Hemostatic composition

• US 7,670,623 B2
• Filed: 05/31/2002
• Issued: 03/02/2010
• Est. Priority Date: 05/31/2002
• Status: Expired due to Term

• Current Assignee: Materials Modification Inc.
• Original Assignee: Materials Modification Inc.
• Inventors: Kotha, Sanjay, Sudarshan, Tirumalai S.
• Primary Examiner(s): VU, JAKE MINH
• Application Number:
  US10/157,921
• Publication Number:
  US 20030224056A1
• Time in Patent Office: 2,832 Days
• Field of Search: 424/400, 424/489, 424/490, 600/9, 600/12
• US Class Current: 424/489
• CPC Class Codes: A61K 38/4833 Thrombin (3.4.21.5)
• CPC Class Codes: A61K 38/4846 Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
• CPC Class Codes: A61K 9/501 Inorganic compounds
• CPC Class Codes: A61K 9/5094 Microcapsules containing magnetic carrier material, e.g. ferrite for drug targeting
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Abstract

A hemostatic composition includes a carrier medium including a predetermined amount of a particulate material. The particulate material is comprised of core particles with a coating. The core particles have an average particle size of about 5 nm to 10 μm, and the coating is one of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, or a combination thereof.

Claims

1. A hemostatic composition suitable for controlling external or internal bleeding in a subject, comprising:

a) a biocompatible and non-toxic carrier medium selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

b) a predetermined amount of a particulate material in said medium;

c) said particulate material comprising core particles with a coating;

d) said core particles having an average particle size of about 5 nm to 10 μ

m;

e) the concentration of said particulate material being about 0.1% to 70% (w/w) of the composition;

f) said coating comprising procoagulant molecules; and

g) said core particles comprise a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof; and

h) an optional surfactant or dispersant.

2. The composition of claim 1, wherein:

a) said core particles have an average particle size of about 10 nm to 1 μ

m.

3. The composition of claim 1, wherein:

a) said core particles have an average particle size of about 10 nm to 300 nm.

4. The composition of claim 1, wherein:

a) said core particles comprise a general shape selected from the group consisting of a sphere, a needle, a cube, an oval, irregular, a cylinder, a diamond, and a combination thereof.

5. The composition of claim 1, wherein:

a) said core particles comprise clusters.

6. The composition of claim 1, wherein:

a) said core particles comprise the general shape of blood platelets.

7. The composition of claim 1, wherein:

a) said coating has a thickness of about 1 nm to 1 μ

m.

8. The composition of claim 1, wherein:

a) said coating has a thickness of about 5 nm to 50 nm.

9. The composition of claim 1, wherein:

a) said procoagulant molecules are selected from the group consisting of thrombin, Factor VII a, and a combination thereof.

10. The composition of claim 1, wherein:

a) said particulate material is non-toxic to bio-cells or biomolecules.

25. The composition of claim 1, wherein:

a) said coating further comprises a biocompatible and non-toxic member selected from the group consisting of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, and a combination thereof.

30. The composition of claim 25, wherein:

a) said polymer is selected from the group consisting of polyethylene glycol, dextran, Tween, sorbitol, mannitol, and a combination thereof.

11. A magnetic hemostatic fluid suitable for controlling external or internal bleeding in a subject, comprising:

a) a biocompatible and non-toxic carrier fluid selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

b) a predetermined amount of a magnetic particulate material in said carrier fluid;

c) said particulate material comprising core particles with a coating having a thickness of about 1 nm to 10 μ

m;

d) said core particles having an average particle size of about 5 nm to 10 μ

m;

e) the concentration of said particulate material being about 0.1% to 70% (w/w) of the hemostatic fluid;

f) said core particles comprising a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof;

g) said coating comprising procoagulant molecules; and

h) an optional surfactant or dispersant.

12. The hemostatic fluid of claim 11, wherein:

a) said core particles have an average particle size of about 10 nm to 1 μ

m.

13. The hemostatic fluid of claim 11, wherein:

a) said core particles have an average particle size of about 10 nm to 300 nm.

14. The hemostatic fluid of claim 11, wherein:

a) said core particles comprise a general shape selected from the group consisting of a sphere, a needle, a cube, an oval, irregular, a cylinder, a diamond, and a combination thereof.

15. The hemostatic fluid of claim 11, wherein:

a) said core particles comprise clusters.

16. The hemostatic fluid of claim 11, wherein:

a) said core particles comprise the general shape of blood platelets.

17. The hemostatic fluid of claim 11, wherein:

a) said coating has a thickness of about 5 nm to 50 nm.

18. The hemostatic fluid of claim 11, wherein:

a) said procoagulant molecules are selected from the group consisting of thrombin, Factor VII a, and a combination thereof.

19. The hemostatic fluid of claim 11, wherein:

a) said particulate material is non-toxic to bio-cells or biomolecules.

20. The hemostatic fluid of claim 11, wherein:

a) the magnetic particles comprise paramagnetic or superparamagnetic particles, or a combination thereof.

26. The hemostatic fluid of claim 11, wherein:

a) said coating further comprises a biocompatible and non-toxic member selected from the group consisting of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, and a combination thereof.

31. The hemostatic fluid of claim 26, wherein:

a) said polymer is selected from the group consisting of polyethylene glycol, dextran, Tween, sorbitol, mannitol, and a combination thereof.

21. A method of controlling bleeding in a subject in need thereof, comprising the steps of:

a) administering to a subject having internal or external bleeding a predetermined amount of a hemostatic fluid;

b) the hemostatic fluid, comprising;

i) a biocompatible and non-toxic carrier fluid selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

ii) a predetermined amount of a magnetic particulate material in the fluid;

iii) the particulate material comprising core particles with a coating having a thickness of about 1 nm to 10 μ

m;

iv) the core particles having an average particle size of about 5 nm to 10 μ

m;

v) the concentration of the particulate material being about 0.1% to 70% (w/w) of the hemostatic fluid;

vi) the core particles comprising a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof;

vii) the coating comprising; and

viii) an optional surfactant or dispersant;

c) applying a magnetic field adjacent the site of a lesion causing the bleeding so as to form a cluster of the particulate material for thereby controlling the flow of blood through the lesion.

27. The method of claim 21, wherein:

a) the coating further comprises a biocompatible and non-toxic member selected from the group consisting of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, and a combination thereof.

22. A hemostatic composition suitable for controlling external or internal bleeding in a subject, comprising:

a) a carrier medium selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

b) a predetermined amount of a particulate material in said medium;

c) said particulate material comprising core particles with a coating;

d) said core particles having an average particle size of about 5 nm to 10 μ

m;

e) the concentration of said particulate material being about 0.1% to 70% (w/w) of the composition;

f) said coating comprising procoagulant molecules;

g) said coating further comprising one polymer member selected from the group consisting of polyethylene glycol, dextran, Tween, sorbitol, mannitol, and a combination thereof; and

h) said core particles comprise a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof; and

i) an optional surfactant or dispersant.

23. A hemostatic composition suitable for controlling external or internal bleeding in a subject, comprising:

a) a carrier medium selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

b) a predetermined amount of a particulate material in said medium;

c) said particulate material comprising core particles with a coating;

d) said core particles having an average particle size of about 5 nm to 10 μ

m;

e) the concentration of said particulate material being about 0.1% to 70% (w/w) of the composition;

f) said coating comprising a member biocompatible and non-toxic to blood cells;

g) said member comprising procoagulant molecules; and

h) said core particles comprise a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof; and

i) an optional surfactant or dispersant.

28. The composition of claim 23, wherein:

a) said coating further comprises a member selected from the group consisting of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, and a combination thereof.

24. A hemostatic composition suitable for controlling external or internal bleeding in a subject, comprising:

a) a biocompatible and non-toxic carrier medium selected from the group consisting of water, saline solution, sugar solution, Lactose Ringers, blood plasma, and a combination thereof;

b) a predetermined amount of a particulate material in said medium;

c) said particulate material comprising core particles with a coating;

d) said core particles having an average particle size of more than 500 nm to about 10 μ

m;

e) the concentration of said particulate material being about 0.1% to 70% (w/w) of the composition;

f) said coating comprising procoagulant molecules; and

g) said core particles comprise a member selected from the group consisting of iron, iron oxide, cobalt, cobalt oxide, nickel, nickel oxide, and an alloy or a combination thereof; and

h) an optional surfactant or dispersant.

29. The composition of claim 24 wherein:

a) said coating further comprises a biocompatible and non-toxic member selected from the group consisting of gold, silica, silver, platinum, steel, cobalt, carbon, a polymer, and a combination thereof.