US20120294927A1 - Wound dressing - Google Patents
Wound dressing Download PDFInfo
- Publication number
- US20120294927A1 US20120294927A1 US13/473,138 US201213473138A US2012294927A1 US 20120294927 A1 US20120294927 A1 US 20120294927A1 US 201213473138 A US201213473138 A US 201213473138A US 2012294927 A1 US2012294927 A1 US 2012294927A1
- Authority
- US
- United States
- Prior art keywords
- wound dressing
- elastomer
- dressing according
- wound
- elastomer matrix
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
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- 239000000806 elastomer Substances 0.000 claims abstract description 56
- 239000011159 matrix material Substances 0.000 claims abstract description 51
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- 239000000203 mixture Substances 0.000 claims abstract description 23
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- 239000000416 hydrocolloid Substances 0.000 claims description 11
- 239000004480 active ingredient Substances 0.000 claims description 8
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- 208000005230 Leg Ulcer Diseases 0.000 description 1
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- 206010072170 Skin wound Diseases 0.000 description 1
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
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- BGYHLZZASRKEJE-UHFFFAOYSA-N [3-[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxy]-2,2-bis[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxymethyl]propyl] 3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoate Chemical compound CC(C)(C)C1=C(O)C(C(C)(C)C)=CC(CCC(=O)OCC(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)=C1 BGYHLZZASRKEJE-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- B32—LAYERED PRODUCTS
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- A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2535/00—Medical equipment, e.g. bandage, prostheses or catheter
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/18—Layered products comprising a layer of synthetic resin characterised by the use of special additives
Definitions
- the invention relates to a sterile wound dressing with a backing and an elastomeric polymer matrix as the wound contact layer.
- Wound dressings containing fat have been used successfully for many years for topical treatment of traumatic wounds such as cuts and scrapes and chronic wounds, such as decubital ulcers, leg ulcers, and the like, as well as burns on humans and animals.
- L&R Lohmann & Rauscher GmbH & Co. KG
- This product which is formed from a woven cotton impregnated with a fatty substance based on petroleum jelly, nevertheless has disadvantages such as loss of fatty substances to the handling tools (such as gloves) and to the wound and the wound environment.
- the petroleum jelly softens because of the increase in temperature and tends to be displaced to the periphery of the dressing.
- a wound dressing having a liquid-permeable substrate, which is provided with openings and has an absorbent (at least 50% of the dry weight) non-adhesive polymer composition that contains a hydrophobic organic polymer matrix, a plasticizer and hydrophilic organic microparticles plus optionally bioactive agents is described in EP 1 691 851 B1.
- the aforementioned document describes synthetic and natural bioactive agents. When these agents are used, it has proven problematical that the absorbent (superabsorber) in the dressing binds liquid in a gel form. The openings for exudate (e.g., viscous) become almost impassable due to this swelling process. Free removal of the exudate into the absorbent secondary dressing may then be hindered. Under some circumstances, this may cause maceration of the wound.
- Sticking of the dressing to the wound can be prevented by using a sterile nonsticking compress according to EP 1 143 895 B1.
- This compress contains a polymer composition of a thermoplastic elastomer, an oily plasticizer, petroleum jelly, and hydrophilic particles of a hydrocolloid (CMC, alginate, pectin) and optionally an active ingredient.
- the elastomer matrix comprises a three-block elastomer, in which the concentration of the elastomer should be at least between 3.2% and 8.8%, so that the use of a cohesive, elastic polymer matrix which is stable in a moist medium can be ensured.
- EP 127 229 B1 describes an antiseptic compress which has a wound contact layer of an elastomer matrix, an apolar oil, a hydrocolloid (sodium carboxymethyl cellulose) as a dispersion and at least one surfactant (Tween 80), optionally with at least one antimicrobial agent (silver sulfadiazine).
- a compress has a high total concentration of the synthetic three-block elastomer of more than 4.6 parts by weight. This is problematical in view of the desired avoidance of direct contact between the elastomer and the wound.
- the use of surfactants is not without problems because they have a certain cytotoxic potential.
- EP 0 521 761 describes a nonsticking hydrophobic occlusive dressing consisting of a backing bonded to the matrix surface, wherein the elastomer matrix contains at least 10 30 parts by weight of a block copolymer and 70-90 parts by weight of a plasticizer, preferably petroleum jelly.
- wound dressings In order for all these wound dressings to be usable to promote healing without the risk of microbial contamination, they must first be sterilized. Wound infections have been shown to delay healing. They are caused by pathogenic microorganisms which penetrate into the wound (possibly through the wound dressing), replicate there, and produce toxins which act on the wound tissue itself as well as on the body as a whole.
- a sterile barrier primary packaging material
- an airtight packaging material has been selected to suppress the oxidizing influence of atmospheric oxygen as well as the influence of atmospheric oxygen on the hygroscopic hydrocolloid dispersed in the matrix.
- the technique generally used for sterilization of such wound dressings is sterilization by irradiation, which thus ensures very effective sterilization into the interior of the product.
- Two types of radiation may be used for this purpose, namely ⁇ - and ⁇ -radiation.
- the sterilization dose is adjusted within the context of a dose determination as a function of the initial microbiological burden (bioburden), i.e., the amount of microorganisms present in/on the product prior to sterilization.
- bioburden initial microbiological burden
- an average dose of 25 kGray is generally used for the products to be sterilized.
- a product receives a dose between 25 and 40 kGray, depending on the method used.
- the object of the present invention is to make available an especially biocompatible nonsticking (optionally slightly adhesive) wound dressing based on an elastomer matrix containing fat and hydrocolloid with an improved resistance to radiation sterilization for treatment of traumatic and chronic wounds as well as burns.
- this object is achieved by a refinement of the known wound dressings, characterized essentially in that the wound contact layer contains an elastomer matrix comprising less than 3.2% of an elastomer, in particular 3.0% or less, preferably less than 2.7% of a total polymer component, so that better tissue compatibility is obtained in addition to the economic advantage.
- thermoplastic elastomers TPE
- elastomer mixtures with an especially high molecular weight are used to counteract the negative effects of radiation sterilization on cohesion of the matrix. It has surprisingly been found that the addition/use of the preferred ultrahigh molecular elastomers such as Septon 4077 greatly improves cohesion after sterilization.
- the processing temperature is limited (preferably max. approximately 140-145° C.).
- the expected increase in the processing temperature when using an ultrahigh molecular elastomer is only minor, however, and is within the acceptable range.
- the wound contact layer of a wound dressing according to the invention according to the invention preferably comprises, in addition to an organic polymer matrix, a plasticizer, and hydrophilic organic and/or inorganic microparticles which form a gel on contact with an aqueous solution.
- the wound dressing comprises a flexible open mesh fabric, wherein the fabric comprises fibers sheathed with an elastomeric cohesive and nonsticking gel/matrix, so that the mesh essentially cannot be clogged, i.e., remains permeable.
- the polymer matrix may contain a synthetic thermoplastic hydrophobic three-block copolymer A-B-A, in which the polymer matrix preferably contains no more than 3.2 parts by weight, in particular no more than 2.6 parts by weight of a block polymer, in which the terminal block A may be of the polystyrene type and the central block B may be of the saturated polyolefin type and the styrene component is between 25% and 40%.
- three-block elastomers of the SEBS type or SEPS and/or SEEPS type with high and ultrahigh molecular weights are used.
- SEBS hydrogenated polystyrene-polyethylene-polybutylene-polystyrene copolymers
- SEEPS hydrogenated polystyrene-b-poly(ethylene/propylene)-b-polystyrene copolymers
- At least one three-block elastomer of the SEBS or SEPS type especially SEEPS with a very high molecular weight (at least 200,000 dalton, preferably at least 400,000 dalton) and with a Brookfield viscosity of at least 5000 mPas (for a 10% solution in toluene a 30° C.) is selected.
- Such polymer compositions allow good inclusion of the fibers of the fabric as the backing, which thus remain completely isolated from the wound, so that no direct contact between fiber and regenerated tissue is risked at any time, which could result in a fiber inclusion in the wound, resulting in painful destruction of the tissue when the dressing is pulled away.
- the ultrahigh-molecular polymer with a molecular weight of more than 300,000 dalton in the total polymer content is less than 50 wt %, in particular less than 25 wt % to maintain adequate processability.
- the desired improvement in sterilization stability under radiation sterilization is achieved when the amount of ultrahigh molecular polymer with a molecular weight of more than 300,000 dalton in particular approximately 400,000 to 450,000 dalton in relation to the total polymer content is more than 5%, in particular more than 10%, especially preferably 20% or more.
- the matrix Due to the high oily plasticizer content, which is preferably obtained by starting with a mixture of mineral oil and petroleum jelly, in combination with a very low polymer/elastomer content, the matrix also acts like a pure fatty substance, which thus ensures very good tissue tolerability and properties of nonadhesion to the surface of the compress.
- plasticizers that are readily suitable for plasticizing the elastomer, reference may be made in particular to fatty substances that are liquid or solid at room temperature, in particular paraffin oils, medicinal white oils, mineral oils, ointment paraffins, petroleum jelly, silicone oils or silicone fats and/or waxes as well as mixtures thereof.
- Plasticizers such as petroleum jelly, whose drop point is between 35° C. and 70° C., are preferred.
- Medicinal white oils whose purity requirements conform to Ph. Eur., are also preferred.
- the matrix may also contain antioxidants.
- Suitable antioxidants include the sulfur antioxidants, for example, the zinc dibutyl dithiocarbamate marketed by the company Akzo Nobel Chemicals under the brand name Perkacit ZDBC and/or the phenolic antioxidants, for example, the products marketed under the brand names Irganox® 1010, Irganox® 565, Irganox® 1035 by the company BASF may also be mentioned as suitable antioxidants.
- the compound in Irganox® 1010 is preferred within the scope of the present invention.
- the wound contact layer of a wound dressing according to the invention according to the invention may also comprise an additive selected from the group consisting of another stabilizer, extrusion aids, fillers, pigments, dyes, crosslinking agents, odor suppressants, tackifiers, tolerability mediators, and combinations therefore.
- hydrocolloids which are known in general (CMC, alginates, gelatin, xanthan, pectins) but also silicates such as bentonites, aerosils, or superabsorbers may be used as the hydrophilic organic and/or inorganic microparticles that bind water and undergo gelation in the process.
- the hydrocolloid dispersed in the elastomer matrix in a relatively small amount makes it possible to retain a slightly hydrophilic character, which is sufficient to maintain a moist wound environment that promotes wound healing, but is not sufficient to enable the gel to absorb a great deal of water.
- this absorption capacity is not desirable because it leads to swelling of the gel, which would cause a gradual clogging of the openings left in the structure of the compress.
- the compress would thus become occlusive which would thus suppress the option of eliminating the exudates while also increasing the risk of maceration and would clog the passages formed in the contact layer and cause maceration of the wound.
- a polymer composition comprising a nonabsorbent elastomer matrix/wound contact layer is made available.
- nonabsorbent means that the hydrophobic matrix absorbs less than 35%, preferably less than 25% of the saline solution (aqueous 0.8% NaCl solution) in 24 hours, based on the dry weight of the matrix.
- cohesion refers to the forces which hold the mass together. These cohesive forces are responsible for the toughness (viscosity) and flow behavior (rheology) of the elastomer matrix in processing and are also responsible for the strength of the matrix under stress.
- the cohesive forces in such systems are described by characteristic values such as the elastic modulus, tensile elongation, tensile strength and breaking strength/tensile force, or Shore hardness.
- the tear strength is the quotient of the force F R (tearing force) measured at the moment of tearing and the initial cross section A 0 of the test sample, which is measured at the thinnest location.
- the tensile strength is the quotient of the measured maximum force and the initial cross section of the sample body, which is measured at the thinnest location.
- the tearing force is usually also the maximum force.
- the tear strength and elongation at tear of the elastomer matrix were measured using sterile and nonsterile test bodies at an initial cross section A 0 of 100 mm 2 .
- the length of a test body with an original length of 8 mm is determined on reaching the tearing force.
- a 10 cm 2 sample is weighed using an analytical balance (w1).
- a crystallizing dish is filled with saline solution so that the sample is completely covered with the test solution and there are only a few small air bubbles on it.
- the sample is removed from the solution and patted carefully using a soft paper towel until all the water drops have been removed.
- the dry sample is then weighed using the analytical balance (w2).
- the weight of the backing (43 g/m 2 ) must be subtracted from the weight of the sample for this calculation.
- the absorption data from Table 2 demonstrates clearly that in an especially preferred embodiment of the invention, the elastomer wound contact layer does not absorb any mentionable amount of saline solution and therefore is not absorbent.
- the small quantities of water absorbed are utilized to form a boundary layer which contains fat and hydrocolloid gel and does not stick to the wound.
- Wound dressings according to the invention can be obtained as follows:
- the composition is prepared in a laboratory dissolver. 1110 g of the paraffin oil is placed in the dissolver and mixed with 40 g of an elastomer copolymer SEEPS (Septon 4055, Kuraray) and 1.5 g of an antioxidant (Irganox 1010) and stirred at approximately 135° C. until obtaining a clear homogeneous elastomer composition. After incorporating 154 g petroleum jelly (Vara AB, Sasol) 231 g of the sodium carboxymethyl cellulose (CMC, Blanose 7H4XF, Aqualon) is added. The resulting elastomer composition is stirred for 30 minutes more until obtaining a homogeneous composition.
- composition may also be prepared in a kneader or similar installations/equipment known in general for processing hot melt compositions.
- the composition can be applied to the fabric (mesh tulle) in an immersion bath at approximately 140-145° C., so that the textile structure is completely sheathed but the interspaces/pores remain largely open to ensure that the exudate can flow through.
- the wound dressings may be of particular importance for the wound dressings to absorb only in the range of 5% to 30% of the dry weight. This limits gelation and swelling (due to hydrocolloid solutions), so that the transport of exudate through the openings in the dressing and into the secondary dressing is not hindered.
- the aspect wherein the backing has an open mesh so that an exudate flow can be ensured even after the fibers forming the backing have been coated/sheathed with the elastomer composition.
- the invention is not limited to the exemplary embodiments described above. Instead, another idea involves the use of backing materials in the form of open mesh knits and woven fabrics and/or polyurethane foams, such as Vivo MCF 03 (AMS).
- the wound dressing according to the invention may also contain an additional active ingredient that is based on metals such as silver, copper, selenium, and/or based on metal compounds, in particular metal salts (Ag 2 O, AgCl, ZnO, MgO), and is dissolved/dispersed/distributed in the elastomer matrix.
- the active ingredient comprises an oligomeric/polymeric biguanide, in particular PHMB (e.g., Cosmocil PQ, Arch) and/or an oligomeric/polymeric guanide and/or similar broad-spectrum antiseptics such as octenidine.
- PHMB e.g., Cosmocil PQ, Arch
- oligomeric/polymeric guanide and/or similar broad-spectrum antiseptics such as octenidine.
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
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Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US14/447,835 US9649402B2 (en) | 2011-05-19 | 2014-07-31 | Wound dressing |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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EP11004167.0A EP2524706B1 (de) | 2011-05-19 | 2011-05-19 | Sterile Wundauflage mit einem synthethischen Dreiblock-Elastomer |
EP11004167.0 | 2011-05-19 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US14/447,835 Continuation US9649402B2 (en) | 2011-05-19 | 2014-07-31 | Wound dressing |
Publications (1)
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US20120294927A1 true US20120294927A1 (en) | 2012-11-22 |
Family
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Family Applications (2)
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US13/473,138 Abandoned US20120294927A1 (en) | 2011-05-19 | 2012-05-16 | Wound dressing |
US14/447,835 Active US9649402B2 (en) | 2011-05-19 | 2014-07-31 | Wound dressing |
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US14/447,835 Active US9649402B2 (en) | 2011-05-19 | 2014-07-31 | Wound dressing |
Country Status (10)
Country | Link |
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US (2) | US20120294927A1 (de) |
EP (1) | EP2524706B1 (de) |
CN (1) | CN102784410B (de) |
BR (1) | BR102012012026B1 (de) |
CA (1) | CA2776663C (de) |
DK (1) | DK2524706T3 (de) |
ES (1) | ES2489890T3 (de) |
HK (1) | HK1176025A1 (de) |
PL (1) | PL2524706T3 (de) |
RU (1) | RU2508127C2 (de) |
Cited By (10)
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---|---|---|---|---|
US20100260824A1 (en) * | 2008-08-28 | 2010-10-14 | Tyco Healthcare Group Lp | Antimicrobial Foam Compositions, Articles and Methods |
WO2014113652A1 (en) * | 2013-01-21 | 2014-07-24 | Covidien Lp | Antimicrobial non-adherent dressings and related methods therefor |
US20140314706A1 (en) * | 2013-03-13 | 2014-10-23 | University Of Maryland, Office Of Technology Commercialization | Advanced functional biocompatible polymer putty used as a hemostatic agent for treating damaged tissue and cells |
CN105536038A (zh) * | 2015-12-25 | 2016-05-04 | 厦门百美特生物材料科技有限公司 | 泡沫基敷料及其制备方法 |
US9402770B2 (en) | 2011-12-09 | 2016-08-02 | Covidien | Antimicrobial non-adherent dressings and related methods therefor |
US20160310648A1 (en) * | 2013-12-20 | 2016-10-27 | Urgo Recherche Innovation Et Developpement | Composite material for filling cavity wounds |
US9480770B2 (en) | 2002-10-23 | 2016-11-01 | Covidien Lp | Methods for preparation of medical dressing containing antimicrobial agent |
US9649402B2 (en) | 2011-05-19 | 2017-05-16 | Lohmann & Rauscher Gmbh & Co. Kg | Wound dressing |
US10307505B2 (en) * | 2003-11-24 | 2019-06-04 | Kci Usa, Inc. | Wound dressings for the controlled release of therapeutic agents |
US20220117792A1 (en) * | 2020-10-21 | 2022-04-21 | 4B Ventures LLC | Gauze for topical application on a target area and a packaging thereof |
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FR3030225B1 (fr) | 2014-12-19 | 2017-01-13 | Urgo Lab | Pansement comprenant un support et une matrice elastomerique hydrophobe |
CN104861407A (zh) * | 2015-05-30 | 2015-08-26 | 浙江汪洋高分子材料有限公司 | 一种热塑性弹性体止血带配方 |
FR3039409B1 (fr) * | 2015-07-30 | 2018-11-16 | Urgo Lab | Pansement comprenant un support et une matrice elastomerique hydrophobe |
DE102015226645A1 (de) * | 2015-12-23 | 2017-06-29 | Karl Otto Braun Gmbh & Co. Kg | Bandage |
FR3050937B1 (fr) * | 2016-05-04 | 2018-05-25 | Urgo Recherche Innovation Et Developpement | Composition optimisee pour pansement interface |
FR3053892A1 (fr) * | 2016-07-12 | 2018-01-19 | Urgo Recherche Innovation Et Developpement | Pansement permettant la liberation controlee et prolongee de la metformine |
CN114057982A (zh) * | 2021-12-07 | 2022-02-18 | 广东粤港澳大湾区黄埔材料研究院 | 水基聚氨酯液体敷料及其制备方法、抗菌膜层 |
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- 2011-05-19 DK DK11004167.0T patent/DK2524706T3/da active
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US9480770B2 (en) | 2002-10-23 | 2016-11-01 | Covidien Lp | Methods for preparation of medical dressing containing antimicrobial agent |
US10307505B2 (en) * | 2003-11-24 | 2019-06-04 | Kci Usa, Inc. | Wound dressings for the controlled release of therapeutic agents |
US20100260824A1 (en) * | 2008-08-28 | 2010-10-14 | Tyco Healthcare Group Lp | Antimicrobial Foam Compositions, Articles and Methods |
US9649402B2 (en) | 2011-05-19 | 2017-05-16 | Lohmann & Rauscher Gmbh & Co. Kg | Wound dressing |
US9402770B2 (en) | 2011-12-09 | 2016-08-02 | Covidien | Antimicrobial non-adherent dressings and related methods therefor |
WO2014113652A1 (en) * | 2013-01-21 | 2014-07-24 | Covidien Lp | Antimicrobial non-adherent dressings and related methods therefor |
US20140314706A1 (en) * | 2013-03-13 | 2014-10-23 | University Of Maryland, Office Of Technology Commercialization | Advanced functional biocompatible polymer putty used as a hemostatic agent for treating damaged tissue and cells |
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US20160310648A1 (en) * | 2013-12-20 | 2016-10-27 | Urgo Recherche Innovation Et Developpement | Composite material for filling cavity wounds |
US10398815B2 (en) * | 2013-12-20 | 2019-09-03 | Urgo Recherche Innovation Et Developpement | Composite material for filling cavity wounds |
CN105536038A (zh) * | 2015-12-25 | 2016-05-04 | 厦门百美特生物材料科技有限公司 | 泡沫基敷料及其制备方法 |
US20220117792A1 (en) * | 2020-10-21 | 2022-04-21 | 4B Ventures LLC | Gauze for topical application on a target area and a packaging thereof |
Also Published As
Publication number | Publication date |
---|---|
EP2524706B1 (de) | 2014-07-23 |
BR102012012026B1 (pt) | 2019-10-22 |
RU2012118564A (ru) | 2013-12-20 |
ES2489890T3 (es) | 2014-09-02 |
BR102012012026A2 (pt) | 2014-07-08 |
CN102784410A (zh) | 2012-11-21 |
US20140341969A1 (en) | 2014-11-20 |
CA2776663A1 (en) | 2012-11-19 |
CA2776663C (en) | 2015-03-31 |
DK2524706T3 (da) | 2014-10-06 |
US9649402B2 (en) | 2017-05-16 |
RU2508127C2 (ru) | 2014-02-27 |
PL2524706T3 (pl) | 2014-12-31 |
CN102784410B (zh) | 2015-01-21 |
EP2524706A1 (de) | 2012-11-21 |
HK1176025A1 (en) | 2013-07-19 |
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