CN100434047C - Conformal radiofrequency ablation electrodes for focal prostate cancer - Google Patents

Abstract

Translated fromChinese

一种医疗器械技术领域的局灶性前列腺癌适形射频消融电极，由导管与外套组成，导管在外套管内活动，相互紧密配合，导管为一空芯管，导管一端固定有多根微细空芯子针，子针组成具有记忆功能的扇形束，子针缩入外套内，伸出时恢复成扇形束，导管与套管的尾端装入手柄。本发明由于多根子针构成的扇形束与前列腺左右侧叶的形态相似，射频加热过程的温度场既能有效治疗前列腺癌，又能保护尿道、直肠及前列腺神经血管束等结构免受损伤，达到安全而有效地治疗前列腺癌。

A conformal radiofrequency ablation electrode for focal prostate cancer in the technical field of medical equipment, consisting of a catheter and a sheath, the catheter moves in the sheath and closely cooperates with each other, the catheter is a hollow core tube, and one end of the catheter is fixed with multiple fine hollow cores The needle and sub-needles form a fan-shaped bundle with memory function, the sub-needles are retracted into the overcoat, and return to a fan-shaped bundle when stretched out, and the tail ends of the catheter and the cannula are put into the handle. In the present invention, since the fan-shaped bundle composed of multiple sub-needles is similar to the shape of the left and right lobes of the prostate, the temperature field in the radio frequency heating process can not only effectively treat prostate cancer, but also protect structures such as the urethra, rectum, and prostate neurovascular bundles from damage, achieving Safe and effective treatment of prostate cancer.

Description

Translated fromChinese

局灶性前列腺癌适形射频消融电极Conformal radiofrequency ablation electrodes for focal prostate cancer

技术领域technical field

本发明涉及的是一种医疗器械技术领域的电极，特别是一种局灶性前列腺癌适形射频消融电极。The invention relates to an electrode in the technical field of medical equipment, in particular to a conformal radiofrequency ablation electrode for focal prostate cancer.

背景技术Background technique

前列腺癌是老年男性常见的癌症之一，已严重危及到人类的健康。现有技术中，前列腺癌治疗有手术根治术、内分泌治疗、放射治疗及微创治疗等。肿瘤射频消融术作为微创手段，已在肝、肾等实体性肿瘤治疗取得很好的效果，其疗效得到临床认可，并已试用于前列腺癌治疗，已取得初步疗效。而由于前列腺呈前后稍扁的栗子形，底部宽大，尖部尖细，腺实质前部有尿道通过，后方借直肠膀胱隔与直肠壶腹相邻。而且前列腺癌好发于周缘区，且呈多灶性和多形性特点，不可能对癌灶实施靶向射频消融治疗，而需要对整个周缘区腺体和大部分移形区腺体进行系统性消融。但是，现有的肿瘤射频消融电极(如国外RITA、RTC及国内为尔福公司生产的电极)都没有根据器官形态而设计专用电极，电极有多种，如单极、双极或集束电极，所形成的消融灶多呈球形或椭球形。Prostate cancer is one of the common cancers in elderly men, which has seriously endangered human health. In the prior art, the treatment of prostate cancer includes radical surgery, endocrine therapy, radiation therapy and minimally invasive therapy. Tumor radiofrequency ablation, as a minimally invasive method, has achieved good results in the treatment of liver, kidney and other solid tumors. Its curative effect has been clinically recognized, and it has been tried in the treatment of prostate cancer and has achieved preliminary curative effect. And because the prostate is chestnut-shaped slightly flat front and back, with a wide bottom and a tapered tip, the urethra passes through the front of the gland, and the rear is adjacent to the ampulla of the rectum through the rectovesical septum. Moreover, prostate cancer is more likely to occur in the peripheral area, and it is multifocal and pleomorphic. It is impossible to implement targeted radiofrequency ablation therapy for the cancer focus, but it is necessary to systematically treat the entire peripheral area glands and most of the metamorphic area glands. Sexual ablation. However, the existing tumor radiofrequency ablation electrodes (such as foreign RITA, RTC and domestic electrodes produced by Erfu Company) do not design special electrodes according to the shape of organs. There are many kinds of electrodes, such as unipolar, bipolar or cluster electrodes. The formed ablation lesions were mostly spherical or ellipsoidal.

经对现有技术的检索发现，中国发明专利公开号为：CN1554314A，申请号200310122792.1，该专利公开了一种单针水冷式射频消融电极，其消融灶呈椭球形。检索中还发现，中国发明专利公开号为CN2722849Y，申请号200420006962.X，该专利公开的射频消融切缘电极的消融灶呈扁球形。这两种电极均存在以上所述的不足，不适合用于局限性前列腺癌射频消融治疗。After searching the prior art, it is found that the Chinese invention patent publication number is: CN1554314A, and the application number is 200310122792.1. This patent discloses a single-needle water-cooled radio frequency ablation electrode, and its ablation lesion is ellipsoidal. During the search, it was also found that the Chinese invention patent publication number is CN2722849Y, and the application number is 200420006962.X. The ablation lesion of the radiofrequency ablation margin electrode disclosed in this patent is oblate and spherical. Both of these two electrodes have the disadvantages mentioned above, and are not suitable for radiofrequency ablation of localized prostate cancer.

发明内容Contents of the invention

本发明的目的在于克服现有技术中的不足，提供一种局灶性前列腺癌适形射频消融电极，使其实施“适形”消融，根据前列腺周缘区特殊形态及其表面的弧度(15～30)而将电极针设计成由多根子针组成的扇形束，在该扇形束的侧面观上，子针与导管具有15～30弧度的适形曲度。本发明实现了适合局限性前列腺癌的适形射频消融，使其基于前列腺的解剖特点，具有保护前列腺部尿道、直肠和前列腺血管神经束等结构在有效温度场之外，免受热损伤。The purpose of the present invention is to overcome the deficiencies in the prior art, to provide a conformal radio frequency ablation electrode for focal prostate cancer, which can implement "conformal" ablation, according to the special shape of the peripheral area of the prostate and the radian of its surface (15~ 30) The electrode needle is designed as a fan-shaped bundle composed of multiple sub-needles. On the side view of the fan-shaped bundle, the sub-needles and the catheter have a conformal curvature of 15-30 radians. The present invention realizes the conformal radio frequency ablation suitable for localized prostate cancer, makes it based on the anatomical characteristics of the prostate, and protects structures such as the urethra, rectum, and prostatic vascular and nerve bundles of the prostate from thermal damage outside the effective temperature field.

本发明是通过以下技术方案实现的，本发明由导管与外套组成，导管在外套管内活动，相互紧密配合，导管一端固定有多根微细空芯子针，子针组成具有记忆功能的扇形束。子针缩入外套内，伸出时恢复成扇形束，而每根子针在伸出过程中保持极强的穿透力，在此扇形束的侧面观上，子针与导管具有15～30弧度的适形曲度，导管与套管的尾端装入手柄。The present invention is realized through the following technical solutions. The present invention is composed of a catheter and a sheath. The catheter moves in the sheath and closely cooperates with each other. One end of the catheter is fixed with a plurality of fine hollow needles, and the needles form a fan-shaped bundle with a memory function. The sub-needles are retracted into the jacket, and return to fan-shaped bundles when extended, and each sub-needle maintains a strong penetrating force during the extension process. On the side view of the fan-shaped bundle, the sub-needles and the catheter have an arc of 15-30 The conformal curvature of the catheter and the end of the cannula fit into the handle.

所述的导管为一空芯管，导管前端设有3～7根微细空芯子针，完全展开时针尖之间的距离0.8cm。The catheter is a hollow tube, and the front end of the catheter is provided with 3 to 7 fine hollow needles, and the distance between the needle tips is 0.8cm when fully unfolded.

所述的子针一端均插入导管端口内并焊固，但每根子针内腔均与导管内腔相通。子针的自由端端口内均可设有热电偶，也可按照具体需求仅在特殊位置的子针的自由端端口内设有热电偶，以检测消融区的温度，此热电偶的补偿线从导管内腔引至手柄从尾端口引出。One end of each sub-needle is inserted into the port of the catheter and welded, but the lumen of each sub-needle communicates with the lumen of the catheter. A thermocouple can be installed in the free end port of the sub-needle, or only a thermocouple can be installed in the free end port of the sub-needle at a special position according to specific requirements to detect the temperature of the ablation zone. The compensation line of the thermocouple is from The lumen of the catheter leads to the handle and exits from the tail port.

本发明电极的导管留有空腔以灌注生理盐水及化疗药液等，多根子针组成一扇形束，该扇形束收入外套管内，当伸出外套管就能恢复原形扇形束。当导管向外推时，每根子针均有强而有力的穿透力，并恢复原有的扇形束。The catheter of the electrode of the present invention has a cavity for perfusion of physiological saline and chemotherapy liquid, etc., and a plurality of sub-needles form a fan-shaped bundle. When the catheter is pushed outward, each sub-needle has a strong penetrating force and restores the original fan-shaped bundle.

所述外套管与子针配合的一端设计成30°的斜口，外套管外表面具有标有0.5cm刻度的绝缘层。The end of the outer sleeve that cooperates with the sub-needle is designed as a 30° bevel, and the outer surface of the outer sleeve is provided with an insulating layer marked with a scale of 0.5 cm.

所述导管与外套管的另一端装入手柄，手柄上有定位、导向和注射接口。手柄尾端安置有与射频消融仪相连接的接口。在外套管手柄的前端有一注射接口，通过此接口可在与导管相通的子针的自由端端口注射药液。The catheter and the other end of the outer sleeve are loaded into the handle, and the handle has positioning, guiding and injection ports. The end of the handle is provided with an interface connected with the radiofrequency ablation instrument. There is an injection interface at the front end of the handle of the outer cannula, through which the liquid medicine can be injected into the free end port of the sub-needle communicated with the catheter.

与现有技术相比，本发明由于多根子针构成的扇形束与前列腺左右侧叶的形态相似，射频加热过程的温度场即能有效治疗前列腺癌，又能保护尿道、直肠及前列腺神经血管束等结构免受损伤，达到安全而有效地治疗前列腺癌。Compared with the prior art, because the fan-shaped bundle formed by multiple sub-needles is similar to the shape of the left and right side lobes of the prostate, the temperature field of the radio frequency heating process can not only effectively treat prostate cancer, but also protect the urethra, rectum and prostate neurovascular bundles And other structures from damage, to achieve safe and effective treatment of prostate cancer.

附图说明Description of drawings

图1是本发明前列腺适形射频消融可控专用电极的正视图。Fig. 1 is a front view of the controllable dedicated electrode for conformal radiofrequency ablation of the prostate according to the present invention.

图2是本发明前列腺适形射频消融可控专用电极的纵剖面图。Fig. 2 is a longitudinal sectional view of the controllable dedicated electrode for conformal radiofrequency ablation of the prostate according to the present invention.

图3是本发明前列腺适形射频消融可控专用电极扇形束的局部侧视图。Fig. 3 is a partial side view of the controllable dedicated electrode fan beam for conformal radiofrequency ablation of the prostate according to the present invention.

上述图中：1外套管，2外套管绝缘漆，3外套管刻度标记，4手柄，5导管，6子针扇形束，7热电偶补偿导线，8射频引入线，9电极束与导管焊接处，10热电偶，11斜口，12注射液体装置，13密封圈，14定位鞘，15适形曲度。In the above figure: 1 outer casing, 2 outer casing insulating paint, 3 outer casing scale marks, 4 handle, 5 catheter, 6 sub-pin fan bundle, 7 thermocouple compensation wire, 8 radio frequency lead-in wire, 9 electrode bundle and catheter welding , 10 thermocouples, 11 inclined ports, 12 liquid injection devices, 13 sealing rings, 14 positioning sheaths, and 15 conformal curvatures.

具体实施方式Detailed ways

下面结合附图对本发明的实施例作详细说明：本实施例在以本发明技术方案为前提下进行实施，给出了详细的实施方式，但本发明的保护范围不限于下述的实施例。The embodiments of the present invention are described in detail below in conjunction with the accompanying drawings: the present embodiment is implemented on the premise of the technical solution of the present invention, and detailed implementation is provided, but the protection scope of the present invention is not limited to the following embodiments.

本实施例的结构如图1、2、3所示，包括外套管1、导管5、子针6、手柄4，热电偶10、射频线和热电偶的补偿导线7、定位鞘14和注射口12。本实施例外套管1作穿刺、定位和导向用。导管5在外套管1内，相互之间配合为紧密活动配合。即导管5可松动地在外套管定向下前后伸缩。导管5为一空芯管，导管5一端安置3～7根细微空芯子针6，由具有记忆性能的材料制成，子针6的外径为0.4mm，各子针6在完全展开时针尖间距为0.8cm，可根据不同部位对展开的大小进行调节，子针6一端均插入导管一端内，相互焊接紧固，而每根子针6内腔均与导管内腔相通，子针自由端口可安置热电偶10或空芯可注生理盐水或化疗药液。多根子针相互组成一定形态的扇形束，在此扇形束的侧面观上，子针与导管具有15～30弧度的适形曲度(图3)，当导管5收入外套管1时，此扇形束随着变形缩入外套管1内，当导管5推出时，子针束恢复扇形束原形。另外，外套管一端为斜口11作穿刺用，外套管1的外表面包绕带刻度的绝缘层。导管5与外套管1的尾端均装入有定位、导向的手柄4中，射频线和热电偶的补偿导线7从手柄尾端引出与射频消融仪相连，手柄前端装有可与注射器连接的注射接口。The structure of this embodiment is shown in Figures 1, 2, and 3, including an overtube 1, a catheter 5, a sub-needle 6, a handle 4, athermocouple 10, a radio frequency line and a compensation wire 7 for the thermocouple, a positioning sheath 14, and aninjection port 12. In this embodiment, the overtube 1 is used for puncturing, positioning and guiding. The conduits 5 are in the outer sleeve 1 and cooperate closely with each other. That is, the catheter 5 can be loosely stretched back and forth under the orientation of the outer sleeve. The catheter 5 is a hollow tube, and one end of the catheter 5 is equipped with 3 to 7 fine hollow core needles 6, which are made of a material with memory properties. The distance is 0.8cm, and the size of the expansion can be adjusted according to different parts. One end of the sub-needles 6 is inserted into one end of the catheter, and they are welded and fastened to each other. The lumen of each sub-needle 6 is connected with the inner cavity of the catheter.Arrangement thermocouple 10 or empty core can inject physiological saline or chemotherapeutic liquid. A plurality of sub-needles mutually form a fan-shaped bundle of a certain shape. On the side view of the fan-shaped bundle, the sub-needles and the catheter have a conformal curvature of 15 to 30 radians (Fig. 3). When the catheter 5 is received in the outer sleeve 1, the fan-shaped The bundle retracts into the outer sleeve 1 along with the deformation, and when the catheter 5 is pushed out, the sub-needle bundle returns to the fan-shaped bundle original shape. In addition, one end of the outer sleeve has a bevel 11 for puncturing, and the outer surface of the outer sleeve 1 is wrapped with an insulating layer with scales. Both the catheter 5 and the tail end of the overtube 1 are installed in the handle 4 with positioning and guidance. The compensation wire 7 of the radio frequency line and the thermocouple is led out from the tail end of the handle to connect with the radio frequency ablation instrument. Injection interface.

本发明的前列腺癌适形射频消融电极的外套管1采用外径为16G的直形针状结构，可在经直肠超声的实时引导下清晰显示，以确保外套管1准确从前列腺尖部插入至所治疗靶区，从而避免对前列腺部尿道、膜部尿道、前列腺血管神经束、直肠及膀胱等部位造成损伤。外套管1除斜口11端0.5cm处裸露外均包有绝缘层2，绝缘层2标有0.5cm的刻度，外套管1的绝缘层2避免在射频工作时外套管产热而对周围正常组织造成热损伤。当外套管1穿刺到目标时，通过手柄4的定位鞘14向前推动导管5，从而将子针6沿着前列腺一侧叶展开，这样裸露的子针束6就构成了射频场，展开的子针束6侧面具有15～30°的适形曲度15，此适形曲度15可根据不同大小的前列腺周缘区的弧度进行设置，子针束6的长度可根据治疗区域的大小和形状进行调节。射频引入线8从手柄4的尾部引出，通过插头与射频消融治疗系统的主机相连接。The overtube 1 of the conformal radiofrequency ablation electrode for prostate cancer of the present invention adopts a straight needle-shaped structure with an outer diameter of 16G, which can be clearly displayed under the real-time guidance of transrectal ultrasound to ensure that the overtube 1 is accurately inserted from the apex of the prostate to the The target area to be treated, so as to avoid damage to the prostatic urethra, membranous urethra, prostatic vascular and nerve bundles, rectum and bladder. Outer casing 1 is covered with an insulating layer 2 except for the 0.5cm exposed at the end of the bevel 11. The insulating layer 2 is marked with a scale of 0.5cm. The insulating layer 2 of the outer casing 1 prevents the outer casing from generating heat when the radio frequency is working. Tissue thermal damage. When the outer cannula 1 punctures the target, the positioning sheath 14 of the handle 4 pushes the catheter 5 forward, so that the sub-needles 6 are deployed along one side of the prostate, so that the exposed sub-needles 6 form a radio frequency field. The side of the sub-needle bundle 6 has a conformal curvature 15 of 15-30°. The conformal curvature 15 can be set according to the curvature of the prostate peripheral area of different sizes, and the length of the sub-needle bundle 6 can be adjusted according to the size and shape of the treatment area. Make adjustments. The radio frequency lead-in wire 8 is led out from the tail of the handle 4, and is connected with the host computer of the radio frequency ablation treatment system through a plug.

子针6的自由端端口内设有热电偶10，以检测消融区的温度，此热电偶的补偿线从导管内腔引至手柄从尾端口引出与主机相连，完成信号的传输，通过主机对治疗靶区进行温度控制，避免治疗区域温度过高及加热不足，实现温度反馈精确治疗。在治疗过程中可通过注射液体装置12对治疗靶区进行生理盐水或者药物的注射，生理盐水或者药物通过与导管5内腔相连的子针6进入靶区。通过注射生理盐水冷却子针6的温度，防止组织炭化进而扩大消融灶的范围，也可直接注射化疗药物至靶区。The free end port of the sub-needle 6 is provided with athermocouple 10 to detect the temperature of the ablation zone. The compensation line of the thermocouple leads from the catheter lumen to the handle and connects with the host from the tail port to complete the signal transmission. The temperature of the treatment target area is controlled to avoid overheating and insufficient heating of the treatment area, and to achieve precise treatment with temperature feedback. During the treatment process, physiological saline or medicine can be injected into the treatment target area through theliquid injection device 12 , and the physiological saline or medicine enters the target area through the sub-needle 6 connected with the inner cavity of the catheter 5 . The temperature of the sub-needle 6 is cooled by injecting physiological saline to prevent tissue charring and expand the range of the ablation lesion, and it is also possible to directly inject chemotherapy drugs to the target area.

在本发明的实施例中，为确保前列腺癌适形射频消融电极的优良性能，对电极各部分的选材作了优化选择，同时其生物相容性符合GB/T16886.1-2001的规定，所选选材价格低廉。In the embodiment of the present invention, in order to ensure the excellent performance of the conformal radiofrequency ablation electrode for prostate cancer, the material selection of each part of the electrode is optimized, and its biocompatibility complies with the provisions of GB/T16886.1-2001. The selection of materials is cheap.

Claims (7)

1, a kind of focal prostate cancer conformal radiofrequency ablation electrode, form by conduit and trocar sheath, it is characterized in that conduit is movable in trocar sheath, closely cooperates mutually, conduit is a hollow pipe, conduit one end is fixed with the many sub-pins of fine hollow, and sub-pin is formed the fladellum with memory function, in the sub-pin retraction trocar sheath, revert to fladellum when stretching out, the tail end of conduit and the trocar sheath handle of packing into;

Be equipped with thermocouple in the free end port of described sub-pin, perhaps only be provided with thermocouple in the free end port of parton pin, the compensating line of thermocouple causes handle from conduit cavity and draws from the tail end mouth.

2, focal prostate cancer conformal radiofrequency ablation electrode according to claim 1 is characterized in that: the front end of described conduit is fixed with 3～7 sub-pins of fine hollow.

3, focal prostate cancer conformal radiofrequency ablation electrode according to claim 1 is characterized in that: described fladellum, see that in its side sub-pin and conduit have 15～30 ° suitable shape curvature.

4, according to arbitrary described focal prostate cancer conformal radiofrequency ablation electrode of claim 1-3, it is characterized in that: described sub-pin, one end all insert in the catheter port and solid welding, but every root pin inner chamber all communicates with conduit cavity.

5, focal prostate cancer conformal radiofrequency ablation electrode according to claim 1 is characterized in that: described trocar sheath is into 30 ° angle with the end that sub-pin cooperates.

6, according to claim 1 or 5 described focal prostate cancer conformal radiofrequency ablation electrodes, it is characterized in that: described trocar sheath outer surface has the graduated insulating barrier of the 0.5cm of indicating.

7, focal prostate cancer conformal radiofrequency ablation electrode according to claim 1, it is characterized in that: described handle is provided with location, guiding and injection interface, front end at the trocar sheath handle has an injection interface, and the handle tail end is mounted with the interface that is connected with the radio-frequency (RF) ablation instrument.

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