Catheter assembly and vapor ablation apparatus for peripheral blood vessels
By using a steam generator and multilayer catheter design in peripheral vascular treatment, precise and controllable vascular ablation is achieved, solving the problems of invasiveness and restenosis in existing treatment methods, reducing the risk of vascular rupture, and providing a safe and efficient treatment option.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- 腾云医疗(深圳)有限公司
- Filing Date
- 2025-07-18
- Publication Date
- 2026-07-07
AI Technical Summary
Current treatments for peripheral vascular disease have problems such as slow treatment effect, high invasiveness, vascular elastic recoil and restenosis, and lack of precision and controllability.
By using a steam generator to convert liquid into steam to fill the balloon structure, combined with a multi-layer catheter design and pressure monitoring, precise and controllable vascular ablation can be achieved, reducing the risk of vascular rupture.
It achieves minimally invasive and efficient vascular ablation, reduces the risk of vascular rupture, avoids the invasiveness and restenosis problems of traditional treatments, and provides a precise and controllable treatment method.
Smart Images
Figure CN224461796U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to catheter assemblies and steam ablation devices for peripheral vascular steam ablation. Background Technology
[0002] Currently, treatment methods for peripheral vascular lesions mainly fall into three categories: drug therapy, surgical treatment, and minimally invasive interventional therapy. While drug therapy is simple to perform, it has significant drawbacks such as slow therapeutic effects, long treatment cycles, and the ability to only temporarily relieve symptoms without curing the disease. Surgical treatment, while offering direct results, is highly invasive, posing significantly increased risks and a prolonged recovery period for elderly or patients in poor health. Interventional therapy, a rapidly developing minimally invasive treatment method in recent years, primarily includes balloon angioplasty and stent implantation, but it still has several technical limitations: restenosis may occur due to elastic recoil after balloon dilation; in-stent restenosis or stent migration may occur after stent implantation; and all these interventional methods carry the risk of vascular rupture. Furthermore, current treatment methods lack precise control over the management of vascular lesions. Utility Model Content
[0003] This invention aims to solve at least one of the technical problems existing in related technologies. To this end, this invention proposes a catheter assembly for peripheral vascular vapor ablation, which aims to have the advantages of precise control, minimally invasive and efficient operation, and reduced risk of vascular rupture.
[0004] This utility model also proposes a steam ablation device.
[0005] The catheter assembly for peripheral vascular vapor ablation according to a first aspect embodiment of the present invention includes:
[0006] Central catheter;
[0007] A balloon catheter, which is sleeved outside the central catheter, is adapted to allow the introduction of liquid;
[0008] A balloon structure is disposed outside the balloon catheter and communicates with the internal space of the balloon catheter. The balloon structure is adapted to inflate and contract.
[0009] A steam generator is disposed inside the balloon catheter, the steam generator being used to convert the passing liquid into steam, the steam being used to fill the balloon structure.
[0010] The catheter assembly for peripheral vascular steam ablation according to the present invention converts liquid into steam to fill the balloon structure through a steam generator, thereby achieving precise and controllable vascular ablation. At the same time, the multi-layer catheter structure and pressure monitoring design effectively reduce the risk of vascular rupture, and has the advantages of precise control, minimally invasive and efficient operation, and reduced risk of vascular rupture.
[0011] According to one embodiment of the present invention, the balloon catheter includes a first catheter and a second catheter. The first catheter is sleeved outside the central catheter, and the second catheter is sleeved outside the first catheter. One end of the first catheter extends out of the second catheter. The balloon structure includes an inner balloon and an outer balloon. The inner balloon is located at the portion of the first catheter that extends out of the second catheter. The outer balloon is connected to the second catheter and wraps around the inner balloon. The inner balloon is connected to the internal space of the first catheter. The steam generator is located inside the first catheter and is adapted to generate steam to inflate the inner balloon. The second catheter (22) is adapted to introduce gas.
[0012] According to one embodiment of the present invention, the first conduit is provided with a balloon section, the balloon section extends out of the second conduit, and the steam generator is located inside the balloon section.
[0013] According to one embodiment of the present invention, the steam generating device is located at one end of the balloon segment adjacent to the second conduit.
[0014] According to one embodiment of the present invention, the balloon segment has a plurality of small holes to connect the inner balloon, and the plurality of small holes are arranged at intervals along the length direction of the balloon segment.
[0015] According to one embodiment of the present invention, the diameter of the small hole ranges from 0.1 mm to 0.5 mm.
[0016] According to one embodiment of the present invention, the balloon catheter is provided with a first identifier and a second identifier, the first identifier and the second identifier being located at both ends of the balloon structure, respectively.
[0017] According to one embodiment of the present invention, the central conduit has a through hole, the through hole connecting the central conduit and the balloon conduit, and the central conduit is used to connect to an external pressure sensing device.
[0018] According to one embodiment of the present invention, the central catheter is provided with an independent guidewire pushing channel and a pressure monitoring channel, and the through hole is connected to the pressure monitoring channel.
[0019] According to one embodiment of the present invention, the catheter assembly for peripheral vascular vapor ablation includes a temperature sensing device disposed on the balloon catheter.
[0020] According to a second aspect of the present invention, the steam ablation device includes a device body and the aforementioned catheter assembly for peripheral vascular steam ablation, wherein the catheter assembly for peripheral vascular steam ablation is connected to the device body.
[0021] The steam ablation device according to the present invention includes the catheter assembly for peripheral vascular steam ablation described above, and therefore has all the technical effects of the catheter assembly for peripheral vascular steam ablation described above, which will not be repeated here.
[0022] Additional aspects and advantages of this invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description
[0023] To more clearly illustrate the technical solutions in the embodiments of this utility model or related technologies, the drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0024] Figure 1 This is a schematic diagram of the structure of a catheter assembly for peripheral vascular steam ablation provided in an embodiment of the present invention.
[0025] Figure 2 yes Figure 1 A magnified view of a portion of point A in the middle.
[0026] Figure 3 This is a magnified view of a portion of the structure of one end of the catheter assembly for peripheral vascular steam ablation provided in this embodiment of the present invention.
[0027] Figure label:
[0028] 1. Central catheter; 11. Guidewire pushing channel; 12. Pressure monitoring channel; 13. Through hole; 2. Balloon catheter; 21. First catheter; 211. Balloon segment; 2111. Small hole; 22. Second catheter; 3. Balloon structure; 31. Inner balloon; 32. Outer balloon; 4. Steam generator; 5. Connection port. Detailed Implementation
[0029] The embodiments of this utility model will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and should not be construed as limiting the scope of this utility model.
[0030] In the description of the embodiments of this utility model, it should be noted that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this utility model 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. Therefore, they should not be construed as limitations on the embodiments of this utility model. In addition, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0031] In the description of the embodiments of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this utility model based on the specific circumstances.
[0032] In this embodiment of the utility model, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through 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. "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.
[0033] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.
[0034] In current technologies, the treatment of peripheral vascular disease mainly relies on drug control, open surgery, and interventional devices. Drug treatment has a long cycle and cannot completely cure the diseased tissue, open surgery has stringent requirements on the patient's physiological condition, and traditional interventional treatment has problems such as vascular elastic recoil and restenosis of metal stents.
[0035] To address the aforementioned issues, clinical treatment requires a comprehensive solution that maintains minimally invasive characteristics while achieving tissue ablation and lumen formation. Traditional thermal ablation techniques are limited by energy conduction methods, making it difficult to achieve uniform and controllable heat distribution within blood vessels. Analysis of vapor phase change characteristics reveals that liquid water can carry a large amount of latent heat when it transforms into a gaseous state, and vapor possesses the physical property of spontaneously filling cavities. Based on this, a vapor generation module is integrated inside the catheter, utilizing the balloon structure 3 as the heat conduction medium to form a closed heat transfer system.
[0036] Therefore, please refer to the following: Figure 1 and Figure 2 This application proposes a catheter assembly for peripheral vascular steam ablation, including a central catheter 1, a balloon catheter 2 sleeved outside the central catheter 1, a balloon structure 3 communicating with the balloon catheter 2, and a steam generator 4 disposed inside the balloon catheter 2.
[0037] The central conduit 1 is a tubular structure with an axially continuous channel, which can be implemented using a thin-walled conduit made of polymer material, providing axial support for the balloon conduit 2. The balloon conduit 2 is an annular channel with liquid delivery function, which can be implemented using a double-layer composite tube structure, with the inner wall forming an annular gap with the outer wall of the central conduit 1. The balloon structure 3 is an expandable flexible membrane, which can be implemented using a sac-like structure made of biocompatible silicone material, and is connected to the steam generator 4 through the internal space of the balloon conduit 2. The steam generator 4 is an energy conversion component capable of generating phase change steam, which can be implemented using a resistance heating element or a laser fiber assembly, and is arranged in the liquid flow channel of the balloon conduit 2.
[0038] Specifically, the central catheter 1 serves as the basic supporting component, ensuring the stability of the balloon catheter 2 during its delivery within the blood vessel. The annular channel formed inside the balloon catheter 2 continuously delivers liquid media such as purified water. When the liquid flows through the built-in steam generator 4, it is heated and converted into high-temperature steam. The steam enters the balloon structure 3 directly through the internal space of the catheter, causing it to expand and conform to the blood vessel wall. During this process, the heat energy carried by the steam is evenly conducted to the lesion tissue through the balloon wall, achieving controlled thermal ablation. The coaxial nested design of the central catheter 1 and the balloon catheter 2 ensures both the independence of the liquid delivery channel and prevents heat loss of the steam during delivery.
[0039] This approach utilizes a steam-filled balloon to achieve planar heat conduction, avoiding the risk of vascular perforation caused by concentrated energy. Compared to simple balloon dilation, the steam heat energy simultaneously dilates the blood vessel and disrupts the proliferating intima, reducing the probability of elastic recoil. Compared to stent implantation, this technique eliminates the need for permanent foreign body placement, fundamentally removing the risk of in-stent restenosis.
[0040] Through the above technical solution, this application achieves closed-loop control of minimally invasive endovascular steam ablation, simultaneously completing lumen formation and tissue ablation in a single interventional procedure. The direct connection design between the steam generator 4 and the balloon structure 3 ensures that the heat transfer efficiency meets clinical treatment requirements. The spatial layout of the multi-layer catheter maintains the flexibility of the device while ensuring the airtight delivery of high-temperature steam, providing a safe and effective treatment method for peripheral vascular lesions.
[0041] In one embodiment, the catheter assembly for peripheral vascular vapor ablation further includes a connection port 5, which is connected to the balloon catheter 2 and communicates with the space inside the catheter. The connection port 5 is used to connect to external devices to improve connection convenience.
[0042] This application further proposes a balloon catheter 2 including a first catheter 21 and a second catheter 22. The first catheter 21 is sleeved outside the central catheter 1, and the second catheter 22 is sleeved outside the first catheter 21, with one end of the first catheter 21 extending out of the second catheter 22. The balloon structure 3 includes an inner balloon 31 and an outer balloon 32. The inner balloon 31 is located at the portion of the first catheter 21 that extends out of the second catheter 22. The outer balloon 32 is connected to the second catheter 22 and encloses the inner balloon 31. The inner balloon 31 is connected to the internal space of the first catheter 21. A steam generating device 4 is located inside the first catheter 21 and is adapted to generate steam to inflate the inner balloon 31. The second catheter 22 is adapted to introduce gas.
[0043] Optionally, the central catheter 1, the first catheter 21, and the second catheter 22 can be connected to external devices via Luer connectors to improve connection convenience.
[0044] The first catheter 21 is a tubular structure fitted over the central catheter 1, which may be made of a polymer material and serves to form a vapor transport channel. The second catheter 22 is a tubular structure fitted over the first catheter 21, which may be made of a flexible material and serves to connect to the outer balloon 32 and limit the expansion range of the inner balloon 31. The inner balloon 31 is an elastic sac located in the extension of the first catheter 21, which may be sealed to the first catheter 21 through a thermoforming process and serves to receive vapor and expand. The outer balloon 32 is an elastic sac wrapped around the inner balloon 31, which may be connected to the second catheter 22 by bonding or welding and serves to contact the blood vessel wall and transfer heat.
[0045] Specifically, one end of the first catheter 21 extends to the outside of the second catheter 22, forming a structure that independently supports the inner balloon 31. The steam generated by the steam generator 4 enters the inner balloon 31 directly through the inside of the first catheter 21, avoiding temperature loss caused by steam transfer between multiple catheters. When the inner balloon 31 inflates, it squeezes the outer balloon 32 outward. The outer balloon 32 is constrained by the second catheter 22, resulting in uniform expansion and maintaining a stable contact area between the outer balloon 32 and the blood vessel wall. The encapsulating structure of the outer balloon 32 physically limits the expansion range of the inner balloon 31, preventing excessive expansion of the inner balloon 31 and resulting in excessively high local temperatures.
[0046] Understandably, traditional single-layer balloon catheters 2 are prone to local temperature runaway when filled with steam due to the thinness of the balloon wall. In contrast, the double-layer balloon structure 3 restricts the expansion and deformation of the inner balloon 31 by wrapping the outer balloon 32, so that the steam heat energy is evenly transferred to the blood vessel wall through the outer balloon 32, avoiding tissue damage caused by direct contact with high-temperature steam.
[0047] Through the above technical solution, this application can reduce the risk of steam directly contacting the blood vessel wall by encasing the inner balloon 31 with the outer balloon 32. Simultaneously, the uniform heat conduction characteristics of the outer balloon 32 are utilized to control the steam temperature within a safe range. The layered design of the inner balloon 31 and outer balloon 32 allows the release of steam heat energy to occur in stages. The rapid expansion of the inner balloon 31 provides mechanical support, while the slow heat transfer of the outer balloon 32 achieves controllable thermal damage, thereby solving the problem of temperature runaway caused by an excessively thin single-layer balloon. Of course, in other embodiments, multiple balloons can be used sequentially to further control the steam temperature within a safe range.
[0048] This application further proposes that the first conduit 21 is provided with a balloon section 211, the balloon section 211 extends out of the second conduit 22, and the steam generator 4 is located inside the balloon section 211.
[0049] The balloon segment 211 refers to the tubular structure from which the second catheter 22 extends from the tip of the first catheter 21, and its length can be adjusted according to the target vascular region. This structure is used to directly accommodate the steam generator 4, so that the steam generation position corresponds spatially with the expansion area of the inner balloon 31. The device is confined inside the balloon segment 211 to prevent long-distance steam transmission within the catheter.
[0050] Specifically, the balloon segment 211 extends outward from the distal end of the second catheter 22 to form an independent working area, and the steam generator 4 is fixed inside this segment. When the liquid medium is delivered to the balloon segment 211 through the balloon catheter 2, the steam generator 4 immediately performs a phase change transformation on the medium, and the generated high-temperature steam directly enters the cavity of the inner balloon 31 through the small hole 2111 opened in the wall of the balloon segment 211. Since the steam generation point coincides with the expansion area of the inner balloon 31, the steam can act on the target site without passing through the inside of the catheter, effectively eliminating the heat loss of steam during the delivery process. At the same time, due to the enclosure of the inner balloon 31, the high-temperature steam will not be directly transmitted to the vascular tissue through the outer wall of the catheter, avoiding thermal damage to the vascular tissue.
[0051] Through the above technical solution, this application achieves precise spatial matching between the steam generation location and the balloon expansion area, so that the steam energy can be fully applied to the target lesion tissue, reducing the energy loss and risk of unexpected tissue thermal damage caused by excessively long steam transmission path, while avoiding the problem of reduced treatment efficiency caused by premature condensation of steam in the catheter.
[0052] Optionally, the diameters of the central catheter 1, the first catheter 21, and the second catheter 22 can be selected according to the actual situation, and the lengths of the catheters can also be selected according to the actual treatment location, such as 80cm, 120cm, 150cm, etc., without limitation. Different combinations of catheter diameters and lengths can form a variety of catheter specifications and models. Selecting the appropriate specification and model of catheter according to the actual situation of the lesion area can achieve better treatment results.
[0053] In one embodiment, the outer balloon 32 has a contraction outer diameter of 1.7mm-2.8mm, an expansion outer diameter of 2mm-8mm, and a length of 25mm, 40mm, 60mm, or 80mm; the inner balloon 31 has a contraction outer diameter of 1.45mm-2mm, an expansion outer diameter of 1.65mm-7.5mm, and a length of 15mm, 30mm, 50mm, or 70mm.
[0054] This application further proposes that the steam generating device 4 is located at one end of the balloon segment 211 adjacent to the second conduit 22.
[0055] The end of the balloon segment 211 adjacent to the second catheter 22 refers to the proximal region at the connection between the first catheter 21 and the second catheter 22. Specifically, this can be achieved by setting a positioning mark or a mechanical limiting structure at the catheter connection. This position selection allows the steam to diffuse evenly along the axial direction of the balloon segment 211 after it is generated.
[0056] Specifically, the steam generator 4 is fixed at the starting end of the balloon segment 211 near the second conduit 22. When liquid flows through this area, it is heated and converted into steam. The steam flows from the proximal end to the distal end along the length of the balloon segment 211 and enters the inner balloon 31 through the small hole 2111. Since the steam generation point is located at the conduit connection, the steam flow direction is consistent with the conduit axis, avoiding local accumulation caused by disordered diffusion of steam within the balloon segment 211. At the same time, the pressure of the steam is gradually released during the flow, ensuring that the inner balloon 31 expands uniformly as a whole.
[0057] Through the above technical solution, this application solves the problem of obstructed steam flow caused by the unreasonable position of the steam generator 4, ensuring that steam can smoothly enter the inner balloon 31 to achieve a stable balloon expansion effect, while reducing the risk of vascular damage caused by uneven steam distribution and improving the safety of the treatment process.
[0058] This application further proposes a technical solution of opening a plurality of small holes 2111 arranged at intervals along the length direction in the balloon segment 211 to connect the inner balloon 31.
[0059] The multiple small holes 2111 refer to the steam channels penetrating the wall of the balloon segment 211. These can be achieved using laser drilling or mechanical stamping processes, forming a path for steam to be transported from the inside of the conduit to the balloon cavity. The spaced arrangement refers to the distribution pattern in which adjacent small holes 2111 maintain a specific distance. This can be achieved using an equidistant or gradually varying spacing pattern, and the uniformity of steam diffusion can be adjusted by controlling the hole density.
[0060] Specifically, when the steam generated by the steam generator 4 passes through the balloon section 211, multiple small holes 2111 form a distributed steam outlet. The steam flows through the small holes 2111 at different positions into the inner balloon 31 cavity, forming a multi-directional diffusion path in three-dimensional space. The spaced arrangement of the small holes 2111 allows the steam to cover areas at different axial positions of the balloon section 211, preventing the steam from being concentrated and ejected from a single outlet.
[0061] Through the above technical solution, this application achieves uniform diffusion of steam within the inner balloon 31 cavity, effectively reducing the risk of vascular tissue damage caused by local overheating. The steam, delivered through a three-dimensional transport network formed by the porous structure, makes the temperature distribution on the balloon surface more stable, improving the heat conduction efficiency in the diseased tissue and providing controllable thermal damage conditions for peripheral vascular steam ablation therapy.
[0062] This application further proposes that the balloon segment 211 has multiple small holes 2111, the diameter of which ranges from 0.1 mm to 0.5 mm.
[0063] The diameter of the orifice 2111 refers to the inner diameter of the through-hole opened on the balloon segment 211, and its size range can ensure that hydrodynamic stability is maintained when steam passes through. The orifice 2111 is spaced along the length of the balloon segment 211, which means that the through-holes are linearly distributed in the axial direction of the conduit. Specifically, it can adopt an equidistant or gradually varying spacing arrangement, and its distribution density matches the steam diffusion requirements.
[0064] Specifically, by limiting the diameter of the orifice 2111 within a specific range, a controllable pressure gradient distribution of steam is formed inside the balloon. When liquid water is converted into gas in the steam generator 4, the steam flow constrained by the orifice 2111 generates a Venturi effect as it passes through the orifice, increasing the flow velocity while decreasing the pressure, thus forming a stable steam release pattern. This physical property allows the steam to uniformly cover the vascular lesion area, avoiding sudden pressure changes caused by excessively high local flow velocities. Furthermore, the lower limit of the orifice diameter ensures that the steam has sufficient kinetic energy to penetrate the collagen tissue of the blood vessel wall, while the upper limit prevents the concentrated release of steam from forming turbulence, thereby precisely controlling the boundary of thermal damage.
[0065] Through the above technical solution, this application achieves uniform diffusion of steam at the site of vascular lesions. Furthermore, this aperture range can maintain the internal pressure of the balloon within a safe range, preventing structural damage to the blood vessel wall due to pressure fluctuations.
[0066] This application further proposes that the balloon catheter 2 is provided with a first mark (not shown in the figure) and a second mark (not shown in the figure), the first mark and the second mark being located at both ends of the balloon structure 3, respectively.
[0067] The first marker refers to a contrast-enhancing mark located proximally to the balloon structure 3, which can be implemented using a platinum-iridium alloy ring or a barium sulfate-containing polymer material, forming a high-contrast image point in X-ray imaging. The second marker refers to a contrast-enhancing mark located distally to the balloon structure 3, which can be made of the same or different contrast-enhancing material as the first marker, forming symmetrically distributed positioning reference points in medical imaging. These two contrast-enhancing marks are physically isolated and fixed to the outer surface of the balloon catheter 2, maintaining identifiable spacing from the vessel wall even after balloon inflation.
[0068] Specifically, during interventional treatment, when balloon structure 3 deploys within the blood vessel, the first and second markers appear as two independent contrast points on the medical imaging equipment. By measuring the relative positions of these two contrast points to the lesion tissue, the operator can determine in real time whether balloon structure 3 completely covers the target treatment area. If a deviation is found between the contrast point and the edge of the vascular lesion, the catheter depth can be adjusted for repositioning, ensuring that the effective working length of balloon structure 3 accurately covers the lesion segment.
[0069] like Figure 3As shown, this application further proposes that the central catheter 1 has a through hole 13, the through hole 13 connects the central catheter 1 and the balloon catheter 2, and the central catheter 1 is used to connect to an external pressure sensing device; optionally, the catheter assembly for peripheral vascular vapor ablation includes a temperature sensing device, the temperature sensing device being disposed on the balloon catheter 2.
[0070] The via 13 refers to a channel structure penetrating the wall of the central catheter 1, which can be formed using laser drilling or mechanical drilling processes. It establishes a connection path between the internal pressure monitoring channel 12 of the central catheter 1 and the internal space of the balloon catheter 2, enabling real-time transmission of pressure data. The temperature sensing device refers to a sensor capable of detecting local temperature changes, specifically a thermocouple or thermistor element, which continuously acquires temperature signals by embedding it on or inside the balloon catheter 2.
[0071] Specifically, the through-hole 13 transmits the internal pressure of the balloon structure 3 to the pressure monitoring channel 12 of the central catheter 1. An external pressure sensor acquires pressure data in real time through this channel, dynamically adjusting the balloon inflation level to prevent the pressure from exceeding the vessel wall's tolerance threshold. A temperature sensor directly contacts the working area of the balloon catheter 2, monitoring the temperature distribution during the steam ablation process in real time and feeding the data back to the control system. By adjusting the output parameters of the steam generator 4, the treatment temperature is maintained within a range that ablates diseased tissue while avoiding damage to healthy tissue; for example, the temperature needs to be controlled between 40°C and 60°C, such as 50°C. The pressure and temperature monitoring systems form a closed-loop control system to ensure the safety of the treatment process.
[0072] Through the above technical solution, this application can acquire real-time pressure data inside the balloon, preventing mechanical damage to blood vessels caused by excessive pressure, while accurately monitoring the temperature distribution in the ablation area to avoid irreversible tissue damage due to local overheating. The coordinated control of pressure and temperature data improves the safety of the treatment process, ensuring that steam ablation is completed within a controllable range.
[0073] This application further proposes that the central catheter 1 is provided with an independent guidewire pushing channel 11 and a pressure monitoring channel 12, and the through hole 13 is connected to the pressure monitoring channel 12.
[0074] The guidewire delivery channel 11 is a tubular structure specifically designed for guidewire delivery. It can be made of smooth-walled polyurethane or nylon material, and its inner diameter must be compatible with the standard guidewire diameter. This channel physically isolates the guidewire from frictional resistance caused by the pressure monitoring device. The pressure monitoring channel 12 is an independent conduit connected to an external pressure sensor. It can be made of flexible silicone tubing, and its end connects to the balloon catheter 2 via a through-hole 13. This channel uses an independent sealing structure to ensure the accuracy of pressure signal transmission. The through-hole 13 is a through-hole penetrating the wall of the central catheter 1. It can be formed using laser drilling, and its diameter must meet the requirements for fluid pressure transmission. This structure directly connects the pressure monitoring channel 12 to the balloon catheter 2, eliminating signal attenuation caused by intermediate tubing.
[0075] Specifically, the guidewire is pushed to the target blood vessel position via the guidewire delivery channel 11. Simultaneously, pressure changes within the balloon catheter 2 are transmitted to the pressure monitoring channel 12 through the via 13, and data is collected in real time by an external sensor. The physical isolation design of the two channels ensures that guidewire operation and pressure monitoring do not interfere with each other. The accuracy of guidewire delivery is not affected by pressure fluctuations, and the acquisition of pressure data is not affected by guidewire movement.
[0076] Through the above technical solution, this application achieves simultaneous and independent operation of guidewire delivery and pressure monitoring functions. While improving guidewire positioning accuracy, it ensures the real-time nature and accuracy of pressure data, effectively preventing the risk of vascular rupture due to abnormal pressure. During the procedure, the operator can simultaneously obtain guidewire position and balloon pressure information without frequently switching devices, significantly shortening the operation time and reducing the probability of operational errors.
[0077] This application further proposes a steam ablation device, including a device body and a catheter assembly for peripheral vascular steam ablation, the catheter assembly being connected to the device body.
[0078] The main body of the device refers to the operating unit integrating the control module and the liquid supply system. Specifically, it can be implemented using medical equipment with a pressure pump, heating controller, and data monitoring interface, used to provide liquid delivery power to the catheter assembly and regulate steam generation parameters. The catheter assembly refers to a multi-layered tubing containing a balloon structure 3 and a steam generator 4. Specifically, it can be implemented using a coaxial nested catheter with an inflatable balloon, used for positioning within the blood vessel and performing steam ablation. The connection relationship refers to the formation of a liquid channel and signal transmission path between the main body of the device and the catheter assembly. Specifically, it can be achieved using Luer connectors and connection ports 5 with sealed tubing, ensuring real-time interaction of liquid delivery and monitoring data.
[0079] Specifically, the main body of the device delivers liquid to the catheter assembly via connecting tubing. Inside the catheter, the liquid is converted into high-temperature steam by a steam generator 4. The steam expands through the balloon structure 3 and comes into contact with the vascular lesion tissue. The pressure and temperature sensors built into the main body monitor the internal state of the balloon in real time and adjust the liquid flow rate and heating power based on feedback to maintain the steam ablation process within the set pressure and temperature range. Under the control of the main body, the catheter assembly distributes the steam evenly to the vessel wall through balloon expansion, avoiding vascular perforation due to localized overheating and eliminating foreign body irritation as is common after traditional stent implantation.
[0080] Through the above technical solutions, this application reduces the risk of mechanical damage to the blood vessel wall and avoids stent restenosis. Simultaneously, by precisely controlling the steam's range and intensity, it reduces thermal damage to healthy tissue. The integrated design of the device body and catheter assembly simplifies the operation process, making the steam ablation process repeatable and controllable, thus overcoming the technical shortcomings of traditional interventional treatments, such as high invasiveness and numerous postoperative complications.
[0081] Finally, it should be noted that the above embodiments are only used to illustrate the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the embodiments, those skilled in the art should understand that various combinations, modifications, or equivalent substitutions of the technical solutions of the present invention do not depart from the spirit and scope of the technical solutions of the present invention and should be covered within the scope of the claims of the present invention.
Claims
1. A catheter assembly for peripheral vascular vapor ablation, characterized in that, include: Central catheter; A balloon catheter, which is sleeved outside the central catheter, is suitable for introducing liquids and gases; A balloon structure is disposed outside the balloon catheter and communicates with the internal space of the balloon catheter. The balloon structure is adapted to inflate and contract. A steam generator is disposed inside the balloon catheter, the steam generator being used to convert the passing liquid into steam, the steam being used to fill the balloon structure.
2. The catheter assembly for peripheral vascular vapor ablation according to claim 1, characterized in that, The balloon catheter includes a first catheter and a second catheter. The first catheter is sleeved outside the central catheter, and the second catheter is sleeved outside the first catheter, with one end of the first catheter extending outside the second catheter. The balloon structure includes an inner balloon and an outer balloon. The inner balloon is located at the portion of the first catheter that extends outside the second catheter. The outer balloon is connected to the second catheter and encloses the inner balloon. The inner balloon is in communication with the internal space of the first catheter. The steam generator is located inside the first catheter and is adapted to generate steam to inflate the inner balloon. The second catheter is adapted to introduce gas.
3. The catheter assembly for peripheral vascular vapor ablation according to claim 2, characterized in that, The first conduit has a balloon section that extends out of the second conduit, and the steam generator is located inside the balloon section.
4. The catheter assembly for peripheral vascular vapor ablation according to claim 3, characterized in that, The steam generator is located at one end of the balloon segment adjacent to the second conduit.
5. The catheter assembly for peripheral vascular vapor ablation according to claim 3, characterized in that, The balloon segment has multiple small holes to connect to the inner balloon, and the multiple small holes are arranged at intervals along the length of the balloon segment.
6. The catheter assembly for peripheral vascular vapor ablation according to claim 5, characterized in that, The diameter of the small hole ranges from 0.1 mm to 0.5 mm.
7. The catheter assembly for peripheral vascular vapor ablation according to claim 1, characterized in that, The balloon catheter is provided with a first identifier and a second identifier, which are located at both ends of the balloon structure, respectively.
8. The catheter assembly for peripheral vascular vapor ablation according to any one of claims 1 to 7, characterized in that, The central conduit has a through hole that connects the central conduit and the balloon conduit. The central conduit is used to connect to an external pressure sensing device.
9. The catheter assembly for peripheral vascular vapor ablation according to claim 8, characterized in that, The central catheter is equipped with an independent guidewire pushing channel and a pressure monitoring channel, and the via is connected to the pressure monitoring channel.
10. The catheter assembly for peripheral vascular vapor ablation according to any one of claims 1 to 7, characterized in that, The catheter assembly for peripheral vascular vapor ablation includes a temperature sensing device disposed on the balloon catheter.
11. A steam ablation device, characterized in that, It includes a device body and a catheter assembly for peripheral vascular vapor ablation as described in any one of claims 1 to 10, wherein the catheter assembly for peripheral vascular vapor ablation is connected to the device body.