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

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-11648102-B2

Patent

Publication Date

2023-05-16

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 double-structured tissue implant for treating a tissue defect. The implant includes a three-dimensional primary scaffold having a plurality of pores, where the pores comprise a secondary scaffold comprising lyophilized and dehydrothermally treated collagen and a surfactant, forming a fibrous and cross-linked collagen network within the plurality of pores.

The tissue implant is prepared for implantation as part of a method for treating a tissue defect. A tissue defect is prepared, the double-structured tissue implant is precut, and the defect is coated with a first tissue adhesive. The implant is implanted into the defect, rehydrated with a physiologically acceptable solution or buffer before or after implantation, and covered with a second tissue adhesive.

The collagen-based secondary scaffold is formed by introducing a soluble collagen solution with a non-ionic surfactant into the primary scaffold pores, followed by solidifying using precipitation/gelation, then washing, lyophilization, and dehydrothermal treatment to yield a fibrous, cross-linked collagen network within the pores. The implant may be implanted dry or rehydrated, and a stand-alone secondary scaffold is also described.

Claims Coverage

Independent claim 1 covers a complete method for treating a tissue defect using a double-structured tissue implant with a primary porous scaffold whose pores contain a secondary lyophilized and dehydrothermally treated collagen/surfactant scaffold forming a fibrous, cross-linked collagen network, combined with defect preparation, precutting, adhesive coating, and implant implantation with pre- or post-implantation rehydration using a physiologically acceptable solution or buffer, followed by covering with a second tissue adhesive. No other independent claims are explicitly provided in the supplied text.

Double-structured tissue implant forming a fibrous cross-linked collagen network in pores

The three-dimensional primary scaffold comprises 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 method with adhesive coating and precutting of the double-structured tissue implant

Preparing a double-structured tissue implant comprising a three-dimensional primary scaffold; preparing said tissue defect for implantation; precutting said double-structured tissue implant; coating said defect with a first tissue adhesive; implanting said double-structured tissue implant into said defect; and covering said implant with a second tissue adhesive.

Rehydration with physiologically acceptable solution or buffer before or after implantation

Implanting said double-structured tissue implant into said defect, wherein said implant is rehydrated with a physiologically acceptable solution or buffer before or after implantation.

The core claim coverage centers on a double-structured implant in which secondary collagen that is lyophilized and dehydrothermally treated with a surfactant forms a fibrous, cross-linked collagen network inside pores of a three-dimensional primary scaffold, together with defect preparation, precutting, first and second tissue adhesive coating steps, and implantation with rehydration using a physiologically acceptable solution or buffer before or after implantation.

Stated Advantages

Improved wettability and rapid rehydration (<2 s).

High collagen retention (~99% initially).

Minimal shrinkage and swelling (about 2–5% surface area change in the first hour).

Good cell compatibility/viability (about 96–100%) with extracellular matrix deposition after 14 days.

Documented Applications

Treating a tissue defect using a method comprising implantation of a double-structured tissue implant, with first and second tissue adhesive coating and rehydration with a physiologically acceptable solution or buffer.

Implantation with optional cells and growth factors or drugs, including localization in primary scaffold versus secondary scaffold.

Use of the implant in a dry or rehydrated implantation option.

Stand-alone secondary scaffold application is described.

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