Dynamic bioactive bone graft material and methods for handling
Inventors
Bagga, Charanpreet S. • Bae, Hyun W. • Day, Thomas E.
Assignees
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Publication Number
US-8567162-B2
Publication Date
2013-10-29
Expiration Date
Abstract
The present disclosure relates to a dynamic bioactive bone graft material and a method of handling the material to prepare an implant. In one embodiment, a method of preparing a dynamic bioactive bone graft implant is provided. The method includes the step of providing a porous, fibrous composition of bioactive glass fibers, wherein the fibers are characterized by fiber diameters ranging from about 5 nanometers to about 100 micrometers, and wherein the porosity of the matrix ranges from about 100 nanometers to about 1 millimeter. The porous, fibrous composition is introduced into a mold tray, and a shaped implant is created using the mold tray. The composition may be wetted with a fluid such as saline or a naturally occurring body fluid like blood prior to creating the shaped implant. In another embodiment, the porous, fibrous composition is provided with the mold tray as a kit.
Core Innovation
A dynamic bioactive bone graft implant is based on a porous, fibrous composition of bioactive glass fibers. The fibers are engineered with tunable fiber diameters ranging from about 5 nanometers to about 100 micrometers, and the matrix porosity ranges from about 100 nanometers to about 1 millimeter. This tunability supports a fibrin-like fibrous architecture in which the material functions as osteoconductive and osteostimulatory tissue support for bone healing.
The material is described as engineered to create a physiologic bone-healing mechanism, including staged or differential resorption over time. The fibrinogen-to-fibrin via thrombin behavior is referenced as part of forming a fibrous architecture that promotes interaction with the healing environment. CaP layer formation is described as occurring in a dynamic manner, associated with the bioactive nature of the porous fibrous structure.
The invention also addresses preparation and clinical handling using a molded, enclosed system. A mold tray is used having a base component and a lid component configured to form an enclosed container when fitted together. Kits and tray systems include predefined molded shapes and molded features, with enclosed/disposable tray configurations that support low-contamination handling and fluid management for shaping and delivery.
Claims Coverage
The document provides two independent claims that cover a porous fibrous bioactive glass composition and a mold tray system for preparing a dynamic bioactive bone graft implant. Across these independent claims, the inventive features are organized into two main groupings: the composition specifications and the mold-tray/base-lid system configured to form and define a shaped, enclosed molded implant.
Porous fibrous bioactive glass fiber composition with tunable dimensions
A porous, fibrous composition of bioactive glass fibers, wherein the fibers are characterized by fiber diameters ranging from about 5 nanometers to about 100 micrometers, and wherein the porosity of the matrix ranges from about 100 nanometers to about 1 millimeter.
Enclosed mold tray with base and lid components for shaping
Introducing the porous, fibrous composition into a mold tray and creating a shaped implant with the mold tray, wherein the mold tray comprises a base component and a lid component configured to fit onto the base component to form an enclosed container.
Kit with porous fibrous bioactive glass fiber composition and shape-forming mold tray
A kit for preparing a dynamic bioactive bone graft implant, comprising a porous, fibrous composition of bioactive glass fibers with fibers characterized by fiber diameters ranging from about 5 nanometers to about 100 micrometers and matrix porosity ranging from about 100 nanometers to about 1 millimeter; and a mold tray including a base component and a lid component configured to nest within the base component, each of the base and lid components having corresponding depressed or raised portions to form a predefined molded shape.
Independent claim coverage centers on a porous, fibrous bioactive glass composition defined by fiber diameter and matrix porosity ranges and a mold tray architecture having a base component and lid component that fit or nest to form an enclosed container and create a predefined molded shape for the dynamic bioactive bone graft implant.
Stated Advantages
Rapid wicking and fluid retention during handling and shaping.
Formation of a CaP layer associated with the bioactive behavior of the material.
Documented Applications
Preparation of a dynamic bioactive bone graft implant using a molded, enclosed tray system and corresponding kit for shaping and delivery.
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