ECMO

(DISPOSABLES)
TUBING PACK AND
CANNULATION

Lena Hsiao
Associate Product Manager, CVII
2021-05-27 (2021-06-09)
PERFUSIONIST
MOST IMPORTANT PARTNER WITH CARDIAC SURGEONS
PERFUSIONISTS

3 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
WHAT’S ECMO MEANING?
A KIND OF EXTRACORPOREAL LIFE SUPPORT

ExtraCorporeal Membrane Oxygenation

體外膜氧合器

ECMO

prolonged partial cardiopulmonary bypass
➢ Prolonged = Probably Up to Several Week
➢ Partial = Patient’s Heart & Lungs must Work

4 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
BASIC CARDIOPULMONARY CIRCUIT

Normal body circulation

Heart & Lungs

SVC
RA RV Lungs LA LV Ao
IVC

Cardiopulmonary
ECMO circulation
Reservoir Pump Heat Ex Oxygenator Filter

5 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
EXTRACORPOREAL MEMBRANE OXYGENATION
體外膜氧合系統
Tubing ECMO
VA Mode (Short-term)
Sensors Cardiac Problem
For 1-7 days
Oxygenator
氧合器
NTD 44,306
Cannulae

Pump VV Mode (Long-term)

Respiratory Problem
Over 7 days
ECMO NTD 98,010
PACK
Console

6
ECMO SYSTEMS

7 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
CPB V.S ECMO

CPB ECMO

Site OR ICU

Venous reservoir Yes No

Heparin (ACT) >600 160-220

Autotransfusion Yes No
自體輸血
Hypothermia Yes No
低溫
Hemolysis Yes No
透析
Hemodilution Yes No
稀釋
Arterial filter Yes No
動脈過濾

Reference: ECMO手冊 第二版, 柯文哲, 蔡璧如

EXTRACORPOREAL MEMBRANE OXYGENATION

Indication : Both lung & heart Indication : For lung disease only
support Purpose : To decrease ventilator
Purpose : Hemodynamic setting (Prevent ventilator
support induced lung injury)

V-A ECMO V-V ECMO

9 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
January, 2006

ECMO is mainly used for neonatal respiratory

diseases. (63%)

Only 5% ECMO were used in Adults.

After 10 years…
It’s rising to 26.3% for ECMO in Adult.
13 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
 UPDATE OF WORLDWIDE ECMO
From ECLS website

▪ In 2019, there are 1500 cases in Taiwan, and this is 11.7% of worldwide cases.

14 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
ECMO IN REAL WORLD
2016年的春天…流感重症激增
葉克膜一機難求

http://www.appledaily.com.tw/appledaily/article
/headline/20160304/37092671/

(蘋果日報, 2016-03-04)

16 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
MAIN COMPONENT OF ECMO

▪ Equipment ▪ Disposables
▪ Bio-Console 560 主機 ▪ Custom ECMO Pack 套包
Speed Controller System -Oxygenator (Lung)
▪ Biotrend 血氧監測 -Pump (Heart)
Oxygenation saturation and -Circuit
hematocrit monitor -Monitoring supplies
▪ ACT Plus 凝血監測 ▪ Cannula 股動靜脈導管
Anticoagulation monitor ▪ ACT kit
▪ Gas Flow Meter
▪ Heater

17 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
BIO-CONSOLE 560
 BIO-CONSOLE® 560 FEATURE
Safety Mechanical
stop at 2000 rpm
• Prevent back flow

External Drive
Optimum placement
Accessories of Bio-Console® 560
540T External
Drive motor drive

Ongoing Change
BPX 80 or BP50 Flow Transducer
TX50 or TX50P
 Arterial Blood Pumps
Hardware and Disposables

BioConsole 560
Speed Controller
BioPump
BPX80

Affinity CP
AP40
Low Prime

Global Logistics, Transportation, International Trade & License Compliance 21 | MDT Confidential
OLD BIO-PUMP
ONLY SERVED IN PACKS

• Gentlest blood flow

• Very low blood trauma
• Cannot pump air to patient more safety
• Carmeda Circuit and Bio-pump improves
patient outcome

Smooth cones

22 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
 AFFINITY™ CP CENTRIFUGAL BLOOD PUMP
AP40
Low Prime = 40 mL Ceramic Pivot = Low heat

Short Impeller Design = High efficiency

23
NEW PUMP – AP40
REPLACE THE BIO-PUMP IN FY22

MORE EFFICIENT
LOWER HEAT
 Angled Blood Inlet
Gentle flow of blood
into pump

Blood Outlet

6 Low Profile Impeller Fins

Low turbulence to blood and
higher efficiency allowing for
Ceramic Pivot Bearing lower operating speed to
Offers increased durability achieve targeted flow rate
and low heat generation
Smooth Cone
Results in low shear on RBC

Internal Molded Magnet

CLOSER TO SEE THE CERAMIC PIVOT

Angled Inlet does not interfere

with Pivot bearing

Ceramic Pivot Bearings

Low Profile Impeller Fin

26
NEXTGEN FEMORAL CANNULA

1. Ease of insertion and are engineered for smooth transitions.

2. Fingerlet supports are formed into the tapered tip to create an even smoother
transition betweenthe introducer and the thin cannula wall.

27 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
MICS CANNULATION
NEXT GENERATION CANNULA

▪ https://youtu.be/kFOyemrYVb4

28 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
BIO-TREND MONITORING

▪ OVERVIEW
• Real-time, in-line SO2 and HCT values
• Advanced optical sensing technology
• No lab values needed for calibration
• Setup takes only minutes
• TMC Tri-optic Measurement Cells in 1/4",
3/8" and 1/2" sizes

29 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
MEDTRONIC CUSTOMERIZE ECMO PACK
OXYGENATOR, PUMP, CIRCUIT

Centrifugal Pump Oxygenator

30 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
 https://www.youtube.com/watch?v=xDllovrdDG4

31 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
Medtronic’s ECMO Oxygenator
Affinity NT
Oxygenator: Assumes the function of lungs in bringing
oxygen and removing carbon dioxide from blood

Oxygen in

Oxygenated
blood outlet
Oxygen out

De-Oxygenated blood
Water in & out inlet

Heat exchanger
33 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
Oxygenator + Arterial Filter (OXY+AF)

34
Performance Attributes
Affinity NT with Affinity Fusion
Description
Trillium with Balance
Membrane Type Polypropylene Polypropylene
Membrane Surface Area 2.5m² 2.5m²
Static Priming Volume 270 mL 260 mL
Recommended Blood Flow Rate 1 – 7 L/min 1 – 7 L/min
Oxygen Transfer @ 7lpm 390 ml/min 431 ml/min
Carbon Dioxide Transfer @ 7lpm 305 ml/min 312 ml/min
Heat Exchange @ 7lpm 0.47 0.57
Blood ∆P @ 7lpm (oxy & filter, mmHg) 121 + 42 = 163 171
Microemboli Filtration NA 25 μm
Data on file at Medtronic. Results are based on in vitro bench testing and may not be indicative of clinical performance .

35
Gross Air Design Approach – Unique Feature
Proactive Air Handling

Mimics common bubble

trap method on AFs
– Blood and air enter tangentially
into chamber and spin
– Air is pulled to the center and
purged through purge line with
integrated one-way valve
– Fixed chamber volume of
30 ml
– No air handling degradation
Insert Video to Size Here over time

36
Transition-free Radial Flow – Unique Feature
Radial design contributes to:
– Uniform flow distribution through the
oxygenator
– Minimal blood’s contact with foreign
surfaces
– Fiber bundle winding on top of the
Heat Exchanger
– Decreased prime volume
– Shortened blood flow paths

37
Filtration Approach – Unique Feature
Progressive Fiber Filtration
Fiber Bundle Assembly (FBA)
Using existing Affinity NT fiber winding technology
to create 25 μm integral arterial filter

Zone 1 Zone 2 Zone 3 Zone 4 Zone 5 Zone 6

FBA Zone Average Particulate Filtration

Number Efficiency (25 µm)
Zone 1 77%
FBA

Zone 2 92%
Zone 3 97%
Zone 4 99%
Zone 5 99%
– Wound with six (6) separate and progressively Zone 6 99%
tighter zones
Particulates in saline flowed through oxygenator and collected
– Maintains even blood flow and accomplishes at outlet, and analyzed for number passing through oxy
Sample size each zone = 3 Zone 6 sample size = 11
gas exchange and particulate filtration
Data on file at Medtronic
Results are based on in vitro bench testing and may not be
indicative of clinical performance
38
Metal Shunt Wire Design – Unique Feature
A metal alloy wire shunt is built-in
between the water and blood path
– Equilibrates voltage between the blood
and water pathways
– Reduces the potential for electrostatic
discharge that may develop due to the
rotation of roller pump heads

39
 The Biosurface
Cortiva® 2
– Durable, non-leaching End Point attached
Heparin
– Provides thromboresistance and enhanced
blood compatibility

Balance® 1 ®
Carmeda Bioactive surface
– Biosurface without heparin
– Blood-friendly surface
• Sulfate/sulphonate groups
• PEO chains
– Inhibit thrombin by binding to antithrombin in a
heparin-like manner
– Reduces platelet activation
– Lowers platelet adhesion
– Preserves platelet function
®
Balance Biosurface
1. Technology licensed under agreement from Biointeractions, Limited, United Kingdom
1

2. Carmeda® is manufactured under license from Carmeda AB for use only as part of an extracorporeal blood
1
ECMO WAREHOUSE

FOR EXAMPLE BY
NTUH ECMO TEAM
NTUH ECMO Team
 ECMO cart

All you have to do is setting up ECMO.

Put everything in your ECMO cart, then

you can support OR, ICU, Cath room,
ES, Ward… etc

Make the
Works More
Efficiently!

NTUH ECMO Team

ECMO IN TAIWAN
台灣ECMO健保給付適應症
2002年12月1日開始給付,
2012年06月01日修訂

一、心因性休克：
1. 心臟手術重建後，暫時性心臟功能障礙(Stunned heart)
2. Bridge：為準備心臟手術或心室輔助器或心臟移植，而暫代心臟功能
3. 可回復性的心肌病變
4. 肺栓塞 (Pulmonary embolism)
5. 急性心肌梗塞併心因性休克
6. 其他心因性休克

二、呼吸衰竭：
1. FiO2：1.0, PaO2＜60 mmHg，已排除可逆轉之原因
2. CO2 retention, 造成血行動力學不穩，已排除可逆轉之原因
3. 過渡至肺臟移植

45 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
台灣ECMO健保給付適應症
2002年12月1日開始給付,
2012年06月01日修訂

三、小兒及新生兒
1. 吸入性胎便肺炎症候群( MAS；Meconium aspiration syndrome)
2. 呼吸窘迫症候群( Hyaline membrane disease)
3. 先天性橫膈膜疝氣(CDH；Congenital diaphragm hernia)
4. 新生兒頑固性肺高壓(PPHN；Persistent pulmonary hypertension of
neonate)
5. 上述疾病經傳統治療(含呼吸器)，並合乎下列呼吸衰竭指數

四、其他
1. 氣道外傷
2. 極低體溫(核心體溫≤30℃)

46 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
使用ECMO之禁忌症
2002年12月1日開始給付, 2012年06月01日修訂

▪ 絕對禁忌症（健保不給付）
1. 不可逆之腦病變
2. 惡性腫瘤末期
3. 不可逆之心、肺疾患且不適合做臟
器移植者
4. 不可逆之多重器官衰竭

▪ 相對禁忌症（需逐案審查之個案）
1. 持續進展之退化性全身性疾病
2. 不可控制之感染
3. 不可控制之出血
4. 重度免疫不全之患者

47 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only
ADVANTAGES OF ECMO
WHY IT’S A KIND OF IMPORTANT SUPPORT?

▪ Rapid priming, bedside, local anesthesia

➔ suitable for critical patients
▪ RV, LV, lung support
➔ for unknown diagnosis
▪ Cheaper than VAD
➔ Earlier use
▪ Both Adults & Children
▪ Neck, femoral, transthoracic route

48 CSH Regional Alignment FY17 | September, 2016 | Confidential, for Internal Use Only