Hollow balloon embedded medicine local injection system

Abstract

The invention discloses a hollow balloon embedded medicine local injection system, and relates to the technical field of medical instruments. The device comprises an expandable balloon, a hollow catheter, a medicine storage unit and an injection control unit. A pre-buried medicine layer is arranged on the outer surface of the balloon, the hollow catheter directionally impacts the inner wall of the balloon through the fluid jet holes to rapidly dissolve the medicine layer, the medicine storage unit maintains the temperature and pressure of a medicine solution to be stable, and the injection control unit achieves intermittent high-pressure jet output. According to the system, the injection hole design, the porous structure layer and the double-cavity catheter structure are optimized, the drug release efficiency and adaptability are improved, the problems that in the prior art, drug release is uncontrollable, and the system flexibility is insufficient are solved, and the system is suitable for the scenes of vascular interventional therapy, tumor ablation and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a local injection system for pre-embedded drugs in a hollow balloon. Background Art

[0002] With the rapid development of minimally invasive interventional therapy, local drug delivery systems are playing an increasingly important role in the treatment of vascular diseases and tumors. By directly applying drugs to the lesion site, the therapeutic effect can be significantly improved and systemic side effects can be reduced. However, in actual applications, the efficiency and uniformity of drug delivery may be affected by many factors, such as the release rate of the drug carrier, the temperature and pressure conditions of the local environment, etc. Although traditional drug-coated balloon technology can achieve a certain degree of local drug release, its release process usually relies on the natural dissolution of blood or tissue fluid, which may result in a slow drug release rate and difficulty in precise control.

[0003] In addition, existing balloon catheter designs may lack adaptability when addressing the needs of different lesion sites. For example, in complex vascular structures or high-velocity blood flow environments, the drug coating may be washed away prematurely, thereby affecting the therapeutic effect. At the same time, the temperature control and pressure regulation capabilities of the drug storage and delivery system also have a significant impact on drug activity and delivery efficiency. Failure to maintain an appropriate temperature range or accurate pressure output may result in drug inactivation or uneven delivery.

[0004] In view of this, the present invention is proposed. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a hollow balloon pre-embedded drug local injection system, which solves the problems raised in the above-mentioned background technology.

[0006] In order to solve the above technical problems, the basic concept of the technical solution adopted by the present invention is:

[0007] A hollow balloon pre-embedded drug local injection system, comprising:

[0008] An inflatable balloon, a hollow catheter, a drug storage unit, and an injection control unit. The outer surface of the inflatable balloon is provided with a pre-embedded drug layer; the hollow catheter penetrates the interior of the inflatable balloon and forms a sealed connection with the balloon inner wall; the hollow catheter has at least one fluid injection hole formed on the wall of the hollow catheter, facing the balloon inner wall; the drug storage unit is connected to the proximal end of the hollow catheter via a fluid channel; the injection control unit is used to drive the drug solution in the drug storage unit through the hollow catheter and the fluid injection hole to directionally impact the balloon inner wall, causing the pre-embedded drug layer to quickly dissolve and release to the target area.

[0009] The pre-embedded drug layer is composed of a composite of a therapeutic agent and a degradable carrier material, and the carrier material is selected from at least one of polyvinyl pyrrolidone, chitosan, and polylactic acid-glycolic acid copolymer. The degradable carrier material gradually decomposes during the drug release process to release the therapeutic agent, and its decomposition rate can be controlled by adjusting the material ratio. The opening direction of the fluid injection hole forms an acute angle of 20°-70° with the inner wall of the balloon, and the aperture of the injection hole is 50-200μm. This angle range and aperture design ensure that the drug solution can act on the inner wall of the balloon with appropriate impact force and coverage area, thereby promoting the uniform dissolution of the drug layer.

[0010] The drug storage unit includes a drug tank, a pressure sensor, and a temperature controller. The tank stores the drug solution, the pressure sensor monitors pressure changes in the drug solution in real time, and the temperature controller maintains the drug solution at a constant temperature of 25°C–37°C. The temperature controller, through its built-in heating element and cooling device, precisely regulates the drug solution's temperature, preventing temperature fluctuations that could reduce drug activity or render it ineffective.

[0011] The injection control unit includes a microprocessor, a pulse injection pump and a pressure feedback module. The microprocessor controls the pulse injection pump to output the drug solution in an intermittent high-pressure jet according to a preset program. The pulse injection pump forms an intermittent high-pressure jet by periodically changing the output pressure and flow rate, so that the drug solution can act on the inner wall of the balloon with a higher impact force, thereby accelerating the dissolution process of the drug layer. The pressure feedback module monitors the fluid pressure in the hollow catheter in real time, and automatically triggers the pressure relief valve to open when the pressure exceeds the threshold of 50kPa. The opening action of the pressure relief valve is achieved by a mechanical linkage mechanism to ensure that excess pressure can be quickly released when the pressure exceeds the safety range.

[0012] The hollow catheter is embedded with a guidewire channel, which forms a parallel dual-lumen structure with the fluid channel. The guidewire channel is used to accommodate a guidewire and is separated from the fluid channel by a partition to ensure that their functions do not interfere with each other. The inner diameter of the guidewire channel ranges from 0.5–1.5 mm, and the inner diameter of the fluid channel ranges from 0.8–2.0 mm to meet the needs of different application scenarios.

[0013] The expandable balloon features a porous outer surface, with the pre-embedded drug layer coated within the pores of the porous layer. The porous layer has a porosity of 40%–80%. Laser etching is used to create a uniform and controllable pore distribution, effectively increasing the drug layer's surface area while minimizing drug loss during delivery. The balloon has an inflated diameter of 2–10 mm and an operating pressure range of 1–15 atm, making it suitable for use in vessels of varying sizes or lesions.

[0014] The therapeutic agent is an antiproliferative drug, an anti-inflammatory drug, or a gene therapy vector, and is selected from at least one of paclitaxel, rapamycin, dexamethasone, and siRNA. The choice of therapeutic agent is based on the specific needs of the target lesion. For example, in vascular interventional therapy, antiproliferative drugs are preferred to inhibit intimal hyperplasia; in tumor ablation, gene therapy vectors are preferred to achieve precise targeted treatment.

[0015] After adopting the above technical solution, the present invention has the following beneficial effects compared with the prior art. Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described below at the same time:

[0016] The present invention significantly improves the dissolution efficiency and release rate of the drug layer by directing the drug solution to impact the inner wall of the balloon in the form of intermittent high-pressure jets. The angle and aperture design of the fluid injection hole further optimize the impact effect of the drug solution, enabling it to evenly cover the inner wall of the balloon, avoiding the problem of local drug overdose or underdose. In addition, the temperature controller of the drug storage unit maintains the drug solution within a suitable temperature range, ensuring the activity and stability of the drug. The real-time monitoring function of the pressure feedback module combined with the design of the pressure relief valve effectively prevents system failure or drug waste caused by excessive pressure.

[0017] The porous structure layer design of the present invention increases the adhesion area of the drug layer while reducing drug loss during delivery. The introduction of a degradable carrier material not only achieves sustained drug release but also avoids the premature drug shedding that can occur with traditional coating technologies. The parallel dual-lumen design of the guidewire channel and fluid channel provides the system with greater operational flexibility and adaptability in complex vascular environments.

[0018] Through the aforementioned technical means, the present invention addresses the existing issues of low drug release efficiency, uncontrollable release rate, and insufficient system adaptability. In practical applications, this system can meet a variety of clinical needs, such as achieving efficient antiproliferative drug delivery in vascular interventional therapy and precise gene therapy vector delivery in tumor ablation. By optimizing the drug release process and system design, the present invention significantly improves the efficacy and safety of localized drug delivery, providing a new technical solution for minimally invasive interventional therapy.

[0019] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings described below are only some embodiments. A person skilled in the art can derive other drawings based on these drawings without inventive effort. In the drawings:

[0021] Figure 1 This is a schematic structural diagram of the hollow balloon pre-embedded drug local injection system of the present invention;

[0022] It should be noted that these drawings and textual descriptions are not intended to limit the conceptual scope of the present invention in any way, but rather to illustrate the concept of the present invention for those skilled in the art by referring to specific embodiments. DETAILED DESCRIPTION

[0023] The present invention will now be described in further detail with reference to the accompanying drawings.

[0024] See also Figure 1As shown, in this embodiment, a hollow balloon pre-embedded drug local injection system is provided, including an expandable balloon, a hollow catheter, a drug storage unit and an injection control unit. The outer surface of the expandable balloon is provided with a porous structure layer, and the pores of the porous structure layer are coated with a pre-embedded drug layer; the pre-embedded drug layer is a graded porous layer, which is formed by 3D laser etching. The graded porous layer contains large pores and small pores, and the inner wall of the pore is coated with a super-hydrophilic coating, wherein the large pores are 100-500nm and the small pores are 10-50nm. The super-hydrophilic coating material can be polyethylene glycol. Femtosecond laser etching technology can achieve precise processing of nano-scale pores with an accuracy of up to ±5nm. Compared with traditional laser etching, the thermal damage to the balloon substrate (such as polyurethane) is reduced by more than 80%. The super-hydrophilic coating (polyethylene glycol) forms a molecular layer with a thickness of 2-5nm through chemical grafting, which reduces the amount of blood protein adsorption by 90% and can improve the stability of the drug layer in the blood flow environment. The hollow catheter extends through the inflatable balloon and forms a sealed connection with the balloon's inner wall. The hollow catheter is provided with at least one fluid injection orifice, which forms an acute angle of 20° to 70° with the balloon's inner wall and has an aperture of 50 to 200 microns. The hollow catheter also contains a guidewire channel, which is a parallel dual-lumen structure separated by a partition to ensure functional independence. The fluid and guidewire channels are independently located within the hollow catheter, with an inner diameter of 0.5 to 1.5 mm for the guidewire channel and 0.8 to 2.0 mm for the fluid channel. The drug storage unit is connected to the proximal end of the hollow catheter through a fluid channel. The drug storage unit includes a drug storage tank, a pressure sensor and a temperature controller. The drug storage tank is used to store the drug solution. The pressure sensor monitors the pressure change of the drug solution in real time, and the temperature controller maintains the drug solution at a constant temperature of 25°C to 37°C. The drug storage unit stores a degradable carrier solution containing a therapeutic agent. The degradable carrier is a pH-responsive composite carrier in which polyvinyl pyrrolidone and chitosan are blended in a ratio of 1:1-3:1. When the PVP / chitosan ratio is 2:1, the degradation rate of the carrier in pH 7.4 (blood environment) is less than 5% / 24h, while the degradation rate in pH 6.5 (tumor microenvironment) is 80% / 24h, achieving a 16-fold degradation rate difference. The coupling density of the anti-VEGF antibody is 50-100μg / m 2The drug accumulation in vascular endothelial cells is 3-5 times higher than that of non-targeted carriers. The injection control unit includes a microprocessor, a pulsed syringe pump, and a pressure feedback module. The microprocessor controls the pulsed syringe pump according to a preset program to output the drug solution in an intermittent high-pressure jet. The pressure feedback module monitors the fluid pressure in the hollow catheter in real time and automatically triggers the pressure relief valve to open when the pressure exceeds 50kPa. The pulsed syringe pump delivers high-pressure fluid to the fluid channel. The end of the fluid channel is configured as an adaptive injection hole made of shape memory alloy. The hole diameter automatically adjusts within the range of 50-200μm with pressure changes. The closed-loop feedback system includes a pressure-flow sensor and a temperature controller. It monitors the pressure in the fluid channel (threshold 50kPa) and the temperature of the drug storage unit in real time, and jointly adjusts the syringe pump output and the pressure relief valve. The pressure-flow sensor (accuracy ±0.1kPa) collects data in real time. When the temperature deviates from 37℃±2℃, the microprocessor automatically adjusts the heating / cooling power (at a rate of 0.5℃ / min) according to the PID control algorithm. At the same time, according to the pressure-temperature coupling model, its formula is:

[0025] P=kT+C

[0026] Wherein, k is the temperature-pressure coefficient, C is a constant, and the syringe pump pressure is fine-tuned synchronously (adjustment step size 1 kPa) to ensure that the drug activity maintenance rate is greater than 95%.

[0027] In practice, a guidewire is first inserted into the target site through the guidewire channel. The inner diameter of the guidewire channel ranges from 0.5 to 1.5 mm to accommodate guidewires of varying diameters. The inner diameter of the fluid channel, meanwhile, ranges from 0.8 to 2.0 mm, ensuring smooth delivery of the drug solution. Once the guidewire is in place, the inflatable balloon is inflated using an external pressurizing device, increasing its diameter to 2 to 10 mm. The operating pressure ranges from 1 to 15 atm to accommodate vessels of varying sizes or lesions. At this point, the drug solution in the drug storage unit, driven by the injection control unit, enters the hollow catheter through the fluid channel and is directed toward the balloon's inner wall via the fluid injection orifice. Because the fluid injection orifice's opening forms an acute angle of 20° to 70° with the balloon's inner wall and has an aperture of 50 to 200 microns, this design ensures that the drug solution impacts the balloon's inner wall with appropriate impact force and coverage, promoting uniform dissolution of the pre-embedded drug layer. The pre-embedded drug layer is composed of a composite of a therapeutic agent and a degradable carrier material. The carrier material is selected from at least one of polyvinyl pyrrolidone, chitosan, and polylactic acid-glycolic acid copolymer. The decomposition rate of the degradable carrier material can be controlled by adjusting the material ratio to achieve a sustained release effect of the drug.

[0028] During the drug release process, the microprocessor of the injection control unit controls the pulsed injection pump according to a preset program to periodically change the output pressure and flow rate to form an intermittent high-pressure jet, so that the drug solution acts on the inner wall of the balloon with a higher impact force, thereby accelerating the dissolution process of the drug layer. The pressure feedback module monitors the fluid pressure in the hollow catheter in real time, and triggers the pressure relief valve to open through a mechanical linkage mechanism when the pressure exceeds 50kPa, ensuring that excess pressure can be quickly released when the pressure exceeds the safe range. At the same time, the temperature controller of the drug storage unit maintains the drug solution at a constant temperature of 25°C to 37°C through a built-in heating element and cooling device to avoid reduced drug activity or failure due to temperature fluctuations.

[0029] The porous structure layer is processed using laser etching technology, with a porosity of 40% to 80%. The pore distribution is uniform and controllable, which can effectively increase the adhesion area of the drug layer while reducing drug loss during delivery. The introduction of degradable carrier materials not only achieves a sustained release effect of the drug, but also avoids the problem of premature drug shedding that may occur in traditional coating technologies. The choice of therapeutic agent is based on the specific needs of the target lesion site. For example, in vascular interventional therapy, anti-proliferative drugs such as paclitaxel or rapamycin are preferred to inhibit vascular intimal hyperplasia; in tumor ablation, gene therapy vectors such as siRNA are used to achieve precise targeted therapy.

[0030] In specific application scenarios, such as in vascular interventional treatment, the guidewire is guided to the target vascular site through the guidewire channel, and then the expandable balloon is inflated and fits tightly against the vascular wall. Driven by the injection control unit, the drug solution in the drug storage unit enters the hollow catheter through the fluid channel, and directionally impacts the inner wall of the balloon through the fluid injection hole, so that the pre-embedded drug layer is quickly dissolved and released to the target site. Since the angle and aperture design of the fluid injection hole optimize the impact effect of the drug solution, the drug solution can evenly cover the inner wall of the balloon, avoiding the problem of local drug overdose or deficiency. In addition, the temperature controller of the drug storage unit maintains the drug solution within an appropriate temperature range to ensure the activity and stability of the drug. The real-time monitoring function of the pressure feedback module combined with the design of the pressure relief valve effectively prevents system failure or drug waste due to excessive pressure.

[0031] During tumor ablation, the guidewire is guided to the tumor site through the guidewire channel, and the expandable balloon is inflated and in contact with the tumor tissue. Driven by the injection control unit, the gene therapy vector solution in the drug storage unit enters the hollow catheter through the fluid channel and directionally impacts the inner wall of the balloon through the fluid injection hole, causing the pre-embedded drug layer to quickly dissolve and release into the tumor tissue. The design of the porous structure layer increases the adhesion area of the drug layer while reducing the loss of the drug during the delivery process. The introduction of degradable carrier materials achieves a sustained release effect of the drug, ensuring that the gene therapy vector can continue to exert its effect in the tumor tissue. The parallel dual-lumen structure design of the guidewire channel and the fluid channel gives the system greater operational flexibility and adaptability in complex vascular environments.

[0032] In the above embodiment, the various components of the system achieve an efficient and stable drug delivery process through precise design and coordination. The design of the porous structure layer and the pre-embedded drug layer of the inflatable balloon significantly improves the drug adhesion area and delivery efficiency. The dual-cavity structure of the fluid injection hole and the guidewire channel of the hollow catheter ensures the uniform impact of the drug solution and the flexible operation of the guidewire. The temperature controller and pressure sensor of the drug storage unit ensure the stability and safety of the drug solution. The microprocessor and pressure feedback module of the injection control unit achieve precise control of the drug release process. Through the above technical means, this system solves the problems of low drug release efficiency, uncontrollable release rate and insufficient system adaptability in the existing technology. In actual application, it can meet a variety of clinical needs, such as achieving efficient anti-proliferative drug delivery in vascular interventional therapy and achieving precise gene therapy vector delivery in tumor ablation. It significantly improves the effect and safety of local drug delivery and provides a new technical solution for minimally invasive interventional therapy.

[0033] In order to better enable relevant personnel in this technical field to fully understand and implement the present invention, the operating principle and implementation steps of the present invention are supplemented below with reference to specific application scenarios.

[0034] In specific applications of vascular interventional therapy, a guidewire is first inserted through a guidewire channel into the target vessel. The guidewire channel's inner diameter is designed to be 0.5 to 1.5 mm, accommodating guidewires of varying diameters and ensuring operational flexibility. Once the guidewire is guided to the target location, an external pressurizing device inflates the inflatable balloon, causing it to expand and conform tightly to the vessel wall. The inflated balloon's diameter ranges from 2 to 10 mm, and its operating pressure ranges from 1 to 15 atm, accommodating vessels of varying sizes or lesions. At this point, the drug solution in the drug storage unit, driven by the injection control unit, enters the hollow catheter through the fluid channel and is directed toward the balloon's inner wall via the fluid injection orifice. The fluid injection orifice's opening forms an acute angle of 20° to 70° with the balloon's inner wall, and its aperture ranges from 50 to 200 microns. This angle and aperture ensure that the drug solution evenly covers the balloon's inner wall with appropriate impact force, promoting rapid dissolution of the pre-embedded drug layer. The pre-embedded drug layer is composed of a therapeutic agent and a degradable carrier material. The carrier material is selected from at least one of polyvinyl pyrrolidone, chitosan, and polylactic acid-glycolic acid copolymer. Its decomposition rate can be controlled by adjusting the material ratio to achieve a sustained release effect of the drug.

[0035] During the drug release process, the microprocessor of the injection control unit controls the pulsed syringe pump according to a preset program to output the drug solution in the form of an intermittent high-pressure jet. The pulsed syringe pump forms an intermittent high-pressure jet by periodically changing the output pressure and flow rate, so that the drug solution acts on the inner wall of the balloon with a higher impact force, accelerating the dissolution process of the drug layer. The pressure feedback module monitors the fluid pressure in the hollow catheter in real time, and triggers the pressure relief valve to open through a mechanical linkage mechanism when the pressure exceeds 50kPa, ensuring that the system pressure always remains within a safe range. At the same time, the temperature controller of the drug storage unit maintains the drug solution at a constant temperature of 25°C to 37°C through a built-in heating element and cooling device to avoid reduced drug activity or failure due to temperature fluctuations.

[0036] The porous structure layer is processed using laser etching technology and has a porosity of 40% to 80%. The pore distribution is uniform and controllable, which can effectively increase the adhesion area of the drug layer while reducing drug loss during delivery. The pre-embedded drug layer is coated within the pores of the porous structure layer. This design significantly improves the adhesion stability of the drug and avoids the problem of premature drug shedding that may occur with traditional coating technologies. The choice of therapeutic agent is based on the specific needs of the target lesion site. Anti-proliferative drugs such as paclitaxel or rapamycin are preferred in vascular interventional treatment to inhibit vascular intimal hyperplasia.

[0037] In the specific application of tumor ablation, the guidewire is guided to the tumor site through the guidewire channel, and then the expandable balloon is inflated and brought into contact with the tumor tissue. Driven by the injection control unit, the gene therapy vector solution in the drug storage unit enters the hollow catheter through the fluid channel and directionally impacts the inner wall of the balloon through the fluid injection hole, causing the pre-embedded drug layer to quickly dissolve and release into the tumor tissue. The design of the porous structure layer increases the adhesion area of the drug layer while reducing the loss of the drug during the delivery process. The introduction of degradable carrier materials achieves a sustained release effect of the drug, ensuring that the gene therapy vector can continue to play a role in the tumor tissue. The parallel dual-lumen structure design of the guidewire channel and the fluid channel gives the system higher operational flexibility and adaptability in complex vascular environments.

[0038] In the above scenario, the various components of the system achieve an efficient and stable drug delivery process through precise design and coordination. The design of the porous structure layer and the pre-embedded drug layer of the expandable balloon significantly improves the drug adhesion area and delivery efficiency. The dual-lumen structure of the fluid injection hole and the guidewire channel of the hollow catheter ensures uniform impact of the drug solution and flexible operation of the guidewire. The temperature controller and pressure sensor of the drug storage unit ensure the stability and safety of the drug solution, while the microprocessor and pressure feedback module of the injection control unit achieve precise control of the drug release process. Through the above technical means, this system solves the problems of low drug release efficiency, uncontrollable release rate and insufficient system adaptability in the existing technology. In actual application, it can meet a variety of clinical needs, such as achieving efficient anti-proliferative drug delivery in vascular interventional therapy and achieving precise gene therapy vector delivery in tumor ablation. It significantly improves the effect and safety of local drug delivery and provides a new technical solution for minimally invasive interventional therapy.

[0039] The present invention is not limited to the above-described embodiments. Any structural changes made under the guidance of the present invention, which have the same or similar technical solutions as the present invention, should be understood to fall within the scope of protection of the present invention. The technologies, shapes, and structural parts not described in detail in the present invention are all well-known technologies.

Claims

1. A hollow balloon pre-embedded drug local injection system, characterized in that: include: an inflatable balloon, a hollow catheter, a drug storage unit, and an injection control unit; The outer surface of the expandable balloon is provided with a pre-embedded drug layer; The hollow catheter passes through the interior of the inflatable balloon and forms a sealed connection with the inner wall of the balloon. The wall of the hollow catheter is provided with at least one fluid injection hole, and the opening direction of the fluid injection hole is toward the inner wall of the balloon. The drug storage unit is in communication with the proximal end of the hollow catheter via a fluid channel; The injection control unit is used to drive the drug solution in the drug storage unit to pass through the hollow catheter and the fluid injection hole to directionally impact the inner wall of the balloon.

2. A hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The pre-embedded drug layer is formed by compounding a therapeutic agent and a degradable carrier material, and the carrier material is selected from at least one of polyvinyl pyrrolidone, chitosan, and polylactic acid-glycolic acid copolymer.

3. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The drug storage unit includes a drug storage tank, a pressure sensor and a temperature controller; the drug storage tank is used to store drug solution; The pressure sensor is used to monitor the pressure change of the drug solution in real time; the temperature controller maintains the drug solution at a constant temperature of 25°C to 37°C.

4. A hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The injection control unit includes a microprocessor, a pulse injection pump and a pressure feedback module; The microprocessor controls the pulsed syringe pump to output the drug solution in an intermittent high-pressure jet manner according to a preset program; The pressure feedback module monitors the fluid pressure in the hollow conduit in real time and automatically triggers the pressure relief valve to open when the pressure exceeds 50 kPa.

5. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: A guidewire channel is embedded in the hollow catheter. The guidewire channel and the fluid channel are a parallel double-lumen structure. The inner diameter of the guidewire channel is 0.5 to 1.5 mm, and the inner diameter of the fluid channel is 0.8 to 2.0 mm.

6. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The outer surface of the expandable balloon is provided with a porous structure layer, the pre-embedded drug layer is coated in the pores of the porous structure layer, and the porosity of the porous structure layer is 40% to 80%.

7. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The inflatable balloon has an inflated diameter of 2 to 10 mm and a working pressure range of 1 to 15 atm.

8. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The therapeutic agent is selected from at least one of an antiproliferative drug, an anti-inflammatory drug or a gene therapy vector, the antiproliferative drug is selected from paclitaxel or rapamycin, the anti-inflammatory drug is selected from dexamethasone, and the gene therapy vector is selected from siRNA.

9. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The pressure relief valve is opened by a mechanical linkage mechanism.

10. The hollow balloon pre-embedded drug local injection system according to claim 1, characterized in that: The porous structure layer is processed by laser etching technology.

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