PowerPoint Presentation (PDF) - Perfusion.com
PowerPoint Presentation (PDF) - Perfusion.com
PowerPoint Presentation (PDF) - Perfusion.com
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The Role of the Manufacturer,<br />
Technology and Clinical Practice-<br />
Arterial Filtration<br />
David Fallen<br />
Director of Clinical Support<br />
Terumo Cardiovascular Systems<br />
June, 2009
“Whenever there is a demonstrated<br />
need for a new product, industry is<br />
usually quick to produce its own<br />
interpretation of the answer to suit that<br />
need. ”<br />
Charles C. Reed. Cardiopulmonary <strong>Perfusion</strong> 1975, page 261
The “Demonstrated Need”<br />
Blood management is an evidence‐based,<br />
multidisciplinary process designed to minimize the need<br />
for blood products, reduce patient morbidity and<br />
ultimately reduce hospital costs.<br />
We are helping clinicians ac<strong>com</strong>plish these goals through<br />
the development of innovative products, educational<br />
opportunities and clinical/technical support.
The Quest for “No Impact” CPB;<br />
Are We There Yet?
We Are Getting There….Through<br />
Incremental Change<br />
• Increased emphasis on CPB circuit size, hemodilution and<br />
prime reduction<br />
• Techniques to reduce allogeneic transfusion, RAP, AAP,<br />
transfusion protocols and ANH<br />
• Broad adoption of coated circuit technologies<br />
• Improved cardiac team effort to adopt evidence based<br />
practices<br />
• Better appreciation of the deleterious effects of micro–air.<br />
• New integrated perfusion circuit product designs
CAPIOX ® FX – Design of Integrated Filter<br />
32 µm Arterial Filter<br />
Hollow Fibers
CAPIOX ® FX – Principle of Air Removal<br />
Blood side 100-400 mmHg<br />
1.<br />
2.<br />
Gas side<br />
0-15 mmHg<br />
3.<br />
1. Air bubbles<br />
trapped by the<br />
integrated filter<br />
2. Pressure<br />
difference between<br />
blood side and gas<br />
side facilitates<br />
transit of air<br />
bubbles into<br />
lumen of hollow<br />
fibers<br />
3. Air bubbles are<br />
eliminated via gas<br />
outlet of<br />
oxygenator
Product design process for FX<br />
Oxygenator<br />
• Phase 1 Concept: New product ideas based on continuous<br />
customer input<br />
• A product that will support improvements in clinical practice.<br />
• Reduce the inflammatory response.<br />
• Reduce the need for blood products.<br />
• <strong>Perfusion</strong> circuits smaller, reduce foreign surface area, lower prime<br />
volume, all without t <strong>com</strong>promising i product performance or safety.
Product design process for FX Oxygenator<br />
Phase 2 Feasibility: Customer input to confirm initial device<br />
concept.<br />
• Customer feedback on integration concept of oxygenator and<br />
arterial filter<br />
• No <strong>com</strong>promise in safety<br />
• Improved biopassivity, reduced surface area and pressure<br />
drop<br />
• No increase in prime volume<br />
• No decrease in oxygen transfer performance<br />
• Must handle GME equal to or better than current CPB circuits<br />
• Must be easy to set up, prime, debubble
Product design process for FX Oxygenator<br />
• Phase 3 Development: Translate original design input to product performance<br />
characteristics<br />
• FX oxygenator with integrated arterial filter development<br />
• Arterial filter truly integrated into oxygenator housing<br />
• Oxygenator/filter housing designed for optimal blood flow path<br />
• Benefits: reduced prime volume, decreased surface area, and lower pressure drop<br />
• Optimal filter media and micron size were determined<br />
• Test performance characteristics<br />
• Oxygen transfer<br />
• Hemolysis<br />
• Pressure drop<br />
• Air handling<br />
• Prove that product manages GME equal to or better than current products<br />
• Hatteland<br />
• EDAC Quantifier
Hatteland Bubble Counter
Taking Advantage of a Technology<br />
Leap!!<br />
• Industry standard for air handling testing – Hatteland air<br />
bubble detector.<br />
• During this product development project that the Luna EDAC<br />
emboli detection system was released for sale.<br />
• EDAC Quantifier provided improved accuracy and allowed for<br />
multiple sensors within the circuit as well as being the first<br />
clinically approved device.<br />
• Re tested for air handling ability to ensure we met product<br />
requirements.<br />
• Tested against other oxygenators/arterial filters available in<br />
the market.
EDAC Quantifier
Test Protocol for GME Removal Comparison<br />
Tank<br />
Bovine Blood<br />
Approx. 15 liter<br />
Hct =25%<br />
•Test Purpose:<br />
•Compare air handling characteristics of various<br />
oxygenator/arterial filters to FX25 oxygenator with<br />
integrated arterial filter using the EDAC Quantifier.<br />
100 mL/min<br />
cont. bubble<br />
1000mL<br />
Flow meter<br />
EDAC<br />
Bubble sensor #1<br />
RX25 Oxy.<br />
For<br />
Bubble removal.<br />
Trapping micro emboli.<br />
Heat exchange.<br />
Heater/cooler<br />
37degree<br />
Pressure monitor<br />
1 50mmHg, 250mmHg<br />
EDAC<br />
Bubble sensor #3<br />
Blood pump<br />
(roller, centrifugal)<br />
EDAC<br />
Bubble sensor #2<br />
Sample
Test Protocol<br />
Blood<br />
Bovine<br />
Hematocrit 25%<br />
Temperature 37°<br />
Flow Rate 4.5 LPM 7.0LPM<br />
Sampling Time<br />
3 minutes<br />
Back Pressure 150mmHg+/-10% 250mmHg +/-10%<br />
Sampling<br />
Locations<br />
Air Injection<br />
Reservoir Level<br />
Bubble Detector<br />
Post reservoir, post<br />
oxygenator and post<br />
arterial filters<br />
100mL/min<br />
continuous air (roller<br />
pump) for one minute<br />
1000mL<br />
EDAC Quantifier Luna<br />
Innovations
CAPIOX ® FX – Air Handling<br />
Test conditions:<br />
Bovine blood, Hct 25±1%, Temp. 37±1° C<br />
4.5 L/min blood flow & 7 L/min<br />
100 mL/min air for 1min, EDAC bubble counter<br />
Product Air Removal 4.5 L/min Air Removal 7.0 L/min<br />
FX25 97% 97%<br />
RX25 & AF125 99% 97%
Product design process for FX Oxygenator<br />
Phase 4 Scale up/Launch: Final customer checks,<br />
regulatory clearance<br />
• Confirm product design, packaging.<br />
• Validate design requirements through in vitro testing – GME<br />
removal, oxygen transfer testing, etc<br />
• FDA clearance<br />
• Commercialize
Comparison of Total Emboli Counts @ 4.5 LPM<br />
Size Range (um)<br />
Post<br />
Reservoir<br />
FX25<br />
Post<br />
Oxy/AF<br />
Unit<br />
Adult Oxygenators 4.5 LPM Average over three samples/unit<br />
RX25 Affinity PrimeOx Quadrox i Synthesis<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir<br />
Post<br />
Oxy/AF<br />
Unit<br />
Post<br />
Reservoir<br />
10-20 14727 619 15050 3532 359 8635 7781 4638 10610 3963 1023 6300 1874 8599 2946<br />
20-30 7703 147 8657 1109 87 5913 4471 1791 5057 2460 563 3380 1226 4702 1863<br />
30-40 4359 35 5401 307 26 4959 2850 627 2830 1801 254 2296 690 3224 1126<br />
40+ 3695 11 5633 106 7 14585 2792 333 3660 2462 195 3657 449 6364 739<br />
Total 30484 812 34741 5054 479 34093 17894 7390 22157 10687 2035 15633 4239 22889 6674<br />
% Removal 97.3% 98.6% 78.3% 90.8% 72.9% 70.8%<br />
Post<br />
Oxy/AF<br />
Unit<br />
Adult Oxygenators 7.0 LPM Average over three samples/unit<br />
FX25 RX25 Affinity PrimeOx Quadrox i Synthesis<br />
Post<br />
Post<br />
Post<br />
Size Range (um)<br />
Post<br />
Reservoir<br />
Oxy/AF<br />
Unit<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir Post Oxy Post AF<br />
Post<br />
Reservoir<br />
Oxy/AF<br />
Unit<br />
Post<br />
Reservoir<br />
Oxy/AF<br />
Unit<br />
10-20 11453 656 9959 4139 492 4832 5928 3415 8270 5194 1394 4296 3636 4286 3353<br />
20-30 6516 115 6092 848 127 3363 3472 853 4534 1905 549 2970 1387 3001 1230<br />
30 40 3835 22 4136 242 33 3017 1963 263 2695 819 272 2075 665 2354 581
Summary<br />
• Product development is an arduous process<br />
• Product development is a very customer/clinician focused<br />
process<br />
• The latest testing methodologies available should be incorporated<br />
into the development effort whenever possible<br />
• Partnership between <strong>Perfusion</strong>ists ,Cardiac teams and Industry<br />
will enhance product development<br />
•Thank you.
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