Complex of hardware components for reinforcing synthetic blood vessels

Diseases of the cardiovascular system rank top in the globe in terms of prevalence and mortality toll. The successful treatment of these disorders necessitates the development of substantially new ways of cardiac implantation as well as novel vascular prosthetic technologies.

According to official figures, over 130 thousand cardiovascular procedures were conducted in Russia alone in 2018. Every year, several arterial reconstructions involving vascular implants are performed in addition to the regular surgical treatments. One of the most typical issues with vascular prostheses is the inflection of the vascular implant at the sites of physiological bends in the joints, which frequently results in a blood flow violation. Surgeons utilise reinforced-wall prostheses to avert such a problem. There is a possibility of profuse bleeding through the walls of the prosthesis following its insertion into the bloodstream if the prosthesis does not conform to the norm (leakage).

As a result, the production of a vascular implant necessitates not only high-quality compliance with medical criteria, but also high-precision porosity testing (surgical porosity). At the time, vascular endoprostheses are being manufactured in Russia, and while various simple implantation solutions are available on the Russian market, a substantial number of patients require more complicated and effective goods to restore the fundamental functioning of the heart and blood arteries.

Sample of prosthetic blood vessel

Such problems need novel methods and a varied set of capabilities, which were made feasible by the ART-UP Design Studio's collaboration with Medtechnoproekt, with assistance from the Skolkovo Foundation and the R&D Services Department.

Medtechnoproject is a Skolkovo resident in the Biomed Cluster, where it develops and implements technologies for the complete cycle manufacture of textile vascular endoprostheses for general and cardiovascular surgery, traumatology, and other applications.

Since 2014, our firm, ART UP Studio (ART-UP Design Studio), has held the official status of the Skolkovo Collective Use Center, delivering industrial design and prototype services to technopark members under the Skolkovo Foundation co-financing initiative.

How did it all begin?

The ART-UP Design Studio was tasked with developing a method for attaching a polymer reinforcing spiral to vascular prosthesis, enclosing them in a device with no analogues in Russia or the globe.

Because it was necessary to design a new sort of equipment to carry out such a work, the project team came up with the notion of employing additive technologies for the task as a result of pre-project study. We opted to use the material application approach, supplemented with the ability to rotate the surface of a given item (in our case, the surface of vascular implants).

The second duty was to inspect the quality of the resultant reinforcing spiral as well as the material of vascular beds created by specialist manufacturers for the fabrication of vascular endoprostheses.

As a result, it became clear that before beginning the reinforcement stage, a preliminary check of the specialised material for porosity was required, and that after applying the spiral, the ready-made reinforced vascular bed required checking for tightness and the ability to withstand a given internal pressure.

Following a conceptual engineering research, it was determined to develop two devices with separate functional purposes that would be linked into a single hardware complex.

The complex's composition:

1. A device for applying and fastening a biopolymer coating with an anti-thrombogenic coating to the surface of textile-based vascular prosthesis, as well as for reinforcing the walls of tubular vascular prostheses. The device buttresses the vascular prosthesis, providing flexibility, elasticity, and fracture resistance.

2. A method for assessing the degree of porosity of textile-based vascular prostheses impregnated with a biopolymer composition estimates the surgical porosity of a vascular prosthesis at a medium pressure of 120-160 mmHg.

The first product is a device for applying and securing a polymer spiral

The gadget was created using the principles of applying polymer material and the element basis features of 3D printing equipment. However, owing to the unique characteristics of the application, it was required to construct a fundamentally new device, identify kinematic principles, and refine the component base for medical usage. Traditional printers use three-dimensional coordinates and cannot use spiral shapes. The technical team included an electronic stepper motor control module to enable rotation of the interior object (vascular bed) around its axis and synchronisation with the dosing and application of polymer material.

Polytetrafluoroethylene is the polymer (Teflon). Because of its biological compatibility with the human body, it is effectively employed in the fabrication of implants for cardiovascular and general surgery, dentistry, and ophthalmology. Teflon is regarded as the best material for the manufacture of artificial blood arteries and cardiac stimulants.

The overall size and internal arrangement of the device's functioning section established the important technical specifications, namely varied diameters ranging from 6 to 10 mm and the length of the vascular bed itself ranging from 80 to 400 mm.

Given these characteristics, it became important to assure the diversity of the applied spiral's size, which necessitated the creation of specific software with a control interface for defining the initial printing settings. To complete this work, a layout solution for storing specialist equipment—guide rods to support the vascular bed throughout the strengthening process—was necessary.

Industrial design

After determining the final layout of the future device, an analytical pre-project research was done to assess the scope of use and probable constraints of the hardware complex. The devices enable desktop operation in clean room laboratory settings, which served as the foundation for shape, styling, and colour solutions.

The designs for the future gadget were presented to the client, and the device's operating principle was offered. One of the critical steps was the selection of a stylistic solution, materials, and production technologies that would unite the line of future devices. The device's design is minimalistic. Functional aspects are accentuated in bright colours, making the device interface more intuitive and facilitating user engagement with them.

The gadget is placed in an aluminium container covered with powder paint that is suitable for contact in the fabrication of medical equipment, and it is also outfitted with plastic panels that are resistant to the impacts of hostile chemicals. As a result, all surfaces have greater resistance to disinfectants.

The work area is accentuated visually with contrasting orange and black colours. We devoted careful attention to ergonomics: a lifting mechanism was added to reach the work area, which efficiently and smoothly opens the device's door upwards. This design allows you to take up less space and makes working with the gadget more easy. A drawer under the working area stores the equipment for various diameters of prosthesis.