CN106913909A - It is a kind of to dry bioprosthesis valve and preparation method thereof - Google Patents
It is a kind of to dry bioprosthesis valve and preparation method thereof Download PDFInfo
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- CN106913909A CN106913909A CN201710108807.0A CN201710108807A CN106913909A CN 106913909 A CN106913909 A CN 106913909A CN 201710108807 A CN201710108807 A CN 201710108807A CN 106913909 A CN106913909 A CN 106913909A
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- valve
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- bioprosthesis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3625—Vascular tissue, e.g. heart valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
- A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/20—Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/40—Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
Abstract
The present invention disclose it is a kind of dry bioprosthesis valve and preparation method thereof, the preparation method includes step：By in the polymer solution of the bioprosthesis valve immersion hydroxyl after crosslinked fixation, taken out after the immersion scheduled time and dried at 5~45 DEG C, obtain drying bioprosthesis valve.Bioprosthesis valve is dried using prepared by preparation method of the present invention, with good physicochemical property and biocompatibility；Preparation method of the present invention improves the service life of valve, makes valve that flexible nature still can be kept in the state of drying, so as to reduce production, the cost of transportation of valve, simplifies the use flow of valve.
Description
Technical field
The present invention relates to medical instruments field, more particularly to a kind of dry bioprosthesis valve and preparation method thereof.
Background technology
With economic development and aging population, the incidence of disease of veteran form calcific aortic disease (CAVD) is presented
The trend of liter, as the angiocardiopathy for being only second to coronary heart disease and hypertension.The retrospective non-randomized studies analysis prompting of one, China
The incidence of disease of the middle-older patient calcific aortic valve (AVC) of more than 50 years old is up to 49.38%.With the aging of population, calcification
Property aortic stenosis (CAS) the incidence of disease increase, will turn into China's valvular heart disease the primary cause of disease.
Aorta petal plant is carried out using artificial valve change the gold mark that (AVR) is the various types of aortic valve diseases for the treatment of
It is accurate.It is increasing (TAVR, or TAVI) art application trend worldwide to be inserted through conduit sustainer bioprosthetic valves.This can
Can be because compared with the excessive risk of conventional surgical AVR, the technology be reduced the potentiality of the death rate and the incidence of disease.Through conduit actively
Arteries and veins valve implantation is smaller as a kind of wound, and the relatively low treatment method of risk gives severe aortic stenosis in patients, particularly
The patient of open chest surgery is unable to, new hope is brought.With widely using for intervention artificial heart biological cardiac valve, how it is improved
Service life, the failure for reducing biovalve is the important problem that we face.
Existing biovalve is essentially all to be crosslinked using single glutaraldehyde solution, and reach makes under certain condition
With the mechanical property and durability of scope, and possess good biocompatibility, then biovalve is sewed and is remembered in one kind
On metallic support, then it is stored in finite concentration glutaraldehyde preservation liquid.Before Cardiac valve replacement is carried out, by valve
Film is transported to hospital operating room, and valve is cleaned, and valve is delivered in heart of patient by conveyer device then.
During the making of above-mentioned valve, sewing, transport and use, valve must be maintained in specifically preserving in liquid and ensure that valve is
Wet state.
Biovalve after domestic and international existing crosslinking is during making, sewing, transport and use, it is necessary to be stored in spy
In fixed preservation liquid and ensure that valve is wet state so that valve needs extra condition so that preparing in preparation process
Process is cumbersome, valve must be separated with conveyer in transportation, and valve needs preoperative loading, and valve must be washed during loading
The preservation liquid of upper residual, causes easily loss to cause calcification and inactivate and increase the risk of bacterial infection, while limit its clinic should
With popularization, the cost that biovalve preserves, transports and use is increased.And biovalve is by after glutaraldehyde cross-linking, valve
Can usually remain the carboxyl on the unpaired aldehyde radical from glutaraldehyde and valve proteinaceous tissue on film, aldehyde radical and carboxyl easily with
Calcium binding, causes there are calcification sites in bioprosthetic valves, and this is a major reason for causing bioprosthetic valves calcification.Simultaneously because wet
Film is loaded, and valve compressed dimension cannot further reduce, and reduces patient's accommodation, and limitation valve is inserted path, be increased
Vascular complication.
With the gradually accumulation of TAVR clinical experiences, its complication is gradually decreased, and idicatio has gradually to younger trouble
Person, in it is low danger patient extension trend.At present it is all it is commercialized through conduit aortic valve in application process, potential problems
Gradually highlight, mainly include as follows：
1. valve durability is inadequate, it is impossible to meet valvular heart disease people's rejuvenation trend；
2. valve compressed dimension cannot further reduce, and reduce patient's accommodation, and limitation valve is inserted path, increased
Vascular complication；
3. valve need preoperative loading, easy calcification and inactivate, the defect such as poor durability and manufacture accumulating condition harshness limits it
Clinical practice is promoted；
4. the biocompatibility of existing artificial bio-prosthetic valve is still not enough；The biocompatibility of artificial bio-prosthetic valve is influence valve
One major reason of film service life, eliminates the immunogenicity of valve and can strengthen host ECs and climb and cover function, reduces
Perivalvular leakage Probability.
Therefore, prior art has yet to be improved and developed.
The content of the invention
In view of above-mentioned the deficiencies in the prior art, bioprosthesis valve and its system are dried it is an object of the invention to provide a kind of
Preparation Method, it is intended to solve existing bioprosthesis valve durability not enough, valve compressed dimension cannot further reduce, valve is needed
Preoperative loading, easy calcification and inactivate, manufacture accumulating condition is harsh and problem of poor biocompatibility.
Technical scheme is as follows：
A kind of preparation method for drying bioprosthesis valve, including step：By the bioprosthesis valve after crosslinked fixation
Immerse in the polymer solution of hydroxyl, taken out after the immersion scheduled time and dried at 5~45 DEG C, obtain drying artificial bio-prosthetic valve
Film.
The described preparation method for drying bioprosthesis valve, wherein, the polymer solution of the hydroxyl is poly- second two
One or more mixed solution in alcohol, polyvinyl alcohol, polyether Glycols solution.
The described preparation method for drying bioprosthesis valve, wherein, the concentration of the polymer solution of the hydroxyl is
10%~50%.
The described preparation method for drying bioprosthesis valve, wherein, the scheduled time is 1~7 day.
The described preparation method for drying bioprosthesis valve, wherein, by the bioprosthesis valve leaching after crosslinked fixation
When being soaked in the polymer solution for entering hydroxyl, soaking temperature is 25~45 DEG C.
The described preparation method for drying bioprosthesis valve, wherein, by the bioprosthesis valve leaching after crosslinked fixation
It is 3.0~5.5 by adding hydrochloric acid control solution pH value when being soaked in the polymer solution for entering hydroxyl.
The described preparation method for drying bioprosthesis valve, wherein, bioprosthesis valve is carried out using glutaraldehyde solution
Crosslinking fix.
The described preparation method for drying bioprosthesis valve, wherein, use concentration molten for 0.1%~5% glutaraldehyde
The bioprosthesis valve crosslinking that liquid is carried out 2~5 days at normal temperatures is fixed.
A kind of to dry bioprosthesis valve, it uses the preparation method described in any of the above to be obtained.
Beneficial effect：Bioprosthesis valve is dried using prepared by preparation method of the present invention, with good physics and chemistry
Performance and biocompatibility；Preparation method of the present invention improves the service life of valve, make valve in the state of drying still
Flexible nature can be kept, so as to reduce production, the cost of transportation of valve, the use flow of valve is simplified.
Brief description of the drawings
Fig. 1 is the reaction equation schematic diagram of aldehyde radical and carboxyl and hydroxyl in polymer in valve of the present invention.
Specific embodiment
Present invention offer is a kind of to dry bioprosthesis valve and preparation method thereof, to make the purpose of the present invention, technical scheme
And effect is clearer, clear and definite, the present invention is described in more detail below.It should be appreciated that specific implementation described herein
Example is only used to explain the present invention, is not intended to limit the present invention.
The invention by the bioprosthesis valve (abbreviation valve) after crosslinked fixation, by the polymerization of hydroxyl
The treatment of thing solution, contained chemical functional group chemically reacts with group in valve in solution, while polymer is played to valve
Submissiveization modifying function, is then processed through low temperature drying again, so that valve has good physicochemical property and biocompatibility,
Improve the service life of valve.
The preparation method for drying bioprosthesis valve of present pre-ferred embodiments, including step：After crosslinked fixation
Bioprosthesis valve immersion hydroxyl polymer solution in, immersion the scheduled time after take out at 5~45 DEG C dry, obtain
Dry bioprosthesis valve.
In the present embodiment, the drying of valve is 5~45 DEG C of low temperature drying.The present invention is by by the polymer of hydroxyl
Bioprosthesis valve after mixed solution treatment takes out, and is dried under low-temperature condition, makes the artificial bio-membrane after being completely dried
Valve, remains able to ensure good pliability and mechanical property.
It should be noted that bioprosthesis valve of the present invention includes but is not limited to pig pericardium heart valve, bovine pericardium valve
Deng animal pericardium heart valve.
, it is necessary to be first crosslinked bioprosthesis valve before in the polymer solution of immersion hydroxyl, to be handed over
Bioprosthesis valve after connection is fixed.In the present embodiment, the crosslinking for carrying out bioprosthesis valve using glutaraldehyde solution is fixed.
Preferably, the artificial bio-prosthetic valve for using concentration to be carried out at normal temperatures for 0.1%~5% glutaraldehyde solution 2~5 days
Film crosslinking is fixed.Glutaraldehyde cross-linking is carried out to biovalve to fix, can eliminate the bioactivity of biovalve, make its power first
Learn performance and endurance quality reaches requirement.
During specific implementation, can at normal temperatures be protected in the glutaraldehyde solution of bioprosthesis valve immersion 0.1%~5%
Hold 2~5 days, and ensure the smooth expansion of valve simultaneously.
Generally, preparation method of the present invention includes：1. the crosslinking of biovalve；2. biovalve chemical treatment and
Submissiveization treatment；3. low temperature drying.Wherein, biovalve chemical treatment and submissiveization are processed as committed step of the invention, its
To mainly be soaked in the polymer solution of the bioprosthesis valve immersion hydroxyl after crosslinked fixation, made hydroxyl
Polymer chemically reacts with bioprosthesis valve.
After the present invention is using valve crosslinking, it is chemically treated through hydroxyl polymer-containing, then is dehydrated through low temperature drying, drying is obtained
Bioprosthesis valve.The polymer solution of hydroxyl is combined by chemical covalent bonds with valve surface, valve is also possessed very
Good pliability, and excellent pliability can be in dry conditions remained in that, realize the kept dry of valve.It is simultaneously poly-
The chemical functional group of polymer solution is chemically reacted with the aldehyde radical or carboxyl of residual in biovalve, is not only closed these and is dissociated
Chemical group, reduces the adhesion of bioprosthetic valves and calcium ion, and significantly reduces valve material thickness and possess fold from calming down
Function, tissue deactivates, and reduces the immunogenicity of material, enhances host ECs and climbs the ability of covering, and reduces valve at a specified future date
The incidence of week leakage, increased the service life of biovalve.
Further, in the present embodiment, the polymer solution of the hydroxyl is polyethylene glycol, polyvinyl alcohol, polyethers
One or more mixed solution in glycol solution.The polymer solution of the hydroxyl is a kind of to the nontoxic liquid of human body
Body, and be a kind of excellent toughener.
As shown in figure 1, aldehyde radical and carboxylic of the polymer of hydroxyl of the present invention by residual in terminal hydroxyl and valve
Base is chemically reacted, and valve surface is covered one layer of polymeric.The molecular weight of polymer is larger, then single polymer molecule exists
The scope of valve surface covering is also larger, therefore the polymer of the hydroxyl is easy to assign the Chemical Physics performance of itself
Bioprosthesis valve.
The present invention uses the polymer of the hydroxyl with toughening effect, can be by chemical covalent bonds and valve surface knot
Close, valve is also possessed good pliability, valve is remained in that excellent pliability in dry conditions, so that real
The kept dry of existing valve.
Further, in the present embodiment, the concentration of the polymer solution of the hydroxyl is 10%~50%.Namely
It is, during the bioprosthesis valve immersion concentration after crosslinked fixation is the polymer solution of 10%~50% hydroxyl by the present invention
Soaked.
Further, in the present embodiment, the bioprosthesis valve after crosslinked fixation is immersed the polymer of hydroxyl
Drying is further taken out after being soaked 1~7 day in solution, i.e., the described scheduled time is 1~7 day.
Further, in the present embodiment, the bioprosthesis valve after crosslinked fixation is immersed the polymer of hydroxyl
When being soaked in solution, soaking temperature is 25~45 DEG C.
Further, in the present embodiment, the bioprosthesis valve after crosslinked fixation is immersed the polymer of hydroxyl
It is 3.0~5.5 by adding hydrochloric acid control solution pH value when being soaked in solution.Polymer is deposited due to space steric effect, reaction
Speed it is slow, the time is long the shortcomings of, therefore the present invention is 3.0~5.5 by adjusting the pH value of solution, so as to activate artificial bio-membrane
Aldehyde radical and carboxyl in valve, strengthen the reactivity of aldehyde radical and carboxyl in hydroxyl and valve in the polymer of hydroxyl.
During specific implementation, can be by the polymer of the hydroxyl of the good biovalve immersion 10%~50% of glutaraldehyde cross-linking
1~7 day in solution, temperature is controlled for 25~45 DEG C, while being 3.0~5.5 by adding hydrochloric acid control solution pH value, and ensure
The smooth expansion of valve.
Further, bioprosthesis valve is dried present invention also offers a kind of, it is to dry people using above-described
The preparation method of work biovalve is obtained.
The present invention makes leaflet thinner by unique dry film process technology, more firmly, more durable, and biocompatibility is more preferable,
Proterties is more stable.The reduction of leaflet thickness causes the appearance and size reduction by 80% after valve compression, and the dry film process technique
Realize valve and can be filled in induction system in advance and dispatch from the factory, can use at any time, without preoperative installation, shorten operating time, reduce
The mortality risk for waiting valve to be caused during being implanted into patient's art.Drying and other treatment tissue deactivates, and need not be positioned over containing
In the storing liquid of glutaraldehyde preserve can preloaded system, thoroughly solve valve endurance issues, improve the biofacies of valve
Capacitive, reduces the endocarditis probability of happening that immunogene risk causes, and enhances host ECs and climbs and covers function, reduces
Perivalvular leakage probability of happening.
The present invention is elaborated with specific embodiment below：
Embodiment 1
Pig pericardium heart valve is soaked 2 days in the glutaraldehyde solution that concentration is 5%, is taken out and is rinsed, after obtaining crosslinking fixation
Bioprosthesis valve；Then fixed bioprosthesis valve will be crosslinked at a temperature of 45 DEG C, pH value is that 5.5, concentration is 20%
Polyethylene glycol, polyvinyl alcohol solution in immersion take out after 7 days, be finally completely dried at 20 DEG C, obtain drying artificial
Biovalve.
Find after testing, it is manufactured in the present embodiment to dry bioprosthesis valve, with excellent pliability, after valve compression
Appearance and size reduction by 80%, and biocompatibility is good, proterties stabilization.
Embodiment 2
Pig pericardium heart valve is soaked 3 days in the glutaraldehyde solution that concentration is 4%, is taken out and is rinsed, after obtaining crosslinking fixation
Bioprosthesis valve；Then fixed bioprosthesis valve will be crosslinked at a temperature of 40 DEG C, pH value is that 4.5, concentration is 30%
Polyethylene glycol, polyvinyl alcohol solution in immersion take out after 5 days, be finally completely dried at 25 DEG C, obtain drying artificial
Biovalve.
Find after testing, it is manufactured in the present embodiment to dry bioprosthesis valve, with excellent pliability, after valve compression
Appearance and size reduction by 80%, and biocompatibility is good, proterties stabilization.
Embodiment 3
Pig pericardium heart valve is soaked 4 days in the glutaraldehyde solution that concentration is 3%, is taken out and is rinsed, after obtaining crosslinking fixation
Bioprosthesis valve；Then fixed bioprosthesis valve will be crosslinked at a temperature of 35 DEG C, pH value is that 4.0, concentration is 40%
Polyglycol solution in immersion 3 days after take out, be finally completely dried at 30 DEG C, obtain drying bioprosthesis valve.
Find after testing, it is manufactured in the present embodiment to dry bioprosthesis valve, with excellent pliability, after valve compression
Appearance and size reduction by 80%, and biocompatibility is good, proterties stabilization.
Embodiment 4
Pig pericardium heart valve is soaked 5 days in the glutaraldehyde solution that concentration is 1%, is taken out and is rinsed, after obtaining crosslinking fixation
Bioprosthesis valve；Then fixed bioprosthesis valve will be crosslinked at a temperature of 25 DEG C, pH value is that 3.0, concentration is 50%
Polyglycol solution in immersion 1 day after take out, be finally completely dried at 45 DEG C, obtain drying bioprosthesis valve.
Find after testing, it is manufactured in the present embodiment to dry bioprosthesis valve, with excellent pliability, after valve compression
Appearance and size reduction by 80%, and biocompatibility is good, proterties stabilization.
Embodiment 5
Pig pericardium heart valve is soaked 5 days in the glutaraldehyde solution that concentration is 0.1%, is taken out and is rinsed, obtained crosslinking and fix
Bioprosthesis valve afterwards；Then fixed bioprosthesis valve will be crosslinked at a temperature of 25 DEG C, pH value is that 3.0, concentration is
Taken out after being soaked 7 days in 10% polyether Glycols solution, be finally completely dried at 5 DEG C, obtain drying bioprosthesis valve.
Find after testing, it is manufactured in the present embodiment to dry bioprosthesis valve, with excellent pliability, after valve compression
Appearance and size reduction by 80%, and biocompatibility is good, proterties stabilization.
In sum, bioprosthesis valve and preparation method thereof, the preparation method bag are dried the invention provides a kind of
Include step：By in the polymer solution of the bioprosthesis valve immersion hydroxyl after crosslinked fixation, taken after the immersion scheduled time
Go out and dried at 5~45 DEG C, obtain drying bioprosthesis valve.The drying prepared using preparation method of the present invention is manually given birth to
Thing valve, with good physicochemical property and biocompatibility；Preparation method of the present invention improves the service life of valve, makes valve
Film still can keep flexible nature in the state of drying, so as to reduce production, the cost of transportation of valve, simplify valve
Use flow.
It should be appreciated that application of the invention is not limited to above-mentioned citing, and for those of ordinary skills, can
To be improved according to the above description or converted, all these modifications and variations should all belong to the guarantor of appended claims of the present invention
Shield scope.
Claims (9)
1. a kind of preparation method for drying bioprosthesis valve, it is characterised in that including step：It is artificial after by crosslinked fixation
In the polymer solution of biovalve immersion hydroxyl, taken out after the immersion scheduled time and dried at 5~45 DEG C, obtain drying people
Work biovalve.
2. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that the hydroxyl it is poly-
Polymer solution is one or more mixed solution in polyethylene glycol, polyvinyl alcohol, polyether Glycols solution.
3. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that the hydroxyl it is poly-
The concentration of polymer solution is 10%~50%.
4. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that the scheduled time is
1~7 day.
5. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that after crosslinked fixation
Bioprosthesis valve immersion hydroxyl polymer solution in when soaking, soaking temperature is 25~45 DEG C.
6. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that after crosslinked fixation
Bioprosthesis valve immersion hydroxyl polymer solution in when soaking, by add hydrochloric acid control solution pH value for 3.0~
5.5。
7. the preparation method for drying bioprosthesis valve according to claim 1, it is characterised in that use glutaraldehyde solution
The crosslinking for carrying out bioprosthesis valve is fixed.
8. the preparation method for drying bioprosthesis valve according to claim 7, it is characterised in that use concentration for
The bioprosthesis valve crosslinking that 0.1%~5% glutaraldehyde solution is carried out 2~5 days at normal temperatures is fixed.
9. it is a kind of to dry bioprosthesis valve, it is characterised in that using the preparation method system described in any one of claim 1~8
.
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| CN109260517A (en) * | 2018-09-19 | 2019-01-25 | 杭州启明医疗器械有限公司 | One kind can pre-install dry biological cardiac valves and preparation method thereof |
| CN109820625A (en) * | 2018-09-30 | 2019-05-31 | 四川大学 | A kind of artificial bio-prosthetic valve membrane processing method of crosslinking |
| CN110507856A (en) * | 2019-09-29 | 2019-11-29 | 四川大学 | A kind of full prepackage is dry to intervene aorta petal membrane material and preparation method thereof |
| WO2020057414A1 (en) * | 2018-09-19 | 2020-03-26 | 杭州启明医疗器械股份有限公司 | Dry biological heart valve capable of rapidly absorbing water and flattening, and preparation method therefor |
| CN111494716A (en) * | 2020-04-15 | 2020-08-07 | 青岛市妇女儿童医院（青岛市妇幼保健院、青岛市残疾儿童医疗康复中心、青岛市新生儿疾病筛查中心） | Heart surgery autologous pericardium patch processor and rapid anti-calcification treatment method |
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| EP3854424A4 (en) * | 2018-09-19 | 2022-06-22 | Venus MedTech (HangZhou), Inc. | Preload biological heart valve capable of rapid rehydration and preparation method therefor |
| US11931253B2 (en) | 2020-01-31 | 2024-03-19 | 4C Medical Technologies, Inc. | Prosthetic heart valve delivery system: ball-slide attachment |
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| US10653523B2 (en) | 2017-01-19 | 2020-05-19 | 4C Medical Technologies, Inc. | Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves |
| US11857441B2 (en) | 2018-09-04 | 2024-01-02 | 4C Medical Technologies, Inc. | Stent loading device |
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