Activatable devices containing a chemonucleolysis agent

摘要

Effective devices and methods using a chemonucleolysis agent are provided for treating an intervertebral disc or treating spinal arachnoiditis. The devices and methods comprise a chemonucleolysis agent to degrade or to shrink at least a portion of the intervertebral disc. In some embodiments, the methods and devices are configured to immediately release an effective amount of the chemonucleolysis agent within 24 hours when the device comes in contact directly or indirectly with an activator and provide sustained release of the chemonucleolysis agent over a period of up to one year to treat the intervertebral disc. In some embodiments, the chemonucleolysis agent in the device is administered in or near the intrathecal space and/or thecal sac to treat spinal arachnoiditis.

主权项

1. A device for treating an intervertebral disc in a patient in need of such treatment, the device being biodegradable and implantable within the intervertebral disc, the device comprising a chemonucleolysis agent in an amount of at least 15 U/mL to degrade or to shrink at least a portion of the intervertebral disc and being configured to immediately release an effective amount of the chemonucleolysis agent within 24 hours; and the device comprising a distinct immediate release layer, a distinct sustained release layer and a distinct therapeutic layer, the immediate release layer configured to contact an exogenous activator configured to be inserted within the intervertebral disc after the device has been implanted within the intervertebral disc such that the exogenous activator causes immediate release of the chemonucleolysis agent, and the activator comprises sorbitan monolaurate, triethanolamine oleate, triethyl citrate, methyl benzoate, ethyl benzoate, n-propyl benzoate, isopropyl benzoate, butyl benzoate, isobutyl benzoate, sec-butyl benzoate, tert-butyl benzoate, isoamyl benzoate, benzyl benzoate, or butyrolactone, and the immediate release layer further comprises trehalose, and the device further comprises a pore forming agent.