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Soft-tissue-anchored percutaneous device for long-term intracorporeal access
1Department of Periodontology, Institute for Postgraduate Dental Education, Jönköping, Sweden.
Summary
This study introduces a new percutaneous device for long-term internal body access. Promising results in animal and human trials suggest it is safe and effective for medical applications.
Area of Science:
- Biomedical Engineering
- Medical Devices
Background:
- Percutaneous devices are crucial for long-term intracorporeal access.
- Ensuring biocompatibility and minimizing complications are key challenges.
Purpose of the Study:
- To present a novel percutaneous device system for long-term intracorporeal access.
- To evaluate the healing and functional performance of the device in preclinical and clinical settings.
Main Methods:
- Technical description of the percutaneous device system.
- Assessment of device healing and function in experimental animals (short- and long-term).
- Evaluation in human volunteers and patients (short- and long-term).
- Histological analysis of animal tissues.
- Clinical inspection for complications.
Main Results:
- No major complications observed during clinical inspection.
- Histological analysis showed arrested epidermal downgrowth and moderate sinus tracts without heavy inflammation in animals.
- Device dummies and functioning devices demonstrated successful healing and function.
Conclusions:
- The device's clinical success is attributed to specific design factors including titanium interface, surface geometry, preformed cavities, stress relief, and surgical precision.
- Results are promising, warranting further controlled clinical trials and extended observation.