Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Reexamination Certificate
2000-06-30
2002-11-12
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
C602S042000, C606S213000, C606S214000, C424S078250, C424S078310, C424S078320, C424S078360
Reexamination Certificate
active
06479725
ABSTRACT:
TECHNICAL FIELD
This invention relates generally to the treatment of a wound or incision. More particularly, this invention relates to the treatment of a wound or incision via the application of a cyanoacrylate material for use on lacerations, incisions and wound sites.
BACKGROUND OF THE INVENTION
In the medical field, there are several methods currently known for use in the treatment and closing of wounds that result from surgical incisions, lacerations, punctures and the like. In particular, devices such as sutures, surgical staples, surgical skin tapes, and adhesives have been used to assist in the closure of different types of wounds. Many of these devices have several shortcomings, however. For example, sutures and surgical staples involve adding additional trauma to the wound since the needle or staple must be passed through tissue on the edges of the wound site. This results in increased scarring due to the fact that the sutures or staples will cause an increase in the tension at the site. When sutures and staples are used, the body responds by increasing the rate of reepithelilization to the wound site. This reepithelilization increases the amount of scarring that develops around the site. Furthermore, in the case of sutures or surgical staples, these items often have to be removed in a second procedure, resulting in added inconvenience and potential discomfort to the patient. Surgical strips, on the other hand, are typically only used for superficial wounds since the adhesives that are used with the strips have a relatively low holding power and will become loose or fall off the site rather easily, particularly when in the presence of moisture.
For these reasons, it has become more common for medical personnel to apply adhesives directly to a wound or incision site. For example, 1-butyl cyanoacrylates, commonly sold under the names Indermil™ and Histacryl Blue™, have been used to aid in the closure of wounds and lacerations. These materials are directly applied to the wound site and permit the wound to heal over time without the use of sutures, surgical staples or surgical skin tapes. The use of 1-butyl cyanoacrylates, however, is also fairly limited. First, 1-butyl cyanoacrylates, although originally in a liquid form, set upon the skin almost immediately. If the medical personnel applying the material apples it incorrectly, he or she will not have the opportunity to remove the material from the patient before it sets. Additionally, 1-butyl cyanoacrylates become very brittle once they are set. at the wound site. As a result, the material cannot flex in conjunction with skin movement. Furthermore, the brittleness of 1-butyl cyanoacrylates prevents the substance from being used on wounds that are longer than about one inch. or 25.4 millimeters in length.
Another type of material that is used in the medical field is 2-octyl cyanoacrylate, which is sold under the commercial name Dermabond™ by Ethicon, Inc. Dermabond™ adhesive is a glue that can be used on any low-tension area of the body for wounds of varying lengths and sizes. Currently, the recommended and approved technique for applying Dermabond™ adhesive to a wound site is to apply three thin layers of Dermabond™ adhesive over the top of the wound. Each layer extends approximately five millimeters to each side of the wound's edge.
2-octyl cyanoacrylate has been found to have superior strength and flexibility when used as a dressing for low-tension wounds. When used on a low-tension wound, 2-octyl cyanoacrylate will decrease the overall surface tension, which in turn reduces the amount of reepithelilization and scarring at the wound or incision site. When used on a high-tension wound, however, 2-octyl cyanoacrylate may actually increase the amount of tension at the wound site due to the increase in tension that occurs when a recently-opened wound is resealed. In the case where an incision is made, the amount of pressure resulting from resealing the wound will increase significantly. An increase in tension may also occur when the wound is located an area that undergoes a large amount of flexing, such as knee and elbow joints. In fact, it is possible that using 2-octyl cyanoacrylate at a high tension wound site via conventional methods may result in more scarring than would otherwise occur through the use of sutures. Furthermore, the use of 2-octyl cyanoacrylate via conventional methods can also result in dehiscence of the wound at the edge of the dressing material.
Additionally, when 2-octyl cyanoacrylate is used in a conventional manner, users often have a tendency to pick at the edge of the surface around the wound, resulting in the material peeling away from the wound site and impeding the healing process. This is particularly problematic in the case of pediatric patients, mentally ill patients and the elderly, all of whom may be more likely to pick at the wound covering.
SUMMARY OF THE INVENTION
A method for forming an incision or wound dressing comprises the application of first, second, and third layers 2-octyl cyanoacrylate adhesive to a wound or incision site, with each layer covering the site and extending to at least about five millimeters from each side of the site. After the first, second, and third layers are allowed to polymerize, a fourth layer of 2-octyl cyanoacrylate adhesive is applied, the fourth layer substantially covering at least one millimeter of the extending edge of the first, second, and third layers. In the case of a high-tension wound or a wound near a joint, the fourth layer extends at least about ten millimeters from each side of the site, and a fifth layer of 2-octyl cyanoacrylate adhesive is applied. The fifth layer substantially covers at least one millimeter of the extending edge of the first, second, and third layers and extends from each side of the site a distance less than the distance the fourth layer extends from each side of the site. A similar method may be used for pediatric cases in order to prevent the patient from picking off the adhesive. This method involves the use of four 2-octyl cyanoacrylate layers.
It is therefore an object to the invention to provide an improved method for applying an adhesive material to a wound or incision site.
It is a further object of the invention to provide a method of treating a wound or incision with a cyanoacrylate material that reduces or minimizes the amount of scarring around the site.
It is still another object of the invention to provide a method of applying a cyanoacrylate material to a wound site that reduces or minimizes dehiscence around the wound site.
It is yet another object of the present invention to provide a method for applying a cyanoacrylate material to a high-tension wound or incision site that will reduce or minimize the occurrence of scarring and/or dehiscence around the site.
Finally, it is another object of the present invention to provide a method of applying a cyanoacrylate material to a wound site, such that an individual will have increased difficulty picking or peeling the material away from the wound site.
These and other objects, advantages and features of the invention, together with organization and manner of operation thereof, will become apparent from the following detailed description when taken into conjunction with the accompanying drawings, wherein like elements have like numerals throughout the drawings described below.
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patent: 600
Foley & Lardner
Lewis Kim M.
LandOfFree
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