External defibrillator with CPR prompts and ACLS prompts and...

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Reexamination Certificate

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Reexamination Certificate

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06356785

ABSTRACT:

FIELD OF THE INVENTION
This invention relates generally to a defibrillator with a built-in cardiopulmonary resuscitation (“CPR”) prompt system. This invention also relates generally to a defibrillator with a built-in Advanced Cardiac Life Support (“ACLS”) prompt system. Defibrillators include, manual defibrillators, automatic or semi-automatic external defibrillators (referred to collectively as “AEDs”) and defibrillator trainers.
DESCRIPTION OF THE PRIOR ART
Each day thousands of Americans are victims of cardiac emergencies. Cardiac emergencies typically strike without warning, oftentimes striking people with no history of heart disease. Because of the potentially life threatening nature of cardiac emergencies, it is imperative that victims receive immediate care to prevent permanent damage to the brain or, worse yet, death. Cardiac emergencies include: acute myocardial infarction (commonly referred to as “heart attacks”); bradycardia; tachycardia; hypotension and pulmonary edema; ventricular fibrillation (“VF”) and ventricular tachycardia (“VT”); pulseless electrical activity (“PEA”); and asystole. Each cardiac emergency has its own treatment protocol which is determined by the specific symptoms manifested by the victim.
One of the most common cardiac emergencies is sudden cardiac arrest (“SCA”). It is estimated that more than 1000 people per day are victims of sudden cardiac arrest in the United States alone.
SCA occurs when the heart stops pumping blood. Usually SCA is due to abnormal electrical activity in the heart, resulting in an abnormal rhythm (arrhythmia). One such abnormal rhythm, VF, is caused by abnormal and very fast electrical activity in the heart. During VF the heart cannot pump blood effectively. VF may be treated by applying an electric shock to the patient's heart through the use of a defibrillator. The shock clears the heart of the abnormal electrical activity (in a process called “defibrillation”) by depolarizing a critical mass of myocardial cells to allow spontaneous organized myocardial depolarization to resume.
Another abnormal rhythm, treatable by defibrillation, is pulseless VT (“shockable VT”). Shockable VT consists of three consecutive QRS complexes originating from the ventricles and recurring at a rapid rate (over 100 beats/minute). More detailed information about electrocardiography and the various types of heart rhythms may be obtained from Wagner “Marriott's Practical Electrocardiography,” 9th Ed. (1994).
It is important to note that not all abnormal heart rhythms are treatable by an electric shock. Several abnormal heart rhythms that are treated as a cardiac emergency require interventions other than defibrillation. However, it is possible for the nature of a cardiac emergency to change during the course of treatment. As a result a cardiac emergency initially having a heart rhythm that is not treatable by defibrillation may become a cardiac emergency where defibrillation is appropriate. Alternatively, a heart rhythm that is treatable by defibrillation may convert to a rhythm that is not treatable by defibrillation during the course of treatment. Accordingly, it is important to adapt the treatment protocol followed in administering care to a victim as the condition of the victim changes.
Even for the abnormal rhythms that are treatable by defibrillation, an electric shock does not always immediately restore a normal heart rhythm. Oftentimes, more than one shock is required.
Because blood may no longer be pumping effectively during a cardiac emergency, the chances of surviving decrease with time after the onset of the emergency. Brain damage can occur after the brain is deprived of oxygen for four to six minutes.
For SCA, if the initial defibrillation shocks are unsuccessful, CPR may be performed in order to keep oxygenated blood flowing to the brain. CPR may also be beneficial after a successful defibrillation shock when the post-shock heart rhythm does not pump a sufficient amount of blood. CPR can also prolong VF, thus maintaining a rhythm that can be analyzed and potentially defibrillated. Effective CPR may make the heart healthier for subsequent defibrillation in patients with VF.
Because quick response to a cardiac arrest is critically important, the American Heart Association (“AHA”) developed the “Chain of Survival” guidelines, which recite the following steps:
1. Early access to an emergency medical service (“EMS”), such as by activating an emergency response system (e.g. calling an ambulance or calling “911”);
2. Early CPR initiated by a bystander or other early caregiver to help the patient survive until more advanced care arrives;
3. Early defibrillation; and
4. Early application of Advanced Cardiac Life Support (“ACLS”), such as airway management, drugs, etc.
The benefits of this approach to survival are discussed in more detail in Cummins, et al. “Improving Survival from Sudden Cardiac Arrest: the ‘Chain of Survival’ Concept”
Circulation
83:1832-1847 (1991). With the exception of the defibrillation step (#3.), these guidelines are appropriate for treating victims of all cardiac emergencies, not just SCA.
CPR is a combination of artificial respiration (“rescue breathing,” of “expired air resuscitation”) and artificial circulation (“external cardiac compression” or “external chest compression”). Typically, if the patient is unconscious and is not breathing, but has a pulse, rescue breathing only is required. Whereas, if the patient is unconscious, is not breathing, and has no pulse, rescue breathing along with external cardiac compression is required.
Rescue breathing is performed by first clearing and opening the air passage. Once the airway is cleared, if the patient is still unable to breathe, the rescuer pinches the nose of the patient and slowly breathes into the mouth of the patient until the patient's chest rises. Additionally, a barrier mask, bag-valve mask, automatic transport ventilators (“ATVs”), or oxygen-powered, manually triggered devices may be used by the rescuer during rescue breathing in order to protect the rescuer from direct contact with the patient's bodily fluids. According to current AHA guidelines, the patient should be ventilated by rescue breathing twice before performing the remaining steps of CPR. Once the patient has been ventilated twice, the patient's pulse is checked. If a pulse is present, and the patient's breathing has not resumed on its own, then the rescue breathing procedure should be continued.
Typically with VF, the patient is unconscious, is not breathing and has no pulse. As a result, the patient requires rescue breathing combined with external chest compression.
The rate at which CPR is administered to a patient also depends upon the age of the patient. For example, under the AHA protocol, CPR is performed by administering a repeated sequence of fifteen compressions to two inflations for an initial period of one minute for an adult patient. The pulse and breathing are checked after each one minute interval. Up-to-date CPR protocols recommended by the AHA may be obtained from the AHA internet web site at www.amhrt.org.
The current standards recommended by the AHA for CPR are:
Make sure the scene is safe for help.
Make sure you have the universal precautions: gloves, pocket mask, etc.
Make sure you know how many patients you have.
Determine if they are conscious by tapping and shouting “Are you okay?”
If there is no response, have someone call 911.
Position the patient on their back.
Open the airway with a head-tilt, chin-lift or jaw-thrust maneuver.
Look-listen-and-feel for breaths. Check breathing for 5-10 seconds.
If they are not breathing, ventilate twice.
Check pulse for 10 seconds.
If there is no pulse, begin chest compressions and breathing at the following rate for one minute (depending upon the age of the patient):
Age of Patient
Compressions
Breaths
Infant (0-1 yr)
 5
1
Child (1-8 yrs)
 5
1
Adult (8+ yrs)
15
2
After one minute, recheck the pulse and repeat the compression/breathing cycle rechecking the pulse at one minute

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