Therapy system

• US 7,212,858 B2
• Filed: 04/28/2004
• Issued: 05/01/2007
• Est. Priority Date: 06/26/1999
• Status: Expired due to Term

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Inventors: Lang, Volker, Schaldach, legal representative Jr., Ameling, Walter, Schaldach, deceased
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Bertram; Eric D.
• Application Number:
  US10/833,385
• Publication Number:
  US 20050027324A1
• Time in Patent Office: 1,098 Days
• Field of Search: 607/4,5,9,17,27
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

A medical therapy system has logic and/or signal processing stages between sensors on the input side and therapy applicators on the output side. A signal parameter is determined from the input signals using the logic/processing stages, and/or an indicator signal is determined from the input signals using a logic/processing module consisting of several logic/processing stages. The indicator signal is a measure of the probability of a future event requiring therapy, or a measure of the success of the therapy.

Claims

1. A medical therapy system for treatment of the heart with electrical pulses, comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration on data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of the control signal, the indicator signal, and the predictor signal, and

wherein the system output signal additionally has a time reference signal which contains a predictor of the probable moment in time of the occurrence of the therapy-liable event or the therapy outcome.

2. The therapy system of claim 1, wherein the input signals are clinical observation parameters.

3. The therapy system of claim 2 wherein the clinical observation parameters are arrhythmia indicators.

4. The therapy system of claim 1, wherein the input signals for the derivation of system output signals arc arrhythmia indicators which can include the occurrence of extra systoles, the degree of prematurity of extra systoles, the number of premature cardiac contractions, arrhythmic patterns and conduction times within the ventricles.

5. The therapy system of claim 4, wherein at least one of the following is provided as one of a mathematical processes and a filter means for finding a signal event in a signal mix:

correlation, pattern comparison, comparison of the signal sets as status vectors using the least squares method, fuzzy logic, wavelets, non-linear linkages, Lorenz attractors, mathematical functions with a plurality of variables, and n-dimensional orthogonal systems.

6. The therapy system of claim 1, wherein extraction of system output signals is effected with at least one process which includes at least one—

or multi-stage mathematical processes and filter means for finding a signal event in a signal mix.

7. The therapy system of claim 1, wherein at least one sensor means, sensor signal is fed as an input signal to a first linking/processing stage, and a processed sensor signal appears as an output signal of the first linking/processing stage, and wherein the first linking/processing stage includes geometry evaluation of at least one of the sensor means and time and frequency correction of the sensor signals.

8. The therapy system of claim 1, further comprising:

at least one linking/processing module comprising a plurality of linking/processing stages;

wherein the module comprises a multi-usable processing and linking module which can be used as at least one of a first, second, third and fourth linking stage in time sequence, and

wherein input signals, the nature of the input signals to be linked and processed, a processing algorithm and a linking algorithm can be fed to the linking/processing module.

9. The therapy system of claim 8, wherein the processing and linking module additionally has an item of linking information.

10. The therapy system of claim 9 wherein the item of linking information defines which input values are to be superimposed in what manner.

11. The therapy system of claim 8 wherein the linking algorithm, the processing algorithm or the combination thereof are formed by one of plug-ins and applets as additional processor or software portions, which are either disposed in the data memory or are loaded into the data memory as required by way of telemetry means from an external source.

12. The therapy system of claim 8 wherein the linking module is one of circuit or software.

13. The therapy system of claim 1, wherein the performance of a linking/processing stage is variable by means of the system data, which can be read into the memory.

14. The therapy system of claim 1 comprising a plurality of linking/processing stages which make up a processing/linking module.

15. The therapy system of claim 1 wherein the treatment of the heart comprises electrostimulation.

16. The therapy system of claim 1, wherein the stored data are empirical values extracted from a plurality of similar therapy cases.

17. A method of treating a heart with electrical pulses from a therapy system having an input side sensor, and output side therapy applicator, a data memory, and at least one processor between the sensor and applicator and in signal communication with the data memory, the processor having the capability to ascertain a control signal from the sensor input signals and the data stored in the data memory for controlling the operation of the therapy applicator, a time-dependent indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, the method comprising the steps of:

ascertaining a system output signal from input signals and stored data, which are put into the processor, the system output signal representing a signal selected from the group consisting of;

the therapy applicator control signal, the time-dependent indicator, and the predictor signal;

forming a signal/data set having at least one of a reference time statement and a validity time range statement which characterizes one of a moment in time at which the signal/data set was received and a time validity range at which the signal/data set is valid, wherein the beginning and end of the validity range do not need to be fixed, and wherein the signal/data set contains at least one of output signals from the sensor, indicator signals, patient condition signals, therapy application signals, system description signals, input signals to the processor, output signals from the processor, and system configuration data;

transmitting data set by telemetry means to a remote data processing station in order of time references associated with the signal/data sets by at least one of the following operations;

reducing memory required by signal compression of signal/datasets according to the age of the signal/data set;

checking die signal/data sets for inconsistencies, and one of correcting and erasing the inconsistencies;

investigating dynamic stability of the system to detect unusual data/signal sets;

investigating operability of the system by switching the generation of the therapy signals over to a backup system if a deviation between the predicted and the actual therapy outcome is detected, and stopping the previously active system;

comparing at least part or the signal data sets that are associated with a predictor of the therapy-liable event or therapy outcome with at least part of the signal/data sets that are associated with an actual therapy-liable event or therapy outcome, wherein when a predetermined deviation between the two is detected, a predetermined change in at least one system condition parameter is made; and

converting one of a frequency spectrum of the signal/data set into time-dependent signals and time-dependent signals of the signal data set into a frequency spectrum.

18. The method of claim 17 wherein the step of converting the signal/data set is by Past-Fourier or wavelet transformation.

19. A medical therapy system for treatment orate heart with electrical pulses, comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement or either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein the system output signal is a predictor signal which includes a probability evaluation parameter for the probability of the occurrence of the therapy-liable event or the therapy outcome.

20. A medical therapy system for treatment of the heart with electrical pulses, comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling to operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein at least a first and a second linking/processing stage, wherein at least one signal value from the first linking/processing stage is fed as an input signal to the second linking/processing stage, whose output signal forms the system output signal, and

wherein the second linking/processing stage output signal forms the input signal of a third linking/processing stage, which produces an output signal that supplies a therapy applicator crude signal, and

wherein the therapy applicator crude signal forms an input signal of a fourth linking/processing stage which supplies as its output signal a therapy applicator signal, wherein the fourth linking/processing stage includes geometry evaluation of at least one of the therapy application means, a time, and a frequency correction of the therapy applicator crude signal.

21. A medical therapy system for treatment of the heart with electrical pulses, comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and, the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein at least one of the signals from or between the at least one input side sensor, the individual linking/processing stages, the memory, and the therapy applicator forms a signal/data set having at least one of a reference time statement and a validity time range statement which characterizes one of a moment in time at which the signal/data set was received an a time validity range at which the signal/data set is valid, wherein the beginning or the end of the validity range does not need to be fixed so that the signal/data set can be suitably taken into consideration or allocated in the subsequent processing operation, and

wherein associated with the signal/data set is an alpha-numeric identification which serves to identify and select the corresponding signal/data set.

22. The therapy system of claim 21 wherein the signal/data sets are stored in the data memory.

23. The therapy system of claim 21 wherein the reference time statement is one of a real time statement, a time statement which refers to a cyclic time period of a patient condition parameter, and a time statement which refers to a cyclic time period of a therapy parameter.

24. The therapy system of claim 21 wherein the signal/data set includes at least one of the following items of information:

Boolean logic data, amplitude data, amplitude pattern data, spectral information data associated with the reference time, information relating to the geometrical arrangement of at least one of the sensor and application means, patient condition data, system configuration data, linking algorithms and processing algorithms.

25. The therapy system of claim 21 wherein a change in one of the input signals and signal/data sets for a linking/processing stage triggers an updating of the output signals of the linking/processing stage.

26. The therapy system of claim 25 wherein a condition fir triggering updating of the output signals of the linking/processing stage is the fulfillment of a condition for the reference time and time range information.

27. The therapy system of claim 21 wherein one of external processing and calculation of the system output is effected by the signal/data sets of a collection of similar signals with comparable signal/data contents and/or a patient model which is stored as data in the data memory.

28. The therapy system of claim 21 wherein one 6f the input of signals, data values of the signal/data set, and execution of calculations is provided from the exterior by way of telemetry.

29. The therapy system of claim 28 wherein the telemetry is provided at least in part by way of the Internet.

30. A medical therapy system for treatment of the heart with electrical pulses comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data a stored in the data memory, control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein at least one of the signals from or between the at least one input side sensor, the individual linking/processing stages, the memory, and the therapy applicator forms a signal/data set having at least one of a reference time statement and a validity time range statement which characterizes one of a moment in time at which the signal/data set was received an a time validity range at which the signal data set is valid, wherein the beginning or the end of the validity range does not need to be fixed so tat the signal/data set can be suitably taken into consideration or allocated in the subsequent processing operation, and the therapy system further comprising;

at least one linking/processing module comprising a plurality of linking/processing stages;

wherein a plurality of linking/processing stages or linking/processing modules, independently of or in coordination with linking/processing stages that are responsive to output signals of the sensor means, execute at least one of the following operations by data transmission using telemetry means to a remotely disposed data processing station in order of the time references associated with the signal/data sets;

compressing the memory needed for the signal/data sets by reducing data associated with the signal/data sets by replacing more complex data structures with simpler structures by increasing age of the reference times associated with the signals/data using an additional processing and linking stage for compacting patient condition data by combining a plurality of signal data sets of patient condition data associated with various moments in time or periods of time to give patient condition data associated with a greater period of time, said compression effect being proportionally greater, the further back the moments in time or periods of time are in relation to the current system time,

checking of the signal/data sets for possible inconsistencies, and correction of inconsistent data/signals or erasure thereof,

implementing investigations in respect of dynamic stability of the system in the case of possible unusual data/signal conditions,

implementing investigations in regard to operability of the system by switching over the generation of the therapy signals using one of an additionally provided backup and a conventional system in the event of a remaining deviation between predicted and occurred therapy outcome and stoppage of the previously active system,

comparison of at least a part of the signal/data set which is associated with a predictor of the probably imminent, therapy-liable event or the therapy outcome, with the at least a part of the signal/data set associated with the therapy-liable event or the therapy outcome which actually occurred, and in the event of a predetermined deviation being exceeded, a change in at least one predetermined system condition parameter by a predetermined amount, and conversion of the frequency spectrum into time-dependent signals and vice versa of a signal data set.

31. The therapy system of claim 30 wherein the telemetry includes use of the Internet.

32. The therapy system of claim 30 wherein the conversion of the frequency spectrum into time-dependent signals is by Fast-Fourier or wavelet transformation.

33. A medical therapy system for treatment of the heart with electrical pulses, comprising:

at least one input side sensor;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein at least one of the signals from or between the at least one input side sensor, the individual linking/processing stages, the memory, and to therapy applicator forms a signal/data set having at least one of a reference time statement and a validity time range statement which characterizes one of a moment in time at which the signal/data set was received an a time validity range at which the signal/data set is valid, wherein the beginning or the end of the validity range does not need to be fixed so that the signal/data set can be suitably taken into consideration or allocated in the subsequent processing operation, and

wherein one of external processing and calculation of the system output as effected by the signal/data sets of a collection of similar signals with comparable signal/data contents and/or a patient model which is stored as data in the data memory.

34. A medical therapy system for treatment of the heart with electrical pulses, comprising:

at least one input side senior;

at least one output side therapy applicator;

a data memory for storing patient, system condition and system configuration data; and

at least one linking/processing stage for processing indicator and predictor input signals connected between the at least one input-side sensor and the at least one output-side therapy applicator and in signal communication with the data memory;

wherein time-dependent sensor input signals are received by the at least one linking/processing stage, and

wherein the system has the capability to ascertain, from the sensor input signals and the data stored in the data memory, a control signal for controlling the operation of the therapy applicator, an indicator signal which represents a measurement of either a therapy-liable event or a therapy outcome, and a predictor signal which represents a probability of either a future therapy-liable event or a future therapy outcome, and wherein a system output signal is ascertained, the system output signal being selected from the group consisting of;

the control signal, the indicator signal, and the predictor signal, and

wherein predictive processing for handling possibly occurring signal/data conditions is precautionarily effected according to at least one of the procedures selected from the group consisting of;

interrupting the processing and discarding the acquired data/signals if prerequisites under which the predictive processing was effected no longer apply.