Implantable medical device and methods for automated detection of infection

• US 8,583,224 B2
• Filed: 08/03/2007
• Issued: 11/12/2013
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lee, Kent, Kwok, Jonathan T., Belalcazar, Hugo Andres, Pavlovic, Jennifer Lynn, Heil, Ronald W. Jr.
• Primary Examiner(s): TOWA, RENE T
• Application Number:
  US11/833,548
• Publication Number:
  US 20080064980A1
• Time in Patent Office: 2,293 Days
• Field of Search: 600300-301, 600/547, 607/3, 607/6, 607/18, 607 21- 22
• US Class Current: 600/547
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

The invention relates to systems, devices, and methods for detecting infections associated with implantable medical devices. In an embodiment, the invention includes a method of detecting infection in a patient including measuring a physiological parameter using a chronically implanted sensor at a plurality of time points and evaluating the physiological parameter measurements to determine if infection is indicated. In an embodiment, the invention includes an implantable medical device including a first chronically implantable sensor configured to generate a first signal corresponding to a physiological parameter and a controller disposed within a housing, the controller configured to evaluate the first physiological parameter signal to determine if an infection is indicated. Other embodiments are also included herein.

Claims

1. A method of detecting infection in a patient comprising:

providing a medical device that is configured to be implanted in a pocket of a patient;

measuring an impedance using a chronically implanted sensor at a plurality of time points, wherein the impedance measurement is taken in the pocket where the medical device is implanted;

measuring the concentration of a chemical species using an implanted chemical sensor;

evaluating the impedance measurement in conjunction with the concentration of the chemical species to determine if infection is indicated, wherein evaluating include comparing the impedance measurement to a detection threshold; and

evaluating additional patient data to detect systemic sepsis including at least one selected from the group consisting of evaluating a respiration rate of the patient to determine if it is greater than 20 breaths per minute and evaluating a heart rate of the patient to determine if it is greater than 90 beats per minute.

2. The method of claim 1, wherein infection is indicated by a decline in an average impedance.

3. The method of claim 1, further comprising initiating therapy to treat infection if infection is indicated.

4. The method of claim 3, the therapy comprising administration of an anti-microbial active agent.

5. The method of claim 3, the therapy comprising initiation of anti-microbial electrical therapy.

6. The method of claim 3, further comprising evaluating the impedance measurements to determine if infection is clearing.

7. The method of claim 1, wherein evaluating the impedance measurements comprises determining a baseline value for the impedance and comparing a current measurement to the baseline value.

8. The method of claim 7, wherein infection is indicated if the current measurement of the impedance differs from the baseline value by at least a threshold amount.

9. The method of claim 1, further comprising providing a notification if infection is indicated.

10. The method of claim 9, wherein providing a notification comprises providing a warning indication to a medical professional via a signal transmitted to a non-implanted device.

11. The method of claim 1, further comprising evaluating the impedance measurements to determine whether or not sepsis is occurring.

12. The method of claim 1, further comprising displaying data regarding the physiological parameter on an external device.

13. The method of claim 1, wherein the chemical species is selected from the group consisting of ionic and non-ionic species.

14. The method of claim 1, wherein the chemical species is selected from the group consisting of hydrogen ion, potassium ion, sodium ion, calcium ion, lactate, glucose, blood gases, and C-reactive protein (CRP).

15. An implantable medical device comprising:

a housing configured to be disposed in a tissue pocket of a patient;

a first electrode disposed on the exterior of the housing configured to provide a first impedance signal;

a second electrode disposed on the exterior of the housing configured to provide a second impedance signal;

a chemical sensor;

a controller disposed within the housing, the controller configured to evaluate the first impedance signal and second impedance signal in conjunction with data from the chemical sensor to determine if an infection is indicated, the controller configured to compare at least one of the first and second impedance signals to a detection threshold;

wherein the first and second impedance signals are reflective of impedance within the tissue pocket of the patient; and

evaluating additional patient data to detect systemic sepsis including at least one selected from the group consisting of evaluating a respiration rate of the patient to determine if it is greater than 20 breaths per minute and evaluating a heart rate of the patient to determine if it is greater than 90 beats per minute.

16. The device of claim 15, wherein the threshold is lower during periods of time when the patient is at increased risk of developing an infection.

17. The device of claim 15, further comprising a reservoir and an anti-microbialactive agent disposed within the reservoir, the device configured to release the anti-microbial active agent from the reservoir if an infection is indicated.

18. The device of claim 16, the anti-microbial active agent comprising an antibiotic.

19. The device of claim 16, where the implantable medical device further includes memory configured to store a treatment threshold, where the implantable medical device is configured to compare at least one of the first and second impedance signals to the treatment threshold to determine the efficacy of any medical treatments initiated after an infection is detected.