WO2005097231A1 - Appareil de filtration extracorporel destine a eliminer les lipides du plasma - Google Patents
Appareil de filtration extracorporel destine a eliminer les lipides du plasma Download PDFInfo
- Publication number
- WO2005097231A1 WO2005097231A1 PCT/CN2005/000239 CN2005000239W WO2005097231A1 WO 2005097231 A1 WO2005097231 A1 WO 2005097231A1 CN 2005000239 W CN2005000239 W CN 2005000239W WO 2005097231 A1 WO2005097231 A1 WO 2005097231A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- plasma
- filter
- blood
- lipid
- bag
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3472—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3472—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate
- A61M1/3482—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate by filtrating the filtrate using another cross-flow filter, e.g. a membrane filter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3623—Means for actively controlling temperature of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/3472—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration with treatment of the filtrate
- A61M1/3486—Biological, chemical treatment, e.g. chemical precipitation; treatment by absorbents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0456—Lipoprotein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/08—Lipoids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3355—Controlling downstream pump pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3368—Temperature
Definitions
- the invention relates to a plasma filtration method and a device thereof, in particular to a plasma lipid filtration method and a device thereof in vitro. Background technique
- Blood lipids refer to fatty substances in the blood, usually cholesterol and triglycerides. Lipids are important for human development and play an important role in cell composition and body metabolism. Hyperlipidemia refers to high cholesterol (TC) and / or triglyceride (TG) or low-density lipoprotein cholesterol (LDL-C) in the blood, which is called dyslipidemia in modern medicine.
- TC high cholesterol
- TG triglyceride
- LDL-C low-density lipoprotein cholesterol
- Dyslipidemia leading to atherosclerosis is the most important risk factor for coronary heart disease.
- the famous FRAMINGHAM study has shown that TC decreases by 1% and CVE decreases by 2%. Reducing TC and / or LDL-C is the key to preventing and treating coronary heart disease. In patients with cerebral infarction, the incidence of hyperviscosity is as high as 63.7%.
- lipid lowering devices In order to quickly reduce blood lipids, lipid lowering devices have been used clinically. However, this type of lipid-lowering device usually uses physical-chemical methods to reduce lipids. Although its lipid-lowering effect is more direct and significant compared with drugs, it is still not ideal, and there are certain safety problems.
- This type of lipid lowering device is to first adjust the pH value of the patient's plasma by chemical treatment; After that, the blood lipids in the plasma were filtered after chemical precipitation. Using this device to lower blood lipids usually takes 3 hours to complete, and the fat removal effect after filtering twice is only 30% -50%. It is particularly worth mentioning that after chemical treatment, a part of the blood coagulation factors in plasma will be lost, and the equipment is expensive and complicated to operate.
- the purpose of the present invention is to provide an in vitro plasma lipid filtration method to overcome the above-mentioned shortcomings of the prior art and solve the problem that the prior art cannot directly and efficiently and safely remove blood lipids from blood.
- the present invention provides a method for filtering plasma lipids in vitro, including the following steps: separating plasma from the collected blood; pre-rinsing the device with saline; performing peristaltic, temperature, and pressure control on the blood mass; The plasma is filtered through a filter; the filtered plasma is pooled into the blood.
- staged blood separation is performed on the collected blood, and the separated plasma is 150-250 ml each time.
- the plasma is passed through the filter at a flow rate of 20-30 ml per minute.
- the pressure in the filter is controlled below 60KPa.
- Plasma is heated to a temperature equal to body temperature.
- the blood lipid filter includes three layers of films, the first layer may be a film having filter holes with a pore diameter of 0.3 to 0.65 micrometers and contains a liposuction material; the second layer is a film having filter holes with a pore diameter of 0.3 micrometers; The triple layer is a nylon-based film with 0.2 micron pore size filter holes. One or more layers of the first layer of film are further provided between the second layer and the third layer of film.
- the liposuction material here is silica particles.
- Another object of the present invention is to provide an extracorporeal plasma lipid filter, which solves the problem that the prior art cannot directly and efficiently and safely remove blood lipids from blood.
- the present invention provides an extracorporeal plasma lipid filter, including: a blood collection device, a blood separation device, a pre-filtered blood paddle bag, a blood lipid filter, a filtered plasma bag, and a plasma return device.
- the above devices pass The pipes are connected in turn, A peristaltic pump is connected in series in the pipeline, and pressure and temperature control devices are respectively provided on the pipeline.
- the extracorporeal plasma lipid filter is also provided with a pre-flushing saline bag and a waste saline bag, in which a pre-flushing saline bag interface is connected. The output port of the plasma bag before filtration, and the port of the waste water bag is connected to the input port of the filtered plasma bag.
- the pre-filtration blood paddle bag has an automatic weight or volume detection device, and sends a signal that the plasma is full to a blood separation device and / or a blood collection device to order it to stop working.
- the volume of the plasma bag before filtration is 150-250 ml.
- the pressure control device can read the current pressure in the pipeline.
- the pressure control device controls the pressure below 60KPa.
- the speed of the peristaltic pump is controlled so that the blood blades flow at a flow rate of 20-30 ml per minute.
- the temperature control device is set on the filter, and its maximum heating temperature is controlled at 38 ° C.
- the blood lipid filter includes three layers of films, the first layer may be a film having filter holes with a pore diameter of 0.3 to 0.65 micrometers and contains a liposuction material; the second layer is a film having filter holes with a pore diameter of 0.3 micrometers; The triple layer is a nylon-based film with 0.2 micron pore size filter holes. The second and third films are further provided with one or more layers of the first film.
- the liposuction material here is oxidized kiwi particles.
- the present invention can physically remove blood lipids, it can be applied to refractory hyperlipidemia with poor drug treatment effects, such as: hypercholesterolemia, high IT oil trilipidemia, high and low levels Density lipoproteinemia and hyperviscosity.
- the invention also has obvious effects on removing fibrinogen in blood, preventing stroke, and reducing blood viscosity.
- the invention can remove about 50% of blood lipids by filtering once, and can be repeated, so it has the characteristics of accurate curative effect and quick effect.
- the present invention adopts a pure physical affinity adsorption method, it has high safety and good tolerance, and patients generally do not feel obvious discomfort during treatment.
- the treatment time is short, and the treatment time for a patient is about 2 hours, and the operation is simple without the need for professionals and special training.
- FIG. 1 is a schematic structural diagram of an embodiment of the present invention. Detailed ways
- FIG. 1 is a schematic structural diagram of an embodiment of the present invention.
- the blood separation device uses a centrifugal separation method to separate the blood collection device from the blood from the patient's vein, and the blood cells and other components in the blood are returned to the patient in the original way.
- the separated plasma enters the pre-filtration plasma bag, and a pre-rinsing saline bag for pre-rinsing equipment and pipes is connected to the equipment at the pipe part of the output port of the pre-filtration plasma bag. Pre-flushing saline or blood flows into the peristaltic pump along the pipeline.
- the peristaltic pump provides the power and pressure of the entire extracorporeal circulation device.
- a pressure control device is provided at the end to adjust and control the pressure, making the treatment process safer and more comfortable.
- the pipeline is connected to a plasma lipid filter.
- a large number of functional particles are evenly distributed on the filter membrane of the filter.
- TC, TG, LDL, etc. are firmly adsorbed on the filter membrane.
- the clean plasma flows out of the filter and enters the filtered plasma bag through the tube.
- the tubing between the filtered paddle bag inlet has a bifurcation leading to the waste saline bag.
- the pipeline leading to the filtered plasma bag is cut off, and the flushed saline flows into the waste saline bag.
- the pipeline leading to the waste saline bag is cut off, and the filtered blood flows into the filtered plasma bag.
- the blood paddle also passes a temperature control device to maintain a certain temperature, and the temperature-adjusted plasma is returned to the body through the plasma return device.
- the blood collection device can collect blood or return components such as blood cells. Therefore, it can be a general blood drawing device or a specially designed double-tube single-needle device. Of course, it can also be designed as a separate blood drawing and return tube and needle, but this requires two needle insertions, which increases the patient's pain.
- the blood separation device is a centrifugal device that separates plasma from blood. The separated components such as plasma and blood cells are output separately. In some embodiments the blood separation device also provides power for the output of the separated components.
- the blood separation device may be a plasma apheresis.
- the separated plasma flows into a pre-filtration plasma bag, which has a certain volume or weight.
- a pre-filtration plasma bag which has a certain volume or weight.
- the plasma bag has an automatic weight or volume detection device and sends a signal that the plasma is full to a blood separation device and / or a blood collection device to order them to stop working.
- the volume of a plasma bag is 200 ml. This volume can meet the filtration efficiency without causing the patient to feel pain or cause harm to his body.
- the present invention also has a set of saline pre-flushing device.
- the pre-flushing saline bag is generally fed into the rear device in parallel with the pre-filtered plasma bag, and the chandelier before the filtered plasma bag input port has a branch leading to the waste saline bag.
- the blood water bag is shut down, the saline flush pipes and equipment in the pre-flush saline bag are flushed, and the flushed saline enters the waste saline bag.
- the pre-rinsing of saline water is based on the following considerations.
- the plasma in the plasma bag before filtering flows into the peristaltic pump, which provides the power for the liquid flowing in the pipe.
- the pressure control device can read the current pressure in the pipeline.
- the pressure control device may further adjust the rotation speed of the peristaltic pump.
- the speed of the peristaltic pump generates the power of the plasma flow, and the blood paddle is subject to resistance in the subsequent filter to generate pressure. Excessive stress can damage the device and can cause discomfort to the patient. If the speed of the peristaltic pump is too small, the plasma flow rate will be slow, and the filtering time will be prolonged.
- this pressure control can be either a simple pressure gauge or an automatic speed regulation system composed of a pressure sensor and a peristaltic pump speed control device.
- the critical pressure value in the present invention is generally 60 KPa. Because the generation of pressure is related to the plasma concentration, by observing the reading of the pressure control device, the patient's blood concentration and condition can be judged.
- the plasma lipid filter is composed of multiple layers of filtration membranes.
- the first layer can be a membrane with a pore size of 0.3 to 0.65 micrometers and contains a liposuction material. This layer of membrane can absorb lipids in the blood paddle.
- Liposuction Materials can be silica particles and other adsorbent particles. In addition, it can filter other foreign particles larger than its pore size.
- the second layer is a membrane with a pore size of 0.3 microns. This membrane can filter out bacteria and chyloproteins because their diameter is greater than 0.3 microns.
- the third layer is a nylon-based film with a 0.2 micron pore size filter to filter foreign particles that may be generated during the previous filtering process, such as wooden paddle substrates or adsorbent particles of some films.
- the amount of film with liposuction function should be estimated based on its adsorption capacity and the amount of blood to be filtered. If one layer is not enough, multiple layers can be added, and multiple layers can be stacked together, or other thin films with liposuction functions required to make up for the insufficient filtering ability of the first layer can be placed between the second and third layers mentioned above.
- the blood paddle is filtered and flows into the filtered plasma bag, which is returned to the patient through the plasma return device.
- the temperature control device may be a heating plate, and the maximum heating temperature is controlled at about 38 ° C.
- the temperature control device can be placed in any suitable heated place of the pipe or equipment.
- the heating plate can be arranged on the filter.
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/599,708 US7686777B2 (en) | 2004-04-06 | 2005-02-28 | Plasma lipids in-vitro filtering method and apparatus |
EP05714770A EP1733748A4 (en) | 2004-04-06 | 2005-02-28 | EXTRACORPOREAL FILTRATION APPARATUS FOR REMOVING PLASMA LIPIDS |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN200420021636.6 | 2004-04-06 | ||
CNU2004200216366U CN2698358Y (zh) | 2004-04-06 | 2004-04-06 | 血液过滤装置 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2005097231A1 true WO2005097231A1 (fr) | 2005-10-20 |
Family
ID=34770020
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CN2005/000239 WO2005097231A1 (fr) | 2004-04-06 | 2005-02-28 | Appareil de filtration extracorporel destine a eliminer les lipides du plasma |
Country Status (4)
Country | Link |
---|---|
US (1) | US7686777B2 (zh) |
EP (1) | EP1733748A4 (zh) |
CN (1) | CN2698358Y (zh) |
WO (1) | WO2005097231A1 (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8187465B2 (en) | 2006-09-08 | 2012-05-29 | Gelanus B.V. | Blood recuperation device and method |
CN107537076A (zh) * | 2016-06-23 | 2018-01-05 | 江苏博发生物科技有限公司 | 高脂血症治疗过滤器 |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101332323B (zh) * | 2007-06-27 | 2011-03-30 | 上海达华医疗器械有限公司 | 一种利于血浆均匀流动的血浆过滤器 |
AT505433B1 (de) * | 2007-07-06 | 2009-10-15 | Technoclone Ges M B H | Plasmafiltration |
TWI461230B (zh) * | 2010-10-07 | 2014-11-21 | Univ Nat Cheng Kung | 用於過濾血清之過濾薄膜及其製造方法與過濾裝置 |
CN105477722A (zh) * | 2015-08-10 | 2016-04-13 | 常州华岳微创医疗器械有限公司 | 一种用于血液灌流机的过滤装置 |
CN106563183A (zh) * | 2015-10-12 | 2017-04-19 | 江苏博发生物科技有限公司 | 一种去除胆红素血液净化过滤器 |
CN109395190A (zh) * | 2017-08-15 | 2019-03-01 | 滤生生物技术(上海)有限公司 | 一种用于治疗免疫性疾病的体外血浆吸附/血液灌注的方法及其装置 |
CN112055601A (zh) | 2017-12-28 | 2020-12-08 | 艾赛普公司 | 用于处理出血流体以便自体输注的系统和方法 |
US10816446B2 (en) | 2018-05-07 | 2020-10-27 | Fremon Scientific, Inc. | Thawing biological substances |
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US4350156A (en) | 1980-05-29 | 1982-09-21 | Japan Foundation For Artificial Organs | Method and apparatus for on-line filtration removal of macromolecules from a physiological fluid |
GB2184670A (en) | 1985-12-19 | 1987-07-01 | Cleveland Clinic Foundation | Thermofiltration of plasma |
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US20030104350A1 (en) * | 2001-06-25 | 2003-06-05 | Bomberger David C. | Systems and methods using a solvent for the removal of lipids from fluids |
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2005
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- 2005-02-28 US US10/599,708 patent/US7686777B2/en active Active
- 2005-02-28 WO PCT/CN2005/000239 patent/WO2005097231A1/zh active Application Filing
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US4895558A (en) * | 1985-07-15 | 1990-01-23 | University Of Queensland | Autologous plasma delipidation using a continuous flow system |
GB2184670A (en) | 1985-12-19 | 1987-07-01 | Cleveland Clinic Foundation | Thermofiltration of plasma |
CN2233746Y (zh) * | 1995-01-26 | 1996-08-28 | 天津哈娜好医材有限公司 | 一次性密闭式冲洗器 |
CN2386827Y (zh) * | 1998-09-11 | 2000-07-12 | 彭罗民 | 自动血透滤过机 |
CN2424776Y (zh) * | 2000-05-29 | 2001-03-28 | 万苏来 | 多功能血液净化机 |
CN2507460Y (zh) * | 2001-01-15 | 2002-08-28 | 北京京精医疗设备有限公司 | 一种全封闭的体外去除高血脂设备 |
WO2002078769A1 (fr) * | 2001-03-28 | 2002-10-10 | Terumo Kabushiki Kaisha | Dispositif de collecte de composants sanguins |
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Non-Patent Citations (1)
Title |
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See also references of EP1733748A4 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8187465B2 (en) | 2006-09-08 | 2012-05-29 | Gelanus B.V. | Blood recuperation device and method |
CN107537076A (zh) * | 2016-06-23 | 2018-01-05 | 江苏博发生物科技有限公司 | 高脂血症治疗过滤器 |
Also Published As
Publication number | Publication date |
---|---|
EP1733748A1 (en) | 2006-12-20 |
CN2698358Y (zh) | 2005-05-11 |
EP1733748A4 (en) | 2012-04-04 |
US7686777B2 (en) | 2010-03-30 |
US20080058694A1 (en) | 2008-03-06 |
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