CN111888084A - An intraluminal hyperthermia catheter for prostate - Google Patents

Abstract

Translated fromChinese

本发明的一个目的在于提供一种前列腺腔内热疗导管，其能够根据患者的尿道内径对加热球囊进行自适应大小调节。为实现前述一个目的的前列腺腔内热疗导管包括管体、定位球囊以及热疗球囊。管体内部具有第一球囊腔道、回流腔道以及布线腔道。定位球囊设置于管体外侧，与第一球囊腔道连通，气体或液体可自第一球囊腔道充入定位球囊。热疗球囊设置于管体外侧，内部设置有热疗组件，布线腔道内布设有连接热疗组件的布线。其中，回流腔道连通定位球囊以及热疗球囊，充入的气体或液体通过回流腔道在定位球囊以及热疗球囊之间流通，以保持定位球囊与热疗球囊内的压力平衡，使热疗球囊充盈膨胀至适合与尿道内壁贴合的大小。

One object of the present invention is to provide an intraluminal hyperthermia catheter for the prostate, which can adjust the size of the heating balloon adaptively according to the inner diameter of the patient's urethra. The intraluminal hyperthermia catheter for achieving the aforementioned object includes a tubular body, a positioning balloon and a hyperthermia balloon. The inside of the tube body has a first balloon lumen, a return lumen and a wiring lumen. The positioning balloon is arranged on the outside of the tube body and communicated with the first balloon cavity, and gas or liquid can be filled into the positioning balloon from the first balloon cavity. The hyperthermia balloon is arranged on the outside of the tube body, a hyperthermia component is arranged inside, and a wiring for connecting the hyperthermia component is arranged in the wiring cavity. The backflow channel is connected to the positioning balloon and the hyperthermia balloon, and the inflated gas or liquid circulates between the positioning balloon and the hyperthermia balloon through the backflow channel, so as to keep the distance between the positioning balloon and the hyperthermia balloon. The pressure is balanced, so that the hyperthermia balloon is inflated to a size suitable for fitting with the inner wall of the urethra.

Description

Translated fromChinese

一种前列腺腔内热疗导管An intraluminal hyperthermia catheter for prostate

技术领域technical field

本发明涉及医疗器械领域，尤其涉及一种前列腺腔内热疗导管。The invention relates to the field of medical devices, in particular to a catheter for intracavitary hyperthermia of the prostate.

背景技术Background technique

前列腺炎是男性的常见病和多发病，目前对于男性前列腺增生、前列腺炎的治疗通常采用的是腔内热疗或口服药物治疗的方法。腔内热疗是将治疗所用的热疗导管插入患者尿道至膀胱，使热疗囊在前列腺部位定位，采用物理方法对患部加热的热疗治疗方法，它使增生部位逐渐萎缩、控制炎症，由此减轻和解除患者的症状和痛苦。Prostatitis is a common and frequently-occurring disease in men. At present, intracavitary hyperthermia or oral drug therapy are usually used for the treatment of male prostatic hyperplasia and prostatitis. Intracavitary hyperthermia is a hyperthermia treatment method in which the hyperthermia catheter used for treatment is inserted into the patient's urethra to the bladder, the hyperthermia bag is positioned at the prostate, and the affected part is heated by physical methods. This relieves and relieves the patient's symptoms and pain.

现有的热疗治疗方法是通过在插入患者尿道导管在患部位置设置一加热球囊，向加热球囊内部打入定量生理盐水，再通过球囊内射频回路加热生理盐水使球囊发热，达到患部热疗的目的。The existing hyperthermia treatment method is to set a heating balloon at the position of the affected part by inserting the patient's urethral catheter, injecting a quantitative physiological saline into the heating balloon, and then heating the physiological saline through the radio frequency circuit in the balloon to make the balloon heat up, so as to achieve the desired effect. The purpose of hyperthermia in the affected area.

然而发明人发现，由于前列腺增生或炎症程度的不同使患者尿道狭窄程度有所不同，或因患者的身高或生理结构的不同使尿道腔内径不同，当热疗导管上的加热球囊插入患者尿道内后，常会发生对于前列腺增生或炎症程度比较严重、尿道严重狭窄的患者会有加热球囊压迫的不舒适感，而对于尿道内径相对大的患者，加热球囊可能无法紧贴尿道内腔壁而影响治疗效果。However, the inventors have found that the degree of urethral stenosis varies with the degree of prostatic hyperplasia or inflammation, or the inner diameter of the urethral lumen varies with the height or physiological structure of the patient. When the heating balloon on the hyperthermia catheter is inserted into the urethra of the patient Patients with benign prostatic hyperplasia or severe inflammation and severe urethral stricture may feel uncomfortable under the pressure of the heating balloon, while for patients with a relatively large urethral diameter, the heating balloon may not be able to stick to the inner wall of the urethra. affect the treatment effect.

发明内容SUMMARY OF THE INVENTION

本发明的一个目的在于提供一种前列腺腔内热疗导管，其能够根据患者的尿道内径对加热球囊进行自适应大小调节。An object of the present invention is to provide an intraluminal hyperthermia catheter for the prostate, which can adjust the size of the heating balloon adaptively according to the inner diameter of the patient's urethra.

为实现前述一个目的的前列腺腔内热疗导管，包括：The intraluminal hyperthermia catheter for achieving the above-mentioned purpose includes:

管体，内部具有多条内腔道，所述内腔道包括第一球囊腔道、回流腔道以及布线腔道；The tube body has a plurality of inner lumens, and the inner lumens include a first balloon lumen, a return lumen and a wiring lumen;

定位球囊，设置于所述管体外侧，与所述第一球囊腔道连通，气体或液体可自所述第一球囊腔道充入所述定位球囊，以使所述定位球囊在膀胱口充盈膨胀定位；以及A positioning balloon is arranged on the outside of the tube body and communicated with the first balloon cavity, and gas or liquid can be filled into the positioning balloon from the first balloon cavity, so that the positioning ball The balloon is inflated and positioned at the bladder ostium; and

热疗球囊，设置于所述管体外侧，与所述布线腔道连通，内部设置有热疗组件，所述布线腔道内布设有连接所述热疗组件的布线；a hyperthermia balloon, which is arranged on the outside of the tube body, communicates with the wiring cavity, and is provided with a hyperthermia component inside, and the wiring cavity is arranged with a wiring connecting the hyperthermia component;

其中，所述回流腔道连通所述定位球囊以及所述热疗球囊，充入的气体或液体通过所述回流腔道在所述定位球囊以及所述热疗球囊之间流通，以保持所述定位球囊与所述热疗球囊内的压力平衡，使所述热疗球囊充盈膨胀至适合与尿道内壁贴合的大小。Wherein, the return channel communicates with the positioning balloon and the hyperthermia balloon, and the filled gas or liquid circulates between the positioning balloon and the heat therapy balloon through the return channel, In order to maintain the pressure balance between the positioning balloon and the hyperthermia balloon, the hyperthermia balloon is inflated to a size suitable for fitting with the inner wall of the urethra.

在一个或多个实施方式中，所述管体的两端分别设置有导头以及后端组件，所述导头用于引导所述导管插入尿道，所述后端组件提供多个接口，所述接口包括第一球囊腔道接口以及连接插头；In one or more embodiments, both ends of the tube body are respectively provided with a guide head and a rear end assembly, the guide head is used to guide the catheter to be inserted into the urethra, and the rear end assembly provides a plurality of interfaces, so The interface includes a first balloon lumen interface and a connection plug;

所述第一球囊腔道接口通过所述第一球囊腔道与所述定位球囊相连通，以通过所述第一球囊腔道接口向所述定位球囊注入气体或液体，在所述第一球囊腔道接口处设置有单向阀；The first balloon lumen interface is communicated with the positioning balloon through the first balloon lumen, so as to inject gas or liquid into the positioning balloon through the first balloon lumen interface, and then A one-way valve is arranged at the interface of the first balloon cavity;

其中，所述连接插头与所述布线腔道内的所述布线连接，所述回流腔道与所述后端组件之间被封堵。Wherein, the connection plug is connected to the wiring in the wiring channel, and the backflow channel and the rear end assembly are blocked.

在一个或多个实施方式中，所述内腔道还包括导尿内腔，所述导头处具有导尿口，所述后端组件中的所述接口包括导尿内腔接口，所述导尿口通过所述导尿内腔与所述导尿内腔接口相连通。In one or more embodiments, the inner lumen further includes a catheterization lumen, the guide head has a catheterization port, the interface in the rear end assembly includes a catheterization lumen interface, and the The catheterization port is communicated with the catheterization lumen interface through the catheterization lumen.

在一个或多个实施方式中，所述热疗导管还包括封闭球囊，所述定位球囊、所述热疗球囊以及所述封闭球囊自所述导头朝所述后端组件依次设置；In one or more embodiments, the hyperthermia catheter further includes a sealing balloon, and the positioning balloon, the hyperthermia balloon and the sealing balloon are in sequence from the guide head to the rear end assembly set up;

所述内腔道还包括第二球囊腔道，所述后端组件中的所述接口包括第二球囊腔道接口，所述第二球囊腔道接口通过所述第二球囊腔道与所述封闭球囊相连通，在所述第二球囊腔道接口处设置有单向阀，通过所述第二球囊腔道接口向所述封闭球囊注入气体或液体，以使所述封闭球囊充盈膨胀；The inner lumen further includes a second balloon lumen, the interface in the rear end assembly includes a second balloon lumen interface, and the second balloon lumen interface passes through the second balloon lumen A one-way valve is provided at the second balloon lumen interface, and gas or liquid is injected into the closed balloon through the second balloon lumen interface, so that The sealing balloon is inflated and expanded;

其中，充盈膨胀后的定位球囊以及封闭球囊分别封闭尿道，以在尿道患部形成封闭腔道，所述热疗球囊在所述封闭腔道处对患部进行热疗。The inflated positioning balloon and the sealing balloon respectively seal the urethra to form a closed cavity in the affected part of the urethra, and the hyperthermia balloon performs hyperthermia on the affected part at the closed cavity.

在一个或多个实施方式中，在所述热疗球囊的至少一侧的所述管体壁上开设有药液出口，所述内腔道还包括药液内腔，所述后端组件中的所述接口还包括药液内腔接口，所述药液内腔接口处设置有单向阀；In one or more embodiments, a medicinal liquid outlet is opened on at least one side of the tube body wall of the hyperthermia balloon, the inner lumen further includes a medicinal liquid lumen, and the rear end assembly The interface in the device also includes a medicinal liquid cavity interface, and a one-way valve is provided at the medicinal liquid cavity interface;

其中，所述药液内腔连通所述药液出口以及所述药液内腔接口，以允许通过所述药液内腔接口向所述封闭腔道内输送药液。Wherein, the medicinal liquid cavity is communicated with the medicinal liquid outlet and the medicinal liquid cavity interface, so as to allow the medicinal liquid to be delivered into the closed cavity through the medicinal liquid cavity interface.

在一个或多个实施方式中，所述药液出口分别开设于所述热疗球囊两侧的所述管体壁上。In one or more embodiments, the medicinal liquid outlets are respectively opened on the tubular body walls on both sides of the hyperthermia balloon.

在一个或多个实施方式中，所述热疗组件包括多个加热单元以及至少一个测温单元；In one or more embodiments, the thermotherapy assembly includes a plurality of heating units and at least one temperature measurement unit;

每个所述加热单元包括套设于所述管体外侧的射频电极圈以及射频导线，所述射频导线连接所述插头与所述射频电极圈；Each of the heating units includes a radio frequency electrode ring and a radio frequency wire sleeved on the outside of the tube body, and the radio frequency wire connects the plug and the radio frequency electrode ring;

所述测温单元包括套设于所述管体外侧的测温电极圈以及测温导线，所述测温导线连接所述插头与所述测温电极圈。The temperature measurement unit includes a temperature measurement electrode ring and a temperature measurement wire sleeved on the outside of the pipe body, and the temperature measurement wire connects the plug and the temperature measurement electrode ring.

在一个或多个实施方式中，所述热疗组件还包括套设于所述管体外侧的传热电极圈，所述传热电极圈与所述射频电极圈均布于所述热疗球囊内的所述管体外侧。In one or more embodiments, the thermotherapy assembly further includes a heat transfer electrode ring sleeved on the outside of the tube body, and the heat transfer electrode ring and the radio frequency electrode ring are evenly distributed on the thermotherapy ball outside of the tubular body within the sac.

在一个或多个实施方式中，所述热疗球囊具有不大于所述定位球囊的壁厚。In one or more embodiments, the hyperthermia balloon has a wall thickness no greater than that of the positioning balloon.

在一个或多个实施方式中，所述布线在所述布线腔道内布设后，所述布线腔道由硅胶封堵。In one or more embodiments, after the wiring is routed in the wiring cavity, the wiring cavity is sealed by silica gel.

本发明的进步效果包括以下之一或组合：The progressive effects of the present invention include one or a combination of the following:

1)通过在导管中设置连通热疗球与定位球囊的回流腔道，使得热疗球囊与定位球囊内部压力平衡，从而保证了当导管插入到具有不同内径的尿道时，利用尿道内壁对热疗球囊的压力，实现了能够根据不同尿道内腔径来调节热疗球囊的大小，从而实现热疗球囊在患者尿道中的自适应大小调节。1) By arranging a return channel connecting the hyperthermia ball and the positioning balloon in the catheter, the internal pressure of the hyperthermia balloon and the positioning balloon is balanced, thereby ensuring that when the catheter is inserted into the urethra with different inner diameters, the inner wall of the urethra is utilized. The pressure on the hyperthermia balloon realizes that the size of the hyperthermia balloon can be adjusted according to different urethral lumen diameters, thereby realizing self-adaptive size adjustment of the hyperthermia balloon in the patient's urethra.

2)通过在热疗球囊中设置传热电极圈，以使热疗球囊内的流体能够被加热更加均匀。2) By arranging a heat transfer electrode ring in the hyperthermia balloon, the fluid in the hyperthermia balloon can be heated more uniformly.

附图说明Description of drawings

本发明的上述的以及其他的特征、性质和优势将通过下面结合附图和实施例的描述而变得更加明显，其中：The above and other features, properties and advantages of the present invention will become more apparent from the following description taken in conjunction with the accompanying drawings and examples, wherein:

图1示出了前列腺腔内热疗导管一个实施方式下的示意图；Fig. 1 shows the schematic diagram under one embodiment of the intraluminal hyperthermia catheter of the prostate;

图2为图1中沿A-A方向的剖面示意图；Fig. 2 is a schematic cross-sectional view along the A-A direction in Fig. 1;

图3为图2沿B-B方向的剖视示意图；3 is a schematic cross-sectional view of FIG. 2 along the B-B direction;

图4示出了图3中E部局部放大示意图；Fig. 4 shows the partial enlarged schematic diagram of E part in Fig. 3;

图5示出了图2中沿D-D方向的剖视示意图；Figure 5 shows a schematic cross-sectional view along the D-D direction in Figure 2;

图6为图2中沿C-C方向的剖视示意图。FIG. 6 is a schematic cross-sectional view along the C-C direction in FIG. 2 .

具体实施方式Detailed ways

下述公开了多种不同的实施所述的主题技术方案的实施方式或者实施例。为简化公开内容，下面描述了各元件和排列的具体实例，当然，这些仅仅为例子而已，并非是对本申请的保护范围进行限制。例如在说明书中随后记载的第一特征在第二特征上方或者上面形成，可以包括第一和第二特征通过直接联系的方式形成的实施方式，也可包括在第一和第二特征之间形成附加特征的实施方式，从而第一和第二特征之间可以不直接联系。另外，这些公开内容中可能会在不同的例子中重复附图标记和/或字母。该重复是为了简要和清楚，其本身不表示要讨论的各实施方式和/或结构间的关系。进一步地，当第一元件是用与第二元件相连或结合的方式描述的，该说明包括第一和第二元件直接相连或彼此结合的实施方式，也包括采用一个或多个其他介入元件加入使第一和第二元件间接地相连或彼此结合。The following discloses a variety of different implementations or examples for implementing the described subject technical solutions. In order to simplify the disclosure, specific examples of various elements and arrangements are described below, which are, of course, only examples and are not intended to limit the scope of protection of the present application. For example, where a first feature described later in the specification is formed on or above a second feature, it may include embodiments in which the first and second features are formed in a direct relationship, and may also include those formed between the first and second features. Implementation of additional features so that there may be no direct connection between the first and second features. Additionally, reference numerals and/or letters may be repeated in various instances throughout these disclosures. This repetition is for brevity and clarity and does not in itself represent a relationship between the various embodiments and/or structures being discussed. Further, when a first element is described as being connected or combined with a second element, the description includes embodiments in which the first and second elements are directly connected or combined with each other, and also includes the addition of one or more other intervening elements. The first and second elements are indirectly connected or joined to each other.

需要注意的是，在使用到的情况下，如下描述中的上、下、左、右、前、后、顶、底、正、反、顺时针和逆时针仅仅是出于方便的目的所使用的，而并不暗示任何具体的固定方向。事实上，它们被用于反映对象的各个部分之间的相对位置和/或方向。It should be noted that, in the case of use, up, down, left, right, front, back, top, bottom, forward, reverse, clockwise and counterclockwise in the following description are only used for the purpose of convenience , and does not imply any specific fixed orientation. In fact, they are used to reflect the relative position and/or orientation between parts of the object.

需要注意的是，这些以及后续其他的附图均仅作为示例，其并非是按照等比例的条件绘制的，并且不应该以此作为对本发明实际要求的保护范围构成限制。此外，不同实施方式下的变换方式可以进行适当组合。It should be noted that these and other subsequent drawings are only examples, they are not drawn according to the condition of equal scale, and should not be taken as a limitation on the protection scope of the actual requirements of the present invention. In addition, the transformation modes under different embodiments can be appropriately combined.

未解决前述现有技术中存在的一个或多个问题，本发明的提供了一种前列腺腔内热疗导管，如图1示出了前列腺腔内热疗导管一个实施方式下的示意图，图2为图1中沿A-A方向的剖面示意图。Without solving one or more problems existing in the prior art, the present invention provides an intraluminal hyperthermia catheter of the prostate. Figure 1 shows a schematic diagram of an embodiment of the intraluminal hyperthermia catheter of the prostate, and Figure 2 It is a schematic cross-sectional view along the A-A direction in FIG. 1 .

请结合参见图1以及图2，前列腺腔内热疗导管包括：管体1、定位球囊2以及热疗球囊3。Please refer to FIG. 1 and FIG. 2 in combination, the intraluminal prostatic hyperthermia catheter includes: a tube body 1 , apositioning balloon 2 and ahyperthermia balloon 3 .

其中，管体1内部具有多条内腔道，如图2所示，内腔道包括第一球囊腔道11、回流腔道12以及布线腔道13。多个内腔道之间可以是如图2所示，由在管体1内侧设置及延伸的多个内壁体100相隔开。多个内壁体100之间围出多个内腔道。Wherein, the inside of the tube body 1 has a plurality of inner cavities, as shown in FIG. As shown in FIG. 2 , a plurality of inner lumens may be separated by a plurality ofinner wall bodies 100 arranged and extended inside the tube body 1 . A plurality of inner cavities are enclosed between the plurality ofinner wall bodies 100 .

定位球囊2是设置于管体1的外周侧，并与第一球囊腔道11连通。具体地，可以是如图1所示，在管体1的外壁上开设有定位球囊开口20，从而通过定位球囊开口20是的定位球囊2内部与第一球囊腔道11的一端连通，当于第一球囊腔道11的另一端通入气体或液体时，气体或液体可自第一球囊腔道11充入至定位球囊2中，定位球囊2内部充盈流体并膨胀，以使得管体1在膀胱口处由膨胀状态下的定位球囊2定位。Thepositioning balloon 2 is disposed on the outer peripheral side of the tubular body 1 and communicates with thefirst balloon lumen 11 . Specifically, as shown in FIG. 1 , apositioning balloon opening 20 is opened on the outer wall of the tube body 1 , so that the inside of theballoon 2 and one end of thefirst balloon lumen 11 are positioned through thepositioning balloon opening 20 . Communication, when gas or liquid is passed through the other end of thefirst balloon cavity 11, the gas or liquid can be filled into thepositioning balloon 2 from thefirst balloon cavity 11, and thepositioning balloon 2 is filled with fluid and filled with fluid. Inflate so that the tubular body 1 is positioned at the bladder opening by thepositioning balloon 2 in the inflated state.

在一些其他与图示不同的实施方式中，本发明一个或多个实施方式中所提及的连通可以有许多合适的变形或变化，但不以此为限，如在第一球囊腔道11与定位球囊2的连通方式中，第一球囊腔道11可以具有延伸出管体外侧壁的一段细管，定位球囊2通过该细管与第一球囊腔道11连通。后文所述的一个或多个实施方式中所提及的连通方式也可以采用相同或等同的方式，故不再赘述。In some other embodiments different from the illustrations, the communication mentioned in one or more embodiments of the present invention may have many suitable deformations or changes, but not limited thereto, such as in the first balloon lumen In the communication mode between 11 and thepositioning balloon 2, thefirst balloon lumen 11 may have a thin tube extending out of the outer wall of the tube, and thepositioning balloon 2 communicates with thefirst balloon lumen 11 through the thin tube. The connection manners mentioned in one or more embodiments described later may also adopt the same or equivalent manners, and thus will not be repeated here.

请继续参见附图，热疗球囊3设置于管体1的外周侧，并与布线腔道13相连通，热疗球囊3的内部设置有热疗组件，热疗组件用于在热疗球囊3发热以实现对患者病灶处进行热疗。其中，布线腔道13内布设有连接热疗组件的布线。具体而言，可以是如图1所示，在管体1的外壁上开设有布线开口30，布线通过布线开口进入至布线腔道13中，并沿布线内腔13进行延伸布线。Please continue to refer to the drawings, thehyperthermia balloon 3 is arranged on the outer peripheral side of the tube body 1 and communicates with thewiring cavity 13, and a hyperthermia component is arranged inside thehyperthermia balloon 3, and the hyperthermia component is used in the hyperthermia Theballoon 3 generates heat to achieve hyperthermia on the patient's lesion. Wherein, thewiring cavity 13 is provided with wiring for connecting the hyperthermia components. Specifically, as shown in FIG. 1 , awiring opening 30 may be opened on the outer wall of the pipe body 1 , and the wiring enters thewiring cavity 13 through the wiring opening, and extends the wiring along the wiringinner cavity 13 .

其中，回流腔道12连通于定位球囊2以及热疗球囊3之间，被充入至定位球囊2中的气体或液体通过回流腔道12在定位球囊2以及热疗球囊3之间流通，从而保持定位球囊2与热疗球囊3的压力平衡，以使热疗球囊3被充盈至合适与尿道内壁贴合的大小。具体地，可以是如图1所示，在管体1的外壁上分别开设有回流内腔出口121以及回流内腔入口122，回流内腔入口122与热疗球囊3内腔连通，回流内腔出口121与定位球囊内腔连通。Thereturn channel 12 is connected between the positioningballoon 2 and thehyperthermia balloon 3 , and the gas or liquid filled into thepositioning balloon 2 passes through thereturn channel 12 between the positioningballoon 2 and thehyperthermia balloon 3 . Thereby, the pressure balance between the positioningballoon 2 and thehyperthermia balloon 3 is maintained, so that thehyperthermia balloon 3 is inflated to a size suitable for fitting with the inner wall of the urethra. Specifically, as shown in FIG. 1 , abackflow lumen outlet 121 and abackflow lumen inlet 122 are respectively opened on the outer wall of the tube body 1 , and thebackflow lumen inlet 122 communicates with the inner lumen of thehyperthermia balloon 3 , and the backflow lumen Thelumen outlet 121 communicates with the positioning balloon lumen.

具体而言，当定位球囊2充盈后球囊内压增大，由于定位球囊2通过回流腔道12与热疗球囊3相通，所以定位球囊2内的流体会自回流内腔出口121释放热疗球囊3内部压力使流体从回流内腔入口122流入热疗球囊3中，当热疗球囊3内部充入流体后球囊表面慢慢膨胀，并能紧贴前列腺患部粘膜。当球囊表面紧贴患部粘膜时，由于粘膜对热疗球囊3外壁的压迫作用，会使热疗球囊3内部产生内压，逐步使定位球囊2内部压力与热疗球囊3内部压力平衡，从而达到热疗球囊3能紧贴尿道患部内壁。同时定位球囊2也能够充盈膨胀，并封闭尿道入口。Specifically, when thepositioning balloon 2 is inflated, the internal pressure of the balloon increases. Since thepositioning balloon 2 communicates with thehyperthermia balloon 3 through thereturn channel 12, the fluid in thepositioning balloon 2 will flow from the exit of the return cavity. 121 releases the internal pressure of thehyperthermia balloon 3 to make the fluid flow into thehyperthermia balloon 3 from thereturn lumen inlet 122. When the interior of thehyperthermia balloon 3 is filled with fluid, the balloon surface slowly expands and can be close to the mucosa of the affected part of the prostate. . When the surface of the balloon is close to the mucous membrane of the affected part, due to the pressing effect of the mucous membrane on the outer wall of thehyperthermia balloon 3, an internal pressure will be generated inside thehyperthermia balloon 3, and gradually the internal pressure of thepositioning balloon 2 and the interior of thehyperthermia balloon 3 will be The pressure is balanced, so that thehyperthermia balloon 3 can stick to the inner wall of the affected part of the urethra. At the same time, thepositioning balloon 2 can also be inflated and inflated, and the entrance of the urethra is closed.

现有热疗导管中，产品插入患者尿道内的热疗导管上的加热球囊外径是不可调节的，即插入患者尿道的导管对不同尿道内腔径的加热球囊扩张力相同，对患者尿道腔内径压力相同。通过在导管中设置连通热疗球囊3与定位球囊2的回流腔道12，使得热疗球囊3与定位球囊2内部压力平衡，从而保证了当导管插入到具有不同内径的尿道时，利用尿道内壁对热疗球囊3的压力，实现了能够根据不同尿道内腔径来调节热疗球囊3的大小，从而实现热疗球囊3在患者尿道中的自适应大小调节。Among the existing hyperthermia catheters, the outer diameter of the heating balloon on the hyperthermia catheter inserted into the patient's urethra is not adjustable, that is, the catheter inserted into the patient's urethra has the same expansion force for the heating balloon with different urethral lumen diameters, and it is not suitable for the patient. The inner diameter of the urethral lumen is the same. By arranging areturn channel 12 in the catheter that communicates with thehyperthermia balloon 3 and thepositioning balloon 2, the internal pressures of thehyperthermia balloon 3 and thepositioning balloon 2 are balanced, thereby ensuring that when the catheter is inserted into the urethra with different inner diameters , using the pressure of the inner wall of the urethra to thehyperthermia balloon 3, the size of thehyperthermia balloon 3 can be adjusted according to different urethral lumen diameters, thereby realizing the adaptive size adjustment of thehyperthermia balloon 3 in the patient's urethra.

虽然前列腺腔内热疗导管的一个实施例如上所述，但是在前列腺腔内热疗导管的其他实施例中，前列腺腔内热疗导管相对于上述实施例在许多方面都可以具有更多的细节，并且这些细节的至少一部分可以具有多样的变化。下面以一些实施例对这细节和些变化中的至少一部分进行说明。While one embodiment of a prostatic hyperthermia catheter is described above, in other embodiments of a prostatic hyperthermia catheter, the prostatic hyperthermia catheter may have more detail in many respects than the embodiments described above. , and at least some of these details may have various changes. These details and at least some of these variations are illustrated below with some examples.

图3为图2沿B-B方向的剖视示意图，请参见图1至图3，在前列腺腔内热疗导管的一个实施方式中，管体1的两端分别设置有导头4以及后端组件5，导头4用于引导导管插入到患者的尿道中，后端组件5提供有多个接口，其中包括有第一球囊腔道接口51以及连接插头52。第一球囊腔道接口51通过第一球囊腔道11与定位球囊2相连通，从而通过第一球囊腔道接口51能够向定位球囊2注入气体或液体，其中，在第一球囊腔道接口51处设置有单向阀，以防止流体回流。连接插头52与布线腔道13中的布线相连接，从而通过将连接插头52插入至如射频热疗仪上，以使热疗组件开始加热。FIG. 3 is a schematic cross-sectional view of FIG. 2 along the B-B direction. Please refer to FIGS. 1 to 3. In one embodiment of the intraprostatic hyperthermia catheter, both ends of the tube body 1 are respectively provided with aguide head 4 and arear end assembly 5. Theguide head 4 is used for guiding the insertion of the catheter into the urethra of the patient, and therear end assembly 5 is provided with a plurality of interfaces, including a firstballoon lumen interface 51 and a connectingplug 52 . The firstballoon lumen interface 51 communicates with thepositioning balloon 2 through thefirst balloon lumen 11 , so that gas or liquid can be injected into thepositioning balloon 2 through the firstballoon lumen interface 51 . A one-way valve is provided at theballoon lumen interface 51 to prevent fluid backflow. The connection plug 52 is connected to the wiring in thewiring channel 13, so that by inserting theconnection plug 52 into, for example, a radio frequency hyperthermia apparatus, the heating of the hyperthermia component is started.

其中，回流腔道12与后端组件5之间被封堵，以使热疗球囊3、定位球囊2以及回流腔道12之间形成自平衡腔道。The space between thereturn channel 12 and therear end assembly 5 is blocked, so that a self-balancing channel is formed between thehyperthermia balloon 3 , thepositioning balloon 2 and thereturn channel 12 .

在其他一些与图示不同的实施方式中，前列腺腔内热疗导管的结构形式还可以存在许多合适的变形或变化，但不以此为限。如在一个实施方式中，前列腺腔内热疗导管可以设置与图中导头4形式不同、其他形式的引导部件引导进入患者尿道。如在另一实施方式中，后端组件5也可以不设置于管体1端部一体成形，而通过分体制造后连接形成。如在又一实施方式中，第一球囊腔道接口51处可以不设置单向阀，通过手动方式对球囊内部的充盈程度进行操作。如在再一实施方式中，回流腔道12是仅设置于热疗球囊3与定位球囊2之间，而不朝向后端组件5延伸。In other embodiments different from those shown in the drawings, the structural form of the intraluminal prostatic hyperthermia catheter may also have many suitable deformations or changes, but is not limited thereto. As in one embodiment, the intraluminal hyperthermia catheter for the prostate may be provided with a guide member of a different form from that of theguide head 4 in the figure, and other forms of guide members to guide the catheter into the patient's urethra. For example, in another embodiment, therear end assembly 5 may not be integrally formed at the end of the pipe body 1, but may be formed by connection after being manufactured separately. For example, in another embodiment, the firstballoon lumen interface 51 may not be provided with a one-way valve, and the filling degree inside the balloon can be operated manually. As in another embodiment, thereturn channel 12 is only provided between thehyperthermia balloon 3 and thepositioning balloon 2 , and does not extend toward therear end assembly 5 .

请继续参见图1至图3，在前列腺腔内热疗导管的一个实施方式中，内腔道还包括导尿内腔14，在导头4处具有导尿口40，后端组件5中的接口包括导尿内腔接口53，导尿口40通过导尿内腔14与导尿内腔接口53相连通，以实现对患者尿道内的排尿。在一个实施方式中，导尿内腔接口53可以与外部导尿袋或积液袋等医疗器械连接诶，以实现在治疗中对患者的导尿。Please continue to refer to FIG. 1 to FIG. 3 , in one embodiment of the intraluminal hyperthermia catheter for the prostate, the inner lumen further includes acatheterization lumen 14 , acatheterization port 40 is provided at theguide head 4 , and a catheter in therear end assembly 5 is provided. The interface includes acatheterization lumen interface 53, and thecatheterization port 40 communicates with thecatheterization lumen interface 53 through thecatheterization lumen 14 to realize urination in the patient's urethra. In one embodiment, thecatheterization lumen interface 53 can be connected with a medical device such as an external catheterization bag or a fluid collection bag, so as to implement catheterization of the patient during treatment.

在前列腺腔内热疗导管的一个实施方式中，热疗导管还包括封闭球囊6，定位球囊2、热疗球囊3以及封闭球囊6是如图中所示，自导头4朝后端组件5依次设置，定位球囊2与导头4所在端部相邻。封闭球囊6更靠近后端组件5所在一端，热疗球囊3设置于定位球囊2以及封闭球囊6之间。In one embodiment of the intraprostatic hyperthermia catheter, the hyperthermia catheter further includes a sealing balloon 6, and thepositioning balloon 2, thehyperthermia balloon 3 and the sealing balloon 6 are as shown in the figure, and are directed from theguide head 4 toward the Therear end assemblies 5 are arranged in sequence, and thepositioning balloon 2 is adjacent to the end where theguide head 4 is located. The sealing balloon 6 is closer to the end where therear end assembly 5 is located, and thehyperthermia balloon 3 is arranged between the positioningballoon 2 and the sealing balloon 6 .

内腔道还包括第二球囊腔道15，后端组件5中的接口包括第二球囊腔道接口54，第二球囊腔道接口54通过第二球囊腔道15与封闭球囊6相连通，在第二球囊腔道接口54处也设置有单向阀，以防止流体回流。通过第二球囊腔道接口54向封闭球囊6中注入气体或液体，以使得封闭球囊6由流体充盈并膨胀。The inner lumen also includes asecond balloon lumen 15, the interface in therear end assembly 5 includes a secondballoon lumen interface 54, and the secondballoon lumen interface 54 communicates with the sealing balloon through thesecond balloon lumen 15. 6 is connected, and a one-way valve is also provided at the secondballoon lumen interface 54 to prevent fluid backflow. Gas or liquid is injected into the sealing balloon 6 through the secondballoon lumen interface 54 so that the sealing balloon 6 is inflated and inflated by the fluid.

充盈状态下的定位球囊2与封闭球囊6分别膨胀并封闭尿道，从而在尿道患部形成封闭的腔道，热疗球囊3在封闭腔道处对患部进行热疗。Thepositioning balloon 2 and the sealing balloon 6 in the inflated state are respectively inflated to seal the urethra, thereby forming a closed cavity in the affected part of the urethra, and thehyperthermia balloon 3 performs heat therapy on the affected part at the closed cavity.

请继续参见图1至图3，在前列腺腔内热疗导管的一个实施方式中，在热疗球囊3的至少一侧的关闭上开设有药液出口160，内腔道还包括药液内腔16，后端组件5中的接口还包括药液内腔接口55，药液内腔接口55处设置有单向阀，以防止流体回流。其中，药液内腔16连通药液出口160以及药液内腔接口55，以允许通过药液内腔接口55向定位球囊2与封闭球囊6之间的封闭腔道中输送药液，从而实现对热疗部位输送药液的功能。Please continue to refer to FIG. 1 to FIG. 3 , in one embodiment of the intraprostatic hyperthermia catheter, a medicinalliquid outlet 160 is opened on the closure of at least one side of thehyperthermia balloon 3 , and the inner lumen also includes a medicinalliquid outlet 160 . In thecavity 16, the interface in therear end assembly 5 also includes a medicinalliquid cavity interface 55, and a one-way valve is provided at the medicinalliquid cavity interface 55 to prevent fluid backflow. The medicinalliquid cavity 16 is connected to the medicinalliquid outlet 160 and the medicinalliquid cavity interface 55 to allow the medicinal liquid to be delivered into the closed cavity between the positioningballoon 2 and the sealing balloon 6 through the medicinalliquid cavity interface 55 , thereby Realize the function of delivering medicinal liquid to the hyperthermia site.

在前列腺腔内热疗导管的一个实施方式中，药液出口160是如图中所示，设置于热疗球囊3两侧的管体壁上，在其他一些与图示不同的实施方式中，药液出口160的数量以及设置位置可以有许多合适的变形或变化，但不以此为限，如在一个实施方式中，药液出口160可以仅设置在热疗球囊3单侧的管体壁上。如在另一实施方式中，药液出口160可以是分别设置于热疗球囊3两侧的多个。In one embodiment of the intra-prostatic hyperthermia catheter, thedrug liquid outlet 160 is as shown in the figure, and is disposed on the walls of the tube body on both sides of thehyperthermia balloon 3. In other embodiments that are different from those shown in the figure , the number and arrangement position of the medicinalliquid outlet 160 can have many suitable deformations or changes, but not limited to this, for example, in one embodiment, the medicinalliquid outlet 160 can only be arranged on the tube on one side of thehyperthermia balloon 3 on the body wall. For example, in another embodiment, the medicalliquid outlet 160 may be a plurality of which are respectively provided on both sides of thehyperthermia balloon 3 .

如图4示出了图3中E部局部放大示意图，热疗球囊3的热疗组件包括多个加热单元以及至少一个测温单元。其中加热单元包括套设于管体1外侧的射频电极圈31以及射频导线32，测温单元包括套设于管体1外侧的测温电极圈33以及测温导线34。其中，射频导线32连接射频电极圈31与连接插头52，以通过外部装置通电使得射频电极圈31通电生热。测温导线34连接测温电极圈33与连接插头52，以通过外部装置通电使得测温电极圈3对热疗球囊3内的温度进行监测。FIG. 4 shows a partial enlarged schematic diagram of part E in FIG. 3 . The hyperthermia component of thehyperthermia balloon 3 includes a plurality of heating units and at least one temperature measurement unit. The heating unit includes a radiofrequency electrode ring 31 and aradio frequency wire 32 sleeved on the outside of the tube body 1 , and the temperature measurement unit includes a temperaturemeasurement electrode ring 33 and atemperature measurement wire 34 sleeved on the outside of the tube body 1 . Wherein, theradio frequency wire 32 is connected to the radiofrequency electrode ring 31 and theconnection plug 52, so that the radiofrequency electrode ring 31 is energized to generate heat by energizing the external device. Thetemperature measurement lead 34 is connected to the temperaturemeasurement electrode ring 33 and theconnection plug 52 , so that the temperaturemeasurement electrode ring 3 can monitor the temperature in thehyperthermia balloon 3 by energizing the external device.

请继续参见图4，在前列腺腔内热疗导管的一个实施方式中，热疗组件还包括套设于管体1外侧的传热电极圈35，传热电极圈35用于对热疗球囊3内部进行均匀传热，其中，传热电极圈35与射频电极圈31在热疗球囊3内呈沿管体1的延伸方向均布，从而实现对热疗球囊3内流体的均匀导热。Please continue to refer to FIG. 4 , in one embodiment of the intraprostatic hyperthermia catheter, the hyperthermia component further includes a heattransfer electrode ring 35 sleeved on the outside of the tube body 1 , and the heattransfer electrode ring 35 is used to heat the hyperthermia balloon. 3. Uniform heat transfer is carried out inside, wherein the heattransfer electrode ring 35 and the radiofrequency electrode ring 31 are evenly distributed along the extension direction of the tube body 1 in thehyperthermia balloon 3, so as to achieve uniform heat conduction to the fluid in thehyperthermia balloon 3 .

在前列腺腔内热疗导管的一个实施方式中，热疗球囊3具有不大于定位球囊2的壁厚，从而当定位球囊2与热疗球囊3共同充盈膨胀后与尿道内壁相抵时，由于热疗球囊3具有更薄的内壁，故热疗球囊3内的流体对尿道内壁压迫相对定位球囊2更小，同时热量更易于传递到尿道患处。In one embodiment of the intra-prostatic hyperthermia catheter, thehyperthermia balloon 3 has a wall thickness no greater than that of thepositioning balloon 2, so that when thepositioning balloon 2 and thehyperthermia balloon 3 are inflated together and inflated together, they abut against the inner wall of the urethra , Because thehyperthermia balloon 3 has a thinner inner wall, the fluid in thehyperthermia balloon 3 compresses the inner wall of the urethra less than thepositioning balloon 2, and heat is more easily transferred to the affected part of the urethra.

在前列腺腔内热疗导管的一个实施方式中，布线在布线腔道13内布设后，布线腔道13由硅胶封堵，以实现绝缘。In one embodiment of the intraluminal hyperthermia catheter for the prostate, after the wiring is routed in thewiring lumen 13, thewiring lumen 13 is sealed by silica gel to achieve insulation.

在前列腺腔内热疗导管的一个实施方式中，如前所述一个或多个实施方式中通入的气体或液体为生理盐水。In one embodiment of the intraluminal prostatic hyperthermia catheter, the gas or liquid introduced in one or more of the aforementioned embodiments is physiological saline.

图5示出了图2中沿D-D方向的剖视示意图，图6为图2中沿C-C方向的剖视示意图，请结合参见图1至图6。FIG. 5 shows a schematic cross-sectional view along the D-D direction in FIG. 2 , and FIG. 6 is a cross-sectional schematic view along the C-C direction in FIG. 2 . Please refer to FIGS. 1 to 6 in combination.

如前所述一个或多个实施方式中的前列腺腔内热疗导管可以应用于一种热疗仪中，治疗时把导管近端导头4从患者尿道插入，直至定位球囊2完全到达膀胱后，通过第一球囊腔道接口51的单向阀注入生理盐水使定位球囊2充盈后向外拉导管直至定位球囊2在膀胱口定位。此时热疗球囊3已放置于患者尿道前列腺患部，定位球囊2充盈后球囊内压增大，由于定位球囊2通过回流腔道12与热疗球囊3相通，所以定位球囊2内的生理盐水会自动从回流内腔出口121释放定位球囊2内部压力使生理盐水从回流内腔入口122流入热疗球囊3中，当热疗球囊3内部充入生理盐水后球囊表面慢慢膨胀，并能紧贴前列腺患部粘膜，只要球囊表面紧贴患部粘膜使热疗球囊3内部产生内压，逐步使定位球囊2内部压力与热疗球囊3内部压力平衡，从而达到热疗球囊3能紧贴尿道患部内壁。同时通过第二球囊腔道接口54单向阀注入生理盐水使封闭球囊6充盈后封闭患者尿道，使尿道患部基本形成封闭腔道。As mentioned above, the intraluminal hyperthermia catheter in one or more embodiments can be used in a hyperthermia apparatus. During treatment, the catheterproximal guide 4 is inserted from the patient's urethra until thepositioning balloon 2 completely reaches the bladder Then, inject normal saline through the one-way valve of the firstballoon lumen interface 51 to inflate thepositioning balloon 2 and pull the catheter outward until thepositioning balloon 2 is positioned at the bladder opening. At this time, thehyperthermia balloon 3 has been placed on the affected part of the patient's urethra and prostate, and the internal pressure of the balloon increases after thepositioning balloon 2 is inflated. The physiological saline in 2 will automatically release the internal pressure of thepositioning balloon 2 from thereturn lumen outlet 121, so that the physiological saline flows into thehyperthermia balloon 3 from thereturn lumen inlet 122. When thehyperthermia balloon 3 is filled with physiological saline, the balloon The surface of the balloon expands slowly and can be close to the mucosa of the affected part of the prostate. As long as the surface of the balloon is close to the mucosa of the affected part, the internal pressure of thehyperthermia balloon 3 is generated, and the internal pressure of thepositioning balloon 2 and the internal pressure of thehyperthermia balloon 3 are gradually balanced. , so that thehyperthermia balloon 3 can be closely attached to the inner wall of the affected part of the urethra. At the same time, normal saline is injected through the one-way valve of the secondballoon lumen interface 54 to fill the sealing balloon 6 to seal the patient's urethra, so that the affected part of the urethra basically forms a closed lumen.

此时把连接插头52连接射频热疗仪，热疗球囊3内热疗组件中的加热单元将射频热疗仪输出的可控射频功率通过连接插头52、射频导线32传递射频电极圈31，加热疗球囊3内生理盐水为介质进行电-热转换；而热疗组件中的测温单元将测得的即时温度通过测温导线34、测温电极圈33、连接插头52传送到射频热疗仪达到即时控温，使热疗球囊3保持在恒定温度，即对患者病灶部位进行热疗。At this time, theconnection plug 52 is connected to the radio frequency hyperthermia apparatus, and the heating unit in the hyperthermia assembly in thehyperthermia balloon 3 transmits the controllable radio frequency power output by the radio frequency hyperthermia apparatus through theconnection plug 52 and theradio frequency wire 32 to transmit the radiofrequency electrode ring 31, The physiological saline in thethermotherapy balloon 3 is used as a medium for electrical-thermal conversion; and the temperature measurement unit in the thermotherapy component transmits the measured instant temperature to the radio frequency through thetemperature measurement lead 34, the temperaturemeasurement electrode ring 33, and theconnection plug 52. The hyperthermia device achieves instant temperature control, so that thehyperthermia balloon 3 is kept at a constant temperature, that is, hyperthermia is performed on the patient's lesion.

同时还可从药液内腔接口55注射器接口注入药液、使药液通过药液内腔16从药液出口160流出，药液被置留在热疗球囊3周边定位球囊2与封闭球囊6之间的封闭区域、通过加热的热疗球囊3使封闭区域内药液温热达到药液靶向热疗的目的。At the same time, the medicinal liquid can also be injected from the medicinalliquid cavity interface 55 and the syringe interface, so that the medicinal liquid flows out from the medicinalliquid outlet 160 through the medicinalliquid cavity 16, and the medicinal liquid is placed at the periphery of thehyperthermia balloon 3 to locate theballoon 2 and seal it. The closed area between the balloons 6 is heated by theheated hyperthermia balloon 3 to warm the medicinal liquid in the closed area to achieve the purpose of targeted hyperthermia of the medicinal liquid.

本发明的进步效果包括以下之一或组合：The progressive effects of the present invention include one or a combination of the following:

1)通过在导管中设置连通热疗球与定位球囊的回流腔道，使得热疗球囊与定位球囊内部压力平衡，从而保证了当导管插入到具有不同内径的尿道时，利用尿道内壁对热疗球囊的压力，实现了能够根据不同尿道内腔径来调节热疗球囊的大小，从而实现热疗球囊在患者尿道中的自适应大小调节。1) By arranging a return channel connecting the hyperthermia ball and the positioning balloon in the catheter, the internal pressure of the hyperthermia balloon and the positioning balloon is balanced, thereby ensuring that when the catheter is inserted into the urethra with different inner diameters, the inner wall of the urethra is utilized. The pressure on the hyperthermia balloon realizes that the size of the hyperthermia balloon can be adjusted according to different urethral lumen diameters, thereby realizing self-adaptive size adjustment of the hyperthermia balloon in the patient's urethra.

2)通过在热疗球囊中设置传热电极圈，以使热疗球囊内的流体能够被加热更加均匀。2) By arranging a heat transfer electrode ring in the hyperthermia balloon, the fluid in the hyperthermia balloon can be heated more uniformly.

本发明虽然以较佳实施例公开如上，但其并不是用来限定本发明，任何本领域技术人员在不脱离本发明的精神和范围内，都可以做出可能的变动和修改。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所作的任何修改、等同变化及修饰，均落入本发明权利要求所界定的保护范围之内。Although the present invention is disclosed above with preferred embodiments, it is not intended to limit the present invention, and any person skilled in the art can make possible changes and modifications without departing from the spirit and scope of the present invention. Therefore, any modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solutions of the present invention all fall within the protection scope defined by the claims of the present invention.

Claims (10)

Translated fromChinese

1.一种前列腺腔内热疗导管，其特征在于，包括：1. a prostate cavity hyperthermia catheter, is characterized in that, comprises:管体，内部具有多条内腔道，所述内腔道包括第一球囊腔道、回流腔道以及布线腔道；The tube body has a plurality of inner lumens, and the inner lumens include a first balloon lumen, a return lumen and a wiring lumen;定位球囊，设置于所述管体外侧，与所述第一球囊腔道连通，气体或液体可自所述第一球囊腔道充入所述定位球囊，以使所述定位球囊在膀胱口充盈膨胀定位；以及A positioning balloon is arranged on the outside of the tube body and communicated with the first balloon cavity, and gas or liquid can be filled into the positioning balloon from the first balloon cavity, so that the positioning ball The balloon is inflated and positioned at the bladder ostium; and热疗球囊，设置于所述管体外侧，与所述布线腔道连通，内部设置有热疗组件，所述布线腔道内布设有连接所述热疗组件的布线；a hyperthermia balloon, which is arranged on the outside of the tube body, communicates with the wiring cavity, and is provided with a hyperthermia component inside, and the wiring cavity is arranged with a wiring connecting the hyperthermia component;其中，所述回流腔道连通所述定位球囊以及所述热疗球囊，充入的气体或液体通过所述回流腔道在所述定位球囊以及所述热疗球囊之间流通，以保持所述定位球囊与所述热疗球囊内的压力平衡，使所述热疗球囊充盈膨胀至适合与尿道内壁贴合的大小。Wherein, the return channel communicates with the positioning balloon and the hyperthermia balloon, and the filled gas or liquid circulates between the positioning balloon and the heat therapy balloon through the return channel, In order to maintain the pressure balance between the positioning balloon and the hyperthermia balloon, the hyperthermia balloon is inflated to a size suitable for fitting with the inner wall of the urethra.2.如权利要求1所述的前列腺腔内热疗导管，其特征在于，所述管体的两端分别设置有导头以及后端组件，所述导头用于引导所述导管插入尿道，所述后端组件提供多个接口，所述接口包括第一球囊腔道接口以及连接插头；2. The intracavitary hyperthermia catheter of claim 1, wherein both ends of the tube body are respectively provided with a guide head and a rear end assembly, and the guide head is used to guide the catheter into the urethra, The rear end assembly provides a plurality of interfaces, the interfaces include a first balloon lumen interface and a connection plug;所述第一球囊腔道接口通过所述第一球囊腔道与所述定位球囊相连通，以通过所述第一球囊腔道接口向所述定位球囊注入气体或液体，在所述第一球囊腔道接口处设置有单向阀；The first balloon lumen interface is communicated with the positioning balloon through the first balloon lumen, so as to inject gas or liquid into the positioning balloon through the first balloon lumen interface, and then A one-way valve is arranged at the interface of the first balloon cavity;其中，所述连接插头与所述布线腔道内的所述布线连接，所述回流腔道与所述后端组件之间被封堵。Wherein, the connection plug is connected to the wiring in the wiring channel, and the backflow channel and the rear end assembly are blocked.3.如权利要求2所述的前列腺腔内热疗导管，其特征在于，所述内腔道还包括导尿内腔，所述导头处具有导尿口，所述后端组件中的所述接口包括导尿内腔接口，所述导尿口通过所述导尿内腔与所述导尿内腔接口相连通。3 . The intraluminal hyperthermia catheter of claim 2 , wherein the inner lumen further comprises a urinary catheterization lumen, the guide head is provided with a urinary catheterization port, and all the components in the rear-end assembly. The interface includes a catheterization lumen interface, and the catheterization port is communicated with the catheterization lumen interface through the catheterization lumen.4.如权利要求2所述的前列腺腔内热疗导管，其特征在于，所述热疗导管还包括封闭球囊，所述定位球囊、所述热疗球囊以及所述封闭球囊自所述导头朝所述后端组件依次设置；4. The intraluminal hyperthermia catheter of claim 2, wherein the hyperthermia catheter further comprises a sealing balloon, the positioning balloon, the hyperthermia balloon and the sealing balloon are self-contained. The guide heads are arranged in sequence toward the rear end assembly;所述内腔道还包括第二球囊腔道，所述后端组件中的所述接口包括第二球囊腔道接口，所述第二球囊腔道接口通过所述第二球囊腔道与所述封闭球囊相连通，在所述第二球囊腔道接口处设置有单向阀，通过所述第二球囊腔道接口向所述封闭球囊注入气体或液体，以使所述封闭球囊充盈膨胀；The inner lumen further includes a second balloon lumen, the interface in the rear end assembly includes a second balloon lumen interface, and the second balloon lumen interface passes through the second balloon lumen A one-way valve is provided at the second balloon lumen interface, and gas or liquid is injected into the closed balloon through the second balloon lumen interface, so that The sealing balloon is inflated and expanded;其中，充盈膨胀后的定位球囊以及封闭球囊分别封闭尿道，以在尿道患部形成封闭腔道，所述热疗球囊在所述封闭腔道处对患部进行热疗。The inflated positioning balloon and the sealing balloon respectively seal the urethra to form a closed cavity in the affected part of the urethra, and the hyperthermia balloon performs hyperthermia on the affected part at the closed cavity.5.如权利要求4所述的前列腺腔内热疗导管，其特征在于，在所述热疗球囊的至少一侧的所述管体壁上开设有药液出口，所述内腔道还包括药液内腔，所述后端组件中的所述接口还包括药液内腔接口，所述药液内腔接口处设置有单向阀；5 . The intracavitary hyperthermia catheter according to claim 4 , wherein a medicinal liquid outlet is opened on at least one side of the tube body wall of the hyperthermia balloon, and the inner lumen is further including a medicinal liquid cavity, the interface in the rear end assembly further includes a medicinal liquid cavity interface, and a one-way valve is provided at the medicinal liquid cavity interface;其中，所述药液内腔连通所述药液出口以及所述药液内腔接口，以允许通过所述药液内腔接口向所述封闭腔道内输送药液。Wherein, the medicinal liquid cavity is communicated with the medicinal liquid outlet and the medicinal liquid cavity interface, so as to allow the medicinal liquid to be delivered into the closed cavity through the medicinal liquid cavity interface.6.如权利要求5所述的前列腺腔内热疗导管，其特征在于，所述药液出口分别开设于所述热疗球囊两侧的所述管体壁上。6 . The intracavitary hyperthermia catheter of claim 5 , wherein the medicinal liquid outlets are respectively opened on the walls of the tube body on both sides of the hyperthermia balloon. 7 .7.如权利要求2所述的前列腺腔内热疗导管，其特征在于，所述热疗组件包括多个加热单元以及至少一个测温单元；7. The intracavitary hyperthermia catheter of claim 2, wherein the hyperthermia assembly comprises a plurality of heating units and at least one temperature measuring unit;每个所述加热单元包括套设于所述管体外侧的射频电极圈以及射频导线，所述射频导线连接所述插头与所述射频电极圈；Each of the heating units includes a radio frequency electrode ring and a radio frequency wire sleeved on the outside of the tube body, and the radio frequency wire connects the plug and the radio frequency electrode ring;所述测温单元包括套设于所述管体外侧的测温电极圈以及测温导线，所述测温导线连接所述插头与所述测温电极圈。The temperature measurement unit includes a temperature measurement electrode ring and a temperature measurement wire sleeved on the outside of the pipe body, and the temperature measurement wire connects the plug and the temperature measurement electrode ring.8.如权利要求7所述的前列腺腔内热疗导管，其特征在于，所述热疗组件还包括套设于所述管体外侧的传热电极圈，所述传热电极圈与所述射频电极圈均布于所述热疗球囊内的所述管体外侧。8 . The intracavitary hyperthermia catheter of claim 7 , wherein the hyperthermia assembly further comprises a heat transfer electrode ring sleeved on the outside of the tube body, the heat transfer electrode ring and the The radio frequency electrode rings are evenly distributed on the outside of the tube body in the hyperthermia balloon.9.如权利要求1所述的前列腺腔内热疗导管，其特征在于，所述热疗球囊具有不大于所述定位球囊的壁厚。9 . The intraluminal hyperthermia catheter of claim 1 , wherein the hyperthermia balloon has a wall thickness no greater than that of the positioning balloon. 10 .10.如权利要求1所述的前列腺腔内热疗导管，其特征在于，所述布线在所述布线腔道内布设后，所述布线腔道由硅胶封堵。10 . The intracavitary hyperthermia catheter of claim 1 , wherein after the wiring is arranged in the wiring cavity, the wiring cavity is blocked by silica gel. 11 .

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