|Publication number||USRE40471 E1|
|Application number||US 10/255,988|
|Publication date||Aug 26, 2008|
|Filing date||Sep 25, 2002|
|Priority date||Oct 29, 1998|
|Also published as||US6125299|
|Publication number||10255988, 255988, US RE40471 E1, US RE40471E1, US-E1-RE40471, USRE40471 E1, USRE40471E1|
|Inventors||Allen W. Groenke, James E. Brewer|
|Original Assignee||Cardiac Science, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (66), Referenced by (11), Classifications (14), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present invention relates to devices useful for assisting in the administration of cardiopulmonary resuscitation (CPR). More particularly, the present invention relates to a sensor for being disposed on the body of a victim to measure parameters related to the CPR.
CPR is a technique used by a rescuer in an emergency situation to get oxygen into a victims blood when that persons heart has stopped beating and/or they are not breathing spontaneously. When performing CPR the rescuer creates blood circulation in the victims body by periodically compressing the victims chest.
The American Heart Association (AHA) recommends that the rescuer press down on the sternum with a force sufficient to depress it between 4 and 5 cm. The recommended rate for these periodic depressions is 100 times a minute (ILCOR Advisory Statement for Single-Rescuer Adult Basic Life Support). Chest compressions produce blood circulation as the result of a generalized increase in intrathoracic pressure and/or direct compression of the heart. The guidelines state “Blood circulated to the lungs by chest compressions will likely receive enough oxygen to maintain life when the compressions are accompanied by properly performed rescue breathing.” A victim can be kept alive using CPR provided the rescuer(s) are able to continue delivering properly performed chest compressions and rescue breaths.
Administering chest compressions and rescue breaths is a very physically demanding task. The quality of chest compressions and rescue breaths delivered can degrade as rescuers become fatigued. When a rescuer is fatigued they may not realize that they are compressing the chest with inadequate force.
Administering CPR is a very physically demanding procedure which is performed under stressful (i.e. life and death) circumstances. Under these circumstances, the rescuer is given the difficult tasks of estimating the time between compression's, and the distance which the chest is being compressed. Much of the difficulty in estimating the distance which the chest is being compressed stems from the relative position of the rescuer and the victim. When performing chest compression's, the rescuer positions his or her shoulders directly above the victim's chest, and pushes straight down on the sternum. In this position, the rescuer's line of sight is straight down at the victim's chest. With this line of sight, the rescuer has no visual reference point to use as a basis for estimating the distance that he or she is compressing the chest.
For this reason, there is a need in the art for a practical device which provides the rescuer with feedback to indicate that the rescuer is using proper compression force and that the rate of compressions is correct. A device of this type will provide rescuers with coaching which will enable them to deliver chest compressions consistently and beneficently. To be practical, this device should be one which is already at the rescue scene so that the rescuer is not required to bring an additional piece of equipment to the scene.
Because AEDs are being widely deployed, they are often present at a rescue scene. Prior art AEDs are only capable of defibrillation. There is a need in the industry for an AED which is capable of aiding a rescuer in administering proper chest compressions to a victim.
The present invention is an AED which is capable of detecting when a rescuer is performing CPR on a victim. This AED is also capable of providing a rescuer with helpful voice prompts to coach them through a CPR procedure. Rescuers who are trained in the use of AEDs are also trained in cardiopulmonary resuscitation (CPR) and will be able to make ready use of the AED of the present invention. AEDs are presently being widely deployed, and they are often on the scene when CPR is administered.
The present invention substantially meets the aforementioned needs. The present invention provides a sensor for sensing both the force applied to the victim's chest and the frequency with which the compressions are applied in order to assist a rescuer in resuscitating a stricken victim. Feedback, preferably by means of voice prompts, is provided to the rescuer by an emergency electronic device in communication with the sensor in order to optimally time the administration of chest compressions and to deliver a chest compression that provides an optimal amount of compression of the chest.
The present invention is a force sensor, for use in combination with an automated electronic defibrillator (AED), includes a first conductive layer. A second conductive layer is spaced apart from the first conductive layer such that no electrical communication occurs between the first and second conductive layers. Electrical communication means are provided for establishing an electrical communication path between the first and second conductive layers responsive to the application of a force to said electrical communication means.
The present invention includes a method of prompting a rescuer in the application of cardiopulmonary resuscitation to a victim having the steps of:
An AED is shown generally at 22 in FIG. 1. AED 22 is used for emergency treatment of victims of cardiac arrest and is typically used by first responders. AED 22 automatically analyzes a patient's cardiac electrical signal and advises the user to shock a patient upon detection of (1) ventricular fibrillation; (2) ventricular tachycardia; (3) other cardiac rhythms with ventricular rates exceeding 180 beats per minute and having amplitudes of at lease least 0.15 millivolts. When such a condition is detected, AED 22 will build up an electrical charge for delivery to the patient to defibrillate the patient with a defibrillation shock. The operator of AED 22 is guided by voice prompts and an illuminated rescue (shock) button. Olson, et al. U.S. Pat. No. 5,645,571, incorporated herein by reference, discloses the general construction and manner of use of an AED.
AED 22 includes case 12 with carrying handle 14 and battery 80, the battery 80 being removably disposed within a battery compartment (not shown) defined in case 12. Battery 80 functions as an energy source for AED 22. Visual maintenance indicator 20 and data access door 44 are located on the outside of case 12 to facilitate access by the operator. A data communication serial port 42 is situated behind data access door 44. Case 12 also includes panel 24 and electrode compartment 26 defined in a top portion thereof. Panel 24 includes illuminable rescue switch 18 and diagnostic display panel 36 with “electrodes” indicator light 28. Panel 24 and electrode compartment 26 are enclosed by selectively closeable lid 27.
Electrode compartment 26 contains connector 32 and electrode package 60. Electrode compartment 26 hermetically encloses a patient interface which includes a pair of electrodes 50 depicted in
AED 22 also includes a digital microprocessor-based electrical control system (see the block diagram of
To insure operable electrodes 50, an electrode self-test is conducted (e.g., daily or upon opening lid 27) in which the interconnection and operability of electrodes 50 are checked with the impedance measuring circuit. If electrodes 50 are missing or unplugged from connector 32, if electrodes 50 are damaged, or if the conductive hydrogel adhesive on electrodes 50 is too dry, the control system of AED 22 will illuminate “Electrodes” indicator light 28 on diagnostic display panel 36.
Defibrillator 22 also includes electrocardiogram (EKG) filter and amplifier 104 which is connected between electrode connector 32 and A/D converter 102. The EKG or cardiac rhythm of the patient is processed by filter and amplifier 104 in a conventional manner, and digitized by A/D converter 102 before being coupled to processor 74.
The rescue mode operation of defibrillator 22 is initiated when an operator opens lid 27 to access the electrode package 60. The opening of the lid 27 is detected by lid switch 90, which effectively functions as an on/off switch. In response to this action, power control circuit 88 activates power generation circuit 84 and initiates rescue mode operation of processor 74. Processor 74 then begins its rescue mode operation and initiates the generation of an audible voice prompt “To attempt a rescue, disconnect charger.” if a charger is connected when lid 27 is opened.
If the lid-opened self-test is successfully completed, processor 74 initiates the generation of an audible “Place electrodes.” voice prompt. In response to this voice prompt, and following the instructions on the inside of lid 27, the operator should remove electrode package 60 from compartment 26, open the package, peel electrodes 50 from the release liner and place the electrodes on the patient's chest. While this action is being performed, processor 74 monitors the impedance signals received through A/D converter 102 to determine whether the impedance across the electrodes indicates that they have been properly positioned on the patient. If the correct impedance is not measured, processor 74 initiates the generation of a “Check electrodes.” voice prompt.
After detecting an impedance indicating the proper placement of electrodes 50, and without further action by the operator (i.e., automatically), processor 74 begins a first analyze sequence by initiating the generation of a “Do not touch patient. Analyzing rhythm.” voice prompt, and analyzing the patient's cardiac rhythm. In one embodiment, processor 74 collects and analyzes a nine second segment of the patient's cardiac rhythm. The cardiac rhythm analysis program executed by processor 74 is stored in program memory 76. Algorithms of the type implemented by the rhythm analysis program are generally known and disclosed, for example, in the W. A. Tacker Jr. book Defibrillation of the Heart, 1994. If the processor 74 determines that the patient has a nonshockable cardiac rhythm that is not susceptible to treatment by defibrillation pulses (e.g., no pulse rather than a fibrillating rhythm), it initiates the generation of a “Check pulse. If no pulse, give CPR.” voice prompt. One minute after this voice prompt, processor 74 repeats the initiation of the “Do not touch patient. Analyzing rhythm.” voice prompt and the associated cardiac rhythm analysis.
When a shockable cardiac rhythm is detected, processor 74 begins a first charge sequence by initiating the generation of a “Charging.” voice prompt, and causes high voltage generation circuit 86 to operate in the charge mode. When the high voltage generation circuit 86 is charged, processor 74 begins a first shock sequence by initiating the generation of a “Stand clear. Push flashing button to rescue.” voice prompt, and the flashing illumination of rescue switch 18. The operator actuation of rescue switch 18 will then cause processor 74 to operate high voltage generation circuit 86 in the discharge mode, and results in the application of a defibrillation pulse to the patient to complete the first series of analyze/charge/shock sequences. In one embodiment, the first defibrillation pulse delivered by defibrillator 22 has an energy content of about two hundred joules.
Following the first series of analyze/charge/shock sequences, processor 74 times out a short pause of about five seconds to allow the heart to reestablish its cardiac rhythm before beginning a second series of analyze/charge/shock sequences. The second series of analyze/charge/shock sequences is identical to the first series described above, except the energy content of the defibrillation pulse can be about two hundred joules or three hundred joules. If the second series of analyze/charge/shock sequences ends with the delivery of a defibrillation pulse, processor 74 again times out a short pause of about five seconds before beginning a third analyze/charge/shock sequence. The third series is also identical to the first series, but processor 74 controls the high voltage generation circuit 86 in such a manner as to cause the defibrillation pulse delivered upon the actuation of the rescue switch 18 to have an energy content of about three hundred and sixty joules.
Following the delivery of a defibrillation pulse at the end of the third series of analyze/charge/shock sequences, or after identifying a nonshockable cardiac rhythm, processor 74 initiates the generation of a “Check Pulse. If no pulse, give CPR.” voice prompt. Processor 74 then times a one minute CPR period to complete a first set of three series of analyze/charge/shock sequences. Rescue mode operation then continues with additional sets of three series of analyze/charge/shock sequences of the type described above (all with three hundred and sixty joule pulses). Processor 74 ends rescue mode operation of defibrillator 22 when a total of nine series of analyze/charge/shock sequences have been performed, or lid 27 is closed.
Throughout the analyze, charge and shock sequences, processor 74 monitors the impedance present across connector 32 to determine whether electrodes 50 remain properly positioned on the patient. If the monitored impedance is out of range (e.g., too high if the electrodes have come off the patient, or too low is shortened), processor 74 initiates the generation of a “Check Electrodes.” voice prompt, and causes high voltage generation circuit 86 to discharge any charge that may be present through internal load 98. Rescue mode operation will resume when processor 74 determines that the electrodes have been properly repositioned on the patient.
Insulated lead wire 52 is terminated with a wire terminal 1 70. Wire terminal 1 70 is electrically connected to conductive portion 56 via conductive rivet 1 74 and washer 1 72. Conductive rivet 1 74 is covered on a first side with insulating disk 1 76. Conductive rivet 1 74, washer 1 72, and wire terminal 1 70 are all covered on a second side with insulating pad 1 78. Further examples of electrode pad construction for use with AED 22 are described and shown in U.S. Pat. Nos. 5,697,955, 5,579,919, and 5,402,884, all hereby incorporated by reference.
For example, referring to
The conductive layer 315 is shown to be disposed on the first or patient side of base layer 314. It functions to transfer (disperse) current or voltage from the lead 316 (or to the lead in a sensing application) to the patient contact layer 317. Although the conductive layer 315 is shown to have a surface area which is smaller than that of the base layer 314 or contact layer 317, it may alternatively have a dimension which is larger than that shown, or even on which is coextensive with the base and contact layers 314 and 317. The conductive layer 315 is preferably a homogeneous, solid, thinly deposited metallic substance, or a conductive ink material. Alternatively, the conductive layer 315 may be formed of a flexible mesh material, a conductive adhesive or a deposited ink pattern. Flexible conductive ink compounds known in the art have a conductive filler of Gold, Silver, Aluminum or other conductive materials.
The lead 316 is preferably an insulated wire conductor which extends from a mating point with the conductive layer 315, through the base layer 314, and then has a freely movable end. Various alternatives of this lead 316 design exist and are useable consistent with the general teachings of the invention, including but not limited to uninsulated wire conductors and conductive strips or traces deposited between the contact layer 317 and the base 314 or conductive layers 315. Such a trace or strip may also extend just beyond the base layer 314 for connection with an ancillary connection means such as a wiring harness including conductive clip means.
The conductive contact layer 317 is preferably a thin layer of semi-liquid gel material. The gel maintains direct electrical contact with the skin, to reduce variations in conductance, and it permits such contact for long periods of time. The gel is a conductive, gelatinous compound which is also flexible for contoured adhesion to the body of a patient. The gel also preferably has a pressure sensitive, moisture resistant adhesive property. Compounds having these characteristics have been developed by Minnesota Mining and Manufacturing, Medtronic, and Lec Tec (Synkara TM), Corporations, all of Minnesota, U.S.A. Generally, these compounds have low resistivities. The contact layer 317 is for direct contact with the patient's body to transfer current or voltage thereto or therefrom. Overall, although the electrode 311 and its constituent elements are shown to have circular configurations, they may alternatively be formed in various other shapes such as rectangular or square patches.
The package structure 312 is shown to have an envelope-like structure formed of a substantially continuous thin, homogeneous layer 318 of a polymeric, preferably non-gas permeable, material. Alternatively, as shown in
The package further comprises a pair of conductive connectors 319 and 320 which are separated a predetermined distance from one another for contact with separate areas of the contact layer 317 of the enclosed electrode 311. The connectors 319 and 320 are conductive areas which are shown to have a unitary construction with the package layer 318. The contacts 319 and 320 may alternatively be formed of thin layer strips of conductive material, or a printed conductive ink, disposed on the interior side of the package layer 318, extending from contact nodes to peripheral contact areas on the exterior of the package 318. Yet another snap-type embodiment 379 is shown in
In the case of the electrode system 310, a current loop is formed including the connector 319, the gel of the contact layer 317 (along a substantially horizontal plane), and the connector 320 which is located at a remote location on the contact layer 314 with respect to the connector 319. Current conducts easily in fresh, semi-liquid gel of the contact layer 317. In contrast, no current conducts, or current conduction is attenuated, in stale, dried gel. This is indicative of the need to dispose of the stored electrode without using it. And, this condition is determinable without the need to open the package 312 and thereby risk compromising the freshness or sterility of a viable electrode 311.
The package 366 is shown to have at least one body layer 371 which is coupled to the electrode 365 base layer 367 at tear-away perforated lines 373. A connector 372 is shown disposed for contact with the electrode 365 gel layer 370. In a test mode, a current loop is formed between the connector 372, the gel layer 370, and the connector members 368 and 369.
The package is shown to have a pair of layers 399 and 400 which overlap to form an interior cavity 407 and area sealingly connected at their peripheries 408. In a test mode, a current loop is formed between the lead 404, the gel layer 402 and the test strip 403, which like the lead 404 is shown extended through the package periphery 408 for contact with an external test apparatus.
In a test mode, a current loop is formed between, for example, a lead 432, a gel layer 431, the resistive layer 437, and the remaining gel layer 434 and lead 435. The circuit can be altered to include the lead 439.
Power generation circuit 84 is also connected to lid switch 90, watch dog timer 92, real time clock 79 and processor 74. Lid switch 90 is a magnetic read relay switch in one embodiment, and provides signals to processor 74 indicating whether lid 27 is open or closed. Data communication port 42 is coupled to processor 74 for two-way serial data transfer using an RS-232 protocol. Rescue switch 18, maintenance indicator 20, the indicator lights of diagnostic display panel 36, the voice circuit 94 and piezoelectric audible alarm 96 are also connected to processor 74. Voice circuit 94 is connected to speaker 34. In response to voice prompt control signals from processor 74, circuit 94 and speaker 34 generate audible voice prompts for consideration by a rescuer.
High voltage generation circuit 86 is also connected to and controlled by processor 74. Circuits such as high voltage generation circuit 86 are generally known, and disclosed, for example, in the commonly assigned Persson et al. U.S. Pat. No. 5,405,361, which is hereby incorporated by reference. In response to charge control signals provided by processor 74, high voltage generation circuit 86 is operated in a charge mode during which one set of semiconductor switches (not separately shown) cause a plurality of capacitors (also not shown), to be charged in parallel to the 12V potential supplied by power generation circuit 84. Once charged, and in response to discharge control signals provided by processor 74, high voltage generation circuit 86 is operated in a discharge mode during which the capacitors are discharged in series by another set of semiconductor switches (not separately shown) to produce the high voltage defibrillation pulses. The defibrillation pulses are applied to the patient by electrodes 50 through connector 32 connected to the high voltage generation circuit 86.
Impedance measuring circuit 100 is connected to both connector 32 and real time clock 79. Impedance measuring circuit 100 is interfaced to processor 74 through analog-to-digital (A/D) converter 102. Impedance measuring circuit 100 receives a clock signal having a predetermined magnitude from clock 79, and applies the signal to electrodes 50 through connector 32. The magnitude of the clock signal received back from electrodes 50 through connector 32 is monitored by impedance measuring circuit 100. An impedance signal representative of the impedance present across electrodes 50 is then generated by circuit 100 as a function of the ratio of the magnitudes of the applied and received clock signals (i.e., the attenuation of the applied signal).
For example, if electrodes 50 within an unopened package 60 are connected by lead wires 52 and connector 58 is properly connected to connector 32 on AED 22, a relatively low resistance (e.g., less than about 10 ohms) is present across electrodes 50. If the hydrogel adhesive 54 on electrodes 50 is too dry, or the electrodes 50 are not properly positioned on the patient, a relatively high resistance (e.g., greater than about two hundred fifty ohms) will be present across the electrodes 50. The resistance across electrodes 50 will then be between about twenty-five and two hundred fifty ohms when fresh electrodes 50 are properly positioned on the patient with good electrical contacts. It should be noted that these resistance values are given as exemplary ranges and are not meant to be absolute ranges. The impedance signal representative of the impedance measured by circuit 100 is digitized by A/D converter 102 and provided to processor 74.
Impedance measuring circuit 110 is connected to connector 32 and real time clock 79, and is interfaced to processor 74 through analog-to-digital (A/D) converter 102. Impedance measuring circuit 110 receives a clock signal having a predetermined magnitude from clock 79, and applies the signal to force sensor 200 through connector 32. The magnitude of the clock signal received back from force sensor 200 through connector 32 is monitored by impedance measuring circuit 110. An impedance signal representative of the impedance present across force sensor 200 is then generated by circuit 110 as a function of the ratio of the magnitudes of the applied and received clock signals (i.e., the attenuation of the applied signal). The impedance signal representative of the impedance measured by circuit 110 is digitized by A/D converter 102 and provided to processor 74.
Electrode 50A is shown applied to the upper right chest of torso 98. Electrode 50A is electrically connected to lead wire 52A. Electrode 50B is applied to the lower left side of torso 98 and is electrically connected to lead wire 52B. Lead wires 52A, 52B, 52C, and 52D are terminated with connector 58. Connector 58 is adapted to make releasable, electrical contact with connector 32 of AED 22.
Those skilled in the art will readily recognize that electrodes 50A, 50B and force sensing pad 102 may be placed in locations on torso 98 other than those shown in
Substrate 202 includes apertures 208. Conductive pads 206A and 206B are situated on each side of substrate 202 as shown in FIG. 8. Conductive pads 206A, 206B are preferably made of a deformable, conductive material. Materials which have been found suitable include conductive silicone rubber, conductive foam rubber, and conductive urethane rubber.
Referring now to both FIG. 9 and
Those with skill in the art will recognize that other methods may be used to attach lead wires 222A, 222B to conductive traces 212A, 212B. Possible methods include soldering, the use of a connector designed to mate with flexible circuits, and the use of conductive adhesive.
When pressure is applied to force sensor 200, conductive pads 206A, 206B extrude through apertures 208. When pads 206A, 206B contact each other, they complete an electrical circuit between conductive layer 204A and conductive layer 204B. Increasing the force F applied to force sensor 200 increases the surface area of the electrical connection between conductive pads 206A, 206B, thereby decreasing the electrical resistance between pads 206A, 206B. The electrical resistance of the circuit between conductive layer 204A and conductive layer 204B is therefore indicative of the magnitude of the force F applied to force sensor 200.
Force sensor 200 includes second substrate 226. A conductive pattern 228 is situated on second substrate 226. Second substrate 226 is situated on first substrate 222. First substrate 222 and second substrate 226 may be held together with a layer of pressure sensitive adhesive (not shown).
Substrate 222 includes apertures 230. A conductive pad 232 is situated on, and makes electrical contact with conductive pattern 224 as shown in FIG. 14. Conductive pad 232 is preferably made of a deformable, conductive material. Materials which have been found suitable include conductive silicone rubber, conductive foam rubber, and conductive urethane rubber.
When a force F is applied to force sensor 200, conductive pad 232 extrudes through apertures 230. When conductive pad 232 contacts conductive pattern 228 it completes an electrical circuit between conductive pattern 224 and conductive pattern 228. Increasing the force F applied to force sensor 200 increases the surface area of the electrical connection between conductive pads 232 and conductive pattern 228, thereby reducing the electrical resistance between pad 232 and pattern 228. Accordingly, change in contact area creates a change in electrical resistance which is indicative of the force applied to force sensor 200.
Force sensor 200 includes second substrate 246 which includes apertures 250. Second substrate 246 is comprised of a non-conductive material. Polyester, polyethylene, and polypropylene have been found to be suitable materials for second substrate 246. A conductive pad 252 is situated on second substrate 246. As in the previous embodiments, conductive pad 232 is preferably made of a deformable, conductive material.
FIG 18 is a plan view illustrating second substrate 246 and apertures 250.
When pressure is applied to force sensor 200, conductive pad 252 extrudes through apparatus 250. When conductive pad 252 contacts conductive patterns 244A, 244B it completes an electrical circuit between conductive pattern 244A and conductive pattern 244B. Increasing the force applied to force sensor 200 increases the surface area of the electrical connection between conductive pad 252 and conductive patterns 244A, 244B. This change in contact area creates a change in electrical resistance which is indicative of the force applied to force sensor 200.
Processor 74 compares the measured rate of chest compressions to a range of desired values.
If the current chest compression rate value delivered by the rescuer is less than the desired range, processor 74 will produce a control signal which causes voice circuit 94 and speaker 34 to generate an appropriate voice prompt such as “faster”. If the current chest compression rate value is greater than the desired range, processor 74 will produce a control signal which causes voice circuit 94 and speaker 34 to generate an appropriate voice prompt such as “slower”.
Processor 74 also compares the measured chest compression force to a range of desired values. If the chest compression force delivered by the rescuer is less than the desired range, processor 74 will produce a control signal which causes voice circuit 94 and speaker 34 to generate an appropriate voice prompt such as “harder”. If the chest compression force is greater than the desired range, processor will produce a control signal which causes voice circuit 94 and speaker 34 to generate an appropriate voice prompt such as “softer”.
AED 22 may also provide other types of audible feedback to the rescuer. For example, AED 22 may give an audible signal each time the force measured using force sensor 200 reaches a desired value.
The present invention may be embodied in other specific forms without departing from the spirit of the essential attributes thereof. Therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.
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|U.S. Classification||607/6, 607/3, 600/16, 607/5|
|International Classification||A61N1/39, A61H31/00|
|Cooperative Classification||A61H2201/5007, A61H2201/5061, A61H2201/5043, A61H31/007, A61N1/3925, A61H2201/5048|
|European Classification||A61H31/00H6, A61N1/39C|
|Sep 25, 2006||AS||Assignment|
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