Collagen Vascular Puncture Sealing Device
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Solution Overview
Problem
Current methods for controlling bleeding after vascular procedures, such as external pressure, are inefficient, uncomfortable for patients, and require extensive hospital resources, and existing devices for sealing punctures often fail to consistently and quickly close wounds, risking prolonged bleeding and infection.
Innovation Solution
A medical device featuring a structural member with biodegradable components and a sealing material made from reconstituted or naturally-derived collagenous material, which expands to seal punctures by deploying a rod with obstructing bodies that secure on both inner and outer vessel surfaces, ensuring effective hemostasis and tissue ingrowth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If external pressure is applied to control bleeding, then bleeding is controlled, but patient comfort deteriorates and blood flow may be excessively restricted
Solution Approach 1:
The invention extracts the function of bleeding control from external pressure application and relocates it to an implanted device (sealing member) that provides hemostasis internally through physical occlusion and tissue ingrowth, thereby eliminating the need for uncomfortable external compression while maintaining reliable bleeding control
Solution Approach 2:
The sealing member acts as an intermediary device between the puncture site and the external environment, providing a mechanical barrier that prevents blood leakage without requiring direct external pressure on the patient's body, thus resolving the contradiction between effective hemostasis and patient comfort
2Reliability
If external pressure techniques are used, then bleeding is controlled, but patient mobility is restricted and monitoring requirements increase
Solution Approach 1:
The sealing member is designed to be self-sustaining, providing continuous hemostasis through its structural integrity and promoting tissue ingrowth to seal the puncture site autonomously, thereby eliminating the need for continuous external monitoring and intervention while maintaining reliable bleeding control
Solution Approach 2:
The device provides more than sufficient occlusion of the puncture site through its design features (obstructing bodies, sealing material), ensuring complete hemostasis without requiring additional external pressure or monitoring measures, thus reducing overall system complexity
3Reliability
If natural clot formation is used to seal puncture, then sealing occurs, but time required is prolonged (30-90 minutes)
Solution Approach 1:
The sealing member is pre-positioned at the puncture site before withdrawal of the catheter or introducer, creating an immediate mechanical barrier that prevents blood leakage from the outset, thereby eliminating the prolonged waiting period required for natural clot formation while ensuring reliable puncture sealing
Solution Approach 2:
The device skips the slow natural clotting process by providing immediate mechanical occlusion of the puncture site, rushing through the critical period where bleeding could occur, and achieving reliable sealing in a fraction of the time required for natural clot formation
4Reliability
If plug devices are used to block puncture, then sealing is achieved, but risk of introducing infectious organisms into circulatory system increases
Solution Approach 1:
The sealing member creates a copy or replica of the natural vessel wall structure through its porous biocompatible material that promotes tissue ingrowth, forming an integrated seal that prevents infection without requiring foreign plug materials that could introduce pathogens, thereby maintaining reliable sealing while minimizing infection risk
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 rapidly and reliably seals vascular punctures, reducing bleeding time, minimizing the need for external pressure, and preventing infection by maintaining structural support and promoting tissue healing, even in hypertensive or anticoagulated patients.
Implementation Method 1
When the plug is exposed to body fluids, it swells to block the wound in the vessel wall
Implementation Method 2
The first obstructing body is affixed against an inner surface of the wall of the blood vessel or body cavity and the second obstructing body is affixed against an outer surface of the wall of the blood vessel or body cavity
Data Source
AI summary
The invention is generally directed to devices and methods for sealing a puncture or an opening through a wall of a blood vessel or a body cavity. The device includes a structural member and a sealing material associated with the structural member. The structural member includes a rod, a first obstructing body and a second obstructing body. The first obstructing body is affixed against an inner surface of the wall of the blood vessel or body cavity and the second obstructing body is affixed against an outer surface of the wall of the blood vessel or body cavity once placed at the puncture or the opening. The sealing material includes a reconstituted or naturally-derived collagenous material, which can expand at the puncture or the opening to restore hemostasis and enhance sealing.