An infusion system for a vapor ablation system

Abstract

The application provides an infusion system for a steam ablation system, which is electrically connected with a control system of the steam ablation system, and comprises an infusion module, a driving module and a fixing module; the infusion module comprises a liquid containing assembly and a propelling assembly, the steam ablation liquid is arranged in the liquid containing assembly, the proximal end of the propelling assembly is connected with the driving module, the distal end is sleeved in the liquid containing assembly, the axis of the liquid containing assembly and the axis of the propelling assembly are arranged in a collinear manner which meets a preset deviation condition, the propelling assembly realizes axial movement after changing a movement space track, and the liquid in the liquid containing assembly is output for steam ablation when the propelling assembly moves axially from the proximal end to the distal end. The scheme can improve the pressure detection precision and the infusion metering precision, improve the system response speed, reduce the relative position stress deviation, shorten the pressure balance establishment time, and improve the stability of steam generation and the conveying quality.

Description

Technical Field

[0001] This invention relates to the field of steam ablation technology, and in particular to an injection system for a steam ablation system. Background Technology

[0002] Steam ablation systems are important devices in modern medicine used to treat diseases such as benign prostatic hyperplasia. Their core working principle involves precisely controlling a syringe to propel liquid and generate steam, thereby achieving precise ablation of target tissue. The infusion system, as the source of the liquid in the steam ablation system, is crucial for controlling the amount of steam delivered precisely.

[0003] Currently available steam ablation systems on the market mainly consist of a traditional syringe, a control system, a drive mechanism, a propulsion mechanism, and a clamping mechanism. The traditional syringe, drive mechanism, and propulsion mechanism are all mounted on the clamping mechanism. The control system can be mounted on the clamping mechanism or externally, as long as the control system is electrically connected to the drive mechanism. The drive mechanism mainly includes a drive motor and other structures. The propulsion mechanism mainly includes a lead screw, a slide bar, a slider, a connecting rod, and a push block. The lead screw and slide bar are arranged in parallel and both pass through the slider. A nut matching the lead screw is set at the point where the lead screw passes through the slider. The slider is connected to one end of the connecting rod, and a push block is set at the other end of the connecting rod. The connecting rod is also arranged in parallel with the lead screw. When the traditional syringe is mounted on the clamping mechanism, the connecting rod is arranged parallel to the axis of the traditional syringe. Its working principle involves mounting a traditional syringe on a clamping mechanism. A drive motor indirectly drives a lead screw via gears, causing a slider to move axially along the lead screw. The slider then drives a connecting rod to move axially, which in turn drives a push block to move axially. This push block then drives a push rod to move axially, thus achieving the axial movement of the push rod along the traditional syringe, enabling the liquid infusion process. However, in practical applications, this infusion system has revealed numerous technical defects, severely impacting the performance and therapeutic effect of the steam ablation system. The main problems are as follows: (1) Insufficient pressure detection accuracy or easy damage to the pressure detector Currently, most steam ablation systems do not support pressure detection, making it impossible to monitor and control pressure changes during the injection process in real time.

[0004] Some models are equipped with pressure detection functionality, and their pressure detectors typically employ one of the following three layouts: 1) Installed at the connection between the slider and the connecting rod, it detects the force between the slider and the connecting rod. Due to the deflection torque generated on the push block, the clearance fit design of the traditional syringe plunger, and the compression deformation of the plunger and piston during force transmission, there will be some error when calculating the injection volume by detecting the force between the slider and the connecting rod. The detection accuracy is difficult to meet the needs of high-precision treatment. Furthermore, since the compression deformation of the plunger and piston will change nonlinearly depending on the force, there will also be some deviation in the error caused at different times during the infusion process. It is difficult to obtain an accurate injection volume by calculating the error in advance.

[0005] 2) Installed at the connection between the plunger and the traditional syringe plunger, it detects the force between the plunger and the plunger. Due to errors caused by the clearance fit design of the traditional syringe plunger, the deformation of the plunger and piston under pressure, and the gap caused by the flatness deviation at the joint between the plunger and the plunger during force transmission, there will be a certain error when calculating the injection volume based on the detected force between the plunger and the plunger. The detection accuracy is difficult to meet the needs of high-precision treatment. Similarly, since the deformation of the plunger and piston under pressure will change non-linearly depending on the force, the error caused at different times during the infusion process will also have a certain deviation, making it difficult to obtain an accurate injection volume by calculating the error in advance.

[0006] 3) The contact surface between the distal end of a conventional syringe and the clamping mechanism exposes the pressure detector, making it susceptible to damage.

[0007] Clearly, layout schemes 1) and 2) will result in insufficient precision, which will lead to problems such as inaccurate control of the physical parameters of steam generation, difficulty in maintaining stable treatment pressure, affecting the repeatability and consistency of treatment effects, and increasing safety risks during treatment; while layout scheme 3) will increase the risk of damage to the pressure detector.

[0008] (2) Measurement inaccuracies caused by mechanical structure design defects Because the existing infusion system's mechanical structure design uses a non-coaxial arrangement between the propulsion mechanism and the traditional syringe, this design results in a deflection torque on the push block when force is applied. Since the push block typically uses a clearance fit, this deflection torque can further cause a small displacement deviation, leading to problems such as inaccurate metering in micro-injections and performance degradation due to pressure fluctuations in steam ablation applications.

[0009] (3) Traditional syringes are prone to deformation under pressure. During low-speed infusion, if a sudden pressure change occurs in the tubing, the system must first overcome the tubing deformation caused by the pressure change before it can continue infusing at a specific flow rate. Even though the tubing volume change caused by the pressure change is usually less than 0.1 ml, it still takes several seconds for the flow rate to stabilize in systems with low infusion rates. Furthermore, if flow rate changes are controlled during this process, they are usually accompanied by changes in tubing pressure. Therefore, the deformation of the plunger of a traditional syringe during axial compression can lead to problems such as slower system response at higher pressures and lag in response to rapid pressure changes. In addition, the piston of a traditional syringe is made of rubber, which will also undergo compression deformation under pressure, further slowing down the response. Moreover, since the axial positioning of a traditional syringe relies on the proximal flange of the syringe barrel, the proximal flange is also prone to deformation under pressure, further affecting the system response speed.

[0010] (4) Structural stability issues The existing infusion system has a relatively loose overall structural design, which can easily lead to large structural deformation under stress. In addition, the several positioning points are fixed on the plastic base shell. When under stress, the strain of the material will cause relative positional movement, which will further amplify the aforementioned problems of inaccurate measurement and pressure fluctuation, affect the long-term stability and reliability of the equipment, and increase the frequency and difficulty of maintenance and calibration.

[0011] (5) Negative impact on steam dissipation performance The aforementioned technical defects make it easy for the existing injection system to cause the following problems during steam generation when applied in the field of steam ablation: 1) Continuous pressure fluctuations in the pipeline: Sudden pressure changes cause large fluctuations in the fluid infusion flow rate, making it difficult to control the steam generation process and affecting the accuracy and safety of the treatment; 2) Longer time to establish pressure balance: It takes longer to reach stable therapeutic pressure, which reduces treatment efficiency and increases patient discomfort; 3) Saturated steam condensation problem: Pressure fluctuations can easily cause saturated steam to condense, resulting in an unstable steam state, which is not conducive to the stable generation and delivery of steam and affects the consistency of treatment effects.

[0012] In view of the above-mentioned defects in the existing technology, the industry urgently needs a new type of steam ablation system delivery system design to solve the problems of pressure detection accuracy, mechanical structure design, pressure deformation, structural stability, and negative impact on steam ablation performance in the existing steam ablation system delivery system. Summary of the Invention

[0013] This invention provides a delivery system for a steam ablation system to overcome the shortcomings of the prior art. It improves pressure detection accuracy and delivery metering accuracy, enhances system response speed, reduces relative positional force offset, shortens pressure balance establishment time, improves the stability of steam generation and delivery quality, and ensures long-term system stability and reliability.

[0014] To solve the above-mentioned technical problems, the present invention provides the following technical solution: According to an embodiment of the present invention, an injection system for a steam ablation system is provided, which is electrically connected to the control system of the steam ablation system, and includes an injection module, a drive module and a stationary module; The infusion module includes a liquid container assembly and a propulsion assembly. The liquid container assembly contains liquid for vapor ablation. The proximal end of the propulsion assembly is connected to the drive module, and the distal end is fitted inside the liquid container assembly. The axis of the liquid container assembly and the axis of the propulsion assembly are collinear to meet a preset deviation condition. The propulsion assembly achieves axial movement after changing its trajectory in the motion space. When the propulsion assembly moves axially from the proximal end to the distal end, the liquid in the liquid container assembly is output for vapor ablation. The fixing module is used to fix the infusion module and the drive module; The control system is electrically connected to the drive module and is configured to regulate the drive module to regulate the axial movement of the propulsion component, thereby regulating the amount of stored liquid in the liquid container component, thus realizing the regulation of the output liquid volume of the liquid container component; wherein, the propulsion component can avoid generating deflection torque and deflection play during the propulsion process, thereby shortening the pressure / flow balance establishment time in the event of pressure change during low-dose output, thereby reducing / eliminating unexpected pressure fluctuations in the vapor ablation pipeline.

[0015] In one exemplary embodiment, the fixing module includes a fixing frame and a liquid containing component baffle. The fixing frame has a transversely arranged F-shaped structure. The drive module is connected to the proximal end of the fixing frame. The propulsion component is connected through to the proximal and middle ends of the fixing frame, respectively. The liquid containing component baffle is disposed at the distal end of the fixing frame and has a first slot that matches the distal end of the liquid containing component. This slot is used to restrict the axial and circumferential positioning of the liquid containing component, forming a centering constraint at the distal end. The overall assembly formed by the liquid containing component baffle and the fixing frame has a W-shaped structure to ensure the coaxiality of the liquid containing component and the propulsion component, thereby achieving the axial positioning of the infusion module.

[0016] In one exemplary embodiment, the distal end face of the liquid receiving assembly that is perpendicular to the axial direction and contacts the first slot is set as a spherical surface, and the surface in the first slot corresponding to the distal end face of the liquid receiving assembly is set as a conical surface, so that reliable contact between the tangent of the spherical surface and the conical surface can still be guaranteed when the actual mounting axis of the liquid receiving assembly deviates from the ideal mounting axis at an angle.

[0017] In one exemplary embodiment, the fixing module further includes a clamping member disposed at the proximal end of the liquid containing assembly and sleeved on the outside of the propulsion assembly. The clamping member is connected to the middle end of the fixing frame via evenly distributed elastic members. The fixing frame is provided with a second slot that matches the clamping member. Under the elastic force of the elastic members, the clamping member contacts the proximal end face of the liquid containing assembly, providing axial clamping force to the liquid containing assembly to improve the centering constraint effect at the distal end, and can move axially within the second slot.

[0018] In one exemplary embodiment, the clamping member has a cylindrical annular structure or a convex annular structure, and the distal end of the elastic member is connected to or embedded in the proximal end face of the clamping member.

[0019] In one exemplary embodiment, the mounting bracket is further provided with a third slot that matches the outer side of the liquid containing assembly. The distal end of the third slot is connected to the first slot, and the proximal end is connected to the second slot, so as to achieve overall coaxial constraint of the liquid containing assembly and ensure overall coaxiality and operational stability.

[0020] In one exemplary embodiment, the propulsion assembly includes a push rod and a lead screw whose axes are collinearly arranged to meet a preset deviation condition. The push rod is sleeved on the outside of the lead screw, and its distal end is sleeved inside the liquid containment assembly. The proximal end of the lead screw is connected to the drive module to realize the spatial trajectory change of converting rotational motion into linear motion. The push rod has a thread that matches the lead screw; or, the near end of the push rod has a connecting structure, the lead screw passes through the connecting structure, and the connecting structure has a thread that matches the lead screw. Under the driving action of the drive module, the lead screw rotates, thereby realizing the axial movement of the push rod.

[0021] In one exemplary embodiment, when the connecting structure is provided at the proximal end of the push rod, the propulsion assembly further includes a slide rod, which is arranged parallel to the lead screw and passes through the connecting structure and is slidably connected to the connecting structure to improve the stability of axial movement.

[0022] In one exemplary embodiment, the connection structure includes a slider having a thread that matches the lead screw, or the slider has a nut embedded therein having a thread that matches the lead screw.

[0023] In one exemplary embodiment, the liquid containment assembly includes an infusion cylinder and a piston, the piston being slidably connected to the inner wall of the infusion cylinder, a pressure detector being disposed at the distal end of the push rod, the pressure detector being connected to the piston and used to measure the thrust of the liquid in the infusion cylinder on the piston, and the pressure detector being electrically connected to the control system.

[0024] In one exemplary embodiment, a protective cover is provided at the distal end of the push rod. One side of the protective cover is movably connected to the piston, and the other side is connected to the pressure detector, so as to simultaneously prevent water ingress and reduce errors.

[0025] In one exemplary embodiment, the push rod has a double-tube structure, including an inner push tube and an outer push tube. The outer push tube is hollow. The inner push tube is coaxial with the outer push tube and disposed inside the outer push tube. The proximal end of the outer push tube is connected to the proximal end of the inner push tube. The length of the inner push tube is less than the length of the outer push tube. The lead screw is sleeved inside the inner push tube. The pressure detector is disposed at the distal end of the outer push tube and located inside the outer push tube to provide wiring space so that the electrical connection wire of the pressure detector can be disposed between the outer push tube and the inner push tube.

[0026] In one exemplary embodiment, the piston is made of a hard material and has a seal on its outer periphery to reduce / eliminate the amount of compression deformation of the piston under pressure.

[0027] In one exemplary embodiment, the drive module includes a drive component and a transmission component, the drive component being connected to the transmission component and electrically connected to the control system, and the transmission component being connected to the propulsion component; or, the drive module includes a drive component, and the drive component is connected to the propulsion component.

[0028] By adopting the above technical solution, the present invention has the following beneficial effects: (1) The infusion system of the present invention achieves the effect of supporting pressure detection by setting a pressure detector at the far end of the push rod, which is affected by the thrust of the liquid in the liquid container assembly on the piston. The piston and the pressure detector are separated by only a protective cover, so that the reaction force of the liquid inside the liquid container assembly on the piston is equivalent to acting directly on the pressure detector, which can intuitively and with minimal error reflect the magnitude of the internal pressure of the liquid container assembly. Furthermore, the pressure detector is set inside the push rod and is not exposed. Therefore, it can effectively avoid the problems of insufficient pressure detection accuracy and easy damage of the pressure detector caused by the layout of the pressure detector in the prior art. Currently, experiments have shown that the linearity error of the pressure detection of the present invention is <5%.

[0029] (2) The axis of the liquid container component and the axis of the propulsion component of the present invention are collinearly arranged to meet the preset deviation conditions, so that no deflection torque or deflection play is generated during the infusion process, thereby improving the metering accuracy during the infusion process; and since the infusion system needs a longer time to reach pressure / flow balance when the pressure changes at low doses, the infusion system provided by the present invention has a more significant improvement in metering accuracy at low doses compared with the traditional infusion system that generates deflection torque and deflection play.

[0030] (3) The liquid container assembly of the present invention directly realizes the change of liquid volume inside the liquid container assembly through the propulsion assembly, omitting the built-in push rod design, thereby avoiding the problems caused by the deformation of the traditional syringe push rod part during axial compression, which leads to slow system response when the pressure is high and lag response when the pressure changes rapidly, effectively improving the system response speed.

[0031] (4) The piston of the present invention adopts a design with hard material and sealing elements on the outer periphery. Compared with the rubber piston design of traditional syringes, it reduces / eliminates the amount of compression deformation of the piston after being compressed, avoids the problem of slow system response caused by piston compression deformation, and effectively improves the system response speed.

[0032] (5) The liquid containment assembly of the present invention does not have a proximal flange. Its axial positioning relies on the axial clamping force provided by the clamping member provided at its proximal end, which avoids the problem of the traditional syringe axial positioning relying on the proximal flange which is easily deformed by pressure, thus further affecting the system response speed and effectively improving the system response speed.

[0033] (6) The present invention maximizes the system response speed by omitting the push rod of the liquid container assembly, using a hard piston in conjunction with the outer peripheral seal, and changing the axial positioning of the liquid container assembly from the proximal flange to the proximal end face.

[0034] (7) The present invention designs the far end face of the liquid container assembly as a spherical surface and the surface in the first slot corresponding to the far end face of the liquid container assembly as a conical surface, so that when the actual mounting axis of the liquid container assembly and the ideal mounting axis have a small angular offset, this fit can still ensure reliable contact between the tangent of the spherical surface and the conical surface, and will not have the suspension situation that may occur when the end face is in plane fit. Especially for the case of a large end face area, this suspension may lead to differences in accuracy between different installation positions.

[0035] (8) By setting a third slot on the fixed frame, the present invention can further constrain the overall coaxiality of the liquid container assembly and further ensure the overall coaxiality; and since the third slot plays a limiting role in the vertical direction of the axial direction of the liquid container assembly, setting a third slot can also further ensure the stability of the operation of the liquid container assembly.

[0036] (9) The present invention sets the push rod as a double sleeve structure so that the inner sleeve and the outer sleeve can be used to accommodate wire harness structures such as electrical connection wires, providing wiring space for the wire harness structure, which is beneficial to the protection of the wire harness structure. It can effectively avoid damage to the built-in wire harness structure caused by friction from the movement of other structures, and can also avoid the risk of damage caused by the external wire harness structure.

[0037] (10) The overall structural design of the present invention is more integrated than the existing infusion system, which can avoid the problem of large structural deformation under stress due to loose overall structural design, reduce the probability and amount of structural deformation, and improve structural stability.

[0038] (11) The main positioning points of the present invention are all located on the same axis / distributed around the same axis. Compared with the existing decentralized positioning design of multiple positioning points in the infusion system, it can eliminate the datum conversion deviation, realize the datum uniformity, suppress the cumulative error, and thus achieve the accuracy improvement. Compared with the existing decentralized positioning design, it realizes the optimization of force flow path and the improvement of torsional stiffness, thereby realizing the strengthening of anti-offset capability, thus ensuring the long-term stability and reliability of the system, reducing the frequency of maintenance and calibration, and reducing the difficulty of maintenance and calibration.

[0039] (12) The fixing module of the present invention is made of high precision and high strength materials. Therefore, since the present invention installs all the parts that need to be positioned on the high precision and high rigidity fixing module, the influence of the deformation of the positioning point of the parts on the accuracy is reduced. This avoids the problem of material strain causing relative position movement when subjected to force, which is caused by fixing several positioning points on the plastic bottom shell respectively in the existing infusion system. That is, the present invention reduces the force offset of the relative position by using the high strength fixing module, so as to minimize the force offset of the relative position.

[0040] (13) Since the present invention avoids the technical defects of existing infusion systems, when applied in the field of steam ablation, the infusion of the present invention can reduce / eliminate pressure fluctuations in the pipeline, shorten the pressure balance establishment time, so as to establish pressure balance in the shortest time, improve treatment efficiency, reduce / avoid saturated steam condensation problems, improve the stability of steam generation and delivery quality, and ensure the consistency of treatment effect. Attached Figure Description

[0041] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments 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 these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of the structure of a steam ablation system provided in the first or second embodiment of the present invention; Figure 2 This is a schematic diagram of the main unit of a steam ablation system provided in the first or second embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of an injection system for a steam ablation system provided in the first embodiment of the present invention; Figure 4 This is a cross-sectional schematic diagram of an injection system for a steam ablation system provided in the first embodiment of the present invention; Figure 5 This is a cross-sectional schematic diagram of another delivery system for a steam ablation system provided in the first embodiment of the present invention; Figure 6 This is a cross-sectional schematic diagram of an injection system for a steam ablation system provided in the second embodiment of the present invention.

[0043] In the picture: 1. Infusion module; 11. Liquid containment assembly; 111. Infusion cylinder; 1112. Distal end face; 1113. Proximal end face; 112. Piston; 12. Propulsion assembly; 121. Push rod; 1211. Inner push tube; 1212. Outer push tube; 122. Lead screw; 123. Pressure detector; 1231. Electrical connection wire; 124. Protective cover; 125. Connection structure; 1251. Slider; 1252. Nut; 126. Slide rod; 2. Drive module; 21. Drive assembly; 22. Transmission assembly; 3. Fixed module; 31. Fixed frame; 311. Base; 312. Liquid containment component slot structure; 3121. Guide groove; 3122. Second slot; 3123. Third slot; 313. Middle fixing plate; 314. Proximal fixing plate; 32. Liquid containment component baffle; 321. First slot; 3211. Corresponding surface; 33. Clamping element; 331. Guide element; 332. Groove. Detailed Implementation

[0044] 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. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0045] The term "an embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the invention. In the description of the embodiments of the invention, it should be understood that the terms "upper," "lower," "top," "bottom," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first" and "second" may explicitly or implicitly include one or more of that feature. Moreover, the terms "first," "second," etc., are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein.

[0046] In this invention, "proximal end" corresponds to "distal end," and "distal end" is defined as the end where the liquid output end of the infusion system is located.

[0047] First embodiment: Please see Figure 1 The diagram shown is a structural schematic of a steam ablation system provided in this embodiment. The system mainly includes a handheld end and a main unit. The main unit provides liquid to the handheld end and controls the handheld end to achieve steam ablation.

[0048] Please see Figures 2-5This embodiment provides an injection system for a steam ablation system, which is electrically connected to the control system of the steam ablation system. Both the injection system and the control system are located in the host unit. The injection system includes an injection module 1, a drive module 2 and a fixed module 3. The infusion module 1 includes a liquid container 11 and a propulsion assembly 12. The liquid container 11 contains liquid for vapor ablation. The proximal end of the propulsion assembly 12 is connected to the drive module 2, and the distal end is fitted into the liquid container 11. The axis of the liquid container 11 and the axis of the propulsion assembly 12 are collinearly arranged to meet the preset deviation conditions. The propulsion assembly 12 achieves axial movement after changing its trajectory in the motion space. When the propulsion assembly 12 moves axially from the proximal end to the distal end, the liquid in the liquid container 11 is output for vapor ablation. Fixed module 3 is used to fix infusion module 1 and drive module 2; The control system is electrically connected to the drive module 2 and is configured to regulate the drive module 2 to regulate the axial movement of the propulsion component 12, thereby regulating the amount of liquid stored in the liquid container component 11, thus realizing the regulation of the output liquid volume of the liquid container component 11; wherein, the propulsion component 12 can avoid generating deflection torque and deflection play during the propulsion process, thereby shortening the pressure / flow balance establishment time in the case of pressure change during low dose output, thereby reducing / eliminating unexpected pressure fluctuations in the steam ablation pipeline.

[0049] Specifically, the control system mainly consists of a control circuit board, which can be mounted on the fixed module 3 or installed separately and electrically connected to the drive module 2 via wired / wireless connection (e.g., ...). Figure 2(As shown); the fixed module 3 can be made of high-precision, high-strength materials so that all components requiring positioning are installed on the high-precision, high-rigidity fixed module 3, reducing the impact of component positioning point deformation on accuracy. This avoids the problem of relative positional movement caused by material strain under stress, which is common in existing infusion systems where several positioning points are fixed separately to the plastic base shell. In other words, by using the high-strength fixed module 3, the relative positional force offset is reduced, minimizing the relative positional force offset. The collinear setting that meets the preset deviation conditions refers to taking the collinearity of the axis of the liquid container assembly 11 and the axis of the propulsion assembly 12 as the assembly reference target, and ensuring that the liquid container in the assembled state is collinear with the axis of the propulsion assembly 12. The positional error between the axis of component 11 and the axis of propulsion component 12 meets the preset deviation condition; Unexpected pressure fluctuations refer to abnormal instantaneous pressure surges, pressure drops, pressure oscillations, and pressure pulsations caused by pressure and flow matching lag and asynchronous medium response in the steam pipeline during the low-dose output of the infusion system and the transient pressure change in the pipeline. Such fluctuations are not normal small pressure fluctuations under the rated steady-state operation of the system. They are additional disturbing pressure deviations caused by the switching of operating conditions and pressure changes, which can easily cause pipeline impact, decreased operating stability, and inaccurate output parameters. Unexpected pressure fluctuations can be specifically manifested as pressure fluctuations exceeding the preset pressure fluctuation threshold.

[0050] In this embodiment, the infusion system is configured to have the axis of the liquid container 11 and the axis of the propulsion component 12 collinear to meet a preset deviation condition, so that no deflection torque or deflection play is generated during the infusion process, thereby improving the metering accuracy during the infusion process. Furthermore, since the infusion system requires a longer time to reach pressure / flow balance when there is a sudden pressure change at low doses, the metering accuracy improvement of this infusion system at low doses is more significant compared to traditional infusion systems that generate deflection torque and deflection play.

[0051] Furthermore, by omitting the built-in push rod 121 of the liquid container assembly 11, the liquid volume inside the liquid container assembly 11 is changed directly through the push assembly 12. This avoids the problems caused by the deformation of the push rod 121 of a traditional syringe during axial compression, which leads to a slow system response at high pressure and a lag in response when the pressure changes rapidly. This effectively improves the system response speed.

[0052] In one specific embodiment, the fixing module 3 includes a fixing frame 31, a liquid containing component baffle 32, and a clamping member 33.

[0053] The fixing frame 31 has a horizontally arranged F-shaped structure, and the liquid container assembly baffle 32 is located at the far end of the fixing frame 31, so that the overall assembly formed by the liquid container assembly baffle 32 and the fixing frame 31 has a W-shaped structure. The coaxiality of the liquid container assembly 11 and the propulsion assembly 12 is ensured by the three-point positioning method, thereby realizing the axial positioning of the infusion module 1.

[0054] The mounting bracket 31 includes a base 311, a liquid containment component slot structure 312, a mid-end fixing plate 313, and a proximal fixing plate 314, all of which are mounted on the base 311. The drive module 2 is mounted on the proximal fixing plate 314, and the propulsion component 12 is connected through to both the mid-end fixing plate 313 and the proximal fixing plate 314. The liquid containment component slot structure 312 is located at the liquid containment component stop. Between plate 32 and middle fixing plate 313, and connected to liquid container assembly baffle 32 and middle fixing plate 313, the upper end surface of liquid container assembly slot structure 312 is provided with a second slot 3122 matching the clamping member 33 and a third slot 3123 matching the outer side of liquid container assembly 11; by setting the third slot 3123, the liquid container assembly 11 can be further coaxially constrained, further ensuring overall coaxiality, even if due to machining accuracy issues When the liquid container assembly 11 is replaced, the replaced liquid container assembly 11 may not completely fit with the third slot 3123, but there will still be contact points. Therefore, the third slot 3123 can still provide further overall coaxial constraint for the liquid container assembly 11, further ensuring overall coaxiality. Furthermore, since the third slot 3123 plays a limiting role in the vertical direction of the axial direction of the liquid container assembly 11, the setting of the third slot 3123 can also further ensure the stability of the operation of the liquid container assembly 11. The liquid container assembly baffle 32 is provided with a first slot 321 that matches the distal end of the liquid container assembly 11. The first slot 321 has a convex structure on the top view, a U-shaped structure on the side view, and a stepped structure in the cross section to limit the axial and circumferential positioning of the liquid container assembly 11. The distal end of the third slot 3123 connects to the first slot 321, and the proximal end connects to the second slot 3122, with a smooth transition at the connection point.

[0055] The clamping member 33 is disposed at the proximal end of the liquid containing assembly 11 and sleeved on the outside of the propulsion assembly 12. The clamping member 33 is connected to the liquid containing assembly slot structure 312 through evenly distributed elastic members. At this time, the liquid containing assembly slot structure 312 is a horizontally arranged L-shaped structure when viewed from the front, and its proximal end matches the middle fixing plate 313. Alternatively, the clamping member 33 is connected to the middle fixing plate 313 through evenly distributed elastic members (not shown in the figure). At this time, the liquid containing assembly slot structure 312 is a horizontally arranged L-shaped structure when viewed from the front, and the whole structure formed by it and the middle fixing plate 313 is a horizontally arranged L-shaped structure when viewed from the front. The clamping member 33 contacts the proximal end face 1113 of the liquid containing assembly 11 under the elastic force of the elastic members, providing axial clamping force to the liquid containing assembly 11, and can move axially within the second slot 3122. When the liquid containing assembly 11 is installed in place, the clamping member 33 is in Under the elastic force of the elastic element, it contacts the proximal end face 1113 of the liquid container assembly 11, providing axial clamping force to the liquid container assembly 11, thereby centering the liquid container assembly 11 and making the axial movement of the propulsion assembly 12 within the liquid container assembly 11 more stable. When disassembling / replacing the liquid container assembly 11, the clamping element 33 can move axially from the distal end to the proximal end within the second slot 3122 to unload the axial clamping force applied to the liquid container assembly 11, thus facilitating the disassembly and installation of the liquid container assembly 11. By setting the clamping element 33 and the elastic element so that the distal end face 1112 of the clamping element 33 contacts the proximal end face 1113 of the liquid container assembly 11, it provides axial clamping force to the liquid container assembly 11, thereby forming a centering mechanism, so that both the distal end face 1112 and the proximal end face 1113 of the liquid container assembly 11 are subjected to clamping force, thereby achieving centering.

[0056] Optionally, the clamping element 33 has a straight cylindrical annular structure (e.g., Figure 3 As shown), at this time, the cross-section of the second slot 3122 is a straight structure, and the near end of the first slot 321, the third slot 3123 and the bottom cross-section of the second slot 3122 are all located on the same plane, or, the clamping member 33 has a convex ring structure (as shown). Figure 2 As shown), at this time, the cross-section of the second slot 3122 has a stepped structure. The bottom cross-sections of the near end of the first slot 321, the third slot 3123, and the far end of the second slot 3122 are all located on the same plane. The height of the bottom cross-section of the near end of the second slot 3122 is lower than the height of the bottom cross-section of the far end of the second slot 3122.

[0057] Preferably, guide members 331 are symmetrically arranged on both sides of the clamping member 33. The plane where the guide member 331 is located is the same plane as the plane where the axis of the clamping member 33 is located. The upper end face of the liquid containing component slot structure 312 is also provided with a guide groove 3121 that matches the guide member 331, so as to facilitate the guidance and operation of the axial movement of the clamping member 33.

[0058] Optionally, the distal end of the elastic element is connected to or embedded in the proximal end face of the clamping element 33. When the distal end of the elastic element is embedded in the clamping element 33, the proximal end face of the clamping element 33 is provided with a groove 332 that matches the elastic element. Preferably, the elastic element can be a spring.

[0059] The liquid containment assembly 11 includes an infusion cylinder 111 and a piston 112, with the piston 112 slidably connected to the inner wall of the infusion cylinder 111. The infusion cylinder 111 contains liquid for a vapor ablation system. When the propulsion assembly 12 moves axially from the proximal end to the distal end within the infusion cylinder 111, it drives the piston 112, which is in contact with it, to move axially from the proximal end to the distal end, thereby achieving the output of liquid from the infusion cylinder 111. The distal end face 1112 of the infusion cylinder 111, which is perpendicular to the axial direction and contacts the first slot 321, is set as a spherical surface. The surface 3211 within the first slot 321 corresponding to the distal end face 1112 of the infusion cylinder 111 is set as a conical surface, so that the actual mounting axis of the liquid containment assembly 11 has a small angle with the ideal mounting axis. Even during offset, this fit still ensures reliable contact between the tangent of the spherical surface and the conical surface, avoiding the suspension that may occur with end-face planar fits. This suspension is particularly important for cases with large end-face areas, as it can lead to differences in accuracy between different installation positions. The piston 112 is made of a hard material, and a seal is provided on the outer periphery of the piston 112. The piston 112 achieves a seal with the inner wall of the infusion cylinder 111 through the seal. Compared with the rubber piston 112 design of traditional syringes, this reduces / eliminates the amount of compression deformation of the piston 112 under pressure, avoiding the problem of slow system response caused by piston 112 compression deformation, and effectively improving the system response speed. Optionally, the piston 112 can be made of hard plastic, and the seal can be an O-ring.

[0060] It should be noted that, compared with traditional syringes, this liquid containment assembly 11 omits the proximal flange of the built-in plunger 121 and the infusion cylinder 111. This avoids the problems caused by the deformation of the plunger 121 of traditional syringes during axial compression, which leads to slow system response at high pressure and lag response when pressure changes rapidly. It also avoids the problem of the axial positioning of traditional syringes relying on the easily deformable proximal flange, which further affects the system response speed, thus effectively improving the system response speed.

[0061] The infusion system maximizes the system's response speed through a comprehensive design that omits the push rod 121 of the liquid container assembly 11, adopts a hard piston 112 in conjunction with an outer peripheral seal, and changes the axial positioning of the proximal end of the liquid container assembly 11 from the proximal flange to the proximal end face 1113.

[0062] The propulsion assembly 12 includes a push rod 121 and a lead screw 122 whose axes are collinearly arranged to meet a preset deviation condition. The push rod 121 has a double-tube structure, including an inner push tube 1211 and an outer push tube 1212. The outer push tube 1212 has a hollow structure. The inner push tube 1211 is coaxial with the outer push tube 1212 and is disposed inside the outer push tube 1212. The proximal end of the outer push tube 1212 is connected to the proximal end of the inner push tube 1211. The length of the inner push tube 1211 is less than the length of the outer push tube 1212. The lead screw 122 is sleeved inside the inner push tube 1211.

[0063] The pressure detector 123, affected by the thrust of the liquid in the liquid containment assembly 11 on the piston 112, is located at the far end of the outer push tube 1212 and inside the outer push tube 1212 to avoid the pressure detector 123 being vulnerable due to exposure. The inner diameter of the outer push tube 1212 is larger than the outer diameter of the inner push tube 1211, so that there is a gap between the outer push tube 1212 and the inner push tube 1211, so that the electrical connection wire 1231 of the pressure detector 123 can be set between the outer push tube 1212 and the inner push tube 1211. By providing space between the inner sleeve and the outer sleeve for accommodating the wiring harness structure such as the electrical connection wire 1231, wiring space is provided for the wiring harness structure, which is beneficial to the protection of the wiring harness structure. It can effectively avoid damage to the built-in wiring harness structure caused by friction from the movement of other structures, and can also avoid the risk of damage caused by the external wiring harness structure. Optionally, the pressure detector 123 can be a pressure sensor.

[0064] The distal end of the external push tube 1212 is fitted inside the infusion cylinder 111, and a protective cap 124 is also provided at the distal end of the external push tube 1212. One side of the protective cap 124 is movably connected to the piston 112 (e.g., in contact with it), and the other side is connected to the pressure detector 123. This allows the infusion system to support pressure detection. Since the piston 112 and the pressure detector 123 are separated only by the protective cap 124, the reaction force of the liquid inside the liquid container 11 acting on the piston 112 is equivalent to acting directly on the pressure detector 123. This allows for a direct and minimally erroneous reflection of the internal pressure of the liquid container 11. Therefore, it effectively avoids the problem of insufficient pressure detection accuracy caused by the layout of the pressure detector 123 in the prior art. Currently, experiments have shown that the linearity error of the pressure detection of this invention is <5%.

[0065] The push rod 121 is also provided with a connecting structure 125 at its proximal end. At this time, the push assembly 12 may also include a slide rod 126. One end of the slide rod 126 is connected to the middle fixing plate 313, and the other end is connected to the proximal fixing plate 314. The slide rod 126 is arranged parallel to the lead rod 122. Both the slide rod 126 and the lead rod 122 pass through the connecting structure 125. The slide rod 126 is slidably connected to the connecting structure 125, and the lead rod 122 is threadedly connected to the connecting structure 125. The proximal end of the lead rod 122 is connected to the drive module 2. Under the driving action of the drive module 2, the lead rod 122 rotates, thereby realizing the axial movement of the push rod 121. The connecting structure 125 includes a slider 1251. The slider 1251 is provided with a thread that matches the lead rod 122. Alternatively, the slider 1251 is embedded with a nut 1252, and the nut 1252 is provided with a thread that matches the lead rod 122.

[0066] The drive module 2 is mounted on the proximal fixing plate 314. The drive module 2 includes a drive component 21 and a transmission component 22. The drive component 21 is connected to the transmission component 22 and is electrically connected to the control system. The transmission component 22 is connected to the proximal end of the lead screw 122, that is, the drive component 21 indirectly drives the lead screw 122 to rotate through the transmission component 22; or, the drive module 2 is mounted on the proximal fixing plate 314. The drive module 2 includes the drive component 21, which is connected to the proximal end of the lead screw 122, that is, the drive component 21 directly drives the lead screw 122 to rotate; optionally, the drive component 21 can be an electric motor, and the transmission component 22 can be a gear set, belt set, or other structure.

[0067] As can be seen from the above, the overall structural design of this embodiment is more integrated than that of the existing infusion system, which can avoid the problem of large structural deformation under stress due to loose overall structural design, reduce the probability and amount of structural deformation, and improve structural stability.

[0068] Furthermore, in this embodiment, the main positioning points are all located on the same axis or distributed around the same axis. Compared with the existing decentralized positioning design of multiple positioning points in the infusion system, it can eliminate the reference plane conversion deviation, achieve reference uniformity, and suppress cumulative errors, thereby improving accuracy. Moreover, compared with the existing decentralized positioning design, it achieves force flow path optimization and torsional stiffness improvement, thereby enhancing the anti-offset capability, thus ensuring the long-term stability and reliability of the system, reducing the frequency of maintenance and calibration, and lowering the difficulty of maintenance and calibration.

[0069] Since this embodiment avoids the technical defects of existing infusion systems, when applied in the field of steam ablation, the infusion system provided by this embodiment can reduce / eliminate pressure fluctuations in the pipeline, shorten the pressure balance establishment time, establish pressure balance in the shortest time, improve treatment efficiency, reduce / avoid saturated steam condensation problems, improve the stability of steam generation and delivery quality, and ensure the consistency of treatment effects.

[0070] It should be noted that the various structural schemes provided in this embodiment can be freely combined and are not limited to those shown in the accompanying drawings.

[0071] Second Embodiment like Figure 6 As shown, the injection system for the steam ablation system provided in this embodiment differs from the first embodiment in that it has a more simplified structure. In this embodiment, the inner wall of the inner push tube 1211 of the injection system is provided with a thread that matches the lead screw 122, so that the lead screw 122 drives the push rod 121 to move axially through the drive module 2. In this system, to ensure the stability of the push rod 121 during axial movement, the total length of the lead screw 122 needs to be designed based on factors such as the effective length of the lead screw 122, the diameter of the lead screw 122, the elastic modulus of the lead screw 122, the mass of the push rod 121, the length of the push rod 121, the mass of the lead screw 122, and the fitting accuracy between the lead screw 122 and the push rod 121.

[0072] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An infusion system for a vapor ablation system, in electrical connection with a control system of the vapor ablation system, characterized in that, Includes infusion module, drive module and stationary module; The infusion module includes a liquid container assembly and a propulsion assembly. The liquid container assembly contains liquid for vapor ablation. The proximal end of the propulsion assembly is connected to the drive module, and the distal end is fitted inside the liquid container assembly. The axis of the liquid container assembly and the axis of the propulsion assembly are collinear to meet a preset deviation condition. The propulsion assembly achieves axial movement after changing its trajectory in the motion space. When the propulsion assembly moves axially from the proximal end to the distal end, the liquid in the liquid container assembly is output for vapor ablation. The fixing module is used to fix the infusion module and the drive module; The control system is electrically connected to the drive module and is configured to regulate the drive module to regulate the axial movement of the propulsion component, thereby regulating the amount of stored liquid in the liquid container component, thus realizing the regulation of the output liquid volume of the liquid container component; wherein, the propulsion component can avoid generating deflection torque and deflection play during propulsion, thereby shortening the pressure / flow balance establishment time in the event of pressure change during low-dose output, thereby reducing / eliminating unexpected pressure fluctuations in the steam pipeline.

2. The infusion system for a steam ablation system of claim 1, wherein, The fixed module includes a fixed frame and a liquid containing component baffle. The fixed frame has a transversely arranged F-shaped structure. The drive module is connected to the proximal end of the fixed frame. The propulsion component is connected through to the proximal and middle ends of the fixed frame, respectively. The liquid containing component baffle is located at the distal end of the fixed frame and has a first slot that matches the distal end of the liquid containing component. This slot is used to restrict the axial and circumferential positioning of the liquid containing component, forming a centering constraint at the distal end. The overall component formed by the liquid containing component baffle and the fixed frame has a W-shaped structure to ensure the coaxiality of the liquid containing component and the propulsion component, thereby achieving the axial positioning of the infusion module.

3. The infusion system for a steam ablation system of claim 2, wherein, The distal end face of the liquid receiving assembly that is perpendicular to the axial direction and in contact with the first slot is set as a spherical surface, and the surface in the first slot corresponding to the distal end face of the liquid receiving assembly is set as a conical surface, so that when the actual mounting axis of the liquid receiving assembly deviates from the ideal mounting axis, reliable contact between the tangent of the spherical surface and the conical surface can still be guaranteed.

4. The infusion system for a steam ablation system of claim 2, wherein, The fixing module further includes a clamping member, which is disposed at the proximal end of the liquid containing assembly and sleeved on the outside of the propulsion assembly. The clamping member is connected to the middle end of the fixing frame through evenly distributed elastic members. The fixing frame is provided with a second slot that matches the clamping member. Under the elastic force of the elastic members, the clamping member contacts the proximal end face of the liquid containing assembly, providing axial clamping force to the liquid containing assembly to improve the centering constraint effect at the distal end, and can move axially within the second slot.

5. The infusion system for a steam ablation system of claim 4, wherein, The clamping member has a cylindrical ring structure or a convex ring structure, and the distal end of the elastic member is connected to the proximal end face of the clamping member or embedded in the clamping member.

6. The infusion system for a steam ablation system of claim 4, wherein, The mounting bracket is also provided with a third slot that matches the outside of the liquid containing assembly. The far end of the third slot is connected to the first slot, and the near end is connected to the second slot, so as to achieve overall coaxial constraint of the liquid containing assembly and ensure overall coaxiality and operational stability.

7. The infusion system for a steam ablation system of any one of claims 1 to 6, wherein, The propulsion assembly includes a push rod and a lead screw whose axes are collinearly arranged to meet a preset deviation condition. The push rod is sleeved on the outside of the lead screw, and its distal end is sleeved inside the liquid containment assembly. The proximal end of the lead screw is connected to the drive module to realize the spatial trajectory change of converting rotational motion into linear motion. The push rod has a thread that matches the lead screw; or, the near end of the push rod has a connecting structure, the lead screw passes through the connecting structure, and the connecting structure has a thread that matches the lead screw. Under the driving action of the drive module, the lead screw rotates, thereby realizing the axial movement of the push rod.

8. The delivery system for a steam ablation system as described in claim 7, characterized in that, When the connecting structure is provided at the proximal end of the push rod, the propulsion assembly further includes a slide rod, which is arranged parallel to the lead screw. The slide rod passes through the connecting structure and is slidably connected to the connecting structure to improve the stability of axial movement.

9. The delivery system for a steam ablation system as described in claim 8, characterized in that, The connecting structure includes a slider, which has a thread that matches the lead screw, or the slider has a nut embedded in it, which has a thread that matches the lead screw.

10. The delivery system for a steam ablation system as described in claim 7, characterized in that, The liquid containment assembly includes an infusion cylinder and a piston. The piston is slidably connected to the inner wall of the infusion cylinder. A pressure detector is provided at the distal end of the push rod. The pressure detector is connected to the piston and is used to measure the thrust of the liquid in the infusion cylinder on the piston. The pressure detector is electrically connected to the control system.

11. The delivery system for a steam ablation system as described in claim 10, characterized in that, The distal end of the push rod is provided with a protective cover. One side of the protective cover is movably connected to the piston, and the other side is connected to the pressure detector, so as to simultaneously prevent water ingress and reduce errors.

12. The delivery system for a steam ablation system as described in claim 10, characterized in that, The push rod has a double-tube structure, including an inner push tube and an outer push tube. The outer push tube is hollow. The inner push tube is coaxial with the outer push tube and is disposed inside the outer push tube. The proximal end of the outer push tube is connected to the proximal end of the inner push tube. The length of the inner push tube is less than the length of the outer push tube. The lead screw is sleeved inside the inner push tube. The pressure detector is disposed at the distal end of the outer push tube and is located inside the outer push tube to provide wiring space so that the electrical connection wire of the pressure detector can be disposed between the outer push tube and the inner push tube.

13. The delivery system for a steam ablation system as described in claim 10, characterized in that, The piston is made of a hard material, and a seal is provided on the outer periphery of the piston to reduce / eliminate the amount of compression deformation of the piston after being pressed.

14. The delivery system for a steam ablation system as described in any one of claims 1 to 6, characterized in that, The drive module includes a drive component and a transmission component. The drive component is connected to the transmission component and electrically connected to the control system. The transmission component is connected to the propulsion component. Alternatively, the drive module includes a drive component, which is connected to the propulsion component.

Images