WO2005107668A2 - Pansement et méthode de traitement d'une blessure - Google Patents

Pansement et méthode de traitement d'une blessure Download PDF

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Publication number
WO2005107668A2
WO2005107668A2 PCT/US2005/015153 US2005015153W WO2005107668A2 WO 2005107668 A2 WO2005107668 A2 WO 2005107668A2 US 2005015153 W US2005015153 W US 2005015153W WO 2005107668 A2 WO2005107668 A2 WO 2005107668A2
Authority
WO
WIPO (PCT)
Prior art keywords
layer
wound
dressing
applying
beyond
Prior art date
Application number
PCT/US2005/015153
Other languages
English (en)
Other versions
WO2005107668A3 (fr
Inventor
Lisa M. Brothers
Original Assignee
Zymurgy, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/837,452 external-priority patent/US7482504B2/en
Priority claimed from US10/837,453 external-priority patent/US20050244366A1/en
Application filed by Zymurgy, Llc filed Critical Zymurgy, Llc
Publication of WO2005107668A2 publication Critical patent/WO2005107668A2/fr
Publication of WO2005107668A3 publication Critical patent/WO2005107668A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • A61K31/79—Polymers of vinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • This invention relates generally to the treatment of a wound. More particularly, this invention relates to the treatment of a moderate-tension wounds, high-tension wounds, and pediatric wounds via the application of a 1 -butyl cyanoacrylate material directly to the wound site.
  • a 1 -butyl cyanoacrylate material directly to the wound site.
  • sutures and surgical staples involve inflicting additional trauma to the wound surface since the needle or staple must pass through the tissue on the edges of the wound. Sutures and staples can also cause increased tension at the site, which will result in increased scarring. Further, when sutures and staples are used, the body treats them as foreign objects. This causes the body to increase its rate of reepithelialization at the wound site. The greater the rate of reepithelialization, the greater amount of scar tissue produced. Finally, sutures or surgical staples often require removal in a second procedure, resulting in additional inconveniences and potential discomfort to the patient. Surgical strips, on the other hand, are typically used on superficial wounds due to their poor tensile strength.
  • 1 -butyl cyanoacrylate Due to the known brittleness of the 1 -butyl cyanoacrylate, the material has problems flexing with the movement of the body. This has led those skilled in the art to use 1 -butyl cyanoacrylate material in only short, low-tension wounds. When applied properly, 1 -butyl cyanoacrylate has the potential for much more than what it is presently used for. Butyls are cheaper, easier, and faster to use than octyl cyanoacrylates. Another type of material that is used in the medical field is 2-octyl cyanoacrylate, which is sold under the commercial name DermabondTM and NexabandTM.
  • 2-octyl cyanoacrylate is a type of glue that can be used on any area of the body for wounds of varying lengths and sizes.
  • the recommended and approved technique for applying 2-octyl cyanoacrylate to a wound is by applying multiple layers of 2-octyl cyanoacrylate over the top of the wound.
  • U.S. Patent No. 6,479,725 to Brothers describes a technique for dressing high-tension wounds using octyl cyanoacrylate.
  • this technique has problems; the tensile strength of the layers is higher than surrounding skin. This condition may be exceptionally prevalent in patients with poor skin turgor, such as the elderly and those on extended regiments of steroids.
  • the present invention discloses a new dressing having a much lower tensile strength that is very close to the actual strength of human skin and animal hide. By creating new techniques that utilize fewer layers, less adhesive material is used, resulting in cost savings. Instead of using one vial for every four inches, one vial may be used for 5 to 6 inches.
  • the 1 -butyl cyanoacrylates have also been polymerized for the use of wound closure inside the body. The development of oxyalkene, alkylene carbonate, alkyl ester and alkyl cyanoacrylate, among others, have facilitated this.
  • a dressing and method for treating a wound on a pediatric patient or a patient having poor skin turgor comprises the steps of preparing the wound site for treatment, applying a first layer comprising a butylcyanacrylate adhesive directly to the wound site such that a peripheral edge of the first layer extends beyond all edges of the wound site, and applying a second layer comprising a butylcyanacrylate adhesive directly over the peripheral edge of the first layer and extending beyond all edges of the wound.
  • the wound dressing consist of a first layer of an adhesive which extends beyond the peripheral edge of the wound site, and a second layer of an adhesive which is applied to overlap the peripheral edge of the first layer a distance. It is an aspect of an embodiment of the present invention that the overlapping distance is at least one-half millimeter (0.5 mm). It is another aspect of another embodiment that the overlapping distance is at least 100% of the first layer.
  • a dressing and method for treating a high-tension wound comprising the application of a first and second layer of 1 -butyl cyanoacrylate to a short, high-tension wound, and a first, second and third layer to a long, high-tension wound, with each layer covering the wound or a portion of the wound and extending to at least about 5mm from each side of the wound.
  • the first layer is allowed to set and polymerize before applying the second layer of 1 -butyl cyanoacrylate adhesive.
  • the first and second layers are allowed to set and polymerize before applying the third layer of 1 -butyl cyanoacrylate adhesive.
  • the third layer is applied substantially perpendicular to the first and second layers, and occurs intermittently over the length of the wound. It is therefore an object of the invention to provide an improved method for applying an adhesive material to a wound. It is a further object of the invention to provide a method for treating a wound with 1 -butyl cyanoacrylate material that reduces or minimizes the amount of scarring around the wound site. It is still another object of the invention to provide a method of applying 1 -butyl cyanoacrylate material to a wound that reduces or minimizes dehiscence around the wound.
  • FIG. 1 is an isometric view of one embodiment of the present invention illustrating the application of cyanoacrylate to a wound site.
  • FIG. 2 is a top view of one embodiment of the present invention illustrating a wound after two layers of cyanoacrylate have been applied.
  • FIG. 3 is a top view of one embodiment of the present invention illustrating a wound after three layers of cyanoacrylate have been applied.
  • FIG. 4 is a top view of one embodiment of the present invention illustrating, for example, a pediatric wound after two layers of cyanoacrylate have been applied.
  • FIG. 5 is a top view of an alternative embodiment of the present invention illustrating, for example, a moderate-tension wound site after two layers of cyanoacrylate have been applied.
  • the treatment of a wound comprises the use of the adhesive material 1 -butyl cyanoacrylate 16.
  • This topical skin adhesive is sold under the commercial name IndermilTM, Histacryl BlueTM, and VetbondTM and is applied to a wound site 10 through the use of an applicator 12.
  • a vial (not shown) inside the applicator 12 stores the unused 1 -butyl cyanoacrylate 16 until application, and the material is applied to the wound site 10 via the applicator tip 18. While in the applicator 12, the unused 1 -butyl cyanoacrylate 16 is in liquid form. The material will quickly set after it is applied to the wound site 10.
  • 1-butyl cyanoacrylate 16 adhesive can be applied to wounds located both internally and externally on either a human or animal patient. More specifically, this invention is directed to high-tension wounds.
  • wound is intended to include wounds resulting from surgical incisions, lacerations, punctures, cuts, and the like.
  • High-tension wound sites are defined as areas at or near a joint, and include areas at or near an elbow or knee. Other high tension areas are mid-sternal chest, post cesarean section wound, and joint replacement surgeries. It is important to provide extra tensile strength to high-tension wounds to prevent a high rate of reepithelialization that causes severe scars.
  • the joint should preferably be tensioned to at least about a 45-degree angle before applying the adhesive in order to compensate for any stretching of the area that may occur after application.
  • 1-butyl cyanoacrylate 16 is applied to a wound site 10 as shown in FIGS. 1-3.
  • One embodiment of the present invention is directed to both short, high-tension wounds and long, high-tension wounds.
  • a short, high-tension wound is a wound that is about 2.5cm (0.984 in.) or smaller.
  • a long, high-tension wound is a wound that is greater than about 2.5cm (0.984 in.).
  • a first layer 20 and a second layer 22 of adhesive material are applied to wound site 10, with none of the layers 20 and 22 extending more than about five millimeters away from the nearest edge of the wound site 10.
  • the second layer 22 is preferably applied to the wound site 10 at least about ten to fifteen seconds after the first layer 20 has been applied, allowing the first layer 20 to properly set and polymerize.
  • the third layer 24 is preferably applied about ten to fifteen seconds after the second layer 22 has been applied, allowing both the first layer 20 and the second layer 22 to properly set and polymerize.
  • the user Before and while applying the layers 20, 22, and 24 the user may approximate the wound edges with their fingers while wearing latex-free gloves.
  • the first layer 20 should be applied directly over the wound site 10 extending at least about 5mm (0.197 in.) from each edge of the wound site 10.
  • the second layer 22 should be applied directly over the wound site 10 extending at least about 2.5mm (0.0984 in.) beyond both sides of the wound site 10.
  • the second layer 22 should cover a portion of the first layer 20, and the second layer 22 should also extend at least about 2.5mm (0.0984 in.) beyond the first layer 20 on both ends as shown in FIG. 2.
  • the first layer 20 should be applied directly over the wound site 10 extending at least about 5mm (0.197 in.) from each edge of the wound site 10.
  • the second layer 22 should be applied directly over the wound site 10 extending at least about 2.5mm (0.0984 in.) beyond both sides of the wound site 10.
  • the second layer 22 should cover a portion of the first layer 20.
  • the second layer 22 will also extend at least about 2.5mm (0.0984 in.) beyond the first layer 20 on both ends.
  • the third layer 24 should be applied so that it covers a portion of the first layer 20, a portion of the second layer 22, and a portion of the wound site 10.
  • the third layer 24 may be a strip that is at least about 5mm in width.
  • the third layer 24 should be substantially perpendicular to the first and second layers 20 and 22, as well.
  • the third layer is multiple strips, as shown in FIG. 3, the strips should occur at least about every 2.5cm (0.984 in.) over the length of the wound site 10.
  • the third layer 24 will extend beyond each edge of the first layer 20 by at least about 5mm (0.197 in.).
  • the additional third layer aids in strengthening the entire wound dressing and helps distribute the tension across the dressing.
  • the enlarged surface area created by this application decreases the surface tension on the dressing. Furthermore, by decreasing the surface tension, the rate of reepithelialization is decreased.
  • the adhesive may comprise additional cyanoacrylate polymers including an oxyalkene, and alkylene carbonate, and alkyl ester and an alkyl cyanoacrylate.
  • 1-butyl cyanoacrylate could be applied in slightly different locations relative to the wound site, or that a different number of layers and orientations could be used to create an effective dressing.
  • other materials with properties similar to 1-butyl cyanoacrylate such as a compound selected from the group consisting of oxyalkene, alkylene carbonate, alkyl ester, and alkyl 1-butyl cyanoacrylate, could be used on a wound while still creating an effective wound dressing in accordance with the invention's broader aspects.
  • the present invention may also be used to treat wounds on skin having poor elasticity or poor skin turgor.
  • skin having poor elasticity or poor skin turgor includes the skin of the elderly and patients on certain medications, such as steroids.
  • the poor skin turgor is typically less elastic than that of an otherwise healthy adult because such skin is typically thinner than that of an adult.
  • Another example of skin having low elasticity is skin that is already stressed, swollen or otherwise distended. This type of skin is already pre-stretched and therefore is naturally less elastic than prior to the prestressing.
  • a common problem associated with directly applying an adhesive to a wound surrounded by skin having poor elasticity is that of dehiscence.
  • a first layer 50 of butylcyanoacrylate is applied to a wound 52 as shown in FIG. 4.
  • a first layer edge 54 should preferably extend at all locations to a distance of approximately 5mm (0.197 in.) from the wound 52.
  • a second layer 56 of butyl-cyanoacrylate is then applied to the wound 52.
  • the second layer 56 overlaps a portion of the first layer 50 and a portion of the skin surrounding the wound 52.
  • an inner edge 58 of the second layer 56 overlaps the first layer edge 54. It is preferred that the inner edge 58 of the second layer 56 overlap the first layer edge 54 by at least 1 mm (0.039 in.).
  • An outer edge 60 of the second layer 56 will extend away from the wound 52. It is preferred that the outer edge 60 of the second layer 56 will extend to no less than about 1 cm (0.394 in.) from the wound 52. It has been found that this arrangement of adhesive layers 50, 56 reduces the occurrence of dehiscence.
  • the second layer 56 reduces the ability of the patient to pick at or attempt to peel the adhesive from the skin.
  • the present invention may also be used to treat wounds in skin subject to moderate tension, such as that found in diabetic patients, patients having a large percentage of adipose tissue, or those on long term steroid therapy. As shown in FIG. 5, a first layer 62 of butyl-cyanoacrylate is applied to the wound 64 such that an outer edge 66 of the first layer 62 extends no less than about 5 mm (0.197 in.) from the wound 64 in all directions.
  • a second layer 68 of butyl-cyanoacrylate is applied to the wound 64 such that it entirely covers the first layer 62 and extends beyond the outer edge 66 of the first layer 62. It can be seen that the second layer 68 covers the first layer 62 and a portion of the skin surrounding the wound. An outer edge 70 of the second layer 68 preferably extends no less than 5 mm (0.197 in.) past the outer edge 66 of the first layer 62.
  • This arrangement of adhesive layers 62, 68 has been found to be superior in treating wounds to skin subjected to moderate tension. While the specific embodiments and various details thereof have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the following claims:

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Materials Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un pansement pour une blessure et une méthode d'utilisation de semblable. Le pansement comprend une première couche comprenant un adhésif butyle-cyanoacrylate appliqué directement sur la blessure et plus largement autour de la blessure pour former une bordure périphérique. Le pansement comprend aussi une seconde couche comprenant un adhésif butyle-cyanoacrylate appliqué directement sur la première couche et recouvrant la bordure périphérique de la première couche. Sur une blessure à tension modérée la seconde couche étend toute la zone de la première couche, mais aussi étend au-delà de la bordure périphérique. Il est aussi prévu un pansement et une méthode de traitement des blessures à tension élevé. Les première et seconde couches d'un adhésif 1-butyle-cyanoacrylate 16 sont appliquées sur une blessure à tension élevée, avec la première et seconde couches couvrant la blessure et s'étendant sur au moins 2,5mm de chaque côté de la blessure. La première couche est autorisée à reposer et se polymériser avant que la seconde couche de 1-butyle-cyanoacrylate soit appliquée. La seconde couche s'étend sur au moins 2,5mm au-delà de chaque bord de la première couche. Dans le cas d'une blessure longue, à tension élevée, une troisième couche est appliquée après que la première et la seconde couches se soient reposées et polymérisées. La troisième couche fait au moins 2,5mm de large et est perpendiculaire aux première et seconde couches. La troisième couche peut apparaître par intermittences tous les 2,5cm sur la longueur de la blessure, et s'étend de préférence sur au moins 5mm au-delà du bord de la première couche.
PCT/US2005/015153 2004-04-30 2005-05-02 Pansement et méthode de traitement d'une blessure WO2005107668A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10/837,453 2004-04-30
US10/837,452 2004-04-30
US10/837,452 US7482504B2 (en) 2004-04-30 2004-04-30 Dressing for treatment of short wounds located in high tension areas
US10/837,453 US20050244366A1 (en) 2004-04-30 2004-04-30 Dressing and method of treatment for a wound

Publications (2)

Publication Number Publication Date
WO2005107668A2 true WO2005107668A2 (fr) 2005-11-17
WO2005107668A3 WO2005107668A3 (fr) 2008-02-07

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Family Applications (2)

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PCT/US2005/015324 WO2005107669A2 (fr) 2004-04-30 2005-04-29 Pansement et methode de traitement d'une plaie
PCT/US2005/015153 WO2005107668A2 (fr) 2004-04-30 2005-05-02 Pansement et méthode de traitement d'une blessure

Family Applications Before (1)

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PCT/US2005/015324 WO2005107669A2 (fr) 2004-04-30 2005-04-29 Pansement et methode de traitement d'une plaie

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030050590A1 (en) * 2001-07-19 2003-03-13 Kirsch Wolff M. Adhesive including medicament and device and method for applying same

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030050590A1 (en) * 2001-07-19 2003-03-13 Kirsch Wolff M. Adhesive including medicament and device and method for applying same

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BRUNS ET AL.: 'Using Tissue Adhesive for Wound Repair: A Pratical Guide to Dermabond' AMERICAN ACADEMY OF FAMILY PHYSICIANS vol. 61, no. 5, March 2000, pages 1 - 13 *
ETHICON, INC.: 'High Viscosity Dermabond Topical Skin Adhesive, package insert' 2003, *

Also Published As

Publication number Publication date
WO2005107669A2 (fr) 2005-11-17
WO2005107668A3 (fr) 2008-02-07

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