A Saudi invents a heart valve and obtains an American patent

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After about 7 years of working on his idea, King Saud University obtained a US patent for a three-leaflet mechanical heart valve, created by Dr. Rakan bin Ibrahim Nazer, professor of cardiology at the university’s College of Medicine, in an attempt to develop the mechanism of artificial valves and improve blood flow within the heart.

Despite obtaining the patent, Nazer confirmed in an exclusive interview with Al Arabiya.net that the valve is still in the idea and development stage, and has not yet been subjected to experiments on animals or clinical tests on humans, indicating that reaching the stage of medical use may take years.

Nazer explained that work on the innovation took about 6 to 7 years, and that current efforts are focused on developing the design and obtaining the support and ethical approvals necessary to move to the testing stages.

The valve consists of three movable leaflets connected to a central mechanism and a peripheral ring, allowing them to be opened and closed in a coordinated manner to regulate blood flow and reduce its reflux.

The design aims to provide a mechanism different from traditional mechanical valves, by taking into account the nature of blood movement within the heart and its flow paths.

Nazer revealed that the design idea was inspired by the shapes of natural shells on the beaches, in addition to benefiting from recent developments in heart imaging techniques and studying the movement of blood within it.

He pointed out that the traditional understanding of blood flow relied on imagining it as a regular movement similar to its flow inside tubes, while recent studies have shown that the movement of blood inside the heart is more complex, and includes spiral paths that contribute to the efficiency of the flow.

Accordingly, the three leaflets were designed to match these characteristics, with the aim of improving blood movement within the valve.

Nazer explained that the design is being evaluated using “computational fluid dynamics” techniques, which is a computer simulation that allows the study of fluid movement and blood flow through the valve.

He pointed out that the initial results of these studies appear promising, and may indicate improved flow efficiency and reduced mechanical stress, which may reduce the possibility of valve malfunction or clot formation inside it.

But he stressed that these results are still preliminary, and cannot be taken as evidence of the safety or effectiveness of the valve in patients before the necessary laboratory tests and experiments are completed.

Regarding the stages required before clinical use, Nazer explained that developing the valve goes through a series of tests, starting with examining its mechanical performance outside the body, then experiments on animals, all the way to clinical studies on humans.

He added that mechanical valves that reach the market usually undergo endurance tests that include at least a billion opening and closing cycles, to ensure the efficiency of their mechanism and their ability to work for long periods.

He pointed out that the basic designs of mechanical valves have not witnessed radical changes for decades, explaining that one of the most important major developments in this field dates back to 1972.

Nazer stressed that talking about the potential therapeutic benefits of the new valve is still early, given that it has not reached the stage of animal or clinical trials.

He explained that the mechanical valves currently used are characterized by their high durability, but they usually require taking anticoagulant medications for life, to reduce the possibility of clot formation.

On the other hand, there are biovalves available that are used according to the patient’s health condition, age, and other medical considerations.

Patients may need to replace heart valves as a result of various diseases, including rheumatic disorders, age-related changes, and loose or inflammatory valves.

The transition of Saudi innovation from design to medical use remains linked to the results of future tests and the extent to which its safety and efficiency are proven, which requires stages of development and experimentation that may extend for years.