Composite Tissue Repair Device with Porous Scaffold and Anchor
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Solution Overview
Problem
Current soft tissue repair methods, such as suturing, rely heavily on mechanical fixation and often fail due to poor tissue quality, vascular supply, and dynamic functional nature of repair sites, leading to high failure rates and complications, especially at the interface between host tissue and fixation devices.
Innovation Solution
A composite implantable tissue attachment device combining a mechanical reinforcing component with a cellular scaffold, providing enhanced load distribution and biological interaction through a wider surface area contact, which can be used for both mechanical repair and tissue augmentation in a single step procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple sutures and anchors are used to distribute load, then load distribution is improved, but device complexity and surgical time increase
Solution Approach 1:
The device is segmented into distinct functional zones: a porous body portion for tissue ingrowth and load distribution, and a non-porous anchor portion for secure fixation. This segmentation allows each zone to optimize its specific function while being part of a single integrated device, avoiding the need for multiple separate sutures and anchors.
Solution Approach 2:
The device combines materials with different porosity characteristics within a single structure. The porous body portion facilitates tissue ingrowth and distributes load, while the non-porous anchor portion provides stable mechanical fixation. This composite material approach resolves the contradiction by integrating multiple functional properties into one device rather than requiring multiple separate components.
2Reliability
If multiple sutures and anchors are used to maximize contact, then tissue contact is improved, but surgical time and complication risk increase
Solution Approach 1:
The device merges the functions of multiple sutures, anchors, and tissue augmentation materials into a single integrated implantable device. This combination allows the surgeon to deploy one device that simultaneously provides mechanical fixation, tissue contact, and biological augmentation, thereby reducing surgical time and the risk of complications associated with multiple separate procedures.
Solution Approach 2:
The device is designed to perform multiple functions simultaneously: mechanical anchoring, load distribution, tissue contact maximization, and biological augmentation. This multi-functionality eliminates the need for separate mechanical repair and tissue augmentation steps, directly addressing the time and complication issues while maintaining improved tissue contact.
3Strength
If strict mechanical fixation is used to restore anatomy, then mechanical function is restored, but biological healing is not facilitated
Solution Approach 1:
The device applies different material properties to different regions: the body portion is highly porous to maximize biological interaction and tissue ingrowth, while the anchor portion is non-porous to provide strong mechanical fixation. This local differentiation of material quality allows the device to simultaneously optimize both mechanical strength and biological healing in their respective zones.
Solution Approach 2:
The device uses composite materials with contrasting porosity characteristics to reconcile mechanical and biological requirements. The non-porous anchor material provides the necessary mechanical strength for fixation, while the porous body material facilitates biological healing through tissue ingrowth. This composite approach allows both mechanical fixation and biological healing to be optimized without compromise.
4Reliability
If tissue augmentation is performed separately after mechanical repair, then both mechanical and biological needs are met, but surgical time and complication risk increase
Solution Approach 1:
The device merges mechanical repair and tissue augmentation into a single integrated implantable unit. The mechanical anchor portion provides immediate structural support and fixation, while the porous body portion simultaneously serves as a scaffold for tissue regeneration and augmentation. This merging eliminates the need for separate mechanical repair and tissue augmentation procedures, directly reducing surgical time and complication risk while meeting both mechanical and biological needs.
Solution Approach 2:
The device is pre-configured with both mechanical fixation components and tissue augmentation components in a single integrated structure before implantation. This preliminary integration allows the surgeon to deploy both functions simultaneously in one step, rather than performing mechanical repair first and then separately adding tissue augmentation, thereby reducing surgical time and the risk of complications from multiple procedural steps.
Data Source
AI summary
Disclosed are composite implantable tissue attachment devices comprising a mechanical reinforcing component and a cellular scaffold component. Disclosed devices include a wide, relatively flat portion for supporting long term repair of tissue. Disclosed devices can include a tapered portion at the end of the wide portions that can lead into a narrower elongated extension for aiding in placement of the device during a surgical procedure. The wide portion of the device can provide tensile strength along the longitudinal axis of the device as well as porosity. The wide devices can cover a larger surface area of a delivery site than standard suture. Disclosed materials can be utilized in, e.g., soft tissue repair such as tendon and ligament reconstruction and repair.