Abstract:
The invention regards a resuscitation system having a chest compression device to repeatedly compress the chest of a patient and thereafter cause or allow the chest to expand. The device includes an electric motor connected to a compression element. A controller is coupled to the electric motor and causes the motor to actuate the compression element according to a predetermined profile. The controller is further operable to draw the compression element away from a patient&#39;s chest upon detecting a malfunction.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims the benefit of U.S. Provisional Patent Application No. 60/746,993, filed May 11, 2006, and is a continuation-in-part of U.S. patent application Ser. No. 11/603,976, filed Nov. 21, 2006.  
         [0002]     The entire disclosure of each of the prior applications is considered to be part of the disclosure of the instant application and is hereby incorporated by reference therein. 
     
    
     TECHNICAL FIELD  
       [0003]     The invention relates generally to apparatus for treating cardiac arrest and, more specifically, chest compression devices.  
       BACKGROUND OF THE INVENTION  
       [0004]     Sudden cardiac arrest is a leading cause of death in developed countries in the Western World, like United States and Canada. To increase the chance for survival from cardiac arrest, important aspects are CPR (Cardio Pulmonary Resuscitation) and heart defibrillation given in the first few critical minutes after the incident. CPR is performed to ensure a sufficient flow of oxygenated blood to vital organs by external compression of the chest combined with rescue breathing. Heart defibrillation is performed to re-establish normal heart rhythm by delivery of external electric shock.  
         [0005]     The quality of CPR is essential for survival. Chest compressions must be given with a minimum of interruptions, and be of sufficient depth and rate. Manually performed chest compressions is an extremely exhausting task, and it is practically impossible to give sufficient quality manual CPR during transportation of a patient.  
         [0006]     Many different types of automatic chest compression devices have been developed to overcome this, based on a wide variety of technical solutions. Some devices comprise a piston which presses the patient&#39;s chest down with a given frequency and a given force. These devices comprise hydraulic/pneumatic mechanisms to provide a reciprocating movement for the piston. Other devices comprise a belt embracing the chest and a rotating motor with a spindle being engaged and disengaged.  
         [0007]     Chest compressions given by automatic devices have the potential to be more forceful than manual compressions. There is a balance between (1) giving optimal blood flow to vital organs, and (2) limiting the impact to the chest to avoid internal injuries as a result of the external force being applied to the patient. Previously known automatic chest compression devices are designed mainly with respect to (1), and in many cases do not provide a satisfactory balance between (1) and (2).  
       SUMMARY OF THE INVENTION  
       [0008]     The invention comprises a chest compression device that permits control of the compression characteristics. In some embodiments, this is achieved by providing the device with an electric motor and a controller. Such embodiments may also comprise a transmission mechanism for transferring mechanical energy between the motor and a compression element. Other advantageous features of the invention are mentioned in the appended claims.  
         [0009]     In some embodiments, a satisfactory quality for chest compressions (frequency, speed and force) has been achieved using motors that are able to accelerate very rapidly and at the same time are able to provide high power in short periods of time. These requirements may be fulfilled by servo motors. In some embodiments, the servo motors have low rotational inertia and are adapted for high peak power.  
         [0010]     In some embodiments, control of the motor is performed by a controller. Use of an electric motor with a controller enables full control of compression with respect to most or all of the important factors, such as compression depth, compression force, compression frequency, duration of compressions, rate of relieving and applying pressure, etc. In some embodiments, control of these factors is performed by controlling the waveform of the compressions.  
         [0011]     By having control of the compression waveform as applied to the patient, it is possible to achieve an improved balance for each patient/recipient and for each stage in the treatment. In this way the pulse pattern of the compression/decompression can be adapted to the individual patient at different stages in treatment, thus leading to improved therapy concerning both blood flow and avoidance of internal injuries.  
         [0012]     The controller may further provide the ability to extract and log chest compression data from the system controller, enabling clinical studies and optimization of the system. Internal injuries could be related to, for instance, the depth profile of the compression piston, etc. Logging data would enable research into this topic and others. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]     The invention will now be described by means of examples illustrated in the drawings, wherein:  
         [0014]      FIG. 1  is a block diagram of a chest compression device according to an embodiment of the present invention.  
         [0015]      FIG. 2  is a more detailed block diagram of an embodiment of the device according to an embodiment of the present invention.  
         [0016]      FIG. 3  is another more detailed block diagram of an embodiment of the device according to an embodiment of the present invention.  
         [0017]      FIG. 4  is a graph showing an example of compression depth and motor velocity vs. time according to an embodiment of the present invention.  
         [0018]      FIGS. 5A  is a graph showing a compression pattern according to the prior art.  
         [0019]      FIG. 5B  is a graph showing a compression pattern in accordance with an embodiment of the present invention.  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0020]      FIG. 1  shows a block diagram of an embodiment of a chest compression device providing compressions to a patient in a controlled manner. The device comprises a servo motor  1  connected to a transmission mechanism  2  for transforming rotational movement in the motor  1  into a reciprocating movement. The transmission mechanism  2  is connected to a compression element  3 , which can, for example, be formed as a plate, a vacuum cup, or a round shaped body. The compression element  3  is driven by the motor  1  to perform compressions. The device may also comprise a servo controller  4 , which among other functions controls the motor&#39;s operating cycle. The servo controller  4  is adapted to drive the motor  1  with a digital modulated or analog pulse pattern. The pulse pattern may be input to the controller by input means known in the art and may be also calculated by the controller based on force and depth measurements of compressions performed on the patient. The controller may also calculate the pulse pattern based on characteristics of the patient input to the controller such as age, chest circumference, or a measurement of the rigidity of the patient&#39;s chest. As shown in the figure, there may be provided feedback signals  6  from the patient  5  to the servo controller  4 . It is also possible to provide control signals  7  related to the transmission mechanism  2  as feedback for motor control. The device also comprises a power source  8 .  
         [0021]     As mentioned previously, the motor  1  may advantageously fulfill certain requirements regarding: (a) kinetic energy at max speed, (b) peak power, (c) efficiency (at a given power), (d) weight and dimensions.  
         [0022]     Limited kinetic energy provides dynamic performance, that is, the ability to freely select a displacement profile for the compression element without high power consumption. Limited kinetic energy also provides improved safety if there is a fault in the electrical power system causing all the kinetic energy to be released into the patient&#39;s chest. In some embodiments, the limit for the kinetic energy of the motor is about 4 J (breast stiffness 200N×displacement 0.02 m=4 J).  
         [0023]     In one example, peak power with, for example, a maximum force of 550N transferred to a patient and a maximum retraction speed for the compressing element of 0.63 m/s is: P=550N×0.63 m/s=347 W. This is the power necessary, in one embodiment, at the patient&#39;s end, and losses in the transmission mechanism may advantageously be taken into consideration. This leads to a peak power for the motor in one embodiment of the invention of 400 W-600 W.  
         [0024]     In one embodiment of the invention, substantially free return of the patient&#39;s chest to a non-compressed position is permitted by retracting the compressing element at high speed (e.g. 0.63 m/s). In another embodiment a substantially free return of the chest to an uncompressed position is permitted by means of the transmission mechanism (e.g., by mechanically disconnecting the motor from the compression element). Where the transmission mechanism is disconnected to permit return of the chest, the maximum return speed requirement may be ignored and a motor with a peak power of 300 W-500 W has been found to be adequate.  
         [0025]     High efficiency leads to long battery life and little generation of heat. In one embodiment of the invention, motor  1  has an efficiency of about 75%, however motors with other efficiencies may also be used.  
         [0026]     Weight and dimensions are limited in an embodiment of the device adapted for portable use. In said embodiment the motor&#39;s weight may be limited to 500 grams.  
         [0027]     Other relevant parameters of the motor may include average power, voltage (insulation strength), motor constants (rpm/V, etc), durability, radial and axial load on bearing. Average power may be controlled to avoid overheating a motor. In one embodiment of the invention the motor  1  has an average power greater than 100 W.  
         [0028]     Motor  1  can, for example, be a brushless DC motor (e.g., a motor with a peak power equal or higher than 400 W and efficiency higher than 75%, or, a motor with a peak rating up to 500 W and 150 W average rating, such as a brushless Minebae 40S40A), or it can be a DC motor with brushes. If transistors provide the commutation, any variant or combination of block commutation or sinusoidal commutation might be used. Motor  1  may comprise a controller structure with feed forward.  
         [0029]      FIG. 2  shows a more detailed block diagram of the device according to an embodiment of the invention. This diagram shows controller  4  comprising three elements: a motor controller  11 , a main controller  12 , user controls and data logging  13 . This division is done purely for illustration purposes as the three elements can be integrated in a single device, or any two elements can be integrated while one element is provided separately. Motor controller  11  functions to sense the motor rotational position and to control operation of the motor, and also the motor&#39;s connection to the power source  10 . Main controller  12  can receive signals from different sensors and provide feedback signals to control the device. Main controller  12  is also able to receive signals not generated by the device itself, such as, for example, user controls, patient feedback data and output values of signals providing data logging.  
         [0030]      FIG. 3  is another more detailed block diagram of one embodiment of the device according to the invention. The embodiment of  FIG. 3  includes a power source equipped with a battery  10  for providing power to the motor  1  via a three phase bridge  21 . The battery  10  has, in one embodiment of the invention (shown in  FIG. 4 ), a capacity of 2.3 Ah, is able to deliver more than 600 W of peak effect, and has an inner resistance lower than 0.3Ω. In portable versions of the device, the battery may have a weight of less than 1 kg and a volume of approximately 200 mm×80 mm×80 mm. The battery preferably does not overheat when it delivers an average power of 150 W at an ambient temperature of 40 degrees Celsius. These criteria are met, for example, by high power lithium ion cells such as ANR26650MI available from A123 Systems Inc., or by other batteries capable of delivering energy directly to the motor (that is, without intermediate energy storage).  
         [0031]     Intermediate storage of energy may advantageously be provided in embodiments of the device which comprise batteries not complying with the above mentioned criteria, energy storage in capacitors may help to achieve the 600 W peak power requirement. If boost circuitry is used to achieve a substantially constant battery current during the compression cycle, the battery heat dissipation can be reduced and batteries with less power handling capability than the A123 system may be used.  
         [0032]     Another possibility (not shown) is to provide a power source adapted for connection to AC or DC mains with a small 100 W power supply if the high power lithium ion battery (or batteries) is connected in parallel with the supply. The battery will provide the peak power needed for the device operation while the power supply will ensure that the battery does not discharge. Using batteries in stead of capacitors as an energy storage will ensure that the device operation is not interrupted if the power supply is disconnected for a short period when moving the patient from one room to another, etc. In one embodiment of this invention capacitors are used instead of batteries.  
         [0033]     A combination of the above mentioned embodiments is also possible.  
         [0034]     A motor power control circuit may be activated in case of an error situation. The circuit may cut the supply to the motor, for example, by opening the battery high side connection to the bridge circuitry. The motor power control  20  may be activated by: (a) a motor controller circuit  25 , (b) manually (emergency stop  22 ), (c) the main controller  12 , (d) a low battery voltage signal, (e) low/high regulated 5V and 3.3V (not shown), and/or (d) hardware shutdown as a consequence of high peak current. If the motor controller  25  fails and the bridge current rises, the main controller  12  may initiate a shut down. A hardware solution may be used if faster shutdown is needed. Some embodiments of the invention can comprise only one or a selected group of the above mentioned activating inputs. In one embodiment, substantially all input lines to the motor power control  20  have to be activated in order for the switch to turn “on” and allow compressions of the patient.  
         [0035]     As mentioned above, in one embodiment, the battery  10  delivers power to the motor  1  via the motor power control  20  and the three phase bridge  21 . The bridge circuit  21  can have an energy storage capacitor (not shown) which may aid compression element return in an error mode. The bridge  21  comprises high side transistors (not shown) which preferably run at 100% duty cycle in order to achieve block commutation of the motor  1 . In one embodiment of the invention battery voltage is limited to 30V and the bridge can comprise mosfets with a breakdown voltage of 60V.  
         [0036]     The motor controller circuit  25  drives the motor in accordance with a drive profile, that is a determined sequence of digitally modulated pulses with a determined shape. Controller  25  will encompass all the necessary drive algorithms needed.  
         [0037]      FIG. 3  shows many inputs to controller  25 , and some of these may be omitted in some embodiments. Some of the possible inputs include:  
         [0038]     (a) Hall sensor  28  for indication of the position of the motor rotor and thus the compression element&#39;s position;  
         [0039]     (b) Two absolute position indicators corresponding to monitoring of the position of the compression element with respect to two limits: a bottom position (full compression) and a high position (no compression). The position limit interval at the bottom may preferably be regarded as an absolute stop position, such that movement beyond this position is very small. The top position may be used for resetting a Hall sensor signal count. Counting Hall sensor pulses from this position may provide information relating to the piston position. A middle position is used for checking the mechanical movement during operation;  
         [0040]     (c) Force sensor ( 29 ) analog input;  
         [0041]     (d) Motor current monitoring;  
         [0042]     (e) Battery output current and voltage monitoring;  
         [0043]     (f) Input power from regulator;  
         [0044]     (g) Input from main controller  12 , activating compression element movement;  
         [0045]     (h) Input from motor power control  20 ; and,  
         [0046]     (i) Motor temperature measurement.  
         [0047]     Outputs from the controller  25  may include:  
         [0048]     (a) Power off signal to motor power control  20 ;  
         [0049]     (b) Outputs for test and verification;  
         [0050]     (c) Bridge gate signals for/from the mosfets of the bridge  21 ;  
         [0051]     (d) Charge pump switch signal to enable the drive voltage for the top mosfets (not shown); and,  
         [0052]     (e) Signals to the alarm circuits.  
         [0053]     The motor controller may comprise software for performing the following tasks:  
         [0054]     (a) Communication and control between the main controller  12  and the motor controller  25 . For example, the main controller can download a “drive profile” to the motor controller  25  prior to activation of device movement. The drive profile encompasses desired depth waveforms with respect to time and force limitations;  
         [0055]     (b) Communicating relevant status/measurement data obtained by the motor controller  25 . The communication protocol is preferably designed to detect deviations from normal functionality;  
         [0056]     (c) Identify erroneous movement or lack of movement of the device, overheating. The motor controller may deactivate the motor power control  20  in order to safeguard the “patient”. The software must preferably also respond to overheating of the motor and the drive electronics; and,  
         [0057]     (d) Preferably both the processor  12  and controller  25  can shut down the system and initiate alarms.  
         [0058]     Motor controller  25  controls operation of motor  1  by controlling operation of the three phase bridge  21 . As a safety measure, the device may be adapted to proceed in such a way that if battery  10  is suddenly removed, the main controller  12  notices the removal and immediately initiates a controlled shut down.  
         [0059]     Safe termination of operation may be limited to turning off bridge  21  thus allowing the compression element  3  ( FIGS. 1 and 2 ) to return using the chest force to push the piston to the top position. In an alternative embodiment, a controlled return to high compression element position is used.  
         [0060]     During start up, the main processor  12  preferably controls all the device&#39;s parts. When the system is “good to go” a signal will be given to the motor controller  25 . The software may comprise drive algorithms in order to safely drive the motor/device in various states of operation, illustrated in  FIG. 4 , which include:  
         [0061]     (a) Start position: the compression element is kept close to the upper compression position when mounting the machine on the patient;  
         [0062]     (b) Upper compression position: the compression element can be kept in position by the force from the patient&#39;s chest;  
         [0063]     (c) Movement down according to depth profile;  
         [0064]     (d) Transition from a limited force to a maximum force;  
         [0065]     (e) Hold at accurate depth; and,  
         [0066]     (f) Return to upper position.  
         [0067]      FIG. 4  shows two curves. The upper curve shows inverted compression depth vs. time, where the value of compression depth is multiplied by 0.125 (400=50 mm). The lower curve shows the motor RPM, where the maximum speed at compression is limited to 3500 RPM in order to avoid chest injuries while the decompression is done at a higher speed (−5000 RPM) in order to increase the patient&#39;s blood flow. In one embodiment of the invention, the motor speed during decompression is between 1.2 and 1.6 times the motor speed during compression. In a preferred embodiment, the motor speed during decompression is about 1.4 times that of the motor during compression. As one can see from the lower curve, the motor is accelerated at the beginning of a compression cycle and thereafter it experiences a reduction in velocity until the lowest compression point is reached. After a short interval with constant speed (maximum compression), a high acceleration period follows to allow the chest to decompress naturally.  
         [0068]     The waveform shown in this figure is only meant for illustrative purposes as the invention permits use of any waveform in the compression process. In some embodiments, linear motors may be used, in which case the curves of  FIG. 4  may describe the linear speed of the motor, rather than RPM. Where a linear motor is used, the curves of  FIG. 4  may have a similar shape but be scaled larger or smaller.  
         [0069]      FIG. 5A  shows a pulse pattern (compression depth vs. time) which corresponds to prior automatic chest compression devices. Here the compressions  30  and decompressions  31  are performed with similarly quick velocity during a short period of time. This implies the necessary compression force to be directed onto the patient during the same short period of time, and the compressions therefore have a violent impact on the patient. The time  32  between compression and decompression and the time  33  between decompression and compression have the same order of magnitude.  
         [0070]     The curve in  FIG. 5B  shows a modified pulse pattern which provides controlled compression  34  (e.g., a longer compression time at a slower rate), and thus a more limited patient impact combined with a more rapid decompression  35 . The time  36  between compression and decompression and the time  37  between decompression and compression can be equal or different and have the same or different orders of magnitude.  
         [0071]     This is an example of a pulse pattern which can be achieved by means of the invention. The process will be more gentle to the patient, with reduced risk for injuries. Other pulse patterns may be applied with other properties, for example, according to what is assumed to be optimal for the patient according to new knowledge and/or guidelines within the art. Such patterns may, for example, have different delays between compression/decompression and decompression/compression, or other curvatures of the compressions/decompressions.  
         [0072]     In some embodiments, the decompression  35  has duration that is greater than about 1.5 times the duration of the compression  34 . In other embodiments, the decompression  35  has a duration that is between about 2 and 5 times the duration of the compression  34 . In a preferred embodiment, the decompression  35  has a duration that is between about 2 and 3 times the duration of the compression  34 . For example, in the illustrated embodiment, the decompression  35  has a duration that is about 2.7 times greater than the duration of the compression  34 .  
         [0073]     In some embodiments, the maximum speed of the decompression  35  is greater than about 4 times the maximum speed of the compression  34 . In other embodiments, the maximum speed of the decompression  35  is between about 5 and 8 times the maximum speed of the compression  34 . In a preferred embodiment, the maximum speed of the decompression  35  is greater than about 6 times the maximum speed of the compression  34 .  
         [0074]     As one can see the device according to the invention permits performance of controlled, swift and effective CPR. The use of an electric motor also permits easy adaptation of the compression parameters to different patients and different situations.