Implantable Device with Offset Aspiration Port for Neurological Therapy
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Solution Overview
Problem
Current implantable medical devices for treating neurological disorders face challenges such as inadequate spatial and temporal distribution of therapeutic agents in the brain due to the blood-brain barrier, risk of brain hemorrhage, and complications related to scar tissue from burr hole surgery, especially in pediatric patients where skull growth can lead to device malfunction or difficulty in removal.
Innovation Solution
An implantable device configured to be placed between the scalp and the skull, offset from the burr hole, featuring dual lumen and single lumen catheters with separate infusion and aspiration pathways, allowing percutaneous access through unscarred tissue and accommodating skull growth, thereby reducing the risk of complications and improving therapeutic agent delivery and sampling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the device is aligned with the burr hole to provide positional stability, then the device is securely positioned, but the aspiration port becomes inaccessible through unscarred tissue and requires needle insertion through scar tissue
Solution Approach 1:
The device is divided into distinct functional components: a burr hole alignment portion that provides stable positioning, and a separately accessible aspiration port that can be reached through unscarred tissue. This segmentation allows each component to fulfill its specific function independently, resolving the contradiction between stability and accessibility.
Solution Approach 2:
The device structure acts as an intermediary between the burr hole (providing stability) and the aspiration port (requiring accessibility). By positioning the aspiration port offset from the burr hole and providing a separate access pathway through unscarred tissue, the device mediates between these two conflicting requirements.
2Reliability
If the device is placed in the burr hole to ensure secure positioning, then the device remains stable, but repeated needle insertions through scar tissue increase the risk of infection and device malfunction
Solution Approach 1:
The aspiration port function is extracted from the burr hole location and positioned separately, allowing access through unscarred tissue. This extraction removes the harmful factor of repeated needle insertions through scar tissue while maintaining device stability through the burr hole alignment portion.
Solution Approach 2:
The scar tissue from burr hole surgery, which initially presents a harm (infection risk, difficulty of penetration), is worked around by designing the aspiration port to be accessible through unscarred tissue. The scar tissue's location is used to inform the design of an alternative access pathway that avoids its harmful effects.
3Reliability
If the device is snugly implanted in the burr hole of a pediatric subject, then the device is securely positioned, but skull growth causes green stick fracturing, buckling, and device malfunction
Solution Approach 1:
The device design incorporates dynamic adaptability to accommodate the changing skull structure in pediatric patients. By offsetting the aspiration port from the burr hole and providing flexible access pathways, the device can adapt to skull growth without causing fracturing or buckling, maintaining both security and adaptability.
Solution Approach 2:
The device design accounts for parameter changes in the pediatric skull over time. The offset configuration and flexible catheter pathways allow the device to maintain proper function as the skull grows and changes shape, preventing the green stick fracturing and buckling associated with rigid, snug implants.
4Quantity of substance
If therapeutic agents are systemically administered to achieve therapeutic levels in the brain, then the blood-brain barrier is crossed, but systemic concentrations become undesirably high
Solution Approach 1:
The therapeutic agent delivery is extracted from the systemic circulation pathway and directed locally to the brain through the implantable device. This extraction allows achievement of therapeutic brain concentrations without the harmful effect of high systemic concentrations, as the drug is delivered directly to the target site.
Solution Approach 2:
The implantable device with its catheter and port system acts as an intermediary delivery mechanism between the external administration and the brain target. This intermediary pathway enables controlled, localized delivery that avoids the blood-brain barrier limitations of systemic administration while preventing systemic toxicity.
Data Source
AI summary
An implantable device includes a housing having a bottom configured to face the skull and a top configured to face a scalp when implanted. The device includes a first catheter connector configured to couple to a first dual lumen catheter. The first connector extends from the housing. The device comprises a second catheter connector configured to couple to a single lumen catheter. The second catheter connector extends from the housing. The device includes an opening defined by the top of the housing. The opening is configured to be accessed by a needle percutaneously inserted through the scalp when the device is implanted. The device includes a first fluid pathway from the first catheter connector to the opening defined by the top of the housing, and the device includes a second fluid pathway from the first catheter connector to the second catheter connector.