CN104353106A - Composition of fast hemostatic sponge gel and preparation method of composition - Google Patents
Composition of fast hemostatic sponge gel and preparation method of composition Download PDFInfo
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- CN104353106A CN104353106A CN201410623794.7A CN201410623794A CN104353106A CN 104353106 A CN104353106 A CN 104353106A CN 201410623794 A CN201410623794 A CN 201410623794A CN 104353106 A CN104353106 A CN 104353106A
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Abstract
The invention relates to a composition of fast hemostatic sponge gel and a preparation method of the composition. Particularly, xerogel which can quickly form gel in the presence of water is combined with hemostatic sponge to quickly stop bleeding.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, about a kind of compositions and preparation method of rapid hemostatic sponge gel, specifically a kind of water of meeting can be formed rapidly the xerogel of gel and sthptic sponge and combines and carry out quick-acting haemostatic powder.
Background technology
Wound is that normal skin (tissue) is caused injury in the external world factor, as surgical operation, external force, heat, electric current, chemical substance, low temperature and body intrinsic factor, as lower in effect such as local blood supply obstacle etc. the infringement caused, normal with the destruction of skin integrity and the loss of a certain amount of normal structure, the normal function of skin is impaired simultaneously.The healing of wound is a complicated physiological process, is also one of most significant problems of paying close attention to of medical circle always.The characteristic of director David Morgan to desirable wound dressing from the medicine publilc health department of Wales National Public Health office has been described in detail: the environment keeping wound and dressing composition surface humidity; There is thermal insulation properties; Low or not easily adhere to; Do not require often to change; Mechanical protection ability is provided; Granule not easily stains, nontoxic, insensitive, not irritated; Fit closely with wound, plasticity is good; There is good moisture-absorption characteristics; Microorganism can not be through; Easily affine with the wounded, than if alleviate patient suffering; Cost performance is high; Aseptic; The style of arbitrary size can be made into.
Except traditional raw cotton, gauze, lint etc., the product at present for wound mainly comprises: low-adhesion dressing; There is the plastic layer dressing of absorption, through hole structure; There are the absorption of Adhesion Interface, open-work dressing; Multicomponent dressing; Adhesion layer that can be ventilative; Hydrogel; Hydrocolloid; Polysaccharide dressing; Alginate dressing; Foam; Abnormal flavour absorbent dressing (deodorization); Silicon dressing; Collagen; Tissue adhesive; Shield layer; Plaster bandage; Other special antibiotic of tulle (pastille and not pastille) dressing; Antibacterium; Anticorrosion; Silver dressings; Skin substitutes; The flexible complete binder of multilamellar etc.
Chinese patent 201310070982.7 relates to one and comprises binder body and Wound healing and bone regeneration pad, and Wound healing and bone regeneration pad is combined in a side surface of one end of the length direction of binder body, and maintains the first-aid hemostatic binder of transition distance with the end of this one end.The feature of this first-aid dressing is that treatment pad is made up of alginic acid fibre non-woven fabrics, anti-adhesion membrane and polyurethane breathable films, anti-adhesion membrane is combined in alginic acid fibre non-woven fabrics in a state of use towards the side of patient wound, polyurethane breathable films is combined in the side of alginic acid fibre non-woven fabrics towards described binder body, and described binder body is medical absorbent cotton/gauze.Not only there is good imbibition antiseepage and divulge effect, and to such as the stopping blooding of wound, antibacterial, short more and the excellent effect of pain relieving; Adhesion can not be caused to wound; Industrial amplification production requirement can be met.Chinese patent 201310166880.5 relates to a kind of by modified starch of the prior art degeneration the sthptic sponge be finally prepared from through ultrasonic Treatment again.This sthptic sponge soaking effect is excellent, safety, stable, is a kind of biocompatibility, the sthptic sponge that can be directly used in blood wound surface.Chinese patent 201210550731.4 relates to a kind of absorbability cross-link haemostatic starch taking potato starch as raw material and obtain after crosslinked, adds a certain proportion of dehydrated alcohol in cross-linking process, finally by washing sucking filtration, obtains after dry.Crosslinked starch after the method process, on its absorptive basis of maintenance, greatly improves its biological degradability, solves the degradation problem in crosslinked starch clinical hemostasis.Chinese patent 2013103151155 provide a kind of comprise percentage by weight be 25% to 50% the chitosan fiber through acidification and percentage by weight be that the chitosan fiber through crosslinking Treatment of 50% to 75% is as bleeding-stopping dressing.The bleeding-stopping dressing of this invention has preferably haemostatic effect and can maintain heavily stressed intensity in use.Chinese patent 2012100337938 relates to a kind of chitosan-based styptic sponge with thrombin immobilization role, and it is by the cellular sponge having the chitosan-based of thrombin immobilization role and hemorrhage and make.This invention by chitosan or carboxymethyl chitosan to being fixed of thrombin, improve stability and the blood coagulation activity of thrombin, the character of obtained chitosan-based styptic sponge is more stable, and blood coagulation more wound Be very effective strengthens, and can be widely used in wound or surgical hemostasis.Chinese patent 2011800287294 u s company provides the hemostasis porous composite sponge that a kind of biomaterial matrix is connected with the hydrophilic polymer component comprising reactive group.
These patents mainly prepare bleeding-stopping dressing in employing special material, special process etc., thus play the effect of hemostasis.A kind of special dry gel particle and sponge combine by the present invention, and what utilize dry gel particle runs into the gel that blood forms thickness fast, adds the effect of sponge to blood absorption, can fast and effeciently stop blooding.Specifically one comprises polyvinyl alcohol, collagen protein, the compositions of the dry gel particle that the special sponge of chitosan, hyaluronic acid and gelatin and carbomer, hypromellose, hydroxypropyl cellulose, poloxamer are made.To large-scale wound, or the wound of type can be goed deep into like this, stop blooding.Play the dual-use function of the absorption hemostasis of sponge and gel condensation wound hemostasis, stopped rapidly the blood flow of wound and blood vessel, avoided the situation because of burst to cause massive blood loss, for chance and time are won in the rescue in later stage and treatment.
Summary of the invention
Dry gel particle has the characteristic combining formation gel fast with water.Run into blood dry gel particle equally and also can combine formation gel with the moisture in blood, the gel of thickness can be fitted in the surface of bleed blood vessel and wound, to the extraordinary sealing process of bleeding wound, compared with common binder better effects if, even the blood of gushing in arteries.
The sponge material of the present invention's preparation containing dry gel particle can be the macromolecular material materials such as gelatin, polyvinyl alcohol, chitosan and hyaluronic acid, these materials all have the characteristic forming sponge under certain circumstances, slightly different according to technique prepared by the difference of molecular weight, source, the degree of polymerization.
Dry gel particle prepared by the present invention mainly comprises carbomer, hypromellose, hydroxypropyl cellulose, poloxamer, these materials can be converted into gel state by graininess under certain condition, thus closed and coagulation are produced to bleeding wound, dry gel particle joins various gelfoam, in polyvinylalcohol sponge and chitosan sponge, these sponges can absorb the blood of weight tens times own, can not only be condensed after dry gel particle is converted into gel state wound, and the fiber that can depend on sponge makes blood flow quick solidification, dual like this coagulation process combines, make the effect of hemostasis more effective.
These dry gel particles are prepared by the mode of lyophilizing, gets carbomer, hypromellose, hydroxypropyl cellulose or poloxamer and add water and be prepared into gel, then by these gel refrigeration dryings, pulverizes, sieve, make dry gel particle.Dry gel particle has three-dimensional network structure, absorbs rapidly after running into moisture, forms gel fast and is attached to the surface of container or attachment.
Obtain after the dry gel particle of preparation can carry out lyophilization by a kind of gel solution of carbomer, hydroxypropyl cellulose, poloxamer and hypromellose, also can the mixing of any two kinds or three kinds arbitrary proportions of gel solution of carbomer, hydroxypropyl cellulose, poloxamer and hypromellose.
The gelatin concentration of these Polymer materialspreparations is selected very important, and concentration is low, and dry gel particle is difficult to molding, and excessive concentration, then moisture is difficult to remove, and the dry gel particle water absorbing force of preparation is not enough, forms slowing of gel and affects haemostatic effect.The carbomer concentration adopted in the present invention is 2% ~ 5%, and preferred concentration is 3-3.5%; The concentration of hypromellose is 3% ~ 6%, and preferred concentration is 3 ~ 5%; The concentration of hydroxypropyl cellulose is 5 ~ 35%, and preferred concentration is 10 ~ 15%; The concentration of poloxamer is 5 ~ 35%, and preferred concentration is 10 ~ 15%.
Dry gel particle is actually a kind of loose precursor gel form, and run into water and water suction can become gel rapidly with other aqueous solution, the preparation process macromolecular material that avoiding problems conventional GPC needs swelling slowly, stirring, the processes such as aerofluxus.Dry granulated gel can make powder, granule and irregular block in the present invention.
The preparation of sponge is also the method adopting lyophilizing, and sponge material chitosan, polyvinyl alcohol or gelatin is appropriate, and add appropriate water, in the water-bath of uniform temperature, heated and stirred makes chitosan, polyvinyl alcohol or gelatin all be dissolved into a kind of glue.Add fixative and be incubated about certain hour in the bath of certain temperature.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Lyophilization immediately, by moisture removal.The gel particle of preparation is dispersed in sponge surface, gel particle is distributed in the space of sponge.Sponge is cut into the block of suitable size or shape, to obtain final product.
The gelatin viscosity of preparation is extremely important to the quality forming sponge, the weight ratio of chitosan, polyvinyl alcohol or gelatin and water controls between 1: 3-1: 30, preferred ratio is between 1: 8: 1: 15, and preferred part by weight is between 1: 10-1: 15.
Temperature is for different sponge material in invention, and required temperature does not need obvious control, and in general gelatin and chitosan are at about 60 DEG C, and polyvinyl alcohol changes greatly according to the difference of molecule.
The cross-linking agent adopted in the present invention is any one of formaldehyde or glutaraldehyde solution or the mixed liquor of its arbitrary proportion, be 1: 2 ~ 1: 30 with the volume ratio of glue, the preparation of formaldehyde and glutaraldehyde is mainly and all water, suitably adds appropriate organic solvent such as ethanol, methanol etc. and likely plays better effect.
Freeze-drying process is a process prepared by dry gel particle, and the general pre-freeze time is no less than 1h, and freeze-drying time is no less than 24h.
Dry gel particle is added in sponge, the uniformity of attention dispersion.Ensure that gel particle is all scattered in the space of sponge as far as possible, avoid spilling of in use gel particle.
Crosslinking temperature and time are particularly important in the present invention, and in the present invention, sponge material be made to be cross-linked, and it is suitable that temperature controls at 15 ~ 45 DEG C, and temperature is lower, and crosslinked process can be slower, and usually crosslinked time controling is advisable at 30 ~ 80min.Preferred temperature is 25 ~ 40 DEG C in the present invention, more preferred temperature is 32 ~ 38 DEG C; In the present invention, preferred crosslinking time is 40 ~ 70min, more preferably crosslinking time is 50 ~ 60min.
By the glue agitator vigorous stirring after crosslinked, glue will form foam, is loaded in appropriate container by foam, puts into freezer dryer or refrigerator and cooled is frozen.After rear employing lyophilizing or oven drying at low temperature or the mode of drying remove moisture, sponge just prepares molding.
The dry gel particle of preparation is dispersed in sponge surface, gel particle is distributed in the space of sponge.Sponge containing gel particle can be cut into different size, thickness as required, the block of shape just can use.
In the present invention, the weight ratio of dry granulated gel and sponge is 1: 20-20: 1, the combination of this bi-material all can be better than using a kind of haemostatic effect of material, preferred part by weight is 1: 10: 1: 1, wherein sponge is as skeleton in hemostasis, and wound or the blood vessel surface of the laminating that the gel formed fast is seamless carry out quick-acting haemostatic powder.
In the present invention, dry granulated gel granule also can be used in combination with sponge particles; specifically can by the sponge particles mixing of the dry gel particle of slightly small grain size and slightly coarsegrain; mix homogeneously; dry gel particle is adsorbed onto in sponge particles; can directly powder be poured in wound during use; again by the wrapping of other wounds, reach rapid hemostasis.
These sponges containing dry gel particle can be prepared into and variously be prepared into adhesive bandage according to certain technique, hemostatic adhesive bandage uses, and also can coordinate adhesive bandage as independently rapid hemostatic material granule, hemostatic adhesive bandage uses together with other dressing.
Detailed description of the invention:
Embodiment 1
Take Carbopol 971PNF 3g, add water 100ml, stir, be prepared into carbomer gel, for subsequent use.Take gelatin 20g, add water 200ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add the formaldehyde diluent 10ml of 12%, in 35 DEG C of water-baths, be incubated about 50 ~ 60min.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Put into freezer dryer together with the carbomer gel prepared before immediately and carry out lyophilization.After lyophilization terminates, carbomer xerogel block is pulverized and sieved, carbomer dry gel particle is evenly spread in sponge, cutting, packaging, sterilizing and get final product.
Embodiment 2
Take hydroxypropyl cellulose 5g, add water 100ml, stir, be prepared into hydroxypropyl cellulose gel, for subsequent use.Take gelatin 20g, add water 200ml, in 60 DEG C of water-baths, heated and stirred makes gelatin all dissolve.Add the formaldehyde diluent 10ml of 12%, in 35 DEG C of water-baths, be incubated about 50 ~ 60min.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Put into freezer dryer together with the hydroxypropyl cellulose gel prepared before immediately and carry out lyophilization.After lyophilization terminates, hydroxypropyl cellulose xerogel block is pulverized and sieved, hydroxypropyl cellulose dry gel particle is evenly spread to sponge surface, cutting, packaging, sterilizing and get final product.
Embodiment 3
Take Carbopol 971PNF 3g, add water 100ml, stir, be prepared into carbomer gel, for subsequent use.The appropriate 20g of weighing polyvinyl alcohol, adds water 200g, and in 70 DEG C of water-baths, heated and stirred makes polyvinyl alcohol all dissolve.Take above-mentioned poly-vinyl alcohol solution 60g, add 5ml 1% glutaraldehyde solution, 3ml pentane, 10ml0.1mol/L hydrochloric acid.Stirring paddle high-speed stirred is about 10min, after foam volume no longer increases, pours in mould, puts into freezer dryer together immediately carry out lyophilization with the carbomer gel prepared before.After lyophilization terminates, dry carbomer gel is pulverized and sieved, by dry carbomer gel uniform particles and the mixing of polyvinylalcohol sponge granule, packaging, sterilizing and get final product.
Embodiment 4
Take poloxamer 8g, add water 100ml, stir, be prepared into poloxamer gel, for subsequent use.Take chitosan 10g, add water 250ml, in 65 DEG C of water-baths, heated and stirred makes gelatin all dissolve.6% formaldehyde diluent 10ml, is incubated about 2h in 35 DEG C of water-baths.After insulation terminates, while blast a small amount of air limit agitator rapid stirring in solution.After complete soln foam generated, pour in mould.Put into freezer dryer together with the poloxamer gel prepared before immediately and carry out lyophilization.After lyophilization terminates, poloxamer is done gelling block and pulverize, dry gel particle is evenly spread in sponge, cutting, packaging, sterilizing and get final product.
Claims (8)
1. a rapid hemostatic sponge gel combination, containing dry gel particle and sthptic sponge.
2. sthptic sponge gel combination according to claim 1, is characterized in that described dry gel particle is with the preparation of carbomer, hypromellose, hydroxypropyl cellulose and poloxamer.
3. sthptic sponge gel combination according to claim 2, what it is characterized in that described sthptic sponge comprises polyvinylalcohol sponge, collagen protein sponge, chitosan sponge, hyaluronic acid sponge and gelfoam.
4. sthptic sponge gel combination according to claim 3, is characterized in that the mixing by a kind of of carbomer, hydroxypropyl cellulose, poloxamer and hypromellose or any two kinds, three kinds arbitrary proportions of the dry gel particle prepared.
5. the carbomer concentration described in claim 4 is 2% ~ 5%, and preferred concentration is 3-3.5%; The concentration of hypromellose is 3% ~ 6%, and preferred concentration is 3 ~ 5%; The concentration of hydroxypropyl cellulose is 5 ~ 35%, and preferred concentration is 10 ~ 15%; The concentration of poloxamer is 5 ~ 35%, and preferred concentration is 10 ~ 15%.
6. the method for the dry gel particle described in claim 5 is characterized in that: gel solution postlyophilization carbomer, hypromellose, hydroxypropyl cellulose and poloxamer being mixed with respective concentration, crushes and screens.
7. the dry gel particle described in claim 6 and the weight ratio of sthptic sponge are 1: 20-20: 1, and preferred part by weight is 1: 10-1: 1.
8. the absorbable hemostatic compositions method described in claim 1, is characterized in that, by the dispersed sthptic sponge of dry gel particle of hemostasis, being cut by sponge or pulverizing rear packaging, sterilizing and get final product.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016178829A1 (en) * | 2015-05-06 | 2016-11-10 | Gyrus Acmi, Inc. (D.B.A. Olympus Surgical Technologies America) | Carboxymethyl chitosan sponge formulation |
| CN108187128A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable hemostasis bone wax and preparation method thereof |
| CN110051878A (en) * | 2019-05-28 | 2019-07-26 | 南昌大学第二附属医院 | The preparation method of Pen Zhu Shi Ming gelatin sponge gruel applied to central nervous system surgical hemostasis |
| CN111542290A (en) * | 2017-09-24 | 2020-08-14 | 雷德助莱斯有限公司 | Wound packing devices, assemblies, and methods |
| CN112999407A (en) * | 2021-03-25 | 2021-06-22 | 杭州维力医疗器械有限公司 | Degradable hemostatic sponge, preparation method and application thereof, and degradable drug-loaded hemostatic sponge |
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| WO2009111282A2 (en) * | 2008-03-04 | 2009-09-11 | Hemostasis, Llc | Hemostatic sponge and method of manufacture |
| CN102068714A (en) * | 2011-01-19 | 2011-05-25 | 北京大学 | Collagen sponge and preparation method thereof |
| CN102416194A (en) * | 2011-11-11 | 2012-04-18 | 汤小国 | Novel chitosan hemostatic sponge and preparation method thereof |
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2014
- 2014-11-05 CN CN201410623794.7A patent/CN104353106A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009111282A2 (en) * | 2008-03-04 | 2009-09-11 | Hemostasis, Llc | Hemostatic sponge and method of manufacture |
| CN102068714A (en) * | 2011-01-19 | 2011-05-25 | 北京大学 | Collagen sponge and preparation method thereof |
| CN102416194A (en) * | 2011-11-11 | 2012-04-18 | 汤小国 | Novel chitosan hemostatic sponge and preparation method thereof |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2016178829A1 (en) * | 2015-05-06 | 2016-11-10 | Gyrus Acmi, Inc. (D.B.A. Olympus Surgical Technologies America) | Carboxymethyl chitosan sponge formulation |
| CN111542290A (en) * | 2017-09-24 | 2020-08-14 | 雷德助莱斯有限公司 | Wound packing devices, assemblies, and methods |
| CN111542290B (en) * | 2017-09-24 | 2021-10-15 | 雷德助莱斯有限公司 | Wound packing devices, assemblies, and methods |
| CN108187128A (en) * | 2018-02-07 | 2018-06-22 | 广州迈普再生医学科技有限公司 | A kind of absorbable hemostasis bone wax and preparation method thereof |
| CN108187128B (en) * | 2018-02-07 | 2021-08-31 | 广州迈普再生医学科技股份有限公司 | Absorbable hemostatic bone wax and preparation method thereof |
| CN110051878A (en) * | 2019-05-28 | 2019-07-26 | 南昌大学第二附属医院 | The preparation method of Pen Zhu Shi Ming gelatin sponge gruel applied to central nervous system surgical hemostasis |
| CN112999407A (en) * | 2021-03-25 | 2021-06-22 | 杭州维力医疗器械有限公司 | Degradable hemostatic sponge, preparation method and application thereof, and degradable drug-loaded hemostatic sponge |
| CN112999407B (en) * | 2021-03-25 | 2022-07-12 | 杭州维力医疗器械有限公司 | Degradable hemostatic sponge, preparation method and application thereof, and degradable drug-loaded hemostatic sponge |
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Application publication date: 20150218 |