Cryoablation catheter and system

Abstract

The utility model relates to a cryoablation catheter and system. The cryoablation catheter comprises a sheathing canal, an air inlet cavity, an air return cavity, an inner tube, a balloon and a handle. The far end of the sheath tube is fixedly connected with the near end of the balloon, and the air inlet cavity, the air return cavity and the inner tube are all located in the sheath tube. The air inlet cavity and the air return cavity are communicated with fluid of the balloon; the far end of the balloon is connected with the far end of the inner tube, and the joint of the far end of the balloon and the far end of the inner tube is located in the balloon; the handle is connected to the near end of the sheath tube and provided with an air inlet connector and an air return connector, and the air inlet connector and the air return connector are in fluid communication with the air inlet cavity and the air return cavity respectively. The cryoablation catheter and system are wide in application range and simple in structure.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a cryoablation catheter and system. Background Technology

[0002] Cryoablation is a minimally invasive technique that, under the guidance of medical imaging equipment, involves percutaneous puncture or through natural cavities to reach the target treatment site and using a refrigerant to ablate the target tissue. It utilizes a low-temperature medium to lower the temperature of the target ablation site (the diseased tissue), destroying its tissue cells and thus achieving the therapeutic goal.

[0003] Currently, in cryoablation, traditional cryoablation catheters, due to the distal tip of the balloon being located outside the balloon, are only suitable for vascular and natural cavity pathways, thus limiting their applicability. For lesions at vascular bifurcation points or in non-tubular natural cavity walls, such as the uterus, gallbladder wall, atrial wall, and oral cavity wall, the presence of the tip prevents the balloon from directly contacting the lesion tissue, significantly restricting the application of cryoablation. Summary of the Invention

[0004] Based on this, this application provides a cryoablation catheter and system with a wide range of applications.

[0005] One embodiment of this application provides a cryoablation catheter, including a sheath, an inlet chamber, a return chamber, an inner tube, a balloon, and a handle; the distal end of the sheath is fixedly connected to the proximal end of the balloon, and the inlet chamber, the return chamber, and the inner tube are all located within the sheath; the inlet chamber and the return chamber are both in fluid communication with the balloon; the distal end of the balloon is connected to the distal end of the inner tube, and the connection between the distal end of the balloon and the distal end of the inner tube is located within the balloon; the handle is connected to the proximal end of the sheath, and the handle is provided with an inlet connector and a return connector, the inlet connector and the return connector being in fluid communication with the inlet chamber and the return chamber, respectively.

[0006] In an optional embodiment, the handle is further provided with an adjustment mechanism, which is fixedly connected to the proximal end of the inner tube and can drive the inner tube to move back and forth relative to the sheath. When the inner tube moves toward the handle, the ablation area at the distal end of the balloon increases.

[0007] In one alternative embodiment, the distal surface of the balloon is a planar or toroidal structure.

[0008] In an alternative embodiment, the distal end of the balloon is connected to the distal end of the inner tube via a connector.

[0009] In an alternative embodiment, the air intake chamber is formed by an air intake tube disposed within the sheath, and the distal portion of the air intake tube extends out of the sheath and is located within the balloon.

[0010] In one alternative embodiment, the portion of the air intake pipe located inside the balloon has a plurality of jet holes.

[0011] In one alternative embodiment, the cryoablation catheter further includes a thermocouple located inside the balloon for measuring the temperature inside the balloon; the handle is also provided with a temperature measuring connector connected to the thermocouple.

[0012] In one alternative embodiment, the balloon is a compliant balloon or a semi-compliant balloon.

[0013] In an optional embodiment, the cryoablation catheter further includes a bending wire fixed inside the wall of the sheath, the distal end of the bending wire being connected to the distal end of the sheath, and the proximal end of the bending wire being connected to the bending unit of the handle.

[0014] Another embodiment of this application provides a cryoablation system, including a cryoablation device and the aforementioned cryoablation catheter. The cryoablation catheter is connected to the cryoablation device via a connector, and is used to deliver the refrigerant in the cryoablation device to the balloon through the air inlet connector, and to perform cryoablation.

[0015] Compared with the prior art, the advantages of the embodiments of this application are as follows:

[0016] 1. In this embodiment, the distal end of the balloon is directly connected to the distal end of the inner tube, and the connection between the distal end of the balloon and the distal end of the inner tube is located inside the balloon. That is, the cryoablation catheter in this embodiment does not need to be equipped with a TIP head, and the distal end of the balloon can directly abut against the lesion tissue. Therefore, it can be applied not only to the ablation of blood vessels and natural cavities, but also to planar lesions such as the uterus, gallbladder wall, atrial wall, and oral cavity wall, thus expanding the application range of cryoablation. Moreover, it has a simple structure and saves costs.

[0017] 2. Because the inner tube can move back and forth relative to the sheath, when the inner tube moves towards the handle, since the distal end of the inner tube is connected to the distal end of the balloon, the distal end of the balloon also moves towards the handle under the traction of the force. Therefore, the distal end of the balloon gradually concaves into the balloon, and the ablation area at the distal end of the balloon gradually increases. Thus, the ablation catheter of this embodiment can adjust the size of the ablation area at the distal end of the balloon according to the size of the target tissue, further expanding its application scope. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the structure of a balloon catheter in the prior art.

[0019] Figure 2 This is a schematic diagram of the structure of a cryoablation catheter according to an embodiment of this application.

[0020] Figure 3 This is a schematic diagram of the cryoablation catheter according to another embodiment of this application.

[0021] Figure 4 This is a schematic diagram of the structure of a cryoablation system according to an embodiment of this application.

[0022] Figure label:

[0023] 100 - Cryoablation catheter; 200 - Cryoablation equipment;

[0024] 1-Sheath; 2-Inlet chamber; 3-Return chamber; 4-Inner tube; 5-Balloon; 6-Handle; 7-Connector; 11-Inlet connector; 12-Return connector; 13-Adjustment mechanism; 14-Temperature measuring connector; 15-Bending unit;

[0025] 201 - Human-computer interaction module; 202 - Control module; 203 - Pneumatic circuit module. Detailed Implementation

[0026] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0027] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0028] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0029] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0030] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0031] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0032] In existing cryoablation procedures, traditional cryoablation catheters have the distal tip of the balloon located outside the balloon, such as... Figure 1As shown, the existing cryoablation catheter is only applicable to vascular and natural cavity passages, limiting its applicability. For vascular bifurcation points and non-tubular natural cavity walls, such as the uterus, gallbladder wall, atrial wall, and oral cavity wall, the presence of the tip prevents the balloon from directly contacting the lesion tissue, significantly restricting the application of cryoablation. Therefore, this application provides a cryoablation catheter and system without a tip, avoiding the drawbacks of the prior art where the tip is located outside the balloon.

[0033] The technical solutions provided by the embodiments of this application are described below with reference to the accompanying drawings.

[0034] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator.

[0035] like Figures 2-4 As shown, this application provides a cryoablation catheter 100, including a sheath 1, an inlet chamber 2, a return chamber 3, an inner tube 4, a balloon 5, and a handle 6; the distal end of the sheath 1 is fixedly connected to the proximal end of the balloon 5, and the inlet chamber 2, the return chamber 3, and the inner tube 4 are all located within the sheath 1; and the inlet chamber 2 and the return chamber 3 are both in fluid communication with the balloon 5; the distal end of the balloon 5 is connected to the distal end of the inner tube 4, and the connection between the distal end of the balloon 5 and the distal end of the inner tube 4 is located within the balloon 5; the handle 6 is connected to the proximal end of the sheath 1, and the handle 6 is provided with an inlet connector 11 and a return connector 12, and the inlet connector 11 and the return connector 12 are in fluid communication with the inlet chamber 2 and the return chamber 3, respectively.

[0036] In this embodiment, both the inlet connector 11 and the return connector 12 are connected to the cryoablation device 200 to deliver or recover refrigerant (such as N2, N2O, liquid nitrogen, etc.) to the cryoablation catheter 100. The refrigerant in the cryoablation device 200 enters the balloon 5 through the inlet chamber 2 via the inlet connector 11. After cryoablation, the refrigerant is discharged from the return connector 12 via the return chamber 3. In this embodiment, the distal end of the balloon 5 is directly connected to the distal end of the inner tube 4, and the connection between the distal end of the balloon 5 and the distal end of the inner tube 4 is located inside the balloon 5. That is, the cryoablation catheter in this embodiment does not require a TIP head, and the distal end of the balloon 5 can directly abut against the lesion tissue. (Refer to...) Figure 2 As shown, it can be applied not only to the ablation of blood vessels and natural cavities, but also to lesions such as the uterus, gallbladder wall, atrial wall, and oral cavity wall, thus expanding the application scope of cryoablation. Moreover, it has a simple structure and saves costs.

[0037] In an optional embodiment, the distal end of the balloon 5 is connected to the distal end of the inner tube 4 via a connector 7. Specifically, in this embodiment, the connector 7 is located inside the balloon 5, as shown below. Figure 3As shown, by setting the connector 7, it is easier to fix the distal end of the balloon 5 to the distal end of the inner tube 4.

[0038] In an optional embodiment, the handle 6 is further provided with an adjustment mechanism 13, which is fixedly connected to the proximal end of the inner tube 4. The adjustment mechanism 13 can drive the inner tube 4 to move back and forth relative to the sheath 1. When the inner tube 4 moves toward the handle 6, since the distal end of the inner tube 4 is connected to the distal end of the balloon 5, the distal end of the balloon 5 also moves toward the handle 6 under the traction of the force. Therefore, the distal end of the balloon 5 gradually concaves into the interior of the balloon 5, and the ablation area at the distal end of the balloon 5 gradually increases. Therefore, the ablation catheter of this embodiment can adjust the size of the ablation area at the distal end of the balloon 5 according to the size of the target tissue, further expanding the application range.

[0039] In an optional embodiment, the distal surface of the balloon 5 is a planar or toroidal structure. In this embodiment, when the adjusting mechanism 13 moves the inner tube 4 toward the handle 6, the distal surface of the balloon 5 also changes accordingly. For example, since the connection between the distal end of the balloon 5 and the distal end of the inner tube 4 is located inside the balloon 5, the distal surface of the balloon 5 can form a planar surface. When the distal end of the balloon 5 moves toward the handle 6 under the traction of force, the distal end of the balloon 5 gradually concaves into the interior of the balloon 5, and the distal surface of the balloon 5 forms a toroidal surface. The planar or toroidal ablation surface is more suitable for lesions such as the uterus, gallbladder wall, atrial wall, and oral cavity wall, and is easier to adhere to the wall. Optionally, the balloon 5 is a compliant balloon or a semi-compliant balloon, so that the distal surface of the balloon 5 can better adapt to the shape of the ablation lesion, and thus is easier to adhere to the wall.

[0040] In another alternative embodiment, the air intake chamber 2 may be formed by an air intake pipe disposed within the sheath 1, with the distal portion of the air intake pipe extending out of the sheath 1 and located within the balloon 5. This application provides an implementation mode for the air intake chamber 2; in practical applications, the air intake chamber 2 may also be formed by the cavity of the sheath 1 itself.

[0041] In an optional embodiment, the portion of the air inlet pipe located inside the balloon 5 has several jet holes. The jet holes allow for more even distribution of refrigerant onto the inner surface of the balloon, improving the freezing effect.

[0042] In an optional embodiment, the cryoablation catheter further includes a thermocouple (not shown) located inside the balloon 5 for measuring the temperature inside the balloon 5; the handle 6 also has a temperature measuring connector 14 connected to the thermocouple. Specifically, the thermocouple can be attached to the inner surface of the balloon 5 to sense the temperature of the refrigerant flowing inside the balloon 5, while the other end of the temperature measuring connector 14 is connected to the cryoablation device, thereby providing the cryoablation device with accurate real-time temperature of the balloon 5, so that the cryoablation device can control the refrigerant flow rate delivered to the inlet chamber 2 based on this temperature.

[0043] In an optional embodiment, the cryoablation catheter further includes a bending wire (not shown in the figure), which is fixed inside the wall of the sheath 1. The distal end of the bending wire is connected to the distal end of the sheath 1, and the proximal end is connected to the bending unit 15 of the handle 6. By setting the bending wire, the curvature of the sheath 1 can be adjusted, thereby adjusting the curvature of the balloon 5 for better fit with the target tissue. Furthermore, there are two bending wires, which are symmetrically located on both sides of the sheath 1. This allows for bidirectional bending of the balloon 5, making it more flexible to use.

[0044] Another aspect of this application provides a cryoablation system, referencing... Figure 4 The device includes a cryoablation device 200 and the aforementioned cryoablation catheter 100. The cryoablation catheter 100 is connected to the cryoablation device 200 via a connector and is used to deliver the refrigerant in the cryoablation device 200 to the balloon 5 through the air inlet connector 11 and perform cryoablation.

[0045] Specifically, in this embodiment, the cryoablation device 200 includes a human-machine interface module 201, a control module 202, and a gas path module 203. The human-machine interface module 201 is electrically connected to the control module 202, and the control module 202 is electrically connected to the gas path module 203. The gas path module 203 can be connected to the handle 6 of the cryoablation catheter 100 via a connector. Specifically, the gas path module 203 is connected to the inlet connector 11 and the return connector 12 on the handle 6 via connectors, for delivering or recovering refrigerant to the cryoablation catheter 100. During operation, the cryoablation device 200 is first started, and the cryoablation catheter 100 is inserted into the patient's body. Then, the control module 202 controls the gas path module 203 to begin delivering refrigerant to the balloon 5. After the balloon 5 is filled with refrigerant, it expands inside the patient's body. Pull the bending unit 15 to adjust the bending angle of the sheath 1, thereby adjusting the bending arc of the balloon 5, so that the ablation surface of the balloon 5 is in contact with the lesion, and then start the ablation operation. The ablation parameters are returned to the control module 202, processed by the control module 202 and finally fed back to the human-machine interaction module 201. After the ablation is completed, the operation control module 202 causes the gas circuit module 203 to stop the delivery of refrigerant.

[0046] The above is an exemplary description of a cryoablation system. In practical applications, cryoablation devices can also employ other existing technologies, which will not be elaborated upon here.

[0047] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0048] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A cryoablation catheter, characterized in that, It includes a sheath, an inlet chamber, an outlet chamber, an inner tube, a balloon, and a handle; The distal end of the sheath is fixedly connected to the proximal end of the balloon, and the air inlet chamber, the air return chamber, and the inner tube are all located inside the sheath; and the air inlet chamber and the air return chamber are in fluid communication with the balloon. The distal end of the balloon is connected to the distal end of the inner tube, and the connection between the distal end of the balloon and the distal end of the inner tube is located inside the balloon. The handle is connected to the proximal end of the sheath. The handle is provided with an air inlet connector and an air return connector, which are in fluid communication with the air inlet chamber and the air return chamber, respectively.

2. The cryoablation catheter according to claim 1, characterized in that, The handle is also provided with an adjustment mechanism, which is fixedly connected to the proximal end of the inner tube. The adjustment mechanism can drive the inner tube to move back and forth relative to the sheath. When the inner tube moves toward the handle, the ablation area at the distal end of the balloon increases.

3. The cryoablation catheter according to claim 2, characterized in that, The distal surface of the balloon is a planar or annular structure.

4. The cryoablation catheter according to claim 1, characterized in that, The distal end of the balloon is connected to the distal end of the inner tube via a connector.

5. The cryoablation catheter according to claim 1, characterized in that, The air intake chamber is formed by an air intake tube disposed within the sheath, and the distal portion of the air intake tube extends out of the sheath and is located within the balloon.

6. The cryoablation catheter according to claim 5, characterized in that, The portion of the air intake pipe located inside the balloon has several air jet holes.

7. The cryoablation catheter according to claim 1, characterized in that, The cryoablation catheter also includes a thermocouple located inside the balloon for measuring the temperature inside the balloon. The handle is also provided with a temperature measuring connector that is connected to the thermocouple.

8. The cryoablation catheter according to claim 1, characterized in that, The balloon is a compliant balloon or a semi-compliant balloon.

9. The cryoablation catheter according to claim 1, characterized in that, The cryoablation catheter also includes a bending wire, which is fixed inside the wall of the sheath. The distal end of the bending wire is connected to the distal end of the sheath, and the proximal end of the bending wire is connected to the bending unit of the handle.

10. A cryoablation system, characterized in that, The device includes a cryoablation apparatus and a cryoablation catheter as described in any one of claims 1 to 8, wherein the cryoablation catheter is connected to the cryoablation apparatus via a connector for delivering refrigerant from the cryoablation apparatus to the balloon via the inlet connector and performing cryoablation.

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