Vascular Access Guide with Needle Angle Constraint
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Solution Overview
Problem
Current vascular access systems for hemodialysis lack effective guidance and monitoring mechanisms, leading to potential complications such as needle misplacement and back-wall perforation of blood vessels during needle insertion.
Innovation Solution
An implantable device with a guide that constrains a hemodialysis needle to an angle of less than 5 degrees and includes a sensor and indicator system to ensure precise needle placement within a predetermined area on the blood vessel wall, preventing misplacement and facilitating safe insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a guide is used to constrain needle angle and position, then manufacturing precision and reliability are improved, but device complexity increases
Solution Approach 1:
The guide is pre-formed with the target area and angle constraints built into its structure before use. The lumen is pre-shaped to constrain the needle to less than 5 degrees angle, and the distal end is pre-configured with the target area of less than 90 mm², eliminating the need for complex real-time adjustments during needle insertion.
Solution Approach 2:
The guide acts as an intermediary device between the practitioner and the blood vessel. It mediates the needle insertion process by providing a pre-formed pathway that automatically constrains the needle angle and position, simplifying the overall system while improving precision.
2Reliability
If a sensor and indicator system is added for real-time monitoring, then reliability is improved, but device complexity increases
Solution Approach 1:
The sensor attached to the guide provides real-time feedback on needle position by detecting when the needle tip passes a predetermined position within 4 mm of the distal end. This feedback is immediately communicated to the practitioner through the indicator system, allowing for precise control and reducing the risk of back-wall perforation.
Solution Approach 2:
The sensor system replaces complex mechanical measurement mechanisms with electronic or optical sensing. Instead of using elaborate mechanical gauges or rulers to measure needle depth, the patent uses sensors that can detect needle position electronically, simplifying the overall system while improving reliability.
3Manufacturing precision
If the guide length is increased to improve needle guidance, then manufacturing precision is improved, but ease of operation worsens
Solution Approach 1:
The guide length is optimized to provide just enough constraint for precise needle placement without being excessively long. The patent specifies a guide length between 7 to 35 mm, which is sufficient to constrain the needle angle to less than 5 degrees and position the tip within 4 mm of the distal end, while remaining manageable for insertion and operation.
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 ensures accurate needle placement, reduces the risk of complications like back-wall perforation, and allows for real-time monitoring of needle position, enhancing the safety and efficacy of vascular access procedures.
Implementation Method 1
the sensor includes at least one of sensing a metal detector
Implementation Method 2
the sensor includes at least one of sensing a metal detector, a magnetic field detector
Implementation Method 3
the indicator is configured to be visible from outside through the skin under indoor fluorescent lighting
Implementation Method 4
the sensor includes an ultrasound emitter
Data Source
AI summary
A vascular access device is disclosed including a needle insertion guide having a proximal end and a distal end a the guide including a needle insertion guide having a proximal end and a distal end and a vessel interface configured for attaching the distal end of the guide to a target on an unbroken outer wall of a blood vessel of a living subject and a skin interface configured for attaching the proximal end of the guide to a skin of the living subject. Optionally the vessel interface is connected to the guide by a flexible joint configured. Optionally two vascular access devices are connected by an electrically conductive connection. Optionally the vascular access device includes a sensor to determine when a needle enters the blood vessel. Optionally the vascular access device serves as a marker for a sensor determining a status of the blood vessel.