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Shanghai Chengsi Intelligent Technology Co.
, Ltd.
chooses the navigation service for you.
The egg retrieval needle is a puncture device that completes the ovulation induction process, produces mature follicles, and takes surgery to obtain the egg cells in the mature follicle before the normal rupture of the follicle
.
The size of the oocyte retrieval needle affects the extraction speed of follicular fluid and the bleeding after puncture, but it is not the case that the larger the diameter of the puncture needle, the better the oocyte retrieval treatment
.
After egg retrieval, it is recommended to take appropriate rest, avoid sitting and standing for long periods of time, and avoid fatigue that may lead to increased postoperative bleeding and affect recovery
.
What kind of test tube egg retrieval needle is? The egg retrieval needle is slender and not very thick.
The egg retrieval needle needs to be fixed together by a puncture frame and a vaginal ultrasound probe, and is inserted into the ovary through vaginal puncture for puncture and egg retrieval
.
At present, anesthesia can be selected for egg retrieval surgery.
After anesthesia, the whole process is basically painless, so don’t worry
.
At present, most or 99.
999% of IVF egg retrieval methods are puncture and egg retrieval under the guidance of B-ultrasound
.
Under the guidance of the B-ultrasound finger, a longer needle is used to pass through the vagina, and then through the posterior fornix to directly reach the inside of the ovary.
The follicles are seen under the B-ultrasound, and then the follicle puncture is performed to suck out the follicular fluid and egg cells, and then wear it down.
follicle
.
The overall damage is small.
Generally, one ovary is punctured once, and the follicles in the entire ovary can be sucked clean, the eggs are taken out, and then the other ovary can be punctured in another direction
.
In individual cases, the position of the ovary is not good or the ovary is too large, sometimes 2-3 punctures are required, and sometimes it may even penetrate the uterine muscle wall to reach the ovary
.
When an individual patient performs puncture, even a thin needle may damage the bladder and blood vessels and cause bleeding, but the incidence is low
.
This method is more effective, less damage, and there will be pain
.
Some reproductive centers can take painless egg retrieval, and some reproductive centers can not do everyone painless, so there will be pain relief methods
.
Part 1: Test standard for rigidity test of reproductive puncture and oocyte retrieval needle: GB/T18457-2015 Stainless steel needle tube for manufacturing medical devices ISO9626-2016 Requirements and test methods for stainless steel needle tube for medical device manufacturing Technical parameters: Operation interface: Simplified Chinese/English Tube wall: Normal wall, thin wall, ultra-thin wall, and ultra-thin wall are optional; nominal size: 0.
1～6.
5mm (all sizes can be tested); set load: 0.
01～120N, accuracy: ±0.
001N; loading rate : 1±0.
1mm/min; span: 5～50mm, automatic control system span distance setting accuracy: ±0.
01mm (11 specifications); deflection test: 0～10mm, accuracy: ±0.
001mm; configuration micrometer 0-25mm Printing method of deflection test items: 100 times of test data and average deflection value and deviation value can be printed each time
.
Programmable controller: PLC/ARM Touch screen: 7-inch color touch screen Weiluntong Sensor: high-precision force sensor Force measuring mechanism: Built-in printer: Airborne needle printer Part II: Reproductive puncture needle toughness test Detailed introduction: The tester adopts a 7-inch color LCD screen, and the Chinese menu displays: tube wall type, bending angle, nominal specification, distance between fulcrum and action point, and bending times
.
The program is set by the PLC programmable controller, and the test is automatic
.
The working principle of the medical needle tube (needle) toughness tester is to fix one end of the needle tube, apply a force from the fixed point to the needle tube with a specified span, first bend it in one direction and then in the opposite direction by a specified angle, and repeat the bending regulations.
The experimental operation steps are as follows: 1.
Take an appropriate amount of injection needle, and fix a section of the needle body firmly on the fixture; 2.
Fix one end of the needle firmly on the fixture, and adjust the corresponding needle tube according to Table 3.
The specified span load selects the following bending angles, normal wall 25°, thin wall 20°, and ultra-thin wall 15°
.
3.
Apply a large enough force at the specified span position, apply the force 20 times in both directions at a frequency of 0.
5Hz, and visually observe the breakage of the needle tube
.
The third part: Reproductive puncture and egg retrieval needle flow test catheter flow tester weighing method to collect and calculate catheter flow, which fully complies with the relevant provisions of YY0285, GB/T15812.
1 standard test requirements
.
Test range: 1.
00～600.
00g (varies accordingly according to the specifications of the catheter)
.
Test accuracy: ±0.
01%F.
S (one ten thousandth of full scale)
.
Still water level height: 200 ± 5 mm and 1000 ± 5 mm; automatic circulation of the water pump (adjustable still water level)
.
Time controller fixture: adapt to various conduits; flow calculation: weighing method measurement
.
Flow rate: 525ml/min ±5 ml/min Net weight: 12.
5kg Dimensions: about 1200 × 400 × 300 (mm) The puncture needle for assisted reproduction refers to the operation of in vitro fertilization-embryo transfer and its derivative techniques.
Special equipment for puncturing the follicles in the ovary to obtain oocytes, managed as Class II medical devices
.
Part 4: The vacuum leak test of reproductive puncture and egg retrieval needle adopts 7-inch (color PLC LCD touch screen, Chinese menu display
.
The nominal capacity of the product is selected by the touch screen.
Display mode: the pressure output value can be set arbitrarily, and it can be printed Output report, adjustable display time, suitable for equipment used in research and development products
.
The
verification error is not greater than ±1% of the reading
.
Fully comply with the YYT1698-2020 standard 1.
PLC control system, color 7-inch touch screen display operation interface; 7.
A set of professional testing software for medical devices, and remote free upgrades; 2.
Test time: test duration: 1 second to 99.
9 minutes, The error is not greater than ±1S; 3.
Positive pressure: 0-300KP; 4.
Negative pressure: -90KPA-300KP; Pack filters, pipes, conduits, quick connectors,
etc.
8, The constant pressure and constant water temperature control system is equipped with a constant temperature tank of 15L, the temperature range is 0-99°, with refrigeration function, made of stainless steel; 9, High-precision pressure sensor is used to ensure stable voltage; 10, Embedded printer; 11, Built-in gas storage The tank is made of stainless steel 1 liter 12, the shell is made of Q235 plate, the outer surface is painted, and the color matches the atmosphere; 13, the fixture is made of SUS304, the surface is polished, and the rust function is not applied; 1.
The research and development experiment of the puncture needle for assisted reproduction Requirements 1.
Product performance research The structure, size, surface, and internal handling of the needle for oocyte retrieval, as well as the vacuum suction device, have an impact on intraoperative pain and bleeding, egg cell quality and subsequent embryo development
.
In order to meet the requirements of expected performance, the design and development should take into account the damage to the patient during the puncture process when the product is used, and the potential damage to the egg cells during vacuum suction
.
The product performance research materials should include but not limited to the relevant performance indicators in the product technical requirements, and should cover the effectiveness, safety indicators and the basis for determining the indicators related to quality control, the standards/methods adopted and the reasons for adoption,
etc.
(1) Describe in detail the basis for determining all performance indicators and inspection methods, give the reasons for adoption and theoretical basis, and issue the research materials, literature materials and/or standard texts involved
.
(2) If the composition of the declared product is quite different from that of similar products already on the market in China, the research data on the effect of the product on the success rate of egg retrieval and the shape of egg cells should be provided
.
(3) Bacterial endotoxin and its setting basis should be explained, and ethylene oxide and other impurities and their setting basis should be explained
.
(4) Special performance research For the products made by the registration applicant using new materials and other special performances such as coatings or claimed to be safer/simpler to operate, the enterprise should formulate corresponding performance requirements according to the product characteristics, and design and verify the special performance.
Test methods for performance, clarify the source of test methods or issue methodological confirmation data
.
(5) Explain the products used in conjunction with the product, such as negative pressure suction devices, clarify the range of negative pressure values and provide the basis for verification
.
Indicate whether the product should be used under ultrasound guidance
.
The thickness of oocyte retrieval needles varies from 0.
90mm to 1.
6mm
.
Clinically, there are six types of egg retrieval needles, namely 16G, 17G, 18G, 19G, 20G, and 21G
.
Among them, the diameter of 16G needle is about 1.
60mm, the diameter of 17G is about 1.
36mm, the diameter of 18G is about 1.
21mm, the diameter of 19G is about 1.
08mm, the diameter of 20G needle is about 0.
90mm, and the diameter of 21G needle is about 0.
82mm
.
During the operation, different types of egg retrieval needles are usually selected according to the operator’s habits and the requirements of different reproductive centers.
Generally speaking, 17G and 18G are more commonly used.
Some reproductive centers may choose 17G (1.
36mm) size egg retrieval needles, and some may choose 18G(1.
21mm)
.
, Ltd.
chooses the navigation service for you.
The egg retrieval needle is a puncture device that completes the ovulation induction process, produces mature follicles, and takes surgery to obtain the egg cells in the mature follicle before the normal rupture of the follicle
.
The size of the oocyte retrieval needle affects the extraction speed of follicular fluid and the bleeding after puncture, but it is not the case that the larger the diameter of the puncture needle, the better the oocyte retrieval treatment
.
After egg retrieval, it is recommended to take appropriate rest, avoid sitting and standing for long periods of time, and avoid fatigue that may lead to increased postoperative bleeding and affect recovery
.
What kind of test tube egg retrieval needle is? The egg retrieval needle is slender and not very thick.
The egg retrieval needle needs to be fixed together by a puncture frame and a vaginal ultrasound probe, and is inserted into the ovary through vaginal puncture for puncture and egg retrieval
.
At present, anesthesia can be selected for egg retrieval surgery.
After anesthesia, the whole process is basically painless, so don’t worry
.
At present, most or 99.
999% of IVF egg retrieval methods are puncture and egg retrieval under the guidance of B-ultrasound
.
Under the guidance of the B-ultrasound finger, a longer needle is used to pass through the vagina, and then through the posterior fornix to directly reach the inside of the ovary.
The follicles are seen under the B-ultrasound, and then the follicle puncture is performed to suck out the follicular fluid and egg cells, and then wear it down.
follicle
.
The overall damage is small.
Generally, one ovary is punctured once, and the follicles in the entire ovary can be sucked clean, the eggs are taken out, and then the other ovary can be punctured in another direction
.
In individual cases, the position of the ovary is not good or the ovary is too large, sometimes 2-3 punctures are required, and sometimes it may even penetrate the uterine muscle wall to reach the ovary
.
When an individual patient performs puncture, even a thin needle may damage the bladder and blood vessels and cause bleeding, but the incidence is low
.
This method is more effective, less damage, and there will be pain
.
Some reproductive centers can take painless egg retrieval, and some reproductive centers can not do everyone painless, so there will be pain relief methods
.
Part 1: Test standard for rigidity test of reproductive puncture and oocyte retrieval needle: GB/T18457-2015 Stainless steel needle tube for manufacturing medical devices ISO9626-2016 Requirements and test methods for stainless steel needle tube for medical device manufacturing Technical parameters: Operation interface: Simplified Chinese/English Tube wall: Normal wall, thin wall, ultra-thin wall, and ultra-thin wall are optional; nominal size: 0.
1～6.
5mm (all sizes can be tested); set load: 0.
01～120N, accuracy: ±0.
001N; loading rate : 1±0.
1mm/min; span: 5～50mm, automatic control system span distance setting accuracy: ±0.
01mm (11 specifications); deflection test: 0～10mm, accuracy: ±0.
001mm; configuration micrometer 0-25mm Printing method of deflection test items: 100 times of test data and average deflection value and deviation value can be printed each time
.
Programmable controller: PLC/ARM Touch screen: 7-inch color touch screen Weiluntong Sensor: high-precision force sensor Force measuring mechanism: Built-in printer: Airborne needle printer Part II: Reproductive puncture needle toughness test Detailed introduction: The tester adopts a 7-inch color LCD screen, and the Chinese menu displays: tube wall type, bending angle, nominal specification, distance between fulcrum and action point, and bending times
.
The program is set by the PLC programmable controller, and the test is automatic
.
The working principle of the medical needle tube (needle) toughness tester is to fix one end of the needle tube, apply a force from the fixed point to the needle tube with a specified span, first bend it in one direction and then in the opposite direction by a specified angle, and repeat the bending regulations.
The experimental operation steps are as follows: 1.
Take an appropriate amount of injection needle, and fix a section of the needle body firmly on the fixture; 2.
Fix one end of the needle firmly on the fixture, and adjust the corresponding needle tube according to Table 3.
The specified span load selects the following bending angles, normal wall 25°, thin wall 20°, and ultra-thin wall 15°
.
3.
Apply a large enough force at the specified span position, apply the force 20 times in both directions at a frequency of 0.
5Hz, and visually observe the breakage of the needle tube
.
The third part: Reproductive puncture and egg retrieval needle flow test catheter flow tester weighing method to collect and calculate catheter flow, which fully complies with the relevant provisions of YY0285, GB/T15812.
1 standard test requirements
.
Test range: 1.
00～600.
00g (varies accordingly according to the specifications of the catheter)
.
Test accuracy: ±0.
01%F.
S (one ten thousandth of full scale)
.
Still water level height: 200 ± 5 mm and 1000 ± 5 mm; automatic circulation of the water pump (adjustable still water level)
.
Time controller fixture: adapt to various conduits; flow calculation: weighing method measurement
.
Flow rate: 525ml/min ±5 ml/min Net weight: 12.
5kg Dimensions: about 1200 × 400 × 300 (mm) The puncture needle for assisted reproduction refers to the operation of in vitro fertilization-embryo transfer and its derivative techniques.
Special equipment for puncturing the follicles in the ovary to obtain oocytes, managed as Class II medical devices
.
Part 4: The vacuum leak test of reproductive puncture and egg retrieval needle adopts 7-inch (color PLC LCD touch screen, Chinese menu display
.
The nominal capacity of the product is selected by the touch screen.
Display mode: the pressure output value can be set arbitrarily, and it can be printed Output report, adjustable display time, suitable for equipment used in research and development products
.
The
verification error is not greater than ±1% of the reading
.
Fully comply with the YYT1698-2020 standard 1.
PLC control system, color 7-inch touch screen display operation interface; 7.
A set of professional testing software for medical devices, and remote free upgrades; 2.
Test time: test duration: 1 second to 99.
9 minutes, The error is not greater than ±1S; 3.
Positive pressure: 0-300KP; 4.
Negative pressure: -90KPA-300KP; Pack filters, pipes, conduits, quick connectors,
etc.
8, The constant pressure and constant water temperature control system is equipped with a constant temperature tank of 15L, the temperature range is 0-99°, with refrigeration function, made of stainless steel; 9, High-precision pressure sensor is used to ensure stable voltage; 10, Embedded printer; 11, Built-in gas storage The tank is made of stainless steel 1 liter 12, the shell is made of Q235 plate, the outer surface is painted, and the color matches the atmosphere; 13, the fixture is made of SUS304, the surface is polished, and the rust function is not applied; 1.
The research and development experiment of the puncture needle for assisted reproduction Requirements 1.
Product performance research The structure, size, surface, and internal handling of the needle for oocyte retrieval, as well as the vacuum suction device, have an impact on intraoperative pain and bleeding, egg cell quality and subsequent embryo development
.
In order to meet the requirements of expected performance, the design and development should take into account the damage to the patient during the puncture process when the product is used, and the potential damage to the egg cells during vacuum suction
.
The product performance research materials should include but not limited to the relevant performance indicators in the product technical requirements, and should cover the effectiveness, safety indicators and the basis for determining the indicators related to quality control, the standards/methods adopted and the reasons for adoption,
etc.
(1) Describe in detail the basis for determining all performance indicators and inspection methods, give the reasons for adoption and theoretical basis, and issue the research materials, literature materials and/or standard texts involved
.
(2) If the composition of the declared product is quite different from that of similar products already on the market in China, the research data on the effect of the product on the success rate of egg retrieval and the shape of egg cells should be provided
.
(3) Bacterial endotoxin and its setting basis should be explained, and ethylene oxide and other impurities and their setting basis should be explained
.
(4) Special performance research For the products made by the registration applicant using new materials and other special performances such as coatings or claimed to be safer/simpler to operate, the enterprise should formulate corresponding performance requirements according to the product characteristics, and design and verify the special performance.
Test methods for performance, clarify the source of test methods or issue methodological confirmation data
.
(5) Explain the products used in conjunction with the product, such as negative pressure suction devices, clarify the range of negative pressure values and provide the basis for verification
.
Indicate whether the product should be used under ultrasound guidance
.
The thickness of oocyte retrieval needles varies from 0.
90mm to 1.
6mm
.
Clinically, there are six types of egg retrieval needles, namely 16G, 17G, 18G, 19G, 20G, and 21G
.
Among them, the diameter of 16G needle is about 1.
60mm, the diameter of 17G is about 1.
36mm, the diameter of 18G is about 1.
21mm, the diameter of 19G is about 1.
08mm, the diameter of 20G needle is about 0.
90mm, and the diameter of 21G needle is about 0.
82mm
.
During the operation, different types of egg retrieval needles are usually selected according to the operator’s habits and the requirements of different reproductive centers.
Generally speaking, 17G and 18G are more commonly used.
Some reproductive centers may choose 17G (1.
36mm) size egg retrieval needles, and some may choose 18G(1.
21mm)
.
