CN104353092B - Sterilization method for improving synostosis of SLA implant - Google Patents
Sterilization method for improving synostosis of SLA implant Download PDFInfo
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- CN104353092B CN104353092B CN201410564177.4A CN201410564177A CN104353092B CN 104353092 B CN104353092 B CN 104353092B CN 201410564177 A CN201410564177 A CN 201410564177A CN 104353092 B CN104353092 B CN 104353092B
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Abstract
The invention discloses a sterilization method for improving synostosis of an SLA implant. The sterilization method comprises the following steps: putting the SLA implant into a sealed container, adding water or an aqueous solution serving as a sterilization medium, enabling the water or the aqueous solution to immerse the implant, packaging an aluminum foil on the surface of a cover when the cover of the container is approximately sealed, then putting the container in a pressure steam sterilization device for sterilization, sealing the cover of the container in the pressure steam sterilization device after the sterilization, and taking out the container. The sterilization method has the advantages that the purpose of sterilizing the SLA implant is fulfilled, the wettability of the implant is improved, the mutual action of the implant material and a cell is improved, then the bone cell is more rapidly adhered, spread, propagated, proliferated and differentiated on the surface of the implant, so that the surface energy and the biological activity of the SLA implant are improved, and the bonding strength between the implant and the natural bone is improved. Meanwhile, the method is simple to operate, conventional sterilizing installation is used, the processing cycle is short, and the method is suitable for clinical application.
Description
Technical field
The present invention relates to a kind of sterilizing methods, more particularly, to one kind improve sandblasting-acid etching surface (SLA) Osseointegrated implants
The sterilizing methods of energy, belong to surgical implant technical field.
Background technology
SLA is implant surface treatment technology the most ripe in the world, can be effectively improved surface biocompatible,
Promote New born formation, strengthen the bond strength between planting body and bone, therefore SLA planting body is clinical practice most commonly used
Class planting body.But extend its surface wettability in time in SLA planting body storage and gradually degenerate, with connecing of distilled water
Feeler reaches as high as 140 °, assumes serious hydrophobicity.This be unfavorable for Gegenbaur's cell in its surface adhesion, sprawl, more can postpone
The propagation of cell and differentiation, lead to bone regeneration around implant new bone formation amount to decline, planting body is weakened with the adhesion of bone.The opposing party
Face, planting body needs through sterilizing before implantation human body, and sterilizing methods have a significant effect to the synosteosis ability of planting body.Document
1(Enhancement of bone-titanium integration profile with UV-
Photofunctionalized titanium in a gap healing model, Biomaterials, 31 (7), 2010：
1546-1557) report and the wetability although shadow surface is processed to the pure titanium sample with SLA surface using ultraviolet light
Can be improved significantly, but planting body is three-dimensional structure, and this method do not enable to implant surface uniform treatment.Additionally,
In the method, time of ultraviolet irradiation is up to 48 hours, and the cycle is longer.Another kind of sterilizing methods are high pressure steam sterilization, and this is also mesh
The most extensive sterilizing methods of front clinical practice.After the shortcoming of this method is to sterilize, the surface wettability of SLA planting body will not
Obtain any improvement, such as document 2 (The roles of titanium surface micro/nanotopography and
Wettability on the differential response of human osteoblast lineage cells,
Acta Biomaterialia, 9 (4)：6268-6277) report, at a temperature of 121 DEG C, after steam sterilizing, SLA implant surface connects
Up to 157 ° of feeler, assumes strong hydrophobicity.Other sterilizing methods such as gamma-radiation irradiation nor improve SLA implant surface
Wettability, and radiogenic management is very strict.In addition, ethylene oxide sterilizing rule is likely to result in hazard residue.Comprehensive
Upper described, none method can be while sterilizing at present, wettability that is efficient, comprehensively improving SLA planting body, in view of
This is it is necessary to invent a kind of new sterilizing methods.
Content of the invention
Goal of the invention：It is an object of the invention to provide a kind of surface super hydrophilic enabling SLA planting body, to improving
Its biologically active, promotes the combination of planting body and bone tissue, reduces the incidence of aseptic loosening, increase the service life
The sterilizing methods of SLA Osseointegrated implants.
Technical scheme：Sterilizing methods of the present invention, comprise the steps：
(1) SLA planting body is loaded in the sealing container of inorganic, stainless steel or titanium matter, add into this container and make
Water for sterile medium or the aqueous solution, and this water or the aqueous solution cover SLA planting body completely, when the lid of container is close
During sealing, can prevent bacterium from entering the aluminium foil in container in lid surface parcel；
(2) container that will be equipped with SLA planting body is placed in sterilizing in pressure steam sterilizer, and sterilising temp controls in 121-
Between 140 DEG C, sterilization time is 5-20 minute；
(3), after sterilizing terminates, in pressure steam sterilizer, take out container by after the lid sealing of container.
Wherein, above-mentioned SLA planting body is made by the pure titanium and its alloy with SLA surface.
In step (1), the water as sterile medium is ultra-pure water or distilled water；The aqueous solution is physiological saline or low concentration
Calcium chloride solution；And the liquid level of this water or the aqueous solution should lie against 3 times of peak during container bottom beyond planting body
More than, so that planting body is constantly in water or the aqueous solution in sterilization process；The packages length of aluminium foil exceedes container simultaneously
The lower limb of lid.
Before step (1), using in absolute ethyl alcohol, ultra-pure water, ultrasonic wave cleaning is carried out to described SLA planting body successively.
After step (3) terminates, container is transferred to operating room, outwell water therein or the aqueous solution before implantation, with sterilizing
Tweezers press from both sides out planting body, you can carry out implant procedure.
Beneficial effect：Compared with prior art, its remarkable advantage is the present invention：The inventive method not only achieves SLA kind
The sterilizing purpose of implant, improves the wettability of planting body simultaneously, and good wettability improves cell and embedded material
Between interaction, so that osteocyte is quickly adhered in implant surfaces, sprawl, breed and break up, thus improving SLA kind
The surface energy of implant and biologically active, improve the bond strength between planting body and natural bone.Meanwhile, the inventive method operation
Simply, using conventional sterilant equipment, process cycle is short, suitable clinical practice.
Brief description
Fig. 1 is contact angle schematic diagram in the SLA implant surface of non-sterilized process for the distilled water；
Fig. 2 is the upper contact angle schematic diagram in the SLA implant surface through high pressure steam sterilization for the distilled water；
Fig. 3 is contact angle schematic diagram in the SLA implant surface processing through sterilizing methods of the present invention for the distilled water.
Specific embodiment：
Below technical scheme is elaborated.
Embodiment 1
Made by the pure titanium with SLA surface and obtain planting body.After testing, distilled water this SLA kind before sterilization treatment
Contact angle on implant surface is 143.5 °, as shown in Figure 1.
It is possible, firstly, to be carried out to above-mentioned SLA planting body, specially：Successively in absolute ethyl alcohol and ultra-pure water (18M Ω *
Cm in), ultrasonic wave cleaning is carried out to SLA planting body, scavenging period controls at 10 minutes about, and certainly, ultra-pure water can be replaced steaming
Distilled water or deionized water.Then, this planting body is transferred in 250ml sealing container, adds the ultra-pure water as sterile medium
150ml is used for soaking planting body, and wherein, ultra-pure water can be replaced calcium chloride solution of distilled water, physiological saline or low concentration etc.,
Good wetting effect all can be played；In addition, container can be the inorganic with screw socket, stainless steel or titanium matter etc..By container
Lid circles round after tightening (i.e. lid is not completely tightened) after a circle again, then is covering parcel aluminium foil, certainly, in order to increase further
The sealing of container, aluminium foil can be bilayer, and aluminium foil length exceedes the lower limb of lid.Then, will be equipped with planting body
Reagent bottle is put in pressure steam sterilizer, fastens top cover, and sterilising temp is set to 121 DEG C.Open heater switch, device subject to sterilization
After interior temperature rises to 121 DEG C, start recording sterilization time, sterilization time is 20 minutes.After sterilizing terminates, barometer pointer is extensive
Arrive " 0 " position again, in sterilizer, temperature drops to less than 60 DEG C, then uncaps.Both hands wear medical latex glove, and are disappeared with medicinal alcohol
Poison, further takes out container after tightening container lid in sterilizer.Finally, the container that will be equipped with implant transfers to operating room.
Before implantation, outwell ultra-pure water, press from both sides out planting body with the tweezers sterilizing and can carry out implant procedure.
After testing, contact angle in the SLA implant surface after sterilization treatment for the distilled water is 0 °, and this explanation utilizes this reality
Apply a method and enable SLA implant surface super hydrophilicization, as shown in Figure 3.
Before sterilizing, prepare two peaces equipped with the self-contained biological indicator of 4ml RAVEN PROSPORE (Mai Sen company)
Small jar.Wherein one ampoule puts into blue lid bottle together with above-mentioned SLA planting body, is subsequently adding ultra-pure water and is sterilized.Will after sterilizing
This ampoule is disposed vertically in 55-60 DEG C of incubator, and simultaneously another non-sterilized ampoule compares to confirm gemma
Activity.Culture compares ampoule color from purple after 48 hours and changes to yellow, and muddiness, and the color of the ampoule that sterilizes does not have
Change, muddiness does not occur yet.This shows that the sterilization effect of the method for the invention is fine.
Bar-shaped planting body after said method sterilizing for a diameter of 1mm is implanted rat thigh 2 weeks and finds after 4 weeks,
It is 6.5N and 24.1N using the sample of the inventive method sterilizing and the adhesion of bone.
Comparative example 1：Ordinary high pressure steam sterilizing
SLA planting body, cleaning process and sterilization process are substantially the same manner as Example 1；Difference：Seal after planting body cleaning
Enter in self-sealing sterilizing paper plastic bag, rather than be placed in solution.After sterilizing terminates, by planting body together with paper plastic bag at 60 DEG C
It is dried 1 hour in baking oven.
After testing：Distilled water is 140.3 ° in the upper contact angle of the SLA implant surface through ordinary high pressure steam sterilizing,
As shown in Fig. 2 compared with before sterilizing, having almost no change.
Self-contained biological indicator monitoring result shows that the sterilization effect of ordinary high pressure method for steam sterilization is also fine.
Bar-shaped for a diameter of 1mm planting body is implanted rat thigh 2 weeks and finds after 4 weeks, using common steam sterilization
The sample of sterilizing and the adhesion of bone are 3.5N and 14.8N.
Therefore, using sterilizing methods of the present invention compared with ordinary high pressure method for steam sterilization, go out obtaining identical
The adhesion between planting body and biological bone can be significantly improved while bacterium effect.
Embodiment 2
Process step is substantially the same manner as Example 1, and difference is：Planting body is the Ti6A14V alloy with SLA surface
Planting body (after testing, contact angle in this SLA implant surface before sterilization treatment for the distilled water is 142 °), sterilising temp is
130 DEG C, sterilization time is 10min.
After testing, contact angle in this SLA implant surface after sterilization treatment for the distilled water is 0 °, and this explanation is using this
Embodiment method enables SLA implant surface super hydrophilicization.
Embodiment 3
Process step is substantially the same manner as Example 1, and difference is：Planting body is that the pure titanium with SLA surface is made to
To planting body (after testing, contact angle in this SLA implant surface before sterilization treatment for the distilled water is 139 °), sterilising temp
For 140 DEG C, sterilization time is 5min.
After testing, contact angle in the SLA implant surface after sterilization treatment for the distilled water is 0 °, and this explanation utilizes this reality
Apply a method and enable SLA implant surface super hydrophilicization.
Claims (7)
1. a kind of sterilizing methods of raising SLA Osseointegrated implants are it is characterised in that comprise the steps：
(1) SLA planting body is loaded in the sealing container of inorganic, stainless steel or titanium matter, add conduct into this container and go out
The water of bacterium medium or the aqueous solution, and this water or the aqueous solution cover SLA planting body completely, when the lid of container is close to sealing
When, can prevent bacterium from entering the aluminium foil in container in lid surface parcel；
(2) container that will be equipped with SLA planting body is placed in sterilizing in pressure steam sterilizer, and sterilising temp controls at 121-140 DEG C
Between, sterilization time is 5-20 minute；
(3), after sterilizing terminates, in pressure steam sterilizer, take out container by after the lid sealing of container.
2. according to claim 1 improve SLA Osseointegrated implants sterilizing methods it is characterised in that：In step (1),
The described water as sterile medium is ultra-pure water or distilled water；The described aqueous solution is physiological saline.
3. raising SLA Osseointegrated implants according to claim 1 or claim 2 sterilizing methods it is characterised in that：Step (1)
In, described SLA planting body is made by the pure titanium and its alloy with SLA surface.
4. raising SLA Osseointegrated implants according to claim 1 or claim 2 sterilizing methods it is characterised in that：Step (1)
In, the packages length of described aluminium foil exceedes the lower limb of container lid.
5. according to claim 1 improve SLA Osseointegrated implants sterilizing methods it is characterised in that：Before step (1),
Using in absolute ethyl alcohol, ultra-pure water, ultrasonic wave cleaning is carried out to described SLA planting body successively.
6. according to claim 1 improve SLA Osseointegrated implants sterilizing methods it is characterised in that：Step (1)
In, the liquid level of the described water as sterile medium or the aqueous solution should lie against peak during container bottom beyond planting body
More than 3 times.
7. according to claim 1 improve SLA Osseointegrated implants sterilizing methods it is characterised in that：After step (3),
Container is transferred to operating room, before implantation, outwells water therein or the aqueous solution, press from both sides out planting body with the tweezers sterilizing, you can enter
Row implant procedure.
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| CN201410564177.4A CN104353092B (en) | 2014-10-21 | 2014-10-21 | Sterilization method for improving synostosis of SLA implant |
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| CN104353092B true CN104353092B (en) | 2017-02-22 |
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| CN110141684B (en) * | 2019-05-20 | 2020-10-09 | 江苏科技大学 | Hydrothermal sterilization method for in-situ synthesis of antibacterial silver phosphate on surface of hydroxyapatite coating |
| CN114308850A (en) * | 2021-11-29 | 2022-04-12 | 山东优纳贸易有限公司 | Method for processing aseptic bearing used in human body and animal body |
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| CN102345134A (en) * | 2011-09-13 | 2012-02-08 | 蔺增 | Preparation method for wettability controllable porous structure of titanium and titanium alloy surface |
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| CA2859232C (en) * | 2011-12-16 | 2018-03-27 | Herbert Jennissen | Substrate with a structured surface and methods for the production thereof, and methods for determining the wetting properties thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102345134A (en) * | 2011-09-13 | 2012-02-08 | 蔺增 | Preparation method for wettability controllable porous structure of titanium and titanium alloy surface |
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Application publication date: 20150218 Assignee: Center for technology transfer Jiangsu University of Science and Technology Assignor: JIANGSU University OF SCIENCE AND TECHNOLOGY Contract record no.: X2021980006173 Denomination of invention: A sterilization method for improving bone adhesion of SLA implant Granted publication date: 20170222 License type: Common License Record date: 20210714 |
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Assignee: Center for technology transfer Jiangsu University of Science and Technology Assignor: JIANGSU University OF SCIENCE AND TECHNOLOGY Contract record no.: X2021980006173 Date of cancellation: 20210826 |
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