Tissue overgrowth detector for implantable medical device

• US 6,125,290 A
• Filed: 10/30/1998
• Issued: 09/26/2000
• Est. Priority Date: 10/30/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/182,972
• Time in Patent Office: 697 Days
• Field of Search: 600/322, 600/323, 600/324, 600/325, 600/332, 600/333, 600/339, 600/341, 607/22, 607/122
• US Class Current: 600/325
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

An implantable sensor assembly for use with an implantable medical device are disclosed. The sensor assembly preferably includes two or more physiologic sensors coupled to the medical device via a pair of lead conductors, or alternatively an oxygen sensor having certain features. The oxygen sensor permits more accurate and reliable measurement of oxygen saturation in blood masses flowing within the human body.

Claims

1. A body implantable medical electrical lead, comprising:

(a) a lead body having proximal and distal ends and comprising an electrically insulative material;

(b) at least first and second electrical conductors disposed within at least portions of the lead body, the conductors having at least portions of the electrically insulative material disposed therebetween;

(c) an oxygen sensor attached to the lead body, comprising;

(i) a housing having proximal and distal ends, an exterior, and first and second interior portions disposed therewithin;

(ii) at least one light emitter disposed within the first interior portion of the housing;

(iii) a first light detector disposed within the second interior portion of the housing;

(iv) at least one light transmissive lens disposed over the light emitter and the light detector, the at least one lens being mounted in the housing between the exterior and the first and second interior portions, and

(v) a second self-test light detector disposed in the first interior portion of the housing near the at least one light emitter.

2. The body implantable medical electrical lead of claim 1, wherein the second self-test light detector is selected from the group consisting of a photosensor and a photodiode.

3. The body implantable medical electrical lead of claim 1, wherein the second self-test light detector detects light reflected from portions of the at least one lens covered by tissue overgrowth.

4. The body implantable medical electrical lead of claim 1, wherein a light gathering structure is disposed near the second self-test light detector, the light gathering structure gathering light reflected from portions of the at least one lens covered by tissue overgrowth for detection by the second self-test light detector.

5. The body implantable medical electrical lead of claim 1, wherein the second self-test light detector comprises a plurality of light detectors.

6. The body implantable medical electrical lead of claim 5, wherein the plurality of light detectors is selected form the group consisting of photosensors and photodiodes.

7. The body implantable medical electrical lead of claim 1, wherein the at least one lens comprises a light transmissive first lens disposed over the light emitter and mounted in the housing between the exterior and the first interior portions of the housing such that at least portions of light emitted by the light emitter pass through the first lens from the first interior portion to the exterior.

8. The body implantable medical electrical lead of claim 1, wherein at least one of the first and second light detectors sequentially senses light.

9. The body implantable medical electrical lead of claim 1, wherein the second light detector is mounted on an oxygen sensor hybrid.

10. The body implantable medical electrical lead of claim 1, wherein the second light detector provides an output signal for calibrating or adjusting the output signal provided by the first light detector to compensate or adjust for the degree of tissue overgrowth of the at least one lens.

11. The body implantable medical electrical lead of claim 1, wherein the second self-test light detector is connected to means for detecting a predetermined light threshold.

12. The body implantable medical electrical lead of claim 11, wherein the means for detecting a predetermined light threshold further includes means for providing an output signal in response to the predetermined light threshold being sensed thereby.

13. The body implantable medical electrical lead of claim 12, wherein the means for detecting a predetermined light threshold is employed to cause oxygen saturation data generated in response to signals provided by the first light detector to be ignored or assigned less weight or reliability by at least one of a microprocessor and a DSP.

14. The body implantable medical electrical lead of claim 12, wherein a microprocessor or a DSP is mounted in one of the oxygen sensor housing and an implantable medical device connected to the lead.

15. The body implantable medical electrical lead of claim 1, wherein a light gathering device for directing light rays towards the second light detector is mounted or positioned near the second self-test light detector.

16. The body implantable medical electrical lead of claim 1, wherein a self-test light detector channel is disposed between the second light detector and the at least one lens.

17. The body implantable medical electrical lead of claim 16, wherein at least portions of the self-test light detector channel include upwardly extending rims or reflective surfaces for at least one of preventing or impeding direct light rays emitted by the light emitter from entering the light detector channel.

18. The body implantable medical electrical lead of claim 1, wherein the lead further comprises at least a first electrode for stimulation of cardiac tissue.

19. The body implantable medical electrical lead of claim 18, wherein the first electrode is disposed one of near and at the distal end of the lead body.

20. The body implantable medical electrical lead of claim 18, wherein the oxygen sensor is disposed proximally of the first electrode.

21. The body implantable medical electrical lead of claim 1, wherein a first output signal provided by the second self-test light detector is combined, mixed with or subtracted from a second output signal provided by the first light detector to thereby correct or adjust an estimate of blood oxygen saturation provided by the first light detector for tissue overgrowth of the at least one lens.

22. An implantable medical device system, comprising:

(a) an implantable medical device;

(b) a body implantable medical electrical lead attached to the implantable medical device, the lead comprising;

(i) a lead body having proximal and distal ends and comprising an electrically insulative material;

(ii) at least first and second electrical conductors disposed within at least portions of the lead body, the conductors having at least portions of the electrically insulative material disposed therebetween;

(iii) an oxygen sensor attached to the lead body, comprising;

(1) a housing having proximal and distal ends, an exterior, and first and second interior portions disposed therewithin;

(2) at least one light emitter disposed within the first interior portion of the housing;

(3) a first light detector disposed within the second interior portion of the housing;

(4) at least one light transmissive lens disposed over the light emitter and the light detector, the at least one lens being mounted in the housing between the exterior and the first and second interior portions, and

(5) a second self-test light detector disposed in the first interior portion of the housing near the at least one light emitter.

23. The implantable medical device system of claim 22, wherein the implantable medical device is selected from the group consisting of a heart monitor, a therapy delivery device, a pacemaker, an implantable pulse generator, a pacer-cardio-defibrillator, an implantable cardio-defibrillator, a cardiomyo-stimulator, a nerve stimulator, a brain stimulator, a gastric stimulator and a drug delivery device.

24. The implantable medical device system of claim 22, wherein the second self-test light detector is selected from the group consisting of a photosensor and a photodiode.

25. The implantable medical device system of claim 22, wherein the second self-test light detector detects light reflected from portions of the at least one lens covered by tissue overgrowth.

26. The implantable medical device system of claim 22, wherein a light gathering structure is disposed near the second self-test light detector, the light gathering structure gathering light reflected from portions of the at least one lens covered by tissue overgrowth for detection by the second self-test light detector.

27. The implantable medical device system of claim 22, wherein the second self-test light detector comprises a plurality of light detectors.

28. The implantable medical device system of claim 27, wherein the plurality of light detectors is selected form the group consisting of photosensors and photodiodes.

29. The implantable medical device system of claim 22, wherein the at least one lens comprises a light transmissive first lens disposed over the light emitter and mounted in the housing between the exterior and the first interior portions of the housing such that at least portions of light emitted by the light emitter pass through the first lens from the first interior portion to the exterior.

30. The implantable medical device system of claim 29, wherein the at least one lens further comprises a light transmissive second lens disposed over the first light detector and mounted in the housing between the exterior and second interior portions of the housing such that at least portions of light emitted by the light emitter and reflecting from exterior portions of the housing when surrounded by a blood mass pass through the second lens from the exterior to the second interior portion, the first and second lenses being separated and spaced apart from one another.

31. The implantable medical device system of claim 22, wherein at least one of the first and second light detectors sequentially senses light.

32. The implantable medical device system of claim 22, wherein the second light detector is mounted on an oxygen sensor hybrid.

33. The implantable medical device system of claim 22, wherein the second light detector provides an output signal for calibrating or adjusting the output signal provided by the first light detector to compensate or adjust for the degree of tissue overgrowth of the at least one lens.

34. The implantable medical device system of claim 22, wherein the second self-test light detector is connected to means for detecting a predetermined light threshold.

35. The implantable medical device system of claim 34, wherein the means for detecting a predetermined light threshold further includes means for providing an output signal in response to the predetermined light threshold being sensed thereby.

36. The implantable medical device system of claim 35, wherein the means for detecting a predetermined light threshold is employed to cause oxygen saturation data generated in response to signals provided by the first light detector to be ignored or assigned less weight or reliability by at least one of a microprocessor and a DSP.

37. The implantable medical device system of claim 35, wherein a microprocessor or a DSP is mounted in one of the oxygen sensor housing and an implantable medical device connected to the lead.

38. The implantable medical device system of claim 22, wherein a light gathering device for directing light rays towards the second light detector is mounted or positioned near the second self-test light detector.

39. The implantable medical device system of claim 22, wherein a self-test light detector channel is disposed between the second light detector and the at least one lens.

40. The implantable medical device system of claim 39, wherein at least portions of the self-test light detector channel include upwardly extending rims or reflective surfaces for at least one of preventing or impeding direct light rays emitted by the light emitter from entering the light detector channel.

41. The implantable medical device system of claim 23, wherein a first output signal provided by the second self-test light detector is combined, mixed with or subtracted from a second output signal provided by the first light detector to thereby correct or adjust an estimate of blood oxygen saturation provided by the first light detector for tissue overgrowth of the at least one lens.

42. The implantable medical device system of claim 22, wherein the lead further comprises at least a first electrode for stimulation of cardiac tissue.

43. The implantable medical device system of claim 42, wherein the first electrode is disposed one of near and at the distal end of the lead body.

44. The implantable medical device system of claim 42, wherein the oxygen sensor is disposed proximally of the first electrode.

45. The implantable medical device system of claim 42, wherein the first electrode is a tip electrode.

46. The implantable medical device system of claim 42, wherein the lead further includes a second electrode.

47. The implantable medical device system of claim 46, wherein the second electrode is a ring electrode.

48. A body implantable medical oxygen sensor, comprising:

(a) a housing having proximal and distal ends, an exterior, and first and second interior portions disposed therewithin;

(b) at least one light emitter disposed within the first interior portion of the housing;

(c) a first light detector disposed within the second interior portion of the housing;

(d) at least one light transmissive lens disposed over the light emitter and the light detector, the at least one lens being mounted in the housing between the exterior and the first and second interior portions, and

(e) a second self-test light detector disposed in the first interior portion of the housing near the at least one light emitter.

49. The implantable oxygen sensor of claim 48, wherein the second self-test light detector is selected from the group consisting of a photosensor and a photodiode.

50. The implantable oxygen sensor of claim 48, wherein the second self-test light detector detects light reflected from portions of the at least one lens covered by tissue overgrowth.

51. The implantable oxygen sensor of claim 48, wherein a light gathering structure is disposed near the second self-test light detector, the light gathering structure gathering light reflected from portions of the at least one lens covered by overgrowth tissue for detection by the second self-test light detector.

52. The implantable oxygen sensor of claim 48, wherein the second self-test light detector comprises a plurality of light detectors.

53. The implantable oxygen sensor of claim 52, wherein the plurality of light detectors is selected form the group consisting of photosensors and photodiodes.

54. The implantable oxygen sensor of claim 48, wherein the at least one lens comprises a light transmissive first lens disposed over the light emitter and mounted in the housing between the exterior and the first interior portions of the housing such that at least portions of light emitted by the light emitter pass through the first lens from the first interior portion to the exterior.

55. The implantable oxygen sensor of claim 54, wherein the at least one lens further comprises a light transmissive second lens disposed over the first light detector and mounted in the housing between the exterior and the second interior portions of the housing such that at least portions of light emitted by the light emitter and reflecting from exterior portions of the housing when surrounded by a blood mass pass through the second lens, from the exterior to the second interior portion, the first and second lenses being separated and spaced apart from one another.

56. The implantable oxygen sensor of claim 48, wherein at least one of the first and second light detectors sequentially senses light.

57. The implantable oxygen sensor of claim 48, wherein the second light detector is mounted on an oxygen sensor hybrid.

58. The implantable oxygen sensor of claim 48, wherein the second light detector provides an output signal for calibrating or adjusting the output signal provided by the first light detector to compensate or adjust for the degree of tissue overgrowth of the at least one lens.

59. The implantable oxygen sensor of claim 48, wherein the second self-test light detector is connected to means for detecting a predetermined light threshold.

60. The implantable oxygen sensor of claim 59, wherein the means for detecting a predetermined light threshold further includes means for providing an output signal in response to the predetermined light threshold being sensed thereby.

61. The implantable oxygen sensor of claim 60, wherein the means for detecting a predetermined light threshold is employed to cause oxygen saturation data generated in response to signals provided by the first light detector to be ignored or assigned less weight or reliability by at least one of a microprocessor and a DSP.

62. The implantable oxygen sensor of claim 61, wherein the microprocessor or the DSP is mounted in one of the oxygen sensor housing and an implantable medical device connected to the lead.

63. The implantable oxygen sensor of claim 48, wherein a light gathering device for directing light rays towards the second light detector is mounted or positioned near the second self-test light detector.

64. The implantable oxygen sensor of claim 48, wherein a self-test light detector channel is disposed between the second light detector and the at least one lens.

65. The implantable oxygen sensor of claim 64, wherein at least portions of the self-test light detector channel include upwardly extending rims or reflective surfaces for at least one of preventing or impeding direct light rays emitted by the light emitter from entering the light detector channel.

66. The implantable oxygen sensor of claim 48, wherein a first output signal provided by the second self-test light detector is combined, mixed with or subtracted from a second output signal provided by the first light detector to thereby correct or adjust an estimate of blood oxygen saturation provided by the first light detector for tissue overgrowth of the at least one lens.

67. A method of making a body implantable medical electrical lead, the lead comprising a lead body having proximal and distal ends and an electrically insulative material, at least first and second electrical conductors disposed within at least portions of the lead body, the conductors having at least portions of the electrically insulative material disposed therebetween, an oxygen sensor being attached to the lead body and comprising a housing having proximal and distal ends, an exterior, and first and second interior portions disposed therewithin, at least one light emitter disposed within the first interior portion of the housing, a first light detector disposed within the second interior portion of the housing, at least one light transmissive lens disposed over the light emitter and the light detector, the at least one lens being mounted in the housing between the exterior and the first and second interior portions, and a second self-test light detector disposed in the first interior portion of the housing near the at least one light emitter, the method comprising the steps of:

(a) providing the lead body;

(b) providing the oxygen sensor, and

(c) attaching the oxygen sensor to the lead body.

68. The method of claim 67, wherein the method further comprises the step of forming the lead body.

69. The method of claim 67, wherein the method further comprises the step of forming the oxygen sensor.

70. The method of claim 69, wherein the oxygen sensor forming step further comprises the step of providing a photodiode for one of the first and second light detectors.

71. The method of claim 69, wherein the oxygen sensor forming step further comprises the step of mounting at least one of the first and second light detectors on an oxygen sensor hybrid.

72. The method of claim 69, wherein the oxygen sensor forming step further comprises the step of connecting the second self-test light detector to means for detecting a predetermined light threshold.

73. The method of claim 69, wherein the oxygen sensor forming step further comprises the step of disposing a light gathering device for directing light rays towards the second light detector near the second light detector.

74. The method of claim 69, wherein the oxygen sensor forming step further comprises the step of disposing a self-test light detector channel between the second light detector and the at least one lens.

75. The method of claim 74, wherein the oxygen sensor forming step further comprises the step of providing at least portions of the self-test light detector channel with upwardly extending rims or reflective surfaces for preventing or impeding direct light rays emitted by the light emitter from entering the light detector channel.

76. A method of operating an implantable medical device system comprising an implantable medical device and a body implantable medical electrical lead, the lead being attached to the implantable medical device, the lead comprising a lead body having proximal and distal ends and an electrically insulative material, at least first and second electrical conductors disposed within at least portions of the lead body, the conductors having at least portions of the electrically insulative material disposed therebetween, an oxygen sensor being attached to the lead body and comprising a housing having proximal and distal ends, an exterior, and first and second interior portions disposed therewithin, at least one light emitter disposed within the first interior portion of the housing, a first light detector disposed within the second interior portion of the housing, at least one light transmissive lens disposed over the light emitter and the light detector, the at least one lens being mounted in the housing between the exterior and the first and second interior portions, and a second self-test light detector disposed in the first interior portion of the housing near the at least one light emitter, the method comprising the steps of:

(a) providing the implantable medical device;

(b) providing the lead;

(c) providing the oxygen sensor;

(d) attaching the oxygen sensor to the lead;

(e) attaching the lead to the implantable medical device;

(f) implanting the system in a mammalian subject such that the oxygen sensor is at least partially surrounded by a flowing blood mass;

(g) emitting light from the light emitter through the at least one lens into the blood mass;

(h) detecting, with the first light detector, light reflected from the blood mass into the second interior portion, and

(i) detecting, with the second light detector, light reflected from tissue overgrowth disposed over at least portions of the at least one lens.

77. The method of claim 76, wherein the method further comprises the step of providing an output signal from the second light detector that is proportional to the amount of light detected thereby.

78. The method of claim 77, wherein the method further comprises the step of not using oxygen sensor data generated in response to a first output signal provided by the first light detector when the second output signal has an amplitude exceeding a predetermined threshold value.

79. The method of claim 76, wherein the oxygen sensor forming step further comprises the step of providing a photodiode for one of the first and second light detectors.

80. The method of claim 76, wherein the oxygen sensor forming step further comprises the step of connecting the second self-test light detector to means for detecting a predetermined light threshold.