AILIN Medical's Innovative Transjugular Intrahepatic Puncture Device Achieves Multiple Industry Firsts, Significantly Enhancing TIPS Procedure Success Rates

The “Ceiling” of Interventional Surgery Successfully “Penetrated” by Domestically Produced Devices!

Transjugular Intrahepatic Portosystemic Shunt (TIPS) is regarded as the pinnacle of interventional techniques. As a Grade IV interventional procedure, it is hailed as the “ceiling” of interventional surgeries. This procedure establishes an artificial shunt by placing a stent between the hepatic vein and the portal vein, allowing blood from the portal vein to flow directly into the hepatic vein and inferior vena cava through the shunt, thereby addressing portal hypertension.

The greatest challenge in the Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure lies in puncturing from the hepatic vein to the portal vein. Due to the complex anatomy and significant individual variability in the course of the hepatic and portal veins, physicians must rely on Digital Subtraction Angiography (DSA) or contrast-enhanced CT scans to localize the vessels. This not only tests the physician’s profound understanding of three-dimensional anatomical structures but also demands precise puncture judgment, advanced technical skills, and extensive clinical experience. Consequently, experts who have mastered the TIPS procedure are few and far between.

The success rate of puncture is directly related to the efficacy and prognosis of TIPS procedures. Repeated punctures may lead to complications such as intra-abdominal hemorrhage. The selection of the puncture site also affects stent patency, blood flow velocity, and the incidence of restenosis. Therefore, surgical success relies not only on advanced medical imaging technology and the physician’s expertise but also on the support of high-performance puncture kits; these three elements are complementary and indispensable.

An ideal puncture device should “combine rigidity with flexibility”—the needle must be sufficiently sharp and robust, while exhibiting excellent flexibility during delivery. This enables efficient puncture and smooth advancement, even in extremely stiff livers, thereby simplifying the operational workflow, reducing procedural steps, shortening surgical time, lowering procedural complexity, and improving puncture success rates.

In May 2024, Beijing Ailin Medical Technology Co., Ltd. (hereinafter referred to as “Ailin Medical”), a subsidiary of Haijieya Medical, reached a significant milestone as its independently developed “Transjugular Intrahepatic Puncture Device” was approved for market launch through the National Medical Products Administration’s Green Channel for Special Review of Innovative Medical Devices.

Notably, although this puncture device is not the first domestically approved product of its kind, Ailin Medical’s “Transjugular Intrahepatic Puncture Device” integrates multiple “firsts” and “premieres.” It features a pioneering one-piece flexible metal needle that facilitates easy puncture while resisting deformation. It also introduces a variable-diameter gradient puncture cannula, which significantly enhances puncture performance, minimizes procedural trauma, and promotes the healing of ineffective puncture wounds. Furthermore, it is the first to apply hydrophilic coating technology to transjugular intrahepatic puncture devices, effectively reducing insertion resistance and improving deliverability. This device enables efficient puncture in various clinical scenarios, including cases of severe liver cirrhosis, offering greater safety and efficacy while being better tailored to the characteristics of Chinese patients.

Ailin Medical's Transjugular Intrahepatic Puncture Device

Ailin Medical, established in 2018, represents Haijieya Group’s strategic initiative in the field of minimally invasive oncology therapies. Focusing on the research and development of products for tumor vascular therapy, Ailin Medical is driven by technological innovation and guided by actual clinical needs. The company actively collaborates with universities, research institutions, and clinical centers, promoting deep integration of industry, academia, and research through cross-disciplinary medical-engineering partnerships. Its product portfolio includes transjugular intrahepatic puncture devices, as well as a comprehensive range of balloons, catheters, microspheres, coils, and related series.

Discussing the current domestic market for endovascular interventional products in oncology, Wang Chuanyong, General Manager of Ailin Medical, told VCBeat that the TIPS puncture kit market in China has long been dominated by U.S. manufacturers. Their products have been present in the Chinese market for nearly 30 years, leveraging first-mover advantages from early market entry to maintain leadership in technical standards and clinical education. Most domestically produced TIPS puncture kits also follow this manufacturer’s technology.

The current heavy reliance on imported devices not only constrains the development of Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures in China, but also leaves room for optimization in the practical application of imported products—particularly regarding puncture capability and sheath passage performance—due to differences in ethnicity and lifestyle habits. For instance, while imported puncture devices perform adequately in cases of ordinary liver cirrhosis, their puncture needles, which are welded from multiple segments of steel tubes, steel wires, and springs, are prone to plastic deformation under increased puncture resistance when used in the numerous patients with severe liver cirrhosis in China. This deformation can prevent the needle from retracting properly, leading to product failure. In such scenarios, clinicians are often forced to replace the surgical instruments, which not only prolongs operative time but also increases the financial burden on patients.

Furthermore, the outer diameter of imported puncture trocars remains consistent (5 Fr) from the proximal to the distal end. When managing patients with liver cirrhosis, operators often require multiple puncture attempts to locate the portal vein. This not only increases the number of ineffective punctures but also results in significant puncture trauma, which heals slowly and may precipitate potential complications.

Furthermore, the sheaths of traditional puncture products lack hydrophilic coatings, making it significantly more difficult to establish the sheath channel. Additionally, the long and tortuous vascular pathway from the jugular vein to the portal vein further increases the difficulty and complexity of the procedure, as well as patient pain.

In response to the aforementioned challenges, Ailin Medical has implemented targeted optimizations and integrated human factors engineering principles into its overall design. This has resulted in a higher success rate and simplified operation for transjugular intrahepatic puncture devices, making the procedure safer, more effective, and more patient-friendly.

To address the issue of elevated liver stiffness in patients with cirrhosis in China, Ailin Medical, after in-depth consultations with medical experts and rigorous validation, has leveraged its extensive design and manufacturing expertise to comprehensively innovate across design philosophy, material selection, and processing techniques. This has enabled a breakthrough in achieving “a balance of rigidity and flexibility,” resulting in the pioneering development of an integrated metal flexible needle. This biopsy needle ensures exceptional puncture force while maintaining flexibility and resistance to plastic deformation, perfectly combining rigidity with toughness.

According to Wang Chuanyong, imported biopsy needles are metallic segmented needles, consisting of four welded components: multi-section steel tubes, steel wires, and springs. Although the metal materials themselves possess a certain degree of strength, they are prone to plastic deformation during deep tissue puncture due to factors such as puncture resistance and stress variations.

Ailin Medical has innovatively adopted a monolithic needle design, where the entire needle is formed through integral machining, completely eliminating potential connection weaknesses associated with split welded needles. During puncture, particularly in high-resistance environments, the monolithic needle better withstands external forces. Its integrated structure ensures more uniform stress distribution, allowing the material’s inherent mechanical properties to be fully utilized. This results in superior puncture performance and prevents plastic deformation.

Meanwhile, in consideration of practical clinical needs, this product is specially equipped with stylets featuring two types of needle tip structures: conical and three-faceted. This design aims to address failure modes such as plastic deformation observed in imported split needles, as well as to eliminate the need to replace the entire puncture kit due to initial puncture failure.

For the operator, it is not only more convenient and user-friendly but also improves puncture efficiency and success rate. In particular, it addresses the challenge of difficult portal vein puncture in patients with severe liver cirrhosis, thereby enhancing both the puncturability of the product and the surgical success rate.

For patients, the improved puncture success rate not only means a safer procedure and shorter operation time, but also, since Ailin Medical has resolved the plastic deformation issue of metal split needles, offering superior puncture force and more comprehensive needle compatibility, it effectively eliminates the need to purchase two separate sets of products, thereby reducing the financial burden on patients.

During TIPS procedures, the puncture cannula must be used in conjunction with a stylet needle to complete the puncture. To this end, Ailin Medical pioneered the variable-diameter gradient puncture cannula. This innovative design smoothly transitions the diameter from the traditional 5F to 4F, achieving a significant 36% reduction in trauma area in cases of unsuccessful puncture.

This innovation not only significantly enhances the overall performance of puncture procedures but also effectively reduces the risk of infection associated with large trauma areas during surgery, thereby substantially lowering the risk of related complications and delivering tangible benefits to patients.

Ailin Medical achieved the first application of hydrophilic coating technology on transjugular intrahepatic puncture devices.

When discussing the origin of this idea, Wang Chuanyong recalled: “I have a vivid memory of an 18-year-old patient who cried out in pain during liver parenchymal dilation surgery. Although local anesthesia was administered, the surgeon encountered significant difficulty advancing the sheath into the portal vein due to the patient’s hepatic parenchymal sclerosis, elastic recoil between the blood vessels and liver parenchyma, and vascular tortuosity. This prompted us to consider how to reduce intraoperative pain for patients while facilitating sheath advancement and minimizing resistance. Consequently, we thought of using a hydrophilic coating.”

Hydrophilic coatings provide lubrication to the device surface, which not only reduces the force required for intervention and facilitates smoother navigation of the device within the body, but also accelerates sliding during surgical procedures, thereby enhancing surgical efficiency and accuracy. Meanwhile, hydrophilic coatings effectively minimize friction and irritation between the device and internal tissues, reducing tissue rejection responses. Furthermore, these coatings significantly inhibit the growth and proliferation of microorganisms on the device surface, thereby substantially lowering the incidence of infection.

Wang Chuanyong also admitted that although hydrophilic coatings cannot completely eliminate the pain associated with sheath insertion, they can significantly reduce patient discomfort compared to products without such coatings.

Ailin Medical, a subsidiary of Haijieya Medical, has received approval for the market launch of its transjugular intrahepatic puncture device. This milestone not only marks Ailin Medical’s debut in the field of endovascular intervention but also represents Haijieya Medical’s first “endovascular” access product in the realm of minimally invasive tumor intervention.

Since its establishment in 2010, Haijieya Medical has always taken innovative R&D as its core driving force, and has developed into a national high-tech enterprise and a national specialized, refined, distinctive, and innovative “Little Giant” enterprise. Over more than ten years of development, the company has focused on technological innovation and product development in the fields of minimally invasive tumor therapy and cryomedicine. It has successfully established multiple R&D platforms, including the Beijing Key Laboratory of Cryobiomedical Engineering and a Postdoctoral Research Station, and has built a comprehensive system of independent intellectual property rights.

Leveraging Haijieya’s first-mover advantage, Ailin Medical and Haijieya demonstrate significant synergies across multiple dimensions.

In the product domain, Haijieya’s deep expertise in minimally invasive oncology complements Ailin Medical’s technological capabilities, creating a strong synergy. During the product development phase, both parties can share knowledge resources, team management insights, laboratory facilities, and clinical trial channels. When confronting key technical challenges, they can collaborate effectively to reduce R&D costs and accelerate the development process.

In terms of product upgrades and market expansion, both parties can draw on each other’s successful experiences based on market feedback, jointly explore new market segments, and provide comprehensive minimally invasive treatment solutions for patients with cancer and liver diseases.

In terms of expert resources, Ailin Medical and Haijieya can jointly organize academic seminars and expert forums, inviting top-tier domestic and international experts to participate, thereby enhancing the quality of research projects and accelerating the translation and application of scientific achievements. Meanwhile, oncology and hepatology experts can provide professional guidance and training to both parties’ clinical teams, sharing cutting-edge treatment experiences to improve clinicians’ professional competencies and therapeutic concepts.

At the clinical terminal level, both parties can jointly establish a data-sharing platform to integrate data resources for in-depth analysis, thereby providing personalized treatment plans for patients. Through collaboration, they aim to expand the sample size of clinical trials, enhance the scientific rigor and validity of the experiments, reduce costs, and accelerate the product launch process. Furthermore, the two parties plan to set up joint diagnosis and treatment centers in hospitals, bringing together experts in oncology and hepatology to provide patients with one-stop, high-quality medical services.

With the approval of this product, Ailin Medical will further intensify its marketing efforts and actively establish partnerships with leading medical institutions in the industry. Meanwhile, the company is systematically advancing its strategic layout in the endovascular segment—including balloons, catheters, microspheres, and coils—in accordance with its established development plan, aiming to achieve more comprehensive synergy across its product portfolio. Furthermore, the company plans to actively explore overseas markets, considering the reverse export of its advanced technologies and products to international markets to realize a global presence.