Implantable pressure sensors

• US 7,028,550 B2
• Filed: 12/28/2004
• Issued: 04/18/2006
• Est. Priority Date: 12/11/2003
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark, Costello, Benedict James
• Primary Examiner(s): Noori, Max
• Assistant Examiner(s): Ellington, Alandra
• Application Number:
  US11/025,657
• Publication Number:
  US 20050160823A1
• Time in Patent Office: 476 Days
• Field of Search: 737/15, 73700-756
• US Class Current: 73/715
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: G01L 9/0042 Constructional details associated with semiconductive diaphragm sensors, e.g. etching, or constructional details of non-semiconductive diaphragms details about the integration or bonding of piezoresistor in or on the diaphragm G01L9/0052 and G01L9/0057 respectively
• CPC Class Codes: G01L 9/0055 bonded on a diaphragm
• CPC Class Codes: G01L 9/045 with electric temperature compensating means non electric temperature compensating means G01L19/04
• CPC Class Codes: G01L 9/065 with temperature compensating means non electric temperature compensating means G01L19/04

Abstract

Implantable pressure sensors and methods for making and using the same. A feature of at least some of the subject pressure sensors is that they are low-drift sensors. Additional features of representative pressure sensors include the presence of at least one strain transducer that is fabricated from a stable gauge material. The subject pressure sensors find use in a variety of applications.

Claims

1. An implantable pressure sensor structure comprising:

a substrate formed with an opening;

a compliant member mounted on said substrate and spanning said opening in a manner such that said compliant member has first and second opposing exposed surfaces; and

at least first and second strain transducers positioned on the same surface or opposing surfaces of said compliant member so that their outputs respond oppositely to deflection of said compliant member resulting from differential pressure across said complaint member but respond similarly to deformation of said substrate;

wherein said first and second strain transducers comprise piezoresistors fabricated from a stable gauge material and covered by a passivating layer; and

wherein said pressure sensor structure is a low-drift pressure sensor structure.

2. The structure according to claim 1, wherein said structure further comprises an integrated circuit.

3. The structure according to claim 1, wherein said substrate comprises an opening and said compliant member spans said opening.

4. The structure according to claim 1, wherein said structure exhibits a drift of no more than about 1 mmHg/year.

5. The structure according to claim 1, wherein said structure exhibits little or no drift over a period of from about 1 to about 40 years.

6. The structure according to claim 1, wherein said structure has a length along an edge of no more than about 500 μ

m and width of nor more than about 100 μ

m.

7. The structure according to claim 1, wherein said structure has a sensitivity sufficient to measure pressure changes of about ±

1 mmHg.

8. The structure according to claim 1, wherein said stable gauge material comprises platinum.

9. The structure according to claim 8, wherein said stable gauge material is pure platinum.

10. The structure according to claim 8, wherein said stable gauge material is a platinum alloy.

11. The structure according to claim 1, wherein said passivating layer has a thickness ranging from about 50 nm to about 100 nm.

12. The structure according to claim 1, wherein said passivating layer comprises silicon nitride.

13. The structure according to claim 1, wherein said compliant member comprises single crystal silicon.

14. The structure according to claim 1, wherein said first and second strain transducers are positioned on the same surface of said compliant member.

15. The structure according to claim 14, wherein said first and second strain transducers are positioned symmetrically on said same surface on opposite sides of a line of symmetry.

16. The structure according to claim 15, wherein said first and second strain transducers are positioned adjacent to each other on a surface of said compliant member on one side of a line of symmetry.

17. The structure according to claim 1, wherein said first and second transducers are positioned on opposing surfaces of said compliant member.

18. The structure according to claim 17, wherein said structure further comprises third and fourth strain transducers on opposing surfaces of said compliant member.

19. The structure according to claim 18, wherein said third and fourth strain transducers are piezoresistors.

20. The structure according to claim 17, wherein said first and second strain transducers are directly opposed to each other.

21. The structure according to claim 1, wherein said structure further comprises a boss member on at least one surface of said compliant member.

22. The structure according to claim 1, wherein said structure further comprises first and second boss members on opposing surfaces of said compliant member.

23. The structure according to claim 18, wherein said structure further comprises third and fourth strain transducers on opposing surfaces of said compliant member.

24. The structure according to claim 23, wherein said structure further comprises first and second boss members on opposing surfaces of said compliant member.

25. The structure according to claim 1, wherein said compliant member is positioned at least proximal to said structure'"'"'s neutral plane.

26. The structure according to claim 25, wherein said structure comprises an upper rim member positioned on a top surface of said compliant member.

27. The structure according to claim 25, wherein said second exposed surface bounds an enclosed volume in said substrate.

28. The structure according to claim 25, wherein said second exposed surface bounds an open volume in said substrate.

29. The structure according to claim 1, wherein said at least one strain transducer is separated from said surface of said compliant member by a spacer.

30. The structure according to claim 29, wherein said spacer separates said sensor from said compliant member by a distance ranging from about from about 1 to about 1,000 μ

m.

31. The structure according to claim 29, wherein said structure comprises two or more transducers each separated from said surface by a spacer.

32. A system comprising:

a conductive member; and

a physiological pressure sensor operatively coupled to said conductive member, wherein said physiological pressure sensor comprises a pressure sensor structure according to claim 1.

33. The system according to claim 32, wherein said system comprises a plurality of said physiological pressure sensors operatively coupled to said conductive member.

34. The system according to claim 32, wherein said system further comprises an energy source coupled to said conductive member.

35. The system according to claim 32, wherein said system further comprises a processing element for determining pressure changes in a volume in response to output signals from said transducer.

36. The system according to claim 32, wherein said system is configured to be implanted into a patient.

37. The system according to claim 36, wherein said system is configured so that said sensor is positioned on a heart wall upon implantation into a patient.

38. A method for fabricating a pressure-sensor structure, said method comprising:

positioning a layer of a compliant material on a surface of a first substrate; and

producing at least one strain transducer on a first surface of said compliant material opposite said substrate to produce a pressure-sensor structure according to claim 1;

wherein said pressure sensor structure is a low-drift pressure sensor.

39. The method according to claim 38, wherein said method is a microfabrication method.

40. The method according to claim 39, wherein said method comprises a photolithographic method.

41. The method according to claim 38, wherein said method further comprises producing a boss member on said first surface of said compliant layer.

42. The method according to claim 38, wherein said method further comprises coupling said structure to a conductive member.

43. A method for detecting a pressure change in a volume, said method comprising:

contacting a pressure sensor structure according to claim 1 with said volume;

obtaining an output signal from said pressure sensor; and

using said output signal to detect a pressure change in said volume.

44. The method according to claim 43, wherein said volume is present in a subject.

45. The method according to claim 44, wherein said subject is a human.

46. The method according to claim 45, wherein said method comprises implanting said pressure sensor structure in said human.

47. The method according to claim 44, wherein said volume is a cardiovascular volume.

48. The method according to claim 47, wherein said cardiovascular volume is a heart chamber.

49. The method according to claim 47, wherein said cardiovascular volume is in an artery.

50. The method according to claim 44, wherein said method is a method of monitoring a condition in a subject.

51. The method according to claim 50, wherein said method comprises monitoring said condition remotely.

52. The method according to claim 50, wherein said condition is a cardiovascular condition.

53. The method according to claim 44, wherein said method is employed in a method of one of:

a) treating a subject for heart failure;

b) performing cardiac resynchronization in a subject;

c) managing arrhythmia in a subject;

d) detecting ischemia in a subject;

e) treating a subject for coronary artery disease;

f) monitoring heart valve function in a subject; and

g) monitoring graft function in a subject.