IP Library Granted Patent US 9,320,905
Granted Patent B2
US 9,320,905 · App. 13/707,391 · Granted Apr 26, 2016

Effective capture test

Inventors: Subham Ghosh (Blaine, MN); Robert W. Stadler (Shoreview, MN)
Assignee: Medtronic, Inc.
A61N1/371A61B5/0452A61B5/4836A61B5/686A61N1/3627A61N1/37247
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Quick Facts
Patent No.
US 9,320,905
App. No.
13/707,391
Granted
Apr 26, 2016
Kind
B2
Abstract

The present disclosure pertains to cardiac pacing methods and systems, and, more particularly, to cardiac resynchronization therapy (CRT). In particular, the present disclosure pertains to determining the efficacy of CRT through use of an effective capture test (ECT). One or more embodiments comprises sensing a signal in response to a ventricular pacing stimulus. Through signal processing, a number of features are parsed from the signal. Exemplary features parsed from the signal include a maximum amplitude, a maximum time associated with the maximum amplitude, a minimum amplitude, and a minimum time associated with the minimum amplitude. The data is evaluated through use of the ECT. By employing the ECT, efficacy of CRT is easily and automatically evaluated.

Claims (195)

1. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal, processing means for determining from the signal a maximum amplitude, a maximum time associated with the maximum amplitude (Max) (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude;

(d) means for repeatedly activating (a)-(c); and

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c),

wherein the effective capture test comprising one of:

T max− T min>30 ms  (1)

0.2<|Max− a baseline( BL )|/| BL −Min|<5;  (2)

(|Max− BL |/|Min− BL|≦LL and BL <|Min/8|)  (3)

T min<60 ms; and  (4)

Max−Min>3.5 mV.  (5)

2. The apparatus of claim 1 wherein ineffective capture is determined after an implantable medical device has been chronically implanted.

3. The apparatus of claim 1 further comprising:

means for determining whether greater than 75% of daily tests relative to the left ventricle pass the effective capture test.

4. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

processing means for determining when effective capture is occurring wherein effective capture is determined when greater than 75% of daily tests successfully pass the effective capture test.

5. The apparatus of claim 4 further comprising:

processing means for determining a diagnostic classification for ineffective capture, the diagnostic classification selected from the group consisting of loss of capture, RV pre-excitation, a left ventricular lead and a right ventricular lead are too close together, AT/AF, a long SAV during biventricular pacing, a long PAV during biventricular pacing, a long SAV during left ventricular pacing, and a long PAV during left ventricular pacing.

6. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c); and

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c),

wherein effective capture is determined when greater than 85% of daily tests successfully pass the effective capture test.

7. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal and for determining from the signal a minimum amplitude and a minimum time associated with the minimum amplitude;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

processing means for determining whether the minimum time is greater than a predetermined time for greater than 75% of daily tests.

8. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

means for terminating further processing of diagnostic classifications once two diagnostic conditions are applied to a patient.

9. The apparatus of claim 8 further comprising:

processing means for determining effective capture is occurring for biventricular pacing wherein effective capture is determined when greater than 75% of daily tests successfully pass the effective capture test.

10. The apparatus of claim 9 further comprising:

processing means for determining whether ineffective LV capture exists during AT/AF for greater than or equal to 25% capture monitoring results (CMR).

11. The apparatus of claim 10 further comprising:

means for generating a signal; and

means for displaying AT/AF classification in response to determining ineffective capture is due to AT/AF.

12. The apparatus of claim 9 wherein ineffective LV capture occurs when AP-BV+AS-BV>25% CMR.

13. The apparatus of claim 12 further comprising determining whether a AS-BV count is greater than AP-BV count.

14. The apparatus of claim 13 further comprising:

processing means for determining when a long SAV is present during biventricular pacing; and

displaying means for displaying that the long SAV is present during biventricular pacing.

15. The apparatus of claim 12 further comprising determining whether a AP-BV count is greater than AS-BV count.

16. The apparatus of claim 15 further comprising:

processing means for determining when a long PAV is present during biventricular pacing; and

displaying means for displaying that the long PAV is present during biventricular pacing.

17. The apparatus of claim 9 further comprising:

processing means for determining whether ineffective LV capture exists during AP-LV+AS-LV>25% CMR.

18. The apparatus of claim 17 further comprising

determining means for determining whether a AS-LV count is greater than AP-LV count.

19. The apparatus of claim 18 further comprising:

processing means for determining when a long SAV is present during left ventricular pacing; and

displaying means for displaying that the long SAV is present during left ventricular pacing.

20. The apparatus of claim 17 further comprising determining whether a AP-LV count is greater than AS-LV count.

21. The apparatus of claim 20 further comprising:

processing means for determining when a long PAV is present during left ventricular pacing; and

displaying means for displaying that the long PAV is present during left ventricular pacing.

22. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal and for determining from the signal a maximum amplitude (Max), a maximum time associated with the maximum amplitude (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

processing means for determining whether a left ventricular lead is located in a poor substrate.

23. The apparatus of claim 22 wherein determination that a left ventricular lead is located in a poor substrate is distinguished from loss of capture by observing that Tmax>Tmin and Tmin>60 ms.

24. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

processing means for determining whether a right ventricle is experiencing pre-excitation.

25. The apparatus of claim 24 further comprising:

processing means for determining whether a time between premature delivery of an LV pace (LVp) to sensing of ventricular activation by a right ventricular (RVR) lead is less than 80 ms; and

processing means for determining that the left ventricular lead is located too closely to a right ventricular lead in response to determining that LVp-RVR lead is less than 80 ms.

26. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

displaying on a graphical user interface that a reason for ineffective capture is that the right ventricle is experiencing pre-excitation.

27. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c); and

means for displaying on a graphical user interface that the reason for ineffective capture is that the left ventricular lead and a right ventricular lead are physically located too close to each other.

28. A method for using an implantable medical device for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering a ventricular pacing stimulus;

(b) sensing a signal in response to the ventricular pacing stimulus;

(c) applying an effective capture test to the sensed signal;

(d) repeatedly activating (a)-(c); and

(e) determining the reason for ineffective capture following the repeated activation of (a)-(c), determining from the signal a maximum amplitude, (Max) a maximum time associated with the maximum amplitude (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, wherein the effective capture test comprising one of:

T max− T min>30 ms  (1)

0.2<|Max− a baseline( BL )|/| BL −Min|<5;  (2)

(|Max− BL |/|Min− BL|≦LL and BL <|Min/8|)  (3)

T min<60 ms; and  (4)

Max−Min>3.5 mV.  (5)

29. The method of claim 28 wherein ineffective capture is determined after an implantable medical device has been chronically implanted.

30. A method for using an implantable medical device for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering a ventricular pacing stimulus;

(b) sensing a signal in response to the ventricular pacing stimulus;

(c) applying an effective capture test to the sensed data;

(d) repeatedly activating (a)-(c);

(e) determining the reason for ineffective capture following the repeated activation of (a)-(c), processing determining from the signal a maximum amplitude, a maximum time associated with the maximum amplitude (Max), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, wherein the effective capture test comprising one of:

( 1 ) Tmax−Tmin>30ms;

( 2 ) 0.2<|Max-a baseline (BL)|/|BL-Min|<5;

( 3 ) (|Max-BL|/|Min-BL|≦LL and BL <|Min/8|)

( 4 ) Tmin<60ms; and

( 5 ) Max-Min>3.5mV,

(f) determining when effective capture is occurring wherein effective capture is determined when greater than 75% of daily tests successfully pass the effective capture test.

31. A method for using an implantable medical device for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering a ventricular pacing stimulus;

(b) sensing a signal in response to the ventricular pacing stimulus;

(c) applying an effective capture test to the sensed data;

(d) repeatedly activating (a)-(c);

(e) determining the reason for ineffective capture following the repeated activation of (a)-(c), processing determining from the signal a maximum amplitude, a maximum time associated with the maximum amplitude (Max), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, wherein the effective capture test comprising one of:

( 1 ) Tmax−Tmin>30ms;

( 2 ) 0.2<|Max-a baseline (BL)|/|BL-Min|<5;

( 3 ) (|Max-BL|/|Min-BL|≦LL and BL<|Min/8|)

( 4 ) Tmin<60ms; and

( 5 ) Max-Min>3.5mV,

determining whether a minimum time is greater than a predetermined time for greater than 75% daily tests.

32. A method for using an implantable medical device for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering a ventricular pacing stimulus;

(b) sensing a signal in response to the ventricular pacing stimulus;

(c) applying an effective capture test to the sensed data;

(d) repeatedly activating (a)-(c);

(e) determining the reason for ineffective capture following the repeated activation of (a)-(c), processing determining from the signal a maximum amplitude, a maximum time associated with the maximum amplitude (Max), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, wherein the effective capture test comprising one of:

( 1 ) Tmax−Tmin>30ms;

( 2 ) 0.2<|Max-a baseline (BL)|/|BL-Min|<5;

( 3 ) (|Max-BL|/|Min-BL|≦LL and BL<|Min/8|)

( 4 ) Tmin<60ms; and

( 5 ) Max-Min>3.5mV,

determining a diagnostic classification for ineffective capture, the diagnostic classification selected from the group consisting of loss of capture, RV pre-excitation, a left ventricular lead and a right ventricular lead are too close together, AT/AF, a long SAV during biventricular pacing, a long PAV during biventricular pacing, a long SAV during left ventricular pacing, and a long PAV during left ventricular pacing.

33. A method for using an implantable medical device for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering a ventricular pacing stimulus;

(b) sensing a signal in response to the ventricular pacing stimulus;

(c) applying an effective capture test to the sensed data;

(d) repeatedly activating (a)-(c);

(e) determining the reason for ineffective capture following the repeated activation of (a)-(c), processing determining from the signal a maximum amplitude, a maximum time associated with the maximum amplitude (Max), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, wherein the effective capture test comprising one of:

( 1 ) Tmax−Tmin>30ms;

( 2 ) 0.2<|Max-a baseline (BL)|/|BL-Min|<5;

( 3 ) (|Max-BL|/|Min-BL|≦LL and BL<|Min/8|)

( 4 ) Tmin<60ms; and

( 5 ) Max-Min>3.5mV,

wherein determination that a left ventricular lead is located in a poor substrate is distinguished from loss of capture by observing that Tmax>Tmin and Tmin>60ms.

34. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed signal;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c), wherein the effective capture test relies on a processing means for determining from the signal a maximum amplitude (Max), a maximum time associated with the maximum amplitude (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, the effective capture test comprising one of:

T max− T min>30 ms  (1)

0.2<|Max− a baseline( BL )|/| BL −Min|<5;  (2)

(|Max− BL |/|Min− BL|≦LL and BL <|Min/8|)  (3)

T min<60 ms; and  (4)

Max−Min>3.5 mV.  (5)

35. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed data;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c), wherein the reason is selected from a group consisting of a SAV that is too long, a PAV that is too long, RV pre-excitation, and AF.

36. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed data;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c), wherein the effective capture test relies on a processing means for determining from the signal a maximum amplitude (Max), a maximum time associated with the maximum amplitude (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, the effective capture test comprising Tmax−Tmin>30 ms.

37. An apparatus for determining a reason for ineffective capture of a ventricle, comprising:

(a) delivering means for delivering a ventricular pacing stimulus;

(b) sensing means for sensing a signal in response to the ventricular pacing stimulus;

(c) processing means for applying an effective capture test to the sensed data;

(d) means for repeatedly activating (a)-(c);

(e) processing means for determining the reason for ineffective capture following the repeated activation of (a)-(c), wherein the effective capture test relies on a processing means for determining from the signal a maximum amplitude (Max), a maximum time associated with the maximum amplitude (Tmax), a minimum amplitude (Min), and a minimum time (Tmin) associated with the minimum amplitude, the effective capture test comprising one of:

(1) Tmin<60 ms, and

(2) Max−Min>3.5 mV.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 6, 2012
From: GHOSH, SUBHAM; STADLER, ROBERT W
To: MEDTRONIC, INC.
Reel/Frame 029421/0428 →
Continuity (1)
Related Publication 20140163633A1 · Jun 12, 2014