Porous Sternal Implant Scaffold for Compression and Hemostasis
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Solution Overview
Problem
Conventional sternotomy procedures often result in non-union, excessive bleeding, prolonged recovery, and increased risk of infection due to inadequate compression and alignment of sternal sections, leading to complications such as dehiscence, pain, and prolonged hospital stays.
Innovation Solution
A bone implant system comprising an inner and outer layer, optionally with tacks, designed to be placed between sternal sections to provide compression, promote bone fusion, and include cellular growth factors to accelerate healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sternotomy closure methods are used, then surgical access is achieved, but inadequate compression and alignment of sternal sections result in non-union and dehiscence
Solution Approach 1:
The implant serves as an intermediary device placed between the two sternal sections to facilitate proper alignment and compression. The implant includes alignment features such as guide pins or registration pins that engage with corresponding features in the sternal sections, ensuring precise positioning. The implant also provides a compression surface that distributes force evenly across the sternal interface, promoting reliable union while maintaining precise alignment during the healing process.
2Reliability
If conventional sternotomy closure methods are used, then surgical access is achieved, but excessive bleeding occurs from the sternal edge
Solution Approach 1:
The implant acts as an intermediary barrier between the surgical site and the external environment, providing a hemostatic function. The implant material includes hemostatic agents or features that promote clotting and reduce bleeding from the sternal edge. By placing the implant at the interface, it applies direct pressure to bleeding vessels and provides a matrix for clot formation, thereby reducing blood loss while maintaining the surgical access achieved through sternotomy.
3Reliability
If conventional sternotomy closure methods are used, then surgical access is achieved, but fibrous scar tissue forms instead of new bone
Solution Approach 1:
The implant modifies the local biological and mechanical parameters at the sternal interface to promote osteogenesis. The implant material is designed with osteoconductive properties, providing a scaffold that encourages bone cell growth and differentiation. The implant also maintains optimal compression forces and spacing that favor bone formation over fibrous tissue development. By controlling these parameters—mechanical stress, material composition, and spatial configuration—the implant directs the healing process toward new bone formation rather than scar tissue formation.
4Productivity
If conventional sternotomy closure methods are used, then surgical access is achieved, but prolonged hospital stays and extended intubation periods result
Solution Approach 1:
The implant performs preliminary actions to prevent complications before they occur during the postoperative period. By providing stable alignment, compression, and hemostasis immediately after surgery, the implant creates optimal conditions for rapid healing. This preliminary stabilization prevents dehiscence, reduces bleeding complications, and minimizes pain, thereby accelerating recovery and reducing the need for prolonged hospitalization and intubation.
5Ease of operation
If conventional sternotomy closure methods are used, then surgical access is achieved, but significant post-operative pain occurs due to sternal motion
Solution Approach 1:
The implant serves as a mediator that stabilizes the sternal sections during the healing process, reducing motion between the two halves. The implant includes friction surfaces, interlocking features, or compression mechanisms that minimize micromotion and gross movement at the sternal interface. By reducing sternal motion, the implant decreases mechanical irritation of surrounding tissues and nerves, thereby significantly reducing post-operative pain while maintaining the necessary stability for healing.
Data Source
AI summary
A synthetic implant is provided that is operable to be disposed between and fuse two sections of a bone. The synthetic implant includes a synthetic material that is operable to abut against the two sections of the bone. The synthetic material is porous and/or fibrous and is operable to receive at least one cellular growth factor. The synthetic material can be combined with other synthetic materials or human bone tissue or animal bone tissue or other human or animal tissue that is suitable to act as a platform or scaffold on which new bone can grow or to cause bone to fuse together.