Closed loop programming for individual adjustment of electro-mechanical synchrony

• US 7,751,889 B1
• Filed: 04/11/2007
• Issued: 07/06/2010
• Est. Priority Date: 04/11/2007
• Status: Expired due to Fees

• 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:
  US11/734,117
• Time in Patent Office: 1,182 Days
• Field of Search: 600/509, 600/513, 600/300, 600/314, 600/315, 600/484, 607 2- 4, 607 10- 11, 607/18, 607/20, 607/24, 607116-122
• 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. An implantable cardiac 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; and

a controller in communication with the at least one lead said controller programmed to receive signals indicative of the patient'"'"'s physiologic activity and with the stimulation pulse generator such that the controller can selectively induce delivery of the therapeutic stimulation and wherein the controller operates under a first programmed set of a plurality of variable operational parameters wherein the operational parameters define timing intervals under which the therapy is delivered and characteristics of the therapy delivered, and wherein the controller is further adapted to periodically evaluate signals indicative of the patient'"'"'s cardiac activity for effectiveness of the therapy delivery in achieving improved synchrony between heart chambers as compared to a predetermined eucontractile performance for the patient, wherein the 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 wherein the controller is further adapted to automatically self-reprogram the first set of operational parameters to a second set of operational parameters to improve effectiveness of the timing intervals of the therapy delivery to obtain improved synchrony between heart chambers as compared to the predetermined eucontractile performance for the patient.

2. The device of claim 1, wherein the controller is adapted to evaluate the signals indicative of the patient'"'"'s cardiac activity for effectiveness of the timing intervals on a regular periodic basis.

3. The device of claim 1, wherein the controller is adapted to evaluate the signals indicative of the patient'"'"'s cardiac activity for effectiveness of the therapy delivery upon triggering by a change in the observed cardiac performance.

4. The device of claim 1, wherein the signals indicative of the patient'"'"'s cardiac activity are indicative of synchrony between heart chambers.

5. The device of claim 1, wherein the signals indicative of the patient'"'"'s cardiac activity are indicative of peak amplitude of a transcardiac impedance signal.

6. The device of claim 1, wherein the signals indicative of the patient'"'"'s cardiac activity correspond to impedance measurements of activity along different spatial vectors and wherein integrals of the impedance measurements over time are calculated as bounded by the signals along different vectors and wherein the patient'"'"'s cardiac activity is evaluated at least partially based on differences of the integrals of the impedance measurements between different spatial vectors.

7. The device of claim 1, wherein the controller evaluates the signals indicative of the patient'"'"'s cardiac activity by comparing the signals to a template of desired activity.

8. 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; and

a controller in communication with the at least one lead said controller programmed 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 in order to achieve improved synchrony between heart chambers as compared to a predetermined eucontractile performance for the patient, wherein the 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 autonomously closed-loop reprogram at least the interval timing parameters to improve delivery of the therapeutic stimulation for improved electromechanical synchrony between the chambers of the heart as compared to a predetermined eucontractile performance for the patient.

9. The system of claim 8, wherein the implantable device is adapted to compare the at least one physiologic parameter indicative of a patient'"'"'s cardiac activity to predetermined desired values for the at least one physiologic parameter to determine if adjustment of the interval timing is indicated.

10. The system of claim 8, wherein the implantable device is further adapted to evaluate the patient'"'"'s physiologic activity for indications of adjustment of the interval timing parameters based at least partially on a physiologic parameter that is not directly utilized for determination of therapy delivery.

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 partially on transcardiac impedance measurements.

12. The system of claim 8, wherein the controller is adapted to evaluate the signals indicative of the patient'"'"'s cardiac activity for effectiveness of the timing intervals on a regular periodic basis.

13. The system of claim 8, wherein the controller is adapted to evaluate the signals indicative of the patient'"'"'s cardiac activity for effectiveness of the therapy delivery upon triggering by a change in the observed cardiac performance.

14. The system of claim 8, wherein the signals indicative of the patient'"'"'s cardiac activity are indicative of peak amplitude of a transcardiac impedance signal.

15. The system of claim 8, wherein the signals indicative of the patient'"'"'s cardiac activity correspond to impedance measurements of activity along different spatial vectors and wherein integrals of the impedance measurements over time are calculated as bounded by the signals along different vectors and wherein the patient'"'"'s cardiac activity is evaluated at least partially based on differences of the integrals of the impedance measurements between different spatial vectors.

16. The system of claim 8, wherein the controller evaluates the signals indicative of the patient'"'"'s cardiac activity by comparing the signals to a template of desired activity.