During hysteroscopic resection, removing resection chips is often a slow and repetitive manual process.
Surgeons typically extract tissue chip by chip with the resectoscope itself or a curette, repeatedly entering and exiting the uterine cavity.
This approach:
– Extends the duration of the procedure and the general anaesthetic (often up to 18 minutes)
– Increases patient discomfort and risk of cervical laceration
– Interrupts surgical flow and adds fatigue for the clinician
The need for a faster, safer, and more efficient extraction method was clear.
ICE was conceived as a controlled aspiration system capable of removing tissue fragments and blood in a single, smooth sequence without withdrawing the resectoscope.
The goal:
– Less painful and invasive for the patient
– Faster and more efficient for the surgeon
– More procedures performed within the same operating time
Clinical evaluations confirmed the potential: steps that previously took 15–18 minutes were reduced to just a few minutes with ICE.
ICE is connected to an inner sheath, which is compatible with Delmont resectoscope outer sheaths, which remain in place throughout the surgery.
Once activated, ICE gently aspirates and collects resection chips into a dedicated basket, separating them from the water flow.
Key advantages:
– No repeated insertion/removal of the resectoscope
– Reduced risk of cervical injury
– Single-handed activation
– Rapid clearing of the uterine cavity and collection of resection chips
This results in a smoother, more fluid and safer surgical experience.
“For one of its most innovative and patented devices, Delmont imaging has been collaborating with Creanova from design to development, industrialization and manufacturing. It was not an easy journey, but the result reaches our expectations. Creanova has been efficient and supportive since day one, even when we were close to give up! Their design approach is very structured but still flexible and their industrialization team has been quick to manufacture and validate the injection molds we needed. In their assembly factory in Serbia we met people with an excellent know how of medical devices regulation & sterilization process. I thank Wilco and all his team for this great achievement”
Pierre Montillot
CEO
The development of ICE followed a structured, multidisciplinary process combining clinical insight, ergonomic research, engineering rigor, and manufacturability analysis.
From the first sketches to the final functional prototype, every decision was guided by real surgical needs, regulatory requirements, and the practical constraints of a single-use medical device.
The result is a solution that seamlessly integrates usability, performance, and production feasibility, ensuring reliable function in the demanding environment of the operating room while maintaining efficiency and cost-effectiveness for large-scale manufacturing.
From the beginning, ICE was shaped around real surgical needs. Creanova refined ergonomics through mock-ups and simulated-use tests to optimize:
– Activation force and button placement
– Handling comfort for both right- and left-handed users
– Stable grip with wet hands and gloves
– One-handed operation and rotation inside the sheath
Early physical prototypes helped validate the ideal shape, proportions, and usability in conditions similar to the OR.
Ergonomics, performance, and manufacturability were developed in parallel.
Creanova used a parametric 3D CAD model to optimize:
– Injection-moulding feasibility
– Geometries, draft angles, and split lines
– Single-use production efficiency
– Layouts for button placement, rotation, and handle shape
These studies defined the final rear-button architecture. Creanova also created a quick, intuitive centering system for the internal basket.
A detailed material assessment led to the choice of a polycarbonate, selected for:
– Transparency for immediate visual control
– High mechanical strength
– Chemical resistance in wet surgical environments
– Compatibility with sterilization
– Suitability for ISO 10993 biocompatibility requirements
This enabled ICE to meet strict clinical and safety standards while maintaining excellent performance.
A fully functional proof of concept was tested using a peristaltic pump, a vacuum source, a transparent 3D-printed uterus model, and realistic tissue chips.
The tests confirmed consistent suction, effective chip–water separation, and reliable performance of the threaded connection, leading to ergonomic improvements such as a better cap grip and piston shape.
They also showed that the initial vacuum-release solution required refinement to ensure greater overall reliability.
Given its disposable nature, ICE underwent deep cost optimization.
A full contract manufacturing analysis—covering tooling, molding, assembly, and sterilization—was conducted to support scalability and industrial feasibility.
From a development standpoint, the challenges combined ergonomics, performance, and manufacturability. Creanova’s integrated approach made the difference, aligning clinical needs with industrial constraints from the start.
Key challenges:
– Ensuring intuitive, one-handed usability validated through realistic testing
– Balancing device performance with injection-moulding feasibility for single-use production
– Selecting materials compliant with biocompatibility and sterilization standards
– Optimizing cost and scalability across the entire manufacturing process
A holistic approach ensured a solution that is efficient, reliable, and ready for large-scale production.
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