Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing
Reexamination Certificate
1999-04-30
2001-08-28
Jones, Dameron L. (Department: 1616)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
C424S001110, C600S101000, C606S045000
Reexamination Certificate
active
06280702
ABSTRACT:
The invention relates to a permanent stain for marking of internal sites for endoscopic identification, e.g., in the gastrointestinal tract, bladder, or lungs. The invention also includes a method and kit for marking of the sites.
At present, there is an absence of FDA approved marking compositions formulated especially for use in endoscopy for the staining of internal sites in the body. Endoscopists have had to make do by adapting their techniques to use commercially available writing inks and other standard stains which are not approved for use in humans. Available approved stains are not permanent markers.
Endoscopic stains including Lugol's solution, methylene blue, toluidine blue, congo red, phenol red, indigo carmine and India ink are described by the American Society for Gastrointestinal Endoscopy (ASGE) in
Technology Assessment Status Evaluation, Endoscopic Tissue Staining and Tattooing,
published by American Society for Gastrointestinal Endoscopy, Manchester, Mass., October 1995. The only known permanent stain for endoscopic tattooing is India ink. The use of India ink to endoscopically label colonic lesions was first described by J. L. Ponsky and J. F. King,
Gastrointest Endosc.
1975, 22:42-3. India ink has also been used for marking esophageal lesions as described by R. T. Shaffer et al.,
Gastrointest. Endosc.
1998, 47:257-260.
It was found that other permanent fountain pen inks are not an acceptable substitute for commercially available India ink. E. L. Goldman,
Internet Medicine News,
Feb. 1, 1997, p. 50.
The compositions of various commercially available India inks and comparisons of their use in endoscopic tattooing of the colon have been described by P. S. Salomon et al.,
Gastrointest. Endosc.
1991, 39(6): 803-804. The composition of India ink made by Higgins (Faber-Castell, Lewisberg, Tenn.) is described as containing about 7% carbon pigment, 5% propylene glycol and smaller concentrations of shellac, ammonium hydroxide and surfactant and when the composition was diluted in equal parts (50:50) with bacteriostatic water, it caused an inflammatory response. The composition of India ink made by Pelikan (Hanover, Germany) is described as containing ethylene glycol, sodium tetraborate decahydrate, ammonia and gelatin, and when diluted in 1:10 dilution in sterile water, it caused an abscess. India ink made by Koh-I-Noor (Bloomsburg, N.J.) is described as composed of carbon particles (approximately 7% by weight) with stabilizing diluents present in all commercial products, including ethylene glycol methyltert-butyl ether (Methyl Carbitol), phenol, ammonium hydroxide and shellac, and was diluted 1:100 with 0.9% normal saline solution and successfully tested by Salomon et al. An attempt by Salomon et al. to test a “homemade” India ink of dry carbon pigment, 0.1% by weight mixed with normal saline solution was unsuccessful.
Although some endoscopists have found small volumes of India ink for tattooing of the colon to be safe (see, e.g., B. A. Shatz,
Gastrointest. Endosc.
1997, 45(2): 153-156), others have found complications following colonoscopic India ink injection. V. A. Botoman et al. 1994,
Dis. Colon Rectum
37:775-776; J. Lightdale,
Gastrointest. Endosc.
1991, 37(1): 99-100; S. I. Park et al.,
Gastrointest. Endosc.
1991, 37(1): 68-70.
Following reports of complications using India ink, some have looked for alternatives. A pure suspension of charcoal was tested for colonoscopic tattoo, using 5% weight/volume aqueous suspension of micronized charcoal particles. S. Naveau et al. 1991,
Gastrointest. Endosc.
1991, 37(6): 624-25. Indocyanine green was also used for the marking of lesions of the colon by D. C. Hammond, et al.,
The American Surgeon
1993, 59(3): 205-210, but this stain does not have long term permanence. Problems still remain in endoscopic tissue marking.
It is an object of the invention to provide an improved endoscopic tissue staining composition for permanent marking of internal sites in the body.
It is a further object of the invention to provide a staining composition which can be used at internal sites with no adverse effects.
SUMMARY OF THE INVENTION
An endoscopic tissue staining composition comprises carbon particles in a pharmaceutically acceptable delivery vehicle. The carbon is in an effective amount for substantially permanent staining of internal mucosa or other sites in the body, preferably in an amount from about 0.01% to 1.0% based on weight. In a preferred embodiment, the carbon particles are carbon black. Also in a preferred embodiment, the composition includes a suspending/viscosity-increasing agent in an amount sufficient for suspending the carbon particles in solution. Preferred suspending/viscosity-increasing agents include glycerol, propylene glycol, isopropylene glycol, polyethylene glycol or cellulose.
An embodiment of the invention includes a composition comprising carbon particles, suspending/viscosity-increasing agent, anti-foaming agent and surfactant, respectively in internal staining, suspending/viscosity-increasing, anti-foaming and surface-active amounts, prepared in a pharmaceutically acceptable vehicle, preferably water. The carbon preferably includes amorphous carbon powders such as carbon black and activated or unactivated (nonactivated) carbon. Carbon is “activated” by heating to about 800-900° C. resulting in a porous internal structure. “Unactivated” carbon is not treated this way. Preservative may also be added in anti-microbial amounts.
In a particularized embodiment, the composition comprises:
0.01% to 1.0% carbon, preferably 0.1% to 1.0%,
5% to 25% suspending/viscosity-increasing agent, preferably 10% to 20%,
0.005% to 0.05% anti-foaming agent, preferably 0.01% to 0.04%,
0.5% to 1.5% surfactant, preferably 0.75% to 1.25%,
zero to 2.0% preservative, preferably 0.5% to 1.5%, and
sufficient water, for example, about 70% to 90%, for a 100% composition. All percentages herein are based on weight. The carbon is carbon black, activated or unactivated carbon.
In a preferred embodiment, the suspending/viscosity-increasing agent is glycerol, the anti-foaming agent is simethicone, the surfactant is esterified polyoxyethylene sorbitan, and the anti-microbial is benzyl alcohol. Therefore this embodiment of the invention comprises
0.01% to 1.0% carbon, preferably 0.01% to 1.0%,
5% to 25% glycerol, preferably 10% to 20%,
0.005% to 0.05% simethicone, preferably 0.01% to 0.04%,
0.5% to 1.5% polyoxyethylene sorbitan esterified with fatty acid, preferably
0.75% to 1.25%,
zero to 2.0% benzyl alcohol, preferably 0.5% to 1.5%, and
sufficient water for a 100% composition.
The composition is used for marking internal sites, e.g., in the gastrointestinal tract, urinary bladder or bronchi.
A method for marking or tattooing of internal sites, e.g., in the gastrointestinal tract, urinary bladder or lungs for endoscopic identification includes injecting a staining amount of the composition of the invention comprising carbon black in a pharmaceutically acceptable delivery vehicle such as water. In another embodiment, the injected composition includes carbon, humectant, anti-foaming agent and surfactant, respectively in staining, wetting, anti-foaming, and surface-active amounts, injected in proximity to the site. Preferred embodiments for the method utilize the compositions of the inventions described above. In a particularized embodiment, the method for marking internal sites comprises injecting the site with a composition comprising
0.01% to 1.0% carbon, preferably 0.01% to 1.0%,
5% to 25% suspending/viscosity-increasing agent, preferably 10% to 20%,
0.005% to 0.05% anti-foaming agent, preferably 0.01% to 0.04%,
0.5% to 1.5% surfactant, preferably 0.75% to 1.25%,
zero to 2.0% preservative, preferably 0.5% to 1.5%, and sufficient water, for example, about 70% to 90%, for a 100% composition. The carbon is carbon black, activated or unactivated carbon.
In a preferred embodiment for a method of marking internal sites, the suspending/viscosity-increasing agent is glycerol, the anti-foaming agent is simethicone, the surf
Carter Frank C.
Jackson Frank W.
Whalen Robert G.
Chek-Med Systems, Inc.
Chovanes Eugene
Jones Dameron L.
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