Surgery – Miscellaneous – Methods
Reexamination Certificate
2000-10-30
2002-05-14
Nguyen, Dinh X. (Department: 3738)
Surgery
Miscellaneous
Methods
Reexamination Certificate
active
06386203
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to sealing media used for wound closure. More particularly, the present invention relates to sealing media of the type useful for bonding adjacent sections of skin separated by percutaneous incision or traumatic injury.
Every year, over 10 million traumatic wounds are treated by emergency physicians in the United States. A great many incisions ranging from a few millimeters to several centimeters in length are closed each year by medical personnel. Countless more less serious wounds are treated by non-medical persons, such as athletic trainers, parents of an injured child, or the injured individual himself.
Small wounds and lacerations may be treated by simply bandaging the wound or by using tape to keep the edges of the wound in apposition. Such methods may be performed with a minimum of time and training, as well as causing little or no additional trauma to the wound or causing the patient additional pain.
More serious wounds or incisions are generally treated by conventional methods such as suturing. Suturing requires the use of a needle and often involves a local anesthetic. Suturing can be costly because it is time-intensive and the procedure requires that the individual performing it have some medical training. Additionally, suturing can be painful and the use of needles may cause further distress for an already traumatized patient, as well as expose medical personnel to potential needlestick injury. Furthermore, because most sutures used topically do not dissolve, the patient generally must make a return visit at a later date for the often uncomfortable procedure of removal of the sutures.
In recent years, cyanoacrylate tissue adhesives have been tried as an alternative for such conventional methods. The most commonly used cyanoacrylates, which include ethyl- and butylcyanoacrylate, have some advantages over suturing, such as faster and less painful closure. They do, however, have several drawbacks. One drawback is that they have a very low viscosity. The low viscosity makes precise application difficult, in that the adhesive flows over areas of the skin surface well beyond the immediate region of the closure and that the adhesive is readily drawn into the wound, effectively creating a barrier between the two tissue surfaces which are desirably rejoined in the natural healing process. Furthermore, certain cyanoacrylate adhesives form a closure which is hard, brittle, and inflexible, and which sets up too quickly to allow for adjustment of the opposing skin surfaces following its application.
Thus, there remains a need for a simple and effective method and composition for effecting wound closure. Preferably, the method and composition can be utilized with minimal training time and risk of error, and will not materially increase complications, immunogenicity, scarring, infection, or other negative factors.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, there is provided a method of closing a percutaneous opening, having a first dermal surface on a first side of the opening and a second dermal surface on a second side of the opening and generally coplanar with the first dermal surface. The method comprises applying an adhesive layer across at least a portion of the first and second dermal surfaces and spanning the opening, wherein the adhesive exhibits a sufficient viscosity to substantially prevent flow of the adhesive into the opening.
In accordance with another aspect of the present invention, there is provided a method of closing and sealing a wound in a patient. The method includes positioning opposing sides of a wound in an adjacent configuration and delivering a wound closure medium comprising an adhesive component and a viscosity enhancing component to the surface of the skin spanning said wound in a quantity sufficient to retain closure of said wound. In the method, the viscosity enhancing component is present in an amount sufficient to substantially prevent the medium from flowing into a gap of about 1 mm or less at normal skin temperature.
In accordance with a further aspect of the present invention, there is provided a method of closing and sealing a wound in a patient. The method comprises the steps of identifying a percutaneous wound having first and second sides, delivering a layer of wound closure media to the surface of skin on each of the first and second sides and across the wound in a quantity sufficient to retain closure and sealing of said would, and restraining the media from entering the wound.
Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.
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