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.

Description

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 adhesiv...

AI Technical Summary

Benefits of technology

[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.

[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.

Problems solved by technology

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.

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.

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.

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.

A difficulty with these combined adhesive / flexible substrate approaches is in the application and polymerization of the adhesive composition.

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.

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.

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