This invention relates generally to the field of ultrasonic blood flow sensors, which find utility in cardiac resuscitation and the guidance of the administration of cardiopulmonary resuscitation (CPR) by measuring vascular blood flow.
In emergencies and during operative procedures, the assessment of the state of blood flow of the patient is essential for both diagnosis of the problem and determining the appropriate therapy for the problem. The presence of a cardiac pulse in a patient is typically detected by palpating the patient's neck and sensing palpable pressure changes due to the change in the patient's carotid artery volume. When the heart's ventricles contract during a heartbeat, a pressure wave is sent throughout the patient's peripheral circulation system. A carotid pulse waveform rises with the ventricular ejection of blood at systole and peaks when the pressure wave from the heart reaches a maximum. The carotid pulse falls off again as the pressure subsides toward the end of the pulse.
The absence of a detectable cardiac pulse in a patient is a strong indicator of cardiac arrest. Cardiac arrest is a life-threatening medical condition in which the patient's heart fails to provide blood flow to support life. During cardiac arrest, the electrical activity of the heart may be disorganized (ventricular fibrillation), too rapid (ventricular tachycardia), absent (asystole), or organized at a normal or slow heart rate without producing blood flow (pulseless electrical activity).
The form of therapy to be provided to a patient without a detectable pulse depends, in part, on an assessment of the patient's cardiac condition. For example, a caregiver may apply a defibrillation shock to a patient experiencing ventricular fibrillation (VF) or ventricular tachycardia (VT) to stop the unsynchronized or rapid electrical activity and allow a perfusing rhythm to return. External defibrillation, in particular, is provided by applying a strong electric shock to the patient's heart through electrodes placed on the surface of the patient's chest. If the patient lacks a detectable pulse and is experiencing asystole or pulseless electrical activity (PEA), defibrillation cannot be applied and the caregiver may perform cardiopulmonary resuscitation (CPR), which causes some blood to flow in the patient.
Before providing therapy such as defibrillation or CPR to a patient, a caregiver must first confirm that the patient is in cardiac arrest. In general, external defibrillation is suitable only for patients that are unconscious, apneic, pulseless, and in VF or VT. Medical guidelines indicate that the presence or absence of a cardiac pulse in a patient should be determined within 10 seconds. For example, the American Heart Association protocol for cardiopulmonary resuscitation (CPR) requires a healthcare professional to assess the patient's pulse within five to ten seconds. Lack of a pulse is an indication for the commencement of external chest compressions. Assessing the pulse, while seemingly simple on a conscious adult, is the most often failed component of a basic life support assessment sequence, which may be attributed to a variety of reasons, such as lack of experience, poor landmarks, or error in either finding or not finding a pulse. Failure to accurately detect the presence or absence of the pulse will lead to adverse treatment of the patient either when providing or not providing CPR or defibrillation therapy to the patient.
Electrocardiogram (ECG) signals are normally used to determine whether or not a defibrillating shock should be applied. However, certain rhythms that a rescuer is likely to encounter cannot be determined solely by the ECG signal, e.g., pulseless electrical activity. Diagnoses of these rhythms require supporting evidence of a lack of perfusion despite the myocardial electrical activity as indicated by the ECG signal.
Thus, in order for a rescuer to quickly determine whether or not to provide therapy to a patient, it is necessary to quickly and easily analyze the patient's pulse, the amount of blood flow, and perhaps the ECG signals in order to correctly determine whether there is any pulsatile flow in the arteries of the patient.
This necessity is particularly dire in situations or systems in which the rescuer is untrained and/or inexperienced person, as is the case with rescuers for which the system described in U.S. Pat. No. 6,575,914 (Rock et al.) is designed. The '914 patent is assigned to the same assignee as the present invention and is hereby incorporated by reference in its entirety. The '914 patent discloses an Automated External Defibrillator (AED) (hereinafter both AEDs and Semi-Automated External Defibrillators—SAEDs—will be referred to jointly as AEDs) which can be used by first-responding caregivers with little or no medical training to determine whether or not to apply defibrillation to an unconscious patient.
The Rock AED has a defibrillator, a sensor pad for transmitting and receiving Doppler ultrasound signals, two sensor pads for obtaining an ECG signal, and a processor which receives and assesses the Doppler and ECG signals in order to determine whether defibrillation is appropriate for the patient (i.e., whether or not there is a pulse) or whether another form of treatment such as CPR is appropriate. The Doppler pad is secured to a patient's skin above the carotid artery to sense the carotid pulse, which is a key indicator of the sufficiency of pulsatile blood flow. Specifically, the processor in the Rock AED analyzes the Doppler signals to determine whether there is a detectable pulse and analyzes the ECG signals to determine whether there is a “shockable rhythm.” See, e.g., FIG. 7 and accompanying description at col. 6, line 60, to col. 7, line 52, in the '914 patent. The determination of a detectable pulse by the processor in the Rock AED is made by comparing the received Doppler signals against a threshold statistically appropriate with the Doppler signals received. Based on the results of these two separate analyses, the processor determines whether or not to advise defibrillation.
If defibrillation is not advised, the defibrillator can advise that CPR be administered to the patient. When the defibrillator is being operated by a medical professional the medical professional will generally administer CPR in the proper manner. However since an automated defibrillator can be operated by a layperson with no medical training, it is desirable that the defibrillator be capable of coaching the layperson rescuer in the proper application of CPR. CPR coaching can be integrated into a defibrillator as described in U.S. Pat. No. 6,125,299 (Groenke et al.), U.S. Pat. No. 6,351,671 (Myklebust et al.) and U.S. Pat. No. 6,306,107 (Myklebust et al.) The '299 and '671 patents both describe a force sensor which is placed on the patient's chest and to which chest compressions are applied. The force sensor is connected to a defibrillator which senses the applied force of the chest compressions and, using the defibrillator's audible prompts, coaches the rescuer to press “harder” or “softer” or “faster” or “slower.” The '107 patent describes a compression pad with an accelerometer instead of a force sensor which senses the depth of the chest compressions rather than their force. This approach is preferable as CPR guidelines are directed to the depth of compression rather than the applied force, which does not always correlate with compression depth due to different chest resistances to CPR compression.
These techniques are effective for CPR coaching because their quantification capability is directed to measuring the compression of the chest, which causes the lungs to inflate and deflate, thereby at least partially oxygenating the blood. These techniques do not measure the other intended effect of CPR, which is causing at least some circulation of blood. Inducing blood flow to the heart muscle can increase electrical activity in the heart, increasing the probability that a defibrillating shock will restore normal heart rhythm. Inducing blood flow to the brain can lengthen the time before irreversible brain injury is caused by the heart stoppage. Accordingly it is desirable for a CPR measurement system to provide a measure of blood flow to the brain in addition to lung inflation and deflation.
In accordance with the principles of the present invention an ultrasonic transducer pad is provided which is suitable for attachment on the neck above the carotid artery. The transducer pad includes a plurality of transducer elements exhibiting a triangular geometry. The triangular geometry of the elements improves the sensitivity of the transducers to carotid blood flow as it decreases the possibility that the carotid artery will be aligned with a kerf (space) between adjacent transducer elements. In use, a transducer pad of the present invention is attached over the carotid artery and used to sense the flow of blood in the carotid artery during the administration of CPR and/or in conjunction with patient assessment for defibrillation. One or more measures of blood flow are developed from the processing of the ultrasound signals which are used in the guidance of the administration of CPR or cardiac resuscitation.
In the drawings:
Referring first to
a is a side view of an example of transducers 1-5. In this example it is seen that the top transmitting surfaces 6 of the transducer elements are rounded. In this example the transducer elements are curved with a 25 mm radius of curvature. The rounding of the transmitting surfaces causes the emitted ultrasound to diverge and thereby insonify a greater area of the body, increasing the likelihood that a target vessel will be insonified and preventing any dead zones between the transducer elements. As an alternative to rounding the shape of the transducer a lens may be used above a flat emitting surface to cause the emitted ultrasound to diverge.
b shows electrical connections made to the transducers 1-5. The transmitting surfaces of the transducer elements which face the skin are covered with an electrode 22 which is grounded for safety. Individual electrodes 22 may be formed on the individual elements which are then electrically connected to the connector 20 by way of cable 18. Alternately the electrode 22 may be a continuous sheet of foil or other flexible, conductive material which covers groups or all of the transducer elements. The sides of the elements which face away from the skin surface have signal electrodes 24 on them. Conductors of cable 18 are connected to these electrodes 24 to provide transmit (drive) signals and return received echo signals from the transducer elements.
In accordance with the principles of the present invention, the transducer elements 1′-9′ of the sensor strip 10 have a triangular geometry as shown in
A triangular-shaped sensor strip as shown in
a shows one example of how the transducer elements of a transducer pair may be positioned in the matrix 12 for improved signal reception. A Doppler ultrasound signal is angle-dependent. When the angle between the direction of the ultrasound beam and the direction of blood flow is 90°, the Doppler signal is at a minimum, and is strongest when the direction of blood flow is directly toward or away from the transducer. Since vessels close to the skin surface 30 such as the carotid artery 32, which is at an average depth in the body of 20 mm, are approximately parallel to the skin surface, a transducer orientation which transmits ultrasound waves normal to the skin surface 30 will have an angle of incidence of approximately 90°to the direction of flow. To reduce the probability of this orthogonal beam-to-flow-direction orientation the transducer elements are inclined at a shallow angle as shown in
In the example of
The power Doppler signals are coupled to an analysis module 100, included in the CPR measurement subsystem 180, which can analyze the Doppler signals in various ways. In one example the multiplexer 44 selects the signal from a different receive transducer element every 10 msec as described in international patent application publication WO 2006/003606, the contents of which is incorporated herein by reference. The multiplexer first selects the signal from nearby transmit elements. After this first sampling period the multiplexer selects the signal from element R2. The multiplexer continues by selecting signals from elements R3, R4, and R5, then repeats the sequence. During this time the analysis module 100 is looking for a strong power Doppler signal which exceeds a given threshold, such as a predetermined noise level. A valid power Doppler signal is recognized as one which exceeds the threshold by a given signal to noise ratio. In this example the defibrillator system is sampling the power Doppler signals while CPR is performed on the patient. When the rescuer compresses the chest of the patient an amount of blood is forced out of the heart and the pressure wave will emanate through the vascular system, generally causing a pulsatile flow of blood in the carotid artery. The onset of this blood flow is detected during the polling sequence and, when recognized as a valid power Doppler signal by the analysis module, the multiplexer stops polling and continuously couples the valid Doppler signal to the system. In this example the valid Doppler signal is detected by receive transducer element R3 which is immediately above the carotid artery 32. The signals from receive element R3 are then continuously sampled by the system. The Doppler frequency fD of the valid signal indicates the flow velocity and the peak signal indicates the maximum instantaneous flow rate caused by the CPR.
The sampling sequence effected by the multiplexer 44 may exhibit any of a number of variations. For instance, if the analysis module senses a decline in the strength of the power Doppler signal from a selected receive element, the multiplexer may be controlled to begin sampling the signals from the receive elements on either side of the selected element to try to find a stronger signal at an adjacent receive element. If a stronger Doppler signal is not found at either of these adjacent transducer locations the multiplexer will return to sampling the signal from transducer element R3. If multiple processing channels are available in a given device, multiple transducer elements can be monitored simultaneously and the strongest Doppler signal used for analysis.
In addition to detecting velocity, the period of the Doppler waveform is sensed by detecting the recurring peak velocity over several chest compressions. The periodicity of this rate of recurrence indicates the rate of chest compressions during CPR. As a result of this analysis the rescuer is audibly and/or visually coached to administer CPR properly. For instance, a typical CPR protocol may call for the rescuer to administer 15 compressions at the rate of 100 compressions per minute. If the rate of recurrence sensed by the analysis module is less than this desired rate the analysis module will apply a signal to an audio synthesizer 102 or the display screen to issue a verbal “press faster” instruction. The audio synthesizer will produce an audio signal which is amplified by an amplifier 104 and applied to a loudspeaker 106 which audibly instructs the rescuer to “press faster.” The analysis module will also compare the peak velocity of blood flow during the compressions to a desired minimum blood flow velocity to be attained by each chest compression. For instance a typical peak velocity value is about 1 m/sec. The reference used by the analysis module may be less than this nominal rate and if the desired reference velocity is not being attained the analysis module can issue a “press harder” command through the audio synthesizer and loudspeaker of the user interface 164. A visual display such as a row of LEDs or a graphical display can illustrate visually the strength of the flow signal in absolute or relative terms and/or the position along the row of transducer sensors where the strongest flow signal has been detected.
In addition to detecting the peak velocity and period of the Doppler waves the analysis module may produce other measures of the sufficiency of the blood flow caused by the CPR compressions, such as mean velocity, volume flow rate, pulsation index, and flow index as described in international patent application publication WO 2006/030354, the contents of which is hereby incorporated by reference.
The systems of
Doppler flow signals. For instance, each occurrence of a compression signal should correlate in time with the sensing of a valid Doppler flow signal by the sensor strip 10. Thus, the compression signal can be used to time gate the analysis of the Doppler signal or to correlate and confirm the rate of compression periodicity sensed by the analysis module. The ECG signal, when present, can also be used as a time gate. The amplitude of the force or twice-integrated acceleration signal is a measure of the compressive force or compression depth of the applied compression and can be used in deciding whether to issue a “press harder” or “press softer” command. For instance, while a low flow velocity or volume flow rate may indicate that the rescuer should press harder, the compression signal may show that the rescuer is already pressing as hard or as deep as is safely done on a patient. The analysis module may then withhold the “press harder” command in consideration of this compression information.
The system of
ECG, impedance module 96 and coupled to the analysis module where they may be used to assist in CPR coaching. For instance, as explained in the '671 patent, the impedance signal will exhibit a change when the chest is compressed and again when the compressive force is relaxed. The times of occurrence of these impedance changes can be used to correlate with or time-gate the Doppler signal analysis to confirm or improve the detection of these signals and the appropriateness of CPR coaching commands.
Other variations of the sensor strip configuration will occur to those skilled in the art. For instance, it may be desirable to use different shaped transducer elements. For instance, the transmit elements could be rectangular and the receive elements triangular, or the reverse.
This is a continuation-in-part of pending U.S. patent application Ser. No. 12/085,133, filed May 15, 2008.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2010/050613 | 2/10/2010 | WO | 00 | 9/26/2011 |
Number | Date | Country | |
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61154844 | Feb 2009 | US |