Apparatus And Method For The Cardio-Synchronized Stimulation Of Skeletal Or Smooth Muscles

• US 20080215114A1
• Filed: 08/31/2005
• Published: 09/04/2008
• Est. Priority Date: 11/16/2004
• Status: Active Grant

• Current Assignee: CTI Vascular AG
• Original Assignee: Cardiola Ltd.
• Inventors: Lapanashvili, Larry, Stuerzinger, Christian, Zimmermann, Thomas, Piguet, Christian, Perotto, Jean-Felix, Eggli, Armin
• Granted Patent: US 8,577,471 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

An apparatus for the cardio-synchronised stimulation of skeletal or smooth muscle, but excluding the heart muscles, in a counterpulsation mode of a patient having a heart and a cardiovascular system. The apparatus comprises at least one active electrode (14) and at least one passive electrode (16) adapted for attachment to said patient, a signal processor (18) having an associated configuration input (20) for varying at least a time delay associated with counterpulsation mode stimulation, a sensing system (22) for sensing information relating to the performance of the patient'"'"'s heart and for transmission of information signals to said signal processor, said signal processor being adapted to produce control signal information relating to stimulation signals to be applied to said at least one active electrode in a counterpulsation mode, a stimulation signal generator (24) associated with said active electrode for generating stimulation signals, wireless transmission means (26, 27) for transmitting said control signal information from said signal processor to said stimulation signal generator whereby said stimulation signal generator applies stimulation signals to said active electrode in a counterpulsation mode in accordance with said signal information.

Claims

1. Apparatus (10) for the cardio-synchronised stimulation of skeletal or smooth muscle, but excluding the heart muscles, in a counterpulsation mode of a patient having a heart and a cardiovascular system, the apparatus comprising:

at least one active electrode (14;

14′

;

14″

;

14′

″

;

14″

″

) and at least one passive electrode (16;

16′

;

16″

;

16′

″

;

16″

″

) adapted for attachment to said patient,

a signal processor (18) having an associated configuration input (20) for varying at least a time delay associated with counterpulsation mode stimulation,

a sensing system (22) for sensing information relating to the performance of the patient'"'"'s heart and for transmission of information signals to said signal processor (18),

said signal processor (18) being adapted to produce control signal information relating to stimulation signals to be applied to said at least one active electrode (14) in a counterpulsation mode,

at least one stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) associated with said active electrode (14) for generating stimulation signals,

wireless transmission means (26) for transmitting said control signal information from said signal processor (18) to said at least one stimulation signal generator (24), whereby said stimulation signal generator (24) applies stimulation signals to said active electrode (14) in a counterpulsation mode in accordance with said control signal information.

2. Apparatus in accordance with claim 1, wherein said information relating to the performance of the heart is selected from the group comprising heart rate information, ECG information, ECG derived information, ECG information and information resulting from electrical stimulation, ECG derived trigger signals, R-R information, end of T-wave information, blood pressure information and blood pressure derived information.

3. Apparatus in accordance with claim 1, wherein said sensing system includes at least one of an invasive sensor, an intercavity sensor, a non-invasive sensor, a body surface sensor and a remote sensing system detached from the patient'"'"'s body.

4. Apparatus in accordance with claim 3, wherein a remote sensing system (22) is provided and said signal processor (18) is integrated into said remote sensing system.

5. Apparatus in accordance with claim 1, wherein said sensing system (22) is adapted for wireless transmission of said heart information to said signal processor (18).

6. Apparatus in accordance with claim 1, wherein said sensing system (22) is adapted to transmit said heart information to a medical evaluation unit (32) and said medical evaluation unit is adapted to transmit signal configuration information to said signal processor (18) and said signal processor takes account of said configuration information when generating said control signal information.

7. Apparatus in accordance with claim 6, wherein said sensing system (22) is adapted to transmit said heart information to said medical evaluation unit (32) by wireless transmission.

8. Apparatus in accordance with claim 6, wherein said medical evaluation unit (32) is adapted for wireless transmission of said configuration information to said signal processor (18).

9. Apparatus in accordance with claim 1, wherein said signal processor (18) is adapted to transmit said heart information to a medical evaluation unit (32) and said medical evaluation unit (32) is adapted to transmit signal configuration information to said signal processor (18) and said signal processor takes account of said configuration information when generating said control signal information.

10. Apparatus in accordance with claim 9, wherein said signal processor (18) is adapted to transmit said heart information to said medical evaluation unit (32) by wireless transmission.

11. Apparatus in accordance with claim 9, wherein said medical evaluation unit (32) is adapted for wireless transmission of said configuration information to a configuration input associated with said signal processor (18).

12. Apparatus in accordance with claim 1, wherein a plurality of active electrodes (14;

14′

;

14″

;

14′

″

;

14″

″

) is provided, each having a respective stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

), said signal processor being adapted to transmit a respective control signal uniquely associated with one of said active electrodes (14;

14′

;

14″

;

14′

″

;

14″

″

) to each said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

).

13. Apparatus in accordance with claim 1, wherein a plurality of active electrodes (14;

14′

;

14″

;

14′

″

;

14″

″

) is provided, each having a respective stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) connected thereto via a respective lead.

14. Apparatus in accordance with claim 1, wherein a respective lead is provided for each active electrode (14;

14′

;

14″

;

14′

″

;

14″

″

) and means is associated with said stimulation signal generator (24) for applying stimulation signals to said active electrodes in sequence via said leads.

15. Apparatus in accordance with claim 12, wherein said signal processor (18) has a single transmitter (26) adapted to transmit control signal information to all said stimulation signal generators (24;

24′

;

24″

;

24′

″

;

24″

″

), there being means for uniquely associating associated control signals with a respective one of said stimulation signal generators.

16. Apparatus in accordance with claim 12, wherein said signal processor (18) has a plurality of transmitters each adapted to transmit control signal information to a respective one or group of said stimulation signal generators (24;

24′

;

24″

;

24′

″

;

24″

″

), there being means for uniquely associating associated control signals with a respective one of said stimulation signal generators.

17. Apparatus in accordance with claim 12, wherein said signal processor (18) is adapted to transmit control signal information for a train of stimulation signals applied to an active electrode (14;

14′

;

14″

;

14′

″

;

14″

″

), said control signal information being selected from the group comprising;

amplitude of the stimulation signals,

frequency of the stimulation signals,

duration of the train of the stimulation signals,

width of the individual stimulation signals of the train,

delay of the train of the stimulation signals relative to a reference selected for counterpulsation stimulation, and

a recognition code by which said stimulation signal generator recognizes that said control signal information is intended for it.

18. Apparatus in accordance with claim 16, wherein said signal processor (18) is adapted to transmit control signal information for a train of stimulation signals applied to an active electrode (14;

14′

;

14″

;

14′

″

;

14″

″

) by a respective one of said stimulation signal generators (24;

24′

;

24″

;

24′

″

;

24″

″

), said control signal information being selected from the group comprising;

amplitude of the stimulation signals,

frequency of the stimulation signals,

duration of the train of the stimulation signals,

width of the individual stimulation signals of the train,

delay of the train of the stimulation signals relative to a reference selected for counterpulsation stimulation, and

a recognition code by which an associated one of said stimulation signal generators recognizes that said control signal information is intended for it.

19. Apparatus in accordance with claim 1, wherein means is provided at said stimulation signal generator (24) or at each said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) for storing control signal information relating to any respectively associated active electrode.

20. Apparatus in accordance with claim 19, wherein means is provided at said signal processor (18) for receiving, storing and optionally transmitting at least one of a program for processing said control signal information, any subsequent changes to said program and a new program for processing said control signal information.

21. Apparatus in accordance with claim 1, wherein the or each said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) includes at least some of the following items;

its own controller,

its own clock,

its own receiving antenna (RX),

a power circuit, and

a battery.

22. Apparatus in accordance with claim 21, wherein the or each said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) includes at least some of the following additional items;

a transmitter (TX),

means for data storage,

means for program storage, and

a signal generator trigger.

23. Apparatus in accordance with claim 22, wherein the or each said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) has a program providing a wake mode, a sleep mode and a death mode.

24. Apparatus in accordance with claim 1, wherein a display is provided at least one of said signal processor (18), said configuration input (20) associated with the signal processor, said stimulation signal generator (24) and a medical evaluation unit (32) associated with said apparatus, said display being for the display of at least said control signal information.

25. Apparatus in accordance with claim 24, wherein said display is adapted to display data representing an image of the electrical stimulation applied to said patient.

26. Apparatus in accordance with claim 25, wherein said display is adapted to display one of an actual ECG-trace and a representation of an ECG-trace with said image superimposed thereon.

27. Apparatus in accordance with claim 25, wherein a medical evaluation unit (32) is provided and said medical evaluation unit has an associated printer for printing said data.

28. Apparatus in accordance with claim 1, wherein said sensing system is adapted to send timing signals to said stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) or generators (24;

24′

;

24″

;

24′

″

;

24″

″

).

29. Apparatus in accordance with claim 28, wherein said sensing system includes a non-electrical sensor and transmits data from said non-electrical sensor to said signal processor (18).

30. Apparatus in accordance with claim 1, wherein said sensing system (22) includes an associated signal processor and a transmitter (28).

31. Apparatus in accordance with claim 30, wherein said sensing system includes at least one of an A/D converter, a data storage memory and a data compressor.

32. Apparatus in accordance with claim 31, wherein at least one of said A/D converter, said data storage memory and said data compressor are embodied in said associated signal processor (18).

33. Apparatus in accordance with claim 6, wherein said sensing system (22) includes a data compressor for compressing information for transmission to said signal processor into packages and said medical evaluation unit is adapted to assemble said data packages into a continuous data stream, optionally in the form of an ECG-trace.

34. Apparatus in accordance with claim 1, wherein a code is uniquely associated with said sensing system (22), said signal processor and said electrical stimulation signal generator (24).

35. Apparatus in accordance with claim 6, wherein a code is uniquely associated with said sensing system (22), said signal processor (18), said medical evaluation unit (32) and said electrical stimulation signal generator (24).

36. Apparatus in accordance with claim 1, wherein said electrical stimulation signal generator has an associated power supply in the form of a battery and a boost converter (50, 52, 54, 56, 58;

50, 52, 54, 5658, Soo).

37. Apparatus in accordance with claim 1 in which said stimulation signal generator (24) is one of a mobile phone, a personal digital assistant with phone function or any dedicated or standard piece of equipment having a transceiver, a microprocessor, a memory for storing software and data, a battery or other source of power, a clock and the necessary interface(s) for connection to the sensor or sensors (21) at the patient, such a ECG sensors, and to active and passive electrodes (14, 16;

14′

, 16′

;

14″

, 16″

;

14′

″

, 16′

″

;

14″

″

, 16″

″

).

38. Apparatus in accordance with claim 1 in which said signal processor (18) is one of a mobile phone, a personal digital assistant with phone function or any dedicated or standard piece of equipment having a transceiver, a microprocessor, a memory for storing software and data, a battery or other source of power and a clock.

39. Apparatus in accordance with claim 1 in which said medical evaluation unit (32) is one of a personal computer, a mainframe computer, a series of interlinked computers, any of the foregoing with an inbuilt transceiver, a personal digital assistant with phone function or any dedicated or standard piece of equipment having a transceiver, a microprocessor, a memory for storing software and data, a battery or other source of power and a clock.

40. Apparatus in accordance with claim 37 in which any one of said sensing system (22), said stimulation signal generator (24), said signal processor (18), the configuration input (20) associated with the signal processor (18) or said medical evaluation unit (32) includes a screen for displaying a trace symbolizing and relating to the positions of the R-R peaks and the end of the T-wave and possibly a signal relating to the stimulation applied.

42. Apparatus in accordance with claim 1 in which the configuration input (20) is adapted to communicate with the signal processor and/or with a medical evaluation unit by wireless means.

44. Apparatus in accordance with claim 42 in which said configuration input is one of a mobile phone, a personal digital assistant with phone function or any dedicated or standard piece of equipment having a transceiver, a microprocessor, a memory for storing software and data, a battery or other source of power and a clock.

41. Apparatus (10) for the cardio-synchronised stimulation of skeletal or smooth muscle, but excluding the heart muscles, in a counterpulsation mode of a patient having a heart and a cardiovascular system, the apparatus comprising:

at least one active electrode (14;

14′

;

14″

;

14′

″

;

14″

″

) and at least one passive electrode (16;

16′

;

16″

;

16′

″

;

16″

″

) adapted for attachment to said patient,

a signal processor (18) having an associated configuration input (20) for varying at least a time delay associated with counterpulsation mode stimulation,

a sensing system (22) for sensing information relating to the performance of the patient'"'"'s heart and for wireless transmission of information signals to said signal processor (18),

said signal process (18) being adapted to produce control signal information relating to stimulation signals to be applied to said at least one active electrode (14) in a counterpulsation mode,

a stimulation signal generator (24;

24′

;

24″

;

24′

″

;

24″

″

) associated with said active electrode (14) for generating stimulation signals said signal processor being connected to said stimulation signal generator by a lead or being integrated therewith for passing said control signal information from said signal processor (18) to said stimulation signal generator (24) whereby said stimulation signal generator (24) applies stimulation signals to said active electrode (14) in a counterpulsation mode in accordance with said control signal information.

43. Apparatus in accordance with claim 41 in which said communication is bidirectional.

45. Apparatus in accordance with claim 41 in which a respective signal processor is provided for each stimulation signal generator and each stimulation signal generator is associated with at least one passive electrode and at least one active electrode and is either permanently or releasably connected thereto.

46. A method of operating an apparatus (10) for the cardio-synchronised stimulation of skeletal or smooth muscles, but excluding the heart muscles, in a counterpulsation mode on a patient having a heart and a cardiovascular system, for example of operating an apparatus in accordance with any one of the apparatus claims, comprises the steps of using a sensing system (22) providing heart information from the patient to communicate said heart information by wireless means (28) to at least one of a signal processor (18) and a medical evaluation unit (32) adapted to input configuration data to the signal processor (18) and the step of using the signal processor to send trigger data to one of more stimulation signal generators (24;

24′

;

24″

;

24′

″

;

24″

″

) adapted to apply electrical stimulation signals to electrodes (14, 16;

14′

, 16′

;

14″

, 16″

;

14′

″

, 16′

″

;

14″

″

, 16″

″

) provided on or in the patient.

47. A method in accordance with claim 46 wherein said signal processor sends said trigger data, i.e. said control signal information, to said one or more stimulation signal generators by wireless transmission.

48. A method of operating an apparatus (10) for the cardio-synchronised stimulation of skeletal or smooth muscles, but excluding the heart muscles, in a counterpulsation mode on a patient having a heart and a cardiovascular system, for example of operating an apparatus in accordance with any one of the apparatus claims, comprises the steps of using a sensing system (22) providing heart information from the patient to communicate said heart information to a signal processor connected by at least one lead to or integrated with the sensing system and the step of using the signal processor to send trigger data, i.e. control signal information, by wireless transmission to one or more stimulation signal generators (24;

24′

;

24″

;

24′

″

;

24″

″

) adapted to apply electrical stimulation signals to electrodes (14, 16;

14′

, 16′

;

14″

, 16″

;

14′

″

, 16′

″

;

14″

″

, 16″

″

) provided on or in the patient.