Compositions for removing necrotic or infected tissues from body surface lesions and from oral cavity

Inventors

Bignozzi, Carlo Alberto • Carinci, Francesco • Cogo, Alberto

Assignees

Debx Medical Holding BV

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Publication Number

US-12208072-B2

Patent

Publication Date

2025-01-28

Expiration Date


Abstract

A composition, usable for removing a biofilm and necrotic or infected tissues from skin lesions and lesions of the oral cavity, comprises methanesulfonic acid 99.0% and a proton acceptor. The proton acceptor is selected from the group consisting of: anhydrous sodium carbonate, 5-amino-2-mercaptobenzimidazole, ethylenediaminetetraacetic acid tetrasodium salt, sodium gluconate, sodium tartrate dihydrate, 2-mercapto-5-benzimidazole sodium sulfonate, dimethyl sulfoxide, polyethylene glycol 400, polyethylene glycol 600, silicon dioxide, tetraethoxysilane, and mixtures thereof. The aforesaid composition can be prepared in the form of a solution, gel or cream.

Core Innovation

The invention describes a method for rapidly removing biofilm and necrotic or infected tissues from skin lesions or lesions of the oral cavity by applying a composition comprising methanesulfonic acid onto the lesions and removing the biofilm or the necrotic or the infected tissues. The disclosed context includes chronic skin ulcers and oral cavity lesions such as periodontal/peri-implant pockets and aphthae. The approach is framed around modulating acidity using methanesulfonic acid in combination with proton acceptors.

The problem addressed is the presence of biofilm and necrotic/infected tissues in chronic skin ulcers and lesions of the oral cavity, including periodontal/peri-implant pockets and aphthae, and the need for removal of those tissues. The described rationale includes dehydration/desiccation and a proton-driven mechanism, where hydrogen ions/protons (H+) denature inflammatory proteins and dehydrate/detach necrotic tissues. Protonation equilibrium (HA + B ⇄ A− + HB) is described in connection with the proton acceptors included in the composition.

The disclosed compositions are described in multiple formulation variants, including a solution, a gel, or a cream. Proton acceptors are provided as named classes and examples, including inorganic/organic salts, benzimidazole sulfonates, and chelating salts, as well as other components listed in the description. Qualitative and quantitative formulation ranges are reported in tables, and the composition is applied to achieve removal of biofilm and necrotic or infected tissues.

Claims Coverage

The document contains one independent claim for the method and multiple dependent claims that narrow the method by refining methanesulfonic acid purity or amount and by specifying proton acceptor selection, formulation form, and ingredient sets.

Applying methanesulfonic acid composition for tissue removal

Applying a composition comprising methanesulfonic acid onto skin lesions or lesions of the oral cavity of a patient in need thereof and removing the biofilm or the necrotic or the infected tissues from said lesions.

Methanesulfonic acid purity threshold

Applying a composition including methanesulfonic acid at least 70% by weight and, in a further dependent refinement, methanesulfonic acid with a purity of 99.0%.

Proton acceptor selection for the composition

Using a proton acceptor selected from anhydrous sodium carbonate, 5-amino-2-mercaptobenzimidazole, ethylenediaminetetraacetic acid tetrasodium salt, sodium gluconate, sodium tartrate dihydrate, 2-mercapto-5-benzimidazole sodium sulfonate, dimethyl sulfoxide, polyethylene glycol 400, polyethylene glycol 600, silicon dioxide, tetraethoxysilane, and mixtures thereof.

Specific multi-component formulation ranges

Using a composition whose formulation includes specific weight-percentage ranges of methanesulfonic acid, sodium gluconate, sodium tartrate dihydrate, silicon dioxide, tetraethoxysilane, and polyethylene glycol 400 or polyethylene glycol 600.

Form selected from solution, gel, or cream

Using a composition prepared in one of the forms selected from solution, gel, and cream.

Across the claim set, coverage centers on the method of applying a methanesulfonic acid composition to skin or oral cavity lesions followed by removal of biofilm and necrotic or infected tissues, while dependent claims further narrow the method by specifying methanesulfonic acid purity or amount, selecting proton acceptors from listed compounds, and defining formulation form and multi-component weight-percentage ranges.

Stated Advantages

Rapid removal of biofilm and necrotic or infected tissues from skin lesions or lesions of the oral cavity.

Restoration of granulation and reduction of periodontal pocket depth in non-surgically treated patients.

Statistically significant reduction of total bacterial load in periodontitis as reported using PCR/16S rRNA approaches.

Lack of adverse reactions.

Documented Applications

Treatment of chronic skin ulcers by removing biofilm and necrotic or infected tissues.

Treatment of periodontal/peri-implant pockets in oral cavity lesions by removing biofilm and necrotic or infected tissues.

Treatment of aphthae in oral cavity lesions by removing biofilm and necrotic or infected tissues.

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