Detection and/or monitoring of diastolic heart failure

• US 7,662,086 B2
• Filed: 06/17/2004
• Issued: 02/16/2010
• Est. Priority Date: 06/17/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical AB (Abbott Laboratories Incorporated)
• Inventors: Bjorling, Anders
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/628,838
• Publication Number:
  US 20080262365A1
• Time in Patent Office: 2,070 Days
• Field of Search: 607/19, 607/17, 607/9, 607/18, 607/25, 600/322, 600/335, 600/323
• US Class Current: 600/17
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

In an implantable medical device for detecting and/or monitoring the progression of diastolic heart failure (DHF), and a corresponding method, a parameter is measured that is indicative of left ventricular ejection fraction (LVEF), and a variable is also measured that is indicative of the workload of the patient, and a relation is determined between LVEF and the workload, and DHF is detected and/or the progression of DHF is monitored, dependent on this relation.

Claims

1. An implantable medical device for detecting and/or monitoring progression of diastolic heart failure DHF of a patient, comprising a first measurement unit that measures in vivo a parameter indicative of left ventricular ejection fraction LVEF, an implantable second measurement unit that measures in vivo a variable indicative of the workload of the patient, an implantable determination unit that determines a relation between LVEF and the workload of the patient, and an implantable DHF unit that detects DHF and/or monitors progression of DHF from said relation.

2. The device according to claim 1, wherein said second measurement unit is an accelerometer sensor.

3. The device according to claim 1 wherein said second measurement unit is a unit that measures the intrinsic heart rate.

4. The device according to claim 1 wherein said second measurement unit is a unit that measures minute ventilation.

5. The device according to claim 1 wherein said first measurement unit is an impedance measuring means for measuring the unit that measures an impedance between electrodes (4,6,8,10,12;

26,28,30,32,34,36) implanted in the patient'"'"'s heart.

6. The device according to claim 5, wherein said impedance measuring unit measures a cardiogenic impedance for detecting opening and closing of the aortic valve.

7. The device according to claim 1 wherein said first measurement unit is a unit that measures a pre-ejection period PEP starting with onset of QRS and ending with opening of the aortic valve, and left ventricular ejection time LVET starting with opening and ending with closing of the aortic valve, and that estimates LVEF from PEP/LVET.

8. The device according to claim 7, wherein said unit that measures a parameter indicative of LVEF calculates LVEF from a formula

LVEF=k₃−

k₄×

(PEP/LVET)

where k₃ and k₄ denote predetermined numerical constants.

9. The device according to claim 7 wherein said unit that measures a parameter indicative of LVEF comprises a sensor for detecting opening and closing of the aortic valve.

10. The device according to claim 9, wherein said sensor is a pressure sensor.

11. The device according to 9, wherein said sensor is a sound sensor for picking-up heart sounds.

12. The device according to claim 1 wherein said determination unit determines said relation by modeling LVEF as a linear function of the workload, A,

LVEF=k₁+k₂*A

where k₁ and k₂ denote two patient dependent, numerical constants.

13. The device according to claim 12, wherein said DHF unit calculates the constant K₂ from the formula

$k_2=\frac{n}{}$

∑

i = 1 n ⁢

⁢

A i ⁢

E i - ( ∑

i = 1 n ⁢

⁢

A i ) ⁢

( ∑

i = 1 n ⁢

⁢

E i n ⁢

∑

i = 1 n ⁢

⁢

A i 2 - ( ∑

i = 1 n ⁢

⁢

A i ) 2

where A_i and E_i denote measured workload and ejection fraction values respectively and n the number of measurement values.

14. The device according to claim 12 comprising a memory is provided for storing k₂ values.

15. The device according to claim 14, comprising a transmitter that transmits stored k₂ values to an external receiver upon request.

16. The device according to claim 14, comprising a transmitter that transmits stored k₂ values to an external receiver automatically on a regular basis.

17. An implantable cardiac stimulator comprising:

an implantable device for detecting and/or monitoring progression of diastolic heart failure DHF of a patient comprising an implantable first measurement unit that measures in vivo a parameter indicative of left ventricular ejection fraction LVEF a second measurement unit that measures a variable indicative of the workload of the patient, an implantable determination unit that determines a relation between LVEF and the workload of the patient, and an implantable DHF unit that detects DHF and/or monitors progression of DHF from said relation and that emits an output corresponding thereto; and

an implantable device configured to interact with the patient to deliver cardiac therapy in vivo to the patient dependent on said output.

18. The heart stimulator according to claim 17 comprising a sensor for delivering photo-plethysmographic signals, and wherein said first measurement unit is a unit that measures LVEF from said photo-plethysmographic signals.

19. A device as claimed in claim 17 wherein said first measuring unit is an impedance measuring unit that measures an impedance between electrodes implanted in the patient'"'"'s heart.

31. The heart stimulator according to claim 19, comprising a stimulating case, a bipolar right ventricular lead and a left ventricular lead and wherein said impedance measuring;

unit comprises a current source for applying a current between a tip electrode of the right ventricular lead and the case, and a voltage measuring unit for measuring voltage between a ring electrode of the right ventricular lead and a tip electrode of the left ventricular lead resulting from said current.

20. A method of detecting and/or monitoring the progression of diastolic heart failure DHF, of a patient, comprising measuring a parameter indicative of left ventricular ejection fraction LVEF, measuring a variable indicative of the workload of the patient, determining a relation between LVEF and workload of the patient, and detecting DHF and/or monitoring progression of DHF from said relation.

21. The method according to claim 20, comprising measuring intrinsic heart rate for determining the workload of the patient.

22. The heart stimulator according to claim 21, comprising a bipolar right ventricular lead and a bipolar left ventricular lead, and wherein said impedance measuring unit comprises a current source for applying a current between a tip electrode of to the right ventricular lead and a ring electrode of the left ventricular lead, and voltage measuring unit for measuring a voltage between ring electrode of the right ventricular lead and a tip electrode of the left ventricular lead resulting from said current.

23. The method according to claim 20, comprising measuring minute ventilation for determining the workload of the patient.

24. The method according to claim 20, comprising measuring a parameter indicative of LVEF by measuring the impedance between electrodes implanted in the patient'"'"'s heart.

25. The method according to claim 20 by measuring a parameter indicative of LVEF comprises measuring a pre-ejection period PEP, starting from onset of a ORS and ending with the opening of the aortic valve, and left ventricular ejection time starting with opening and ending with closing of the aortic valve, and estimating LVEF from PEP/LVET.

26. The method according to claim 25, comprising calculating LVEF from

LVEF=k₃−

k₄×

(PEP/LVET)

where k₃ and k₄ denote predetermined numerical constants.

27. The method according to claim 20 comprising determining said relation between LVEF and workload by modeling LVEF as a linear function of the workload A,

LVEF=k₁+k₂*A

where k₁ and k₂ denote two patient dependent, numerical constants.

28. The method according to claim 27, comprising calculating the constant k₂ from

$k_2=\frac{n}{}$

∑

i = 1 n ⁢

⁢

A i ⁢

E i - ( ∑

i = 1 n ⁢

⁢

A i ) ⁢

( ∑

i = 1 n ⁢

⁢

E i n ⁢

∑

i = 1 n ⁢

⁢

A i 2 - ( ∑

i = 1 n ⁢

⁢

A i ) 2

where A₁ and E₁ denote measured workload and ejection fraction values respectively and n the number of measurement values.

29. The method according to claim 27 comprising storing k₂ values and transmitting the stored k₂ values to an external receiver upon request.

30. The method according to claim 27 comprising storing k₂ values and transmitting the stored k₂ values to an external receiver means automatically on a regular basis.