Angled Tip Catheter with Deployable Stylet for Tibial Re-entry
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Solution Overview
Problem
Current methods lack a reliable and repeatable re-entry device for recanalizing small tibial vessels below the knee, which are often calcified and difficult to access using standard techniques.
Innovation Solution
A micro-catheter with an angled tip and a deployable stylet needle, actuated by a mechanical, pneumatic, hydraulic, or magnetic mechanism, designed to penetrate the vessel wall and facilitate re-entry into the true lumen, allowing for precise and repeatable re-entry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard re-entry techniques are used in small tibial vessels, then the procedure becomes difficult and unreliable, but using specialized re-entry devices for larger arteries is not feasible due to size constraints
Solution Approach 1:
The catheter is designed with a micro-scale diameter (≤4 French) specifically adapted for small tibial vessels, while the distal tip incorporates a specialized angled geometry with a deployable needle for reliable re-entry. This local differentiation allows the device to be both small enough for BTK vessels and effective for penetration.
Solution Approach 2:
The catheter tip is designed with a specific angled geometry (e.g., 30 degrees) relative to the longitudinal axis, creating a three-dimensional re-entry configuration that facilitates controlled penetration through the vessel wall at optimized angles for small vessels.
2Strength
If a deployable needle is used to penetrate the vessel wall, then penetration capability is improved, but device complexity increases
Solution Approach 1:
The needle is nested within the catheter body in a retracted position during navigation, then deployed outward through the catheter wall when needed. This nesting approach allows the penetration function to be integrated into the catheter structure without requiring separate devices or complex external mechanisms.
Solution Approach 2:
The needle deployment mechanism is designed to be self-actuating or easily actuated by the operator through simple manual manipulation, reducing the need for complex external control systems while maintaining reliable penetration capability.
3Measurement precision
If an angled tip is used to facilitate re-entry, then re-entry precision is improved, but manufacturing precision requirements increase
Solution Approach 1:
The catheter tip is pre-formed during manufacturing with a specific angled geometry (e.g., 30 degrees) to optimize re-entry precision. This preliminary shaping ensures consistent performance while allowing standard manufacturing tolerances to be applied, as the angle is established once during fabrication rather than requiring adjustment during use.
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 reliable and repeatable re-entry into the true lumen of small tibial vessels, improving treatment efficacy for peripheral arterial disease by providing a precise and controlled method for recanalization.
Implementation Method 1
An actuator is provided at a proximal end portion of the catheter for advancing the stylet from a retracted position within the catheter to a deployed position projecting from the distal open end of the angled tip
Implementation Method 2
The actuator may be manually operable, or may pneumatic, hydraulic, or magnetic
Implementation Method 3
The actuator may be manually operable, or may pneumatic, hydraulic, or magnetic
Implementation Method 4
The actuator may be manually operable, or may pneumatic, hydraulic, or magnetic
Implementation Method 5
In one particular version, the actuator comprises a solenoid
Data Source
AI summary
A re-entry device for recanalization of a vessel using a subintimal technique. A catheter (10) includes a first inner lumen (14) extending to a distal end portion (12b) of the catheter, the distal end portion including an angled tip (20) having a distal open end (20a). An elongated stylet (24) is located in the first inner lumen, the stylet having an angled distal end portion (24a) forming a needle. An actuator (26) at a proximal end portion (12a) of the catheter is for advancing the stylet from a retracted position within the catheter to a deployed position projecting from the distal open end of the angled tip for penetrating a wall of the vessel.