Vascular Closure Device with Controlled Hemostatic Agent Release
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Solution Overview
Problem
Current devices for achieving hemostasis at vascular puncture sites are either ineffective in highly anti-coagulated patients, cause tissue reactions, or suffer from complications due to uncontrolled injection of thrombogenic substances, and lack simplicity and reliability in application.
Innovation Solution
A device that uses an expansible member to occlude the puncture site and delivers chemical or biological agents to promote hemostasis, with a sealing member to control exposure and prevent blood contact, ensuring safe and controlled release of agents to accelerate the natural healing process without external pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If highly thrombogenic substances are injected to accelerate hemostasis, then hemostatic speed is improved, but safety deteriorates due to uncontrolled injection and risk of substance entry into bloodstream
Solution Approach 1:
A biocompatible matrix material serves as an intermediary carrier for thrombogenic substances. The matrix is delivered through a catheter to the puncture site, where it provides a controlled environment for hemostasis acceleration without direct injection risks. The matrix material confines the thrombogenic substances, preventing their uncontrolled entry into the bloodstream while still allowing them to accelerate clotting at the target site.
Solution Approach 2:
The biocompatible matrix employs porous material structure that allows controlled interaction with blood components. The porosity enables blood to penetrate the matrix and contact thrombogenic substances in a controlled manner, accelerating hemostasis while the matrix structure itself prevents uncontrolled dispersion of thrombogenic substances into the vascular system.
2Reliability
If foreign objects such as plugs, sutures, or staples are used to achieve hemostasis, then hemostatic effectiveness is improved, but tissue reaction and infection risk increase
Solution Approach 1:
The invention extracts and eliminates the need for permanent foreign objects like sutures and staples. Instead, it uses a temporary biocompatible matrix that delivers therapeutic agents and then degrades or is naturally expelled by the body. This removes the long-term foreign body burden while maintaining effective hemostasis during the critical healing period.
Solution Approach 2:
The biocompatible matrix is designed as a temporary, short-lived device that fulfills its hemostatic function and then degrades or is naturally eliminated by the body. This disposable approach avoids long-term tissue reactions and infection risks associated with permanent foreign objects, while still providing effective hemostasis when needed.
3Device complexity
If simple occlusion devices are used to seal puncture sites, then device simplicity is improved, but hemostatic speed deteriorates in highly anti-coagulated patients
Solution Approach 1:
The invention merges mechanical occlusion function with pharmacological acceleration into a single integrated device. The biocompatible matrix combines the physical barrier function of simple occlusion devices with embedded or associated thrombogenic substances that accelerate clotting. This combination maintains device simplicity while overcoming the slow hemostasis problem in anti-coagulated patients.
Solution Approach 2:
The biocompatible matrix utilizes composite material composition, combining biocompatible polymers or natural materials with thrombogenic substances. This composite structure provides both the mechanical occlusion properties of simple devices and the accelerated hemostatic effect of thrombogenic agents, resolving the contradiction between simplicity and effectiveness.
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
The device provides immediate and complete hemostasis, reducing bleeding, hematoma, thrombosis, and infection risks, while being safe and easy to apply, even in challenging conditions such as highly anti-coagulated patients.
Implementation Method 1
providing physical occlusion of the puncture site
Implementation Method 2
Blood within the vessel wall puncture and the tissue tract proximal to the puncture is exposed to a chemical and/or biological agent selected to promote hemostasis
Data Source
AI summary
Vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. A combination of the body's own natural mechanism with chemical and/or biological agents is relied upon to accelerate the hemostatic process. Included are steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A sealing member disposed proximal the expansible member is then displaced by retracting and tensioning a coil spring so as to expose a chemical and/or biological region or release region of the device. The retraction and tensioning of the coil spring is limited by a coupling member. Exposure of blood and tissue to the chemical and/or biological sealing member promotes the clotting processing to accelerate the occlusion process in the tract.