Access Needle Alignment Indicators for Smaller Subcutaneous Ports
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Solution Overview
Problem
Existing subcutaneous medical devices, particularly lower-profile ports, are difficult to locate and align accurately due to their smaller size, leading to increased risks of mis-sticks and patient discomfort.
Innovation Solution
An access assembly with a needle hub and an indicator system that includes a capacitance sensor or induction coil to detect changes in dielectric constant or magnetic field, providing visual, audible, or tactile alerts when the needle is aligned with the port, allowing for precise alignment without requiring palpation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If smaller, lower-profile ports are used, then wound healing is improved and scarring is reduced, but the port becomes more difficult to locate by palpation and alignment accuracy decreases
Solution Approach 1:
The patent employs an indicator system that provides real-time feedback to the operator during needle insertion. When the needle is correctly positioned over the port, the indicator (such as an LED light or visual marker) activates or aligns, giving immediate feedback on proper alignment. This feedback mechanism enables accurate targeting of smaller ports without requiring large palpable surfaces.
Solution Approach 2:
The patent introduces an intermediary alignment indicator system between the operator and the port. This intermediary component (such as a visual indicator, marker, or alignment guide) mediates the alignment process by providing a clear visual or tactile reference that bridges the gap between the operator's needle and the small, difficult-to-palpate port, thereby improving alignment accuracy without increasing port size.
2Measurement precision
If larger ports are used, then alignment accuracy is improved through easier palpation, but wound healing is compromised and scarring increases
Solution Approach 1:
The indicator system provides continuous feedback during the alignment process, allowing operators to achieve high alignment accuracy with smaller ports. The feedback mechanism (visual, tactile, or auditory) replaces the need for large palpable surfaces by giving precise directional and positional information about needle-port alignment, thereby maintaining accuracy while using smaller ports that heal better.
Solution Approach 2:
The patent replaces the mechanical palpation-based alignment system with an indicator-based alignment system. Instead of relying on tactile detection of port boundaries through skin palpation (mechanical method), the system uses visual indicators, optical markers, or electronic signals to guide needle placement, substituting mechanical sensing with non-contact or minimal-contact detection methods.
3Reliability
If indicator systems are added to improve alignment accuracy, then mis-sticks are reduced, but device complexity increases
Solution Approach 1:
The indicator system implements a simple feedback mechanism that activates only under specific conditions (when the needle is correctly positioned). This conditional feedback approach provides reliable alignment information without requiring complex continuous monitoring systems. The indicator may be a simple LED, visual marker, or tactile feature that engages passively or through minimal actuation, maintaining low device complexity while significantly improving reliability by reducing mis-sticks.
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 system enhances alignment accuracy, reduces mis-sticks, and enables the use of smaller ports with improved wound healing and aesthetics by providing real-time feedback on needle alignment.
Implementation Method 1
a capacitance sensor configured to detect a change in a dielectric constant between the subcutaneous medical device and a surrounding tissue
Implementation Method 2
detect a change in a dielectric constant between the subcutaneous medical device and a surrounding tissue
Implementation Method 3
an induction coil configured to induce a current in the voltmeter sensor to actuate the indicator to provide an alert
Data Source
AI summary
Embodiments disclosed herein are directed to access devices configured to access a subcutaneous medical device. The access device can include a needle supported by a needle hub and in some embodiments a housing slidably engaged therewith and configured to align the needle axis at a predetermined angle. The access device can include an indicator system configured to detect when the needle is correctly aligned with a target window of a port. This can allow for smaller, lower profile ports with smaller target windows while mitigating mis sticks. The indicator system can be contained within the access device little or no increase to the overall size of the access device. The indicator system can employ various modalities including capacitance, induction, magnetic, thermal, acoustic, or radio frequency (RF).