Implantable nuclear prosthesis, kits, and related methods

Inventors

FRANCIS, W. Loren • Novotny, Mark A. • Hallam, Cory R. A. • Ganem, Jake

Assignees

Spinal Stabilization Technologies LLC

Abstract

The present disclosure includes devices, apparatuses, kits, and methods for replacing a nucleus pulposus of an intervertebral disc with an implantable nuclear prosthesis filled with a curable silicone material in situ. Configurations of the present spinal implant devices include a flexible body defining an outer fillable enclosure that defines an outer chamber, an inner fillable enclosure that defines an inner chamber, and a proximal plug configured to be coupled to the inner fillable enclosure.

Core Innovation

The invention provides an implantable nuclear prosthesis for nucleus pulposus replacement that includes a spinal implant device with a flexible body defining nested, dual-chamber fillable enclosures. The flexible body includes an outer fillable enclosure defining an outer chamber having a body aperture and an inner fillable enclosure defining an inner chamber, where the outer fillable enclosure at least partially surrounds the inner fillable enclosure. The inner fillable enclosure has an opening in fluid communication with the inner chamber.

Fluid communication between the inner chamber opening and the outer fillable enclosure is controlled by a proximal plug. The proximal plug is configured to be coupled to the inner fillable enclosure such that the proximal plug controls fluid communication through the opening, the proximal plug defining a receptacle with a plug aperture and including a re-sealable membrane to control fluid communication through a proximal opening of the inner chamber. The receptacle includes a first retaining element, and the plug aperture is positioned between the first retaining element and the re-sealable membrane to enable fluid communication to the outer fillable enclosure.

An inflation stylet is provided that mates with the proximal plug and extends at least partially through the proximal plug, enabling controlled fluid delivery and removal. The inflation stylet includes a first lumen configured to deliver fluid to and remove fluid from the inner chamber and a second lumen surrounding the first lumen and configured to deliver fluid to the outer chamber. The second retaining element controls insertion depth and secures the inflation stylet to the proximal plug.

The device is described with radiographic features, dual-chamber filling behavior, and optional imaging balloon assessment for nuclectomy and implant sizing. In further aspects, the invention uses radiopaque markers and a curable radiopaque silicone material in the implant chambers, and the flexible implant device is described with material and geometry selections intended to dampen loads and mitigate subsidence and migration while restoring stress distribution through annular bridging behavior when cured.

Claims Coverage

The document includes two independent claims that cover a kit for implanting a nuclear prosthesis with a dual-chamber spinal implant device, a proximal plug with a re-sealable membrane, and a dual-lumen inflation stylet, and a spinal implant device itself with the same nested-enclosure and proximal-plug fluid-control structure. Across the independent claims, the core inventive features are the nested outer and inner fillable enclosures, plug-controlled fluid communication via a re-sealable membrane and plug aperture, and an inflation stylet having two lumens with a retaining-element-based coupling and insertion depth control.

Overall, the independent claims focus on a nested dual-chamber spinal implant device where a proximal plug with a re-sealable membrane and plug aperture controls fluid communication between an inner-chamber opening and an outer chamber, and where an inflation stylet with first and second lumens delivers and removes fluids to the inner and outer chambers while retaining elements control coupling and insertion depth.

Stated Advantages

Documented Applications