Interwoven is partnering with TKDG and Nuwellis to create a wearable health solution to aid patients while undergoing Aquapheresis therapy. For patients suffering from Congestive Heart Failure (CHF), fluid overload is a dangerous condition. If your heart is weakened by heart failure, your kidneys may not get enough blood to work as well as they should. As a result, your body retains salt and water in a misguided attempt to boost your blood volume. Aquapheresis therapy uses ultrafiltration to remove the excess fluid.
Wearable Medical Device for Aquapheresis Therapy
What we did
- Design Research
- Concept Development
- Ideation and Sketches
- Form Exploration
- Hard & Soft Goods Integration
- Prototyping
- Medical Testing
Clients / Collaborators
Product Description
This project focused on improving catheter protection and vein access for patients undergoing fluid management therapy due to Congestive Heart Failure (CHF). The goal was to develop an external arm stabilization and protection device that minimizes the risk of catheter dislodgement, vein compression, and patient interference—while accommodating various patient anatomies, treatment postures, and ambulation levels. The resulting design explores modular physical prototypes that provide targeted support, restraint, and protection to optimize catheter performance across clinical settings.
Design Process
Our work began with deep user research, clinical collaboration, and biomechanical analysis. We identified several critical challenges: improper arm positioning could constrict blood flow, full elbow flexion threatened catheter stability, and patients often interfered with the catheter—consciously or unconsciously. These insights led to a focused exploration of structural and wearable concepts that promote safe positioning, reduce vein compression, and protect the catheter entry point.
We created eight functional concept prototypes—including inflatable sleeves, rigid cuffs, foam bridges, and angled supports—each mapped to a specific clinical insight such as elbow extension, arm elevation, or compression protection. We selected Baymedix® froth foams as the core material for their softness, moldability, and ability to manage moisture and pressure comfortably against the skin.
Testing & Validation
Following early feedback from physicians at the NYC VA Hospital, we refined and iterated several
concepts based on usability, comfort, and clinical viability. Prototypes were evaluated for ease of
application, patient variability, and compatibility with real-world hospital protocols. Notably, the
Foam Bridge and Angled Support earned strong clinician interest for their protection without
restricting patient mobility.
To further validate our design assumptions, we conducted a comprehensive ultrasound study,
analyzing venous blood flow under different resting postures and prototype configurations. This
included comparative testing at multiple arm positions and vein locations (from cubital fossa to
subclavian vein) with and without external compression. The results directly informed the next
stage of development, helping us define design parameters that preserve venous flow, reduce
insertion risks, and enhance catheter performance.
Aquapheresis therapy, delivered by the Aquadex SmartFlow® System, uses a simplified approach to ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload.
Effective treatment for fluid overload
Aquapheresis is a medical therapy designed to remove excess salt and water from the body safely, predictably, and effectively from patients suffering from fluid overload for whom diuretics have failed.
Aquapheresis therapy, delivered by the Aquadex SmartFlow® System, uses a simplified approach to ultrafiltration for the removal of salt and water in patients with hypervolemia, or fluid overload.
Interwoven Partners with TKDG
Rebeccah Pailes-Friedman, a leading expert in wearable technology & Soft Goods, and Yukiko Naoi, a medical product design specialist from Tanaka Kapec Design Group, have joined forces to form a visionary, award-winning industrial design team. Together, they bring over 60 years of combined experience in innovative product design, spanning wearable technology and advanced medical instruments.
Their latest collaboration is with Nuwellis, a global leader in fluid management technologies. They are supporting the design of the Aquadex SmartFlow® System and its patented ultrafiltration Blood Circuit—advancing the prediction, measurement, and optimization of fluid balance. This project has also led to multiple patents, marking a milestone in their shared commitment to innovation.
