Vascular Closure Device Procoagulant Injection Sheath
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Solution Overview
Problem
Existing vascular closure devices require manual compression for several minutes after a procedure, which limits their effectiveness and increases procedure time, and may lead to complications like hematomas and pseudoaneurysms due to imperfect sealing.
Innovation Solution
A vascular closure device and method that involves inserting a sheath with a nozzle into a tissue tract adjacent to the vascular access site, injecting a procoagulant material to interact with blood, and using a positioning catheter to temporarily seal the site, eliminating the need for post-procedure pressure application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing vascular closure devices are used, then hemostasis can be achieved, but manual compression is required for several minutes which increases procedure time and may lead to complications
Solution Approach 1:
The procoagulant material is delivered to the vascular access site before complete hemostasis is achieved, initiating the clotting process in advance. This preliminary action allows the clot to form and stabilize during device removal, eliminating the need for prolonged manual compression and reducing overall procedure time while maintaining reliable hemostasis
Solution Approach 2:
A procoagulant material serves as an intermediary substance between the blood and the closure mechanism. This mediator accelerates the natural clotting process by providing coagulation factors directly at the arteriotomy site, enabling faster hemostasis without requiring extended manual compression time
2Reliability
If manual compression is applied for several minutes, then hemostasis is maintained, but this increases the risk of complications like hematomas and pseudoaneurysms
Solution Approach 1:
The procoagulant material acts as an intermediary that facilitates hemostasis through biochemical coagulation rather than mechanical compression. By delivering coagulation factors directly to the arteriotomy site, the system achieves reliable hemostasis while avoiding the tissue trauma and complications associated with prolonged manual compression
Solution Approach 2:
The invention replaces the mechanical compression system with a biochemical coagulation system. Instead of relying on external manual compression to achieve hemostasis, the procoagulant material initiates and accelerates the natural clotting cascade, substituting mechanical force with biochemical action to reduce tissue damage and complications
3Reliability
If procoagulant material is delivered close to the arteriotomy, then hemostis is enhanced, but device complexity increases
Solution Approach 1:
The sheath serves multiple functions: it provides access to the vascular site, delivers the procoagulant material, and facilitates device removal. By integrating the procoagulant delivery capability into the existing sheath structure, the invention enhances hemostasis without requiring separate complex delivery systems, thus minimizing the increase in device complexity
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 reduces the need for manual compression, enhances hemostasis by delivering procoagulant close to the arteriotomy, and minimizes vascular complications by forming an effective plug at the access site, thereby shortening procedure time and improving adhesion.
Implementation Method 1
injecting a procoagulant material into the tissue tract at a location adjacent to the vascular access site via the nozzle such that at least a portion of the procoagulant material begins to interact with blood in the tissue tract at the location
Data Source
AI summary
The present application discloses a device and methods for performing a vascular closure procedure that comprises inserting a sheath into a tissue tract defined in a body part and injecting a procoagulant material into the tissue tract adjacent a vascular access site via the sheath.