Self-orientating Suture Closure Device for Vascular Opening Detection
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Solution Overview
Problem
Current vascular closure techniques lack the ability to determine the orientation of a vascular opening, which is crucial for selecting the appropriate closure method, leading to potential complications such as ischemia, thrombosis, and renewed bleeding.
Innovation Solution
A device comprising a collapsible foot and shaft system that expands within the vessel to indicate the orientation of the opening through a rotating mechanism, allowing the physician to determine if the opening is on the top, left, or right side, facilitating the choice of appropriate closure techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure is applied to achieve hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires prolonged patient immobility
Solution Approach 1:
The device performs preliminary orientation detection and classification of the vascular opening before hemostasis is applied. The collapsible foot is expanded and rotated to determine opening orientation (top, left, or right side) prior to deploying the closure mechanism, allowing the physician to select the appropriate hemostasis technique in advance, thereby reducing overall procedure time
Solution Approach 2:
The collapsible foot automatically rotates to align with the vascular opening orientation when pulled back into the catheter. This self-orientating mechanism eliminates the need for manual manipulation to determine opening position, providing automatic orientation detection that speeds up the procedure
2Reliability
If mechanical clamps are used to apply pressure, then hemostasis is achieved, but patient comfort deteriorates and analgesics are frequently required
Solution Approach 1:
The device determines the orientation of the vascular opening (top, left, or right side) before applying any pressure or closure mechanism. This preliminary orientation detection allows the physician to select the most appropriate and least invasive closure technique for the specific opening position, thereby minimizing patient discomfort while achieving reliable hemostasis
3Adaptability or versatility
If larger sheath sizes are used for interventional procedures, then procedural capability is improved, but the risk of complications increases
Solution Approach 1:
The device performs preliminary orientation detection and classification of the vascular opening created by larger sheaths. By determining whether the opening is on the top, left, or right side of the vessel before closure, the system enables selection of the most appropriate closure technique, thereby reducing complications such as ischemia, thrombosis, and renewed bleeding that are more common with larger sheath sizes
Solution Approach 2:
The rotation of the collapsible foot provides visual feedback to the physician about the opening orientation through markings on the catheter. This feedback mechanism allows real-time adjustment of the closure approach based on the detected orientation, reducing the risk of complications associated with larger sheath sizes
4Manufacturing precision
If suturing procedures are performed through a catheter, then closure precision is improved, but the difficulty of operation increases
Solution Approach 1:
The device performs preliminary orientation detection and classification of the vascular opening (top, left, or right side) before any suturing is attempted. This advance knowledge of opening orientation allows the physician to select the most appropriate suturing technique and approach, thereby maintaining high closure precision while reducing operational difficulty
Solution Approach 2:
The collapsible foot acts as an intermediary mechanism that translates the three-dimensional orientation of the vascular opening into a readable indication on the catheter. This intermediary provides the physician with clear orientation information, making the complex task of catheter-based suturing more manageable and precise
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 accurate determination of the vascular opening orientation, reducing complications by allowing for the appropriate closure method to be employed, thereby improving hemostasis and reducing the risk of adverse events.
Implementation Method 1
The wire comprises a first proximal end connected to a first shaft section connected to the foot that is connected to a second shaft section terminating at a second proximal end. The foot may be pushed distally out of the tube and through the opening in the vessel where it expands.
Data Source
AI summary
A device is disclosed for providing an indication as to the relative position of a vessel or artery opening thereby facilitating the choice of which several closure techniques to use. A disclosed device includes an outer tube and a collapsible foot slidably disposed within a distal end of the outer tube. The device may further include one or more threaded suture needles, a biodegradable plug or other wound closing device that is connected to another shaft. The collapsed or folded foot is pushed distally out of the tube and through the opening in the vessel whereupon the foot expands. Pulling the expanded foot in the proximal direction provides an indication as to the orientation of the opening in the vessel, which assists in determining the type of closing procedure to be carried out.