Patent Application
20190274902
The present invention pertains to an integrated wound dressing device for treatment of an insertion site of percutaneous and drug delivery devices.
Intravascular (IV) catheters are widely used in clinical situations. All patients with IV catheters risk developing complications related to catheter placement. Among the many complications reported, infection is the most problematic. When skin is compromised, such as during catheter insertion, it provides a path for bacteria to migrate along the catheter wall and cause an infection. This bacterial migration is further facilitated by catheter movement and micropistoning. The estimates of the occurrences of Central Line Blood Stream Infections (CLABSIs) in the United States is approximately 250,000 cases per year. These infections are associated with a high mortality rate (12-25%) and extended hospital stays of an additional 9-12 days. This can result in an increase of the cost of treatment by $34,000-$56,000 per patient.
Recently, a product that incorporates antimicrobial properties and is placed around the catheter insertion site, has been introduced in the clinical practice. The product is design to decrease bacterial flora on the skin surface around the catheter insertion site. The product comes in a form of circular patch made of synthetic and biopolymer composite foam/sponge impregnated with Chlorohexidine Gluconate (CHG). The product is referred to by its trademark, BIOPATCH™. However, BIOPATCH™ is non-transparent and it does not have an adhesive on its lower/patient side. It is secured around the insertion site by secondary transparent film with adhesive. A transparent film dressing that permits a visual observation of catheter insertion site is disclosed in U.S. Pat. No. 5,372,589. The product utilizing this patent is sold under the trademark SorbaView SHIELD™, but it is for a transparent dressing alone. U.S. Pat. No. 5,833,665 discloses a non-transparent foam pad with an adhesive layer on the bottom/patient side. U.S. Pat. No. 8,969,649 discloses a transparent film with acrylic adhesive impregnated with CHG
The use of these commercially available products has decreased the potential for infection, but it could be further decreased. One way to achieve a further decrease is to detect a local infection at its very beginning stage before it spreads systemically. The first sign of local infection is often local skin redness accompanied with elevated skin temperature around the insertion site. Thus, a device that aids in early detection of infections at catheter insertion sites is desired.
The present invention pertains to an integrated wound dressing device for treatment of an insertion site of percutaneous and drug delivery devices. The integrated wound dressing device preferably comprises a transparent film layer having a bottom side, a top side and a perimeter. The bottom side is coated with an adhesive impregnated with an antimicrobial agent. The transparent film has a radius cutout between a central opening and the perimeter. A liquid crystal temperature sensitive film with an adhesive placed on the top side of the transparent film layer is preferably near and around the central opening. The dressing also has a layer of double folded release paper below the bottom side of the transparent film layer. The preferred TLCs used are cholesteryl esters with a preferable temperature detection range of 35-40° C. The preferred antimicrobial agent is chlorohexidine gluconate (CHG).
The objects and features of the present invention, which are believed to be novel, are set forth with particularity in the appended claims. The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description, taken in connection with the accompanying drawings.
Various embodiments are now described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of one or more embodiments. It may be evident, however, that such embodiment(s) may be practiced without these specific details.
In the following paragraphs, the present invention will be described in detail by way of example with reference to the attached drawings. Throughout this description, the preferred embodiment and examples shown should be considered as exemplars, rather than as limitations on the present invention. As used herein, the “present invention” refers to any one of the embodiments of the invention described herein, and any equivalents. Furthermore, reference to various feature(s) of the “present invention” throughout this document does not mean that all claimed embodiments or methods must include the referenced feature(s). The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventors of carrying out their invention. Various modifications, however, will remain readily apparent to those skilled in the art, since the general principles of the present invention have been defined herein specifically to provide an improved integrated wound dressing device for treatment of an insertion site of percutaneous and drug delivery devices.
The invention preferably incorporates Temperature Sensitive Liquid Crystal (TLC) carrier with antimicrobial carrier, for early detection of local infection, by displaying changes in skin temperature around catheter insertion site. This integrated device preferably provides: a delivery of antibacterial agent around the catheter insertion site, a removal of exudate from around the insertion site, and a detection of changes in skin temperature around the insertion site.
Delivery of antimicrobial agents is preferably obtained by incorporating substances like CHG with sponge like materials, copolymers films or castings and adhesives. Some examples of other antimicrobial agents that can be used are: Chlorohexidine acetate, silver iodine, silver bromide, nano-particulate metallic silver, benzo conium chloride, and triclosone.
Removal of exudate is preferably done by selecting a transparent film or casting that has the most adequate ratio of static fluid absorption and gas/vapor transmission.
Change in temperature is preferably observed by placing TLC film in different areas over the antimicrobial transparent film, or by mixing non-toxic mixtures of TLC with CHG within co-polymers or adhesives. The TLC, in order to function properly, is preferably protected from the environment. This protection can be achieved by:
The preferred urethane compounds for this invention are polyols, polyamines, polyamides or other suitable compounds. The preferred TLCs used are cholesteryl esters such as chloride, iodide, bromide, cinnamate, oleyl carbonate, acetate, nonanoate, hexanoate, linolineate, oleate, laurate, caproate, myristrate, hydrogen phthalate, benzoate, and others disclosed in U.S. Pat. No. 3,872,050. Different temperature ranges can be detected using different mixtures or rations of several TLC compounds in a single formulation or using a multilayer dispersion of several specific TLC. The temperature range is preferably 35-40 degrees Celsius (° C.).
To obtain better visibility of changes in colors, as a result in changes in temperature, the following can be performed: 1.) Polymerized temperature sensitive compound can be deposited on a dark background film; 2.) A carbonaceous black powder can be mixed during the TLC dispersion process; or, 3.) carbonaceous powder can be mixed during the microencapsulation process.
Referring now to
[12] Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Referring now to
Thus, an improved integrated wound dressing device for treatment of an insertion site of percutaneous and drug delivery devices is described above. In each of the above embodiments, the different positions and structures of the present invention are described separately in each of the embodiments. However, it is the full intention of the inventor of the present invention that the separate aspects of each embodiment described herein may be combined with the other embodiments described herein. Those skilled in the art will appreciate that adaptations and modifications of the just-described preferred embodiment can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.
Various modifications and alterations of the invention will become apparent to those skilled in the art without departing from the spirit and scope of the invention, which is defined by the accompanying claims. It should be noted that steps recited in any method claims below do not necessarily need to be performed in the order that they are recited. Those of ordinary skill in the art will recognize variations in performing the steps from the order in which they are recited. In addition, the lack of mention or discussion of a feature, step, or component provides the basis for claims where the absent feature or component is excluded by way of a proviso or similar claim language.
While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example architectural or other configuration for the invention, which is done to aid in understanding the features and functionality that may be included in the invention. The invention is not restricted to the illustrated example architectures or configurations, but the desired features may be implemented using a variety of alternative architectures and configurations. Indeed, it will be apparent to one of skill in the art how alternative functional, logical or physical partitioning and configurations may be implemented to implement the desired features of the present invention. Also, a multitude of different constituent module names other than those depicted herein may be applied to the various partitions. Additionally, with regard to flow diagrams, operational descriptions and method claims, the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise.
Although the invention is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead may be applied, alone or in various combinations, to one or more of the other embodiments of the invention, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments.
Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.
A group of items linked with the conjunction “and” should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as “and/or” unless expressly stated otherwise. Similarly, a group of items linked with the conjunction “or” should not be read as requiring mutual exclusivity among that group, but rather should also be read as “and/or” unless expressly stated otherwise. Furthermore, although items, elements or components of the invention may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated.
The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “module” does not imply that the components or functionality described or claimed as part of the module are all configured in a common package. Indeed, any or all of the various components of a module, whether control logic or other components, may be combined in a single package or separately maintained and may further be distributed across multiple locations.
As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives may be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
