Introducer Sheath and Puncture Tool for Minimizing Tissue Trauma
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Solution Overview
Problem
Current medical procedures for introducing and placing catheters often result in tissue damage, bleeding, and contamination risks due to multiple tool introductions, and multi-lumen catheters cannot be delivered through standard needles.
Innovation Solution
A medical device comprising a handle, needle, sheath, and barrier, where the needle and sheath are simultaneously introduced, with a releasable connection and expandable barrier to maintain aseptic conditions, allowing for the insertion of multi-lumen catheters without guidewires and minimizing tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple tools are introduced sequentially into the wound space, then the catheter can be placed, but tissue damage and bleeding increase
Solution Approach 1:
The patent combines the needle and sheath into a single integrated introducer assembly that is inserted through the tissue in one motion. The needle serves as the puncture element while the sheath is positioned within the needle, allowing both components to be introduced simultaneously rather than sequentially. This merging eliminates the need for multiple separate insertions, thereby reducing tissue trauma and bleeding while maintaining the ability to place the catheter.
Solution Approach 2:
The sheath is pre-positioned within the needle before insertion, and the entire assembly is inserted together in a single action. The needle and sheath are connected through a releasable coupling mechanism that is prepared in advance, allowing the sheath to be deployed immediately after needle insertion without requiring separate introduction steps. This preliminary preparation enables simultaneous introduction, reducing the time the wound is open and minimizing tissue damage.
2Device complexity
If the catheter hub is retained in standard needles, then the needle structure is simple, but multi-lumen catheters cannot be delivered
Solution Approach 1:
The introducer is divided into distinct functional segments: the needle portion for puncture, the sheath portion for catheter delivery, and a releasable coupling mechanism connecting them. The sheath itself is segmented into a proximal portion within the needle and a distal portion extending outward. This segmentation allows the needle to maintain its simple puncture function while the sheath provides the expanded capability to deliver multi-lumen catheters through its larger internal diameter and structured opening.
Solution Approach 2:
The sheath is nested within the needle in a telescoping arrangement, with the proximal portion of the sheath positioned inside the needle lumen. The releasable coupling mechanism allows the nested components to be separated after insertion. This nesting enables the compact storage and simultaneous introduction of both components while allowing the sheath to extend beyond the needle for catheter delivery, effectively combining the simplicity of the needle with the versatility of the sheath.
3Ease of operation
If the needle and sheath are introduced at different times, then insertion is simplified, but contamination risk increases
Solution Approach 1:
The needle and sheath are merged into a single introducer assembly that is inserted through the tissue in one continuous motion. The releasable coupling mechanism connects the needle and sheath proximal portions together during insertion, ensuring they are introduced simultaneously. This merging eliminates the time gap between needle insertion and sheath introduction, maintaining the sterile barrier and preventing contamination while keeping the insertion process simple through the integrated design.
Solution Approach 2:
The insertion process is made continuous by pre-assembling the needle and sheath in a releasable coupling arrangement. The entire assembly is inserted in one uninterrupted motion, and the coupling mechanism releases automatically or on command after penetration is complete. This continuity ensures the sterile field is maintained throughout the procedure without breaks that would allow contamination, while the automated or simple release mechanism keeps the operation straightforward.
4Device complexity
If a straight needle is used, then the needle structure is simple, but catheter repositioning is difficult
Solution Approach 1:
The introducer assembly incorporates dynamic elements that allow for adjustment and repositioning after initial insertion. The releasable coupling mechanism between the needle and sheath can be detached and reconnected at different positions, enabling the operator to adjust the catheter placement. The sheath itself can be manipulated independently once the coupling is released, allowing for dynamic repositioning without requiring removal and reinsertion of the entire assembly, thus maintaining simplicity while adding flexibility.
Data Source
AI summary
Disclosed embodiments include methods and devices for introducing a sheath into a human or animal subject. Some embodiments include a puncture tool that may simultaneously deliver a sheath and a needle to a desired anatomical location. The needle may be removed and the sheath may be used to define a space that may be used to conduct a procedure.