Gel suitable for implantation and delivery system

Abstract

The invention concerns a dried form of a porous polymer gel material which may be rehydrated and placed under pressure or compression to induce solvation, thereby forming a high concentration gel, in the form of an injectable viscous putty or dough, which may be implantated in the body.

Description

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] This application relates generally to medical implant devices and methods of use, specifically relating to the preparation of an implantable device, the sterilization and storage of the device, and the use and delivery of the device. The material of the present invention may serve as an implantable material in order to aid tissue healing, serve as a void filler, prevent adhesions, and / or serve as a drug delivery vessel, among other beneficial uses. [0003] 2. Discussion of Related Art [0004] Hydrogels may be formed from a variety of polymeric materials and are useful in a variety of biomedical applications, for example, wound management, soft contact lens construction, surgical applications, and drug delivery applications. To be suitable for implantation in a living being, the polymer material should be sterile to minimize opportunity for infection. An implantable polymer material may be manufactured through an asept...

AI Technical Summary

Benefits of technology

[0019] A need exists for a high viscosity material suitable for injection or in-situ molding supplied in dry form, which is readily and quickly rehydratable or resolvable upon addition

Problems solved by technology

It is commonly known that high energy sterilization (e.g., gamma irradiation, e beam radiation, etc.) results in changes to polymers (e.g., molecular weight loss, cross-linking, etc.) that may be undesirable in the final product.

It is also known that these changes are more severe when the product is in a hydrated or solvated state.

Delmotte does not address the need for a material that does not require milling or grinding before the addition of a liquid or glue in creating a bone void filling material.

Kennedy et al. do not disclose a gel material that may be dried, and rehydrated for implantation without adding heat and / or heated solutions.

The gel material is unsuitable for gamma sterilization as the gel is destroyed.

Hubbard does not disclose a gel material that may be readily gamma sterilized, stored dry, and then be rehydrated to form a viscous injectable putty or dough for implant.

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