1. The Field of the Invention
The present application is directed to devices for mixing, storing and dispensing time-sensitive dental compositions. More particularly, the application is directed to methods and systems for mixing, storing and dispensing two-part dental compositions that can become destabilized over time within their useful life.
2. The Relevant Technology
Many chemical formulations are packaged in two initially separate parts, often known as A and B components. Separate storage of the A and B components is often necessary where the composition resulting from mixing is unstable over time. For example, a self-etching dental primer composition may be provided in two initially separate parts to prevent the acid component from slowly destabilizing the polymerizable resin component by hydrolyzing off the functional group(s) to which the backbone of the resin is chemically bonded. Although such destabilization may not occur immediately upon mixing, with many such compositions, it is often recommended that the composition be used up or discarded within a certain time period (e.g., 30, 60, or 90 days) after initial mixing.
Because such compositions are typically only used in small amounts in any particular procedure, it can be difficult to determine how much time has elapsed since initial mixing, and whether or not the useful shelf-life of the mixed composition has expired. Simply discarding composition remaining after a single use is effective in preventing use of shelf-life expired product, but is wasteful and unnecessarily expensive. Alternatively, it may be possible to write the date of mixing onto the outside of the mixing or storage syringe. However, such writing can easily become smeared, smudged, altered, worn away, or otherwise rendered illegible, particularly when stored in a typical dental or medical environment. In addition, the smooth molded plastic surfaces of such mixing systems often do not readily accept writing from many writing utensils (e.g. most pens and pencils). In light of the above, it would be an advantage to provide a time-indicating mixing system for use with a two-part composition that would allow a user to record a mixing date within the system for later reference that would be at least somewhat protected from damage or alteration.
The present invention is directed to time-indicating syringe mixing systems for mixing, storing, and dispensing a two-part composition that becomes less stable upon mixing. In one embodiment, the system includes a first plunger comprising an elongate stem and a plug at a distal end of the elongate stem, a hollow first chamber configured to contain a first component, a hollow second chamber configured to contain a second component, means for indicating a recorded date when a first component initially contained within the hollow first chamber is mixed with a second component initially contained within the hollow second chamber. The inventive syringe mixing systems may be configured as a syringe-in-syringe system and/or as a syringe-to-syringe system.
In one embodiment, the means for indicating a recorded date may comprise means for providing a region of increased space sufficient to receive a label on which is recorded a mixing and/or expiration date (i.e., at least about 0.0005 inch), the region being defined between an outside surface of the elongate stem of the first plunger and an interior surface of a wall that defines the hollow first chamber. The inventive systems advantageously allow a user to mix a two-part composition and to visibly record a mixing and/or expiration date (e.g. on the elongate stem and/or on a label that is inserted into a defined region of increased space) such that the date is carried with the system for later reference. The visible recorded date indicates to the user how much shelf life remains until the mixed composition should be used up or discarded. As a further advantage, the system may also include means for protecting the recorded date from damage and/or alteration.
One example of a syringe-in-syringe system includes a first plunger, a hollow second plunger configured to contain a first component, and a syringe barrel configured to contain a second component. When assembled, the first plunger is slidably disposed within the hollow second plunger, and the hollow second plunger is slidably disposed within the syringe barrel. As mentioned above, the system further includes means for indicating a recorded date when a first component was mixed with a second component.
An example of means for indicating a recorded date comprises an indented substantially flat label surface formed into a portion of the first plunger on which can be recorded a mixing date. The date may be written directly onto the label surface. Alternatively, the date may be written on an adhesive label which is afterwards adhered to the indented substantially flat label surface. An example of means for protecting the recorded date comprises disposing the label surface on the stem of the first plunger, and forming at least a portion of the hollow second plunger so as to be transparent or translucent. Pressing the first plunger (including the label surface) into the hollow second plunger protects the recorded date, as the recorded date is covered and protected from damage or alteration by the hollow second plunger. The recorded date advantageously remains visible to the user through the transparent or translucent hollow second plunger.
In another embodiment, the label surface may comprise a roughened surface formed into the surface of the system and on which a date (e.g. mixing and/or expiration date) can be recorded. The roughened label surface may be an indented substantially flat label surface, or may simply be a roughened surface on the outside surface somewhere on the system components (e.g. the stem of the first plunger, a syringe barrel, or a hollow second plunger). For example the roughened surface may not be substantially indented relative to the surrounding portions of the plunger stem. In another embodiment, a roughened label surface may be disposed on an outside surface of a syringe barrel or hollow plunger (i.e., so as to be accessible for receiving writing by the practitioner).
Another example of means for indicating a recorded date comprises a plurality of removable plugs, i.e., “knock-outs” disposed somewhere on the system components (e.g. on a head of the first plunger and/or on a flange of a syringe barrel or hollow plunger). The plurality of “knock-outs” may include a first series of “knock-outs” for indicating the month (e.g. numbered 1-12), and a second series for indicating the day (e.g. numbered 1-31) or week (e.g. numbered 1-4). The practitioner simply removes selected “knock-outs” (e.g. one within a series denoting the month, and one within a series denoting a day or a week) by pushing them out with a pointed tool or other object so as to record a mixing and/or expiration date.
The inventive mixing systems allow a user to mix a two-part dental composition while at the same time providing a record of the mixing date when the first and second components were mixed together. Advantageously, the recorded date may be protected from damage or alteration. The systems are particularly useful with two-part compositions that expire, lose potency or otherwise become unusable after a certain period of time has elapsed (e.g., a two-part self etching primer having a shelf-life of about thirty days after initial mixing).
Advantageously, embodiments in which the mixing and/or expiration date is written on a first plunger may include a locking mechanism to prevent the first plunger from being withdrawn once inserted into the hollow second plunger, so as to provide further protection against damage or alteration of the recorded date. For this purpose, the first plunger may advantageously comprise a plurality of longitudinally extending interlock ribs or an annular interlock ring formed near its proximal end. The interlock ribs or annular interlock ring are configured for insertion into the hollow second plunger, which includes a corresponding surface that engages the interlock ribs or ring so as to prevent the first plunger from being withdrawn once the ribs or ring have been inserted into the hollow second plunger, thereby locking the first plunger within the hollow second plunger of an exemplary syringe-in-syringe mixing system.
The hollow second plunger may advantageously include a transparent or translucent window portion (or the whole hollow second plunger may be transparent or translucent), so as to allow a user to read the recorded date through the hollow second plunger. Because the first plunger is covered by the hollow second plunger, the recorded date is advantageously protected from damage or alteration that might otherwise occur if the recorded date were exposed (e.g. simply written on an outside surface of an exposed syringe barrel). Providing a locking mechanism for preventing withdrawal of the first plunger after insertion advantageously provides additional protection to the recorded date.
Alternatively the syringe mixing system may comprise a syringe-to-syringe mixing system. One example of a syringe-to-syringe system includes a first plunger slidably disposed within a first syringe barrel, the first syringe barrel being configured to contain a first component, a second syringe barrel configured to contain a second component, and a second plunger slidably disposed within the second syringe barrel. As mentioned above, the system further includes means for indicating a recorded date when a first component was mixed with a second component (e.g. any of the recorded date indicating means described above or any other structure capable of performing the same function).
These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
In order that the manner in which the above recited and other benefits, advantages and features of the invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
The present invention is directed to time-indicating syringe mixing systems for mixing, storing, and dispensing a two-part composition that becomes less stable upon mixing. The system includes a first plunger comprising an elongate stem and a plug at a distal end of the elongate stem, a hollow first chamber configured to contain a first component, a hollow second chamber configured to contain a second component, and means for indicating a recorded date when a first component initially contained within the hollow first chamber is mixed with a second component initially contained within the hollow second chamber. The inventive syringe mixing systems may be configured as syringe-in-syringe systems and/or as syringe-to-syringe systems.
The inventive systems advantageously allow a user to mix a two-part composition and to visibly record a mixing and/or expiration date (e.g. on the elongate stem, on an outside surface of a syringe barrel, on a label which is carried with the system, and/or through a plurality of “knock-outs” used to designate a date) such that the date is carried with the system for later reference. The visible recorded date indicates to the user how much shelf life remains until the mixed composition should be used up or discarded. As a further advantage, the system may also include means for protecting the recorded date from damage or alteration.
First and second components 108a and 108b may each be a liquid, or one may be a solid powder, as dictated by the characteristics of the two-part composition to be mixed. One contemplated two-part composition is a two-part self etching dental primer composition described in U.S. patent application Ser. No. 11/261,171, filed Oct. 28, 2005, and entitled SELF-ETCHING DENTAL PRIMER COMPOSITIONS AND METHODS AND SYSTEMS UTILIZING SUCH COMPOSITIONS, herein incorporated by reference.
Depending on the length of hollow second plunger 104 and first plunger 102 relative to syringe barrel 106, locating label surface 114 near a proximal end of first plunger 102 allows a user to view the label surface 114 and a date recorded thereon even after first plunger 102 and hollow second plunger 104 have been fully inserted into syringe barrel 106, even if syringe barrel 106 is opaque. In other words, forming hollow second plunger 104 and first plunger 102 so as to be approximately equal in length and longer than syringe barrel 106 allows the proximal ends of hollow second plunger 104 and first plunger 102 to extend out of syringe barrel 106, even when fully inserted. For example, if syringe barrel 106 is shorter than hollow second plunger 104 and first plunger 102 by about the length of the label surface 114 (e.g. between about 0.75 inch and about 1 inch), label surface 114 and a date recorded thereon will still be visible to the user when the last of the mixed composition is dispensed. Keeping label surface 114 and a date recorded thereon visible through hollow second plunger 104 is helpful to the user as it indicates whether the shelf life of the composition has expired. Alternatively, or in addition, the barrel 106 may itself be sufficiently transparent or translucent so that the recorded date remains visible even if partially or completely inserted into barrel 106.
As perhaps best seen in
Sealing plug 119 and rupturable membrane 118 may advantageously be formed of a thermoplastic elastomer (TPE), which advantageously provides an excellent seal against syringe barrel 106, while also providing a desired strength to rupturable membrane 118. According to one embodiment, sealing plug 119 and membrane 118 are integrally formed as a single piece of material (e.g. TPE). Embodiments of such integrally formed sealing plugs and membranes are disclosed in U.S. patent application Ser. No. 11/673,334 entitled SYRINGE IN SYRINGE HOLLOW INNER BARREL/PLUNGER WITH INTEGRAL SEAL AND RUPTURABLE MEMBRANE AND RELATED KITS, SYSTEMS, AND METHODS, filed Feb. 9, 2007, herein incorporated by reference.
Advantageously, the system may be configured so that the force required to rupture membrane 118 is approximately equal to the force required to insert and engage the locking mechanism (e.g. interlock ribs 117 or annular interlock ring 117′) of first plunger 102 into hollow second plunger 104. Such a configuration provides a smooth and continuous movement and feel during use of the system as first plunger 102 is pressed into hollow second plunger 104, rupturing membrane 118 and locking first plunger 102 into hollow second plunger 104. Rupturable membrane 118 preferably has a thickness ranging from about 0.0005 inch to about 0.04 inch, more preferably from about 0.002 inch to about 0.025 inch, and most preferably from about 0.005 inch to about 0.015 inch. Of course, the actual thickness of rupturable membrane 118 will depend on the strength and other physical properties of the selected material, along with the configuration and desired level of force required to break the membrane 118 and/or engage the selected locking mechanism. One particularly suitable material from which to form sealing plug 119 and rupturable membrane 118 is ENGAGE, a TPE sold by DuPont-Dow Elastomers located in Wilmington, Del.
As perhaps best seen in
Because label surface 214 is indented relative to surrounding portions of stem 210, a region of increased space is defined between the stem 210 and the wall of first syringe barrel 204. The recorded mixing and/or expiration date is advantageously protected from being scraped off, worn off, or otherwise altered when first plunger 202 is pressed into first syringe barrel 204.
Recessed portion 211″ is illustrated as being located near the plug 212″, at the distal end of elongate stem 210″, although it may be located anywhere along the length of elongate stem 210″. Locating portion 211″ at the distal end of stem 210″ may be advantageous as it is less likely to be pulled out (and thus potentially exposed) of a syringe barrel or hollow second plunger, which is most helpful in a syringe-to-syringe mixing system. Similarly, the label surfaces of the other embodiments may be located anywhere along the length of the elongate stem of the first plunger. Preferably, recessed portion 211″ is located somewhere along stem 210″ that will be covered (and remain covered) by the first syringe barrel of a syringe-to-syringe mixing system or a hollow second plunger of a syringe-in-syringe system once first plunger 202″ is inserted.
When first plunger 202′″ is inserted within hollow second plunger 204′″, a region of increased space exists between elongate stem 210′″ and wall 215′″ such that a recorded date written on an outer surface of elongate stem 215′″ or written on a label inserted into the region of increased space is protected from damage or alteration once first plunger 202′″ is received within first syringe barrel 204′″. Although it may be possible to use a configuration as illustrated in
First syringe barrel 204 and/or hollow second plunger 204′″ are examples of a first hollow chamber, while second syringe barrel 206 is an example of a second hollow chamber. Although described above principally in the context of a syringe-to-syringe mixing system, one of skill in the art will appreciate that the first plungers described above may alternatively be used in a syringe-in-syringe mixing system, in which the first hollow chamber comprises a hollow second plunger and the second hollow chamber comprises a syringe barrel (e.g. similar to the system illustrated in
Rough label area 414 may be as large or small as desired, so long as it provides sufficient space on which the practitioner may write a mixing and/or expiration date. It may be advantageous to form label area 414 so that it is recessed into stem 410 and to provide a label surface which is substantially flat, although label surface 414 may alternatively be disposed elsewhere, e.g. on the outside surface of a syringe barrel or hollow plunger.
In one related embodiment (
The laminate label material separates from the backing layer carrier material, leaving the laminate label in place on the substrate where applied, ready for use. The backing layer carrier material is discarded. The top layer is typically white or lightly colored to provide contrast to a recorded date, and is formed of a material which readily accepts writing thereon. The Kerr product is one example of a laminate label surface, and others, whether applied in a similar or different manner, will be apparent to one of skill in the art. A roughened label surface or an applied laminate writing label surface as described above have been found to be superior to a relatively smooth molded plastic surface for purposes of writing thereon, as it can be difficult to record a date with a ball-point or similar type pen because the label surface is so smooth that it may not “grip” the writing end of the pen.
In addition, writing on smooth molded plastic surfaces is often easily rubbed or smeared off, which is less likely to occur with a roughened surface and/or a laminate label surface. Similar to the TPE materials described above, providing a roughened label surface or a laminate writing label surface is advantageously helpful when a ball-point pen or similar writing instrument is used to record a mixing and/or expiration date onto label surface 414 or 414′, as these surfaces act to grip the writing end of such a pen, which makes it much easier to write the date directly onto label surface 414 or 414′. Felt-tip pens, markers, or even a pencil may also be used to write on the surface. Although roughened label surfaces as described above can be used, it has been found that laminate writing label surfaces and/or TPE overmolded label surfaces provide a surface which accepts writing more readily than a roughened surface, and as such may be preferred over a roughened surface formed for example by molding a texture into the label surface, or sanding or grinding the surface so as to roughen it.
Although it is preferable for the label surface to be disposed on the stem of a plunger, a roughened label surface, a laminated writing label surface, or even the TPE coated label writing surface as described above may be disposed elsewhere on the mixing system. For example, a roughened surface, an overmolded TPE label surface, and/or a laminate label surface may be provided on the outside surface of a hollow second plunger (
For example, in the illustrated embodiment, a first series of knock-outs 515a may be disposed on flange 509 of syringe barrel 506. First series of knock-outs 515a may comprise, for example, twelve knock-outs, each designating one month of the year. In the illustrated example, the twelve knock-outs 515a are labeled 1-12 similar to a clock (i.e., “1” designates January, “2” designates February, and so on). Letters (e.g. the first letter of each month) or another labeling scheme could alternatively be used. A second series of knock-outs 515b is illustrated as being disposed on a proximal head 503 of first plunger 502. Second series of knock-outs 515b may comprise, for example, four knock-outs, each designating a week of a month.
Another embodiment could alternatively include a second series of knock-outs numbered 1-31 to indicate the day of the month, although because of the limited available space, a series of only four knock-outs may be preferred, as illustrated. The practitioner is able to remove one knock-out from each series of knock-outs so as to record and indicate a mixing and/or expiration date. For example, if the practitioner removes the knock-out labeled “5” from the first series and the knock-out labeled “4” from the second series, a mixing and/or expiration date of the fourth week of May is indicated to the practitioner when looking at the mixing system days or weeks later. By further example, to indicate dates between the 1st day and the 7th day of a month, a practitioner may punch out the “knock-out” labeled “1” from the second series, the “knock-out” labeled “2” may be punched out to indicate dates between the 8th day and the 14th day of a month, the “knock-out” labeled “3” may be punched out to indicate dates between the 15th day and the 21st day of a month, and the knock-out labeled “4” may be punched out to indicate dates between the 22nd day and the 31st day of a month. Such information is helpful to the practitioner in determining whether the mixed composition is still useful, or whether it should be discarded and a new batch of composition mixed. Other methods and “knock-out” configurations will be apparent to one skilled in the art in light of the present disclosure.
Once the mixing date 114′ has been recorded on label surface 114, the user may press first plunger 102 into hollow second plunger 104 so as to compress first component 108a. As shown in
In the locked configuration as shown, it is difficult, if not impossible, to withdraw first plunger 102 from hollow second plunger 104 without destroying the system. Enlarged diameter portion 116a is disposed within the center of flange 120, while ribs 117 extend distally from flange 120 further into hollow second plunger 104. Because flange 120 has increased barrel strength relative to the area of hollow second plunger 104 immediately distal to flange 120, the inside wall surface of hollow second plunger will be deformed by ribs 117 so as to form a depression into the portion of the inside wall contacted. At the same time, the inside surface of hollow second plunger 104 directly under flange 120 will be deformed only slightly if at all because of the increased barrel strength of the flange region 120 compared to the region contacted by ribs 117. In other words, ribs 117 create an interlock with the inside surface of hollow second plunger 104, preventing, or at least inhibiting, subsequent withdrawal of first plunger 102 from hollow second plunger 104.
As seen in
By way of another example,
System 300 is illustrated as similar to system 200 of
In any case, the recorded date 314a is advantageously not located on a surface of stem 310 that will be rubbed against the inside surface of the wall of first syringe barrel 304, which may otherwise cause the date to be smeared, worn away, or otherwise rendered illegible. Rather than writing the date on a label, the user may write the date directly onto recessed surface 311. In addition, first syringe barrel 304 includes a transparent or translucent window portion (e.g. the whole syringe barrel 304 may be transparent or translucent) so that the practitioner can read the recorded date through the barrel 304 a hollow second plunger.
Once the mixing and/or expiration date 314a has been recorded and label 314 has been positioned within recess 311, the user may press first plunger 302 into first syringe barrel 304 so as to compress first component 308a. As shown in
If necessary, the second plunger 302a may be used in conjunction with first plunger 302 to more completely mix first component 308a and second component 308b. The user may alternatingly press the first and second plungers in order to cycle the two-part composition back and forth between second syringe barrel 306 and first syringe barrel 304, resulting in more homogeneous mixing. Such additional mixing may not be necessary, particularly where any rupturable membrane, valve, or other separation means is configured to only pass first component 308a for mixing with second component 308b under a pressure sufficiently high to cause jetting of the first component into the second component (e.g. so as to create turbulence sufficient to mix the two components together). Once mixed, the composition may be dispensed for use as illustrated and described in conjunction with
Although exemplary methods are illustrated and described above in conjunction with specific mixing systems, it is to be understood that any mixing system including means for indicating a recorded date (e.g. any of those described herein), or any other structure capable of providing similar function could alternatively be used, and as such are within the scope of the invention.
It will be appreciated that the present claimed invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.
The present application is a continuation of U.S. patent application Ser. No. 11/736,457, filed Apr. 17, 2007 and entitled TIME-INDICATING SYRINGE MIXING DEVICES AND RELATED METHODS FOR STORING AND DISPENSING TWO-PART DENTAL COMPOSITIONS, which is a continuation-in-part of copending U.S. patent application Ser. No. 11/414,964, filed May 1, 2006 and entitled “TIME-INDICATING SYRINGE-IN-SYRINGE MIXING DEVICES AND RELATED METHODS FOR STORING AND DISPENSING TWO-PART DENTAL COMPOSITIONS”, U.S. patent application Ser. No. 11/537,883, filed Oct. 2, 2006 and entitled “TIME-INDICATING SYRINGE MIXING DEVICES AND RELATED METHODS FOR STORING AND DISPENSING TWO-PART DENTAL COMPOSITIONS”, and U.S. patent application Ser. No. 11/673,334, filed Feb. 9, 2007 and entitled “SYRINGE IN SYRINGE HOLLOW INNER BARREL/PLUNGER WITH INTEGRAL SEAL AND RUPTURABLE MEMBRANE AND RELATED KITS, SYSTEMS, AND METHODS”, each of which is incorporated by reference in its entirety.
Number | Date | Country | |
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Parent | 11736457 | Apr 2007 | US |
Child | 12242555 | US |
Number | Date | Country | |
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Parent | 11414964 | May 2006 | US |
Child | 11736457 | US | |
Parent | 11537883 | Oct 2006 | US |
Child | 11414964 | US | |
Parent | 11673334 | Feb 2007 | US |
Child | 11537883 | US |