Lead condition assessment for an implantable medical device

• US 7,567,840 B2
• Filed: 10/28/2005
• Issued: 07/28/2009
• Est. Priority Date: 10/28/2005
• Status: Expired due to Fees

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Primary Examiner(s): Schaetzle; Kennedy J.
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/262,243
• Publication Number:
  US 20070100407A1
• Time in Patent Office: 1,369 Days
• Field of Search: 607/1, 607/9, 607 45- 46, 607 27- 29, 607/547, 600/547
• US Class Current: 607/27
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

A method, system, and apparatus for performing a lead condition assessment and/or a lead orientation determination associated with an implantable medical device (IMD). A first impedance is determined. The first impedance relates to the impedance relative to a first electrode and a portion of the IMD. A second impedance is determined. The second impedance relates to the impedance relative to a second electrode and the portion of the IMD. The first impedance is compared with the second impedance to determine an impedance difference. A determination is made whether the impedance difference is outside a predetermined tolerance range. Furthermore, artifact measured during impedance measurements or test pulses may be compared to assess lead orientation. An indication of a lead condition error is provided in response to determining that the impedance difference is outside the predetermined tolerance range.

Claims

1. A method for assessing a condition of a lead assembly coupled to an implantable medical device (IMD), comprising:

determining by an impedance unit of the IMD or an external unit in communication with the IMD a first impedance relative to a first electrode and a reference electrode;

determining by the impedance unit of IMD or the external unit in communication with the IMD a second impedance relative to a second electrode and said reference electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said first impedance to said second impedance to determine an impedance difference;

determining by the impedance unit of the IMD or the external unit in communication with the IMD whether said impedance difference is outside a predetermined tolerance range; and

providing by the impedance unit of the IMD or the external unit in communication with the IMD an indication of a lead condition error in response to determining that said impedance difference is outside said predetermined tolerance range to a memory of the IMD or a communication unit of the IMD.

2. The method of claim 1 wherein said reference electrode comprises a portion of said IMD.

3. The method of claim 1, further comprising providing by the impedance unit of the IMD or the external unit in communication with the IMD an indication of a passing condition of said lead condition in response to determining that said impedance difference is not outside said predetermined tolerance range to memory of the IMD or the communication unit of the IMD.

4. The method of claim 1, further comprising receiving by the IMD from an external source a signal prompt for performing said lead condition assessment.

5. The method of claim 1, further comprising:

determining by the impedance unit of the IMD or the external unit in communication with the IMD a third impedance, said third impedance comprising the impedance relative to said first electrode and said second electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said impedance difference to said third impedance; and

identifying by the impedance unit of the IMD or the external unit in communication with the IMD a source of said lead condition error based upon said comparing of said impedance difference to said third impedance, said source comprising at least one of said first electrode, said second electrode, and a physiological impedance.

6. The method of claim 1, wherein determining said first impedance comprises:

providing by the IMD a test current signal to said first electrode;

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a voltage signal across said first electrode and said reference electrode, said voltage signal resulting from said test current signal; and

determining by the impedance unit of the IMD or the external unit in communication with the IMD said first impedance based upon said test current signal and said voltage signal.

7. The method of claim 1, wherein determining said second impedance comprises:

providing by the IMD a test current signal to said second electrode;

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a voltage signal across said second electrode and said reference electrode, said voltage signal resulting from said test current signal; and

determining by the impedance unit of the IMD or the external unit in communication with the IMD said second impedance based upon said test current signal and said voltage signal.

8. The method of claim 1, further comprising:

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a first signal artifact relating to said second electrode, said first signal artifact resulting from a test current signal being applied to said first electrode;

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a second signal artifact relating to said first electrode, said second signal artifact resulting from a test current signal being applied to said second electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said first signal artifact to said second signal artifact to determine a signal artifact differential;

determining by the impedance unit of the IMD or the external unit in communication with the IMD whether said signal artifact differential is outside a predetermined tolerance range; and

providing by the impedance unit of the IMD or the external unit in communication with the IMD an indication of a lead condition error in response to determining that said signal artifact differential is outside said predetermined tolerance range to a memory of the IMD or a communication unit of the IMD.

9. The method of claim 8, further comprising determining by the impedance unit of the IMD or the external unit in communication with the IMD which of said first electrode and said second electrodes is positioned distal to said reference electrode based upon said signal artifact differential.

10. The method of claim 1, further comprising determining by the impedance unit of the IMD or the external unit in communication with the IMD which of said first electrode and said second electrode is positioned distal to said reference electrode based upon said comparing of said first impedance to said second impedance.

11. The method of claim 10 wherein determining by the impedance unit of the IMD or the external unit in communication with the IMD which of said first electrode and said second electrode is positioned distal to said reference electrode comprises determining whether said first impedance is greater than said second impedance.

12. The method of claim 10, wherein determining by the impedance unit of the IMD or the external unit in communication with the IMD which of said first electrode and said second electrode is positioned distal to said reference electrode comprises determining whether the positioning of said first and second electrodes is the reverse of an expected positioning.

13. A method for determining a condition of a lead assembly associated with an implantable medical device (IMD), comprising:

determining by an impedance unit of the IMD or an external unit in communication with the IMD a first impedance relative to a first electrode and a reference electrode;

determining by the impedance unit of the IMD or the external unit in communication with the IMD a second impedance relative to a second electrode and said reference electrode;

determining by the impedance unit of the IMD or the external unit in communication with the IMD a third impedance relative to said first electrode and said second electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said first impedance to said second impedance to determine an impedance difference;

determining by the impedance unit of the IMD or the external unit in communication with the IMD whether said impedance difference is outside a predetermined tolerance range;

providing by the impedance unit of the IMD or the external unit in communication with the IMD an indication of a lead condition error in response to determining that said impedance difference is outside a predetermined tolerance range to a memory of the IMD or a communication unit of the IMD;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said impedance difference to said third impedance; and

identifying by the impedance unit of the IMD or the external unit in communication with the IMD a source of said lead condition error based upon said comparing of said impedance difference to said third impedance, said source comprising at least one of said first electrode, said second electrode, and a physiological impedance.

14. A method for determining a condition of a lead assembly associated with an implantable medical device (IMD), comprising:

providing by the IMD a first test signal to a first electrode coupled to said IMD through a first lead;

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a first signal artifact relating to a second electrode coupled to said IMD through a second lead, said first signal artifact resulting from said first test signal being applied to said first electrode;

providing by the IMD a second test signal to said second electrode;

measuring by the impedance unit of the IMD or the external unit in communication with the IMD a second signal artifact relating to said first electrode, said second signal artifact resulting from said second test signal being applied to said second electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said first signal artifact to said second signal artifact to determine a signal artifact differential;

determining by the impedance unit of the IMD or the external unit in communication with the IMD whether said signal artifact differential is outside a predetermined tolerance range; and

providing by the impedance unit of the IMD or the external unit in communication with the IMD an indication of a lead condition error in response to determining that said signal artifact differential is outside said predetermined tolerance range to a memory of the IMD or a communication unit of the IMD.

15. The method of claim 14, further comprising determining by the impedance unit of the IMD or the external unit in communication with the IMD whether said signal artifact differential relates to at least one of a resistive characteristic, an inductive characteristic and a capacitive characteristic to determine whether the source of said lead condition error relates to at least one of said first electrode, said second electrode, and a physiological impedance.

16. A method for determining an orientation of a lead assembly associated with an implantable medical device (IMD), comprising:

determining by the impedance unit of the IMD or the external unit in communication with the IMD a first impedance relative to a first electrode and a reference electrode;

determining by the impedance unit of the IMD or the external unit in communication with the IMD a second impedance relative to a second electrode and said reference electrode;

comparing by the impedance unit of the IMD or the external unit in communication with the IMD said first impedance to said second impedance to determine whether said first impedance is greater than said second impedance;

determining by the impedance unit of the IMD or the external unit in communication with the IMD which of said first electrode and said second electrodes is positioned distal to said reference electrode based upon comparing said first and second impedances.

17. The method of claim 16, wherein determining by the impedance unit of the IMD or the external unit in communication with the IMD said first electrode is distal to said reference electrode compared to said second electrode is based upon a determination that said first impedance is greater than said second impedance.

18. The method of claim 17, further comprising determining by the impedance unit of the IMD or the external unit in communication with the IMD whether the positioning of first and second leads are the reverse of an expected positioning based upon determining which of said first electrode and said second electrodes is positioned distal to said reference electrode.

19. A medical device system (MDS) for providing therapy, comprising:

an implantable medical device (IMD) for delivering an electrical signal to a patient'"'"'s body;

a first electrode coupled to said IMD and to a first portion of the patient'"'"'s body;

a second electrode coupled to said IMD and to a second portion of the patient'"'"'s body;

an external device to communicate with said IMD; and

wherein said MDS comprises a controller to determine a first impedance relative to a first electrode and a reference electrode, determine a second impedance relative to a second electrode and said reference electrode, compare said first impedance and said second impedance to determine an impedance difference, and determine whether said impedance difference is outside a predetermined tolerance range; and

and wherein said MDS provides an indication of a lead condition error in response to determining that said impedance difference is outside said predetermined tolerance range to a memory of the IMD or the external device.

20. The medical device system of claim 19, wherein said controller also determines a third impedance relative to the first electrode and the second electrode, and wherein said controller further compares the impedance difference to the third impedance, and identifies a source of the lead condition error based upon comparing the impedance difference to the third impedance, said source comprising at least one of the first electrode, the second electrode, and a physiological impedance.

21. A computer readable program storage device encoded with instructions that, when executed by a computer, performs a method for determining a condition of a lead assembly associated with an implantable medical device (IMD), comprising:

determining a first impedance, said first impedance relating to the impedance relative to a first electrode and a reference electrode;

determining a second impedance, said second impedance relating to the impedance relative to a second electrode and said reference electrode;

comparing said first impedance to said second impedance to determine an impedance difference;

determining whether said impedance difference is outside a predetermined tolerance range; and

providing an indication of a lead condition error in response to determining that said impedance difference is outside said predetermined tolerance range to a memory of the IMD or a communication unit of the IMD.