This disclosure relates generally to medical treatment systems for treating tissue sites and processing fluids. More particularly, but not by way of limitation, the disclosure relates to a dressing capable of generating and distributing iodine to a tissue site. The dressing may be used with or without reduced pressure to treat a tissue site.
Iodine and iodine solutions have been proven to have effective antiseptic properties against pathogens. Iodine is commonly used as a skin cleanser and antiseptic in preoperative hand scrubs. Early solutions of iodine were known to have side effects, including irritation and/or staining of skin. These side effects were generally associated with the relatively high iodine concentration of the solutions delivered to the skin. To reduce and control the dosage of iodine delivered to the skin site, iodophors were developed, which are essentially water-soluble continuous phases that contain the iodine, which is only released when water solubilizes the continuous phase.
However, in all of the water-soluble systems containing iodine, the carrier or continuous phase becomes mobile upon contact with water, and may block or hinder the removal of wound fluids in negative-pressure wound dressings. In addition, if a highly-exuding wound is encountered, or additional fluid (saline) is added to a wound as part of a cleaning or irrigation operation, a high dosage of iodine may be released, which may be undesirable. Furthermore, the water-soluble dressings may also be rather cumbersome and messy upon removal and can prove difficult to handle and contain. Additionally, given that elemental iodine is effectively stored within the dressing, storage risks or hazards may be posed.
Thus, while the benefits of using iodine solutions as antiseptics in the medical context are known, the complexity of treating wounds can be a limiting factor, particularly when combined with negative-pressure therapy.
The disclosure provides a dressing member for treating a tissue site. The dressing member provides iodine to the tissue site. According to an illustrative embodiment, a dressing member for treating a tissue site may include a plurality of iodine-forming reagents and a covering material. The plurality of iodine-forming reagents may be dispersed in the dressing member and adapted to react to form iodine. The covering material may encapsulate each of the iodine-forming reagents. The plurality of iodine-forming reagents may be coated with varying thicknesses of the covering material. The dressing member may also include a carrier material. The covering material of the dressing member may be further adapted to absorb fluid and to release the iodine-forming reagents, wherein the fluid may be a wound exudate from the tissue site, a saline solution, or water. The covering material may include a water-swellable material or a water-soluble material. The covering material may also include a mixture of water-swellable and water-soluble materials. The water-swellable material may form one or more water-swellable fibers, and the water-soluble material may form one or more water-soluble beads. The water-soluble beads may include water-sensitive polymers, which may be polyvinyl alcohol or polyvinyl pyrrolidone. The water-soluble beads may also include a coating that includes a biodegradable matrix. The biodegradable matrix may be formed from a glass, a ceramic, sodium phosphates, apatites, or polymers, which may be a caprolactam or a lactate. The covering material of the dressing member may further include an indicator for detecting the release of iodine, which may be a starch. The plurality of iodine-forming reagents may include an iodide salt and an iodate salt. The iodide salt may be potassium iodide (KI), and the iodate salt may be potassium iodate (KIO3). The iodine produced from the dressing member may be released over differing time periods. The water-swellable fibers may be in the form of hollow fibers, and two or more hollow fibers may be combined, for example by twisting, to form a yarn where the first hollow fiber may contain a first iodine-forming reagent and the second hollow fiber may contain a second iodine-forming reagent. Two or more yarns are bundled or twisted together to form a woven or a non-woven matrix. The water-swellable material may include a gelatine or a gelatine/carbohydrate blend, and the carbohydrate may be a cellulose derivative such as carboxymethyl cellulose (CMC).
According to another illustrative embodiment, a system for treating a tissue site may include a manifold, a dressing member, a drape, and a reduced-pressure interface. The manifold may be adapted to receive reduced pressure and distribute the reduced pressure to the tissue site. The dressing member may be adapted to form a sealed space around the tissue site and manifold, and may include a plurality of iodine-forming reagents and a covering material. The drape may be adapted to cover the dressing member. The reduced-pressure interface may be adapted to deliver reduced pressure and may be in fluid communication with the sealed space and the manifold. The system may further include a reduced-pressure source in fluid communication with the reduced-pressure interface. The manifold may be an open-cell, reticulated polyurethane foam, and may include at least one material selected from the group of polyurethane foam, polyvinyl alcohol foam, polyethylene foam, expanded polytetrafluoroethylene, silicone foam, loofa sponge, sea sponge, gauze, and felted mats. The system may further include a reduced-pressure delivery tube fluidly connected to the reduced-pressure interface for delivering a reduced pressure to the tissue site.
According to yet another illustrative embodiment, a method of manufacturing a dressing member may include providing a plurality of iodine-forming reagents adapted to react with each other to form iodine and coating the plurality of iodine-forming reagents with a covering material. The method may further include disposing the plurality of coated iodine-forming reagents in a carrier material. The covering material may include a water-swellable material or a water-soluble material. The water-swellable material may be formed from gelatine or gelatine/carbohydrate blends, wherein the carbohydrate may be a cellulose derivative such as carboxymethyl cellulose (CMC). The plurality of iodine-forming reagents may include an iodide salt and an iodate salt, where the iodide salt may be potassium iodide (KI) and the iodate salt may be potassium iodate (KIO3). The method may further include twisting a first hollow fiber containing a first iodine-forming reagent with a second hollow fiber containing a second iodine-forming reagent to form a combined yarn. The hollow fibers may be formed by electrospinning. The method may further include bundling or twisting together the combined yarn to form a woven or non-woven matrix.
According to yet another illustrative embodiment, a system for treating a tissue site may include a dressing member, a drape, and a reduced-pressure interface. The dressing member may be adapted to be disposed proximate the tissue site and may include a carrier material and a plurality of iodine-forming reagents. The iodine-forming reagents may be adapted to react to produce iodine. The drape may be adapted to cover the dressing member. The reduced-pressure interface may be adapted to deliver reduced pressure and may be in fluid communication with the dressing member.
According to still another illustrative embodiment, a method for treating a tissue site may include applying a dressing member adjacent to the tissue site and providing iodine formed from the dressing member to the tissue site. The iodine may be released over a length of time. The plurality of reagents may include an iodide salt and an iodate salt. The method may further include providing a starch in the dressing member, wherein the starch is adapted to form a blue-black color when exposed to iodine. Additionally, the method may further include applying reduced pressure to the tissue site. The reduced pressure may be applied to the tissue site prior to the application of the dressing member, subsequent to the application of the dressing member, or while the dressing member is applied to the tissue site.
Other aspects, features, and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.
In the following detailed description of non-limiting, illustrative embodiments, reference is made to the accompanying drawings that form a part hereof. Other embodiments may be utilized, and logical, structural, mechanical, electrical, and chemical changes may be made without departing from the scope of the appended claims. To avoid detail not necessary to enable those skilled in the art to practice the embodiments described herein, the description may omit certain information known to those skilled in the art. The following detailed description is non-limiting, and the scope of the illustrative embodiments are defined by the appended claims.
The disclosed iodine-forming dressing members can overcome shortcomings of previous iodine-containing wound dressings by generating iodine after being applied to a tissue site and in response to coming into contact with wound fluids such as wound exudates. The iodine-forming dressing members disclosed herein provide controlled release of iodine. In one embodiment, iodine-forming dressing members provide a low-level release of iodine, which may prevent a high and/or uncontrolled dose of iodine from being released. Additionally, the iodine-forming dressing members in the present disclosure may be easily removed and discarded. Furthermore, storage risks associated with elemental iodine may be reduced or even eliminated.
In one embodiment, the carrier material 104 may be comprised of any substantially pure hydrophobic material and may have a variety of structures, including materials and structures that allow fluid, e.g., liquid or gas, to pass through the carrier material 104 without being absorbed by the carrier material 104. As defined herein, a hydrophobic material that is substantially pure will be substantially free of hydrophilic components due to the tendency for hydrophilic materials to retain fluid. The carrier material 104, for example, may comprise a hydrophobic elastomer, such as a hydrophobic silicone elastomer. The hydrophobic characteristics of the carrier material 104 may prevent the carrier material 104 from directly absorbing fluid, such as exudate, from a tissue site, but may allow the fluid to pass through. Thus, the carrier material 104 may permit the passage of fluid away from the peripheral surface 110 to allow the fluid to come into contact with the fibers 106.
The carrier material 104 may have any size, shape, or thickness depending on a variety of factors, such as the type of therapy being implemented or the nature of a tissue site or the peripheral surface 110. The thickness of the carrier material 104 may be increased or decreased to optimize the effectiveness of the carrier material 104 as a separator between a tissue site and the plurality of iodine-forming reagents 108. The thickness of the carrier material 104 may also be adjusted according to a desired ratio of hydrophobic carrier material to iodine-forming reagents 108, depending on the application.
For example, in the example embodiment of
The water-swellable material 220 may be a material capable of absorbing fluid. The water-swellable material 220 may be substantially formed into fibers, such as the fiber 106. The fibers, such as the fiber 106, may be a hollow fiber formed by extrusion from a melt or solution, as could be achieved through electrospinning, which involves using a high voltage to create an electrically-charged jet of solution or melt, which may dry or solidify to produce a fiber. In other embodiments, the water-swellable material 220 may be formed into a yarn or a sheet-like layer. In one embodiment, the water-swellable material 220 may be formed from gelatin or gelatin/carbohydrate blends, where the carbohydrate may be a cellulose derivative such as carboxymethyl cellulose (CMC).
The plurality of iodine-forming reagents 208 may include an iodide salt reagent and an iodate salt reagent. The iodine-forming reagents 208 may react according to the following general chemical equation:
IO3−+5I−+6H+→3I2+3H2O.
In accordance with this chemical equation, IO3− represents an iodate reagent, and 5I− represents an iodide reagent. In some embodiments, the iodide salt reagent may be potassium iodide (KI), and the iodate salt reagent may be potassium iodate (KIO3).
In the exemplary embodiment of
Referring now to
The wicking properties of the water-swellable material 220 may belp to quickly draw fluid, e.g., exudate, away from a tissue site, and thus may prevent the accumulation of fluid at or near the tissue site. In a similar manner, the carrier material 104 may facilitate the evaporation of fluid absorbed by the water-swellable material 220 or otherwise transferred through the carrier material 104 towards the external surface 112 of the iodine-forming dressing member 102. Since fluid from a tissue site passes through the carrier material 104 to reach the water-swellable material 220 as described above, the carrier material 104 may provide a separation between a tissue site and the water-swellable material 220, i.e., the carrier material 104 may be positioned between the peripheral surface 110 of the iodine-forming dressing member 104 and the water-swellable material 220.
Still referring to
In other embodiments, the iodine-forming reaction 330 may not occur in the carrier material 304. For example, the released iodide salt reagent 322 and iodate salt reagent 324 may be released into the carrier material 304 and travel out of the iodine-forming dressing member 302 and into another structure, such as a manifold, before coming into contact with each other to result in an iodine-forming reaction. In some embodiments, the released iodide salt reagent 322 and the released iodate salt reagent 324 may further travel to a tissue site before coming into contact with each other to cause an iodine-forming reaction to occur.
In other embodiments, to provide for a slower release of the iodine-forming reagents 408, the water-soluble beads 406 may also be coated with a biodegradable matrix. In some embodiments, the biodegradable matrix may be formed from glass or ceramic, for example bioglass, sodium phosphates and apatites, or polymers, for example caprolactams and lactates. Other suitable polymers may include starches, polyglycolic acid, cellulose, and chitosan.
In order to allow for a wide range of controlled iodine release levels over time, other embodiments of iodine-forming dressing members may include a mixture of water-swellable and water-soluble materials for encapsulating the iodine reagents. As previously discussed, water-soluble materials may include, among others, CMC salts, xanthan gum, guar gum, polyvinyl alcohols, polyethylene oxides, and polyvinyl pyrrolidones. In some embodiments, the water-soluble fractions will enable a higher dose of iodine to be formed by and released from the iodine-forming dressing member. Including a mixture of water-swellable and water-soluble materials may also allow for a variety of dressing integrity options, which may be tailored to the particular application and/or therapy involved.
In some embodiments, the iodine-forming dressing member 502 may include strands of iodine-forming yarn 552, where the iodine reagent fibers 550 vary in thickness. For example, the iodine-forming reagents 508 may be encapsulated in iodine reagent fibers 550, which have differing amounts, and therefore thicknesses, of water-swellable material 520. By varying the thickness of the water-swelling material 520, the dosage of the produced iodine may be released over differing time periods. For example, as fluid from a tissue site is absorbed by the water-swellable material 520 of the iodine reagent fibers 550 which contain less water-swelling material 520, the absorbed fluid may more quickly mobilize the iodine-forming reagents 522 and 524. Contrarily, iodine reagent fibers 550 which contain a greater amount of water-swelling material 520 may delay the absorbed wound fluid from mobilizing the iodine-forming reagents 522 and 524. This configuration ensures that the beneficial effects of the iodine are delivered for a continuous period of time. Such a controlled time release may not otherwise be the case if all iodine reagent fibers 550 have the same amount, and therefore thickness, of water-swellable material 520, as a majority of the iodine may be released from the fibers simultaneously. In some embodiments, strands of iodine-forming yarn 552 with iodine reagent fibers 550 having different thicknesses of water-swellable material 520 will be evenly distributed about the structure, however this does not necessarily have to be the case. For example, depending on the type of wound or tissue site, strands of iodine-forming yarn 552 with iodine reagent fibers 550 having lesser thicknesses of water-swellable material 520 may be placed towards the edges of the dressing member 502. Such a configuration may result in more quickly delivering a greater amount of therapeutic iodine to the most severe, or deepest, portions of a wound or tissue site.
Iodine-forming dressing members, such as the iodine-forming dressing members in
The term “tissue site” may refer to a wound or defect located on or within a tissue, including without limitation, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A tissue site may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term “tissue site” may also refer to areas of any tissue that are not necessarily wounded or defective, but are instead areas in which it may be desirable to add or promote the growth of additional tissue. For example, reduced pressure may be used in certain tissue areas to grow additional tissue that may be harvested and transplanted to another tissue location.
A reduced-pressure source, such as the reduced-pressure source 884, may be a reservoir of air at a reduced pressure, or may be a manually or electrically-powered device that can reduce the pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example. The reduced-pressure source may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate reduced-pressure therapy. While the amount and nature of reduced pressure applied to a tissue site may vary according to therapeutic requirements, the pressure may be a rough vacuum between about −5 mm Hg (−667 Pa) and about −500 mm Hg (−66.7 kPa). In some embodiments, the pressure may be between about −75 mm Hg (−9.9 kPa) and about −300 mm Hg (−39.9 kPa).
In general, exudates and other fluids may flow toward lower pressure along a fluid path. Further, fluids may be attracted to flow through permeable materials along a path of increasing hydrophilicity or absorbency among the materials. Thus, the term “downstream” may refer to components that are further along a fluid path than components that may be referred to as “upstream.” Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or “outlet” in such a frame of reference. This orientation is generally presumed for purposes of describing various features and components of negative-pressure therapy systems herein. However, the fluid path may also be reversed in some applications (such as by substituting a positive-pressure source for a negative-pressure source) and this descriptive convention should not be construed as a limiting convention.
“Reduced pressure” may refer to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. The local ambient pressure may also be the atmospheric pressure at which a patient is located. Further, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. Similarly, references to increases in reduced pressure typically refer to a decrease in absolute pressure, while decreases in reduced pressure typically refer to an increase in absolute pressure.
The components of the reduced-pressure therapy system 800 may be coupled directly or indirectly. Components may be fluidly coupled to each other to provide a path for transferring fluids (for example, liquid and/or gas) between the components. In some exemplary embodiments, components may be fluidly coupled with conduits, such as tubes. A “tube,” as used herein, may refer to a pipe, hose, conduit, or other elongated structure with one or more lumina adapted to convey fluids between two ends. In some exemplary embodiments, components may additionally or alternatively be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, or chemical coupling (such as a chemical bond) in some contexts.
The manifold 886 may be adapted to be in fluid communication with a tissue site, the iodine-forming dressing member 802, and the drape 888. For example, the manifold 886 may be placed within, over, on, or otherwise proximate to a tissue site. The iodine-forming dressing member 802 may be placed between the tissue site or the manifold 886 and the drape 888. The drape 888 may be placed over the manifold 886 and the iodine-forming dressing member 802 and sealed to tissue proximate to the tissue site. The tissue proximate to the tissue site may be undamaged epidermis peripheral to the tissue site. Thus, the dressing 882 can provide a sealed therapeutic environment proximate to the tissue site, substantially isolating the tissue site from the external environment. The reduced-pressure source 884 can reduce the pressure in the sealed therapeutic environment. Reduced pressure applied uniformly through the manifold 886 in the sealed therapeutic environment can induce macrostrain and microstrain in the tissue site, as well as remove exudates and other fluids from the tissue site.
In some embodiments, the manifold 886 may be adapted to contact a tissue site. The manifold 886 may be partially or fully in contact with a tissue site. If a tissue site extends into tissue from a tissue surface, for example, the manifold 886 may partially or completely fill the tissue site. In other exemplary embodiments, the manifold 886 may be placed over a tissue site. The manifold 886 may take many forms, and may have many sizes, shapes, or thicknesses depending on a variety of factors, such as the type of treatment being implemented or the nature and size of the tissue site. For example, the size and shape of the manifold 886 may be adapted to the contours of deep and irregular shaped tissue sites.
The manifold 886 may comprise a substance or structure adapted to distribute reduced pressure across a tissue site, remove fluids from across a tissue site, or both. In some exemplary embodiments, the manifold 886 may also facilitate delivering fluids across a tissue site, for example, if a fluid path is reversed or a secondary fluid path is provided. The manifold 886 may include flow channels or pathways that distribute fluids provided to and removed from a tissue site around the manifold 886. In one exemplary embodiment, the flow channels or pathways may be interconnected to improve distribution of fluids provided to or removed from a tissue site. For example, cellular foam, open-cell foam, porous tissue collections, and other porous material, such as gauze or felted mat may include structural elements arranged to form flow channels. Liquids, gels, and other foams may also include or be cured to include flow channels configured to distribute fluid across a tissue site.
In one exemplary embodiment, the manifold 886 may be a porous foam material having interconnected cells or pores adapted to distribute reduced pressure across a tissue site in a substantially uniform manner. The foam material may be either hydrophobic or hydrophilic. In one non-limiting example, the manifold 886 can be an open-cell, reticulated polyurethane foam such as GranuFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex.
In an example embodiment in which the manifold 886 may be made from a hydrophilic material, the manifold 886 may also wick fluid away from the tissue site, while continuing to distribute reduced pressure to the tissue site. The wicking properties of the manifold 886 may draw fluid away from the tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.
The manifold 886 may further promote granulation at the tissue site when pressure within the sealed therapeutic environment is reduced. For example, any or all of the surfaces of the manifold 886 may have an uneven, coarse, or jagged profile that can induce microstrains and stresses at the tissue site when reduced pressure is applied through the manifold 886 to a tissue site.
In one exemplary embodiment, the manifold 886 may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include, without limitation, polycarbonates, polyfumarates, and capralactones. The manifold 886 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the manifold 886 to promote cell-growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
The drape 888 is an example of a sealing member. A sealing member may be constructed to provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The sealing member may be, for example, an impermeable or semi-permeable, elastomeric film that can provide a seal adequate to maintain a reduced pressure at a tissue site for a given reduced-pressure source. For semi-permeable materials, the permeability generally should be low enough that a desired reduced pressure may be maintained. An attachment device may be used to attach a sealing member to an attachment surface, such as undamaged epidermis, a gasket, or another sealing member. The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive that extends about a periphery, a portion of, or an entirety of the sealing member. Other exemplary embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, organogel, or an acrylic adhesive.
In some embodiments, the reduced pressure developed by the reduced-pressure source 884 may be delivered through a tube to a connector. The connector may be a device configured to fluidly couple the reduced-pressure source 884 to the sealed therapeutic environment formed by the drape 888. In some embodiments, the connector may include a flange portion that couples to the drape 888 and a port portion that fluidly couples to the tube. In one exemplary embodiment, the connector may be a T.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from Kinetic Concepts, Inc. of San Antonio, Tex. In other exemplary embodiments, the connector may also be a conduit inserted through the drape 888. The connector allows the reduced pressure to be delivered to the sealed therapeutic environment between the drape 888 and the tissue site. In some embodiments, the connector may extend through the drape 888 to the iodine-forming dressing member 802, but numerous arrangements are contemplated. The connector can deliver the reduced pressure through the drape 888 of the dressing 882 to the manifold 886.
The iodine-forming dressing member 802 is also preferably permeable to gases. For example, in some embodiments, the iodine-forming dressing member 802 may include fibers 106. Reduced pressure may be transferred with and through spaces or voids between the fibers 106 in such embodiments of the iodine-forming dressing member 802.
The container 890 is representative of a container, canister, pouch, or other storage component that can be used to manage exudates and other fluids withdrawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with reduced-pressure therapy. Some exemplary embodiments of the reduced-pressure therapy system 800 may not include the container 890; instead, these exemplary embodiments of the therapy system 800 handle fluid storage with the dressing 882.
In operation, the reduced-pressure source 884 may supply reduced pressure to the dressing 882, including the manifold 886, and ultimately a tissue site. The reduced pressure source may draw fluids out of the tissue site, and the manifold 886 may distribute the fluids from the tissue site to the dressing 882. Upon reaching the dressing 882, the fluids may come into contact with and travel into the iodine-forming dressing member 802. Upon entry into the iodine-forming dressing member 802, the fluids may be absorbed by water-swellable material, which may be included in the fibers 106, the iodine reagent fibers 550, the matrix 660, the iodine reagent fibers 750, or any suitable combination of features of these embodiments. Upon absorption by the water-swellable material, the fluid may come into contact with iodine-forming reagents, and as a result, cause the iodine-forming reagents to be released from the water-swellable material and to come into contact with each other causing an iodine-forming reaction. The resulting iodine that is formed from the reaction may then come into contact with the components of the dressing 882, including the manifold 886. The formed iodine may also be released into the wound or other tissue site, in order to provide its intended antimicrobial functions. In some embodiments, while much of the fluid drawn from a tissue site may be absorbed by the dressing 882, fluid not retained by the dressing 882 may be drawn to the container 890.
Reduced pressure may be applied to the dressing, such as dressing 882, at various times associated with the treatment of a tissue site with an iodine-forming dressing member, such as iodine-forming dressing member 802. For example, in some embodiments, reduced pressure may be delivered to a tissue site prior to the application of the iodine-forming dressing member 802, and thus before the delivery of iodine to the tissue site. In other embodiments, reduced pressure may be applied to a tissue site after the iodine-forming dressing member 802 has been applied to the tissue site, which in some cases may be after iodine has been delivered to the tissue site. Finally, in some embodiments, reduced pressure may be applied to the tissue site while iodine-forming dressing member 802 is applied to the tissue site, and thus while iodine may be being delivered to the tissue site.
The systems, apparatuses, and methods described herein may provide significant advantages, some of which have already been mentioned. For example, the dressing member may improve the controlled release of iodine over time to a wound or tissue site, which may prevent a high uncontrolled dose of iodine from being released. Furthermore, because of these advances, high doses of iodine-forming reagents may be stored in dressings, which may allow the dressings to be applied for longer periods of time or for smaller-sized dressings to be used to deliver the same potential dosage of iodine. Importantly, such dressings may be safer to store, as the elemental iodine is only generated as needed when applied to a wound.
While some exemplary embodiments are described in the context of reduced-pressure therapy applications, many of the features and advantages are readily applicable to other environments and industries.
Although certain illustrative, non-limiting exemplary embodiments have been presented, various changes, substitutions, permutations, and alterations can be made without departing from the scope of the appended claims. Any feature described in connection to any one exemplary embodiment may also be applicable to any other exemplary embodiment.
Further, the steps of the methods described herein may be carried out in any suitable order, or simultaneously where appropriate.
This application is a divisional of U.S. patent application Ser. No. 15/571,356, entitled “Controlled Release Iodine Structure for Use with Wound Care,” filed Nov. 2, 2017, which is a U.S. National Stage Entry of PCT/US2016/031398, filed May 8, 2016, which claims the benefit of the filing of U.S. Provisional Patent Application No. 62/158,321, entitled “Controlled Release Iodine Structure for Use with Wound Care,” filed May 7, 2015, which are incorporated herein by reference for all purposes.
Number | Name | Date | Kind |
---|---|---|---|
1355846 | Rannells | Oct 1920 | A |
2547758 | Keeling | Apr 1951 | A |
2632443 | Lesher | Mar 1953 | A |
2682873 | Evans et al. | Jul 1954 | A |
2910763 | Lauterbach | Nov 1959 | A |
2969057 | Simmons | Jan 1961 | A |
3066672 | Crosby, Jr. et al. | Dec 1962 | A |
3367332 | Groves | Feb 1968 | A |
3520300 | Flower, Jr. | Jul 1970 | A |
3568675 | Harvey | Mar 1971 | A |
3648692 | Wheeler | Mar 1972 | A |
3682180 | McFarlane | Aug 1972 | A |
3826254 | Mellor | Jul 1974 | A |
4080970 | Miller | Mar 1978 | A |
4096853 | Weigand | Jun 1978 | A |
4139004 | Gonzalez, Jr. | Feb 1979 | A |
4165748 | Johnson | Aug 1979 | A |
4184510 | Murry et al. | Jan 1980 | A |
4233969 | Lock et al. | Nov 1980 | A |
4245630 | Lloyd et al. | Jan 1981 | A |
4256109 | Nichols | Mar 1981 | A |
4261363 | Russo | Apr 1981 | A |
4275721 | Olson | Jun 1981 | A |
4284079 | Adair | Aug 1981 | A |
4297995 | Golub | Nov 1981 | A |
4333468 | Geist | Jun 1982 | A |
4373519 | Errede et al. | Feb 1983 | A |
4382441 | Svedman | May 1983 | A |
4392853 | Muto | Jul 1983 | A |
4392858 | George et al. | Jul 1983 | A |
4419097 | Rowland | Dec 1983 | A |
4465485 | Kashmer et al. | Aug 1984 | A |
4475909 | Eisenberg | Oct 1984 | A |
4480638 | Schmid | Nov 1984 | A |
4525166 | Leclerc | Jun 1985 | A |
4525374 | Vaillancourt | Jun 1985 | A |
4540412 | Van Overloop | Sep 1985 | A |
4543100 | Brodsky | Sep 1985 | A |
4548202 | Duncan | Oct 1985 | A |
4551139 | Plaas et al. | Nov 1985 | A |
4569348 | Hasslinger | Feb 1986 | A |
4605399 | Weston et al. | Aug 1986 | A |
4608041 | Nielsen | Aug 1986 | A |
4640688 | Hauser | Feb 1987 | A |
4655754 | Richmond et al. | Apr 1987 | A |
4664662 | Webster | May 1987 | A |
4710165 | McNeil et al. | Dec 1987 | A |
4733659 | Edenbaum et al. | Mar 1988 | A |
4743232 | Kruger | May 1988 | A |
4758220 | Sundblom et al. | Jul 1988 | A |
4787888 | Fox | Nov 1988 | A |
4826494 | Richmond et al. | May 1989 | A |
4838883 | Matsuura | Jun 1989 | A |
4840187 | Brazier | Jun 1989 | A |
4863449 | Therriault et al. | Sep 1989 | A |
4872450 | Austad | Oct 1989 | A |
4878901 | Sachse | Nov 1989 | A |
4897081 | Poirier et al. | Jan 1990 | A |
4906233 | Moriuchi et al. | Mar 1990 | A |
4906240 | Reed et al. | Mar 1990 | A |
4919654 | Kalt | Apr 1990 | A |
4941882 | Ward et al. | Jul 1990 | A |
4953565 | Tachibana et al. | Sep 1990 | A |
4969880 | Zamierowski | Nov 1990 | A |
4985019 | Michelson | Jan 1991 | A |
5037397 | Kalt et al. | Aug 1991 | A |
5086170 | Luheshi et al. | Feb 1992 | A |
5092858 | Benson et al. | Mar 1992 | A |
5100396 | Zamierowski | Mar 1992 | A |
5134994 | Say | Aug 1992 | A |
5149331 | Ferdman et al. | Sep 1992 | A |
5167613 | Karami et al. | Dec 1992 | A |
5176663 | Svedman et al. | Jan 1993 | A |
5215522 | Page et al. | Jun 1993 | A |
5232453 | Plass et al. | Aug 1993 | A |
5261893 | Zamierowski | Nov 1993 | A |
5278100 | Doan et al. | Jan 1994 | A |
5279550 | Habib et al. | Jan 1994 | A |
5298015 | Komatsuzaki et al. | Mar 1994 | A |
5342376 | Ruff | Aug 1994 | A |
5344415 | DeBusk et al. | Sep 1994 | A |
5358494 | Svedman | Oct 1994 | A |
5437622 | Carion | Aug 1995 | A |
5437651 | Todd et al. | Aug 1995 | A |
5527293 | Zamierowski | Jun 1996 | A |
5549584 | Gross | Aug 1996 | A |
5556375 | Ewall | Sep 1996 | A |
5607388 | Ewall | Mar 1997 | A |
5636643 | Argenta et al. | Jun 1997 | A |
5645081 | Argenta et al. | Jul 1997 | A |
6071267 | Zamierowski | Jun 2000 | A |
6135116 | Vogel et al. | Oct 2000 | A |
6241747 | Ruff | Jun 2001 | B1 |
6287316 | Agarwal et al. | Sep 2001 | B1 |
6345623 | Heaton et al. | Feb 2002 | B1 |
6458460 | Griffiths | Oct 2002 | B1 |
6488643 | Tumey et al. | Dec 2002 | B1 |
6493568 | Bell et al. | Dec 2002 | B1 |
6553998 | Heaton et al. | Apr 2003 | B2 |
6814079 | Heaton et al. | Nov 2004 | B2 |
7846141 | Weston | Dec 2010 | B2 |
8062273 | Weston | Nov 2011 | B2 |
8216198 | Heagle et al. | Jul 2012 | B2 |
8251979 | Malhi | Aug 2012 | B2 |
8257327 | Blott et al. | Sep 2012 | B2 |
8398614 | Blott et al. | Mar 2013 | B2 |
8449509 | Weston | May 2013 | B2 |
8529548 | Blott et al. | Sep 2013 | B2 |
8535296 | Blott et al. | Sep 2013 | B2 |
8551060 | Schuessler et al. | Oct 2013 | B2 |
8568386 | Malhi | Oct 2013 | B2 |
8679081 | Heagle et al. | Mar 2014 | B2 |
8834451 | Blott et al. | Sep 2014 | B2 |
8926592 | Blott et al. | Jan 2015 | B2 |
9017302 | Vitaris et al. | Apr 2015 | B2 |
9198801 | Weston | Dec 2015 | B2 |
9211365 | Weston | Dec 2015 | B2 |
9289542 | Blott et al. | Mar 2016 | B2 |
10568770 | Robinson | Feb 2020 | B2 |
20020077661 | Saadat | Jun 2002 | A1 |
20020115951 | Norstrem et al. | Aug 2002 | A1 |
20020120185 | Johnson | Aug 2002 | A1 |
20020143286 | Tumey | Oct 2002 | A1 |
20100249688 | Ambrosio | Sep 2010 | A1 |
20120245540 | Zimnitsky | Sep 2012 | A1 |
20140163491 | Schuessler et al. | Jun 2014 | A1 |
20140255379 | Davis | Sep 2014 | A1 |
20150080788 | Blott et al. | Mar 2015 | A1 |
Number | Date | Country |
---|---|---|
550575 | Mar 1986 | AU |
745271 | Mar 2002 | AU |
155496 | Dec 2002 | AU |
2005436 | Jun 1990 | CA |
26 40 413 | Mar 1978 | DE |
43 06 478 | Sep 1994 | DE |
29 504 378 | Sep 1995 | DE |
0100148 | Feb 1984 | EP |
0117632 | Sep 1984 | EP |
0161865 | Nov 1985 | EP |
0358302 | Mar 1990 | EP |
1018967 | Jul 2000 | EP |
692578 | Jun 1953 | GB |
2195255 | Apr 1988 | GB |
2 197 789 | Jun 1988 | GB |
2 220 357 | Jan 1990 | GB |
2 235 877 | Mar 1991 | GB |
2 329 127 | Mar 1999 | GB |
2 333 965 | Aug 1999 | GB |
4129536 | Aug 2008 | JP |
71559 | Apr 2002 | SG |
8002182 | Oct 1980 | WO |
8704626 | Aug 1987 | WO |
90010424 | Sep 1990 | WO |
93009727 | May 1993 | WO |
9420041 | Sep 1994 | WO |
9605873 | Feb 1996 | WO |
9718007 | May 1997 | WO |
9913793 | Mar 1999 | WO |
WO-03090800 | Nov 2003 | WO |
WO-2012092908 | Jul 2012 | WO |
Entry |
---|
Louis C. Argenta, MD and Michael J. Morykwas, PHD; Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Clinical Experience; Annals of Plastic Surgery; vol. 38, No. 6, Jun. 1997; pp. 563-576. |
Susan Mendez-Eatmen, RN; “When wounds Won't Heal” RN Jan. 1998, vol. 61 (1); Medical Economics Company, Inc., Montvale, NJ, USA; pp. 20-24. |
James H. Blackburn II, MD et al.: Negative-Pressure Dressings as a Bolster for Skin Grafts; Annals of Plastic Surgery, vol. 40, No. 5, May 1998, pp. 453-457; Lippincott Williams & Wilkins, Inc., Philidelphia, PA, USA. |
John Masters; “Reliable, Inexpensive and Simple Suction Dressings”; Letter to the Editor, British Journal of Plastic Surgery, 1998, vol. 51 (3), p. 267; Elsevier Science/The British Association of Plastic Surgeons, UK. |
S.E. Greer, et al. “The Use of Subatmospheric Pressure Dressing Therapy to Close Lymphocutaneous Fistulas of the Groin” British Journal of Plastic Surgery (2000), 53, pp. 484-487. |
George V. Letsou, MD., et al; “Stimulation of Adenylate Cyclase Activity in Cultured Endothelial Cells Subjected to Cyclic Stretch”; Journal of Cardiovascular Surgery, 31, 1990, pp. 634-639. |
Orringer, Jay, et al; “Management of Wounds in Patients with Complex Enterocutaneous Fistulas”; Surgery, Gynecology & Obstetrics, Jul. 1987, vol. 165, pp. 79-80. |
International Search Report for PCT International Application PCT/GB95/01983; dated Nov. 23, 1995. |
PCT International Search Report for PCT International Application PCT/GB98/02713; dated Jan. 8, 1999. |
PCT Written Opinion; PCT International Application PCT/GB98/02713; dated Jun. 8, 1999. |
PCT International Examination and Search Report, PCT International Application PCT/GB96/02802; dated Jan. 15, 1998 & Apr. 29, 1997. |
PCT Written Opinion, PCT International Application PCT/GB96/02802; dated Sep. 3, 1997. |
Dattilo, Philip P., Jr., et al; “Medical Textiles: Application of an Absorbable Barbed Bi-directional Surgical Suture”; Journal of Textile and Apparel, Technology and Management, vol. 2, Issue 2, Spring 2002, pp. 1-5. |
Kostyuchenok, B.M., et al; “Vacuum Treatment in the Surgical Management of Purulent Wounds”; Vestnik Khirurgi, Sep. 1986, pp. 18-21 and 6 page English translation thereof. |
Davydov, Yu. A., et al; “Vacuum Therapy in the Treatment of Purulent Lactation Mastitis”; Vestnik Khirurgi, May 14, 1986, pp. 66-70, and 9 page English translation thereof. |
Yusupov. Yu.N., et al; “Active Wound Drainage”, Vestnki Khirurgi, vol. 138, Issue 4, 1987, and 7 page English translation thereof. |
Davydov, Yu.A., et al; “Bacteriological and Cytological Assessment of Vacuum Therapy for Purulent Wounds”; Vestnik Khirugi, Oct. 1988, pp. 48-52, and 8 page English translation thereof. |
Davydov, Yu.A., et al; “Concepts for the Clinical-Biological Management of the Wound Process in the Treatment of Purulent Wounds by Means of Vacuum Therapy”; Vestnik Khirurgi, Jul. 7, 1980, pp. 132-136, and 8 page English translation thereof. |
Chariker, Mark E., M.D., et al; “Effective Management of incisional and cutaneous fistulae with closed suction wound drainage”; Contemporary Surgery, vol. 34, Jun. 1989, pp. 59-63. |
Egnell Minor, Instruction Book, First Edition, 300 7502, Feb. 1975, pp. 24. |
Egnell Minor: Addition to the Users Manual Concerning Overflow Protection—Concerns all Egnell Pumps, Feb. 3, 1983, pp. 2. |
Svedman, P.: “Irrigation Treatment of Leg Ulcers”, The Lancet, Sep. 3, 1983, pp. 532-534. |
Chinn, Steven D. et al.: “Closed Wound Suction Drainage”, The Journal of Foot Surgery, vol. 24, No. 1, 1985, pp. 76-81. |
Arnljots, Bjöm et al.: “Irrigation Treatment in Split-Thickness Skin Grafting of Intractable Leg Ulcers”, Scand J. Plast Reconstr. Surg., No. 19, 1985, pp. 211-213. |
Svedman, P.: “A Dressing Allowing Continuous Treatment of a Biosurface”, IRCS Medical Science: Biomedical Technology, Clinical Medicine, Surgery and Transplantation, vol. 7, 1979, p. 221. |
Svedman, P. et al: “A Dressing System Providing Fluid Supply and Suction Drainage Used for Continuous of Intermittent Irrigation”, Annals of Plastic Surgery, vol. 17, No. 2, Aug. 1986, pp. 125-133. |
N.A. Bagautdinov, “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of Soft Tissues,” Current Problems in Modern Clinical Surgery: Interdepartmental Collection, edited by V. Ye Volkov et al. (Chuvashia State University, Cheboksary, U.S.S.R. 1986); pp. 94-96 (copy and certified translation). |
K.F. Jeter, T.E. Tintle, and M. Chariker, “Managing Draining Wounds and Fistulae: New and Established Methods,” Chronic Wound Care, edited by D. Krasner (Health Management Publications, Inc., King of Prussia, PA 1990), pp. 240-246. |
G. {hacek over (Z)}ivadinovi?, V. ?uki?, {hacek over (Z)}. Maksimovi?, ?. Radak, and P. Pe{hacek over (s)}ka, “Vacuum Therapy in the Treatment of Peripheral Blood Vessels,” Timok Medical Journal 11 (1986), pp. 161-164 (copy and certified translation). |
F.E. Johnson, “An Improved Technique for Skin Graft Placement Using a Suction Drain,” Surgery, Gynecology, and Obstetrics 159 (1984), pp. 584-585. |
A.A. Safronov, Dissertation Abstract, Vacuum Therapy of Trophic Ulcers of the Lower Leg with Simultaneous Autoplasty of the Skin (Central Scientific Research Institute of Traumatology and Orthopedics, Moscow, U.S.S.R. 1967) (copy and certified translation). |
M. Schein, R. Saadia, J.R. Jamieson, and G.A.G. Decker, “The ‘Sandwich Technique’ in the Management of the Open Abdomen,” British Journal of Surgery 73 (1986), pp. 369-370. |
D.E. Tribble, An Improved Sump Drain-Irrigation Device of Simple Construction, Archives of Surgery 105 (1972) pp. 511-513. |
M.J. Morykwas, L.C. Argenta, E.I. Shelton-Brown, and W McGuirt, “Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Animal Studies and Basic Foundation,” Annals of Plastic Surgery 38 (1997), pp. 553-562 (Morykwas I). |
C.E. Tennants, “The Use of Hypermia in the Postoperative Treatment of Lesions of the Extremities and Thorax,” Journal of the American Medical Association 64 (1915), pp. 1548-1549. |
Selections from W. Meyer and V. Schmieden, Bier's Hyperemic Treatment in Surgery, Medicine, and the Specialties: A Manual of Its Practical Application, (W.B. Saunders Co., Philadelphia, PA 1909), pp. 17-25, 44-64, 90-96, 167-170, and 210-211. |
V.A. Solovev et al., Guidelines, The Method of Treatment of Immature External Fistulas in the Upper Gastrointestinal Tract, editor-in-chief Prov. V.I. Parahonyak (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1987) (“Solovev Guidelines”). |
V.A. Kuznetsov & N.a. Bagautdinov, “Vacuum and Vacuum-Sorption Treatment of Open Septic Wounds,” in II All-Union Conference on Wounds and Wound Infections: Presentation Abstracts, edited by B.M. Kostyuchenok et al. (Moscow, U.S.S.R. Oct. 28-29, 1986) pp. 91-92 (“Bagautdinov II”). |
V.A. Solovev, Dissertation Abstract, Treatment and Prevention of Suture Failures after Gastric Resection (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1988) (“Solovev Abstract”). |
V.A.C.® Therapy Clinical Guidelines: A Reference Source for Clinicians; Jul. 2007. |
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