Expedited set-up of multi-electrode lead (MEL)

• US 7,792,585 B1
• Filed: 05/17/2007
• Issued: 09/07/2010
• Est. Priority Date: 05/17/2007
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Shelchuk, Anne M.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/750,153
• Time in Patent Office: 1,209 Days
• Field of Search: 607/6, 607/8, 607/9, 607/27, 607/28, 607115-123
• US Class Current: 607/27
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Methods and systems are provided for expediting set-up of a multi-electrode lead (MEL). In accordance with specific embodiments, such an MEL includes N groups of electrodes, with each of the N groups including at least M electrodes, where N≧2 and M is ≧2. Electrodes in a same group are within 5 mm of one another. Electrodes in separate groups are at least 10 mm from one another. Specific embodiments relate to methods for identifying cathode-anode electrode configurations that can be used to not exceed a maximum acceptable capture threshold, and that provide a sensed intrinsic R-wave amplitude of at least a minimum acceptable sensing threshold. Such thresholds can be default values, or can be defined by a user (e.g., clinician, physician, nurse, or the like).

Claims

1. For use with an implantable system that includes

an implantable cardiac stimulation device and a multi-electrode lead (MEL) that includes N groups of electrodes,

with each of the N groups including at least M electrodes,

where N≧

2 and M is ≧

2,

where electrodes in a same group are within 5 mm of one another, and

where electrodes in separate groups are at least 10 mm from one another,

a method for identifying cathode-anode electrode configurations that can be used to not exceed a maximum acceptable capture threshold, and that provide a sensed intrinsic R-wave amplitude of at least a minimum acceptable sensing threshold,

the method comprising;

(a) identifying each electrode that can be used as a cathode by

(a.1) connecting each electrode of the MEL individually as the cathode;

(a.2) determining, for each electrode individually connected as the cathode, a capture threshold and a sensed intrinsic R-wave amplitude;

(a.3) storing data indicative of the capture threshold and the sensed intrinsic R-wave amplitude, for each electrode individually connecting as the cathode; and

(a.4) identifying, as an electrode that can be used as the cathode, each electrode that achieves both a capture threshold that does not exceed a maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches a minimum acceptable sensing threshold, said identifying based on the data stored at (a.3);

(b) for each electrode of the MEL identified as an electrode that can be used as the cathode, identifying one or more other electrode in the same group that can be used as a corresponding anode by

(b.1) connecting, individually as the anode, each other electrode in the same group as the electrode that can be used as the cathode, while the electrode that can be used as the cathode is connected as the cathode;

(b.2) determining, for each cathode-anode combination of (b.1), a capture threshold and a sensed intrinsic R-wave amplitude;

(b.3) storing data indicative of the capture threshold and the sensed intrinsic R-wave amplitude, for each cathode-anode electrode configuration of (b.1); and

(b.4) identifying, as an electrode that can be used as the anode, each other electrode connected as the anode at (b.1) that provided a cathode-anode electrode configuration that achieves both a capture threshold that does not exceed the maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches the minimum acceptable sensing threshold, said identifying based on the data stored at (b.3).

2. The method of claim 1, wherein at step (a), when a said electrode is individually connected as the cathode, all the electrodes in another group of electrodes electrically are connected together as the anode.

3. The method of claim 1, wherein at step (a), when a said electrode is individually connected as the cathode, all the electrodes in an adjacent group of electrodes are electrically connected together as the anode.

4. The method of claim 3, wherein at step (a), when an electrode has two adjacent groups of electrodes, the more proximal group of electrodes are electrically connected together as the anode.

5. The method of claim 1, wherein at step (a), when a said electrode is individually connected as the cathode, all the other electrodes in the same group of electrodes are electrically connected together as the anode.

6. The method of claim 1, wherein at step (a), when a said electrode is individually connected as the cathode, one or more electrode on the same MEL or on a different lead is connected as the anode, or an electrically conductive housing of the implantable cardiac stimulation device is connected as the anode.

7. The method of claim 1, wherein steps (a) and (b) are performed under the control of a non-implantable device in communication with the implantable cardiac stimulation device.

8. The method of claim 1, further comprising:

after step (a) is performed, allowing a user to adjust at least one of the maximum acceptable capture threshold, and the minimum acceptable sensing threshold; and

repeating (a.4) in view of the adjustment, using the data stored at (a.3), without repeating (a.1), (a.2) and (a.3).

9. The method of claim 1, wherein where a group includes 3 or more electrodes:

(b.1) also includes connecting together, as the anode, combinations of other electrodes in the same group as the electrode that can be used as the cathode, while the electrode that can be used as the cathode is connected as the cathode; and

(b.4) also includes identifying multiple electrode combinations that can be used as the anode.

10. The method of claim 1, wherein:

step (a) further comprises (a.5) displaying a graphical representation of the MEL to a user in a manner that shows the user each electrode that can be used as the cathode; and

step (b) further comprises (b.5) displaying a graphical representation of each cathode-anode electrode configuration that achieves both a capture threshold that does not exceed the maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches the minimum acceptable sensing threshold.

11. For use with an implantable system that includes

an implantable cardiac stimulation device and a multi-electrode lead (MEL) that includes N groups of electrodes,

with each of the N groups including at least M electrodes,

where N≧

2 and M is ≧

2,

where electrodes in a same group are within 5 mm of one another, and

where electrodes in separate groups are at least 10 mm from one another,

a method for identifying a preferred cathode-anode electrode configuration that can be used to not exceed a maximum acceptable capture threshold, and that provide a sensed intrinsic R-wave amplitude of at least a minimum acceptable sensing threshold,

the method comprising;

(a) identifying a preferred electrode for use as a cathode by

(a.1) configuring each electrode of the MEL individually as the cathode;

(a.2) determining, for each electrode individually connected as the cathode, a capture threshold and a sensed intrinsic R-wave amplitude;

(a.3) storing data indicative of the capture threshold and the sensed intrinsic R-wave amplitude, for each electrode individually connecting as the cathode; and

(a.4) identifying, as the preferred electrode for use as the cathode, the electrode that achieves both a lowest capture threshold not exceeding the maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches a minimum acceptable sensing threshold, said identifying based on the data stored at (a.3);

(b) identifying a preferred electrode for use as an anode by

(b.1) connecting, individually as the anode, each other electrode in the same group as the preferred electrode for use as the cathode, while the preferred electrode for use as the cathode is connected as the cathode;

(b.2) determining, for each cathode-anode combination of (b.1), a capture threshold and a sensed intrinsic R-wave amplitude;

(b.3) storing data indicative of the capture threshold and the sensed intrinsic R-wave amplitude, for each cathode-anode electrode configuration of (b.1); and

(b.4) identifying, as the preferred electrode for use as the anode, the electrode connected as the anode at (b.1) that provided the cathode-anode electrode configuration that achieves both a lowest capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches the minimum acceptable sensing threshold, said identifying based on the data stored at (b.3).

12. The method of claim 11, wherein at step (a), when a said electrode is individually connected as the cathode, all the electrodes in another group of electrodes electrically connected together as the anode.

13. The method of claim 11, wherein at step (a), when a said electrode is individually connected as the cathode, all the electrodes in an adjacent group of electrodes are electrically connected together as the anode.

14. The method of claim 13, wherein at step (a), when an electrode has two adjacent groups of electrodes, the more proximal group of electrodes are electrically connected together as the anode.

15. The method of claim 11, wherein at step (a), when a said electrode is individually connected as the cathode, all the other electrodes in the same group of electrodes are electrically connected together as the anode.

16. The method of claim 11, wherein at step (a), when a said electrode is individually connected as the cathode, one or more electrode on the same MEL or on a different lead is connected as the anode, or an electrically conductive housing of the implantable cardiac stimulation device is connected as the anode.

17. The method of claim 11, wherein steps (a) and (b) are performed under the control of a non-implantable device in communication with the implantable cardiac stimulation device.

18. The method of claim 11, further comprising:

after step (a) is performed, allowing a user to adjust at least one of the maximum acceptable capture threshold, and the minimum acceptable sensing threshold; and

repeating (a.4) in view of the adjustment, using the data stored at (a.3), without repeating (a.1), (a.2) and (a.3).

19. The method of claim 11, wherein where a group includes 3 or more electrodes:

(b.1) also includes connecting together, as the anode, combinations of other electrodes in the same group as the preferred electrode for use as the cathode, while the preferred electrode for use as the cathode is connected as the cathode; and

(b.4) also includes identifying multiple electrode combinations that can be used as the anode.

20. The method of claim 11, wherein:

step (a) further comprises (a.5) displaying a graphical representation of the MEL to a user in a manner that shows the user the preferred electrode for use as the cathode; and

step (b) further comprises (b.5) displaying a graphical representation of a preferred cathode-anode electrode configuration.

21. For use with an implantable system that includes

an implantable cardiac stimulation device and a multi-electrode lead (MEL) that includes N groups of electrodes,

with each of the N groups including at least M electrodes,

where N≧

2 and M is ≧

2,

where electrodes in a same group are within 5 mm of one another, and

where electrodes in separate groups are at least 10 mm from one another,

a method for identifying cathode-anode electrode configurations that can be used to not exceed a maximum acceptable capture threshold, and that provide a sensed intrinsic R-wave amplitude of at least a minimum acceptable sensing threshold,

the method comprising;

(a) identifying, as an electrode that can be used as the cathode, each electrode that achieves both a capture threshold that does not exceed a maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches a minimum acceptable sensing threshold, and storing data indicative thereof; and

(b) for each electrode of the MEL identified as an electrode that can be used as the cathode, identifying as an electrode that can be used as a corresponding anode, each other electrode in the same group as the electrode that can be used as the cathode, that provides a cathode-anode electrode configuration that achieves both a capture threshold that does not exceed the maximum acceptable capture threshold, and a sensed intrinsic R-wave amplitude that at least reaches the minimum acceptable sensing threshold, and storing data indicative thereof.

22. For use with an implantable system that includes

an implantable cardiac stimulation device and a multi-electrode lead (MEL) that includes N groups of electrodes,

with each of the N groups including at least M electrodes,

where N≧

2 and M is ≧

2,

where electrodes in a same group are within 5 mm of one another, and

where electrodes in separate groups are at least 10 mm from one another,

a method for identifying cathode-anode electrode configurations that can be used to not exceed a maximum acceptable capture threshold,

the method comprising;

(a) identifying each electrode that can be used as a cathode by

(a.1) connecting each electrode of the MEL individually as the cathode;

(a.2) determining, for each electrode individually connected as the cathode, a capture threshold;

(a.3) storing data indicative of the capture threshold, for each electrode individually connecting as the cathode; and

(a.4) identifying, as an electrode that can be used as the cathode, each electrode that achieves a capture threshold that does not exceed a maximum acceptable capture threshold, said identifying based on the data stored at (a.3);

(b) for each electrode of the MEL identified as an electrode that can be used as the cathode, identifying one or more other electrode in the same group that can be used as a corresponding anode by

(b.1) connecting, individually as the anode, each other electrode in the same group as the electrode that can be used as the cathode, while the electrode that can be used as the cathode is connected as the cathode;

(b.2) determining, for each cathode-anode combination of (b.1), a capture threshold;

(b.3) storing data indicative of the capture threshold, for each cathode-anode electrode configuration of (b.1); and

(b.4) identifying, as an electrode that can be used as the anode, one or more other electrode connected as the anode at (b.1) that provided a cathode-anode electrode configuration that achieves a capture threshold that does not exceed the maximum acceptable capture threshold, said identifying based on the data stored at (b.3).