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  Adhesive-containing wound closure device and methodUSPTO Application #: 20060009099Title: Adhesive-containing wound closure device and method Abstract: An article, such as a tissue bonding article, includes a flexible material, a polymerization initiator or rate modifier disposed in or on the flexible material, and a polymerizable adhesive composition permeated throughout at least a portion of the flexible material, where the polymerization initiator or rate modifier is a polymerization initiator or rate modifier for the polymerizable adhesive composition. (end of abstract) Agent: Hutchison & Mason PLLC - Raleigh, NC, US Inventors: Jerry Jonn, Julian Quintero, Glenn Hoskin, Susan L. Roweton USPTO Applicaton #: 20060009099 - Class: 442043000 (USPTO) Related Patent Categories: Fabric (woven, Knitted, Or Nonwoven Textile Or Cloth, Etc.), Scrim (e.g., Open Net Or Mesh, Gauze, Loose Or Open Weave Or Knit, Etc.), Woven Scrim, Coated Or Impregnated The Patent Description & Claims data below is from USPTO Patent Application 20060009099. Brief Patent Description - Full Patent Description - Patent Application Claims
BACKGROUND OF THE INVENTION [0001] 1. Field of Invention [0002] The present invention relates to medical and surgical wound closure and management, and methods for making and using such devices. In particular, the present invention relates to medical and surgical wound closure and management, and related methods, where the tissue bonding article or wound closure device incorporates a polymerizable adhesive material applied to an initiator-loaded textile material. The materials and methods of the present invention provide an improvement over, and a substitute for, conventional bandages, sutures and staples, and provide improved methods for both approximating and covering and/or closing wounds, thus providing improved wound management. [0003] 2. Description of Related Art [0004] There are currently in primary use at least four basic ways for closing wounds resulting from surgical incisions or accidental lacerations. These are sutures, surgical staples, surgical skin tapes, and adhesive compositions. Sutures are generally recognized as providing adequate wound support for the duration of wound healing. However, suturing involves additional trauma to the wound, as the needle and suture material must be passed through the tissue at the margins of the wound. In addition, suturing can cause cosmetically unattractive wound closure marks, can be time consuming, and, depending on techniques and types of sutures used, may require removal. Such removal entails further medical attention and can involve additional pain and trauma to the patient particularly if the sutures become embedded in the wound. In some cases, suture removal can require anesthetic, and can result in a railroad track appearance at the wound site. [0005] Surgical staples have disadvantages similar to sutures in terms of cosmetic result. However, staples are generally believed to be even worse then sutures, at least in terms of the pain and trauma inflicted on the patient, and the resultant cosmetic appearance of the staple and wound marks. Further, removal of the staples can be painful and, depending on location and patient pain threshold, may require topical anesthetics. [0006] Skin closure strips, such as conventional adhesive bandages, are utilized for closure of relatively superficial skin wounds, but their use is limited to only certain types and degrees of wounds. However, the contact adhesives that are used with such strips typically retain holding power for no more than a day or two and can lose holding power quickly in the presence of moisture, for example, perspiration. [0007] Direct application of adhesives has also been proposed and used for wound closure purposes, especially involving cyanoacrylate adhesives. Such materials are achieving more widespread use for wound closure. [0008] For example, monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the .alpha.-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made .alpha.-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues. [0009] It is known that monomeric forms of .alpha.-cyanoacrylates are extremely reactive, polymerizing rapidly in the presence of even minute amounts of an initiator, including moisture present in the air or on moist surfaces such as animal tissue. Monomers of .alpha.-cyanoacrylates are anionically polymerizable or free radical polymerizable, or polymerizable by zwitterions or ion pairs to form polymers. Once polymerization has been initiated, the cure rate can be very rapid. [0010] Medical applications of 1,1-disubstituted ethylene adhesive compositions include use as an alternate or an adjunct to surgical sutures and staples in wound closure as well as for covering and protecting surface wounds such as lacerations, abrasions, burns, stomatitis, sores, and other surface wounds. When an adhesive is applied, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond. [0011] For example, polymerizable 1,1-disubstituted ethylene monomers, and adhesive compositions comprising such monomers, are disclosed in U.S. Pat. No. 5,328,687 to Leung et al. Suitable methods for applying such compositions to substrates, and particularly in medical applications, are described in, for example, U.S. Pat. Nos. 5,582,834, 5,575,997, and 5,624,669, all to Leung et al. [0012] Combinations of the above approaches have also been used in the art. For example, attempts have been made to combine the use of sutures or staples and adhesive compositions. See, for example, U.S. Pat. No. 5,254,132. Likewise, attempts have been made to combine the use of conventional bandages or tapes and adhesive compositions. See, for example, U.S. Pat. Nos. 5,259,835 and 5,445,597. However, these approaches have typically met the same issues as described above for the individual approaches, namely difficulties arising from the use of the sutures, staples and/or bandages or tapes. [0013] Current approaches for combining the above wound closure approaches also include combining the use of adhesive compositions and bandage-like dressings. For example, U.S. Patent Publications Nos. 2002-0049503 and 2004-0106888 each disclose the combined use of adhesive compositions and mesh bandage-like materials. In each case, a mesh-like structure is applied to a wound, and an adhesive composition is applied to the mesh-like structure. When the adhesive composition sets, it bonds the mesh-like structure to the wound. In U.S. Patent Publication No. 2004-0106888, the wound dressing includes removable ends that adhere the mesh-like structure to the wound, but which can be removed after the adhesive composition sets, leaving the adherent dressing in place. [0014] Commonly assigned U.S. patent application Ser. No. 10/779,721, filed Feb. 18, 2004, also discloses a combined adhesive composition and bandage-like dressing. The application discloses a tissue bonding article, comprising: a flexible material; an adhesive substance applied over at least a portion of a bottom side of said flexible material, for at least temporarily adhering the flexible material to a wound surface; and a polymerizable adhesive composition permeated throughout at least a portion of said flexible material. When the polymerizable adhesive polymerizes, the flexible material is adhered to the wound surface to provide an adherent composite dressing. The entire disclosure of this application is incorporated herein by reference. [0015] A difficulty with these combined adhesive/flexible substrate approaches is in the application and polymerization of the adhesive composition. For example, where a polymerizable adhesive composition is applied to the substrate, the adhesive is either applied from an applicator device that includes a polymerization initiator, or the adhesive composition (which contains no initiator) is applied to the flexible substrate and wound site where polymerization is initiated by moisture or other fluids present at the wound site. In the first instance, polymerization of the adhesive composition is rapid, but the presence of the polymerization initiator in the applicator device creates a short working time, requiring that the adhesive composition be applied rather quickly. In the second instance, the working time of the adhesive composition is longer because the applicator device does not include a polymerization initiator. However, polymerization of the adhesive composition on the wound site is typically much longer and less consistent because polymerization relies upon weaker species (such as moisture or other natural substances present on the skin and not added specifically for polymerization initiation) that may be present in differing amounts. [0016] Accordingly, a need continues to exist for improved materials and methods for wound approximation. A need also continues to exist for improved materials and methods that have a wider range of applications, from external to internal use, and from essentially non-biodegradable (where the materials are removed from the application site) to biodegradable (where the materials are not directly removed from the application site, but instead degrade over time). SUMMARY OF THE INVENTION [0017] The present invention addresses the above needs in the art, and others, by providing improved materials and methods for wound management, bonding, and approximation. [0018] In embodiments, the materials and methods of the present invention provide significant advantages over the current materials and methods for wound closure. The materials and methods of the present invention can fully replace the use of bandages, sutures, and/or staples on a variety of wounds and tissue surfaces. These advantages include, among others, improved wound closure, improved wound approximation, provision of an improved durable microbial barrier, reduced procedure time, improved working time, improved cosmesis, less pain (during staple/suture removal) resulting in increased patient satisfaction, and improved financial/economic outcomes by eliminating follow-up visits for staple/suture removal. [0019] In embodiments, the materials and methods of the present invention also provide significant advantages in terms of application of the wound closure device. In particular, because the flexible material is loaded with initiator for the subsequently applied polymerizable adhesive material, the polymerizable adhesive material rapidly and uniformly polymerizes on and in the flexible material to form an adherent device, but without unacceptably high heat generation. This faster set time (the time between application and substantial polymerization of the polymerizable adhesive material) means that wound closure can be quickly effected. Furthermore, because the flexible material is loaded with initiator for the subsequently applied polymerizable adhesive material, the polymerizable adhesive material does not need to be applied in a mixed state including initiator or through an applicator device that provides an initiator. As such, the working time (the time during which the polymerizable adhesive material can be applied before becoming polymerized in the applicator) is unlimited. [0020] In an embodiment, the present invention provides an article, comprising: a flexible material; a polymerization initiator or rate modifier disposed in or on said flexible material; and a polymerizable adhesive composition permeated throughout at least a portion of said flexible material, wherein said polymerization initiator or rate modifier is a polymerization initiator or rate modifier for said polymerizable adhesive composition. The article can be a tissue bonding article for bonding tissue surfaces, or can be used in other applications. [0021] In another embodiment, the present invention provides a method of bonding tissue, comprising: placing a flexible material over a substrate, wherein a polymerization initiator or rate modifier disposed in or on said flexible material; applying a polymerizable adhesive composition over and substantially covering at least a portion of the flexible material; and allowing the polymerizable adhesive composition to permeate into and under the flexible material and polymerize to form a composite structure bonded to said substrate. [0022] The composite structures of the present invention, when used as tissue bonding articles, can be used to bond a variety of tissue ranging from hard tissue (such as bone) to soft tissue (such as skin, organs, mucous membranes, and the like). The tissue can be either internal or external. Continue reading... Full patent description for Adhesive-containing wound closure device and method Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Adhesive-containing wound closure device and method patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Adhesive-containing wound closure device and method or other areas of interest. ### Previous Patent Application: Inflatable object with an illuminating device Next Patent Application: Waterproofing membrane Industry Class: Fabric (woven, knitted, or nonwoven textile or cloth, etc.) ### FreshPatents.com Support Thank you for viewing the Adhesive-containing wound closure device and method patent info. 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