Faceted Piercing Head Guidewire for Transseptal Puncture
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Solution Overview
Problem
Existing transseptal puncture devices leave jagged cuts in the atrial septum, causing the opening to close back to a smaller diameter than the guidewire, making it difficult to pass catheters or other medical devices through the septum.
Innovation Solution
A guidewire with a piercing head featuring three tapered facets forming cutting edges, which cuts the septum tissue smoothly and maintains an opening diameter similar to the guidewire, reducing tissue relaxation and facilitating catheter passage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conical-shaped piercing tip is used, then the guidewire can penetrate the septum wall, but it leaves a jagged cut causing the opening to close back to a smaller diameter
Solution Approach 1:
The conical piercing tip is segmented into multiple facets (typically three) that form distinct cutting edges. Each facet creates a planar surface that contributes to a cleaner, more controlled cut through the septal tissue, preventing the jagged closure issue associated with smooth conical tips.
Solution Approach 2:
The piercing head incorporates facets with specific geometric properties at the cutting interface, creating localized planar cutting surfaces that differ from the overall conical shape. This local geometric modification enables cleaner cutting while maintaining the penetrating capability of the conical form.
2Strength
If a conical piercing tip is used, then the guidewire can puncture the septum, but the tissue readily relaxes back to its original shape reducing opening diameter
Solution Approach 1:
The cutting surface is divided into multiple facets that create stable, planar incisions in the tissue. This segmentation allows the tissue to be cut along defined planes rather than being compressed and deformed by a smooth conical surface, resulting in an opening that maintains its diameter.
Solution Approach 2:
The facet geometry provides localized cutting action at the tissue interface, creating a stable opening that resists relaxation. The planar surfaces of the facets interact with the tissue differently than a curved conical surface, maintaining opening stability while preserving penetration strength.
3Device complexity
If a conical taper similar to a pencil head is used, then the guidewire structure is simple, but the cut is jagged and traumatic to body tissue
Solution Approach 1:
The piercing head is segmented into a small number of facets (typically three) that form cutting edges. This minimal segmentation provides clean, controlled cuts without significantly increasing structural complexity, balancing simplicity with improved tissue interaction.
Solution Approach 2:
The facets create localized planar cutting surfaces at the tissue interface, improving cut quality and reducing tissue trauma. The overall conical structure remains simple, but the local geometry at the cutting edge is modified to achieve better tissue interaction.
Data Source
AI summary
A guidewire that is specifically designed for performing an intracardiac transseptal puncture procedure is described. A piercing head for the guidewire has a conically-shaped section that tapers to a cutting section comprised of three tapered facets extending to a pointed tip. The three facets form three cutting edges that each provide for smooth cutting of body tissue, for example, cutting of the septum wall. The cut tissue does not tend to close or relax as readily as if the tissue had been punctured with a conically-shaped piercing tip, for example, one that has a structure similar to a pencil tip, This helps with subsequently moving a catheter and similar medical device through the pierced body tissue. Consequently, the faceted piercing head leaves an opening having a diameter that is substantially similar to the maximum outer diameter of piercing head.