RenoVue®/ RenoPort® Novel Intra-Abdominal Lens Cleaning Device Approved for Marketing!

On 6 December 2023, RenoVue® / RenoPort® Novel Intra-Abdominal Lens Cleaning Device (hereinafter referred to as RenoVue® / RenoPort® products), an innovative product originally developed by Bluesail Surgical, was granted the Certificate of Registration by the Drug Administration through a special review process and was successfully launched on the market.

RenoVue® / RenoPort® is not only the result of in-house development, research and innovation by Bluesail Surgical's R&D team, but also the industry's World first Intra-Abdominal Lens Cleaning Device. It had previously been approved to enter the national special approval process ("green channel") for innovative medical devices.

Bluesail Surgical will take this innovative product launch as an opportunity to build on clinical needs, to benefit global patients with more R&D innovations, and to provide safer, higher quality and more efficient product solutions for the surgical community.

In recent years, with the rapid development of medical science and technology, surgical diagnostic and treatment techniques have tended to be more minimally invasive, precise, efficient and focus on fast recovery. Compared with traditional open surgery, laparoscopic minimally invasive surgery requires the establishment of an access pathway to complete the visual observation, and to perform the surgery. In minimally invasive surgery, the laparoscope is as essential as the surgeon's eyes. During surgical operations, water mist or oil mist will be generated by the use of energy instruments will blur the vision. In addition, blood or tissue fluid splashes generated during tissue or blood vessel handling may contaminate the lens. Apart from the above situations, when dealing with these contaminations, the surgeon removes the laparoscope to clean and wipe it and then passes it through the cannula which may also cause secondary contamination of the lens (there is often residue of blood or tissue fluid in the pipeline).

All of the above will affect the surgical field of view, leading to intermittent interruptions of the surgery, thus increasing the length of the surgery and affecting the overall efficiency and quality of the operation. At the same time, repeated cleaning and wiping of the lens will also increase the patient's anaesthesia time and anaesthesia medication. Which will eventually affect the patient's postoperative recovery, and also bring about a potential increase in the cost of treatment (surgical charges are positively correlated with the length of the surgery and the increase in the amount of anaesthesia medications used).

In summary, the challenge of how to maintain a consistently clear lens during minimally invasive surgery, and how to efficiently clean the lens in the event of contamination, is a common pain point for many surgeons. As mentioned by some clinical experts, the obstacle of "vision" will definitely affect the "minimally invasive" surgery. What was hoped to be a "minimally invasive" procedure may become a "grossly invasive" procedure due to complications arising from these minor problems or inadvertent injuries.

Innovation leads to technological innovation; Solutions arise based on customer pain point; Novel Intra-Abdominal Lens Cleaning Device is Launched!!

Imagine the Impossible, Experience the Ease of Cleaning

The core advantage of the RenoVue® / RenoPort® is the new closed-looped cleaning system: an integrated closed-looped system that combines a minimally invasive access and a cleaning flow path; it allows for the creation of a surgical pathway that maintains the core functions of the traditional trocar, such as abdominal wall anchorage, surgical insufflation, and bladeless minimally invasive access, at the same time providing intra-abdominal cleaning of the lenses- All in One! This combined function allows the surgeon to focus on the minimally invasive surgery itself and improves surgical efficiency. This feature was clearly demonstrated by pre-market clinical trial data: an average of 20 minutes per procedure can be saved compared to the traditional lens cleaning method for minimally invasive surgeries.

More importantly, the closed-looped cleaning design can achieve in-situ lens cleaning, without the need to pull out the lens from the abdominal cavity; thus fully guarantee the coherence of the operation. The R & D team of Bluesail Surgical, has perform tens of thousands of simulation tests to fully verified the airtight performance of the closed-looped system, and really achieved zero leakage during the cleaning process. At the same time avoiding the secondary contamination caused by the leakage of cleaning liquid into the abdominal cavity and guaranteeing the safety of the surgery.

Another core advantage of RenoVue® / RenoPort® is th- pulsed air-ballistic flow technology. The organic mixing of cleaning fluid through the cleaning solution inlet, combined with the synergistic effect of a negative pressure of more than 20 kPa, the mixture of gas and liquid phases can form a Pulsed Air-Ballistic flow in the capillary pipeline. Utilizing high-pressure pulsed air-ballistic cleaning for contaminated lenses, as opposed to the traditional method of removing the lens and manually wiping it, significantly reduces the time required for each cleaning session and markly increased the surgical efficiency. Highly efficient cleaning of the lens, truly realizing "Just 3 seconds to acquire immaculate sight". This feature is shown in the pre-clinical trial data. Cdompared with the traditional way of wiping the lens in minimally invasive surgical operations, a single wipe can save up to 24 seconds during each cleaning.

 What's more, the technology of pulsed air-ballistic flow has been repeatedly tested and verified by Bluesail surgical’s R&D team. Using specific negative pressure values, the air-ballistic flow is able to quickly and effectively clean a wide range of intra-operative contaminants (blood, grease, mist, etc.) in simulated situations, which can meet the demand of the surgeons, without worrying of the ever-changing intra-operative contaminants that RenoVue® / RenoPort® can deal with. RenoVue® / RenoPort® can cope with the wide variety of intraoperative contaminations! At the same time, the R&D team has also considered all the mainstream brands of laparoscope on the market and done thousands of times of compatibility verification. The pulsed air-ballistic flow technology is efficient in cleaning and at the same time will not cause any damage to the lens, so surgeons will have a peace of mind!

Anti-Fog Film Coating: Pro-longed Fog-free Vision

The third major advantage of RenoVue® / RenoPort® is that, after thousands of parameter mapping and optimisation by the R&D team, the anti-fog coating system has achieved the optimal flow channel and leak-proof coating structure, forming a unique "W-base" design. The design of the "W-base" structure allows the lens to form a uniform "Coating-film" on the surface of the lens when it is pushed out after the completion of the cleaning process. This was completed simultaneously with the step of wiping the lens, thus effectively preventing the formation of "temperature difference fog”. Moreover, through the pre-market clinical trial data analysis, the lens film protection time can reach up to 30 minutes, which truly realizes the effective protection of the clear surgical field. Moreover, it is even more critical that, compared with some of the so-called cleaning function of the trocars on the market, it effectively reduces the potential secondary contamination of the lens that may be caused by the lens passing through the cannula, and thus reduces the rate of repeated lens cleaning. When compared with some instruments that can provide cleaning function in the cannula, the "W-bottom" design does not require additional instrument operation, which simplifies the operation steps and perfectly improves the efficiency of surgery;

Smart control, Safety and Secure

The fourth major unique pointe of the RenoVue® / RenoPort® is the Smart Contactless switch design. This design originates from the unique innovation in material science. The application of special material design of the flow channel in the cleaning pipeline, forming the Smart Contactless switch switch technology, realizing the fully automated cleaning of the lens. The hand holding the lens only needs a simple backwards and forward action, there is no need to consider the angle of the insertion and extraction, and there is no need for additional adjustment of the cleaning function switch. This helps the operator to quickly and easily respond to the emergency situation during the surgery. He/She can complete the cleaning rapidly and also able to quickly re-focus on to the target field. Avoiding the reduction of surgical efficiency brought about by repeated focusing, and truly achieving safe surgery.

As a rising star in the field of minimally invasive surgery, Bluesail Surgical, with a clear company strategy and excellent organizational execution, insists on the independent path of novel design and mass production capability. In the past three years, we have successfully achieved the launch of core surgical products such as the Astrolux™ & Siderlux™ Smart Powered Endocutter and TisFree® Ultrasonic Soft Tissue Dissecting & Haemostasias Device. At the same time we have more than ten other launched products in minimally invasive surgery.     

As China is the largest minimally invasive surgical market with the largest volume of surgeries in the world, Bluesail Surgical is empowering surgeons with the latest technology and committed to provide all rounded protection for every surgery. This has also become the common goal pursued by all surgeons in the medical field.

Bluesail Surgical is based on a deep knowledge in the surgical medical device field and has made huge investment and in-depth knowledge of the whole industrial chain consisting of supply chain, production, core technology research and development as well as branding. The company has been adhering to the product differentiation against competition and insists on novel research and development. On the basis of building the core underlying technology, we not only provide the layout of the next-generation full product line in the field of surgical consumables, but also devote ourselves to the long-term novel research and development of disruptive and innovative surgical technology and new therapeutic products to serve healthcare professionals and patients worldwide. in order to serve the world's medical practitioners and the majority of patients as their own responsibility. With the successive approval of many innovative products, the era of Bluesail Surgical leading the advancement of surgical technology has quietly arrived.