José Francisco Noguera Aguilar ⁽¹⁾, Juan Alfonso Gómez Herrero ⁽²⁾, Francisco José Navarro García ⁽²⁾, José L. Peris Serra ⁽²⁾, Carlos M. Atienza Vicente ^(2),, María Jesús Solera Navarro ⁽²⁾

(1) Galician Health Service

(2) Instituto de Biomecánica (IBV) Universitat Politècnica de València (Edificio 9C) Camino de Vera s/n (E-46022) Valencia (España)

In collaboration with the Galician Health Service (SERGAS) and VECMEDICAL SPAIN S.L., the Instituto de Biomecánica (IBV) has developed an innovative multichannel device for flexible or rigid intrarectal endoscopy and rigid instrument-assisted removal of rectal lesions that cannot be treated using conventional flexible endoscopy techniques. The starting point was a conceptual idea defined by the clinical group, led by Dr. José Noguera, and all the stages of the development were carried out jointly, beginning with the conceptual design and including risk assessment, in vitro functionality tests, redesign, animal experimentation, design for manufacturing and the generation of the necessary documentation for CE marking and to begin clinical trials in humans.

INTRODUCTION

Single-incision laparoscopic surgery is an innovative concept that is currently proving to be a challenge for surgeons. For some time now, these healthcare professionals have been seeking new technologies and devices that facilitate surgical procedures and at the same time reduce, to the extent possible, complications and patient recovery times.

In laparoscopic surgery, a fixed camera is introduced through one of the trocars. On the other hand, endoscopic surgery uses versatile flexible endoscopes, which are highly mobile and easy to move inside the body and are also equipped with their own instruments. Dr. José Noguera’s objective was to combine both kinds of surgery to be able to use a flexible endoscope in laparoscopic surgery, but the problems that arose when trying to introduce a flexible endoscope through any commercial trocar was that large amounts of CO₂ would leak and the endoscope itself was damaged. IBV’s work was based on an idea that the doctor himself had to solve this problem.

The main objective of the development of a new device was therefore to increase the applicability of scarless surgery through natural orifices using single-incision surgery, thereby achieving a reduction in procedure time and eliminating complications and additional costs. In addition to the benefits described above for both surgeon and patients, the goal was to find a technology that would reduce the number of colonoscopies, as well as hospitalization and consultation times associated with patients diagnosed with colon cancer.

METHODOLOGY USED

The work methodology was based on co-design, such that the clinical and research staff were able to guide the choice of shapes, materials and components, thereby ensuring that the approach focused on patient safety. The interaction between the clinical professionals and the work team made it possible to examine in depth all the functionality and usability requirements in order to optimize the design.

An initial pilot project was carried out to assess the viability of the solution that Dr. Noguera had come up with. First, the IBV designed a very basic prototype to determine whether a pneumatic system, consisting of an inflatable bag, was able to prevent or minimize the leakage of CO₂ and at the same time make it possible to smoothly introduce the flexible endoscope. As this prototype successfully passed the leak tightness tests required by Dr. Noguera, the next step was to design and manufacture a prototype for animal experimentation (Figure 1). The prototype was manufactured in polyamide by 3D printing and consisted of a single-port device with two channels and a gel membrane that made it possible to introduce two commercial trocars, and a third channel with the pneumatic system. Animal experimentation tests were carried out at the CHUAC center (Complexo Hospitalario Universitario A Coruña) with very good results, both in terms of leaks and functionality when simulating a laparoscopy operation.

Figure 1: Functional prototype manufactured entirely at IBV and used for the 1st animal experimentation

With this pre-prototype, not to mention the results of the previous R&D work carried out by the Experimental Surgery Unit (UCEX) of the Technological Training Center (CTF), of the lntegrated Management Area of A Coruña and the regulatory study developed by SERGAS, we applied for European patent no. EP17382349, which is the property of SERGAS.

To continue with the process of translating this technology in its pre-prototype stage to a device that was ready to be used with patients, R&D capabilities were required that SERGAS could not cover with its own resources. A Public Procurement of Innovation procedure was therefore proposed, through the Código 100 healthcare innovation plan, which materialized in a Partnership for Innovation procedure. The project sought to meet this healthcare need, taking advantage of the knowledge generated to date and using the technological development capacity of a company that specializes in medical devices, VECMEDICAL (the awardee of the contract), in collaboration with a technology center (Instituto de Biomecánica, IBV). This opened up a business opportunity that directly addressed the problem detected by the healthcare professionals.

In order to industrialize the device and obtain the CE marking needed to bring the product to market, the following steps were taken:

• Risk analysis was performed to obtain the design requirements and the necessary tests and protocols to minimize risks. The design specifications were defined, based on the results.

• The device was redesigned to a pre-production level, in order to carry out performance tests. Leak tightness tests were carried out on the device (Figure 2). These yielded good results.

• Several units of the device were manufactured, and application was made to carry out animal experimentation.

• The device was redesigned to make it able to be fully mass-produced. New units of the final device were manufactured, and new animal experimentation carried out.

• All the necessary support documentation was drawn up for the medical devices conformity assessment procedure.

• New units of the final device for human experimentation were manufactured. Application for permits. Clinical trial in patients to assess safety and efficacy in a prospective cohort of patients with early-stage benign or malignant tumors located in the rectum, with a total duration of 9 months.

Figure 2: Leak tightness test of the pneumatic locking system.

Animal experimentation was carried out at the CHUAC center (Complexo Hospitalario Universitario A Coruña).

Clinical validation has already been successfully carried out in 5 patients from the Complejo Hospitalario Universitario of A Coruña - CHUAC, the Hospital Universitario of Valladolid and the Hospital Universitario Mutua of Terrassa, and 3 more hospitals are currently participating in the recruitment of patients.

CONCLUSIONS

Finally, all the objectives that the device needed to meet have been achieved:

• It is a single-port device with two channels for commercial trocars and a pneumatic channel for the introduction of a flexible endoscope.

• It makes it possible to combine the techniques of both endoscopic and laparoscopic surgery, which provides great versatility as it can combine instruments typically used in laparoscopies •with a flexible endoscope, which is a major breakthrough and a revolution in the field of minimally invasive surgery.

• The device meets the requirements for the protection of the flexible endoscope and minimizes leakage of CO₂, as well as all the other objective requirements identified in the risk analysis.

• Both animal experimentation and a clinical study on patients have been carried out which, together with the rest of the documentation, will allow the device to obtain the CE marking and be marketed in the European Union.

As a final conclusion, we can state that a device has been developed which, once it obtains the CE marking, will be manufactured by a Spanish company. The device is expected to be a major commercial success because of its ability to simplify and reduce the time and cost of laparoscopic surgery. 

The project is an example of successful collaboration between a clinical group, a technology center and a medical device manufacturing company, which have brought to the market an innovative healthcare product that solves a clinical problem and improved the quality of the healthcare provided to patients.

ACKNOWLEDGEMENTS

To SERGAS, for promoting and funding the research. The Código 100 healthcare innovation plan is implemented within the framework of a collaboration agreement between SERGAS and the Ministry of Economy, Industry and Competitiveness (MEIC), 80% of which is funded by the FEDER 2014-2020 funds of the Smart Growth Operational Program (POCINT).

To VECMEDICAL SPAIN S.L.