OXYGEN SENSOR

• US 20110288389A9
• Filed: 03/02/2010
• Published: 11/24/2011
• Est. Priority Date: 03/02/2009
• Status: Abandoned Application

• Current Assignee: Seventh Sense Biosystems, Inc.
• Original Assignee: Seventh Sense Biosystems, Inc.
• Inventors: Levinson, Douglas A., Bernstein, Howard
• Application Number:
  US12/716,222
• Publication Number:
  US 20100249560A1
• Time in Patent Office: Days
• US Class Current: 600/364
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

The present invention generally relates to systems and methods for determining oxygen in a sample, or in a subject. In one aspect, the present invention is generally directed to an article exhibiting a determinable feature responsive to oxygen, such as oxygen-sensitive particles. The particles may exhibit a determinable change with a change in oxygen concentration, and such particles can accordingly be used to determine oxygen. For example, in one set of embodiments, the particles may be at least partially coated with a protein, such as hemoglobin, that is able to interact with oxygen. In some cases, the protein may aggregate under certain conditions (e.g., under relatively low oxygen concentrations), and such protein aggregation may be used, for example, to cause the particles to become aggregated, which can be determined in some way. In some cases, such aggregation may be irreversible; i.e., the degree of aggregation corresponds to the most extreme oxygen concentrations that the proteins were exposed to. Such articles may be used, for example, to determine oxygen within a sample, or within a subject, such as a human subject. For instance, the article may be formed as a skin patch, or administered to the skin of a subject, e.g., on the surface of the skin, within the dermis or epidermis, etc., to determine oxygen within the subject.

Claims

1. A device able to determine localized oxygen proximate the skin when the device is applied to the skin of a subject.

2. The device of claim 1, wherein at least a portion of the device is at least partially inserted into the skin.

3. The device of claim 1, wherein the device comprises a patch.

4. The device of claim 3, wherein the patch comprises an adhesive layer.

5. The device of claim 3, wherein the patch comprises a substantially oxygen-impermeable layer.

6. The device of claim 3, wherein the patch comprises a layer comprising particles.

7. The device of claim 1, wherein the device comprises particles.

8. The device of claim 7, wherein the device consists essentially of particles.

9. The device of claim 7, wherein the device is completely insertable into the skin of the subject.

10. The device of claim 7, wherein the particles have an average diameter of less than about 1 mm.

11. The device of claim 7, wherein the particles have an average diameter of less than about 100 micrometers.

12. The device of claim 7, wherein at least some of the particles are nanoparticles.

13. The device of claim 7, wherein at least some of the particles are anisotropic.

14. The device of claim 7, wherein at least some of the particles comprise a polymer.

15. The device of claim 7, wherein at least some of the particles comprise a biodegradable polymer.

16. The device of claim 7, wherein at least some of the particles comprise a hydrogel.

17. The device of claim 7, wherein at least some of the particles comprise an semiconductive material.

18. The device of claim 7, wherein at least some of the particles are spherical.

19. The device of claim 7, wherein at least some of the particles contain at least two distinct surface regions including at least a first surface region and a second surface region.

20. The device of claim 19, wherein the first surface region comprises an oxygen-sensitive agent.

21. The device of claim 20, wherein the agent exhibits increasing aggregation with decreasing oxygen concentration.

22. The device of claim 19, wherein the first surface region comprises a protein.

23. The device of claim 22, wherein the protein is hemoglobin.

24. The device of claim 22, wherein the protein is sickle cell hemoglobin.

25. The device of claim 21, wherein the agent exhibits different degrees of polymerization when exposed to different oxygen concentrations.

26. The device of claim 21, wherein the agent exhibits at least about 10% polymerization when exposed to blood within the subject containing a concentration of oxygen less than about 90% of the saturation oxygen concentration of the blood.

27. The device of claim 1, wherein at least a portion of the device exhibits a determinable change upon a change in localized oxygen concentration.

28. The device of claim 27, wherein the determinable change is a change in color.

29. The device of claim 27, wherein the determinable change is a change in temperature.

30. The device of claim 27, wherein the determinable change is determinable by the unaided human eye.

31. The device of claim 1, wherein the device is able to determine localized oxygen in the dermis of the skin.

32. The device of claim 1, wherein the device is able to determine localized oxygen in the epidermis of the skin.

33. The device of claim 1, wherein the device is able to determine localized oxygen in interstitial fluid within the skin.

34. The device of claim 1, wherein the device is able to determine localized oxygen proximate the skin.

35. A device at least partially insertable into the skin of a subject, the device able to determine oxygen concentration proximate at least a portion of the skin of the subject.

36. A skin patch exhibiting a determinable feature responsive to oxygen when the skin patch is applied to a subject.

37. A device containing a plurality of agents that exhibit increasing aggregation with decreasing oxygen concentration.

38. An article, comprising:

a plurality of particles at least partially coated with sickle-cell hemoglobin.

39. An article, comprising:

a liquid containing a plurality of agents that are able to aggregate when the concentration of oxygen within the liquid is less than about 90% of the saturation oxygen concentration of the liquid, but are not able to substantially aggregate when the liquid is saturated with oxygen.

40. An article, comprising:

a plurality of particles coated with a polymer that exhibits at least about 10% polymerization when exposed to blood containing a concentration of oxygen less than about 90% of the saturation oxygen concentration of the blood.

41. A method, comprising:

determining blood oxygen in a subject by administering an oxygen-sensitive agent to the subject.

42. The method of claim 41, wherein the subject is suspected or at risk of having sleep apnea.

43. The method of claim 41, wherein the subject is an infant.

44. The method of claim 41, wherein the subject is suspected or at risk of having pressure ulcers or blisters.

45. The method of claim 41, wherein the subject is human.

46. The method of claim 41, wherein the subject is suspected or at risk of having bed sores.

47. The method of claim 41, wherein the oxygen-sensitive agent comprises particles.

48. The method of claim 47, wherein at least some of the particles are at least partially coated with hemoglobin.

49. The method of claim 48, wherein the hemoglobin is sickle cell hemoglobin.

50. The method of claim 41, wherein the oxygen-sensitive agent is able to determine the lowest blood oxygen concentration experienced by the subject.

51. The method of claim 41, comprising administering the oxygen-sensitive agent to the skin of the subject.

52. The method of claim 51, comprising inserting the oxygen-sensitive agent into the skin of the subject.

53. The method of claim 51, comprising inserting the oxygen-sensitive agent into the dermis of the subject.

54. The method of claim 51, comprising inserting the oxygen-sensitive agent into the epidermis of the subject.

55. The method of claim 47, comprising:

creating a suction blister in the skin of the subject; and

inserting the oxygen-sensitive agent into the suction blister.

56. The method of claim 41, wherein the oxygen-sensitive agent is applied to the skin of the subject.

57. The method of claim 56, further comprising examining the skin where the oxygen-sensitive agent was applied to determine blood oxygen in the subject.

58. The method of claim 57, further comprising identifying a color or color change in the skin where the oxygen-sensitive agent was applied to determine blood oxygen in the subject.

59. The method of claim 41, further comprising determining a change in a property of the oxygen-sensitive agent.

60. The method of claim 41, comprising determining a change in color of the oxygen-sensitive agent.

61. A method, comprising:

determining blood oxygen in a subject by applying a skin patch to the subject.

62. A method, comprising:

applying an oxygen-sensitive agent to a tissue in vitro.