HEMOSTATIC BANDAGE FOR MUCOSAL MEMBRANES, KIT CONTAINING THE SAME, AND METHOD OF USING THE SAME

A kit that includes a bandage adapted for mucosal membrane hemostasis, and instructions using the bandage is disclosed. The bandage can include a liquid permeable pouch, and at least one sheet of absorbent material within the liquid permeable pouch. The instructions can include rolling and/or folding the bandage, placing the rolled and/or folded bandage proximate the site of the bleeding, and applying pressure to the bandage. Methods of utilizing the bandage and the kit are also disclosed.

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Description
FIELD OF THE INVENTION

The present invention relates generally to hemostatic bandages, particularly, hemostatic bandages adapted for use in mucosal membranes.

BACKGROUND

Individuals experience bleeding of the mucous membranes from time-to-time. The cause of these bleeding incidents can range from surgical procedures, to bloody noses, to tooth eruption and exfoliation generally experienced by children, as well as, accidents. While medical professionals and consumers frequently use gauze to treat such situations, gauze does not retain blood and other bodily fluids well. In addition, both professionals and consumers have difficulty visualizing and localizing regular gauze to the area in need of hemostasis.

SUMMARY

In one embodiment, a kit that includes a bandage adapted for mucosal membrane hemostasis, and instructions for applying the bandage to bleeding tissue is provided. The bandage can include a pre-sized liquid permeable pouch, and an absorbent material contained within the liquid permeable pouch.

In another embodiment, a kit that includes a bandage adapted for mucosal membrane hemostasis, and instructions using the bandage is provided. The bandage can include a liquid permeable pouch, and at least one sheet of absorbent material within the liquid permeable pouch. The instructions can include rolling and/or folding the bandage, placing the rolled and/or folded bandage proximate the site of the bleeding, and applying pressure to the bandage.

In another embodiments, a method of hemostasia in a mucosal membrane is provided. The method can include providing a bandage that includes a liquid permeable pouch, and at least one sheet of absorbent material contained within the liquid permeable pouch, placing the bandage proximate the site of the bleeding; and applying pressure to the bandage. In some embodiments, the pressure can be applied using the teeth opposing the site of the bleeding or, in the case of the nasal cavity, digital pressure on the outside skin of the nasal cavity bilaterally.

These and other features, objects and advantages of the present invention will become more apparent to one skilled in the art from the following description and claims when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front, perspective view of a kit containing a bandage and instructions.

FIG. 2 is an exploded view of a bandage with a liquid permeable pouch formed of two sheets of pouch material sealed together to form an enclosed space containing a sheet of absorbent material.

FIG. 3 is an exploded view of a bandage with a liquid permeable pouch formed of two sheets of pouch material sealed together to form an enclosed space containing a sheet of rolled absorbent material.

FIG. 4 is an exploded view of a bandage with a liquid permeable pouch formed of two sheets of pouch material sealed together to form an enclosed space containing a folded sheet of absorbent material.

FIG. 5 is an front elevation view of a bandage with a liquid permeable pouch formed of one sheet of pouch material folded in half and sealed along the perimeter edges to form an enclosed space.

FIG. 6 is a cross-sectional view of the bandage of FIG. 5 showing two layers of absorbent material within the enclosed space formed by the liquid permeable pouch.

FIG. 7 is a front perspective view of a rolled bandage.

FIG. 8 is a front, perspective view of a rolled and folded bandage.

FIG. 9 is an environmental view showing a folded bandage with a rolled absorbent material, where the bandage has been placed between two teeth in a space where a tooth has fallen out or been removed.

FIG. 10 is another environmental view showing a folded bandage with a rolled absorbent material, where the bandage has been placed between two teeth in a space where a tooth has fallen out or been removed.

FIG. 11A is an environmental view showing a folded bandage that has been placed between two teeth in a space where a tooth has fallen out or been removed, while FIG. 11B is an environmental view showing a bandage with a folded or multi-layered absorbent material, wherein the bandage has been placed between two teeth in a space where a tooth has fallen out or been removed.

FIG. 12A is an environmental view showing a rolled bandage placed into a nostril to facilitate hemostasia of a bloody nose (i.e., epistaxis), while FIG. 12B is an environmental view showing a bandage with a rolled absorbent placed into a nostril to facilitate hemostasia of a bloody nose.

FIG. 13 is a top view of a bandage that includes a string.

FIG. 14 is a cut away of the bandage of FIG. 13, where the upper sheet of pouch material has been removed exposing the absorbent material.

FIG. 15 is a front, perspective view showing a sterile pouch that has been torn along the upper edge to expose the bandage contained therein.

DETAILED DESCRIPTION

As shown in FIG. 1, a kit 2 containing a bandage 10 for facilitating hemostasis in a mucosal membrane, and instructions 4 for applying the bandage to bleeding tissue is disclosed. FIGS. 1-15 show a variety of bandages 10 and applications of the bandages 10 as described herein. The bandage 10 can include a liquid permeable pouch 12 and an absorbent material 14 contained within the liquid permeable pouch 12.

In some embodiments, the liquid permeable pouch 12 can be formed of a liquid permeable sheet 13 of material. In some embodiments, the liquid permeable pouch 12 is formed of more than one liquid permeable sheet 13 of material. In some embodiments, the liquid permeable sheet 13 of material comprises a thermoplastic material. In some embodiments, the thermoplastic can be selected from the group including, but not limited to, polyethylene, polypropylene, polystyrene, polyvinyl chloride, fluoropolymers (e.g., polytetrafluoroethylene), polybenzimidazole, nylon, polyacrylate, and combinations thereof. The liquid permeable sheet 13 of material can be inherently permeable or can include apertures 26. Although some figures show the liquid permeable pouch 12 including apertures 28, it should be understood that the apertures may be present in the natural structure of the material, such as holes in a mesh, spunbond, or meltblown material, in some embodiments. The apertures 26 can be holes that were punched in a material (e.g., a film) to make it appropriate for use as the liquid permeable pouch 12.

In some embodiments, the liquid permeable pouch 12 can be hydrophllic in order to allow blood to pass into the bandage and contact the absorbent material 14. In some embodiments, the liquid permeable pouch 12 can be formed from a material that is naturally hydrophobic (e.g., a polymer), but is treated to make an cuter surface of the liquid permeable pouch 12 hydrophllic. In some embodiments, an interior surface of the liquid permeable pouch 12 proximate the absorbent material 14 is hydrophobic. In this manner, the liquid permeable pouch 12 can facilitate transfer of blood into the bandage 10, while preventing the blood from exiting the liquid permeable pouch 12.

In some embodiments, an exterior surface of the liquid permeable pouch 12 can be treated to make it more hydrophllic or wettable. For example, the exterior surface of the pouch cant be treated with a surfactant, a plasma treatment, a corona treatment, a poloxamer or other copolymer treatment solution or other surface treatment (e.g., pluronics available from BASF).

In some embodiments, the liquid permeable pouch 12 can be formed of a material with an open area ranging from 25-60%, or from 28-50%, or from 30-40%, or any combination of these ranges. In some embodiments, the liquid permeable pouch 12 can be formed of a material with a mesh opening ranging from 50-250 μm, or from 60-200 μm, or from 85-150 μm, or any combination of these ranges. In some embodiments, the liquid permeable pouch 12 can be formed of a material with a basis weight ranging from 20-150 g/m2, or from 25-100 g/m2, or from 27-75 g/m2, or from 30-60 g/m2, or any combination of these ranges. In some embodiments, the liquid permeable pouch 12 can be formed of a material with a mesh count ranging from 50-250 per cm, or from 75 to 230 per cm, or from 100 to 225 per cm, or from 150 to 220 per cm, or any combination of these ranges.

In some embodiments, the pores or apertures 26 in the liquid permeable pouch 12 can be designed to allow blood to pass into the bandage 10, while preventing more viscous bodily fluids, such as mucous, from passing into the bandage 10. For example, the size of the pores and/or apertures and the surface wettability treatments applied to the liquid permeable pouch 12 can be adjusted to achieve this goal.

In some embodiments, the liquid permeable pouch 12 is thermally bonded to form a seal 16. In other embodiments, the seal 18 of the liquid permeable pouch 12 can be formed using thermal bonding, adhesive bonding, and/or ultrasonic bonding techniques. In some embodiments, each perimeter edge 18A, 18B, 18C, 18D of the liquid permeable pouch is either folded 20, thermally bonded 22 (including, but not limited to, radio frequency bonding and ultrasonic bonding), or adhesively bonded 22. As used herein, the “perimeter edge” refers to the edge itself and areas immediately adjacent to the edge. Examples of seals 18 extending along perimeter edges are shown in the figures.

In some embodiments, the entire pouch 12 forms an enclosed space 24 surrounding the absorbent 14 using a single, continuous seal 16, with or without folded edges 20. For example. FIGS. 2-4 & 13 show embodiments where a single, continuous seal is used to form a pouch 12 defining an enclosed space 24. For example, FIGS. 1 & 5 show embodiments where a single, continuous seal and a folded edge 20 are used to form a pouch 12 defining an enclosed space 24. As used herein, “enclosed space” is intended to encompass spaces that are in fluid communication with the external environment through porosity (including apertures) in the sheets 13 used to form the liquid permeable pouch 12, while the bulk absorbent material 14 is retained within the pouch 12.

In some embodiments, the liquid permeable pouch 12 and/or sheets 13 forming the same include or are a non-woven material, while the liquid permeable pouch 12 and/or sheets 13 can include or can be woven materials (e.g., mesh, gauze, etc.) in other embodiments. Examples of non-woven materials include, but are not limited to, spunbond, meltblown, polymeric film with apertures, bonded-carded webs (BCW), paper, polymer stabilized materials, filter paper, hydroentangled materials, and combinations thereof. In some embodiments, the liquid permeable pouch 12 and/or sheets 13 can be formed of a polymer containing non-woven, which may be treated with a surfactant. In some embodiments, the liquid permeable pouch 12 and/or sheets 13 can be formed of a cellulosic material including, but not limited to, paper, polymer stabilized paper, filter paper, hydroenfangled materials, and combinations thereof, which may be treated with a surfactant.

In some embodiments, the liquid permeable pouch 12 and/or sheets 13 include a plurality of apertures 26. In other embodiments, the liquid permeable pouch 12 and/or sheets 13 are permeable because it is formed from a permeable material, e.g., spunbond, mesh, BCW, polymeric film with apertures, paper, polymer stabilized paper, filter paper, etc.

In some embodiments, wherein the absorbent material 14 comprises a cefluloslc material. Cellulosic materials can include both woven and non-woven materials. Examples of woven cellulosic materials include, but are not limited to, gauze and meshes. Examples of non-woven cellulosic materials include, but are not limited to, paper, polymer stabilized paper, filter paper, hydroentangled materials.

In some embodiments, as shown in FIGS. 2-6 & 14, there is a gap between the edge of the absorbent material 14 and the seal 16. In some embodiments, the gap is at least 0.1 cm, or at least 0.2 cm, or at least 0.3 cm. This gap enables the absorbent material 14 to swell as it absorbs fluids, such as blood. In addition, the swelling helps the bandage stay in place once inserted into a nostril or tooth socket.

In some embodiments, absorbent material 14 includes a stabilized sheet comprising cellulosic material. Examples of stabilized sheets containing cellulosic materials include, but are not limited to, paper, polymer stabilized paper, filter paper, and hydroentangled materials. Examples of cellulosic materials include, but am not limited to, wood fibers, modified cellulosic materials (e.g., cellophane and rayon) and combinations thereof. Exampled of modified cellulose materials include, but are not limited to, cellulose acetate, cellulose triacetate, cellulose propionate, cellulose acetate propionate (CAP), cellulose acetate butyrate (CAB), nitrocellulose (cellulose nitrate), cellulose sulfate, and combinations thereof.

In some embodiments, the absorbent material 14 can have a rapidity rate for water of at least 200 ml/min, or at least 300 ml/min, or at least 400 ml/min. In some embodiments, the absorbent material 14 can have a rapidity rate of up to 800 ml/min, or up to 700 ml/min, or up to 600 ml/min, or up to 500 ml/min. In some embodiments, the absorbent material (e.g., filter paper) is designed to remove fine particles larger than 10 μm, or larger than 15 μm, or larger than 20 μm, or larger than 28 μm.

In some embodiments, the stabilized sheet is rolled, as shown in FIG. 3, while the stabilized sheet can be folded in other embodiments, such as the one shown in FIG. 4. As shown in FIGS. 6 & 14, in some embodiments, the stabilized sheet comprises a plurality of stabilized sheets of cellulosic material.

In some embodiments, such as the one in FIG. 7, the bandage 10 maintains a rolled configuration. In some embodiment, such as the one shown in FIG. 8, the bandage 10 can maintain a rolled and folded configuration. Such configurations can be maintained by thermal bonding, a string, a sleeve, such as a sleeve made of shrink-wrap materials, or a combination of these approaches.

In some embodiments, the instructions 4 include rolling and/or folding the bandage, and placing the bandage proximate the site of the bleeding. In some embodiments, the instructions 4 can include placing the rolled and/or folded bandage against the site of the bleeding. In some embodiments, the instructions 4 can include placing the bandage 10 in a sulcus where there is bleeding, while the instructions 4 can include placing a relied and/or folded bandage 10 in a sulcus where there is bleeding in other embodiments. FIGS. 9-11 show examples of a bandage 10 placed over a sulcus where a tooth has fallen out or was removed. In some instances, the absorbent material 14 can be rolled and/or folded, while the entire bandage 10 can be rolled and/or folded in other instances. In some embodiments, as shown in FIGS. 9-10, the absorbent material 14, but not the bandage 10, can be rolled and then entire bandage can be folded. In instances where a string 28 is bonded to the bandage 10, the instructions 4 can include placing the bandage 10 in a manner that the string extends from the mouth for easy retrieval of the bandage 10.

In other embodiments, the instructions 4 can include tilting the head backward to facilitate hemostasis. The instructions 4 can also include placing a portion of the bandage 10 in a nostril of an individual experiencing epistaxis (i.e., a nose bleed), in some embodiments, the instructions 4 can include rolling or folding the bandage 10 and inserting the rolled or folded bandage 10 into the nostril of the patient, as shown in FIG. 12A. In other embodiments, the instructions 4 can be adapted for a bandage 10 that includes an absorbent material 14 that is rolled and/or layered within the liquid permeable pouch 12 and inserting an end of the bandage 10 into the nostril of a person experiencing epistaxis, as shown in FIG. 12B. As shown in FIGS. 12A & 12B, the instructions 4 can include applying pressure to the nostril that is the site of the epistaxis. in instances where a string 28 is bonded to the bandage 10, the instructions 4 can include inserting the bandage 10 in a manner that the string 28 extends from the nostril for easy retrieval of the bandage 10. Even in embodiments where a string 28 is not present the fact the liquid permeable pouch 12 is made from stable materials and extends beyond the absorbent material, facilitates easy removal of the bandage 10 even after being saturated with blood or other bodily fluids.

In some embodiments, the bandage 10 can be designed so that the rolled or folded absorbent material 14 has a minor cross-sectional area that approximates the size of an adult nostril or tooth socket, or the nostril or tooth socket size of a child or teen, in other embodiments, the bandage can be sized so that, when rolled or folded, it assumes a minor cross-sectional area that approximates the size of an adult nostril or tooth socket, or the nostril or tooth socket size of a child or teen. Alternately, in either embodiment, the minor cross-sectional area can approximate half the size of an adult/child/teen nostril or tooth socket, so that the bandage fits snuggly in the nostril or tooth socket when folded in half.

In some embodiments, the instructions 4 can include applying pressure to a bandage 10 that has been placed on or proximate the source of the bleeding. The pressure is represented by arrows in FIGS. 9-11, and can be applied by a finger or by biting down with the opposing set of teeth (i.e., top teeth if the bottom tooth is out or the bottom teeth if an upper tooth is missing).

In some embodiments, the bleeding can originate from the nasal cavity (i.e., epistaxis). In such embodiments, the rolled bandage 10 can be inserted lengthwise into the nasal cavity, as shown in FIG. 12. In some embodiments,, pressure can be applied by placing a finger against the side of the nose that is bleeding. In some embodiments, the pressure can be applied by squeezing the nose with one finger (e.g., pointer finger or long finger) and the thumb.

In some embodiments, as shown in FIG. 13, the bandage 10 includes a string 28 extending from the liquid permeable pouch. The string 23 can be adapted for retrieving the liquid permeable pouch 12 from the mucosal membrane (e.g., the mouth or the nose).

In some embodiments, the absorbent material 14 can include a coagulating material. Examples of coagulating materials include, but are not limited to, tannic acid, regenerated oxidized cellulose, gelatin sponges, collagen with or without fibrinogen, aluminum chloride, ferric chloride, chlorhexadine, and derivatives thereof. The coagulating material can be in a dried form, such as a powder or a coating. If a coating is used, if can be applied using techniques know in the art, such as, application as a solution containing the coagulating material and then drying the coagulating material on the absorbent substrate.

In some embodiments, the cellulosic material used in the absorbent and/or the liquid permeable pouch can include a modified, soluble cellulose that thickens blood as it dissolves. Examples of modified, soluble cellulose materials include regenerated oxidize cellulose, such as that sold in woven form under the mark SURGICEL® by Ethicon®.

In some embodiments, the bandage 10 is contained within a sterile pouch 30, and the instructions 4 include removing the bandage 10 from the sterile pouch 30 before applying the bandage 10 to the bleeding tissue. An example of such an embodiment is shown in FIG. 15, where the sterile pouch 30 has been torn to show the bandage 10 contained within the sterile pouch 30. Using this approach, the bandage 10 can be sterilized during packaging and remain sterile until the bandage 10 is ready to be used.

In some more specific embodiments, the kit 2 can include a bandage 10 adapted for mucosal membrane hemostasia and instructions 4 for using the bandage 10. The kit 2 can be a first aid kit and can include additional products for providing aid. Examples include, alcohol, elastic wraps, gauze, adhesive bandages, cotton swabs, etc.

The bandage 10 can include a liquid permeable pouch 12, and at least one sheet of absorbent material 14 contained within the liquid permeable pouch 12. The instructions 4 can include rolling and/or folding the bandage 10, placing the rolled and/or folded bandage 10 proximate the site of the bleeding, and applying pressure to the bandage 10. Examples of rolled and/or folded bandages 10 placed proximate the site of bleeding are shown in FIGS. 9-12. Because the bandages 10 include a liquid permeable pouch 12 to stabilize and contain the absorbent material 14, the bandage can remain in a nostril or tooth socket for an extended period of time (e.g., 36 minutes, 1 hour, 2 hours, etc.).

The bandages 10 can come in a variety of sizes. For example, some bandages 10 can be adapted for use by children or infants, while some bandages 10 can be adapted for use by adults. For example, bandages 10 adapted for children may be smaller in area, and may also include smaller amounts of absorbent material 14. In some embodiments, the diameter of the rolled absorbent material 14 or thickness of the folded or multiply absorbent material 14 can range from 1-4 cm (or 1-3 cm) in bandages adapted for use by adults and can range from 0.5-2.0 cm (or 0.5-1.5 cm) in bandages adapted for use by children. In some embodiments, the length (L) of the bandages 10 adapted for children can range from 2-4 cm, while the length (L) of bandages 10 adapted for adults can range from 3-8 cm. In some embodiments, the width of the bandages 10 adapted for children can range from 0.5-2.0 cm (or 0.5 to 1.5 cm), while the width of bandages 10 adapted for adults can range from 1-4 cm (or 1-3 cm).

In some embodiments, the kit 2 can include one or more bandages 10 adapted for use by children and one or more bandages 10 adapted for use by adults. In some embodiments, the bandages 10 adapted for use by children include a string 28. in some embodiments, the kit 2 can include other first aid products, such as adhesive bandages, antiseptic solutions (isopropyl alcohol., hydrogen peroxide, etc.), tape, scissors, gauze, etc.

In some embodiments, such as the ones shown in FIGS. 9 & 11, the instructions 4 include placing a width of the rolled and/or folded bandage 10 over the site of the bleeding. In some embodiments, such as the ones shown in FIGS. 10 & 12, the instructions include placing an end of the rolled and/or folded bandage 10 over the site of the bleeding.

In some embodiments, the bandage 10 can be flexible and/or compressible. For instance, in some embodiments, the bandage 10 can be folded in half even after it has been rolled. The flexibility facilitates comfort during use, as well as, the ability of the bandage 10 to conform to non-uniform shapes, such as the nostril or the sulcus from a missing teeth. The compressibility facilitates comfort when pressure is applied to a bandage 10 contacting the site of the bleeding, which may be tender.

A method of hemostasia in a mucosal membrane is also disclosed. The method can include providing any bandage 10 as disclosed herein, placing the bandage 10 proximate the site of the bleeding; and applying pressure to the bandage 10. The method can also include folding and/or rolling the bandage 10 before placing it proximate the site of the bleeding.

Dental practitioners, periodontists, oral surgeons, and physicians treat the mucus membranes of patients using surgical procedures on a daily basis. Bleeding as a result of these procedures is inevitable and clot formation in the “wet” environment of the mouth or nose becomes a significant challenge. Typically sutures, epinephrine, or cautery can be used intraorally or intranasal during surgical procedures to initiate hemostasia. In challenging locations, gelatin sponges or collagen products can be condensed (or “packed”) into a wound by the surgeon to further assist in the development of hemostasis.

With the surge in ageing baby boomers, blood thinner medications to treat cardiac conditions have increased significantly. These medications include, but are not limited to aspirin, Coumadin®, Plavix®, and Effient®. Older medications like Aspirin and Coumadin® can be titrated and quantified which makes it easier to predict the susceptibility of a patient to have clotting complications following a surgical procedure. New age blood thinners like Plavix® and Effient® can have a “variable response” in patients, meaning that it is more effective in some people than in others. This can range from severe life threatening internal bleeding to no effect on bleeding at all. From a surgical perspective, there is no way to quantify how these medications are affecting the individual patient to be treated and the bleeding response the patient will have during and after a procedure. In addition, alcohol consumption can significantly reduce the body's ability to clot. This effect varies significantly based on the amount, length of time and habits of the individual patient Several common chemotherapy medications, such as Avastin®, also predispose a patient to profuse bleeding from the mouth and gums.

Achieving clot formation after a surgical procedure in the intraoral or nasal environment is a challenge due to the constant dilution of the clotting cascade by saliva or nasal mucosal discharge. These difficulties can be increased tenfold by factors such as a patient's medical history, use of blood thinners, and alcohol consumption. Post-operative bleeding is a consequence commonly found with infra-oral and intranasal procedures and the typical patient instruction is to treat the wound by applying pressure or packing with regular gauze or biting on a tea bag. These methods do not always achieve hemostasia.

In some embodiments, the bandage can include a three dimensional absorbent (e.g., a cylinder, log-shaped, an elongated, rectangular solid) contained within a liquid permeable pouch formed using heat sealed (thermally bonded) sheets of nylon mesh. The absorbent cars be formed from filter paper, or a similar absorbent, placed in layers. In some embodiments, the components of the bandage are nontoxic, porous, malleable, hydrophilic and can be irradiated prior to use. If required to achieve hemostasia with intraoral bleeding, in some embodiments, the user places the bandage over the wound and applies pressure either digital or through a masticatory (i.e., by biting on the bandage) hold. If required to achieve hemostasis with intranasal bleeding, in some embodiments, the user inserts the bandage within the nasal cavity and applies digital pressure to the outside skin of the nose.

In some embodiments, a string is attached to the bandage, inclusion of a string can be particularly useful to prevent swallowing and allow for easy retrieval when placed within the mouth by a caregiver (e.g., when used with infants, children, medicated individuals, or other individuals who may not be able to retrieve the bandage themselves). The string can be used to facilitate easy retrieval of the bandage from, the nostril as well.

In some embodiments, the bandage is sealed in an easily opened “tear-away” foil packaging that eliminated contamination and air sensitivity of the product. The bandage could come in multiple sizes. In some embodiments, a bandage for adults would be roughly double the size of the bandage for infants and children. These bandages could be distributed for both professional and consumer use to assist in hemostasia of bleeding in the mouth or other mucosal membranes (e.g., epistaxis).

The bandage could be purchased by caregivers or by medical professionals for distribution to patients, particularly those at higher risk for post-operative bleeding. The bandages and kits can also be sold in pharmacies, grocery stores, and in big-box store environments in the “dental problem section” for consumer use. This can range from wound oozing after intraoral surgery to tooth eruption and exfoliation often associated with bleeding in children. The bandages described herein can be used by caregivers and consumers to assist in clot formation and hemostasis in a liquid environment like the mouth or nose.

General Examples

As evident from the description above, the bandages can be sized for use by children, teens, and/or adults. The bandages can be used in a wide variety of environments and settings. For instance, the bandages can be used by consumers, care-givers, and medical professionals.

In some instances, the bandage can include an absorbent material that is folded or rolled or can be folded or rolled to approximate the width of an average child's tooth socket and/or nasal orifice. The bandage could then be used by a child experiencing normal baby-tooth exfoliation, which typically incurs bleeding on loosening, tooth loss, and eruption of the adult tooth. The soft components of the bandage would then allow for easy use in a tender area of a child's mouth. The capillary action isolates the blood in the absorbent material where it is obscured from the user by the liquid permeable pouch. This design decreases the potential for fear and emotion by a child (or parent) when bleeding of the mouth is observed. Such devices would be useful after dental or nasal trauma is experienced by a child.

In other embodiments, the bandage can be sized to approximate the width of an average adult tooth socket and/or nasal orifice when folded or rolled (any may be folded or rolled within the liquid permeable pouch). The bandage could be used by any adult experiencing hemorrhaging associated with dental bleeding common after oral surgical and periodontal procedures. Alternately, the bandage could be utilized to control nose bleeds that are a common side effect of blood thinner medications or nasal procedures, such as rhinoplasty or sinus surgery. The bandage could also be used in connection with any other dental or nasal trauma experienced by a teen or an adult.

In other embodiments, the bandages could be utilized by dentists, pediatric dentists, periodontists, and oral surgeons as a post-operative adjunct to treat hemorrhage typical with any intraoral procedure. The bandages could also be utilized by physicians performing surgery in the nasal cavity to utilize as a post-operative adjunct for treatment of hemorrhage typical with nasal procedures, such as a rhinoplasty or sinus surgery. The bandages could also be distributed by surgeons to patients who are recovering from a medical procedure.

Specific Examples

In order to evaluate the efficacy of the bandages described herein over a similar application using gauze, prototypes were produced using nylon mesh as the liquid permeable pouch and filter paper as the absorbent material The combination of the hydrophllic liquid permeable pouch material and filter paper absorbent was far superior to gauze in terms of absorbency and fluid distribution, it is believed that the bandages described herein are superior to gauze because the hydrophillic liquid permeable pouch allowed blood to freely pass through to the absorbent, but prevented mucous from being absorbed by the filter paper.

The examples were produced using nylon mesh with 38% open area, mesh openings of 78 μm, a mesh count of 77 per cm, a thread diameter of 48 μm, a basis weight of 43 gsm, and a thickness of 80 μm (Saatifil® PES 78/36 sold by Saati S.p.a.) and a filter paper with a high intake rate (440 mis/min) and retention (30 microns), such as Grade 983 available from Ahlstrom Filtration LLC. An experienced Board Certified Periodontist applied the example prototype bandage to a blood source, Compared with a rolled gauze, the example bandage exhibited significantly improved absorption, fluid retention within the liquid permeable pouch, and fluid distribution. In addition, the example bandage was much easier to place for both the surgical practitioner and the patient than traditional gauze. Upon inspection of the used example bandages, mucosal fluids were consistently excluded by the outside nylon mesh from the inside absorbent filter paper, while blood passed through the nylon mesh and into the absorbent filter paper. Capillary action of blood within the inner absorbent material kept the blood within the bandage and prevented release of the slurry of blood and blood components commonly observed with traditional gauze.

The foregoing is provided for purposes of illustrating, explaining, and describing embodiments of this invention. Modifications and adaptations to these embodiments will be apparent to those skilled in the art and may be made without departing from the scope or spirit of this invention.

Claims

1. A kit comprising:

a bandage adapted for mucosal membrane hemostasis, and
instructions for applying the bandage to bleeding tissue, wherein tie bandage comprises: a liquid permeable pouch, and an absorbent material contained within the liquid permeable pouch.

2. The kit according to claim 1, wherein the liquid permeable pouch comprises a sheet of material comprising a thermoplastic, wherein said liquid permeable pouch is thermally bonded.

3. The kit according to claim 2, wherein each perimeter edge of said liquid permeable pouch is either folded or thermally bonded.

4. The kit according to claim 1, wherein said liquid permeable pouch comprises a woven material.

5. The kit according to claim 4, wherein said liquid permeable pouch comprises a mesh.

6. The kit according to claim 1, wherein said absorbent material comprises a cellulosic material.

7. The kit according to claim 1, wherein said absorbent material comprises a stabilized sheet comprising cellulosic material.

8. The kit according to claim 7, wherein said stabilized sheet is rolled or folded.

9. The kit according to claim 7, wherein said stabilized sheet comprises a plurality of stabilized sheets of cellulosic material.

10. The kit according to claim 1, wherein said bandage maintains a rolled configuration.

11. The kit according to claim 1, wherein said absorbent material is a sheet and said instructions comprise:

rolling and/or folding the bandage, and
placing the bandage proximate the site of the bleeding.

12. The kit according to claim 11, wherein said instructions further comprise applying pressure to the bandage.

13. The kit according to claim 1, further comprising a string extending from said liquid permeable pouch, said string adapted for retrieving said liquid permeable pouch from said mucosal membrane.

14. The kit according to claim 1, wherein the absorbent material comprises a cellulose-based material, a coagulating material, or both.

15. The kit according to claim 1, wherein the bandage is contained within a sterile pouch, and the instructions include removing the bandage from the sterile pouch before applying the bandage to the bleeding tissue.

16. A kit comprising;

a bandage adapted for mucosal membrane hemostasis, wherein the bandage comprises: a liquid permeable pouch, and at least one sheet of absorbent material contained within the liquid permeable pouch; and
instructions using the bandage, said instructions comprising: rolling and/or folding the bandage, placing the rolled and/or folded bandage proximate the site of the bleeding, and applying pressure to the bandage.

17. The kit according to claim 16, wherein the instructions include placing a width of the rolled and/or folded bandage over the site of the bleeding.

18. The kit according to claim 18, wherein the instructions include placing an end of the rolled and/or folded bandage over the site of the bleeding.

19. A method of hemostasia in a mucosal membrane, comprising:

providing a bandage comprising: a liquid permeable pouch, and at least one sheet of absorbent material contained within the liquid permeable pouch;
placing the bandage proximate the site of the bleeding; and
applying pressure to the bandage.

20. The method according to claim 19, wherein the site of the bleeding is the mouth or the nasal cavity.

Patent History
Publication number: 20170095374
Type: Application
Filed: Oct 5, 2015
Publication Date: Apr 6, 2017
Inventor: Daniel Stuart Lauer (Palm Beach Gardens, FL)
Application Number: 14/875,188
Classifications
International Classification: A61F 13/00 (20060101);