Method and apparatus for analyte sensing

• US 7,226,414 B2
• Filed: 10/03/2003
• Issued: 06/05/2007
• Est. Priority Date: 10/09/2002
• Status: Expired due to Fees

• Current Assignee: BioTex Incorporated
• Original Assignee: BioTex Incorporated
• Inventors: Gowda, Ashok, McNichols, Roger, Ballerstadt, Ralph
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/678,814
• Publication Number:
  US 20040072358A1
• Time in Patent Office: 1,341 Days
• Field of Search: None
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: G01N 33/5432 Liposomes or microcapsules
• CPC Class Codes: G01N 33/54326 Magnetic particles
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

In one aspect, the present invention is directed to a glucose sensing device for implantation within subcutaneous tissue of an animal body. In one embodiment, the glucose sensing device includes a first chamber containing first magnetic particles and a hydrocolloid solution (for example, ConA-dextran hydrocolloid) wherein the first magnetic particles are dispersed in the hydrocolloid solution. In operation, glucose within the animal may enter and exit the first chamber and the hydrocolloid solution changes in response to the presence or concentration of glucose within the first chamber. The sensing device also includes a reference chamber containing second magnetic particles and a reference solution wherein the second magnetic particles are dispersed in the reference solution. The reference solution (for example, oil or alcohol compounds) includes a known or fixed viscosity. The reference solution may also be a hydrocolloid solution (for example, ConA-dextran hydrocolloid). The first and/or second magnetic particles may include amine-terminated particles, at least one rare earth element (for example, neodymium or samarium), and/or a ferromagnetic material.

Claims

1. A glucose sensor for implantation within subcutaneous tissue of an animal body, the glucose sensor comprising:

a first chamber containing (i) first magnetic particles and (ii) a first hydrocolloid solution having a viscosity which is dependent on and/or a function of the concentration of glucose in the first chamber, wherein the first magnetic particles are dispersed in the first hydrocolloid solution and wherein, when the first chamber is implanted in subcutaneous tissue of the animal body, glucose in the animal body may enter and exit the first chamber; and

a reference chamber containing (i) second magnetic particles and (ii) a reference solution wherein the second magnetic particles are dispersed in the reference solution, and wherein, when the reference chamber is implanted in subcutaneous tissue of the animal body, glucose in the animal body does not enter the reference chamber.

2. The glucose sensor of claim 1 wherein the first hydrocolloid solution is a ConA-dextran hydrocolloid.

3. The glucose sensor of claim 2 wherein first hydrocolloid solution includes a combination of any glucose specific lectin, other glucose-specific binding protein, a glucose-containing glycoconjugate, or mannose-containing glycoconjugate.

4. The glucose sensor of claim 1 wherein the reference solution is a second hydrocolloid solution.

5. The glucose sensor of claim 4 wherein the second hydrocolloid solution is a ConA-dextran hydrocolloid.

6. The glucose sensor of claim 5 wherein second hydrocolloid solution includes a combination of any glucose specific lectin, other glucose-specific binding protein, a glucose-containing glycoconjugate, or mannose-containing glycoconjugate.

7. The glucose sensor of claim 1 wherein the first and second magnetic particles are amine-terminated particles.

8. The glucose sensor of claim 7 wherein the amine-terminated particles having a mean diameter of about 1 μ

m.

9. The glucose sensor of claim 1 wherein the first and second magnetic particles include at least one rare earth element.

10. The glucose sensor of claim 9 wherein the at least one rare earth element is selected from the group consisting of neodymium and samarium.

11. The glucose sensor of claim 1 wherein the first and second magnetic particles are selected from the group consisting of neodymium, samarium, neodymium-iron-boron, samarium-cobalt, iron, permalloy, superpermalloy, cobalt, nickel, steel, and alnico.

12. The glucose sensor of claim 1 wherein the first and second magnetic particles include a ferromagnetic material.

13. The glucose sensor of claim 1 wherein the first chamber includes a semipermeable membrane.

14. The glucose sensor of claim 1 wherein the first chamber includes a semipermeable membrane comprising regenerated cellulose, polyurethane, polysulfone or other material that is capable of unrestricted glucose in and efflux.

15. The glucose sensor of claim 1 wherein the first chamber is a dialysis hollow fiber having semipermeable membrane properties.

60. The glucose sensor of claim 1 wherein the hydrocolloid solution includes a known viscosity and the reference solution includes a constant viscosity.

61. The glucose sensor of claim 1 wherein the hydrocolloid solution includes a known viscosity and the reference solution includes a known viscosity.

62. The glucose sensor of claim 1 wherein the reference solution includes oil or alcohol compounds.

63. The glucose sensor of claim 1 wherein the first magnetic particles are amine-terminated particles.

64. The glucose sensor of claim 63 wherein the amine-terminated particles having a mean diameter of about 1 μ

m.

65. The glucose sensor of claim 1 wherein the first magnetic particles include at least one rare earth element.

66. The glucose sensor of claim 1 wherein the first magnetic particles include a ferromagnetic material.

16. A glucose sensing system comprising:

a glucose sensor which is implanted in subcutaneous tissue of an animal body, the glucose sensor including;

a first chamber containing (i) first magnetic particles and (ii) a hydrocolloid solution having a viscosity which is dependent on and/or a function of the concentration of glucose in the first chamber, wherein the first magnetic particles are dispersed in the hydrocolloid solution and wherein, when the first chamber is implanted in subcutaneous tissue of an animal body, glucose in the animal body may enter and exit the first chamber; and

a reference chamber containing (i) second magnetic particles and (ii) a reference solution wherein the second magnetic particles are dispersed in the reference solution; and

instrumentation to determine data which is representative of a change in viscosity of the hydrocolloid solution in the first chamber.

17. The glucose sensing system of claim 16 wherein the hydrocolloid solution includes a known viscosity.

18. The glucose sensing system of claim 16 wherein the reference solution includes a constant viscosity.

19. The glucose sensing system of claim 16 wherein the reference solution includes a known viscosity.

20. The glucose sensing system of claim 16 wherein the reference solution includes oil or alcohol compounds.

21. The glucose sensing system of claim 16 wherein the hydrocolloid solution is a ConA-dextran hydrocolloid.

22. The glucose sensing system of claim 16 wherein the hydrocolloid solution includes any glucose specific lectin, other glucose-specific binding protein, a glucose-containing glycoconjugate, or mannose-containing glycoconjugate.

23. The glucose sensing system of claim 16 wherein the first magnetic particles are amine-terminated particles.

24. The glucose sensing system of claim 23 wherein the amine-terminated particles having a mean diameter of about 1 μ

m.

25. The glucose sensing system of claim 16 wherein the first magnetic particles include at least one rare earth element.

26. The glucose sensing system of claim 16 wherein the first magnetic particles include a ferromagnetic material.

27. The glucose sensing system of claim 16 wherein the first chamber includes a semipermeable membrane.

28. The glucose sensing system of claim 16 wherein the first chamber includes a semipermeable membrane comprising regenerated cellulose, polyurethane, polysulfone or other material that is capable of unrestricted glucose in and efflux.

29. The glucose sensing system of claim 16 wherein the first chamber is a dialysis hollow fiber having semipermeable membrane properties.

30. A glucose sensor for measuring the concentration of glucose in a fluid medium, the glucose sensing comprising:

a first chamber containing (i) first magnetic particles and (ii) a hydrocolloid solution having a viscosity which is dependent on and/or a function of the concentration of glucose in the first chamber, wherein the first magnetic particles are dispersed in the hydrocolloid solution and wherein, when the first chamber is in fluidic contact with the fluid medium, glucose from the fluid medium may enter and exit the first chamber; and

a reference chamber containing (i) second magnetic particles and (ii) a reference solution wherein the second magnetic particles are dispersed in the reference solution, and wherein, when the reference chamber is in fluidic contact with the fluid medium, glucose from the fluid medium does not enter the reference chamber.

31. The glucose sensor of claim 30 wherein the hydrocolloid solution includes a known viscosity.

32. The glucose sensor of claim 30 wherein the reference solution includes a constant viscosity.

33. The glucose sensor of claim 30 wherein the reference solution includes a known viscosity.

34. The glucose sensor of claim 30 wherein the reference solution includes oil or alcohol compounds.

35. The glucose sensor of claim 30 wherein the hydrocolloid solution is a ConA-dextran hydrocolloid.

36. The glucose sensor of claim 30 wherein the hydrocolloid solution includes any glucose specific lectin, other glucose-specific binding protein, a glucose-containing glycoconjugate, or mannose-containing glycoconjugate.

37. The glucose sensor of claim 30 wherein the first magnetic particles are amine-terminated particles.

38. The glucose sensor of claim 37 wherein the amine-terminated particles having a mean diameter of about 1 μ

m.

39. The glucose sensor of claim 30 wherein the first magnetic particles include at least one rare earth element.

40. The glucose sensor of claim 30 wherein the first magnetic particles include a ferromagnetic material.

41. The glucose sensor of claim 30 wherein the first chamber includes a semipermeable membrane.

42. The glucose sensor of claim 30 wherein the first and second magnetic particles include at least one rare earth element.

43. The glucose sensor of claim 42 wherein the at least one rare earth element is selected from the group consisting of neodymium and samarium.

44. The glucose sensor of claim 30 wherein the first and second magnetic particles are selected from the group consisting of neodymium, samarium, neodymium-iron-boron, samarium-cobalt, iron, permalloy, superpermalloy, cobalt, nickel, steel, and alnico.

45. The glucose sensor of claim 30 wherein the first and second magnetic particles include a ferromagnetic material.

46. The glucose sensor of claim 30 wherein the viscosity of the first hydrocolloid solution changes in response to the presence of glucose.

47. The glucose sensor of claim 30 wherein the first chamber includes a semipermeable membrane comprising regenerated cellulose, polyurethane, polysulfone, or other material that is capable of unrestricted glucose in and efflux.

48. The glucose sensor of claim 30 wherein the first chamber is a dialysis hollow fiber having semipermeable membrane properties.

49. A glucose sensor for measuring the concentration of glucose in a fluid, the glucose sensing comprising:

a first chamber;

a first plurality of magnetic particles disposed in the first chamber;

a first solution disposed in the first chamber, wherein the first solution includes a viscosity which is dependent on and/or a function of the concentration of glucose in the first chamber; and

wherein the first plurality of magnetic particles are dispersed in the first solution and wherein, when the first chamber is in fluidic contact with the fluid, glucose in the fluid may enter and exit the first chamber.

50. The glucose sensor of claim 49 wherein the first solution includes a hydrocolloid.

51. The glucose sensor of claim 50 wherein the hydrocolloid is a solution of glucose-binding molecules and macromolecules.

52. The glucose sensor of claim 51 wherein the macromolecules are glucose-terminated or mannose-terminated.

53. The glucose sensor of claim 51 wherein the glucose binding molecules are Concanavalin A and the macromolecules are dextran.

54. The glucose sensor sensing of claim 51 wherein the device further includes a semipermeable membrane wherein the first chamber is enclosed by the semipermeable membrane.

55. The glucose sensor of claim 54 wherein the semipermeable membrane is a hollow cellulose acetate dialysis fiber.

56. The glucose sensor of claim 51 further including:

a second chamber, wherein the second chamber includes a second solution and a second plurality of magnetic particles; and

wherein the second plurality of magnetic particles are dispersed in the second solution.

57. The glucose sensor of claim 56 wherein second solution is a hydrocolloid, an oil, or an alcohol.

58. The glucose sensor of claim 56 further including an impermeable membrane wherein the second chamber is enclosed by the impermeable membrane.

59. The glucose sensor of claim 49 wherein the first plurality of magnetic particles are capable of moving within the first solution.