TED External Home Defibrillator for Home Consumer innovation

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Sudden Cardiac Arrest (SCA)-ventricular fibrillation (VF)- kills 350000 people in the US alone, each year, about 3 million worldwide, at the prime-time of their life, mostly witnessed and at home …

Sudden Cardiac Arrest (SCA)-ventricular fibrillation (VF)- kills 350000 people in the US alone, each year, about 3 million worldwide, at the prime-time of their life, mostly witnessed and at home /office.
Defibrillation procedure must be performed as soon as possible: survival decreases by 10% for every minute of delay-therefore ambulance help at home-too late! At present, only very few of SCA victims at home survive and many- in coma, in nursing homes.
TED is a home consumer solution that is much more affordable and reliable.
The novelty in our defibrillator device is based on a computerized modification of the alternating current, from the mains , existing in every home, to the FDA-approved biphasic defibrillatory wave .

Inventors and patent holders:
Prof. A. Teddy Weiss & team at Hadassah Hospital, Jerusalem, Israel
Contact: atweiss@hadassah.org.il

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  • 1. TED-­‐Time  and  life-­‐saving  External   Defibrillator:  a  Home  AED   Inventors  and  patent  holders:       Prof.  A.  Teddy    Weiss  &  team  at  Hadassah   Hospital,  Jerusalem,  Israel      atweiss@hadassah.org.il  
  • 2. Sudden  Cardiac  Arrest   The  Need   •  Sudden  Cardiac  Arrest  (SCA)-­‐ventricular  fibrilla<on  (VF)-­‐    kills  350000  people  in   the  US  alone,  each  year,  about  3  million  worldwide,  at  the  prime-­‐<me  of  their   life,  mostly  witnessed  and  at  home  /office.   •  Defibrilla<on  procedure  must  be  performed  as  soon  as  possible:  survival   decreases  by  10%  for  every  minute  of  delay-­‐therefore  ambulance  help  at  home-­‐ too  late!  At  present,  only  very  few  of  SCA  vic<ms  at  home  survive  and  many-­‐  in   coma,  in  nursing  homes.   •  TED  is  a  home  consumer  solu<on  that  is  much  more  affordable  and  reliable.              The  novelty  in  our  defibrillator  device  is  based  on  a  computerized  modifica<on  of     the  alterna<ng  current,  from  the  mains  ,  exis<ng  in  every  home,  to  the  FDA-­‐ approved  biphasic    defibrillatory    wave.    
  • 3. Sudden  Cardiac  Arrest   The  Evolu<on   •  External  Defibrillators-­‐  used  in  hospitals,  since  1960s   •  AICD-­‐for  the  very  high  risk  pts-­‐since  1980s   •  AED  used  by  trained  emergency  personnel  have  become  an   essen<al  link  in  the  “Chain  of  Survival”(CPR),  since  1980s         •  The  logical  extension  of  the  AED  concept  is  the  Public  Access   Defibrillator  (in  airplanes,  airport,  casino)-­‐infrequent  use,  by   laymen  and  since  safe-­‐  FDA  approved  its  use  at  home-­‐2000   •  A  further  logical  extension  of  the  Public  Access  Defibrillator  is  our   TED  -­‐  Personal  Defibrillator  to  be  used  at  home/office  
  • 4. Current  Solu<ons     AICD   •  •  •  •  •  •  VERY  HIGH  COST    (20,000$)   NEEDS  OPERATIVE  PROCEDURE  (RISKY)   MAY  DELIVER  INAPROPRIATE  SHOCKS   NEEDS  CARE  AND  REPLACEMENT   PSYCHOLOGIC  BURDEN   END-­‐OF-­‐LIFE  PROBLEMS  
  • 5. Current  Solu<ons     AEDs-­‐  in  public  places   •  HIGH  COST  PER  UNIT  (1000-­‐2000$)   •  HIGH  COST  FOR  MAINTENANCE  (about  2000$  PER  YEAR).            -­‐-­‐  SINCE  INTENDED  FOR  LONG  STORAGE-­‐  MAY  NEVER  BE  USED  OR   CHECKED        -­‐-­‐WHEN  NEEDED  IN  EMERGENCY-­‐MAY  NOT  WORK:  BATTERY  OR   CAPACITOR  FAILURE   •  NO  PACING  CAPABILITIES  IN  CASE  OF  VERY  SLOW  HEART  RATE  OR   ASYSTOLE   •  NOT  CLOSE  ENOUGH  TO  SCA  VICTIMS  (ONLY  7%  OF  SCA-­‐WERE  IN  4   MINUTE  DISTANCES  FROM  AEDs  LOCATED  IN  PUBLIC  PLACES).  
  • 6. Current Solutions AED   •  MAINTENANCE    COST  IS   HIGH-­‐2363$/YEAR   •  AS  REPORTED  BY  ZOLL  
  • 7. TED  Solu<on   Main  ideas   •  Use  the  AC  mains  as  source  of  energy   •  Shape  by  computer  the  sinusoidal  waveform-­‐to  a  similar   defibrilla<on  wave  as  that  of  a  standard  AED   •  Maximum  flexibility  in  future  waveform  genera<on                achieving  bener  results  with  less  Energy     •  Use  a  High  Voltage  Step  Up  Transformer                      
  • 8. A Typical Monophasic Waveform Basic Output Waveform Classic Style 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
  • 9. TED  Solu<on   A  Typical    AC-­‐derived  Biphasic  Waveform   Basic Biphasic Output Waveform Classic Style 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
  • 10. TED  Solu<on   Advantages   •  Immediately  opera<onal   •  No  delay  in  repeated  opera<on  allowing:   –  Repeated  defibrilla<on  ,  no  need  to  recharge   –  Pacing  in  case  of  Cardiac  Stands<ll  or  Bradycardia     –  Pacing  override  for  VT  termina<on   •  No  Need  for  baneries  and  capacitor   •  Lower  cost  ,  more  reliable  than  AEDs              Therefore-­‐ideal  for  home-­‐use          
  • 11. Leading to … •  Lower cost per unit •  Maintenance Free •  Reliable Therefore ideal for Use at Home Preferable to existing AEDs
  • 12. Sudden  Cardiac  Arrest       The  market   •  It  should  be  recommended  by  physicians  to  pa<ents  at    increased  risk   of  SCA-­‐following  myocardial  infarc<on(MI),  hypertrophic  or  dilated   cardiomyopathy  or  gene<c  inclina<on  for  ventricular  arrhythmias   •  It  could  be  an  alterna<ve  treatment    for  pa<ents  who  are  candidates   for  surgically  implanted  defibrillator-­‐  AICDs:  poor  Leo  Ventricular   Func<on-­‐in  US  alone,  A.  Moss  es<mates  about  10  million  pts=200   billion  $-­‐NO  state  economy  can  afford  it!  Its  use  in  developing   countries-­‐limited   •  Pa<ents  post  MI,  or  at  risk  for  MI,  or  with  heart  failure   •  50%  of  men  and  63%  of  women  SCA  vic<ms  previously  reported  no   CHD  symptoms,-­‐it  may  afflict  anyone,  any<me...    
  • 13. Sudden  Cardiac  Arrest   AICD   Automa<c  Internal   Cardiac  Defibrilla<on   (X20)     LVD   Leo  Ventricular     Dysfunc<on  (X10)       CHF   Conges<ve  Heart   Failure  (X8)     MI   Myocardial   Infarc<on  (X5)     The  market   TED  targets  by  risk  group       AICD   candidates   LVD-­‐CHF   Post  MI   Good  LV   High  risk  for  MI   Age>  40  
  • 14. Sudden  Cardiac  Arrest   The  market   Ideally  a  personal  AED  should  be  present  in  every  home   exactly  like  fire  ex<nguishing  equipment.     Lower  Cost  will  lead  to  an  almost  unlimited  market.    
  • 15. First  Animal  Study:  Defibrilla<on   5  small  pigs  (30-­‐40  Kg  body  weight)   General  anesthesia  with  ketamin  and  isofluoran   A  single  quadripolar  pacing  catheter  was  inserted  percutaneously   through  one  of  the  femoral  veins  or  jugular  vein   VF  was  induced  with  rapid  ventricular  burst  pacing  or  T  wave  shock   Defibrilla<on  of  stable  VF  aoer  15  seconds   If  failed  ,  immediate  rescue  shock  with  a  higher  energy  or  DC  shock   DFT  determined  with  AC  shock,  than  again  with  DC  shock  delivered   with  a  commercial  external  defibrillator  (Zoll)  using  a  step-­‐down   protocol   Comparison  of  DFT  between  modified  AC  and  standard  DC  shock    
  • 16. First  Animal  Study:  Defibrilla<on   49  J  AC   Successful  Defibrilla<on  
  • 17. Successful  Defibrilla<on   50 J DC
  • 18. An Advanced Biphasic Waveform Advanced Biphasic Output Waveform 0 5 10 15 20 25 Time (msec) 30 35 40 45 50
  • 19. Comparison  of  AC  and  DC  DFT  in  each   pig     a b
  • 20. First  Animal  Study:  Defibrilla<on   DFT  with  MAC  versus  DC  Shocks  
  • 21. First  Animal  Study:  Defibrilla<on   Rescue  Shock-­‐18  sec  aoer  first  shock  
  • 22. Second  Animal  Study   •  •  •  •  •  •  Six  rats   Mean  weight  491.7±123.7  grams   mid  LAD  was  occluded  at  3  moths  age   3-­‐6  months  for  complete  recovery   MAC  defibrilla<on-­‐successful  in  all   External  pacing-­‐at  a  rate  above  sinus  rhythm-­‐ successful  in  all  
  • 23. Second  Animal  Study:  External  pacing   Pacing   8  Volts  Threshold   Sinus  
  • 24. Conclusions   •  Modified  AC  Shock  Defibrilla<on  is  feasible  and  as  effec<ve   as  the  standard  biphasic  DC  Defibrilla<on   •  Repeated  higher  energy  shocks  are  quickly  available   •  External  Pacing  is  feasible  and  durable    due  to  unlimited   energy   We  suggest  this  type  of  defibrilla<on  shock  to    be   implemented  in  Automa<c  External  Home  Defibrillators     This  low-­‐cost  new  technology  should  be  used  to  treat  sudden   cardiac  arrest  occurring  at  home/office  and  to  save  lives  
  • 25. Publica<ons   Europace   Shimon  Rosenheck,  Shraga  Gorni,  Ioni   Katz,  Asaf  Rabin,  Uri  Shpoliansky,   Mendel  Mandelbaum,  and  Abraham   Teddy  Weiss  (2009)  Modified   alterna2ng  current  defibrilla2on:  a   new  defibrilla2on  technique,  Europace   11,  239–244.         Awards:   Neufeld  prize  for  the  best  paper  from   the  Israeli  Heart  Society  (2010)  
  • 26. Thank  you