CN104738027B - A kind of Cranial-bone-flap storage method - Google Patents
A kind of Cranial-bone-flap storage method Download PDFInfo
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Abstract
A kind of Cranial-bone-flap storage method of the present invention, comprises the steps: S1, adopts cleaning fluid to clean the Cranial-bone-flap taken off; S2, use cleaning fluid submergence Cranial-bone-flap; S3, low-temperature quick-freezing, make Cranial-bone-flap be fixed in the ice cube of cleaning fluid formation; S4, in the first clean area, through described ice cube, drill through several Cranial-bone-flap through holes; S5, thawing ice cube, take out Cranial-bone-flap and also carry out drying process to it; S6, in the second clean area, encapsulation process is carried out to Cranial-bone-flap; S7, irradiation sterilization is carried out to the Cranial-bone-flap through encapsulation process; S8, the Cranial-bone-flap after irradiation sterilization is placed in low temperature environment under preserve.Technique is simple, easily realizes standardization, scale and can reviewing; Remain biologically active and the natural attribute of described Cranial-bone-flap to greatest extent, effectively prevent the problem of microbial contamination that described Cranial-bone-flap easily runs in storage process and chemical residue.
Description
Technical field
The present invention relates to medical science and bioengineering field, be specifically related to a kind of storage method of Cranial-bone-flap.
Background technology
Neurosurgery decompressive craniectomy removes the effective means because of the caused intracranial hypertension such as brain trauma, cerebral hemorrhage, brain tumor and Big Area Cerebral Infarction.But, the skull defeci that bone lobe causes is removed in operation, patient is made to lose the barrier action of normal calvarial, and have a strong impact on outward appearance, patient's physiology that recurrence is social in the future and psychology are all made a big impact, therefore, the general 3-6 month after surgery, treat that intracranial hypertension is removed completely, after the basic rehabilitation of patient, Most patients needs the repairing operation accepting skull defeci.
At present, in dissimilar materials, the titanium alloy material such as lucite, silica gel relatively in one's early years, its histocompatbility is good, and rejection is little, be widely used clinically, but the web plate of titanium alloy still has problems: (1) wrinkling, distortion, edge warping and web plate loosen etc. is the distinctive defect of metal, and the plastic deformation especially produced when it is hit, not only affects attractive in appearance, and the easy prick skin in sharp keen edge, cause titanium net to expose and skin infection; (2) non-autologous tissue, easily makes patient produce mental handicape; (3) artifact can be produced when imaging examination; (4) titanium net only covers skull outer surface, and at the inner surface in the thicker region of skull, the incised injury of brain tissue can be caused because of corner angle in the skull inner edge of defect; (5) thermal conductivity is strong, and patient cannot stand long-time solar exposure and severe cold, can not play heat insulation, every the function of cold, shockproof, sound insulation and buffering, easily there is headache and epileptic attack; (6) price is high.Autologous skull flap is as the patching material of skull defeci, and have without the need to moulding, without rejection, patients ' psychological easily accepts, and can regenerating reactivating, recovers the natural qualities such as skull thermal insulation, sound insulation, shockproof and buffering, has wide potential applicability in clinical practice.
But the storage method of Preserve selef-cranium is still the huge difficult problem of puzzlement industry.In prior art, the storage method of Preserve selef-cranium mainly comprises two kinds: store and external storage in body.Store in so-called body, refer to by the femoribus internus of the direct patients with implantation of Cranial-bone-flap that takes out in operation or subcutaneous abdomen for subsequent use, when needing row skull repairing after the patient 3-6 month, then Cranial-bone-flap is taken out.But, due to " autologous bone information phenomenon ", after Cranial-bone-flap is implanted, prolongation in time and reducing gradually, to such an extent as to original defect cannot be repaired.Meanwhile, this storing mode must experience twice wound, not only increases new scar, also add infection risk.Therefore, target is placed on the external storage method of Autologous skull flap by increasing researcher.
Chinese patent literature CN103623464A discloses the preparation method that a kind of Autologous skull flap returns planting technology, comprise the steps: (1) decontamination process: adopt conventional detergent to be cleaned up by the impurity such as the greasy dirt of bone surface, and then clean with distilled water flushing, dry rear acquisition Preserve selef-cranium matrix completely; (2) virus inactivation technology: at ambient temperature, the Peracetic acid-alcohol mixeding liquid formed with 10g/L Peracetic acid and volume fraction 24% ethanol, Preserve selef-cranium matrix 4-6 hour is soaked in microwave concussion; (3) deproteinized technique: at ambient temperature, puts into the hydrogen peroxide microwave concussion immersion 48-72 hour that concentration is 10-20%, and then rinses well by purified water by Preserve selef-cranium matrix; (4) degreasing process: with alcohol, the ether of 95%, and detergent soak degreasing and purified water are rinsed, after Preserve selef-cranium matrix is put into centrifuge dewatering, natural seasoning at normal temperatures; (5) de-cell technique: under 2-5 DEG C of condition, the bone matrix obtained after above-mentioned degrease step being put into the lauryl sodium sulfate that concentration is 0.5-1.0% and concentration is that the mixed liquor of the protease inhibitors PMSF of 0.8-1.2% adopts the mode stirring concussion to soak 24-48 hour, and then with purified water circulation flushing 24-48 hour; Under 2-5 DEG C of condition, then Preserve selef-cranium matrix to be put into concentration be that the trypsase of 0.1-0.4% soaks 12-24 hour, and then with purified water circulation flushing 20-28 hour, obtain de-cell based bone; (6) freeze-dry process: by the Preserve selef-cranium prepared after de-cell technique, put into freeze drier freeze-drying; (7) packaging, sterilization process: encapsulate in clean room, adopts oxirane or Co-60 to carry out sterilizing.
Said method; for reaching sterilizing object, washing agent decontamination need be adopted, the mixed liquor inactivation of virus of Peracetic acid and ethanol; hydrogen peroxide deproteinized; acetic acid and ether defatting and lauryl sodium sulfate, protease inhibitors take off the processing steps such as cell, not only complex procedures, cannot realize scale process; and; the application of a large amount of chemicals, makes the active substance in Cranial-bone-flap lose in a large number, even makes Cranial-bone-flap completely lose activity and become sequestrum.More perplexing, how to drain those and residue in chemical substance in Cranial-bone-flap, and whether these chemical substances produce long-range harm to health, there is no conclusive theoretical foundation and final final conclusion at present.
Summary of the invention
For this reason, the invention provides a kind of technique simple, retain bone lobe active substance, without chemical residue, easily realize standardization, scale and can the external storage method of Autologous skull flap of reviewing.
For solving the problems of the technologies described above, the technical solution used in the present invention is as follows:
A kind of Cranial-bone-flap storage method of the present invention, comprises the steps:
S1, employing cleaning fluid clean the Cranial-bone-flap taken off;
S2, with Cranial-bone-flap described in described cleaning fluid submergence;
S3, low-temperature quick-freezing, make described Cranial-bone-flap be fixed in the ice cube of described cleaning fluid formation;
S4, in the first clean area, through described ice cube, drill through several Cranial-bone-flap through holes;
S5, melt described ice cube, take out described Cranial-bone-flap and drying process is carried out to it;
S6, in the second clean area, encapsulation process is carried out to described Cranial-bone-flap;
S7, irradiation sterilization is carried out to the described Cranial-bone-flap through encapsulation process;
S8, Cranial-bone-flap described after irradiation sterilization is placed in low temperature environment under preserve.
Described step S2 comprises:
The ice cube that described cleaning fluid is formed is placed in the first container;
Described Cranial-bone-flap convex surface is placed on described ice cube upward;
Described cleaning fluid is injected, with Cranial-bone-flap described in submergence in described first container;
Capping is carried out to the first container.
Also comprise between described step S3 and described step S4:
Described first container is placed in second container, and capping is carried out to described second container.
Also comprise after described second container carries out capping:
Described second container is placed in aseptic PE packaging bag, and carries out enclosed package.
Irradiation sterilization step described in described step S7 is electron beam sterilization or γ ray sterilization.
Described electron beam is produced by electron accelerator, and described gamma-rays is produced by Co-60.
Described electron beam or described gamma-ray sterilizing dose is adopted to be 25kGy ~ 35kGy to described Cranial-bone-flap.
The temperature of low-temperature quick-freezing step described in described step S3 is-4 DEG C ~-80 DEG C.
Described in described step S4, the grade of the first clean area is not less than 100,000 grades, and the environmental temperature in described first clean area is-18 DEG C ~ 8 DEG C.
The drying steps of Cranial-bone-flap described in described step S5 adopts freeze drying process, is dried to the moisture of described Cranial-bone-flap not higher than 6wt%.
Described in described step S6, the grade of the second clean area is not less than 100,000 grades, and the environmental temperature in described second clean area is 0 DEG C ~ 8 DEG C.
Described step S6 comprises:
Described Cranial-bone-flap is placed in the 3rd container;
Isolation lid is set above described Cranial-bone-flap;
Airtight capping is carried out to described 3rd container.
After airtight capping is carried out to described 3rd container, also comprise:
Described 3rd container is placed in the 4th container, and airtight capping is carried out to described 4th container.
After airtight capping is carried out to described 4th container, also comprise:
Described 4th container is placed in aseptic PE packaging bag, and carries out enclosed package.
Before described Cranial-bone-flap being placed in the 3rd container, also comprise:
Dried described Cranial-bone-flap is carried out to the step of Vacuum Package.
After airtight capping is carried out to described 3rd container, also comprise:
Described 3rd container is placed in the 5th container, in described 5th container, dry ice and/or liquid nitrogen is housed.
Described first container, described second container, described 3rd container and described 4th container are the aseptic uncovered casing be made up of macromolecular material.
Described macromolecular material is radiation-resistant PETG-1,4-CHDM ester (PETG) or radiation-resistant polyamide (PA) or radiation-resistant polyethylene (PE).
In described step S6, described 3rd container and described 4th container carry out airtight capping by aluminum-plastic composite membrane or polyamide/polyethylene (PA/PE) composite multilayer membrane.
Described first container is by the first lid snap on closure; Described second container is by described second lid snap on closure.
Described first container and described 3rd container are same container, and/or described second container and described 4th container are same container.
Described cleaning fluid is sodium-chloride water solution.
Described cleaning fluid also comprises at least one in sodium lactate, sodium bicarbonate, magnesium sulfate, potassium chloride, calcium carbonate, glucose.
The each described container being also included in Cranial-bone-flap described in splendid attire is arranged the step of pattern identification.
Described pattern identification is Quick Response Code or bar code.
Technique scheme of the present invention has the following advantages compared to existing technology:
1, the external storage method of Autologous skull flap of the present invention, do not use any chemicals, whole process processes at low temperatures, effectively can avoid the microbiological pollution that described Cranial-bone-flap easily runs in storage process, thoroughly can solve again the residue problem of chemical substance.
2, Cranial-bone-flap storage method of the present invention, becomes bone alive after realizing Cranial-bone-flap Hui Zhi to the full extent.Because the Hui Zhi of Preserve selef-cranium is without the rejection of antigen-antibody, thus greatly reduce the operation risk of Hui Zhi.Meanwhile, Autologous skull flap remains the biology structure and the active substance needed for skeletonization that are different from dissimilar materials, has broken away from the dependence to dissimilar materials, has achieved the Regeneration and Repair of skull defeci.
3, Cranial-bone-flap storage method of the present invention, technique simply, easily realizes standardization, scale and can reviewing, can manually, semi-automation is even full-automatic implements, and has far-reaching social value and meaning.
4, Cranial-bone-flap storage method of the present invention, utilize the liquid state of cleaning fluid and solid-state between mutual conversion, irregular Cranial-bone-flap is fully fastened in the ice cube of described cleaning fluid formation, form rigid support to implement boring to Cranial-bone-flap, avoid in the damage to described Cranial-bone-flap fixed and cause because of the fixing difficulty of Cranial-bone-flap and irregular structure in boring procedure.Secondly, the high temperature produced when described ice cube environmental energy fully absorbs boring, thus effectively prevent the overheated and harmful effect to active component in skull of drill bit.Meanwhile, for the ice cube of fastening Cranial-bone-flap, described Cranial-bone-flap and external environment condition effectively can also be isolated, thus fall oligosaprobic possibility.
Accompanying drawing explanation
In order to make content of the present invention be more likely to be clearly understood, below according to a particular embodiment of the invention and by reference to the accompanying drawings, the present invention is further detailed explanation, wherein
Fig. 1 is the flow chart of the Cranial-bone-flap storage method of the embodiment of the present invention.
Embodiment
In order to make the object, technical solutions and advantages of the present invention clearly, below in conjunction with accompanying drawing, embodiments of the present invention are described in further detail.
The present invention can implement in many different forms, and should not be understood to be limited to embodiment set forth herein.On the contrary, provide these embodiments, make the disclosure to be thorough and complete, and design of the present invention fully will be conveyed to those skilled in the art, protection scope of the present invention will only be limited by claim.
Fig. 1 shows the Cranial-bone-flap storage method of the embodiment of the present invention, comprises the steps:
S1, employing cleaning fluid clean the Cranial-bone-flap taken off, and described cleaning fluid is the aqueous solution of sodium chloride, and the content of sodium chloride is 0.9wt%.
As convertible embodiment of the present invention; described cleaning fluid can also comprise one or more the combination in sodium lactate, sodium bicarbonate, magnesium sulfate, potassium chloride, calcium carbonate, glucose; to form the solution of allied organization's extracellular fluid; all can realize object of the present invention, belong to protection scope of the present invention.
As the preferred embodiments of the present invention, described Cranial-bone-flap takes off in the aseptic operating room of standard.
S2, in the first container, place the ice cube formed by described cleaning fluid, described Cranial-bone-flap convex surface is placed on described ice cube upward, in the first container, injects described cleaning fluid with Cranial-bone-flap described in submergence.
In the present embodiment, described first container is aseptic uncovered macromolecule casing, described first container is by the first lid snap on closure, the casing of described first container is identical with described first cover materials, for radiation-resistant PETG-1,4-cyclohexanedimethanoester ester (PETG), is more preferably the PETG-6763 that described PETG is purchased from American Eastman Chemical Company.As convertible embodiment of the present invention; casing and described first cover materials of described first container can be different macromolecular materials; independently be selected from radiation-resistant PETG-1; 4-cyclohexanedimethanoester ester (PETG), radiation-resistant polyamide (PA), radiation-resistant polyethylene (PE); all can realize object of the present invention, belong to protection scope of the present invention.
The piling height of described ice cube is 1cm ~ 3cm, and the present embodiment is preferably 3cm.
In the present embodiment; described in described cleaning fluid submergence, the most shallow degree of depth of Cranial-bone-flap is 1cm, and as convertible embodiment of the present invention, described in described cleaning fluid submergence, the most shallow degree of depth of Cranial-bone-flap is 1cm ~ 3cm; all can realize object of the present invention, belong to protection scope of the present invention.
The present embodiment also comprises described first container is placed in second container, and carries out the step of capping to described second container.Described second container is aseptic uncovered macromolecule casing, described second container is by the second lid snap on closure, the casing of described second container is identical with described second cover materials, for radiation-resistant PETG-1,4-cyclohexanedimethanoester ester (PETG), is more preferably the PETG-6763 that described PETG is purchased from American Eastman Chemical Company.As convertible embodiment of the present invention; casing and described second cover materials of described second container can be different macromolecular materials; independently be selected from radiation-resistant PETG-1; 4-cyclohexanedimethanoester ester (PETG), radiation-resistant polyamide (PA), radiation-resistant polyethylene (PE); all can realize object of the present invention, belong to protection scope of the present invention.
The present embodiment also comprises described second container is placed in aseptic PE packaging bag, and carries out the step of enclosed package.
As convertible embodiment of the present invention, described first container also can not arrange second container and/or aseptic PE packaging bag outward, all can realize object of the present invention, belong to protection scope of the present invention.
As convertible embodiment of the present invention; the capping mode of the capping mode of described first container and the first lid, described second container and described second lid is not limited to fasten, spiral screws up, the capping mode such as sealed; the first container can be realized and described second container capping method all can realize object of the present invention, belong to protection scope of the present invention.
S3, capping is carried out to described first container and carries out low-temperature quick-freezing, in described Cranial-bone-flap is fixed on ice cube that described cleaning fluid formed.
The temperature of described low-temperature quick-freezing step is preferably-4 DEG C ~-80 DEG C, and the present embodiment is more preferably-18 DEG C.
S4, be, in 100,000 grade of first clean area of-4 DEG C, open described first container, use cranium to bore, through described ice cube, with described ice cube for rigid support, described Cranial-bone-flap drills through several Cranial-bone-flap through holes in environmental temperature.As convertible embodiment of the present invention; described in described step S4, the grade of the first clean area is not less than 100,000 grades; the temperature of the environment in described first clean area can also be-18 DEG C ~ 8 DEG C, all can realize object of the present invention, belong to protection scope of the present invention.
The storage method of Cranial-bone-flap of the present invention, utilize the liquid state of cleaning fluid and solid-state between mutual conversion, irregular Cranial-bone-flap is fully fastened in the ice cube of described cleaning fluid formation, form rigid support to implement boring to Cranial-bone-flap, avoid in the damage to described Cranial-bone-flap fixed and cause because of the fixing difficulty of Cranial-bone-flap and irregular structure in boring procedure.Secondly, the high temperature produced when described ice cube environmental energy fully absorbs boring, thus effectively prevent the overheated and harmful effect to active component in skull of drill bit.Meanwhile, for the ice cube of fastening Cranial-bone-flap, described Cranial-bone-flap and external environment condition effectively can also be isolated, thus fall oligosaprobic possibility.
In the present embodiment, the drill bit of described cranium drilling length 8cm, therefore, in step s 2, the piling height of described ice cube is 1cm ~ 3cm, described in described cleaning fluid submergence, the most shallow degree of depth of Cranial-bone-flap is 1cm ~ 3cm, in the sagitta of conventional Cranial-bone-flap for 2cm, namely the thickness of the ice cube of the final fastening described Cranial-bone-flap formed need be less than 8cm, to ensure described cranium when being drilled in boring all the time in described ice cube, and the ice sheet below skull is not drilled, thus ensure the high temperature that described ice cube environmental energy produces when fully absorbing cranium boring, effectively prevent the overheated and harmful effect to active component in skull of drill bit.As convertible embodiment of the present invention; described in the piling height of ice cube described in step S2 and described cleaning fluid submergence, the most shallow degree of depth of Cranial-bone-flap is not limited thereto; choose reasonable can be carried out according to the length of described cranium drill bit; all can realize object of the present invention, belong to protection scope of the present invention.
Described ice cube is melted in S5,40 DEG C of water-baths, takes out described Cranial-bone-flap, carries out drying by freeze drying process to described Cranial-bone-flap, and be dried to moisture lower than 6wt%.As convertible embodiment of the present invention, described Cranial-bone-flap drying process is not limited thereto, and baking temperature is-50 DEG C ~ 40 DEG C, all can realize object of the present invention, belong to protection scope of the present invention.
S6, be, in 100,000 grade of second clean area of 5 DEG C, described Cranial-bone-flap is placed in the 3rd container, and carries out airtight capping in environmental temperature.
Described in described step S6, the grade of the second clean area is not less than 100,000 grades, and the temperature of the environment in described second clean area can also be 0 DEG C ~ 8 DEG C, all can realize object of the present invention, belong to protection scope of the present invention.
Preferably, before described Cranial-bone-flap being placed in described 3rd container, also comprise the step of dried described Cranial-bone-flap being carried out to Vacuum Package, the described Cranial-bone-flap after encapsulation is placed in described 3rd container.
Described Cranial-bone-flap is by flexible material Vacuum Package, and described flexible material is aluminum-plastic composite membrane or polyamide/polyethylene (PA/PE) composite multilayer membrane.
Preferably, after described Cranial-bone-flap is placed in described 3rd container, is also included in the step that isolation lid is set above described Cranial-bone-flap, and then airtight capping is carried out to described 3rd container.The heat that described isolation lid produces when not only can intercept described 3rd closing flaps is to the transmission of Cranial-bone-flap, and described isolation lid is fastened on the inwall of described 3rd container, the effect spacing to described Cranial-bone-flap can also be played, can effectively avoid described Cranial-bone-flap owing to rocking in described 3rd container, vibrating, colliding the defect phenomenon produced, to ensure its integrality.
The present embodiment also comprises described 3rd container is placed in the 4th container, and carries out the step of airtight capping to described 4th container.
The present embodiment also comprises described 4th container is placed in aseptic PE packaging bag, and carries out the step of enclosed package.
Described 3rd container and described 4th container can carry out sealing capping by aluminum-plastic composite membrane or polyamide/polyethylene (PA/PE) composite multilayer membrane, and the present embodiment carries out airtight capping preferably by aluminum-plastic composite membrane.
S7, irradiation sterilization is carried out to the described Cranial-bone-flap be placed in described 3rd container; Described irradiation sterilization step is preferably electron beam sterilization or γ ray sterilization.
Described electron beam is produced by electron accelerator, and described gamma-rays is preferably produced by Co-60.
In the present embodiment, described irradiation sterilization is preferably described electron beam irradiation sterilization, and the sterilizing dose of described electron beam is preferably 25kGy ~ 35kGy.
In the present invention, when irradiation sterilization is carried out to described Cranial-bone-flap, preferably, also comprise the step described 3rd container being placed in the 5th container, in described 5th container, dry ice and/or liquid nitrogen are housed, for ensureing that described Cranial-bone-flap is in low temperature environment when irradiation.If during irradiation; described 3rd external container is also packaged with other container; as as described in the 4th container and/or as described in aseptic PE packaging bag; then without the need to opening said vesse; by be contained with described 3rd container other described in container be directly placed in described 5th container; all can realize object of the present invention, belong to protection scope of the present invention.
S8, described 3rd container that described Cranial-bone-flap is housed is placed in the environment of-4 DEG C ~-80 DEG C under preserve, the present embodiment be preferably-18 DEG C.
If when preserving; described 3rd external container is also packaged with other container; as as described in the 4th container and/or as described in aseptic PE packaging bag; then without the need to opening said vesse; by be contained with described 3rd container other described in container directly preserve; all can realize object of the present invention, belong to protection scope of the present invention.
As convertible embodiment of the present invention, described first container and described 3rd container are same container, and/or described second container and described 4th container are same container, all can realize object of the present invention, belong to protection scope of the present invention.
As the preferred embodiments of the present invention, also comprise the step each described container to Cranial-bone-flap described in splendid attire being arranged identifiable design pattern identification, all can tracing management with the information ensureing described Cranial-bone-flap each step in storage process, described pattern identification is preferably Quick Response Code or bar code.
Preferably, cleaning fluid described in the present embodiment is aseptic cleaning fluid.
Test case
According to the Cranial-bone-flap storage method described in above-described embodiment, process 30 routine Cranial-bone-flaps, wherein 10 examples store 3 months, 10 examples store 6 months, 10 examples store 12 months.
After storage terminates, adopt thioglycollate medium to soak described Cranial-bone-flap and cultivate, take out test after 14 days, above-mentioned 30 routine Cranial-bone-flaps are feminine gender, namely all can reach sterility requirements.
Cranial-bone-flap storage method of the present invention, do not use any chemicals, whole process processes at low temperatures, effectively can avoid the microbiological pollution that described Cranial-bone-flap easily runs in storage process, thoroughly can solve again the residue problem of chemical substance.
And, adopt Autologous skull flap Hui Zhi, after Cranial-bone-flap Hui Zhi being realized to the full extent, become bone alive.Because the Hui Zhi of Preserve selef-cranium is without the rejection of antigen-antibody, thus greatly reduce the operation risk of Hui Zhi.Meanwhile, Autologous skull flap remains the biology structure and the active substance needed for skeletonization that are different from dissimilar materials, has broken away from the dependence to dissimilar materials, has achieved the Regeneration and Repair of skull defeci.
In addition, described Cranial-bone-flap storage method, technique simply, easily realizes standardization, scale and can reviewing, and manually can implement, semi-automaticly implement even full-automatic enforcement, have far-reaching social value and meaning.
Obviously, above-described embodiment is only for clearly example being described, and the restriction not to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.And thus the apparent change of extending out or variation be still among protection scope of the present invention.
Claims (23)
1. a Cranial-bone-flap storage method, is characterized in that, comprises the steps:
S1, employing cleaning fluid clean the Cranial-bone-flap taken off;
S2, with Cranial-bone-flap described in described cleaning fluid submergence;
S3, low-temperature quick-freezing, make described Cranial-bone-flap be fixed in the ice cube of described cleaning fluid formation;
S4, in the first clean area, through described ice cube, drill through several Cranial-bone-flap through holes;
S5, melt described ice cube, take out described Cranial-bone-flap and drying process is carried out to it;
S6, in the second clean area, encapsulation process is carried out to described Cranial-bone-flap;
S7, irradiation sterilization is carried out to the described Cranial-bone-flap through encapsulation process;
S8, Cranial-bone-flap described after irradiation sterilization is placed in low temperature environment under preserve;
Described cleaning fluid is sodium-chloride water solution, or also comprises at least one in sodium lactate, sodium bicarbonate, magnesium sulfate, potassium chloride, calcium carbonate, glucose.
2. Cranial-bone-flap storage method according to claim 1, is characterized in that, described step S2 comprises:
The ice cube that described cleaning fluid is formed is placed in the first container;
Described Cranial-bone-flap convex surface is placed on described ice cube upward;
Described cleaning fluid is injected, with Cranial-bone-flap described in submergence in described first container;
Capping is carried out to the first container.
3. Cranial-bone-flap storage method according to claim 2, is characterized in that, also comprises between described step S3 and described step S4:
Described first container is placed in second container, and capping is carried out to described second container.
4. Cranial-bone-flap storage method according to claim 3, is characterized in that, also comprises after described second container carries out capping:
Described second container is placed in aseptic PE packaging bag, and carries out enclosed package.
5. the Cranial-bone-flap storage method according to any one of claim 1-4, is characterized in that, irradiation sterilization step described in described step S7 is electron beam sterilization or γ ray sterilization.
6. Cranial-bone-flap storage method according to claim 5, is characterized in that, described electron beam is produced by electron accelerator, and described gamma-rays is produced by Co-60.
7. Cranial-bone-flap storage method according to claim 6, is characterized in that, adopts described electron beam or described gamma-ray sterilizing dose to be 25kGy ~ 35kGy to described Cranial-bone-flap.
8. Cranial-bone-flap storage method according to claim 1, is characterized in that, the temperature of low-temperature quick-freezing step described in described step S3 is-4 DEG C ~-80 DEG C.
9. Cranial-bone-flap storage method according to claim 1, is characterized in that, described in described step S4, the grade of the first clean area is not less than 100,000 grades, and the environmental temperature in described first clean area is-18 DEG C ~ 8 DEG C.
10. Cranial-bone-flap storage method according to claim 1, is characterized in that, the drying steps of Cranial-bone-flap described in described step S5 adopts freeze drying process, is dried to the moisture of described Cranial-bone-flap not higher than 6wt%.
11. Cranial-bone-flap storage methods according to claim 1, it is characterized in that, described in described step S6, the grade of the second clean area is not less than 100,000 grades, and the environmental temperature in described second clean area is 0 DEG C ~ 8 DEG C.
12. Cranial-bone-flap storage methods according to claim 1 or 11, it is characterized in that, described step S6 comprises:
Described Cranial-bone-flap is placed in the 3rd container;
Isolation lid is set above described Cranial-bone-flap;
Airtight capping is carried out to described 3rd container.
13. Cranial-bone-flap storage methods according to claim 12, is characterized in that, after carrying out airtight capping, also comprise described 3rd container:
Described 3rd container is placed in the 4th container, and airtight capping is carried out to described 4th container.
14. Cranial-bone-flap storage methods according to claim 13, is characterized in that, after carrying out airtight capping, also comprise described 4th container:
Described 4th container is placed in aseptic PE packaging bag, and carries out enclosed package.
15. Cranial-bone-flap storage methods according to claim 14, is characterized in that, before described Cranial-bone-flap being placed in the 3rd container, also comprise:
Dried described Cranial-bone-flap is carried out to the step of Vacuum Package.
16. Cranial-bone-flap storage methods according to claim 15, is characterized in that, after carrying out airtight capping, also comprise described 3rd container:
Described 3rd container is placed in the 5th container, in described 5th container, dry ice and/or liquid nitrogen is housed.
17. Cranial-bone-flap storage methods according to claim 16, is characterized in that, described first container, described second container, described 3rd container and described 4th container are the aseptic uncovered casing be made up of macromolecular material.
18. Cranial-bone-flap storage methods according to claim 17, it is characterized in that, described macromolecular material is radiation-resistant PETG-1,4-CHDM ester (PETG) or radiation-resistant polyamide (PA) or radiation-resistant polyethylene (PE).
19. Cranial-bone-flap storage methods according to any one of claim 13-18, it is characterized in that, in described step S6, described 3rd container and described 4th container carry out airtight capping by aluminum-plastic composite membrane or polyamide/polyethylene (PA/PE) composite multilayer membrane.
20. Cranial-bone-flap storage methods according to claim 19, is characterized in that, described first container is by the first lid snap on closure; Described second container is by described second lid snap on closure.
21. Cranial-bone-flap storage methods according to claim 20, is characterized in that, described first container and described 3rd container are same container, and/or described second container and described 4th container are same container.
22. Cranial-bone-flap storage methods according to claim 21, is characterized in that, each described container being also included in Cranial-bone-flap described in splendid attire are arranged the step of pattern identification.
23. Cranial-bone-flap storage methods according to claim 22, is characterized in that, described pattern identification is Quick Response Code or bar code.
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| WO2018107487A1 (en) * | 2016-12-16 | 2018-06-21 | 厦门大开生物科技有限公司 | Method of sterilizing cornea by irradiation and cornea sterilized thereby |
| WO2018107482A1 (en) * | 2016-12-16 | 2018-06-21 | 厦门大开生物科技有限公司 | Preparation method for decelluralized swine cornea, decellularized lamellar cornea thereof, and use method |
| WO2018107485A1 (en) * | 2016-12-16 | 2018-06-21 | 厦门大开生物科技有限公司 | Decellularized dried swine lamellar cornea, used method for same, and uses thereof |
| CN109526942A (en) * | 2018-12-29 | 2019-03-29 | 林卫军 | A kind of external deep-bed drying method of Preserve selef-cranium |
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Effective date of registration: 20160805 Address after: 215163, building 1, No. 8, Jinfeng Road, Suzhou hi tech Zone, Jiangsu, 419 Patentee after: Suzhou ever run medical technology Co., Ltd. Address before: 215004, room 31, 301 Xin Kang Garden, Suzhou District, Jiangsu, Suzhou, China Patentee before: Zhu Wenyu Patentee before: Wei Xiaofeng |