Patent Application
20090152137
Surgical site infections (SSI) occur following about 2-3 percent of surgeries in the United States with an estimated 500,000 incidents of SSI occurring annually, which can lead to significant patient morbidity and mortality. In addition to the negative impact of such infections on patient health, these potentially avoidable infections contribute significantly to the financial burden experienced by the health care system. SSIs result when an incision becomes contaminated by bacteria, and for most surgeries the primary source of these infection-causing microorganisms is the skin (an exception being surgeries in which the gastrointestinal tract is penetrated).
Various compositions are used to prepare the skin prior to surgery. Skin preparations or “preps” are used to remove some level of microbial load on the skin prior to making an incision. Skin preps are applied to the skin and allowed to dry to maximize effectiveness for reducing microorganisms. After the skin prep has dried, a clear drape may be positioned over the area of the skin in which an incision will be made. Referred to as an “incise drape,” such a drape frequently also has an antimicrobial agent formed therewith and/or applied thereto, to reduce the introduction of microorganisms into the incision.
Such skin preps currently are predominantly povidone-iodine or chlorhexidine gluconate based formulations and may contain alcohol for fast drying and more effective killing of organisms. Time constraints in the operating room may result in the skin remaining wet when draping and/or surgery begin, creating the possibility of infection. Drawback are present in the incise drape as well.
The incise drape is clear, flexible, and has an adhesive surface. When it is applied to a patient, the incise drape conforms to and adhesively seals against a patient's skin. However, it is common to see a plurality of small pockets of air that are trapped between the incise drape and the patient's skin. Such air pockets permit undesirable microorganisms to contaminate in and around the incision.
Skin sealant materials are used to protect patients from bacterial infections associated with surgical site incisions and insertion of intravenous needles. Skin preps are applied to the skin and allowed to dry to maximize effectiveness for reducing microorganisms. After the skin prep has dried, the sealant may be applied directly to the skin in liquid form. The sealant forms a coherent film with strong adhesion to the skin through various techniques based on the chemistry of the sealant composition.
Skin sealants now use a polymer composition that dries to form a film through evaporation of a solvent, for example. Other skin sealants contain monomeric units that polymerize in situ to from a polymeric film. Cyanoacrylate sealants containing alkyl cyanoacrylate monomer are an example of the latter type wherein the monomer polymerizes in the presence of a polar species such as hydroxide, water or protein molecules to form an acrylic film. The resulting film formed serves to immobilize bacterial flora found on the skin and prevents their migration into an incision made during a surgical procedure or skin puncture associated with insertion of an intravenous needle.
Skin sealants may contain additives such as plasticizing agents to improve film flexibility and conformance, viscosity modifiers to aid in application of the liquid composition, free radical and anionic scavengers to stabilize the product prior to use, biocidal agents to kill immobilized bacteria under the film, and the like. Therefore, skin sealants often replace incise drapes due to their advantages. Such skin sealants do have disadvantages.
Drapes surrounding the skin sealant must be taped or adhesively coupled to the edge of the skin sealant. Such taping or adhesion is awkward, time consuming, and does not always assure a good seal and/or anchor of the surrounding drapes to the area of the incision. When such a seal on a drape is breached or opened, the opportunity for contamination from such an opening to migrate to the incision is present. This is unlike an incise drape, which seals over the incision, the site adjacent the incision and also to the surrounding drapes. In this manner, the incise drape acts as an anchor to secure and hold in place all of the drapes used about the surgical site.
Therefore, there is a need to combine the advantages of a skin sealant with the advantages of an incise drape. Such combination, however, necessarily needs to preserve the advantages while substantially removing the disadvantages.
In response to the difficulties and problems discussed herein, a combination drape is provided. The drape includes a skin sealant and an incise drape. The skin sealant is disposed on the incise drape and the combination skin sealant and incise drape is applied to a patient's skin such that the skin sealant is positioned adjacent the skin and the incise drape is positioned over the skin sealant and the skin. The skin sealant substantially fills contours of the incise drape positioned thereover such that any air pockets and wrinkles positioned between the incise drape and the skin sealant are sealed and isolated from the skin.
In another aspect of the invention, a kit for draping an incision site is provided. The kit includes a combination drape, including a skin sealant and an incise drape. The kit also includes Instructions. The skin sealant is disposed on the incise drape and the combination skin sealant and incise drape is applied to a patient's skin such that the skin sealant is positioned adjacent the skin and the incise drape is positioned over the skin sealant and the skin. The skin sealant substantially fills contours of the incise drape positioned thereover such that any air pockets and wrinkles positioned between the incise drape and the skin sealant are sealed and isolated from the skin. The instructions provide guidance on the selection and sequence of use of items in the kit.
As used herein the following terms have the specified meanings, unless the context demands a different meaning, or a different meaning is expressed; also, the singular generally includes the plural, and the plural generally includes the singular unless otherwise indicated.
As used herein, the terms “comprise”, “comprises”, “comprising” and other derivatives from the root term “comprise” are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof. Similarly, the terms “include”, “includes”, “has” and/or “have”, and derivatives thereof, are intended to be interpreted as the word “comprise”, and are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof.
As used herein, the term “layer” when used in the singular can have the dual meaning of a single element or a plurality of elements.
As used herein the terms “bonded” and “bonding” refer to the joining, adhering, connecting, attaching, or the like of two elements. Two elements will be considered to be bonded together when they are bonded directly to one another or indirectly to one another, such as when each is directly bonded to intermediate elements. Such bonding may occur for example, by adhesive, thermal or ultrasonic methods.
As used herein, the term “film” may refer to a breathable film or a nonbreathable film. A film layer used as a portion of the fabric described herein can be formed of any film that can be suitably bonded or attached to top and/or bottom layers of the fabric or nonwoven to yield a barrier material having the unique combination of performance characteristics and features described herein. Such a film layer is desirably formed from a polymer.
As used herein, the term “contaminant” shall mean a chemical agent or biological organism/pathogen that can potentially harm a human being or animal.
As used herein, the term “liquid” refers to any liquid, fluid, or mixture of gas and liquid; various types of aerosols and particulate matter may be entrained with such liquids.
As used herein, the term “couple” includes, but is not limited to, joining, connecting, fastening, linking, tying, adhering (via an adhesive), or associating two things integrally or interstitially together.
As used herein, the term “configure” or “configuration”, and derivatives thereof means to design, arrange, set up, or shape with a view to specific applications or uses. For example: a military vehicle that was configured for rough terrain; configured the computer by setting the system's parameters.
As used herein, the terms “substantial” or “substantially” refer to something which is done to a great extent or degree; a significant or great amount; for example, as used herein “substantially” as applied to “substantially” covered means that a thing is at least 70% covered.
As used herein, the term “alignment” refers to the spatial property possessed by an arrangement or position of things in a straight line or in parallel lines.
As used herein, the terms “orientation” or “position” used interchangeably herein refer to the spatial property of a place where or way in which something is situated; for example, “the position of the hands on the clock.”
As used herein, the term “about” adjacent to a stated number refers to an amount that is plus or minus ten (10) percent of the stated number.
These terms may be defined with additional language in the remaining portions of the specification.
Reference will now be made in detail to one or more embodiments of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the invention include these and other modifications and variations as coming within the scope and spirit of the invention.
Turning now to the drawings as illustrated in
Skin preparations or “preps” are used to remove some level of microbial load on the skin prior to making an incision. Skin preps are applied to the skin and allowed to dry to maximize effectiveness for reducing microorganisms. Skin preps currently are predominantly povidone-iodine or chlorhexidine gluconate based formulations and may contain alcohol for fast drying and more effective killing of organisms. Povidone iodine, available commercially as Betadine® is estimated to be used in 80 percent of surgeries as a skin preparation. Betadine® skin prep is an aqueous solution of 10 percent povidone iodine having 1 percent titratable iodine content. When Betadine® skin prep is applied to the skin, it imparts an orange-brown see-through color tint. It is necessary to permit the skin prep to completely dry, before the combined skin sealant and incise drape is applied to the prepped skin. Skin sealant materials are used to protect patients from bacterial infections associated with surgical site incisions and insertion of intravenous needles.
Skin sealants are often applied directly over or on top of (Betadine®) skin preps. The sealant forms a coherent film with strong adhesion to the skin through various techniques based on the chemistry of the sealant composition. The skin sealants used herein contain a film former and a plasticizer and other optional ingredients like viscosity modifiers to aid in application of the liquid composition, free radical and anionic scavengers to stabilize the product prior to use, biocidal agents to kill immobilized bacteria under the film, and the like.
One film former available in a skin sealant composition is commercially known as InteguSeal® and is available from Medlogic Global, Ltd of Plymouth, England. InteguSeal® skin sealant contains medical grade n-butyl cyanoacrylate monomer (80% w/w). Medical grade cyanoacrylate is double distilled. Non-medical grade cyanoacrylate, in contrast, is single distilled and is typically marketed as a “super glue” type adhesive for gluing a wide variety of substrates together.
Incise drapes are often applied over or on top of (Betadine®) skin preps. Incise drapes usually have an antimicrobial agent applied to and/or formed with the drape. Incise drapes also have an adhesive applied substantially to one side of the drape, that is, the portion of the drape that is positioned against a patient's prepped skin. Such incise drapes are clear but often have a tint, such as a slightly orange-brown tint, due to the antimicrobial agent. One incise drape available is commercially known as Ioban™ and is available from 3M Corporation, St. Paul, Minn.
In the present invention, a skin sealant, such as, for example, but not by way of limitation, Integuseal® is combined with an incise drape, such as, for example, but not by way of limitation, Ioban™. The skin sealant 12 is positioned on the incise drape 14 to provide the combined skin sealant and incise drape 10 (hereinafter “combined drape” or “combination drape”).
Turning now generally to
Alternatively, a portion 28 adjacent the outer peripheral edge 20 of the incise drape 14 which extends a distance toward the central area 26 of the incise drape 14 is formed to provide a thicker incise drape 14 near the outer peripheral edge 20, and a thinner area of the incise drape 14 is provided in the central area 26 such that the reservoir 24 is formed in the thinner area (
A skin sealant 12 is desirably positioned in the reservoir 24. The skin sealant 12 is held in place and maintained in a non-hardened position in the reservoir 20 of the incise drape 14 by a cover 30, as shown in
To apply the combined drape 10 to a patient's prepped skin 38, the cover 30 is removed to expose the skin sealant 12 (
When the surgery is nearing completion, the incise drape 14 may be removed before final sutures, staples, or other closing materials are applied to close the incision. In most instances, when the incise drape 14 is removed, the skin sealant 12 will substantially peel away from the incision area as well, thereby substantially removing the combined drape 10 (not shown). In some instance, this is a desired result.
In other instances, it may be desirable for the skin sealant 12 to remain in place about the incision site. When it is desirable to leave the skin sealant 12 in place about the area of the incision, the reservoir 24 of the incise drape 14 may be modified.
Such modification may be in the form of a thin piece of polymer film 42, shown in
The combined drape 10 may be provided with several variations: one with the polymer film 42 sealed to the incise drape 14 in the reservoir 24, and one without. The polymer film 42 coupled to the incise drape 14 in the reservoir 24 permits the skin sealant 12 to remain on and about the incision site even after the incise drape 14 of the combined drape 10 is removed. In addition, any portions of the skin sealant 12 which extend beyond the area of the polymer film 42 will be substantially removed with the incise drape 14 as well. When the combined drape 10 is provided without the polymer film 42 positioned against the reservoir of the incise drape 14, it is understood that the combined drape 10 (incise drape 14 and a substantial portion of the skin sealant 12) is removed together. Further, as previously described, the combined drape 10 may be provided with a porous film 36 included with the skin sealant 12 to provide a more evenly placed skin sealant 12 within the reservoir 24 and when applied to the prepped skin 38. Alternatively, the combined drape 10 may be provided without the porous film 36 included with the skin sealant 12. In a further alternative, the porous film 36 may be provided as a separate element or component in a package, and its use or non-use may be decided at the time the package is opened and the combined drape 10 is utilized.
The combined drape 10 may be provided in a kit or package 46, as illustrated in
In another embodiment of the present invention, the combined drape 110 is provided in a package 146, as illustrated in
In this embodiment, the incise drape 114 may have one or a combination of any of the previously described features provided therewith. Alternatively, however, the incise drape 114 may be covered across at least substantially its entirety by a peel strip 122, or the incise drape may be provided without a peel strip and rolled, folded, and so forth, to protect its adhesive lower surface 118 (not shown).
The incise drape 14 may include one or any combination of the features already discussed (i.e., peel strips and/or portions of the incise drape formed in such a manner as to provide at least a portion of a reservoir 24). Alternatively, the incise drape 114 may be provided without a reservoir. The skin sealant 12 is applied to the incise drape 114 after at least a portion of the peel strip 122 is removed, or after a portion of the adhesive lower surface 18 of the incise drape 114 is exposed. The skin sealant 12 and/or the incise drape 114 may or may not form a reservoir 24 upon the application of the skin sealant 12 to the incise drape 114.
In this embodiment, the package 146 may also contain a piece of polymer film 42 to place in the reservoir 24 or on the central area 26 of the incise drape 114 which is to receive the skin sealant 12, if it is desired to remove the incise drape 114 and leave the skin sealant 12 in place after the surgery is completed. In addition, a piece of clear porous film 36 may be provided separately to use along with the skin sealant 12 so that the skin sealant 12 is dispersed evenly across the reservoir 24 or central area 26 of the incise drape 114. Alternatively, the porous film 36 may be provided with the skin sealant 12 in the same container 150, and both may be applied to the incise drape 114 together.
The kit or package 146 may also provide instructions 148 for use. Such instructions 146 may be provided separately, as shown, or may be printed on the package 146 (not shown). Such instructions 148 provide guidance as to the separate components of the combined drape 110, the selection and/or sequence of their use and/or removal, and indications for use or non-use, so that the combined drape 110 and the components thereof are utilized in an appropriate and desired manner.
As illustrated in
The use of the incise drape 14, 114 with the skin sealant 12 removes the disadvantage of the skin sealant 12, which is unable to act to stabilize, support, and anchor the surrounding drapes relative to the incision site. Tape, and/or adhesive on the surrounding drapes, are usually used to adhere to the skin sealant 12. However, it is easier for tape or adhesive on the drapes to have breaches or openings in the connection therebetween which are not readily apparent, and which may provide contaminants to the incision site. Further, it is easier to destabilize the overall surgical site when separate drapes can fail to remain adhered to the skin sealant 12. Again, this occurrence can result in contamination to the incision site. The use of the incise drape 14, 114 over the skin sealant 12, and its use to uniformly adhere and connect to the surrounding drapes, provides greater stability to the entire set of surgical drapes, thereby reducing the opportunity for contamination to the incision site.
The use of an incise drape with a skin sealant appears time consuming, more expensive, and redundant. That is, both are provided to do essentially the same job: cover an incision and the surrounding area. Therefore, this redundancy has been seen as a legitimate disadvantage, and each was used separately. And, the disadvantages of each remained a problem to be solved. Only after experimental, confidential use was it discovered that the incise drape and the skin sealant together created a synergy and cooperation. It was recognized that each substantially overcame the disadvantages of the other.
While the present invention has been described in connection with certain preferred embodiments it is to be understood that the subject matter encompassed by way of the present invention is not to be limited to those specific embodiments. On the contrary, it is intended for the subject matter of the invention to include all alternatives, modifications and equivalents as can be included within the spirit and scope of the following claims.
