Coating implements with material supply – Including rupturable means or sealed-cartridge receiver
Reexamination Certificate
2001-08-29
2003-04-15
Huson, Gregory (Department: 3751)
Coating implements with material supply
Including rupturable means or sealed-cartridge receiver
C206S438000, C206S532000, C206S813000, C222S541100, C401S133000, C401S177000, C401S179000, C401S182000, C401S183000, C401S205000, C401S219000, C401S263000, C401S270000, C604S003000, C604S232000, C604S310000, C604S311000
Reexamination Certificate
active
06547467
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to microapplicators, delivery systems and methods for applying adhesive and sealant compositions such as cyanoacrylate adhesives, particularly for medical use.
Numerous swabs, applicators, dispensers and kits for dispensing and applying various materials, including adhesive materials, are known. However, these known arrangements possess various shortcomings that make them undesirable in many applications.
For example, U.S. Pat. No. 5,660,273 to Discko, Jr. discloses a package having wells or depressions for holding a medicament or material and an applicator for applying the medicament or material. The package includes a tray and a cover extending over the entire top surface of the tray. The tray includes an applicator well and a separate medicament well. A mixing area is placed on the cover. The tray further includes medicament wells and an applicator well. However, the '273 patent does not address providing effective storage and application of a polymerizable monomer compound. Moreover, the applicator disclosed in the '273 patent comprises a relatively large brush that is not suitable for certain medical applications.
U.S. Pat. No. 5,989,205 to Pond et al. discloses a solution applicator system having a retainer and a plurality of containers for holding a solution, such as fluoride or anesthetic, and an applicator member. Each container encloses the applicator and a solution-retaining receptacle with a puncturable sealing means. The '205 patent also does not address providing effective storage and application of a polymerizable monomer compound. Moreover, the applicator disclosed in the '205 patent comprises a relatively large swab that is not suitable for certain medical applications.
Monomer and polymer adhesives are used in both industrial (including household) and medical applications. Included among these adhesives are the 1,1-disubstituted ethylene monomers and polymers, such as the &agr;-cyanoacrylates. Since the discovery of the adhesive properties of such monomers and polymers, they have found wide use due to the speed with which they cure, the strength of the resulting bond formed, and their relative ease of use. These characteristics have made the &agr;-cyanoacrylate adhesives the primary choice for numerous applications such as bonding plastics, rubbers, glass, metals, wood, and, more recently, biological tissues.
It is known that monomeric forms of &agr;-cyanoacrylates are extremely reactive, polymerizing rapidly in the presence of even minute amounts of an initiator, including moisture present on moist surfaces such as animal (including human) tissue. Monomers of &agr;-cyanoacrylates are anionically polymerizable or free radical polymerizable, or polymerizable by zwitterions or ion pairs to form polymers. Once polymerization has been initiated, the cure rate can be very rapid.
Medical applications of 1,1-disubstituted ethylene adhesive compositions include use as an alternate or an adjunct to surgical sutures and staples in wound closure as well as for covering and protecting tissue wounds such as lacerations, abrasions, burns, stomatitis, sores, and other open surface wounds. When such an adhesive is applied, it is usually applied in its monomeric form, and the resultant polymerization gives rise to the desired adhesive bond.
However, due to the need to apply the adhesive in its monomeric form, and due to the rapid polymerization rate of the monomers, applicators and/or delivery systems must counterbalance the competing requirements that the monomer not prematurely polymerize, that the monomer be easily applied, that the monomer polymerize at a desired rate upon application, and that the sanitary and/or sterile properties of the monomer and applicator—whether real or perceived—be maintained. This latter requirement, that the actual or perceived sanitary and sterile condition of the monomer and applicator be maintained, is particularly important in medical applications, where the user and/or the patient desires a clean product so as not to introduce further bacteria or foreign matter into a wound site. Further, applicators and/or delivery systems, as well as the monomer itself, should be sterilizable by conventional techniques.
In order to meet the above requirements, various packaging systems for monomeric adhesives have been proposed. These systems include large bottles with a single applicator, such as a large single- or multi-use brush; small applicators such as small ampoules containing monomer, for example within an internal frangible vial, that can be expelled through an integral applicator; and the like. However, a problem with many of these applicator systems is that the product contains more adhesive material than is necessary for a particular use. Because of the rapid polymerization rate of the monomers, any unused adhesive must often be discarded, because the remaining monomer undergoes polymerization, often within the applicator, to render the applicator unusable.
A further problem in addressing the above requirements of adhesive applicators and packaging is the need to provide a stable monomer product. Particularly in small quantities, cyanoacrylate monomers are prone to premature polymerization, which would render the product useless. Thus, industrial production of monomeric adhesive compositions has had to balance rapid cure rates and high bond strengths with shelf-life. The shelf-life of these adhesives is primarily related to stability (i.e., constancy of compositional nature), uncured physical properties, rate of cure of the adhesive, as well as final cured properties of the composition. For example, the shelf-life of a monomeric &agr;-cyanoacrylate composition may be measured as a function of the amount of time the composition can be stored before unacceptable levels of polymerization, such as measured by viscosity increase, occur. Unacceptable levels are indicated by a level of polymerization product that reduces the usefulness of the composition in the application for which it is produced.
One proposed solution to this reduced shelf-life problem is to incorporate one or more stabilizers into the adhesive composition. For example, as disclosed in U.S. Pat. No. 3,559,652 to Banitt et al. and U.S. Pat. No. 5,582,834 to Leung et al., suitable stabilizers for medically useful &agr;-cyanoacrylate compositions include Lewis acids such as sulfur dioxide, nitric oxide, and boron trifluoride, as well as free-radical stabilizers including hydroquinone, monomethyl ether hydroquinone, nitrohydroquinone, catechol, and monoethyl ether hydroquinone. The combination of the two anionic stabilizers sulfur dioxide and sulfonic acid is also known and is disclosed in, for example, British Patent Application GB 2 107 328 A.
However, while the proposed solution of adding stabilizers provides compositions that are more stable, a different problem arises. That new problem is that as the concentration of the added stabilizers increases in the composition, the cure rate of the composition tends to decrease. Thus, further components must be provided, such as in a separate composition, to be mixed with the adhesive composition (either directly or at the application site) to increase the polymerization rate of the monomer. Such additional materials, such as polymerization initiators or rate modifiers, increase the cost of the final composition, and may increase the complexity of use of the composition.
Known devices fail to provide applicators and delivery systems that are optimized for convenient dispensing and application of adhesive materials on a variety of surfaces and structures. The known applicators are generally either optimized for delivery of other compositions or are inconvenient or impractical for use in conjunction with adhesives or particular applications. Furthermore, such conventional devices and packaging generally do not address the competing needs of ease of use and adhesive stability prior to application.
SUMMARY OF THE INVENTION
The present invention addresses the above needs by
Closure Medical Corporation
Huson Gregory
Oliff & Berridg,e PLC
Prunner Kathleen
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