Implantation Compositions for Use in Tissue Augmentation

Abstract

A composition of matter and method for preparation of a tissue augmentation material. A polysaccharide gel composition is prepared with rheological properties selected for a particular selected application. The method includes preparing a polymeric polysaccharide in a buffer to create a polymer solution or gel suspending properties in the gel and selecting a rheology profile for the desired tissue region.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS[0001]The present application is a continuation-in-part of U.S. patent application Ser. No. 11 / 348,028, filed Feb. 6, 2006 and U.S. patent application Ser. No. 11 / 650,696 filed Jan. 8, 2007 both of which are incorporated herein by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention relates generally to tissue augmentation, and more particularly to injection of resorbable, biocompatible, gel and solid composites to correct and augment soft tissue with specific application for cosmetic augmentation of tissues.BACKGROUND OF THE INVENTION[0003]There are a number of non-resorbable, particle-based compositions used for permanent correction or augmentation of soft tissue defects or augmentation for cosmetic purposes. Each composition is associated with certain advantages and disadvantages. Silicone gel was frequently used to treat dermal defects, such as wrinkles, folds, and acne scars in the 1970's and 1980's but has ...

AI Technical Summary

Benefits of technology

[0010]The present invention is directed to systems and methods for preparation of implant materials which enable compatible tissue augmentation. In particular, the systems and methods relate to augmentation implants preformed in accordance with carefully preparing implant matrix materials using a precise protocol to manipulate a plurality of chemical variables to achieve a designed end product and with well define rheological characteristics. In one embodiment, the implants comprise gels having specific compatibility and stability at the tissue implant site; controlled and proper tissue in-growth to implement integration into the tissue, minimized immuno-histo tissue response, and improved mechanical and visual appearance In one embodiment, the implant comprises gels having particles suspended therein with specific compatibility and stability at the tissue implant site; controlled and proper tissue in-growth to implement integration into the tissue, minimized immuno-histo tissue response, and improved mechanical and visual appearance. The implants have physical and chemical properties selected to achieve a desired rheological and chemical behavior when implanted. For example, it is preferable to replace or augment tissue structure with a material exhibiting physiological properties, including rheological, chemical, biological, and mechanical properties, which are similar to and / or compatible with those of the treated tissue and / or designed to accommodate tissue in growth in a controlled manner.

Problems solved by technology

This composition has been withdrawn from commercial application due to frequent chronic inflammation and tissue rejection.

In addition, the composition is associated with sterilization challenges; the bovine collagen dispersion is damaged by standard terminal sterilization techniques, including heat and gamma irradiation.

Further, conventional methods and products fail to address several problems with current gels.

More specifically, the injectable materials of the prior art fail to address the specific difficulties in applying implants across a wide range of locations in the body and consequently fail to provide the appropriate type of implant.

For example, current implants can experience occlusion, or irregular implantation during the implantation procedure when a fine gauge needle is used.

Furthermore, the propensity for occlusions often results in uneven, erratic and discontinuous implantation, which causes highly undesirable results.

In another aspect of conventional methods and products, current implants have failed to address the viscoelastic properties of the implant in the syringe, such that current implants require a significant amount of force, and even irregular levels of force, to extrude the implant from the needle, much more so as the needle gauge is reduced.

This presents fatigue issues for medical professionals who may well be performing many injections in a day.

This also makes any given injection more difficult to perform, and also perform proper injection amounts and distributions, because of the necessity to exert a large amount, or an irregular amount of force on the syringe, while maintaining a steady needle during injection.

Conventional methods and current implant materials also fail to address the wide range of distinctions in the different tissues in which the implants are placed.

Implants can undergo unwanted agglomeration, chemical reaction, phase separation, and premature breakdown of the implanted mass into discontinuous variable shapes, all of which can consequently manifest different undesirable mechanical properties and performance relative to the implant tissue region.

In particular, prior art implants utilizing gels have relied on the gel as a carrier but have failed to recognize and solve the problem of providing an implant with a gel which is designed to cooperate with the solid particles to mimic, both mechanically and chemically, the tissue into which it is injected and to behave in a symbiotic controlled manner when embedded in the tissue.

Implants using prior art gels exhibit a tendency to form nodules, or to migrate from the desired implantation location, or to undergo unwanted and undesired chemical and / or mechanical breakdown, such as phase separation or formation of unwanted geometries and cosmetic appearance in the body.

None of these is an acceptable result for a patient.

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