CN206671076U - A kind of surgical operation sealing agent constant temperature BURSTING STRENGTH detection means - Google Patents
A kind of surgical operation sealing agent constant temperature BURSTING STRENGTH detection means Download PDFInfo
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- CN206671076U CN206671076U CN201621312612.5U CN201621312612U CN206671076U CN 206671076 U CN206671076 U CN 206671076U CN 201621312612 U CN201621312612 U CN 201621312612U CN 206671076 U CN206671076 U CN 206671076U
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- sealing agent
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- bursting strength
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Abstract
The utility model discloses a kind of surgical operation sealing agent constant temperature BURSTING STRENGTH detection means, including matrix lock chamber(1), matrix retainer ring(2), piston(3), pressure sensor(4), recorder(6), booster pump(7), piston limit device(8), temperature sensor(9), thermoregulator(10)With heating cooling piece(11);Wherein, matrix retainer ring(2)It is fixed on matrix lock chamber(1)On;Matrix lock chamber(1)Upper end open, inside set piston(3), piston limit device(8), temperature sensor(9)With heating cooling piece(11), bottom passes through thribble road(5)Respectively with pressure sensor(4)And booster pump(7)Connection, pressure sensor(4)With recorder(6)It is connected.Surgical operation sealing agent constant temperature BURSTING STRENGTH structure of the detecting device described in the utility model is simple, easy to use, solves current surgical operation sealing agent BURSTING STRENGTH testing result easily by temperature change interference problem.
Description
Technical field
The invention belongs to material property testing equipment field, and in particular to a kind of surgical operation sealing agent constant temperature BURSTING STRENGTH
Detection means.
Background technology
Hydrogel is a kind of three-dimensional net structure polymer with hydrophilic radical as a kind of biocompatible materials,
Because the physical crosslinking between polymer chain and chemical crosslinking act on, hydrogel can be water-swellable but not soluble in water and keep certain
Shape.Medically, hydrogel can be used for Wound dressing, Post operation to prevent adhesion, perform the operation in hemostasis, tissue filling, prevent tissue
Liquid seepage or gas leakage etc..When hydrogel is used as tissue fluid seepage or gas leakage mechanical and blocked, also referred to as surgery hand
Art sealing agent.
Sealing agent of performing the operation has many potential medical applications, including closes wound, suture is aided in surgical operation
Or suturing nail, as barrier for preventing post-operation adhesion and as hemostasis sealing agent etc..Fibrin Glue is commonly used for outer at present
Section's operation sealing agent, it is made up of human or animal's fibrinogen, fibrin ferment and gel accelerator.Bonded as a kind of two-component
Agent, rapid react forms gel after mixing.It is straight that the gel formed can adhere to tissue, hemostasis, the bridge joint tissue surface of a wound etc.
Untill healing.
The hydrogel material gel time of two-component can be adjusted according to composition, such as glutaraldehyde/bovine serum albumin(BSA)
The gel time is more than 30 seconds, Bard companies Progel(Albumin/polyethylene glycol gel)Gel time is less than 15 seconds,
Baxter companies Coseal(Two-component polyethylene glycol gel)Gel time is less than 10 seconds.It is very fast for gelation rate(Such as gel
Time is less than the gel of 20 seconds)Two-component gel be difficult to by rheometer detect gel modulus of elasticity.Burst by detection
Intensity can be evaluated the intensity of surgical operating sealing agent.
Chinese patent application 201610194316.8 provides a kind of surgical operation sealing agent BURSTING STRENGTH detection means, can
The sealing strength that detection surgical operation sealing agent is sprayed to after material surface.During clinical practice use, surgical operation envelope
The gel formed after mixture spraying, it will be swelled with absorbing moisture after bioresorbable, with the soaking temperature in body fluid
Change, the sealing strength of gel will likely change.Therefore, it is necessary to develop a kind of hydrogel isothermal liquid immersion in it is swollen
Broken intensity detecting device, can be evaluated the mechanical property after surgical operation sealing agent use.
The content of the invention
The present invention provides a kind of surgical operation sealing agent constant temperature BURSTING STRENGTH detection means easily to operate, can be to surgery hand
The mechanical property of art sealing agent gel isothermal liquid soaking conditionses is detected.
Material BURSTING STRENGTH detection means described in the utility model, including matrix lock chamber(1), matrix retainer ring(2)、
Piston(3), pressure sensor(4), recorder(6), booster pump(7), piston limit device(8), temperature sensor(9), temperature adjust
Save device(10)With heating cooling piece(11);Wherein, matrix retainer ring(2)It is fixed on matrix lock chamber(1)On;Matrix lock chamber
(1)Upper end open, inside set piston(3), piston limit device(8), temperature sensor(9)With heating cooling piece(11), bottom
Pass through thribble road(5)Respectively with pressure sensor(4)And booster pump(7)Connection, pressure sensor(4)With recorder(6)Phase
Even.
In above-mentioned intensity detecting device, thermoregulator, temperature sensor and heating cooling piece electrical connection.Temperature adjustment
Device temperature control scope is 15-40 DEG C.Heating cooling piece uses semiconductor chilling plate or heating wire.
In above-mentioned intensity detecting device, matrix lock chamber is by hard material systems such as stainless steel, polyformaldehyde or polyether-ether-ketones
Into.Its shape can be cylinder, cube or other arbitrary shapes, preferably cylinder.Preferably matrix lock chamber is
External diameter 20-80mm, internal diameter 18-78mm, high 5-50mm cavity.
In above-mentioned intensity detecting device, piston is set inside matrix lock chamber, can be moved freely, piston inner diameter 18-
78mm, height h are 1-10mm.The effect of piston is to isolate the liquid in matrix lock chamber with bottom, prevents liquid from matrix
Flowed in lock chamber in thribble road.
In above-mentioned intensity detecting device, matrix retainer ring is fixed on matrix lock chamber by screw thread, screw or fastener
On, preferably it is threadably secured.The effect of matrix retainer ring is that matrix membrane is fixed on matrix chamber, and matrix membrane is casing, pig
The uncrosslinked albuminous membranae material such as skin or pericardium, in favor of simulated human tissue contact with surgical operating sealing agent material
State.Matrix membrane when in use, is first covered on matrix lock chamber by intensity detecting device, by matrix retainer ring by matrix membrane
Fixed, matrix center membrane is punched with card punch, and pore diameter range is preferably 2-5mm.
In above-mentioned intensity detecting device, booster pump can be gas boosting pump or liquid booster pump.Booster pump pressure limit
Preferably 0-50kPa.
In above-mentioned intensity detecting device, preferably a liquid crystal display recorder is connected with pressure sensor, in favor of note
Record Strength Changes.Pressure sensor preferred scope is in 0-100kPa, accuracy rating ± 0.1%-0.5%.
In above-mentioned intensity detecting device, piston limit device is set inside matrix lock chamber.The effect of piston limit device is anti-
Only in pressurization, piston removes matrix lock chamber.
Material BURSTING STRENGTH detection means described in the utility model, it is simple in construction, it is easy to use, material is can detect in liquid
BURSTING STRENGTH under body soaking conditionses.The utility model also demonstrates described detection means and burst by force in surgical operation sealing agent
Application in degree detection.When in use, piston is first slided into matrix lock chamber bottom, injects liquid into matrix lock chamber
In, after filling liquid, thermoregulator setting liquid soaking temperature.Matrix membrane is covered on matrix lock chamber, passes through matrix
Matrix membrane is fixed on matrix lock chamber by retainer ring.Liquid can be physiological saline or isotonic phosphate buffer liquid, in favor of
Simulate human body fluid.Matrix membrane is the uncrosslinked albuminous membranae material such as casing, pigskin or pericardium, in favor of simulated human tissue with
Surgical operating seals the contact condition of agent material.After fixing, matrix center membrane is punched with card punch, and pore diameter range is preferably
2-5mm.Then material to be detected such as surgical operating sealing agent is sprayed into stromal surface, treats surgical operation sealing agent gel
Afterwards, a small amount of physiological saline is injected on gel upper strata, gel is submerged.After soaking a period of time, booster pump, recorder are opened
Record Strength Changes.Surgical operation sealing agent gel breaks, or sealing agent are peeled off with matrix, and intensity reduces.What intensity reached
Maximum is surgical operation sealing agent BURSTING STRENGTH.It is adapted to the surgical operating sealing agent such as hydrogel material of detection, such as
The Progel sealing agents of Bard companies(Albumin/polyethylene glycol gel), Baxter companies Coseal sealing agents(Two-component is gathered
Ethylene glycol gel), Confluent Surgical companies DuraSeal sealing agents, HyperBranch Medical
Technology companies Adherus sealing agents and Ocuseal sealing agents, CryoLife companies BioGlue surgical adhesives
Deng.In addition, the device is also applied for tissue adhesive(Such as Ethicon DERMABOND surgical appliance adhesives)And styptic(As frozen
Dry condition of human blood fibrin glue)Sealing strength detection.Surgical operation sealing agent BURSTING STRENGTH detection means of the present invention, knot
Structure is simple, easy to use.
The maximum of intensity that recorder records when surgical operation sealing agent bursts is Pmax, immersion liquid density is ρLiquid, leaching
Bubble liquid height is HLiquid, acceleration of gravity g, piston density is ρPiston, depth pistion hPiston, surgical operation is calculated as follows
Sealing agent BURSTING STRENGTH P:P=Pmax-ρLiquid×g×HLiquid-ρPiston×g×hPiston。
Described material BURSTING STRENGTH detection means of the present utility model, it preferably can also be used to detect seralbumin gel
BURSTING STRENGTH, the specific preparation technology of the gel may be referred to Chinese patent application 201510960917.0, herein all
It is incorporated herein by reference.Described seralbumin gel can be prepared by following preferable method:
(1), prepare the first liquid component:Seralbumin is dissolved in pH scopes to be prepared in 6 .0-10 .0 cushioning liquid
It is 5%-45% to obtain concentration(w/v)Serum albumin solution;Preferably, described serum albumin solution can be located via radiation
Reason, irradiation dose scope is between 5kGy-45kGy;
(2), prepare second liquid component:Hydrophilic polymer solid constituent containing electrophilic functional group is dissolved in pH models
Enclose in the cushioning liquid for 6 .0-10 .0, preparation obtains concentration as 5%~45%(w/v)The hydrophily containing electrophilic functional group
Polymers compositions solution, wherein the serum in the hydrophilic polymer components and the first liquid component containing electrophilic functional group
The mass ratio of albumin is 0 .3-2;
(3), the first liquid component mixed with second liquid component, be cross-linked to form seralbumin gel.
Hydrophilic polymer containing electrophilic functional group can be selected from double amber imide propionic acid ester group polyethylene glycol, double ambers
Amber acid imide butanedioic acid ester group polyethylene glycol, double amber imide glutaric acid ester group polyethylene glycol, double amber imide decanedioic acid
Ester group polyethylene glycol, the succinimidyl glutarate of pentaerythritol polyethylene glycol ether four, the succinyl of pentaerythritol polyethylene glycol ether four
One or more in imines succinic acid, the succinimide decanedioic acid of pentaerythritol polyethylene glycol ether four, molecular weight 1000-
100000, preferably 2000-50000, more preferably 3000-20000.It is preferred that double amber imide butanedioic acid ester group polyethylene glycol,
Molecular weight is 1000-100000, preferably 2000-50000, more preferably 3000-20000.
Described seralbumin gel can be used for the bonding of wound in the various surgical operations of human body, hemostasis, antiseep or
Application in preventing adhesion, such as medically can be used for angiocarpy, department of general surgery, department of plastic surgery, neurosurgery, ophthalmology, bone surgery
Or defective tissue is sealed during pulmonary surgery.
BURSTING STRENGTH detection means described in the utility model be particularly suitable for use in organize the surgical operation sealing agent that contacts or
Sealing strength detection of the person tissue adhesive under isothermal liquid soaking conditionses.The device is economical and practical, convenient, high performance-price ratio,
Light and flexible, the operation of convenient use personnel is detected, it is safer, reliable, environmentally friendly, convenient to have the characteristics that.
Brief description of the drawings
Fig. 1 is material constant temperature BURSTING STRENGTH detection means schematic diagram described in the utility model.1 is matrix lock chamber in figure, 2
For matrix retainer ring, 3 be piston, and 4 be pressure sensor, and 5 be thribble road, and 6 be liquid crystal display recorder, and 7 be booster pump, 8
It is temperature sensor for piston limit device, 9,10 be thermoregulator, and 11 be heating cooling piece.
Embodiment
Preferred embodiment of the present utility model is described in detail below in conjunction with the accompanying drawings, so that the advantages of the utility model
It can be easier to be readily appreciated by one skilled in the art with feature, it is apparent bright so as to be made to the scope of protection of the utility model
Really.
Embodiment 1
As shown in figure 1,1 it is matrix lock chamber in figure, 2 be matrix retainer ring, and 3 be piston, and 4 be pressure sensor, and 5 be three
Union road, 6 be liquid crystal display recorder, and 7 be booster pump, and 8 be piston limit device, and 9 be temperature sensor, and 10 be temperature adjustment
Device, 11 be semiconductor heating cooling piece.
Matrix lock chamber is external diameter 35mm, internal diameter 30mm, high 50mm cavity, is made up of aluminium alloy.Piston diameter 30mm,
Height h is 10mm, is made up of aluminium alloy, density 2.7g/cm3.Piston is first slided into matrix lock chamber bottom, by physiology salt
Water is injected into matrix lock chamber, and cavity fills physiological saline.It is 25 DEG C that temperature control equipment, which sets soaking temperature,.Host material
For casing membrane material, a diameter of 80mm, center is punched with card punch, aperture 3mm.Host material is fixed by matrix retainer ring
On matrix lock chamber, matrix retainer ring and matrix lock chamber are fixed by fastener or screw.
Take 0.2 gram of gelatin(10%, w/v)It is dissolved in 2mL purified waters(10mM, pH 7.4).37 DEG C of occasional agitations 1 hour,
Make its dissolving, after thoroughly dissolving turns into transparence liquid after gelatin, be evacuated with vavuum pump and make it that within 30 minutes that bubble is quick in solution
Eliminate.Take 1mL25% glutaraldehyde solutions to add 1mL purified waters and obtain 12.5% glutaraldehyde solution.
After gelatin solution is well mixed in equal volume with 12.5% glutaraldehyde solution, stromal surface is sprayed to, treats gel
Afterwards, a small amount of physiological saline is injected on gel upper strata, gel is submerged.After immersion 1 minute, booster pump is opened, recorder record is strong
Degree change.Gelatin/glutaraldehyde gel breaks, the maximum P that the intensity of record reachesmaxFor 9.5kPa, gelatin/bis- succinyl Asia
It is 2.8kPa that amine butanedioic acid ester group polyethylene glycol section operation sealing agent, which soaks 1 minute BURSTING STRENGTH,(P=Pmax-ρLiquid×g×HLiquid-
ρAluminium alloy×g×hAluminium alloy=9.5×103Pa -1×103×10×0.4Pa-2.7×103×10×0.1Pa=2.8×103Pa).
Embodiment 2
As shown in figure 1, being matrix lock chamber in figure, 2 be matrix retainer ring, and 3 be piston, and 4 be pressure sensor, and 5 be three
Union road, 6 be liquid crystal display recorder, and 7 be booster pump, and 8 be piston limit device, and 9 be temperature sensor, and 10 be temperature adjustment
Device, 11 be semiconductor heating cooling piece.
Matrix lock chamber is external diameter 35mm, internal diameter 30mm, high 50mm cavity, is made up of aluminium alloy.Piston diameter 30mm,
Height h is 10mm, is made up of aluminium alloy, density 2.71g/cm3.Piston is first slided into matrix lock chamber bottom, by physiology
Salt solution is injected into matrix lock chamber, and cavity fills physiological saline.It is 37 DEG C that temperature control equipment, which sets soaking temperature,.Matrix material
Expect to be punched with card punch for casing membrane material, a diameter of 80mm, center, aperture 3mm.Host material is consolidated by matrix retainer ring
It is scheduled on matrix lock chamber, matrix retainer ring and matrix lock chamber are fixed by fastener or screw.
Take .2 grams of gelatin 0(10%, w/v)It is dissolved in 2mL purified waters(The .4 of 10mM, pH 7).37 DEG C of occasional agitations 1 are small
When, make its dissolving, after thoroughly dissolving turns into transparence liquid after gelatin, be evacuated with vavuum pump and make it that within 30 minutes that bubble is fast in solution
Speed eliminates.Take 1mL25% glutaraldehyde solutions to add 1mL purified waters and obtain 12.5% glutaraldehyde solution.
After gelatin solution is well mixed in equal volume with 12.5% glutaraldehyde solution, stromal surface is sprayed to, treats gel
Afterwards, a small amount of physiological saline is injected on gel upper strata, gel is submerged.After immersion 10 minutes, booster pump is opened, recorder record is strong
Degree change.Gelatin/glutaraldehyde gel breaks, the maximum P that the intensity of record reachesmaxFor 12.5kPa, gelatin/bis- succinyl Asia
It is 5.8kPa that amine butanedioic acid ester group polyethylene glycol section operation sealing agent, which soaks 10 minutes BURSTING STRENGTHs,(P=Pmax-ρLiquid×g×HLiquid-
ρAluminium alloy×g×hAluminium alloy=12.5×103Pa -1×103×10×0.4Pa-2.7×103×10×0.1Pa=5.8×103Pa).
Embodiment 3
As shown in figure 1,1 it is matrix lock chamber in figure, 2 be matrix retainer ring, and 3 be piston, and 4 be pressure sensor, and 5 be three
Union road, 6 be liquid crystal display recorder, and 7 be booster pump, and 8 be piston limit device, and 9 be temperature sensor, and 10 be temperature adjustment
Device, 11 be heating wire.
Matrix lock chamber is external diameter 35mm, internal diameter 30mm, high 50mm cavity, is made up of aluminium alloy.Piston diameter 30mm,
Height h is 5mm, is made up of aluminium alloy, density 2.71g/cm3.Piston is first slided into matrix lock chamber bottom, by physiology salt
Water is injected into matrix lock chamber, and cavity fills physiological saline.It is 25 DEG C that temperature control equipment, which sets soaking temperature,.Host material
For casing membrane material, a diameter of 80mm, center is punched with card punch, aperture 3mm.Host material is fixed by matrix retainer ring
On matrix lock chamber, matrix retainer ring and matrix lock chamber are fixed by fastener.
Take 0.4 gram of recombination human serum albumin(20%, w/v), it is dissolved in the 2mL phosphate-buffereds prepared by deionized water
Liquid(10mM, pH 8.0).37 DEG C of occasional agitations 1 hour, make its dissolving, after after albumen, thoroughly dissolving turns into transparence liquid, use
Vavuum pump, which is evacuated, causes that bubble quickly eliminates in solution for 30 minutes.By the human serum albumin solution in blood plasma source through electron beam spoke
According to irradiation dose 20kGy.
The double amber imide butanedioic acid ester group polyethylene glycol 0.3g that molecular weight is 4000 is weighed, is dissolved in by deionized water
The 2ml phosphate buffers of preparation(10mM, pH 8.6), being vortexed makes its dissolving turn into transparence liquid.
Recombination human serum albumin solution is mixed in equal volume with double amber imide succinate polyglycol solution
After even, spray to host surface and be cross-linked to form seralbumin gel.A small amount of physiological saline is injected on gel upper strata, will be solidifying
Glue submerges.After immersion 1 minute, booster pump, recorder record Strength Changes are opened.Human serum albumins/double amber imide amber
Amber perester radical polyethylene glycol surgical operation sealing agent gel breaks, the maximum P that the intensity of record reachesmaxFor 29.4kPa, people
Seralbumin/double amber imide butanedioic acid ester group polyethylene glycol section operation sealing agent soaks 1 minute BURSTING STRENGTH and is
23.5kPa(P=Pmax-ρLiquid×g×HLiquid-ρAluminium alloy×g×hAluminium alloy=29.4×103 Pa -1×103×10×0.45 Pa -2.7
×103×10×0.05 Pa =23.5×103Pa).
Embodiment 4
As shown in figure 1,1 it is matrix lock chamber in figure, 2 be matrix retainer ring, and 3 be piston, and 4 be pressure sensor, and 5 be three
Union road, 6 be liquid crystal display recorder, and 7 be booster pump, and 8 be piston limit device, and 9 be temperature sensor, and 10 be temperature adjustment
Device, 11 be heating wire.
Matrix lock chamber is external diameter 35mm, internal diameter 30mm, high 50mm cavity, is made up of aluminium alloy.Piston diameter 30mm,
Height h is 5mm, is made up of aluminium alloy, density 2.71g/cm3.Piston is first slided into matrix lock chamber bottom, by physiology salt
Water is injected into matrix lock chamber, and cavity fills physiological saline.It is 37 DEG C that temperature control equipment, which sets soaking temperature,.Host material
For casing membrane material, a diameter of 80mm, center is punched with card punch, aperture 3mm.Host material is fixed by matrix retainer ring
On matrix lock chamber, matrix retainer ring and matrix lock chamber are fixed by fastener.
Take 0.4 gram of recombination human serum albumin(20%, w/v), it is dissolved in the 2mL phosphate-buffereds prepared by deionized water
Liquid(10mM, pH 8.0).37 DEG C of occasional agitations 1 hour, make its dissolving, after after albumen, thoroughly dissolving turns into transparence liquid, use
Vavuum pump, which is evacuated, causes that bubble quickly eliminates in solution for 30 minutes.By the human serum albumin solution in blood plasma source through electron beam spoke
According to irradiation dose 20kGy.
The double amber imide butanedioic acid ester group polyethylene glycol 0.3g that molecular weight is 4000 is weighed, is dissolved in by deionized water
The 2ml phosphate buffers of preparation(10mM, pH 8.6), being vortexed makes its dissolving turn into transparence liquid.
Recombination human serum albumin solution is mixed in equal volume with double amber imide succinate polyglycol solution
After even, spray to host surface and be cross-linked to form seralbumin gel.A small amount of physiological saline is injected on gel upper strata, will be solidifying
Glue submerges.After immersion 6 hours, booster pump, recorder record Strength Changes are opened.Human serum albumins/double amber imide amber
Amber perester radical polyethylene glycol surgical operation sealing agent gel breaks, the maximum P that the intensity of record reachesmaxFor 22.6kPa, people
BURSTING STRENGTH is after seralbumin/double amber imide butanedioic acid ester group polyethylene glycol section operation sealing agent immersion 6 hours
16.8kPa(P=Pmax-ρLiquid×g×HLiquid-ρAluminium alloy×g×hAluminium alloy=22.6×103 Pa -1×103×10×0.45 Pa -2.7
×103×10×0.05 Pa =16.8×103Pa).
Claims (7)
1. a kind of surgical operation sealing agent constant temperature BURSTING STRENGTH detection means, including matrix lock chamber(1), matrix retainer ring(2)、
Piston(3), pressure sensor(4), recorder(6), booster pump(7), piston limit device(8), temperature sensor(9), temperature adjust
Save device(10)With heating cooling piece(11);Wherein, matrix retainer ring (2) is fixed on matrix lock chamber(1)On;Matrix lock chamber
(1)Upper end open, inside set piston(3), piston limit device(8), temperature sensor(9)With heating cooling piece(11), bottom
Pass through thribble road(5)Respectively with pressure sensor(4)And booster pump(7)Connection, pressure sensor(4)With recorder(6)Phase
Even.
2. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The dress
That puts mesostroma lock chamber is shaped as cylinder or cube.
3. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The work
Plug can move freely in matrix lock chamber.
4. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The temperature
It is 15-40 DEG C to spend adjuster temperature control scope.
5. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The temperature
Spend sensor, thermoregulator and heating cooling piece electrical connection.
6. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The system
Refrigeration heat piece uses semiconductor chilling plate.
7. surgical operation sealing agent constant temperature BURSTING STRENGTH detection means according to claim 1, it is characterised in that:The system
Refrigeration heat piece uses heating wire.
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