It is estimated that around 150,000 Mexicans suffer from Chronic Kidney Disease, and in the medium term, people with this condition could benefit from this new highly functional, and low-cost technology
Claudia Villalobos
Due to its association with chronic diseases of high prevalence in the Mexican population, such as diabetes mellitus and hypertension, Chronic Kidney Disease (CKD) constitutes a public health problem in our country. The National Institute of Public Health (INSP) estimates that around 6.2 million Mexicans with diabetes currently have kidney failure in its various stages. However, due to a lack of visibility and preventive culture, people visit doctors when the only solution is dialysis, hemodialysis, or a kidney transplant.
In response to this situation and considering the growing need for more infrastructure to offer patient care, Christopher René Torres San Miguel, a scientist from the Instituto Politécnico Nacional (IPN), along with a group of students, materialized their ingenuity and vocation for service by designing and building an automated peritoneal dialysis machine. This invention aims to improve the quality of life for thousands of Mexicans with Chronic Kidney Disease undergoing peritoneal dialysis treatment.
Under the innovative seal of the Polytechnic, the device, which performs the same function as a conventional cycler but is simpler to operate, was built at the Escuela Superior de Ingeniería Mecánica y Eléctrica (ESIME), Zacatenco Unit, adhering to strict international quality standards and regulatory requirements.
“The cost of a commercial imported peritoneal dialysis machine is approximately 400,000 pesos, making it difficult to acquire. Patients must go to hospitals for their treatment, where demand is high, and infrastructure is insufficient due to the high cost of acquisition,” noted the Polytechnic researcher.
The development of connectors to adapt different types of dialysis bags to an automated machine, requested by specialists from the Institute of Security and Social Services for State Workers (ISSSTE) to Dr. Torres San Miguel, was the starting point for designing this national technology. Conceived from the outset as an economical and effective solution to address CKD challenges, it would facilitate ambulatory treatments by being portable.
The mechanical engineering expert stated that ISSSTE serves around 9,000 patients with CKD, while approximately 11,000 people with this condition are affiliated with the Mexican Social Security Institute (IMSS). “As a result, the investment these health institutions make in dialysis supplies is onerous. By developing innovative technology, we aim to reduce costs and strengthen the medical care for beneficiaries,” he specified.
Chronic Kidney Disease progresses when damaged kidneys cannot properly filter blood. Peritoneal dialysis helps the patient eliminate waste products from the bloodstream.
The treatment involves introducing a cleansing solution through a catheter into the abdominal lining (peritoneum), which acts as a filter and removes waste from the blood. After remaining in the abdomen for a certain period, the fluid is drained along with the waste.
The treatment is carried out in three cycles: infusion (introduction of the cleansing fluid), dwell time (the period the fluid remains in the abdominal cavity), and drainage (evacuation of waste). Conventional machines require 7 or 8 steps to perform three or four connections of different hoses to carry out the process phases, while the machine designed in the Sección de Es[1]tudios de Posgrado e Investigación (SEPI) of ESIME Zacatenco only requires connecting one hose.
Simplifying these connections reduces the risk of infections, as the bags containing the dialysate are made with a thin plastic membrane susceptible to puncture due to constant handling, which can affect the substance's sterility, especially when patients need to perform the treatment two or three times a day.
The specialist, affiliated with level II in the National System of Researchers (SNII), reported that in the project's first stage, a prototype was developed with the participation of Master of Science Sergio Rodrigo Méndez García. The components were printed in 3D, and a wooden structure was built with the necessary electronic elements to function correctly.
Without losing sight of the goal of generating functional and economical technology, Dr. Torres San Miguel and his team evolved the prototype. Unlike conventional equipment that works with a cassette operated by pneumatic pressures and air pressures, the updated Polytechnic machine operates with custom-designed peristaltic pumps.
“This way, air is not introduced into the treatment, and there is no contact with the fluid, as it passes through rollers, and the circular movement of the hose compresses the fluid to move it. Additionally, the mechanism allows purging the infusion lines, which connect to the bag and, in one part of the process, expel the air from the hose to ensure the equipment's sterility,” detailed the IPN scientist, who added that the mechanism has already been submitted for patent registration with the Mexican Institute of Industrial Property (IMPI).
Master Méndez García, who will obtain a doctoral degree in science with this line of research, explained that the machine is made of 316L stainless steel and a 3D-printed high-density polypropylene platform is installed on the base, serving as a temperature bed where up to two bags of dialysate can be placed, unlike conventional equipment, which only has space for one bag.
He highlighted that the importance of this platform is essential for the treatment, as the dialysate must be at a temperature of 36 degrees Celsius (similar to body temperature) to avoid thermal shock to the patient.
A significant contribution of the IPN peritoneal dialysis machine is the incorporation of a turbidity sensor that provides valuable information about the treatment's effectiveness and allows visualizing whether the waste is being properly removed.
In addition to the infusion and drainage sensors that regulate the dialysate's entry and exit according to each patient's needs, another significant contribution of Polytechnic technology is the inclusion of a turbidity sensor. This sensor provides valuable information about the treatment's effectiveness, allowing the physician to visualize whether the waste is being correctly removed. Based on the fluid's clarity or turbidity, the physician can timely determine the presence of an infection and make treatment decisions.
The automated machine was manufactured following international quality standards and subjected to functionality tests conducted by scientists from the Escuela Nacional de Ciencias Biológicas (ENCB), Edgar Cano Europa and Margarita Franco Colín, who used an animal model with CKD (rabbits) to evaluate the treatment phases.
“Based on the results obtained, various adjustments were made to the machine, some modifications were applied to the motors and cassettes, and improvements were made to the connections, allowing for a corrected version of the prototype,” he explained.
Although the cost of any innovation is high, scaling up production reduces costs. Dr. Christopher Torres estimates that manufacturing this technology could cost around 20,000 pesos, primarily because sensors, boards, and actuators were acquired in Mexico, and various components were designed and manufactured using 3D technology, making the price accessible.
Dr. Torres San Miguel believes that creating a micro-enterprise represents a long-term path. Therefore, they will seek mechanisms to transfer the technology to an established company that can handle the necessary procedures with the Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) and manufacture this applied technology. This technology involves a high degree of innovation, and there are already publications on animal model tests in prestigious international scientific journals.
The ESIME specialist announced that to continue innovating in generating technology that improves the quality of life for patients with Chronic Kidney Disease, and as part of the doctoral work of Master Méndez García, they will start developing an automated machine for providing hemodialysis therapy. This machine is projected to be built using microcircuits, so it can be placed in a bracelet and, for user comfort, adapt the treatment components (bags) into a special vest.
The Polytechnic researchers reiterated their commitment to developing cutting-edge technology for the benefit of the population in need. “Without institutional support, this would not be possible, and the collaboration of students, who are trained under high-quality standards, learn to work as a team and contribute to materializing ideas,” pointed out the Polytechnic scientist with over 100 scientific articles published in renowned global journals.
Selección Gaceta Politécnica #175. (June 30th, 2024). IPN Imagen Institucional: Read the full magazine in Spanish here.
INSTITUTO POLITÉCNICO NACIONAL
D.R. Instituto Politécnico Nacional (IPN). Av. Luis Enrique Erro S/N, Unidad Profesional Adolfo López Mateos, Zacatenco, Alcaldía Gustavo A. Madero, C.P. 07738, Ciudad de México. Conmutador: 55 57 29 60 00 / 55 57 29 63 00.
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