Claims for Patent: 7,175,430

Summary for Patent: 7,175,430

Title:	Support materials and imaging method for intraoral diagnostic purposes
Abstract:	The invention relates to deformable, curable or film-forming support materials which contain diagnostically useful additives for locus- and substance-specific intraoral diagnostics, and processes for the preparation of images for intraoral locus- and substance-specific diagnostic purposes, in which diagnostically useful additives are applied to deformable, curable or film-forming support materials containing no diagnostically useful additives, in such a quantity that a diagnostic signal can be observed, the diagnostic result being obtained without a cultivation step.
Inventor(s):	Gasser; Oswald (Seefeld, DE), Guggenberger; Rainer (Herrsching, DE), Gangnus; Bernd (Andechs, DE), Haberlein; Ingo (Weilheim, DE)
Assignee:	3M ESPE AG (Seefeld, DE)
Application Number:	10/009,603
Patent Claims:	1. A deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material, wherein the support material comprises a material that is (i) an impression material or film based on silicon, polyether-silicon, polyether, alginate or hydrocolloid, (ii) a polyethylene, polypropylene, poly(meth)acrylate, polyurethane, polycarbonate, polysulphide or polyvinylchloride plastic, (iii) a rubber composition, (iv) a polyvinylpyrrolidone-based or polyvinylalcohol-based hydrogel, or (v) a dental plaster preparation; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material, wherein at least one diagnostically useful additive is useful for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate mouth diseases or healing processes. 2. The composition according to claim 1, in which the diagnostic additives are contained in a quantity of from 0.0001 to 10 wt.- %. 3. The composition according to claim 1, in which the diagnostic additives are contained in a quantity of from 0.01 to 1 wt.- %. 4. The composition according to claim 1 that is based upon N-alkylaziridinopolyether. 5. The composition of claim 1 in which at least one signal is development of a visible color, a fluorescent signal, an ultraviolet signal, a phosphorescent signal or a luminescent signal. 6. The composition of claim 1, in which the at least one diagnostically useful additive comprises an indicator selected from the group consisting of bromo phenol blue, Congo red, bromo cresol green, Oregon green derivatives, rhodol derivatives, redox indicators, such as methylene blue, 5-cyano-2,3-ditolytetrazolium chloride, 2-(4-iodophenyl)-3-(4-nitrophenyl)-5-phenyl-2H-tetrazolium chloride, 8-dimethylamino-2,3-benzophenoxazine, 1-methoxyphenazine methosulphate, 5-(3-carboxymethoxyphenyl)-2-(4,5-dimethylthiazolyl-3-(4-sulphophenyl)tet- razolium, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, 3,3'-(3,3'-dimethoxy-4,4'-biphenylene)-bis[2-(4-nitrophenyl-5-phenyl)]-2H- -tetrazolium chloride, nitrotetrazolium violet, phenazinmethosulphate, sodium-3'-[1-[(phenylamino)carbonyl]-3,4-tetrazolium]bis(4-methoxy-6-nitr- o)benzenesulphonic acid, phenazinethosulphate, Oregon green 488 BAPTA, calcium green, calcium orange, calcium crimson, 5-brom-2'-deoxyuridine, a p-nitroaniline derivative, a 2-naphthylamine derivative, a 7-amino-4-methylcoumarin derivative, a 7-amino-4-chloromethylcoumarin derivative, a 6-aminoquinoline derivative, a rhodamine derivative, 5,5'-dithiobis-(2-nitrobenzoic acid), a monobrombiman derivative, a tetramethylrhodamine derivative, an eosine derivative, an erythrosine derivative, a Texas red derivative, a coumarin derivative, a pyridyloxauzol derivative, a benzofurazan derivative, a naphthaline derivative, a didansyl cysteine, a dansyl derivative, an aziridine derivative, a pyrene derivative and Coomassie blue. 7. The composition of claim 6 in which the indicator is covalently bound to an enzyme, a protein, a glycoprotein, a lipopolysaccharide, a polysaccharide, a polyclonal antibody, a monoclonal antibody, a DNA molecule, a RNA molecule, a cell organelle or a microorganism cell. 8. The composition of claim 1 in which the diagnostically useful additive is an enzyme selected from the group consisting of an oxidoreductase, a dehydrogenase, an oxidase, a peroxidase, a reductase, a monooxygenases, a dioxygenase, a transferase, a hydrolase, a lyase, an isomerase and a ligase. 9. The composition of claim 8 in which the diagnostically useful additive in an enzyme selected form the group consisting of lactate dehydrogenase, C.sub.1-transferase, glycosyl transferase, glusoyltransferase, fructosyltransferase, aminotransferase, phospho-transferase esterase, a glycosidase, glucanase, fructanase, a peptidase, a dipeptidylpeptidase, Arg-gingipain, Lys-gingipain, a collagenase, a gelatinase, a cathepsin, an elastase, an amidase, a C--C-lyase, a C--O-lyase, a C--N-lyase, a C--S-lyase, an epimerase, a cis-trans-isomerase, an intramolecular transferase, a C--C-ligase, a C--O-ligase, a C--N-ligase, and a C--S-ligase. 10. The composition of claim , in which a plurality of diagnostically useful additives are present and each is micro-encapsulated. 11. The composition of claim in which a plurality of diagnostically useful additives are present and at least one is micro-encapsulated and at least one is free in the support material. 12. A deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material, wherein at least one diagnostically useful additive is useful for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate mouth diseases or healing processes and wherein at least one diagnostically useful additive is present in micro-encapsulated form. 13. A process for making an intraoral diagnostic material comprising applying to a deformable, curable or film-forming support material containing no diagnostically useful additives at least one diagnostically useful additive that is useful for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate mouth diseases or healing processes, in a quantity effective for producing a diagnostic signal within or upon the surface of the support material or by binding of a detectable agent to the surface of the support material after the support material is applied to the oral cavity of a subject, wherein the support material comprises a material that is (i) an impression material or film based on silicon, polyether-silicon, polyether, alginate or hydrocolloid, (ii) a polyethylene, polypropylene, poly(meth)acrylate, polyurethane, polycarbonate, polysulphide or polyvinylchloride plastic, (iii) a rubber composition, (iv) a polyvinylpyrrolidone-based or polyvinylalcohol-based hydrogel, or (v) a dental plaster preparation. 14. The process according to claim 13 in which the diagnostically useful additives are present in micro-encapsulated form. 15. The process according to claim 13 or 14, in which the signal is development of a visible color, a fluorescent signal, an ultraviolet signal, a phosphorescent signal or a luminescent signal. 16. The process according to claim 13 or 14 in which the diagnostically useful additives are used in a quantity of 0.0001 to 10 wt.- %. 17. The process according to claim 16 in which the support material comprises: (A) 30 to 96.9999 wt.- % of at least one N-alkylaziridinopolyether with a molecular mass in the range of 1,000 to 20,000 g/mol and an aziridino equivalent mass in the range of 500 to 8,000 g/equivalent, (B) 1 to 10 wt.- % starter substances, which are suitable to effect the curing of the N-alkylaziridinopolyethers, (C) 1 to 50 wt.- % organic diluting agents, and (D) 1 to 50 wt.- % of at least one modifier, selected from the group consisting of fillers, dyes, pigments, thixotropes, flow improvers, polymeric thickeners, surfactants, fragrances, and flavourings. 18. The process according to claim 13 in which the support material is an impression material based on N-alkylaziridinopolyether. 19. A method for simultaneous examination of multiple intraoral loci for the presence of at least one specific substance comprising: i) taking an impression of the oral cavity, or apart thereof, of a subject with a deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material, wherein at least one diagnostically useful additive is useful for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate mouth diseases or healing processes; ii) optionally applying to the oral cavity or to the impression at least one further diagnostically effective additive; and iii) obtaining a signal from said diagnostically effective additive(s) at multiple intraoral loci. 20. The method of claim 19, wherein the specific substance that is detected is one that is diagnostic for caries, early onset parodontitis, prepubertal parodontitis, juvenile parodontitis, rapid progressive parodontitis (RPP), adult parodontitis, refractory parodontitis, gingivitis, halitosis, infections with Candida albicans, Candida krusei, Candida glabrata, Candida iusitaniae, Candida dubliniensis or cancer. 21. The method of claim 19 in which the specific substance is a substance that induces one or more cytokines. 22. The method of claim 21 in which the diagnostically effective additive is a monoclonal or polyclonal antibody that specifically binds to a lipopolysaccharide, a lipoarabinomannan, a peptidoglycan, a teichoic acid derivative, an extracellular polysaccharide, lipid A, interleukin-1, interleukin-2, interleukin-3, interleukin-4, interleukin-5, interleukin-6, interleukin-7, interleukin-8, tumor necrosis factor .alpha., interferon .alpha., interferon .beta., interferon .gamma., colony-forming factors M-CSF, epidermal growth factor, transforming growth factor .alpha., the chemokine MCP, an arachidonic acid derivative, or prostaglandin E.sub.2. 23. The method of claim 19, in which the diagnostically effective additive is a substrate for an enzyme selected from the group consisting of alkaline phosphatase, arylsulphatase, aspartataminotransferase, .beta.-glucuronidase, cathepsin G, cathepsin B, cathepsin D, elastase, hyaluronidase, lactate-dehydrogenase, lysocyme, a matrix metal proteinase, a collagenase, a gelatinase, a tissue inhibitor of a metal proteinase, stomelysin, lactoferrin, tryptase and myeloperoxidase that produces a color reaction. 24. The method of claim 19, in which the diagnostically effective additive is a pH indicator or a calcium indicator. 25. The method of claim 19 in which the image is transferred to a positive impression. 26. A deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material, wherein at least one diagnostically useful additive is used for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate mouth diseases or healing processes, wherein the composition is in the form of polymerizable liquid that can be applied by spraying into the oral cavity or painting upon a surface of the oral cavity. 27. A method for producing a diagnostic image of the oral cavity comprising: i) applying to the oral cavity, or a part thereof, of a subject a deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material, wherein at least one diagnostically useful additive is useful for intraoral locus-specific detection of pathogenic substances and/or microorganisms or for intraoral locus-specific detection of substances that indicate growth mouth diseases or healing processes; optionally applying to the oral cavity or to the impression at least one further diagnostically effective additive; and iii) imaging the diagnostic signal(s) produced by the diagnostically effective additive(s) thereby producing a diagnostic image of the oral cavity. 28. A deformable, curable, or film-forming composition comprising: a deformable, curable or film-forming support material, wherein the support material comprises a material that is (i) an impression material or film based on silicon, polyether-silicon, polyether, alginate or hydrocolloid, (ii) a polyethylene, polypropylene, poly(meth)acrylate, polyurethane, polycarbonate, polysulphide or polyvinylchloride plastic, (iii) a rubber composition, (iv) a polyvinylpyrrolidone-based or polyvinylalcohol-based hydrogel, or (v) a dental plaster preparation; and at least one diagnostically useful additive for locus-specific and substance-specific intraoral diagnosis that provides such diagnostic result without a cultivation step and presents the diagnostic result by signal development in or upon the surface of the support material or by binding of a detectable agent to the support material.

Details for Patent 7,175,430

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	05/05/2004		2019-06-11
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	12/02/2004		2019-06-11
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	10/26/2004		2019-06-11
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	10/25/2005		2019-06-11
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2019-06-11