Catheter Suturing Device for PFO Closure Without Open Surgery
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Solution Overview
Problem
Existing methods for closing patent foramen ovale (PFO) are invasive and pose significant morbidity and mortality risks, while catheter-based procedures using expandable structures are prone to failure and dislodgment, necessitating a more reliable and secure closure device and method.
Innovation Solution
A suturing device with elongate body and movable arms, equipped with suture mounting portions and needles, is designed to percutaneously suture the PFO by extending clasp arms around the septum primum and secundum, engaging sutures, and drawing the septa closed using actuator-driven needles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open surgery is performed to ligate and close the PFO defect, then the closure is secure and reliable, but the procedure becomes highly invasive with substantial morbidity and mortality risks
Solution Approach 1:
A catheter-based suturing device serves as an intermediary tool, delivering needles and sutures through the vascular system to the PFO site without requiring open surgical access. The device includes an elongate body with hollow lumens that guide needles through the septal tissue, enabling secure closure while avoiding the invasiveness of open surgery.
Solution Approach 2:
The invention replaces the mechanical open surgical system with a catheter-based delivery system. Instead of external surgical instruments and direct visual access, the system uses flexible catheters navigable through blood vessels, with needles deployed through lumens in the catheter body to perform the suturing action remotely.
2Object-affected harmful factors
If catheter-based expandable structures are used to close the PFO, then the procedure is less invasive, but the structures may fail or become dislodged during the patient's life
Solution Approach 1:
The closure mechanism is segmented into multiple components: separate needles for piercing the septal tissue, sutures for creating the closing force, and a knot-tying mechanism for securing the closure. This segmentation allows each component to perform its specific function optimally, with the knot providing long-term stability unlike monolithic expandable structures.
Solution Approach 2:
The sutures are pre-positioned through the septal tissue using the catheter-delivered needles before the knot-tying action occurs. This preliminary placement ensures proper positioning and tension distribution, allowing the subsequent knot to secure a pre-established closure configuration that is less prone to dislodgment.
3Ease of operation
If a knot-tying device is integrated into the catheter system, then the suture application becomes more precise and controllable, but the device complexity increases
Solution Approach 1:
The knot-tying functionality is merged with the catheter delivery system. The actuator mechanisms for deploying needles, advancing sutures, and forming knots are integrated within the catheter body structure, sharing common lumens and actuation pathways. This merging reduces the need for separate devices while maintaining precise control over the suture application process.
Data Source
AI summary
Methods and apparatuses are disclosed for closing a patent foramen ovale. Some of the disclosed apparatuses include an elongate body having a proximal end and a distal end, with first and second suture clasp arms adapted to hold end portions of a suture when in an extended position. A first suture catch mechanism is slidably housed in the elongate body and moves in a proximal-to-distal direction to engage the suture end held by the first suture clasp arm, and a second suture catch mechanism is slidably housed in the elongate body and moves in a distal-to-proximal direction to suture end held by the second suture clasp arm. The first suture clasp arm can be positioned around the septum primum to deliver a suture thereto, and the second suture clasp arm can be positioned around the septum secundum to deliver a suture thereto.