1. An Implantable Magnetic Drive Mechanism for Non-Invasive Arteriovenous Conduit Blood Flow Control.
- Author
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White NA, van der Kroft SL, van der Bogt KEA, Vrielink TJCO, Camenzuli C, Calleja-Agius J, Sanchez-Margallo JA, Sanchez-Margallo FM, van de Stadt HJF, Dankelman J, Rotmans JI, and Horeman T
- Subjects
- Animals, Sheep, Equipment Design, Torque, Renal Dialysis instrumentation, Renal Dialysis methods, Arteriovenous Shunt, Surgical instrumentation
- Abstract
Objective: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions., Methods: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses., Results: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm., Conclusion: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects., Significance: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.
- Published
- 2024
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