2A10Model
Hollow fiber

2A20

Material

Ethylene vinyl alcohol copolymer

Inner diameter

175 μmWall thickness

40 μm

Material
Housing

Priming volume

Polycarbonate resin

Membrane surfacearea

1.0 m22.0 m2Outer dimension

45φ x 280 L mm

57φ x 280 L mm

Outside hollow fibers

Approx. 85 mL

Approx. 108 mL

Inside hollow
fibersApprox. 82 mL

Approx. 150 mL

Filled liquid

Sterile water

Sterilization method

Gamma-ray irradiation

Autoimmune neurologicaldisorderTargetClinical condition

1 anti acetylcholine receptor
Myasthenia Gravis (MG)

Autoimmune disease of theneuromuscular junction(AChR) antibody

2 anti muscle specific receptor

1 IgG1, IgG3
2 IgG4tyrosine kinase (MusK) antibody

Guillain-Barré
Syndrome (GBS)

Acute progressive paralyzing
illness affecting both motorand sensory peripheral nerves
Autoimmune disorder ofganglioside of myelin sheath(spontaneous recovery inmost patients )anti ganglioside antibody

Chronic Inflammatory
Demyelinating
Polyradiculoneuropathy(CIDP)

Autoimmune disorder ofganglioside of myelin sheath(progress and relapses forover two or more months )anti ganglioside antibody

IgG1, IgG3
IgM, IgA

IgG1, IgG3
IgM, IgA

Blood cells
High molecular weight substances

From patient(Immunoglobulin,LDL,Lp(a) etc.)

Low molecular weight substances(Albumin etc.)

Multiple Sclerosis (MS)Autoimmune disorder ofcentral nervous system
white matter demyelination
involved by cellular immunity

anti myelin basic protein (MBP)
antibody,anti myelin oligodendrocyte
glycoprotein (MOG) antibody, etc.

Membrane Plasma Separator
or Centrifugal Cell Separator

1

IgG1,IgM
Back to patient2
Neuromyelitis Optica (NMO) /Devic’ syndrome

Autoimmune disorder of
optical nerve and spinal cord
involved by humoral immunity

anti aquaporin 4 (AQP4) antibody

Whole blood is separated
into blood cells and plasma.

IgG1

PlasmaFractionator

The plasma fraction containing
high molecular weight such as
Lipids is discarded.

3

4
RemovedLambert-Eaton syndrome
Myasthenic Syntrome (LEMS)

1

Autoimmune disorder of theneuromauscular junction andnerve ending

The plasma fraction,containing low molecularweight substances such as albumin,is returnedto the patient.

anti voltage-gated calcium channel(VGCC) antibody

IgG12High molecular weight substances andlow molecular weight substances inplasma are divided.

Blood Pump

Plasma Pump

Substitution Fluid (Albumin)< Optional >Drain Pump

1.0

5A

4A

3A

2A

Membrane
PlasmaSeparator

Anticoagulant

Sieving Coefficient (S.C.)

0.8

Evaflux TM(Specifications)

n=12,13,15,140.6

0.4

0.2

0.0(M.W.)
Waste Fluid

Untreated Plasma Bag

Plasma Pump

Drain Pump
< Optional >Albumin
67,000lgG160,000lgM
950,000

HDLLDL

EvafluxTM 2A

Alb.

lgGlgMS.C.

0.62

0.19

0.00

Substitution Fluid (Albumin)< Optional >Evaflux TM

Evaflux TM2A

Waste Fluid

3Fibrinogen
340,000

S.C.is a parameter indicating the membrane permeability at a certain point.

Albumin 62%lgG 19%lgM 0%Centrifugal
Cell Separator

TP4

Membrane Plasma /Centrifugal Cell SeparatorTC

Plasmapheresis-pulse
therapy groupn=6

Received DFPP followed by pulse therapy[DFPP] 1 – 3 times (every 7 days) per patient, using Evaflux 2A[Pulse therapy ] methylprednisolone 1,000mg/day

Supportive care group

n=6Only rehabilitation

lgG

lgM

mg/dlmg/dl

300

1500
200

1000
100500prepost0

P＜0.01

pre54433

2

ADL Grade

ADL GradeC3
5

Case 1Case 2
Case 3
Case 4
Case 5
Case 6

1

C4

mg/dl

mg/dl

100

60

45250

30

10

15

001234

56

Time

7M

012

34

Time

5

67M

0

prepostP＜0.01< Grading Scale for ADL >5post

P＜0.01

0: Bedridden

3: able to walk with aid

1: Able to stand with support

4: Unstable walk with effort

2: Able to stand without support but unable to walk

5: Normal

60

prepostP＜0.01