Steerable Tissue Puncture Device with Direct Vision Imaging
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Solution Overview
Problem
Current cardiovascular access devices struggle to accurately locate and orient themselves at the fossa ovalis for efficient tissue access, often causing damage to surrounding heart tissue and the pericardium due to inadequate precision and safety features.
Innovation Solution
A tissue puncture device with a tubular sheath and a needle control mechanism that allows for precise deployment and retraction of a needle, featuring a steerable catheter and direct vision imaging components to ensure accurate positioning and minimize tissue damage, along with a mechanism for automatic needle retraction to prevent unintended perforation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current cardiovascular access devices are used for trans-septal procedures, then access to the left atrium can be obtained, but accurate location and orientation at the fossa ovalis cannot be achieved, leading to tissue damage
Solution Approach 1:
The patent replaces traditional mechanical navigation methods (fluoroscopy and intra-cardiac echo guidance) with a direct vision imaging system that provides optical visualization of the fossa ovalis. This substitution enables precise visual alignment and accurate needle placement, eliminating the imprecision of conventional mechanical navigation systems while reducing tissue damage through controlled, visually-guided access.
Solution Approach 2:
The patent introduces a steerable catheter as an intermediary device that facilitates precise positioning of the puncture needle at the fossa ovalis. The catheter acts as a guide and delivery mechanism, enabling controlled navigation and stable positioning before needle deployment, thereby improving location accuracy and minimizing tissue trauma through gradual, controlled access.
2Ease of operation
If needles are used for tissue access, then puncture capability is achieved, but control over needle deployment and retraction is insufficient, causing damage to surrounding tissue and pericardium
Solution Approach 1:
The patent implements a dynamic needle control mechanism that allows real-time adjustment of needle deployment and retraction. The needle can be extended beyond the sheath when needed and retracted back inside when not in use, providing dynamic control over the puncture process. This dynamic capability enables precise tissue access while minimizing exposure time and reducing the risk of damage to surrounding tissue and pericardium.
Solution Approach 2:
The patent segments the needle system into distinct functional components: a needle, a protective sheath, and a control mechanism. The needle is disposed within the sheath, which can be retracted to expose the needle for puncture and then advanced to cover and protect the needle after use. This segmentation allows independent control of each component, improving operational precision and safety.
Data Source
AI summary
Tissue puncture devices, and systems and methods for accessing tissue (e.g., cardiovascular tissue) according to the present disclosure may include a tubular sheath extending along a longitudinal axis, the tubular sheath having a proximal end and a distal end, a needle disposed coaxially in the sheath, the needle having a proximal end and a distal end and being movable along the longitudinal axis of sheath, and a needle control mechanism disposed at the proximal end of the needle, the needle control mechanism being configured to lock the distal end of the needle in a first position retracted within the distal end of the sheath, and release the needle to an unlocked second position such that the distal end of the needle is extendable beyond the distal end of the sheath.