Source: http://www.google.com/patents/US7968114?dq=6,993,661
Timestamp: 2015-01-26 00:45:24
Document Index: 751494266

Matched Legal Cases: ['Application No. 2', 'Application No. 2', 'Application No. 2', 'Application No. 2', 'Application No. 200580039691', 'Application No. 200680008795', 'Application No. 200680008795', 'art 1', 'Application No. 182630', 'Application No. 3474', 'Application No. 2006']

Patent US7968114 - Clay-based hemostatic agents and devices for the delivery thereof - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another...http://www.google.com/patents/US7968114?utm_source=gb-gplus-sharePatent US7968114 - Clay-based hemostatic agents and devices for the delivery thereofAdvanced Patent SearchPublication numberUS7968114 B2Publication typeGrantApplication numberUS 11/590,427Publication dateJun 28, 2011Filing dateOct 30, 2006Priority dateMay 26, 2006Fee statusPaidAlso published asCA2665108A1, CA2665108C, CN101541274A, DE602007010501D1, EP2077811A1, EP2077811B1, EP2292196A1, EP2446867A1, US8257732, US8460699, US8784876, US20070275073, US20090186071, US20110268784, US20120321691, US20130267923, WO2008054566A1Publication number11590427, 590427, US 7968114 B2, US 7968114B2, US-B2-7968114, US7968114 B2, US7968114B2InventorsRaymond J. Huey, Denny Lo, Daniel J. Burns, Giacomo Basadonna, Francis X. HurseyOriginal AssigneeZ-Medica CorporationExport CitationBiBTeX, EndNote, RefManPatent Citations (105), Non-Patent Citations (191), Referenced by (14), Classifications (36), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetClay-based hemostatic agents and devices for the delivery thereofUS 7968114 B2Abstract A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.
1. A device capable of providing a hemostatic effect on bleeding, said device comprising:
a gauze substrate;
a clay material disposed on said gauze substrate; and
polyvinyl alcohol binder disposed on said gauze substrate to bind said clay material to said gauze substrate;
wherein the gauze substrate initially exists separately from the clay; and
wherein said device is configured such that when treating bleeding, application of said device is capable of causing at least a portion of said clay material to come into contact with blood to assist in accelerating clotting.
2. The device of claim 1, wherein said clay material comprises kaolin.
3. The device of claim 1, wherein said clay material comprises a material selected from the group consisting of attapulgite, bentonite, kaolin, and combinations of the foregoing materials.
4. The device of claim 1, further comprising diatomaceous earth disposed on said gauze substrate.
5. The device of claim 1, wherein said clay material further comprises a material selected from the group consisting of magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, hydrates of the foregoing materials, and combinations of the foregoing materials.
6. The device of claim 1, wherein said clay material further comprises a pharmaceutically-active composition selected from the group consisting of antibiotics, antifungal agents, antimicrobial agents, anti-inflammatory agents, analgesics, antihistamines, compounds containing silver or copper ions, and combinations of the foregoing compositions.
7. The device of claim 1, wherein said gauze substrate is fabricated from a material selected from the group consisting of cotton, silk, wool, plastic, cellulose, rayon, polyester, and combinations of the foregoing.
8. The device of claim 1, wherein said gauze substrate is flexible to allow said gauze substrate to form to a shape of said bleeding wound and to retain a shape of said bleeding wound.
9. A hemostatic cloth, comprising:
a hemostatic material disposed on said fabric substrate; and
polyvinyl alcohol binder disposed on said fabric substrate to bind said hemostatic material to said fabric substrate;
wherein the fabric substrate initially exists separately from the clay; and
wherein said cloth is configured such that when treating bleeding, application of said hemostatic cloth is capable of causing at least a portion of said hemostatic material to come into contact with blood to assist in accelerating clotting.
10. The hemostatic cloth of claim 9, wherein said fabric substrate comprises at least one of woven strands and unwoven strands.
11. The hemostatic cloth of claim 9, wherein said fabric substrate comprises a felt.
12. The hemostatic cloth of claim 9, wherein said hemostatic material comprises a material selected from the group consisting of clays, silica-based material, diatomaceous earth, chitosan, and combinations of the foregoing.
13. A hemostatic sponge, comprising:
a hemostatic material disposed on a first surface of said substrate;
polyvinyl alcohol binder disposed on said first surface of the substrate to bind said hemostatic material to said substrate;
and a release agent disposed on a second surface of said substrate;
wherein the substrate initially exists separately from the hemostatic material.
14. The hemostatic sponge of claim 13, wherein said substrate comprises a material selected from the group consisting of cotton, rayon/polyester cellulose blends, cellulose, paper, and combinations of the foregoing.
15. The hemostatic sponge of claim 13, wherein said hemostatic material comprises kaolin.
16. The hemostatic sponge of claim 13, wherein said hemostatic material comprises a material selected from the group consisting of attapulgite clay, bentonite clay, kaolin clay, bioactive glass, biological hemostats, diatomaceous earth, and combinations of the foregoing.
17. The hemostatic sponge of claim 13, further comprising a binder to adhere said hemostatic material to said substrate.
18. The hemostatic sponge of claim 17, wherein said binder is chitosan or polyvinyl alcohol.
19. The hemostatic sponge of claim 13, wherein said release agent is selected from the group consisting of polyvinyl alcohol, silicone, and gelatinized starch.
20. The hemostatic sponge of claim 13, further comprising at least one of water and alcohol.
21. The hemostatic sponge of claim 13, further comprising a radioopaque agent.
CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of: U.S. Provisional Patent Application Ser. No. 60/808,618, filed May 26, 2006, entitled �Blood Clotting Compound�; U.S. Provisional Patent Application Ser. No. 60/810,447, filed Jun. 1, 2006, entitled �Hemostatic Device with Oxidized Cellulose Pad�; the contents of all of the above-referenced applications being incorporated herein by reference in their entireties.
TECHNICAL FIELD The present invention relates generally to agents and devices for promoting hemostasis and, more particularly, to clay-based hemostatic agents and devices incorporating such agents for the delivery thereof to bleeding wounds.
BACKGROUND OF THE INVENTION 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, solublized 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.
In a wide variety of circumstances, animals, including humans, can be wounded. 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. Unfortunately, however, in other circumstances substantial bleeding can occur. These situations usually require specialized equipment and materials as well as personnel trained to administer appropriate aid. If such aid is not readily available, excessive blood loss can occur. When bleeding is severe, sometimes the immediate availability of equipment and trained personnel is still insufficient to stanch the flow of blood in a timely manner.
Moreover, severe wounds can often be inflicted in remote areas or in situations, such as on a battlefield, where adequate medical assistance is not immediately available. In these instances, it is important to stop bleeding, even in less severe wounds, long enough to allow the injured person or animal to receive medical attention.
In an effort to address the above-described problems, materials have been developed for controlling excessive bleeding in situations where conventional aid is unavailable or less than optimally effective. Although these materials have been shown to be somewhat successful, they are sometimes not effective enough for traumatic wounds and tend to be expensive. Furthermore, these materials are sometimes ineffective in some situations and can be difficult to apply as well as remove from a wound.
Additionally, or alternatively, the previously developed materials can produce undersirable side effects. For example, one type of prior art blood clotting material is generally a powder or a fine particulate in which the surface area of the material often produces an exothermic reaction upon the application of the material to blood. Oftentimes excess material is unnecessarily poured onto a wound, which can exacerbate the exothermic effects. Depending upon the specific attributes of the material, the resulting exothermia may be sufficient to cause discomfort to or even burn the patient. Although some prior art patents specifically recite the resulting exothermia as being a desirable feature that can provide clotting effects to the wound that are similar to cauterization, there exists the possibility that the tissue at and around the wound site may be undesirably impacted.
Furthermore, to remove such materials from wounds, irrigation of the wound is often required. If an amount of material is administered that causes discomfort or burning, the wound may require immediate flushing. In instances where a wounded person or animal has not yet been transported to a facility capable of providing the needed irrigation, undersirable effects or over-treatment of the wound may result.
Bleeding can also be a problem during surgical procedures. Apart from suturing or stapling an incision or internally bleeding area, bleeding is often controlled using a sponge or other material 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. Moreover, any highly exothermic bleed-control material may damage the tissue surrounding the bleed site and may not be configured for easy removal after use.
Based on the foregoing, it is a general object of the present invention to provide a hemostatic agent that overcomes or improves upon the drawbacks associated with the prior art. It is also a general object of the present invention to provide devices capable of applying such hemostatic agents.
SUMMARY OF THE INVENTION According to one aspect, the present invention resides in a device for promoting the clotting of blood, thereby controlling bleeding. The device comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh having openings therein such that when the device is applied to a bleed site, the particles of clay come into contact with blood through the openings.
According to another aspect, the present invention resides in another device capable of providing a hemostatic effect on a bleeding wound to control blood flow from the wound. The device comprises a gauze substrate and a clay material disposed on the gauze substrate. Upon the application of the device to the bleeding wound, at least a portion of the clay material comes into contact with the blood to cause the hemostatic effect.
According to another aspect, the present invention resides in a bandage that can be applied to a bleeding wound to promote the clotting of blood, thereby controlling bleeding. The bandage comprises a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. The mesh is defined by a plurality of members arranged to define openings that allow for the flow of blood into the mesh and into the clay material, thereby producing a clotting effect.
According to another aspect, the present invention resides in a hemostatic sponge that can be applied to a bleeding wound to clot blood and control bleeding. Such a sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate to inhibit the adherence of the sponge to the wound tissue after clot formation. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.
According to yet another aspect, the present invention resides in other forms of hemostatic sponges. In such forms the hemostatic sponge may comprise a film and a hemostatic material incorporated into the film; a substrate, a hemostatic material disposed on the substrate, and a film disposed over the hemostatic material; or a hemostatic material sandwiched between two substrates.
An advantage of the present invention is that unlike other materials, such as, for example zeolites, the clay component produces no exothermic reaction with blood. Eliminating the generation of heat at a wound site is useful in minimizing discomfort and/or further injury to a patient and may be especially useful in the treatment of certain patients such as pediatric or geriatric patients or when the wound being treated is in a particularly sensitive or delicate area.
Another advantage is that the clay can be finely divided and deposited on a multitude of surfaces, thereby facilitating its use as a component in a variety of blood control devices. In particular, the clay can be used in particle form (e.g., retained in a mesh or in a film), or it can be used in powder form (e.g., deposited on a fibrous substrate to form a gauze or a sponge). In any embodiment, the efficacy of the clay in promoting hemostasis at a wound site is improved over similar agents that can be used only in one form (e.g., as particles of a particular size) to limit undesirable side effects such as excessive exothermic reactions.
Still another advantage of the present invention is that the devices and agents of the present invention are easily applied to open wounds. Particularly when the hemostatic agent is retained in a mesh or similar device, or when it is incorporated into a woven structure to form a gauze, the device can be readily removed from a sterilized packaging and placed or held directly at the points from which blood emanates to cause clotting.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic representation of a mesh structure of a blood clotting device of the present invention.
FIG. 2 is a side view of the blood clotting device of FIG. 1 illustrating the retaining of clay particles in the mesh structure.
FIG. 3 is a perspective view of a blood clotting device that incorporates a clay material into a gauze.
FIG. 4 is a perspective view of a blood clotting device that incorporates a clay material into a cloth.
FIG. 5 is a perspective view of a bandage incorporating the clay particles in a mesh container for application to a bleeding wound.
FIG. 6 is a schematic representation of a sponge having hemostatic capabilities.
FIG. 7 is a schematic representation of another embodiment of a sponge having hemostatic capabilities.
FIG. 8 is a schematic representation of another embodiment of a sponge having hemostatic capabilities.
FIG. 9 is a schematic representation of another embodiment of a sponge having hemostatic capabilities.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Disclosed herein are hemostatic devices and hemostatic agents that are applicable to bleeding wounds to promote hemostasis. The hemostatic agents generally include clay materials or other silica-based materials that, when brought into contact with a bleeding wound, can minimize or stop blood flow by absorbing at least portions of the liquid phases of the blood, thereby facilitating clotting. The present invention is not limited to clay, however, as other materials such as bioactive glasses, biological hemostats, molecular sieve materials, diatomaceous earth, combinations of the foregoing, and the like are within the scope of the present invention and can be used in conjunction with the clay or separately as a hemostatic agent.
As used herein, the term �clay� refers to a crystalline form of hydrated aluminum silicate. The crystals of clay are irregularly shaped and insoluble in water. The combination of some types of clay with water may produce a mass having some degree of plasticity. Depending upon the type of clay, the combination thereof with water may produce a colloidal gel having thixotropic properties.
In one preferred embodiment of the present invention, the clay material is kaolin, which includes the mineral �kaolinite.� Although the term �kaolin� is used hereinafter to describe the present invention, it should be understood that kaolinite may also be used in conjunction with or in place of kaolin. The present invention is also not limited with regard to kaolin or kaolinite, however, as other materials are within the scope of the present invention. Such materials include, but are not limited to, attapulgite, bentonite, combinations of the foregoing, combinations of the foregoing with kaolin and/or diatomaceous earth, and the like.
As used herein, the term �kaolin� refers to a soft, earthy aluminosilicate clay (and, more specifically, to a dioctahedral phyllosilicate clay) having the chemical formula Al2Si2O5(OH)4. Kaolin is a naturally occurring layered silicate mineral having alternating tetrahedral sheets and octahedral sheets of alumina octahedra linked via the oxygen atoms of hydroxyl groups. Kaolin comprises about 50% alumina, about 50% silica, and trace impurities.
More preferably, the clay is Edgar's plastic kaolin (hereinafter �EPK�), which is a water-washed kaolin clay that is mined and processed in and near Edgar, Fla. Edgar's plastic kaolin has desirable plasticity characteristics, is castable, and when mixed with water produces a thixotropic slurry.
The kaolin material of the present invention may be mixed with or otherwise used in conjunction with other materials to provide additional clotting functions and/or improved efficacy. Such materials include, but are not limited to, magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, combinations of the foregoing materials, and hydrates of the foregoing materials.
Various materials may be mixed with, associated with, or incorporated into the kaolin to maintain an antiseptic environment at the wound site or to provide functions that are supplemental to the clotting functions of the clay. Exemplary materials that can be used include, but are not limited to, pharmaceutically-active compositions such as antibiotics, antifungal agents, antimicrobial agents, anti-inflammatory agents, analgesics, antihistamines (e.g., cimetidine, chloropheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride), compounds containing silver or copper ions, combinations of the foregoing, and the like. Other materials that can be incorporated to provide additional hemostatic functions include ascorbic acid, tranexamic acid, rutin, and thrombin. Botanical agents having desirable effects on the wound site may also be added.
For use in the present invention, the kaolin (or other clay material or diatomaceous earth) is preferably in particle form. As used herein, �particles� include beads, pellets, granules, rods, or any other surface morphology or combination of surface morphologies. Irrespective of the surface morphology, the particles are about 0.2 mm (millimeters) to about 10 mm, preferably about 0.5 mm to about 5 mm, and more preferably about 1 mm to about 2 mm in effective diameter.
The clay particles can be produced by any of several various methods. Such methods include mixing, extrusion, spheronizing, and the like. Equipment that can be utilized for the mixing, extruding, or spheronizing of the clay is available from Caleva Process Solutions Ltd. in Dorset, United Kingdom. Other methods include the use of a fluid bed or a pelletizing apparatus. Fluid beds for the production of clay particles are available from Glatt Air Technologies in Ramsey, N.J. Disk pelletizers for the production of clay particles are available from Feeco International, Inc., in Green Bay, Wis. Preferably, the clay is extruded through a suitable pelletizing device. The present invention is not limited in this regard, however, as other devices and methods for producing particlized clay are within the scope of the present invention.
The EPK used in the present invention is particlized, dried, and fired to about 600 degrees C. In order to achieve a suitably homogenous mixture of the EPK to form the particles, a relatively high shear is applied to a mass of the EPK using a suitable mixing apparatus. Prior to shearing, the water content of the clay is measured and adjusted to be about 20% by weight to give a sufficiently workable mixture for extrusion and subsequent handling.
During the firing of the EPK to about 600 degrees C., the material is vitrified. Vitrification is effected via repeated melting and cooling cycles to allow the EPK (or other clay material) to be converted into a glassy substance. With increasing numbers of cycles, the crystalline structure is broken down to result in an amorphous composition. The amorphous nature of the EPK allows it to maintain its structural integrity when subsequently wetted. As a result, the EPK maintains its structural integrity when wetted during use, for example, when applied to blood. The present invention is not limited to the use of vitrified clays, however, as clay material that has not been vitrified is still within the scope of the present invention. In particular, unvitrified clay can still be applied to a bleeding wound to provide hemostasis.
It is believed that the cellular clotting mechanism of clay activates certain contact factors when applied to blood. More specifically, it is believed that kaolin (particularly EPK) initiates mechanisms by which water in blood is absorbed to facilitate clotting functions.
Referring now to FIG. 1, one embodiment of a hemostatic device into which the kaolin in particle form is incorporated is shown. The device is a permeable pouch that allows liquid to enter to contact the kaolin particles retained therein. Sealed packaging (not shown) provides a sterile environment for storing the hemostatic device until it can be used. The device, which is shown generally at 10 and is hereinafter referred to as �pouch 10,� comprises a screen or mesh 12 and the particlized kaolin 14 retained therein by the screen or mesh. The mesh 12 is closed on all sides and defines openings that are capable of retaining the particlized kaolin 14 therein while allowing liquid to flow through. As illustrated, the mesh 12 is shown as being flattened out, and, by way of example, only a few particles of particlized kaolin 14 are shown. The particlized kaolin 14 may be blended with particles of other types of clay, diatomaceous earth, and the like to form a homogenous mixture.
The mesh 12 is defined by interconnected strands, filaments, or strips of material. The strands, filaments, or strips can be interconnected in any one or a combination of manners including, but not limited to, being woven into a gauze, intertwined, integrally-formed, and the like. Preferably, the interconnection is such that the mesh can flex while substantially maintaining the dimensions of the openings defined thereby. The material from which the strands, filaments or strips are fabricated may be a polymer (e.g., nylon, polyethylene, polypropylene, polyester, or the like), metal, fiberglass, or an organic substance (e.g., cotton, wool, silk, or the like).
Referring now to FIG. 2, the openings defined by the mesh 12 are sized to retain the particlized kaolin 14 but permit the flow of blood therethrough. Because the mesh 12 may be pulled tight around the particlized kaolin 14, the particles may extend through the openings by a distance d. If the particles extend through the openings, they will directly contact tissue against which the pouch 10 is applied. Thus, blood emanating from the tissue immediately contacts the particlized kaolin 14, and the water phase thereof is wicked into the kaolin, thereby facilitating the clotting of the blood. However, it is not a requirement of the present invention that the particles protrude through the mesh.
To apply the pouch 10 to a bleeding wound, the pouch is removed from the packaging and placed on the bleeding wound. The particlized kaolin 14 in the mesh 12 contacts the tissue of the wound and/or the blood emanating from the wound, and at least a portion of the liquid phase of the blood is adsorbed by the clay material, thereby promoting clotting. The flexibility of the mesh 12 allows the mesh to conform to the shape of the bleeding wound and to retain that shape upon application.
Referring now to FIG. 3, another embodiment of a hemostatic device of the present invention is a kaolin gauze, which is shown generally at 20 and is hereinafter referred to as �gauze 20.� Kaolin is coated onto a gauze substrate using any suitable method to result in the gauze 20. One exemplary method of coating kaolin onto the gauze substrate is to immerse the substrate in a kaolin/water slurry. The kaolin material used for the slurry is preferably finely ground kaolin powder, although the present invention is not limited in this regard as kaolin particles, flakes, chips, beads, rods, granules, or the like may alternatively or additionally be used. The gauze substrate may be any suitable woven or non-woven fibrous material including, but not limited to, cotton, silk, wool, plastic, cellulose, rayon, polyester, combinations of the foregoing, and the like. The present invention is not limited to woven or non-woven fibrous materials as the gauze substrates, however, as felts and the like are also within the scope of the present invention.
The gauze 20 of the present invention is not limited to kaolin, however, as other clays such as attapulgite, bentonite, and combinations thereof may be used in place of or in addition to the kaolin. Furthermore, other silica-based materials such as bioactive glasses, diatomaceous earth, combinations of the foregoing, and the like may also be utilized in addition to or in place of any of the foregoing clay materials.
In any embodiment, once the kaolin is dried onto the gauze substrate to form the gauze 20, the gauze is sufficiently flexible to allow the gauze to be folded, rolled, or otherwise manipulated for packaging.
The flexibility of the substrate of the gauze 20 allows the gauze to form to a shape of the bleeding wound and to retain the shape of the bleeding wound upon application.
One manner of depositing the kaolin (or other clay) coating on the gauze substrate includes heating the kaolin/water slurry. Preferably, the slurry is heated to boiling because higher temperatures tend to facilitate the adhesion of the kaolin to the substrate. The present invention is not limited in this regard, however, as the slurry may be heated to a lower temperature depending on the desired characteristics of the kaolin coating. Boiling the slurry also provides an effective form of agitation that uniformly disperses the kaolin in the liquid phase.
The substrate is then immersed in the boiling slurry for an amount of time sufficient to cause the kaolin to deposit onto the substrate. Given the rheology of wetted kaolin and the material from which the gauze or substrate is fabricated, the kaolin may adhere as a film directly to the surfaces of the substrate, or it may agglomerate in the interstices of the strands as well as along the strands themselves, thereby being trapped in the fiber matrix.
Another manner of depositing the kaolin coating on the substrate includes applying the kaolin in slurry form on one side of the gauze substrate using a spraying technique, a slot die technique, or a combination thereof. In using any technique, the amount of slurry applied to the gauze substrate is limited to avoid or at least minimize the saturation of the substrate. Preferably, a colloidal form of the kaolin (or other clay) is used to provide a stable suspension of the material with suitable viscosity for application using the slot die technique.
Once sprayed or applied using the slot die technique, the coated gauze substrate is then rolled or scraped to further embed the kaolin into the material of the substrate. The gauze substrate is then dried.
In some embodiments, the kaolin may be attached to the gauze substrate using a binder. In embodiments in which a binder is used, the material of the binder is biocompatible. Preferred binders include chitosan as well as polyvinyl alcohol, both of which have adhesive qualities, are compatible with biological tissue, and also exhibit hemostatic properties.
One exemplary method for the production of this device may comprise the steps of unwinding cotton gauze from a roll, immersing the gauze in a slurry of hemostatic material and water, applying pressure to the gauze by rolling the wet gauze under high pressure to incorporate the hemostatic material into the material of the gauze, drying the rolled, wet gauze, and removing dust from the gauze (e.g., via blasting with air knives or air nozzles, through the use of electrostatic energy, vacuuming, or brushing with direct contact brushes). Following the removal of dust from the gauze, the gauze back may be wound back onto a roll, or it may be cut into sheets for individual packaging.
One or more variables may be manipulated to optimize the amount and integrity of the kaolin retained on the gauze. These variables include, but are not limited to, slurry temperature, immersion time, the slurry agitation method, and the type of liquid (of the slurry). The elevation of the slurry temperature, as indicated above, aids in the retention of the kaolin on the gauze. The agitation may be effected by forcing air or other gas through nozzles, stirring, bubbling, boiling, or ultrasonic vibration.
The liquid used for the slurry may also be something other than water. For example, the liquid may be an aqueous ammonia solution. Aqueous ammonia has been found to induce swelling in certain fibrous materials, such as the materials typically utilized to fabricate gauze.
Referring now to FIG. 4, another embodiment of a hemostatic device of the present invention is a cloth having hemostatic properties, shown generally at 20, and which is hereinafter referred to as �cloth 30.� The cloth 30 is a fabric which may be defined by woven or unwoven strands or a felt or the like into which a biological hemostatic material is infused or impregnated. Hemostatic materials that may be infused or impregnated into the fabric of cloth 30 include, but are not limited to, clays (such as kaolin) in the form of particles 32, other slica-based material (such as diatomaceous earth, combinations thereof, or the like), chitosan, combinations of the foregoing, and the like. In embodiments in which such materials are infused or impregnated into a cloth, the material is preferably incorporated into the cloth in a hydrated state and subsequently dried.
In either gauze or cloth embodiments, the gauze or cloth material may be cross-linked with a polysaccharide or similar material.
Referring now to FIG. 5, another embodiment of the present invention is a bandage, shown at 50, which comprises particlized kaolin 14 (or some other clay material or diatomaceous earth) retained in the mesh 12 and mounted to a flexible substrate 52 that can be applied to a wound (for example, using a pressure-sensitive adhesive to adhere the bandage 50 to the skin of a wearer). The mesh 12 is stitched, glued, or otherwise mounted to a substrate 52 to form the bandage 50.
The substrate 52 is a plastic or a cloth member that is conducive to being retained on the skin of an injured person or animal on or proximate a bleeding wound. An adhesive 54 is disposed on a surface of the substrate 52 that engages the skin of the injured person or animal. Particularly if the substrate 52 is a non-breathable plastic material, the substrate may include holes 56 to allow for the dissipation of moisture evaporating from the skin surface.
Referring now to FIG. 6, another embodiment of the present invention is a sponge, shown at 60, which comprises a substrate 62, the particlized kaolin 14 (or some other clay material or diatomaceous earth) disposed on one face of the substrate 62, and a release agent 64 disposed on an opposing face of the substrate. The sponge 60 allows for sufficient contact of the particlized kaolin 14 with blood emanating from a wound and through the release agent 64 and the substrate 62 while minimizing the adhesion of the sponge to the wound tissue. The sponge 60 is also compatible with living tissue.
The substrate 62 is an absorbent gauze material that defines a matrix. The present invention is not so limited, however, as other materials such as rayon/polyester cellulose blends and the like are also within the scope of the present invention. Other materials from which the substrate 62 may be fabricated include woven fabric, non-woven fabric, paper (e.g., kraft paper and the like), and cellulose material (e.g., cotton in the forms of balls, swabs, and the like). Any material from which the substrate 62 may be fabricated may have an elastic quality. When elastic materials are used as the substrate 62, the sponge 60 becomes both a hemostatic device and a pressure bandage, particularly in embodiments in which a surface cohesive agent or mechanical fastener is added to secure the sponge in place over a wound.
The hemostatic agent used in the sponge 60 is not limited to particlized kaolin 14. Other materials such as attapulgite, bentonite, combinations of the foregoing, or a combination of the foregoing with kaolin may be used. The present invention is also not limited to clays, as other materials such as bioactive glass, biological hemostats, diatomaceous earth, combinations thereof, the combinations thereof with clay are also within the scope of the present invention.
The particlized kaolin 14 may be bound to the substrate 62 via coulombic forces, by impregnating or otherwise incorporating the clay or other hemostatic material directly into the material of the substrate, by using a binder, by trapping the hemostatic material within the matrix, or the like.
When using a binder to bind the particlized kaolin 14 to the substrate 62, the binder material may provide additional functionality to the sponge 60. Materials from which the binder may be fabricated include, but are not limited to, chitosan, polyvinyl alcohol, guar gum, gelatinized starches, polysaccharides, cellulose (e.g., carboxymethyl cellulose), calcium alginate, and the like, as well as combinations of the foregoing.
In embodiments in which the particlized kaolin 14 is incorporated into the substrate 62 directly, the particlized kaolin may be added during the substrate fabrication. If the substrate is a non-woven gauze material containing rayon and polyester, then the particlized kaolin 14 may be incorporated into or onto the fibers of rayon and polyester. For example, the particlized kaolin 14 may be in powder form and applied to molten polyester, and polyester fibers may be drawn from the polyester/hemostatic material melt. If the substrate is a woven gauze (e.g., cotton), the kaolin 14 in powder form may be incorporated into the cotton threads during formation of the threads.
The release agent 64 is a material that is disposed on the wound-contacting side of the substrate 62 to facilitate the easy removal of the sponge 60 from the wound tissue after the formation of blood clots. The release agent 64 may be a continuous film, or it may be discontinuous on the surface of the substrate. One material that may be used as a release agent is polyvinyl alcohol, which is a biocompatible material that may be formed as a thin film and that does not significantly affect the absorbency and liquid permeability of the sponge 60. The release agent 64 may be applied directly to the wound-contacting surface of the substrate 62.
In the alternative, the release agent 64 may be applied to the non-wound contacting surface of the substrate 62 as a slurry of clay and release agent. In such an embodiment, the concentration of the polyvinyl alcohol is such that at least some of the alcohol seeps to the wound-contacting surface of the substrate 62, while the clay material remains on or near the non-wound contacting surface. In any embodiment, the polyvinyl alcohol serves not only as a release agent, but as an agent that suppresses the dust of the particlized kaolin 14.
Other materials that may be used as release agents that are within the scope of the present invention include, but are not limited to, silicone and gelatinized starches. As with polyvinyl alcohol, either may be applied in film form.
The sponge 60 may further include a component that imparts a radiopaque characteristic to the sponge. In such an embodiment, barium sulfate may be incorporated into a slurry that includes the particlized kaolin 14 and applied to the substrate 62.
The sponge 60 may further include water or alcohol, thereby allowing the sponge to be used as a wipe.
Referring now to FIG. 7, another embodiment of a sponge is shown generally at 160. The sponge 160 comprises a film 162 into which particlized kaolin 14 is dispersed. The physical integrity of the sponge 160 is maintained by the film 162. Preferably, the material from which the film 162 is fabricated is polyvinyl alcohol. In fabricating the sponge 160, the particlized kaolin 14 is dispersed into polyvinyl alcohol, which is then formed into a sheet. The sponge 160 is especially useful when incorporated into a bandage.
Referring now to FIG. 8, another embodiment of a sponge is shown generally at 260. The sponge 260 comprises a substrate 262, particlized kaolin 14 disposed on the substrate, and a film 266 disposed over the hemostatic material. The particlized kaolin 14 is unbound (without a binder) blood coagulating agent and is preferably disposed on the substrate 262 in strips to facilitate the folding of the sponge 260. The film 266 is polyvinyl alcohol or the like and is applied to both contain the particlized kaolin 14 and to minimize the generation of dust. Upon application to a bleeding wound, blood from the wound is wicked into the substrate 262 and contacts the particlized kaolin 14.
Referring now to FIG. 9, another embodiment of a sponge is shown generally at 360. The sponge 360 comprises particlized kaolin 14 sandwiched between two substrates 362. The substrates 362 can be bound together in any suitable manner such as heat sealing through areas selectively absent of particlized kaolin 14, using an adhesive or binder in select areas, applying a containment film of material (such as polyvinyl alcohol) over the entire sponge 360, or a combination of any of the foregoing.
The sponge 60 (as well as the sponges shown at 160, 260, and 360) may be. folded and used in various manners. The sponge 60 may be folded such that the surfaces on which the particlized kaolin 14 is disposed are on the inside surfaces of the folded sponge, so as to minimize problems of dusting and detachment of the hemostatic material from the substrate 62. The sponge 60 (and the sponges 160, 260, and 360) can also be folded into a pleated form or into a configuration to produce a number of distinct plies attached along the edges. By configuring the sponge 60 in such a manner, the compliancy and absorbency requirements of different applications can be addressed. The sponge 60 can also be cut or formed into elongated strips for wrapping over the wounds of an injured person or animal or for incorporation into cylinders or swabs. The sponge 60 can also be cut, ripped, ground, or otherwise formed into small pieces for applications such as stuffing into mesh containers.
EXAMPLE 1 The Effect of Slurry Temperature on the Ability of Cotton Gauze to Retain Kaolin Clay Temperatures of kaolin/water slurries were varied to assess the ability of cotton gauze to retain kaolin clay. Slurries of water and EPK were prepared in which the kaolin was 40% of the total weight of the slurry. Three sponges were made (one from each piece of gauze) by immersing the cotton gauzes into the slurries of varying temperatures, rolling the wet sponges under pressure, and drying. The Table below indicates the parameters for each slurry and the results obtained.
% kaolin
The gauze weight after is the weight of the gauze after rolling and drying. It was noted that the elevated slurry temperature increased the amount of retained kaolin. One theory for this is that the cotton fiber structure of the gauze is loosened and swollen by its immersion in the hot liquid.
EXAMPLE 2 Application of Dry Kaolin to Dry Cotton Gauze to Form Hemostatic Device Dry kaolin was applied to a dry cotton gauze. The gauze was then rolled. The amount of kaolin retain on the gauze was visibly and significantly less than the amount of kaolin retained on the gauze of Sample 3 (Example 1). This sample, however, accelerated the clot time in sheep whole blood by 70% over the unaccelerated clot time of the blood.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS2688586Mar 17, 1950Sep 7, 1954Johnson & JohnsonImproved hemostatic alginic surgical dressings and method of makingUS3122140 *Mar 29, 1962Feb 25, 1964Johnson & JohnsonFlexible absorbent sheetUS3181231Aug 6, 1963May 4, 1965Union Carbide CorpMolecular sieve-metal agglomerates and their preparationUS3189227Dec 7, 1962Jun 15, 1965American Home ProdFluid dispenserUS3366578Dec 7, 1964Jan 30, 1968Universal Oil Prod CoZeolite and method for making the improved zeoliteUS3386802Jul 28, 1967Jun 4, 1968Universal Oil Prod CoMethod for preparing spherically-shaped crystalline zeolite particlesUS3538508Aug 8, 1968Nov 10, 1970Fairfield Wool Co IncCombination pillow and crash helmetUS3550593Feb 2, 1967Dec 29, 1970Kaufman Jack WTherapeutic apparatusUS3723352Jan 25, 1971Mar 27, 1973Air Prod & ChemSupported silver catalystsUS3979335Dec 27, 1974Sep 7, 1976Georgy Anatolievich GolovkoProcess for the preparation of synthetic zeolitesUS4373519Jun 26, 1981Feb 15, 1983Minnesota Mining And Manufacturing CompanyHighly absorbent particles, non-adherent to woundUS4374044Jan 19, 1981Feb 15, 1983General Motors CorporationCordierite bead catalyst support and method of preparationUS4379143Feb 1, 1982Apr 5, 1983Pq CorporationTopical liquid or ointmentUS4435512Nov 24, 1981Mar 6, 1984Nippondenso Co., Ltd.Process for producing cordierite ceramic productsUS4514510Sep 8, 1983Apr 30, 1985American Colloid CompanySulfonated divinylbenzene-styreneion exchange resinUS4524064May 24, 1983Jun 18, 1985Nippon Oil Company, LimitedPolyvinyl alcohol and water soluble polyhydric alcohol solidifiedUS4525410Aug 24, 1983Jun 25, 1985Kanebo, Ltd.Particle-packed fiber article having antibacterial propertyUS4569343Sep 6, 1983Feb 11, 1986Firma Carl FreudenbergSkin application medicamentUS4626550Oct 7, 1985Dec 2, 1986Pq CorporationZeolite for personal care productsUS4631845May 17, 1985Dec 30, 1986Intermec CorporationLuggage tagUS4651725 *Apr 15, 1986Mar 24, 1987Unitika Ltd.Fabrics/non-woven/, chitin fiber, fibrous binderUS4748978Sep 27, 1985Jun 7, 1988Kamp Herman FPaste of bentonite, kaolinite, and illite with water and glycerine and support; lightweightUS4822349Apr 25, 1984Apr 18, 1989Hursey Francis XApplying dehydrated zeolite molecular sieve materialUS4828081Mar 4, 1988May 9, 1989Samsonite CorporationLuggage identification systemUS4911898Dec 28, 1988Mar 27, 1990Kanebo LimitedIon exchanging zeolite with a silver compoundUS4938958Dec 2, 1987Jul 3, 1990Shinagawa Fuel Co., Ltd.Antibiotic zeoliteUS4956350 *Aug 18, 1988Sep 11, 1990Minnesota Mining And Manufacturing CompanyWound filling compositionsUS5140949Sep 12, 1991Aug 25, 1992Mobil Oil CorporationZeolite-clay composition and uses thereofUS5146932Nov 1, 1990Sep 15, 1992Mccabe Francis JElastic counterpressure garmentUS5474545Dec 7, 1992Dec 12, 1995Chikazawa; OsamuDiaper and/or sanitary napkinUS5486195Jul 26, 1993Jan 23, 1996Myers; GeneMethod and apparatus for arteriotomy closureUS5538500Feb 8, 1995Jul 23, 1996Peterson; Donald A.Postoperative wound dressingUS5556699Jun 5, 1995Sep 17, 1996Shingawa Fuel Co. Ltd.Antibiotic zeolite-containing filmUS5597581Jun 28, 1994Jan 28, 1997Karl W. An HaakChitosan foil for wound sealing and process for its preparationUS5599578Nov 1, 1994Feb 4, 1997Butland; Charles L.Applying a mark with a visible ink and a nonvisible ultraviolet or infrared radiation dye, or an ink which displays selected measurable electrical resistanc, or a biological markerUS5696101Apr 16, 1996Dec 9, 1997Eastman Chemical CompanyOxidized cellulose and vitamin E blend for topical hemostatic applicationsUS5716337Jul 13, 1994Feb 10, 1998Johnson & Johnson Medical, Inc.Absorbent productUS5725551Apr 27, 1995Mar 10, 1998Myers; GeneMethod and apparatus for arteriotomy closureUS5728451Mar 26, 1997Mar 17, 1998Langley; John D.Breathable non-woven composite viral penetration barrier fabric and fabrication processUS5766715Apr 3, 1996Jun 16, 1998Michel Gar�onnetCompact disposable packing that forms a kitUS5788682Apr 28, 1995Aug 4, 1998Maget; Henri J.R.Apparatus and method for controlling oxygen concentration in the vicinity of a woundUS5801116Jun 20, 1997Sep 1, 1998Rhodia Inc.Specified particle size; diapers, feminine hygeine productsUS5826543Jan 20, 1995Oct 27, 1998Ralston Purina CompanyMontmorillonite, polytetrafluoroethyleneUS5916511Aug 11, 1998Jun 29, 1999Ngk Insulators, Ltd.Produced by extrusion; used as an exhaust gas purifying catalyst carrier, a filter, or a heat exchanger for automobiles or the industrial useUS5941897May 9, 1997Aug 24, 1999Myers; Gene E.Energy activated fibrin plugUS5964239May 23, 1996Oct 12, 1999Hewlett-Packard CompanyHousing assembly for micromachined fluid handling structureUS5964349Feb 11, 1998Oct 12, 1999Sony CorporationCassette, storage case, and label to be applied to such cassette and storage caseUS5981052Aug 26, 1997Nov 9, 1999Rengo Co., Ltd.Inorganic porous crystals-hydrophilic macromolecule compositeUS5993964Apr 22, 1998Nov 30, 1999Chisso CorporationFibers and fibrous moldings using the sameUS6037280Sep 2, 1997Mar 14, 2000Koala KonnectionA protective clothing comprising silicate mineral particles binding to fabricUS6060461Feb 8, 1999May 9, 2000Drake; James FranklinTopically applied clotting materialUS6086970Apr 28, 1998Jul 11, 2000Scimed Life Systems, Inc.Lubricious surface extruded tubular members for medical devicesUS6123925Jul 27, 1998Sep 26, 2000Healthshield Technologies L.L.C.Antibiotic toothpasteUS6159232 *Dec 15, 1998Dec 12, 2000Closys CorporationClotting cascade initiating apparatus and methods of use and methods of closing woundsUS6187347Feb 9, 2000Feb 13, 2001Ecosafe, Llc.Coagulation of blood from woundsUS6203512Jun 28, 1999Mar 20, 2001The Procter & Gamble CompanyMethod for opening a packaging device and retrieving an interlabial absorbent article placed thereinUS6372333Feb 24, 1999Apr 16, 2002Rengo Co., Ltd.Composition containing inorganic porous crystals-hydrophilic macromolecule composite and product made therefromUS6428800Oct 1, 1998Aug 6, 2002Usbiomaterials CorporationMixture of bioactive glass and topical antibioticUS6450537Jan 19, 2001Sep 17, 2002Polaroid CorporationSelf-service postage stamp assemblageUS6475470Sep 10, 1999Nov 5, 2002Kao CorporationCompositions for oral cavityUS6481134Apr 2, 2001Nov 19, 2002Alicia AledoTag for attaching to a garment having an attribute and identifying the attribute to a person unable to visually identify the attributeUS6486285Jan 23, 2001Nov 26, 2002Kuraray Co., Ltd.Water-swellable polymer gel and process for preparing the sameUS6495367Dec 3, 1998Dec 17, 2002Sekisui Kagaku Kogyo Kabushiki KaishaA blood component deposition-preventing agent and a blood coagulation accelerator are provided, which are substantially indifferent to blood coagulation activity and serum chemistry parameters. also provided is plastic blood test ware and aUS6523778Jun 25, 2001Feb 25, 2003The Night Fun Co., LlcIlluminated emergency signaling device and flying balloonUS6573419May 2, 2001Jun 3, 2003Sody NaimerElastic adhesive wound dressing for control of bleeding and for dressing bleeding woundsUS6622856Apr 25, 2001Sep 23, 2003Johnson & Johnson Consumer Companies, Inc.Relief kitUS6630140Mar 3, 1999Oct 7, 2003The Children's Hospital Of PhiladelphiaCompositions and methods for treatment of asthmaUS6685227Jul 13, 2001Feb 3, 2004Safer Sleep LimitedLabel, a label system and methodUS6700032Mar 7, 1997Mar 2, 2004Leatherite Pty LimitedWound care managementUS6701649Dec 12, 2002Mar 9, 2004Gunter BrosiCombat identification markerUS6745720Oct 29, 2002Jun 8, 2004Cycle Group Limited Of DelawareClumping animal litter and method of making sameUS6998510Feb 4, 2003Feb 14, 2006Damage Control Surgical Technologies, Inc.Three dimensional pack comprising soft, pliable substrate at least partially covered with fluid impermeable covering and attachment means adapted for releasably securing pack to other packs; emergency surgical dressingsUS7125821Sep 5, 2003Oct 24, 2006Exxonmobil Chemical Patents Inc.Low metal content catalyst compositions and processes for making and using sameUS7371403Dec 23, 2003May 13, 2008Providence Health System-Oregonhemostatic dressings with strength and durability; resists dissolution during use; compressed sponge for hemorrhage control; hydrophilic polymer; alginate, chitosan, polyamine, a chitosan, polylysine, polyethylenimine, xanthan, carrageenan, chondroitin sulfate, starch, dextran, hyaluronan, celluloseUS7595429Sep 13, 2004Sep 29, 2009Z-Medica CorporationCalcium zeolite hemostatic agentUS7604819Mar 6, 2007Oct 20, 2009Z-Medica CorporationClay-based hemostatic agents and devices for the delivery thereofUS20020077653Nov 28, 2001Jun 20, 2002Hudson John OvertonHemostatic system for body cavitiesUS20020197302 *May 22, 2002Dec 26, 2002Cochrum Kent C.Hemostatic polymer useful for rapid blood coagulation and hemostasisUS20030133990Oct 25, 2002Jul 17, 2003Hursey Francis X.Bandage using molecular sievesUS20030175333Feb 28, 2003Sep 18, 2003Adi SheferInvisible patch for the controlled delivery of cosmetic, dermatological, and pharmaceutical active ingredients onto the skinUS20030176828Feb 4, 2003Sep 18, 2003Damage Control Surgical Technologies, Inc.Three dimensional pack comprising soft, pliable substrate at least partially covered with fluid impermeable covering and attachment means adapted for releasably securing pack to other packs; emergency surgical dressingsUS20030199922Apr 22, 2002Oct 23, 2003Buckman James S.Pneumatic pressure bandage for medical applicationsUS20030208150Sep 17, 2001Nov 6, 2003Bruder Mark H.Wound and therapy compress and dressingUS20030212357May 10, 2002Nov 13, 2003Pace Edgar AlanMethod and apparatus for treating wounds with oxygen and reduced pressureUS20040005350Mar 25, 2003Jan 8, 2004Looney Dwayne LeeUtilizes a fibrous, fabric substrate made from carboxylic-oxidized cellulose and containing a first surface and a second surface opposing the first surface, the fabric having flexibility, strength and porosity for use as a hemostat; andUS20040038893Jun 6, 2003Feb 26, 2004Dyax Corp.Administering polypeptide for preventing or reducing ischemiaUS20040166172Sep 29, 2003Aug 26, 2004Coni RosatiBioctive tissue abrasivesUS20040243043Dec 23, 2003Dec 2, 2004Mccarthy Simon J,hemostatic dressings with strength and durability; resists dissolution during use; compressed sponge for hemorrhage control; hydrophilic polymer; alginate, chitosan, polyamine, a chitosan, polylysine, polyethylenimine, xanthan, carrageenan, chondroitin sulfate, starch, dextran, hyaluronan, celluloseUS20040249899Jul 12, 2004Dec 9, 2004Clyde ShiigiMethod and system for creating and sending handwritten or handdrawn messages via mobile devicesUS20050058721Sep 13, 2004Mar 17, 2005Hursey Francis X.Coagulant and zeolite type A ion exchanged with oxide(s) of calcium, sodium, potassium, silver, magnesium disposed in binder; moisture content of zeolite is adjusted by drying and rehydration; clotting blood in woundsUS20050070693Aug 2, 2004Mar 31, 2005Immunomedics, Inc.Chimeric monoclonal antibody specific to leukocyte receptor for use as tool in treatment and prevention of cell proliferative, autoimmune, prion, liver and inflammatory disorders; immunotherapyUS20050074505Sep 13, 2004Apr 7, 2005Hursey Francis X.Reduced heat of hydration in wound area; adjusted calcium content; one step treatment; rapid clotting; minimizing discomfortUS20050107826Aug 16, 2004May 19, 2005Zhu Yong H.Vascular wound closure device and methodUS20050118230Oct 22, 2004Jun 2, 2005Encelle, Inc.Methods and compositions for regenerating connective tissueUS20050119112Sep 13, 2004Jun 2, 2005Zeochem, LlcProcess for production of molecular sieve adsorbent blendsUS20050137512Dec 23, 2003Jun 23, 2005Campbell Todd D.hemostatic dressings with strength and durability; resists dissolution during use; compressed sponge for hemorrhage control; hydrophilic polyacrylic acid ; calcium, thrombin, factor VIIa, factor XIII, thromboxane A2, prostaglandin-2a, epidermal growth factor, platelet derived growth factor, antibioticsUS20050143689Aug 11, 2004Jun 30, 2005Ramsey Maynard IiiInternal compression tourniquet catheter system and method for wound track navigation and hemorrhage controlUS20050246009Mar 18, 2005Nov 3, 2005Toner John LMultiple drug delivery from a balloon and a prosthesisUS20060034935Jul 22, 2005Feb 16, 2006Pronovost Allan DCompositions and methods for treating excessive bleedingUS20060078628Aug 17, 2005Apr 13, 2006Karl KomanWound treating agentUS20060116635Nov 28, 2005Jun 1, 2006Med Enclosure L.L.C.Arterial closure deviceUS20060141018Feb 17, 2006Jun 29, 2006Crosslink-D, Incorporated, A Delaware CorporationHemostatic compositions and methods for controlling bleedingUS20060141060Dec 27, 2004Jun 29, 2006Z-Medica, LlcMolecular sieve materials having increased particle size for the formation of blood clotsUSD386002Oct 1, 1996Nov 11, 1997 Combined pouch for first aid safety kit with instruction cardWO2006088912A2 *Feb 15, 2006Aug 24, 2006Univ Virginia CommonwealthMineral technologies (mt) for acute hemostasis and for the treatment of acute wounds and chronic ulcers* Cited by examinerNon-Patent CitationsReference1Alam, et al., Application of a Zeolite Hemostatic Agent Achieves 100% Survival in a Lethal Model of Complex Groin Injury in Swine, May 2004, The Journal of Trauma Injury, Infection, and Critical Care, vol. 56, pp. 974-983.2Alam, et al., Comparative Analysis of Hemostatic Agents in a Swine Model of Lethal Groin Injury, Jun. 2003, The Journal of Trauma Injury, Infection, and Critical Care, vol. 54, No. 6, pp. 1077-1082.3Aldrich�Handbook of Fine Chemicals and Laboratory Equipment, 2000-2001, pp. 1177-1178.4Analgesics and Anti-inflammatory agents 2004, retrieved from the internet on May 26, 2010, URL: http://web.archive.org/web/20040904151322/http://faculty.weber.edu/ewalker/Medicinal�Chemistry/topics/Analgesia�antiinflam/Analgesics�anti-inflamitory.htm.5Army halts use of new first aid item to study more, Seattle PI, Dec. 24, 2008.6Army halts use of WoundStat, http://stripes.com, Apr. 23, 2009.7Army pulls anti clotting agent after Fort Sam study finds threat, MySanAntonio Military, Dec. 24, 2008.8Baker, Sarah E. et al., Controlling Bioprocesses with Inorganic Surfaces: Layered Clay Hemostatic Agents, Department of Chemistry and Biochemistry, University of California, Santa Barbara, American Chemical Association 2007, 19, pp. 4390-4392 (3 pages total).9Bethesda, MD, TraumaCure, Life-saving News for Battlefield Soldiers & Wounded Civilians FDA Clears Product to Stop Severe Bleeding, Sep. 10, 2007.10Butenas�Mechanism of factor VIIa-dependent coagulation in hemophilia blood, Hemostasis, Thrombosis, and Vascular Biology, Blood, Feb. 1, 2002�vol. 99, No. 3.11CA Office Action re Application No. 2,590,595, filed Dec. 22, 2005, Office Action dated Apr. 17, 2009.12CA Office Action re Application No. 2,597,243 Feb. 8, 2006, Office Action dated Apr. 12, 2010.13CA Office Action re Application No. 2,665,108, filed Jul. 20, 2007, Office Action dated Aug. 24, 2010.14CA Office Action re Application No. 2,677,606 filed Mar. 6, 2008, Office Action dated Jul. 27, 2010.15Carraway, et al., Comparison of a new mineral based hemostatic agent to a commercially available granular zeolite agent for hemostasis in a swine model of lethal extremity arterial hemorrhage, Resuscitation vol. 78, Issue 2.16Clay makers (raw materials) retrieved from the internet on Mar. 15, 2010, URL: http://web.archive.org/web/20020609175053/http://www.claymaker.com/ceramic�central/info/raw�clays.htm (year 2002, pp. 104).17CN First Office Action re Application No. 200580039691.5, filed Dec. 22, 2005, First Office Action dated Jul. 24, 2009.18CN First Office Action re Application No. 200680008795.4, filed Feb. 8, 2006, First Office Action dated Jan. 8, 2010.19CN Second Office Action re Application No. 200680008795.4, filed Feb. 8, 2006, Second Office Action dated Jun. 29, 2010.20Comparative Testing of Hemostatic Dressings in a Severe Groin Hemorrhage, Trauma & Resuscitative Medicine Department, NMRC.21Co-pending U.S. Appl. No. 10/939,687, filed Sep. 13, 2004.22Co-pending U.S. Appl. No. 10/939,869, filed Sep. 13, 2004.23Co-pending U.S. Appl. No. 11/023,869, filed Dec. 27, 2004.24Co-pending U.S. Appl. No. 11/054,918, filed Feb. 9, 2005.25Co-pending U.S. Appl. No. 11/082,716, filed Mar. 16, 2005.26Co-pending U.S. Appl. No. 11/303,607, filed Dec. 16, 2005.27Co-pending U.S. Appl. No. 11/404,126, filed Apr. 13, 2006.28Co-pending U.S. Appl. No. 11/544,238, filed Oct. 6, 2006.29Co-pending U.S. Appl. No. 11/584,079, filed Oct. 20, 2006.30Co-pending U.S. Appl. No. 11/586,968, filed Oct. 25, 2006.31Co-pending U.S. Appl. No. 11/590,427, filed Oct. 30, 2006.32Co-pending U.S. Appl. No. 11/592,477, filed Nov. 2, 2006.33Co-pending U.S. Appl. No. 11/606,617, filed Nov. 29, 2006.34Co-pending U.S. Appl. No. 11/633,687, filed Dec. 4, 2006.35Co-pending U.S. Appl. No. 11/634,531, filed Dec. 6, 2006.36Co-pending U.S. Appl. No. 11/634,673, filed Dec. 5, 2006.37Co-pending U.S. Appl. No. 11/654,409, filed Jan. 17, 2007.38Co-pending U.S. Appl. No. 11/710,106, filed Feb. 22, 2007.39Co-pending U.S. Appl. No. 11/715,057, filed Mar. 6, 2007.40Co-pending U.S. Appl. No. 12/101,336, filed Apr. 11, 2008.41Co-pending U.S. Appl. No. 12/101,346, filed Apr. 11, 2008.42Co-pending U.S. Appl. No. 12/140,356, filed Jun. 17, 2008.43Co-pending U.S. Appl. No. 12/204,129, filed Sep. 4, 2008.44Donald Voet & Judith Voet, "Molecular Physiology", Biochemistry, p. 1087-1096, vol. 64, 1990, John Wiley & Sons.45Dyer, A. et al. "Diffusion in heteroionic zeolites: Part 1. Diffusion of water in heteroionics natrolites." Microporous and Mesoporous Materials. 1998, pp. 27-38, vol. 21.46EPO Exam Report dated Dec. 2, 2008 re EP App. No. 06123557.8.47EPO Exam Report dated Jul. 18, 2007 re EP App. No. 05445078.8.48EPO Exam Report dated Sep. 22, 2009 re EP App. No. 06123557.8.49EPO Exam Report for EP 05020602, dated Oct. 16, 2007.50EPO Exam Report for EP 05020602, dated Sep. 15, 2006.51EPO Examination Report dated Mar. 30, 2010 re EP 08726591.4.52EPO Examination Report dated Mar. 30, 2010 re EP App. No. 07836179.7.53EPO Examination Report dated Sep. 4, 2009 re EP App. No. 07836179.7.54EPO Examination Report for Application No. EP04783867 dated Nov. 27, 2008.55EPO Search Report and Opinion, re EP 1 797 850, dated May 11, 2007.56EPO Supplemental Search Report re EP 1 663 090, dated Jun. 22, 2010.57European Search Report for Applilcation No. 05445078 dated Jun. 27, 2006.58Fruijtier-Polloth, "The safety of synthetic zeolites used in detergents", Arch Toxicol (2009) 83:23-25.59Galan, et al.: "Technical properties of compound kaolin sample from griva (Macedonia, Greece)", Applied Clay Science 1996 10:477-490.60Gibbar-Clements, et al.: "The Challenge of Warfarin Therapy", JSTOR: The American Journal of Nursing,vol. 100, No. 3 (Mar. 2000), pp. 38-40.61Griffin, John H., Role of surface in surface-dependent activation of Hageman factor (blood coagulation Factor XII), Proc. Natl. Acad. Sci. USA, vol. 75, No. 4, Apr. 1978, pp. 1998-2002 (5 pages total).62HemCon Medical Technologies Inc. 510(k) Summary, ChitoGauze, Mar. 20, 2009.63Hursey, et al., Bandage Using Molecular Sieves, Apr. 18, 2002, International Application Published Under the PCT, WO 02/30479 A1.64IL Office Action re Application No. 182630, filed Dec. 22, 2005, Office Action dated Oct. 12, 2009.65 *IMA-EU, Kaolin, Oct. 2006, p. 1-2.66IN First Office Action re Application No. 3474/CHENP/2007, filed Feb. 8, 2006, First Office Action dated Sep. 8, 2009.67International Preliminary Report and Written Opinion for Application No. PCT/US2007/023265, dated Sep. 29, 2009.68International Preliminary Report and Written Opinion for PCT/US2004/029809, dated Mar. 13, 2006.69International Preliminary Report and Written Opinion re PCT/US2006/004594, dated Aug. 14, 2007.70International Preliminary Report and Written Opinion Report for Application No. PCT/US2008/060177, dated Oct. 13, 2009.71International Report on Patentability and Written Opinion for Application No. PCT/US2008/003082, dated Sep. 29, 2009.72International Search Report for Application No. PCT/US2004/029812, dated Jun. 14, 2005.73International Search Report for Application No. PCT/US2006/004594, dated Nov. 3, 2006.74International Search Report for Application No. PCT/US2006/012487, dated Sep. 12, 2006.75International Search Report for Application No. PCT/US2007/023265, dated Sep. 17, 2009.76International Search Report for Application No. PCT/US2008/003082, dated Sep. 24, 2009.77International Search Report for Application No. PCT/US2008/060177, dated Jun. 22, 2009.78International Search Report for Application No. PCT/US2008/075191, dated Jun. 26, 2008.79James, "Silver Copper Zeolite Guinea Pig Sensitization Study�Beuhler Method", Data Evaluation Report dated Oct. 3, 1989.80JP Office Action re Application No. 2006-301871, filed Nov. 7, 2006, Office Action dispatched Jul. 6, 2010.81Kheirabadi, Army Assessment of New Hemostatic Products Suitable for Treating Combat Wounds, US Army Institute of Surgical Research, Aug. 11, 2008.82Kheirabadi, et al., Session IV-B, Paper 28, 8:20 a.m., Comparison of New Hemostatic Dressings with Currently Deployed Hemcon Bandage in a Model of Extremity Arterial Hemorrhage in Swine.83Kheirabadi, et al., The Journal of Trauma Injury, Infection, and Critical Care, Comparison of New Hemostatic Granules/Powders with Currently Deployed Hemostatic Products in a Lethal model of Extremity Arterial Hemorrhage in Swine, Feb. 2009, pp. 316-328.84Kheirabadi, Final Report, Title: Assessment of Efficacy of New Hemostatic Agents in a Model of Extremity Arterial Hemorrhage in Swine, U.S. Army Institute of Surgical Research, Ft. Sam Houston, TX 78234, Mar. 4, 2008.85Le Van Mao, Raymond et al. "Mesoporous Aluminosilicates prepared from Zeolites by Treatment with Ammonium Fluorosilicate." J. Mater. Chem. 1993. pp. 679-683, vol. 3, No. 6.86M. Gielen, Solid State Organometallic Chemistry: Methods and Applications Physical Organometallic Chemistry, 1999, New York John Wiley & Sons, Ltd. (UK), V. 2, p. 156.87Macrina, VCU's Research Enterprise, Structure and Resources, Oct. 23, 2008.88Margolis, J., The Kaolin Clotting Time: A Rapid One-Stage Method for Diagnosis of Coagulation Defects, J. Clin. Pathol 1958, 11, pp. 406-409 (5 pages total).89Office Action for U.S. Appl. No. 11/398,161 dated Apr. 30, 2008.90Okada, et al.: "Preparation of zeolite-coated cordierite honeycombs prepared by an in situ crystallization method", Science and Technology of Advanced Materials 2004 5:479-484.91O'Reilly et al.: "Studies on Coumarin Anticoagulant Drugs�lnitiaion of Warfarin Therapy Without a Loading Dose", Circulation by the American Heart Association, http://circ.ahajournals.org, 1968, 38, 169-177.92Ore-Medix, Traumastat Hemostatic Bandage, Aug. 7, 2008.93PCT International Preliminary Report for PCT/US2007/016509, dated May 14, 2009.94PCT Search Report for PCT/US2004/29809, dated Feb. 24, 2005.95PCT Search Report for PCT/US2005/046700 dated Jul. 6, 2006.96PCT Search Report for PCT/US2005/046700, dated Jul. 6, 2006.97Permanent suspension of Woundstat use, https://email.z-medica.com.98Reprinted related contents of US Abstract regarding QuikClot CombatGauze.99Reprinted related contents of US Alaract regarding QuikClot CombatGauze.100Sadler et al.: "Biochemstry and Genetics of Van Willebrand Factor", Annual Review of Biochemistry; 1998. 67:395-424.101Scott Sackinger's Medical Devices Professional Summary dated Mar. 2009.102Search Report for EP 05020602 dated Jul. 6, 2006.103Search Report for EP 05020602, dated Jul. 6, 2006.104Search report for EP 06123557, dated Feb. 29, 2008.105Search report for EP 06126082, dated May 11, 2007.106Sinter. (2004). In the New Penguin Dictionary of Science. London: Penguin. Retrieved May 7, 2009, from http://www.credoreference.com/entry/7463549/.107Spring, et al., Comparative Testing of Hemostatic Dressings in a Severe Groin Hemorrhage, Trauma & Resuscitative Medicine Department, NMRC.108Supplementary Partial European Search Report for Application No. EP04783867 dated Jan. 29, 2008.109Tactical Combat Casualty Care Guidelines, Feb. 2009.110The Merck Index; 1989, pp. 1596-1597, abstract 10021.111Top, Ayben et al. "Silver, zinc, and copper exchange in a Na-clinoptilolite and resulting effect on antibacterial activity." Applied Clay Science. 2004, pp. 13-19, vol. 27.112TraumaCure, Innovative Wound Care Products for Wound Care Solutions.113U.S. Appl. No. 10/939,687, filed Sep. 13, 2004 including prosecution history, including but not limited to Non-Final Rejection dated Oct. 16, 2006, Final Rejection dated May 24, 2007, Non-Final Rejection dated Sep. 6, 2007, Final Rejection dated Nov. 28, 2007 and Examiner's Answer to Appeal Brief.114U.S. Appl. No. 10/939,869, filed Sep. 13, 2004 including prosecution history, including but not limited to Non-Final Rejection dated Feb. 8, 2008, Non-Final Rejection dated Sep. 17, 2008 and Final Rejection dated Apr. 17, 2009.115U.S. Appl. No. 11/023,869, filed Dec. 27, 2004 including prosecution , history, including but not limited to Requirement for Restriction/Election dated Mar. 31, 2008, Non-Final Rejection dated May 12, 2008 and Non-Final Rejection dated Dec. 11, 2008.116U.S. Appl. No. 11/023,869, filed Dec. 27, 2004 including prosecution history, including but not limited to Requirement for Restriction/Election dated Mar. 31, 2008, Non-Final Rejection dated May 12, 2008 and Non-Final Rejection dated Dec. 11, 2008.117U.S. Appl. No. 11/054,918, filed Feb. 9, 2005 including prosecution history, including but not limited to Non-Final Office Rejection dated Mar. 18, 2008, Final Rejection dated Sep. 16, 2008 and Non-Final Rejection dated Mar. 9, 2009.118U.S. Appl. No. 11/082,716, filed Mar. 16, 2005 including prosecution history, including but not limited to Non-Final Rejection dated Oct. 9, 2008.119U.S. Appl. No. 11/303,607, filed Dec. 16, 2005 including prosecution history, including but not limited to Requirement for Restriction/Election dated Feb. 21, 2008, Non-Final Rejection dated Apr. 29, 2008 and Non-Final Rejection dated Sep. 8, 2008.120U.S. Appl. No. 11/404,126, filed Apr. 13, 2006 including prosecution history, including but not limited to Requirement for Restriction/Election dated Sep. 16, 2008 and Non-Final Rejection dated Dec. 3, 2008.121U.S. Appl. No. 11/544,238, filed Oct. 6, 2006 including prosecution history, including but not limited to Requirement for Restriction/Election dated Dec. 11, 2008; Non-Final Office Action dated May 29, 2009.122U.S. Appl. No. 11/584,079, filed Oct. 20, 2006 including prosecution ; history, including but not limited to Non-Final Rejection dated Apr. 6, 2009.123U.S. Appl. No. 11/584,079, filed Oct. 20, 2006 including prosecution history, including but not limited to Non-Final Rejection dated Apr. 6, 2009.124U.S. Appl. No. 11/590,427, filed Oct. 30, 2006 including prosecution history, including but not limited to Non-Final Rejection dated Aug. 19, 2008 and Final Rejection dated May 26, 2009.125U.S. Appl. No. 11/592,477, filed Nov. 2, 2006 including prosecution history, including but not limited to Non-Final Rejection dated May 28, 2008 and Final Rejection dated Dec. 22, 2008.126U.S. Appl. No. 11/633,687, filed Dec. 4, 2006 including prosecution history, including but not limited to Requirement for Restriction/Election dated Jun. 25, 2008, Non-Final Rejection dated Sep. 4, 2008, and Final Office Action dated Jun. 1, 2009.127U.S. Appl. No. 11/633,687, filed Dec. 4, 2006 including prosecution history, including but not limited to Requirement for Restriction/Election dated Jun. 25, 2008; Non-Final Rejection dated Sep. 4, 2998 and Final Office Action dated Jun. 1, 2009.128U.S. Appl. No. 11/634,673, filed Dec. 5, 2006 including prosecution history, including but not limited to Requirement for Restriction/Election dated Apr. 9, 2008, Non-Final Rejection dated May 12, 2008, Final Rejection dated Nov. 14, 2008 and Non-Final Rejection dated May 21, 2009.129U.S. Appl. No. 11/715,057, filed Mar. 6, 2007 including prosecution history, including but not limited to Non-Final Rejection dated Aug. 20, 2008 and Final Rejection dated Apr. 2, 2009.130U.S. Appl. No. 12/352,513, filed Jan. 12, 2009.131U.S. Appl. No. 12/417,802, filed Apr. 3, 2009 including prosecution history.132U.S. Appl. No. 60/668,022, filed Apr. 4, 2005.133U.S. Appl. No. 60/708,206, filed Aug. 15, 2005.134U.S. Appl. No. 60/902,738, filed Feb. 21, 2007.135U.S. Appl. No. 60/955,854, filed Aug. 14, 2007.136US Offce Action re U.S. Appl. No. 11/584,079, filed Oct. 20, 2006, Office Action dated Apr. 6, 2009.137US Offce Action re U.S. Appl. No. 12/417,802, filed Apr. 3, 2009, Office Action dated Jun. 11, 2010.138US Office Action re U.S. Appl. No. 10/939,869, filed Sep. 13, 2004, Final Office Action dated Apr. 1, 2010.139US Office Action re U.S. Appl. No. 10/939,869, filed Sep. 13, 2004, Final Office Action dated Apr. 17, 2009.140US Office Action re U.S. Appl. No. 10/939,869, filed Sep. 13, 2004, Final Office Action dated Dec. 12, 2010.141US Office Action re U.S. Appl. No. 10/939,869, filed Sep. 13, 2004, Office Action dated Feb. 8, 2008.142US Office Action re U.S. Appl. No. 10/939,869, filed Sep. 13, 2004, Office Action dated Sep. 17, 2008.143US Office Action re U.S. Appl. No. 11/023,869, filed Dec. 27, 2004, Office Action dated Dec. 11, 2008.144US Office Action re U.S. Appl. No. 11/023,869, filed Dec. 27, 2004, Office Action dated Jan. 26, 2010.145US Office Action re U.S. Appl. No. 11/023,869, filed Dec. 27, 2004, Office Action dated May 12, 2008.146US Office Action re U.S. Appl. No. 11/023,869, filed Dec. 27, 2004, Office Action dated Sep. 16, 2010.147US Office Action re U.S. Appl. No. 11/054,918, filed Feb. 9, 2005, Office Action dated Mar. 18, 2008.148US Office Action re U.S. Appl. No. 11/082,716, filed Mar. 16, 2005, Office Action dated Oct. 9, 2008.149US Office Action re U.S. Appl. No. 11/303,607, filed Dec. 16, 2005, Office Action dated Apr. 29, 2008.150US Office Action re U.S. Appl. No. 11/303,607, filed Dec. 16, 2005, Office Action dated Sep. 8, 2008.151US Office Action re U.S. Appl. No. 11/404,126, filed Apr. 13, 2006, Notice of Abandonment dated Oct. 8, 2010.152US Office Action re U.S. Appl. No. 11/404,126, filed Apr. 13, 2006, Office Action dated Dec. 21, 2009.153US Office Action re U.S. Appl. No. 11/404,126, filed Apr. 13, 2006, Office Action dated Dec. 3, 2008.154US Office Action re U.S. Appl. No. 11/544,238, filed Oct. 6, 2006, Office Action dated Jun. 25, 2010.155US Office Action re U.S. Appl. No. 11/544,238, filed Oct. 6, 2006, Office Action dated May 29, 2009.156US Office Action re U.S. Appl. No. 11/586,968, filed Oct. 25, 2006, Office Action dated Feb. 19, 2010.157US Office Action re U.S. Appl. No. 11/586,968, filed Oct. 25, 2006, Office Action dated Jun. 3, 2010.158US Office Action re U.S. Appl. No. 11/590,427, filed Oct. 30, 2006, Office Action dated Aug. 19, 2008.159US Office Action re U.S. Appl. No. 11/590,427, filed Oct. 30, 2006, Office Action dated Jun. 7, 2010.160US Office Action re U.S. Appl. No. 11/590,427, filed Oct. 30, 2006, Office Action dated May 26, 2009.161US Office Action re U.S. Appl. No. 11/592,477, filed Nov. 2, 2006, Office Action dated Dec. 22, 2008.162US Office Action re U.S. Appl. No. 11/592,477, filed Nov. 2, 2006, Office Action dated Jun. 18, 2009.163US Office Action re U.S. Appl. No. 11/592,477, filed Nov. 2, 2006, Office Action dated May 28, 2008.164US Office Action re U.S. Appl. No. 11/606,617, filed Nov. 29, 2006, Office Action dated Jun. 12, 2009.165US Office Action re U.S. Appl. No. 11/633,687, filed Dec. 14, 2006, Office Action dated Jun. 1, 2009.166US Office Action re U.S. Appl. No. 11/633,687, filed Dec. 14, 2006, Office Action dated Sep. 4, 2008.167US Office Action re U.S. Appl. No. 11/634,531, filed Dec. 6, 2006, Office Action dated Feb. 4, 2009.168US Office Action re U.S. Appl. No. 11/634,531, filed Dec. 6, 2006, Office Action dated Mar. 29, 2010.169US Office Action re U.S. Appl. No. 11/634,531, filed Dec. 6, 2006, Office Action dated Sep. 4, 2009.170US Office Action re U.S. Appl. No. 11/634,673, filed Dec. 5, 2006, Final Office Action dated Mar. 25, 2010.171US Office Action re U.S. Appl. No. 11/634,673, filed Dec. 5, 2006, Office Action dated May 12, 2008.172US Office Action re U.S. Appl. No. 11/634,673, filed Dec. 5, 2006, Office Action dated May 21, 2009.173US Office Action re U.S. Appl. No. 11/634,673, filed Dec. 5, 2006, Office Action dated Nov. 14, 2008.174US Office Action re U.S. Appl. No. 11/654,409, filed Jan. 17,2007, Office Action dated Mar. 30, 2010.175US Office Action re U.S. Appl. No. 11/710,106, filed Feb. 22, 2007, Office Action dated Oct. 1, 2010.176US Office Action re U.S. Appl. No. 12/101,336, filed Apr. 11, 2008, Notice of Abandonment dated Oct. 7, 2010.177US Office Action re U.S. Appl. No. 12/101,336, filed Apr. 11, 2008, Office Action dated Mar. 22, 2010.178US Office Action re U.S. Appl. No. 12/101,346, filed Apr. 11, 2008, Office Action dated Mar. 19, 2010.179US Office Action re U.S. Appl. No. 12/101,346, filed Apr. 11, 2008, Office Action dated Sep. 15, 2010.180US Office Action re U.S. Appl. No. 12/140,356, filed Jun. 17, 2008, Office Action dated Sep. 28, 2010.181US Office Action re U.S. Appl. No. 12/417,802, filed Apr. 3, 2009, Office Action dated Jan. 25, 2011.182US Office Action re U.S. Appl. No. 12/417,802, filed Apr. 3, 2009, Office Action dated Jun. 11, 2010.183US Office Action re U.S. Appl. No. 12/503,481, filed Jul. 15, 2009, Office Action Dated Dec. 27, 2010.184US Office Action re U.S. Appl. No. 12/555,876, filed Sep. 9, 2009, Office Action dated Dec. 28, 2010.185Vitrify�(2001). in Chambers 21s5t Century Dictionary. London. Chambers Harrap. Retrieved May 7, 2009, from http://www.credoreference.com/entry/1236485/.186Ward, et al., Comparison of a New Hemostatic Agent to Current Combat Hemostatic Agents in a Swine Model of Lethal Extremity Arterial Hemorrhage, The Journal of Trauma Injury, Infection and Critical Care, Aug. 2007.187Ward, et al., The Journal of Trauma Injury, Infection, and Critical Care, Comparison of a New Hemostatic Agent to Current Combat Hemostatic Agents in a Swine Model of Lethal Extremity Arterial Hemorrhage, Aug. 2007, pp. 276-284.188Wound Stat, hhtp://shadowspear.com.189WoundStat found to be potentially hazardous, http://armytimes.com.190Wright, J.K. et al., "Thermal Injury Resulting from Application of a Granular Mineral Hemostatic Agent." The Journal of Trauma Injury, Infection, and Critical Care. 2004, pp. 224-230, vol. 57, No. 2.191Z-Medica Corporation 510(k) Summary, QuikClot eX, Oct. 4, 2007.* Cited by examinerReferenced byCiting PatentFiling datePublication dateApplicantTitleUS8114433Oct 19, 2009Feb 14, 2012Z-Medica CorporationClay-based hemostatic agents and devices for the delivery thereofUS8202532Nov 3, 2009Jun 19, 2012Z-Medica CorporationClay-based hemostatic agents and devices for the delivery thereofUS8252344Sep 13, 2004Aug 28, 2012Z-Medica CorporationPartially hydrated hemostatic agentUS8257731Sep 9, 2009Sep 4, 2012Z-Medica CorporationDevices and methods for the delivery of molecular sieve materials for the formation of blood clotsUS8257732May 25, 2011Sep 4, 2012Z-Medica CorporationClay-based hemostatic agents and devices for the delivery thereofUS8343537Jan 31, 2012Jan 1, 2013Z-Medica, LlcClay-based hemostatic agents and devices for the delivery thereofUS8383148Jun 18, 2012Feb 26, 2013Z-Medica, LlcClay-based hemostatic agents and devices for the delivery thereofUS8460699Aug 23, 2012Jun 11, 2013Z-Medica, LlcClay-based hemostatic agents and devices for the delivery thereofUS8512743Aug 29, 2012Aug 20, 2013Z-Medica, LlcDevices and methods for the delivery of molecular sieve materials for the formation of blood clotsUS8557278Aug 27, 2012Oct 15, 2013Z-Medica, LlcDevices and methods for the delivery of blood clotting materials to bleeding woundsUS8784876Jun 6, 2013Jul 22, 2014Z-Medica, LlcClay-based hemostatic agents and devices for the delivery thereofUS20120171255 *Jul 7, 2010Jul 5, 2012Fontas ValerieSubstrate impregnated with sprayed clay, and method for manufacturing sameWO2013056116A1 *Oct 12, 2012Apr 18, 2013The Trustees Of Columbia University In The City Of New YorkHemostatic dressing for arterial bleedingWO2013126707A1 *Feb 22, 2013Aug 29, 2013Luna Innovations IncorporatedMedical training kits and methods to simulate treatment of uncontrolled hemorrhage* Cited by examinerClassifications U.S. Classification424/445, 424/446, 602/43, 602/47, 602/45, 602/56, 602/53, 424/444, 602/48, 502/80, 602/52, 424/443, 424/447, 602/58, 602/46, 602/42, 602/54, 424/489, 602/41, 602/57International ClassificationA61F13/00, A61K9/14, A61L15/16, A61L15/14, A61L15/18Cooperative ClassificationA61L2300/404, A61F13/534, A61L2300/418, A61L2300/41, A61L2400/04, A61L2300/102, A61L15/44, A61L2300/402, A61L15/18European ClassificationA61L15/18, A61L15/44Legal EventsDateCodeEventDescriptionJul 1, 2014FPAYFee paymentYear of fee payment: 4Sep 6, 2012ASAssignmentFree format text: SECURITY AGREEMENT;ASSIGNOR:Z-MEDICA, LLC;REEL/FRAME:028917/0898Owner name: ABACUS FINANCE GROUP, LLC, NEW YORKEffective date: 20120905Sep 4, 2012ASAssignmentEffective date: 20120831Free format text: MERGER;ASSIGNOR:Z-MEDICA CORPORATION;REEL/FRAME:028896/0108Owner name: Z-MEDICA, LLC, CONNECTICUTMay 25, 2010ASAssignmentOwner name: Z-MEDICA CORPORATION,CONNECTICUTFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BASADONNA, GIACOMO;HURSEY, FRANCIS X.;SIGNED BETWEEN 20100506 AND 20100510;US-ASSIGNMENT DATABASE UPDATED:20100526;REEL/FRAME:24440/76Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BASADONNA, GIACOMO;HURSEY, FRANCIS X.;SIGNING DATES FROM20100506 TO 20100510;REEL/FRAME:024440/0076Sep 15, 2008ASAssignmentOwner name: Z-MEDICA CORPORATION, CONNECTICUTFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HUEY, RAYMOND J.;LO, DENNY;BURNS, DANIEL J.;REEL/FRAME:021527/0865;SIGNING DATES FROM 20080828 TO 20080829RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services