The invention relates to the packaging of orthodontic devices, in particular to a packaged, pre-pasted orthodontic bracket wherein the prepasted portion of the bracket is protected with an elastomeric cover.
Modern orthodontic techniques include repositioning teeth that are misaligned, too close together or otherwise mis-positioned. In order to reposition the teeth, the teeth are connected to an arch wire that serves as a guide, urging the teeth into the desired position and orientation. In order to connect the teeth to the arch wire, small brackets with slots for receiving the arch wire are attached to the teeth. The ends of the arch wire are normally attached to the molars with another orthodontic appliance known as a buccal tube. In some cases, the bracket or tube is brazed or welded or brazed to a metal band placed around the patient's tooth. However, the preferred method of attaching brackets to a patient's teeth is by means of an adhesive. Bonding brackets to a patient's teeth is more comfortable for the patient, cosmetically more appealing and faster in practice than the use of metal bands.
Applying an appropriate amount of adhesive to the base of an orthodontic appliance such as a bracket or buccal tube can be a time consuming and tedious task for the orthodontist or his or her assistant. Too little adhesive may result in the bracket coming loose from the tooth after installation while an excessive amount of adhesive will be pushed out from between the bracket and tooth, requiring removal. Further, while two-part chemically curing adhesive systems are available for bonding orthodontic brackets to a patient's teeth, many practitioners prefer photo sensitive adhesives that are cured upon exposure to light in the visible spectrum for a relatively short period. Consequently, time is also a factor insofar as the adhesive applied to the bracket can only be exposed to visible light for a limited period before the bracket is positioned on the tooth.
In order to address these issues, pre-pasted orthodontic appliances were developed. Pre-pasted orthodontic appliances have an adhesive, normally a photo sensitive, light curing adhesive, applied to the base of the bracket before the bracket is packaged. Pre-pasted brackets reduce the amount of time required to install brackets on the patient's teeth by eliminating the need for the orthodontist to apply the adhesive to the bracket. Pre-pasted brackets also reduce the amount of wasted adhesive as the manufacturer can precisely control the amount and placement of the adhesive on the base of the bracket.
Packaging for brackets with a pre-applied light curing adhesive must protect the adhesive from exposure to light, as well as from contamination and evaporation. Further, if the adhesive adheres to the package, the adhesive coating may be disturbed when the bracket is removed from the package. Thus, in some cases, the pre-pasted portion of the orthodontic appliance is isolated from the package material with a release coating or layer. In addition, the package should present the bracket to the orthodontist in a fashion that facilitates quick and convenient removal of the bracket from the package.
A packaged, pre-pasted orthodontic bracket according to the invention includes an orthodontic bracket having a base, a central portion extending from the base, at least two opposed tie wings extending from the central portion and a layer of light-curable adhesive is disposed on the base. A cover for protecting the light-curable adhesive is disposed over the layer of light-curable adhesive and at least a lower portion of the base. The cover has a lip or upper edge portion that is secured about the central portion of the bracket to retain the cover on the bracket. Preferably, the cover is made of an elastomeric material that is stretched over the base. In one variation, the upper edge portion of the cover comprises an endless lip that sealingly engages a sloped upper surface of the base of the bracket around the periphery of the central portion of the bracket where the central portion is narrower than the base. The cover may engage the exposed face of the layer of light-curable adhesive or it may be slightly spaced from an exposed face of the layer of light-curable adhesive.
Referring to
Cover 22 is formed from an elastomeric material such as silicone, polyurethane, polyethylene, polypropylene or polyester, preferably with a hardness of 70 A Shore or less. Preferably, cover 22 is relatively thin, on the order of 0.015 inches in thickness. The elastomeric material may be filled with a light blocking agent or filler such as carbon black to protect the paste layer from exposure to light and premature curing. As illustrated, cover 22 is formed with an upper edge portion or endless lip 24 around the perimeter of the cover that faces inwardly toward bracket 12 when the cover is stretched over the bracket. In this manner, lip 24 encircles central portion 16 at a location where the perimeter of bracket 12 is smaller than the perimeter of base 14, enhancing retention of cover 22 on bracket 10 since lip 24 must be stretched to remove the cover from the bracket. Preferably, lip 24 engages the upper sloped surface 28 of base 14 at or adjacent the lower end of central portion 16 of the bracket 10 to provide a gas tight seal between cover 22 and bracket 10 when the cover is installed on the bracket. Cover 22 includes a tab 32 which may be grasped to stretch the cover to facilitate removal from bracket 12.
Cover 22 is provided with an opaque liner 30 positioned on the inner surface of a central portion 26 of the cover. Liner 30 serves to protect the paste layer 20 from light that would cause the paste to cure prematurely. Liner 30 may be formed from mylar, polyethylene, polypropylene or a similar material so long as the material is opaque to actinic radiation, for example in the range 400-510 nm wavelength. Liner 30 may be adhered to cover 22 with an adhesive, preferably near the center of the liner such that the liner does not inhibit stretching cover 22 when the cover is installed on bracket 12. If liner 30 protects paste layer 20 sufficiently from light, then a filler or blocking agent may be omitted from the elastomeric material, which may then be translucent or transparent. As shown, liner 30 has preferably has dimensions slightly greater than the underlying paste layer 20 to ensure complete coverage.
In an alternate embodiment, illustrated in
Turning to
Covers such as those described above could be applied manually to pre-pasted brackets, but are preferably applied by a machine that robotically engages and stretches opening 36 as it pulls the cover over the pre-pasted bracket, which is held in a fixture. To make this process easier, it is preferred according to the invention to make the inner edge of the cover thinner adjacent opening 36 than elsewhere. Lip 24 may be inwardly tapered for this purpose.
Referring to
While certain embodiments of the invention have been illustrated for the purposes of this disclosure, numerous changes in the method and apparatus of the invention presented herein may be made by those skilled in the art, such changes being embodied within the scope and spirit of the present invention as defined in the appended claims. For purposes of the invention and the claims, use of relative terms such as “substantially”, “generally” and “about”, unless otherwise specifically defined, are meant to permit functionally insignificant variations from exact mathematical values that might otherwise be implied from the use of specific numbers. With respect to properties such as rigidity, for example, the words “generally rigid” or “substantially rigid” mean that total rigidity is not required as long as the piece does not collapse under normal use as described in the specification.
This application claims priority of U.S. Provisional Ser. No. 60/690,658, filed Jun. 15, 2005.
Number | Date | Country | |
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60690658 | Jun 2005 | US |