Ionic component sensor and method for making and using same

• US 5,081,042 A
• Filed: 03/20/1990
• Issued: 01/14/1992
• Est. Priority Date: 03/20/1990
• Status: Expired due to Term

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: 3M Company
• Inventors: Yan, Chong F., Yafuso, Masao
• Primary Examiner(s): Johnston, Jill
• Application Number:
  US07/496,561
• Time in Patent Office: 665 Days
• Field of Search: 422/82.06, 422/82.07, 422/82.08, 422/57, 422/58, 436/68, 436/172, 350/96.3, 350/96.33, 427/2, 356/39, 356/402, 356/410, 128/634, 385/12
• US Class Current: 436/68
• CPC Class Codes: G01N 2021/6434 Optrodes
• CPC Class Codes: G01N 2021/772 Tip coated light guide
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 31/221 for investigating pH value

Abstract

A composition of matter useful in a sensor for sensing the concentration of an ionic component a medium is disclosed. This composition comprises a first material including a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies, and a first matrix material, and a second material which includes a second matrix material which is compatible with the first matrix material, and an opague agent in an amount sufficient to render the second material effectively opaque. The first material and the second material are partially intermingled. Apparatus including such composition of matter and methods for making and using such compositions of matter are also disclosed.

Claims

1. A composition of matter useful in sensing the concentration of an ionic component in a medium comprising:

a first layer including a first matrix material which is solid and is permeable to the ionic component, and a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies; and

a second layer which includes a second matrix material which is solid, is permeable to the ionic component, and is compatible with said first matrix material, and an opaque agent in an amount sufficient to render said second layer effectively opaque, said first layer and said second layer being partially intermingled to form an intermingled zone;

wherein said second layer and said intermingled zone are formed by solubilizing said second matrix material in a liquid medium, contacting said first layer with said liquid medium such that a portion of said first matrix material in said first layer is also solubilized in said liquid medium, and solidifying the solubilized first matrix material and the solubilized second matrix material such that said solidified first matrix material and a portion of said solidified second matrix material form said intermingled zone and the remainder of said solidified second matrix material forms said second layer.

2. The composition of claim 1 wherein both said first matrix material and said second matrix material are polymeric.

3. The composition of claim 1 wherein said first matrix material and said second matrix material have substantially the same chemical composition.

4. The composition of claim 1 wherein both said first matrix material and said second matrix material are cellulose.

5. The composition of claim 1 wherein both said first matrix material and said second matrix material are cellulose and said liquid medium is an aqueous basic medium.

6. The composition of claim 5 wherein said liquid medium includes a basic component selected from the group consisting of metal hydroxides, organic amines and mixtures thereof.

7. The composition of claim 1 wherein the ionic component is H⁺ or OH^-.

8. The composition of claim 1 wherein said sensing component is an optical indicator.

9. The composition of claim 1 wherein said sensing component is a fluorescence indicator.

10. The composition of claim 1 wherein said sensing component is selected from the group consisting of hydroxypyrene trisulfonic acid, derivatives of hydroxypyrene trisulfonic acid, and mixtures thereof.

11. The composition of claim 1 wherein said second layer acts to substantially optically isolate at least a portion of said first layer.

12. The composition of claim 1 wherein the ratio of the thickness of the first layer to the thickness of the intermingled zone is within the range of from about 1:

0.005 to about 1;

0.25.

13. An apparatus useful in sensing the concentration of an ionic component in a medium comprising:

sensor means comprising a first layer which includes a first matrix material which is solid and is permeable to the ionic component and a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies, and a second layer which includes a second matrix material which is solid, is permeable to the ionic component, and is compatible with said first matrix material and an opaque agent in an amount sufficient to render said second layer effectively opaque, said first and second layers being partially intermingled to form an intermingled zone;

wherein said second layer and said intermingled zone are formed by solubilizing said second matrix material in a liquid medium, contacting said first layer with said liquid medium such that a portion of said first matrix material in said first layer is also solubilized in said liquid medium, and solidifying the solubilized first matrix material and the solubilized second matrix material such that said solidified first matrix material and a portion of said solidified second matrix material form said intermingled zone and the remainder of said solidified second matrix material forms said second layer; and

signal means capable of transmitting said signal from said sensing component.

14. The apparatus of claim 13 wherein said sensing component is an optical indicator and said signal means comprises an optical fiber.

15. The apparatus of claim 14 wherein both said first matrix material and said second matrix material are cellulose and said liquid medium is an aqueous basic medium.

16. The apparatus of claim 15 wherein said liquid medium includes a basic component selected from the group consisting of metal hydroxides, organic amines and mixtures thereof.

17. The apparatus of claim 14 wherein said optical indicator is spaced apart from said optical fiber.

18. The apparatus of claim 13 further comprising holder means includes a cavity having an open end and being sized and adapted to receive at least a portion of said first layer, said sensor means being structured and oriented so that said first layer is located away from said open end of said cavity.

19. The apparatus of claim 18 wherein said holder means is substantially transparent, and said second layer, together with said holder means, substantially completely surrounds said first layer.

20. The apparatus of claim 13 wherein the ratio of the thickness of the first layer to the thickness of the intermingled zone is within the range of from about 1:

0.005 to about 1;

0.25.

21. A method for sensing the concentration of an ionic component in a medium comprising:

contacting said medium with a composition comprising a first layer including a first matrix material which is solid and is permeable to the ionic component and a sensing component in an amount effective to provide a signal which varies as the concentration of said ionic component in said medium varies, and a second layer which includes a second matrix material which is solid, is permeable to the ionic component, and is compatible with said first matrix material and an opaque agent in an amount sufficient to render said second layer effectively opaque, said first layer and said second layer being partially intermingled to form an intermingled zone;

wherein said second layer and said intermingled zone are formed by solubilizing said second matrix material in a liquid medium contacting said first layer with said liquid medium such that a portion of said first matrix material in said first layer is also solubilized in said liquid medium, and solidifying the solubilized first matrix material and the solubilized second matrix material such that said solidified first matrix material and a portion of said solidified second matrix material form said intermingled zone and the remainder of said solidified second matrix material forms said second layer;

causing said sensing component to emit a signal which varies as the concentration of said ionic component in said medium varies; and

analyzing said signal to determine the concentration of said ionic component in said medium.

22. The method of claim 21 wherein said medium is blood.

23. The method of claim 21 wherein said ionic component is H⁺ or OH^-.

24. The method of claim 21 wherein said both first matrix material and said second matrix material are polymeric.

25. The method of claim 21 wherein both said first matrix material and said second matrix material are cellulose.

26. The method of claim 21 wherein both said first matrix material and said second matrix material are cellulose and said liquid medium is an aqueous basic medium.

27. The method of claim 21 wherein said sensing component is selected from the group consisting of hydroxypyrene trisulfonic acid, derivatives of hydroxypyrene trisulfonic acid, and mixtures thereof, and wherein said opaque agent is carbon black.

28. The method of claim 21 wherein the ratio of the thickness of the first layer to the thickness of the intermingled zone is within the range of from about 1:

0.005 to about 1;

0.25.

29. A method for making a sensor useful in sensing the concentration of an ionic component in a medium comprising:

applying to a surface of a first layer of liquid composition, said first layer comprising a first matrix material which is solid prior to said applying and a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies, said liquid composition comprising a liquid medium, an opaque agent, and a second matrix material which is compatible with said first matrix material and which is solubilized in said liquid medium, a portion of said first matrix material from said first layer becoming solubilized in said liquid medium upon said applying; and

solidifying the solubilized second matrix material and the solubilized first matrix material such that said solidified first matrix material and a portion of said solidified second matrix material form an intermingled zone and the remainder of said solidified second matrix material forms a second layer.

30. The method of claim 29 wherein both said first matrix material and said second matrix material are cellulose and said liquid medium is an aqueous basic medium.

31. The method of claim 30 wherein said aqueous basic medium includes an amine.

32. The method of claim 30 wherein said aqueous basic medium comprises water, cupric hydroxide and ethylene diamine.

33. The method of claim 29 which further comprises positioning said first layer in proximity to the optical surface of an optical fiber.

34. The method of claim 29 wherein both said first matrix material and said second matrix material are polymeric and wherein said first layer is positioned in a cavity of a sensor holder, said cavity having an open end.

35. The method of claim 29 wherein both said first matrix material and said second matrix material are cellulose.

36. The method of claim 35 wherein said solidifying step includes contacting said solubilized second matrix material and said solubilized first matrix material with an aqueous acidic medium.

37. The method of claim 29 wherein said first matrix material and said second matrix material have substantially the same chemical composition.

38. The method of claim 29 wherein the ratio of the thickness of the first layer to the thickness of the intermingled zone is within the range of from about 1:

0.005 to about 1;

0.25.

39. A method of making a sensor useful in sensing the concentration of an ionic component in a medium comprising:

applying to a surface of a first composition a second composition, said first composition comprising a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies and a first matrix material which is solid prior to said applying, said second composition comprising a liquid medium, an opaque agent, and a second matrix material which is compatible with said first matrix material and is solubilized in said liquid medium, a portion of said first matrix material from said first composition becoming solubilized in said liquid medium upon said applying, both said first matrix material and said second matrix material being cellulose, said liquid medium including a basic component selected from the group consisting of metal hydroxides, organic amines, and mixtures thereof; and

solidifying the solubilized second matrix material and the solubilized first matrix material.

40. A composition of matter useful in sensing the concentration of an ionic component in a medium comprising:

a first layer including a first matrix material which is solid and is permeable to the ionic component, and a sensing component in an amount effective to provide a signal which varies as the concentration of the ionic component in the medium varies; and

a second layer which includes a second matrix material which is solid, is permeable to the ionic component, and is compatible with said first matrix material, and an opaque agent in an amount sufficient to render said second layer effectively opaque, said first layer and said second layer being partially intermingled to form an intermingled zone;

wherein the ratio of the thickness of the first layer to the thickness of the intermingled zone is within the range of from about 1;

0.005 to about 1;

0.25.

41. The composition of claim 40 wherein the ionic component is H⁺ or OH^-.