Coiled Wire Medical Access Tool for Controlled Tissue Piercing
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Solution Overview
Problem
Existing methods for implanting medical electrical leads in extravascular spaces, such as the sub-sternal space or pericardial sac, face challenges in accessing these areas without risking perforation of bodily organs, especially when vascular access is difficult or when transvenous leads become fibrosed over time.
Innovation Solution
A medical access tool featuring a needle member and a coiled wire with an open pitch, where the coiled wire engages tissue and guides it to a piercing distal tip of the needle member, allowing controlled piercing and minimizing the risk of organ perforation, while a lumen in the needle member facilitates the advancement of a guide wire into the desired space.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to pierce tissue to access extravascular spaces, then access to the target space is achieved, but the risk of uncontrolled organ perforation increases
Solution Approach 1:
The coiled wire acts as an intermediary element between the operator and the tissue. It engages the tissue first and guides it toward the needle tip through controlled rotation, mediating the interaction to ensure the needle pierces only after proper positioning. This intermediary mechanism prevents direct uncontrolled needle insertion and reduces organ perforation risk.
Solution Approach 2:
The coiled wire performs preliminary tissue engagement and positioning before the needle piercing action. By rotating the coiled wire to guide tissue onto the needle tip, the system prepares the tissue-needle interface in advance, ensuring controlled piercing rather than direct insertion. This preliminary action sequence enhances reliability and reduces harmful perforation risks.
2Ease of manufacture
If transvenous leads are used for cardiac therapy delivery, then vascular access is utilized, but fibrosis of leads in the heart occurs over time making revision and extraction challenging
Solution Approach 1:
The invention extracts the lead implantation from the traditional transvenous pathway and relocates it to an extravascular space (sub-sternal or pericardial). By accessing the target space through the diaphragm rather than through veins, the lead is placed in a location that avoids cardiac fibrosis issues, making future revision and extraction significantly easier while maintaining therapeutic effectiveness.
3Strength
If the needle tip is exposed at the same level as the coiled wire tip, then piercing capability is maximized, but the risk of uncontrolled tissue damage increases
Solution Approach 1:
The coiled wire performs preliminary tissue engagement and guidance before the needle tip makes contact. The tissue is guided onto the needle tip through controlled rotation of the coiled wire, ensuring that piercing occurs only after proper positioning. This sequence maintains piercing capability while preventing uncontrolled tissue damage.
Solution Approach 2:
The coiled wire serves as a mediator that controls the interaction between the needle and tissue. It engages the tissue first and guides it precisely onto the needle tip, mediating the piercing action to ensure it occurs only when properly positioned. This intermediary function maintains effective piercing while minimizing harmful uncontrolled tissue damage.
Data Source
AI summary
A medical access tool includes a needle member extending along a longitudinal axis, and a coiled wire extending around the axis. An inner surface of the coiled wire, along a proximal segment thereof, is spaced radially apart from an outer surface of the needle member, and a distal segment of the coiled wire extends distally to a tissue-engaging tip of the coiled wire, a piercing distal tip of the needle member being recessed proximally from the tissue-engaging tip at a fixed distance. An operator may rotate the coiled wire to engage tissue, for example, that of a pericardial sac or a diaphragmatic attachment, which then travels proximally along the coiled wire and into contact with the needle member's distal tip, to be pierced through thereby. At least one lumen of the needle member provides a passageway through which the operator may advance a guide wire and/or inject a fluid.