Anti-expulsion Device for Nucleus Disc Replacement
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Solution Overview
Problem
Current nucleus disc replacement devices face challenges in maintaining the implant within the spinal disc annulus due to the soft and pliable nature of the materials used, which can lead to expulsion through existing fissures or openings, especially in degenerated annulus tissues.
Innovation Solution
The development of an anti-expulsion device that can be inserted in a compressed configuration to fit through the annulus opening and expand within the nucleus void, featuring mating elements to interlock with the nucleus disc replacement implant and annulus, preventing expulsion and potentially reinforcing the annular wall with tissue regenerative materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the NDR device is made of soft and pliable biocompatible materials to closely mimic the native nucleus, then the device can elastically deform during normal activities and allow motion, but the device increases the likelihood of being expulsed from the opening(s) formed in the annulus
Solution Approach 1:
The device is segmented into an inner NDR component and an outer anti-expulsion device component, allowing each to perform its specialized function independently while working together as a system
Solution Approach 2:
The anti-expulsion device serves as an intermediary between the soft NDR device and the annulus, providing mechanical containment while allowing the NDR device to maintain its motion capabilities
2Ease of operation
If the NDR device is made soft and pliable to allow motion, then the device can elastically deform during normal activities, but the device cannot prevent expulsion through existing or developing fissures in the degenerated annulus
Solution Approach 1:
The system is divided into two functional components: the soft NDR device for motion and the rigid anti-expulsion device for containment, with the latter providing structural support against fissures
Solution Approach 2:
The combined system uses composite construction with soft biocompatible materials for the NDR device and harder structural materials for the anti-expulsion device, achieving both flexibility and containment
3Reliability
If a TDR procedure is performed to replace all or most of the disc tissue, then the functionality of surrounding structures is compromised, but the risk of expulsion is reduced
Solution Approach 1:
The harmful function of expulsion risk is extracted from the NDR device by adding a separate anti-expulsion device, allowing the NDR device to remain soft and biocompatible without compromising containment
Solution Approach 2:
The replacement strategy is segmented into nucleus replacement only (NDR) rather than total disc replacement, preserving surrounding structures while adding an anti-expulsion component to address containment concerns
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The anti-expulsion device effectively secures the nucleus disc replacement implant within the spinal disc, reducing the risk of expulsion and facilitating the regeneration or reinforcement of the annular wall, thereby enhancing the stability and longevity of the implant.
Implementation Method 1
a body movable between a compressed configuration in which the body is adapted to fit through an opening in an annulus of a spinal disc, and an expanded configuration in which the body has a size larger than a size of the opening in the annulus
Implementation Method 2
a mating feature that is adapted to interlock with at least one of a nucleus disc replacement implant and an annulus of a spinal disc to prevent expulsion
Data Source
AI summary
Devices and methods for preventing the migration or expulsion of a nucleus disc replacement implant are provided. In one embodiment, an anti-expulsion device includes a body that is movable between a compressed configuration where it is adapted to fit through an opening in an annulus of a spinal disc, and an expanded configuration where it has a size that is larger than a size of the opening in the annulus of a spinal disc. The body can also include one or more mating features that allow the body to interact with a nucleus disc replacement implant and/or an annular wall of an annulus. As a result, since the body is larger than the opening of the annulus in the expanded configuration, the interlocking connection between the body and the nucleus disc replacement implant and/or annular wall will allow the body to prevent the nucleus disc replacement implant from being expulsed from the opening in the annulus.