ID: 2018-002 A prosthetic venous valve that can be implanted in the veins of the legs to replace lost valve function due to varicose veins or related medical issues.
Principal Investigator: Brian Jensen
Chronic Venous Insufficiency (CVI) is a disease of the lower limbs that affects millions of people in the United States. It is categorized by constant venous hypertension, which can lead to swelling of the legs, pain, skin changes and ulcers. One of the widely known symptoms that can lead to CVI is varicose veins. The main source of the problem of CVI is incompetent venous valves. The purpose of venous valves is to direct blood through the veins to the heart and prevent retrograde flow to the lower limbs. CVI can be caused by leg injury, pregnancy, genetics, age, and prolonged standing. Current treatments of the disease include compression stocking therapy, ablation, vein stripping, and valve reconstruction. CVI has become such a problem for patients, especially those with secondary incompetence in the deep veins, because the current treatments are used to alleviate the symptoms of the disease but do not treat the source of the problem. One solution that has great potential is to create an implantable venous valve that could restore function of the venous system.
In the past many prosthetic venous valves have been made, but none are clinically used because of problems with biocompatiblility, thrombogenicity caused by high shear rates, and longterm functionality that has been hindered by leaflet stiffening.
The prosthetic valve developed at BYU was designed to be made out of carbon-infiltrated carbon nanotubes (CI-CNTs). This material has been proven to be thrombo-resistant, biocompatible due to its non-reactive properties, and durable. The valve was designed to be initially open and to close with physiological pressures. The shear rate caused by implantation of the valve was minimized to reduce the likelihood of thrombus formation. FEA and CFD analysis was performed to verify the valve would function under physiological conditions and that shear rates would be in the normal range. The final design was tailored for implantation in the common femoral vein. It had a diameter of 12.7 mm, length of approximately 40 mm, and thickness of 0.3 mm. With a hydrostatic pressure of 20 mmHg it fully closed with a maximum stress of 117 MPa, which is below the ultimate strength of CI-CNTs. The CFD analysis demonstrated the valve would cause a maximum shear rate of 225.1 s−1, which is less than the maximum shear rate in the body. Currently, this is the lowest shear rate induced by a prosthetic venous valve. These results demonstrate that a CI-CNT prosthetic venous valve has the potential to be an effective treatment for CVI.
About the Market:
Varicose veins affect more than 25 million adults in the United States, and more than 6 million are affected with advanced venous diseases. The global varicose vein treatment market is estimated to reach $475 million by 2024.
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