Recently, Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University) released a public notice on the conversion of scientific and technological achievements, proposing to transfer itsPatents Related to Guidewires and BalloonsCompleted a transaction with Nanjing Maiteng Medical Technology Co., Ltd. through an "assignment + licensing" model, with the transaction amount beingRMB 5.9 million。
The core patents involved in the transaction are"Ascending Aorta Balloon Catheter Conforming to Vascular Anatomical Features", this patent is byTao Tingting, Xie Xinjiang, and eight othersR&D, focusing on the pain points in the treatment of coronary heart disease, targetingTraditional Percutaneous Mechanical Circulatory Support (pMCS) Technologies(For example, IABP, Impella, and ECMO). Based on human vascular anatomy and hemodynamic characteristics, the balloon catheter is designed with a length of 40 mm and a diameter of 14 mm, accompanied by a 20-mm counterpulsation pump connecting tube. This design minimizes complications caused by size mismatch, optimizes coronary perfusion, and is suitable for percutaneous coronary intervention and coronary artery bypass grafting in high-risk patients with coronary heart disease.
Coronary Heart DiseaseAs the leading cause of sudden cardiac death among residents in China, it not only exerts severe adverse effects on patients’ hemodynamics, but some patients still face the risk of microvascular obstruction even after recanalization of occluded vessels, highlighting an urgent unmet clinical need. Percutaneous mechanical circulatory support (pMCS), widely used in high-risk percutaneous coronary intervention and coronary artery bypass grafting, primarily functions throughIntra-aortic Balloon Pump (IABP), Axial Flow Pump (Impella), Extracorporeal Membrane Oxygenation (ECMO)Three implementation approaches exist, but each has significant limitations: IABP fails to fully account for human vascular anatomy and hemodynamic characteristics, resulting in limited improvement in coronary perfusion and myocardial oxygen consumption; relevant studies have confirmed that it does not reduce 30-day all-cause mortality in patients with acute myocardial infarction complicated by cardiogenic shock, and it is no longer routinely recommended by domestic and international guidelines. Impella increases the risk of bleeding in patients, and its therapeutic efficacy remains controversial. Although ECMO can reduce cardiac preload, it increases cardiac afterload and fails to improve myocardial perfusion. These technological pain points create substantial market opportunities for the development and application of novel medical devices.
Addressing the core shortcomings of traditional technologies, this patented technology utilizes"Physiological Compatibility"Driven by innovation, it achieves precise alignment between device design and human vascular anatomy, establishing three core competitive advantages:
First,Length parameters precisely match anatomical structures, the balloon catheter length is set at 40 mm, which conforms to the range of aortic lumen lengths from the ostia of the left and right coronary arteries to the proximal end of the brachiocephalic trunk ostium in normal human anatomy, thereby proactively avoiding complications such as vascular injury and uneven perfusion caused by size mismatch;
Second,Diameter design balances safety and efficacy,By comprehensively evaluating key anatomical parameters of the ascending aorta and aortic arch, including vessel diameter, wall thickness, wall area, and lumen area, the balloon catheter diameter was set at 14 mm. This ensures optimal expansion upon inflation, thereby guaranteeing effective circulatory support while avoiding direct contact with the vessel wall to prevent additional injury.
Third,Connecting Tube Designed to Conform to Variations in Vascular MorphologyThe length of the counterpulsation pump connecting tube, from the distal end of the balloon catheter to the distal side of the brachiocephalic trunk ostium, is set at 20 mm. This design fully accommodates the variations in vessel lengths across the ascending aorta and aortic arch. Furthermore, by optimizing based on the diameter of the brachiocephalic trunk ostium and the length of the non-extended portion of the balloon catheter, the adaptability and safety of the device are significantly enhanced, thereby thoroughly addressing the core limitation of traditional techniques, which failed to adequately account for human physiological anatomy.
In the current market for vascular interventional devices, centered around"Conforms to the anatomical characteristics of human blood vessels"Guided by this design philosophy, multiple balloon catheter products have either achieved clinical application or entered the R&D phase. Although their application scenarios vary in focus, they all enhance treatment safety and efficacy through “anatomical adaptation,” thereby establishing a differentiated development landscape.
MarketedRuikangtong SpaceGate™ Balloon Guide Catheterhighly representative, withMulti-Dimensional Adaptation to Vascular StructureAt its core, the device is dimensionally compatible with 8F vascular sheaths and various 6F intermediate catheters, reducing vascular injury during concurrent use of multiple devices. The compliant balloon material conforms tightly to the vessel wall upon inflation, balancing effective occlusion with vascular protection. The catheter shaft is reinforced with stainless steel braiding and features a multi-segment gradual hardness design to navigate tortuous vascular segments. This design logic aligns closely with “anatomically conforming to vascular structures,” while its application is specifically focused on assisting thrombectomy in neurointerventions, distinguishing it from ascending aortic circulatory support.
No fully consistent ascending aortic balloon catheter products have yet emerged in the field of cardiovascular intervention; however, the design concepts of peripheral artery drug-coated balloons (such as the Orchid™ and Dhali™ series) can serve as references. These domestically produced products focus on matching the anatomical dimensions of balloons to peripheral vessels, offering multiple specifications ranging from 4 to 10 mm, while achieving functional upgrades through optimized drug coatings. Their R&D logic of “anatomical compatibility + functional compatibility” aligns with that of this patent, except that their application scenarios are concentrated on the treatment of peripheral vascular stenosis.
From an industry trend perspective,“Customized Size Adaptation”It has become a core development direction for balloon catheters. The National Medical Products Administration (NMPA) classifies it as a key category of intravascular catheters, and industry platforms have clearly defined a development path involving multi-specification products designed for vascular diameters at different anatomical sites. Currently, there are few products specifically targeting the ascending aorta, with circulatory support as their core function and matched to relevant anatomical parameters, which provides a solid industrial foundation for the commercialization of this patent.