Rapidly Insertable Central Catheter Assembly With Hard-Sheath Support
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Solution Overview
Problem
The Seldinger technique for inserting central venous catheters is time-consuming and involves multiple medical devices, leading to potential patient trauma and contamination risks due to the handling of numerous components.
Innovation Solution
A rapidly insertable central catheter (RICC) assembly comprising a soft catheter tube with an introducing aperture and a hard introducer catheter, where the introducer needle is disposed through both the aperture and a hole in the introducer catheter, providing column strength for easy advancement into a blood vessel using guidewires.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the Seldinger technique is used to insert a central venous catheter, then the catheter can be successfully introduced into the patient's vasculature, but the process becomes time-consuming and involves multiple medical devices that increase the risk of patient trauma and contamination
Solution Approach 1:
The patent combines multiple separate medical devices (catheter, introducer, guidewire) into a single integrated assembly where the catheter is pre-loaded within the introducer sheath. This merging eliminates the need for multiple separate device manipulations and reduces insertion time while maintaining successful catheter placement through the integrated design.
Solution Approach 2:
The catheter is pre-positioned within the introducer sheath during manufacturing, so that when the assembly is inserted, the catheter is already in place and requires no separate manipulation. This preliminary action eliminates time-consuming steps during the actual insertion procedure while ensuring reliable catheter placement.
2Reliability
If the Seldinger technique uses multiple medical devices (needle, scalpel, guidewire, introducer sheath, dilator), then the catheter can be advanced through the vasculature, but the complexity of handling multiple devices increases the risk of contamination and patient trauma
Solution Approach 1:
The patent merges the catheter, introducer sheath, and guidewire into a single integrated assembly that functions as one unit during insertion. This eliminates the need to handle and interchange multiple separate devices, reducing contamination risk while maintaining the ability to advance the catheter through the vasculature.
Solution Approach 2:
The integrated assembly performs multiple functions simultaneously: the introducer sheath provides vascular access, the catheter establishes the therapeutic pathway, and the guidewire provides positioning and support. This multi-functionality in a single device reduces the number of components needed while maintaining reliable catheter advancement.
3Ease of operation
If a soft catheter tube is used to ensure comfort and flexibility, then the catheter can be comfortably inserted, but the catheter lacks column strength needed for advancement through the vasculature
Solution Approach 1:
The patent employs a composite structure where a soft catheter tube is nested within a harder introducer sheath. The soft catheter tube maintains flexibility and comfort for vascular insertion, while the harder introducer sheath provides the column strength needed to advance the assembly through the vasculature. This composite approach resolves the contradiction between softness for comfort and hardness for strength.
Data Source
AI summary
Rapidly insertable central catheter (“RICC”) assemblies include a RICC and an introducer. The RICC can include a soft catheter tube having an introducing aperture that opens into a primary lumen of the RICC. The introducer can include an introducer catheter including a hard catheter tube having an introducing hole that opens into a single lumen of the introducer catheter. When the RICC assembly is in a ready-to-deploy state, the introducer catheter is disposed in the primary lumen of the RICC such that a distal end of the introducer catheter extends past a distal end of the RICC. An introducer needle of the introducer can be disposed in the introducer catheter through both the introducing aperture and the introducing hole such that a beveled tip of the introducer needle extends past the distal end of the introducer catheter.