CN109878907A - A kind of magnesium alloy bracket the storage box and method - Google Patents
A kind of magnesium alloy bracket the storage box and method Download PDFInfo
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- CN109878907A CN109878907A CN201910155214.9A CN201910155214A CN109878907A CN 109878907 A CN109878907 A CN 109878907A CN 201910155214 A CN201910155214 A CN 201910155214A CN 109878907 A CN109878907 A CN 109878907A
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- magnesium alloy
- alloy bracket
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Abstract
It includes that sealed box body is placed in the intracorporal padding of box and the gas full of box body that the present invention, which discloses a kind of magnesium alloy bracket the storage box and method, the storage box,；Padding successively includes netted thermal insulation layer, water absorption layer, netted thermal insulation layer and plastic silical gel layer from bottom to up, and magnesium alloy bracket is placed on plastic silical gel layer, and gas includes the mixed gas of hydrogen and helium；Method includes 1) heated dry air sterilizing is carried out to magnesium alloy bracket the storage box of the invention；2) it is down to room temperature to the storage box temperature, magnesium alloy bracket is placed in the storage box after sterilizing；3) it is filled with the mixed gas of hydrogen and helium that volume ratio is 1:1-1:5 into box body, and box body is sealed；4) box body after sealing is subjected to radiation sterilization；The present invention provides a kind of effective the storage box and method for magnesium alloy bracket.
Description
Technical field
The present invention relates to biomedicine field more particularly to a kind of magnesium alloy bracket the storage box and method.
Background technique
The principle of cardiac stent operation is to be widened the blood vessel of obstruction again by implantation bracket, and blood flow is enabled to restore logical
Freely.Forth generation biodegradable stent uses degradation material, can voluntarily dissolve after two years, will not leave metallic support in human body,
The psychological burden for mitigating patient, is the ideal chose of most of cardiovascular patients.But some patients are due to patch class in angiocarpy
The problems such as type or blocking position, possibly can not install forth generation biodegradable stent.Therefore, the 5th generation biodegradable stent -- magnesium alloy
Cardiac stent just comes into being.Magnesium alloy cardiac stent (Magmaris BRS), is manufactured with magnesium alloy, with metallic support
Supporting force, it is rounded to protect blood vessel after the implantation, keeps blood flow unimpeded.Each magnesium alloy hypersorption bracket (Magmaris BRS)
Containing 8 points 5 milligrams of magnesium, and there is biological dissolution coating, it is ensured that drug is released effectively.After the implantation, through contact moisture content gradually one
Dissolve after year, be finally absorbed by the body, artery can restore original form and function, and it is mobile as healthy blood vessel and
Bending.
Magnesium alloy bracket has the history of more than ten years, and 2003, Heublein etc. was for the first time using magnesium alloy AE21 production hat
Shape arterial bracket is implanted into the coronary artery of pig, and AE21 bracket early stage leads to neointimal hyperplasia as the result is shown, but thrombosis,
Inflammatory reaction is less.Its main problem is that rack body degradation speed is too fast, can not provide effective mechanical support.Then,
Biotronik company improves magnesium alloy materials, has developed absorbable metal bracket of new generation with magnesium alloy WE43
(absorbable metalstent, AMS), results of animal is shown, compared with ordinary stent, AMS can inhibit inner membrance increasing
It is raw, while reducing blood vessels caliber loss.AMS and stainless steel stent are equally implanted in porcine coronary by Waksman etc., are obtained
Similar conclusion, but since magnesium alloy degradation cycle is too short, balance can not be reached with effective treatment time, therefore still need to improved magnesium conjunction
Golden ingredient and support Design are to control degradation speed.2005, magnesium alloy bracket first entered clinic, and dynamic applied to periphery
Arteries and veins.Peeters etc. treats 20 critical extremity ischemia patients with magnesium alloy bracket, the results showed that it has preferable biology peace
Quan Xing, vascular patency is also up to 89.5% after 3 months.But subsequent one is covered 117 arterial occlusions in lower limbs of multicenter and is suffered from
The research of person points out that 6 months patency rates of magnesium alloy bracket are far below traditional angioplasty (31.8% to 58.0%), studies carefully its original
Cause, it may be possible to which bracket premature breakdown causes support force insufficient, causes long-term effect undesirable.Erbel etc. is by degradable magnesium alloy
Stent applications have carried out perspective, multicenter, nonrandom clinical test in coronary occlusion, which is included in 63 trouble
Person is implanted into 71 pieces of degradable magnesium brackets altogether, carries out follow-up using intravascular ultrasound and radiography.Bracket long-term patency rate as the result is shown
Lower than expection, postoperative 4 months, target vessel reconstruct rate caused by ischemic after being 23.8%, 1 year overall target lesion vascular remodeling rate be
45%, although degradable magnesium alloy bracket is short-term after surgery to can get the observation similar with metallic support as a result, long-term effect
It is still undesirable.The research is added medication coat and may be reached more also it is further proposed that imagine, extending bracket degradation cycle
Good effect.The complete design optimization on the basis AMS of Biotronik company, and antiproliferative agents are added in rack surface
Object --- taxol releases degradable magnesium alloy medicine coating bracket DREAMS1.0 of new generation.Compared with previous generation bracket,
DREAMS1.0 has stronger mechanical performance, and reduces degradation speed, it is possible to provide longer mechanical support, at the same time,
The anti-proliferative drugs taxol for including in the degradable polymer coating of surface, can be effectively suppressed endometrial hyperplasia.2013, Haude
Deng having delivered the result of study of degradable magnesium alloy medicine coating bracket (DREAMS) for human body for the first time, including 46 patients
Experimental result shows, DREAMS bracket advanced stage caliber is lost less compared with AMS, and Revascularization rate is only at 6 months
4% (2/46), bracket is in the serious bad thing such as being basically completed degradation, and do not occur cardiac death and stent thrombosis in 6 months
Part.This result has also further demonstrated that the huge applications value and potentiality of degradable magnesium alloy bracket.On this basis,
Biotronik company has developed second generation medication coat degradable magnesium alloy bracket (DREAMS2.0) again, and fills in rack surface
Carry the stronger rapamycin of antiproliferative effect.Compared with the first generation, the inflammatory reaction of DREAMS2.0 bracket is lighter, endothelialization speed
Faster, clinical test (BIOSOLVE- II) result also demonstrates this viewpoint.Totally 123 patients are included in statistics, at 6 months
The visible normal vasomotor function of 80% patient, average lumen lose 0.27mm, and neointimal area is only 0.08mm2, target
Lesion revascularization rate is less than 2%.Similar when Follow-up results were with 6 months at 12 months, average lumen, which is lost, increases deficiency
0.05mm, and become vascular occlusion patient without neopathy, any thrombus in stents patient is not found during entire follow-up.Section, China
Grind the research and development that worker also pays close attention to biodegradable magnesium-alloy stent always, Metal Inst., Chinese Academy of Sciences's scientific research
AZ31 magnesium alloy biodegradable stent is implanted into rabbit abdominal aorta by personnel, and bracket is gradually degraded in implantation 2 months as the result is shown
Fracture, loses mechanical support, and 4 months whens are absorbed by organisms completely, and point out that extending its supporting time is to inhibit blood vessel advanced stage
The key of remodeling.It is modified that Liu et al. using APTES carries out surface to magnesium bracket, and is verified in animal body, as the result is shown its
The advantages of good biocompatibility and antithrombus formation.In addition to this, the optimization of magnesium alloy ingredient and proportion are also research
Hot spot.Degradable magnesium alloy bracket is studied and surrounds the commercial magnesium alloy such as AZ31, WE43 mostly both at home and abroad at present, and commercial magnesium alloy
Original design intention be structural material, biocompatibility is poor, and there are application risks.In consideration of it, group, Shanghai Communications University, China
Team is dedicated to the design and improvement of medical bio magnesium alloy materials, and independent research goes out good biocompatibility, intensity height, homogeneous corrosion
Novel high-performance medical magnesium alloy Mg-Nd-Zn-Zr based alloy it is serial (abbreviation JDBM), a series of experiments result also shows that
Its good application prospect.
But magnesium alloy bracket causes it to be easy to happen oxidation, deformation etc., because of the particularity of its material so as to cause branch
Frame reduced performance.
The prior art also has research about the storage mode of bracket, but effectively depositing for magnesium alloy bracket not yet
Storage mode.
Summary of the invention
In view of the above technical problems, the present invention provides a kind of effective the storage box and method for magnesium alloy bracket.
The first aspect of the invention provides a kind of magnesium alloy bracket the storage box, including, sealed box body is placed in box body
Interior padding and the gas full of box body；The padding successively includes netted thermal insulation layer, water absorption layer, netted thermal insulation layer from bottom to up
With plastic silical gel layer, magnesium alloy bracket is placed on the plastic silical gel layer, and the gas includes the mixing of hydrogen and helium
Gas.
Preferably, the volume ratio of hydrogen and helium is 1:1-1:5；It is further preferred that the volume ratio of hydrogen and helium is
1:2。
Preferably, the water absorption layer is graphite carbon-coating.
Preferably, the netted thermal insulation layer is reticular glass fiber.
The second aspect of the invention provides a kind of magnesium alloy bracket storage method, including,
1) heated dry air sterilizing is carried out to magnesium alloy bracket the storage box of the present invention；
2) it is down to room temperature to the storage box temperature, magnesium alloy bracket is placed in the storage box after sterilizing；
3) it is filled with the mixed gas of hydrogen and helium that volume ratio is 1:1-1:5 into box body, and box body is sealed；
4) box body after sealing is subjected to radiation sterilization.
Preferably, the condition of heated dry air sterilizing is 140 DEG C, 3.5h.
Preferably, the dose of radiation of the radiation sterilization is 10-50KGy.
Preferably, the volume ratio of the hydrogen and helium is 1:2.
Compared with prior art, technical solution of the present invention has the advantage that the present invention provides can preferably keep
The Storage Box and storage method of magnesium alloy bracket performance, magnesium alloy bracket are placed in plastic silical gel layer, and plastic silical gel layer
Under be additionally provided with netted thermal insulation layer, water absorption layer, netted thermal insulation layer, water absorption layer can absorb vapor, and netted thermal insulation layer can be kept away again
The moisture for exempting to absorb evaporates again and leads to corrode magnesium alloy bracket, and plastic silical gel layer can preferably fix magnesium alloy bracket
And the physical structure feature of magnesium alloy bracket is maintained, the present invention, as filling, is on the one hand due to hydrogen using hydrogen and helium
Non-corrosive to magnesium alloy bracket with helium, the mixed gas of hydrogen and helium that another aspect volume ratio is 1:1-1:5 can
Help magnesium alloy bracket reduces physical hazard in sterilization process, and the present invention also using classification repeatedly sterilizing, can guarantee to go out
Under the conditions of bacterium is sufficient, the loss to magnesium alloy bracket is utmostly avoided, therefore magnesium alloy bracket of the invention is protected for a long time
Still there is preferable performance after depositing.
Detailed description of the invention
In order to more clearly explain the embodiment of the invention or the technical proposal in the existing technology, to embodiment or will show below
There is attached drawing needed in technical description to be briefly described, it should be apparent that, the accompanying drawings in the following description is only this
Some embodiments of invention without any creative labor, may be used also for those of ordinary skill in the art
To obtain other drawings based on these drawings.
Fig. 1 is that the hardness of magnesium alloy bracket the storage box storage examination magnesium alloy bracket and the result of time relationship of the invention are shown
It is intended to.
Specific embodiment
The technical effect of design of the invention, specific structure and generation will be described further below, with fully
Solve the purpose of the present invention, feature and effect.
Embodiment 1
Magnesium alloy bracket the storage box includes sealed box body, is placed in the intracorporal padding of box and the gas full of box body, the present invention
The box body is not the shape of proper box, or the packaging bag of filling gas.Padding is from bottom to up
It successively include netted thermal insulation layer, water absorption layer, netted thermal insulation layer and plastic silical gel layer, magnesium alloy bracket is placed in plastic silical gel layer
On.
In the present embodiment, gas is the mixed gas of hydrogen and helium that volume ratio is 1:2.
In the present embodiment, water absorption layer is graphite carbon-coating.
In the present embodiment, netted thermal insulation layer is reticular glass fiber.
The magnesium alloy bracket the storage box of the present embodiment is used to store the specific steps of magnesium alloy bracket are as follows:
1) heated dry air sterilizing, the condition of heated dry air sterilizing are carried out to magnesium alloy bracket the storage box manufactured in the present embodiment
For 140 DEG C, 3.5h；
2) it is down to room temperature to the storage box temperature, magnesium alloy bracket is placed in the storage box after sterilizing；
3) it is filled with the mixed gas of hydrogen and helium that volume ratio is 1:2 into box body, and box body is sealed；
4) box body after sealing is subjected to radiation sterilization, the dose of radiation of radiation sterilization is 10-50KGy.
Embodiment 2
Magnesium alloy bracket is stored using the storage box and method of embodiment 1, storage condition is normal temperature and pressure, and storage 12 coexists
A magnesium alloy bracket, each the storage box stores 1 magnesium alloy bracket, and point moon one magnesium alloy bracket of taking-up is tested.
Crush resistance can test result is as follows shown in table with contracting property,
Hardness than the result with time change as shown in Figure 1,
By upper table and Fig. 1 it is found that the storage box and method using embodiment 1 store magnesium alloy bracket, magnesium is closed in 12 months
The golden anti-extrusion reduced performance 0.8%-5.2% of bracket, contracting property reduce 0.6%-3.2%, and hardness reduces 0-10%.
Embodiment 3
Magnesium alloy bracket same as Example 2 is placed in seal box, seal box is then subjected to radiation sterilization, then
Carry out detection the same manner as in Example 2.
The magnesium alloy bracket testing result saved using the method for embodiment 3 are as follows: magnesium alloy bracket is anti-extrusion in 12 months
Reduced performance 10.0%-32.8%, contracting property reduce 9.1%-30.0%, and hardness reduces 5-40%.
By the comparison of embodiment 2 and embodiment 3 as it can be seen that Storage Box and storage method of the invention can store well
Magnesium alloy bracket.
The preferred embodiment of the present invention has been described in detail above.It should be appreciated that those skilled in the art without
It needs creative work according to the present invention can conceive and makes many modifications and variations.Therefore, all technologies in the art
Personnel are available by logical analysis, reasoning, or a limited experiment on the basis of existing technology under this invention's idea
Technical solution, all should be within the scope of protection determined by the claims.
Claims (9)
1. a kind of magnesium alloy bracket the storage box, which is characterized in that including sealed box body is placed in the intracorporal padding of box and full of box
The gas of body；The padding from bottom to up successively include netted thermal insulation layer, water absorption layer, netted thermal insulation layer and plastic silical gel layer,
Magnesium alloy bracket is placed on the plastic silical gel layer, and the gas includes the mixed gas of hydrogen and helium.
2. magnesium alloy bracket the storage box as described in claim 1, which is characterized in that the volume ratio of hydrogen and helium is 1:1-1:5.
3. magnesium alloy bracket the storage box as claimed in claim 2, which is characterized in that the volume ratio of hydrogen and helium is 1:2.
4. magnesium alloy bracket the storage box as described in claim 1, which is characterized in that the water absorption layer is graphite carbon-coating.
5. magnesium alloy bracket the storage box as described in claim 1, which is characterized in that the netted thermal insulation layer is that Reticulated Vitreous is fine
Dimension.
6. a kind of magnesium alloy bracket storage method, which is characterized in that including,
1) the magnesium alloy bracket the storage box described in claim 1-5 any one carries out heated dry air sterilizing；
2) it is down to room temperature to the storage box temperature, magnesium alloy bracket is placed in the storage box after sterilizing；
3) it is filled with the mixed gas of hydrogen and helium that volume ratio is 1:1-1:5 into box body, and box body is sealed；
4) box body after sealing is subjected to radiation sterilization.
7. magnesium alloy bracket storage method as claimed in claim 6, which is characterized in that heated dry air sterilizing condition be 140 DEG C,
3.5h。
8. magnesium alloy bracket storage method as claimed in claim 6, which is characterized in that the dose of radiation of the radiation sterilization is
10-50KGy。
9. magnesium alloy bracket storage method as claimed in claim 6, which is characterized in that the volume ratio of the hydrogen and helium is 1:
2。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910155214.9A CN109878907A (en) | 2019-03-01 | 2019-03-01 | A kind of magnesium alloy bracket the storage box and method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910155214.9A CN109878907A (en) | 2019-03-01 | 2019-03-01 | A kind of magnesium alloy bracket the storage box and method |
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| Publication Number | Publication Date |
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| CN109878907A true CN109878907A (en) | 2019-06-14 |
Family
ID=66930184
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| Application Number | Title | Priority Date | Filing Date |
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| CN201910155214.9A Pending CN109878907A (en) | 2019-03-01 | 2019-03-01 | A kind of magnesium alloy bracket the storage box and method |
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2162442Y (en) * | 1993-04-14 | 1994-04-20 | 王永明 | Multifunction micro-appliances box for medicine |
| CN1164827A (en) * | 1995-09-08 | 1997-11-12 | 阿斯特拉公司 | Aseptic transfer |
| US20050268573A1 (en) * | 2004-01-20 | 2005-12-08 | Avantec Vascular Corporation | Package of sensitive articles |
| US20080011640A1 (en) * | 2004-02-12 | 2008-01-17 | Medtronic Vascular, Inc. | Packaged System Including a Protective Housing for a Treatment Device Carried on a Catheter |
| CN101920799A (en) * | 2009-06-09 | 2010-12-22 | 曲靖师范学院 | Hydrogen charging food packaging technology |
| EP2415405A2 (en) * | 2007-12-12 | 2012-02-08 | Tyco Healthcare Group LP | Medical device package |
| CN103879669A (en) * | 2012-12-20 | 2014-06-25 | 上海微创医疗器械（集团）有限公司 | Biodegradable polymer support storing method |
| CN205312250U (en) * | 2016-01-26 | 2016-06-15 | 富阳市金宇包装有限公司 | High packing carton of security |
-
2019
- 2019-03-01 CN CN201910155214.9A patent/CN109878907A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2162442Y (en) * | 1993-04-14 | 1994-04-20 | 王永明 | Multifunction micro-appliances box for medicine |
| CN1164827A (en) * | 1995-09-08 | 1997-11-12 | 阿斯特拉公司 | Aseptic transfer |
| US20050268573A1 (en) * | 2004-01-20 | 2005-12-08 | Avantec Vascular Corporation | Package of sensitive articles |
| US20080011640A1 (en) * | 2004-02-12 | 2008-01-17 | Medtronic Vascular, Inc. | Packaged System Including a Protective Housing for a Treatment Device Carried on a Catheter |
| EP2415405A2 (en) * | 2007-12-12 | 2012-02-08 | Tyco Healthcare Group LP | Medical device package |
| CN101920799A (en) * | 2009-06-09 | 2010-12-22 | 曲靖师范学院 | Hydrogen charging food packaging technology |
| CN103879669A (en) * | 2012-12-20 | 2014-06-25 | 上海微创医疗器械（集团）有限公司 | Biodegradable polymer support storing method |
| CN205312250U (en) * | 2016-01-26 | 2016-06-15 | 富阳市金宇包装有限公司 | High packing carton of security |
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Application publication date: 20190614 |