Zebra Pressure-Sensing Ureteroscope: China's First and World's Second Real-Time Intraoperative Intrarenal Pressure Monitoring System Approved

On April 22, 2023, Anhui Happiness Workshop Medical Instruments Co., Ltd. (hereinafter referred to as “Happiness Workshop”) self-developed Zebra^®Disposable Intraoperative Pressure-Measuring Ureteroscope Catheter Approved for Market Launch by Anhui Provincial Medical Products Administration. This is the first such device in China and the second globally capable of real-time intraoperative monitoring of intrarenal pressure, filling a gap in related technological products.

This product possesses complete independent intellectual property rights. It assists physicians in real-time, precise monitoring of intrarenal pressure, providing immediate feedback of pressure values to the operating surgeon. This facilitates control over intraoperative intrarenal pressure and the duration of high-pressure episodes, thereby reducing the incidence of postoperative sepsis and other complications, and improving patient prognosis.

Happiness Workshop Medical Zebra^®Disposable Intraoperative Pressure-Measuring Ureteroscopic Catheter

Urinary System StonesUrinary system stones are among the most common conditions in urology. Epidemiological studies indicate that 5%–10% of individuals will experience at least one episode of urinary system stones during their lifetime.

With the continuous development and improvement of endourological techniques, endoscopic procedures such as flexible ureteroscopic lithotripsy and percutaneous nephrolithotomy have been widely applied in the treatment of upper urinary tract stones. Currently, endoscopic surgeries within the urinary tract require continuous irrigation with normal saline. The purposes are threefold: first, to dissipate heat generated by the laser and prevent thermal injury; second, to facilitate the removal of stone fragments; and third, to maintain a clear surgical field through water circulation.

However, studies have shown that intrarenal pressure (IRP) often increases during perfusion and irrigation. This is primarily related to the flow rate and pressure of intraoperative perfusion and irrigation, as well as factors such as the size and number of access tracts and the ratio of the flexible ureteroscope’s outer diameter to the inner diameter of the ureteral access sheath. Any factor leading to improper perfusion or inadequate drainage can cause elevated IRP. When IRP exceeds 30 mmHg, it may result in backflow of irrigation fluid into the bloodstream and lymphatic system, perirenal extravasation, and spread of infection, further leading to renal impairment and sepsis; in severe cases, it can even cause septic shock, endangering the patient’s life. “Hemorrhage risks loss of the kidney; infection risks loss of life.””It has become a consensus among endourologists.

Therefore,Real-time and effective intraoperative monitoring of changes in intrarenal pelvic pressure (IRP), timely elimination of factors causing IRP elevation, and maintaining IRP within a safe range are particularly important for preventing infectious complications.

Although renal pelvic pressure monitoring has been recognized by guidelines in multiple countries as a critical concern during minimally invasive surgery for kidney stones, the absence of commercially available solutions for upper urinary tract pressure monitoring worldwide means that current practices for renal pelvic pressure monitoring and complication prevention rely primarily on surgeons’ experience. Such practices include perioperative antibiotic administration, controlling irrigation pressure and rate based on return flow through the gap between the endoscope and its sheath, and adjusting operative duration according to patient-specific factors. There is currently a global lack of user-friendly, accurate flexible ureteroscopes equipped with precise pressure measurement capabilities.

In February 2023, Boston Scientific’s world-first single-use digital ureteroscope pressure monitoring system (outer diameter 9.5 Fr) received FDA approval for market launch in the United States. On April 22, 2023, Happiness Workshop Medical’s single-use intraoperative pressure-monitoring ureteroscopic catheter (outer diameter 8.6 Fr) was also approved for market launch by the Anhui Provincial Medical Products Administration. This not only marked the first instance of precise renal pelvic pressure monitoring in China but also signified that domestic and international single-use pressure-monitoring ureteroscopes are now on an equal footing. Moreover, Chinese-made products offer greater cost competitiveness while ensuring accuracy and performance.

Happiness Workshop Medical’s self-developed disposable intraoperative pressure-measuring ureteroscope catheter features three major highlights.

First, it enables real-time visualization of intrarenal pressure during surgery, addressing the issue of intraoperative pressure blind spots, reducing reliance on empirical judgment, and enhancing surgical safety.It not only provides strong support for physicians to take timely measures, thereby preventing severe infections caused by elevated intrarenal pressure after surgery, but also enables more young doctors to perform surgeries with greater safety.

Second, it provides a complete record and statistical analysis of intraoperative pressure data throughout the entire procedure. Through automated analytical functions, it displays its proprietary Zebra Index, which includes key metrics such as the total duration of intrarenal hypertension exceeding safety thresholds and the cumulative pressure index above the upper hypertensive limit, thereby assisting physicians in predicting postoperative risks.

Third, the endoscope body is slimmer.Although equipped with a pressure sensor, Zebra^®The manometry endoscope maintains a diameter of only 8.6 Fr, representing a 9.5% reduction in outer diameter compared to similar manometry endoscopes. When used with a matching 12/14 Fr sheath, the scope-to-sheath ratio is significantly reduced from 79.2% to 71.6%, which facilitates better irrigation return flow through the gap between the scope and sheath during surgery, thereby lowering intrarenal pressure.

Happiness Workshop Medical Disposable Intraoperative Pressure-Measuring Ureteroscope Catheter Can Display Intrarenal Pressure Second by Second

In terms of product performance, this product is based on Happiness Workshop Medical's self-developed star product—the already launched Zebra^®Upgraded from a disposable flexible ureteroscope. It retains the advantages of easy handling, lightweight operation, and clear visualization, embodying the characteristics of “clarity, precision, and flexibility.” Weighing only 185g, with a minimum bending radius of 8mm, it achieves 275° bidirectional deflection and features a 12.5° three-dimensional angulation in both left and right directions. This design allows easier access to the lower pole calyces via small infundibulopelvic angles (IPA) compared to conventional planar-deflection flexible scopes, ensuring that “where the stone is, the scope reaches.”

In terms of safety, the newly approved disposable pressure-measuring ureteroscope adopts a disposable data connection cable and is a 100% “fully disposable” flexible scope, thereby eliminating the risk of cross-infection. Furthermore, the product design incorporates Happiness Workshop Medical’s proprietary “snake-bone airbag” technology, in which the articulated section is encased in a braided metal mesh. This design prevents injury risks associated with snake-bone fracture and avoids the risk of being unable to withdraw the scope due to jamming, thus preventing medical accidents.

According to Han Tiegong, founder of Happiness Workshop Medical, the newly approved product is designed to be used in conjunction with the company’s developing automatic pressure control platform. This integration creates an all-in-one automated measurement and pressure control system that combines flexible endoscope manometry with platform-based pressure regulation, thereby mitigating the risk of high-pressure complications associated with flexible endoscopic surgery.

Happiness Workshop Medical’s single-use pressure-measuring ureteroscope has simultaneously submitted applications for CE and FDA certification, and the company will strategically expand its overseas presence in the future.

Since obtaining China’s first Class III registration certificate for a single-use electronic ureteroscope catheter in 2020, Happiness Workshop Medical has secured six registration certificates for single-use ureteroscopes, including 8.6Fr, 7.5Fr, coated, limited-reuse, kit-based, and pressure-measuring models. The company also has multiple approved and marketed products, such as the ureteral imaging host system and single-use flexible electronic cystoscopes. Its products are used in more than 1,500 hospitals across China, serving over 6,000 urologists, with tertiary hospitals accounting for more than 45% of this base.

“Healthy China, Urology Takes the Lead. ‘We aim to support primary healthcare institutions nationwide in achieving the health strategy of “stone treatment within the county,”’ said Han Tiegong, founder of Happiness Workshop Medical, in an interview with VCBeat. To achieve this goal, the company has extensively conducted hands-on training courses on flexible ureteroscopic lithotripsy across China, having trained over 800 physicians to date, with plans to cover 2,000 county-level hospitals nationwide within three years.”

According to Han Tiegong, founder of Happiness Workshop Medical, the current Happiness Workshop Zebra^®Happiness Workshop Medical holds a leading position in the market share of the disposable flexible ureteroscope segment within the broader disposable electronic ureteroscope market. With the recent approval and launch of its disposable pressure-measuring ureteroscope, Happiness Workshop Medical’s commercialization efforts and market penetration are poised to reach new heights.

In terms of development strategy, Happiness Workshop Medical adheres to the first-principles philosophy of “from clinical practice, back to clinical practice.” Centered on the innovation and widespread adoption of systematic diagnostic and therapeutic technologies for single-use endoscopes, it prioritizes urology, deploying a matrix-style product pipeline encompassing energy-based devices, visualization systems, and consumables. By establishing itself as a leader in urolithiasis management, the company will gradually expand its innovative efforts into other specialties, including gynecology, gastroenterology, spinal surgery, neurosurgery, and pulmonology.

Finally, let us introduce the core team of Happiness Workshop Medical. The company’s founder, Han Tiegong, was formerly a general surgeon at Peking University Shougang Hospital. After a skiing accident left him unable to perform surgeries, he transitioned into the field of pharmaceutical and medical device marketing. With over 15 years of experience in the research and development, regulatory registration, and marketing of urological and andrological medical devices, he has successfully introduced multiple products in these specialties, including the AMS 700 (inflatable penile prosthesis), AMS 800 (artificial urinary sphincter), Allium covered urethral stent, and Renova low-energy linear shockwave therapy system. Other members of the core team also possess more than two decades of professional background and R&D experience in the pharmaceutical and medical device industries.