Sternal Fusion Implant with Segmented Compression and Realignment
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Solution Overview
Problem
Conventional sternotomy procedures often result in non-union of sternal halves due to inadequate compression and realignment, leading to pain, infection, excessive bleeding, and prolonged recovery times.
Innovation Solution
A system comprising an at least partially synthetic implant with bone anchors and a bone clamp with a single-handed handle arrangement, used in conjunction with a cancellous bone manipulator tool, to securely fuse and compress two sections of bone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional sternotomy procedures are used to separate and rejoin sternal halves, then access to thoracic contents is achieved, but non-union of sternal halves occurs due to inadequate compression and realignment
Solution Approach 1:
The implant is divided into multiple segments including a compression member, realignment member, and stabilization member that can be independently positioned and secured. This segmentation allows each component to address specific aspects of sternal healing - compression for reducing gaps, realignment for proper positioning, and stabilization for maintaining the repair.
Solution Approach 2:
The implant components are designed and positioned before the surgical procedure is completed. The compression member is placed to pre-compress the sternal halves, the realignment member is positioned to pre-align the bone surfaces, and the stabilization member is installed to pre-stabilize the construct, ensuring proper conditions are established before final closure.
2Productivity
If inadequate compression is applied during sternotomy closure, then the procedure is simpler and faster, but motion between sternal halves occurs leading to pain and infection
Solution Approach 1:
The compression member is positioned and activated before final closure to pre-compress the sternal halves and eliminate gaps. This preliminary compression action prevents motion between bone surfaces during subsequent healing, eliminating pain and infection risk without requiring prolonged surgical time.
Solution Approach 2:
The implant components are designed to self-secure and self-maintain the compression and alignment forces throughout the healing process. The stabilization member and compression member work together to automatically maintain proper positioning without requiring external fixation or prolonged surgical intervention.
3Reliability
If proper compression and realignment are achieved using advanced implant systems, then bone fusion is successful, but device complexity increases
Solution Approach 1:
The complex function of achieving compression, realignment, and stabilization is divided into separate implant segments. Each component has a specific function - the compression member for applying force, the realignment member for positioning, and the stabilization member for maintaining the construct. This segmentation makes the system more manageable and easier to implement while achieving reliable bone fusion.
Solution Approach 2:
The implant system is designed as a multi-functional unit that can be adapted for different bone types and healing requirements. The same basic components can be used for sternal closure, spinal fusion, and other bone repair applications, making the complex device versatile and widely applicable across different surgical scenarios.
Data Source
AI summary
A system for fusing two sections of bone includes an implant, a bone clamp, and/or a cancellous bone manipulator tool. The implant, bone clamp, and cancellous bone manipulator tool can form an integrated medical kit. The implant has geometric protrusions extending from a first side and a second side to form bone anchors that mate with the cancellous tissue of the sections of bone. Additionally, the bone clamp has a single-handed handle arrangement for opening and closing the bone clamp with one hand. For instance, a first handle of the bone clamp extends from a shaft and a second handle of the bone clamp is spaced apart from the first handle and extends from a spring-loaded slider slidably coupled to the shaft. Upon compressing and securing the two sections of bone and the implant together, a carrier component can be introduced into the implant through a preformed port.