Balloon catheters and ablation systems

Abstract

The present invention relates to a balloon catheter and an ablation system, wherein the balloon catheter comprises a catheter body, a balloon, a temperature measuring component and a limiting component; the balloon is arranged at the distal end of the catheter body; the temperature measuring component comprises a temperature measuring module and a wire, the temperature measuring module is arranged on the balloon or the catheter body, a part of the wire of the temperature measuring component is arranged in the cavity of the catheter body and extends along the axial direction of the cavity; the limiting component is arranged in the cavity of the catheter body and is used to limit the position of the wire of the temperature measuring component in the cavity. The present invention uses the limiting component to limit the wire of the temperature measuring component to protect it, thereby avoiding the risk of the wire being pulled and broken when the balloon is extended or the catheter moves, and also preventing the wire from hindering the movement of the catheter body.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter and an ablation system. Background Art

[0002] Patients with atrial fibrillation have a high risk of stroke. When atrial fibrillation occurs, the atria beat irregularly and rapidly, losing their contractile function. Blood easily stagnates in the atria and forms thrombi. The thrombi break off and enter the brain through the arteries, causing a stroke. By applying energy to the pulmonary veins through interventional catheters for ablation, the pulmonary vein potential is isolated, which can achieve the desired therapeutic effect. Hypertension has the characteristics of high incidence, low awareness, and great harm. Experimental data have shown that hypertension is related to the high excitability of the patient's renal sympathetic nerves. Blocking the renal sympathetic nerves by ablation can not only lower blood pressure, but also have an impact on chronic organ-specific diseases caused by overactivation of the sympathetic nerves.

[0003] Ablation can be performed by cryoballoon ablation. Cryoballoon ablation is based on anatomical considerations and uses the contact between the balloon and the tissue for freezing. It has the characteristics of one-time and continuity. Specifically, a cryoablation balloon catheter is used, a balloon is set at the distal end of the catheter, and a freezing device is connected to the proximal end. During the operation, the operator places the cryoablation balloon catheter into the heart cavity through a percutaneous puncture route, reaches the pulmonary vein orifice, and fills the balloon, adjusts the contact between the outer wall of the balloon and the myocardial tissue, and then the liquid inlet tube in the cryoablation balloon catheter sprays the freezing liquid directly onto the inner surface of the balloon. The freezing liquid is rapidly vaporized and absorbs heat due to the heat conduction of the myocardial temperature, causing the myocardial tissue in contact with the balloon to cool down and produce cryoablation. Generally, effective ablation lesions can only be formed when myocardial tissue is kept at a low temperature for a sufficient period of time. For this reason, a temperature sensor is installed inside the cryoablation balloon catheter. The temperature sensor is placed in the middle of the balloon to monitor the internal temperature of the balloon, and then the temperature of the balloon surface is estimated based on the internal temperature. However, there may be a large deviation between the estimated balloon surface temperature and the actual temperature, resulting in low accuracy of the balloon surface temperature, which directly affects the ablation effect.

[0004] A balloon catheter with a linear sensor has been disclosed in the prior art. The temperature measuring component can be displaced relative to the balloon, so that the temperature measuring component can better adapt to the expansion or contraction of the balloon. However, the applicant found that as the number of temperature measuring components of the balloon increases, the number of wires of the temperature measuring component between the outer tube and the core rod of the balloon catheter will also increase. During ablation, the expansion and contraction of the balloon and the rotation and twisting of the catheter will force the wires to make corresponding movements. Once the wires interfere with each other during the movement, the activity space of the wires will be restricted, which may easily lead to the wires being broken by force, thereby failing to monitor the surface temperature of the balloon, affecting the use of the balloon catheter. Moreover, the mutual entanglement of the wires will also hinder the movement of the core rod, affecting the surgical operation and increasing the difficulty of the surgical operation. Summary of the invention

[0005] In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a balloon catheter and ablation system. By setting a limiting component on the outside of the wire of the temperature measuring component, interference between the wires can be effectively prevented, and the problem of the wires being broken due to stress can be avoided. The problem of the wires hindering the movement of the catheter body can also be solved, thereby improving the reliability of the instrument and reducing the difficulty of surgical operation.

[0006] To achieve the above-mentioned purpose or other related purposes, the present invention provides a balloon catheter, comprising a catheter body, a balloon, a temperature measuring component and a limiting component;

[0007] The balloon is arranged at the distal end of the catheter body; the temperature measuring component comprises a wire and a temperature measuring module, the temperature measuring module is arranged on the balloon or the catheter body, and a part of the wire of the temperature measuring component is arranged in the cavity of the catheter body and extends along the axial direction of the cavity of the catheter body;

[0008] The limiting component is arranged in the cavity of the catheter body and is used to limit the position of the wire of the temperature measuring component in the cavity of the catheter body.

[0009] Optionally, the catheter body includes an outer tube and a core rod arranged in the outer tube, the distal end of the core rod extends out of the outer tube, an annular cavity is formed between the outer tube and the core rod, the distal end of the balloon is connected to the core rod, the proximal end of the balloon is connected to the outer tube, and the cavity of the catheter body includes the annular cavity; the limiting component is arranged in the annular cavity.

[0010] Optionally, there are multiple temperature measuring components;

[0011] The number of the limiting components is the same as the number of the temperature measuring components, and the plurality of limiting components are separately arranged in the cavity of the catheter body, and the wires of the plurality of temperature measuring components pass through different limiting components respectively, or the number of the limiting components is at least one and less than the number of the temperature measuring components, the wires of some of the temperature measuring components pass through the limiting components, and each limiting component is provided for the wire of one temperature measuring component to pass through.

[0012] Optionally, the wires of the temperature measuring component equipped with the limiting component are not arranged adjacent to each other, or at least adjacent limiting components are staggered along the axial direction of the cavity of the catheter body.

[0013] Optionally, the limiting component is fixedly connected to the inner wall of the outer tube or the outer wall of the core rod, or the balloon catheter further includes a control handle disposed at the proximal end of the catheter body, and the limiting component is fixedly connected to the control handle.

[0014] Optionally, there are multiple limiting components, and the multiple limiting components are arranged at intervals in the circumferential direction around the axis of the core rod, and the multiple limiting components are sequentially connected to form a ring structure.

[0015] Optionally, the limiting component includes a sleeve, the interior of the sleeve is used to pass the wire of the temperature measuring component to limit the position of the wire of the temperature measuring component, and a plurality of the sleeves are connected in sequence to form the annular structure; or, the limiting component includes an annular ring, the interior of the annular ring is used to pass the wire of the temperature measuring component to limit the position of the wire of the temperature measuring component, and a plurality of the annular rings are connected in sequence to form the annular structure, and a linear elastic body is connected between adjacent annular rings.

[0016] Optionally, the limiting component includes a first limiting component and a second limiting component, the first limiting component is used to limit the position of the wire of the temperature measuring component, and the second limiting component is used to limit the position of the first limiting component;

[0017] There are multiple first limiting components, and the multiple first limiting components are circumferentially spaced around the axis of the core rod;

[0018] The number of the second limiting components is multiple and less than the number of the first limiting components, the second limiting components are arranged outside some of the first limiting components, and the multiple second limiting components are connected in sequence to form a ring structure, or the number of the second limiting components is the same as the number of the first limiting components, and one second limiting component is arranged outside each of the first limiting components, and the second limiting components are connected in sequence to form a ring structure.

[0019] Optionally, the first limiting component is a sleeve, and the second limiting component is an annular ring. The sleeve is arranged inside the annular ring, and the interior of the sleeve is used to pass the wire of the temperature measuring component. A plurality of the annular rings are connected in sequence to form the annular structure, and a linear elastic body is connected between adjacent annular rings.

[0020] Optionally, the number of the annular structures is one or more, and the plurality of annular structures are arranged at intervals along the axial direction of the cavity of the catheter body.

[0021] Optionally, there are multiple temperature measuring components, and a portion of the conductive wires of the multiple temperature measuring components are arranged in the cavity of the catheter body and extend axially along the cavity of the catheter body; wherein a conductive wire of the temperature measuring component is passed through the interior of each of the limiting components constituting the annular structure, and the number of the limiting components constituting the annular structure is less than or equal to the number of the temperature measuring components.

[0022] Optionally, the limiting component includes a sleeve, and the interior of the sleeve is used to movably penetrate the wire of the temperature measuring component to limit the position of the wire of the temperature measuring component;

[0023] The sleeve comprises a contraction portion and at least one expansion portion, wherein the cross-sectional area of ​​the inner cavity of the contraction portion is smaller than the cross-sectional area of ​​the inner cavity of the expansion portion;

[0024] The conductive wire of the temperature measuring component comprises an extension portion and at least one bending portion, and the bending portion is capable of expansion and contraction; the extension portion is arranged in the contraction portion, and the bending portion is arranged in the expansion portion.

[0025] Optionally, the balloon catheter comprises a plurality of the temperature measuring components, and a portion of the wires of the plurality of the temperature measuring components are arranged in the cavity of the catheter body and extend along the axial direction of the cavity of the catheter body;

[0026] The number of the sleeves is the same as the number of the temperature measuring components, and the plurality of sleeves are separately arranged in the cavity of the catheter body, and the conductive wires of the plurality of temperature measuring components can be movably passed through different sleeves respectively, and at least the expanded parts of the sleeves outside the conductive wires of adjacent temperature measuring components are staggered along the axial direction of the cavity of the catheter body; or, the number of the sleeves is at least one and less than the number of the temperature measuring components, and the conductive wires of some of the temperature measuring components can be movably passed through the sleeves, each sleeve is provided for the conductive wire of one temperature measuring component to pass through, and the conductive wires of the temperature measuring components equipped with the sleeves are not adjacent to each other, or at least the expanded parts of the sleeves outside the conductive wires of adjacent temperature measuring components are staggered along the axial direction of the cavity of the catheter body.

[0027] Optionally, the balloon is a double-layer balloon, and there are multiple temperature measuring components, and the temperature measuring modules of the multiple temperature measuring components are arranged in the interlayer of the double-layer balloon, and / or, the temperature measuring modules of the multiple temperature measuring components are arranged on the tube section of the catheter body located inside the double-layer balloon.

[0028] In order to achieve the above-mentioned purpose or other related purposes, the present invention also provides an ablation system, comprising any one of the above-mentioned balloon catheters, an ablation energy output device and a control device, wherein the ablation energy output device is connected to the balloon catheter and is used to provide an ablation medium to the balloon catheter; the control device is used to control the ablation energy output device to adjust the temperature of the ablation medium according to the temperature information detected by the temperature measuring component, so that the temperature of the balloon surface is within a preset ablation temperature range.

[0029] Compared with the prior art, the balloon catheter and ablation system provided by the present invention have the following advantages:

[0030] First, the limiting component is used to limit the wire of the temperature measuring component, which increases the mobility of the wire when the balloon is extended and the catheter is moved, making it difficult for the wire to break or get entangled with each other, thereby ensuring the reliability of balloon catheter temperature monitoring. At the same time, it also avoids the wire from hindering the movement of the catheter body, reducing the difficulty of surgical operation;

[0031] Second, the expansion part on the limiting component is used to store the curved part of the wire (such as the serpentine curve), which ensures the mobility of the curved part when the balloon is extended and the catheter is moved, thereby further ensuring that the wire will not be broken when it is stressed, and further improving the reliability of temperature monitoring;

[0032] Third, when there are multiple temperature measuring components, multiple limiting components can be used to limit the positions of the wires of different temperature measuring components, for example, non-adjacent wires are limited by limiting components, or all wires are limited by limiting components, so as to effectively avoid interference between multiple wires, and better solve the problems of wire breakage and obstruction of catheter movement caused by a large number of wires. In particular, when multiple limiting components are sequentially connected into a ring structure or a second limiting component is set outside the first limiting component, and the second limiting component is connected into a ring structure, the position of the first limiting component can be further limited to avoid mutual interference between multiple first limiting components in the cavity of the catheter body, thereby reducing the obstruction of the sleeve to the movement of the catheter body and further reducing the difficulty of surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0034] Figure 1 is a schematic diagram of the ablation system in a preferred embodiment of the present invention performing cardiac ablation;

[0035] Figure 2 is a schematic diagram of performing renal artery ablation using an ablation system in a preferred embodiment of the present invention;

[0036] Figure 3 is a flowchart of the ablation system in a preferred embodiment of the present invention;

[0037] Figure 4 is a flow chart of cryoablation performed by the ablation system in a preferred embodiment of the present invention;

[0038] Figure 5 is a front view of an ablation catheter in a preferred embodiment of the present invention;

[0039] Figure 6 yes Figure 5 A left side view of the ablation catheter is shown;

[0040] Figure 7 is a schematic diagram of the distal end of the ablation catheter in a preferred embodiment of the present invention;

[0041] Figure 8 is a schematic end view of a catheter body of an ablation catheter in a preferred embodiment of the present invention;

[0042] Fig. 9 It is a partial schematic diagram of the sleeve in the preferred embodiment of the present invention;

[0043] Fig.10 It is a schematic diagram of a first limiting component in a preferred embodiment of the present invention limiting the wires of all temperature measuring components in the cavity of the catheter body, wherein a second limiting component is arranged outside the first limiting component, and a plurality of second limiting components are connected to form a ring structure;

[0044] Fig.11 It is a schematic diagram of the second limiting component or the limiting components connected into a ring structure in the preferred embodiment of the present invention.

[0045] The following are the descriptions of the reference numerals:

[0046] 1-ablation catheter; 2-ablation energy output device; 3-control device; 4-renal artery orifice; 5-pulmonary vein; 6-control handle; 7-renal artery; 8-temperature measuring point; 9-electrical input and output interface; 10-inner cavity interface; 11-fluid interface; 13-catheter body; 131-outer tube; 132-core rod; 15-second temperature measuring component; 16-ablation area; 17-first temperature measuring component; 18-development mark; 19-soft head; 20-double-layer balloon; 21-outer balloon; 22-inner balloon; 23-fixing part; 24-guide wire; 241-bending part; 242-extension part; 25-sleeve; 251-expansion part; 252-contraction part; 27-liquid inlet tube; 28-pull wire tube; 29-annular ring; 30-dotted frame; 31-annular structure; 32-linear elastic body. DETAILED DESCRIPTION

[0047] In order to make the content of the present invention more clear and easy to understand, the present invention is further described below in conjunction with the drawings of the specification. Of course, the present invention is not limited to this specific embodiment, and general replacements known to those skilled in the art are also covered within the scope of protection of the present invention. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of detailing examples of the present invention and should not be used as limitations of the present invention.

[0048] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0049] Herein, "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the product. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the product that is close to the doctor during normal operation, while "distal" generally refers to the end that first enters the patient's body. As used in this specification, the singular forms "one", "an", and "the" include plural objects unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise. In addition, the term "circumferential" generally refers to the direction around the axis of the balloon catheter; the term "axial" generally refers to the direction parallel to the axis of the balloon catheter.

[0050] As the background technology, the prior art discloses a balloon catheter with a linear sensor, which is recorded in the invention patent with the authorization announcement number CN109646106B, wherein the temperature measuring component in the interlayer of the double-layer balloon can be displaced relative to the balloon, so that the temperature measuring component can better adapt to the expansion or contraction of the balloon. However, the inventor of the present application found that when the number of temperature measuring components in the interlayer increases, the number of wires in the cavity of the catheter body will also increase, and the space in the cavity is relatively limited. When more wires are arranged in the limited space, when the balloon is extended and contracted, and the catheter is rotated and twisted, the wires also need to make corresponding movements. During the movement, once the wires are interfered, such as aggregation, stacking or entanglement, the movement of the wires will be restricted and cannot move with the expansion and contraction of the balloon and the movement of the catheter, and then the wires are easily broken when they are stressed, so that the temperature of the balloon surface cannot be monitored, and the movement of the catheter is also hindered.

[0051] In view of this, the present invention provides a balloon catheter, which aims to overcome the defects of the above invention patents. However, those skilled in the art should understand that although the temperature measuring component located in the interlayer of the double-layer balloon in the embodiment of the present invention is similar to the temperature measuring component in the invention patent of the applicant's authorization announcement number CN109646106B, it should not be limited to the method disclosed in the invention patent to achieve the arrangement of the temperature measuring component in the interlayer. Moreover, those skilled in the art should also understand that the balloon in the embodiment of the present invention is not limited to the double-layer balloon. In addition, the temperature measuring component in the embodiment of the present invention is not limited to being arranged on the balloon, but can also be arranged on the tube section of the catheter body located inside the balloon. In other words, the balloon catheter of the present invention aims to solve the above-mentioned problem when the number of wires in the cavity of the catheter body is large, without limiting the specific arrangement position and arrangement method of the temperature measuring component. The structure of the balloon catheter listed above is only one embodiment of the problem solved by the present invention. The present application does not limit the type, material and structural arrangement of the catheter body of the balloon.

[0052] Specifically, the balloon catheter provided by the present invention includes: a catheter body; a balloon, which is arranged at the distal end of the catheter body; a temperature measuring component, including a wire and a temperature measuring module, the temperature measuring module is arranged on the balloon or on the catheter body, and a part of the wire of the temperature measuring component is arranged in the cavity of the catheter body and extends along the axial direction of the cavity of the catheter body; and a limiting component is arranged in the cavity of the catheter body and is used to limit the position of the wire of the temperature measuring component in the cavity of the catheter body. In some embodiments, the wire of the temperature measuring component can move relative to the limiting component, so that the movement of the wire is not restricted when the balloon is extended and contracted to avoid wire breakage. In other embodiments, the wire of the temperature measuring component is fixed relative to the limiting component, such as when an annular ring is set outside the wire, multiple annular rings are connected in sequence to form an annular structure, and a linear elastic body is connected between adjacent annular rings. Because the annular rings are elastic, they can withstand a certain tension when the balloon is extended and contracted. At this time, even if the wire is fixed with the annular ring, it will not cause the wire to break.

[0053] The balloon catheter of the present invention uses a limiting component to limit the wires of the temperature measuring component to protect them, thereby avoiding interference problems such as aggregation, stacking, and entanglement between the wires, thereby ensuring that the wires have the necessary space to move in the cavity of the catheter body without being restrained, thereby avoiding the risk of the wires being broken due to force, and also avoiding obstruction of the movement of the catheter body (core rod and / or outer tube) due to interference problems such as aggregation, stacking, and entanglement of the wires, thereby reducing the difficulty of surgical operation.

[0054] In one embodiment, the catheter body includes an outer tube and a core rod arranged in the outer tube, the distal end of the core rod extends out of the outer tube, an annular cavity is formed between the outer tube and the core rod, the distal end of the balloon is connected to the core rod, the proximal end of the balloon is connected to the outer tube, the cavity of the catheter body includes the annular cavity, and the limiting component is arranged in the annular cavity.

[0055] In a preferred embodiment of the present invention, the balloon is preferably a double-layer balloon, comprising an inner balloon and an outer balloon surrounding the inner balloon, the distal end of the double-layer balloon is connected to the core rod, and the proximal end of the double-layer balloon is connected to the outer tube.

[0056] In a preferred embodiment of the present invention, the number of the temperature measuring components is multiple. In some embodiments, the temperature measuring modules of the multiple temperature measuring components are arranged in the interlayer between the inner balloon and the outer balloon, such as being arranged on the outer surface of the inner balloon or on the inner surface of the outer balloon. In other embodiments, the temperature measuring modules of the multiple temperature measuring components are arranged on the catheter body (core rod) and are located inside the inner balloon. In other embodiments, some temperature measuring modules are arranged in the interlayer, and some temperature measuring modules are arranged on the catheter body (core rod) and are located inside the inner balloon. Wherein when the temperature measuring module is arranged in the interlayer, such as on the outer surface of the inner balloon or the inner surface of the outer balloon, at this time, the temperature measuring module can be displaced relative to the inner balloon or the outer balloon connected thereto, so that the temperature measuring module will not affect the expansion or contraction of the balloon, and the temperature measuring module will not be pulled and broken.

[0057] The balloon catheter proposed by the present invention is further described below in conjunction with the accompanying drawings and preferred embodiments, and the balloon catheter of the present invention is not limited to ablation catheters, but can also be a mapping catheter, or other catheters that need to monitor the balloon surface temperature. Although the following description uses a double-layer balloon and an ablation catheter as an example, this illustration does not constitute a limitation of the present invention, and the solution of the present invention is also applicable to single-layer balloons and balloon catheters for other purposes.

[0058] Figure 1 is a schematic diagram of the ablation system in a preferred embodiment of the present invention performing cardiac ablation, Figure 2 It is a schematic diagram of renal artery ablation performed by the ablation system in a preferred embodiment of the present invention.

[0059] like Figure 1 and Figure 2 As shown, this embodiment provides an ablation system, including an ablation catheter 1, an ablation energy output device 2 and a control device 3, wherein the ablation energy output device 2 is fluidically connected to the ablation catheter 1 to provide an ablation medium to the ablation catheter 1. In some embodiments, the control device 3 is connected to the ablation energy output device 2, and the ablation energy output device 2 is connected to the ablation catheter 1. In other embodiments, the control device 3 may also be connected to the ablation energy output device 2 and the ablation catheter 1 respectively. In other embodiments, the control device 3 and the ablation energy output device 2 may be integrated in the same device. The present invention does not limit this. The main function of the control device 3 is to control the ablation energy output device 2 to adjust the temperature of the ablation medium (such as the temperature of the freezing liquid) according to the temperature information detected by the temperature measuring component, so that the temperature of the double-layer balloon surface is within a preset ablation temperature range. The ablation system includes but is not limited to cryoablation of the target tissue, and the target tissue may be a cardiac cavity or a renal artery, etc., without specific limitation.

[0060] For example Figure 1As shown, the ablation system can be applied to cardiac chamber treatment, and the ablation catheter 1 is inserted into the cardiac chamber by interventional means to ablate the pulmonary vein 5 to achieve the treatment of arrhythmia. Figure 2 As shown, the ablation system can also be applied to the renal artery, where the ablation catheter 1 is placed at the entrance 4 of the renal artery through an interventional method to ablate the renal artery 7, thereby regulating the renal artery blood pressure.

[0061] Further, taking pulmonary vein cryoablation as an example, combined with Figure 3 The working principle of the ablation system is further explained.

[0062] Step S1 : before cryoablation, the control handle 6 of the ablation catheter 1 is connected to the ablation energy output device 2 .

[0063] Step S2, inserting the ablation catheter 1 into the target tissue that needs to undergo ablation surgery, such as inserting it into the tubular tissue inside the heart cavity, that is, inserting it into the pulmonary vein opening.

[0064] In step S3 , the double-layer balloon 20 at the distal end of the ablation catheter 1 is inflated, and freezing liquid is released into the double-layer balloon 20 .

[0065] Step S4, adjusting the position of the double-layer balloon 20 in the tubular tissue.

[0066] Step S5, analyzing the temperature of the outer surface of the double-layer balloon 20 through the temperature information detected by the temperature measuring component.

[0067] Step S6, judging the contact between the double-layer balloon 20 and the tubular tissue, if the contact between the double-layer balloon 20 and the tubular tissue is good, proceeding to the next step, if the contact between the double-layer balloon 20 and the tubular tissue is poor, returning to step S4.

[0068] Step S7, start cryoablation.

[0069] Step S8, analyzing the temperature of the outer surface of the double-layer balloon 20 through the temperature information detected by the temperature measuring component to confirm the ablation effect.

[0070] Step S9, after verifying the ablation result, the effect of cryoablation is evaluated according to the change of pulmonary vein potential during the cryoablation operation. If the effect of cryoablation is not good, cryoablation can be repeated until the tissue achieves the ideal tissue ablation effect.

[0071] Step S10, ending the ablation surgery.

[0072] The control device 3 analyzes and determines the contact between the double-layer balloon 20 and the target tissue according to the temperature information detected by the ablation catheter 1, and controls the ablation energy output device 2 to adjust the ablation temperature of the freezing liquid accordingly.

[0073] The control device 3 may include a refrigeration control unit. The ablation energy output device 2 includes a refrigeration unit, a fluid source and a fluid output channel. The fluid source is connected to the fluid output channel, and the fluid output channel is further used to output the fluid in the fluid source to the ablation catheter 1. For example, the fluid output channel is connected to the fluid input interface on the control handle 6, and the ablation medium is input to the ablation catheter 1 through the interface. The refrigeration unit is arranged on the fluid output channel, and is used to refrigerate the fluid transported in the fluid output channel. The refrigeration unit can be a compressor or other refrigeration device, and the present invention does not specifically limit its structure. The refrigeration unit is used to communicate with the refrigeration control unit to control the working state of the refrigeration unit through the refrigeration control unit. Furthermore, the refrigeration control unit is used to control the operation of the refrigeration unit according to the received cryoablation instruction, so that the fluid output channel provides the freezing liquid to the ablation catheter 1. In the embodiment of the present invention, a cryoablation button can be set on the control handle 6 or the computer interface. When the operator activates the cryoablation button, the cryoablation instruction is sent to the refrigeration control unit. The computer interface can be set on the control device 3 or the ablation energy output device 2. In a non-limiting operation, the refrigeration control unit sends a refrigeration signal to the refrigeration unit, and the refrigeration unit performs refrigeration according to the received refrigeration signal.

[0074] During cryoablation, the refrigeration control unit can control the refrigeration unit to adjust its refrigeration temperature according to the temperature information fed back by the multiple temperature measuring components, so as to control the temperature of the balloon surface within a preset cryoablation temperature range.

[0075] In more detail, Figure 4 As shown, the working process of the ablation system implementing cryoablation specifically includes:

[0076] Step 401: the fluid source outputs fluid to the fluid output channel;

[0077] Step 402: The refrigeration control unit controls the refrigeration unit to refrigerate;

[0078] Step 403: After refrigeration, the fluid reaches a preset refrigeration temperature;

[0079] Step 404: spraying the refrigerated liquid onto the inner layer of the balloon; here, steps 401, 402, 403, and 404 can actually be performed simultaneously, that is, the refrigeration is turned on and the refrigerated liquid is sprayed onto the inner surface of the balloon;

[0080] Step 405: During the refrigeration process, the refrigeration control unit controls the refrigeration temperature of the refrigeration unit in real time according to the temperature information fed back by the temperature measuring component;

[0081] Step 406: When the temperature of the balloon surface reaches the temperature required for cryoablation (eg, -40°C to -60°C) and is maintained for a period of time (eg, 120 to 180 seconds), cryoablation is terminated.

[0082] After completing one cryoablation, the doctor determines whether to perform the next cryoablation based on the actual cryoablation effect. However, it should be noted that after each cryoablation, in step 407, the double-layer balloon 20 needs to be naturally rewarmed to body temperature in the body before the next cryoablation can be performed.

[0083] The preferred structure of the ablation catheter 1 is as follows: Figure 5 and Figure 6 As shown, combined with Figure 8 and Fig.10 The ablation catheter 1 includes a double-layer balloon 20, a first temperature measuring component 17, a catheter body 13, a fixing member 23 and a liquid inlet tube 27. The double-layer balloon 20 is arranged at the distal end of the catheter body 13, and a part of the catheter body 13 is located inside the double-layer balloon 20. The catheter body 13 includes an outer tube 131 and a core rod 132, wherein the core rod 132 is arranged inside the outer tube 131, and the distal end of the core rod 132 extends out of the outer tube 131 and is connected to the distal end of the double-layer balloon 20, while the proximal end of the double-layer balloon 20 is connected to the outer tube 131. The distal end of the liquid inlet tube 27 is placed inside the double-layer balloon 20 and is spirally arranged on the core rod 132, and is used to spray an ablation medium to the double-layer balloon 20, wherein the ablation medium includes but is not limited to freezing liquid. An annular cavity is formed between the core rod 132 and the outer tube 131.

[0084] The double-layer balloon 20 includes an outer balloon 21 and an inner balloon 22, wherein the outer balloon 21 surrounds the inner balloon 22, and the proximal and distal ends of the outer balloon 21 and the inner balloon 22 are fixed to the catheter body 13. Both the outer balloon 21 and the inner balloon 22 can be expanded, for example, by spraying a freezing liquid into the inner cavity of the inner balloon 22 through the distal end of the liquid inlet tube 27, and the freezing liquid instantly vaporizes and expands after absorbing the heat of human tissue, thereby expanding the inner balloon 22. When the inner balloon 22 expands, the outer balloon 21 expands under the action of the inner balloon 22.

[0085] The first temperature measuring component 17 includes a wire 24 and a temperature measuring module. The number of the wires 24 is generally two, for example, two parallel wires of Cu-CuNi, and the Cu wire and the CuNi wire can be connected at a specific area of ​​the balloon to form the temperature measuring module (i.e., the temperature measuring point 8, Figure 5 to Figure 7). The temperature measuring module is used to sense temperature and generate temperature information. The temperature measuring module is also used to convert temperature information into electrical information and transmit the electrical information through a group of wires, thereby transmitting the electrical information. There is at least one first temperature measuring component 17, and its temperature measuring module is arranged in the interlayer (not shown) formed by the inner balloon 22 and the outer balloon 21. Since the temperature measuring module of the first temperature measuring component 17 can detect the temperature information of the ablation area 16 adjacent to the first temperature measuring component 17, and the temperature measuring module of the first temperature measuring component 17 is arranged in the interlayer formed by the inner balloon 22 and the outer balloon 21, the distance between the inner balloon 22 and the outer balloon 21 and the outer surface of the double-layer balloon 20 is relatively close. Therefore, when estimating the temperature information of the outer surface of the double-layer balloon 20 by the temperature information detected by the first temperature measuring component 17, the accuracy of the estimated temperature information of the outer surface of the double-layer balloon 20 can be improved, thereby improving the ablation effect. In addition, the first temperature measuring component 17 is attached to the inner layer balloon 22 or the outer layer balloon 21 through the fixing member 23, for example, Figure 7 In the embodiment, the first temperature measuring component 17 is attached to the outer surface of the inner layer balloon 22 or the inner surface of the outer layer balloon 21 through the fixing member 23, so that the temperature measuring module of the first temperature measuring component 17 can monitor the temperature at a specified position on the double-layer balloon 20. In order to make the first temperature measuring component 17 adapt to the expansion and contraction of the double-layer balloon 20, through the adsorption capacity or other suitable capacity of the fixing member 23, when the double-layer balloon 20 expands or contracts, the fixing member 23 can be displaced relative to the double-layer balloon 20 as the balloon surface material connected thereto is deformed, and because the first temperature measuring component 17 is attached to the inner layer balloon 22 or the outer layer balloon 21 through the fixing member 23, the first temperature measuring component 17 can also be displaced relative to the double-layer balloon 20 or the fixing member 23, and the first temperature measuring component 17 and the fixing member 23 may also be relatively displaced. In a preferred embodiment of the present invention, the fixing member 23 is connected to the first temperature measuring component 17 and the corresponding balloon surface by physical adsorption. The implementation method of this solution has been recorded in the invention patent of the applicant with authorization announcement number CN109646106B, so it will not be described in detail.

[0086] Next reference Figure 6 and Figure 7 , the first temperature measuring components 17 are preferably multiple (herein, multiple means at least two), and the temperature measuring modules of the multiple first temperature measuring components 17 are distributed at different positions in the interlayer, preferably, uniformly distributed along the circumference around the central axis of the inner balloon 22, so that multiple temperature measuring points 8 can be formed, and each temperature measuring module of the first temperature measuring component 17 constitutes a temperature measuring point 8. In this embodiment, since multiple first temperature measuring components 17 are provided, the temperature information at multiple positions can be detected by the first temperature measuring components 17. The number of temperature measuring points 8 is not limited to Figure 6The six shown in the figure may be less than six or more than six. Further, the first temperature measuring component 17 is a linear sensor, such as a thermocouple temperature sensor or a thermistor temperature sensor, that is, the temperature measuring module may be a commonly used thermocouple or thermistor, and the thermocouple may be, for example, a T-type or a K-type. Part of the wire 24 of all the first temperature measuring components 17 is arranged in the inner cavity of the balloon, and the other part is arranged in the annular cavity between the outer tube 131 and the core rod 132 and extends along the axial direction of the annular cavity, and the proximal end of the wire 24 of each first temperature measuring component 17 is connected to the electrical input and output interface 9 on the control handle 6, so as to output the measured temperature information to the outside.

[0087] It should be understood that in addition to setting the temperature measurement module in the interlayer of the double-layer balloon 20, the temperature measurement module can also be set in other positions. For the sake of distinction, in this article, the temperature measurement module set in the interlayer of the double-layer balloon 20 is defined as the temperature measurement module of the first temperature measurement component 17, and the temperature measurement module in other positions is defined as the temperature measurement module of the second temperature measurement component. Figure 5 As shown, at least one temperature measuring module of a second temperature measuring component 15 is also arranged on the tube section of the core rod 132 located inside the double-layer balloon 20, for obtaining temperature information inside the balloon, and the temperature measuring module of the second temperature measuring component 15 is also connected to the electrical input and output interface 9 on the control handle 6 through a wire 24. Of course, different temperature measuring components can be connected to the same electrical input and output interface 9, and different data channels can be arranged in the electrical input and output interface 9, so that each temperature measuring component transmits data through different data channels.

[0088] In a preferred embodiment of the present invention, at least one temperature measuring module of the first temperature measuring component 17 is arranged in the interlayer of the double-layer balloon 20, and at least one temperature measuring module of the second temperature measuring component 15 is arranged on the tube section of the core rod 132 located in the balloon. Preferably, there are multiple first temperature measuring components 17. Further, in the following description, six first temperature measuring components 17 and one second temperature measuring component 15 are used as an example to further illustrate the limiting method of the wires 24 of multiple temperature measuring components in the annular cavity. In this embodiment, each temperature measuring component (such as the first temperature measuring component 17 and the second temperature measuring component 15) includes a temperature measuring module and a group of wires 24 (usually two wires in one group).

[0089] Please continue reading Figure 5 to Figure 7Six temperature measuring modules of the first temperature measuring component 17 can be arranged on the outer surface of the inner layer balloon 22, and one temperature measuring module of the second temperature measuring component 15 can be arranged on the core rod 132. The wires 24 of the six first temperature measuring components 17 and the wire 24 of the second temperature measuring component 15 are partially arranged in the annular cavity between the core rod 132 and the outer tube 131, and the other part is arranged in the inner cavity of the balloon. When the sizes of the core rod 132 and the outer tube 131 are constant, as the number of wires 24 increases, the activity space of the wires 24 in the annular cavity is also easily restricted. In order to solve this technical problem, a limiting component is provided outside the wires 24 of at least some of the temperature measuring components, so that the positions of the wires 24 of at least some of the temperature measuring components are limited by the limiting component, thereby isolating or separating the wires 24 of multiple temperature measuring components in the annular cavity, avoiding interference (such as aggregation, entanglement, etc.) of multiple wires 24 in the annular cavity, and the wires 24 limited by the limiting component can be movable relative to the limiting component or fixed relative to the limiting component, and the present invention does not limit this. In this way, the limiting component can avoid mutual interference between the wires 24, ensure that the movement of the wires 24 will not be restricted, so that it is not easy to break when subjected to force, and also avoid the wires 24 from hindering the movement of the core rod 132 and / or the outer tube 131.

[0090] In some embodiments, the number of the limiting components is the same as the number of the temperature measuring components, and the plurality of limiting components are separately arranged in the annular cavity, and the wires 24 of the plurality of temperature measuring components respectively pass through different limiting components, so that the wires 24 of all the temperature measuring components are limited and protected by the limiting components, thereby achieving mutual isolation in the annular cavity, thereby effectively avoiding the problem of mutual interference between the plurality of wires 24.

[0091] In other embodiments, the number of the limiting components is at least one and is less than the number of the temperature measuring components, and only the wires 24 of some of the temperature measuring components pass through the limiting components, and each limiting component is provided for the wires 24 of one temperature measuring component to pass through. Further, the wires 24 limited by the limiting components are arranged non-adjacently, and at this time, the positions of the wires 24 of all the temperature measuring components are not limited, but only the positions of the non-adjacent wires 24 are limited. In this way, the effect of isolating or separating multiple wires 24 can also be achieved, avoiding the problem of mutual interference between the wires 24, and can minimize the occupation of the limited space by the limiting components.

[0092] Furthermore, when the position of the wire 24 of each temperature measuring component is limited by a limiting component, it is preferred that at least adjacent limiting components are staggered along the axial direction of the annular cavity (ie, not in the same circumferential direction) to avoid the problem of mutual interference among multiple limiting components.

[0093] Furthermore, the limiting component can be fixedly arranged in the annular cavity, or can be movably arranged in the annular cavity. When the limiting component is fixedly arranged in the annular cavity, the limiting component can be fixedly connected to the inner wall of the outer tube 131, or fixedly connected to the outer wall of the core rod 132, or the limiting component extends to the proximal end of the catheter body 13 and is fixedly connected to the control handle 6. Therefore, the present invention does not limit the fixing method of the limiting component.

[0094] In addition, it should be understood that in order to limit the position of the wire 24, the limiting component has an axially through-limiting groove. As long as the wire 24 of the temperature measuring component is inserted into and out of the limiting groove, the purpose of limiting the wire 24 can be achieved. The structure is simple, and the limiting component can be arranged in a limited space. In this embodiment, the limiting groove can cooperate with the inner wall of the outer tube 131 to fully surround the wire 24, that is, the limiting groove is designed as a non-closed cavity, or the limiting groove itself is designed as a closed cavity, so that the limiting groove itself can fully surround the wire 24. In addition, the present invention does not impose any special restrictions on the length of the limiting component around the wire 24, and can surround a part of the length of the wire 24 in the annular cavity, or surround the entire length of the wire 24 in the annular cavity. That is, the axial length of the limiting component can be less than or equal to the axial length of the outer tube 131. It should be further understood that, in this article, each temperature measuring component includes two wires 24 and forms a group, and the position of the group of wires is limited by one or more limiting components.

[0095] Furthermore, the limiting component can be designed as a sleeve 25 (see Figure 7 ), the sleeve 25 can be a circular or elliptical tube. In actual operation, it is sufficient to sleeve the sleeve 25 on the outside of the wire 24, and the wire 24 is preferably movable relative to the sleeve 25, which can better ensure that the wire 24 can be freely extended and retracted. And the sleeve 25 can be movable or fixed in the annular cavity. Further, one or more sleeves 25 can be sleeved on the wire 24 of the same temperature measuring component, and the multiple sleeves 25 on the same group of wires are arranged at intervals along the extension direction of the wire 24.

[0096] The material of the sleeve 25 is a polymer material, more preferably a thermoplastic material, and the thermoplastic material includes one or more combinations of polymer materials such as PET (polyethylene terephthalate), Pebax (polyetheramide), PTFE (polytetrafluoroethylene), PI (polyimide) and PA (nylon), so as to obtain a sleeve 25 with a certain hardness and softness, which not only avoids damage to the wire 24, but also can better isolate the wire 24. More preferably, the material of the sleeve 25 is PET material, so as to obtain a sleeve 25 with a certain hardness, avoid deformation of the sleeve 25 during the movement of the wire 24, increase the difficulty of using the catheter, and make the use effect of the catheter better.

[0097] Considering the small size of the annular cavity between the outer tube 131 and the core rod 132, the size of the sleeve 25 cannot be designed to be large, and in order to save space during manufacturing, the inner wall of the sleeve 25 can be further made close to the wire 24 inside it, that is, the inner size (such as the inner diameter) of the sleeve 25 matches the outer diameter of the wire 24 or is slightly larger than the outer diameter of the wire 24, and the wire 24 can be moved in the sleeve 25. The sleeve 25 can be fixedly connected to the outer tube 131 or the core rod 132 by glue, or extended to the proximal end and fixedly connected to the control handle 6. In addition, the present invention does not limit the length of the sleeve 25, for example, it can be consistent with the length of the outer tube 131, or shorter than the length of the outer tube 131, for example, only a small section of the sleeve 25 is set near the proximal end of the double-layer balloon 20. When the length of the sleeve 25 is short, it can be directly attached to the inner wall of the outer tube 131. When the length of the sleeve 25 extends to the proximal control handle 6, the sleeve 25 can also be attached to the control handle 6.

[0098] Furthermore, the wire 24 can also be partially processed into a curved shape, such as a serpentine shape, so as to obtain a wire 24 having a curved portion 241 (see Fig. 9 ).like Fig. 9 As shown, the guide wire 24 includes an extension portion 242 and at least one bend 241, and the extension portion 242 is a guide wire without a bend. When the bend 241 is in a contracted state, the overall radial dimension of the bend 241 is greater than the radial dimension of the extension portion 242 of the guide wire 24. In actual production, the copper wire can be bent into a snake shape under heating and then quenched to finalize the shape. The bend 241 has properties similar to those of a spring, and can stretch when subjected to tension, and automatically retract after the external force disappears. Therefore, by providing the bend 241, a certain amount of expansion and contraction margin can be provided for the movement of the guide wire 24, thereby preventing it from breaking when the catheter moves or the balloon expands and contracts. Preferably, the bend 241 is in a contracted state (i.e. Fig. 9The axial length of the wire in the dotted frame 30 shown above is 2 mm to 5 mm). Further, the overall stretchable displacement of the wire 24 does not exceed 60% of the outer diameter of the inner balloon 22 after inflation. In this embodiment, the distal end of the wire 24 of the first temperature measuring component 17 is set on the hemisphere of the double-layer balloon 20. Such a size setting enables the wire 24 to expand and contract with the balloon due to a certain expansion margin when the balloon changes from a contracted state. At the same time, the stretchable displacement of the wire 24 does not need to be too large. On the one hand, because the space of the cavity of the catheter body is limited, it is not necessary to occupy too much space. On the other hand, it also avoids the mutual entanglement of the wires 24. The present invention does not limit the number and position of the curved portion 241. The curved portion 241 can be located at any position on the wire 24, such as near the proximal end of the balloon or near the control handle 6, or at any position between the proximal end of the balloon and the control handle 6.

[0099] Continue reading Fig. 9 The sleeve 25 preferably includes a contraction portion 252 and at least one expansion portion 251 ( Fig. 9 In the figure, the expansion part 251 is circled by the dotted frame 30, and the cross-sectional area of ​​the inner cavity of the contraction part 252 is smaller than the cross-sectional area of ​​the inner cavity of the expansion part 251. Therefore, the bending part 241 of the wire 24 is stored by the expansion part 251, and the bending part 241 is limited and protected to prevent the bending parts 241 on different wires from being entangled with each other when the balloon is expanded or the catheter is moved, thereby further reducing the problem of wire interference and reducing the risk of the wire being broken by force. In addition, the contraction part 252 stores the extension part 242 of the wire 24. And the maximum outer dimension (outer diameter) of the expansion part 251 is smaller than the width of the annular cavity between the outer tube 131 and the core rod 132. Such a structure ensures the mobility of the bending part 241 when the balloon is expanded or contracted, and further ensures that the wire 24 will not be broken when subjected to force. In some embodiments, the number of the sleeves 25 is the same as the number of the temperature measuring components, and the plurality of sleeves 25 are separately arranged in the annular cavity, and the wires 24 of the plurality of temperature measuring components can movably pass through different sleeves 25, respectively. In this case, it is preferred that at least the expansion parts 251 of the sleeves 25 outside the wires 24 of adjacent temperature measuring components are staggered along the axial direction of the annular cavity (i.e., not at the same circumferential position of the core rod 132), thereby reducing the risk of interference between the sleeves 25. Alternatively, the number of the sleeves 25 is at least one and less than the number of the temperature measuring components, and the wires 24 of some temperature measuring components can movably pass through the sleeves 25, each sleeve 25 is provided for the wire 24 of a temperature measuring component to pass through, and the wires 24 of the temperature measuring components equipped with the sleeves 25 are not arranged adjacently, or at least the expansion parts 251 of the sleeves 25 outside the wires 24 of adjacent temperature measuring components are staggered along the axial direction of the annular cavity.

[0100] Furthermore, during assembly, the sleeve 25 is simply put on the wire 24 of the temperature measuring component, and the sleeve 25 is moved to the curved portion 241 of the wire 24 to ensure that the curved portion 241 of the wire is in the expanded portion 251 of the sleeve 25. Further, in order to reduce material costs, it is preferred to design a shorter sleeve 25, for example, the axial length of the sleeve 25 is 10 mm to 20 mm, and it is preferably arranged near the proximal end of the balloon. Such a size design can reduce costs while ensuring that the curved portion 241 of the wire is in the expanded portion 251 of the sleeve 25, thereby avoiding interference between the wires 24.

[0101] The present invention does not limit the shape of the sleeve 25, and is not limited to the oval and circular shapes mentioned above, but may also be other shapes, such as regular shapes such as circular and rectangular shapes, or other irregular shapes.

[0102] Further reading Figure 8 For example, six first temperature measuring components 17 and one second temperature measuring component 15 are arranged on the balloon catheter, with a total of seven temperature measuring components. Preferably, at least one sleeve 25 is arranged outside the wire 24 of each temperature measuring component. The sleeves 25 on different wires 24 can be arranged uniformly or unevenly along the circumference of the annular cavity, or can be arranged randomly in the annular cavity. In addition, other lumens or other wires are usually arranged in the annular cavity, such as a liquid inlet tube 27 and a wire pull tube 28, and there are two wire pull tubes 28. A wire is arranged in the wire pull tube 28 to control the bending deformation of the distal end of the balloon catheter.

[0103] Further, the ablation catheter 1 includes a plurality of limiting components. Taking the sleeve 25 as a limiting component as an example, the plurality of sleeves 25 are arranged circumferentially at intervals around the axis of the core rod 132, and the plurality of sleeves 25 are preferably connected in sequence to form an annular structure. That is, in some embodiments, the plurality of circumferentially arranged sleeves 25 are independent of each other and not connected, and in other embodiments, the plurality of circumferentially arranged sleeves 25 are connected to each other to form an annular structure. It should also be understood that in this scheme, the plurality of sleeves 25 can be movably arranged in the annular cavity and connected to each other. Further, the number of the annular structures is one or more, and the plurality of annular structures are arranged at intervals along the axial direction of the core rod 132, so that the plurality of annular structures can be arranged along the extension direction of the wire 24 for limiting. In actual use, a wire 24 can be inserted into each sleeve 25 constituting the annular structure, and the number of sleeves 25 of the annular structure is less than or equal to the number of temperature measuring components, so that the wire 24 of each temperature measuring component is restricted by the sleeve 25, or the wire 24 of some temperature measuring components is restricted by the sleeve 25. Here, it should be understood that the annular structure is elastic and can produce corresponding deformation with the movement of the sleeve 25 or the wire 24, which will not only not hinder the movement of the catheter and the expansion and contraction of the balloon, but also avoid mutual interference between multiple sleeves 25. At this time, the wire 24 inside the sleeve 25 is preferably movable relative to the sleeve 25.

[0104] In another embodiment, Fig.11 As shown, the limiting component can be designed as an annular structure 31 with an annular ring, and adjacent annular rings 29 are connected by a linear elastic body 32 to form an annular structure 31. The inside of the annular ring 29 is provided with the wire 24 of the temperature measuring component, and the number of the annular rings 29 is less than or equal to the number of the temperature measuring components, so that the wire of each temperature measuring component is limited by the annular ring 29, or the wire of some temperature measuring components is limited by the annular ring 29, and the annular ring 29 and the linear elastic body 32 are both made of elastic materials, such as silicone rubber, PA, Pebax, PI, etc., and there is no requirement for specific materials. The number of the annular structure 31 can be set to one or more, and multiple annular structures 31 are arranged at intervals along the axial direction of the core rod 132, so that multiple annular structures 31 can be arranged along the extension direction of the wire 24 for limiting. Such a design can prevent the wires 24 from interfering with each other, and can also prevent the movement of the wire 24 from affecting the operation of the internal components of the catheter body 13. Further, the annular ring 29 can be either an annular coil structure or a PI tubular structure, which is not limited here.

[0105] In other embodiments, the limiting component includes a first limiting component and a second limiting component, wherein the second limiting component is used to limit the position of the first limiting component, and the first limiting component is used to limit the position of the wire 24 of the temperature measuring component. Specifically, the wire 24 is passed through the inside of the first limiting component, and the first limiting component is arranged inside the second limiting component.

[0106] Furthermore, when there are multiple first limiting components, the multiple first limiting components are arranged circumferentially around the axis of the core rod 132. In this case, the number of second limiting components can be the same as the number of first limiting components, so that each first limiting component is limited by the second limiting component. Alternatively, when there are multiple first limiting components, the number of second limiting components is multiple and less than the number of first limiting components, so that some of the first limiting components are limited by the second limiting components. In this embodiment, the second limiting component can be designed as an annular ring 29, and multiple annular rings 29 are sequentially connected to form an annular structure 31 ( Fig.11 ), adjacent annular rings 29 are connected by a linear elastic body 32, wherein a first limiting component is arranged inside each annular ring 29, and the first limiting component here can be a sleeve 25 or other suitable structure.

[0107] In a preferred embodiment of the present invention, the ablation catheter 1 includes a first limiting component and a second limiting component arranged around the first limiting component. Fig.10 As shown, the first limiting component is preferably a sleeve 25, and the second limiting component is preferably an annular ring 29. The annular ring 29 and the sleeve 25 are both arranged circumferentially around the axis of the core rod 132. The interior of the sleeve 25 is used to pass the wire 24 of the temperature measuring component to limit the position of the wire 24 through the sleeve 25. Preferably, the wire 24 of the temperature measuring component can be movably arranged in the sleeve 25. The sleeve 25 is arranged inside the annular ring 29, wherein a plurality of the annular rings 29 are sequentially connected to form the annular structure 31, and a linear elastic body 32 is connected between adjacent annular rings 29. Preferably, the sleeve 25 is fixedly arranged in the annular ring 29. The annular ring 29 can be wound into a ring shape by one or more filaments, and its length can be almost omitted compared to the sleeve 25. The annular structure 31 is similar to the structure of a spring coil, so that all the sleeves 25 are fixed by the annular structure 31. In actual use, the annular structure 31 is firstly put on the outside of the core rod 132, and then the sleeve 25 containing the wire is passed through the annular ring 29 on the circumference of the elastic coil. The size of the annular ring 29 can be close to the size of the contraction part 252 and / or the expansion part 251 on the sleeve 25, so as to disperse and fix the wire 24 and the sleeve 25 around the core rod 132 in the outer tube 131.

[0108] The annular structure 31 is made of elastic material, such as silicone rubber, PA, Pebax, PI, etc. It should be understood that the annular structure 31 can produce corresponding deformation with the movement of the sleeve 25 or the guide wire 24. The material of the annular structure 31 is preferably silicone rubber. Since silicone rubber is more commonly used and has good biocompatibility and high elasticity, it is safer and more reliable to use. Preferably, the position of the annular structure 31 can be limited by the friction between the annular structure 31 and the outer tube 131 and the core rod 132. Compared with the use of glue fixation, the use of the annular structure 31 can effectively reduce the overall hardness of the catheter at the limiting component.

[0109] Furthermore, the plurality of annular structures 31 may be sequentially arranged at intervals from the proximal end of the balloon of the ablation catheter 1 toward the control handle 6 , for example, at intervals of 100 mm.

[0110] Continue to refer Figure 5 In this embodiment, the catheter body 13 is a non-rigid structure and can be bent arbitrarily. The material of the catheter body 13 is preferably a polymer material, such as thermoplastic polyurethanes (TPU) with metal braided wire, block polyetheramide resin (Pebax) or nylon, or a metal braided tube. Preferably, a control handle 6 is provided at the proximal end of the catheter body 13, and the control handle 6 can be specifically used to manipulate and control the bending state of the catheter body 13. An electrical input and output interface 9 is provided on the control handle 6, and the proximal end of the first temperature measuring component 17 passes through the catheter body 13 and is connected to the electrical input and output interface 9, so as to transmit the detected temperature information to an external device. The control handle 6 may also include: at least one fluid interface 11; and at least one inner cavity interface 10. The inner cavity interface 10 is used to insert a guide wire, a mapping catheter, a contrast agent delivery device, etc. The fluid interface 11 is in fluid communication with the liquid inlet tube 27, and is used to input the ablation medium provided by the outside into the ablation catheter 1, and can also be used to discharge the ablation medium or other media in the double-layer balloon 20. The distal end of the liquid inlet tube 27 is disposed in the inner layer balloon 22, and is used to spray the ablative medium onto the inner surface of the inner layer balloon 22. Further, the liquid inlet tube 27 specifically includes a spiral structure at the distal end and a longitudinal extension portion in fluid communication with the spiral structure, and the longitudinal extension portion passes through the catheter body 13 and is connected to the fluid interface 11. The spiral structure is provided with a plurality of fluid injection ports, and the plurality of fluid injection ports are used to spray the ablative medium a in different directions.

[0111] The control handle 6 is arranged on the outer tube 131, and the liquid inlet tube 27 and the core rod 132 are arranged side by side in the outer tube 131. The core rod 132 is a hollow structure and is movably arranged in the outer tube 131, and the core rod 132 can be moved in the outer tube 131 by adjusting the control handle 6 to complete the release and withdrawal of the double-layer balloon 20. The proximal end of the core rod 132 is connected to the inner cavity interface 10 on the control handle 6, which is used to transport related instruments such as guide wires, mapping catheters or contrast fluids. In actual application, the fluid discharge pipeline is arranged between the core rod 132 and the outer tube 131. In addition, the distal end of the core rod 132 extending out of the double-layer balloon 20 is preferably provided with a soft head 19, and the material of the soft head 19 is relatively soft to avoid damage to the tissue. Preferably, a developing mark 18 is provided at the distal end of the core rod 132 , and the material of the developing mark 18 is a metal developing material. During the operation, the doctor can use the developing equipment and the developing mark 18 to confirm the position of the double-layer balloon 20 relative to the outer sheath.

[0112] Finally, the preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments. For example, the limiting component is not limited to a tubular structure surrounding the wire. For example, the wire can also be surrounded by a spiral winding method, or by a ring coil. Therefore, there is no special restriction on the structure of the limiting component surrounding the wire, as long as it can achieve the effect of separating multiple wires from each other. The various embodiments provided in the present application can also be used in combination, for example: the wire is provided with a bending portion, the sleeve is provided with an expansion portion, the bending portion is provided in the expansion portion, there are multiple sleeves, which are arranged circumferentially along the axis of the core rod, and multiple sleeves are provided with annular rings outside, the annular rings are used to limit the sleeves, and an annular structure is formed between adjacent annular rings, etc. The present application does not limit this.

[0113] Although the innovation of the present invention comes from the technical field of electrophysiological balloon catheters and ablation systems thereof, those skilled in the art can understand that the present invention can also be applied to catheter technologies in other fields, such as multi-claw catheters, each of which is provided with a plurality of electrodes. The multi-claw catheter can be controlled to achieve the purpose of diagnosis and treatment according to actual needs, but during the process of controlling the bending, the plurality of electrode wires on its claws are easily stretched and broken, or the wires of the plurality of electrodes are entangled in the inner cavity of the catheter, affecting the use of the catheter. In this case, the above-mentioned technology can be used to solve the problem of the wires of the plurality of electrodes being broken or entangled with each other; for another example, a balloon radiofrequency ablation catheter, which is provided with a plurality of electrodes and sensors on the balloon for diagnosis, treatment or monitoring of tissue conditions, the wires of the electrodes and sensors on the balloon are also easily broken when the balloon is extended or stretched, or they are easily entangled with each other in the inner cavity of the catheter, etc. In this case, the above-mentioned technology can also be used to solve the problem of the wires of the electrodes and sensors being broken or entangled with each other. It can even be applied to other fields where it is necessary to solve the problems of mutual interference of wires or wire entanglement and breakage, and the technical concept of the present invention can be applied, and only structural adaptive adjustments are required.

[0114] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A balloon catheter, characterized in that: It includes a catheter body, a balloon, a temperature measuring component and a limiting component; The balloon is arranged at the distal end of the catheter body; the temperature measuring component comprises a wire and a temperature measuring module, the temperature measuring module is arranged on the balloon or the catheter body, and a part of the wire of the temperature measuring component is arranged in the cavity of the catheter body and extends along the axial direction of the cavity of the catheter body; The limiting component is arranged in the cavity of the catheter body and is used to limit the position of the wire of the temperature measuring component in the cavity of the catheter body; The limiting component includes a sleeve, the interior of the sleeve is used to movably pass the wire of the temperature measuring component to limit the position of the wire of the temperature measuring component; The sleeve comprises a contraction portion and at least one expansion portion, wherein the cross-sectional area of ​​the inner cavity of the contraction portion is smaller than the cross-sectional area of ​​the inner cavity of the expansion portion.

2. The balloon catheter according to claim 1, characterized in that: The catheter body includes an outer tube and a core rod arranged in the outer tube, the distal end of the core rod extends out of the outer tube, an annular cavity is formed between the outer tube and the core rod, the distal end of the balloon is connected to the core rod, the proximal end of the balloon is connected to the outer tube, and the cavity of the catheter body includes the annular cavity; the limiting component is arranged in the annular cavity.

3. The balloon catheter according to claim 1 or 2, characterized in that: The number of the temperature measuring components is multiple; The number of the limiting components is the same as the number of the temperature measuring components, and the plurality of limiting components are separately arranged in the cavity of the catheter body, and the wires of the plurality of temperature measuring components pass through different limiting components respectively, or, The number of the limiting components is at least one and is less than the number of the temperature measuring components, the wires of some of the temperature measuring components pass through the limiting components, and each limiting component is provided for the wire of one temperature measuring component to pass through.

4. The balloon catheter according to claim 3, characterized in that: The conductive wires of the temperature measuring component equipped with the limiting component are not arranged adjacent to each other, or at least adjacent limiting components are staggered along the axial direction of the cavity of the catheter body.

5. The balloon catheter according to claim 2, characterized in that: The limiting component is fixedly connected to the inner wall of the outer tube or the outer wall of the core rod, or the balloon catheter further comprises a control handle disposed at the proximal end of the catheter body, and the limiting component is fixedly connected to the control handle.

6. The balloon catheter according to claim 2, characterized in that: There are multiple limiting components, and the multiple limiting components are arranged circumferentially around the axis of the core rod at intervals, and the multiple limiting components are sequentially connected to form a ring structure.

7. The balloon catheter according to claim 6, characterized in that: A plurality of the sleeves are connected in sequence to form the annular structure; or, the limiting component includes an annular ring, the interior of the annular ring is used to pass the wire of the temperature measuring component to limit the position of the wire of the temperature measuring component, and a plurality of the annular rings are connected in sequence to form the annular structure, and a linear elastic body is connected between adjacent annular rings.

8. The balloon catheter according to claim 6, characterized in that: The limiting component includes a first limiting component and a second limiting component, the first limiting component is used to limit the position of the wire of the temperature measuring component, and the second limiting component is used to limit the position of the first limiting component; There are multiple first limiting components, and the multiple first limiting components are circumferentially spaced around the axis of the core rod; The number of the second limiting components is multiple and less than the number of the first limiting components, the second limiting components are arranged outside some of the first limiting components, and the multiple second limiting components are sequentially connected to form a ring structure, or, The number of the second limiting components is the same as the number of the first limiting components, and one second limiting component is arranged outside each of the first limiting components, and the second limiting components are sequentially connected to form a ring structure.

9. The balloon catheter according to claim 8, characterized in that: The first limiting component is a sleeve, and the second limiting component is an annular ring. The sleeve is arranged inside the annular ring. A plurality of the annular rings are sequentially connected to form the annular structure, and a linear elastic body is connected between adjacent annular rings.

10. The balloon catheter according to any one of claims 6 to 9, characterized in that: The number of the annular structures is one or more, and the plurality of annular structures are arranged at intervals along the axial direction of the cavity of the catheter body.

11. The balloon catheter according to claim 10, characterized in that: There are multiple temperature measuring components, and part of the conductive wires of the multiple temperature measuring components are arranged in the cavity of the catheter body and extend axially along the cavity of the catheter body; wherein a conductive wire of the temperature measuring component is passed through the interior of each of the limiting components constituting the annular structure, and the number of the limiting components constituting the annular structure is less than or equal to the number of the temperature measuring components.

12. The balloon catheter according to claim 1 or 2, characterized in that: The conductive wire of the temperature measuring component comprises an extension portion and at least one bending portion, and the bending portion is capable of expansion and contraction; the extension portion is arranged in the contraction portion, and the bending portion is arranged in the expansion portion.

13. The balloon catheter according to claim 12, characterized in that: The balloon catheter comprises a plurality of the temperature measuring components, and a portion of the wires of the plurality of the temperature measuring components are arranged in the cavity of the catheter body and extend along the axial direction of the cavity of the catheter body; The number of the sleeves is the same as the number of the temperature measuring components, and the plurality of sleeves are separately arranged in the cavity of the catheter body, and the wires of the plurality of temperature measuring components can movably pass through different sleeves, and at least the expanded parts of the sleeves outside the wires of the adjacent temperature measuring components are staggered along the axial direction of the cavity of the catheter body; or, The number of the sleeves is at least one and is less than the number of the temperature measuring components, the conductive wires of some of the temperature measuring components can movably pass through the sleeves, each sleeve is provided for the conductive wire of one temperature measuring component to pass through, and the conductive wires of the temperature measuring components equipped with the sleeves are not arranged adjacent to each other, or at least the expanded parts of the sleeves outside the conductive wires of adjacent temperature measuring components are staggered along the axial direction of the cavity of the catheter body.

14. The balloon catheter according to claim 1 or 2, characterized in that: The balloon is a double-layer balloon, and there are multiple temperature measuring components. The temperature measuring modules of the multiple temperature measuring components are arranged in the interlayer of the double-layer balloon, and / or the temperature measuring modules of the multiple temperature measuring components are arranged on the tube section of the catheter body located inside the double-layer balloon.

15. An ablation system, characterized in that: It comprises a balloon catheter, an ablation energy output device and a control device as described in any one of claims 1 to 14, wherein the ablation energy output device is connected to the balloon catheter and is used to provide an ablation medium to the balloon catheter; the control device is used to control the ablation energy output device to adjust the temperature of the ablation medium according to the temperature information detected by the temperature measuring component so that the temperature of the balloon surface is within a preset ablation temperature range.

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