Percutaneous Suturing Device for Septal Defect Closure
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Solution Overview
Problem
Current devices and methods are inadequate for effectively suturing septal defects, such as patent foramen ovale, which can lead to blood shunting and increased risk of embolic stroke, particularly in patients prone to venous thrombosis.
Innovation Solution
A suturing device comprising two tissue engaging members connected by an interconnecting member, which is inserted through holes formed in overlapping tissue layers, allowing for percutaneous closure of septal defects, optionally using a tissue stabilization device and materials like collagen or bioabsorbable polylactic acid for tissue integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing methods are used for septal defects, then the procedure requires open surgery with high invasiveness, but patient recovery time and surgical risk increase
Solution Approach 1:
The patent replaces traditional mechanical open surgery with a percutaneous catheter-based delivery system. The suturing device is delivered through a catheter inserted via the femoral vein, eliminating the need for open chest surgery. The device uses a push-wire mechanism and controlled deployment system to position the sutures through the septal defect from the right atrium side, closing the PFO without direct surgical exposure of the heart.
Solution Approach 2:
The patent introduces a catheter as an intermediary delivery vehicle and a push-wire as an intermediary actuation mechanism. The catheter provides a safe percutaneous access route through the femoral vein to the heart, while the push-wire transmits force from the operator to deploy the suturing device at the precise location of the septal defect, enabling minimally invasive closure.
2Ease of operation
If percutaneous closure devices are used, then surgical invasiveness is reduced, but the ability to securely suture overlapping tissue layers is insufficient
Solution Approach 1:
The suturing device is segmented into multiple independent components: a first suture for capturing the septum primum, a second suture for capturing the septum secundum, and an interconnecting member joining them. This segmentation allows each suture to independently engage its respective tissue layer, providing secure capture of both overlapping septal structures while maintaining percutaneous delivery capability.
Solution Approach 2:
The device incorporates dynamic deployment mechanisms where sutures are progressively released and tensioned during the procedure. The push-wire system allows dynamic adjustment of suture positioning and tensioning to optimize capture of the overlapping septal tissues, adapting to the specific anatomy encountered during the procedure.
Data Source
AI summary
The invention relates to devices, systems, and methods for percutaneously suturing biological material, such as a patient's tissues. In one embodiment, a suturing device includes first and second tissue engaging members connected to one another by a first interconnecting member. In another embodiment, systems and methods are provided for forming holes through two overlapping layers of tissue. Subsequent to forming holes through the two layers of tissue, the suturing device is positioned through the holes to join or bring into contact the two layers of overlapping tissue.