WO2007137671A2

WO2007137671A2 - System for the stimulation of organs, e.g. the heart

Info

Publication number: WO2007137671A2
Application number: PCT/EP2007/003871
Authority: WO
Inventors: Christian Chaussy; Bernd Forssmann; Franz-Christoph Himmler
Original assignee: Christian Chaussy; Bernd Forssmann; Franz-Christoph Himmler
Priority date: 2006-05-26
Filing date: 2007-05-02
Publication date: 2007-12-06
Also published as: WO2007137671A3; DE102006024701A1

Abstract

The invention relates to a system (1) for stimulating organs, e.g. the heart, comprising an impulse wave source (2; 2') for generating an impulse wave or pressure wave, a stimulation device (3; 3') for generating an electrical stimulation pulse, and a control device (5) for controlling the generation of the impulse wave or pressure wave by the impulse wave source (2; 2') and the generation of the electrical stimulation pulse by the stimulation device (3; 3'). The invention further relates to a system (20) for stimulating organs, e.g. the heart, comprising an impulse wave source (21; 21') for generating an impulse wave or pressure wave, a locating device (22; 22', 23) for detecting a target zone by means of Doppler ultrasound, and a control device (24) for controlling the generation of the impulse wave or pressure wave by the impulse wave source based on the detection of the target zone by the locating device.

Description

System for stimulation of organs, such. The heart

The present invention relates to a system for the stimulation of organs, such. As the heart, a patient in emergency situations, such as. As the stoppage of the heart or too slowly beating heart chamber, or even for diagnosis and therapy.

However, the present invention particularly relates to an externally applicable system for stimulating organs.

The stimulation of a healthy heart starts from the so-called sinus node in the anterior chamber. As a result, electrical signals generated by the sinus node are transmitted, which propagate at a rate of a few ms across the ventricle walls and cause the contraction of the heart muscle tissue. The arousal and excitation in the heart is based on the fact that the resting potential of a cell is reduced to a so-called threshold potential. The further depolarization of the cell, which ultimately produces the contraction, as well as the propagation of the excitation wave to other cells then proceeds independently.

It is known, for example from DE 24 18 631 A1, to stimulate a resting or slow-beating heart by means of an externally applicable device which generates pressure waves. The pressure waves exert mechanical stimuli on the chamber wall of the heart, leading to cardiac stimulation. By means of the pressure wave generator pulses without danger to the patient can be generated periodically until either the heart activity is maintained spontaneously or measures for cardiac stimulation can be initiated by means of an artificial pacemaker. Further shock wave sources that generate shock waves or pressure waves (ie shock and / or pressure waves) and are suitable for outputting these shock or pressure waves from the outside to a human heart are described, for example, in EP 0 929 347 A1 or EP 0 369 177 Bl described. The article "Hit / Miss Monitoring Of ESWL By Spectral Doppler Ultrasound", Boris et al., Ultrasound in Med. & Biol., Vol. 29, No. 5, pages 705-712, 2003, describes a device for the destruction of kidney stones by means of Shock or pressure waves, whereby the success of the fragmentation is checked by means of a spectral Doppler ultrasound device.

The present invention now has the object to provide an improved system for stimulating organs, such. To provide the heart by means of shock waves (i.e., shock and / or pressure waves).

The above object is achieved by a system for stimulating organs, such. The inventive system comprises a shock wave source for outputting a shock wave, stimulation means for outputting an electrical stimulation pulse, and control means for controlling the output of the shock wave through the shock wave source and the Output of the electrical stimulation pulse by the stimulation device. In particular, however, this system according to the invention is not exclusively advantageous for use in emergency situations, since the mechanical energy of the shock wave or pressure wave changes the permeability or permeability of the cell membrane, which reduces the stimulation energy required for electrical stimulation and avoids negative reactions to the human organism become.

Advantageously, the system according to the invention comprises a triggered by the control device triggering device for triggering the output of the shock or pressure wave by the shock wave source and the output of the electrical stimulation pulse by the stimulation device.

Further advantageously, the inventive system comprises a Zeiteinstelleinrichtung for adjusting the timing of the output of Stoßbzw. Pressure wave through the shock wave source and the output of the electrical stimulation pulse by the stimulation device. Here, the time setting means is advantageously a delay means for delaying the output of the electrical stimulation pulse through the Stimulation device. Since the mechanical waves of the shock or pressure wave propagate at a lower speed (speed of sound) in the tissue than the electrical stimulation pulses (speed of light), this time shift must be compensated for, corresponding to the output of the shock wave and the electrical stimulation pulse to control and adjust the desired application.

Advantageously, the system according to the invention comprises an ECG device (electrocardiogram device) with at least two electrodes for acquiring ECG data of a patient before, during and / or after the output of the shock wave and the electrical stimulation pulse. In this case, the control device advantageously provides the energy of the shock or pressure wave and / or the electrical stimulation pulse and / or the timing of the output of the shock or pressure wave and the output of the electrical stimulation pulse on the basis of the ECG detected by the ECG device Data.

Advantageously, the system according to the invention further comprises a locating device for locating and / or locating a target area with respect to the organ to be stimulated. If the organ is a human heart, this locating device can detect, for example, the application window with respect to the ribs and the lung and thus locate the target area. Advantageously, the locating device is an ultrasound device.

Advantageously, the locating device and a Doppler ultrasound device for detecting the target area with Doppler ultrasound, z. A color Doppler, the controller controlling the output of the shock wave and the output of the electrical stimulation pulse based on the detection of the target area by the Doppler ultrasound device. The advantage here is that the application of Doppler ultrasound, the target area, the distance between the shock wave source and the target area, etc., both in time and place is precisely adjustable and regulated.

The above object is further achieved by a system for stimulation of organs, such. The heart of a patient according to claim 11 System according to the invention comprises a shock wave source for outputting a Stoßbzw. Pressure wave, a locating device for detecting a target area by means of Doppler ultrasound and a control device for controlling the output of Stoßbzw. Pressure wave through the shock wave source based on the detection of the target area by the locating device. The advantage of this system is that by using the Doppler ultrasound the target area including treatment window and the distance between the target area and the shockwave source can be determined exactly, whereby the necessary application energy of the shock or pressure wave can be precisely adjusted via the energy loss through the tissue. Furthermore, by the time resolution of the Doppler ultrasound control and regulation of the energy of the shock or pressure wave very soon possible.

The control device of this system according to the invention advantageously determines the distance between the shockwave source and the target area on the basis of the detection of the target area by the locating device and, on the basis of this calculation, adjusts the intensity of the shock or pressure wave to be output by the shockwave source. In this case, advantageously, a feedback circuit for automatically adjusting the intensity of the output from the shock wave source shock or pressure wave can be provided.

Advantageously, an adjusting device for spatially adjusting the shock wave source is further provided, wherein the control device controls the adjusting device on the basis of a detection of the target area. In this case, advantageously, a feedback circuit for automatically controlling the adjusting device may be provided on the basis of the detection of the target area. The adjusting device is, for example, a mechanical device for two- or three-dimensional adjustment of the emission direction of the shockwave source, but may also be an electrical or otherwise configured suitable device.

Alternatively, the detection of the target area for controlling the adjusting device can be carried out by a device for detecting reflected shock waves. Here, the reflections of the transmitted from the shock wave source shock or pressure waves are received and evaluated. Advantageously, the shockwave source has a focusing system for focusing the output shock waves onto the target area, wherein an adjustment means is provided for adjusting the focusing system depending on the detection of the target area. Here, advantageously, a feedback circuit for automatically adjusting the focusing system is provided depending on the detection of the target area. For example, the focusing system is a suitable system for varying the focal length of a lens through which the shock wave passes.

Advantageously, an ECG device with at least two electrodes for acquiring ECG data of a patient before, during and / or after the output of the shock or pressure wave by the shock wave source is further provided. In this case, the control device can set the energy of the shock or pressure wave and / or the time of the output of the shock or pressure wave by the shock wave source on the basis of the ECG data detected by the ECG device.

The shock wave source can advantageously comprise at least two elements for outputting a shock or pressure wave, wherein the elements are selectively controllable by the locating device depending on the location or localization of the target area. For example, the shock wave source in this case consist of a number of juxtaposed segments for outputting shock or pressure waves, which can be switched on or off independently of each other.

The present invention will be further elucidated in the following detailed description with reference to exemplary embodiments with reference to the attached figures, in which:

1 shows a schematic representation of a first embodiment of a system according to the invention for the stimulation of organs,

FIG. 2 shows a schematic representation of a modified embodiment of the system according to the invention of FIG. 1, FIG. 3 shows a schematic representation of the part of the system according to the invention to be placed on the body of a patient,

Fig. 4 shows a schematic representation of another exemplary embodiment of a system according to the invention for the stimulation of organs, and

Fig. 5 is a schematic representation of a shock wave source used in the system according to the invention with a focusing device and an adjusting device.

Fig. 1 shows a schematic representation of a first embodiment of a system according to the invention for stimulating organs, such. B. the heart of a patient. In the following description, the various embodiments and modifications thereof with respect to the treatment and stimulation of a human heart are explained, but this is not intended to limit the application of the system according to the invention to other suitable organs.

The system 1 shown in FIG. 1 is designed for the mechanical and electrical stimulation of a heart. For this purpose, the system 1 comprises a

Shock wave source 2 for generating and outputting a shock wave, which may or may not be focused, and an electrical stimulation device 3 for generating and outputting an electrical stimulation pulse to the heart of a patient. The shock wave source 2 and the stimulation device 3 are realized, for example, as a shock wave applicator 2 'or stimulation electrodes 3', which can be combined in a common device that can be placed on the thorax of a patient.

The shock wave source 2 and the stimulation device 3 are controlled by a common control device 5, which controls the triggering of the shock or pressure wave by the shock wave source 2 and the electrical stimulation pulse through the stimulation device 3 via a trigger device 7. Between the triggering device 7 and the stimulation device 3 may be a Timing device 8 may be provided, for example, in the form of a delay device to control the timing of the output of the electrical stimulation pulse in relation to the output of the shock or pressure wave depending on the desired application. If the electrical stimulation pulse and the shock or pressure wave are to act simultaneously or substantially simultaneously on the heart, then the output of the electrical stimulation pulse in comparison to the Stoßbzw. Pressure source are delayed because electrical signals propagate faster than mechanical waves. Since the mechanical energy of the shock or pressure wave changes the permeability of the cell membrane, it may be advantageous to design the drive so that the electrical stimulation pulse strikes the heart immediately after the shock wave has passed through the heart electrical energy can only be fully effective if it hits the cells of the cardiac muscle at the optimum of the tension or expansion of the cell membranes.

The inventive system 1 according to the first embodiment further comprises an ECG device 4 with at least two electrodes 4 'for acquiring ECG data of a patient. The acquisition of the data may occur before, during and / or after the output of the shock wave and the output of the electrical stimulation pulse. The control device 5 can be configured simultaneously as an evaluation device that receives the ECG data acquired by the patient and for calculating and adjusting the energy or intensity of Stoßbzw. Pressure wave and / or the electrical stimulation pulse and / or the timing of the output of the shock or pressure wave and the output of the electrical stimulation pulse used. The ECG electrodes 4 'may be formed with the shock wave applicator 2' and the electrical stimulation electrodes 3 'in a common device or a common device as a unit or as separate elements.

The stimulation system 1 according to the invention further comprises a locating device 9, which is for example an ultrasound device (eg ultrasound B-scan). The ultrasound device may, for example, be designed as an ultrasound scanner 9 ', which is implemented as a unit with the shockwave applicator 2' and the stimulation electrodes 3 'in a device. The locating device 9 is designed to be the region of interest of the treating organ by means of an application window analyzer 11 and to locate the distance to the organ to be treated by means of a distance analysis device 10. Particularly in the case of the heart, it is important that a suitable application window is detected and fixed between the ribs, the triggering of a shock wave being permitted only when a sufficient minimum area is available to initiate the shock or pressure wave. Furthermore, the intensity or energy of the shock or pressure wave and / or the electrical stimulation pulse can be calculated and adjusted via the control device 5 via the size of the application window and the distance to the organ to be treated. The advantage is that the radiated electrical and mechanical energy can be reduced to a necessary minimum and possible side effects can be largely eliminated. In order to be able to optimally set the intensity or energy of the incident shock or pressure wave, as shown in FIG. 3, the shock wave applicator 2 'may, for example, consist of a number of segments 2 ", which can be controlled individually, around the surface For this purpose, the shockwave source 2 can be preceded by an energy setting device 6, which is controlled correspondingly by the control device 5. In FIG. 3, the shockwave applicator 2 'is shown in FIG. With an oval or elliptical shape, the surface being adapted to the size of the respective rib window to be used, any other suitable shapes may be used for the shock wave applicator 2 ' Shock Wave Applicator 2 'electrical stimulation electrodes 3' shown, with which the shock wave applicator 2 'is connected to a combined device. There may be additional electrodes for electrical stimulation. Furthermore, in the example shown in FIG. 3, an ultrasound scanner 9 'is embedded in the middle of the shockwave applicator 2'. The ultrasound scanner 9 'can also be arranged at other suitable locations. Furthermore, FIG. 3 shows three ECG electrodes 4 ', which are either part of the device with the shock wave applicator 2' and the electrical stimulation electrodes 3 'and the ultrasound scanner 9', or alternatively are formed as separate elements.

It should be emphasized that the embodiment of the stimulation system 1 according to the exemplary embodiment shown in FIG. 1 is particularly suitable for emergency situations where a resting or slowly beating heart can be stimulated by means of a simple and easy-to-use yet effective device. For special application in extreme emergency situations, in the stimulation system 1 of FIG. 1, the application analysis device 11 and the distance analysis device 10 may be omitted, so that immediate action can be taken without time-wasting adjustment devices. However, without altering the basic structure, the pacing system 1 of FIG. 1 may become a pacing system that may be used for therapy and diagnosis, with minor changes. A corresponding modified embodiment of the stimulation system according to the invention is shown in FIG.

Fig. 2 shows a schematic representation of a system 1 'for stimulating organs, such. As the heart of a patient, which is particularly suitable for therapy and diagnosis. The stimulation system shown in Fig. 2 corresponds in basic structure to that shown in FIG. 1 and described stimulation system 1 and contains the identical elements as the system 1 shown in FIG. 1, such as a shock wave source 2 with a shock wave applicator 2 ', a stimulation device. 3 with electrodes 3 'for outputting an electrical stimulation pulse, a control and analysis device 5, an ECG device 4 with at least two electrodes 4', a triggering device 7, a time setting 8 whose structure and function are identical and their description therefore not again is repeated. Optionally, individual elements may be configured somewhat differently due to the application in therapy and diagnosis, without changing their fundamental function.

The stimulation system 1 'shown in FIG. 2 differs from the stimulation system 1 shown in FIG. 1 in that, instead of the energy or intensity adjustment device 6, an energy feedback circuit 14 for the automatic adjustment and regulation of the energy or intensity of the shock wave source 2 created and issued shock or pressure wave is provided. This feedback circuit 14 allows a timely adjustment of the energy or intensity of the shock or pressure wave during the therapy or diagnosis depending on data generated by a Doppler ultrasound device 19 be recorded. This is another difference to the stimulation system 1 of Fig. 1, namely that a Doppler ultrasound device 19 is provided with a Doppler ultrasound scanner 19 ', which is able to detect movements and flow rates, etc. and by means of a target analyzer 12 and the 1 already known from the system 1 of Fig. 1 distance analysis means 10 and application window analysis means 11 accurate data about size, location, distance, etc. of a target object with respect to the shock wave source calculated and passed on to the control device 5, which the triggering device 7 and the energy feedback circuit 14th controls. The data acquired by the Doppler ultrasound device can also be transmitted via the control device 5 by means of the

Timing means 8 are used for accurately timing the output of the electrical stimulation pulse by the stimulation means 3 with respect to the output of the shock wave through the shock wave source 2.

Fig. 4 shows a schematic representation of another embodiment of a system 20 according to the invention for stimulating organs, such. The heart of a patient. The stimulation system 20 shown in FIG. 4 is designed in particular for diagnosis and therapy and comprises a shock wave source 21 for outputting a shock or pressure wave. The shockwave source 21 includes or is configured as a shockwave applicator 21 'that may be placed on the chest of a human patient, for example, to radiate a shockwave onto the heart. The structure and function of the shock wave source 21 corresponds to the structure and the function of the shock wave source 2 shown in FIG. 1 and explained. The system 20 shown in Fig. 4 further comprises a locating device 22 and a target analysis device 33 for detecting a target area by means of Doppler ultrasound, which comprises an ultrasound scanner 22 '. The Doppler ultrasound device 22 corresponds in construction and function to the Doppler ultrasound device 19 of the system 1 'of FIG. 2. The Doppler ultrasound device 22 can detect the size and the position in the target area by means of the target analysis device 33 and via a Doppler motion detector device 23 movements in the target area, a distance analysis device 28, the distance between the shock wave source 21 and the target area and an application window analysis device 29, the size of the available Pass application window for the shock or pressure wave to a control and evaluation 24, which adjusts the energy and intensity and the timing of the shock or pressure wave through the shock wave source 21 and controls accordingly. For this purpose, a triggering device 27 is provided, which is controlled accordingly by the control device 24 and causes the triggering of the shock or pressure wave. Between the triggering device 27 and the shockwave source 21, there may be provided an energy feedback circuit 26 for automatically adjusting the energy or intensity of the shockwave outputted by the shockwave source 21 which timely records the intensity or energy of the output shockwave can regulate and control. Between the control means 24 and the Doppler motion detection means 23 and the shock wave source 21 may further be provided a positioning feedback means 25 for automatically controlling the spatial position of the shock wave source 21 with respect to the target area. For this purpose, the shock wave applicator 21 'is equipped with an adjusting device 32, which allows a spatial adjustment of the shock wave source.

Fig. 5 shows a schematic example of such an adjusting device 32 in the form of mechanically adjustable adjusting screws, which engage three positions of the shock wave applicator 21 ', so that a spatial tilting, pivoting, etc. of the Einstrahlachse the shock or pressure wave is enabled. However, the adjusting device 32 can also have any other suitable shape and design. By means of the positioning feedback device 25, therefore, the shock wave applicator 21 'can be adjusted and adjusted automatically and promptly in terms of space.

As shown in FIG. 5, the shock wave applicator 21 'may further include a focusing system 31 for focusing the output shock wave on the target area by means of a diaphragm 34 including a medium 35 for transmitting the shock wave and on the body 36 is applied, wherein the focusing system is adjustable or adjustable by a suitable adjustment. For example, as indicated in Fig. 5, the focusing system 31 may consist of a movable lens or a movable lens system. Also conceivable is the use of a jelly-like lens, which in Ring segments is taken, wherein by radial displacement of the ring segments, the diameter of the lens is increased or reduced by their internal stress. By changing the curvature of the lens dome a change in the focal length of the lens is effected (so-called zoom lens). Likewise, dome-shaped, elliptical or parabolic shock wave generation segments 2 'can be used. For timely adjustment of the focusing system 31, a further feedback circuit for automatically adjusting the focusing system depending on the detection of the target area may be provided. Optionally, this task can be taken over by the positioning feedback system 25.

The stimulation system 20 may further comprise an ECG device 30 with at least two electrodes 30 'for acquiring ECG data of a patient before, during and / or after the output of a shock or pressure wave. The task and function as well as the design of the ECG device 30 correspond to the ECG device 4 of the system 1 of FIG. 1. The control device 24 can provide the data provided by the ECG device 30 for controlling the intensity or energy as well as the position and Focus on the width control of the shockwave source 21.

The shock wave applicator 21 of the system 20 of FIG. 4, similar to the shock wave applicator 2 'shown in FIG. 3, may be provided with a number of different elements or segments which are individually and separately energized to control the energy and / or the irradiation area for the set emitted shock or pressure wave depending on the application.

Claims

claims

A system (1) for stimulating organs, e.g. the heart, with a shock wave source (2, 2 ') for outputting a shock wave, a stimulation device (3, 3') for outputting an electrical stimulation pulse, and a control device (5) for controlling the output of the shock or Pressure wave through the shock wave source (2, 2 ') and the output of the electrical stimulation pulse by the stimulation device (3, 3').

2. system (1) for stimulating organs according to claim 1, with a by the control device (5) controlled triggering device (7) for triggering the output of the shock or pressure wave by the shock wave source

(2, 2 ') and the output of the electrical stimulation pulse by the stimulation means (3, 3').

3. System (1) for the stimulation of organs according to claim 1 or 2, with a time setting device (8) for setting the timing of the

Output of the shock or pressure wave by the shock wave source (2, 2 ') and the output of the electrical stimulation pulse by the stimulation device (3, 3').

The system (1) for stimulating organs according to claim 3, wherein the time setting means (8) is a delay means for delaying the output of the electrical stimulation pulse by the stimulation means (3; 3 ').

5. System (1) for stimulation of organs according to one of claims 1 to 4, comprising an ECG device (4) with at least two electrodes (4 ') for acquiring ECG data of a patient before, during and / or after Output of the shock or pressure wave by the shock wave source (2, 2 ') and the output of the electrical stimulation pulse by the Stimulation device (3; 3 ').

6. System (1) for stimulating organs according to claim 5, wherein the control device (5) the energy of the shock or pressure wave and / or the electrical stimulation pulse and / or the timing of the output of the shock or pressure wave through the Shock wave source (2; 2 ') and the output of the electrical stimulation pulse (3; 3') by the stimulation device on the basis of the ECG data detected by the ECG device (4) sets.

7. System (1) for the stimulation of organs according to one of claims 1 to 6, with a locating device (9; 9 ') for locating and / or locating a target area with respect to the organ to be stimulated.

8. System (1) for stimulating organs according to claim 7, wherein the locating device (9) is an ultrasound device.

The system (1) for stimulating organs according to claim 7 or 8, wherein the shock wave source (2; 2 ') comprises at least two elements (2 ") for outputting a shock wave, the elements (2") being dependent from the locating or localization of the target area by the locating device (9; 9 ') are selectively controllable.

10. System (1) for stimulating organs according to claim 7, wherein the locating means is a Doppler ultrasound device (9 ') for detecting the target area with Doppler ultrasound and the control device (5) the output of the shock or pressure wave through the Shock wave source (2, 2 ') and the output of the electrical stimulation pulse by the stimulation means (3, 3') on the basis of the detection of the target area by the Doppler ultrasound device (9 ') controls.

11. System (20) for stimulating organs, such as the heart, with a shock wave source (21, 21 ') for outputting a shock or pressure wave, a locating device (22, 22', 23) for detecting a target area by means of Doppler ultrasound, and control means (24) for controlling the output of the shock wave by the shock wave source based on the detection of the target area by the locator.

12. A system (20) for stimulating organs according to claim 11, wherein the control means (24) calculates the distance between the shock wave source (21; 21 ') and the target area based on the detection of the target area by the locating means and on the basis thereof Calculation sets the intensity of the output from the shock wave source shock or pressure wave.

The system (20) for stimulating organs according to claim 12, comprising a feedback circuit (26) for automatically adjusting the intensity of the shock or pressure wave to be delivered by the shockwave source

14. The system (20) for stimulating organs according to claim 11, 12 or 13, comprising an adjusting device (32) for spatially adjusting the shock wave source, wherein the control device controls the adjusting device on the basis of a detection of the target area.

The organ stimulating system (20) of claim 14, wherein a feedback circuit (25) is provided for automatically controlling the adjusting means based on the detection of the target area.

16. A system (20) for stimulating organs according to claim 14 or 15, wherein the detection of the target area for controlling the adjusting device (32) by the locating device (22; 22 ') takes place.

17. The system (20) for stimulating organs according to claim 14 or 15, wherein the detection of the target area for controlling the adjusting device (32) by means for detecting reflected shock waves.

18. The system (20) for stimulating organs according to one of claims 11 to 17, wherein the shock wave source (21; 21 ') has a focusing system (31) for focusing the output shock waves onto the target area, wherein an adjusting means for Adjusting the focusing system is provided depending on the detection of the target area.

The system (20) for stimulating organs according to claim 18, wherein a feedback circuit for automatically adjusting the focusing system is provided depending on the detection of the target area.

20. System (20) for stimulation of organs according to one of claims 11 to 19, comprising an ECG device (30) with at least two electrodes (30 ') for acquiring ECG data of a patient before, during and / or after Output of the shock or pressure wave by the shock wave source.

The system (20) for stimulating organs according to claim 20, wherein the control means (24) controls the energy of the shock wave and / or the

Sets the timing of the output of the shock or pressure wave by the shock wave source based on the ECG data detected by the ECG device.

22. A system (20) for stimulating organs according to any one of claims 11 to 21, wherein the shock wave source at least two elements for outputting a Stoßbzw. Comprises pressure wave, wherein the elements are selectively controllable by the locating device depending on the location or localization of the target area.