Drug-eluting vascular closure device with collagen matrix
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Solution Overview
Problem
Current devices for achieving hemostasis at vascular puncture sites are either ineffective, cause tissue reactions, or require external foreign objects, and are slow in highly anti-coagulated patients, with existing methods being technique-dependent and potentially leading to complications.
Innovation Solution
A drug-eluting, self-tensioning closure device that utilizes the body's natural healing mechanism by integrating a bio-chemical sealing member and tensioning element to safely and controlledly release biochemical agents into the tissue tract, preventing entry into the bloodstream and ensuring complete hemostasis without foreign objects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external foreign objects such as plugs, sutures, or staples are used to seal the puncture site, then hemostasis is achieved, but tissue reaction, inflammation, and/or infection may occur
Solution Approach 1:
The invention extracts and removes the foreign object component from the hemostasis mechanism. Instead of leaving plugs, sutures, or staples in the body, the device uses a self-dissolving collagen matrix that provides structural support during healing then naturally degrades and is absorbed by the body, eliminating foreign body reactions while maintaining reliable hemostasis
Solution Approach 2:
The collagen matrix serves as a temporary intermediary substance that facilitates hemostasis during the critical healing period. It provides a scaffold for clot formation and tissue repair, then gradually dissolves and is absorbed by the body, acting as a transient mediator rather than a permanent foreign object
2Object-affected harmful factors
If devices use the body's own natural mechanism to achieve hemostasis without foreign objects, then tissue reaction and infection are reduced, but the hemostatic process becomes slow, particularly in highly anti-coagulated patients
Solution Approach 1:
The device performs preliminary action by pre-loading the collagen matrix with concentrated thrombin and/or fibrinogen before insertion. These clot-promoting substances are prepared in advance within the matrix structure, ready to be delivered immediately upon deployment at the puncture site, accelerating the natural hemostatic process without requiring foreign objects
Solution Approach 2:
The invention changes the concentration and availability parameters of clot-promoting substances by incorporating high concentrations of thrombin and/or fibrinogen directly into the collagen matrix. This localized concentration enhancement speeds up the coagulation cascade and hemostatic process, overcoming the slowness of natural mechanisms in anti-coagulated patients
3Productivity
If highly thrombogenic substances are injected to accelerate hemostasis, then the hemostatic process is sped up, but severe complications may occur due to uncontrolled injection and potential entry of substances into the bloodstream
Solution Approach 1:
The invention extracts the injection step entirely from the procedure. Instead of requiring manual injection of thrombogenic substances, the pre-loaded collagen matrix with embedded clot-promoting agents is simply deployed into position, where it automatically releases the substances in a controlled manner without needle injection, eliminating injection-related complications
Solution Approach 2:
The collagen matrix acts as an intermediary delivery system that controls the release of thrombin and/or fibrinogen. It provides a controlled release mechanism through diffusion and degradation, preventing the uncontrolled injection of highly thrombogenic substances while still achieving accelerated hemostasis
4Reliability
If manual compression is used to close the puncture site, then hemostasis can be achieved, but it requires continuous user intervention and is time-consuming
Solution Approach 1:
The device enables self-service hemostasis by providing a self-expanding collagen matrix that automatically deploys and maintains compression at the puncture site. The matrix self-regulates the hemostatic process through its structural integrity and embedded clot-promoting substances, eliminating the need for continuous manual compression and user intervention while maintaining reliable hemostasis
Data Source
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Figure 3~4
Figure 5A~5B
AI summary
Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with bio-chemical agents to accelerate the hemostatic process. One method includes the 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 bio-chemical sealing member disposed proximal the expansible member is then displaced so as to expose a bio-chemical region or release region of the device. At least one bio-chemical agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.