Spinal Implant Cage and Staple for Vertebral Alignment Correction
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Solution Overview
Problem
Current spinal implant technologies fail to effectively address chronic trauma and fractures resulting in collapsed vertebrae and intervertebral discs, leading to back and leg pain, as they often result in poor outcomes, higher reoperation rates, and adjacent level disease due to inadequate stabilization and alignment correction.
Innovation Solution
An orthopedic implant system comprising a cage and a staple with a slidable and pivotable design, allowing for secure anchoring to vertebral bodies with a compression force, and an anchor frame that conforms to the bone surface, enabling precise alignment and stabilization to restore foraminal height and correct sagittal and coronal deformities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional spinal implant technologies are used, then the procedure can be performed with existing devices, but the outcomes are poor with higher reoperation rates and adjacent level disease due to inadequate stabilization and alignment correction
Solution Approach 1:
The staple is designed with a slidable shaft that can move longitudinally within the cage, allowing dynamic adjustment of the anchoring force and position. This enables the implant to adapt to varying bone densities and anatomical configurations, providing optimized stabilization without compromising reliability
Solution Approach 2:
The implant system is divided into distinct functional components: the cage for structural support, the staple for anchoring, the shaft for adjustment, and the head for bone engagement. This segmentation allows each component to be optimized independently for its specific function, improving overall stabilization and alignment correction capabilities
2Manufacturing precision
If the staple is fixed in position, then the structure is simple, but the alignment precision and adaptability to bone surface variations are insufficient
Solution Approach 1:
The slidable shaft allows the staple head to be positioned at different locations along the shaft's length, enabling precise alignment with the bone surface. The shaft can slide longitudinally to accommodate variations in bone anatomy while maintaining a relatively simple overall structure
Solution Approach 2:
The staple is pre-configured with the shaft in a retracted position that allows easy insertion through the cage. Once in place, the shaft can be extended to achieve precise alignment. This preliminary configuration simplifies the implantation process while maintaining alignment precision
3Adaptability or versatility
If the anchor frame is rigid and fixed, then the manufacturing is easier, but the ability to conform to bone surface variations is limited
Solution Approach 1:
The anchor frame incorporates a pivotable connection that allows it to rotate and conform to the curved surface of the vertebral body. This dynamic adaptation capability enables the frame to match anatomical variations without requiring complex custom manufacturing for each patient
Solution Approach 2:
The pivotable connection merges the anchor frame with the cage through a rotational joint, combining the structural integrity of a rigid frame with the adaptability of a movable connection. This achieves bone surface conformance while maintaining manufacturing simplicity
4Ease of operation
If decompression without fusion is performed, then the surgical intervention is minimal, but the risk of deformity progression and reoperation increases due to failure to address facet joint subluxation and disc collapse
Solution Approach 1:
The implant system performs preliminary stabilization by securing the cage and staple to the vertebral body before fusion occurs. This preliminary action addresses facet joint subluxation and prevents deformity progression early in the treatment process, maintaining reliability while keeping the initial surgery minimally invasive
Solution Approach 2:
The cage acts as an intermediary structure that provides immediate structural support and alignment correction while fusion is developing. This mediator maintains spinal integrity and prevents deformity progression during the healing period, bridging the gap between minimal surgery and reliable long-term stabilization
Data Source
AI summary
An implant system comprising a staple and a cage is disclosed. The implant system is secured to the bone by moving the staple rotationally and longitudinally whereby tines of the staple and opposing tines frictionally and mechanically engage or embed themselves in the bone side walls. For vertebral applications, the cage defines an upper surface plane, a lower surface plane and a cage surface angle between these two planes whereby the cage surface angle may alter an endplate surface plane of one or more vertebral body when the cage is implanted in a vertebral body. Implant systems may be configured for use as an interbody or intrabody implant system. The implant system may also be configured for use in arthrodesis procedures with other joints within the body. The implant system may further comprise an anchor frame or plate to further secure the cage and staple to the anatomy.