The Glia Kidney-Cap Project
Quick Links
- Buy a Glia Kidney-CAP
- Glia Kidney-CAP on GitHub
- Support Glia Projects Like This Through Donation
- Kidney-CAP Research Study Abstract
Introduction
Hemodialysis patients often connect to the dialysis machine via fistula, a permanent, surgically created connection between the artery and vein in the patient’s arm. Sometimes, unexpected and uncontrolled bleeding (hemorrhage) occurs at the fistula site, which a hemodialysis patient must emergently manage until medical attention arrives.
The Glia Kidney-CAP helps patients avoid a medical emergency by “capping” the bleeding, which gives the patient time to call medical response services.
Objective
Historically, patients have carried a bottle cap or similar common household items with them to control a potentially dangerous, unexpected hemorrhage at their fistula site. In response, Glia’s objective has been a professional and effective device that can be manufactured at scale, easily duplicated in low-resource settings, and accessibly priced for low-middle income regions where medical devices are limited.
Glia wanted this device to not only be commonplace for patients themselves but also integrated into the fistula bleed protocol implemented by nephrologists, dialysis clinicians, paramedics, and emergency responders.
Accomplishments
In collaboration with renal physicians from major Canadian nephrology programs, Glia created a Kidney-CAP, the first in the world. The Glia Kidney-CAP is either 3D printed or injection molded, open source, low-cost, compact, and effective device for dialysis patient care. It is portable via the beaded lanyard, which can be attached to a keychain or other home-use device.
The Kidney-CAP has been designed for simplicity and use outside a clinic setting, where patients are most likely to experience an emergency bleed. In addition to the device, Glia has developed the mnemonic “F.A.S.T.” to help patients easily remember the urgency of a potential fistula hemorrhage.
In the event that a hemodialysis fistula or graft bleeds, one must act F.A.S.T:
F. Find your Kidney-CAP on your keychain
A. Apply Kidney-CAP to your bleeding fistula or graft.
S. Secure the Kidney-CAP with tape.
T. Telephone 911
To ensure minimal production cost and affordable retail prices, the device has only two components – the Kidney-CAP itself and the ball-chain lanyard which attaches to a keychain, purse, or belt loop. The Glia Kidney-CAP can be manufactured for a total materials cost of USD$1.50. Accounting for all other associated costs, Glia is able to offer the Kidney-CAP at a retail price of CAD$25.
A phase 1 research study has been conducted. This study evaluated the impact of the KIDNEY-CAP on vascular access choices, home dialysis adoption, and transplantation recommendations. Results showed that 41% of healthcare providers were more likely to recommend home dialysis and AVG/AVF use if the device was available. Among end-stage kidney disease (ESKD) patients, 66% were concerned about bleeding, and the same percentage saw a benefit in having the KIDNEY-CAP. Additionally, 27.8% indicated they would be more likely to choose AVG/AVF with access to this device. While attitudes toward home dialysis and transplantation remained unchanged, the KIDNEY-CAP may enhance patient confidence in vascular access and influence clinical decision-making.
In Canada, Glia produces the Kidney-CAP as a Class I device under a Health Canada Medical Device Establishment License (License #6823) to produce Class 1 devices.
Project Timeline
