Steerable Endoluminal Punch for Precise Atrial Wall Access
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Solution Overview
Problem
Current methods for left atrial access, such as using a Brockenbrough needle with a Mullins-type catheter, risk myocardial burning and increased scarring due to radiofrequency ablation, and lack precision in tissue puncture.
Innovation Solution
A steerable endoluminal punch with a large diameter lumen and a blunt stylet to shield the sharp tip during insertion, combined with a guidewire for controlled tissue penetration and a mechanism to prevent inadvertent punctures, allowing for safer and more precise access to body lumens.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency ablation is used to perforate the atrial wall, then tissue penetration is achieved, but myocardial burning and increased scarring occur
Solution Approach 1:
The patent replaces the radiofrequency ablation mechanism with a purely mechanical punching system. The punch device uses mechanical force delivered through a catheter to create a clean incision in the atrial wall, eliminating thermal energy application and its associated harmful effects of myocardial burning and scarring while achieving reliable tissue penetration.
Solution Approach 2:
The patent introduces a mechanical punch as an intermediary device between the catheter and the atrial wall. This punch mechanism serves as a mediator that translates catheter positioning into precise mechanical incision, providing controlled tissue penetration without the harmful thermal effects of radiofrequency ablation.
2Reliability
If a standard Brockenbrough needle is used for tissue puncture, then access is achieved, but precision in tissue puncture is limited
Solution Approach 1:
The patent incorporates a steerable mechanism that allows the punch device to dynamically adjust its orientation and direction of penetration. This steerable capability enables precise positioning and angulation of the punch tip against the target tissue, significantly improving puncture precision compared to fixed-geometry needles while maintaining reliable access achievement.
Solution Approach 2:
The patent changes the geometric parameters of the puncture device by providing adjustable steering angles and orientations. This allows optimization of the punch approach angle and positioning relative to the target tissue, enhancing precision without compromising the ability to achieve access.
3Strength
If a sharp tip is exposed during insertion, then tissue penetration capability is improved, but inadvertent punctures increase
Solution Approach 1:
The patent employs a retractable sheath or protective covering that shields the sharp punch tip during navigation through the vasculature. This protective mechanism is positioned in advance to prevent inadvertent punctures of surrounding tissues, while allowing the sharp tip to be exposed only when needed for the intended tissue penetration, thus eliminating harmful unintended punctures.
Solution Approach 2:
The patent implements preliminary protection of the sharp tip through a retractable sheath that remains in place during catheter insertion and navigation. This preliminary protective action prevents accidental tissue damage before the punch is intentionally deployed, allowing the sharp tip to then be exposed for controlled penetration when required.
Data Source
AI summary
An endoluminal punch and introducer sheath are described wherein the endoluminal punch comprises a guidewire lumen through which a user is capable of placing a guidewire. The endoluminal punch system further comprises a mechanism affixed to the hub which is capable of controlling the axial positioning of the guidewire relative to the endoluminal punch distal end. The control mechanism can be released so that the endoluminal punch can be removed from a patient while retaining the guidewire in place within the patient. The endoluminal punch introducer, including a sheath and dilator, can comprise energy emitting electrodes or transducers for cutting larger size holes in stubborn (friable, scarred, or fibrotic) tissue. In other embodiments, the endoluminal punch can comprise a guidewire or stylet, wherein the guidewire or stylet is capable of emitting energy to cut through tissue.


