# US 10,765,703 B2 · Xenograft soft tissue implants and methods of making

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- Number: US 10,765,703 B2
- Document ID: US10765703B2
- Status: Granted
- Kind: B2
- Application number: 16/113,951
- Filed: 2018-08-27
- Published: 2019-04-18
- Granted: 2020-09-08
- Earliest claimed: 2011-01-14
- Assignees: Tutogen Medical GmbH
- Applicants: Tutogen Medical GmbH
- Inventors: Arnd Wilhelmi; Silke Schreiner; Jake Michaelson; Steven Moore; Jennifer Faleris; Anne Reinlein
- Web page: https://patentgrep.com/patent/US10765703B2

## CPC

- A61K 35/36: Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells (islets of Langerhans A61K35/39)
- A61L 27/362: {Skin, e.g. dermal papillae}
- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

The present application is directed to the field of implants comprising soft tissue for use in implantation in humans. The soft tissue implants of the present application are preferably obtained from xenograft sources. The present application provides a chemical process that sterilizes, removes antigens from and/or strengthens xenograft implants. The present techniques yield soft tissue implants having superior structural, mechanical, and/or biochemical integrity. The present application is also directed to processes for treating xenograft implants comprising soft tissues such as dermis, and to implants produced by such processes.

## Claims

### Claim 1

A method for the preparation of a graft from bovine dermis comprising:
(a) providing a bovine dermis having a native dermal matrix;
(b) treating said dermis with an aqueous, alkaline sodium sulfide solution for at least 1 hour, wherein said solution comprising 0.01% to 1.5% by weight of sodium sulfide and 0.001 M to 0.5 M sodium hydroxide and said solution has a pH greater than 10;
(c) once or several times, treating the dermis with a saline solution;
(d) once or several times, treating the dermis with an aqueous hydrogen peroxide solution;
(e) dehydrating the dermis via solvent dehydration that stars with a lower concentration of solvent and finishes with a higher concentration of solvent; and
(f) maintaining a histoarchitecture of the native matric wherein the graft is non-crosslinked.

### Claim 2 (depends on 1)

The method of claim 1, wherein the dermis in step (b) is treated with the aqueous sodium sulfide solution for 1 to 48 hours.

### Claim 3 (depends on 1)

The method of claim 1, wherein treating the dermis in step (c) with a saline solution comprises treating two to ten times with the saline solution, wherein the saline solution comprises 1% to 50% by weight of salt, and wherein the salt is an alkali metal or alkaline earth metal, selected from the group consisting of sodium chloride, potassium chloride, lithium chloride, magnesium chloride, and calcium chloride.

### Claim 4 (depends on 1)

The method of claim 1, wherein treating the dermis in step (d) with the aqueous hydrogen peroxide solution comprises treating two to five times with the aqueous hydrogen peroxide solution, and wherein the aqueous hydrogen peroxide solution comprises 1% to 10% by weight of hydrogen peroxide.

### Claim 5 (depends on 1)

The method of claim 1, wherein dehydrating the dermis in step (e) the dermis comprises dehydrating two to ten times with an organic solvent selected from the group consisting of acetone, methanol, ethanol, and isopropyl alcohol.

### Claim 6 (depends on 1)

The method of claim 1, further comprising a step of rehydrating the dermis after step (e).

### Claim 7 (depends on 1)

The method of claim 1, further comprising punching or stamping grafts of a desired shape from the dermis.