Biodegradable Guiding Portion for Consistent Vascular Access
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Solution Overview
Problem
Current vascular access techniques for hemodialysis, such as the 'rope ladder' and 'buttonhole' methods, are prone to complications like aneurysms, stenosis, and thrombosis due to skill variability and the need for repeated needling, which increases the risk of trauma to arteriovenous fistulas and complicates home hemodialysis.
Innovation Solution
A vascular access device with a needle and guiding portion that includes a shield for initial penetration and a biodegradable funnel or channel portion to create a consistent scarred track, allowing for repeated and precise needle insertion without the need for extensive medical expertise.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the rope ladder technique is used to rotate cannulation sites, then trauma is distributed across the vessel, but the technique requires long arteriovenous fistulas and strict rotation sequences that are difficult to follow, leading to complications
Solution Approach 1:
The device segments the needle into multiple functional portions: a rigid shield portion for initial penetration and a flexible needle portion for vascular access. This segmentation allows the rigid portion to maintain consistent trajectory while the flexible portion adapts to the vessel, eliminating the need for complex rotation sequences while distributing trauma through controlled, repeated access at the same site.
Solution Approach 2:
The biodegradable guiding portion acts as an intermediary that creates a consistent subcutaneous track. This intermediary structure guides the needle along the same trajectory repeatedly, enabling trauma distribution through controlled access while eliminating the need for manual rotation sequence management by patients or caregivers.
2Reliability
If the buttonhole technique is used to cannulate at the same location, then pain is minimized and arteriovenous fistula lifespan is extended, but the technique is difficult to execute and requires extensive medical expertise and repeated blind needling
Solution Approach 1:
The device performs preliminary action by deploying a biodegradable guiding portion that creates a consistent subcutaneous track before needle insertion. This pre-established track eliminates the need for repeated blind needling and extensive skill development, while maintaining the benefits of consistent cannulation site access that extends arteriovenous fistula lifespan.
Solution Approach 2:
The biodegradable guiding portion serves as an intermediary structure that establishes a consistent access pathway. This intermediary eliminates the complexity and skill requirements of blind buttonhole technique by providing a physical guide that ensures repeated needles follow the same trajectory, while maintaining the reliability benefits of consistent access.
3Manufacturing precision
If blind repeated needling is performed to create a scarred track, then consistent access is achieved, but the process requires 10-20 dialysis sessions and extensive medical professional involvement
Solution Approach 1:
The device performs preliminary action by deploying a biodegradable guiding portion that pre-establishes the consistent subcutaneous track in a single procedure. This eliminates the need for 10-20 repeated dialysis sessions to create a scarred track through blind needling, achieving trajectory consistency immediately while reducing the time required from weeks to a single intervention.
Solution Approach 2:
The biodegradable guiding portion acts as an intermediary that creates the consistent trajectory pathway in one procedure rather than requiring multiple sessions of blind needling. This intermediary structure provides immediate trajectory consistency and eliminates the time loss associated with repeated track creation attempts.
4Strength
If rigid support is provided to the needle for penetration, then penetration strength is sufficient, but the needle cannot conform to the surrounding tissue and may cause trauma
Solution Approach 1:
The device segments the needle into a rigid shield portion and a flexible needle portion. The rigid shield provides sufficient penetration strength to pierce the skin and subcutaneous tissue, while the flexible needle portion can conform to the surrounding tissue and vessel architecture, minimizing trauma. This segmentation resolves the contradiction between needing rigidity for penetration and flexibility to avoid tissue damage.
Solution Approach 2:
Different portions of the needle have different mechanical properties: the shield portion is rigid for penetration while the needle portion is flexible for tissue conformation. This local quality differentiation allows each portion to perform its specific function optimally - the rigid shield provides penetration strength where needed, while the flexible needle minimizes trauma by adapting to tissue contours.
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 reduces the risk of vascular access complications, prolongs the lifespan of arteriovenous fistulas, and simplifies the needle insertion process, making hemodialysis safer and more cost-effective by minimizing trauma and expertise requirements.
Implementation Method 1
a biodegradable funnel or channel portion to create a consistent scarred track
Data Source
AI summary
According to various embodiments, a method and system to obtain access to a blood vessel underneath a skin layer that may preserve lifespan of the blood vessel and reduce executional skill variability may be provided. The method includes placing a guiding portion between the blood vessel and the skin layer; and configuring the guiding portion to receive and guide a needle to reach the same location of the blood vessel repeatedly and consistently; and forming a resultant scarred track between the blood vessel and the skin layer as the guiding portion is resorbed over time. The system includes a vascular access device configurable to first possess strength to penetrate through a tissue layer, subsequently possess flexibility to conform to the surrounding tissue beneath the tissue layer; and a guiding portion which may be resorbable, wherein the inlet includes a larger diameter compared to the outlet.