Xi'an Jiaotong University First Affiliated Hospital Licenses Innovative Visual Adjustable Double-Lumen Endobronchial Tube Technology for RMB 25.8 Million

Recently, the First Affiliated Hospital of Xi’an Jiaotong University released a public notice on the transformation of scientific and technological achievements. The hospital plans to adopt negotiated pricing for the“A Visualizable and Adjustable Double-Lumen Bronchial Tube and Its Manufacturing Method”the related patent portfolio to Henan Tuoren Medical Device Group Co., Ltd. for use. The licensing fee shall be determined by“Zero Licensing Fee + Milestone-Based Conversion Revenue”model, with a total amount of25.8 million yuan. The inventor of this patent isZhu Yaomin and Li Yansong。

The present invention discloses a visually adjustable double-lumen bronchial tube and a manufacturing method thereof. By providing an adjustment device for regulating the bending angle of the distal catheter, the catheter can adjust its curvature in real time, thereby directly changing the direction of the bronchial tube to facilitate its rapid entry into the target lateral bronchus, effectively shortening intubation time and reducing airway injury. Intraoperative displacement of the catheter can also be addressed by synchronously adjusting the direction and depth of the bronchial tip to rapidly restore lung isolation. Furthermore, the present invention discloses a method for manufacturing the bronchial tube, which enables bending of the distal catheter.

During anesthesia for thoracic surgery,Lung Isolation and One-Lung Ventilationis a critical step in ensuring surgical safety.Double-lumen bronchial tubeAs a crucial device for achieving this goal, its clinical application has long been established."Difficult intubation, poor adaptability, and higher risk"...and other multifaceted issues. According to clinical statistical data, approximately 30% of thoracic surgeries experience prolonged anesthesia time due to catheter malpositioning; additionally, about 15% of patients suffer from airway mucosal injury caused by excessively stiff catheter materials or improper fixed angulation. Furthermore, the anatomical variation at the opening of the right upper lobe bronchus is significant (with individual variability exceeding 40%), making it difficult for traditional tubes to achieve precise alignment. This often results in inadequate ventilation of the right upper lung, thereby adversely affecting surgical outcomes and patient recovery. Issues such as impaired oxygenation or postoperative air leak tests, if severe, may even necessitate interruption of the surgery to adjust the tube position, thus increasing anesthesia-related risks.

FromCatheter Adaptability AngleIt can be seen that existing double-lumen endobronchial tubes have"Limited left-right separation, non-adjustable angle"core defect. Traditional products require selection of the appropriate model based on the patient's left/right main bronchial anatomy (left-sided double-lumen tubes are used for left lung surgery, and right-sided double-lumen tubes are used for right lung surgery).

However, inClinical PracticeIn approximately 20% of cases, abnormal angles of the main bronchi (for instance, the angle difference between children and adults can reach 15°–20°) prevent the selected catheter from smoothly entering the target bronchus, necessitating adjustment under fiberoptic bronchoscope guidance. This not only prolongs intubation time (by an average of 10–15 minutes) but may also cause airway injury due to repeated manipulations. More critically, owing to the variable position of the right upper lobe orifice in right-sided double-lumen tubes, even after successful intubation, there is still a 35% probability of inadequate ventilation of the right upper lobe. This compels clinicians to preferentially choose left-sided double-lumen tubes for surgery, further limiting flexibility in clinical decision-making.

AtSafety and Precision of the ProcedureAspects, the existing technology still has significant deficiencies.

On the one hand,Traditional Catheters Lack Real-Time Visualization Capabilities, physicians can only rely on experience to judge the position of intubation, unable to directly observe key anatomical structures such as the carina and bronchial openings, leading to a probability of up to 12% that the catheter may mistakenly enter the contralateral main bronchus. In cases requiring urgent adjustment, this may cause risks such as choking or blood pressure fluctuations in patients.

On the other hand, although some catheters with visualization capabilities can provide imaging,The issue of "fixed angle" has not been resolved.. If the catheter becomes displaced due to changes in patient positioning during surgery (with an incidence of approximately 8%), lung isolation cannot be rapidly restored by simply adjusting the direction of the catheter tip; instead, reintubation or the use of additional instruments is required. This not only increases the complexity of the procedure but also prolongs the duration of one-lung ventilation, thereby elevating the risk of postoperative complications such as atelectasis and infection.

Furthermore, existing catheters also face“Poor compatibility between material and process”issue. To ensure catheter support, most products use PVC materials with a Shore A hardness above 60. Although this maintains the lumen shape, it lacks flexibility and can easily scratch the airway mucosa when passing through tracheal stenosis or adjusting position; a few flexible catheters reduce hardness but are prone to collapse due to thin lumen walls, affecting ventilation efficiency. Meanwhile, traditional catheter manufacturing processes mostly adopt integrated injection molding, which cannot optimize material hardness for different functional requirements of the distal end (requiring bending sections) and proximal end (requiring stable support), further exacerbating the contradiction that "support and flexibility are difficult to balance."

More importantly,Current technologies struggle to meet the demands of personalized diagnosis and treatment.Significant variations exist in airway anatomy among different patients (e.g., main bronchial diameter, carinal angle). However, traditional catheters are available in only 3–4 sizes, failing to precisely accommodate children, obese patients, or those with airway malformations. Consequently, approximately 10% of these special populations require non-standard devices, which not only increases medical costs but also elevates procedural risks. Furthermore, existing catheters lack the capability for dynamic intraoperative adjustment. Once intubation is completed, if positional deviation or ventilation abnormalities are detected, the catheter must be manually pulled for overall adjustment. This process can easily compromise the original lung isolation effect and may even lead to catheter dislodgement, posing serious risks to surgical safety.

It is precisely due to the clinical pain points of double-lumen bronchial catheters, namely “difficult intubation, poor positioning, and high risk,” that Zhu Yaomin, Li Yansong, and their team at the First Affiliated Hospital of Xi’an Jiaotong University School of Medicine were driven to undertake technological innovation. This technology transfer’s"Patented Technology for Visually Adjustable Double-Lumen Bronchial Tube", its core advantage lies inA complete solution built through “real-time imaging guidance” and “dynamic angle adjustment”, achieving breakthroughs across all dimensions—from procedural precision and clinical adaptability to safety protection—and fundamentally transforming the limitations of traditional catheters that rely on experience-based insertion and fixed angles.

This technology pioneered disruptive innovation in the area of “visual functionality”—Overcoming the drawbacks of traditional catheters' "blind insertion," it pioneers an integrated design featuring "high-definition imaging + real-time irrigation."

Although traditional catheters with visualization capabilities can provide imaging, their lenses are prone to contamination by airway secretions, leading to blurred vision. In contrast, the novel catheter developed by the team features independent image sensor and irrigation lumens within the primary catheter body. The former is equipped with a high-definition digital camera at the distal end, surrounded by three LED cold light sources, enabling real-time capture of images of key anatomical structures such as the carina and bronchial openings. These images are transmitted via cable to a proximal display, allowing physicians to intuitively monitor the intubation position. The latter incorporates multiple irrigation nozzles at the distal end that spray saline solution to clean the lens, effectively preventing secretions from obstructing the view and ensuring clear intraoperative imaging. This visualization system theoretically significantly reduces the risk of accidental contralateral bronchial intubation and improves the first-attempt success rate of intubation.

In terms of the core performance metric of "angle adjustment,"The catheterAchieved Precise Adaptation Through “Dual-Wire Control + Flexible Structure Optimization”, effectively addressing the challenges of "significant individual anatomical variations and difficulty in adjusting for intraoperative shifts."

First, its innovatively designed adjustment mechanism:By employing symmetrically arranged first and second traction guide wires (with their distal ends secured near the opening of the second catheter using riveted caps) in conjunction with proximal operating components (including a fixed housing, a rotating shaft, and an actuation element), physicians can tighten the guide wire on one side simply by rotating the actuation element. This action enables flexible bending of the distal second segment of the second catheter to either the left or right. Compared to the limitation of traditional catheters, which require model changes for fixed angles, this design accommodates variations in the main bronchial angle among different patients (such as the 15°–20° angular difference between children and adults). It eliminates the need to distinguish between left- and right-sided double-lumen catheters, significantly enhancing universal applicability.

Second, flexible structural optimization ensures adjustment reliability:The second segment of the second catheter is fabricated from TPU/PVC material with a Shore A hardness of 30–50, balancing flexibility and support to effectively prevent airway abrasion due to excessive stiffness or loss of shape due to excessive softness. Additionally, V-shaped second grooves, characterized by a wider middle and narrower ends, are spaced along the outer wall of the second segment. These grooves provide clearance for bending while ensuring smooth edge transitions to prevent airway injury. Experimental data demonstrate that this structure enables flexible bending of the second segment within a range of ±30°, with no lumen collapse after bending and unaffected ventilation efficiency.

Furthermore, this technology has achieved a dual breakthrough in “Manufacturing Processes and Safety Protection.” In terms of manufacturing processes,Two industrialization solutions are provided:One approach is the use of integrated injection molding.Synchronous groove formation, suitable for large-scale mass production;The second is segmented injection molding.(The second section is formed separately), and then joined via a stepped interface combined with adhesive bonding. This approach allows for the selection of materials with different hardness levels for the distal and proximal ends, respectively, thereby meeting functional requirements while enhancing production efficiency and effectively reducing manufacturing costs.In terms of safety protection,In addition to the smooth transition design of the grooves, the dimensions of the first and second inflatable cuffs are meticulously tailored to accommodate the anatomical differences between the main airway and the bronchi (with the first cuff having a larger diameter after inflation), thereby ensuring effective lung isolation. In the event of catheter displacement during surgery, physicians can rapidly restore its position using “visual imaging guidance plus guidewire angle adjustment,” eliminating the need for reintubation and thus reducing risks such as patient coughing and blood pressure fluctuations.

InAirway Management in Anesthesia for Thoracic SurgeryIn this critical field, as clinical demands for precision and safety increase, companies both in China and abroad are actively pursuing technological upgrades and product iterations of double-lumen bronchial tubes."Market Landscape Dominated by Traditional Products with Breakthroughs in Innovative Technologies"R&D pathways and progress vary across companies, each with its own distinct characteristics.

As a global leader in the medical technology sector,Terumo (USA)(Teleflex) has been deeply engaged in the field of respiratory interventional devices for many years. ItsDouble-lumen bronchial tubeWith mature manufacturing processes and stable clinical performance, it has long maintained a dominant position in the global high-end market. Currently, the company’s flagship“Robertshaw Double-Lumen Bronchial Catheter”Now in its fifth generation. By optimizing the catheter wall thickness and cuff material, this product has achieved significant improvements in airway sealing and biocompatibility, allowing it to accommodate the anatomical structures of most adult patients.

This visualizable, adjustable double-lumen bronchial tube technology integrates real-time imaging guidance with dynamic angle adjustment capabilities, providing an innovative solution that balances universality and safety to address the core challenges in thoracic anesthesia intubation, namely poor adaptability, high operational risk, and insufficient precision.