Drug perfusion system

Abstract

The invention discloses a medicine perfusion system which comprises a catheter body. A plugging balloon is arranged on the catheter main body, and the plugging balloon is used for plugging a target position to form a closed space; a perfusion catheter is arranged at one end of the catheter main body and is inserted into the closed space so as to perfuse medicines into the closed space; the control system is connected with the catheter body through the medicine inflow end and the medicine outflow end to achieve medicine circulation, and the control system comprises a flow speed control module and a temperature control module to achieve control over the flow speed and the temperature of medicine. Dynamic regulation and control of medicine temperature can be realized, so that the medicine is at the optimal temperature, the medicine property of the medicine can be greatly improved, and the treatment effect on lesion can be greatly improved. Meanwhile, the control system can control the flow speed of the circulating medicine, the temperature of the medicine in the circulating process can be kept, heat loss is reduced, and constant-temperature control over the temperature of the medicine is achieved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to a drug infusion system. Background Technology

[0002] Cholangiocarcinoma is a malignant tumor originating from the epithelial cells of the bile ducts. It possesses complex biological characteristics, exhibits high heterogeneity and invasiveness, posing a severe challenge to clinical diagnosis and treatment. Previously, treatment options for cholangiocarcinoma were limited, and the efficacy was often unsatisfactory, resulting in limited patient survival and a generally poor prognosis.

[0003] Pancreatic cancer is one of the most common and deadliest malignant tumors worldwide. Most patients are no longer candidates for surgery at the time of diagnosis, making systemic therapy a crucial treatment approach. Currently, chemotherapy remains the cornerstone of systemic treatment for pancreatic cancer, but traditional chemotherapy regimens suffer from insufficient efficacy and significant toxic side effects. In recent years, significant progress has been made in the treatment of pancreatic cancer through innovations in chemotherapy drug formulations, the development of classic target drugs, the discovery of novel targets, the application of antibody-drug conjugates, the exploration of immunotherapy, and advancements in tumor vaccines and cell therapy, bringing new hope for improving patient prognosis.

[0004] For cholangiocarcinoma, pancreatic cancer, or other lesions, due to the limitations of the tissue structure, the drugs are washed away by tissue fluid when they reach the lesion site, resulting in a short contact time with the lesion and preventing the drugs from exerting their full effect, thus affecting the treatment outcome. Summary of the Invention

[0005] The purpose of this invention is to provide a drug infusion system to solve the problems in the prior art.

[0006] Therefore, the present invention provides a drug infusion system, comprising:

[0007] Catheter body;

[0008] The catheter body is equipped with an occlusion balloon, which occludes the target location to form a closed space;

[0009] One end of the catheter body is provided with an infusion catheter, which is inserted into the closed space to infuse the closed space with medication;

[0010] The control system is connected to the catheter body through a drug inlet and a drug outlet to realize drug circulation. The control system includes a flow rate control module and a temperature control module to control the flow rate and temperature of the drug.

[0011] As a further description of the above technical solution, a syringe is provided in the bypass of the catheter body, and the syringe is used to inject an expansion medium into the occlusion balloon.

[0012] As a further description of the above technical solution, the surface of the infusion conduit is provided with a plurality of infusion holes distributed along the axial direction. The infusion holes are laser-cut and have smooth and flat edges.

[0013] As a further description of the above technical solution, a guidewire cavity is provided inside the catheter body, the guidewire cavity is inside the irrigation catheter and the guidewire cavity passes through the end of the irrigation catheter.

[0014] As a further description of the above technical solution, the drug inflow end is a Luer connector one, the drug outflow end is a Luer connector two, the Luer connector one is connected to the infusion catheter, and the Luer connector two is connected to the guidewire lumen.

[0015] As a further description of the above technical solution, the occlusion balloon is made of a highly elastic and highly ductile material, and the wall thickness of the occlusion balloon is 0.1-0.2 mm.

[0016] As a further description of the above technical solution, the syringe is disposed below the catheter body, and the drug inflow end is disposed above the catheter body.

[0017] As a further description of the above technical solution, the injection hole is at least a circular hole or a rectangular hole.

[0018] As a further description of the above technical solution, the flow rate control module includes a flow pump, a flow rate regulating valve, a flow rate sensor, and an integrated control module.

[0019] As a further description of the above technical solution, the temperature control module includes a micro heater, a temperature sensor, a temperature control switch, an integrated microprocessor, and a heat preservation component.

[0020] Beneficial effects:

[0021] 1. This invention provides a drug infusion system that enables dynamic temperature control of the drug to maintain it at an optimal temperature, thereby significantly improving the drug's efficacy and therapeutic effect on lesions. Simultaneously, the control system can regulate the flow rate of the circulating drug, ensuring temperature maintenance during circulation, reducing heat loss, and achieving constant temperature control of the drug. Attached Figure Description

[0022] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the 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.

[0023] Figure 1 This is a schematic diagram of the drug infusion system provided by the present invention.

[0024] Figure 2 This is a partial schematic diagram of the drug infusion system provided by the present invention.

[0025] Figure 3 This is a schematic diagram of an embodiment of the occlusion balloon perfusion of the drug infusion system provided by the present invention.

[0026] Figure 4 This is a schematic diagram of an embodiment of the occlusion balloon perfusion of the drug infusion system provided by the present invention.

[0027] Figure 5 This is a schematic diagram of the infusion catheter of the drug infusion system provided by the present invention.

[0028] Figure 6 This is a schematic diagram of the control system of the drug infusion system provided by the present invention.

[0029] In the diagram: 1. Catheter body; 2. Occlusion balloon; 3. Infusion catheter; 4. Control system; 5. Drug inlet end; 6. Drug outlet end; 7. Injector; 8. Infusion port; 9. Guidewire lumen. Detailed Implementation

[0030] The invention will be more readily understood by referring to the following detailed description of preferred embodiments and included examples. 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. In case of conflict, the definitions in this specification shall prevail.

[0031] This invention provides a drug perfusion system that solves the problem in existing technologies where, due to the limitations of tissue structure, drugs are washed away by tissue fluid when they reach the lesion site, resulting in short contact time and limited therapeutic effect. Furthermore, at low temperatures, drugs cannot penetrate tissue to reach deeper lesions, thus affecting absorption efficiency and ultimately impacting the therapeutic efficacy.

[0032] The technical concept of this invention lies in creating a sealed space by sealing the leading edge of the lesion with an inflated occlusion balloon, thus reducing the flushing of drugs by tissue fluid. Before occlusion, an infusion catheter at the front end of the occlusion balloon extends into the sealed space. A control system regulates the infusion of drug into the sealed space through the infusion catheter. Simultaneously, the control system can also re-aspirate the drug from the sealed space back into the control system for dynamic temperature regulation, and then re-infuse it into the sealed space, thereby achieving dynamic temperature control of the drug to maintain it at the optimal temperature, greatly improving the drug's efficacy and therapeutic effect on the lesion. Furthermore, the control system can control the flow rate of the circulating drug, ensuring temperature maintenance during circulation, reducing heat loss, and achieving constant temperature control of the drug.

[0033] like Figure 1-6 As shown, a drug infusion system includes: a catheter body 1;

[0034] The catheter body 1 is equipped with a occlusion balloon 2, which occludes the target location to form a closed space. Specifically, this application provides one occlusion balloon 2, which can effectively occlude the leading edge of the target location, i.e., the lesion location. In some embodiments, to improve the occlusion effect on the lesion location and reduce the aspiration of tissue fluid during drug circulation, two occlusion balloons 2 can be provided on the catheter body 1. In this embodiment, the infusion catheter 3 is positioned between the two occlusion balloons 2.

[0035] One end of the catheter body 1 is provided with an infusion catheter 3. The infusion catheter 3 is inserted into the closed space to infuse the closed space with drugs. The drugs can be infused into the closed space through the infusion catheter 3. Since the closed space has been blocked by the blocking balloon 2, the drugs will not be lost after infusion. This can effectively increase the contact time between the drugs and the lesion site, greatly improve the drug penetration rate and the therapeutic effect on the lesion.

[0036] The control system 4 is connected to the catheter body 1 via a drug inlet end 5 and a drug outlet end 6 to achieve drug circulation. The control system 4 includes a flow rate control module and a temperature control module to control the flow rate and temperature of the drug. The control system 4 allows for flexible adjustment of the circulating drug flow rate and temperature as needed, ensuring the drug acts at the optimal temperature on the lesion to improve therapeutic efficacy.

[0037] like Figure 2As shown, in one embodiment, a syringe 7 is provided as a bypass of the catheter body 1. The syringe is used to inject an expansion medium into the occlusion balloon 2 to achieve occlusion. The occlusion balloon 2 is made of a highly elastic and ductile material, with a wall thickness of 0.1mm-0.2mm. The syringe can easily inflate the occlusion balloon 2, and the inflated diameter can be determined based on the amount of liquid injected. In some embodiments, a contrast point is located at each end of the catheter body 1 where the occlusion balloon 2 is located, allowing for intraoperative occlusion positioning.

[0038] like Figure 3 As shown, in one embodiment, one end of the occlusion balloon 2 is connected to the outer tube of the catheter body 1, and the other end is connected to the outer tube of the infusion catheter 3. The infusion medium can flow out from the gap between the outer tube of the catheter body 1 and the outer tube of the infusion catheter 3, thereby inflating the occlusion balloon 2. This eliminates the need for additional drilling, simplifying the catheter's structural design and manufacturing process, and reducing processing complexity. Simultaneously, the intermittent channel reduces fluid flow resistance, allowing fluid to enter the balloon more smoothly, facilitating rapid and stable balloon inflation using a syringe. Figure 4 As shown, in one embodiment, the outer tube of the catheter body 1 can be sealed to the tip of the outer tube of the infusion catheter body 3. Openings are made at the proximal and distal ends of the outer tube of the catheter body 1, allowing the infusion medium to flow into the sealing medium through these openings, thereby inflating the balloon. This method avoids leakage of fluid to non-target areas at the catheter tip, ensuring that fluid flows only from the pre-set proximal and distal openings, precisely guiding it into the balloon and improving inflation efficiency. The layout of separate proximal and distal openings allows fluid to be injected simultaneously from different positions of the balloon, promoting uniform balloon expansion, reducing local overstretching or uneven inflation, and facilitating precise intraoperative positioning of the sealing location through imaging points, ensuring the stability of the sealing effect.

[0039] like Figure 5 As shown, in one embodiment, the surface of the infusion catheter 3 has a plurality of infusion holes 8 distributed axially. These infusion holes 8 are laser-cut, and their edges are smooth and flat. Releasing medication through the infusion holes 8 on the surface of the infusion catheter 3 increases the drug release rate and the contact area with the lesion, effectively improving the treatment effect. Simultaneously, the smooth and flat edges of the infusion holes 8 effectively prevent damage to surrounding tissues when the infusion catheter 3 is delivered to the target location.

[0040] In one embodiment, the infusion port 8 can be a circular or rectangular hole. In some embodiments, the infusion port 8 can also be other regular shapes, such as triangles, which can be selected according to actual needs. The number of infusion ports 8 and the length of the area where the infusion ports 8 are located can be customized according to requirements. There is a contrast point at each end of the infusion catheter 3, which can be used for infusion positioning during the operation. The infused drug can be an anti-inflammatory drug, an anti-tumor proliferative drug, or a thrombolytic drug, etc.

[0041] like Figure 5 As shown, the catheter body 1 has a guidewire lumen 9, which is located within the infusion catheter 3 and extends through the end of the infusion catheter 3. In use, the system delivers the guidewire through the guidewire lumen 9 to the lesion site in the biliary tract or pancreas. The guidewire is then removed, and during subsequent drug infusion, the drug can be withdrawn through the guidewire lumen 9 to achieve drug circulation.

[0042] Specifically, the drug inlet 5 is a Luer connector one, and the drug outlet 6 is a Luer connector two. Luer connector one is connected to the infusion catheter 3, and Luer connector two is connected to the guidewire lumen 9. Both Luer connector one and Luer connector two are connected to the control system 4. Luer connector one is used for drug inflow, while Luer connector two, connected to the guidewire lumen 9, extracts the drug and delivers it to the control system 4 for temperature and flow rate regulation, thereby achieving drug circulation and dynamic temperature control.

[0043] In one embodiment, the syringe is positioned below the catheter body 1 for easy operation by the doctor, and the drug inflow end 5 is positioned above the catheter body 1 for easier operation during the procedure, and the two do not interfere with each other.

[0044] In one embodiment, the control system 4 includes a flow rate control module, which comprises a flow pump, a flow rate regulating valve, a flow rate sensor, and an integrated control module. Specifically, a medical peristaltic pump can be used to provide power for drug circulation (avoiding direct contact between the drug and the pump body, reducing the risk of contamination). The pump speed is adjusted to precisely control the drug flow rate per unit time, adapting to the circulation intensity required for different lesions, and ensuring a stable output flow rate to reduce heat loss due to power fluctuations. The flow rate regulating valve works in conjunction with the flow pump, adjusting the tubing diameter via a mechanical or electronic knob to achieve fine-tuning of the drug flow rate. It can correct the flow rate in real time during circulation, ensuring that the drug's flow rate in the enclosed space matches the absorption efficiency of the diseased tissue. The flow rate sensor monitors the actual drug flow rate in the circulation pathway in real time and feeds the data back to the system control unit, forming a closed-loop control. When the flow rate deviates from the set value, the flow pump or regulating valve can be automatically activated to ensure flow rate stability and indirectly help maintain the drug temperature. The integrated control module integrates flow rate setting, display and adjustment functions. The target flow rate can be set by buttons or touch screen and the current flow rate value can be displayed in real time. At the same time, it is linked with the temperature control system 4 to realize coordinated control of flow rate and temperature.

[0045] In one embodiment, the control system 4 includes a temperature control module, which comprises a micro heater, a temperature sensor, a temperature control switch, an integrated microprocessor, and a heat preservation component. The micro heater can be integrated into the outer wall of the drug circulation pathway or a built-in heating element, converting electrical energy into heat energy to raise the temperature of the flowing drug. Its power is adjustable to adapt to the target temperature required by different drugs, and the heating rate must be stable to avoid local overheating and tissue damage. The temperature sensor monitors the actual temperature of the drug in the circulation pathway in real time. It can be a contact type (such as a thermocouple attached to the inner wall of the pipeline) or a non-contact type (such as an infrared temperature probe), feeding the temperature data back to the integrated microprocessor in real time. The integrated microprocessor can be an electronic control chip that receives the feedback data from the temperature sensor, compares it with the preset target temperature, and automatically adjusts the power of the heating module. When the drug temperature is lower than the set value, the heating power is increased; when it is higher than the set value, heating is reduced or stopped to achieve constant temperature control. The insulation component can be a medical insulation material (such as a silicone heat insulation sleeve) wrapped around the outer layer of the circulation tubing to reduce heat loss of the drug during circulation. Combined with flow rate control, it can further improve the constant temperature stability and ensure that the drug is still at the optimal temperature when it reaches the lesion area.

[0046] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. 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. A drug infusion system, characterized in that, include: Catheter body; The catheter body is equipped with an occlusion balloon, which occludes the target location to form a closed space; One end of the catheter body is provided with an infusion catheter, which is inserted into the closed space to infuse the closed space with medication; The control system is connected to the catheter body through a drug inlet and a drug outlet to realize drug circulation. The control system includes a flow rate control module and a temperature control module to control the flow rate and temperature of the drug.

2. The drug infusion system according to claim 1, characterized in that, A syringe is provided in the bypass of the catheter body, and the syringe is used to inject an expansion medium into the occlusion balloon.

3. The drug infusion system according to claim 1, characterized in that, The surface of the infusion conduit has multiple infusion holes distributed along the axial direction. The infusion holes are laser-cut, and the edges of the infusion holes are smooth and flat.

4. The drug infusion system according to claim 1, characterized in that, The catheter body has a guidewire cavity, which is located within the infusion catheter and extends through the end of the infusion catheter.

5. The drug infusion system according to claim 4, characterized in that, The drug inflow end is a Luer connector one, and the drug outflow end is a Luer connector two. The Luer connector one is connected to the infusion catheter, and the Luer connector two is connected to the guidewire lumen.

6. The drug infusion system according to claim 1, characterized in that, The occlusion balloon is made of a highly elastic and highly ductile material, and the wall thickness of the occlusion balloon is 0.1-0.2 mm.

7. The drug infusion system according to claim 2, characterized in that, The syringe is positioned below the catheter body, and the drug inflow end is positioned above the catheter body.

8. The drug infusion system according to claim 3, characterized in that, The injection hole is at least a round hole or a rectangular hole.

9. The drug infusion system according to claim 1, characterized in that, The flow rate control module includes a flow pump, a flow rate regulating valve, a flow rate sensor, and an integrated control module.

10. The drug infusion system according to claim 1, characterized in that, The temperature control module includes a micro heater, a temperature sensor, a temperature control switch, an integrated microprocessor, and a heat preservation component.

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