Method for use of a double-structured tissue implant for treatment of tissue defects

Inventors

Shortkroff, SonyaTarrant, Laurence J. B.Roos, Eric J.Smith, Robert LaneCLAESSON, HANS P. I.

Assignees

Ocugen Inc

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Publication Number

US-10842610-B2

Patent

Publication Date

2020-11-24

Expiration Date


Abstract

A method for use of a double-structured tissue implant or a secondary scaffold stand-alone implant for treatment of tissue defects. The double-structured tissue implant comprising a primary scaffold and a secondary scaffold consisting of a soluble collagen solution in combination with a non-ionic surfactant generated and positioned within the primary scaffold. A method of use of a stand-alone secondary scaffold implant or unit for treatment of tissue defects.

Core Innovation

The invention relates to a method for treating a tissue defect using a double-structured tissue implant (DSTI). The implant includes a three-dimensional primary scaffold having a plurality of pores and a secondary scaffold formed within the pores.

The secondary scaffold comprises lyophilized and dehydrothermally treated collagen and a surfactant, where the secondary scaffold forms a fibrous and cross-linked collagen network within the plurality of pores. The implant is rehydrated with a physiologically acceptable solution or buffer before or after implantation, and can be provided dry or rehydrated.

The method includes preparing the tissue defect for implantation, precutting the double-structured tissue implant, coating the defect with a tissue adhesive, implanting the double-structured tissue implant into the defect, and covering the implanted DSTI with a tissue adhesive. The description emphasizes improved properties versus single and composite scaffolds, including rapid wettability, resistance to shrinkage/swelling and collagen dissolution, enhanced surface area for cell adhesion and migration, and high cell viability and extracellular matrix production.

A stand-alone secondary scaffold embodiment is also described, prepared such that it supports stability/rehydration and cell viability. The description further states that the implant optionally can be preloaded with cells and/or drugs or growth modulators and can be implanted into a defect, including a cartilage lesion.

Claims Coverage

The partial claim set identifies one independent claim. It covers a complete implantation workflow for a double-structured, three-dimensional implant in which a secondary fibrous and cross-linked collagen-surfactant network forms inside pores of a primary scaffold, with rehydration using a physiologically acceptable solution or buffer.

Double-structured implant with porous primary scaffold and internal secondary collagen-surfactant network

A method for treating a tissue defect comprising preparing a double-structured tissue implant comprising a three-dimensional primary scaffold with a plurality of pores, wherein the plurality of pores comprises a secondary scaffold comprising lyophilized and dehydrothermally treated collagen and a surfactant, and wherein the secondary scaffold forms a fibrous and cross-linked collagen network within said plurality of pores.

Implantation workflow using precutting, tissue adhesive coating, and rehydration with physiologically acceptable buffer

Implanting the double-structured tissue implant into the tissue defect wherein the implant is rehydrated with a physiologically acceptable solution or buffer before or after implantation, including preparing the tissue defect for implantation, precutting the double-structured tissue implant, coating the defect with a tissue adhesive, and covering the implanted double-structured tissue implant with a tissue adhesive.

Across the identified independent claim, the essential coverage combines a primary porous 3D scaffold whose pores contain a secondary lyophilized and dehydrothermally treated collagen plus surfactant network that is fibrous and cross-linked, and an implantation method where the DSTI is precut, adhesively secured at the defect and over the implant, and rehydrated with a physiologically acceptable solution or buffer before or after implantation.

Stated Advantages

Improved wettability (rapid wettability).

Resistance to shrinkage and swelling.

Resistance to collagen dissolution.

Enhanced surface area for cell adhesion and cell migration.

High cell viability and extracellular matrix production, including S-GAG/DNA and Type II collagen.

Documented Applications

Treating a tissue defect, including a cartilage lesion, using the double-structured tissue implant.

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