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H2020-FETOPEN-01-2018-2019-2020: Development of an innovative resectoscope for trans urethral resection of the bladder

Country of Origin: Italy
Reference Number: RDIT20200116001
Publication Date: 16 January 2020

Summary

An italian research team is looking for partners to complete a Consortium for a FET-Open proposal. The aim is developing an innovative resectoscope for trans urethral resection of the bladder (TURB). The Partners (P) sought should be experts: (P1) in novel resectoscope loops development, and/or in bioelectrical properties of tissues; (P2) in medical device optics and their physical interface with an operator; (P3) in  AI-based image recognition and analysis, augmented reality.

Description

An Italian research team is studiyng the development of an innovative, AI-driven resectoscope for Trans Urethral Resection of the Bladder (TURB).

TURB is the removal of dysplastic/neoplastic tissues (polyps, tumours) from the bladder. Currently, it is considered the gold standard for tissue retrieval (biopsies) and treatment of nonmuscle invasive bladder cancer (NMIBC), but has several limitations: NMIBC recurrence rate at 3 months is up to 17%;  it is highly error prone: bleeding, bladder perforation, infections and urethral orifice injuries are the most common complications. This, because TURB depends on surgeon manual ability and the status/size of the lesion. The Italian team plans to build a novel device which will overcome TURB existing limits and introduce a breakthrough in urological surgery. The proposal's aim is to equip a standard resectoscope with a series of highly technological tools that will change it into an innovative and smart instrument. The consortium will place on the cutting wire a sensor that will use electrical tissue properties to discern healthy vs non-healthy and muscle vs non-muscle tissues, and will stop the electricity inside the wire in presence of healthy tissues. The team will connect it to a newly developed 3D camera allowing the surgeon to see the depth of the organ and the lesion. Finally, the team will connect the camera to an AI, developed for this specific task, which will help discriminating the lesion borders in real time. This AI-based information will be sent to special glasses (or similar optical device), worn by the surgeon, in which the operator will see, in real time, the bladder cavity and a signal delimiting the dysplastic/neoplastic tissue, overlapping the bladder view through augmented reality.

• H2020-FETOPEN-01-2018-2019-2020 - Programme Framework conditions are listed in the General Annexes  https://ec.europa.eu/research/participants/data/ref/h2020/other/wp/2018-2020/annexes/h2020-wp1820-annex-ga_en.pdf 

and include list of eligible countries, admissibility and eligibility conditions. 

• Expression of interest deadline: 17 Feb 2020; Call deadline: 13 May 2020; Estimated project duration: 3 years.

• Type and role of the partner (P): 

-  P1 (hardware) is expected to build a resectoscope equipped with a new sensor, or to modify an existing one. Expertise in resectoscope or resectoscope loops manufacturing is mandatory. Knowledge of the bioelectrical properties of human tissues is highly recommended. Previous expertise in developing innovative medical devices, especially in urology, is advisable. A detailed knowledge on a specific resectoscope model/brand as a selection point will be evaluated on a case-by-case basis if appropriately motivated. 

- P2 (hardware) is expected to build a 3D-vision device that will be coupled with a new resectoscope camera and that will substitute the standard optical device. Expertise on medical device optics is mandatory. Expertise on manufacturing other 3D visual devices (e.g., those used in medical robotics) is recommended. Previous expertise in developing innovative medical devices, especially in urology, is advisable. P2 is supposed to closely collaborate with P3 (see below) and, to a lesser extent, with P1. If P2 has renowned expertise also in P3 specific fields (AI and augmented reality), the possibility to assign both parts of the project to the same partner will be evaluated. 

-P3 (software) is expected to create the digital interface between the modified resectoscope (P1 + P2) and the surgeon. Images taken with the device developed by P2 will be analyzed and sent in real time to the operator, who will see both the 3D image registered by the machine and a superimposed indication (in augmented reality of the borders of the borders of the tissue to be removed.These borders will be identified by an AI (developed by P3 as well) that will be instructed through the images collected and provided by the coordinator group.

Advantages and Innovations

The novel device will overcome TURB existing limits and introduce a breakthrough in urological surgery. 

TURB is the removal of dysplastic/neoplastic tissues (polyps, tumours) from the bladder, or the retrieval of a tissue sample for analysis (biopsy). Usually, and particularly with tumours, the borders of the mass to be removed are irregular in both extension and depth and, in its peripheral region, hard to distinguish from the closely surrounding, healthy tissue. To date, the instrument used to remove the mass is the resectoscope, that cuts the tissue using an electrified wire. This instrument is guided by the surgeon without no other help than his hands, eyes, and experience. Thus, the surgeon’s risk is either to damage the healthy bladder wall (perforation, excessive resection) or to incompletely remove the mass, thus potentially increasing the chance of tumour relapse. The proposed modifications to the resectoscope will allow overcoming most of these problems. Despite several technological improvements in the field of robotics and other related, minimally invasive surgical approaches, cystoscopes in general (and the resectoscope in particular) is still, essentially, a manual instrument and did not significantly change in the last decades. In addition, this smart resectoscope  will likely substitute other robotic-assisted approaches, with the advantage to make the surgery easier and faster, as well as less expensive. Despite the several innovations proposed, the basic form of the instrument and its handling will remain largely untouched, thus the adoption of this new instrument by surgeons will have a very smooth learning curve.

The device will significantly drop the frequency of bladder damage and tumour relapse, as well as the duration of surgery, through the lowering of the procedure error rate and the increased speed/precision of the intervention, thus greatly improving patient’s recovery and surgery success.

Stage Of Development

Concept stage

Stage Of Development Comment

All scientific bases are described in the literature, and several parts of the planned technology already exist, although not directly applied to a resectoscope. Thus, the feasibility of the project is high. The italian research team plan to have a working prototype in 12-18 months, that will be tested, optimized and miniaturized in the next 18-24 months.

Requested partner

The Partners sought could be SMEs or research Institutions/universities. The roles are specified below:

Partner 1: expertise in surgical device modification and/or creation (resectoscope)

Partner 2: expertise in medical optical device modification and/or creation (3D visualization of human organs)

Partner 3: expertise in computer/human interface; artificial intelligence; augmented reality tailored for the modified resectoscope (Partners 1 and 2)