Polysaccharide compositions for use in tissue augmentation

a polysaccharide composition and tissue technology, applied in the field of tissue augmentation, can solve the problems of reducing affecting the implantation rate of the graft,

Inactive Publication Date: 2007-08-09
BIOFORM MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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This composition has been withdrawn from commercial application due to frequent chronic inflammation and tissue rejection.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.
The combination of water and an appropriate water-soluble suspending agent renders the corresponding magnetorheological material highly non-Newtonian, thereby inhibiting the settling of particles in spite of their high density and large size.
As a result, the prior art fails to address several problems with current gels.
First, 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 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.
Second, 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 performin...

Method used

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  • Polysaccharide compositions for use in tissue augmentation
  • Polysaccharide compositions for use in tissue augmentation
  • Polysaccharide compositions for use in tissue augmentation

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of 2.3% Sodium CMC Gel in Sterile Water.

[0087] Sodium carboxymethylcellulose was prepared in sterile water for injection and adjusted to a pH of from about 7.1 to about 8.0 using potassium hydroxide. The dispersion was mixed in an orbital Ross mixer @1725 RPM for 5 minutes followed by mixing in an orbital Ross mixer @1725 RPM for 40 minutes. while holding a vacuum @ 26 mm Hg or more. The composition was then steam sterilization at 121 degrees C. for times ranging from 3 minutes to 30 minutes. In addition, one sample was sterilized for time intervals between 3 minutes and 30 minutes @ 121 degree C. Results are shown in FIG. 1 where G′ represents the elastic modulus, G″ represents the viscous modulus and η the complex viscosity. The profile shows that G′ and G″ intersect at 0.495 Hz (3.2 Rad / sec). Above this frequency, the composition exhibits non-newtonian solution characteristics (tan δ<1.0).

example 2

Preparation of 2.4% Sodium CMC Gel in Sterile Water.

[0088] Sodium carboxymethylcellulose was prepared in sterile water for injection and adjusted to a pH of from about 7.1 to about 8.0 using potassium hydroxide. The dispersion was mixed in an orbital Ross mixer @1725 RPM for 5 minutes followed by mixing in an orbital Ross mixer @1725 RPM for 40 minutes. while holding a vacuum @ 26 mm Hg or more. The composition was then steam sterilization at 121 degrees C. for times ranging from 3 minutes to 30 minutes. In addition, one sample was sterilized for time intervals between 3 minutes and 30 minutes @ 121 degree C. Results are shown in FIG. 2 where G′ represents the elastic modulus, G″ represents the viscous modulus and η the complex viscosity. The profile shows that G′ and G″ intersect at 0.0299 Hz (1.8 Rad / sec) (lower frequency than that shown in FIG. 1). Above this frequency, the composition exhibits non-Newtonian solution characteristics (tan δ<1.0).

example 3

Preparation of 2.5% Sodium CMC Gel in Sterile Water.

[0089] Sodium carboxymethylcellulose was prepared in sterile water for injection and adjusted to a pH of from about 7.1 to about 8.0 using potassium hydroxide. The dispersion was mixed in an orbital Ross mixer @1725 RPM for 5 minutes followed by mixing in an orbital Ross mixer @1725 RPM for 40 minutes. while holding a vacuum @ 26 mm Hg or more. The composition was then steam sterilization at 121 degrees C. for times ranging from 12 minutes to 30 minutes. In addition, one sample was sterilized for time intervals between 3 minutes and 12 minutes @121 degree C. Results are shown in FIG. 3 where G′ represents the elastic modulus, G″ represents the viscous modulus and η the complex viscosity. The profile shows that G′ and G″ intersect at 0.157 Hz (1 rad / sec) frequency than shown in FIGS. 1 and 2. Above this frequency, the composition exhibits non-Newtonian solution characteristics (tan δ<1.0).

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Abstract

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

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATION [0001] The present application is a continuation-in-part of U.S. patent application Ser. No. 11 / 348,028, filed Feb. 6, 2006 and incorporated herein by reference in its entirety.FIELD OF THE INVENTION [0002] The present invention relates generally to tissue augmentation, and more particularly to injection of resorbable, biocompatible, solid composites to correct and augment soft tissue defects 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. [0004] 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 since been prohibited from use in these applications. Silicone was fre...

Claims

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Application Information

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IPC IPC(8): A61K31/717A61F2/02
CPCA61L27/20A61L27/50C08L1/286A61K47/38A61K31/167A61K47/02A61K47/10A61L2/0023A61L2400/06A61L2430/34C08L1/26A61F2/20A61L27/54A61L2430/00
Inventor VOIGTS, ROBERTDEVORE, DALE
Owner BIOFORM MEDICAL
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