Sensor including UV-absorbing polymer and method of manufacture

• US 6,413,393 B1
• Filed: 07/07/1999
• Issued: 07/02/2002
• Est. Priority Date: 07/07/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Minimed, Inc. (Medtronic Plc)
• Inventors: Van Antwerp, William P., Mastrototaro, John J.
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/348,771
• Time in Patent Office: 1,091 Days
• Field of Search: 204/415, 204/418, 204/416, 204/403, 356/32-35, 356/39, 356/93-50, 356/51, 422/68.1, 422/50, 422/52, 422/55-62, 422/82-1-, 422/82-5-, 435/4, 435/287.1, 435/287.9, 436/43, 436/149, 436/150, 436/164, 436/165, 600/345, 600/347, 600/348, 600/354
• US Class Current: 600/345
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A sensor is provided that includes at least one functional coating layer that includes a UV-absorbing polymer. Methods for making the inventive sensors are also provided.

Claims

1. An implantable sensor comprising at least one functional coating layer, wherein the functional coating layer includes a UV-absorbing polymer and is biocompatible with human and animal tissue and fluids surrounding the human and animal tissue;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

2. The sensor of claim 1 wherein said UV-absorbing polymer is a polyurethane, a polyurea, a polyurethane/polyurea copolymer, polymethacrylate, polyacrylic acid, polycarbonate, or mixtures of these polymers.

3. The sensor of claim 1 wherein said functional coating layer is selected from the group consisting of an analyte limiting layer, a layer that increases the slipperiness of said sensor, a layer that promotes cellular attachment to said sensor and a layer that reduces cellular attachment to said sensor.

4. The sensor of claim 1, wherein the UV-absorbing polymer is biocompatible with human and animal tissue.

5. A sensor comprising at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer selected from at least a polyurethane, a polyurea, a polyurethane/polyurea copolymer, polymethacrylate, polyacrylic acid, polycarbonate, and mixtures of these polymers and wherein said polymer is formed from a reaction mixture comprising a diisocyanate, at least one selected from the group consisting of a diol, a diamine and mixtures thereof, and a polyfunctional UV-absorbing monomer.

6. A sensor comprising a plurality of functional coating layers each of which comprises a UV-absorbing polymer.

7. A sensor comprising at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer, the sensor being substantially planar and further including a base layer, a cover layer and a sensor element disposed between said base and cover layers, wherein said cover layer has defined therein at least one opening above at least a portion of said sensor element and said base layer is comprised of a flexible material;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

8. A sensor comprising at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer, the sensor being substantially cylindrical and further including a base layer, a cover layer and a sensor element disposed between said base and cover layers, wherein said cover layer has defined therein at least one opening above at least a portion of said sensor element and said base layer is comprised of a flexible material;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

9. A sensor comprising at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer, the sensor further including a base layer, a cover layer and a conductive sensor element disposed between the base and cover layers, wherein the cover layer has defined therein at least one opening above at least a portion of the sensor element and wherein an enzyme is disposed in said opening;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

10. The sensor of claims 9 wherein said enzyme is selected from the group consisting of glucose oxidase, glucose dehydrogenase, lactose oxidase, hexokinase, lactose dehydrogenase.

11. The sensor of claim 10 wherein said enzyme is glucose oxidase.

12. A sensor comprising at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer, the sensor further including a base layer, a cover layer and a sensor element disposed between the base and cover layers, wherein said cover layer has defined therein a plurality of openings with at least one opening being above at least a portion of the sensor element;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

13. The sensor of claim 12 comprising a plurality of sensor elements, wherein at least one said opening is defined above at least a portion of each of said plurality of sensor elements.

14. The sensor of claim 13 wherein said plurality of sensor elements comprise at least two materials that are reactive with different preselected analytes.

15. The sensor of claim 12 further comprising a control sensor element including non-specifically reactive materials.

16. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least one functional coating layer, wherein said functional coating layer comprises a UV-absorbing polymer and is biocompatible; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

17. The sensor of claim 16 wherein said base layer is comprised of an insulative material.

18. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least functional coating layer wherein said functional coating layer comprise a UV-absorbing polymer and is a polyurethane, a polyurea or a polyurethane/polyurea copolymer; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

19. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least functional coating layer wherein said functional coating layer comprise a UV-absorbing polymer having a UV absorption of at least 0.3 AU based on a thickness of 4 mm at at least one wavelength between 400 nm and 100 nm; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

20. The sensor of claim 19 wherein said wavelength is 355 nm.

21. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least functional coating layer wherein said functional coating layer comprise a UV-absorbing polymer formed from a reaction mixture comprising a diisocyanate, at least one selected from the group consisting of a diol, a diamine and mixtures thereof, and a polyfunctional UV-absorbing monomer.

22. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least one functional coating layer, wherein said functional coaring layer comprises a UV-absorbing polymer and is selected from the group consisting of an analyte limiting layer, a biocompatible layer, a layer that increases the slipperiness of said sensor, a layer that promotes cellular attachment to said sensor and a layer that reduces cellular attachment to said sensor; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

23. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least two functional coating layers, each of which comprises a UV-absorbing polymer.

24. A sensor comprising:

a) a base layer comprised of a polyimide,

b) a sensor element disposed on said base layer,

c) a cover layer coveting said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least two functional coating layers wherein said functional coating layers comprise a UV-absorbing polymer.

25. A sensor comprising:

a) a base layer,

b) a sensor element disposed on said base layer,

c) a cover layer covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least two functional coating layers wherein said functional coating layers comprise a UV-absorbing polymer, wherein said cover layer is comprised of an insulative material.

26. A sensor comprising:

a) a base layer comprised of a polyimide,

b) a sensor element disposed on said base layer,

c) a cover layer comprised of an insulative material and covering said sensor element and having defined therein at least one opening above at least a portion of said sensor element, and

d) at least two functional coating layers wherein said functional coating layers comprise a UV-absorbing polymer.

27. A method of making a sensor comprising forming a functional coating layer from a UV-absorbing polymer, wherein the UV-absorbing polymer is biocompatible;

and wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

28. The method of claim 27, wherein said UV-absorbing polymer is a polyurethane, a polyurea or a polyurethane/polyurea copolymer.

29. The method of claim 27 wherein said functional coating layer is selected from the group consisting of an analyte limiting layer, a layer that increases the slipperiness of said sensor, a layer that promotes cellular attachment to said sensor and a layer that reduces cellular attachment to said sensor.

30. A method of making a sensor comprising forming at least two functional coating layers, each of said coating layers being formed from a UV-absorbing polymer.

31. A method of making a sensor comprising:

a) forming a base layer;

b) forming a sensor element on the base layer;

c) forming a cover layer covering the sensor element and at least a portion of the base layer;

d) defining at least one opening in the cover layer above at least a portion of the sensor element; and

e) forming a least one functional coating layer on the cover layer, wherein the functional coating layer includes a UV-absorbing polymer and is biocompatible; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

32. A sensor made by the method of claim 31.

33. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising UV-absorbing polymer, wherein said UV-absorbing polymer is a polyurethane, a polyurea or a polyurethane/polyurea copolymer; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

34. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising UV-absorbing polymer, wherein said UV-absorbing polymer has a UV-absorption of at least 0.3 AU based on a thickness of 4 mm at at least one wavelength between 400 nm and 100 nm; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

35. The method of claim 34 wherein said wavelength is 355 nm.

36. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising UV-absorbing polymer, wherein said UV-absorbing polymer is formed from a reaction mixture comprising a diisocyanate, at least one selected from the group consisting of a diol, a diamine and mixtures thereof, and a polyfunctional UV-absorbing monomer.

37. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising UV-absorbing polymer, wherein said functional coating layer is selected from the group consisting of an analyte limiting layer, a biocompatible layer, a layer that increases the slipperiness of said sensor, a layer that promotes cellular attachment to said sensor and a layer that reduces cellular attachment to said sensor; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

38. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least two functional coating layers on said cover layer, said at least two functional coating layers comprising a UV-absorbing polymer.

39. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layers on said cover layer, said functional coating layer comprising UV-absorbing polymer, wherein said sensor element is a conductive sensor element that is formed on said base layer; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

40. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising a UV-absorbing polymer, wherein said sensor element is formed by depositing on said base layer at least one material that is reactive with a preselected analyte; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

41. A method of making a sensor comprising the steps of:

a) forming a base layer,

b) forming a sensor element on said base layer,

c) forming a cover layer covering said sensor element and at least a portion of said base layer,

d) defining at least one opening in said cover layer above at least a portion of said sensor element, and

e) forming at least one functional coating layer on said cover layer, said functional coating layer comprising a UV-absorbing polymer, wherein at least two sensor elements are formed on said base layer prior to forming said cover layer; and

wherein the UV-absorbing polymer absorbs radiation in substantially the same range as an underlying layer.

42. The method of claim 41 wherein the at least two sensor elements comprise at least two materials that are reactive with different preselected analytes.

43. The method of claim 41 wherein at least two openings are defined in said cover layer, at least one said opening being defined above at least a portion of each of said plurality of sensor elements.

44. The method of claim 41 wherein a second sensor element, which is a-control sensor element formed from non-specifically reactive materials, is disposed on said base layer prior to forming said cover layer.

45. A sensor comprising a base layer and at least one functional coating layer over at least a portion of the base layer, wherein said functional coating layer comprises a UV-absorbing polymer that absorbs radiation in substantially the same range as the base layer.

46. The sensor of claim 45 wherein said UV-absorbing polymer has a UV absorption of at least 0.3 AU based on a thickness of 4 mm at least one wavelength between 400 nm and 200 nm.

47. The sensor of claim 46 wherein the functional coating layer and the base layer absorb radiation at approximately 355 nm.

48. The sensor of claim 45 wherein said UV-absorbing polymer is biocompatible.

49. The sensor of claim 48 wherein the sensor is in contact with human or animal tissue.

50. The sensor of claim 45 wherein the UV-absorbing polymer is a polyurethane, a polyurea, a polyurethane/polyurea copolymer, polymethacrylate, polyacrylic acid, polycarbonate, or mixtures of these polymers.

51. The sensor of claim 45 wherein the functional coating layer is selected from at least an analyte limiting layer, a biocompatible layer, a layer that increases the slipperiness of the sensor, a layer that promotes cellular attachment to the sensor and a layer that reduces cellular attachment to the sensor.