WO2013052577A1

WO2013052577A1 - Hemostatic fibrous material

Info

Publication number: WO2013052577A1
Application number: PCT/US2012/058611
Authority: WO
Inventors: Denny Lo
Original assignee: Z-Medica, Llc
Priority date: 2011-10-04
Filing date: 2012-10-04
Publication date: 2013-04-11

Abstract

This disclosure relates to devices for promoting the clotting of blood in human beings or animals, or hemostatic devices. These devices may comprise a fibrous material or materials comprising one or more multicomponent fibers such as a gauze or a cloth. Some of the fibers in these materials or devices may comprise multicomponent fibers comprising at least two polymeric components, one of which contains a hemostatic additive material such as kaolin or another clay.

Description

HEMOSTATIC FIBROUS MATERIAL

BACKGROUND OF THE INVENTION

Field

[0001] Various embodiments disclosed herein relate generally to hemostatic methods, devices and materials, and specifically to hemostatic fibrous materials.

Description of the Related Art

[0002] Blood is a liquid tissue that includes red cells, white cells, corpuscles, and platelets dispersed in a liquid phase. The liquid phase is plasma, which includes acids, lipids, solubilized electrolytes, and proteins. The proteins are suspended in the liquid phase and can be separated out of the liquid phase by any of a variety of methods such as filtration, centrifugation, electrophoresis, and immunochemical techniques. One particular protein suspended in the liquid phase is fibrinogen. When bleeding occurs, the fibrinogen reacts with water and thrombin (an enzyme) to form fibrin, which is insoluble in blood and polymerizes to form clots.

[0003] In a wide variety of circumstances, wounds can be inflicted as the result of trauma. Often bleeding is associated with such wounds. In some circumstances, the wound and the bleeding are minor, and normal blood clotting functions in addition to the application of simple first aid are all that is required. First aid may include applying pressure to the wound with a sponge or similar device to facilitate clotting functions. Unfortunately, however, in other circumstances substantial bleeding can occur. Bleeding can also be a problem when the trauma is the result of a surgical procedure. Apart from suturing or stapling an incision or internally bleeding area, bleeding encountered during surgery is often controlled using sponges or other materials used to exert pressure against the bleed site and/or absorb the blood. However, when the bleeding becomes excessive, these measures may not be sufficient to stop the blood flow.

SUMMARY

[0004] The embodiments described herein generally relate to devices and methods for promoting the clotting of blood in human beings or animals. In some embodiments, the devices and methods disclosed herein can be used to promote wound healing in addition to or instead of hemostasis. In some embodiments, the devices can comprise a fibrous material or materials comprising one or more multicomponent fibers combined to form a flexible material or substrate such as a textile (e.g., a gauze or a cloth). Some of the fibers in these materials or devices may comprise a plurality of discrete macrocomponents or macrolayers. By way of comparison between components or layers in a fiber, one or more of these components or layers may comprise a material that has higher tensile strength, higher flexural modulus, higher durability, more consistent thickness, higher tear resistance, and/or can be reliably manufactured by way of fiber extrusion, fiber spinning, or fiber drawing, etc. Another of the one or more components or layers of a fiber may comprise a material that consists of or comprises a hemostatic or wound-healing material. In some embodiments, the hemostatic or wound- healing component or layer is applied or produced by a method that is different from fiber extrusion, fiber spinning, and/or fiber drawings.

[0005] In some embodiments, a multicomponent fiber can comprise two or more polymeric segments wherein at least one of the polymeric segments comprises a macromolecular host material and a therapeutic additive useful in the treatment of wounds, such as a hemostatic material, an antimicrobial additive, a release agent, an analgesic, a moisturizer, a bonding agent, and/or a wound-healing material. In some embodiments, the additive material can comprise a hemostatic mineral such as a molecular sieve (e.g., zeolite) or a clay (e.g., kaolin). In some embodiments, the clay material is a refined clay additive material. In some embodiments, the refined claim material may comprise refined kaolin. The additive material can be coated with another material to facilitate processing, application to a wound, sterilization and/or improved binding of the one or more components of the fiber. Examples of macromolecular host materials include materials comprising rayon, polyester, and/or compounds formed from polysaccharides such as compounds comprising alginic acid (e.g., calcium alginate, sodium alginate, potassium alginate, etc.).

[0006] In some embodiments, a device for promoting the clotting of blood may comprise a sterilized fabric substrate comprising a fibrous material and a sterilized packaging. In some embodiments, the fibrous material may comprise: a host which may comprise a polymer and a hemostatic additive which may comprise a hemostatic agent such as a clay or a zeolite. An example of a suitable clay is kaolin or refined kaolin. With respect to structure of the fibrous material, the fibrous material may comprise a plurality of individual fibers at least some of which are multicomponent fibers. At least one component can contain a hemostatic agent or additive. The hemostatic additive in the fibers may be dispersed throughout the interior of the fibers and affixed to the surface of the fibers. In some embodiments, the surface may have a greater hemostatic additive loading level than the interior. The substrate may also be contained within the sterilized packaging.

[0007] Some embodiments may relate to a blood clotting device comprising a sterile gauze substrate comprising a blend of fibers. For example, the substrate may comprise a blend of a first fiber comprising a cellulosic material and a second multicomponent fiber comprising a synthetic polymer. Furthermore, in some embodiments, at least one of the components of the multicomponent fiber may comprise an inorganic additive having hemostatic properties.

[0008] Some embodiments relate to a hemostatic device comprising a fibrous material comprising a macromolecular host material and a clay additive material. The fibrous material and/or the additive material may be stable in the presence of blood. In some embodiments, the fibrous material and/or the additive material will not dissolve, disintegrate, or otherwise rapidly degrade when in contact with blood. In some embodiments, either or both of the fibrous material and additive material may disintegrate, dissolve, be released, or leach out in the presence of liquids such as blood.

[0009] Some embodiments relate to a hemostatic product comprising a gauze in a sterilized packaging. The hemostatic product may be made by a process comprising: forming a gauze from a plurality of fibers comprising a hemostatic agent such as kaolin and a polymer. The fibers may be formed by a process comprising: blending a mixture comprising the hemostatic agent and the polymer in a molten form and extruding the mixture to produce the fibers upon cooling. Products which are structurally similar to products which may be made by such a process are contemplated regardless of how the products are actually made.

[0010] These materials may be used in a variety of methods. For example, any device described herein may be applied to a bleeding wound, or blood issuing from a bleeding wound. In some embodiments, the blood may directly contact a material, such as a fibrous material, a gauze, or a similar substrate, which comprises fibers comprising any hemostatic additive material. In some embodiments, the hemostatic material is positioned on and/or bound to the fiber in such a manner that the hemostatic material is configured to be directly exposed to and/or directly contacted with the bleeding wound surface during use. [0011] Some embodiments provide a method of promoting blood clotting comprising: opening a sterilized packaging containing a hemostatic device; and placing the hemostatic device in direct contact with a bleeding area of a human being or animal. The hemostatic device may comprise a fibrous material comprising a macromolecular host material and a clay additive material, and the fibrous material may be stable in the presence of blood.

[0012] Some embodiments relate to a method of preparing a hemostatic product comprising: forming a textile (e.g., a gauze) from a plurality of fibers comprising a hemostatic agent such as kaolin and a polymer; wherein the fibers are formed by a process comprising: blending a mixture comprising the hemostatic agent and the polymer in a molten form; extruding the mixture to form multicomponent fibers comprising at least two polymers, one of which contains a hemostatic additive; and providing the hemostatic product comprising the gauze in a sterilized packaging.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 is a schematic depiction of a cross section of an embodiment of a multicomponent fiber.

[0014] FIG. 2 is a schematic depiction of a cross section of another embodiment of a multicomponent fiber.

[0015] FIGS. 3A - 3C are schematic depictions of cross sections of other embodiments of multicomponent fibers.

[0016] FIGS. 4A - 4B are schematic depictions of cross sections of other embodiments of multicomponent fibers.

[0017] FIG. 5 illustrates a substrate comprising multicomponent fibers being applied to a wound.

DETAILED DESCRIPTION

[0018] The embodiments described herein generally relate to devices and methods for promoting the clotting of blood in human beings or animals. In some embodiments, the devices and methods disclosed herein can be used to promote one or more aspects of wound treatment or healing, regardless of whether the devices and methods can be used for hemostasis. In some embodiments, the devices may comprise a fibrous material or materials comprising one or more multicomponent fibers combined to form a substrate such as a textile substrate (e.g., a gauze or a cloth). Some of the fibers in these materials or devices may comprise a multicomponent fiber, one component of which may comprise a macromolecular material and a hemostatic additive material.

[0019] In some embodiments, the macromolecular material is a microcomposite material. Microcomposite materials generally include a polymer having micro-sized inorganic platelet particles dispersed therein, e.g., platelet particles having a micrometer-size range in at least one dimension thereof.

[0020] The resultant fibers can be multicomponent fibers, which include at least two structured polymeric components. Generally at least one polymer or macromolecular segment includes a microcomposite material, while at least one other polymeric segment includes a different fiber forming polymeric material, which may or may not include microparticles or may be substantially free of microparticles.

[0021] The size of the microparticles can vary depending upon the material used to make the same. Possible microparticles include platelet- shaped particles. Generally platelet particles can be described as modified clay materials with high aspect ratios (the ratio of the object's width to its thickness). Thus, the particles may also be described as having a minimal thickness relative to their length. Generally such particles have an average diameter less than or equal to about 3 μπι and/or greater than or equal to about 0.5 μπι, and an aspect ratio length/thickness ranging from about 100 to about 1. The particles may have an average thickness of less than or about 0.2 μπι, and preferably an average thickness of less than or about 0.1 μπι. In some embodiments, the average particle thickness can be at least about 0.001 μπι or at leat about 0.003 μπι, or in some cases, from about 0.2 μπι to about 0.01 μπι.

[0022] In some embodiments, a platelet- shaped, cosmetic and pharmaceutical grade kaolin can comprise a median particle size of about 1 μπι or less. In some embodiments, a minority of particles can have a median particle size of less than or equal to about 20 μπι. In some embodiments, it may be necessary to further refine the kaolin so that all substantially particles are less than or equal to about 2 μπι.

[0023] Materials comprising multicomponent fibers wherein at least one of the components comprises macromolecular material and a hemostatic additive material may be useful to promote blood clotting, such as promoting blood clotting in a person or animal that is bleeding. In some embodiments, a material having fibers comprising a macromolecular material, such as a crosslinked macromolecular material, may be useful to promote blood clotting. In some embodiments, the fibers can include a hemostatic additive material. These materials may also be useful for treating chronic wounds or longer term care of wounds such as burns and sores.

[0024] Hemostatic wound care dressings can comprise one or more fibers such as various thermoplastic polymers and additives in a mono-component or bi-component form in a core-sheath, substantially side-by-side, or various other configurations. The hemostatic synthetic fibers can comprise inorganic hemostatic additives, distributed in certain areas and substantially or entirely absent from other areas, in order to reduce the amount of the hemostatic agent used and to facilitate manufacturing and overall product strength and durability. In some embodiments, the hemostatic agents used in the synthetic fibers can remain within the fibers over a long period of time (e.g., multiple weeks or months) even after washing and/or stretching, tightening, wetting, and/or drying because the hemostatic agents are integrally incorporated into the fibers.

[0025] Additionally, in some embodiments, the hemostatic additives completely or virtually completely remain in the multicomponent fiber when exposed to blood. According to some embodiments, hemostatic synthetic fibers may comprise high tenacity polymers (e.g., PET) in one component, such as the "core" component or the component relatively free hemostatic additive. The hemostatic synthetic fibers can further be blended with fibers such as cotton, wool, polyester, acrylic, nylon etc. to provide hemostatic finished wound care dressings and burn dressings that are able to withstand significant wear and any washings they may be given (if the washable type) while maintaining their effectiveness.

[0026] In the microcomposite material, various types of structures can be used. In some embodiments, the structure is intercalated, in which a single extended polymer chain is inserted between layers resulting in a well ordered multilayer with alternating polymer/inorganic layers. In another, referred to as disordered or delaminated, the inorganic layers are substantially uniformly dispersed in the polymer with random orientation throughout the polymer matrix.

[0027] A macromolecular material may comprise any macromolecule as broadly understood in the art, and may include any molecule of a large molecular weight, such as molecules having repeating identical or similar units, such as a polymer, a protein or another polypeptide, a carbohydrate based macromolecule, etc. Other macromolecular materials such as protein based fibers, including fibers based upon wool, silk, or a modified version of these materials may be used.

[0028] In some embodiments, the macromolecular material may comprise a polysaccharide such as cellulose, starch, alginate, or the like, or a derivative thereof. Examples of useful alginates are salts of alginates, such as sodium alginate, potassium alginate, and/or calcium alginate, etc., which may be crosslinked. In some embodiments, an alginate with a high concentration of guluronate monomers can be used to achieve reduced solubility in water or blood. In some embodiments, the macromolecular material may comprise a cellulosic material as broadly understood by those skilled in the art, including cellulose or modified cellulose, such as cellulose which has been chemically modified by hydrolysis, reaction of the hydroxyl groups, or a combination thereof. Examples include, but are not limited to, regenerated cellulose such as rayon, including lyocell; cellulose esters such as nitrocellulose, cellulose acetates, cellulose priopionates, cellulose butyrate; cellulose ethers such as methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, aminoethylcellulose, benzylcellulose, etc.

[0029] Polymers used in some embodiments may include any polymer as broadly understood by those skilled in the art, and may include a polymer based upon a single repeating unit or a copolymer comprising more than one repeat unit distributed throughout the polymer in any arrangement, such as statistically distributed, or in blocks such as those formed by combining two or more oligomers or polymers of different types. In addition to cellulosic materials, examples of polymers may include, but are not limited to, polyolefins such as polyethylene, polypropylene, polybutylene, poly(4-methyl-l- pentene), and poly(l-hexane), etc.; acrylics such as polyacrylic acid, polymethylacrylate, polymethylmethacrylate, polyacrylonitrile, etc.; other substituted ethylenic polymers such as polyvinylchloride, polyvinyl alcohol, polystyrene, etc.; polyamides such as aliphatic polyamides (e.g. PA 6, PA 66, nylon-6, nylon-66, etc.), polyphthalamides (such as PA 6T), aromatic polyamides (such as a paraphenylenediamine-terephthalic acid polyamides including Kevlar and Nomex), etc.; polyurethanes; polyesters such as polyglycolic acid, aliphatic polyesters such as polylactic acid (PLA), polyphenylene sulfide, thermoplastic elastomers, polyacrylonitrile, acetals fluoropolymers, co- and ter-polymers thereof and mixtures thereof, polycaprolactone, polyethylene adipate, polyhydroxyalkanoate, comprising monomer units derived from terephthalic acid such as poly(alkylene terephthalates) such as polyethylene terephthalate (PET), polycyclohexylenedimethylene terephthalate (PCT), PETG, Co-PET; poly(alkylene naphthalates), polyethylene terephthalate, polybutylene terephthalate, polytrimethylene terephthalate, polyethylene naphthalate, vectran, polyesters comprising monomer units derived from cyclohexanedimethanol; etc.; polybenzimazole, poly[2,2'-(m-phenylene)-5,5'- bibenzimidazole], etc.; polyalkylene oxides such as polyethylene oxide, polypropylene oxide, polybutylene oxide, etc.; poly(arylene sulfides); Styrene, Halar^®, etc. As noted above, the fibers of some embodiment disclosed herein can also include other conventional polymers, such as those listed above, but without the exfoliated platelet particles.

[0030] PETG is used here in accordance with its customary meaning and includes an amorphous polyester of terephthalic acid and a mixture of predominately ethylene glycol and a lesser amount of 1,4-cyclohexanedimethanol. PETG can be used in polycarbonate blends to improve impact strength, transparency, processability, solvent resistance and environmental stress cracking resistance. PETG is an amorphous binder fiber which can be blended into yarns with other fibers to form fabrics, as well as non- woven fabrics. After heat activation, the PETG fiber melts, wets the surface of the surrounding fibers, and settles at the crossing points of the fibers, thus forming "a drop of glue" which bonds the fibers together and distributes the anti-microbial additives.

[0031] PETG may be used as one of the polymer blends and/or carriers for a wide variety of applications. PETG is an amorphous binder fiber that can be blended into yarns with other fibers to form woven fabrics, as well as knits and non-woven fabrics. It has two characteristics of particular interest: (1) excellent wetting and (2) low melting temperature (which can be controlled between about 90° C. and about 160° C). It is used according to some embodiments as a carrier to hemostatic additives and possible other additional additives such as anti-microbial additives and is blended with other fibers which may be natural fibers such as cotton, silk, flax, wool, etc. or other synthetic fibers such as: PET, PP, PE, Nylon, Acrylic, etc. After heat activation, the PETG melts, continuously releases the hemostatic or other additives and wets the surface of the surrounding fibers with the hemostatic or other additives it carries. It settles at the crossing points of the fibers, thus forming "a drop of glue" which bonds the fibers together. Therefore, PETG delivers and distributes the hemostatic additives uniformly within a fabric, generating the finished fabrics and/or fabrics having hemostatic properties.

[0032] The fibers can optionally include other components not adversely affecting the desired properties thereof. Examples include, without limitation, antibiotics, antioxidants, stabilizers, particulates, pigments, and the like. These and other additives can be used in conventional amounts.

[0033] In some embodiments, the fibers can be multicomponent fibers, which include at least two structured polymeric components. In some embodiments, multicomponent fibers are formed of two or more polymeric materials which have been extruded together to provide continuous contiguous polymer segments which extend down the length of the fiber. In some embodiments, multicomponent fibers are formed when one or more structural first components are extruded, spin, or drawn, and one or more other components with hemostatic or wound-healing properties are applied in a different manner from the structural first component. In some multicomponent fibers disclosed herein, generally at least one polymer segment includes a microcomposite material (e.g., a hemostatic additive), while at least one other polymeric segment or component generally does not contain is substantially free of microparticles but rather imparts strength and flexibility to the overall fiber. Combinations and/or copolymers of one or more polymers or macromolecular materials, such as any polymer or macromolecular material described herein, may be used.

[0034] The macromolecular materials may be crosslinked. Under some circumstances, cross-linking the polymer may be useful to improve the strength and/or stability of the macromolecular material, which may also improve the strength and/or stability of the fiber. In some embodiments, the macromolecular material may be crosslinked to provide a molecular sieve which may be useful as a hemostatic device. Thus, in some embodiments, the fiber may comprise a crosslinked polymer which is incorporated into a fibrous material for a hemostatic device without the need for a separate hemostatic additive to provide hemostatic properties. For example, crosslinked polystyrene or a crosslinked hydrophilic polymer such as a hydrophilic acrylic, a hydrophilic alkylene oxide, a hydrophilic polyurethane, a hydrophilic polyamide, a hydrophilic polyester, polyvinyl alcohol, or the like, may be a useful hemostatic material without a separate hemostatic additive. Crosslinked calcium alginate is another example of a material that can be used as a macromolecular material for hemostatic applications that does not require a separate hemostatic additive. In some embodiments, a crosslinked alginate can capture a hemostatic agent therein and substantially retain the hemostatic agent therein in a manner that resists solubility in liquids such as water or blood and that resists the release of the hemostatic agent from the alginate when exposed to liquids such as water or blood.

[0035] In some embodiments, the blood clotting device or hemostatic device may comprise a fibrous material such as a gauze or a cloth, which may comprise a blend of two or more fibers, such as a blend of a first fiber comprising a cellulose derivative and a second fiber comprising polymer such as a synthetic polymer. In these embodiments, at least one of these fibers may comprise a multicomponent fiber with a hemostatic additive. In some embodiments, a fiber may comprise a cellulose derivative, such as rayon, and a hemostatic additive. In some embodiments, a fiber may comprise a polyurethane, a polyamide, a polythiazole, or a polyester and a hemostatic additive. In some embodiments, the fibrous material may comprise a blend of polyester fibers and rayon fibers. The combination of polyester and rayon may help to provide qualities such as softness, conformability, strength, and absorbancy, which may be useful for a wound dressing. In some embodiments, the fibrous material comprises a blend of polyester fibers and rayon fibers, and the polyester fibers comprise a hemostatic additive such as kaolin or another clay. In some embodiments, the fibrous material comprises a blend of polyester fibers and rayon fibers, and the rayon fibers comprise a hemostatic additive such as kaolin or another clay.

[0036] In some embodiments, the hemostatic or wound-healing device can be substantially or virtually entirely dry after manufacturing and packing inside of the sterilized package. In some embodiments, the hemostatic or wound-healing device can be highly absorptive to help absorb blood and/or other wound exudate exiting the wound. In some embodiments, the fibers of the hemostatic or wound-healing device can be substantially or entirely free from temporary surface-adhered or surface-bound materials, such as coatings or additional layers.

[0037] A hemostatic additive may be present in any fiber described herein. A hemostatic additive material may include any hemostatic material, including inorganic hemostatic materials such as silicates, including bioactive glass, silica gel (Si0₂); alumina gel (AI₂O₃); silica- alumina, S1O₂-AI₂O₃; and silica-calcia Si0₂-CaO, and the like; aluminosilicates, such as zeolites including (Na) zeolite 4A, ((Na)i₂[(A10₂)i₂(Si0₂)i₂]-27H₂0), available under the trade name PURMOL 4A from Zeochem of Louisville, K.Y., (Ca) zeolite 5A ((Ca)₆[(A10₂)i₂(Si0₂)i₂]-27H₂0), available under the trade name LINDE TYPE A from Union Carbide(Na) zeolite 4A ((Na)₁₂[(A10₂)₁₂(Si0₂)₁₂]-27H₂0 Y ((Na)₅₆(Al₅₆Si₁₃₆O₃84>250H₂O)), (Ca) zeolite Y ((Ca, Na)56(Al56Sii₃₆O₃₈4)-250H₂O)), (K) OMS-2 ((K)Mn₈0i₆ nH₂0) (Ca) OMS-2 ((Ca, K)Mn₈0i₆.nH20), Mg_xAl_y(OH)_zCl_u nH₂0, chabazite (Kii(AlnSi₂5O₇2) 0H₂O), (Ca) OL-1 ((Ca,K,Na)Mni₄0₂₇-21H₂0), ZSM-5 (Na₇(Al₇Si₈₉Oi₉₂)-nH₂0), (Ca) ZSM-5 ((Ca,Na)₇(Al₇Si₈90i₉₂)-nH₂0) zeolite RHO, (Na,Cs)i₂[Ali₂Si₃₆0₉₆]44H₂0, Ca- mordenite, (Na-Ca)₅[Ai₅Si₄₃0₉₆]-nH₂0; or other inorganic molecular sieves, or clays, including clays such as kaolin, refined kaolin, bentonite, montmorillonite, saponite, polygorskite or attapulgite, sepiolite, etc.; oxides such as sodium aluminum oxide (NaA10₂), available from Alfa Aesar Company of Ward Hill, Mass., magnesium oxide (MgO), acid silica (Si0₂ nH₂0), titanium dioxide (Ti0₂), available as TITANIC OXIDE, and barium oxide (BaO), all available from Fisher Scientific Company, activated carbon, available from Strem Chemicals of Newburyport Mass., europium oxide (Eu₂0₃) and cerium oxide (Ce0₂), available from American Potash & Chemical Corp. of West Chicago, 111., copper oxide (CuO), available from Cerac Inc. of Milwaukee, Wis., cobalt oxide (Co₂0₃), available from J. T. Baker, bismuth oxide (Bi₂0₃), available from Baker and Adamson Chemical Co., aluminum oxide (A1₂0₃), available as aluminum oxide neutral type T from EM Reagents, nickel oxide (NiO), available from Matheson, Coleman and Bell of East Rutherford, N.J., zinc oxide (ZnO), stannic oxide (Sn0₂), and iron oxide, (Fe₂0₃) all available from Baker Analyticals, manganese oxide (MnO), available as manganese IV oxide, 99% and zirconium (IV) oxide (Zr0₂), all available from Aldrich, vanadium pentoxide (V₂0₅), available from Mallinkrodt, scandium oxide (Sc₂0₃), available as scandium oxide 98% from A. D. Mackay of New York, yttrium oxide (Y₂0₃), available from Alfa Aesar Company of Ward Hill, Mass., CHROMOSORB P-AW- DMCS, CHROMOSORB 101, and CHROMOSORB 102, all available from Alltech Associates, Deerfield 111; calcium salts such as calcium oxide (CaO), calcium chloride (CaCl₂), dibasic calcium phosphate (CaHP0₄), etc.; activated carbon, etc. Other hemostatic agents may include biologically based hemostatic agents such as chitosan. The hemostatic additive may also be an organic molecular sieve, such as crosslinked polystyrene or a crosslinked hydrophilic polymer such as a hydrophilic acrylic, a hydrophilic alkylene oxide, a hydrophilic polyurethane, a hydrophilic polyamide, a hydrophilic polyester, polyvinyl alcohol, or the like. These cross-linked macromolecules may also be useful as a hemostatic material without requiring a separate hemostatic additive.

[0038] In some embodiments the hemostatic agent may be a clay, such as a kaolin clay or refined kaolin clay, which includes the mineral "kaolinite." The kaolin may be Edgar's plastic kaolin (hereinafter "EPK"), which is a water-washed kaolin clay that is mined and processed in and near Edgar, Fla. EPK may have desirable plasticity characteristics, may be castable, and when mixed with water may produce a thixotropic slurry.

[0039] The amount of the hemostatic additive material may vary. In some embodiments, the weight of the hemostatic additive material as compared to the weight of the overall fiber may be at least about any of the following: 1%, 2%, 5%, or 7%; and/or less than or equal to about any of the following: 15%, 20%, 30%, 50%, or 75%. For example, the weight of the hemostatic additive may be about 10% of the weight of the fiber or of the weight of the component containing the hemostatic additive. In some embodiments, the particle size, such as the particle size of a clay such as a kaolin, may be less than or equal to about any of the following: 50 microns, 20 microns, 2 microns, or 1 micron. In some embodiments at least about 99% of the particles are less than about 50 microns. In some embodiments, at least about 80% of the particles are less than 10 microns. In some embodiments, at least about 20%, at least about 45%, or at least about 80% of the particles are under 2 microns.

[0040] According to some embodiments, one or more components of a multicomponent fiber contain different amounts of the one or more hemostatic additives. For example, in a fiber comprising two components, one component can contain more hemostatic additive than the other component. In a fiber containing three or four components, at least one of the components can contain less hemostatic additive than at least one other component. Moreover, some of the components may contain the same amount of hemostatic additive as at least one other component.

[0041] In some embodiments, at least one of the components in a multicomponent fiber contains one or more hemostatic additives in an amount that is at least about 50% by weight compared to the total weight of that component. While weight percents greater than about 50% may result in a weakened component, the presence of one or more other components, also referred to as structural components, containing less than about 50% hemostatic additive, if any, provides strength to the overall multicomponent fiber. For example, in embodiments in which at least one component contains at least about 50% by weight hemostatic additive, one or more other components contain less than or equal to about 50%, less than or equal to about 40%, less than or equal to about 30%, or less than or equal to about 20% hemostatic additive. In some embodiments, one or more components contain as much as or more than 70% hemostatic additive. In some embodiments, any resulting weakness produced by a high weight content of hemostatic additive can be remedied by combining the one or more components with one or more other components that contain less hemostatic additive. In some embodiments, a structural component may contain substantially less, if any, hemostatic agent to provide increased strength, durability, reduced solubility, etc. as compared to one or more other components. However, in some embodiments it is not necessary to eliminate or diminish the presence of hemostatic additive from the one or more other components or structural components, such as if they provide adequate support or strength to the one or more components that do contain greater amounts of one or more hemostatic additives.

[0042] According to some embodiments, the structural integrity of any particular components of a multicomponent fiber may be low (e.g., such that the fiber need not be durable or strong enough by itself to remain intact in standard hemostatic applications) if one or more other components can be configured to provide the necessary integrity so that the overall fiber can achieve a desired hemostatic effect and remain intact in standard hemostatic applications. For example, in some embodiments it is desirable for at least one component of a multicomponent fiber to contain at least about 50% by weight of a hemostatic additive, even if to do so substantially lessens the structural integrity of that component. The component or components can be combined with at least one other component having less than about 50% hemostatic additive or significantly less than about 50% hemostatic additive, if any, such that the integrity of the one or more other components increases an overall integrity characteristic for the combined fiber.

[0043] Moreover, according to some embodiments, it may be desirable or acceptable for the one or more components containing a greater amount of hemostatic additive than one or more other components to disintegrate or partially dissolve when exposed to blood or water, such as when the overall multicomponent fiber is configured to not disintegrate or dissolve. Thus, a fabric comprising such a multicomponent fiber can be configured to maintain its overall integrity, even if one ore more components individually do not maintain their integrity. Or a bandage or gauze placed in a bleeding wound will not dissolve into the wound even if a portion of the fibers do dissolve.

[0044] According to some embodiments shown in FIGS. 1-4, a multicomponent fiber 100 is formed of a core component 110 and a sheath component 120 using polyethylene terephthalate (PET) (or other thermoplastic polymer) in the core or other component. In some embodiments, the core components comprises between about 20% to about 80% of the fiber by weight. The sheath is also PET, or other thermoplastic polymer, can comprise between about 20% and 80% of the fiber by weight including, as a dispersed solid, hemostatic additive 130 (or compounded with the sheath plastic), to gain the efficiency of the additive on the surface, not wasting the additive in the core, and not diminishing the mechanical strength or durability of the core. Many other embodiments employ different core and sheath materials, respectively, and in different weight percentages. For example, the respective amount of material used in the sheath and core, respectively, may also be determined by the desired thickness of the sheath, which may in part depend on the particle size of the hemostatic additive, or the desired strength, flexibility, or other desirable characteristic of the core material.

[0045] In some embodiments, the sheath may be relatively thin (e.g., substantially smaller in thickness than the core). For example, the thickness of the sheath can be approximately the same size or larger than the average diameter of the hemostatic particles disposed in the sheath. For example, in some embodiments, when the hemostatic particles are approximately platelet- shaped having a diameter of about 2 μπι, the sheath thickness can be at least about 3 μπι or at least a thickness just larger than the 2 μπι particle so as to properly maintain the particle within the sheath material. For example, if hemostatic particles of about 1 μπι are used, the sheath thickness could be approximately the same as or slightly larger than 1 μπι and may be about 1.5 μπι to about 2 μπι. In this manner, the particles of the agent can be firmly held in place by the sheath material. When the particles are larger or smaller, the thickness of the sheath is adjusted accordingly. In some embodiments, the hemostatic or wound-healing effect of the device is primarily or entirely due to interaction between the blood or wound and the therapeutic agent retained within the sheath layer, and not due to therapeutic agents that are released from the sheath layer. As used herein, the terms "core" can refer generally to a structural layer and "sheath" can refer generally to therapeutic layer, such as a hemostatic or wound- healing layer, regardless of whether the core is positioned entirely or mostly within the sheath.

[0046] In some embodiments having a core- sheath configuration, the multicomponent fiber may have an outer diameter of about 20 μπι and the core, or the component that does not contain a hemostatic additive, can have a diameter of about 12 μπι. Thus, the sheath, or the component containing the hemostatic additive can have a thickness of about 4 μπι.

[0047] According to the embodiment illustrated in FIG. 2, a multicomponent fiber 200 may comprise a dual core configuration in which structural component 210 provides strength, flexibility, etc. to the overall fiber and is substantially or entirely free of hemostatic agents and/or other additives or fillers, while hemostatic component 220 comprises one or more different types of hemostatic agents 230. In the embodiment illustrated in FIG. 2, the structural component 210 and the hemostatic component are generally equal in volume, although the hemostatic component may be less consistent in thickness along its length.

[0048] According to other configurations illustrated in FIGS. 3 A - 3C, unequal proportions of the structural component 310 and the hemostatic component 330 may be used for multicomponent fibers. FIG. 3A illustrates a configuration of at least three components 310, 330, 340 that comprise a multicomponent fiber 300. Components 310 and 340 comprise the "core" components in that they provide increased strength, flexibility, etc. to the overall fiber and may be substantially or entirely free from additives such as hemostatic agents and/or fillers. Component 310 and Component 340 can be different from each other. Component 320 can comprise hemostatic additive 330. FIG. 3B illustrates a configuration of at least two components in which the structural component 310 occupies substantially more of the average cross-sectional area (e.g., at least about 60%) and the surface area of the fiber than the hemostatic component 330. FIG. 3C illustrates a configuration of at least two components in which the hemostatic component 330 occupies substantially more of the average cross-sectional area (e.g., at least about 60%) and the surface area of the fiber than the structural component 310. FIG. 3C provides substantially increased surface area for direct contact and/or direct exposure with blood and/or the wound surface, but may exhibit diminished strength or durability.

[0049] FIGS. 4A and 4B represent another configuration of multicomponent fiber 400 comprising at least four components in which structural components 410 and 440 are substantially free of hemostatic additive 430 and may or may not comprise the same material. Hemostatic components 420 and 450 can comprise a hemostatic additive 430 (which can be the same or different in each component 420 or 450). In some embodiments, components 420 and 450 can comprise substantially the same base macromolecular or polymer material.

[0050] The fiber may be of any thickness which is appropriate for a multicomponent fibrous material comprising a hemostatic material. In some embodiments, the fiber diameter may be at least about any of the following: 10 μπι, 15 μπι, 20 μπι, 30 μπι, or 50 μπι. In some embodiments, the fiber diameter may be about 10 μπι to about 100 μπι, about 10 μπι to about 50 μπι, about 5 μπι to about 45 μπι, about 8 μπι to about 71 μπι, or about 40 μπι to about 100 μπι. In some embodiments, the fiber is substantially stable in the presence of blood. The term "stable" is intended to have the meaning generally understood in the art, and includes a fiber which does not disintegrate or dissolve in the presence of blood during the time that it generally takes the blood to clot in a particular type of application. In some embodiments, the fiber remains generally intact, and does not disintegrate or dissolve at all in the presence of blood, or until after at least about 5 minutes, at least about 10 minutes, at least about 60 minutes, or at least about 24 hours, of contact with blood. In some embodiments, the fiber is sufficiently stable that the hemostatic material is not lost from the fiber by disintegration or dissolution of a macromolecular material in the fiber. For example, in some embodiments, the fiber is configured so that if the fiber comes in contact with blood, substantially all of the hemostatic material, such as kaolin or another clay, is retained in or on the fiber for at least about 5 minutes, at least about 10 minutes, at least about 60 minutes, or at least about 24 hours while the fiber is in contact with blood. In some embodiments, the hemostatic material, such as a clay (including kaolin), is affixed to the surface so that substantially all of the particles of the hemostatic material are retained and no clinically significant amount of particles become detached from the fiber. For example, in some embodiments, the fiber is configured so that if the fiber comes in contact with blood, the particles of hemostatic material do not become detached for at least about 5 minutes, at least about 10 minutes, at least about 60 minutes, or at least about 24 hours while the fiber is in contact with blood.

[0051] In some embodiments, the fiber is a bi-component fiber of a core and a sheath as shown in FIG. 1 using PET or other high tenacity polymer in the core at between about 20% and about 80% by weight of the fiber. PCT or other hydrolysis resistant polymer can be used for the sheath at 80% to 20%. The core can provide the strength of the fiber and the modulus can be varied to create a high modulus fiber with properties of high tenacity and low elongation similar to cotton, or a low tenacity and higher elongation fiber with properties similar to wool; or anywhere in between to obtain different fibers to make them as compatible as possible for their end uses and for any blend in which they will be used. In fibers, modulus refers to the area under the curve in a stress/strain curve. In some embodiments, the sheath is at least about 30% of the total cross sectional area. The sheath can use PCT which provides a hydrolysis resistant surface with good wrinkle resistance and resistance to long term washings in boiling water and strong soaps.

[0052] In some embodiments, the hemostatic additive, such as kaolin, refined kaolin, or another clay, may be uncoated. However, in some embodiments, the hemostatic additive may be coated with an organic material such as a fatty acid, such as stearic acid or a stearate salt, including calcium stearate or ammonium stearate. For some extrusion processes, a coating may help the hemostatic additive to remain in the interior of the fiber. A hemostatic additive without a coating may be useful if higher loading is desired at the surface of the fiber, or for other reasons.

[0053] A fiber may contain other additives such as a therapeutically active agent such as an analgesic, including but not limited to, an opiate such as codeine, morphine, oxycodone, etc.; acetaminophen; anti-inflammatory agents, including nonsteroidal anti-inflammatory drugs, aspirin, etc.; an antibiotic or another antimicrobial drug or compound; an antihistamine (e.g., cimetidine, chloropheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride); antifungal agents; anti-microbial compounds such as those containing silver ions; compounds containing copper ions; ascorbic acid; tranexamic acid; rutin; thrombin; botanical agents; etc.; and combinations thereof. Other additives may include magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, and combinations thereof.

[0054] The macromolecular material or polymer and the hemostatic additive may be combined in liquid or slurry form using various methods. For example, the hemostatic additive may be combined with a macromolecule or polymer in a molten form. A slurry can comprise at least one component of the multicomponent fiber. The other component or components can be separately melted so that all the various components can be co-extruded to form a single multicomponent fiber. The hemostatic additive may also be combined with the macromolecule or polymer and water or an organic liquid which dissolves or disperses the macromolecule or polymer, so that the mixture can be thoroughly blended into a liquid or a slurry. The liquid or slurry may then be extruded to form fibers upon evaporation of the liquid. Suitable organic liquids may include, but are not limited to, ethanol, methanol, isopropanol, ethyl ether, dichloromethane, butane, pentane, hexane, heptane, acetone, ethyl acetate, and the like.

[0055] In some embodiments, the polymer may be formed in the presence of the hemostatic additive material such as kaolin and extruded before the material cures. For example, a liquid monomer such as a low molecular weight olefin, acrylic acid, methyl methacrylate, acrylonitrile, etc., may be combined with the hemostatic additive material, and then the polymerization reaction may be initiated. When the polymerization reaction has been initiated, the material may be extruded while still in the liquid state, and the fibers may form as the polymerization reaction progresses or the material cures. A similar process could be carried out with polymer made from two or more components such as polyesters, polyurethanes, etc.

[0056] The extrusion may be carried out with any type of die or other extrusion equipment ordinarily used to produce fibers or multicomponent fibers. In some embodiments, the fibers are produced by extruding the liquid or slurry through spinerette dies. For example, the extrusion may be carried out using DuPont Fiber spinning equipment. In some embodiments, the fibers may be drawn as they are extruded. Drawing, including pulling on the polymer fiber as it exits the extruder die, may help to improve the strength of a polymer fiber.

[0057] The die may have any diameter, in some embodiments, the die diameter may be from about 0.01 mm to about 5 mm in diameter, about 0.05 to about 1 mm in diameter, about 0.5 mm to about 0.6 mm in diameter, about 0.6 mm to about 0.7 mm in diameter, about 0.7 mm to about 0.8 mm in diameter, about 0.8 mm to about 0.9 mm in diameter, about 0.9 mm to about 1 mm in diameter, about 1 mm to about 1.5 mm in diameter, about 1.5 mm to about 2 mm in diameter, about 2 mm to about 2.5 mm in diameter, about 2.5 mm to about 3 mm in diameter, or about 3 mm to about 4 mm in diameter.

[0058] The extrusion rate and temperature may vary. For melt extrusion processes, in some embodiments the temperature may range from about 50 °C, about 20 °C, or about 10 °C below the softening point or melting point of the polymer to about 10 °C, about 20 °C, or about 50 °C above the softening point or melting point of the polymer. As mentioned above, coating may help particles to remain in the interior of the liquid or slurry as opposed to providing greater levels at the surface or interface during the extrusion processes. Coating may be avoided in certain circumstances by using a macromolecule that interacts well with the hemostatic additive. For example, since kaolin and other clays tend to be minerals with charges, they may mix better with more ionic polymers or macromolecules, such as polyacrylic acid, carboxymethylcellulose, or the like, or with more polar polymers or macromolecules such as polyamides, polyurethanes, polyvinyl alcohol, polysaccharides, hydroxypropylmethylcelullose, some polyesters, etc. For less polar hemostatic agents, such as crosslinked polystyrene, a less polar macromolecular material, such as a polyolefin, may be used.

[0059] For embodiments where the fiber has a greater density or loading of the hemostatic additive at the surface of the fiber than in the interior of the fiber, the hemostatic additive particles may make extrusion more difficult. To incorporate a fine powder hemostatic additive into rayon fibers or other polymer fibers, a spinneret may be modified from a standard design to improve the ability to extrude the fibers. For example, a powder additive may clog the holes in a standard spinneret, so holes with larger diameters than standard spinnerets, such as about 0.6 to about 1 mm in diameter, about 0.5 mm to about 0.6 mm in diameter, about 0.6 mm to about 0.7 mm in diameter, about 0.7 mm to about 0.8 mm in diameter, about 0.8 mm to about 0.9 mm in diameter, about 0.9 mm to about 1 mm in diameter, about 1 mm to about 1.5 mm in diameter, about 1.5 mm to about 2 mm in diameter, about 2 mm to about 2.5 mm in diameter, about 2.5 mm to about 3 mm in diameter, or about 3 mm to about 4 mm in diameter, may be used to facilitate extrusion under these circumstances. The profile or longitudinal cross section of each hole may be optimized to enable flow of the cellulose or other polymer and a hemostatic powder. Other variables that may be adjusted include the surface finish (roughness) or coating inside the holes, the number of holes per spinneret, and the material selection (e.g. type of metal alloy) for the spinneret.

[0060] The term "fiber" is used herein according to its customary meaning in this field and comprises fibers of finite length, such as conventional staple fiber, as well as substantially continuous structures, such as continuous filaments, unless otherwise indicated. In some embodiments, the multicomponent fibers can be hollow or non-hollow fibers, and further can have a substantially round or circular cross section or non-circular cross sections (for example, oval, rectangular, multi-lobed, etc.).

[0061] The multicomponent fibers can have a variety of fiber configurations. The fiber components can be arranged so as to form distinct unocclusive cross-sectional segments along the length of the fiber. For example, some embodiments of multicomponent fibers include those having cross-sectional configurations as illustrated (e.g., disproportionate volume and surface area, generally equal side-by-side, segmented round, segmented oval, segmented rectangular, segmented multilobal, hollow, and combinations thereof). Many other configurations are also included within the scope of the present disclosure, including those in which at least a portion of a one fiber segment is partially or fully occluded by an adjacent segment. Examples of other fiber shapes include, without limitation, islands in the sea, sheath/core, and the like. In some embodiments, the multicomponent fibers can be splittable, i.e., capable of separating into microfilaments upon appropriate chemical and/or mechanical action. In some embodiments, the multicomponent fibers can be substantially nondissociable.

[0062] The microcomposite material (and other polymeric resin, if present, for example in a multicomponent fiber) can be either melt- spun into fibers, which may be formed into a web for instance by carding, airlaying, or wetlaying, or melt-spun directly into fibrous webs by a spunbonding or meltblowing process. The web can then be bonded to form a nonwoven fabric. Webs of the fibers according to some embodiments can be made according to any commercial processes for making nonwoven fabrics, including processes that use mechanical, electrical, pneumatic, or hydrodynamic means for assembling fibers into a web, for example carding, wetlaying, carding/hydroentangling, wetlaying/hydroentangling, and spunbonding.

[0063] The webs can be bonded using various techniques, such as but not limited to mechanical bonding, such as hydroentanglement and needle punching, adhesive bonding, thermal bonding, and the like, to form a coherent fabric structure. An example of thermal bonding is through air bonding, although other thermal bonding techniques, such as calendering, microwave or other RF treatments, can be used.

[0064] In some embodiments, the multicomponent fibers can also be used to make other textile structures such as but not limited to woven and knit fabrics. Yarns prepared for use in forming such woven and knit fabrics are similarly included within the scope of the present disclosure. Such yarns may be prepared from the continuous filament or spun yarns comprising staple fibers of the present disclosure by various methods, such as twisting or air entanglement.

[0065] In some embodiments, the multicomponent fibers can also be woven into other textile structures such a gauze or a cloth. Alternatively, the fibrous material or substrate may be formed by a nonweaving method such as spunlace, needlepunch, or the like. Such non-woven methods can equally be employed to form gauze material for hemostatic applications.

[0066] In some embodiments, the gauze or cloth may have a thickness of at least about any of the following: 0.01 mm, 0.5 mm, or 1 mm, to 2 mm, 3 mm, or 5 mm. In some embodiments, the gauze or cloth may be formed into a roll with a width of at least about 1 inch or at least about 2 inches to about 5 inches, about 10 inches, about 2 feet, about 3 feet, about 6 feet, or about 10 feet. In some embodiments, a nonwoven fabric, such as a cloth or gauze may be formed into a roll having a width of about 1 to about 10 feet or about 2 to about 6 feet. In some embodiments, the gauze or cloth may be at least about 3 inches wide. The length of the roll may be at least about any of the following: 0.5 yards, 1 yard, or 3 yards; and/or less than or equal to about any of the following: 5 yards, 10 yards, or 20 yards. In some embodiments, the roll is about 3 inches by about 4 yards. In some embodiments, a gauze or cloth of the dimensions described above may be folded into pleated, or "Z" form. In some embodiments, the gauze or cloth may be cut or otherwise formed into smaller pieces having a length of at least about 1 inch or at least about 2 inches to about 5 inches or about 10 inches, and a width of least about 1 inch or at least about 2 inches to about 5 inches or about 10 inches, and having a generally square or generally rectangular shape. In some embodiments, the cloth or gauze is about 2 inches by about 2 inches.

[0067] In some embodiments, the fibrous material— woven or non-woven— is sufficiently porous to allow blood to readily penetrate the outer layer of fibers, thus allowing more complete contact between blood and the surface of the hemostatic fiber. In some embodiments, the fibrous material is a gauze of cloth having pores which may be at least about 0.01mm, about 0.1 mm, about 0.2 mm, or about 0.3 mm, to about 0.5, about 1 mm, about 1.5 mm, or about 2 mm. In some embodiments, the pores may be about 0.01 to about 0.1 mm, about 0.1 mm to about 0.3 mm, about 0.3 mm to about 0.5 mm, about 0.5 mm to about 0.8 mm, about 0.8 mm to about 1 mm, about 1 to about 1.5 mm, or about 1.5 to about 2 mm. [0068] In some embodiments, it may be useful to further coat the fibers or the fibrous material with additional hemostatic agent that is the same as or different from that used in the fibrous material. In some embodiments, a binder may be useful to help the hemostatic agent to adhere to the fibrous material, or to bind the hemostatic agent to the fibrous material. In some embodiments, a binder is a substance which is similar to the macromolecule or the hemostatic agent. It may be helpful for the binder to be a liquid. For example, oligomers of the macromolecule or polymer in some of the fibers may be useful as binders. For inorganic hemostatic agents and polar fibrous materials, the binder may have some polar groups or hydrogen bonding groups such as hydroxyl, amino, ether, carbonyl, or the like. Examples of useful binders may include, but are not limited to, polyols having a formula HOCH₂(CHOH)_nCH₂OH, wherein n is 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, including glycerin and other sugar alcohols, C₃_₈ alcohols such as butanol, pentanol, etc., polymeric polyols such as polyvinyl alcohol, polysaccharides and derivatives thereof such as guar gum, gelatinized starches, cellulose, alginic acids and salts thereof such as calcium aginate, chitosan, carboxymethyl cellulose, hydroxypropylmethylcellulose, etc.

[0069] In some embodiments, the hemostatic or blood clotting device may comprise a release agent disposed on a fibrous material or a substrate. The release agent may be any material which helps the hemostatic agent or bandage comprising the hemostatic agent to be more easily removed after use. In some embodiments, the release agent may be a material with low adhesion to skin or other body tissue. Examples of useful release agents may include, but are not limited to, polyols having a formula HOCH₂(CHOH)_nCH₂OH, wherein n is 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, including glycerin and other sugar alcohols, C₃_₈ alcohols such as butanol, pentanol, etc., polymeric polyols such as polyvinyl alcohol, polysaccharides and derivatives thereof such as guar gum, gelatinized starches, cellulose, alginic acids and salts thereof such as calcium aginate, chitosan, carboxymethyl cellulose, hydroxypropylmethylcellulose, etc; silicon based materials such as silicone; fluorocarbons such as polytetrafluorethylene; and triglycerides such as vegetable oils, and derivatives thereof.

[0070] In some embodiments, the polymer making up the component comprising the hemostatic additive may be chosen from polymers that are less adherent to a wound, skin, or a blood clot. In this way, a release agent may be unnecessary or the function of the release agent may be aided by the fiber material itself. [0071] The fibrous material, which may comprise a gauze or a fabric type substrate may be directly used as a hemostatic device. The fibrous material may be coupled to other features or components typically associated with stopping bleeding. For example, the fibrous material may comprise a pressure component, which may be used to apply direct pressure by including a tie or strap which wraps around a body part, a stiff backing to apply pressure to an area, an inflatable feature such as a balloon which may be useful to apply pressure to the interior of a wound. The fibrous material may also comprise an attachment component, which helps the hemostatic material to remain in place at the bleeding area. For example, an adhesive strip, a tie or strap, or a wrap or covering comprising a flexible material such as an elastic may be included.

[0072] In some embodiments, the hemostatic device may be sterilized and/or packaged in a sterile or sterilized packaging. Vacuum packing the devices in the packaging may help to reduce the size of the packaging and thus facilitate shipping and storage of the products.

[0073] Although the claims have been described in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the scope of the claims extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and obvious modifications and equivalents thereof.

Claims

THE FOLLOWING IS CLAIMED:

1. A multicomponent hemostatic fiber comprising:

two or more polymeric segments forming an integral fiber; wherein at least one of said polymeric segments comprises a macromolecular host material;

wherein at least another of said polymeric segments comprises a hemostatic clay material comprising particles having an average diameter of between about 0.5 and about 3 μπι and an average thickness of between about 0.010 and about 0.2 μπι; and

wherein the fiber is configured such that when treating a bleeding wound, application of the fiber is capable of causing at least some of the hemostatic material in the fiber to come into direct contact with blood from the bleeding wound to assist in accelerating clotting.

2. The fiber of claim 1, wherein the hemostatic material is a refined clay additive material comprising refined kaolin.

3. The fiber of claim 1, wherein the hemostatic material is uncoated.

4. The fiber of claim 1, wherein the macromolecular host material comprises rayon, polyester, or alginate.

5. A device for promoting the clotting of blood comprising:

a fabric substrate comprising a fibrous material formed of a plurality of components;

a first component of the fiber comprising a host polymer with a hemostatic additive comprising at least about 40% by weight of refined kaolin;

a second component of the fiber comprising a polymer comprising less than about 40% by weight, if any, of a hemostatic additive;

wherein each of said first and second components form a part of an integral fiber; and

wherein the substrate is contained within a sterilized packaging.

6. The device of claim 5, wherein the host polymer comprises an alginate

7. The device of claim 6, where the alginate comprises a crosslinked calcium alginate

8. The device of claim 5, wherein the polymer comprises rayon.

9. The device of claim 5, the plurality of fibers is substantially stable in the presence of blood.

10. The device of claim 5, wherein the fabric substrate has a length of about 1 inch to about 10 inches and a width of about 2 inches to about 5 inches.

11. The device of claim 5, wherein the fabric substrate has a length of about 0.5 yards to about 20 yards and a width of about 1 inch to about 10 inches.

12. A blood clotting device comprising:

a sterile gauze substrate comprising a blend of a first fiber comprising a cellulosic material and a second fiber comprising a synthetic polymer;

wherein the second fiber comprises a multicomponent fiber comprising two or more polymeric segments wherein at least one polymeric segment further comprises a hemostatic additive;

wherein the two or more polymeric segments are intimately associated with each other.

13. The device of claim 12, wherein the cellulosic material comprises rayon and the synthetic polymer comprises a polyester.

14. The device of claim 12, wherein the device is configured so that if the first fiber or the second fiber comes in contact with blood, substantially all of the inorganic hemostatic additive is retained for at least about 10 minutes of contact with blood.

15. The device of claim 12, wherein the inorganic hemostatic additive is about 1% to about 20% of the second fiber by weight.

16. The device of claim 12, wherein the first fiber has a diameter of about 0.1 μπι to about 100 μπι.

17. The device of claim 12, wherein at least one of the first fiber and the second fiber comprises a therapeutically active agent.

18. The device of claim 12, further comprising a release agent disposed on the gauze substrate.

19. The device of claim 12, wherein the device is vacuum packed in a sterile or sterilized packaging.

20. The device of claim 12, wherein the first fiber is rayon and the inorganic hemostatic additive is kaolin.