Transseptal Access Device Using Vacuum-Assisted Septal Puncture
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Solution Overview
Problem
Existing transseptal access methods face challenges in obtaining access through heavily fibrosed tissues, leading to complications such as puncture of the opposite cardiac wall and increased risk of adverse events.
Innovation Solution
A system and method utilizing a device with a flared distal end and a vacuum or negative pressure mechanism to pull the fossa ovalis towards a stationary needle, reducing the need for positive pressure and minimizing tissue stress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If positive pressure is applied to advance the needle through heavily fibrosed tissue, then penetration capability is improved, but the risk of puncturing the opposite cardiac wall increases
Solution Approach 1:
Instead of pushing the needle forward with positive pressure, the invention inverts the approach by using negative pressure (suction) to pull the tissue toward the needle, enabling penetration through heavily fibrosed tissue without applying excessive forward force that could cause opposite wall puncture
Solution Approach 2:
The invention employs pneumatic principles by using a suction mechanism to create negative pressure, which pulls the fossa ovalis tissue toward the needle tip, allowing controlled penetration through resistant fibrosed tissue while minimizing the risk of excessive force causing cardiac wall puncture
2Strength
If significant pressure is applied to advance the needle through heavily fibrotic septum, then penetration through tissue is improved, but tissue stress and tenting increase causing adverse events
Solution Approach 1:
The invention reverses the traditional approach by using suction to pull tissue toward the needle rather than pushing the needle into the tissue, thereby reducing tissue stress and tenting while achieving penetration through heavily fibrotic septum
Solution Approach 2:
The invention replaces the mechanical pushing system with a pneumatic suction system, substituting the force-based penetration mechanism with a pressure-based tissue attraction mechanism that reduces overall tissue stress
3Ease of operation
If the needle is advanced forcefully to penetrate fibrosed tissue, then access through septum is achieved, but perforation and adverse events occur
Solution Approach 1:
The invention uses pneumatic suction to create controlled negative pressure that gradually pulls the tissue toward the needle, enabling safe access through the septum while minimizing the risk of sudden perforation and associated adverse events
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
This approach reduces the risk of cardiac wall puncture and adverse events by stabilizing the tissue with negative pressure, allowing for safer and more controlled transseptal access.
Implementation Method 1
a vacuum, suction, or other negative pressure may be applied
Implementation Method 2
a vacuum, suction, or other negative pressure may be applied
Data Source
AI summary
Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof.