Closed loop programming for individual adjustment of electro-mechanical synchrony

• US 7,970,469 B2
• Filed: 05/26/2010
• Issued: 06/28/2011
• Est. Priority Date: 04/11/2007
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Schecter, Stuart O.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Stice; Paula J
• Application Number:
  US12/788,003
• Publication Number:
  US 20100234913A1
• Time in Patent Office: 398 Days
• Field of Search: 600509-511, 607/17, 607/11, 607 14- 15, 607/19
• US Class Current: 607/17
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7285 for synchronising or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal A61B6/5205, A61B6/541, A61B8/5207, A61B8/543 take precedence
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An implantable therapy system including implantable stimulation and control components. The implantable components operate under a set of variable parameters that can be adjusted for improved performance for an individual patient. The implantable components are adapted to self-evaluate the patients physiologic performance and autonomously adjust an existing set of parameters to improve performance throughout an implantation period without requiring intervention of a clinician, for example with a physicians programmer. The implantable components can compare a patient'"'"'s exhibited activity to a desired template of that activity to determine when adjustments are indicated. The template can be based on observations of one or more third parties exhibiting normal activity. The implantable components can adjust the operating parameters to improve synchrony of multiple heart chambers and/or to increase a peak contractility.

Claims

1. A method of delivering therapy by an implantable stimulation device, the method comprising:

programming an implantable device with a first set of a plurality of operational parameters that define characteristics, including timing characteristics, of therapy to be delivered and conditions under which the therapy is delivered;

designating at least one indicator of cardiac performance;

monitoring a patient'"'"'s physiologic activity by the implantable device;

evaluating the patient'"'"'s physiologic activity by the implantable device;

generating and delivering therapeutic stimulation by the implantable device as a function of the monitored physiologic activity;

at least periodically evaluating the at least one indicator of cardiac performance by the implantable device under therapy provided according to the first set of operational parameters as compared to a predetermined eucontractile performance for the patient, wherein the predetermined eucontractile performance is determined based on assessment of a plurality of patients each exhibiting similar physiology to the patient;

which indicates desired healthy activity at rest and at elevated metabolic levels for the patient; and

reprogramming the first set of operational parameters to a second set of the plurality operational parameters by the implantable device upon indications that delivery of the therapeutic stimulation can be improved as compared to the predetermined eucontractile performance for the patient.

2. The method of claim 1, wherein designating the at least one indicator of cardiac performance is based at least partially on the evaluated physiologic activity.

3. The method of claim 1, wherein evaluating the at least one indicator of cardiac performance by the implantable device comprises comparing the monitored physiologic activity to a desired template corresponding to that activity.

4. The method of claim 3, further comprising evaluating one or more third parties to develop the desired template.

5. The method of claim 4, further comprising selecting the one or more third parties to have similar physiology to the patient.

6. The method of claim 4, further comprising determining physiologic activity of the one or more third parties via sensing substantially similar to the monitoring of the patient'"'"'s physiologic activity performed by the implantable device.

7. The method of claim 1, wherein the evaluating the at least one indicator of cardiac performance by the implantable device comprises evaluating for indications of cardiac stimulation deficits.

8. The method of claim 1, wherein the evaluating the at least one indicator of cardiac performance by the implantable device comprises evaluating for indications of cardiac contraction deficits.

9. The method of claim 1, wherein the evaluating the at least one indicator of cardiac performance by the implantable device is performed along a plurality of different spatial vectors.

10. A therapeutic device system comprising:

an implantable therapeutic stimulation device comprising an implantable stimulation pulse generator adapted to generate therapeutic stimulation;

at least one implantable lead defining at least one stimulation circuit and one sensing circuit adapted to sense at least one physiologic parameter indicative of a patient'"'"'s physiological activity;

a controller in communication with the at least one lead so as to receive signals indicative of the patient'"'"'s cardiac activity and with the stimulation pulse generator such that the controller can selectively induce delivery of therapeutic stimulation under a set of a plurality of operational parameters that define interval timing characteristics and parameters for delivery of the therapy;

an external user interface adapted to display data and convert user inputs into control signals; and

telemetry adapted for communication between the implantable stimulation device and the external user interface such that the external user interface can program an initial set of the operational parameters and wherein the controller is adapted to evaluate the patient'"'"'s cardiac activity and autonomously closed-loop reprogram at least the interval timing parameters to improve delivery of the therapeutic stimulation for improved electromechanical synchrony as compared to a predetermined eucontractile performance for the patient, wherein the predetermined eucontractile performance is determined based on assessment of a plurality of patients each exhibiting similar physiology to the patient which indicates desired healthy activity at rest and at elevated metabolic levels for the patient.

11. The system of claim 10, wherein the implantable device is adapted to evaluate the patient'"'"'s physiologic activity for indications of adjustment of the interval timing parameters based at least partly on transcardiac impedance measurements.