RF Transseptal Cannula for Single-Pass Large Bore Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing transseptal crossing systems are inadequate for enabling large bore access in a single pass, necessitating multiple equipment exchanges and complex procedural steps for procedures like left atrial appendage occlusion and mitral valve replacement.
Innovation Solution
A single pass transseptal crossing device with an insulated cannula and conductive tip that delivers RF energy to facilitate direct tissue penetration, allowing a 0.035 inch guidewire to drive large bore sheaths and dilators directly into the left atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional small bore transseptal sheaths (2.667-3.667 mm) are used, then the procedure can be completed with existing equipment, but multiple equipment exchanges and complex procedural steps are required
Solution Approach 1:
The patent combines the guidewire, RF delivery system, and large bore sheath into a single integrated transseptal access system. The 0.035 inch guidewire is delivered through the large bore sheath along with the RF catheter, eliminating the need for separate small bore sheath and dilator exchanges. This merging of components directly reduces equipment complexity while maintaining procedural simplicity.
Solution Approach 2:
The large bore sheath is designed to perform multiple functions: it serves as the delivery sheath for the RF catheter, accommodates the 0.035 inch guidewire, and provides direct access to the left atrium without requiring exchange for smaller sheaths. This multi-functionality eliminates the need for multiple equipment exchanges, resolving the contradiction between procedural simplicity and equipment complexity.
2Reliability
If multiple equipment exchanges are performed, then access can be achieved with current technology, but procedural time and complexity increase
Solution Approach 1:
The system is pre-configured with the 0.035 inch guidewire and RF catheter delivered through the large bore sheath before the procedure begins. The guidewire is advanced through the sheath and positioned in the left atrium prior to sheath deployment, allowing immediate access without time-consuming exchanges. This preliminary preparation maintains access reliability while significantly reducing procedural time.
3Productivity
If RF energy is delivered through the cannula, then direct tissue penetration is achieved, but the cannula must be insulated to prevent unintended energy delivery
Solution Approach 1:
The cannula is insulated along its length to prevent unintended RF energy delivery, but the insulation is removed or breached at the distal tip where tissue penetration is required. This local differentiation allows the cannula to maintain electrical isolation where needed while enabling direct tissue penetration at the treatment site, resolving the contradiction between productivity and device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables a single pass large bore access to the left atrium, simplifying procedures and reducing the need for multiple equipment exchanges, thereby enhancing procedural efficiency and safety.
Implementation Method 1
The cannula can be energized to deliver RF energy directly to tissues and/or through a separate conductive wire or obturator
Implementation Method 2
The tip of the cannula can be scalloped to deliver high density current to the scalloped edges for improved cutting
Implementation Method 3
The system permits irrigation with hypotonic saline or D5W to preferentially drive current through the myocardium
Data Source
AI summary
A single pass, large bore transseptal crossing catheter system is disclosed. An elongate, flexible tubular body has a proximal end, a distal end and an electrically conductive sidewall defining a central lumen. An insulation layer surrounds the sidewall and leaves exposed a first distal electrode tip. An inner conductive wire is provided, having a second distal electrode tip. The inner wire is axially movably extendable through the central lumen. A tubular insulation layer is provided in between the wire and the electrically conductive sidewall.