Interspinous Implant with Deployable Anchors for Spinal Stabilization
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Solution Overview
Problem
Current interspinous process implants for treating lumbar spinal stenosis lack effective stabilization and long-term migration resistance, and require invasive procedures for placement.
Innovation Solution
A spinal implant with a threaded elongated body and distal anchor, featuring a tapered head with radially deployable blades and a proximal anchor for longitudinal movement, designed for percutaneous insertion to distract and stabilize adjacent spinous processes, utilizing threads and pleats for engagement and stabilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an implant is placed in a minimally invasive surgical procedure, then the ease of operation is improved, but the stability of the implant deteriorates causing migration over time
Solution Approach 1:
The implant incorporates a proximal anchor that can move longitudinally along the body between a first position spaced apart from the head and a second position approximated with the head. This dynamic adjustment capability allows the implant to be inserted minimally invasively and then adjusted to achieve stable compression of the spinous processes, resolving the contradiction between ease of placement and long-term stability.
Solution Approach 2:
The implant uses self-engaging features including a distal anchor with radially deployable blades that engage the distal surface of the spinous process, and a proximal anchor with spikes that engage the proximal surface. These self-service anchoring mechanisms provide stable fixation without requiring additional invasive surgical steps, allowing minimally invasive placement while achieving reliable stability.
2Device complexity
If an implant is designed without stabilization features, then the device complexity is reduced, but the reliability of the implant deteriorates due to migration risk
Solution Approach 1:
The implant is divided into distinct functional segments: a threaded elongated body for insertion, a distal anchor with radially deployable blades for distal engagement, and a proximal anchor with spikes for proximal engagement. This segmentation allows each component to perform its specific function effectively, providing reliable migration resistance while maintaining reasonable overall device complexity.
Solution Approach 2:
Different parts of the implant have different properties optimized for their specific functions. The distal end has deployable blades for anchoring, the body has threads for controlled insertion, and the proximal end has spikes for compression and engagement. This local quality optimization ensures high reliability at each interface with the spinous processes while keeping the overall device design efficient.
3Stability of the object's composition
If an implant uses invasive surgical procedure for placement, then the stability of the implant is improved, but the ease of operation deteriorates
Solution Approach 1:
The implant is designed to be pre-loaded in a delivery system that guides it through a minimally invasive percutaneous approach to the target interspinous process space. The distal anchor blades are held in a retracted state during insertion and then deployed after placement, allowing the implant to be positioned with minimal invasion and then stabilized without requiring additional invasive surgical exposure.
Solution Approach 2:
A delivery system acts as an intermediary between the surgeon and the implant during placement. The delivery system facilitates percutaneous insertion of the implant into the interspinous process space and provides a mechanism for deploying the distal anchor blades and adjusting the proximal anchor position, achieving stable fixation through minimally invasive means.
Data Source
AI summary
A spinal implant includes an elongated body dimensioned and configured to function as a spacer, for placement in a target interspinous process space, between two adjacent spinous processes, a distal anchor associated with a distal end of the body, and a proximal anchor mounted for longitudinal movement along the body between a first position spaced apart from the head and a second position approximated with the head, adapted to compress the two adjacent spinous processes, in conjunction with the distal anchor.