Improved dialysis cannulation needle

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Minnesota Healthsolutions Corporation $628,558 on September 12, 2025, to develop and evaluate an innovative dialysis cannulation needle designed to reduce accidental needle infiltration injury during hemodialysis. The award funds work under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), which supports extramural biomedical research that improves understanding of disease mechanisms and leads to better prevention, diagnosis, and treatment of diabetes, digestive, and kidney diseases.

The project addresses infiltration injuries—which occur when a cannulation needle pierces the vessel wall, causing localized subcutaneous hematoma with pain, swelling, bruising, and psychological impacts—that affect approximately 50 percent of dialysis patients within their first three sessions after arteriovenous fistula maturation, with major infiltrations occurring at a 5 percent annual rate. More than 150 million dialysis cannulations are performed annually in the United States alone, making needle positioning accuracy critical to access preservation.

Minnesota Healthsolutions Corporation, a woman-owned small business located in Minneapolis, Minnesota, will perform the work through August 31, 2027. The company focuses on innovative medical technology and healthcare solutions development and has received prior federal grant support from multiple National Institutes of Health institutes including the National Institute on Aging, National Heart, Lung, and Blood Institute, and National Institute of Child Health and Human Development.

Abstract

The proposed project relates to the development and evaluation of an innovative dialysis cannulation needle that aims to reduce the rate of accidental needle infiltration injury and thereby improve the safety and efficacy of home and in-center renal dialysis therapy. Access to an arterial and venous blood source with adequate blood flow is needed to facilitate hemodialysis. Care and preservation of patent, well-functioning dialysis accesses are among the most difficult clinical problems in the long-term treatment of patients undergoing dialysis and loss of access is frequent. A well-functioning arteriovenous fistula has been recognized as a preferred access modality by the renal community. Dialysis generally requires cannulation with two large-bore needles three-times weekly to achieve blood flow sufficiently high to ensure adequate dialysis and more than 150 million dialysis cannulations are conducted per year in the U.S. Alone. Cannulation accuracy with correct needle position is vital to successful access without damage to the arteriovenous fistula. An infiltration injury occurs when the cannulation needle puncture initially enters the vessel but subsequently pierces the vessel wall elsewhere, resulting in a localized subcutaneous hematoma causing pain, swelling, bruising and other physical and psychological impacts on the patient, which often lead to additional testing and interventions. Minor infiltrations are common, occurring in some 50% of patients within the first three dialysis sessions after arteriovenous fistula maturation. Major infiltrations are less common, more consequential, and occur at a rate of 5% annually for all patients with arteriovenous fistula. Six months after a major infiltration, only 65% of patients have resumed use of their arteriovenous fistula. Qualitative studies evaluating barriers to home dialysis, which comes with many benefits, indicate that self-cannulation is a significant source of fear and anxiety. A novel safer needle is proposed that requires no action from the operator and no change to current dialysis workflow to achieve benefit. An advanced prototype needle will be designed, manufactured and tested.