像监测、冷媒技术发展进步、操作技术成熟而发生了很大变化。临床数据表明，尿道保温措施是前列腺靶冷冻消融手术保护尿道及其泌尿功能必要手段，同时也是影响冷冻消融范围与精度的因素。近年来，TCAP治疗相关并发症发生率明显降低，2002年Bahn等对590例患者的分析数据显示，尿失禁、尿路梗阻和尿道直肠瘘的发生率分别为4.3%、5.5%和0.1%。2010年Dhar等对国际冷冻治疗在线数据库（COLD）中4099例患者分析结果：尿失禁和尿道直肠瘘的发生率分别为3.1%、0.4%。尿道加温导管对保护尿道作用是肯定的，但可能会有周围环状残存癌组织，所以，目前不能取代全腺体冷冻治疗方法。快速、精确地提供尿道保温功能，保护尿道组织同时又尽量小的因素影响有效的冷冻边界是尿道保温的关键技术难题。目前国内TCAP手术中，医生采用加热生理盐水至37℃左右，通过导尿管输送至尿道，防止在手术过程中冷冻伤害尿道，根据冷冻温度区域和冷冻温度的检测数据，结合医生经验通过增大和减少生理盐水的输送速度而进行尿道保温。这种方法简单，但随着手术时间的进行生理盐水温度下降不能有效的提供热水，同时热水速度仅通过医生经验，控制精度差。美国Endocare氩氦刀治疗系统配备的相应的模块，尿道保温装置是一个双层管热水换热器，装置由一个标准的医学导管，接近正常体温下生理盐水，导管泵，换热器组成。导管泵将接近体温的生理盐水从热交换器通过医学导管输送至膀胱，膀胱中的溶液经过与医学导管同轴心的导管外层管流回热交换器，以保证尿道温度高于冰点，减少尿道组织损伤。这种热水循环方法，会给病人膀胱带来压力，同时传热效果受到医学导管的热性能限制，控制灵敏度有限，使得前列腺冷热组织边界依然会存在尿道损伤和残存癌组织的风险。Although TCAP is a minimally invasive technique, there are still obstacles in the treatment of prostate cancer by cryoablation. After the frozen necrotic tissue falls off, it is easy to cause acute or delayed lower urinary tract obstruction, causing related urinary incontinence, sexual dysfunction, urethral rectum, etc. Complications such as fistula. In the early application stage of TCAP, even because of the high incidence of complications, the development of TCAP was forced to stagnate for several years. In recent years, great changes have taken place with the urethral heating cycle, protective devices such as temperature measuring probes, image monitoring, refrigerant technology, and mature operating techniques. Clinical data show that urethral insulation is a necessary means to protect the urethra and its urinary function in prostate target cryoablation, and it is also a factor that affects the scope and accuracy of cryoablation. In recent years, the incidence of complications related to TCAP treatment has been significantly reduced. In 2002, Bahn et al. analyzed data on 590 patients, showing that the incidences of urinary incontinence, urinary tract obstruction, and urethro-rectal fistula were 4.3%, 5.5%, and 0.1%, respectively. In 2010, Dhar et al. analyzed the results of 4099 patients in the International Cryotherapy Online Database (COLD): the incidence rates of urinary incontinence and urethro-rectal fistula were 3.1% and 0.4%, respectively. The urethral warming catheter is sure to protect the urethra, but there may be residual cancer tissue in the surrounding ring, so it cannot replace the whole gland cryotherapy at present. Quickly and accurately providing the urethral insulation function, protecting the urethral tissue while minimizing factors affecting the effective freezing boundary is the key technical problem of urethral insulation. At present, in domestic TCAP operations, doctors heat normal saline to about 37°C and deliver it to the urethra through a catheter to prevent freezing damage to the urethra during the operation. Reduce the delivery rate of saline to keep the urethra warm. This method is simple, but as the temperature of the normal saline drops as the operation time progresses, it cannot effectively provide hot water. At the same time, the speed of hot water is only based on the doctor's experience, and the control accuracy is poor. The American Endocare argon-helium knife treatment system is equipped with the corresponding module. The urethral heat preservation device is a double-tube hot water heat exchanger. The device consists of a standard medical catheter, normal saline at normal body temperature, catheter pump, and heat exchanger. The catheter pump transports physiological saline close to body temperature from the heat exchanger to the bladder through the medical catheter, and the solution in the bladder flows back to the heat exchanger through the outer tube of the catheter coaxial with the medical catheter to ensure that the temperature of the urethra is higher than the freezing point, reducing Damage to the tissue of the urethra. This hot water circulation method will put pressure on the patient's bladder. At the same time, the heat transfer effect is limited by the thermal performance of the medical catheter, and the control sensitivity is limited, so that there will still be risks of urethral damage and residual cancer tissue at the boundary between cold and hot prostate tissues.
经检索现有技术文献发现，目前关于用于前列腺冷冻消融手术测温保温方面，胡兵在2006年申请国家专利“前列腺消融用尿道温度多点监控导管”，该专利主要是用于尿道前列腺段内壁温度的多点、实时监测，并未涉及对尿道进行加热保温。After searching the existing technical literature, it was found that Hu Bing applied for a national patent in 2006 on the use of temperature measurement and heat preservation in prostate cryoablation surgery for "urethral temperature multi-point monitoring catheter for prostate ablation". This patent is mainly used for the inner wall of the prostate segment of the urethra. The multi-point and real-time monitoring of temperature does not involve heating and keeping the urethra warm.
发明内容Contents of the invention
本发明针对现有冷冻手术过程中对尿道保温方法中存在的不足及实际需求，提供一种前列腺肿瘤冷冻消融术中尿道温度可控保护装置，该装置结构简单，方便易用；该装置充分考虑到患者的实际情况，可满足不同患者对保温效果的需求，在尿道组织内能够测量组织的真实温度，同时能够及时对信息给予反馈，实现智能程序控制分段升温，且电阻丝和热电偶温度感应器皆置于导尿管壁内，最大程度地降低患者在治疗过程中的不便与痛苦。Aiming at the deficiencies and actual needs of the existing method for keeping the urethra warm during the cryosurgical process, the present invention provides a temperature-controllable protection device for the urethra during cryoablation of prostate tumors. The device is simple in structure, convenient and easy to use; the device fully considers According to the actual situation of the patient, it can meet the needs of different patients for the heat preservation effect. It can measure the real temperature of the tissue in the urethral tissue, and at the same time give feedback to the information in time, realize the intelligent program control of segmental heating, and the temperature of the resistance wire and thermocouple The sensors are all placed in the wall of the catheter, which minimizes the inconvenience and pain of the patient during the treatment.
目前市场上还没有一款有效的加热保温装置能够很好地解决冷冻消融手术中低温对尿道等造成的伤害的问题，本发明主要针对这一现状展开。At present, there is no effective heating and heat preservation device in the market that can well solve the problem of damage to the urethra caused by low temperature during cryoablation surgery. The present invention is mainly aimed at this current situation.
为了解决上述技术问题，本发明的采用的技术方案是：In order to solve the problems of the technologies described above, the technical solution adopted by the present invention is:
一种前列腺肿瘤冷冻消融术中尿道温度可控保护装置，包括导尿管、热电偶、电阻丝、热电偶补偿导线、显示器、电源、控制面板，所述热电偶和电阻丝分别置于导尿管壁内，所述热电偶通过热电偶补偿导线连接控制面板，控制面板连接显示器，用于实时监测组织的温度；所述控制面板连接电阻丝，通过控制面板自动调节电阻丝的加热电压而达到精确、可控加热。A urethral temperature controllable protection device for prostate tumor cryoablation, including a catheter, a thermocouple, a resistance wire, a thermocouple compensation wire, a display, a power supply, and a control panel, and the thermocouple and the resistance wire are respectively placed in the catheter In the tube wall, the thermocouple is connected to the control panel through the thermocouple compensation wire, and the control panel is connected to the display for real-time monitoring of the temperature of the tissue; the control panel is connected to the resistance wire, and the heating voltage of the resistance wire is automatically adjusted through the control panel to achieve Precise, controlled heating.
所述电阻丝为1～3段螺旋排布于导尿管管壁内，用于分段加热，使尿道组织的温度介于-50～50℃。The resistance wires are 1-3 sections spirally arranged in the wall of the urinary catheter, and are used for segmental heating to make the temperature of the urethral tissue between -50-50°C.
所述的热电偶的温度感应焊接点置于导尿管壁内，位于电阻丝中央处。The temperature sensing welding point of the thermocouple is placed in the wall of the catheter and located at the center of the resistance wire.
所述热电偶监测点设置为1～6个，并且螺旋或直线分布于导尿管壁内不同位置，用于精确测量温度。The thermocouple monitoring points are set at 1 to 6, and are spirally or linearly distributed at different positions in the catheter wall for accurate temperature measurement.
所述热电偶为铜-康铜热电偶，铜丝与康铜丝分别被绝缘漆包裹，外径为0.1mm，测温范围为-100～200℃。The thermocouple is a copper-constantan thermocouple, the copper wire and the constantan wire are respectively wrapped with insulating varnish, the outer diameter is 0.1mm, and the temperature measurement range is -100-200°C.
本发明的有益效果是：The beneficial effects of the present invention are:
本发明不仅能精确地测温，且能根据需要进行加热，保护尿道组织，期望避免或降低前列腺肿瘤冷冻消融术中低温对输尿管等造成的损伤及并发症，最大程度保护患者正常的身体机能。最大的优势在于，本发明的智能加热保温装置能够实现按照病人的实际需求对前列腺内部的不同位置给予不同的热量的要求，能够将实时反馈温度，进行人性化的保护，尽量降低病人的痛苦，减少并发症，保护患者身体的机能。The invention can not only measure temperature accurately, but also can heat according to needs to protect urethral tissue, and it is expected to avoid or reduce the damage and complications caused by low temperature to ureter during cryoablation of prostate tumor, and to protect the normal body function of patients to the greatest extent. The biggest advantage is that the intelligent heating and heat preservation device of the present invention can realize the requirement of giving different heat to different positions inside the prostate according to the actual needs of the patient, can feedback the temperature in real time, perform humanized protection, and reduce the pain of the patient as much as possible. Reduce complications and protect the function of the patient's body.
附图说明Description of drawings
图1是本发明的前列腺肿瘤冷冻消融术中尿道保温装置的结构之一示意图；Fig. 1 is a schematic view of the structure of the urethral heat preservation device in the cryoablation of prostate tumor of the present invention;
图2是本发明的前列腺肿瘤冷冻消融术中尿道保温装置的结构之二示意图。Fig. 2 is a schematic diagram of the second structure of the urethral heat preservation device in the cryoablation of prostate tumors according to the present invention.
具体实施方式Detailed ways
下面结合附图和具体实施例，进一步阐述本发明。The present invention will be further elaborated below in conjunction with the accompanying drawings and specific embodiments.
如图1，2所示，一种前列腺肿瘤冷冻消融术中尿道保温的装置，包括导尿管1、热电偶2、电阻丝3、热电偶补偿导线4、显示器5、电源6、控制面板7。电阻丝3分段螺旋排布在导尿管管壁内，满足分段选择性地加热而保护尿道的要求，热电偶2安装在电阻丝3的中央处，尽可能地监测尿道组织的实际温度，便于调节电压对靶向区域进行加热保温。电阻丝3沿着导尿管1内壁引出，热电偶丝沿着导尿管1内壁引出连接热电偶补偿导线4后，分别与控制面板7连接，与显示器5连接，用于实时显示温度。As shown in Figures 1 and 2, a device for keeping the urethra warm during cryoablation of prostate tumors includes a urinary catheter 1, a thermocouple 2, a resistance wire 3, a thermocouple compensation wire 4, a display 5, a power supply 6, and a control panel 7 . The resistance wire 3 is spirally arranged in segments in the catheter wall to meet the requirements of segmental selective heating and protect the urethra. The thermocouple 2 is installed in the center of the resistance wire 3 to monitor the actual temperature of the urethral tissue as much as possible. , it is convenient to adjust the voltage to heat and insulate the targeted area. The resistance wire 3 is led out along the inner wall of the urinary catheter 1, and the thermocouple wire is led out along the inner wall of the urinary catheter 1 to be connected with the thermocouple compensation wire 4, and then connected to the control panel 7 and the display 5 for real-time temperature display.
本发明优选实施例提供的利用尿道保温装置对尿道进行加热保温的方式有6种，在此仅以两种方式给予简单说明。There are 6 ways to heat and keep the urethra with the urethral warming device provided by the preferred embodiment of the present invention, and only two ways are briefly described here.
实施例1：Example 1:
如图1所示，采用普通医用导尿管1，从导尿管1下端20mm处开始，螺旋排布1段电阻丝3，沿导尿管1壁的电阻丝3排布长度为20mm。以电阻丝3下缘为基准线，在基线上方25mm和35mm处分别，即两个热电偶2间隔10mm，在导尿管壁内且紧靠外缘。As shown in Figure 1, a general medical catheter 1 is used, and a section of resistance wire 3 is helically arranged starting from 20 mm from the lower end of the catheter 1, and the length of the resistance wire 3 arranged along the wall of the catheter 1 is 20 mm. Take the lower edge of the resistance wire 3 as the reference line, at 25mm and 35mm above the baseline, respectively, that is, the two thermocouples 2 are spaced 10mm apart, inside the catheter wall and close to the outer edge.
启动电源6，通过控制面板7启动电阻丝3。设定目标温度为30℃后，开始加热直至组织温度达到30℃，则停止加热；温度保持为30℃；当温度低于30℃后，热电偶测得温度后传输信号给智能程序，则加热重新开始，如此循环。根据实际情况，启动不同位置的电阻丝可对尿道组织不同的位置进行选择性保护。Start the power supply 6, and start the resistance wire 3 through the control panel 7. After setting the target temperature to 30°C, start heating until the tissue temperature reaches 30°C, then stop heating; keep the temperature at 30°C; when the temperature is lower than 30°C, the thermocouple measures the temperature and transmits a signal to the intelligent program, then heats up Start again, and so on. According to the actual situation, activating the resistance wires at different positions can selectively protect different positions of the urethral tissue.
实施例2：Example 2:
如图2所示，采用普通医用导尿管1，从导尿管1下端20mm处开始，螺旋排布三段电阻丝3，每段沿导尿管1壁的电阻丝3排布长度为10mm，每两段电阻丝3之间间隔2mm，总长50mm。以电阻丝3下缘为基准线，在基线上方5mm，17mm，39mm三处，即每两个热电偶2间隔12mm，于电阻丝3外，导尿管1壁外缘内侧开始左右对称定点，两点在同一水平线上，共计六个点。在上述定点放置一个热电偶2，共计六个热电偶。As shown in Figure 2, an ordinary medical catheter 1 is used, starting at 20 mm from the lower end of the catheter 1, three sections of resistance wire 3 are spirally arranged, and the length of each resistance wire 3 arranged along the wall of the catheter 1 is 10 mm. , the distance between every two sections of resistance wire 3 is 2mm, and the total length is 50mm. Take the lower edge of the resistance wire 3 as the baseline, and three places 5mm, 17mm, and 39mm above the baseline, that is, every two thermocouples 2 are separated by 12mm, and outside the resistance wire 3, the inner side of the outer edge of the urinary catheter 1 begins to be symmetrically fixed. Two points are on the same horizontal line, a total of six points. Place a thermocouple 2 at the above fixed point, a total of six thermocouples.
启动电源，通过控制面板7启动三段电阻丝3。设定目标温度为37℃后，电阻丝3加热，直至组织温度达到37℃，则停止加热；温度维持为37℃；当温度低于37℃后，热电偶2测得温度后传输信号给智能程序，则加热重新开始。智能程序会根据尿道组织不同的位置对热量需求不同而提供不同的加热功率，确保达到设定的目标温度。Start the power supply, and start the three-section resistance wire 3 by the control panel 7 . After setting the target temperature to 37°C, the resistance wire 3 is heated until the tissue temperature reaches 37°C, then the heating is stopped; the temperature is maintained at 37°C; when the temperature is lower than 37°C, the thermocouple 2 measures the temperature and transmits a signal to the smart program, heating restarts. The intelligent program will provide different heating power according to the different heat demands of different positions of the urethral tissue to ensure that the set target temperature is reached.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510553498.9ACN105125337A (en) | 2015-09-02 | 2015-09-02 | Urethra temperature controllable protection device in prostatic neoplasm cryoablation |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510553498.9ACN105125337A (en) | 2015-09-02 | 2015-09-02 | Urethra temperature controllable protection device in prostatic neoplasm cryoablation |
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| CN105125337Atrue CN105125337A (en) | 2015-12-09 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201510553498.9APendingCN105125337A (en) | 2015-09-02 | 2015-09-02 | Urethra temperature controllable protection device in prostatic neoplasm cryoablation |
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| EP0449472A1 (en)* | 1990-03-22 | 1991-10-02 | Argomed Ltd | An apparatus for localized thermal treatment of mammals |
| CN2090257U (en)* | 1990-04-12 | 1991-12-11 | 曹其言 | Therapeutic apparatus for prostate |
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| CN1600266A (en)* | 2004-09-09 | 2005-03-30 | 上海交通大学 | Rectal wall temperature measurement and control device |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0370890A1 (en)* | 1988-11-21 | 1990-05-30 | Technomed Medical Systems | Apparatus for the surgical treatment of tissues by hyperthermia, preferably the prostate, equipped with heat protection means preferably comprising means forming radioreflecting screen |
| EP0449472A1 (en)* | 1990-03-22 | 1991-10-02 | Argomed Ltd | An apparatus for localized thermal treatment of mammals |
| CN2090257U (en)* | 1990-04-12 | 1991-12-11 | 曹其言 | Therapeutic apparatus for prostate |
| CN1190340A (en)* | 1995-07-07 | 1998-08-12 | 伦德仪器公司 | Devices for local heat treatment of tissue |
| CN1338915A (en)* | 1999-02-04 | 2002-03-06 | 普罗斯特隆德控制公司 | Method and device for combined heat treatment of body tissue |
| CN1600266A (en)* | 2004-09-09 | 2005-03-30 | 上海交通大学 | Rectal wall temperature measurement and control device |
| CN1969780A (en)* | 2005-11-23 | 2007-05-30 | 天津得鑫电机有限公司 | Thermomagnetic radiation therapeutic device |
| CN100998500A (en)* | 2007-01-11 | 2007-07-18 | 上海交通大学 | Multi-point monitoring catheter for temp. of urethra for ablation of prostate |
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| CN106901827A (en)* | 2017-02-22 | 2017-06-30 | 上海导向医疗系统有限公司 | Urethra temperature preservation control device and method in tumor of prostate cryoablation |
| CN111787890A (en)* | 2017-12-19 | 2020-10-16 | 塞比卡有限公司 | Cryotherapy device capable of preventing nerve damage |
| WO2022077313A1 (en)* | 2020-10-15 | 2022-04-21 | 山前（珠海）医疗科技有限公司 | Cryoballoon catheter having heating function |
| CN112353486A (en)* | 2020-11-27 | 2021-02-12 | 清华大学 | Thermal ablation catheter with thermocouple and thermal ablation device |
| CN112494134A (en)* | 2020-11-27 | 2021-03-16 | 清华大学 | Thermocouple, heat ablation catheter with same and heat ablation device |
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| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| WD01 | Invention patent application deemed withdrawn after publication | Application publication date:20151209 |