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Introduction

In the modern medical field, the high incidence of cardiovascular and cerebrovascular diseases has spurred the continuous development of interventional treatment techniques. The research on the performance and materials of balloon catheters is crucial. The development of medical balloons has gone through several stages, from the initial material application to the current exploration of various high-performance materials, and the shaping technology is also continuously innovating and optimizing. SmartBalloon Medical Technology, as an important participant in the medical technology field, also has unique contributions and explorations in the research, production, and application promotion of medical balloons.

Types and Basic Requirements of Medical Catheter Shaping Materials

(1) Types of Materials

Medical catheter materials are mostly thermoplastic polymers, including common ones such as silicone rubber, polyurethane (PU), polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), nylon (PA), polycarbonate (PC), etc. These materials, with their unique properties, are applied to different medical catheter products.

(2) Basic Requirements

1. Thermal Stability: Must have thermal stability characteristics that can withstand sterilization in an autoclave by radiation or other methods, ensuring that the material properties are not damaged during the sterilization process.

2. Chemical Stability: Have antioxidant and corrosion resistance capabilities, maintaining chemical inertia when in long-term contact with body fluids, without undergoing chemical reactions.

3. Biocompatibility: Good tissue and blood compatibility, with antithrombotic properties to prevent blood clotting, and should not be carcinogenic or cause allergic reactions.

4. Mechanical Properties and Functionality: Possess excellent mechanical properties, even when implanted in the body for a long time, the physical and mechanical properties such as tensile strength and modulus of elasticity will not significantly decrease, while also meeting specific functional requirements.

5. Processability: The material should be easy to process and shape to meet the complex shape and structural requirements of medical catheters.

The Development History of Medical Balloon Materials

(1) Early Materials – Polyvinyl Chloride (PVC)

Initially, soft polyvinyl chloride was used for the manufacture of medical balloons. Its number-average molecular weight is about 36,000 – 93,000, and the degree of polymerization is about 590 – 1500. PVC has a certain chemical stability, stable against organic solvents, acids, alkalis, and salts at room temperature, and has acceptable mechanical, mechanical, and electrical properties. However, it has poor light and heat resistance, with a softening point of only 80°C, a high glass transition temperature, and a melting point close to the decomposition temperature. The material is hard, difficult to process, and the balloon walls made of PVC are thick but have poor pressure resistance. Recent studies have also found that its biocompatibility is poor, and monomer PVC even has the risk of carcinogenesis.

(2) Material Improvement – Cross-linked Polyethylene and Polyethylene Terephthalate (PET)

Since the early 1980s, cross-linked polyethylene and PET have been used for balloon manufacturing. Polyethylene is a linear non-polar molecule with good chemical stability, stable against acids, alkalis, and salts at room temperature, high insulation, strong corrosion resistance, and good biocompatibility, with no adverse reactions when implanted in the body. PET is a linear polyester with aromatic rings between molecules, with good rigidity, creep resistance, high dimensional stability, and low moisture absorption. The viscosity of PET is negatively correlated with crystallinity, and the burst pressure can reach 27atm. Balloons made from cross-linked polyethylene have good shape retention, although their pressure resistance is slightly inferior to PET balloons, but these two materials have hard balloons, which still have limitations in practical applications.

(3) New Materials – Nylon and Thermoplastic Polyurethane

At the turn of the eighties and nineties of the last century, nylon and thermoplastic polyurethane gradually entered the field of balloons. Thermoplastic polyurethane is a linear polymer with hard segments and elastic soft segments, and the soft segments act as crosslinking bonds in the elastic network, with a high glass transition temperature. It has good processability, excellent biocompatibility, and wear resistance, but poor resistance to hydrolysis and cannot be steam sterilized. Nylon has high mechanical strength, good toughness, large tensile and compressive strength, excellent fatigue resistance, smooth surface, low friction coefficient, strong corrosion resistance, and anti-aging ability, but it has large water absorption and poor light resistance. Domestic nylon balloons have been mass-produced and have a large market share. At present, new types of balloon materials are mostly copolymers of rigid chain segments and flexible chain segments or simple blends of compatible polymers, such as alloys of polytetrafluoroethylene and nylon, polyurethane, etc., which are preferred materials for advanced interventional catheters. Although these materials have excellent performance and high added value, they are difficult to process. With the advancement of technology, more high-performance polymer materials will help the development of balloon manufacturing technology. SmartBalloon Medical Technology continues to explore in the application and research of new materials, actively integrating resources, and is committed to developing balloon material combinations with higher performance and biocompatibility, such as its research on a special polyurethane and nylon blend, aiming to further optimize the mechanical properties and bioadaptability of balloons to meet the increasing clinical requirements for balloon catheters.

Domestic and International Research Progress

(1) Foreign Research

LIX IAOWANG et al. introduced the conventional balloon forming method and improvement measures in the U.S. patent specification, that is, placing the mold in a heated heat-conducting medium, placing the thermoplastic material tube blank into the mold, inflating the balloon and stretching the tube blank to form it. Murthy V. Simhambhat la. described the "over the – wire" manufacturing process: first, the extruded tube blank is continuously or semi-continuously expanded into an expansion tube, and then further expanded into a balloon in the balloon mold cavity. M∀ H∀ Jalakani of Obers Medical Technology Co., Ltd. developed a balloon catheter suitable for percutaneous coronary angioplasty, which includes a catheter body and an expandable balloon, with a harder proximal body and a soft distal body, and a soft element connecting the two and extending into the distal body.

(2) Domestic Research

Wang Zhaohua and Du Hui et al. designed a contrast balloon dilator. The production is to seal one end of the catheter, put on the inner and outer balloons and tie them tightly to seal, inject contrast agent solution between the two balloons, and equip with an inflatable balloon and pressure gauge. When used, the balloon arrives at the lesion site and inflates, and the contrast agent is evenly dispersed between the two balloons, which is clearly visible under X-ray, facilitating doctors to observe the expansion of the narrowed part, suitable for esophageal, large blood vessels, heart valve stenosis expansion. Ma Ruikun proposed a method for making medical polyethylene balloon catheters, using cobalt source radiation to cross-link polyethylene, placing it in a mold to inflate and stretch while heating, and then blowing and stretching at the appropriate temperature and pressure, and cooling to set. The balloon has excellent performance, high strength, and non-expansion, which can be used for the treatment of pulmonary valve stenosis and other valve, vascular stenosis diseases. Overall, domestic balloon manufacturing started later, and there are gaps in production environment, materials, and technology compared to foreign countries, and the balloons used in China still largely rely on imports. SmartBalloon Medical Technology is actively advancing in the domestic research environment, cooperating with universities and scientific research institutions, introducing advanced R&D concepts and technical means, striving to narrow the gap with international advanced levels. Its R&D team is focused on solving some key technical problems, such as improving the precision control in the balloon forming process and optimizing the material processing technology to enhance the quality and performance of domestic balloons, gradually achieving the goal of domestic replacement of imported products.

Application Fields of Medical Balloons

(1) Vascular Disease Treatment

Balloon catheters are widely used in the treatment of vascular diseases, especially in the treatment of arterial stenosis. Doctors use fluoroscopy to guide the balloon catheter into the blood vessels, position it at the lesion, and then expand the balloon by pressurizing the liquid to achieve the treatment purpose. This treatment method is minimally invasive, easy to operate, and has few complications, replacing surgical operations with internal intervention to reduce patient suffering. It is particularly prominent in percutaneous transluminal coronary angioplasty (PTCA). With the emergence of drug stents, the function of balloon catheters has expanded, not only for the treatment of vascular stenosis, expansion, and shaping, but also for stent delivery, expansion, and precise shaping before and after stent placement, playing an important role in the treatment of coronary, intracranial nerves, renal arteries, femoral arteries, biliary, and gastrointestinal systems and other vascular diseases. SmartBalloon Medical Technology's balloon catheter products perform well in the treatment of vascular diseases, with good pushability and passability, able to accurately reach the lesion site, and maintain stable pressure during expansion, effectively ensuring the treatment effect. At the same time, the company is continuously developing new types of vascular balloons, targeting different vascular sizes and lesion types, and developing personalized design product series to meet the clinical diversity of needs.

 

SmartBalloon Peripheral Balloon

 

(2) Orthopedic Applications

 

In the field of orthopedics, for patients with osteoporotic vertebral compression fractures, traditional conservative treatment effects are poor and patients suffer greatly. The application of medical balloons has significantly improved treatment effects and reduced patient suffering. The specific operation is to place an expandable bone balloon into the vertebra through the skin and pedicle, inflate the balloon to reduce the fracture, create a safe and effective space in the vertebra, deflate the balloon and withdraw it, and then inject bone cement at low pressure. SmartBalloon Medical Technology is also actively exploring innovative applications of orthopedic balloons, such as developing orthopedic balloons with higher pressure resistance and manipulability to better perform vertebral reduction operations in complex fracture cases, while reducing surgical risks and postoperative complications for patients.

 

(3) Emerging Applications

 

With the advancement of materials and technology, medical balloons have new applications in laser catheters and photoactivation treatment, drug delivery catheters, etc. Balloons used for laser catheters and photoactivation treatment are made of transparent, low light absorption materials, with a laser installed inside, and the cone and tube segments are painted with non-transparent materials, only the working segment is transparent. When used, the balloon is positioned at the lesion site, expanded first, and then the laser is activated to treat the lesion site, which can accurately control the treatment area and avoid affecting normal tissues. The drug delivery catheter's balloon surface has specific micropores, and when the balloon is expanded at the lesion site, the micropore size allows the drug to treat the local lesion, and after the pressure is released, the drug can return to the balloon, reducing the amount of medication and lowering the harm to the normal body, especially suitable for the delivery of expensive and highly toxic drugs. SmartBalloon Medical Technology is keeping up with the technological trend in emerging application fields and investing a lot of resources in R&D. In the field of laser catheters, the company is committed to improving the light transmission and laser conduction efficiency of balloon materials to ensure the accuracy and effectiveness of laser treatment. In the field of drug delivery catheters, SmartBalloon Medical Technology cooperates with pharmaceutical companies to develop balloon micropore structures that match the characteristics of different drugs to achieve more precise drug control release, improving the targeting and safety of drug treatment.

 

SmartBalloon Shockwave Balloon Surgery System

 

Future Prospects of Medical Balloons

With the in-depth study of polymer materials and the continuous improvement of balloon manufacturing technology, the application prospects of medical balloons are broad. In the future, the application of medical balloon catheters will focus on fields such as tumor interventional treatment, cardiac interventional technology, neurological interventional technology, non-vascular internal interventional technology, portal hypertension vascular interventional treatment, non-tumor lesion and peripheral vascular lesion vascular interventional treatment technology, emergency bleeding arterial embolization treatment, and cell and molecular (gene) level interventional treatment. Medical balloons will develop towards better performance and refinement. Performance optimization is reflected in thinner walls, stronger pressure resistance, and better softness, but these three factors are interrelated, and future research needs to find a balance. Since the purposes and requirements of balloons in different fields are different, balloon manufacturing will become more refined and specialized to meet the diverse medical needs and promote further development of medical technology. SmartBalloon Medical Technology will continue to uphold the spirit of innovation and continuously explore in the field of medical balloons. On the one hand, it will increase investment in basic material research and cooperate with the world's top material research institutions to explore the application potential of new polymer materials in balloon manufacturing; on the other hand, it will continuously optimize the balloon forming process and production process to improve production efficiency and product quality. Through these efforts, SmartBalloon Medical Technology is expected to occupy a more important position in the future medical balloon market, contribute more to the development of the global medical cause, and provide safer and more effective medical solutions for patients.

In summary, the shaping materials and technology of medical balloons are continuously evolving and playing an increasingly important role in modern medicine. SmartBalloon Medical Technology's active exploration and innovation in this field have also injected new vitality into the industry development. Its future development is full of potential and opportunities, and it is expected to provide effective solutions for the treatment of more diseases.

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