An implantable magnetic drive mechanism for non-invasive arteriovenous conduit blood flow control.

Nicholas A White, Sander L van der Kroft,Koen E A van der Bogt, Timo J C Oude Vrielink,Christian Camenzuli, Jean Calleja-Agius,Juan A Sanchez-Margallo,Francisco M Sanchez-Margallo, Huybert J F van de Stadt,Jenny Dankelman,Joris I Rotmans,Tim Horeman

IEEE transactions on bio-medical engineering(2024)

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摘要
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.
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关键词
Arteriovenous fistula,Design,Hemodialysis,Implantable device,Transcutaneous energy transmission
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