GB2388323A

GB2388323A - Defibrillation System

Info

Publication number: GB2388323A
Application number: GB0319247A
Authority: GB
Inventors: James L Miller; James Daren Bledsoe; Helge Fossan; Arild J Eikefjord
Original assignee: Agilent Technologies Inc
Current assignee: Agilent Technologies Inc
Priority date: 1999-07-16
Filing date: 2000-07-14
Publication date: 2003-11-12
Anticipated expiration: 2020-07-14
Also published as: GB0319247D0; GB2388323B

Abstract

A defibrillation system (8) includes an automatic external defibrillator (10) and a supply module (14) containing pads (34) and battery means (32), the pads and the battery means having respective expiration dates and the supply module having an expiration date which is the earlier of said two expiration dates, electronic indicia being provided on the supply module (14) relating to its expiration date, and the external defibrillator (10) being configured to receive signals relating to the electronic indicia. The supply module (14) may be physically coupled to the defibrillator (see fig 10). Other items containable by the supply module include ECG leads, gloves, scissors, and PCMCIA cards. Memory (38) or other circuitry may be provided on the supply module (14) to communicate with the defibrillator prior to, during or after operation of the defibrillator to facilitate exchanges of information between the supply module, defibrillator, defibrillator operator and defibrillator maintenance personnel.

Description

] DEFIBRILLATIO?i SYSTE?I The Dresent invention relates enraiv to a

detibrillarion system and Lo a porabie external defibrillator with a replaceable supply mc dale and. more particularly to an accessory for a portable external defibrillator.

!O Sudden cardiac arrest is a disruption of the healt's functioning the; causes a lack of blood floNN, to vital organs. In a majority of instances, sudden cardiac arrest is manifested as an abnormal or chaotic heart rhythm, called fibrillation These instances are Generally identif;,ak]e by the victim's irrnediate loss o;puTse, loss of consciousness and a cessat,o; of breathing.

is Sudden cardiac arrest has been attributed to over >0.000 deaths each year in the United States, roaring it one of the couiltry's leading medical emergencies..'orld-N idle, sudden ca-ciac arrest has been attributed to a much larger number o1 deaths each N'ear. Sinless i.min diate medical intervention is initiated' sudden cardiac arrest can lead to death -within.-i matter of minutes. 20 There at e four critical components of medical treatment that must be adrniniste1 ed to a victim of sudden cardiac arrest: ( I) early access to emergency cafe; (2) early cardiopulmonary resuscitation to lineup the blood ox,vgeated and floNN into to the N,ictim's brain and other N ital organs; (I} early defibrillation (the application of an eiec-=ical shock to the hear t) to restore the heart's regular rhN, then; and (a) early access to advanced medical core. ashen a person is 2:> experiencing sudden cardiac arrest. the electrical ac.iN'ity wi kin the heart becomes chat tic..4.

elect. ic shock from a defibrillator can reorganize the electrical impulses to allow coordinated pumping action to. esume. 'Do d', niste1 this shock, special pads o.. a Remachine called a defibrillator are placed on the victim's chest, and an elect. ic shock is sent through the icti.m's body from one pad to another. As useci herein. the term ' pads" will inc!,ade both pads and 0 paddles.

If prompt cardiopulmonary resuscitation is folio\\ ed is,\! defibrillation u ithin about four .: sites. -he'tir.'s yes:-;-:cr.;'.!" v. = 'i-C c:'.'.t a-, at- e;c-i;: ?C?t PRO,'=t _'!'" 'St-^-i''.' v>,,,i 2.!?, t,j,' a\ j I; Ài -,,:,2,- iS:;-.-.,r-::

of the most important components of eme genc,v medical;Teatment for p, Dentin death from sudden cardiac arrest.

Since prornp defib.illa.io; is cri.icai to s';r-iN al, portable defibri l Ia.ors have beer.

developed that can be carried to the vicim's location to defibrillate the; ctim prior to reaching a 3 \CSnital. Also, fliers is Hi trend to place potable aefiDriiiators in a.eas or hospitals not Generally staffed with emergency personnel and in other public areas Nowhere difficult to reach patients are likely to be encountered, such as airplanes, airports, cruise liners, casinos. sports arenas and other populous facilities that are difficult or time cons-ning to access.

Automatic external defiblillators are tvpicall,Nt used rather infrequently. Indeed, it has JO been estimated that a defih'rilZator will typically riot be used more often than once every one to two y ears. To ensure that the defibrillator is operational, each conventional defibrillator periodically performs a test procedure to ensure the viability of its circuits. If any defect is detected. an alarm or other indication will be provided to the ONNrner/OperatQr of the defibrillator indicating that service is required. Optionally, the alarm may be communicated to a remote l: monitoring location oN'er a network, by telephone, etc. Various supplies are, excited to operate a defibrillator. TN pical]N:. au,onatic ex.ernai def brillators make use of either pre-co. nected or user attached self-adhesixe pads. A gel conductor is provided in the center of each self-adhesive pad to pTON ide a reliable contact between the victim's skin and wires cor.nec ed to Heads The gel on the pads may day over 20 time, reducing the effectiveness of the pads and limiting, the effective shelf-life of the pads to app. o>;imately torso \ears.

LilexA-ise, batteries provided to operate the defibrillator must be. en bat ge d or enlaced ihen depleted The shelf Jibe of a batten, depending on he barely chemistry, is typically around five clears.

5.\laintenance of a fleet of defib:illators is thus complicated by the numerous items necessary for Ortega ion Of ibe deft brillato, that must be moilito. ed in addition to monitoring the opera io.al status ofthe defibrilltc- itself.Ae-cGuin"l;, it oul.i be advantageous TO oroiae a ss, sten whereby the status of the defi-iliator and items associated Pi ith operation of the defibrillator could be monitored easily.

r - 3 The present invention relates to a defibrillation system that includes an automatic external defibrillator and a supply n odule containing items for use in connection with the automatic external defibrillator. The supply module may contain many items, including pads. EC:G 5 leads, gloves, CPR barrier masks, scissors, PCMCIA cards and batteries for the defibrillator, as Novell as any other components or supplies desired to be included by the operator or manufacturer. The supply module tropically is physically coupled to the defibrillator to ensure the availability of the items during operation of the defibrillator. Items within the supply module such as the battery and pads or the supply module itself may be electrically coupled to lo the defibrillator to reduce the amount of time required to deploy the defibrillator when responding to an emergency medical situation. In another aspect of the invention' the supply module may be provided with a visible or electronically readable indicia of the shelf life of the supply module or one or more items contained by the supply module. A memory or other circuitry may be provided on the supply module to communicate with the defibrillator prior to, 5 during or subsequent to operation of the defibrillator to facilitate exchanges of information between the supply module, defibrillator, defibrillator operator and defibrillator maintenance personnel. In one embodiment, a defibrillation system includes an external defibrillator and a replaceable supply module, including pads and a battery, mounted on the external defibrillator.

20 In this embodiment, the replaceable supply module may be physically or electrically connected to the external defibrillator The replaceable supply module may be a container \vith compartments to contain the pads and battery. The container may have a peelable top surface, and may be configured such that operation of the defibrillator is initiated by peeling the peelable top surface. I he replaceable supply module has an expiration date. which may be the earlier of > an expiration date of the pads and an expiration date of the battery. The expiration date may tal<e on many forms, such as visible indicia printed on an surface of the replaceable supply module, Of indicia in machine-readable form readable by the defibrillator. When the expiration date is in machine readable form, the defibrillator is able to monitor the expiration date and communicate information regarding the expiration date locally or remotely.

30 In another aspect, the defibrilla--or is configured to conduct a periodic test of the replaceable supply module in connection faith or separate from periodic self,ss. The results of

( - 4 the periodic tests of the replaceable supply module are communicated locally or remotely ho the defibrillator display or communication unit respectively. The den brillator may be configured to compare the expiration date of the supply module with the current date, and to issue at least one of an audible and visual warning indicating that the supply module has passed its expiration date s or is approaching its expiration date.

In another embodiment, the defibrillation system includes a defibrillator configured to monitor a supply 'nodule and a SUPP!Y module containing pads and a battery electrically connectable to the defibrillator. The supply module may also contain ECG leads, gloves, a CPR barrier mast:, a PCMCIA memory card, scissors and a memory. The memory is configured to lo store information for transmission from the supply module to the defibrillator, such as information related to the expiration date of the supply module, expiration dates of items contained by the supply module, training scenarios, codes necessary for operation of the defibrillator or software and algorithms usable by the den brillator during the defibrillation process. Likewise, the supply, module may contain a memory, : configured to store information : received from the defibrillator, such as ECG data, event data and audio data.

This invention is pointed out with particularity in the appended claims. The above and further advantages of this invention may be better understood by referring to the following 20 description taken in conjunction with the accompanying drawings, in which:

Figure I is perspective view of a defibrillator according to one embodiment of this nvcnton; Figure 2 is a perspective view of a module for use with the defibrillator of Figure 1; Figure 3 is a schematic block diagram ofthe nodule of Figure 2; and as Figure 4 is a functional block diagram of the defibrillator of Figure 1.

With reference to Figure 1, the present invention will now be described. A defibrillation system 8 includes an external defibrillator 10 having a supply module 14 so containing items for use in connection with the external defibrillator 10. As a battery-powered device the defbrila,or i O is high p ortable and therefore suitable fo. pre-hos?i Al Emery

J - - use. The supply module 14 n:ay be any container, holder, receptacle, vessel, box, carton or other de; ice able to contain, connect, retain, collect, or otherwise hold (collecLi\ely contain) items for use in Connection wish G?eration of tile defibrillator IO or items usable to operate line defibrillator 10. The supply module preferably is physically coupled to the defibrillator to ensure the a:ailahilih of the iten.s tar Nat OpJ3LaLlOrL e)L l'2Ji ucLiDriiiaor such as thy a socket 12.

A mechanical latch, magnet, cord or other device capable of physically couplir.g the supply module to the defibrillator may be used to retaira the supply module Ii within the socket 12. Optionally, the sup.p!y n. odule may be physically coupled to the defibrillator via an intermediary structure, such as by being retained in a pccl-et or other compam.ent of the id defibrillators carrying, case.

As shown in Figure 7' items containable by the supply module 14 include pads, FCG leads, loves, a CPP harrier rn.asl;, scissors! PCMCIA cards and batteries. as well as any other components or supplies desired to be included by the operator or manufacturer. The specific selection of components depends on the intended use of the supply module. The supply i. : module l 4 typically is formed from an outer shell 16 in which compar'nents AS are formed for recei\in the above items. Shell 15 is typically for.ied of a hard plastic. Tle downs 90 Within the storage comp2.rtment 18 can be used to retain securely Rae supp!ias within the compartments I8. The supply module 14 may be disposable, and discarded after use, or may be returned to the manufacturer for refurhishmer.t after lose or after e'; piFation.

JO The supply module 14 may be hermetically or otherwise sealed by a layer 92 to ensure the supplies remain fresh for as long as possible and to prevent the skeptics from Dainty contaminated. Layer 22 may be formed of plasfiC o other mate. ial and is adhered Or attached to the periphery of the supply module 14 to pros ide the desired seal. The Lander 2? is remo\,able, such as by, peelin,,, to allow access to the supplies. The layer 22 may be opaque ?5 or clear. One or more electrical connectors 24 may be formed throb, printed on or formed by the layer 22 such that upon removal of the layer 22 to access the contents of the supply module 1. the defThrillator In is aJtonnqrica71y Girded of:.

The supply module 1 A preferably, is electrica,lv intercormecied to the defibrillator 10 ia battery terminals 26, pad terrninais 28, chest electrode terminals 30, memory: terminals A,O : and anal other terminals necessary or desirable for electrically intercon.necti?.n.he sup;:; Cod le or i -us con i.ied vilnn We gal;!.!odle lo defies ilircr.0. As st:;:;; n in Figure

( - 6 4, battery terminals 96 provide an interco,rnecrion between the battery 32 in module 14 and defibrillator 10 Battery 32 supplies power to defibrillator I O. Pad terminals 28 provide an interconnection between the pads 3< and defibrillator IS and chest electrode terminals:0 provide an interconnection between the chest electrodes 36 and defibrillator IO. Where the s sunrlv m-od!e 1 is broiled I ' a.le'.y Ad, cvll-llluilicatioDeepen the memory 38 and the defibrillator 10 may tat-e 21ace over memory termirials SO Referring generally to Figure 4, sock-et i includes a plurality, of battery terminals 96 for attachment to the rechargeable Attic 32 Battery pack,2 preferably includes one or more Matte. ins capable of providing power to the defibrillator 10 for several hours of operation,A^5 JO illustrated, battery pack 39 is electrically coupled to high voltage charging circuit 42 via battery terminals 26 when the supply module 14 is coupled to the soviet 12 on the defibrillator!0 lJpon connection and on demand, battery 32 supplies charge to a large capacitor contained within high voltage charging circuit 49 utilized to store the large charge required to defibrillate a patient suffering from sudden cardiac arrest The high frontage charging circuit 42 is electrically corrected to a pair of pads 34 utilized to deliver a dcTibri]lating shock to the patient \:ia pad tee Finals 28 The delivery of the def bril]atinc shock is controlled by defibrillation control 46 Battery pack 32 is Filcher electrical':, coupled; ia battery terminal 96 to pouffe; supply 44, NNhich supplies pow er to the control and monitoring circuitry withir: the defibrillator l 3 Still referring to Figure 4, defibrillator 10 further includes eleciTocai-diogram (ECG) unit JO 4S, which controls the monitoring functions of the defibrillator 10 From the folIouinc description OI ECG unit 4S, those skilled in the art \;ill appreciate that the ECG uiiit 48 may be

imple;:ented utilizing a conventional microprocessor and Rapport circuitry, oi- altemstiN ely, an app'icatioil-specific integrrated circuit (ASIC) The ECG unit 48 receiN es ECG data from the patient through the chest electrodes 36 connected to the defibrillator O at chest electrode 25 terminals 0 The chest electrodes,6 are preferably disposable electrodes and are preferably coated tN,ith a conductive gel o establish a good electrical contact with the patient. The ECG data ecei\,ed from the patient is te.?^rariy buffered i. a.-l ACNE data offer within Fads tacit 'S and displayed in real-time to the ope,atcr of def brillator I O sA ith displa) device >0 The ECG data is A. eferablv display ad in the follow of a conventional ECG \ aN eforrn trace! and may be : displayed in cor junction with additional information extracted from The LCG d?., such as -h e Meatier. s ista.naneo.s pulse.a e

/ - 7 The supply module..ernorv,8 on the supply n10dule l?+ is corrected to the CC} unit 48 ia me.nor' terminal 40. The sumac module memory 38 may be colored to store information trans.rnitted from. the d fiblillator IS to the supply rmodie id, such as ECG data, audio data or other information relating to the sequence and timing of events occurrincr durin ?tion. of the eli77at<, Isis iOlrrmdLion can De used by a number of people, such as the defibrillator manufacturer in connection with deigning future defibrillator s, or by medical personnel awhile assessing the performance of the rescue team using the defibrillator. Ike su.ply module m l.lory 38 ma-- also be configured to store information for transmission to the defibrillator 0, such as soft are upgrades, codes, passwords or other indici required to ac.i.ate :0 circuitry on the defibrillator, expiration date infol-mation, or any other information necessary or desirable for proper operation of the defibrillator.

The sper ific type of rme.oy used on supply module 14 depends on the intended purpose ofthe supply module rnrnorv 3c' [fthe supply l-nodule memory 38 is to be lead only, ROI:1 may be used. RC)4 is preferable in this situation since it is possible to rnai;tai;1 info'nation in : ROM without connectir.o z source of elec'.ica] Corner to the ROM:,i here the merino:S is to be Heritable, as N7TCII as,adable, random access mle,.mo.) (RAM) may be used As is \;vell Anon, itAM must be refreshed Gr othe.:ise maintained by an external source of electrical power.

Accordir.crly, where R.4M is to be pro'idd, circuitry asso ia,c-d pith rewashing a:d o.her:ise maintaining the RAM using the batted 32 as a source of Owe.- should also be p, o;;ided 9 Op.io.lally. two types of memory may be pros ided: ROM neat, be used to store information for transmission to the defhril'ator and RAM ma;; he pro: ided.G receive ilf:'rmaion 1-rorn the defibrillator Tn this situation, else supply Adele I A may be confide such that the RN\: is only maintained after the defibrillator I O has i.ansmitted ir.'o.matioi to the suppler module memory:S lrn?lementation of the various types of memory is reel!.x.ithin the abilities of a 05 person of ordinally skill in the alp Optionally, the memo): within the supply: noodle cc,'!d comprise a PCMCI4 (19ersonai Coi.l?ute Memory Card Intemational Association) memory ca rr1 Supply; module menorv 38 ma; also be useful to disseminate software, algorithms and other irlrormation to deLb:-illators id For exarnpie, updated instructions relating to operation 9 of the defibrillator 10 or updated aiori-:hrns useful to anaiv.e l:(-G ''_:2.ol.Ns,.a,!a.ec i;-..-.i:l:.-. :i:!i ye....!.- i a-.: So''.r2C.]'.e t-> I F'Fei-2'rFllili"6 shelf jil-2

/ - 8 and chili eventually reed to be replaced, storin, software and alorithrns in the supply module memory 38 enables the software and algorithms used by each defibrillator in a fleet of defibrillatory to be updated without recalling the defibrillators or raquirincr a special instalIa,ion of the new programs or data to each defibrillator. Although several uses for the erode 5: nA'Nte been ^r!'r,., (kAlp....v.rr' Q I, ilk. '.l.e.u;',cc c:, cilia, Clay DO used for additional tasks as Novell. Transfer of information: betN;;=en the defibrillator and the supply module memory 8 may be performed using any lmoitn protocol ECG unit 48 is Usher coupled to user controls 52,:4, such as a;'marK'' button 59 which is depressed by an operator to store ECG data of interest within defibrillator memory:>G.

10 Optionally, this information may be stored in supply module memory 38 as weld Indeed, any information stored within defibrillator memory:6 may optionally be stored within supply module memo y 3S. During, treatment of a patient, the operator tropically utilizes mark button: to record segments of ECG data sensed before and after Me admiristration of drugs, the delivery of shocks, and other major treatment events. The collection of ECG data segments stored in rr.emory 56 by the operator during treatment of a patient! known? as a ' code" summary, can be

printed by the cooperator of defibrillator 10 on thermal prirllcr AS by depressing review button 54.

In addition, the ECC. unit 48 could sio.e ail of tile patient's c.C(] Dada sensed during t eatment within memory 56 in conjunction with a list of walked ever Is for later use. NItematively, ECG unit 48 could automatically repark events pTeseleced by the orator. such as the delivery of 0 shocks.

The F,C'G unit 48 is further coupled to an audio recording and p]aN'Dac, unit 60 that receives audio 'input from a microphone 62 and presents audio QUt7'2t;Q the operator of defb.i]lator 10 through a smellier 64 In response to user input v ia Castro]:.:4, the audio recordings and p] aybaci; unit 60 sense audio data via microphone 6:, digitizes the audio data, and stores the audio data within the memo::6. As will be app. eciated by those sl-il]ed in the art, he audio da,a can be compressed A. lo: to storage utilizing an: Of a number of well-knoNsn data comnfescion a!'nr!-h-rnc i:? o.6ei- t^ iii.rti...iZe the size o.-ne-.??.,.;:!equi-c-d to store the ?.]CiO data. The audio data may be stored!rhin the memory -6 ii? association;:i.h the EC:G data reCC!red ii? response to the same depression o'the mark bunion:0 The auc'io data may also be JO stored by audio reco.ding and playback unit 60 on magnetic take. such as adic1 c User e --i o c.sel t,-

/ To facilitate the memory 56, memory 56 prefe.ab] comprises a r e nofable and pot table data storage device, such As a PCMCIA memor:'c-d howc; :er, the rnemrN >.6 can aliernati:el: be implemented as a nonremovable memo.,. In addition, the defibrillator IO preferably includes an inCa. ed serial port or other data cownunication means (not illustrated) to enable the contents 5 of Remount.6 to be directly downloaded to a compate.r for review Anal!x sis.

As indicated above, items contained in the suppl,N' module I; have predetermined shelf lives. To facilitate monitoring the rernailng shel'life of the items, the supply module 14 is itself provided with a shelf life. The shelf life of the suppler module 44 or the contained items may be printed on an outer surface of the supply module 14 to enable an operator or lO maintenance personnel to determine whether the items contained within the suppl-N! module I! hence expired In another aspect of the invention electronic indicia may be pros ided on the supply module 14 to enable the defibrillator iO lo sense impending or actual expiration of the suppiv module 14. The electronic indicia may be contained villain supply module memory US, in a is separate memory on the supply module. or in an electronic circuit. When the supply module 14 is provided with electronic indicia the defibrillator 10 may he cort!cu-ed to receive signals relating to the electronic indicia and Use the signals Prince periodic self tests or upon sty, t up to ascertain whether the expiration date on the supply module 14 has passed. If so, the defibrillator may issue an audible or Visual Narnir.g indicating that the supply module needs to JO be replaced. The warning may be communicated usin, a corrnunication unit 66 corrected to a cellular or land-based telephone network, or any other network-. too enable one or tito tray communication between the defibrillator 10 and a central station or other resource. The central station can then dispatch a repair technician OF others ise order a Dent suppler module for the defibrillator.

as The corrnurlication unit 66 may be used Dy the defibrillator 10 prior, during or subsequent to defibrillation. For example, the defibrrl!=tor 15 could corrununicate faith the central station the result of a periodic self test including the stands of the spp!! module 'lo, prior to defibrillation. L)uring defibrillation, the d_fib,illator 10 could cornrnuraicate the ECG waNefoln data to a doctor at the central station 10 to receiNe more adNanced medical advice.

JO Finally!, after defibrillation, the code surnmar:,' or other information may be communicated tO the en,!l sea ion over c?nlunic-t.o.unit 66.

- lO In a farther aspect of the invention, module IA may be a training supply module containing items useful for operation of the defibrillator during trainir.. The training supply module preferably is similar to the supply module so that the person operating the defibrillator during the training session experiences a realistic defibrillation simulation. The electrorc of the trairir Jnp!y..!e mall be calf 7red to cn.in. only or.m. cre trainer;> scenarios. For example, the training supply module could contain a memory having samples of ECG data, sample audio data, etc. The training e-apply module could pass this data to the defibrillator as part of the trairing exercise to simulate more accurately an actual resuscitation attempt. Once the training has been completed, the training module could be replaced with lo supply module I4 to render the defibrillator 10 fillly supplied and ready for use.

It should be understood that various changes and modifications of the embodiments shown in the drawings and described in the specification may be made within the

scope of the presen; invention. Accordingly, it is intended that all matter contained in the above description and shown in the accornpa,nying drawings be inte preted in an illustrative and not in a

l: limiting sense. The invention is limited only as defined in the fo] Ioiing claims arid the equivalents thereto.

Claims

' 1 1 CLAIMS

_ 1. A defibrillation system, comprising: a defibrillator, and a supply module containing pads and a battery electrically connected tO said defibrillator, said pads and said battery having respective expiration dates' and said supply module having an expiration date which is the earlier of the expiration date of the pads and the expiration date of the battery, electronic indicia being provided on the supply module relating to its expiration date, and said defibrillator is configured to monitor said supply module by receiving signals relating to said electronic indicia.
2. The defibrillation system of claim 1, wherein said supply module comprises a memory configured to store expiration information for transmission from the supply module to the defibrillator.
3. The defibrillation system of claim 2, wherein said memory is configured to store at least one of training information, code information and software information.
4. A defibrillation system, comprising a defibrillator, and a supply module containing pads and a battery electrically connected to said defibrillator; wherein said defibrillator is configured to monitor said supply module.
5. The defibrillation system of claim 4, wherein said supply module comprises a memory configured to store information for transmission from the supply module to the defibrillator.
6. al he defibrillation so stem of claim wherein said information includes al

( ( 12 least one of expiration date information, training information, code information and software information.
7. A defibrillation system comprising an external defibrillator and a replaceable supply module including pads and a battery, mounted on said external defibrillator.