Integrated Transseptal Needle–Guidewire Access for Fewer Exchanges
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Solution Overview
Problem
Existing transseptal puncture procedures require multiple device exchanges, which can be time-consuming and increase the risk of inadvertent puncture or damage to cardiac tissues.
Innovation Solution
A transseptal system with a dilator body, needle body, and guidewire design that allows for simultaneous or sequential use of the needle and guidewire within the dilator lumen, eliminating the need for multiple instrument exchanges during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple device exchanges are performed during transseptal puncture procedure, then the procedure can be completed using conventional separate instruments, but the procedure becomes time-consuming and increases the risk of inadvertent puncture or damage to cardiac tissues
Solution Approach 1:
The patent combines the needle body, guidewire, and dilator into a single integrated transseptal system. The needle body and guidewire are simultaneously received within the dilator lumen, allowing both instruments to be advanced together through the atrial septum in one continuous motion, eliminating the need for separate device exchanges and reducing procedural time while maintaining safety.
Solution Approach 2:
The guidewire is nested within the lumen of the dilator body, and the needle body is also received within the dilator lumen. This nested configuration allows multiple instruments to be contained within a single delivery system, enabling simultaneous advancement through the septum without requiring separate insertion steps or device exchanges.
2Ease of operation
If multiple device exchanges are performed during transseptal puncture procedure, then conventional separate instruments can be used, but the number of instrument exchanges increases procedural complexity and time consumption
Solution Approach 1:
The patent merges multiple separate instruments (needle, guidewire, dilator) into a single integrated transseptal system. This consolidation simplifies the operational workflow by eliminating repeated device exchanges, allowing the operator to advance all necessary components through one continuous action, thereby improving ease of operation despite the increased complexity of the integrated design.
Solution Approach 2:
The dilator body serves multiple functions: it acts as a protective sheath for the needle body, a delivery conduit for the guidewire, and a dilating instrument for enlarging the puncture site. This multi-functionality reduces the need for separate instruments and exchanges, simplifying the overall procedure while consolidating capabilities into a single universal device.
3Productivity
If the dilator lumen is sized to simultaneously receive both needle body and guidewire, then immediate advancement of guidewire is enabled, but the distal region of lumen must be precisely sized to disallow simultaneous advancement of both instruments
Solution Approach 1:
The dilator lumen exhibits varying cross-sectional dimensions at different locations: the proximal region has a larger cross-section capable of simultaneously receiving both the needle body and guidewire, while the distal region has a reduced cross-section that only accommodates one instrument at a time. This local variation in dimensional quality enables both instruments to be advanced together initially, then prevents simultaneous advancement at the distal end, ensuring proper sequencing without requiring extreme manufacturing precision.
Data Source
AI summary
A transseptal system includes a needle, a guidewire, a handle, and a dilator. The handle defines a needle passage to slidably receive the needle, and a guidewire passage to slidably receive the guidewire. The dilator defines a lumen having a distal region and a proximal region. The dilator is coupled to the handle such that the lumen is open to the needle passage and the guidewire passage. The proximal region of the lumen is sized to simultaneously receive the needle body and the guidewire. The distal region is sized to slidably receive one of the needle and the guidewire on an individual basis. A transseptal puncture and access procedure can be performed, including puncturing tissue with the needle followed by immediate advancement of the guidewire into the accessed area, eliminating the need for multiple instrument exchanges during the procedure.