A phantom study: Evaluation of a novel three-lumen balloon catheter for potential treatment of intractable limb...

Area of Science:

• Biomedical Engineering
• Vascular Surgery
• Medical Device Design

Background:

• Critical limb ischemia (CLI) is a severe manifestation of peripheral arterial disease (PAD), often leading to limb loss.
• Low ankle systolic pressure (≤50 mmHg) is a key indicator of CLI.
• Current treatments aim to restore blood flow and alleviate ischemic pain.

Purpose of the Study:

• To design and fabricate a novel three-lumen catheter with a distal inflatable balloon, based on the Hyper Perfusion Catheter design.
• To evaluate the efficacy of the proposed catheter in increasing ankle systolic pressure in an in vitro critical limb ischemia model.
• To assess the impact of the device on systemic pressure.

Main Methods:

• A custom 9 Fr, three-lumen catheter with an integrated inflatable balloon was designed and fabricated.
• An in vitro critical limb ischemia (CLI) model phantom was constructed using a modified hemodialysis circuit and pump.
• Experiments utilized a blood-mimicking fluid and real-time data collection, verified by medical devices.

Main Results:

• The custom catheter successfully elevated distal pressure (simulating ankle pressure) to over 80 mmHg in the in vitro CLI model.
• The significant pressure increase was achieved without adversely affecting systemic pressure.
• The device demonstrated feasibility in a simulated peripheral arterial disease scenario.

Conclusions:

• The Hyper Perfusion Catheter design is effective in significantly increasing ankle systolic pressure in a simulated critical limb ischemia environment.
• This novel device holds potential for improving healing and pain management in CLI patients.
• Further research and clinical trials are warranted to validate these findings in patients with peripheral arterial disease.