Vessel Wall Puncture Closure Using Anchored Sutures
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Solution Overview
Problem
Current methods for achieving hemostasis after vascular procedures, such as manual compression and bioabsorbable fasteners, are inefficient, uncomfortable for patients, and prone to complications like hematoma, pseudo-aneurysm formation, and vascular occlusion, especially in larger sheath sizes or anticoagulated patients.
Innovation Solution
A device and method for deploying sutures through a vessel wall using needles with hooks that anchor to the vessel wall, allowing for twisting of the sutures to close the puncture, with a closure device providing constant tensioning force to ensure secure closure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compression is used to achieve hemostasis, then bleeding is stopped, but the procedure is time-consuming and requires prolonged patient recumbency
Solution Approach 1:
The closure device is positioned and prepared within the vessel before the actual closure action is performed. The needles are advanced through the vessel wall in advance, and the suture is pre-positioned, allowing rapid closure when the trigger is activated, thus reducing the time required for hemostasis while maintaining reliability
2Reliability
If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient discomfort increases and analgesics are frequently required
Solution Approach 1:
The invention replaces the mechanical compression system (manual pressure application) with a biological sealing system. The seal element (collagen matrix with embedded fasteners) provides hemostasis through material properties rather than sustained mechanical force, eliminating the need for prolonged compression and associated patient discomfort
3Reliability
If excessive compression pressure is applied to ensure hemostasis, then bleeding stops, but vascular occlusion and thrombosis can occur
Solution Approach 1:
The invention substitutes mechanical compression with a material-based sealing approach. The compressible seal element is positioned against the puncture site and provides hemostasis through its material properties and controlled compression by the deployment device, rather than sustained high-pressure manual compression, thereby avoiding vascular occlusion and thrombosis
Solution Approach 2:
The invention changes the parameter of compression from sustained high pressure (manual compression) to controlled, localized compression applied by the deployment device. The compression force is applied only to the seal element at the puncture site, not to the entire vessel, maintaining hemostasis while preventing vascular occlusion
4Reliability
If bioabsorbable fasteners are placed at the superficial arterial wall to stop bleeding, then hemostasis is achieved, but the procedure is difficult to locate properly and may cause complications
Solution Approach 1:
The deployment device integrates multiple functions: it positions the seal element, delivers the fasteners, and provides controlled compression, all through a single integrated system. This multi-functionality ensures proper placement accuracy while simplifying the overall procedure compared to separate steps for each function
Solution Approach 2:
The deployment device acts as an intermediary between the operator and the fasteners. It provides precise positioning and controlled delivery of the fasteners to the puncture site, eliminating the difficulty of manual placement and ensuring accurate positioning for reliable hemostasis
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
This approach provides rapid, reliable, and efficient vascular closure with reduced risk of complications, minimizing patient discomfort and blood loss, while maintaining normal blood flow and vessel integrity.
Implementation Method 1
hooks coupled to each of the distal ends of each wire, each hook being configured to anchor the wire to an interior portion of the vessel wall
Implementation Method 2
allowing for twisting of the sutures to close the puncture
Implementation Method 3
closure device providing constant tensioning force to ensure secure closure
Data Source
AI summary
A device is provided herein for deploying a suture in a puncture through a vessel wall of a blood vessel, the puncture disposed within a tissue tract of a patient body. The device includes a shaft suitable for insertion along the tissue tract and into the vessel through a puncture, a plurality of needles, each needle having a proximal end and a distal end suitable for forming a needle path through the vessel wall, wires associated with each needle, each wire having a distal end and a proximal end, and hooks coupled to each of the distal ends of each wire, each hook being configured to anchor the wire to an interior portion of the vessel wall.