Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2003-09-18
2004-09-28
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S054000, C424S400000, C424S484000, C424S488000, C424S494000, C424S520000, C424S548000, C424S572000, C424S647000, C424S682000, C424S685000, C424S678000, C514S002600, C514S021800, C514S057000, C514S773000, C514S774000, C514S777000, C514S781000, C514S801000, C514S817000, C514S827000, C514S828000, C514S834000, C514S887000, C514S937000, C514S944000, C514S969000, C433S228100
Reexamination Certificate
active
06797260
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to hemostatic compositions and methods for their use, especially in dental procedures. More particularly, the present invention is directed to an improved hemostatic dental composition that can be applied to all dental tissues. In addition, the present invention is directed to hemostatic compositions which are versatile enough to be used to treat most types soft tissue.
Modern dentistry has become very sophisticated in the use of adhesives. “Bonding” is a word known to most patients. The bonding process is often used to improve the surface of a tooth by applying layers of “synthetic enamel” on the tooth to correct stained or damaged teeth. Blood will ruin the bonding seal to the tooth. Also, blood may be a problem in disease transfer. With bleeding in the dental environment, less is better.
After tissue disruption, such as an extraction, it is important to have the tissues heal and close sooner rather than later. Less patient discomfort allows for further medical and dental procedures to be performed sooner.
Hemostat products have evolved from limited use liquids to more controllable gels, but their applications are limited and may compromise bonding success.
Various hemostats and astringents have been used in dental procedures to control bleeding and aid in retraction of tissue. One of the most common hemostatic and retraction agents used in dentistry is an aqueous solution of aluminum chloride, marketed under a variety of trademarks by several manufacturers. Ferric salts have also been used as astringents, such as ferric subsulfate (Monsel's solution), ferric sulfate, and ferric chloride. A ferric sulfate solution is disclosed in U.S. Pat. No. 4,551,100, for use in the gingival area as a hemostatic agent having both coagulant and astringent properties. The solution was prepared from aqueous ferric sulfate having a concentration of about 6 to 20% in water and glycol. An astringent gel is disclosed in U.S. Pat. No. 4,617,950, which includes an astringent salt and a bodying agent such as carboxypolymethylene.
U.S. Pat. No. 4,395,398 is directed to a liquid dental hemostatic composition which comprises one or more astringents selected from the group consisting of aluminum chloride, tannic acid, ferric chloride, zinc chloride and potassium aluminum sulfate; one or more surfactants selected from the group consisting of cationic surfactants, anionic surfactants and nonionic surfactants; and a carrier or diluent selected from the group consisting of water and a mixture of water and one or more pharmaceutically acceptable water soluble organic solvents.
U.S. Pat. No. 4,597,960 discloses an astringent hemostatic preparation which is provided with a granulated hemostatic (a micron sized inorganic aluminum or ferric salt) encapsulated in a cellulose based, biocompatible polymer which is soluble in body fluids. The composition may be used intra orally or dermatologically. For intra oral purposes, the preferred composition is ferric sulfate microencapsulated in ethyl cellulose material.
U.S. Pat. No. 5,785,955 is directed to hemostatic dental compositions that include an aqueous base, a hemostatic agent that provides astringent action for stopping oral bleeding or providing gingival tissue fluid control, and a chemical binding or coating agent for reducing the acidic activity of the hemostatic agent sufficient to reduce substantial removal of the smear layer plugs in the dentinal tubules of a tooth. A preferred hemostatic agent is a ferric salt compound such as ferric sulphate.
Despite these efforts, there is still a need for an easy to use but versatile, effective, bleeding management solution, especially one that produces fewer side effects, including, but not limited to, avoiding or reducing heart rate stimulation, staining, acid irritations, adhesive interference, and handling difficulties.
Accordingly, it is a general object of the present invention to provide an improved bleeding control composition.
An advantage of the present invention is the provision of a composition which promotes sealing of tissue.
Another advantage of the present invention is the provision of a composition which promotes healing of tissue.
Another advantage of the present invention is the provision of a composition which adheres delicately to most instruments and easily transfers to soft tissue surfaces without remaining on the instrument.
SUMMARY OF THE INVENTION
In accordance with the present invention, a novel composition is provided which acts as a bleeding controller, sealer and healing agent. Compositions of the present invention have been shown to stop bleeding and seal open small blood vessels while accelerating the healing process of abraded oral “gum” and other “skin” (epithelial) tissues. The composition is preferably in the form of a paste which promotes application and use of the composition. The composition preferably comprises aluminum chloride, ferric sulfate (subsulfate), regenerated oxidized cellulose, aluminum ammonium sulfate, absorbable gelatin and a solvent. The composition has many other dental and medical applications. The composition has a pleasant gingerbread appearance and a sour pickle taste.
The present invention address the shortcomings of previous hemostatic alternatives. Compositions of the present invention exhibit versatility. The composition can be formulated as a paste, which applies and rinses away easily.
The composition is preferably a paste and not a liquid or gel, which makes it resistant to spilling or spattering accidents. The paste adheres delicately to most instruments while easily transferring to soft tissue surfaces without remaining on the instrument. To the extent, if any, there is occasional metal reaction on some instruments, the reaction product can be easily buffed away.
When the composition is formulated in the preferred embodiment as a paste it is more user-friendly than liquid or gel type hemostatic products. The product can be applied to cover extraction sites and in addition many other surface and sub-surface tissue applications. The paste can be applied before, during and after dental bonding procedures avoiding the need to redo the procedure.
The composition of the present invention provides other advantages including low tissue irritation, aids in achieving adhesion bonds, and improved healing. The use of the product on gum ulcerations reduces discomfort to the patient. When the need arises because of more difficult bleeding conditions, the paste embodying the present invention can be reapplied as necessary.
Compositions of the present invention stop bleeding problems after scaling or curetage. Patients using coumadin are susceptible to increased bleeding. The product is effective during blood thinner therapy. Moist paste can be readily blotted dry with various products.
Compositions of the present invention have been used in a variety of application procedures and no untoward side effects have been observed. Compositions of the present invention effectively seal bleeding small vessels encountered in all dental procedure situations. Compositions of the present invention can be useful in virtually all dental applications and many medical situations where it is desirable to control bleeding, or to promote tissue sealing or healing.
REFERENCES:
patent: 4395398 (1983-07-01), Yamamoto
patent: 4551100 (1985-11-01), Fischer
patent: 4597960 (1986-07-01), Cohen
patent: 4617950 (1986-10-01), Porteous et al.
patent: 4895517 (1990-01-01), Fischer
patent: 5011693 (1991-04-01), Whitefield
patent: 5447940 (1995-09-01), Harvey et al.
patent: 5635162 (1997-06-01), Fischer
patent: 5785955 (1998-07-01), Fischer
Chemical Abstracts 126: 207324 (1997).*
A Clinical Look at a New Gingval Retraction Material, A Supplement to Compendium of Continuing Education in Dentistry, vol. 23, No. 1 (Suppl), Jan. 2002, Dental Leaming Systems, Jamesburg, NJ.
Kerr, We've Sent Cord Packing, downloaded Feb. 18, 2001, www.kerrdental.com/Expa-Syl, p. 1-2.
Kerr, Expa-syl Features & Benefits, downloaded Feb. 18, 2001, www.k
Cook Alex McFarron Manzo Cummings & Mehler, Ltd.
Pak John
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