Bioadhesive Wound Closure Device for Cardiac Puncture Sealing
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Solution Overview
Problem
Minimally invasive cardiac procedures, such as cardiac valve repair or replacement, often result in prolonged recovery times and complications due to vascular access issues, particularly in patients with peripheral vascular disease, as existing sealing methods are inadequate for quickly and effectively closing access openings in the heart.
Innovation Solution
The development of wound closure devices and systems that include a collagen-based or biodegradable polymer shaft with a bioadhesive cap and a self-expandable stent frame, which can be deployed within the heart to secure the closure device and promote tissue growth, along with a bioadhesive for enhanced sealing and healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a median sternotomy is performed to access the interior of the heart, then access to the heart is achieved, but recovery time is prolonged and complications increase
Solution Approach 1:
The closure device is divided into multiple functional sections: a shaft section for insertion through the puncture wound, a cap section for sealing the distal end, and an anchor section for securing to the heart wall. This segmentation allows the device to achieve effective closure through a minimally invasive puncture approach rather than requiring a median sternotomy, thereby reducing recovery time while maintaining access capability during the procedure.
Solution Approach 2:
The closure device acts as an intermediary mechanism between the puncture wound and the heart interior. It seals the access opening created during minimally invasive procedures, preventing blood loss and facilitating rapid closure without requiring the more invasive median sternotomy approach, thus reducing recovery time while maintaining procedural access.
2Object-affected harmful factors
If a minimally invasive introducer is used to access the heart, then surgical trauma is reduced, but sealing of the access opening becomes more challenging
Solution Approach 1:
The closure device incorporates composite material structures combining a shaft portion made of biocompatible material (such as silicone or polyurethane) with a cap portion containing bioadhesive properties. This composite construction ensures effective sealing of the access opening while maintaining the minimally invasive approach, thereby preserving reduced surgical trauma while enhancing sealing reliability through the bioadhesive cap that forms a secure seal against the heart tissue.
Solution Approach 2:
The device replaces purely mechanical sealing methods with a combination of mechanical anchoring and biochemical adhesion. The cap section incorporates bioadhesive properties that chemically bond to heart tissue, providing more reliable sealing than mechanical methods alone, thus maintaining the benefits of minimally invasive surgery while improving sealing effectiveness through biochemical attachment mechanisms.
3Reliability
If existing sealing methods are used to close puncture wounds, then closure is achieved, but the process is too slow and inadequate for patients with peripheral vascular disease
Solution Approach 1:
The closure device is pre-configured with bioadhesive properties in the cap section before insertion. This preliminary preparation of the sealing mechanism allows for rapid and effective closure of the puncture wound, as the bioadhesive is already positioned to immediately bond with heart tissue upon deployment, eliminating the need for time-consuming sealing procedures and providing rapid closure essential for patients with peripheral vascular disease.
Solution Approach 2:
The device utilizes changes in the physical and chemical parameters of the bioadhesive material to achieve rapid sealing. The bioadhesive cap section is designed to undergo phase changes or chemical reactions upon contact with heart tissue, transforming from a pre-positioned state to an actively bonding state, thereby accelerating the closure process and providing rapid, effective sealing for patients requiring quick recovery.
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
These devices and systems minimize blood loss and reduce recovery time by effectively sealing puncture wounds within the heart, facilitating quicker healing and reducing the risk of complications associated with vascular access.
Implementation Method 1
The first section may be formed from a material that is configured to promote tissue growth. In an embodiment, the first material may be a collagen-based material, a gelatin (e.g., porcine gelatin), or a polymer, e.g., a fibrous, resorbable, and/or non-thrombongenic polymer.
Implementation Method 2
a wound closure device may include a first section, e.g., an elongated shaft, and a second section, e.g., a cap, positioned at a distal end of the first section
Data Source
AI summary
Wound closure devices, systems, and methods may be used to close an opening, such as a puncture wound or incision, formed in tissue, such as heart tissue. A wound closure device may be configured and adapted to be placed within the puncture wound or incision to close and/or seal the puncture wound or incision. A bioadhesive may be used to strengthen the closure and/or seal of the puncture wound after placement of the wound closure device relative to the puncture wound.