US 2026/0306714 A1 · VIABLE TISSUE FORMS AND METHODS FOR MAKING AND USING SAME

Abstract

Preserved tissue forms are described which include a lyopreserved tissue sample containing endogenous viable cells and which retain or promote biological activity even after storage at temperatures above freezing. In some embodiments, the lyopreserved tissue sample comprises bone tissue. Methods of use for the lyopreserved bone tissue forms include repairing, reconstructing, otherwise treating a bone defect, such as by rehydrating the lyopreserved bone tissue form and placing it in a subject proximate the bone defect. Methods of use include orthopedic surgery which may involve intervertebral spinal fusion, posterolateral spinal fusion, and other bone fusion treatments. Kits are also described which include the lyopreserved bone tissue sample contained in a first container comprising a moisture barrier, and instructions. The kit may also include storage media, one or more biocompatible fluids, one or more additional tissue matrices and materials, as well as additional containers to contain such additional components.

Claims20

Dependent claims

A method for repairing, reconstructing, otherwise treating a bone defect, comprising the steps of:

providing a lyopreserved bone tissue form comprising a lyopreserved bone tissue sample which is derived from a recovered tissue sample comprising bone tissue, wherein the lyopreserved bone tissue sample contains one or more populations of endogenous viable cells selected from:
(a) a post-lyopreservation population of endogenous viable cells which is at least 85% of a pre-lyopreservation population of endogenous viable cells of the recovered tissue sample,
(b) a post-lyopreservation population of endogenous viable cells which is at least 85% of a pre-contact population of endogenous viable cells of the recovered tissue sample, and
(c) a retained population of endogenous viable cells which is at least 90% of a post-lyopreservation population of endogenous viable cells, after storage of the lyopreserved bone tissue sample at a temperature above freezing from 14 days to 5 years;
and
placing the lyopreserved bone tissue form on or in a subject, at an implantation site which is proximate, adjacent or implanted within the bone defect.

3 more elements

A kit comprising:

a lyopreserved bone tissue form comprising a lyopreserved bone tissue sample which is derived from a recovered tissue sample comprising bone tissue, wherein the lyopreserved bone tissue sample contains one or more populations of endogenous viable cells selected from:
(a) a post-lyopreservation population of endogenous viable cells which is at least 85% of a pre-lyopreservation population of endogenous viable cells of the recovered tissue sample,
(b) a post-lyopreservation population of endogenous viable cells which is at least 85% of a pre-contact population of endogenous viable cells of the recovered tissue sample, and
(c) a retained population of endogenous viable cells which is at least 90% of a post-lyopreservation population of endogenous viable cells, after storage of the lyopreserved bone tissue sample at a temperature above freezing from 14 days to 5 years;
and
packaging which includes at least a first container sized and shaped for containing therein at least the lyopreserved bone tissue sample, with or without storage media and with or without one or more biocompatible fluids, the first container comprising a moisture barrier material which prevents or minimizes moisture from entering or escaping from the first container after sealing with the preserved tissue form therein;
and
instructions for rehydrating and handling the lyophilized bone tissue sample prior to use.

5 more elements

Dependencies are inferred from the claim text.

Viable tissue forms and methods for making and using same

Life of this patent

Viable tissue forms and methods for making and using same

Life of this patent

Abstract

Claims20