Implantable medical system for detecting incipient edema

• US 8,346,353 B2
• Filed: 04/24/2007
• Issued: 01/01/2013
• Est. Priority Date: 04/24/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical AB (Abbott Laboratories)
• Original Assignee: St. Jude Medical AB (Abbott Laboratories)
• Inventors: Hedberg, Sven-Erik, Blomqvist, Andreas, Järverud, Karin, Ljungström, Karin, Lindqvist, Leif, Lönn, Urban
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): EL-KAISSI, HIBA CARINE
• Application Number:
  US12/531,793
• Publication Number:
  US 20100106210A1
• Time in Patent Office: 2,079 Days
• Field of Search: 607/122, 600/510, 600/547
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• 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 1/056 Transvascular endocardial electrode systems

Abstract

An implantable medical system for detecting incipient edema has an implantable medical lead including an optical sensor having a light source and a light detector. The medical system further has an edema detection circuit that activates the light source to emit light, the light being directed into lung tissue of a patient and that obtains a light intensity value corresponding to an intensity of light received by the light detector, and that evaluates the light intensity value to detect a consistency with incipient edema.

Claims

1. A medical system comprising:

an implantable medical lead adapted for implantation in a patient, said implantable medical lead carrying at least one optical sensor comprising a light source configured to emit light in vivo at a predetermined wavelength and at a predetermined intensity, said optical sensor further comprising a light detector, said implantable medical lead being configured to direct the light emitted by said light source into lung tissue of the patient; and

an edema detection circuit connected to said implantable medical lead, said edema detection circuit being configured to activate said light source to emit light during at least one measurement session at said predetermined wavelength and said predetermined intensity and, with said light detector, to detect said light after said light interacts with said lung tissue, the light detected by the light detector having a detected light intensity value, and to evaluate said detected light intensity value by comparing said detected light intensity value with a reference intensity value to obtain a comparison result, and to emit an edema detection circuit output indicating incipient edema when said comparison result is consistent with incipient edema.

2. A medical system as claimed in claim 1 wherein said edema detecting circuit is configured to determine that said comparison result is consistent with incipient edema when said detected light intensity value is below said reference intensity value.

3. A medical system as claimed in claim 1 comprising a posture sensor configured to detect a predetermined posture of the patient, and wherein said edema detection circuit is configured to, upon receiving a signal from said posture sensor that said patient is in said predetermined posture, initiates said measurement session.

4. A medical system as claimed in claim 3 wherein said edema detection circuit is configured to obtain said reference intensity value as a function of said predetermined posture.

5. A medical system as claimed in claim 1 comprising a posture sensor configured to detect a predetermined posture of the patient, and wherein said edema detection circuit is configured to, upon obtaining said detected light intensity value, initiate a posture sensing with said posture sensor to determine a posture of the patient, and wherein said edema detection circuit obtains said reference intensity value as a function of the posture detected by said posture sensor.

6. A medical system as claimed in claim 1 wherein said edema detection circuit is configured to determine said reference intensity value as a function of a predetermined number of detected light intensity values respectively from a plurality of previous measurement sessions.

7. A medical system as claimed in claim 1 comprising an activity sensor configured to sense at least one activity value representing a physical activity level of the patient, and wherein said edema detection circuit is configured to repeatedly compare said activity value to a reference activity value and, when a predetermined number of activity values are below said reference activity value, initiate said measurement session.

8. A medical system as claimed in claim 1 wherein said medical lead is configured for implantation at a location selected from the group consisting of an intrapericardial location, an epipericardial location, and in a coronary vein of the patient.

9. A medical system as claimed in claim 1 comprising an alarm notifier configured to emit a humanly perceptible alarm when said edema detection circuit emits said output indicating incipient edema.

10. A medical system as claimed in claim 1 wherein said implantable medical lead carries said light source and said light detector with a lead length therebetween that is selected from the group consisting of about 1 cm, in a range between 1 and 7 cm, in a range between 2 and 7 cm, and in a range between 3 and 7 cm.

11. A medical system as claimed in claim 1 wherein said implantable medical lead comprises rotation preventing structure configured to prevent in vivo rotation of the implantable medical lead relative to the heart of the patient.

12. A medical system as claimed in claim 11 wherein said rotation preventing structure comprises at least one protrusion extending from an exterior surface of the implantable medical lead.

13. A medical system as claimed in claim 1 wherein said implantable medical lead comprises an orientation indicator configured to indicate a rotational orientation of said implantable medical lead during implantation of said implantable medical lead.

14. A medical system as claimed in claim 13 wherein said orientation indicator comprises at least one x-ray-detector marker.

15. A medical system as claimed in claim 1 wherein said edema detection circuit is integrated with said optical sensor.

16. A medical system as claimed in claim 1 comprising:

a housing configured for implantation in the patient;

a pulse generator in said housing configured to emit cardiac stimulating pulses; and

said edema detection circuit also being contained in said housing, and being connected to said pulse generator for modifying generation of said cardiac stimulating pulses dependent on said output indicating incipient edema.

17. A medical system as claimed in claim 1 wherein said predetermined wavelength is in a range selected from the group consisting of 600-1400 nm, 700-1000 nm, 760-860 nm, and 800-820 nm.

18. A medical system as claimed in claim 1 wherein said predetermined wavelength is a first wavelength and said predetermined intensity is a first intensity, and wherein:

said light source emits light at said first wavelength at said first intensity and at a second wavelength at a second intensity, said light at said second wavelength at said second intensity also being directed in vivo at lung tissue;

said edema detection circuit is configured to activate said light source to emit light, during said measurement session, at said first wavelength at said first intensity, and at said second wavelength at said second intensity;

said light detector being configured to detect said light at said first wavelength at said first intensity to obtain a detected first intensity value, and to detect said light at said second wavelength at said second intensity to detect a second detected intensity value; and

said edema detection circuit being configured to evaluate said first detected intensity value and said second detected intensity value by comparing said first detected intensity value and said second detected intensity value with said reference intensity value to generate said comparison result.

19. A medical system as claimed in claim 18 wherein said edema detection circuit is configured to compare a quotient of said first detected intensity value and said second detected intensity value with said reference intensity value, and to determine consistency of said comparison result with incipient edema when said quotient is below said reference intensity value.

20. An implantable medical lead comprising:

an implantable lead body adapted for implantation in a patient, said implantable lead body carrying at least one optical sensor comprising a light source configured to emit light in vivo at a predetermined wavelength and at a predetermined intensity, and a light detector, said implantable lead body being configured to direct the light emitted by said light source into lung tissue of the patient; and

an edema detection circuit carried by said implantable lead body, said edema detection circuit being configured to activate said light source to emit light during at least one measurement session at said predetermined wavelength and said predetermined intensity and, with said light detector, to detect said light after said light interacts with said lung tissue, the light detected by the light detector having a detected light intensity value, and to evaluate said detected light intensity value by comparing said detected light intensity value with a reference intensity value to obtain a comparison result, and to emit an edema detection circuit output indicating incipient edema when said comparison result is consistent with incipient edema.

21. An implantable medical lead as claimed in claim 20 wherein said edema detecting circuit is configured to determine that said comparison result is consistent with incipient edema when said detected light intensity value is below said reference intensity value.

22. An implantable medical lead as claimed in claim 20 comprising a posture sensor configured to detect a predetermined posture of the patient, and wherein said edema detection circuit is configured to, upon receiving a signal from said posture sensor that said patient is in said predetermined posture, initiates said measurement session.

23. An implantable medical lead as claimed in claim 22 wherein said edema detection circuit is configured to obtain said reference intensity value as a function of said predetermined posture.

24. An implantable medical lead as claimed in claim 20 comprising a posture sensor configured to detect a predetermined posture of the patient, and wherein said edema detection circuit is configured to, upon obtaining said detected light intensity value, initiate a posture sensing with said posture sensor to determine a posture of the patient, and wherein said edema detection circuit obtains said reference intensity value as a function of the posture detected by said posture sensor.

25. An implantable medical lead as claimed in claim 20 wherein said edema detection circuit is configured to determine said reference intensity value as a function of a predetermined number of detected light intensity values respectively from a plurality of previous measurement sessions.

26. An implantable medical lead as claimed in claim 20 comprising an activity sensor configured to sense at least one activity value representing a physical activity level of the patient, and wherein said edema detection circuit is configured to repeatedly compare said activity value to a reference activity value and, when a predetermined number of activity values are below said reference activity value, initiate said measurement session.

27. An implantable medical lead as claimed in claim 20 wherein said implantable lead body is configured for implantation at a location selected from the group consisting of an intrapericardial location, an epipericardial location, and in a coronary vein of the patient.

28. An implantable medical lead as claimed in claim 20 comprising an alarm notifier configured to emit a humanly perceptible alarm when said edema detection circuit emits said output indicating incipient edema.

29. An implantable medical lead as claimed in claim 20 wherein said implantable lead body carries said light source and said light detector with a lead length therebetween that is selected from the group consisting of about 1 cm, in a range between 1 and 7 cm, in a range between 2 and 7 cm, and in a range between 3 and 7 cm.

30. An implantable medical lead as claimed in claim 20 wherein said implantable lead body comprises rotation preventing structure configured to prevent in vivo rotation of the implantable lead body relative to the heart of the patient.

31. An implantable medical lead as claimed in claim 30 wherein said rotation preventing structure comprises at least one protrusion extending from an exterior surface of the implantable lead body.

32. An implantable medical lead as claimed in claim 20 wherein said implantable lead body comprises an orientation indicator configured to indicate a rotational orientation of said implantable lead body during implantation of said implantable medical lead.

33. An implantable medical lead as claimed in claim 32 wherein said orientation indicator comprises at least one x-ray-detector marker.

34. An implantable medical lead as claimed in claim 20 wherein said edema detection circuit is integrated with said optical sensor.

35. An implantable medical lead as claimed in claim 20 wherein said predetermined wavelength is in a range selected from the group consisting of 600 -1400 nm, 700-1000 nm, 760-860 nm, and 800-820 nm.

36. An implantable medical lead as claimed in claim 20 wherein said predetermined wavelength is a first wavelength and said predetermined intensity is a first intensity, and wherein:

said light source emits light at said first wavelength at said first intensity and at a second wavelength at a second intensity, said light at said second wavelength at said second intensity also being directed in vivo at lung tissue;

said edema detection circuit is configured to activate said light source to emit light, during said measurement session, at said first wavelength at said first intensity, and at said second wavelength at said second intensity;

said light detector being configured to detect said light at said first wavelength at said first intensity to obtain a detected first intensity value, and to detect said light at said second wavelength at said second intensity to detect a second detected intensity value; and

said edema detection circuit being configured to evaluate said first detected intensity value and said second detected intensity value by comparing said first detected intensity value and said second detected intensity value with said reference intensity value to generate said comparison result.

37. An implantable medical lead as claimed in claim 36 wherein said edema detection circuit is configured to compare a quotient of said first detected intensity value and said second detected intensity value with said reference intensity value, and to determine consistency of said comparison result with incipient edema when said quotient is below said reference intensity value.

38. A method for detecting incipient edema comprising the steps of:

Implanting a medical lead in a patient, and with said implantable medical lead, carrying at least one optical sensor comprising a light source that emits light in vivo at a predetermined wavelength and at a predetermined intensity, and a light detector, said medical lead, when implanted, causing the light emitted by said light source to be directed into lung tissue of the patient; and

with an edema detection circuit connected to said implantable medical lead, activating said light source to emit light during at least one measurement session at said predetermined wavelength and said predetermined intensity and, with said light detector, detecting said light after said light interacts with said lung tissue, the light detected by the light detector having a detected light intensity value, and automatically evaluating said detected light intensity value by comparing said detected light intensity value with a reference intensity value to obtain a comparison result, and emitting an edema detection circuit output indicating incipient edema when said comparison result is consistent with incipient edema.

39. A method as claimed in claim 38 comprising, with said edema detecting circuit, determining that said comparison result is consistent with incipient edema when said detected light intensity value is below said reference intensity value.

40. A method as claimed in claim 38 comprising detecting a predetermined posture of the patient, and with said edema detection circuit, upon receiving a signal from said posture sensor that said patient is in said predetermined posture, initiating said measurement session.

41. A method as claimed in claim 40 comprising, with said edema detection circuit, obtaining said reference intensity value as a function of said predetermined posture.

42. A method as claimed in claim 38 comprising detecting a predetermined posture of the patient, and with said edema detection circuit, upon obtaining said detected light intensity value, initiating a posture sensing to determine a posture of the patient, and with said edema detection circuit, obtaining said reference intensity value as a function of the detected posture.

43. A method as claimed in claim 38 comprising, with said edema detection circuit, determining said reference intensity value as a function of a predetermined number of detected light intensity values respectively from a plurality of previous measurement sessions.

44. A method as claimed in claim 38 comprising sensing at least one activity value representing a physical activity level of the patient, and with said edema detection circuit, repeatedly comparing said activity value to a reference activity value and, when a predetermined number of activity values are below said reference activity value, initiating said measurement session.

45. A method as claimed in claim 38 comprising implanting said medical lead at a location selected from the group consisting of an intrapericardial location, an epipericardial location, and in a coronary vein of the patient.

46. A method as claimed in claim 38 comprising emitting a humanly perceptible alarm when said edema detection circuit emits said output indicating incipient edema.

47. A method as claimed in claim 38 comprising, on said implantable medical lead, carrying said light source and said light detector with a lead length therebetween that is selected from the group consisting of about 1 cm, in a range between 1 and 7 cm, in a range between 2 and 7 cm, and in a range between 3 and 7 cm.

48. A method as claimed in claim 38 comprising providing said implantable medical lead with rotation preventing structure that prevents in vivo rotation of the implantable medical lead relative to the heart of the patient.

49. A method as claimed in claim 48 comprising forming said rotation preventing structure as at least one protrusion extending from an exterior surface of the implantable medical lead.

50. A method as claimed in claim 38 comprising providing said implantable medical lead with an orientation indicator that indicates a rotational orientation of said implantable medical lead during implantation of said implantable medical lead.

51. A method as claimed in claim 50 comprising forming said orientation indicator as at least one x-ray-detector marker.

52. A method as claimed in claim 38 comprising:

from a pulse generator, emitting cardiac stimulating pulses; and

with said edema detection circuit, modifying generation of said cardiac stimulating pulses dependent on said output indicating incipient edema.

53. A method as claimed in claim 38 emitting said light at said predetermined wavelength in a range selected from the group consisting of 600-1400 nm, 700-1000 nm, 760-860 nm, and 800-820 nm.

54. A method as claimed in claim 38 wherein said predetermined wavelength is a first wavelength and said predetermined intensity is a first intensity, and comprising:

emitting light from said light source at said first wavelength at said first intensity and at a second wavelength at a second intensity, said light at said second wavelength at said second intensity also being directed in vivo at lung tissue;

with said edema detection circuit, activating said light source to emit light, during said measurement session, at said first wavelength at said first intensity, and at said second wavelength at said second intensity;

with said light detector, detecting said light at said first wavelength at said first intensity to obtain a detected first intensity value, and detecting said light at said second wavelength at said second intensity to detect a second detected intensity value; and

in said edema detection circuit, evaluating said first detected intensity value and said second detected intensity value by comparing said first detected intensity value and said second detected intensity value with said reference intensity value to generate said comparison result.

55. A method as claimed in claim 54 comprising, said edema detection circuit, comparing a quotient of said first detected intensity value and said second detected intensity value with said reference intensity value, and determining consistency of said comparison result with incipient edema when said quotient is below said reference intensity value.