Manufacture Instruction - Hytek Scientifics Inc Straw Use-Instruction PPT 2013.pdf · Manufacture...

Preview:

Citation preview

How to Use iVitri®- Straw

system?

Manufacture Instruction

Information of iVitri®-Straw

• iVitri® is individual Vitrification Device,

called iVitri.

• iVitri® -Straw is US patent and patent

pending, and registered product (USPTO),

specifically designed for vitrification by

cooperation between physics and math

scientists, and top embryologist according

to liquid-device dynamics (Liquid droplet

radius is changed base on liquid volume,

however, external osmolality is not

changed with vary liquid volume), which

can be effectively used for freezing oocyte,

embryos and reproductive tissues (ovary

and TESE) in human and mammalian IVF.

Production of Package

Product is individual wrapped

and sterilized device (straw)

Product is individual wrapped and color

sterilized device (straw)

Advantage of iVitri® -Straw

• Special design material

• Special art and clear device

• Easy to use

• Easy to label by writing and label on the

handle

• Color code

• Higher survival rate and pregnancy rate

• Water approval after closing cover

• Multiple purpose for oocyte, embryo,

sperm, tissues.

Intended Use

• iVitri® is consisting primarily of two parts:

device body and outside cover. Each one

labeled with iVitri® Logo in handle as

upside. Patient’s name and ID or DOB can

be labeled by typing and writing in this

side.

BBBB SSSS

DOB: 03-12-65

VITRIFICATION PROCEDURE

• Follow up universal vitrification protocol,

and takes the iVitri® by the labeled side

with patient’ name and ID or necessary

information facing up.

Vitrification Procedure-cont. • Place the iVitri® under a microscope

(iVitri Logo should be up) and adjust the

focus on the black mark of the iVitri® (face

up)

• and put the oocytes or embryos (1~3)

near to the black mark with the minimal

volume of vitrification solution (1~2 μl).

The black mark makes easier to put

outside cover.

Vitrification Procedure-cont.

• and put the oocytes or embryos (1~3) near

to the black mark with the minimal volume of

vitrification solution (1.0~1.5 μl). The black

mark makes easier the cover up.

Vitrification Procedure-cont.

Vitrification Procedure-cont.

•Rapidly plunge the iVitri® into fresh

LN2 holding the IVitri®.

Vitrification Procedure-cont.

•Grab the cover with long tweezers (not surgical

forceps) and plunge it into the liquid nitrogen until stops

burbling, be aware don’t take the iVitri® out of the LN2

while covering up, tight and lock gently.

Vitrification Procedure-cont.

•Place the iVitri® into the cane (goblet) with the cover

facing down and store in LN2 tank.

WARMING PROCEDURE

Take out the patient’s canister from the Dewar and

place it into a LN2 container with LN2 covering

completely the iVitri®, and check patient’s information

on the label.

WARMING PROCEDURE-cont.

With long tweezers grabs the iVitri® body and takes it

off from the cane (goblet).

WARMING PROCEDURE-cont.

With long tweezers grab the cover, and pull cover out

without taking iVitri® body out the LN2, leave it always

inside LN2.

WARMING PROCEDURE-cont.

Quickly take off the iVitri® body (Logo face down) from LN2

and face down into pre-warmed thawing solution (drops or

dish) at 37ºC on the microscope stage or laminar hold surface,

and then follow the warming protocol.

WARMING PROCEDURE-cont.

completing recovery: Oocytes for 2 hours and Embryos for 3

hours.

Clinical Trial Data Analysis

Alteration of osmolality may seriously impact on the

survive rates of oocyte and embryos after warming,

consequently decrease pregnancy rate

Liquid volume and droplet radius can directly impact on

the alteration of osmolality, consequently decreased the

survive rate and quality of oocyte and embryos after

warming

Comparison of survive rates using three different vitri-

devices with loading vary volume of vitrification liquid from

0.5 to1.5µl containing bovine oocytes(900 oocytes)(%)

84

86

88

90

92

94

96

98

100

cryoleaf Cryotop iVitri

0.5µl

1.0µl

1.5µl

Comparison of survive rates using three different vitri-

devices with loading vary volume of vitrification liquid

from 0.5 to1.5µl containing oocytes and blastocyst(350

MII oocytes,360 blastocysts,2-3 oocytes or blastocysts

/device)(%)

90

91

92

93

94

95

96

97

98

99

cryoleaf Cryotop iVitri

Oocyte

Blastocyst

Thank you for your business!

Recommended