MXPA01008536A - Wound closure system - Google Patents

Abstract

A wound closure system (10) for closing a wound on a patient comprises an elongated flexible backing strip (12) having a length and width sufficient to secure facing edges of the wound in close juxtaposition to one another, the backing strip 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 and each provided with a predetermined number of spaced-apart apertures extending through the backing strip from one surface thereof to the other;and a first pressure-sensitive adhesive (18) coated on at least part of the first surface of the backing strip (12) including the second and thirdportions thereof, to adhere the backing strip to the patient with the facing edges of the wound being in close juxtaposition. The wound closure system of the invention further includes a flowable, moisturecurable surgical adhesive (28) for application into the apertures to strengthen the adhesion of the second and third portions of the backing strip to the patient.

Description

WOUND CLOSURE SYSTEM Technical Field The present invention relates to improvements in the field of wound care. More particularly, the invention relates to a wound closure system for closing a wound in a patient.

BACKGROUND OF THE INVENTION When a wound is closed, it is necessary to join and hold together the facing edges of the wound. If the separate sections of the skin are sewn, non-aesthetic scars may remain, and if they are stapled, such scars usually remain. Cyanoacrylate-based adhesives have been suggested as an alternative for sutures. When a cyanoacrylate adhesive is employed, the separate sections of the skin are bonded together and the adhesive is applied to the top of the bonded sections under sterile conditions. The cyanoacrylate adhesive adheres to the skin and polymerizes to hold the joined sections together. Although cyanoacrylate adhesives successfully sell the skin, the use of such adhesives as suture replacements can be accompanied by occasional adhesion failure resulting in re-opening of the wound requiring closure by sutures. The fear of wound reopening is one of the reasons why doctors have been unwilling to use any adhesive including cyanoacrylate-based adhesives instead of sutures.

US Patent No. 5,254,132 proposes a method of treating suturing wounds by suturing or stapling the wound first and then joining the skin between the sutures or staples with a cyanoacrylate adhesive. According to this method, the wound is sutured or stapled in such a way that the sutures or staples are separated from each other but not more than about 1.2 centimeters and not less than about 0.6 centimeters. The butyl 2-cyanoacrylate is thus applied to the opposite and still separated sections of the skin between the sutures or staples in a sufficient amount such that in the polymerization the sections of the skin are joined; the application is conducted in such a way that contact of the cyanoacrylate adhesive with the sutures or staples is avoided. The separate skin sections adjacent thereon are contacted under conditions that allow the adhesive to polymerize in order to join the separate sections of the skin. Such a method is not only a consumer of time and requires particular experience to practice, but also retards wound healing if the cyanoacrylate adhesive penetrates between the sections of the skin. Surgical adhesive bands for closing wounds are also known. These bands generally do not have too much tensile strength in such a way that their use is limited to superficial wounds that require little tension to close. Another main disadvantage lies in its permeability to water, causing the bands to loosen in contact with water or moisture and thus preventing the wound area from being washed. The U.S. Patent No. 5,259,835 discloses a wound closure device employing a porous adhesive member adapted to receive a hygroscopic, fluid surgical adhesive. The adhesive member is placed by means of a vehicle member which is used to achieve the initial apposition of the wound and which can be subsequently removed. Since the adhesive flows into the adhesive member and serves the latter as a binder for the adhesive, the adhesive member becomes rigid as the adhesive therein undergoes healing in such a way that it loses flexibility. Part of the surgical adhesive also flows through the adhesive member and can enter the wound.

BRIEF DESCRIPTION OF THE INVENTION Therefore, an object of the present invention is to overcome the above drawbacks and to provide a wound closure system for closing wounds. In accordance with the invention, a wound closure system is provided to close a wound in a patient, comprising: a flexible, extended backing band having opposite ends, surfaces, first and second facing each other away from each other and a sufficient length and width to secure the facing edges of the wound in close juxtaposition between yes, the backing band comprising a first part placed between the extremities and adapted to cover the facing edges of the wound, and the second and third parts, placed on either side of the first part and provided each with a predetermined number of separate openings extending through the backing band from one surface thereof to the other, the first part of any opening being free; a first pressure sensitive adhesive coated on at least part of the first surface of the backing band including the second and third portions thereof, for adhering at least the second and third portions of the backing band to patient with the edges of facing the wound being in close juxtaposition; a first protective member removably attached to the backing band and covering the pressure sensitive adhesive; and a hygrocurable, fluid surgical adhesive for application in the openings to strengthen the adhesion of the second and third parts of the backing band to the patient. After removal of the protective member to expose the pressure-sensitive adhesive, the application of the backing band with the pressure-sensitive adhesive exposed on the patient to secure the facing edges of the wound in close juxtaposition and application of the Surgical adhesive in the openings, the surgical adhesive flows through the openings in the cure forms discrete bonding sites that cooperate with the backing band to keep the facing edges of the wound in close juxtaposition without the cured adhesive adversely affecting the flexibility of the backup band. The applicant has very unexpectedly found that by using a flexible backing band having a first non-perforated portion positioned between the edges thereof and perforated, second and third portions, placed on either side of the first part, and a sensitive adhesive to the backing. the pressure coated on at least part of the first surface of the backing band including the second and third parts thereof, and applying a hygienic surgical adhesive, fluid in the openings or perforations defined in the second and third parts, After application of the backing band with the pressure sensitive adhesive exposed on the patient to ensure the facing edges of the wound in close juxtaposition, the surgical adhesive flows through the openings in the healing form discrete bonding sites strengthening the adhesion of the parties, second and third, of the backup band to the patient and cooperating with the backup band to maintain the facing edges of the wound in close juxtaposition without the cured adhesive adversely affecting the flexibility of the backing band. Since the surgical adhesive is applied on either side of the first part of the backing band covering the edges of the wound facing, the surgical adhesive does not enter the wound in such a way that the healing of the wound is not delayed. On the other hand, since the flexibility of the backing band is not adversely affected by the cured adhesive, the web remains flexible and can thus allow skin movements. Preferably, the backing band comprises a polymer sheet such as polyurethane or nylon. It may also comprise a fabric of woven material such as cotton, rayon, acrylic or polyester fibers. The protective member, on the other hand, preferably comprises a high density polyethylene film or a sheet of waxed paper.

According to a preferred embodiment of the invention, the openings are perforations having a circular cross section with a diameter ranging from 0.5 to 3 mm, preferably from 1 to 2 mm. For a backing band with the surface, first or second, thereof defining an area of approximately 12 cm2, the number of perforations defined in each of the second and third parts may vary between 4 and 20, and preferably It varies from 8 to 12. Preferably, a second protective member having a second pressure-sensitive adhesive coated on one side thereof removably attaches to the backing band and covers the second surface thereof, the band being placed between the protective members, first and second. The second protective member is provided with a corresponding number of perforations registering with the perforations defined in the second and third portions of the backup band, and being in fluid communication therewith. The provision of such a second protective member prevents the surgical adhesive from contacting the second surface of the backing band during application such that when the second protective member together with the second pressure sensitive adhesive is removed from the backing band afterwards. of the application of the surgical adhesive, there is no surgical adhesive on the second surface, which in the healing could adversely affect the flexibility of the backing band. The second protective member preferably comprises a low density polyethylene film. Instead of using a second pressure sensitive adhesive, it is also possible to removably attach the second protective member to the backing band by applying pressure or heat. According to another preferred embodiment, the second and third portions of the backing band each have an end edge and a pair of opposite side edges, and the openings are U-shaped cuts defined together with the end and side edges. of each of the second, second and third parts. Preferably, a second removable protective member similar to that described above, but having perforations that are recorded with the cuts and in fluid communication therewith, covers the second surface of the backup band. According to a more preferred embodiment, the second and third parts of the backing band are each provided with at least one fold line extending transversely of the band between the openings to increase the flexibility of the backing band. . According to still another preferred embodiment, the second and third portions of the backing band are each provided with a plurality of separate fastening elements positioned between the openings and projecting outwardly from the first surface. These fasteners help to secure the edges of the wound facing in close juxtaposition.

BRIEF DESCRIPTION OF THE DRAWINGS More features and advantages of the present invention will become apparent more readily from the following description of the preferred embodiments as illustrated by way of example in the accompanying drawings, in which: Figure 1 is a top perspective view of a wound closure system according to a preferred embodiment of the invention. Figure 2 is a top perspective view of a wound closure system similar to that illustrated in Figure 1, but with the backing band provided with a plurality of transversely extending, spaced fold lines; Figure 3 is a fragmentary bottom perspective view of a wound closure system similar to that illustrated in Figure 2, but with the backing band provided with a plurality of downwardly extending, separate fastening elements; Figure 4 is a top perspective view of a wound closure system similar to that illustrated in Figure 1, but with the backing band provided with a second protective member; Figure 5 is a top perspective view of a wound closure system according to another preferred embodiment of the invention; Figure 6 is a top perspective view of a wound closure system similar to that illustrated in Figure 5, but with the backing band provided with a plurality of transversely extending, spaced fold lines; Figure 7 is a fragmentary bottom perspective view of a wound closure system similar to that illustrated in Figure 6, but with the backing band provided with a plurality of downwardly extending, fastening elements; and Figure 8 is a top perspective view of a wound closure system similar to that illustrated in Figure 5, but with the backing band provided with a second protective member.

MODES FOR CARRYING OUT THE INVENTION Referring first to Figure 1, a wound closure system that is designated generally by the reference number 10 and is used to close a wound in a patient (not shown) is illustrated. The wound closure system 10 comprises an extended flexible backing band 12 having surfaces 14 and 16 facing each other away from each other with the surface 14 being coated with a pressure sensitive adhesive 18. The backing band 12 they are of sufficient length and width to secure the facing edges of the wound in close juxtaposition with each other. A protective member 20 removably attaches to the backing band 12 and covers the adhesive 18. The protective member 20 extends beyond an end edge of the backing band 12 to define a lug to be gripped by the finger 22. The backup band 12 has a substantially central portion 12a adapted to cover the facing edges of the wound, and two portions 12b, 12c positioned on either side of the portion 12a and each provided with a predetermined number of separate circular perforations 24 that They extend through the backup band from one surface to the other. The wound closure system 10 further includes a source 26 of hygienic, flowable surgical adhesive 28 for application to the perforations 24. Examples of suitable surgical adhesives that can be used include cyanoacrylates such as n-butyl 2-cyanoacrylate and 2- octyl cyanoacrylate. In use, the protective member 20 is first excoriated to expose the pressure sensitive adhesive 18 and one of the parts 12b, 12c of the backing strip 12 with the exposed adhesive 18, adhering to one of the skin's separate sections. , which thus creeps in a direction towards the other separated section of the skin to bring the facing edges of the wound in close juxtaposition with each other, and the other part of the band 12 adheres to the other skin section, closing the wound in such a way and ensuring the edges of facing it in close juxtaposition. The surgical adhesive 28 is thus applied to the perforations 24 defined in the parts 12b, 12c of the backing band 12 to strengthen the adhesion of the parts 12b and 12c to the skin of the patient. The adhesive 28 flows through the perforations 24 and in the cure forms discrete bonding sites cooperating with the band 12 to keep the facing edges of the wound in close juxtaposition without the cured adhesive adversely affecting the flexibility of the band 12. The wound closure system 10A illustrated in Figure 2 is similar to that shown in Figure 1, with the exception that the backing band is provided with a plurality of transversely extending fold lines 30, spaced apart to increase the Flexibility of the band 12. As shown, the fold lines 30 extend between the perforations 24.

The wound closure system 10B that is partially illustrated in Figure 3 is similar to that shown in Figure 2, with the exception that the parts 12b, 12c of the backing band 12 is provided with a plurality of shaped elements. of hook 32 separated between the perforations 24 and projecting externally from the surface 14. The fastening elements 32 help to secure the facing edges of the wound in close juxtaposition. The wound closure system 10C illustrated in Figure 4 is similar to that shown in Figure 1, with the exception that one second, protective member 34 having a pressure sensitive adhesive (not shown) coated on one side of the same removably attaches to the back band 12 and covers the surface 16, the band 12 being placed between the protective members 20 and 34. The protective member 34 is provided with perforations 36 whose number is the same as the number of perforations 24 defined in parts 12b, 12c of the band. The perforations 36 are recorded with the perforations 24 and are in fluid communication therewith. The protective member 34 extends beyond an end edge of the backing band to define a lug for gripping with finger 38 that is free of adhesive. The provision of such a protective member 34 prevents the surgical adhesive 28 from contacting the surface 16 of the backing band during application such that when the protective member 34 together with the pressure-sensitive adhesive coated therein is removed from the backing band 12 after the application of the surgical adhesive 28, there is no surgical adhesive 28 on the surface 16, which in the healing could adversely affect the flexibility of the backing band 12. Returning to Figure 5, it is illustrated another wound closure system which is designated generally by reference numeral 100 and comprises an extended flexible backing band 102 having surfaces 104 (shown in Figure 7) and 106 facing each other away from each other with the surface 104 being coated with a pressure sensitive adhesive 108 (shown in Figure 7). The backing band is of sufficient length and width to secure the facing edges of a wound (not shown) in close juxtaposition with each other. A protective member 1 10 removably attaches to the backing band and covers the adhesive 108. The protective member 1 10 extends beyond an end edge of the backing band 102 to define a lug to grip with the finger 1 12. The backing band has a substantially central portion 102a adapted to cover the facing edges of the wound, and two portions 102b, 102c positioned on either side of the part 102a. A plurality of generally spaced U-shaped cuts 14 are defined together with the end and side edges of each of the portions 102b, 102c. The wound closure system 100 also includes a source 1 16 of hygrocurable adhesive, fluid 1 18 which is the same as the adhesive 28 shown in Figures 1-4, for application in sections 1 14. It is used in the same manner as the wound closure system 10 shown in Figure 1 to close a wound. The wound closure system 100A illustrated in Figure 6 is similar to that shown in Figure 5, with the exception that the backing band 102 is provided with a plurality of fold lines 120 extending transversely, spaced apart to increase the flexibility of the band 102. As shown, the fold lines 120 extend between the cuts 1 14. The wound closure system 100B that is partially illustrated in Figure 7 is similar to that shown in Figure 6, with the exception that each of the parts 102b, 102c of the backing band 12 is provided with a plurality of separate hook-shaped fasteners 122 projecting outwardly from the surface 104. The fasteners 122 serve the same purpose as the fastening elements 32 shown in Figure 3. The wound closure system 100C illustrated in Figure 8 is similar to that shown in Figure 5, with the exception that a s second protective member 124 having a pressure-sensitive adhesive (not shown) coated on one side thereof removably attaches to backing band 102 and covers surface 106, band 102 being placed between protective members 1 10 and 124. The protective member 124 is provided with square perforations 126 whose number is the same as the number of the cuts 1 14. The perforations 126 are recorded with the cuts 1 14 and are in fluid communication therewith. The protective member 124 extends beyond one of the end edges of the backing band 102 to define a lug for gripping with the finger 128, which is free of the adhesive. The protective member 124 also extends beyond the other end edge of the band 102 and the side edges thereof to define an end portion 130 and side portions 132, 134. Likewise, the protective member 110 extends beyond the another end edge of the band 102 and the side edges thereof to define an end portion 136 and side portions 138, 140. The end portions 130, 136 and the side portions 134, 140 are facing each other and are releasably join together by the coated adhesive on the protective member 124. The member 124 serves the same purpose as the member 34 shown in Figure 4. It also serves to limit the surgical adhesive 118 on the cuts 114 during the curing of the adhesive 118. .

Claims (21)

1. CLAIMS 1. A wound closure system for closing a wound in a patient, comprising: a flexible, extended backing band having opposite ends, surfaces, first and second facing each other away from each other and a sufficient length and width to secure the facing edges of the wound in close juxtaposition with each other, said backing band comprising a first part placed between said extremities and adapted to cover the facing edges of said wound, and parts, second and third, placed on either side of said first part and each provided with a predetermined number of separate openings extending through said backing band from said first surface to the second surface; a first pressure sensitive adhesive coated on at least part of the first surface of said backing band including said second and third portions thereof, for adhering said at least said second and third portions of said backing band to said backing band; patient with the facing edges of said wound in said close juxtaposition; a first protective member removably attached to said backing band and covering said pressure sensitive adhesive; and a hygrocurable, fluid surgical adhesive for application in said openings to strengthen the adhesion of said second and third parts of said backing band to the patient; whereby, after removal of said protective member to expose said pressure-sensitive adhesive, the application of said backing band with the pressure-sensitive adhesive exposed in said patient to secure the facing edges of said wound in said close juxtaposition and the application of said surgical adhesive in said openings, said surgical adhesive flows through said openings and in the curing forms discrete bonding sites cooperating with said backing band to maintain the facing edges of said wound in said close juxtaposition without the cured adhesive adversely affecting the flexibility of said backing band.
2. 2. A wound closure system according to claim 1, characterized in that said backing band comprises a fabric of woven material.
3. 3. A wound closure system according to claim 1, characterized in that said backing band comprises a polymer sheet selected from the group consisting of polyurethane and nylon. A wound closure system according to claim 1, characterized in that said openings are perforations defined in said second and third portions of said backing band. A wound closure system according to claim 4, characterized in that said perforations have a circular cross section with a diameter ranging from 0.5 to 3 mm. 6. A wound closure system according to claim 5, characterized in that said perforations have a diameter between 1 and 2 mm. A wound closure system according to claim 5 or 6, characterized in that the number of perforations defined in each of said second and third portions varies from 4 to 20 when the first or second surface of said backup band has an area of approximately 12 cm2. 8. A wound closure system according to claim 7, characterized in that the number of perforations is between 8 and 12. 9. A wound closure system according to any of claims 4 to 8, characterized in that a second protective member having a second pressure sensitive adhesive coated on one side thereof removably attaches to said backing band and covers said second surface, said band being placed between said first and second members, and wherein said protective member is provided with a corresponding number of perforations registered with the perforations defined in said parts, first and second, of said backup band, and being in fluid communication with them. A wound closure system according to any of claims 4 to 8, characterized in that a second protective member is removably attached to said backing band by application of heat or pressure and covers said second surface, said band being placed between said members, first and second, and wherein said protective member is provided with a corresponding number of perforations registering with the perforations defined in said parts, second and third of said trellis plates, and being in fluid communication therewith. eleven . A wound closure system according to claim 1, characterized in that said second and third portions of said backing band each have an end edge and a pair of opposite side edges, and wherein said openings are defined cuts together with the end and side edges of said parts, second and third. A wound closure system according to claim 1, characterized in that said cuts are U-shaped. 13. A wound closure system according to claim 1 or 12, characterized in that a second protective member having a second pressure sensitive adhesive coated on one side thereof removably attaches to said backing band and covers said second surface, said band being placed between said first and second protective members, and wherein said second protective member is provided with a corresponding number of perforations registering with said cuts and being in fluid communication with them. A wound closure system according to claim 1 or 12, characterized in that a second protective member is removably attached to said backing band by the application of heat or pressure and covers said second surface, said band being placed between said protective members, first and second, and wherein said second protective member is provided with a corresponding number of perforations registering with said cuts and being in fluid communication therewith. 15. A wound closure system according to any of claims 9, 11, 13 and 14, characterized in that said second protective member comprises a low density polyethylene film. 16. A wound closure system according to any of claims 1 to 15, characterized in that said first protective member comprises a high density polyethylene film or a sheet of paraffined paper. A wound closure system according to any of claims 1 to 16, characterized in that said second and third portions of the backing band are each provided with at least one fold line extending transversely of said band between said openings to increase the flexibility of said backing band. A wound closure system according to any of claims 1 to 14, characterized in that said second and third portions of said backing band are each provided with a plurality of separate fastening elements placed between said openings and projecting outwardly. from said first surface. 19. A wound closure system according to claim 18, characterized in that said fastening elements are U-shaped. 20. A wound closure system according to any of claims 1 to 19, characterized in that said surgical adhesive comprises a cyanoacrylate. . 21. A wound closure system according to claim 20, characterized in that said cyanoacrylate is n-butyl 2-cyanoacrylate or octyl 2-cyanoacrylate.