Rotating Catheter Tissue Closure for Large Vessel Punctures
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Solution Overview
Problem
Existing suture-based devices for closing vessel punctures are limited by the need for multiple instruments, increased risk of bacterial contamination, and complexity in deploying sutures, especially for large punctures and emergency procedures, with pre-tied knots complicating delivery and increasing infection risk.
Innovation Solution
A single-device system with a catheter having a distal and proximal segment that rotates relative to each other, featuring a handle with actuation mechanisms for needle deployment and suture tensioning, allowing suture loops to be deployed without pre-close techniques, and a securement anchor to tighten sutures without knots, minimizing exposure and infection risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple instruments are used to close large puncture sites, then closure effectiveness is improved, but device complexity and procedural time increase
Solution Approach 1:
The patent combines multiple closure functions (puncture, suture deployment, tissue approximation, and hemostasis) into a single integrated device. The delivery catheter system incorporates needle members, suture members, and actuation mechanisms all in one unit, eliminating the need for separate instruments for each step of the closure process while maintaining effective closure of large puncture sites
Solution Approach 2:
The single device performs multiple functions: it creates the puncture, deploys sutures, approximates tissue edges, and achieves hemostasis. The delivery catheter can be used for both small and large puncture sites, and the suture mechanism can accommodate different suture configurations (simple loops, figure-of-eight patterns) making it a universal solution for various closure needs
2Ease of operation
If pre-tied knots are used for suture securement, then tissue closure is simplified, but infection risk increases due to larger surface area exposure
Solution Approach 1:
The patent extracts the knot-tying function from the suture material itself and replaces it with a mechanical securement mechanism. The suture members are deployed as simple loops or configurations without pre-tied knots, and the distal catheter segment provides the mechanical means for securement, thereby removing the large surface area knots that pose infection risks
Solution Approach 2:
The suture members are designed to be minimal in surface area and can be disposable or single-use configurations. The suture material itself is kept to the essential minimum required for function, reducing the window for bacterial contamination while maintaining adequate tissue securement
3Ease of operation
If sutures are placed before procedure expansion (pre-close technique), then closure timing is simplified, but flexibility in emergency procedures is reduced
Solution Approach 1:
The device is designed to be dynamically deployable at any stage of the procedure. The delivery catheter can be introduced through the puncture site regardless of whether the site has been expanded or not, and the suture deployment mechanism can be activated at any time. This dynamic capability allows the same device to adapt to both planned non-emergency procedures and urgent emergency situations without requiring pre-close techniques
4Ease of operation
If device is introduced through puncture site into vessel, then percutaneous access is achieved, but device deployment may be hindered by vessel size constraints
Solution Approach 1:
The device employs a nested structure where the needle members, suture members, and actuation mechanisms are all contained within the delivery catheter. The distal catheter segment can be introduced through the puncture site and into the vessel, with all functional components nested within it. This nested design allows the entire closure system to pass through relatively small access points and be deployed within vessels of various sizes
Solution Approach 2:
The delivery catheter is segmented into a proximal segment (outside the vessel) and a distal segment (inside the vessel), with the ability to rotate relative to each other. This segmentation allows the device to navigate through the puncture site and adapt to different vessel orientations and sizes, with each segment optimized for its specific location and function
Data Source
AI summary
Tissue closure systems are disclosed wherein one variation generally includes a handle, a proximal catheter segment extending from the handle, a deployment segment coupled to the proximal catheter segment, and a distal catheter segment pivotably coupled to the deployment segment such that the distal catheter segment is rotatable at an angle relative to the proximal catheter segment. A receiver member positioned within the deployment segment is configurable between a low-profile configuration and a deployed configuration. Two or more forward needle members and two or more rear needle members are extendable distally from a first side and a second side of the proximal catheter segment. The two or more forward needle members are receivable into the two or more openings along the first receiver portion and the two or more rear needle members are receivable into the two or more openings along the second receiver portion.