A thermal steam ablation balloon catheter

Abstract

This utility model discloses a hot steam ablation balloon catheter, relating to the field of medical device technology. To address the problem of existing COPD hot steam ablation catheters easily bending due to gravity during use, the following technical solution is proposed: It includes a shell, a catheter body, an air inlet valve, and a connector. The catheter body and connector are respectively located at both ends of the shell, with the catheter body passing through the interior of the shell and communicating with the connector. The air inlet valve is located at the side end of the shell. The catheter body includes an outer sheath, a middle sheath, and a steam conduit arranged sequentially from the outside in. Multiple reinforcing ribs are evenly arranged axially along the inner wall of the outer sheath to hold the middle sheath in place. A metal mesh layer is provided between the middle sheath and the steam conduit to increase the strength and toughness of the catheter. This utility model makes the catheter more stable, preventing it from being damaged by excessive bending or falling due to excessive length or weight during use, thereby reducing the risk of steam leakage and improving the safety of catheter use.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a hot steam ablation balloon catheter. Background Technology

[0002] Transbronchial thermostatic vapor ablation (BTVA) is an emerging non-invasive endoscopic interventional technique for COPD. It involves inserting a steam tube through a bronchoscope into the target lung tissue identified by high-resolution CT. A predetermined amount of high-temperature steam is released, generating a thermal reaction that acts on the target lung tissue, inducing an acute inflammatory response and repair of damage. This can lead to pulmonary fibrosis and scarring, or even atelectasis, thus reducing lung volume. Compared to other methods, this approach does not require the implantation of foreign bodies and can produce a long-lasting therapeutic effect. Currently, clinical data on COPD BTVA is limited, but it has become a hot topic in emphysema treatment research.

[0003] Existing COPD steam ablation catheters typically consist of multiple nested tubing layers for passing hot steam, expanding gas, and water. Moreover, the tubing is relatively thin and long (up to 1 meter). During use, the catheter is prone to bending due to gravity, posing a risk of damage and gas leakage. Utility Model Content

[0004] The purpose of this invention is to provide a hot steam ablation balloon catheter to solve the problem that existing COPD hot steam ablation catheters are prone to bending due to gravity during use.

[0005] The technical solution of this utility model to solve the above-mentioned technical problems is as follows:

[0006] A hot steam ablation balloon catheter includes: a shell, a catheter body, an air inlet valve, and a connector. The catheter body and the connector are respectively disposed at both ends of the shell, and the catheter body passes through the inside of the shell and communicates with the connector. The air inlet valve is disposed at the side end of the shell.

[0007] The conduit body includes an outer sleeve, an intermediate sleeve, and a steam conduit arranged sequentially from the outside to the inside. Multiple reinforcing ribs are evenly arranged along the axial direction on the inner wall of the outer sleeve to hold the intermediate sleeve in place. A metal mesh layer is provided between the intermediate sleeve and the steam conduit to increase the strength and toughness of the conduit.

[0008] Furthermore, the reinforcing ribs are cylindrical in shape.

[0009] Furthermore, the outer sheath is a Pebax polyether block polyamide tube that is biocompatible and flexible.

[0010] Furthermore, the intermediate sleeve is a PI polyamide tube.

[0011] Furthermore, the steam conduit is a polyimide tube.

[0012] Furthermore, a balloon is provided at the distal end of the conduit body, and a metal mesh layer extends to the balloon; a gas delivery pipe is provided on one side of the steam conduit, and the two ends of the gas delivery pipe are connected to the air inlet valve and the balloon, respectively.

[0013] Furthermore, a groove is formed on the inner wall of the intermediate sleeve, and the gas delivery pipe is placed in the groove.

[0014] This utility model has the following beneficial effects:

[0015] This invention increases the strength and toughness of the conduit by setting a metal mesh layer between the intermediate sleeve and the steam conduit. In addition, multiple cylindrical reinforcing ribs on the outer sleeve tighten the intermediate sleeve, making the conduit more stable. This makes the conduit less likely to be damaged by excessive bending or falling due to excessive length or weight during use, thereby reducing the risk of steam leakage and improving the safety of the conduit. Attached Figure Description

[0016] Figure 1 This is an overall structural diagram of the hot steam ablation balloon catheter of this utility model;

[0017] Figure 2 for Figure 1 A sectional view;

[0018] Figure 3 This is a cross-sectional view of the hot steam ablation balloon catheter of this utility model;

[0019] Figure 4 This is a schematic diagram of the front end structure of the hot steam ablation balloon catheter of this utility model;

[0020] Figures 1 to 4 The reference numerals in the attached drawings are respectively: shell 1, conduit body 2, outer sleeve 21, intermediate sleeve 22, steam conduit 23, metal mesh layer 24, gas delivery pipe 25, reinforcing rib 26, air inlet valve 3, connector 4, balloon 5, end cap 6. Detailed Implementation

[0021] The technical solution of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0022] Please refer to Figure 1-4This specific embodiment details the structural composition, material selection, connection relationship, and working principle of the thermal steam ablation balloon catheter, aiming to fully disclose the technical solution and ensure that those skilled in the art can manufacture and use the thermal steam ablation balloon catheter based on this specific embodiment.

[0023] The hot steam ablation balloon catheter mainly consists of a shell 1, a catheter body 2, an air inlet valve 3, and a connector 4. The following will describe in detail the specific structure, material, connection relationship, and working principle of each part (including the outer sheath 21, intermediate sheath 22, steam conduit 23, metal mesh layer 24, gas delivery pipe 25, reinforcing rib 26, and balloon 5 in the catheter body 2).

[0024] The housing 1 is the external support structure for the entire steam ablation balloon catheter. Its shape and size design must take into account factors such as the installation of the catheter body 2, the setting of the air inlet valve 3, and the connection of the connector 4. One end of the housing 1 is used to house the catheter body 2, and the other end is used to house the connector 4. The air inlet valve 3 is located on the side of the housing 1. This layout makes the connection between the components of the catheter more compact during use, facilitating operation and control.

[0025] The catheter body 2 is the core component of the hot steam ablation balloon catheter. It is responsible for delivering gas to the balloon 5 to achieve the ablation function. The catheter body 2 includes an outer sheath 21, an intermediate sheath 22, and a steam conduit 23 arranged sequentially from the outside to the inside.

[0026] The outer sheath 21 is made of Pebax (polyether block polyamide) tubing, which is biocompatible and flexible. Pebax material has excellent biocompatibility, reducing irritation and damage to human tissues, while its flexibility allows for smoother insertion into body cavities, reducing patient discomfort. Multiple reinforcing ribs 26, cylindrical in shape, are evenly arranged axially along the inner wall of the outer sheath 21 to hold the intermediate sheath 22 in place. These reinforcing ribs 26 fix the intermediate sheath 22, preventing loosening or displacement during use, thereby increasing the strength and stability of the catheter body 2. The cylindrical design of the reinforcing ribs 26 not only provides sufficient friction to hold the intermediate sheath 22 in place but also reduces damage to the surface of the intermediate sheath 22, ensuring the normal use of the catheter body 2.

[0027] The intermediate sleeve 22 is made of PI (polyamide) tubing. PI tubing has tensile, compressive, and heat-resistant properties, enabling it to withstand pressure and temperature changes during steam transport, ensuring the normal operation of the conduit body 2. A groove is formed on the inner wall of the intermediate sleeve 22 to accommodate the gas delivery pipe 25. This design allows the gas delivery pipe 25 to be stably installed within the intermediate sleeve 22, preventing displacement or twisting of the gas delivery pipe 25 when the conduit body 2 bends or moves, thus ensuring smooth steam transport.

[0028] The steam conduit 23 is made of polyimide tubing. Polyimide tubing has excellent high-temperature resistance and chemical stability, and can withstand the effects of high-temperature steam without deformation or damage. A gas delivery tube 25 is provided on one side of the steam conduit 23, with its two ends connected to the inlet valve 3 and the balloon 5, respectively. The function of the gas delivery tube 25 is to deliver the gas input from the inlet valve 3 to the balloon 5, causing the balloon 5 to inflate for expanding the trachea and blood vessels.

[0029] A metal mesh layer 24 is provided between the intermediate sleeve 22 and the steam conduit 23. The metal mesh layer 24 is woven from metal wires and its function is to increase the strength and toughness of the conduit body 2. During use, the conduit body 2 is subjected to various external forces, such as bending and stretching. The metal mesh layer 24 can effectively disperse these external forces, preventing the conduit body 2 from breaking or being damaged. The metal mesh layer 24 extends to the balloon 5, further enhancing the connection strength between the balloon 5 and the conduit body 2, ensuring the stability of the balloon 5 during inflation.

[0030] The distal end of the catheter body 2 is equipped with a balloon 5. When external gas enters the balloon 5 through the gas inlet tube 25, the balloon 5 inflates, thereby expanding the trachea and blood vessels. The balloon 5 needs to be made of a material with good elasticity and sealing properties to ensure uniform expansion under gas pressure and to prevent air leakage.

[0031] The inlet valve 3 is located on the side of the housing 1 and its function is to control the gas input. The inlet valve 3 can adopt a common valve structure, such as a ball valve or a gate valve, and the gas flow is controlled by rotating or moving the valve core. When gas needs to be delivered to the balloon 5, the inlet valve 3 is opened, and external gas enters the balloon 5 through the gas delivery tube 25; after ablation is completed, the inlet valve 3 is closed to stop the gas input.

[0032] Connector 4 is located at the other end of housing 1, and its function is to flush the tubing and connect to the steam conduit 23. Connector 4 can adopt a standard medical connector structure for easy connection with other medical devices. Before use, flushing fluid such as saline can be injected into the catheter body 2 through connector 4 to flush the catheter body 2 and remove impurities and air from it. At the same time, connector 4 can also be connected to a steam generator to deliver steam to the steam conduit 23.

[0033] In actual manufacturing, reliable connection methods are required for the various components to ensure the sealing and stability of the conduit body 2. For example, the outer sleeve 21, the intermediate sleeve 22, and the steam conduit 23 can be connected by heat fusion or bonding to ensure a tight connection between the sleeves and prevent steam leakage. The connection between the gas delivery pipe 25 and the inlet valve 3 and the balloon 5 can be achieved by threaded or snap-fit ​​connections for easy installation and disassembly. The connection between the connector 4 and the housing 1 can be achieved by welding or threaded connections to ensure the robustness of the connector 4.

[0034] The working principle of the hot steam ablation balloon catheter is as follows: First, connect the catheter body 2 to the steam generator through connector 4 and close the air inlet valve 3. Then, inject physiological saline into the catheter body 2 through connector 4 to flush it and remove impurities and air. After flushing, open the air inlet valve 3, and the steam generated by the steam generator enters the steam conduit 23 through connector 4. External gas is delivered to the balloon 5 through the gas delivery tube 25. The external gas gradually inflates the balloon 5, which inflates the trachea and blood vessels. Simultaneously, hot steam enters directly into the opening of the end cap 6 through the steam pipe 23 for steam ablation. During the ablation process, the steam input and pressure can be adjusted as needed to achieve the best ablation effect. After ablation, close the air inlet valve 3 to stop the input of steam and gas, and the balloon 5 gradually contracts. Finally, remove the catheter body 2 from the body cavity.

[0035] To ensure the safety and effectiveness of the steam ablation balloon catheter, strict adherence to relevant standards and specifications is required during manufacturing and use. For example, the material of the catheter body 2 must meet the biocompatibility requirements for medical devices, and the dimensions and performance of each component must meet design requirements. Before use, the catheter body 2 must undergo rigorous testing and sterilization to ensure its quality and safety.

[0036] When manufacturing the hot steam ablation balloon catheter, for the Pebax (polyether block polyamide) tubing of the outer sheath 21, appropriate specifications and models need to be selected to ensure that its biocompatibility and flexibility meet the requirements. During the processing of the outer sheath 21, the size and spacing of the reinforcing ribs 26 need to be precisely controlled to ensure that the reinforcing ribs 26 can uniformly hold the intermediate sheath 22 in place. For the PI polyamide tubing of the intermediate sheath 22, advanced processing technology is required to ensure that its tensile, compressive, and heat resistance properties meet the design requirements. When creating the groove, it is necessary to ensure that the size and shape of the groove match the gas delivery tube 25 so that the gas delivery tube 25 can be stably installed within the groove.

[0037] For the polyimide tubing of the steam conduit 23, high-quality raw materials must be selected, and special processing techniques must be employed to improve its high-temperature resistance and chemical stability. When installing the metal mesh layer 24, it is necessary to ensure a tight bond between the metal mesh layer 24 and the intermediate sleeve 22 and the steam conduit 23 to prevent loosening or detachment. The weaving density and wire diameter of the metal mesh layer 24 need to be rationally selected based on the strength and toughness requirements of the conduit body 2.

[0038] When manufacturing the balloon 5, materials with good elasticity and sealing properties must be selected, and advanced molding processes must be employed to ensure that the shape and size of the balloon 5 meet the design requirements. The connection between the balloon 5 and the gas delivery pipe 25 requires a reliable sealing method to prevent vapor leakage.

[0039] The manufacturing of the intake valve 3 requires the selection of appropriate valve structure and materials to ensure its sealing performance and durability. During installation, the intake valve 3 must be securely connected to the housing 1 to prevent air leakage. The connector 4 must be manufactured in accordance with medical connector standards to ensure convenient and reliable connection to other medical devices.

[0040] In actual use, operators must strictly follow the operating procedures. Before inserting catheter body 2, a comprehensive examination of the patient is necessary to ensure suitability for steam ablation therapy. Insertion of catheter body 2 should be slow and gentle to avoid unnecessary injury to the patient. During ablation, the patient's response and the working status of catheter body 2 must be closely monitored, and the steam input and pressure adjusted as needed. After ablation, catheter body 2 must be removed promptly, and the patient should receive subsequent observation and care.

[0041] To improve the effectiveness of the steam ablation balloon catheter, further improvements and optimizations can be made. For example, temperature and pressure sensors can be installed on the catheter body 2 to monitor the temperature and pressure inside the balloon 5 in real time, allowing operators to better control the ablation process. New balloon materials can also be developed to improve the uniformity of balloon expansion and the ablation effect.

[0042] The thermal steam ablation balloon catheter is an innovative medical device with a rational structural design. The materials and connection methods of its components (including the shell 1, catheter body 2 and its outer sheath 21, intermediate sheath 22, steam conduit 23, metal mesh layer 24, gas delivery tube 25, reinforcing rib 26, balloon 5, inlet valve 3, connector 4, etc.) ensure effective thermal steam ablation. Through the detailed description of this specific embodiment, those skilled in the art can clearly understand the technical solution of this thermal steam ablation balloon catheter and manufacture and use it accordingly. Furthermore, this thermal steam ablation balloon catheter has broad application prospects.

[0043] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A hot steam ablation balloon catheter, characterized in that, include: The housing (1), the conduit body (2), the air inlet valve (3) and the connector (4) are respectively disposed at both ends of the housing (1), and the conduit body (2) passes through the inside of the housing (1) and communicates with the connector (4). The air inlet valve (3) is disposed at the side end of the housing (1). The conduit body (2) includes an outer sleeve (21), an intermediate sleeve (22) and a steam conduit (23) arranged sequentially from the outside to the inside. The inner wall of the outer sleeve (21) is uniformly provided with multiple reinforcing ribs (26) along the axial direction to hold the intermediate sleeve (22). A metal mesh layer (24) is provided between the intermediate sleeve (22) and the steam conduit (23) to increase the strength and toughness of the conduit.

2. The hot steam ablation balloon catheter according to claim 1, characterized in that, The reinforcing rib (26) is cylindrical in shape.

3. The hot steam ablation balloon catheter according to claim 1, characterized in that, The outer sheath (21) is a biocompatible and flexible pebax polyether block polyamide tube.

4. The hot steam ablation balloon catheter according to claim 1, characterized in that, The intermediate sleeve (22) is a PI polyamide tube.

5. The hot steam ablation balloon catheter according to claim 1, characterized in that, The steam conduit (23) is a polyimide tube.

6. The hot steam ablation balloon catheter according to claim 1, characterized in that, The distal end of the conduit body (2) is provided with a balloon (5), and the metal mesh layer (24) extends to the balloon (5); a gas delivery pipe (25) is provided on one side of the steam conduit (23), and the two ends of the gas delivery pipe (25) are respectively connected to the air inlet valve (3) and the balloon (5).

7. The hot steam ablation balloon catheter according to claim 6, characterized in that, The inner wall of the intermediate sleeve (22) is provided with a groove, and the gas delivery pipe (25) is disposed in the groove.

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