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“ Development of an Axial Flow Left  Ventricular Assist Device (LVAD) from Inception to Clinical Application” George P. No...
Heart Failure Hospitalizations The number of heart failure hospitalizations is increasing in both men and women CDC/NCHS: ...
CIRCULATORY ASSIST DEVICES The Methodist Hospital/Baylor College of Medicine IABP (1971-2001) 2880 Roller Pump (1971-1988)...
 
Biomedical  Engineering Role in Development of  Total Artificial Heart and Assist Pumps
Biomedical  Engineering <ul><li>Pump Design  </li></ul><ul><li>Blood Contact Surface </li></ul><ul><li>Controller </li></u...
Biomedical  Engineering <ul><li>Blood trauma and clotting </li></ul><ul><li>Blood contacting surface </li></ul><ul><li>Dur...
Biomedical  Engineering <ul><li>Pump Testing </li></ul><ul><ul><ul><li>Mock Loop </li></ul></ul></ul><ul><ul><ul><li>Anima...
First NASA Axial Flow Prototype Two rotating components
NASA - Ames Research Center <ul><li>Flow Field inside impeller </li></ul><ul><li>Minimize hemolysis </li></ul><ul><li>Incr...
Licensed NASA Blood Pump (1996)
Hemolysis Test Setup
Red Cells
Hemolyzed Red Cells
<ul><li>2½ year bench study demonstrated no significant bearing wear </li></ul><ul><li>35 clinical pumps returned for eval...
<ul><li>Titanium construction: 95 Grams </li></ul><ul><li>Speed:  7,500 - 12,500 RPM </li></ul><ul><li>Continuous, axial f...
Schematic Illustration of the DeBakey VAD
Bovine tests at Baylor College of Medicine, Texas A&M Ex-Vivo In-Vivo
Novacor  HeartMate  DeBakey-Noon VAD  Device Comparison
DeBakey VAD ®  and  DeBakey VAD Child
Controller Pump Patient Home Support System Data Acquisition System Result: MicroMed DeBakey VAD ®  System
DeBakey-Noon VAD ® Patient Ergonomics
Comparative VAD Space Requirements HeartMate ®  XVE LVAD Adult Male DeBakey VAD  ® 6 year old girl
DeBakey VAD ®  Implantations More than 110 years of cumulative patient experience Total Patients – 437 <ul><li>Average sup...
Physiologic Blood Flow Systemic Pulmonary Textbook of Medical Physiology, Arthur C. Guyton
Speed, Flow and Delta Pressure
Hypoperfusion Operating Range Potential for Suction Flow Characteristics
Arterial Pressure  - Green  VAD Flow - Yellow Pump speed  VAD flow  (kRPM)  (L/min) OFF   -2.0 7600   2.3 8900   4.5 10,80...
 
Milan Smaller Patients Possible Miniaturization benefits large and small patients. Milan Zurich Muenster
Continuous Flow Provides  Adequate Circulatory Support <ul><li>Resuscitation  </li></ul><ul><li>Rehabilitation </li></ul><...
Results - CFD Baseline Rear Hub Washout Final Rear Hub Washout Increase gap shows an improved circulation pattern in the r...
Results - CFD Baseline Diffuser Inlet Angle Final Diffuser Inlet Angle Flow is entering the diffuser correctly on the pres...
EU Pediatric Device <ul><li>Required CFD of the inflow cannula  </li></ul><ul><li>Results demonstrated pediatric inflow ca...
Results – Flow Visualization Results from increased gap: Less turbulence in the diffuser Baseline Design 2.0x Gap
Results – Hemolysis at 4 L/min INCREASING THE GAP  WITHOUT MODIFYING THE DIFFUSER INLET ANGLE  DEMONSTRATES A TREND TO SLI...
X2 Pump Design ½ cm shorter intra-ventricular and 1cm shorter extra-ventricular length for improved anatomical fitting Smo...
On the horizon…
Clinical Benefits of the MicroMed DeBakey-Noon VAD Size   Surgeon   Patient   Implant   Less Awareness   Explant   Drive L...
Conclusion <ul><li>Increasing incidence of heart failure </li></ul><ul><li>Transplantation limited by donor supply </li></...
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Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc

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  • Transcript of "Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application, pumpsandpipesmdhc"

    1. 1. “ Development of an Axial Flow Left Ventricular Assist Device (LVAD) from Inception to Clinical Application” George P. Noon, MD Professor of Surgery Chief, Division of Transplant & Assist Devices Meyer-DeBakey Chair of Investigative Surgery Pumps & Pipes
    2. 2. Heart Failure Hospitalizations The number of heart failure hospitalizations is increasing in both men and women CDC/NCHS: Hospital discharges include patients both living and dead. AHA Heart and Stroke Statistical Update 2001
    3. 3. CIRCULATORY ASSIST DEVICES The Methodist Hospital/Baylor College of Medicine IABP (1971-2001) 2880 Roller Pump (1971-1988) 94 DeBakey VAD (1963-1966) 6 Liotta, Hall, Crawford (1963) 1 Symbion/Jarvik (1987-1989) 4 Novacor ® LVAS (1987-2005) 53 BioMedicus ® (1986-2005) 274 MicroMed DeBakey-Noon VAD ® (2000-2005) 36 Thoratec ® LVAD (1998-2005) 31 HeartMate ® VAD (2001-2005) 17 Abiomed ® BVS 5000 (2002-2004) 7 Abiomed ® AB 5000 (2003-2004) 1
    4. 5. Biomedical Engineering Role in Development of Total Artificial Heart and Assist Pumps
    5. 6. Biomedical Engineering <ul><li>Pump Design </li></ul><ul><li>Blood Contact Surface </li></ul><ul><li>Controller </li></ul><ul><li>Power Source </li></ul>
    6. 7. Biomedical Engineering <ul><li>Blood trauma and clotting </li></ul><ul><li>Blood contacting surface </li></ul><ul><li>Duration of contact </li></ul><ul><li>Stasis </li></ul><ul><li>Cavitation </li></ul><ul><li>Heat </li></ul><ul><li>Shear </li></ul>
    7. 8. Biomedical Engineering <ul><li>Pump Testing </li></ul><ul><ul><ul><li>Mock Loop </li></ul></ul></ul><ul><ul><ul><li>Animal </li></ul></ul></ul><ul><ul><ul><li>Human </li></ul></ul></ul>
    8. 9. First NASA Axial Flow Prototype Two rotating components
    9. 10. NASA - Ames Research Center <ul><li>Flow Field inside impeller </li></ul><ul><li>Minimize hemolysis </li></ul><ul><li>Increase efficiency </li></ul><ul><li>Provide effective washout </li></ul>Geometry from Johnson Space Center
    10. 11. Licensed NASA Blood Pump (1996)
    11. 12. Hemolysis Test Setup
    12. 13. Red Cells
    13. 14. Hemolyzed Red Cells
    14. 15. <ul><li>2½ year bench study demonstrated no significant bearing wear </li></ul><ul><li>35 clinical pumps returned for evaluation - no evidence of bearing wear </li></ul>Bearing Wear Studies performed by Marconi
    15. 16. <ul><li>Titanium construction: 95 Grams </li></ul><ul><li>Speed: 7,500 - 12,500 RPM </li></ul><ul><li>Continuous, axial flow pump </li></ul><ul><li>Flow rates: 10+ liters/minute </li></ul><ul><li>Technology licensed from </li></ul><ul><li>NASA </li></ul>The DeBakey-Noon VAD
    16. 17. Schematic Illustration of the DeBakey VAD
    17. 18. Bovine tests at Baylor College of Medicine, Texas A&M Ex-Vivo In-Vivo
    18. 19. Novacor  HeartMate  DeBakey-Noon VAD  Device Comparison
    19. 20. DeBakey VAD ® and DeBakey VAD Child
    20. 21. Controller Pump Patient Home Support System Data Acquisition System Result: MicroMed DeBakey VAD ® System
    21. 22. DeBakey-Noon VAD ® Patient Ergonomics
    22. 23. Comparative VAD Space Requirements HeartMate ® XVE LVAD Adult Male DeBakey VAD ® 6 year old girl
    23. 24. DeBakey VAD ® Implantations More than 110 years of cumulative patient experience Total Patients – 437 <ul><li>Average support duration – 106 days </li></ul><ul><li>61 patients > 180 days </li></ul><ul><li>Longest support duration – 841+ days </li></ul>International <ul><li>286 Patients implanted </li></ul>As of October 2007 United States <ul><li>151 Patients implanted </li></ul>
    24. 25. Physiologic Blood Flow Systemic Pulmonary Textbook of Medical Physiology, Arthur C. Guyton
    25. 26. Speed, Flow and Delta Pressure
    26. 27. Hypoperfusion Operating Range Potential for Suction Flow Characteristics
    27. 28. Arterial Pressure - Green VAD Flow - Yellow Pump speed VAD flow (kRPM) (L/min) OFF -2.0 7600 2.3 8900 4.5 10,800 5.6 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140 10 0 -4 0 140
    28. 30. Milan Smaller Patients Possible Miniaturization benefits large and small patients. Milan Zurich Muenster
    29. 31. Continuous Flow Provides Adequate Circulatory Support <ul><li>Resuscitation </li></ul><ul><li>Rehabilitation </li></ul><ul><li>Maintenance </li></ul>
    30. 32. Results - CFD Baseline Rear Hub Washout Final Rear Hub Washout Increase gap shows an improved circulation pattern in the rear hub
    31. 33. Results - CFD Baseline Diffuser Inlet Angle Final Diffuser Inlet Angle Flow is entering the diffuser correctly on the pressure side of the blade indicating a small “angle of attack.”
    32. 34. EU Pediatric Device <ul><li>Required CFD of the inflow cannula </li></ul><ul><li>Results demonstrated pediatric inflow cannula with 2 L/min washed at least as good as adult cannula with 4 L/min </li></ul>
    33. 35. Results – Flow Visualization Results from increased gap: Less turbulence in the diffuser Baseline Design 2.0x Gap
    34. 36. Results – Hemolysis at 4 L/min INCREASING THE GAP WITHOUT MODIFYING THE DIFFUSER INLET ANGLE DEMONSTRATES A TREND TO SLIGHLY HIGHER HEMOLYSIS 2.0X gap Baseline Baseline 2.0X gap, 32 ° TUNING THE DIFFUSER INLET ANGLE WITH THE LARGER GAP DEMONSTRATES A TREND OF HEMOLYSIS LOWER THAN THE BASELINE VALUE; HOWEVER, THERE IS NO STATISTICAL DIFFERENCE IN HEMOLYSIS BETWEEN THE BASELINE AND FINAL DESIGN N.I.H. = 0.006 N.I.H. = 0.014 N.I.H. = 0.009 N.I.H. = 0.006
    35. 37. X2 Pump Design ½ cm shorter intra-ventricular and 1cm shorter extra-ventricular length for improved anatomical fitting Smoother inlet flare for improved blood flow into the pump Seamless connection to pump housing for improved blood flow Smaller flow probe cover Titanium ring integral to gelatin sealed graft for easy, leak-free assembly
    36. 38. On the horizon…
    37. 39. Clinical Benefits of the MicroMed DeBakey-Noon VAD Size Surgeon Patient Implant Less Awareness Explant Drive Line Smaller Patients Noiseless Device Infection  5% Adequate Circulatory Support Less Expensive
    38. 40. Conclusion <ul><li>Increasing incidence of heart failure </li></ul><ul><li>Transplantation limited by donor supply </li></ul><ul><li>Cardiac assist devices increasingly used as </li></ul><ul><ul><li>Bridge to Transplant </li></ul></ul><ul><ul><li>Bridge to Recovery </li></ul></ul><ul><ul><li>Destination Therapy </li></ul></ul>
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