Implantable Access Device Shape Memory Structure
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Solution Overview
Problem
Existing transcutaneous vascular access systems face challenges such as high infection risk due to skin integrity compromise, biofilm formation, device failure, and complex care procedures, leading to severe infections and complications for patients dependent on these devices.
Innovation Solution
An implantable access device with a shape memory base structure and substructure designed for cell adhesion and proliferation, using materials like fibrin, plasma, and polymeric components to support wound healing and integration into tissue, reducing the risk of infection and enhancing skin integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If repeated puncture is performed through the skin for vascular access, then blood access is achieved, but skin integrity is compromised and infection risk increases
Solution Approach 1:
The device performs preliminary action by creating a permanent subcutaneous tunnel and pocket structure before repeated punctures are needed. This pre-established pathway with integrated barrier layers prevents skin integrity compromise during subsequent access procedures, eliminating the vicious cycle of infection while maintaining ease of repeated blood sampling.
Solution Approach 2:
The device introduces an intermediary barrier system consisting of multiple layers including a membrane with micropores and biological barrier layers that mediate between the external environment and the subcutaneous tissue. This intermediary structure allows needle passage while preventing bacterial penetration, thus enabling vascular access without compromising skin integrity or increasing infection risk.
2Ease of operation
If traditional transcutaneous access devices are used, then vascular access is provided, but biofilm formation occurs leading to device failure
Solution Approach 1:
The device converts the harmful effect of repeated puncture-induced inflammation into a beneficial outcome by utilizing the inflammatory response to promote formation of a fibrous capsule around the implant. This fibrous capsule, while initially a response to injury, ultimately serves as a protective barrier that prevents biofilm formation and bacterial colonization, thereby converting the harmful inflammatory process into a protective mechanism that enhances device reliability.
Solution Approach 2:
The device employs composite material structure with multiple functional layers including a base membrane with micropores, biological barrier layers, and fibrous capsule integration. This composite construction combines materials with different properties - the microporous membrane allows fluid passage while the biological barrier layers and fibrous capsule prevent biofilm adhesion, collectively eliminating device failure while maintaining vascular access functionality.
3Object-affected harmful factors
If antibiotics and disinfectants are used for infection prevention, then infection risk is reduced, but skin erosion and wound healing complications occur
Solution Approach 1:
The device extracts and removes the need for antibiotics and disinfectants by implementing a passive physical barrier system. The multi-layer construction with microporous membranes and biological barrier layers provides inherent infection prevention through mechanical filtration and biological resistance, eliminating the requirement for chemical antimicrobial agents and thereby preventing the skin erosion and wound healing complications associated with their use.
Solution Approach 2:
The device enables self-service infection prevention by utilizing the body's own biological responses and materials. The fibrous capsule formation driven by the body's inflammatory response, combined with the biological barrier layers that integrate with host tissue, creates a self-sustaining protective system that prevents infection without requiring external antibiotic or disinfectant application, thus avoiding skin erosion and healing complications.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device integrates biologically with tissue, reducing infection risk, supporting wound healing, and maintaining skin integrity, thereby breaking the cycle of infections and improving patient safety and treatment outcomes.
Implementation Method 1
a shape memory base structure with a substructure suitable for cell adhesion, cell engraftment and proliferation
Implementation Method 2
a substructure suitable for cell adhesion, cell engraftment and proliferation
Data Source
AI summary
The present invention concerns an implantable access device and a method for preparing the device. According to the invention the device comprises a shape memory base structure with a biological substructure suitable for cell adhesion, cell engraftment and proliferation for use in transferring and transporting fluid mixtures (blood, suspensions, drug formulations, emulsions, cell suspensions) in/into/out of a human or animal body.