Software configurable medical device platform and associated methods

• US 20060079942A1
• Filed: 04/28/2005
• Published: 04/13/2006
• Est. Priority Date: 10/13/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stroebel, John C., Deno, D. Curtis, Wilkinson, Jeffrey D.
• Granted Patent: US 8,755,885 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

The invention relates to medical devices such as pacemakers, pulse generators, cardioverter-defibrillators and the like and more particularly relates to modular and reconfigurable medical system platforms and methods of designing, testing, controlling and implementing diverse therapies, diagnostics, physiologic sensors and related instrumentation using said medical system platforms. Methods, systems and devices provide a new design platform for implantable and external medical devices such as pacemakers, defibrillators, neurostimulators, heart monitors, etc. A real-time, highly flexible system of software and hardware modules enables both prototypes and products to respond to patient and customer needs with greater design and manufacturing efficiency. Certain embodiments integrate a general-purpose processor with interface circuitry to provide a standard platform for implementing new and conventional therapies with software models rather than custom circuitry. The platform described may be used as a simulation environment, development and test platform and/or may be used as architecture for building new medical devices.

Claims

1. A platform adapted to provide electrical stimulation to a heart and to receive a feedback data set via physiologic instrumentation coupled to the device and adapted to couple to a subject, said platform comprising:

a controller comprising a general purpose digital processor and a digital memory, wherein the controller operatively provides a first electrical stimulation therapy to a heart as a function of a feedback data set from physiologic instrumentation adapted to couple to a subject; and

an interface electrically coupling the controller to the physiologic instrumentation;

wherein the digital memory comprises software instructions executable by the general-purpose digital processor to receive the feedback data set from the interface and to process the feedback data set using a modeling algorithm to modify the electrical stimulation therapy parameters.

2. A platform according to claim 1, wherein the computer-executable instructions are modifiable to adjust at least one parameter of the first electrical stimulation therapy without physically reconfiguring the controller or interface.

3. A platform according to claim 1, wherein the software instructions comprise an input module configured to receive the feedback data set, a pacing engine configured to deliver the first electrical stimulation therapy and an output module configured to provide information regarding at least one of an operating parameter of the first electrical stimulation therapy and the physiologic instrumentation to the interface.

4. A platform according to claim 3, wherein the pacing engine comprises an atrial therapy path and a ventricular therapy path corresponding to the atria and ventricles of the heart, respectively.

5. A platform according to claim 4, wherein the atrial therapy path and the ventricular therapy path comprise a threshold detector configured to receive an electrogram signal from the input module and to identify a cardiac event of the atria and the ventricles, respectively.

6. A platform according to claim 5, wherein each of the atrial therapy path and the ventricular therapy path further include a refractory module configured to place the pacing engine into a refractory mode following the identified cardiac event.

7. A platform according to claim 6, wherein the pacing engine further comprises a pacing module in communication with the atrial and ventricular portions to thereby produce electrical stimulation of an atrium or a ventricle of the heart, respectively.

8. A platform according to claim 7, wherein an electrical stimulation pulse comprises a pulse width and a pulse amplitude, and wherein the pulse width and amplitude are each configurable solely by modifying the software instructions.

9. A platform according to claim 3, wherein the software instructions further comprise a therapy module configured to execute at least a second electrical stimulation therapy and said second electrical stimulation therapy differs from the first electrical stimulation therapy.

10. A platform according to claim 9, wherein the second electrical stimulation therapy incorporates at least a recirculation fraction parameter and said parameter derives from the physiologic information.

11. A platform according to claim 10, further comprising a pressure processing module in communication with the input module to receive a ventricular pressure reading and to provide a derived calculation of the ventricular pressure to the therapy module for determining the recirculation fraction parameter.

12. A platform according to claim 1, wherein the interface comprises a digital to analog converter electrically coupling the controller to the stimulus lead and an analog to digital converter electrically coupling the sensor lead to the controller.

13. A platform according to claim 1, wherein the physiologic instrumentation comprises structure adapted to gather data of at least two of the group of:

a pH metric, a lactate metric, an blood oxygen metric, a blood pressure metric, a blood flow metric, a partial pressure of blood oxygen (PO2) metric, a saturated venous oxygen metric, a saturated arterial oxygen metric, a saturated carbon dioxide metric, a temperature metric, a heart rate metric.

14. A platform according to claim 1, wherein the first electrical stimulation therapy differs from the first electrical stimulation therapy and at least one of said first and said second electrical stimulation therapy comprises a post-extrasystolic potentiation (PESP) therapy.

15. A software-configurable medical device configured to apply and dynamically assess a therapy applied to a subject, the device comprising a processor in communication with a digital memory having computer-executable instructions stored thereon, wherein the computer-executable instructions comprise:

an input module configured to provide input data about the subject;

a therapy module configured to receive the input data and to generate an output signal corresponding to the therapy applied to the subject as a function of the input data; and

a logging module configured to retain at least a portion of the input data within the digital memory.

16. A medical device according to claim 15, further comprising instrumentation adapted to apply the therapy to the subject and adapted to obtain the input data from the subject.

17. A medical device according to claim 16, further comprising an interface coupling the instrumentation to the processor.

18. A medical device according to claim 15, wherein the instrumentation comprises one of a pressure sensor and an acoustic sensor.

19. A medical device according to claim 15 wherein the therapy comprises at least one of an electrical cardiac stimulation therapy, an electrical neurological stimulation therapy, a pharmaceutical therapy.

20. A medical device according to claim 15 wherein the therapy module and the logging module are configured in communication with an external hardware component.