Recently, the First Affiliated Hospital of Fujian Medical University released a public notice on the transformation of scientific and technological achievements, proposing to transfer its patents through listed transactions.“An Ultrasonic Imaging-Guided Urinary Catheter”Relevant patents are assigned to the industry party, with a transfer fee of500,000 yuan. The inventors of this patent areYan Lei Team。
Yan Lei:The First Affiliated Hospital of Fujian Medical UniversityAssociate Chief Physician,Member of the Communist Party of China, Master of Medicine. Has long been engaged in diagnostic work in the fields of echocardiography, vascular ultrasound, and abdominal ultrasound, with particular expertise in the ultrasonic diagnosis of cardiomyopathy, congenital heart disease, rheumatic heart disease, and various cervical vascular diseases. Currently a key specialist in cardiac and vascular ultrasound imaging, he/she has presided over or participated in eight national and provincial/ministerial-level research projects and published more than 10 papers in domestic and international medical journals.
The essence of the present invention is"Urinary Catheter with Ultrasound Positioning Function", its core function is to accurately determine the insertion position of the urinary catheter within the urethra by identifying anatomical landmarks in conjunction with ultrasound, thereby reducing operational difficulty and enhancing the precision and safety of urinary catheterization.
Urinary catheters, as commonly used clinical medical devices, are primarily inserted into the bladder via the urethra to drain urine. They are widely applied in the treatment and care of surgical patients, patients with urinary incontinence, and patients with bladder dysfunction. TheirAccuracy of Insertion PositionDirectly impacts the safety and efficacy of diagnosis and treatment.
In clinical practice, after a urinary catheter is inserted into the bladder, it must be secured using a balloon or water-filled cuff to prevent dislodgement. Whether the distal end of the catheter accurately reaches the bladder and whether the insertion depth is compatible with the patient’s urethral anatomy are key prerequisites for ensuring smooth urine drainage and avoiding tissue injury.
For instance, in patients requiring long-term urinary catheterization postoperatively, if the catheter is inserted too shallowly, it may lead to insecure fixation and urine leakage, thereby increasing the risk of urinary tract infections. Conversely, if inserted too deeply, it may damage the bladder mucosa or urethral tissue, causing complications such as bleeding and pain. For special patient populations, such as those with urethral malformations or age-related urethral laxity, the risks associated with catheter misplacement are even more pronounced.
Currently, conventional urinary catheters used in clinical practice lack specialized positioning markers and visualization aids. Determination of the insertion depth relies entirely on the operator’s clinical experience. Healthcare professionals must rely on subjective methods, such as tactile feedback and rough estimation of insertion length, to judge whether the catheter tip has reached the target position. This approach has significant limitations.
On the one hand, due to its reliance on experience, the operational threshold is relatively high.Novice or frontline healthcare workers are prone to positioning errors due to misjudgment during procedures. Healthcare institutions must invest significant manpower and time in specialized training to ensure procedural standardization, which inevitably increases medical costs.
On the other hand, subjective assessment cannot quantify catheter position and fails to accommodate individual patient variability.Moreover, during the procedure, healthcare providers cannot verify the accuracy of catheter placement in real time. If patient repositioning causes catheter displacement or dislodgement, it is difficult to detect promptly, which may lead to issues such as interruption of urinary drainage and excessive bladder distension.
Furthermore, even in certain scenarios where imaging modalities are employed to assist with localization, issues such as cumbersome procedures and prolonged operation times persist, failing to meet the demands of emergency rescue and rapid bedside interventions. Moreover, existing urinary catheters lack built-in ultrasound-identifiable markers, making it difficult to clearly visualize the position of their tips during conventional ultrasound examinations.
This lack of precise and convenient positioning methods not only reduces the efficiency and safety of urinary catheterization but may also increase patient suffering and the risk of medical disputes due to complications, making it difficult to align with the trend toward standardized and visualized clinical procedures in the era of precision medicine.
Traditional urinary catheters suffer from numerous limitations due to the lack of precise positioning methods and heavy reliance on operator experience—such as difficulties in quantifying insertion depth, higher procedural risks, and inadequate adaptability to diverse clinical scenarios. It is precisely these pain points that have drivenUltrasound-Guided Urinary Catheterization Technologyinnovative research and development. The core advantage of this patented technology lies in fundamentally revolutionizing the clinical application model of urinary catheters, through deep integration"Ultrasound-Guided Localization" and "Safety-Adaptive Design", developing a precise, safe, and convenient solution for urinary catheterization procedures.
This solution pioneered the implementation ofVisualization and Precision of Urinary Catheter Placementbreakthrough. Traditional urinary catheters do not have built-in positioning markers, and their position determination mainly relies on the operator's subjective experience; whereas this patent innovatively designs three types of ultrasound-visible marker structures in the identification zone at the catheter tip, providing diverse identification options:One is the dotted groove group,Distributed along the length of the catheter, each set of grooves is arranged around the tube wall with a spacing controlled at 0.5–1 mm, enhancing ultrasound echo signals through dense dot-like microstructures;The second is reticular striations,Composed of interlaced engraved patterns distributed around the catheter tip with a spacing of 0.5–1.5 mm, utilizing a three-dimensional mesh structure to achieve multi-angle, omnidirectional ultrasound recognition;The third is an annular groove,Arranged in an orderly manner along the axial direction of the catheter with a spacing of 1–2 mm, their regular annular features facilitate quantitative assessment of insertion depth by clinicians.
These identification markers are integrally molded from medical-grade polymer materials (such as silicone or polyurethane). Without the need for metal or electronic components, they generate high-contrast reflective signals during conventional ultrasound imaging. Healthcare professionals can use bedside ultrasound equipment to capture the position of these markers in real time, clearly confirming whether the catheter tip has entered the bladder and whether the insertion depth is appropriate for the patient’s individual anatomy. This approach upgrades traditional “empirical judgment” to “visualized, quantifiable precise positioning,” thereby fundamentally preventing complications caused by positional deviations, such as urine leakage and injury to the urethral or bladder mucosa.
Under the premise of achieving precise positioning, this technology simultaneously enhances the safety and convenience of the procedure. On one hand, the catheter body contains no metallic components, and all materials have passedBiocompatibility Verification, thereby avoiding the risks of urethral irritation, foreign body reactions, or infections that may be caused by metal components. It is particularly suitable for the long-term catheterization needs of special populations, such as elderly patients and those with urethral stricture or malformation; on the other hand, the catheter connector is designed with aConnecting Sleeve with Anti-Slip Texture, its outer diameter is larger than that of the connector body, which not only facilitates a secure grip by healthcare professionals but also effectively prevents catheter dislodgement due to slippage when connecting the urine bag, significantly improving operational efficiency and connection reliability.
Furthermore, the geometric parameters of the three identification patterns—including a groove depth of 0.1–0.3 mm and the aforementioned spacing range—have been repeatedly validated and optimized. This design ensures high sensitivity for ultrasonic identification without compromising the catheter’s overall flexibility or ease of insertion, thereby accommodating patients of different genders, ages, and urethral anatomies to meet the demands of diverse clinical scenarios.
Currently, clinical urinary catheterization still faces prominent challenges, including suboptimal positioning accuracy and elevated infection risks. Companies both domestically and internationally are increasingly focusing on innovative applications of ultrasound technology in the field of urinary catheters, driving product iteration and upgrades through functional enhancements. Related research and development is exhibiting a dual-track trend characterized by “positioning optimization + risk prevention and control.”
NanoVibronix, Inc. (USA)Centered on ultrasound-based antimicrobial technology, we have launchedUroShield Ultrasonic Antibacterial Catheter System, this product does not directly integrate positioning functionality into the catheter body; instead, it uses ultrasound to prevent bacterial adhesion to the catheter surface, thereby indirectly enhancing clinical safety. Clinical study data show that it can reduce the incidence of urinary tract infectionsReduced by 86%, while reducing catheter blockage and replacement frequency, enhancing patient comfort, and lowering medical costs. The system is compatible with most indwelling urinary catheters available on the market, offering broad applicability across various clinical settings.
The First Affiliated Hospital of Army Medical University of the Chinese People's Liberation ArmyR&D“Adjustable Guide Cone Urinary Catheterization Device”, is a representative technical solution focused on optimizing drainage. The core innovation of this urinary catheter device lies in its "retractable and expandable" guide cone design, which specifically addresses pain points associated with traditional urinary catheters, such as poor drainage flow and bladder irritation discomfort. The guide cone consists of a cylindrical section and a multi-petal conical section. The conical section is initially fixed into a cone shape by a constraining membrane to ensure guidance and smoothness during insertion. After insertion into the bladder, an external pull wire drives the internal mechanism to release the constraining membrane. Under the action of titanium alloy elastic strips, the curved petals of the conical section expand into a flat state, significantly increasing the cross-sectional area at the catheter tip. This design is particularly suitable for efficient drainage in special scenarios involving hematuria or blood clots, thereby preventing residual urine.
Meanwhile, the guide cone can slide along the urinary catheter to adjust its extension length, thereby lowering the height of the catheterization port and further enhancing drainage efficiency. Moreover, its straightened structure after deployment minimizes irritation to the bladder wall, reducing patient discomfort and the risk of inflammation.