Spiral Needle Suturing Device for Transcatheter Heart Apex Closure
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Solution Overview
Problem
Current medical suturing devices are not suitable for use in conjunction with transcatheter procedures, specifically for closing openings formed in the heart apex during prosthetic valve implantation, requiring separate procedures and increasing risks, costs, and recovery time.
Innovation Solution
A suturing device comprising a spiral needle with a hollow central core and a guide wire with a suture eye, driven by a catheter to create a spiral passageway and deliver suture thread for closure, allowing for seamless integration with transcatheter procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing devices are used to close openings in the heart apex, then the opening can be closed, but a separate surgical procedure is required, increasing risk, cost, and recovery time
Solution Approach 1:
The patent combines the suturing function with the transcatheter valve implantation procedure by delivering the spiral needle through the same catheter system. The spiral needle is advanced through the catheter to the heart apex, allowing suture placement during the same procedure without requiring separate surgical intervention, thereby reducing overall procedural risk and recovery time
Solution Approach 2:
The catheter system is designed to perform multiple functions: delivering the prosthetic valve and subsequently delivering the spiral needle for suturing. This multi-functional approach eliminates the need for separate specialized equipment and procedures, integrating two previously separate interventions into one unified process
2Reliability
If a separate surgical procedure is performed to close the heart apex opening, then the opening is closed, but the procedure complexity and cost increase
Solution Approach 1:
The suturing device is integrated into the existing transcatheter valve implantation system, using the same delivery catheter pathway. This merging of functions reduces procedural complexity by eliminating the need for separate surgical teams, equipment setups, and procedural steps while maintaining effective closure
3Strength
If conventional suturing methods are used, then the opening can be closed, but additional procedures are required beyond valve implantation
Solution Approach 1:
The spiral needle is pre-loaded into the delivery catheter system before the valve implantation procedure begins. This preliminary preparation allows the suturing function to be immediately available during the procedure without requiring additional setup or equipment introduction, thereby maintaining suture strength while improving procedural efficiency
Solution Approach 2:
The catheter remains in place throughout both the valve implantation and suturing procedures, providing continuous access to the heart apex. This continuity eliminates the need to withdraw and re-introduce equipment, maintaining procedural efficiency while ensuring proper suture placement for effective closure
Data Source
AI summary
A suturing device for use with a delivery catheter in a transcatheter procedure, for closing an opening formed in the body. Comprising a spiral needle having a central core, a proximal end, and a distal end. The distal end terminates in a sharp point for cutting a spiral passageway through body tissue surrounding the opening that is to be closed. The device includes a guide wire having a suture eye at one end for receiving suture thread after the guide wire has been advanced through the hollow central core of the spiral needle. The device includes driving means, for advancing and retracting of the spiral needle and guide wire with respect to the catheter, and for connecting between the suture thread and the suture eye of the guide wire. The invention also relates to a method for closing an opening formed in the body using a transcatheter procedure.