Arrangement for and method of monitoring, calibrating and optimizing a control of an electromedical implant

• US 20040078061A1
• Filed: 04/02/2003
• Published: 04/22/2004
• Est. Priority Date: 04/05/2002
• Status: Active Grant

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG)
• Original Assignee: Biotronik Mess und Therapiegeraete GmbH and Co (Biotronik SE & Company KG)
• Inventors: Czygan, Gerald, Schaldach, Max, Schaldach, Max Jr.
• Granted Patent: US 7,130,695 B2
• Time in Patent Office: Days
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

The invention concerns an arrangement (10) for and an associated method of monitoring and adjusting a control of an electromedical implant (12) for intracardial cardiac therapy by means of an external control and evaluation unit (14). The arrangement (10) includes:

(a) the electromedical implant (12) which includes the following components:

a clock and timer unit (40) for the co-ordination of a time sequence of control operations,

an energy source for providing an operating voltage and stimulation and shock delivery,

at least one electrode (38) which is connected to the myocardium of the heart and which is suitable for the delivery of electrical pulses,

a sensor means (28) which supplies measurement data about physiological parameters in the region of the heart and about internal status parameters of the implant,

a memory unit (34) for the storage of internal control sequences (SS_in), control parameters (SP) and measurement data of the sensor means (28),

a telemetry unit (16) having a transmitter (24) and a receiver (20) for bidirectional data exchange with the external control and evaluation unit (14), and

a central, autarchically runnable control logic means (30) which on the basis of the internal control sequences (SS_in) and control parameters (SP) controls the activities of the at least one electrode (28), the telemetry unit (16), the sensor means (28) and the memory unit (34), and

(b) the external control and evaluation unit (14) which includes the following components:

a telemetry unit (18) having a transmitter (22) and a receiver (26) for bidirectional data exchange with the electromedical implant (12),

a clock and timer unit (42) for the co-ordination of a time sequence of control operations,

an energy source for providing an operating voltage,

a memory unit (36) for storing control sequences (SS), control parameters (SP) and communicated data (D_im) of the implant (12), and

a central, autarchically runnable evaluation logic means (32) which controls the activities of the telemetry unit (18) and the memory unit (36), which is in contact with the clock and timer unit (42) and which on the basis of the communicated data (D_im) ascertains control sequences and control parameters (SS, SP) for monitoring and adjusting the implant (12) and co-ordinates the transmission thereof to the implant (12).

Claims

1. An arrangement (10) for monitoring and adjusting a control of an electromedical implant (12) for intracardial cardiac therapy by means of an external control and evaluation unit (14) in which

(a) the electromedical implant (12) includes the following components:

a clock and timer unit (40) for the co-ordination of a time sequence of control operations,

an energy source for providing an operating voltage and stimulation and shock delivery,

at least one electrode (38) which is connected to the myocardium of the heart and which is suitable for the delivery of electrical pulses,

a sensor means (28) which supplies measurement data about physiological parameters in the region of the heart and about internal status parameters of the implant,

a memory unit (34) for the storage of internal control sequences (SS_in), control parameters (SP) and measurement data of the sensor means (28),

a telemetry unit (16) having a transmitter (24) and a receiver (20) for bidirectional data exchange with the external control and evaluation unit (14), and

a central, autarchically runnable control logic means (30) which on the basis of the internal control sequences (SS_in) and control parameters (SP) controls the activities of the at least one electrode (28), the telemetry unit (16), the sensor means (28) and the memory unit (34), and

(b) the external control and evaluation unit (14) includes the following components;

a telemetry unit (18) having a transmitter (22) and a receiver (26) for bidirectional data exchange with the electromedical implant (12),

a clock and timer unit (42) for the co-ordination of a time sequence of control operations,

an energy source for providing an operating voltage,

a memory unit (36) for storing control sequences (SS), control parameters (SP) and communicated data (D_im) of the implant (12), and

a central, autarchically runnable evaluation logic means (32) which controls the activities of the telemetry unit (18) and the memory unit (36), which is connected to the clock and timer unit (42) and which on the basis of the communicated data (D_im) ascertains control sequences and control parameters (SS, SP) for monitoring and adjusting the implant (12) and co-ordinates the transmission thereof to the implant (12).

2. An arrangement as set forth in claim 1 characterized in that the evaluation logic means (32) includes an expert system (ES) which is adapted to assess all monitoring and adjusting tasks for the intracardial cardiac therapy on a patient-individual basis and divides the control sequences (SS) on which the monitoring and adjusting tasks are based into internal control sequences (SS_in) for the implant (12) and external control sequences (SS_ex) for the external evaluation and control unit (14).

3. An arrangement as set forth in claim 2 characterized in that the internal control sequences (SS_in) include the therapy and diagnostic sequences which are absolutely necessary for controlling the therapy functions or diagnosis of given cardiac events respectively.

4. An arrangement as set forth in claim 2 characterized in that the internal control sequences (SS_in) include real time-dependent stimulation and diagnostic sequences.

5. An arrangement as set forth in one or more of claims 1 through 4 characterized in that the external control and evaluation unit (14) includes a first input unit (44) for interaction with the patient, by way of which the patient can input controls values (SG) and influence the evaluation logic means (32) or can implement markings and assessments of given states or symptoms.

6. An arrangement as set forth in one or more of claims 1 through 5 characterized in that the external control and evaluation unit (14) includes a second input unit (46) for data exchange with further peripheral devices, by way of which control values (SG) can be inputted, control sequences (SS) for the evaluation logic means (32) can be modified or produced afresh and/or data can be read out of the memory unit (36) for additional evaluation.

7. An arrangement as set forth in one or more of claims 1 through 6 characterized in that the external control and evaluation unit (14) includes a further input unit (45) for data exchange with external sensors, by way of which control values (SG) can be inputted.

8. An arrangement as set forth in one or more of claims 1 through 7 characterized in that the external control and evaluation unit (14) includes a further input unit (47) with integrated sensors, by way of which control values (SG) can be inputted.

9. An arrangement as set forth in one or more of claims 1 through 8 characterized in that the evaluation logic means (32) of the external control and evaluation unit (14) has a memory (48) for a complex matrix into which at least the transmitted data (D_im) of the implant (12) and the control values (SG) pass and which delivers the control parameters (SP) and control sequences (SS) on which the monitoring and adjusting tasks are based.

10. An arrangement as set forth in claim 9 characterized in that the evaluation logic means (32) is such that the control parameters (SP) and/or control sequences (SS) which are provided for the telemetric data exchange are interlinked with weighting factors (G_i), on the basis of which a time progression (t_int) and/or a series (R) of transmission of the individual monitoring and adjusting tasks is established in an interaction scheme (50).

17. A method as set forth in one of claims 10 through 14 characterized in that the control values (SG) include event-dependent control values (SG_ev).

18. A method as set forth in claim 17 characterized in that the event-dependent control values (SG_ev) include a factor which can be inputted by way of the first input unit (44) at the external control and evaluation unit (14) by the patient, passes into the evaluation, and compels monitoring or adjustment of the entire control of the implant (12) or sub-regions of the control at predeterminable time intervals.

19. A method as set forth in claim 17 characterized in that the event-dependent control values (SG_ev) include a factor which can be predetermined by way of the second input unit (46) at the external control and evaluation unit (14) by means of suitable peripheral devices, passes into the evaluation and compels monitoring or adjustment of the entire control of the implant (12) or sub-regions of the control at predeterminable time intervals.

20. A method as set forth in claim 17 characterized in that the event-dependent control values (SG_ev) include a factor which can be predetermined by way of the further input units (45, 47) at the external control and evaluation unit (14) with integrated or external sensors, passes into the evaluation and compels monitoring or adjustment of the entire control of the implant (12) or sub-regions of the control at predeterminable time intervals.

25. An external evaluation and control unit (14) for an arrangement (10) as set forth in one or more of claims 1 through 10 and for carrying out a method as set forth in one or more of claims 11 through 24.

11. A method of monitoring and adjusting a control of an electromedical implant (12) for intracardial cardiac therapy by means of an external control and evaluation unit (14), wherein

(a) in the electromedical implant (12)

a time sequence of the control operations is co-ordinated by a clock and timer unit (40),

electrical pulses are delivered by way of at least one electrode (38) connected to the myocardium of the heart,

measurement data relating to physiological parameters in the region of the heart and internal status parameters of the implant (12) are supplied by a sensor means (28),

internal control sequences (SS_int), control parameters (SP) and measurement data of the sensor means are stored in a memory unit (34),

data are exchanged with the external control and evaluation unit (14) by way of a bidirectional telemetry unit (16), and

the activities of the at least one electrode (38), the telemetry unit (16), the sensor means (28) and the memory unit (34) are co-ordinated on the basis of the internal control sequences (SS_in) and control parameters (SP) in a central autarchically runnable control logic means (30), and

(b) in the external control and evaluation unit (14)

data are exchanged by way of a bidirectional telemetry unit (18) with the electromedical implant (12),

a time sequence of the control operations is co-ordinated by a timer unit (42),

control sequences (SS), control parameters (SP) and communicated data (D_im) of the implant (12) are stored in a memory unit (36), and

in a central autarchically runnable evaluation logic means (32) the activities of the telemetry unit (18) and the memory unit (36) are controlled and on the basis of the communicated data (D_im) control sequences and control parameters (SS, SP) for monitoring and adjusting the implant (12) are ascertained and the transmission thereof to the implant (12) is co-ordinated.

12. A method as set forth in claim 11 characterized in that the evaluation logic means (32) of the external control and evaluation unit (14) includes a memory (48) for a complex matrix into which at least the transmitted data (D_im) of the implant (12) and the control values (SG) pass and which delivers the control parameters (SP) and control sequences (SS) on which the monitoring and adjusting tasks are based.

13. A method as set forth in claim 12 characterized in that the control values (SG) include time-dependent control values (SG_t).

14. A method as set forth in claim 13 characterized in that the time-dependent control values (SG_t) include a factor which compels routine checking of the entire control of the implant (12) or sub-regions of said control at predeterminable time intervals.

15. A method as set forth in claim 13 characterized in that the time-dependent control values (SG_t) include a factor which can be inputted by the patient by way of a first input unit (44) at the external control and evaluation unit (14) and compels routine checking of the entire control of the implant (12) or sub-regions of the control at predeterminable time intervals.

16. A method as set forth in claim 13 characterized in that the time-dependent control values (SG_t) include a factor which can be predetermined by way of a second input unit (46) at the external control and evaluation unit (14) by means of suitable peripheral devices and compels routine checking of the entire control of the implant (12) or sub-regions of the control.

21. A method as set forth in one or more of claims 11 through 20 characterized in that the control parameters (SP) and control sequences (SS) are interlinked with weighting factors (G_i), on the basis of which a time progression of the individual monitoring and adjusting tasks is established in an interaction scheme (50).

22. A method as set forth in claim 21 characterized in that the weighting factors (G_i) serve to establish a series (R) of the monitoring and adjusting tasks which are transmitted during the interaction of the external control and evaluation unit (14) to the implant (12).

23. A method as set forth in claim 21 or claim 22 characterized in that in the normal situation the weighting factors (G_i) are so predetermined that the impending monitoring and adjusting tasks are carried out in a rest phase of the patient.

24. A method as set forth in claim 21 or claim 22 characterized in that in the acute situation the weighting factors (G_i) are so predetermined that the impending monitoring and adjusting tasks begin immediately after production of the interaction scheme (50).