ButtonAid: A protective guiding device for buttonhole tract formation in hemodialysis
ButtonAid is a device designed to support the formation of a reproducible buttonhole tract for hemodialysis access. By protecting the developing access tract during needle insertion and guiding the needle along the established pathway, ButtonAid aims to reduce miscannulation and dependence on individual experience of healthcare professionals.
A complementary adhesive handling and fixation concept has been developed to facilitate placement, fixation and handling of ButtonAid. This adhesive concept constitutes a separate technology and can be adapted to other buttonhole devices independently of ButtonAid. The adhesive technology is therefore also available as a stand-alone licensing opportunity. See separate technology offer: “Adhesive handling and fixation system for buttonhole devices in hemodialysis.”
Situation before
In the buttonhole technique, the dialysis needle is inserted through the same skin entry site and along the same pathway at each dialysis session to create a consistent access tract.
During formation of the buttonhole tract, consistent needle positioning is important. Variations in insertion site, angle or direction may hinder the formation of the desired tract or result in false tracks, causing discomfort and increasing the risk of complications. Consequently, successful tract formation can depend strongly on the experience and consistency of the healthcare professional performing the procedure.
Existing solutions may help maintain the developing tract between dialysis sessions, but are removed before the next puncture, leaving the developing access tract unprotected during needle insertion.
ButtonAid is designed to temporarily occupy the developing buttonhole tract between dialysis sessions and protect it during subsequent needle insertion.
ButtonAid consists of a hollow Button positioned within the developing access tract and a removable Plug that closes the lumen of the Button between dialysis sessions
Following dialysis and once bleeding has stopped, ButtonAid is positioned in the tract. At the following dialysis session, the Plug is removed while the hollow Button remains in position. The dialysis needle is introduced through the Button towards the vascular access. After completion of dialysis, the Button is removed together with the needle. A new Buttonaid device can subsequently be inserted to maintain the developing tract until the next dialysis session.
- Buttonaid offers several advantages compared to state of the art buttonhole devices
- Tract protection: shields the developing buttonhole tract from the sharp needle during needle insertion
- Reproducible needle insertion: guides the needle along the previously established pathway, reducing the risk of creating false tracks
- Patient comfort and safety: limits tissue damage and repeated puncture attempts during tract formation
Development status and pre-clinical validation
ButtonAid has undergone iterative development and pre-clinical evaluation involving dialysis nurses, nephrologists, designers and engineers. The technology was refined through usability studies and validated in human arm and sheep cadaver models before being assessed in a 31-day exploratory sheep study simulating key aspects of the hemodialysis access routine.
The sheep study demonstrated successful access tract formation and repeated access using ButtonAid, while providing preliminary evidence supporting the safety and feasibility of the technology.
These studies provide a solid basis for further product development, preclinical and clinical validation and regulatory approval.
IP position
An international patent application with application number PCT/EP2024/074323 was filed on August 30th, 2024
Partners we search for
- Medical device companies active in hemodialysis, vascular access or interventional devices interested in licensing or acquiring the technology
- Partners for further development, clinical validation and regulatory approval
- Manufacturers and distributors to support production and market introduction
About the researchers/research group
Buttonaid is the result of a multidisciplinary collaboration between Antwerp Design Factory, the pre-incubation unit of the University of Antwerp’s Product Development Research Group, and Antwerp University Hospital (UZA). The collaboration combines the clinical expertise of nephrologists and nurses (Dr. Prof. Hans De Fijter; Dr. Rowena De Vleut; Jonas Vander Vliet) with design-based and user experience research of product designers (Florentijn Vandecasteele and Prof. Lukas Van Campenhout).
More information
University of Antwerp
Valorisation Office
Middelheimlaan 1
2020 Antwerpen