CN105833373A - Hollow fiber membrane oxygenator and method - Google Patents

Hollow fiber membrane oxygenator and method Download PDF

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Publication number
CN105833373A
CN105833373A CN201610409016.7A CN201610409016A CN105833373A CN 105833373 A CN105833373 A CN 105833373A CN 201610409016 A CN201610409016 A CN 201610409016A CN 105833373 A CN105833373 A CN 105833373A
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blood
temperature
chamber
oxygenation
shell
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Inventor
李雷
谢茜
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BEIJING MEDOS AT BIOTECHNOLOGY CO LTD
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BEIJING MEDOS AT BIOTECHNOLOGY CO LTD
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Priority to CN201610409016.7A priority Critical patent/CN105833373A/en
Publication of CN105833373A publication Critical patent/CN105833373A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3601Extra-corporeal circuits in which the blood fluid passes more than once through the treatment unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607Regulation parameters
    • A61M1/3609Physical characteristics of the blood, e.g. haematocrit, urea
    • A61M1/3612Physical characteristics of the blood, e.g. haematocrit, urea after treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3627Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/369Temperature treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0208Oxygen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/02Gases
    • A61M2202/0225Carbon oxides, e.g. Carbon dioxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/202Blood composition characteristics partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/50Temperature

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

The invention discloses a hollow fiber membrane oxygenator and a method, and belongs to the technical field of medical devices. The hollow fiber membrane oxygenator is characterized in that the inner cavity of an outer shell is connected with a middle shell; the outer shell and the middle shell define the cavity of an oxygenation room; the inner cavity of the middle shell is connected with an inner shell; the cavity of a variable-temperature room is formed between the middle shell and the inner shell; an upper cover is connected to the top of the outer shell; an oxygenation membrane is connected to the cavity of the oxygenation room between the outer shell and the middle shell; a variable-temperature membrane is connected to the cavity of the variable-temperature room between the middle shell and the inner shell; a lower bottom is connected with the bottom of the outer shell, and is partitioned into a lower bottom inner cavity, a lower bottom middle cavity and a lower bottom outer cavity; the lower bottom inner cavity is a blood path with a blood inlet; the lower bottom middle cavity is a water path with a water outlet; the top side face of the outer shell is connected with an arterial blood air outlet; the bottom side face of the outer shell is connected with a blood outlet; an arterial blood sampling port is formed in the blood outlet; the bottom side face of the outer shell is connected with a temperature measuring port; the upper cover is partitioned into an upper cover inner cavity and an upper cover outer cavity; the upper cover inner cavity is taken as a water path; the upper cover inner cavity is connected with a water inlet; the upper cover outer cavity is connected with an air inlet; a cardioplegic solution injection port/arterial blood recirculation port is connected to a lower bottom side face.

Description

A kind of hollow-fiber membrane oxygenator and method
Technical field
The present invention relates to a kind of hollow-fiber membrane oxygenator and method, belong to technical field of medical instruments.
Background technology
Extracorporeal circulation is that internal venous blood causes the external oxygenate that carries out, in the most defeated ex vivo, oxygenator It is the necessary devices carrying out extracorporeal circulation in operation on vessels of heart, replaces pulmonary function that blood carries out oxygenate (row Except the CO2 in blood, increase the O2 in blood) and alternating temperature.High performance oxygenator will be greatly improved hands Art success rate, reduces the generation of post-operative complication, improves the quality of life that patient is postoperative.Domestic now The oxygenator being widely used in clinic is bubble oxygenator, is to utilize gas foaming in a foaming bucket Principle carries out oxygenate to blood, and oxygenate effect is poor, and safety is relatively low, membrane oxygenator will gradually take and Instead of.Membrane oxygenator be mainly characterized by blood and gas is not directly contacted with, by a floor height molecule half Permeable membrane carries out oxygen and carbon dioxide exchange.The doughnut structure that membrane oxygenator uses by interior walk blood, outer Flat develop into interior flat, external blood circulation, reduce flowing pressure inside and outside hollow fiber conduit poor, reduce flowing Shearing force, expands oxygenate area, reduces the destruction to blood.Existing domestic membrane oxygenator quality water Flat relatively low, priming volume is relatively big, and oxygenate effect is bad, increases the risk of operation, and imported product is then because becoming This problem cannot be economic and practical in all patients.
Existing membrane oxygenator is typically made up of oxygenation chamber and temperature-changing chamber Liang Ge cylindrical chamber.Existing oxygenate Device is usually and is made up of cylindrical temperature-changing chamber and oxygenation chamber, and the two is nesting type structure, oxygenation chamber outside, Including temperature-changing chamber.Venous blood first passes through temperature-changing chamber, then flows into oxygenation chamber gas exchange, is converted into artery blood flow Go out.
The annular space that shell is constituted with mesochite is oxygenation chamber, loads oxygen press mold, oxygen press mold, and outer wrapping filters Net;The annular space that mesochite is constituted with space occupying core is temperature-changing chamber, loads alternating temperature film;Oxygenation chamber, temperature-changing chamber two End closure glue intercepts bloody path, water route and gas circuit.These oxygenator two ends are upper cover and lower cover respectively, bonding At housing two ends.
Prior art shortcoming:
1, oxygenation membrane, alternating temperature membrane process level are relatively low;
2, oxygenate, alternating temperature efficiency are low;
3. unreasonable structure, priming volume is big;
4, blood pressure drop, alternating temperature hydraulic pressure fall, gas pressure drop height;
5, arterial blood steam vent position is unreasonable, and in blood, bubble cannot effectively be got rid of, and increases operation risk.
Summary of the invention
In order to overcome the deficiencies in the prior art, the present invention provides a kind of hollow-fiber membrane oxygenator and side Method.
A kind of hollow-fiber membrane oxygenator, overall in cylinder, the inner chamber of shell connects mesochite, shell with Mesochite constitutes the cavity of oxygenation chamber, and the inner chamber of mesochite connects inner shell, constitutes temperature-changing chamber between mesochite and inner shell Cavity, the top of upper cover connected with outer casing, the oxygenation chamber cavity that oxygenation membrane is connected between shell and mesochite In, in the cavity of the temperature-changing chamber that alternating temperature film is connected between mesochite and inner shell, the bottom with shell of going to the bottom connects Connecing, inner chamber, go to the bottom lumen and the exocoel of going to the bottom of point going to the bottom of going to the bottom, inner chamber of going to the bottom is that bloody path is with blood inlet;Under End lumen is that water route is with outlet;Cover top portion side connects arterial blood air vent, outer casing bottom side Connecting blood outlet, with arterial blood thief hatch on blood outlet, outer casing bottom side connects temperature-measuring port;Upper cover Divide upper cover cavity and upper cover exocoel;Upper cover cavity is water route, and upper cover cavity connects water inlet;Upper cover exocoel Connect air inlet;Stop jumping the side that liquid inlet/arterial blood recirculation port is connected to go to the bottom.
Upper cover exocoel is gas circuit.Exocoel of going to the bottom is that gas circuit is with gas outlet.Oxygenation chamber and temperature-changing chamber use embedding Nested structure.Oxygenation chamber external diameter 7~15cm, oxygenation chamber inner shell internal diameter 1~5cm, temperature-changing chamber and oxygenate Room high 6~18cm, upper cover external diameter 8~15cm, external diameter 8~15cm of going to the bottom, overall high 10~30cm. Overall priming volume is 250~350ml.The oxygenate area 1.5m of oxygenation chamber2~3m2, temperature-changing chamber Alternating temperature area 0.35m2~0.8m2.Oxygenation chamber and temperature-changing chamber are cylindrical chamber.Blood outlet is positioned at oxygen Closing room bottommost, blood outlet is 2-8cm with the blood inlet distance of lower bottom.
A kind of hollow fiber film type oxygenate method, containing following steps;
Use disposable integrated glue envelope processing step by oxygenation membrane, shell, mesochite combine, with this close by The cavity that shell is constituted with mesochite, forms oxygenation chamber;
Use disposable integrated glue envelope processing step by alternating temperature film, mesochite, inner shell combine, with this close by The cavity that mesochite is constituted with inner shell, forms temperature-changing chamber;
Blood enters oxygenator from the blood inlet gone to the bottom, from bottom to top by becoming from alternating temperature film doughnut The alternating temperature water flowed from top to bottom in greenhouse, with alternating temperature film doughnut carries out heat exchange at fiber surface;
Blood after alternating temperature passes through in oxygenation chamber, with oxygenation membrane the most from top to bottom from oxygenation membrane doughnut The gas flowed from top to bottom in hollow fiber carries out gas exchange by the fenestra on fibre wall;Last alternating temperature, Blood after oxygenate leaves oxygenator by blood outlet;
When blood is by temperature-changing chamber, and between the alternating temperature water in hollow-fibre membrane, form adverse current, improve oxygen The alternating temperature efficiency of clutch;
There is the CO2 concentration step measuring in gas by capnometer;
There is collection arterial blood sample testing sequence,
Have and measure in real time and monitoring arterial blood temperature step;
Oxygenation chamber and temperature-changing chamber is used to use nesting type structure;
Use the macromolecular material hollow-fibre membrane that blood compatibility is excellent;
Oxygenation membrane is produced prepared by microporous polypropylene fibers and the ECMO/ECLS diffusion barrier of standard;
Alternating temperature film is prepared by polypropylene hollow fiber;
Oxygenation membrane is wound around by double layer fibre pad with alternating temperature membrane fiber Shu Jun, and the fiber in each layer of fiber mat is handed over There is angle each other in fork arrangement.
The double layer fibre pad of the present invention, strengthens blood flowing.Oxygenation membrane is double-deck with alternating temperature membrane fiber Shu Jun Fiber mat is wound around, and the fiber crossovers arrangement in each layer of fiber mat exists angle each other so that blood Flow process overcomes boundary region, improves oxygenate, alternating temperature efficiency;
Advantages of the present invention is compact overall structure;Optimum blood path, oxygenate, alternating temperature effect Maximize;Priming volume is little: priming volume is 250~350ml.Take into account and maximize oxygenate area and alternating temperature Area, oxygenate area 1.5m2~3m2, alternating temperature area 0.35m2~0.8m2;Fluid design optimizes, Oxygenate alternating temperature efficiency is high: blood is the most from bottom to top by temperature-changing chamber, then passes through oxygenation chamber from top to bottom, double Layer fiber mat mode makes blood be fully contacted with doughnut, thus improves oxygenate alternating temperature efficiency;Blood During by temperature-changing chamber, and between the alternating temperature water in hollow-fibre membrane, form adverse current, substantially increase oxygenator Alternating temperature efficiency;Gas pressure drop is low, relatively low gas pressure drop substantially reduce in blood produce aeroembolism can Energy;Blood pressure drop is low, has new flow pattern owing to reducing oxygenator height and blood, from And achieve relatively low blood pressure drop so that perform the operation more safe and reliable;Alternating temperature hydraulic pressure reduces so that oxygen Clutch has higher safety.The gas flow design of safety so that even if owing to contingency makes Outlet obstruction, the pressure in oxygenator also will not excessively increase;An arm is devised at gas outlet Road, can measure the CO2 concentration in gas by capnometer.
Excellent bubble removing ability, it is ensured that the two distance is farthest, bubble is discharged more complete.It is fully transparent, Perfect vision, shell is polyurethane material, and internal structure is fully visible, improves safety.
Scientific and reasonable interface position, the fast connection interface of safe and reliable standard, stop jumping liquid/recirculation port and be positioned at Oxygenation chamber obtains minimum point, with blood outlet in same level position, for stoping jumping the oxygenate ability that liquid provides maximum; Into and out of blood mouth with in side, entery and delivery port is with at opposite side, and conveniently operation, prevents alternating temperature water to oxygen The transducer potector of clutch pollutes;Blood collection mouth is positioned at the top of blood outlet, so can be more easily Operate and measure more accurately;Temperature probe in temperature-measuring port bonds in the horizontal aperture of blood outlet, Measure blood heat more accurately;Other technology compatible: can integrated lower resistance Micro-Bolt Filter;Oxygenate Device can be coated, integrated with venous return room adapter, rotatable 180 ° of uses.
Accompanying drawing explanation
When considered in conjunction with the accompanying drawings, by referring to detailed description below, it is possible to more complete the most geographical Solve the present invention and easily learn the advantage that many of which is adjoint, but accompanying drawing described herein is used for providing A further understanding of the present invention, constitutes the part of the present invention, the illustrative examples of the present invention and Illustrate to be used for explaining the present invention, be not intended that inappropriate limitation of the present invention, such as figure wherein:
Fig. 1 is the cross section structure schematic diagram of the present invention.
Fig. 2 is the structural representation of the present invention.
The present invention is further described with embodiment below in conjunction with the accompanying drawings.
Detailed description of the invention
Obviously, those skilled in the art belong to this based on the many modifications and variations that spirit of the invention is done The protection domain of invention.
Those skilled in the art of the present technique are appreciated that unless expressly stated, singulative used herein " one ", " one ", " described " and " being somebody's turn to do " may also comprise plural form.Will be further understood that , the wording used in the description of the present invention " includes " referring to there is described feature, integer, step Suddenly, operation, element and/or assembly, but it is not excluded that existence or add other features one or more, Integer, step, operation, element, assembly and/or their group.It should be understood that when we claim element Being " connected " or during " coupled " to another element, it can be directly connected or coupled to other elements, Or intermediary element can also be there is.Additionally, " connection " used herein or " coupling " can include Wireless connections or couple.Wording "and/or" used herein includes one or more row being associated Go out any cell and all combinations of item.
Those skilled in the art of the present technique are appreciated that unless otherwise defined, all terms used herein (bag Include technical term and scientific terminology) there is the general reason with the those of ordinary skill in art of the present invention Solve identical meaning.Should also be understood that those terms defined in such as general dictionary should be managed Solve for have the meaning consistent with the meaning in the context of prior art and unless fixed as here Justice, will not explain by idealization or the most formal implication.
For ease of the understanding to the embodiment of the present invention, below in conjunction with accompanying drawing as a example by several specific embodiments It is further explained explanation, and each embodiment is not intended that the restriction to the embodiment of the present invention.
Embodiment 1: as shown in Figure 1 and Figure 2, a kind of hollow-fiber membrane oxygenator, overall in cylinder, The inner chamber of shell 1 connects mesochite 2, the oxygenation chamber cavity that shell 1 is constituted with mesochite 2, mesochite 2 interior Chamber connects inner shell 3, constitutes temperature-changing chamber cavity between mesochite 2 and inner shell 3, upper cover 4 connected with outer casing 1 Top, oxygenation membrane 6 is connected in the oxygenation chamber cavity between shell 1 and mesochite 2, and alternating temperature film 7 connects In temperature-changing chamber cavity between mesochite 2 and inner shell 3,
Go to the bottom and 5 be connected with the bottom of shell 1, three layers of chamber of go to the bottom 5 points of inner chambers, lumen and exocoel, inner chamber For bloody path with blood inlet 15;Lumen is that water route is with outlet 16;Exocoel is that gas circuit is with gas outlet 17;
Shell 1 top-side connects arterial blood air vent 8, and shell 1 bottom sides connects blood outlet 10, With arterial blood thief hatch 11 on blood outlet 10, shell 1 bottom sides connects temperature-measuring port 12;
Upper cover 4 points upper cover cavity, two layers of chamber of upper cover exocoel.Upper cover cavity is water route, and upper cover cavity is even Tap into the mouth of a river 13;Upper cover exocoel is gas circuit, and upper cover exocoel connects air inlet 14;
Stop jumping liquid inlet/arterial blood recirculation port 9 be connected to go to the bottom 5 side.
Blood from go to the bottom 5 blood inlet 15 enter oxygenator, from bottom to top from alternating temperature film 7 doughnut Heat is carried out at fiber surface by the alternating temperature water flowed from top to bottom in temperature-changing chamber, with alternating temperature film 7 doughnut Exchange;Blood after alternating temperature passes through oxygenation chamber the most from top to bottom from oxygenation membrane 6 doughnut, with oxygenate The gas flowed from top to bottom in film 6 doughnut carries out gas exchange by the fenestra on fibre wall;Finally Blood after alternating temperature, oxygenate leaves oxygenator by blood outlet 10.
Arterial blood air vent 8 can be used for discharging bubble in blood, stops jumping liquid inlet/arterial blood recirculation port 9 stop jumping liquid and arterial blood recirculation for injection, and arterial blood thief hatch 11 is used for gathering arterial blood sample inspection Test, temperature-measuring port 12 is for measurement in real time and monitors arterial blood temperature.
Embodiment 2: as shown in Figure 1 and Figure 2, a kind of hollow-fiber membrane oxygenator, use blood compatibility Property excellent novel high polymer material hollow-fibre membrane prepare, double layer fibre pad increases blood fluidity, whole Body compact conformation, priming volume is little, takes into account and maximize oxygenate area and alternating temperature area, optimum blood stream Dynamic route, oxygenate alternating temperature efficiency is high, and gas, blood, hydraulic pressure reduce, and the gas flow design of safety is excellent Bubble removing ability, fully transparent with perfect vision, scientific and reasonable interface position, safe and reliable The fast connection interface of standard, can integrated lower resistance Micro-Bolt Filter, can applying coating, adaptive with venous return room Device integration, rotatable 180 ° of uses.
A kind of hollow-fiber membrane oxygenator, uses the novel high polymer material hollow that blood compatibility is excellent Fibrous membrane;Double layer fibre pad, strengthens blood flowing;Oxygenation chamber and temperature-changing chamber use nesting type structure;In advance Charge is little;Optimum blood path, oxygenate, alternating temperature effect maximization: blood first from bottom to top leads to Crossing temperature-changing chamber, more from top to bottom by oxygenation chamber, blood outlet is positioned at oxygenation chamber bottommost, the two distance is Closely, so that blood flow paths is the longest, blood has the doughnut of gas or alternating temperature water to fill with inside Tap is touched, and oxygenate, alternating temperature effect are maximum;Take into account and maximize oxygenate area and alternating temperature area;Fluid sets Meter optimizes, and oxygenate alternating temperature efficiency is high;Gas, blood, hydraulic pressure fall is substantially reduced;Excellent bubble removing ability: Bubble discharge ability with optimum blood path be consistent, blood from bottom to top after temperature-changing chamber, Bubble in blood can be discharged by arterial blood air vent, and arterial blood air vent arranges the top of oxygenation chamber Portion, the blood outlet of distance oxygenation chamber bottommost is farthest, and bubble is discharged more complete.
A kind of hollow-fiber membrane oxygenator, in cylinder, ecto-entad be respectively shell 1, mesochite 2, Inner shell 3, upper cover 4, go to the bottom 5.By disposable integrated glue envelope technique by oxygenation membrane 6, shell 1, mesochite 2 combine, and close, with this, the cavity being made up of shell and mesochite, form oxygenation chamber;Disposable one fill work Alternating temperature film 7, mesochite 2, inner shell 3 are combined by skill, close, with this, the chamber being made up of mesochite 2 with inner shell 3 Body, forms temperature-changing chamber.These oxygenator two ends are upper cover 4 respectively and go to the bottom 5, bonding outer, in, inner shell, Form gas circuit, bloody path, water route.Cover top portion side is arterial blood air vent 8, has immediately below it;Bottom Side is blood outlet 10, and with arterial blood thief hatch 11 on blood outlet 10, there is temperature-measuring port 12 side.On Cover 4 points of inside and outside two layers of chambeies.Inner chamber is water route, with water inlet 13;Exocoel is gas circuit, with air inlet Mouth 14.Go to the bottom in 5 points, in, outer three layers of chamber, inner chamber is that bloody path is with blood inlet 15;Lumen is water route With outlet 16;Exocoel is that gas circuit is with gas outlet 17.
Blood from go to the bottom 5 blood inlet 15 enter oxygenator, from bottom to top from alternating temperature film 7 doughnut Heat is carried out at fiber surface by the alternating temperature water flowed from top to bottom in temperature-changing chamber, with alternating temperature film 7 doughnut Exchange;Blood after alternating temperature passes through oxygenation chamber the most from top to bottom from oxygenation membrane 6 doughnut, with oxygenate The gas flowed from top to bottom in film 6 doughnut carries out gas exchange by the fenestra on fibre wall;Finally Blood after alternating temperature, oxygenate leaves oxygenator by blood outlet 10.
Arterial blood air vent 8 can be used for discharging bubble in blood, stops jumping liquid inlet/arterial blood recirculation port 9 stop jumping liquid and arterial blood recirculation for injection, and arterial blood thief hatch 11 is used for gathering arterial blood sample inspection Test, temperature-measuring port 12 is for measurement in real time and monitors arterial blood temperature.
Hollow-fibre membrane is prepared by the novel high polymer material that blood compatibility is excellent.Oxygenation membrane is by standard Microporous polypropylene fibers and ECMO/ECLS diffusion barrier produce prepare, alternating temperature film is by polypropylene hollow fiber system ?;
Double layer fibre pad, strengthens blood flowing.Oxygenation membrane is twined by double layer fibre pad with alternating temperature membrane fiber Shu Jun Around, there is angle in the fiber crossovers arrangement in each layer of fiber mat so that blood flow process each other In overcome boundary region, improve oxygenate, alternating temperature efficiency;
Compact overall structure: oxygenation membrane and alternating temperature film use import glue disposable integrated glue envelope, oxygen with housing Close film and alternating temperature film and fill oxygenation chamber and temperature-changing chamber Liang Ge cylindrical chamber respectively, and connect upper cover with under The gas circuit chamber at the end and chamber, water route, gas, blood, water route are kept completely separate;Oxygenation chamber and temperature-changing chamber use nested type Structure;Oxygenation chamber external diameter 7~15cm, inner shell internal diameter 1~5cm, temperature-changing chamber, oxygenation chamber high 6~18cm, Upper cover external diameter 8~15cm, external diameter 8~15cm of going to the bottom, membrane oxygenator high 10~30cm.
Optimum blood path, oxygenate, alternating temperature effect maximization: blood is the most from bottom to top by becoming Greenhouse, more from top to bottom by oxygenation chamber, blood outlet is positioned at oxygenation chamber bottommost, distance is positioned under lower The blood inlet 2-8cm in portion, it is ensured that the two is closest, so that blood flow paths is the longest, blood The doughnut having gas or alternating temperature water with inside is fully contacted, and oxygenate, alternating temperature effect are maximum.
Priming volume is little: priming volume is 250~350ml.
Take into account and maximize oxygenate area and alternating temperature area, oxygenate area 1.5m2~3m2, alternating temperature area 0.35m2~0.8m2
Fluid design optimizes, and oxygenate alternating temperature efficiency is high:
Gas is entered by upper upper part of the cover air inlet.Top half is made up of longitudinal flow and cross flow one, The mixed flow that the latter half is made up of longitudinal flow and oblique flow so that product has higher oxygenate effect Rate;
Blood is the most from bottom to top by temperature-changing chamber, then passes through oxygenation chamber, double layer fibre pad mode from top to bottom Blood is fully contacted with doughnut, thus improves oxygenate alternating temperature efficiency;
When blood is by temperature-changing chamber, and between the alternating temperature water in hollow-fibre membrane, form adverse current, be greatly improved The alternating temperature efficiency of oxygenator.
Gas pressure drop is low, and relatively low gas pressure drop substantially reduces the possibility producing aeroembolism in blood;
Blood pressure drop is low, has new flow pattern owing to reducing oxygenator height and blood, from And achieve relatively low blood pressure drop so that perform the operation more safe and reliable;
Alternating temperature hydraulic pressure reduces so that oxygenator has higher safety.
The gas flow design of safety: gas flows from top to bottom, can get rid of issuable condensed fluid, Gas outlet is through special design so that even if owing to contingency makes outlet obstruction, in oxygenator Pressure also will not excessively increase;Devise a bye-pass at gas outlet, titanium dioxide can be passed through Carbon monitor measures the CO2 concentration in gas.
Excellent bubble removing ability.Bubble is discharged ability and is consistent with optimum blood path, blood From bottom to top after temperature-changing chamber, the bubble in blood can be discharged by arterial blood air vent, arterial blood Air vent arranges the top of oxygenation chamber, the blood outlet 5~15cm of distance oxygenation chamber bottommost, it is ensured that two Person's distance is farthest, and bubble is discharged more complete.
Fully transparent, perfect vision.Shell is polyurethane material, and internal structure is fully visible, improves Safety.
Scientific and reasonable interface position, the fast connection interface of safe and reliable standard:
Stop jumping liquid/recirculation port to be positioned at oxygenation chamber and obtain minimum point, with blood outlet in same level position, for stopping Jump the oxygenate ability that liquid provides maximum;
Into and out of blood mouth with in side, entery and delivery port is with at opposite side, and conveniently operation, prevents alternating temperature water The transducer potector of oxygenator is polluted;
Blood collection mouth is positioned at the top of blood outlet, so can more easily operate and survey more accurately Amount;
Temperature probe in temperature-measuring port bonds to, in the horizontal aperture of blood outlet, measure blood more accurately Temperature.
Other technology compatible: can integrated lower resistance Micro-Bolt Filter;Oxygenator can be coated.
Integrated with venous return room adapter, rotatable 180 ° of uses.
Oxygenation membrane is produced prepared, alternating temperature film by microporous polypropylene fibers and the ECMO/ECLS diffusion barrier of standard Prepared by polypropylene hollow fiber.Oxygenation membrane is wound around by double layer fibre pad with alternating temperature membrane fiber Shu Jun, each There is angle each other in the fiber crossovers arrangement in layer fiber mat;Compact conformation, priming volume is little, shell, Oxygenation chamber and temperature-changing chamber nesting type structure that mesochite, inner shell combine have been formed with upper cover, closing of going to the bottom Fully separating gas circuit, bloody path, water route, gas, blood, water are capwise;Outstanding gas circuit design, Blood and alternating temperature hydromining adverse current;Oxygenation membrane and alternating temperature film use the disposable integrated glue of import glue with housing Envelope, is filled in oxygenation chamber and two cylindrical cavity indoor of temperature-changing chamber, oxygenation chamber and temperature-changing chamber respectively and uses Nesting type structure;Bubble is discharged ability and is consistent with optimum blood path;Into and out of blood mouth distance Recently, blood outlet is farthest with tremulous pulse air vent distance;Scientific and reasonable interface position, safe and reliable mark Accurate fast connection interface;The adapter integration of venous return room, rotatable 180 ° of uses.
As it has been described above, embodiments of the invention are explained, but as long as essentially without The inventive point and the effect that depart from the present invention can have a lot of deformation, and this is to one skilled in the art It is apparent from.Therefore, within such variation is also integrally incorporated in protection scope of the present invention.

Claims (10)

1. a hollow-fiber membrane oxygenator, it is characterised in that overall in cylinder, the inner chamber of shell Connecting mesochite, the cavity of the oxygenation chamber that shell is constituted with mesochite, the inner chamber of mesochite connects inner shell, mesochite And constituting the cavity of temperature-changing chamber, the top of upper cover connected with outer casing between inner shell, oxygenation membrane is connected to shell And in the oxygenation chamber cavity between mesochite, the chamber of the temperature-changing chamber that alternating temperature film is connected between mesochite and inner shell In body, the bottom with shell of going to the bottom is connected, inner chamber, go to the bottom lumen and the exocoel of going to the bottom of point going to the bottom of going to the bottom, Inner chamber of going to the bottom is that bloody path is with blood inlet;Lumen of going to the bottom is that water route is with outlet;Cover top portion side Connecting arterial blood air vent, outer casing bottom side connects blood outlet, and blood outlet is sampled with arterial blood Mouthful, outer casing bottom side connects temperature-measuring port;Upper cover divides cover cavity and upper cover exocoel;Upper cover cavity is Water route, upper cover cavity connects water inlet;Upper cover exocoel connects air inlet;Stop jumping liquid inlet/arterial blood Recirculation port is connected to the side gone to the bottom.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that on Lid exocoel is gas circuit.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that under End exocoel is that gas circuit is with gas outlet.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that oxygen Close room and temperature-changing chamber uses nesting type structure.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that oxygen Close outdoor footpath 7~15cm, oxygenation chamber inner shell internal diameter 1~5cm, temperature-changing chamber and oxygenation chamber high 6~ 18cm, upper cover external diameter 8~15cm, external diameter 8~15cm of going to the bottom, overall high 10~30cm.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that whole The priming volume of body is 250~350ml.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that oxygen Close the oxygenate area 1.5m of room2~3m2, the alternating temperature area 0.35m of temperature-changing chamber2~0.8m2
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that oxygen Close room and temperature-changing chamber is cylindrical chamber.
A kind of hollow-fiber membrane oxygenator the most according to claim 1, it is characterised in that go out Blood mouth is positioned at oxygenation chamber bottommost, and blood outlet is 2-8cm with the blood inlet distance of lower bottom.
10. a hollow fiber film type oxygenate method, it is characterised in that containing following steps;
Use disposable integrated glue envelope processing step oxygenation membrane, shell, mesochite to be combined, close with this The cavity being made up of shell and mesochite, forms oxygenation chamber;
Use disposable integrated glue envelope processing step alternating temperature film, mesochite, inner shell to be combined, close with this The cavity being made up of mesochite and inner shell, forms temperature-changing chamber;
Blood enters oxygenator from the blood inlet gone to the bottom, and from bottom to top passes through from alternating temperature film doughnut The alternating temperature water flowed from top to bottom in temperature-changing chamber, with alternating temperature film doughnut carries out heat friendship at fiber surface Change;
Blood after alternating temperature passes through oxygenation chamber the most from top to bottom from oxygenation membrane doughnut, with oxygenation membrane The gas flowed from top to bottom in doughnut carries out gas exchange by the fenestra on fibre wall;Finally become Blood after temperature, oxygenate leaves oxygenator by blood outlet;
When blood is by temperature-changing chamber, and between the alternating temperature water in hollow-fibre membrane, form adverse current, improve The alternating temperature efficiency of oxygenator;
There is the CO2 concentration step measuring in gas by capnometer;
There is collection arterial blood sample testing sequence,
Have and measure in real time and monitoring arterial blood temperature step;
Oxygenation chamber and temperature-changing chamber is used to use nesting type structure;
Use the macromolecular material hollow-fibre membrane that blood compatibility is excellent;
Oxygenation membrane is produced prepared by microporous polypropylene fibers and the ECMO/ECLS diffusion barrier of standard;
Alternating temperature film is prepared by polypropylene hollow fiber;
Oxygenation membrane is wound around by double layer fibre pad with alternating temperature membrane fiber Shu Jun, the fiber in each layer of fiber mat There is angle each other in cross arrangement.
CN201610409016.7A 2016-06-13 2016-06-13 Hollow fiber membrane oxygenator and method Pending CN105833373A (en)

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CN109224163A (en) * 2018-10-16 2019-01-18 广东工业大学 A kind of hollow fiber membrane oxygenator that heat exchange layers are external
CN109364315A (en) * 2018-12-07 2019-02-22 江苏美思康医疗科技有限公司 A kind of band alternating temperature two-chamber membrane oxygenator
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CN113499496A (en) * 2021-07-14 2021-10-15 江苏赛腾医疗科技有限公司 Membrane oxygenator with built-in filter
CN114642780A (en) * 2022-02-16 2022-06-21 山东威高新生医疗器械有限公司 Integrated membrane oxygenator
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CN111701103B (en) * 2020-06-29 2023-03-03 广东省心血管病研究所 Pump-free artificial membrane lung for ECMO
CN111992053A (en) * 2020-08-17 2020-11-27 杭州科百特科技有限公司 Gas exchange membrane, preparation method thereof and gas exchange assembly
CN112007519A (en) * 2020-08-17 2020-12-01 杭州科百特科技有限公司 Oxygenation membrane, preparation method thereof and oxygenation assembly
CN111870757A (en) * 2020-08-19 2020-11-03 清华大学天津高端装备研究院 Hollow fiber membrane oxygenator
WO2022152014A1 (en) * 2021-01-15 2022-07-21 苏州心擎医疗技术有限公司 Extracorporeal membrane oxygenator
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CN113398354A (en) * 2021-07-14 2021-09-17 江苏赛腾医疗科技有限公司 Integrated membrane oxygenator
CN113413504B (en) * 2021-07-30 2023-03-14 北京清瀚医疗科技有限公司 Multi-chamber oxygenator with liquid separation drainage structure
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Application publication date: 20160810