Hemostatic compositions for treating soft tissue

• US 5,785,955 A
• Filed: 09/10/1997
• Issued: 07/28/1998
• Est. Priority Date: 02/23/1995
• Status: Expired due to Term

• Current Assignee: Dan E. Fischer
• Original Assignee: Dan E. Fischer
• Inventors: Fischer, Dan E.
• Primary Examiner(s): Killos, Paul J.
• Application Number:
  US08/926,866
• Time in Patent Office: 321 Days
• Field of Search: 424/49
• US Class Current: 424/49
• CPC Class Codes: A61K 8/23 Sulfur; Selenium; Tellurium; Compounds thereof
• CPC Class Codes: A61K 8/26 Aluminium; Compounds thereof
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A hemostatic composition for controlling oral bleeding or providing gingival tissue fluid control, which includes a hemostatic agent, a chemical agent for reducing the acidic activity of the hemostatic agent, and an aqueous base. The hemostatic compositions are useful in treating wounds in soft tissues in general. The hemostatic composition can be used to stop bleeding or control gingival tissue fluid flow without opening up the dentinal tubules in the dentin of a tooth that has been cut during dental restorative and reconstructive procedures. The hemostatic composition is also less aggressive and more gentle when used to treat wounds in soft tissues in general. The chemical agent is preferably an inorganic filler or high molecular weight polyol that reduces the acidic or other chemical activity of the hemostatic agent. This allows the smear layer plugs in the dentinal tubules to remain substantially intact to occlude passage of potentially harmful contaminants into the tubules and hence into the dental pulp. It also reduces inflammation and other irritating affects in soft tissue when using the hemostatic composition.

Claims

1. A hemostatic composition comprising:

(a) a quantity of a hemostatic agent selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alums, permanganates, tannins, and mixtures thereof;

(b) an effective amount of an inorganic filler for increasing the viscosity of the hemostatic composition and for reducing acidic activity of the hemostatic agent;

(c) a polyol for assisting the inorganic filler in reducing the acidic activity of the hemostatic agent, the polyol being selected from the group consisting of polyethylene glycol, propylene glycol, dipropylene glycol, polypropylene glycol, glycerine, sorbitol, and mixtures thereof; and

(d) an aqueous base.

2. A hemostatic composition as defined in claim 1, wherein the hemostatic agent is present in an amount in a range from about 1% to about 40% by weight of the hemostatic composition.

3. A hemostatic composition as defined in claim 1, wherein the inorganic filler and polyol are present together in an amount in a range from about 0.2% to about 80% by weight of the hemostatic composition.

5. A hemostatic composition as defined in claim 1, wherein the inorganic filler comprises a silica-based absorbing agent.

7. A hemostatic composition as defined in claim 1, wherein the polyol has a molecular weight of at least about 600.

8. A hemostatic composition as defined in claim 1, wherein the polyol has a molecular weight greater than about 1000.

9. A hemostatic composition as defined in claim 1, wherein the hemostatic composition has increased hemostatic activity upon agitating the hemostatic composition.

4. A hemostatic composition as defined in 1, wherein the inorganic filler is present in an amount in a range from about 0.1% to about 30% by weight of the hemostatic composition.

6. A hemostatic composition as defined in 1, wherein the inorganic filler is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, aluminum oxide, titanium dioxide, and mixtures thereof.

10. A hemostatic composition comprising:

(a) a quantity of a hemostatic agent selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alums, permanganates, tannins, and mixtures thereof;

(b) an effective amount of a high molecular weight polyol for increasing the viscosity of the hemostatic composition and for reducing acidic activity of the hemostatic agent, the high molecular weight polyol having a molecular weight of at least about 600 and being selected from the group consisting of polyethylene glycol, polypropylene glycol, and mixtures thereof; and

(c) an aqueous base.

11. A hemostatic composition as defined in claim 10, wherein the hemostatic composition further includes an inorganic filler which assists the high molecular weight polyol in increasing the viscosity of the hemostatic composition and in reducing the acidic activity of the hemostatic agent.

14. A hemostatic composition as defined in claim 10, wherein the hemostatic agent is present in an amount in a range from about 1% to about 40% by weight of the hemostatic composition.

15. A hemostatic composition as defined in claim 10, wherein the high molecular weight polyol is present in an amount in a range from about 0.1% to about 50% by weight of the hemostatic composition.

16. A hemostatic composition as defined in claim 10, wherein the high molecular weight polyol has a molecular weight of at least about 1000.

17. A hemostatic composition as defined in claim 10, wherein the hemostatic composition has increased hemostatic activity upon agitating the hemostatic composition.

12. A hemostatic composition as defined in 11, wherein the inorganic filler is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, aluminum oxide, titanium dioxide, and mixtures thereof.

13. A hemostatic composition as defined in 11, wherein the inorganic filler is present in an amount in a range from about 0.1% to about 30% by weight of the hemostatic composition.

18. A hemostatic composition comprising:

(a) a quantity of a hemostatic agent selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alums, permanganates, tannins, and mixtures thereof;

(b) an effective amount of an inorganic filler for increasing the viscosity of the hemostatic composition and for reducing acidic activity of the hemostatic agent;

(c) a polyol for assisting the inorganic filler in increasing the viscosity of the hemostatic composition and in reducing the acidic activity of the hemostatic agent, the polyol having a molecular weight greater than about 600 and being selected from the group consisting of polyethylene glycol, polypropylene glycol, and mixtures thereof; and

(d) an aqueous base.

19. A hemostatic composition as defined in claim 18, wherein the hemostatic agent is included in an amount in a range from about 1% to about 40% by weight of the hemostatic composition.

20. A hemostatic composition as defined in claim 18, wherein the inorganic filler is included in an amount in a range from about 0.1% to about 30% by weight of the hemostatic composition.

21. A hemostatic composition as defined in claim 18, wherein the inorganic filler is a silica-based absorbing agent.

22. A hemostatic composition as defined in claim 18, wherein the inorganic filler is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, aluminum oxide, titanium dioxide, and mixtures thereof.

23. A hemostatic composition as defined in claim 18, wherein the hemostatic composition has increased hemostatic activity upon agitating the hemostatic composition.

24. A hemostatic composition as defined in claim 18, wherein the polyol has a molecular weight greater than about 1000.

25. A hemostatic composition comprising:

(a) a ferric salt compound in an amount in a range from about 1% to about 40% by weight of the hemostatic composition;

(b) a silica-based absorbing agent in an amount in a range from about 0.1% to about 30% by weight of the hemostatic composition;

(c) a polyol selected from the group consisting of polyethylene glycol, propylene glycol, dipropylene glycol, polypropylene glycol, glycerine, sorbitol, and mixtures thereof, the polyol included in an amount in a range about 0.1% to about 50% by weight of the hemostatic composition; and

(d) water in an amount in a range from about 1% to about 80% by weight of the hemostatic composition.

26. A hemostatic composition as defined in claim 25, wherein the ferric salt compound is selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, and mixtures thereof.

27. A hemostatic composition as defined in claim 25, wherein the silica-based absorbing agent is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, and mixtures thereof.

28. A hemostatic composition as defined in claim 25, wherein the polyol has a molecular weight greater than about 600.

29. A hemostatic composition as defined in claim 25, wherein the polyol has a molecular weight of at least about 1000.

30. A hemostatic composition as defined in claim 25, wherein the hemostatic composition has increased hemostatic activity upon agitating the hemostatic composition.

31. A system for promoting healing of wounds comprising:

(a) a hemostatic composition including;

(i) about 1% to about 40% by weight of a hemostatic agent selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alums, permanganates, tannins, and mixtures thereof;

(ii) about 0.1% to about 30% by weight of a silica-based absorbing agent;

(iii) about 0.1% to about 50% by weight of a polyol selected from the group consisting of polyethylene glycol, propylene glycol, propylene glycol, dipropylene glycol, glycerine, sorbitol, and mixtures thereof; and

(iv) a quantity of water; and

(b) an applicator device capable of applying the hemostatic composition under pressure to an area of bleeding, the applicator device including a padded porous tip through which the hemostatic composition may be delivered to provide agitation of the hemostatic composition when applying the hemostatic tissue to the area of bleeding.

32. A system as defined in claim 31, wherein the silica-based absorbing agent is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, and mixtures thereof.

33. A system as defined in claim 31, wherein the polyol has a molecular weight of at least about 600.

34. A system as defined in claim 31, wherein the polyol has a molecular weight of at least about 1000.

35. A system as defined in claim 31, wherein the hemostatic composition has increased hemostatic activity upon agitating the hemostatic composition.

36. A method for stopping bleeding comprising the steps of:

(a) placing an effective quantity of a hemostatic composition onto a bleeding or wounded area, the hemostatic composition having increased hemostatic activity upon agitating the hemostatic composition, the hemostatic composition including;

(i) a quantity of a hemostatic agent selected from the group consisting of ferric sulfate, ferric subsulfate, ferric chloride, zinc chloride, aluminum chloride, aluminum sulfate, aluminum chlorohydrate, aluminum acetate, alums, permanganates, tannins, and mixtures thereof;

(ii) an effective amount of an inorganic filler for increasing the viscosity of the hemostatic composition and for reducing acidic activity of the hemostatic agent;

(iii) a polyol for assisting the inorganic filler in reducing the acidic activity of the hemostatic agent, the polyol being selected from the group consisting of polyethylene glycol, propylene glycol, dipropylene glycol, polypropylene glycol, glycerine, sorbitol, and mixtures thereof; and

(iv) an aqueous base; and

(b) burnishing the bleeding or wounded area so as to agitate the hemostatic composition to increase the hemostatic activity of the hemostatic composition.

37. A method as defined in claim 36, wherein the hemostatic agent is included in an amount in a range from about 1% to about 40% by weight of the hemostatic composition.

38. A method as defined in claim 36, wherein the inorganic filler and polyol are included in a combined amount in a range from about 0.1% to about 80% by weight of the hemostatic composition.

39. A method as defined in claim 36, wherein the inorganic filler is included in an amount in a range from about 0.1% to about 30% by weight of the hemostatic composition.

40. A method as defined in claim 36, wherein the inorganic filler is selected from the group consisting of colloidal silica, fumed silica, ground silica, precipitated silica, aluminum oxide, titanium dioxide, and mixtures thereof.

41. A method as defined in claim 36, wherein the polyol is included in an amount in a range from about 0.1% to about 50% by weight of the composition.

42. A method as defined in claim 36, wherein the polyol has a molecular weight of at least about 600.

43. A method as defined in claim 36, wherein the polyol has a molecular weight greater than about 1000.