Thermal vapor treatment device

Abstract

The application belongs to the technical field of medical devices, and discloses a hot steam treatment device. The sheath tube assembly of the hot steam treatment device comprises a needle tube body, a head piece, a puncture needle and a plugging device. The needle tube body has a containing cavity extending in a first direction; the head piece is connected with the leading end of the needle tube body, and the head piece has a needle outlet channel in communication with the containing cavity; the puncture needle is used for conveying hot steam, and has a hot steam conveying channel inside; the puncture needle is arranged in the needle tube body and can extend out of or retract into the needle outlet channel; the puncture needle comprises a needle head section, a needle body section and a needle tail section connected in sequence, and the circumferential wall of the needle head section is provided with a plurality of gas outlets in communication with the hot steam conveying channel; and the plugging device is fixedly sleeved on the needle head section, and the outer diameter of the plugging device is greater than the outer diameter of the puncture needle. The application can block the overflow of hot steam and limit the penetration depth of the puncture needle, and is suitable for special glands.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a hot steam therapy device. Background Technology

[0002] Benign prostatic hyperplasia (BPH) is a common disease affecting middle-aged and elderly men, and its prevalence is positively correlated with age. It is often accompanied by clinical symptoms such as frequent urination, urgency, and increased nocturia. Steam ablation is a new and effective technique for treating this disease. It uses high-temperature steam to cause cell necrosis, which is then absorbed by the body, thus achieving the therapeutic goal. The surgical procedure for steam ablation of BPH involves introducing high-temperature sterile steam into the diseased hyperplastic tissue of the prostate. The high-temperature steam heat treatment causes cell necrosis, which is then absorbed or excreted from the body, thereby achieving the goal of treating prostate disease.

[0003] Common disposable prostate steam therapy devices require the needle to be inserted into the gland through a pressure point against the gland's inner wall. Due to the size of the gland and the needs of the treatment, the needle tip, after extending freely, is typically 10mm-15mm from the sheath. When the gland is small, if the needle tip extends beyond this range, it may end up on the opposite edge of the gland, causing burns to non-treatment areas. Furthermore, during the procedure, various factors (different angles of contact between the sheath head and the gland, inconsistencies between the needle and the sheath, or tremors in the surgeon's arm after insertion) can lead to loose contact between the needle and the puncture site, causing steam to escape and burn non-treatment areas. Moreover, because the needle extension distance is fixed, the treatment effect is limited for special glands (such as large glands). Summary of the Invention

[0004] The purpose of this invention is to provide a hot steam therapy device that can not only prevent hot steam from overflowing, but also precisely limit the insertion depth of the puncture needle, and is suitable for special glands.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] A hot steam therapy device includes a sheath assembly, the sheath assembly comprising:

[0007] The syringe body has a receiving cavity extending along a first direction;

[0008] An end piece is connected to the head end of the needle tube body, and the end piece has a needle outlet channel that communicates with the accommodating cavity;

[0009] A puncture needle for delivering hot steam. The puncture needle has a hot steam delivery channel inside. The puncture needle is disposed inside the needle tube body and can extend or retract from the needle delivery channel. The puncture needle includes a needle tip section, a needle body section and a needle tail section connected in sequence. The peripheral sidewall of the needle tip section is provided with multiple air outlets, and all of the multiple air outlets are connected to the hot steam delivery channel.

[0010] An occluder is fixedly sleeved on the needle tip section, and the outer diameter of the occluder is larger than the outer diameter of the puncture needle.

[0011] As an alternative to the hot steam therapy device, the occluder is funnel-shaped or umbrella-shaped, and when the hot steam therapy device is in a non-puncture state, the occluder is housed inside the end piece.

[0012] As an alternative to the hot steam therapy device, the occluder includes a first layer structure and a second layer structure, wherein the first layer structure is wrapped around the outer wall of the second layer structure, the first layer structure is a non-metallic elastic membrane, and the second layer structure is a mesh skeleton.

[0013] As an alternative to the hot steam therapy device, the second layer structure is made of nickel-based alloy or titanium alloy.

[0014] As an alternative to the hot steam therapy device, the second layer structure has a filling space inside, and the plug also includes a third layer structure, which is filled inside the second layer structure and is made of a heat-expanding material.

[0015] As an optional solution for hot steam therapy equipment, a necking annular groove is provided at the connection between the needle section and the occluder.

[0016] As an optional solution for hot steam therapy equipment, the needle body segment extends along the first direction and can move forward or backward along the first direction, the needle tip segment is arc-shaped, and the inner wall of the needle outlet channel is provided with an arc-shaped slide groove, the needle tip segment can slide along the arc-shaped slide groove and extend or retract into the needle outlet channel.

[0017] As an alternative to the hot steam therapy device, the inner diameter of the needle outlet channel gradually increases near the outlet to form a conical opening.

[0018] As an optional embodiment of the hot steam therapy device, the sheath assembly includes a needle holder and a needle hub. The needle holder is fixedly sleeved on the tail end of the needle body, and the needle hub is fixedly sleeved on the needle body segment of the puncture needle. The hot steam therapy device also includes a handle assembly, which includes:

[0019] The handle housing has a needle socket inserted into its insertion port, and a mounting bracket is provided inside the handle housing.

[0020] An ejection device is mounted on the mounting bracket and is connected to the needle holder via a transmission mechanism. The ejection device is used to drive the needle holder to move forward or backward along the first direction.

[0021] As an alternative to the hot steam therapy device, the handle assembly further includes:

[0022] A heater is mounted on the mounting bracket, the heater having a steam generating chamber and an input port and an output port located at both ends of the steam generating chamber;

[0023] A water inlet pipe, which is connected to the input port;

[0024] An adapter hose is provided, one end of which is connected to the output port, and the other end of which is connected to the needle tail section and connected to the hot steam delivery channel.

[0025] The beneficial effects of this invention are:

[0026] The hot steam therapy device provided by this invention has a sheath assembly end piece installed at one end of the needle body. The end piece has a needle outlet channel, and a puncture needle for delivering hot steam is located inside the needle body and can extend or retract through the outlet channel. The hot steam delivery channel inside the puncture needle delivers high-temperature steam heat to the cells at the lesion site through multiple vents. The energy contained in the high-temperature steam acts on the lesion cells, destroying their normal physiological structure and function, leading to cell necrosis. An occluder is fixedly fitted at a specific position on the needle tip according to the gland treatment requirements. The outer diameter of the occluder is larger than the outer diameter of the puncture needle. When the puncture needle enters the puncture hole in the gland, the occluder not only seals the puncture hole to prevent hot steam leakage but also limits the depth of the puncture needle's entry into the gland, preventing the puncture needle from piercing the gland or failing to reach the lesion site. Attached Figure Description

[0027] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the assembly of the hot steam therapy equipment in an embodiment of the present invention;

[0029] Figure 2This is a schematic diagram of the sheath assembly in the non-needle-extraction state in an embodiment of the present invention;

[0030] Figure 3 This is a schematic diagram of the sheath assembly in the needle-out state in an embodiment of the present invention;

[0031] Figure 4 This is a schematic diagram of the puncture needle in an embodiment of the present invention;

[0032] Figure 5 This is a cross-sectional view of the end piece in an embodiment of the present invention;

[0033] Figure 6 This is a schematic diagram of the sheath assembly penetrating the gland in an embodiment of the present invention;

[0034] Figure 7 This is a schematic diagram of an explosion of the hot steam therapy device in an embodiment of the present invention.

[0035] Figure label:

[0036] 1. Sheath assembly; 2. Handle assembly;

[0037] 11. Needle body; 12. End piece; 121. Arc-shaped slide groove; 122. Conical opening; 13. Puncture needle; 131. Needle tip section; 1311. Vent hole; 1312. Neck constriction annular groove; 132. Needle body section; 133. Needle tail section; 14. Occluder; 15. Needle seat; 16. Needle seat; 17. Flushing tube;

[0038] 21. Handle housing; 211. Plug interface; 22. Mounting bracket; 23. Ejection device; 24. Heater; 25. Water inlet pipe; 26. Adapter hose; 27. Control valve; 28. Filling pipe; 29. ​​Drain pipe; 210. Circuit board. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0040] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0041] In the description of this invention, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0042] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar components or components having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0043] Benign prostatic hyperplasia (BPH) is a very common and prevalent urinary system disease among middle-aged and elderly men, and its prevalence shows a strong positive correlation with age. As age increases, the probability of men developing BPH rises significantly. This disease often causes a series of bothersome clinical symptoms, among which urinary frequency, urgency, and increased nocturia are particularly common. These symptoms not only seriously affect patients' quality of life and cause considerable inconvenience to their daily activities, but also greatly interfere with their sleep quality, thus impacting their overall health.

[0044] Among the many techniques for treating benign prostatic hyperplasia (BPH), steam ablation, as a new and effective treatment method, is gradually gaining attention and importance in the medical field. The basic principle of this technique is to utilize the powerful effect of high-temperature steam to cause necrosis of cells in the diseased area. These necrotic cells are then naturally absorbed by the body, thereby achieving the goal of treating the disease. Specifically, the surgical procedure for steam ablation of BPH has a rigorous operational process. First, strictly processed, high-temperature sterile steam is precisely introduced into the diseased hyperplasia area of ​​the patient's prostate tissue. Then, the local hyperplasia tissue is treated with high-temperature steam heat. During this process, the energy contained in the high-temperature steam acts on the diseased cells, destroying their normal physiological structure and function, leading to cell necrosis. Some of these necrotic cells are absorbed by the body's own metabolic mechanisms, while others may be excreted through excretion, ultimately achieving the goal of treating prostate disease.

[0045] Currently available disposable prostate steam therapy devices face several challenges in practical application. These devices require pressing against the inner wall of the gland, and then the needle is manipulated to penetrate the gland. Based on the gland's physiological structure and specific treatment needs, the distance between the needle tip and the sheath is typically controlled within 10-15 mm after the needle extends freely. However, in practice, when the gland is small, the lack of effective restraints in existing devices easily causes the needle tip to extend beyond this range. Once the needle tip extends beyond the normal range, it is highly likely that it will be positioned at the opposite edge of the gland. In this situation, the high-temperature steam, when acting on the diseased tissue, may cause burns to non-treatment areas, resulting in unnecessary harm and pain for the patient.

[0046] Furthermore, several other factors can lead to adverse consequences when operating disposable prostate steam therapy devices. Due to the complexity and variability of actual procedures, the angle of contact between the sheath tip and the gland is often difficult to maintain consistently and can vary. Additionally, there may be some inconsistency between the puncture needle and the sheath, such as their axes not perfectly aligning. Moreover, after the needle is inserted into the gland, the doctor's arm may tremble slightly due to prolonged operation or fatigue. These factors combined can result in a loose contact between the needle and the puncture site on the gland. Once gaps appear between the needle and the puncture site, high-temperature steam can escape from these gaps, potentially burning non-treatment areas and causing secondary injury to the patient.

[0047] Furthermore, existing steam therapy equipment has a significant limitation: the needle extension distance is fixed. This fixed extension distance design has extremely limited effectiveness in treating certain types of glands. For example, for patients with large glands, due to the gland's size, the fixed needle extension distance may prevent the high-temperature steam from fully reaching the entire lesion area, resulting in some diseased tissue not being effectively treated, thus affecting the overall treatment outcome and failing to meet the treatment needs of patients with different types of glands.

[0048] Given the numerous problems associated with disposable prostate steam therapy devices, and to further improve the safety and effectiveness of treatment while meeting the treatment needs of patients with different glands, there is an urgent need to design a new type of steam therapy device. This new device must not only prevent steam leakage to avoid burns to non-treatment areas and ensure patient safety, but also precisely control the insertion depth of the puncture needle to avoid problems caused by improper insertion depth. Furthermore, it must have better adaptability, suitable for treating various special glands, providing a higher quality, safer, and more effective treatment option for patients with benign prostatic hyperplasia. The following is a combination of... Figures 1 to 7 The specific content of this embodiment will be described in detail.

[0049] like Figures 1 to 6As shown, the hot steam therapy device provided in this embodiment includes a sheath assembly 1. The sheath assembly 1 includes key components such as a needle body 11, an end piece 12, a puncture needle 13, and an occluder 14. These components work together to achieve efficient and safe treatment. The needle body 11 serves as the basic support structure of the entire sheath assembly 1, and has a receiving cavity extending along a first direction. This receiving cavity provides a stable and suitable space for the puncture needle 13, ensuring that the puncture needle 13 can be properly placed in the cavity when not in use, and can be smoothly extended or retracted during use, laying a solid foundation for subsequent precise operations. The length and diameter of the needle body 11 are designed based on the convenience of actual operation and its compatibility with human tissues. It is neither too long, which would cause inconvenience to the operation, nor too short, which would fail to meet treatment needs. At the same time, the appropriate diameter ensures that the puncture needle 13 has sufficient room to move within it, while maintaining the stability of the overall structure. The end piece 12 is connected to the head end of the needle body 11. This connection is secure and reliable, ensuring that it will not loosen or fall off during operation. The end piece 12 has a needle outlet channel, which is precisely connected to the accommodating cavity of the needle body 11, forming a continuous channel system. This design allows the puncture needle 13 to extend unimpeded from the needle body 11 and accurately reach the lesion site, providing strong support for subsequent treatment. The size and shape of the needle outlet channel match the outer diameter and shape of the puncture needle 13, ensuring smooth passage of the puncture needle 13 and providing guidance and positioning, further improving the accuracy of the operation. The puncture needle 13 is used to deliver hot steam. The puncture needle 13 has a hot steam delivery channel inside, ensuring that the hot steam is delivered to the lesion site at a stable and rapid flow rate. The puncture needle 13 is located inside the needle body 11 and has a flexible telescopic function, allowing it to extend or retract the needle outlet channel according to actual treatment needs. This telescopic design allows operators to flexibly adjust the extension length of the puncture needle 13 according to factors such as the size, location, and severity of the lesion, achieving precise treatment. The puncture needle 13 comprises a needle tip section 131, a needle body section 132, and a needle tail section 133 connected in sequence. The peripheral wall of the needle tip section 131 has multiple vent holes 1311, all of which are connected to a hot steam delivery channel. When hot steam reaches the needle tip section 131 through the hot steam delivery channel, it is evenly and dispersedly ejected from these vent holes 1311, forming a comprehensive high-temperature steam thermal effect area. This multi-vent design allows the high-temperature steam to cover the lesion site more extensively, ensuring that every diseased cell receives sufficient action from the high-temperature steam, greatly improving the comprehensiveness and effectiveness of the treatment. The enormous energy contained in the high-temperature steam rapidly acts on the diseased cells, destroying their normal physiological structure and function, leading to cell necrosis.These necrotic cells will then be gradually absorbed or excreted by the body's own metabolic mechanisms, thereby achieving the purpose of treating prostate disease. The occluder 14 is fixedly sleeved at a specific position on the needle tip 131, and the outer diameter of the occluder 14 is larger than the outer diameter of the puncture needle 13.

[0050] In short, the hot steam therapy device provided by this invention allows the occluder 14 to fit tightly around the puncture site after the puncture needle 13 enters the gland, acting like a reliable seal to tightly block the puncture site. This sealing effect effectively prevents hot steam from escaping from the puncture site during treatment, preventing burns to non-treatment areas from the high-temperature steam and greatly improving the safety of the treatment. Without the sealing effect of the occluder 14, the high-temperature steam might escape uncontrollably, causing damage to surrounding normal tissues and potentially triggering a series of complications, bringing additional pain and risks to the patient. The presence of the occluder 14 firmly controls the hot steam within the lesion area, ensuring the safe conduct of the treatment. In addition, the occluder 14 also limits the depth of the puncture needle 13 entering the gland. During the procedure, the operator can fix the occluder 14 at a suitable position on the needle tip 131 according to the specific condition of the gland and the treatment needs (various types of puncture needles 13 can also be prepared, with different positions for the occluder 14 on different types of puncture needles 13, allowing selection of the appropriate type of puncture needle 13 according to treatment requirements). When the puncture needle 13 enters the gland, the occluder 14 will contact the gland surface and experience a certain resistance, thus limiting the further penetration of the puncture needle 13. This function effectively prevents the puncture needle 13 from piercing the gland, preventing damage to important tissues and organs behind the gland; at the same time, it also ensures that the puncture needle 13 accurately reaches the lesion site of the gland, avoiding incomplete treatment due to insufficient puncture depth. For example, for some patients with thin glands, if the puncture needle 13 is inserted too deeply, it may penetrate the gland, damaging important organs such as the rectum behind it, leading to serious consequences; while if the puncture needle 13 is inserted too superficially, it may not be able to adequately treat the lesion site, leading to recurrence of the condition. The presence of the occluder 14 allows for precise control of the insertion depth of the puncture needle 13 based on the actual condition of the gland, ensuring the safety and effectiveness of the treatment.

[0051] Furthermore, the occluder 14 is funnel-shaped or umbrella-shaped, and when the steam therapy device is in the non-puncture state, the occluder 14 is housed inside the end piece 12. When the steam therapy device is in the non-puncture state, the occluder 14 can be cleverly housed inside the end piece 12. This greatly saves the overall space of the device, making it more compact and portable when not in use, facilitating storage and carrying by medical staff. It can be easily placed on the instrument rack in the operating room or in a mobile medical equipment case without taking up too much space. From the perspective of operational convenience, during the device preparation stage, medical staff do not need to perform additional complex handling and fixing operations on the occluder 14; they only need to take the entire device out, greatly simplifying the operation process, saving preoperative preparation time, and improving surgical efficiency. Moreover, this housing design can effectively protect the occluder 14 from damage such as impacts and scratches from the external environment when not in use, ensuring that the occluder 14 maintains good performance and condition when needed.

[0052] Furthermore, the occluder 14 can adopt a double-layer structure design, comprising a first layer and a second layer, wherein the first layer is wrapped around the outer wall of the second layer. The first layer is made of a non-metallic elastic membrane, such as common silicone. Silicone has many excellent properties. First, it has good biocompatibility, meaning that when the occluder 14 comes into contact with human tissue, it will not trigger an immune rejection response, nor will it irritate or damage surrounding tissues, making it safe for use in the internal treatment environment. Second, silicone has excellent sealing properties; its soft and elastic nature allows it to fit tightly against tissue surfaces of various shapes, forming a reliable sealing barrier that effectively prevents the leakage of hot vapor. The second layer is a mesh skeleton, which provides the occluder 14 with solid support and excellent shape recovery capability. After the puncture operation is completed, the mesh skeleton can quickly restore the original shape of the occluder 14 due to its elasticity, ensuring that the occluder 14 always maintains a good working condition. For example, after the puncture needle 13 has exited the gland puncture site, the occluder 14 quickly returns to its shape and continues to perform its sealing and limiting functions.

[0053] Furthermore, in other application scenarios, the occluder 14 can also adopt a three-layer structure design. The second layer encloses a unique filling space, and the occluder 14 also includes a third layer that fills the interior of the second layer. The third layer is made of a thermally expanding material. Various thermally expanding materials are available, with thermosensitive materials and hydrogels being common and high-performance choices. These materials share a common characteristic: when the occluder 14 comes into contact with tissue fluid or hot vapor at a specific temperature, it will expand slightly. This expansion phenomenon brings significant technical benefits, achieving adaptive sealing. In actual treatment, the surface of human glandular tissue may not be completely smooth, with some minor unevenness. When the occluder 14 adheres to the tissue surface, a single-material occluder 14 may not be able to completely fill these tiny gaps, leading to a small amount of hot vapor leakage. By employing a heat-expanding material as the third layer, when the occluder 14 comes into contact with tissue and is subjected to hot steam, the heat-expanding material begins to expand. It automatically adjusts its shape and volume according to the unevenness of the tissue surface, filling those tiny gaps and making the fit between the occluder 14 and the tissue surface tighter, further enhancing the sealing effect. This adaptive sealing function is something that a single-material occluder 14 cannot achieve. It greatly improves the safety and reliability of the hot steam therapy equipment, effectively avoiding adverse consequences such as burns that may be caused by minor leaks, and providing patients with safer treatment protection.

[0054] For example, the second layer is made of a nickel-based alloy or a titanium alloy. Both materials have unique performance advantages. Taking nickel-based alloys as an example, their mesh skeleton undergoes a chemical change at 60°C, significantly increasing its strength. This characteristic plays a crucial role during steam therapy when the steam pressure is too high or there is a tendency for leakage. In the face of steam leakage, one can only passively withstand the impact of the steam, and if the impact is too great, it can cause serious consequences such as burns to non-treatment areas. However, the situation is completely different when the sealing device 14 of this steam therapy equipment uses a mesh skeleton made of nickel-based alloy or titanium alloy. When steam leaks, the high-temperature steam raises the ambient temperature. When the temperature reaches about 60°C, the nickel-based alloy mesh skeleton begins to undergo a chemical change, increasing its strength. This change allows the sealing device 14 to better resist the impact of the steam and not be easily broken open, thus effectively preventing steam leakage. More importantly, this design is not just a passive sealing, but can actively enhance the seal according to the actual environment (humidity, temperature). In actual treatment, the surface of human tissue secretes tissue fluid, and the temperature of the tissue fluid varies with the treatment process and environmental changes. The mesh skeleton made of nickel-based alloy or titanium alloy can sense these environmental changes. When the temperature reaches a certain level, it actively adjusts the sealing performance of the occluder 14 through its own changes in properties and increased strength, further enhancing the sealing effect.

[0055] Furthermore, a necking annular groove 1312 is provided at the connection between the needle tip 131 and the occluder 14. The necking design effectively avoids increasing the outer diameter of the puncture needle 13. In the medical field, the outer diameter of the puncture needle 13 is a crucial parameter. A smaller outer diameter reduces tissue damage during puncture, lessens patient discomfort, and facilitates smoother entry of the puncture needle 13 into narrow tissue channels or glandular needle holes. The necking design at the connection avoids a direct, forceful connection between the occluder 14 and the puncture needle 13, preventing an increase in the overall outer diameter of the puncture needle 13. This not only reduces the difficulty of puncture but also avoids more complications such as tissue tearing and bleeding. The necking design ensures a secure connection between the occluder 14 and the puncture needle 13 while maintaining a smaller outer diameter of the puncture needle 13, improving the safety and success rate of the puncture procedure.

[0056] In actual processing, besides the conventional necking bonding method mentioned above, the metal mesh skeleton of the occluder 14 can also be thermally fused together with the puncture needle 13. This thermal fusion connection method has many significant advantages. In terms of connection strength, thermal fusion connection achieves a high degree of fusion between the metal mesh skeleton of the occluder 14 and the puncture needle 13. During the thermal fusion process, the contact surfaces of the metal mesh skeleton and the puncture needle 13 melt under high temperature, then permeate and mix with each other, forming a whole after cooling. This fusion method makes the strength of the connection point far higher than ordinary bonding, capable of withstanding greater external forces. During puncture, even if hard tissue is encountered or significant resistance is experienced, the thermally fused occluder 14 will not separate from the puncture needle 13, ensuring smooth treatment. From the perspective of sealing performance, thermal fusion connection provides a more reliable sealing effect. Since the metal mesh skeleton and the puncture needle 13 form a seamless whole through thermal fusion, there are no gaps or air bubbles that may exist in adhesives, thus effectively preventing hot vapor leakage from the connection point during treatment. In steam therapy, steam leakage not only reduces treatment effectiveness but can also cause serious consequences such as burns to surrounding non-treatment areas. The sealing performance of a heat-fused connection minimizes the risk of such incidents, providing a safer treatment environment for patients. From a stability and durability perspective, the combination of the heat-fused occluder 14 and the puncture needle 13 offers superior stability and durability. Unlike adhesive bonding methods, it is not susceptible to factors such as adhesive aging and detachment during long-term use.

[0057] Furthermore, the needle body segment 132 extends along a first direction and has the function of freely advancing or retracting along the first direction. The needle tip segment 131 is arc-shaped, and the inner wall of the needle outlet channel is provided with an arc-shaped slide groove 121. The needle tip segment 131 can closely conform to the contour of the arc-shaped slide groove 121 and slide smoothly along its trajectory, thereby realizing the action of extending or retracting the needle outlet channel. This arc-shaped design allows the puncture needle 13 to better adapt to the physiological curves and structures of human tissue when entering it, reducing damage to surrounding tissues and lowering the patient's pain and the risk of complications. At the same time, the arc-shaped slide groove 121 provides precise guidance for the movement of the needle tip segment 131, ensuring the stability and accuracy of the needle tip segment 131 during extension and retraction, and improving the success rate of puncture operations.

[0058] As the needle tip 131 slowly extends under the guidance of the arc-shaped slide groove 121, the occluder 14 opens before contacting the gland. This pre-opening action prepares the site for subsequent occlusion. When the puncture needle 13 enters the gland, the opened occluder 14 comes into contact with the gland, tightly sealing the puncture site. The sealing effect of the occluder 14 effectively prevents hot steam from escaping during treatment, avoiding burns to surrounding non-treatment areas and ensuring the safety and effectiveness of the treatment.

[0059] For example, when the puncture needle 13 is fully extended from the end piece 12, the distance between the needle tip and the outer side of the end piece 12 is set within the range of 7mm-25mm, preferably 15mm-25mm. This distance setting fully considers the usage requirements and safety of the puncture needle 13 in different treatment scenarios. Simultaneously, the distance t between the occluder 14 and the needle tip can be designed to be 7mm-25mm. This diverse distance design allows the device to flexibly select appropriate specifications based on different treatment sites, gland size, and tissue characteristics. For example, for smaller glands or shallower tissue layers, a smaller t value can be selected to ensure that the occluder 14 can more accurately close the needle hole; while for larger glands or deeper tissue layers, a larger t value can be selected to provide a wider occlusion range. Therefore, based on different t designs, the device can be derived into various specifications to meet the needs of different clinical situations, improving the applicability and versatility of the device.

[0060] Furthermore, the inner diameter of the inner wall of the needle outlet channel, near the outlet, gradually increases, forming a conical opening 122. In practical applications, to further optimize the performance of the occluder 14, the conical opening 122 at the outlet of the end piece 12 can be designed as a multi-stage stepped or curved slide. During the retraction phase: as the puncture needle 13 slowly passes through the conical opening 122 with the folded occluder 14, the conical opening 122 begins to play its unique role. It is not just a simple directional guide device, but a structure capable of applying precise force to the occluder 14. The conical opening 122 applies a progressive, uniform radial compressive force to the occluder 14. This progressive force application allows the occluder 14 to be gradually compressed as it passes through the conical opening 122, like a slowly compressed spring, storing a large amount of elastic potential energy. During the extension phase: The moment the occluder 14 exits the end piece 12, the stored elastic potential energy is released instantaneously, allowing the occluder 14 to achieve an initial, more rapid opening speed, much like a spring. This rapid opening speed ensures that the occluder 14 reaches its maximum opening diameter in the shortest possible time, quickly adhering to the tissue. In steam therapy, time is crucial; rapid occlusion effectively prevents steam leakage, improving treatment efficacy and safety. This needle outlet channel design with a conical nozzle 122 enables the occluder 14 to achieve instantaneous occlusion, significantly shortening the occlusion time, reducing the risk of steam leakage, and providing patients with more reliable treatment protection. Simultaneously, this design also improves the operational efficiency and stability of the equipment, allowing medical personnel to perform puncture and occlusion procedures more easily and accurately.

[0061] Furthermore, the sheath assembly 1 includes a needle holder 15 and a needle hub 16. The needle holder 15 is securely fitted onto the tail end of the needle body 11 and tightly connected to the needle body 11 via a reliable adhesive bonding method. This fixing and bonding design ensures that the needle holder 15 and the needle body 11 will not loosen or separate, maintaining a stable connection during the puncture operation of the puncture needle 13 and subsequent hot steam delivery, providing a solid foundation for the entire treatment process. The needle hub 16 is also fixedly fitted onto the needle body segment 132 of the puncture needle 13 and securely connected via an adhesive bonding process. The tight connection between the needle hub 16 and the puncture needle 13 allows the puncture needle 13 to move accurately in a predetermined direction and motion when driven by external force, ensuring the accuracy and stability of the puncture operation.

[0062] Furthermore, such as Figure 7As shown, the hot steam therapy device also includes a handle assembly 2, which includes a handle shell 21 and an ejector device 23. The handle shell 21 provides external support and protection for the entire handle assembly 2, and its shape is designed to conform to the human hand grip, making it convenient for medical staff to operate for extended periods without fatigue. The needle holder 15 is inserted into the insertion interface 211 of the handle shell 21, realizing the initial connection between the sheath assembly 1 and the handle assembly 2. A mounting bracket 22 is provided inside the handle shell 21, providing a stable foundation for the installation and fixation of other components. The ejector device 23 is mounted on the mounting bracket 22 and is connected to the needle holder 16 via a transmission. As the core component driving the movement of the puncture needle 13, the ejector device 23 has powerful power output and precise control capabilities. It can drive the needle holder 16 forward or backward in a first direction according to the operating instructions of the medical staff, thereby driving the puncture needle 13 to extend or retract. This ejection-driven method makes the movement of the puncture needle 13 faster and more accurate, greatly improving the efficiency and success rate of the puncture operation and reducing the pain and discomfort of the patient during the puncture process.

[0063] Furthermore, the handle assembly 2 also features a complete hot steam generation and delivery system. The handle assembly 2 includes a heater 24, a water inlet pipe 25, and an adapter hose 26. The heater 24 is mounted on the mounting bracket 22 and has a steam generation chamber with input and output ports at both ends. The water inlet pipe 25 connects to the input port, accurately introducing external water into the steam generation chamber. Under the action of the heater 24, the water entering the steam generation chamber is rapidly heated to boiling, generating a large amount of hot steam. This method of directly heating water with the heater 24 to generate hot steam ensures stable temperature and pressure of the hot steam, providing a reliable heat source for subsequent treatment. One end of the adapter hose 26 connects to the output port, and the other end connects to the needle tail section 133 and communicates with the hot steam delivery channel. The adapter hose 26 has good flexibility and sealing properties, ensuring smooth delivery of hot steam while preventing leakage during delivery. Once the heater 24 generates hot steam, the hot steam is quickly and accurately delivered to the hot steam delivery channel of the puncture needle 13 through the adapter hose 26, and finally reaches the treatment site to achieve hot steam treatment of the diseased tissue.

[0064] Optionally, different sections of the puncture needle 13 can be made of materials with different stiffness or undergo different heat treatment processes. For example, the needle tail section 133 has high stiffness to ensure effective transmission of the injection force, while the needle tip section 131 (especially the curved part) has slightly lower stiffness to increase flexibility. This design allows the puncture needle 13 to better adapt to the soft characteristics of prostate tissue while having sufficient puncture force, reducing tissue tearing, and more flexibly matching the curved slide groove 121 of the end piece 12, making the opening action of the occluder 14 smoother and more reliable.

[0065] Furthermore, the handle assembly 2 also includes buttons, a circuit board 210, a control valve 27, an infusion tube 28, and a drain tube 29. Multiple buttons, the control valve 27, and the ejection device 23 are all electrically connected to the circuit board 210. Pressing different buttons can trigger the ejection device 23 and the control valve 27 to enter different operating modes. The infusion tube 28 is connected to the control valve 27, and the drain tube 29 is also connected to the control valve 27. The sheath assembly 1 also includes a flushing tube 17, one end of which is located inside the needle body 11, and the other end extends into the handle housing 21 and is connected to the control valve 27. The control valve 27 can connect the infusion tube 28 to the flushing tube 17 for flushing or injecting water to expand the gland, and it can also connect the drain tube 29 to the flushing tube 17 for draining blood or other tissue from the gland.

[0066] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. A hot steam therapy device, characterized in that, Includes a sheath assembly (1), the sheath assembly (1) comprising: The syringe body (11) has a receiving cavity extending in a first direction; End piece (12), the end piece (12) is connected to the first end of the needle tube body (11), the end piece (12) has a needle outlet channel, the needle outlet channel is connected to the accommodating cavity; A puncture needle (13) is used to deliver hot steam. The puncture needle (13) has a hot steam delivery channel inside. The puncture needle (13) is disposed inside the needle tube body (11) and can extend or retract the needle delivery channel. The puncture needle (13) includes a needle tip section (131), a needle body section (132) and a needle tail section (133) connected in sequence. The peripheral sidewall of the needle tip section (131) is provided with a plurality of air outlet holes (1311). The plurality of air outlet holes (1311) are all connected to the hot steam delivery channel. An occluder (14) is fixedly sleeved on the needle section (131), and the outer diameter of the occluder (14) is larger than the outer diameter of the puncture needle (13).

2. The hot steam therapy device according to claim 1, characterized in that, The occluder (14) is trumpet-shaped or umbrella-shaped. When the hot steam therapy device is in a non-puncture state, the occluder (14) is housed inside the end piece (12).

3. The hot steam therapy device according to claim 2, characterized in that, The plug (14) includes a first layer structure and a second layer structure. The first layer structure is wrapped around the outer wall of the second layer structure. The first layer structure is a non-metallic elastic membrane, and the second layer structure is a mesh skeleton.

4. The hot steam therapy device according to claim 3, characterized in that, The material of the second layer is a nickel-based alloy or a titanium alloy.

5. The hot steam therapy device according to claim 4, characterized in that, The second layer structure has a filling space inside, and the plug (14) also includes a third layer structure, which is filled inside the second layer structure and is made of a thermally expanding material.

6. The hot steam therapy device according to claim 1, characterized in that, A necking annular groove (1312) is provided at the connection between the needle section (131) and the plug (14).

7. The hot steam therapy device according to claim 1, characterized in that, The needle body segment (132) extends along the first direction and can move forward or backward along the first direction. The needle tip segment (131) is curved in an arc shape. The inner wall of the needle outlet channel is provided with an arc-shaped slide groove (121). The needle tip segment (131) can slide along the arc-shaped slide groove (121) and extend or retract into the needle outlet channel.

8. The hot steam therapy device according to claim 1, characterized in that, The inner diameter of the inner wall of the needle outlet channel gradually increases near the outlet and forms a conical opening (122).

9. The hot steam therapy device according to any one of claims 1-8, characterized in that, The sheath assembly (1) includes a needle holder (15) and a needle seat (16). The needle holder (15) is fixedly sleeved on the tail end of the needle body (11), and the needle seat (16) is fixedly sleeved on the needle body segment (132) of the puncture needle (13). The hot steam therapy device also includes a handle assembly (2), which includes: Handle housing (21), the needle tube seat (15) is inserted into the insertion interface (211) of the handle housing (21), and a mounting bracket (22) is provided inside the handle housing (21); The ejection device (23) is mounted on the mounting bracket (22). The ejection device (23) is connected to the needle seat (16) in a transmission manner. The ejection device (23) is used to drive the needle seat (16) to move forward or backward in the first direction.

10. The hot steam therapy device according to claim 9, characterized in that, The handle assembly (2) further includes: A heater (24) is mounted on the mounting bracket (22), the heater (24) having a steam generating chamber and an input port and an output port located at both ends of the steam generating chamber; Water inlet pipe (25), the water inlet pipe (25) is connected to the input port; The adapter hose (26) has one end connected to the output port and the other end connected to the needle tail section (133) and connected to the hot steam conveying channel.

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