Moisture-curable adhesive suture strip

Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover

Reexamination Certificate

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Details

C602S043000, C606S215000, C606S216000

Reexamination Certificate

active

06559350

ABSTRACT:

FIELD OF THE INVENTION
The present invention pertains to improvements in the field of wound suturing. More particularly, the invention relates to a moisture-curable adhesive closing strip for closing a wound on a patient.
BACKGROUND ART
When closing a wound, it is necessary to join and keep together the facing edges of the wound. If the separated skin sections are sewn, unesthetical scars may remain, and if they are stapled, such scars generally remain.
Cyanoacrylate-based adhesives have been suggested as an alternative to sutures. When a cyanoacrylate adhesive is employed, the separated skin sections are joined and the adhesive is applied on top of the joined sections under sterile conditions. The cyanoacrylate adhesive bonds to the skin and polymerizes so as to keep together the joined sections. Although cyanoacrylate adhesives successfully bind the skin, the use of such adhesives as suture replacements can be accompanied by occasional adhesion failure resulting in wound reopening which requires closure by sutures. Fear of wound reopening is one of the reasons physicians have been reluctant to use any adhesive including cyanoacrylate-based adhesives instead of sutures.
U.S. Pat. No. 5,254,132 proposes a method of treating suturable wounds by first suturing or stapling the wound and then joining the skin between sutures or staples with a cyanoacrylate adhesive. According to this method, the wound is sutured or stapled so that the sutures or staples are separated from each other by no more than about 1.2 centimeter and no less than about 0.6 centimeter. 2-Butylcyanoacrylate is then applied to the opposing and still separated skin sections between the sutures or staples in an amount sufficient so that upon polymerization the skin sections are joined; the application is conducted so that contact of the cyanoacrylate adhesive with the sutures or staples is avoided. The adjacent separated skin sections are thereafter contacted under conditions that permit the adhesive to polymerize so as to join the separated skin sections. Such a method is not only time-consuming and requires particular skill to practice, but also delays healing of the wound if cyanoacrylate adhesive penetrates in between the skin sections.
Surgical adhesive plasters for closing wounds are also known. These plasters generally do not have much tensile strength so that their use is limited to shallow wounds requiring little tension to close. Another major disadvantage resides in their permeability to water, causing the plaster to become unstuck upon contact with water or moisture and thereby preventing the wounded area from being washed.
U.S. Pat. No. 5,259,835 discloses a wound closure device that employs a porous bonding member adapted to receive a flowable moisture-curable surgical adhesive. The bonding member is positioned by a carrier member which is used to achieve initial apposition of the wound and which may later be removed. Since the adhesive flows into the bonding member and the latter serves as a matrix for the adhesive, the bonding member becomes rigid as the adhesive therein undergoes curing so that it looses flexibility. Part of the surgical adhesive also flows through the bonding member and may enter into the wound.
DISCLOSURE OF THE INVENTION
It is therefore an object of the present invention to overcome the above drawbacks and to provide a moisture-curable adhesive suture strip for closing wounds.
According to one aspect of the invention, there is provided a moisture-curable adhesive suture strip for closing a wound on a patient, comprising:
an elongated, flexible air-permeable backing member formed of a chemically inert material and having opposite ends, first and second surfaces facing away from one another and a length and width sufficient to secure facing edges of the wound in close juxtaposition to one another, the backing member comprising a first portion disposed between the ends and adapted to overlie the facing edges of the wound, and second and third portions disposed on either side of the first portion;
a moisture-curable surgical adhesive on at least part of the first surface of the backing member including the second and third portions thereof, for adhering at least the second and third portions of the backing member to the patient with the facing edges of the wound in close juxtaposition; and
a first removable protective member formed of a chemically inert material releasably secured to the backing member and covering the surgical adhesive.
After removal of the protective member to expose the adhesive and application of the backing strip with the exposed adhesive onto the patient to secure the facing edges of the wound in close juxtaposition, the adhesive upon curing together with the backing strip maintain the facing edges of the wound in close juxtaposition, without the cured adhesive adversely affecting the flexibility of the backing strip.
Applicant has found quite unexpectedly that by using a flexible and air-permeable backing member and applying on one surface of such a member a surgical adhesive, one obtains a suture strip which can be easily and rapidly applied onto the patient to secure the facing edges of the wound in close juxtaposition with one another, without the adhesive entering into the wound and delaying healing thereof. The adhesive upon curing together with the backing member maintain the facing edges of the wound in close juxtaposition, thereby preventing adhesion failure and reopening of the wound. Since the flexibility of the backing member is not adversely affected by the cured adhesive, the suture strip remains flexible and can thus follow movements of the skin. The backing member is of course air-permeable to enable the skin to breathe. Examples of suitable surgical adhesives which can be used include cyanoacrylates such as 2-n-butylcyanoacrylate and 2-octylcyanoacrylate. The curing time of 2-n-butylcyanoacrylate is about 30 seconds, whereas that of 2-octylcyanoacrylate is about 60 seconds. Preferably, the surgical adhesive comprises a cyanoacrylate in admixture with a stabilizing agent such as sulfurous acid.
The expression “chemically inert material” as used herein refers to a material which does not react with the surgical adhesive to cause curing thereof during storage of the suture strip. Examples of suitable chemically inert material include polyethylene and tetrafluoroethylene. When the backing member is formed of polyethylene, use is preferably made of a low density polyethylene or a blend of low density polyethylene and high density polyethylene. The protective member, on the other hand, preferably comprises a film of high density polyethylene.
According to a preferred embodiment of the invention, a layer of surgical adhesive completely covers the first surface of the backing member. Preferably, the backing member comprises a canvas of chemically inert material having at the first surface cavities filled with the surgical adhesive to provide an anchoring of the backing member to the patient.
According to another preferred embodiment, a plurality of spaced-apart dots of surgical adhesive are provided only on the second and third portions of the backing member. Preferably, a pressure-sensitive adhesive is provided on the first surface of the backing member between the dots of surgical adhesive, the protective member covering the pressure-sensitive adhesive.
According to a further preferred embodiment, a plurality of spaced-apart strips of surgical adhesive are provided only on the second and third portions of the backing member, the strips of surgical adhesive extending transversely of the backing member. Preferably, a pressure-sensitive adhesive is provided on the first surface of the backing member between the strips of surgical adhesive, the protective member covering the pressure-sensitive adhesive.
Generally, the dots or strips of surgical adhesive define a total area representing from about 10 to about 50%, preferably from about 15 to about 30%, of the area defined by the first surface of the backing member.
According to yet another preferred e

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