Atmospheric pressure low temperature plasma bladder perfusion treatment system and application thereof

Abstract

The application provides a kind of atmospheric pressure low temperature plasma bladder perfusion treatment system and its application, it is related to plasma medical instrument technical field, the system includes master control and parameter setting module, working gas source module, gas flow regulating module, pulse high voltage power supply matching module, CAP generator device, flexible delivery catheter device, bladder intracavity CAP treatment module.The flexible delivery catheter device includes inner catheter and outer sleeve, inner catheter is used to transport plasma, outer sleeve is set on the outside of inner catheter, annular gap channel is formed between inner catheter and outer sleeve, for maintaining intravesical pressure balance.The application is accurately delivered to the inside of bladder by transurethral catheterization with atmospheric pressure low temperature plasma, realizes the safe, accurate delivery of plasma, provides a kind of new technical scheme for the medical instrument in the field of bladder cancer treatment.

Description

Technical Field

[0001] This invention relates to the field of plasma medical device technology, and in particular to an atmospheric pressure low-temperature plasma bladder irrigation therapy system and its application. Background Technology

[0002] Cold Atmospheric Plasma (CAP) is a partially ionized gas generated by high-voltage discharge at atmospheric pressure. Its macroscopic temperature can be maintained between room temperature and 40°C, and it has attracted widespread attention in the biomedical field in recent years. Existing research shows that CAP can selectively induce tumor cell apoptosis by inducing oxidative stress in tumor cells, demonstrating significant effects in the treatment of superficial tumors.

[0003] While plasma-enhanced bladder (CAP) has shown great potential in the treatment of superficial tumors, its application in deep organ tumors still faces many challenges. The bladder, as a hollow organ accessible via a natural cavity (urethra), is theoretically very suitable for local instillation therapy. However, current CAP research for bladder cancer is limited to in vitro cell experiments. Existing plasma generators are large, and their electrode structures are difficult to adapt to the narrow and tortuous environment within the urethra. Furthermore, the presence of thermal effects and pressure changes during treatment poses safety risks, hindering the precise delivery of plasma into the bladder. Summary of the Invention

[0004] To address the technical problem of accurately delivering plasma into the bladder in existing technologies, this invention provides an atmospheric pressure low-temperature plasma bladder instillation therapy system, comprising: The main control and parameter setting module is used to control the operation of the system and adjust the output parameters of the plasma. A working gas source module, which is used to provide working gas; A gas flow regulation module, which is connected to the working gas source module, is used to regulate the gas flow rate; A pulse high-voltage power supply matching module, which is used to provide the power required for high-voltage discharge; A CAP generator device is connected to the gas flow regulation module and the pulse high voltage power supply matching module respectively, and is used to ionize the working gas to generate atmospheric pressure low temperature plasma. A flexible delivery catheter device, connected to the CAP generator device, is used to deliver the plasma into the bladder; An intravesical CAP treatment module, which is connected to the flexible delivery catheter device, is used to apply plasma to bladder lesions.

[0005] Furthermore, the system also includes a monitoring and feedback unit, which is connected to the intravesical CAP treatment module and the main control and parameter setting module, and is used to feed back the detection data during the treatment process to the main control and parameter setting module.

[0006] Furthermore, the system also includes an exhaust gas treatment unit, which is connected to the intrabladder CAP treatment module and is used to collect and treat the exhaust gas generated during the treatment process.

[0007] Furthermore, the system also includes an anesthesia and support unit, which works in conjunction with the intravesical CAP treatment module to provide anesthesia, warming, and operational support during the treatment process.

[0008] Furthermore, the CAP generator device includes a power supply section, a gas input interface, and a CAP generator body. The gas input interface is connected to the CAP generator body, and the CAP generator body is connected to the flexible delivery conduit device.

[0009] Furthermore, the CAP generator body includes a high-voltage electrode, a dielectric insulating tube, a loop electrode, and a discharge chamber. The high-voltage electrode and the loop electrode form a discharge structure inside the dielectric insulating tube, and atmospheric pressure low-temperature plasma is excited and generated inside the discharge chamber.

[0010] Furthermore, the flexible delivery conduit device includes an inner conduit and an outer conduit. The inner conduit serves as a plasma delivery channel, and the outer conduit is fitted over the outside of the inner conduit. An annular gap channel is formed between the outer conduit and the inner conduit, and the annular gap channel is used for reflux, venting, and pressure balancing.

[0011] Furthermore, the system also includes an anti-tumor drug; preferably, the anti-tumor drug includes a PD-1 antibody.

[0012] The present invention also provides the application of the atmospheric pressure low-temperature plasma bladder instillation therapy system in the preparation of bladder cancer treatment devices.

[0013] Compared with existing technologies, the atmospheric pressure low-temperature plasma bladder irrigation therapy system and its application provided by this invention have the following beneficial effects: Based on a flexible delivery catheter device with a double-layered structure of inner and outer catheters, the inner catheter is used to deliver plasma, while the outer catheter provides structural support, forming an annular gap channel between the inner and outer catheters. This allows for precise delivery of plasma through the urethra to the bladder, while the annular gap channel allows for the expulsion of excess gas, maintaining pressure balance within the bladder and preventing damage to bladder tissue caused by pressure changes, thus achieving safe and precise plasma delivery. Attached Figure Description

[0014] The accompanying drawings, which form part of this disclosure, are used to provide a further understanding of this disclosure. The illustrative embodiments of this disclosure and their descriptions are used to explain this disclosure and do not constitute an undue limitation of this disclosure. The spacing or dimensions between parts are exaggerated to show the position of each part, and the schematic diagrams are for illustrative purposes only.

[0015] Figure 1 This is a block diagram of an atmospheric pressure low-temperature plasma bladder instillation therapy system provided in Embodiment 1 of the present invention.

[0016] Figure 2 This is a schematic diagram of the CAP generator and flexible double conduit structure provided in Embodiment 1 of the present invention.

[0017] Figure 3 This is a schematic diagram of the main structure of the CAP generator provided in Embodiment 1 of the present invention.

[0018] Figure 4 This is a schematic diagram of the flexible double-catheter sheath assembly provided in Embodiment 1 of the present invention. Figure 4 In the diagram, A represents the front view of the flexible double-tube sheath assembly; Figure 4 B in the diagram is a cross-sectional schematic of the flexible double conduit sleeve assembly.

[0019] Figure 5 This is a schematic diagram illustrating the working principle of the atmospheric pressure low-temperature plasma bladder instillation therapy system provided in Embodiment 1 of the present invention.

[0020] Figure 6 This is a schematic diagram illustrating the characterization of the plasma jet system provided in Embodiment 1 of the present invention. Figure 6 A in the diagram represents the composition of the plasma generation unit. Figure 6 B in the diagram is a schematic diagram of a plasma jet device used to generate plasma activation media in vitro. Figure 6 C in the figure represents the optical emission spectrum of CAP. Figure 6 In the diagram, D represents the characteristic current-voltage waveform of the in vitro experiment. Figure 6 In the figure, E represents the quantitative analysis of ROS / RNS generated in physiological saline after plasma treatment. The left figure shows NO2 measured using Griess reagent. - Concentration, middle figure: H2O2 concentration measured using a hydrogen peroxide detection kit, right figure: fluorescence emission spectrum of TA solution.

[0021] Figure 7 This is a schematic diagram illustrating the plasma mouse bladder instillation therapy system provided in Embodiment 1 of the present invention. Figure 7 A in the diagram is an intravesical plasma delivery system suitable for in vivo mouse bladder cancer treatment; Figure 7B in the diagram is a schematic diagram and corresponding image of a dual catheter used to deliver externally generated plasma into the bladder cavity via urethral cannulation. Figure 7 C in the image represents a representative MRI image of the mouse bladder after the insertion of two catheters via the urethra, confirming the correct intravesical catheter position and bladder integrity. Figure 7 D in the diagram is a schematic diagram of a disk-shaped plasma system configured for plasma therapy of multiple mice. The system consists of four parallel plasma jet units. Figure 7 E in the figure represents the optical emission spectrum from the in vivo experiment; Figure 7 In this context, F represents the temperature detection in a mouse using a plasma device. Figure 7 G in the figure represents the statistical value of the surface temperature of the plasma device during 15 minutes of continuous operation in a mouse.

[0022] Figure 8 This is a diagram showing the tumor-suppressing effect of plasma treatment on a mouse bladder cancer model provided in Embodiment 1 of the present invention. Figure 8 In the diagram, A represents a mouse orthotopic bladder cancer model and an experimental protocol for intravesical plasma therapy. Figure 8 B in the figure represents a representative image of a mouse bladder tumor and a statistical chart of tumor weight. Figure 8 C in the graph represents the survival curves of the control group and the plasma-treated tumor-bearing mice.

[0023] Figure 9 The graph shows the tumor-suppressing effect of different plasma treatment times on a mouse bladder cancer model, as provided in Embodiment 1 of the present invention. Figure 9 In the image, A represents a representative image of a mouse bladder tumor after treatment with different plasma treatment times. Figure 9 B in the figure represents a statistical graph of bladder tumor weight in mice after treatment with different plasma treatment times.

[0024] Figure 10 This is a diagram illustrating the therapeutic effect of plasma combined with PD-1 antibody on a mouse bladder cancer model, as provided in Embodiment 1 of the present invention. Figure 10 A in the image represents a representative image of a mouse bladder tumor; Figure 10 B in the graph represents the weight statistics of mouse bladder tumors; Figure 10 C in the figure represents the survival curves of the four groups of tumor-bearing mice.

[0025] Figure 11 This is a graph showing the safety evaluation effect of plasma therapy provided in Embodiment 1 of the present invention on major organs in mice.

[0026] In the diagram, 1 is the power supply section; 2 is the gas input interface; 3 is the CAP generator body; 4 is the inner conduit; 5 is the outer tube; 6 is the annular gap channel; 7 is the high-voltage electrode; 8 is the dielectric insulation tube; 9 is the circuit electrode; and 10 is the discharge chamber. Detailed Implementation

[0027] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0028] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0029] It should be noted that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to limit the exemplary embodiments of the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is intended to include the plural form as well. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof. The use of the words "upper," "lower," "left," and "right" in this invention only indicates alignment with the upper, lower, left, and right directions of the drawings themselves and does not limit the structure. They are merely 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. Therefore, they should not be construed as limiting the invention.

[0030] Example 1 This embodiment provides an atmospheric pressure low-temperature plasma bladder irrigation therapy system, and provides a detailed description and experimental verification of the system's structure, performance, and application effects.

[0031] I. Overall System Structure like Figure 1 The atmospheric pressure low-temperature plasma bladder irrigation therapy system constructed in this embodiment includes a main control and parameter setting module, a working gas source module, a gas flow regulation module, a pulse high-voltage power supply matching module, a CAP generator device, a flexible delivery catheter device, an intrabladder CAP therapy module, a monitoring and feedback unit, an exhaust gas treatment unit, and an anesthesia and support unit.

[0032] The main control and parameter setting module are connected to and control the gas flow regulation module and the pulse high voltage power supply matching module, respectively, to control the operation of the system and adjust the output parameters of the plasma.

[0033] The working gas source module is connected to the gas flow rate regulation module to provide the working gas. In this embodiment, the working gas source module uses high-purity argon (99.999% purity) as the working gas. The gas flow rate regulation module is used to precisely adjust the gas flow rate to ensure the stability and repeatability of the plasma discharge. During in vitro experiments, the gas flow rate is set to 72 L / h; during in vivo animal experiments, the gas flow rate for each plasma jet unit is set to 18 L / h.

[0034] The gas flow regulation module and the pulse high-voltage power supply matching module are respectively connected to the CAP generator. The pulse high-voltage power supply matching module is used to provide the power required for high-voltage discharge.

[0035] The CAP generator device is connected to a flexible delivery catheter device, which is connected to an intravesical CAP treatment module, for delivering atmospheric low-temperature plasma through the urethra to the bladder cavity and acting on the bladder cancer lesion.

[0036] The anesthesia and support unit works in conjunction with the intravesical CAP treatment module to provide anesthesia, warmth, and procedural support during treatment.

[0037] The intravesical CAP treatment module is connected to both the monitoring and feedback unit and the waste gas treatment unit. The monitoring and feedback unit feeds relevant data from the treatment process back to the main control and parameter setting module for adjustment and control of the device's operating parameters. The waste gas treatment unit collects and treats the exhaust gases generated during the treatment process.

[0038] II. CAP generator and flexible dual-conduit structure like Figure 2 As shown, the CAP generator device includes a power supply section 1, a gas input interface 2, and a CAP generator body 3. The flexible delivery conduit device includes an inner conduit 4 and an outer conduit 5.

[0039] Gas input interface 2 is connected to CAP generator body 3, and CAP generator body 3 is connected to inner conduit 4.

[0040] like Figure 3 As shown, the CAP generator body 3 includes a high-voltage electrode 7, a dielectric insulating tube 8, a loop electrode 9, and a discharge chamber 10. Working gas enters the CAP generator body 3 through the gas input interface 2. The high-voltage electrode 7 and the loop electrode 9 form a discharge structure within the dielectric insulating tube 8, exciting atmospheric pressure low-temperature plasma within the discharge chamber 10.

[0041] like Figure 4 As shown, the inner conduit 4 serves as the plasma delivery channel, and the outer tube 5 forms an annular gap channel 6 between the inner conduit 4 and the outer tube 5 for reflux, exhaust, and pressure balancing.

[0042] like Figure 5 As shown, the generated plasma enters the flexible dual-catheter assembly, and the distal treatment head enters the bladder cavity 11 via the urethra. During treatment, gas in the bladder cavity is expelled through the annular gap channel 6, maintaining pressure balance within the bladder.

[0043] III. The system provided in this embodiment is used for characterization in in vitro cell experiments. Reference Figure 6 The atmospheric pressure low-temperature plasma bladder instillation therapy system provided in this embodiment was characterized by in vitro cell experiments. For example... Figure 6 As shown in Figure A, the CAP generator and flexible delivery conduit of this system are used to generate the plasma jet. The working gas source module and gas flow regulation module provide the working gas to the system and regulate the gas flow, while the pulse high-voltage power supply matching module provides the power required for high-voltage discharge.

[0044] The working gas source module uses high-purity argon (99.999% purity) as the working gas, and the gas flow rate is precisely adjusted through the gas flow rate adjustment module, with the flow rate set to 72 L / h.

[0045] The pulsed high-voltage power supply matching module and CAP generator device adopt a dual dielectric barrier discharge structure, including a high-voltage electrode (3 mm in diameter), an inner quartz tube (5 mm outer diameter, 3 mm inner diameter), an outer quartz tube (6 mm outer diameter, 4 mm inner diameter), and a copper grounding electrode wound around the nozzle at the bottom of the outer tube. The distance between the high-voltage electrode and the grounding electrode is 6 mm, and the distance between the grounding electrode and the nozzle outlet is 6 mm. The discharge parameters are set to an applied voltage of 15 kV and a driving frequency of 5 kHz.

[0046] like Figure 6 As shown in Figure B, a stable and uniform plasma jet is generated from the nozzle outlet under an argon gas flow. Figure 6 As shown in C, optical emission spectroscopy analysis confirmed the detection of significant emission lines in the 200-900 nm wavelength range, mainly including: N2 lines in the 315-405 nm range, Ar lines in the 696-842 nm range, and ·OH lines at 308 nm, confirming the generation of plasma rich in reactive oxygen / nitrogen species. Figure 6 As shown in D, the characteristic current-voltage waveform has a steep rising edge, which is conducive to the initiation of the discharge process. The sharp current pulse corresponds to the ionization and plasma development process in the working gas.

[0047] like Figure 6 As shown in E, physiological saline was exposed to plasma for different times (1, 2, 5, 10, 15, 20 minutes), and the generation of reactive oxygen species / nitrogen species was detected. (1) H2O2 concentration detection: The H2O2 concentration was measured using a hydrogen peroxide detection kit. The results showed that the H2O2 concentration increased in a time-dependent manner with the extension of plasma treatment time.

[0048] (2) NO2 - Concentration detection: Nitrite concentration was measured using the Griess reagent system. The color of the treated culture medium changed from colorless to multicolored, and the absorbance value increased with increasing plasma irradiation time.

[0049] (3) ·OH radical detection: The formation of 2-hydroxyterephthalic acid was detected by terephthalic acid fluorescence analysis. The results showed that the fluorescence intensity of ·OH radical increased with the extension of plasma irradiation time.

[0050] The above results indicate that the atmospheric pressure cryogenic plasma generated by the plasma generation unit contains reactive oxygen / nitrogen species, including hydroxyl radicals, hydrogen peroxide, and nitrite.

[0051] IV. The system provided in this embodiment is used for in vivo characterization of intravesical plasma perfusion therapy in a mouse orthotopic bladder cancer model. For example... Figure 7 As shown in A, the system's CAP generator and flexible delivery conduit are used to generate and deliver plasma.

[0052] The working gas source module and the gas flow regulation module provide the working gas to the system and regulate the gas flow rate. High-purity argon (99.999% purity) is used as the working gas. The flow rate is precisely regulated by the gas flow regulation module. The gas flow rate of each plasma jet unit is set to 18 L / h.

[0053] The pulsed high-voltage power supply matching module and CAP generator device employ a dual-dielectric barrier discharge plasma jet device suitable for small animal treatment, including a high-voltage rod electrode (0.75 mm in diameter), an inner quartz tube (2 mm outer diameter, 1 mm inner diameter), an outer quartz tube (4 mm outer diameter, 3 mm inner diameter), and a copper grounding electrode wound around the nozzle. The nozzle outlet has an outer diameter of 3 mm and an inner diameter of 2 mm. The distance between the high-voltage electrode tip and the grounding electrode is 6 mm. The discharge parameters are set to an applied voltage of 15 kV and a drive frequency of 1 kHz.

[0054] like Figure 7 As shown in Figure B, the flexible delivery catheter device employs a double-layered polytetrafluoroethylene (PTFE) catheter. The inner catheter extends deep into the bladder for plasma delivery, while the outer catheter is inserted into the urethra first to provide structural support. The annular gap between the inner and outer catheters allows excess gas to escape, maintaining pressure balance within the bladder. Figure 7 As shown in C, representative MRI images of the mouse bladder after urethral cannulation confirm the correct intravesical catheter position and bladder integrity.

[0055] like Figure 7 As shown in D, to improve the efficiency of animal experiments, a disk-shaped plasma array system was developed, configured with four independently controlled CAP generator devices arranged in parallel, capable of processing four mice simultaneously. Figure 7 As shown in E, the electrical output characteristics of this array device are similar to those of a single-channel system. Figure 7 F and Figure 7 As shown in G, the temperature was monitored using a real-time thermal monitoring probe. The results showed that during the 15-minute continuous treatment, the device temperature was maintained at a physiologically safe level (<30℃), ensuring that the bladder tissue was not damaged by heat.

[0056] V. Verification of the System's Application Effect in the Preparation of Bladder Cancer Treatment Devices 1. Animal model establishment: 6-8 week old female C57BL / 6 mice were selected and instilled with 5×10⁻⁶ mice via the urethra. 5 An orthotopic bladder cancer model was established using a mouse bladder cancer cell line (MB49-luci).

[0057] 2. Treatment plan: such as Figure 8 In Part A, tumor-bearing mice were randomly divided into a control group and a plasma therapy group. Treatment began on day 5 after tumor inoculation and was repeated every 5 days. During treatment, a double-layered catheter was inserted into the mouse bladder through the urethra, and the plasma generator was activated for continuous treatment for 15 minutes.

[0058] 3. Evaluation of therapeutic effect: Mice were sacrificed after treatment, and their bladders were dissected. (e.g.) Figure 8 In mice in group B, the plasma therapy group showed a significant reduction in bladder tumor weight compared to the control group. Figure 8 The C-survival curves showed that the median survival time of mice in the plasma therapy group was significantly longer than that in the control group.

[0059] 4. Dose-response study: Orthotopic MB49 bladder cancer-bearing mice were randomly divided into four groups: control group (sham treatment for 15 minutes), CAP-5 min group (exposure time 5 minutes), CAP-15 min group (exposure time 15 minutes), and CAP-25 min group (exposure time 25 minutes). All treatment groups began treatment on day 5 after tumor inoculation, with treatment every 5 days for a total of 4 treatments. Figure 9 As the plasma treatment time increased, the tumor inhibition effect showed an increasing trend: there was no significant difference in tumor volume between the CAP-15 min group and the CAP-25 min group, both of which were significantly smaller than those in the CAP-5 min group and the control group. Based on the combined tumor inhibition effect, histological analysis results, and mouse tolerance assessment, 15 minutes was determined to be the optimal treatment duration.

[0060] 5. Selection and Verification of Working Gas: In this embodiment, high-purity argon gas with a purity ≥99.999% is used as the working gas. In addition, helium, nitrogen, or a mixture of helium and oxygen can also be used as the working gas. The selection of different working gases can adjust the type and concentration of active components in the plasma to meet different processing requirements.

[0061] 6. Combined use of the system and anti-tumor drugs: In this embodiment, the system also includes an anti-tumor drug, specifically a PD-1 antibody. In the MB49 orthotopic bladder cancer model, tumor-bearing mice were randomly divided into four groups: control group (sham treatment + intraperitoneal injection of PBS), CAP monotherapy group (intravesical CAP treatment 15 min / time, once every 5 days), anti-PD-1 monotherapy group (intraperitoneal injection of anti-PD-1 antibody 10 mg / kg, once every 3 days), and combination therapy group (CAP treatment + anti-PD-1 antibody combined administration). All treatments began on day 5 after tumor inoculation and continued until day 21.

[0062] Depend on Figure 10 A and Figure 10 The efficacy evaluation results in the B group showed that the combination therapy group exhibited the most significant anti-tumor effect, with tumor weight significantly lower than that of the single-drug group and the control group. Figure 10 The C-survival curves showed that the median survival of mice in the combination therapy group was significantly longer than that in the control group and the single-drug therapy group. These results indicate that the combination of plasma system and PD-1 antibody can produce a synergistic effect.

[0063] 7. In vivo safety evaluation of the system To evaluate the biosafety of the plasma bladder instillation therapy system, this study conducted systematic histopathological examinations and blood biochemical analyses on the major organs of the treated mice.

[0064] (1) Experimental design: The main organs of mice in each treatment group (control group, CAP single drug group, anti-PD-1 single drug group, and combination therapy group), including heart, liver, spleen, lung and kidney, were taken, fixed in 4% paraformaldehyde, embedded in paraffin, sectioned and stained with H&E.

[0065] (2) Histological assessment of major organs: H&E staining results showed ( Figure 11 ): Heart: Myocardial fibers in all groups were neatly arranged with clear striations, and no myocardial cell degeneration, necrosis, or inflammatory cell infiltration was observed. Compared with the control group, the combined treatment group showed no abnormal changes in myocardial tissue structure.

[0066] Liver: The liver lobules were intact, the hepatocyte cords were regularly arranged, no dilation or congestion was observed in the sinusoids, and no obvious inflammatory cell infiltration was observed in the portal areas. No hepatocellular edema, fatty degeneration, or necrosis was observed in any of the treatment groups.

[0067] Spleen: The red and white pulp were clearly demarcated, the splenic nodules were of normal structure, and no obvious thickening or atrophy was observed in the marginal areas. The splenic tissue structure in each treatment group was consistent with that in the control group.

[0068] Lungs: The alveolar structure is intact, the alveolar walls are not thickened, there is no exudate in the alveolar cavities, the bronchial epithelium is intact, and there is no inflammatory cell infiltration or interstitial fibrosis.

[0069] Kidneys: The glomerular structure is clear, the capsule is normal, the renal tubular epithelial cells are neatly arranged, the brush border is intact, and there is no inflammatory cell infiltration or fibrosis in the renal interstitium.

[0070] (3) Detection of inflammatory markers: There was no significant difference in C-reactive protein levels among the groups, indicating no obvious systemic inflammatory response.

[0071] Based on the above histopathological examination results, the atmospheric pressure low-temperature plasma bladder instillation therapy system of this invention confirms its good in vivo biocompatibility. Multiple treatments did not cause damage to major organs or systemic toxicity, providing a reliable safety basis for subsequent clinical applications.

[0072] In the description of this specification, the terms "connection", "installation", "fixing", "setting", etc. are interpreted broadly. For example, "connection" can be a fixed connection or an indirect connection through an intermediate component without affecting the relationship between components and the technical effect. It can also be an integral connection or a partial connection. In such cases, those skilled in the art can understand the specific meaning of the above terms in this invention or invention according to the specific circumstances.

[0073] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An atmospheric pressure low-temperature plasma bladder instillation therapy system, characterized in that, include: The main control and parameter setting module is used to control the operation of the system and adjust the output parameters of the plasma. A working gas source module is used to provide working gas; the working gas is high-purity argon gas with a purity ≥99.999%. A gas flow regulation module, which is connected to the working gas source module, is used to regulate the gas flow rate; A pulse high-voltage power supply matching module, which is used to provide the power required for high-voltage discharge; A CAP generator device is connected to the gas flow regulation module and the pulse high voltage power matching module respectively, and is used to ionize the working gas to generate atmospheric pressure low temperature plasma. A flexible delivery catheter device, connected to the CAP generator device, is used to deliver the plasma into the bladder; The CAP generator device includes a power supply section, a gas input interface, and a CAP generator body. The gas input interface is connected to the CAP generator body, and the CAP generator body is connected to the flexible delivery conduit device. The CAP generator body includes a high-voltage electrode, a dielectric insulating tube, a loop electrode, and a discharge chamber. The high-voltage electrode and the loop electrode form a discharge structure inside the dielectric insulating tube, and atmospheric pressure low-temperature plasma is excited and generated inside the discharge chamber. The flexible delivery conduit device includes an inner conduit and an outer conduit. The inner conduit serves as a plasma delivery channel and is configured as a hollow tubular structure along its entire length. The outer conduit is sleeved outside the inner conduit and is coaxially arranged with the inner conduit. An annular gap channel is formed between the outer conduit and the inner conduit. The annular gap channel extends continuously along the axial direction of the conduit and its radial width remains constant. The annular gap channel is used for reflux, venting, and pressure balancing. An intravesical CAP treatment module, which is connected to the flexible delivery catheter device, is used to apply plasma to bladder lesions.

2. The system as described in claim 1, characterized in that, It also includes a monitoring and feedback unit, which is connected to the intravesical CAP treatment module and the main control and parameter setting module, and is used to feed back the detection data during the treatment process to the main control and parameter setting module.

3. The system as described in claim 1, characterized in that, It also includes an exhaust gas treatment unit, which is connected to the intrabladder CAP treatment module and is used to collect and treat the exhaust gas generated during the treatment process.

4. The system as described in claim 1, characterized in that, It also includes an anesthesia and support unit, which works in conjunction with the intravesical CAP treatment module to provide anesthesia, warmth, and operational support during the treatment process.

5. The system as described in claim 1, characterized in that, The system also includes anti-tumor drugs.

6. The system as described in claim 5, characterized in that, The anti-tumor drugs include PD-1 antibodies.

7. The use of the atmospheric pressure low-temperature plasma bladder irrigation therapy system according to any one of claims 1 to 6 in the preparation of bladder cancer treatment devices.

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