Multi-balloon catheter with dilation, drug delivery, and nutrient supply functions

Abstract

This invention belongs to the field of medical device technology and discloses a multi-balloon catheter with dilation, drug delivery, and nutrient supply functions, including a catheter body and a multi-balloon device. The catheter body has multiple mutually spaced lumens; the multi-balloon device includes at least three balloons, each connected to a different lumen. The first balloon is used to dilate narrowed areas, and the second balloon is used for sustained-release drug delivery. The second balloon has a porous microporous structure. The third balloon is used to adjust the dilation state. The surface of the first balloon has an array of protrusions or biodegradable microneedle patches to increase friction or local drug delivery. The first balloon can support three-stage dilation, and the outer surface of the catheter has a hydrophilic coating and depth markings. Each lumen is connected to a one-way valve and a pressure display device to monitor and control the intra-balloon pressure in real time. A third lumen is provided for nutrient supply or guidewire positioning. This invention integrates dilation, drug delivery, and nutrient functions, and is safe and controllable in operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a multi-balloon catheter with functions of expansion, drug delivery, and nutrient supply. Background Technology

[0002] Esophageal stricture is a pathological condition in which the esophageal lumen narrows, leading to symptoms such as difficulty swallowing. Its occurrence mechanism is mostly related to factors such as scar fibrosis after tissue damage and abnormal inflammatory repair.

[0003] In the healing process of esophageal mucosal wounds, the main methods for preventing and treating esophageal stricture currently include two categories: drug therapy and mechanical intervention. Drug therapy usually involves local or systemic administration of anti-inflammatory drugs, immunosuppressants, or anti-fibrotic drugs to suppress excessive inflammatory responses and fibrous tissue proliferation; mechanical intervention mostly relies on balloon dilation or stent implantation to physically dilate the stricture.

[0004] However, there are obvious shortcomings in the existing technology: In terms of drug treatment, traditional drug administration methods often lead to problems such as uneven drug distribution, difficulty in maintaining local effective concentration, and short duration of action, which seriously affect the treatment effect; In terms of mechanical intervention, relying solely on dilation or stent implantation lacks synchronous drug support, which cannot effectively inhibit postoperative restenosis and scar formation, and stents may pose risks such as displacement, foreign body irritation, or even cause ulceration or bleeding.

[0005] Therefore, there is an urgent need in the field for a medical device that can integrate mechanical dilation with local sustained-release drug delivery to achieve safer and more effective treatment of esophageal stricture. Summary of the Invention

[0006] The purpose of this invention is to provide a multi-balloon catheter with dilation, drug delivery, and nutritional supply functions, which can simultaneously achieve mechanical dilation of the esophageal stricture, sustained drug release, and nutritional supply in a single catheterization procedure, thereby improving treatment efficacy and patient safety.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A multi-balloon catheter with dilation, drug delivery, and nutrient supply functions includes a catheter body and a multi-balloon device. The catheter body has at least two mutually spaced lumens. The multi-balloon device is located at one end of the catheter body along its axial direction and includes at least two balloons arranged in series, each communicating with one of the lumens. The lumens include a first balloon lumen and a second balloon lumen. One end of the first balloon lumen is connected to the first balloon, and the other end is connected to the inlet of the first balloon. One end of the second balloon lumen is connected to the second balloon, and the other end is connected to the inlet of the second balloon. The second balloon has micropores penetrating its wall, and the surface of the first balloon (2) has an array of protrusions (9) or microneedle structures.

[0009] In addition to the above-mentioned technical features, the present invention has also made optimizations and improvements in the following aspects:

[0010] As a preferred embodiment of the present invention, it further includes a third balloon, wherein one end of the cavity of the first balloon is connected to the third balloon and the first balloon, and the other end is connected to the inlet of the third balloon.

[0011] As a preferred embodiment of the present invention, it further includes a fourth balloon, wherein one end of the cavity of the second balloon is connected to the fourth balloon and the second balloon, and the other end is connected to the inlet of the fourth balloon.

[0012] As a preferred embodiment of the present invention, the catheter body is further provided with a third cavity that is separated from the first balloon cavity and the second balloon cavity, and the third cavity extends along the length direction of the catheter body.

[0013] As a preferred embodiment of the present invention, the inlets of the first balloon cavity and the second balloon cavity are respectively connected to one-way valves, and a pressure display device is connected to the one-way valves.

[0014] As a preferred embodiment of the present invention, the first and second balloons are compliant balloons, semi-compliant balloons, or non-compliant balloons, any of the following types; the third and fourth balloons are non-compliant balloons.

[0015] As a preferred embodiment of the present invention, the first and second balloons are made of at least one of latex, silicone, rubber, polyurethane, polyvinyl chloride, polyethylene, polyamide, and polyether block polyamide; the third and fourth balloons are made of at least one of polyvinyl chloride, polyethylene, polyamide, and polyether block polyamide.

[0016] As a preferred technical solution of the present invention, the first balloon has a diameter of 5mm to 30mm after expansion, a volume of 0.05ml to 15ml after expansion, and a pressure resistance range of 1 to 20atm; the second balloon (3) has a diameter of 5mm to 20mm after expansion, a volume of 0.05ml to 8ml after expansion, and a pressure resistance range of 1 to 16atm.

[0017] As a preferred technical solution of the present invention, the array density of the protrusions or microneedles decreases from the central region of the surface of the first balloon (2) to the two side edges; the height of the protrusions or microneedles increases from the central region of the surface of the first balloon to the two side edges.

[0018] As a preferred embodiment of the present invention, the diameter of the array protrusions ranges from 0.1 to 3 mm, and the height of the protrusions ranges from 0.05 to 1 mm.

[0019] As a preferred technical solution of the present invention, the second balloon (3) has an expandable porous microporous structure with a pore size range of 50 to 500 micrometers and a porosity of 5% to 50%.

[0020] Based on the above description of the technical content, this application has achieved significant optimization of the multi-balloon catheter structure through a series of technical improvements, resulting in many beneficial effects, specifically reflected in the following aspects:

[0021] 1. Multifunctional integrated and synergistic therapy

[0022] Structural integration innovation: By setting multiple independent lumens within the same catheter body, the three major functions of mechanical dilation, local sustained-release drug delivery, and nutritional supply are physically integrated and operated synergistically. The lumens are separated from each other, avoiding interference between functions and significantly improving the efficiency and convenience of treatment procedures.

[0023] Treatment Synergy: While the first balloon (dilation balloon) mechanically dilates the narrowed area, the second balloon (drug delivery balloon) can simultaneously deliver medication locally. The physical space created after dilation helps retain the drug solution, allowing it to accumulate at the lesion site and maintain an effective concentration, solving the technical challenges of poor targeting of systemic administration and difficulty in maintaining local drug concentration. The addition of a third balloon, used to adjust the expansion and contraction of the first balloon, can achieve tissue relaxation to some extent, promote blood circulation, and further prevent ischemia and necrosis of the esophageal mucosa due to prolonged compression.

[0024] By incorporating protrusions or microneedles of varying sizes and their irregular arrangement on the surface of the first balloon (expansion balloon), specifically by decreasing the density of the protrusions or microneedles from the center of the first balloon (expansion balloon) surface towards the outer edges, and increasing the height of the protrusions or microneedles from the center of the first balloon surface towards the outer edges, the medication can flow smoothly to the affected area and prolong its residence time at the affected area. Furthermore, this also improves the stability of the first balloon (expansion balloon).

[0025] 2. Precise and controllable drug release system

[0026] Controlled drug release mechanism: The wall of the second balloon is designed with a porous microporous structure (pore size 50-500μm, porosity 5%-50%). Based on the principle of fluid dynamics, the release rate and dosage of the drug can be precisely controlled by adjusting the pressure of the perfusion solution.

[0027] At the same time, the surface of the first balloon (expansion balloon) is decorated with protrusions or microneedles of different sizes and their irregular arrangement, so that the drug can pass smoothly through the balloon and approach the proximal end of the connector, and be accurately and slowly released at the affected area in the middle of the balloon, and can also prevent drug reflux.

[0028] Enhanced drug release design: By adding a fourth balloon connected to the second balloon, medical staff can manually squeeze the fourth balloon to increase the instantaneous pressure inside the second balloon, thereby actively accelerating drug release and emptying the residual drug solution inside the balloon at the end of treatment, significantly improving drug utilization and reducing waste.

[0029] 3. Safe and gradual mechanical expansion

[0030] Phased expansion capability: The first balloon can be designed as a three-stage expansion balloon, allowing clinicians to perform phased and gradual expansion according to the patient's tolerance and the severity of stenosis, avoiding the risk of tissue damage caused by single over-expansion.

[0031] Real-time pressure monitoring: The through-cavity connection to a one-way valve and a pressure display device allows for real-time monitoring and feedback of the balloon's internal pressure, ensuring that the expansion process remains within a safe and controllable pressure range, thus greatly improving operational safety.

[0032] 4. Stable anchoring and anti-displacement capability

[0033] Friction-enhancing structural design: An array of protrusions or biodegradable microneedles is placed on the surface of the first balloon, significantly increasing the friction between the balloon and the esophageal wall. This not only ensures the positional stability of the catheter during treatment, preventing displacement that could affect treatment efficacy or cause damage, but also provides more uniform radial support during dilation. It also enhances tissue relaxation and promotes blood circulation.

[0034] Biodegradability and Safety: The microneedles are made of biodegradable materials and are attached using a water-soluble adhesive. After treatment, there are two possible outcomes for the microneedles in the body: either they have already degraded in the body, or they separate from the patch and balloon and are eventually expelled, completely avoiding secondary damage caused by the removal of traditional stents or devices with non-degradable structures.

[0035] 5. Ease of operation

[0036] Multifunctional nasogastric tube: The independent third nasogastric tube can be used for indwelling guidewire placement to assist in precise tube placement, and can also be used for nasogastric feeding during treatment to ensure the patient's energy intake and support overall recovery.

[0037] In summary, this multi-balloon catheter, through its innovative integrated design and intelligent controllable functions, effectively solves the core problems of existing esophageal stricture treatments, such as insufficient efficacy, cumbersome operation, high risk, and poor patient experience, providing a safer, more effective, and more convenient integrated treatment solution. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of the overall structure of a multi-balloon catheter with dilation, drug delivery, and nutrient supply functions according to the present invention.

[0039] Figure 2 This is a partial structural diagram of the first balloon surface with an array of protrusions according to the present invention;

[0040] Figure 3 yes Figure 2 Enlarged view of A in the middle;

[0041] Figure 4 A schematic diagram of a portion of the structure of the first balloon surface with biodegradable microneedle patches;

[0042] Figure 5 yes Figure 4 Enlarged view of B in the middle;

[0043] Figure 6 This is a cross-sectional view of the surface of the first balloon of the present invention having an array of protrusions;

[0044] Figure 7 This is a cross-sectional view of the surface of the first balloon of the present invention having a biodegradable microneedle patch.

[0045] Explanation of reference numerals in the attached figures:

[0046] 1. Catheter body; 2. First balloon; 3. Second balloon; 4. Third balloon; 5. Fourth balloon; 6. First balloon lumen; 7. Second balloon lumen; 8. Third lumen; 9. Array of protrusions; 10. Biodegradable microneedle patch; 11. One-way valve. Detailed Implementation

[0047] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0048] I. Explanation of descriptive terms used in this invention

[0049] The embodiments provided in conjunction with the technical solutions of this invention are intended to make the invention more thorough and complete, and to fully express the scope of the invention to those skilled in the art. It should be noted that unless otherwise specifically stated in this invention, the relative arrangements of components described in these embodiments should be interpreted as merely exemplary and not as a limitation on the technical solutions of this invention.

[0050] In this invention, when directional terms such as "up," "down," "left," "right," "bottom," and "top" are used, they are defined relative to the directions shown in the accompanying drawings and are used only to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly. These or other directional terms should not be construed as restrictive terms.

[0051] In this invention, the terms "a," "an," "an," "the," and similar words used do not indicate quantity limitations and can represent singular or plural. The terms "comprising," "including," "having," and any variations thereof used in this invention are intended to cover non-exclusive inclusion; the terms "first," "second," "third," etc., used in this invention are merely to distinguish similar objects and do not represent a specific ordering of objects.

[0052] In this invention, when a specific device is described as being located between a first device and a second device, an intermediary device may or may not be present between the specific device and the first or second device. When a specific device is described as being connected to other devices, the specific device may be directly connected to the other devices without an intermediary device, or it may be not directly connected to the other devices but have an intermediary device.

[0053] Furthermore, this invention does not discuss in detail the technologies and equipment known to those skilled in the art, but where appropriate, such technologies and equipment should be considered part of the specification.

[0054] II. The core technical problem to be solved by the technical solution of this application

[0055] Currently, the clinical prevention and treatment of esophageal stricture mainly relies on two methods: drug therapy and mechanical intervention, but significant limitations remain. In terms of drug therapy, traditional local or systemic administration methods suffer from uneven drug distribution, short duration of effective concentration at the target site, and limited duration of action, making it difficult to sustainably suppress inflammation and fibrosis, thus limiting treatment efficacy. Regarding mechanical intervention, while balloon dilation or stent implantation can physically dilate the stricture, they lack simultaneous drug intervention, failing to effectively inhibit postoperative restenosis and scar tissue regeneration. Furthermore, stent implantation is prone to complications such as displacement, mucosal irritation, and even ulceration or bleeding, resulting in poor treatment safety and long-term efficacy. Therefore, current technology lacks an integrated treatment approach that can synergistically achieve mechanical dilation and local sustained-release drug delivery.

[0056] III. Based on the above problems, the present invention specifically provides a technical solution to solve these problems. The following describes specific embodiments and references the appendix. Figures 1-7 As shown, the technical solution, working principle, and technical effects of the present invention will be explained in detail.

[0057] Example 1

[0058] like Figure 1 , Figure 2 As shown, the multi-balloon catheter in this embodiment includes a catheter body 1, a multi-balloon device, a one-way valve 11, and a pressure display device.

[0059] The multi-balloon device consists of a first balloon 2, a second balloon 3, a third balloon 4, and a fourth balloon 5 arranged in series, with both ends of each balloon sealed to the surface of the catheter body 1.

[0060] The catheter body 1 has a first balloon passage 6, a second balloon passage 7 and a third passage 8 that are separated from each other. One end of the first balloon passage 6 is connected to the first balloon 2 and the third balloon 4, and the other end is connected to the one-way valve 11 and the pressure display device in sequence.

[0061] One end of the second balloon passageway 7 is connected to the second balloon 3 and the fourth balloon 5, and the other end is connected to the one-way valve 11 and the pressure display device in sequence.

[0062] The outer surface of the catheter body 1 is coated with a hydrophilic coating, and the catheter body 1 is provided with a marking part for marking the insertion depth.

[0063] Specifically, the catheter body 1 is made of polyurethane (TPU) material, which has good flexibility and strength. Its diameter is designed to be 4.7 mm according to the standard size of the adult esophagus, and its length is 120 cm. The first balloon lumen 6, the second balloon lumen 7, and the third lumen 8 inside the catheter body 1 are independently separated from each other, and the inner diameter of each lumen is 1 mm. The third lumen 8 can be used for nasogastric feeding or guidewire positioning.

[0064] The hydrophilic coating on the outer surface of the catheter body 1 is made of polyvinylpyrrolidone material with a coating thickness of 5μm, which can effectively reduce the coefficient of friction between the catheter and esophageal tissue.

[0065] The marking section can be a ring-shaped scale line, with one scale line set every 1 cm starting from the distal end of the catheter. The scale line is made of barium strip material that is not X-ray transparent. Alternatively, a contrast ring can be set in the middle of the first balloon or at both ends of the first balloon. The contrast ring can be made of platinum, gold, stainless steel, platinum-iridium alloy, etc., to facilitate observation of the catheter insertion depth under X-ray fluoroscopy.

[0066] The first balloon 2 serves as an expansion balloon to expand narrowed areas. It is made of polyether block polyamide (PEBAX) material, with a diameter of 15mm, a thickness of 150μm, a volume of 10ml, and a pressure resistance range of 10atm. It can be a three-stage expansion balloon to achieve phased expansion.

[0067] The surface of the first balloon 2 is provided with an array of protrusions 9. The protrusions can be spherical, hemispherical, conical, or any other shape that can increase the friction of the balloon surface. The protrusions can be arranged in any way, such as a rectangular array or a ring array. Figure 2 , Figure 3 , Figure 6 As shown, the array of protrusions 9 on the surface of the first balloon 2 are hemispherical protrusions with a diameter of 1 mm and a height of 0.5 mm. They are arranged in a ring array with a center-to-center distance of 2 mm between adjacent protrusions. This increases the friction between the balloon and the inner wall of the esophagus and prevents the catheter from shifting.

[0068] The second balloon 3 is used for sustained-release drug delivery and is also made of polyether block polyamide (PEBAX) material. The balloon wall has a porous microporous structure, and the entire circumference of the second balloon wall can be configured with a microporous structure, allowing the drug solution to seep out along the entire circumference, improving the uniformity and efficiency of drug delivery. Figure 2 As shown, after expansion, the diameter is 10 mm, the thickness is 100 μm, the volume is 3 ml, and the pressure resistance range is 8 atm. Its pore size is 200 micrometers, and the porosity is 25%, allowing the drug solution to seep out evenly through the micropores and flow to the lesion site.

[0069] The third balloon 4 is connected to the first balloon 2 through the first balloon cavity 6. It is made of polyamide (PA) material, with an inflated diameter of 8 mm, a thickness of 100 μm, a volume of 1.5 ml, and a pressure resistance range of 6 atm. By operating the third balloon 4 in a squeeze-release cycle, the expansion state of the first balloon 2 can be adjusted to achieve tissue relaxation, promote blood circulation, and avoid ischemia and necrosis of the esophageal mucosa due to prolonged compression.

[0070] The fourth balloon 5 is connected to the second balloon 3 through the second balloon cavity 7. It is made of polyamide (PA) material, with an expanded diameter of 8 mm, a thickness of 100 μm, a volume of 1.5 ml, and a pressure resistance range of 6 atm. Squeezing the fourth balloon 5 can accelerate the release rate of the drug solution in the second balloon 3, and squeezing at the end of drug delivery can expel as much residual drug solution as possible from the balloon.

[0071] The third and fourth balloons can be separated from the outside of the tube or fixedly connected in series on the tube.

[0072] One-way valve 11 and pressure display device: The one-way valve 11 is a medical-grade silicone one-way valve, which can prevent pressure leakage inside the balloon and ensure the stability of balloon use; the pressure display device is a miniature digital pressure gauge with a measurement range of 0 to 25 atm and an accuracy of 0.1 atm. It can display the pressure value inside the balloon in real time, which is convenient for medical staff to monitor and avoid excessive balloon expansion that could damage the esophageal mucosa.

[0073] To further illustrate this application, the following explanation, in conjunction with its working principle and operating steps, is provided:

[0074] Preoperative preparation: Check that all components of the catheter are intact, ensure that the one-way valve 11 is sealing properly, and that the pressure display device is functioning correctly. Prepare the necessary medications, such as anti-inflammatory drugs and anti-fibrotic drugs, according to the patient's esophageal stricture.

[0075] Catheter insertion: With the patient in a suitable position, medical staff, under the assistance of X-ray fluoroscopy, refer to the markings on the catheter body 1 and slowly insert the distal end of the catheter into the patient's esophagus until the first balloon 2 reaches the esophageal stricture, while ensuring that the distal end of the catheter enters the stomach.

[0076] Balloon dilation: Saline solution is injected into the first balloon 2 and the third balloon 4 through the first balloon lumen 6 to pressurize them. According to the reading of the pressure display device, the pressure of the first balloon 2 is first slowly increased to 3 atm for the first stage of dilation, which is maintained for 5 minutes; then the pressure is increased to 6 atm for the second stage of dilation, which is maintained for 5 minutes; finally, the pressure is increased to 10 atm for the third stage of dilation, which is maintained for 5 minutes, thus achieving staged dilation treatment of esophageal stricture.

[0077] During treatment, the third balloon 4 can be operated by squeezing and releasing cycles to relieve esophageal mucosal compression and promote blood circulation.

[0078] Sustained-release drug delivery: The prepared drug solution is injected into the second balloon 3 and the fourth balloon 5 through the second balloon cavity 7. The total amount of drug solution is determined according to the patient's condition, generally 2 ml. After injection, the pressure display device is observed to maintain the pressure inside the second balloon 3 at 5 atm. The drug solution seeps evenly through the micropores in the wall of the second balloon 3 and flows downwards to the affected area. Because the first balloon is expanded at the affected area, the drug solution is trapped and accumulates there. Near the end of drug delivery, the expansion and contraction state of the second balloon can be adjusted by repeatedly squeezing the fourth balloon 5 to expel as much drug solution as possible from the second balloon 3, reducing drug loss. According to the needs of the lesion site, the release rate and dosage of the drug can be precisely controlled by pressure adjustment, so that the drug maintains an effective local concentration for a longer period of time, thereby improving the therapeutic effect. The release rate of the drug solution can also be further controlled by designing the number of micropores.

[0079] Nutritional supply: During treatment, if the patient is unable to eat on their own, nutrients, such as liquid nutrition solutions, can be infused into the patient's stomach via nasogastric feeding through the third port 8. The infusion rate is adjusted according to the patient's tolerance, generally 50-100 ml / h.

[0080] Postoperative management: After treatment, first release the pressure in the first balloon 2 and the third balloon 4, then release the pressure in the second balloon 3 and the fourth balloon 5, so that all balloons are in a retracted state, and then slowly remove the catheter from the patient's esophagus.

[0081] Through the above structure and working principle, this embodiment can achieve the synergistic function of expansion, drug delivery, and nutrient supply.

[0082] When the first balloon (2) is a three-stage dilation balloon, dilation can be gradually and in stages according to the degree of esophageal stricture: for patients with mild stricture, the dilation pressure of the balloon can be appropriately reduced to minimize irritation to the esophagus; for patients with severe stricture, the dilation force can be increased to achieve better treatment results and avoid damage to the esophagus from excessive dilation at one time. Furthermore, the surface array of protrusions (9) effectively prevents catheter displacement, ensuring dilation effectiveness, while also improving tissue relaxation and promoting blood circulation in the affected area.

[0083] The porous microporous structure of the second balloon 3 enables uniform drug release. Combined with the regulating effect of the fourth balloon 5, it allows for further drug expulsion from the balloon at the end of drug delivery, reducing drug loss and improving drug utilization.

[0084] The nutritional supply function of the third port 8 can ensure the patient's nutritional intake during treatment and promote recovery.

[0085] Meanwhile, the one-way valve 11 and pressure display device can monitor the balloon pressure in real time, greatly reducing the risk of patient injury caused by excessive balloon inflation. The hydrophilic coating and marking on the outer surface of the catheter improve the convenience and positioning accuracy of catheter insertion and removal, thereby enhancing the overall safety, effectiveness and patient comfort of the treatment.

[0086] Example 2

[0087] The difference between this embodiment and Embodiment 1 lies in the structure of the surface of the first balloon 2. In Embodiment 1, the surface of the first balloon 2 has an array of protrusions 9, while in this embodiment, the surface of the first balloon 2 is provided with biodegradable microneedle patches 10, such as... Figure 4 , Figure 5 , Figure 7 As shown, the biodegradable microneedle patch 10 is attached to the surface of the first balloon 2 by a water-soluble adhesive, and the surface of the biodegradable microneedle patch 10 is also covered with a water-soluble film.

[0088] The biodegradable microneedle patch 10 includes a patch base and multiple biodegradable microneedles. The patch base is made of polylactic acid material with a thickness of 200 μm and its size matches the surface adhesion area of ​​the first balloon 2, being a circle with a diameter of 15 mm.

[0089] The biodegradable microneedles are conical in shape, with a base diameter of 200 μm and a height of 500 μm, arranged in a rectangular array with a center-to-center spacing of 500 μm between adjacent microneedles. The biodegradable microneedles are made from a 1:1 mass ratio of gelatin and polyvinyl alcohol, exhibiting good biocompatibility and biodegradability.

[0090] The water-soluble adhesive uses carboxypropyl methylcellulose aqueous solution as the water-soluble adhesive. The adhesive coating thickness is 10μm, and its dissolution cycle is 24 hours, which is shorter than the conventional esophageal stricture dilation treatment cycle (generally 3 to 7 days).

[0091] The water-soluble film is made of polyvinyl alcohol film with a thickness of 5μm, which completely encapsulates the biodegradable microneedle patch 10. The film dissolves within 30 minutes after contacting the liquid in the esophagus.

[0092] Differences between the operating steps and Example 1:

[0093] During catheter insertion, the biodegradable microneedle patch 10 is covered with a water-soluble film, which can prevent the microneedles from scratching the esophageal mucosa during insertion. After insertion, the film dissolves under the action of the esophageal fluid.

[0094] During treatment, as the first balloon 2 expands, the biodegradable microneedles are pressed into the mucosa of the esophageal stricture, further increasing the friction between the first balloon 2 and the esophageal wall, preventing catheter displacement. At the same time, the microneedles can assist in drug penetration and improve drug absorption.

[0095] In the later stages of treatment, as the esophageal wound heals, the biodegradable microneedles gradually degrade. If the microneedles are not completely degraded by the end of treatment, the water-soluble adhesive has dissolved, and the biodegradable microneedle patch 10 separates from the first balloon 2. The detached patch can degrade on its own in the human body or be excreted through the digestive tract.

[0096] Because the surface of the first balloon 2 is made of biodegradable microneedle patch 10, compared with the array protrusion 9 of Example 1, it has greater friction with the inner wall of the esophagus and more stable catheter positioning, which is especially suitable for cases with severe esophageal stenosis and easy catheter displacement.

[0097] After the biodegradable microneedles are inserted into the mucosa, they can assist in drug penetration, making it easier for the drug to enter the diseased tissue. Experimental verification shows that the drug absorption efficiency is improved compared to Example 1.

[0098] The dissolution cycle of the water-soluble adhesive is shorter than that of the treatment cycle, which can ensure the separation of the microneedle patch and the balloon in the later stage of treatment and avoid secondary damage to the esophageal mucosa when the catheter is removed; the water-soluble film solves the problem of microneedles scratching the esophagus during catheter insertion, further improving the safety of treatment and patient comfort.

[0099] In addition, the biodegradable properties of biodegradable microneedles avoid the risk of foreign body residue in the body and reduce the probability of postoperative complications.

[0100] Example 3

[0101] The difference between this embodiment and embodiment 1 lies in the material of the catheter body 1 and the size parameters of the balloon. In embodiment 1, the catheter body 1 is made of polyurethane (TPU) material, while in this embodiment, the catheter body 1 is made of silicone and polyamide mixed in a mass ratio of 3:1. At the same time, the expansion diameter, volume, pressure resistance range and other parameters of the first balloon 2 and the second balloon 3 have also been adjusted.

[0102] Catheter Body 1: The catheter body 1, made of a composite material of silicone and polyamide, has a diameter of 3.3 mm and a length of 80 cm, making it suitable for pediatric patients. This composite material combines the softness of silicone with the strength of polyamide, allowing it to better adapt to the thinner and more delicate esophageal structure of children and reducing irritation to the esophageal mucosa.

[0103] Balloon size parameter adjustment:

[0104] The first balloon 2 is still a three-stage dilatation balloon, made of polyether block polyamide (PEBAX) material, with an expanded diameter of 8 mm, a thickness of 100 μm, a volume of 1.5 ml, and a pressure resistance range of 6 atm.

[0105] The second balloon 3, after expansion, has a diameter of 6 mm, a thickness of 80 μm, a volume of 1 ml, a pressure resistance range of 5 atm, and micropores on the balloon with a diameter of 100 micrometers and a porosity of 15%.

[0106] The third balloon 4, after expansion, has a diameter of 5 mm, a thickness of 60 μm, a volume of 0.8 ml, and a pressure resistance range of 5 atm.

[0107] The fourth balloon 5 has a diameter of 5 mm, a thickness of 60 μm, a volume of 0.8 ml, and a pressure resistance range of 5 atm after expansion.

[0108] The difference between the operation steps and Example 1 is as follows: During balloon dilation, due to the smaller size of the balloon and its lower pressure tolerance range, the first stage dilation pressure is 1.5 atm and maintained for 3 minutes; the second stage dilation pressure is 3 atm and maintained for 3 minutes; and the third stage dilation pressure is 6 atm and maintained for 3 minutes. The dilation pressure and maintenance time of each stage are lower than those in Example 1 to adapt to the tolerance of the child's esophagus.

[0109] When administering medication, the total volume of the solution is adjusted to 0.8 ml, and the pressure inside the second balloon 3 is maintained at 3 atm to avoid excessive medication burden on the child's body. When providing nutrition, pediatric-specific liquid nutrition solution is infused through the third port 8, and the infusion rate is adjusted to 20-50 ml / h, which can be further refined according to the child's age and weight.

[0110] This embodiment takes into account the physiological characteristics of pediatric patients and adjusts the material and size of the catheter body 1 as well as the parameters of the balloon. The catheter made of a mixture of silicone and polyamide is more flexible and can reduce irritation and damage to the pediatric esophagus. The smaller balloon size and lower expansion pressure and drug dosage are within the tolerance range of children's bodies and reduce treatment risks.

[0111] Clinical application has verified that this embodiment reduces the incidence of complications in the treatment of esophageal stricture in children compared to Embodiment 1 (applicable to adults), better meets the treatment needs of pediatric patients, and broadens the applicable population range of the multi-balloon catheter of the present invention.

[0112] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0113] Furthermore, the technical solutions of the various embodiments can be combined with each other, but only if they are feasible for those skilled in the art. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

Claims

1. A multi-balloon catheter with functions of dilation, drug delivery, and nutrient supply, characterized in that, include: The catheter body (1) has at least two mutually spaced lumens inside; A multi-balloon device is disposed at one end of the catheter body (1) along the axial direction, comprising at least three balloons, each communicating with the lumen. The passage includes a first balloon passage (6) and a second balloon passage (7). One end of the first balloon passage (6) is connected to the first balloon (2), and the other end is connected to the inlet of the first balloon. One end of the second balloon passage (7) is connected to the second balloon (3), and the other end is connected to the inlet of the second balloon. The surface of the first balloon (2) is provided with an array of protrusions (9) or microneedle structures, and the second balloon (3) is provided with micropores that penetrate the balloon wall; The third balloon (4) has one end of the first balloon cavity (6) connected to the third balloon (4) and the first balloon (2), and the other end connected to the inlet of the third balloon; It also includes a fourth balloon (5), one end of the second balloon cavity (7) is connected to the fourth balloon (5) and the second balloon (3), and the other end is connected to the inlet of the fourth balloon; The catheter body (1) is also provided with a third cavity (8) that is separated from the first balloon cavity (6) and the second balloon cavity (7), and the third cavity (8) extends along the length direction of the catheter body (1).

2. The multi-balloon catheter according to claim 1, characterized in that, The inlets of the first balloon cavity (6) and the second balloon cavity (7) are respectively connected to a one-way valve (11), and a pressure display device is connected to the one-way valve (11).

3. The multi-balloon catheter according to claim 1, characterized in that, The first balloon (2) and the second balloon (3) are any one of compliant balloons, semi-compliant balloons, and non-compliant balloons; the third balloon (4) and the fourth balloon (5) are non-compliant balloons.

4. The multi-balloon catheter according to claim 3, characterized in that, The first balloon (2) and the second balloon (3) are made of at least one of latex, silicone, rubber, polyurethane, polyvinyl chloride, polyethylene, polyamide, and polyether block polyamide; the third balloon (4) and the fourth balloon (5) are made of at least one of polyvinyl chloride, polyethylene, polyamide, and polyether block polyamide.

5. The multi-balloon catheter according to claim 1, characterized in that, The first balloon (2) has a diameter of 5mm to 30mm after expansion, a volume of 0.05ml to 15ml after expansion, and a pressure resistance range of 1 to 20atm; the second balloon (3) has a diameter of 5mm to 20mm after expansion, a volume of 0.05ml to 8ml after expansion, and a pressure resistance range of 1 to 16atm.

6. The multi-balloon catheter according to claim 1, characterized in that, The array density of the protrusions or microneedles decreases from the central region of the surface of the first balloon (2) towards the two sides; the height of the protrusions or microneedles increases from the central region of the surface of the first balloon towards the two sides.

7. The multi-balloon catheter according to claim 1, characterized in that, The diameter of the array protrusions ranges from 0.1 to 3 mm, and the height of the protrusions ranges from 0.05 to 1 mm.

8. The multi-balloon catheter according to claim 1, characterized in that, The second balloon (3) has an expandable porous microporous structure with a pore size range of 50 to 500 micrometers and a porosity of 5% to 50%.

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