Integrated Dialysis Catheter Access Assembly for Sterile Placement
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Solution Overview
Problem
Existing acute dialysis catheter placement procedures face issues such as needle-hub cracking, prolonged procedure time due to multiple steps, and the need to maintain sterility of numerous components.
Innovation Solution
An access device comprising a longitudinal frame, guidewire clamps, a needle, and a dilator, designed to streamline the catheter placement process by minimizing component handling and maintaining sterility, with features like a transparent housing for visibility and split components for easy removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional manual catheter placement procedure is used, then catheter can be placed in patient, but procedure time is prolonged due to substantial number of steps and idle time between steps
Solution Approach 1:
The patent combines multiple separate components (needle, dilator, guidewire clamps, housing) into a single integrated access device that is pre-assembled and sterile-packaged. This merging eliminates the need for multiple separate steps of component assembly during the procedure, allowing the entire catheter placement process to be completed in a single continuous motion, thereby reducing procedure time from substantial to minimal.
Solution Approach 2:
The access device is pre-assembled with all necessary components (needle, dilator, guidewire clamps, housing) already positioned and configured before the procedure begins. The needle is pre-positioned to establish the insertion site, the dilator is pre-loaded for immediate use after needle removal, and the guidewire clamps are pre-configured to secure the guidewire. This preliminary assembly eliminates idle time between steps and allows continuous progression through the procedure.
2Reliability
If traditional manual catheter placement procedure is used, then catheter can be placed in patient, but substantial number of different components require sterility maintenance during procedure
Solution Approach 1:
The patent merges multiple separate components (needle, dilator, guidewire clamps, housing) into a single integrated access device that maintains sterility as one unified unit. Instead of maintaining sterility across multiple separate components and surfaces, the integrated design requires sterility maintenance for only one device, simplifying the sterility protocol and reducing the complexity of the system while ensuring reliable sterile barrier protection throughout the procedure.
3Ease of operation
If needle hub cracking or other breakage occurs during insertion site creation, then procedure can be completed, but device reliability is compromised
Solution Approach 1:
The needle is pre-assembled with the hub and shaft in a single integrated unit that is sterile-packaged and ready for use. The needle hub is designed with reinforced construction and proper geometric features that prevent cracking during insertion. By preparing the needle assembly in advance with proper structural integrity, the design eliminates the risk of hub cracking that would occur with separate, less robust components assembled during the procedure.
Data Source
AI summary
Disclosed are access systems, devices, and methods for internal access to a patient's body. For example, an access device for placing an acute dialysis catheter can include a frame; a housing, a pair of guidewire clamps, and a needle disposed on the frame; a dilator coupled to the frame, and an access guidewire in a ready-to-deploy state of the access device. The pair of guidewire clamps can be disposed on the frame between an end portion of the frame and a distal end of the housing for clamping the access guidewire. A needle hub of the needle can be disposed on the frame between the pair of guidewire clamps. The dilator can distally extend from the end portion of frame. A needle shaft of the needle can distally extend beyond a distal end of the dilator allowing the needle to establish an insertion site for the acute dialysis catheter.