CN103392691A - Container and method for processing, sterilizing and saving biological tissues - Google Patents
Container and method for processing, sterilizing and saving biological tissues Download PDFInfo
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- CN103392691A CN103392691A CN201310352720XA CN201310352720A CN103392691A CN 103392691 A CN103392691 A CN 103392691A CN 201310352720X A CN201310352720X A CN 201310352720XA CN 201310352720 A CN201310352720 A CN 201310352720A CN 103392691 A CN103392691 A CN 103392691A
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0215—Disinfecting agents, e.g. antimicrobials for preserving living parts
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- Apparatus For Disinfection Or Sterilisation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
The invention provides a multifunctional container for processing and saving biological tissues. The container comprises a container body for providing a space for processing; the body comprises an unclosed edge, at least one inlet and at least one outlet, wherein each inlet is provided with a filter and a valve is arranged at each inlet and outlet; the body of the container is further provided with at least one peelable corner. The multifunctional container for processing and sterilizing can be further used as a protective container for terminal products besides being applied to production and processing. With the multifunctional container, the preparation process of biological tissue matrixes is simplified and the efficiency is improved. After the biological tissue material enters the container and before the terminal products are used, sterile operation does not need to be changed or the container does not need to be removed. The invention further provides a multifunctional method for processing and packing biological tissues.
Description
Technical field
The present invention relates to a kind of container and using method thereof that can be used for tissue processing, terminal sterilization, preservation.
Background technology
The processing of biological tissue and organ and the processing of biomaterial, often will be aseptic, dustless, relatively carry out in the environment of isolation, to avoid introducing pollution source from processing environment, pollute organization material, cross pollution or organization material contamination environment between organization material occur.In practical operation, mainly by special facilities and peculiar technological process, reach and avoid organization material cross pollution or contaminated environment.
At medical domain, allogeneic or the organ material of heterogenous allosome biological tissue, be used for tissue repairing and reparation in clinical operation before, a series of biological treatment need to be arranged, this comprising cleaning, sterilize, take off cell, reduce antigenicity, the processes such as inactivation of virus, sterilizing and packing preservation.Except to avoid processing environment to the pollution of organization material, cross pollution, organization material contamination environment and organization material between organization material to infection of acceptor etc.; the equipment that is used for tissue processing and processing there are requirements at the higher level, as the 26S Proteasome Structure and Function of protection biological organization material.
Various cell free human bodies and animal tissue's organ matrix, also be widely used in various organizational project tests and regenerative medicine research.After the cell component of removing original human body or animal tissue, stayed the 3 D stereo framework that is formed by structural protein and functional protein.This host material has good biomechanical strength, and main component comprises collagenous fibres, glycoprotein, glutinous albumen etc., and other compositions have carbohydrate, some lipids and the growth factors such as GAG (hyaluronic acid, chondroitin sulfate).The histoorgan matrix that makes this 3 D stereo with human body cell is cell and functionalization again, is that produce can be for the feasible method of the histoorgan of being transplanted to human body.Host material this after implanting the host, by with host cell, interacting to regulate the behavior (as adhering to, migration, propagation and differentiation) of cell, along with growing into of host cell, histoorgan matrix itself is progressively degraded and is changed into new tissue.At present, there is the derivative and next host material of nearly 30 kinds of histoorgans in the whole world, is used in the various clinical treatments of tissue repair and regeneration.The histoorgan raw material of these products, from the mankind and multiple mammiferous tissue, comprises blood vessel, cardiac valves, ligament, nerve, skin, small intestinal mucosa, glandular stomach, pericardium, peritonaeum, tendon and bladder etc.
The technological process for preparing histoorgan matrix is very complicated.Method has multiple, and technological process comprises the treatment steps such as physics, chemistry, zymetology.In order to simplify the operation and to raise the efficiency, the invention provides a kind of multifunctional bio tissue treatment container, a kind of tissue processing method also correspondingly is provided simultaneously.
Summary of the invention
In order to solve tissue processing, the sterilizing and problem of preserving, one aspect of the present invention provides a kind of container that addresses the above problem, and realizes by following technical solution:
A kind of multifunctional bio tissue treatment and preservation container, it is characterized in that: have container body, described main body comprises a not enclosed edge, at least one import, at least one outlet and at least one peelable arm of angle, described import is provided with sterilizing filter, and described import and outlet are provided with valve.
Especially, described container is bag.
Preferably, described not enclosed edge can be sealed by thermoplastic.
Further, long 5~60 centimetres of described container, wide 5~40 centimetres.
Again preferably, described container is made by plastic cement or plastics.
Especially, the material of manufacturing container specifically comprises polyester, polyethylene, polypropylene, polystyrene, ethylene diester, Vingon, PEN, polyvinyl chloride, polyamide or its combination.
Further, described container import for liquid or gas enter.
Another aspect of the present invention, a kind of method of tissue processing and packing is provided, it is characterized in that: biological organization material be sealed in multifunctional bio tissue treatment of the present invention and preserve in container, by import and the outlet of container, changing various Treatment Solution and reagent; Tissue treatment and sterilizing after, add biological tissue to preserve liquid, directly be encapsulated in multifunction container and preserve.
Preferably, tissue treatment solution and pack enzyme-containing formulation, washing agent, biological buffer solution, physiological saline, inactivation of virus and germicidal solution.
Preferably, enzyme preparation comprises dispase, picodna ribozyme and alpha-galactosidase.
Washing agent wherein comprises Triton X-100, NaTDC, Tween-20, uncle's Octylphenoxy polyethylene ethoxy ethanol and 3-[(3-cholesterol aminopropyl) dimethylamino]-the 1-propane sulfonic acid, concentration is between 0.1~5%.
Especially, inactivation of virus and germicidal solution comprise 1~5% hydrogen peroxide and 0.05~1.0% peracetic acid soln.
Further preferably, biological tissue's preservation liquid is 5~25% glycerite or 0.02~0.1% chlorhexidine or acetic acid chlorhexidine solution.
Further, described container is bag.
Multifunctional bio tissue treatment of the present invention is after biological tissue's raw material enters container, before using to end product, all to need not to change the sterile working flow process or break away from container with an advantage of preserving container.This makes whole production process can control preferably number of bacteria and sterilizing, can reduce the destruction to biological tissue in sterilizing link and damage.
Description of drawings
Figure 1A is multifunctional bio tissue treatment container of the present invention (bag);
Figure 1B is the enlarged drawing of peelable digression 3 in Figure 1A;
Fig. 2 is the application of multifunctional bio tissue treatment container shown in Figure 1.
Embodiment
Below in conjunction with the drawings and specific embodiments, the present invention is described in further details.
Following examples only are used for technical scheme of the present invention more clearly is described, and can not limit the scope of the invention with this.
Figure 1A is multifunctional bio tissue treatment of the present invention and preservation container, and this container is preferably bag.Comprising import 1, outlet 2, peelable digression 3, the not close mouth limit 4 that thermoplastic can seal, sterilizing filter 5, valve 6.Figure 1B is the enlarged drawing of peelable digression 3 in Figure 1A.
With reference to figure 1, multifunctional bio tissue treatment of the present invention and preservation container, include following part, the main body of container itself, the space that provides processing to process; One side of container does not seal 4, can seal through thermoplastic after biological tissue is put into, and can use additive method to seal yet; The another side of container is to provide the import 1 that liquid or gas enter, and it can be equipped with a plurality of imports 1 as required, and wherein each import is provided with sterilizing filter 5; Container also is provided with the outlet 2 for liquid or gas discharge, and this outlet 2 also can arrange a plurality of as required; Wherein each import 1 and outlet 2 are provided with valve 6; The main body of container itself is provided with the peelable arm of angle 3, and the described peelable arm of angle 3 can be for a plurality of.As an application example of container, it can be bag.This multifunction container after completing each step of production and processing, can be used as the protection container of end product.Multifunctional bio tissue treatment in the present invention and preservation container, can be made by multiple plastic cement, plastics, as polyester, polyethylene, polypropylene, polystyrene, ethylene diester, Vingon, PEN, polyvinyl chloride and polyamide etc.
Fig. 2 is the application of multifunctional bio tissue treatment container of the present invention.A. multifunctional bio tissue treatment and preserve container; B. biological organization material is sealed in the medium processing to be processed of container; C. the direct sterile sealing of organization material after processing is processed is preserved in container.
Multifunctional bio tissue treatment of the present invention and preservation container, simplified operating process and improved efficiency.After biological organization material is sealed in container, can be by feed liquor (gas) mouth 1 and fluid (gas) mouthful 2 replacing Treatment Solution and the reagent of container.When multifunction container is furnished with a plurality of feed liquors (gas) mouthful 1 and fluid (gas) mouthfuls 2; Can be connected respectively to different process solutions storage source or waste collection system.The valve 6 of importing and exporting can be used for regulating solution and gas admission velocity and volume in container.Feed liquor (gas) mouth 1, with sterilizing filter 5, ensures the aseptic container that enters.Tissue treatment and sterilizing after, can add tissue to preserve liquid by feed liquor (gas) mouthful 1, directly be encapsulated in the container preservation.During use,, by the peelable digression 3 of container, take out biological organization material.
Generally, biological tissue's host material after taking off the cell processing, carry out inactivation of virus and sterilizing with chemical reagent; Operation during pack breaks away from original sterile working flow process, will do terminal sterilization after pack.This multifunctional bio tissue treatment is after biological tissue's raw material enters container, before using to end product, all to need not to change the sterile working flow process or break away from container with an advantage of preserving container.This makes whole production process can control preferably number of bacteria and sterilizing, can reduce the destruction to biological tissue in sterilizing link and damage.
In some embodiments, after cell takes off in biological tissue and after reducing antigenicity, can pass through feed liquor (gas) mouthful input inactivation of viruses and sterilizing solution or gas, for example with 0.05~0.30% Peracetic acid, process 1~3 hour, can reduce the bacterial population magnitude is 10
7After cleaning, add the glycerine tissue to preserve liquid, after sealing, low temperature is preserved, and need not other terminal sterilization and processes.
In further embodiments, after cell takes off in biological tissue and after reducing antigenicity, can add sterilization to preserve liquid, the normal saline solution of the acetic acid chlorhexidine as 0.02%.The thermoplastic encapsulation, with one side of liquid in-out pipe, is wiped out the liquid in-out pipe.Can at room temperature preserve.
Embodiment one
Approximately the unhairing pig dermis of 0.8 millimeters thick, put into 0.1% Triton X-100 solution, with Ultrasonic Cleaning, removed blood and surperficial dirt 1 hour.Use the normal saline flushing secondary, each 60 minutes.Be cut into the rectangle of long 14 centimetres, wide 10 centimetres, put into long 20 centimetres, a multi-functional container handling of rectangle of wide 16 centimetres, sealing.Add 100 milliliters every liter to contain the calcium chloride of 2.0 mMs and the dispase of 100 units from inlet, be placed on the shaking table of 37 degrees centigrade and took off cell 20 hours.Discharge dispase solution from liquid outlet, add the deoxycholic acid sodium solution of 100 milliliter 1.0% to take off cell flushing 24 hours at 37 degrees centigrade of shaking tables from inlet.Discharge the deoxycholic acid sodium solution from liquid outlet, from inlet, add 100 ml physiological salines to rinse 60 minutes.Discharge normal saline flushing liquid from liquid outlet, from inlet, again add 100 ml physiological salines to rinse 60 minutes.After flushing liquor is complete, from inlet, again add 100 milliliters every liter calcium chloride that contains 2.0 mMs, 2.0 mMs of magnesium chlorides and 2000 unit deoxyribonucleases, processed 20 hours on the room temperature shaking table.Discharge deoxyribonuclease solution from liquid outlet, from inlet, add 100 ml physiological salines to rinse 60 minutes.Discharge saline flush solution from liquid outlet, from inlet, add 100 milliliter of 0.10% peracetic acid soln to process one hour.Discharge the peracetic acid soln of using from liquid outlet, from inlet, add 100 milliliters of 0.10% fresh peracetic acid solns to process two hours.After Peracetic acid sterilization and inactivation of virus, with stroke-physiological saline solution, rinse three times.Discharge flushing liquor, add the glycerine-normal saline solution of 15 milliliter 20% from inlet, the heating encapsulation, with one side of liquid in-out pipe, is wiped out the liquid in-out pipe.Low temperature is kept at below-20 degree.
Embodiment two
The about unhairing pig dermis of 0.8 millimeters thick, put into 1% ammoniacal liquor and embathed 16 hours.Ammoniacal liquor embathes rear pure water rinsing 1 hour of using.Be cut into the rectangle of long 14 centimetres, wide 10 centimetres, put into long 20 centimetres, a rectangle multifunction container of wide 16 centimetres, sealing.Add the deoxycholic acid sodium solution of 100 milliliter 1.0% to take off cell flushing 24 hours at 37 degrees centigrade of shaking tables from inlet.Discharge the deoxycholic acid sodium solution from liquid outlet, from inlet, add 100 ml physiological salines to rinse 60 minutes, repeatedly rinse three times.Discharge normal saline flushing liquid from liquid outlet, from inlet, again add the hydrogen peroxide of 100 milliliter 3% to process 4 hours.Discharge hydrogen peroxide from liquid outlet, from inlet, added normal saline flushing 60 minutes, repeatedly rinse three times.Discharge finally flushing liquor, from inlet, add 15 milliliters of normal saline solutions that contain 0.02% chlorhexidine.The thermoplastic encapsulation, with one side of liquid in-out pipe, is wiped out the liquid in-out pipe.At room temperature preserve.
It should be noted that; the foregoing is only preferred embodiment of the present invention; not thereby limit scope of patent protection of the present invention, the present invention can also carry out to the structure of above-mentioned various parts the improvement of material and structure, or adopts the technical equivalents thing to replace.Therefore the equivalent structure that all utilizations specification of the present invention and diagramatic content are done changes, or directly or indirectly apply to other correlative technology fields and all in like manner all be contained in the scope that the present invention contains.
Claims (14)
1. a multifunctional bio tissue treatment and preserve container, it is characterized in that: have container body, described main body comprises a not enclosed edge, at least one import, at least one outlet and at least one peelable arm of angle, described import is provided with sterilizing filter, and described import and outlet are provided with valve.
2. container according to claim 1 is characterized in that: described container is bag.
3. container according to claim 1, it is characterized in that: described not enclosed edge can be sealed by thermoplastic.
4. container according to claim 1 is characterized in that: long 5~60 centimetres of described container, and wide 5~40 centimetres.
5. container according to claim 1, it is characterized in that: described container is made by plastic cement or plastics.
6. container according to claim 5 is characterized in that: the material of making container specifically comprises polyester, polyethylene, polypropylene, polystyrene, ethylene diester, Vingon, PEN, polyvinyl chloride, polyamide or its combination.
7. container according to claim 1 is characterized in that: described container import for liquid or gas enter.
8. the method for a tissue processing and packing, it is characterized in that: biological organization material be sealed in the described multifunctional bio tissue treatment of claim 1 to 6 any one and preserve in container, by import and the outlet of container, changing various Treatment Solution and reagent; Tissue treatment and sterilizing after, add biological tissue to preserve liquid, directly be encapsulated in multifunction container and preserve.
9. method according to claim 8, is characterized in that: tissue treatment solution and pack enzyme-containing formulation, washing agent, biological buffer solution, physiological saline, inactivation of virus and germicidal solution.
10., according to method claimed in claim 9, it is characterized in that: enzyme preparation comprises dispase, picodna ribozyme and alpha-galactosidase.
11. method according to claim 9, it is characterized in that: washing agent comprises Triton X-100, NaTDC, Tween-20, uncle's Octylphenoxy polyethylene ethoxy ethanol and 3-[(3-cholesterol aminopropyl) dimethylamino]-the 1-propane sulfonic acid, concentration is between 0.1~5%.
12. method according to claim 13 is characterized in that: inactivation of virus and germicidal solution comprise 1~5% hydrogen peroxide and 0.05~1.0% peracetic acid soln.
13., according to method claimed in claim 8, it is characterized in that: biological tissue's preservation liquid is 5~25% glycerite or 0.02~0.1% chlorhexidine or acetic acid chlorhexidine solution.
14. according to claim 8-13 described methods of any one is characterized in that: described container is bag.
Priority Applications (2)
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CN201310352720.XA CN103392691B (en) | 2013-08-14 | 2013-08-14 | The container of a kind of tissue processing, sterilizing and preservation and method |
PCT/CN2014/078742 WO2015021806A1 (en) | 2013-08-14 | 2014-05-29 | Container and method for processing, sterilizing, and storing biological tissue |
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CN201310352720.XA CN103392691B (en) | 2013-08-14 | 2013-08-14 | The container of a kind of tissue processing, sterilizing and preservation and method |
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CN103392691A true CN103392691A (en) | 2013-11-20 |
CN103392691B CN103392691B (en) | 2015-09-23 |
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Cited By (2)
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CN103636596A (en) * | 2013-11-29 | 2014-03-19 | 东方康瑞(北京)科技发展有限责任公司 | Bio-membrane protective solution as well as preparation and application thereof |
CN107746797A (en) * | 2017-10-31 | 2018-03-02 | 山东亦度生物技术有限公司 | It is a kind of to use the device and method that disposable sack carries out rabies viruses inactivation, inactivator hydrolyzes |
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CN1582111A (en) * | 2001-11-01 | 2005-02-16 | 综合生物系统公司 | Systems and methods for freezing, storing and thawing biopharmaceutical material |
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WO2007044047A1 (en) * | 2005-10-13 | 2007-04-19 | Alamo Scientific, Inc. | Apparatus and method for microbial and forensic sampling and manipulation |
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CN103636596A (en) * | 2013-11-29 | 2014-03-19 | 东方康瑞(北京)科技发展有限责任公司 | Bio-membrane protective solution as well as preparation and application thereof |
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CN107746797A (en) * | 2017-10-31 | 2018-03-02 | 山东亦度生物技术有限公司 | It is a kind of to use the device and method that disposable sack carries out rabies viruses inactivation, inactivator hydrolyzes |
CN107746797B (en) * | 2017-10-31 | 2019-03-05 | 山东亦度生物技术有限公司 | A kind of device and method carrying out rabies viruses inactivation, inactivator hydrolysis using disposable sack |
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CN103392691B (en) | 2015-09-23 |
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