AUTOINJECTOR WITH DESHIELDER COMPRISING TAMPER EVIDENCE MEANS

• US 20100268169A1
• Filed: 09/25/2007
• Published: 10/21/2010
• Est. Priority Date: 09/25/2007
• Status: Active Grant

• Current Assignee: Becton Dickinson France (Becton Dickinson & Co)
• Original Assignee: Becton Dickinson France (Becton Dickinson & Co)
• Inventors: Maritan, Lionel, Llewellyn-Hyde, David, Rich, Vernon, Blanc, Jerome, Perot, Frederic, Abry, Herve
• Granted Patent: US 8,814,828 B2
• Time in Patent Office: Days
• US Class Current: 604/192
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

The invention relates to a device (1) for automatic injection of a product into an injection site, said device (1) further comprising a needle (6) and a needle shield (2) for protection of said needle (6) prior to use of said device, and a housing (300) receiving the container (50) and a deshielder (8) for removing said needle shield (2) from said device (1), said deshielder (8) being coupled to said needle shield (2) and being mounted on the housing (300) in a separable manner, for example through breakable or snap-fit means, said deshielder (8) comprising tamper evidence means that are activated by the removal of at least one part of said deshielder (8). Said at least one part of said deshielder (8) can be removed from the housing (300) by exerting a traction force equal or less to 30 N.

Claims

1. A method to determine the condition and/or identity of a functional fluid comprising

(1) obtaining a sample of the functional fluid;

(2) placing the sample of the functional fluid on a medium;

(3) contacting the functional fluid sample with a reagent solution wherein the solution comprises a redox indicator in combination with an acid reducing agent wherein the acid reducing agent comprises dithiophosphoric acid, a mixture of phosphoric acid and zinc dialkyldithio-phosphate, or combinations thereof;

(4) allowing the indicator in the reagent solution with the functional fluid sample on a medium to produce a color change;

(5) analyzing the results of the reaction by determining or comparing the resultant color change; and

(6) determining the condition or identity of the functional fluid;

wherein the reagent solution is sprayed onto the sample using a pump type sprayer, an aerosol spray, or a mister.

2. The method of claim 1 wherein the functional fluid is selected from the group consisting of automatic transmission fluids, engine oils, traction drive transmission fluids, manual transmission fluids, power steering fluids, antifreeze fluids, lubricating oils, greases, crankcase lubricants, mineral oils, oils with Group 1, 2, 3 or 4 base oils, differential lubricants, turbine lubricants, gear lubricants, gear box lubricants, axle lubricants, brake fluids, farm tractor fluids, transformer fluids, compressor fluids, cooling system fluids, metal working fluids, hydraulic fluids, industrial fluids, fuels, continuously variable transmission fluid, infinitely variable transmission fluids, and mixtures thereof.

3. The method of claim 1 wherein the functional fluid is selected from the group consisting of automatic transmission fluids, power steering fluids, air compressors lubricants, turbine lubricants and engine oils.

4. The method of claim 1 wherein the concentration of oxidizing species in the functional fluid is at least a concentration greater than about 1 ppm calculated as hydrogen peroxide.

5. The method of claim 1 wherein the total base number (TBN) of the basic components in the functional fluid is at least greater than about 0.1 TBN calculated as milligrams of KOH per gram of sample.

6. The method of claim 1 wherein the reagent is used in the range of about 0.001 wt. % to about 5 wt % of the solution applied to the medium.

7. The method of claim 1 wherein the redox indicator is selected from the Group consisting of neutral red, safranine T or O, indigo, indigo carmine, methylene blue, thionine, thymolindophenol, 2,6-dichlorophenolindophenol, gallocyanine, nile blue, variamine blue, diphenyl amine, diphenylamine-4-sulfonic acid, barium salt, tris(2,2dipyridyl)iron(II) sulfate, N-phenylanthranilic acid, ferroin, nitroferroin, 5,6-dimethylferroin, 4-amino-4′

-methyldiphenylamine, diphenylbenzindine-disulfonic acid, o-dianisidine, 3,3′

-dimethylnaphthidine, 3,3′

-dimethylnaphthidine disulfonic acid, bis(5-bromo-1,10-phenanthroline)ruthenium(II) dinitrate, tris(5-nitro-1,10-phenanthroline)iron(II) sulfate, Iron(II)-2,2′

,2″

-tripyridine sulfate, tris(4,7-biphenyl-1,10-phenanthroline)iron(II) disulfate, o,m′

-diphenylaminedicarboxylic acid setopaline, p-nitrodiphenylamine, tris(1,10-phenanthroline)-iron(II) sulfate, setoglaucine O, xylene cyanole FF, erioglaucine A, eriogreen, tris(2,2′

-bipyridine)-iron(II) hydrochloride, 2-carboxydiphenylamine [N-phenyl-anthranillic acid], benzidine dihydrochloride, o-toluidine, bis(1,10-phenanthroline)-osmium(II) perchlorate, diphenylamine-4-sulfonate Na salt), 3,3′

-dimethoxybenzidine dihydrochloride [o-dianisidine], ferrocyphen, 4′

-ethoxy-2,4-diaminoazobenzene, N,N-diphenylbenzidine, diphenylamine, N,N-dimethyl-p-phenylenediamine, variamine blue B hydrochloride, N-phenyl-1,2,4-benzenetriamine, Bindschedler'"'"'s green, 2,6-dichloroindophenol (Na salt), 2,6-dibromophenolindophenol, brilliant cresyl blue [3-amino-9-dimethyl-amino-10-methylphenoxyazine chloride], iron(II)-tetrapyridine chloride, starch (soluble potato, I₃ present), gallocyanine (25°

C.), nile blue A [aminonaphthodiethylamino-phenoxazine sulfate], indigo-5,5′

,7,7′

-tetrasulfonic acid (Na salt), Indigo-5,5′

,7-trisulfonic acid (Na salt), indigo-5,5′

-disulfonic acid (Na salt), phenosatranine, Indigo-5-monosulfonic acid (Na salt), bis(dimethylglyoximato)-iron(II) chloride, induline scarlet, and mixtures thereof.

8. The method of claim 1 wherein the indicator is selected from the group consisting of methylene blue, p-nitrodiphenyl-amine, N,N-diphenylbenzidine, diphenyl-amine, neutral red, and mixtures thereof.

9. The method of claim 1 wherein the reagent solution further comprises (i) an acid/base indicator selected from the group consisting of malachite green, brilliant green, methyl green, picric acid, cresol red, crystal violet, metanil yellow, m-cresol purple, thymol blue, p-xylenol blue, thymol blue sodium salt, quinaldine red, tropaeolin OO, 2,6-dinitrophenol, phloxine B, 2,4-dinitrophenol, 4-dimethylaminoazobenzene, bromochlorophenol blue, bromophenol blue, bromophenol blue sodium salt, congo red, methyl orange, 2,5-dinitrophenol, 1-naphthyl red, bromocresol green, bromocresol green sodium salt, alizarin S, methyl red, methyl red sodium salt, bromophenol red, chlorophenol red, hematoxylin, litmus, bromocresol purple, 4-nitrophenol, bromoxylenol blue, alizarin, bromothymol blue, bromothymol blue sodium salt, nitrazine yellow, phenol red, phenol red sodium salt, cresol red, 3-nitrophenol, neutral red, 1-naphtholphthalein, o-cresolphthalein, phenolphthalein, thymolphthalein, alizarin yellow GG, alkali blue, epsilon blue, indigo carmine, nile blue A and acid fuchsin and mixtures thereof.

10. The method of claim 1 wherein the reagent solution further comprises (i) a metal indicator selected from the group consisting of alizarin complex-one, alizarin S, arsenazo III, aurintricarboxylic acid, 2,2′

-bipyidine, bromopyrogallol red, calcon (eriochrom blue black R), calconcarboxylic acid, chrome azurol S, chromotropic acid, disodium salt, cuprizone, 5-(4-dimethylamino-benzyl idene)rhodanine, dimethylglyoxime, 1,5-diphenylcarbazide, dithizone, eriochrome black T, eriochrome blue SE, eriochrome blue black B, eriochrome cyanine R, fluorescein complexone, glyoxalibis(2-hydroxylanil), hematoxylin, 8-hydroxyquinoline, 2-mercaptobenzothiazole, methylthymol blue, murexide, 1-nitroso-2-naphthol, 2-nitroso-1-naphthol, nitroso-R-salt, 1,10-phenanthroline, phenylfluorone, phthalein purple, 1-(2-pyridylazo)-naphthol, 4-(2-pyridylazo)resorcinol, pyrogallol red, sulfonazo III, 5-sulfosalicylic acid, 4-(2-thiazolylazo)resorcinol, thorin, thymolthalexon, tiron, toluene-3,4-dithiol, xylenol orange, zincon, malachite green, brilliant green, methyl green, picric acid, cresol red, crystal violet, metanil yellow, m-cresol purple, thymol blue, p-xylenol blue, thymol blue sodium salt, quinaldine red, tropaeolin OO, 2,6-dinitrophenol, phloxine B, 2,4-dinitrophenol, 4-dimethylaminoazobenzene, bromochlorophenol blue, bromophenol blue, bromophenol blue sodium salt, congo red, methyl orange, 2,5-dinitrophenol, 1-naphthyl red, bromocresol green, bromocresol green sodium salt, alizarin S, methyl red, methyl red sodium salt, bromophenol red, chlorophenol red, hematoxylin, litmus, bromocresol purple, 4-nitrophenol, bromoxylenol blue, alizarin, bromothymol blue, bromothymol blue sodium salt, nitrazine yellow, phenol red, phenol red sodium salt, cresol red, 3-nitrophenol, neutral red, 1-naphtholphthalein, o-cresolphthalein, phenolphthalein, thymolphthalein, alizarin yellow GG, alkali blue, epsilon blue, indigo carmine, nile blue A and acid fuchsin and mixtures thereof.

12. The method of claim 1 wherein the medium is compatible with the reagent indicator and the medium comprises paper, cellulosic material, chromatography paper, filter paper, polymeric fibers, natural fibers, fabrics, polypropylene woven fabric, nonwoven fabric, metal, glass, plastic, composite materials, and combinations thereof.

13. The method of claim 1 wherein the analysis occurs after an effective period to allow for the reaction between functional fluid and indicator in the reagent solution.

14. The method of claim 1 wherein the reaction is in the range of about immediate to about 1 hour.

15. The method of claim 1 wherein determining the condition of the functional fluid is selected from the group consisting of visually comparing the sample against a set of comparative visual indicia depicting the functional fluid and at least one different condition as a guide, using printed instructions as a guide, comparing photographs depicting at least one different condition, and combinations thereof.

18. The method of claim 1 wherein the aerosol spray uses a propellant and the propellant is selected from the group consisting of nitrogen, hydrocarbons, propane and butane, chlorofluorocarbons (CFCs), hydrocarbons, propane, n-butane, isobutene, dimethyl ether (DME), methylethyl ether, nitrous oxide, hydrofluoro-alkanes (HFA), HFA 134a (1,1,1,2-tetrafluorethane), HFA 227 (1,1,1,2,3,3,3-heptafluoropropane), saturated light hydrocarbons, C₃-C₆, propane, isobutene, nbutane, CFC-11, HCFC-22, HCFC-142b, dimethyl ether CFC-11, HCFC-22, HCFC-142b, HCFC-152a, HFC-125, CFC-11, HCFC-22, HCFC-142b, HFC-227 ea, CFC-11, CFC-12, CFC-114, HCFC-22, HCFC-142b, compressed gases, carbon dioxide, air, nitrogen, nitrous oxide, SF6, fluorinated dimethyl ethers, Bis(difluoromethyl) ether, vinyl chloride monomer, and mixtures thereof.

11. (canceled)

16. (canceled)

17. (canceled)

19. (canceled)

20. A diagnostic kit for the analysis of functional fluids comprising a medium, a liquid, a semi liquid, an aerosol or mist containing a reagent solution, and a method to determine the identity and/or the quality of the condition of the fluid selected from the group consisting of instruction, pictures, drawings, photographs, and combinations thereof;

wherein the reagent solution comprises a redox indicator in combination with an acid reducing agent;

wherein the acid reducing agent comprises dithiophosphoric acid, a mixture of phosphoric acid and zinc dialkyldithiophosphate, or combinations thereof;

further comprising a pump type sprayer, an aerosol spray, a mister, or mixtures thereof which is used to apply the reagent to the medium.

21. The diagnostic kit of claim 20 wherein the indicator in the reagent solution produces a color change in response to reacting with the functional fluid.

22. The diagnostic kit of claim 20 further comprising a set of comparative visual indicia comprising two representations of a functional fluid disposed upon a same, similar or different media and wherein one is in acceptable condition and wherein the other is in unacceptable condition.

23. The diagnostic kit of claim 20 wherein the functional fluid is selected from the group consisting of automatic transmission fluids, traction drive transmission fluids, engine oils, manual transmission fluids, brake fluid, power steering fluids, antifreeze fluids, lubricating oils, greases, crankcase lubricants, mineral oils, oils with Group 1, 2, 3 or 4 base oils, differential lubricants, turbine lubricants, gear lubricants, gear box lubricants, axle lubricants, farm tractor fluids, transformer fluids, compressor fluids, cooling system fluids, metal working fluids, hydraulic fluids, industrial fluids, and mixtures thereof.

24. A method to determine the condition or identity of a functional fluid comprising

a. obtaining a sample of a functional fluid;

b. placing the sample of the functional fluid upon a medium;

c. contacting, spraying and/or atomizing an appropriate reagent solution with or on the media that contains the sample of the functional fluid to be tested;

d. waiting for an effective period of time to allow for the reaction between the components of the functional fluid and an indicator or marker in the reagent solution; and

e. making a visual determination of the sample of the functional fluid on the medium using the printed instructions and/or comparative visual indicia depicting the functional fluid in various conditions;

wherein the reagent solution comprises a redox indicator in combination with an acid reducing agent;

wherein the acid reducing agent comprises dithiophosphoric acid, a mixture of phosphoric acid and zinc dialkyldithiophosphate, or combinations thereof; and

wherein the reagent solution is sprayed onto the sample using a pump type sprayer, an aerosol spray, or a mister.