Systems and methods for activating and controlling impedance-based detection systems of implantable medical devices

• US 8,380,303 B2
• Filed: 02/25/2011
• Issued: 02/19/2013
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Rosenberg, Stuart, Xi, Cecilia Q., Nabutovsky, Yelena, Wenzel, Brian J., Gill, Jong, Hsu, William
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/035,793
• Publication Number:
  US 20120221069A1
• Time in Patent Office: 725 Days
• Field of Search: 607/2, 607/17, 607/18
• US Class Current: 607/2
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36507 controlled by gradient or slope of the heart potential
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation

Abstract

Techniques are provided for use with implantable medical devices for addressing encapsulation effects, particularly in the detection of cardiac decompensation events such as heart failure (HF) or cardiogenic pulmonary edema (PE.) In one example, during an acute interval following device implant, cardiac decompensation is detected using heart rate variability (HRV), ventricular evoked response (ER) or various other non-impedance-based parameters that are insensitive to component encapsulation effects. During the subsequent chronic interval, decompensation is detected using intracardiac or transthoracic impedance signals. In another example, the degree of maturation of encapsulation of implanted components is assessed using impedance frequency-response measurements or based on the frequency bandwidth of heart sounds or other physiological signals. In this manner, impedance-based HF/PE detection systems can be activated as soon as component encapsulation has matured, without necessarily waiting until completion of a preset post-implant maturation interval, often set to forty-five days or more.

Claims

1. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting impedance-based parameters following device implant;

assessing a degree of maturation of encapsulation of components of the implanted device using the impedance-based parameters; and

determining whether the degree of maturation has reached an acceptable level and, if so, controlling at least one impedance-based device function in response thereto wherein controlling at least one device function includes;

activating an impedance-based detection system to detect a possible cardiac decompensation event within the patient.

2. The method of claim 1 wherein the cardiac decompensation event includes one or more of heart failure (HF), congestive heart failure (CHF) and cardiogenic pulmonary edema (PE).

3. The method of claim 1 wherein the device includes at least one pair of electrodes implanted within patient tissues and wherein assessing the degree of maturation of encapsulation is performed to assess the degree of maturation of encapsulation of the electrodes of the pair.

4. The method of claim 3 wherein assessing the degree of maturation of encapsulation of the electrodes includes:

determining an impedance response for the electrodes as a function of frequency; and

determining the degree of maturation of tissues encapsulating the electrodes based on the impedance frequency response.

5. The method of claim 1 wherein the device includes a plurality of pairs of electrodes implanted within patient tissues and wherein assessing the degree of maturation of encapsulation is performed to identify particular pairs of electrodes wherein maturation has occurred.

6. The method of claim 1 wherein detecting impedance-based parameters following device implant includes applying impedance detection pulses to patient tissue between at least one pair of bipolar electrodes coupled to the device and measuring impedance parameters in response thereto.

7. The method of claim 1 wherein detecting impedance-based parameters following device implant includes applying low-level high-frequency alternating current (AC) signals between at least one pair of electrodes coupled to the device and measuring impedance signals in response thereto.

8. The method of claim 1 wherein a housing of the device is equipped with a pair of electrodes and wherein the steps are performed to assess the degree of maturation of encapsulation of the device housing.

9. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting impedance-based parameters following device implant;

assessing a degree of maturation of encapsulation of components of the implanted device using the impedance-based parameters; and

determining whether the degree of maturation has reached an acceptable level and, if so, controlling at least one impedance-based device function in response thereto;

wherein the device includes at least one pair of electrodes implanted within patient tissues and wherein assessing the degree of maturation of encapsulation is performed to assess the degree of maturation of encapsulation of the electrodes of the pair;

wherein assessing the degree of maturation of encapsulation of the electrodes includes;

determining an impedance response for the electrodes as a function of frequency; and

determining the degree of maturation of tissues encapsulating the electrodes based on the impedance frequency response; and

wherein determining the impedance frequency response includes determining one or more of impedance magnitude as a function of frequency and impedance phase as a function of frequency.

10. The method of claim 9 wherein determining the degree of maturation of tissues encapsulating the electrodes includes applying values representative of the impedance frequency response to lookup tables representative of the frequency response in the presence of different types of tissues.

11. The method of claim 10 wherein the lookup tables include values representative of impedance frequency response in the presence of one or more of:

blood, thrombus, inflammatory tissue, myocardium, fibrosis, and endothelium.

12. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting impedance-based parameters following device implant;

assessing a degree of maturation of encapsulation of components of the implanted device using the impedance-based parameters;

determining whether the degree of maturation has reached an acceptable level and, if so, controlling at least one impedance-based device function in response thereto;

wherein detecting impedance-based parameters following device implant includes applying low-level high-frequency alternating current (AC) signals between at least one pair of electrodes coupled to the device and measuring impedance signals in response thereto; and

further including characterizing the health of cardiac tissues based on the low-level high-frequency AC signals.

13. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting impedance-based parameters following device implant;

assessing a degree of maturation of encapsulation of components of the implanted device using the impedance-based parameters;

determining whether the degree of maturation has reached an acceptable level and, if so, controlling at least one impedance-based device function in response thereto;

wherein detecting impedance-based parameters following device implant includes applying low-level high-frequency alternating current (AC) signals between at least one pair of electrodes coupled to the device and measuring impedance signals in response thereto; and

further including tracking progression of heart failure based on the low-level high-frequency AC signals.

14. A method for use with an implantable medical device for implant within a patient, the method comprising:

detecting impedance-based parameters following device implant;

assessing a degree of maturation of encapsulation of components of the implanted device using the impedance-based parameters;

determining whether the degree of maturation has reached an acceptable level and, if so, controlling at least one impedance-based device function in response thereto; and

wherein the device is equipped with a physiological sensor adapted to provide parameters representative of a degree of encapsulation and wherein the steps are performed to assess the degree of maturation of encapsulation of the device housing based on the physiological sensor parameters.

15. The method of claim 14 wherein the physiological sensor includes one or more of an acoustic sensor and a 3D accelerometer and wherein assessing the degree of maturation of encapsulation of the device housing based on the physiological sensor parameters is performed based on a frequency bandwidth of physiological parameters detected by the sensor.

16. The method of claim 15 wherein physiological parameters detected by the sensor include one or more of heart sounds and respiration sounds and wherein assessing the degree of maturation of encapsulation of the device housing is performed based on a frequency bandwidth of the sounds detected by the sensor.

17. A system for use with an implantable medical device for implant within a patient, the system comprising:

an impedance detector operative to detect impedance-based parameters following device implant;

an encapsulation maturation assessment system operative to assess a degree of maturation of encapsulation of components of the implanted device based on the impedance-based parameters;

a maturation-based controller operative to determine whether the degree of maturation has reached an acceptable level and to control at least one device function in response thereto; and

wherein the device function includes detection of a possible cardiac decompensation event within the patient using an impedance-based detection system operative to detect cardiac decompensation events within the patient based on impedance parameters.