The overall goal of this Direct to Phase II SBIR proposal is to develop the Ark, a novel device for providing improved access, protection, and functionality during placement of hemodialysis needles. In the US alone, over 700,000 patients receive hemodialysis treatment, and creation of an arteriovenous fistula (AVF) and access vein is the preferred access point for dialysis needles. Most access veins suffer from the following shortcomings: long waiting periods to mature; challenging to access; prone to damage by needle penetration through the vessel; and limited useful life, failing largely because of both excessive and poor punctures. As a result, many dialysis patients do not receive the treatment required for continued quality of life. The Ark is designed to remediate the limitations of the current practice and aid long-term use of access veins. The Ark is intended for surgical implantation around the access vein, ideally at the time of AVF creation. The infrastructure promotes ingrowth of surrounding soft tissues reinforcing the strength of the vein, while providing an opening for easy needle access and a back wall for vessel protection from inadvertent penetration. The implant provides a palpable structure beneath the skin, promoting more accurate needle puncture, improving both caregiver efficacy and patient comfort. Initial prototypes of the Ark have gone through preliminary benchtop and animal studies demonstrating feasibility and significant promise. Continued efforts will build on these results to optimize the design, perform cannulation studies in a relevant AVF animal model, complete required design controls and validation activities, and perform a chronic GLP study, supporting a planned submission for FDA Clearance. We expect the end result of this effort will greatly facilitate the move toward home-based dialysis, resulting in significant impact on patient health and health care cost savings.
Public Health Relevance Statement: Project Narrative Patients with chronic kidney disease must undergo hemodialysis a minimum of three times per week for up to four hours per treatment, but more frequent dialysis results in a significant improvement in their quality of life. Increasing the treatment frequency comes with its own set of complications, including: increased risk of infiltration, weakening of the vessel wall at the access site, and low blood flow from collapsing vessels, among other factors leading to failure of the access vein. The Ark is intended to improve access, eliminate the need for excessive punctures, and prevent penetration of vessel side and back walls, ultimately lengthening the useful life of the access vein and restoring the ongoing quality of life of long-term dialysis patients.
Project Terms: 3D Print; Anatomy; animal data; Animal Model; Animals; arm; Arteriovenous fistula; Back; base; Blood; Blood flow; Blood Vessels; Caliber; Cannulations; capsule; Caregivers; Characteristics; Chronic; Chronic Kidney Failure; Clinical; Consult; Cost Savings; design; Device Designs; Devices; Dialysis patients; Dialysis procedure; Engineering; Evaluation; exoskeleton; Extravasation; Failure; first-in-human; Frequencies; Goals; Goat; Health Care Costs; Healthcare; Hemodialysis; Histologic; Home environment; Hour; Human; Implant; implantation; Improve Access; improved; Industrialization; Infiltration; Infrastructure; Institutes; Life; Limb structure; Measures; Mechanics; Medical; meetings; member; metallicity; Modeling; Needles; novel; Operative Surgical Procedures; Palpable; Palpation; Patients; Penetration; Phase; Physicians; preclinical study; prevent; product development; Protocols documentation; prototype; Puncture procedure; Quality of life; Regulatory Pathway; response; Risk; Safety; Side; Silicones; Site; Skin; Small Business Innovation Research Grant; soft tissue; Structure; success; Testing; Texas; Time; Tissue Model; Tissues; Titanium; Training; Ultrasonography; Universities; Update; Validation; Variant; Veins; verification and validation; Work
