BACKGROUND OF THE INVENTION Many orthopedic procedures require the use of any one of various types of bone cement compositions. Such compositions aid both in the setting of bone and in securing implants or other devices to bone during orthopedic procedures. Advances in bone cement compositions have led to rapid setting bone cement compositions, which are advantageous because they shorten the time required both for surgery and the time needed for recovery after surgery. Some forms of bone cement compositions are heat-activated. Heat-activated bone cement compositions are caused to set into solid form by exposure to a heat source. Particularly, heat activated bone cement compositions are ideal because they set in response to body heat provided by the host into which they are deposited. Furthermore, some procedures require that such compositions are injected using a syringe.
Certain problems arise when preparing to inject a bone cement composition into a host using a syringe. Particularly, problems arise when attempting to transfer the cement composition from a mixing apparatus into the syringe. Various solutions have been proposed to solve this problem, which may require the use of complicated pumps and tubes to mix or transfer the cement composition. Furthermore, no apparatus has been proposed which allows a user to transfer the cement composition into the syringe without holding the syringe. This presents a problem, in particular, with use of a heat-activated bone cement composition, because the heat from a user's hand will raise the temperature of the syringe and cause the bone cement composition therein to set, becoming a solid mass contained within the syringe that is no longer useable. Therefore, it is ideal to provide an apparatus that aids in the transfer of the bone cement composition into the syringe without requiring the user thereof to physically hold the syringe.
SUMMARY OF THE INVENTION The present invention relates to a stand for use with a syringe having a feature, the stand having a base portion, and a top portion. The top portion has an aperture formed therein, the aperture being structured to engage a feature of the syringe. The top portion is positioned relative to the base portion such that the syringe is maintained in an upright position when the feature of the syringe is engaged within the aperture. In order to better engage the feature of the syringe, a preferred embodiment of the aperture includes a series of projections and recesses configured to form a pressure-fit with the feature.
A particular embodiment of the present invention includes a stand for use with a syringe having a barrel and a nozzle, the stand having a base portion, and a top portion. The top portion has an aperture formed therein, the aperture being structured to engage the nozzle of the syringe. The top portion is positioned relative to said base portion such that the syringe is maintained in an upright position when the nozzle of the syringe is engaged within said aperture.
An alternative embodiment of the present invention includes a stand for use with a syringe having a plunger with a proximal end, the stand having a base portion, and a top portion. The top portion has an aperture formed therein, the aperture being structured to engage the proximal end of the plunger of the syringe. The top portion is positioned relative to the base portion such that the syringe is maintained in an upright position when the proximal end is engaged within the aperture.
In a further embodiment of the present invention, a stand according to one embodiment of the present invention further includes a package portion affixed to the stand at the base thereof. The package portion includes a compartment, preferably in the form of snap channel, wherein the compartment is adapted to hold the syringe within the package in a substantially horizontal position, particularly during shipping and storage of the syringe within the package. This embodiment can further include additional compartments within package portion for other components that are relevant to bone cement preparation such as containers for bone cement ingredients, mixing devices and attachments for the syringe.
The present invention also includes a method of preparing a syringe to deliver a material, the method including the steps of: providing a syringe, providing a stand having an aperture capable of engaging a feature of the syringe, wherein the stand is capable of maintaining the syringe in an upright position; inserting the feature of the syringe within the aperture such that the syringe is maintained in an upright position; and depositing an amount of a material into the syringe.
The present invention also includes a kit having therein a syringe, components used in forming an injectable bone cement composition, and a container used in mixing the bone cement components. The kit of the present invention can further include a stand including a base portion and a top portion. The top portion of the stand has an aperture formed therein, the aperture being structured to engage a feature of the syringe. The top portion is positioned relative to the base portion such that the syringe is maintained in an upright position when the feature of the syringe is engaged within the aperture. The stand can further include a package portion for containing the other components for the kit. In a further embodiment, the kit includes a desiccant to prevent aging of the components used in forming the bone cement composition, particularly those which may be in the form of a powder, and more particularly, those powders which may be more susceptible than others to moisture.
The present invention further includes a syringe for use with a stand, the syringe having a barrel, a nozzle, a plunger. The barrel is divided into a proximal portion and a distal portion, the proximal portion and distal portions being separable to provide an opening into the barrel of the syringe.
BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be better understood on reading the following detailed description of nonlimiting embodiments thereof, and on examining the accompanying drawings, in which:
FIG. 1 is a perspective view of the device according to an embodiment of the present invention;
FIG. 2 is a perspective view of the device according to an embodiment of the present invention;
FIG. 3 is a perspective view of the device according to an embodiment of the present invention;
FIG. 4 is a perspective view of the device according to an embodiment of the present invention;
FIG. 5 is a top view of the device according to an embodiment of the present invention;
FIG. 6 is a perspective view of the device according to an embodiment of the present invention.
DETAILED DESCRIPTION In describing the preferred embodiments of the subject matter illustrated and to be described with respect to the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
Referring to the drawings, wherein like reference numerals represent like elements, there is shown inFIG. 1, in accordance with one embodiment of the present invention, a syringe stand designated generally byreference numeral10. In a preferred embodiment,stand10 includesbase portion12 andtop portion14. Although the shape ofbase12 as shown inFIG. 1 is substantially rectangular,base12 does not require the use of any particular shape; however,base12 should be structured to allowstand10 to stably rest on a surface while in use. As shown inFIG. 2,base12 can include aflat bottom portion24 that is sufficiently wide enough to stably supportsyringe30 during use. Preferably, theflat bottom portion24 includes aflange26 formed thereon. In a further preferred embodiment, shown inFIG. 4-6,stand10 includes apackage portion70 that is preferably attached tobase12. The package portion is useful for transporting and storing withsyringe30, other tools or materials that are used in connection withsyringe30.
Stand10 is preferably made of plastic or any other suitable polymeric material such as polyethylene, and is preferably transparent. The thickness and composition of the material used to formstand10 should result instand10 being flexible. Preferably,stand10 is formed by vacuum molding or other similar methods. Preferably,stand10 is in the form of a blister pack such that it is formed from a thin, unitary piece of material that is molded to form the three-dimensional shape ofstand30. This results in thestand10 having a generally hollow inside portion (not shown). Thematerial comprising stand10 should be thin enough to be flexible, but should be thick enough to be rigid such that it securely engages an appropriate feature ofsyringe30. Such a feature can includebarrel32, including any section thereof, or handles50, which are affixed tobarrel32, but will preferably includenozzle34 orproximal end46 ofplunger44.
In one embodiment of the invention,top portion14 ofstand10 is generally planar, except foraperture16 formed therein. Aperture16 is structured and dimensioned to receivenozzle34 ofsyringe30 and can take a variety of shapes from circular to more complicated geometric designs. Generally, the dimension ofaperture16 should be such that it forms a pressure fit withnozzle34. For example, ifaperture16 is substantially circular,aperture16 can also be circular, having a diameter that is slightly less than that ofnozzle34.
The pressure fit formed betweenaperture16 andnozzle34 should be sufficient to holdsyringe30 in an upright position when inserted in the stand. For purposes of this invention, upright is not limited to a completely vertical position (i.e., orthogonal to the surface on which stand10 rests), but includes any orientation ofsyringe30 whereinopening40 through which theinjectable material80 is deposited intosyringe30 has an elevation that is vertically greater than that of the portion ofsyringe30 which is inserted into the stand.
Syringe30 can vary in size, depending on the application for which it is designed. Accordingly,aperture16 will be dimensioned to fit a specific one of these various sizes. Ideally,syringe30 will be packaged withstand10 having anaperture16 of an appropriate size to match that ofnozzle34 ofsyringe30. In a preferred embodiment, stand10 is integrally formed with part ofpackaging70 forsyringe30.
In a preferred embodiment,aperture16 has abottom portion22 that is positioned belowtop portion14 at a distance such thatshoulder section38 ofsyringe30 contactstop portion14 andport36 ofnozzle34contacts bottom surface22 ofaperture16. Such an arrangement will prevent the material that is placed withinsyringe30 from leaking out ofnozzle34 whilesyringe30 is held upright withinstand10.
As shown inFIG. 5, a preferred embodiment ofstand10 includes anaperture16 having a shape that forms a series ofprojections18 and accompanying recesses20. Any number ofprojections18 and recesses20 can be used in the shape ofaperture16, but preferablyaperture16 has at least threeprojections18 and threerecesses26. In such an arrangement,projections18 make contact withnozzle34, whilerecesses20 are spaced apart therefrom.Projections18 are dimensioned to form a pressure fit withnozzle34. In one embodiment,aperture16 has oneprojection18 and onerecess20, whereinnozzle34 makes contact with a portion ofrecess20 and withprojection18. In a preferred embodiment,aperture16 is tapered, having a greater diameter toward thetop portion14 than toward the bottom22 thereof.
Referring now toFIG. 3, in an alternative embodiment of the present invention,aperture116 is adapted to engage the proximal end146 of plunger144. Plunger144 is of the type normally used in connection with a syringe. Specifically, plunger144 is cylindrical in shape and is dimensioned to fit within the open end140 ofsyringe130. Plunger144 typically includes tip148 which effects a seal between the inside of the barrel132 ofsyringe130. The seal between tip148 and barrel132 is preferably impervious to fluid. Furthermore, the seal formed between tip148 and barrel132 provides a friction force therebetween, which is sufficient to support the weight of barrel132 whensyringe130 is secured in stand110. Such an arrangement eliminates the need present in other embodiments ofstand10 to structureaperture16 to form a seal over the open end ofnozzle34. Furthermore, the present embodiment facilitates the removal of air pockets or bubbles that may be present in the injectable composition when it is transferred intosyringe130.
Proximal end146 of plunger144 varies in shape among differing plunger designs, but will typically form a surface that is larger in area thanplunger rod145.Aperture116 can be adapted to receive any feature which may be present on the proximal end146 of plunger144.Aperture116 can be of any shape that will provide a pressure-fit sufficient to engage proximal end146 to maintain the syringe in an upright position. In its most simple form,aperture116 will have a profile along a horizontal plane therethrough that substantially matches the profile of proximal end146 when intersected by the same plane. Preferably,aperture116 is tapered such that it is wider near thetop surface114 than at the bottom122 of theaperture116. This arrangement aids in inserting proximal end146 into theaperture116.
In a preferred embodiment,aperture116 includes a series ofprojections118 and recesses120 designed to contact proximal end146 at a predetermined number of points. Although any number ofprojections118 and recesses120 may be employed in such a design, it is preferable that the aperture has four projections and four recesses. The overall size ofaperture116, as well as theprojections118 and recesses120 will vary in accordance with the shape of proximal end146 in a manner that can be determined by those having reasonable skill in the art.
Syringe130 of the type depicted inFIG. 3 is particularly advantageous for use with a stand of the present embodiment and, perhaps, for other purposes. This variation ofsyringe130 has a two-part barrel construction, wherein barrel132 is divided into proximal and distal portions132a,132b.Distal portion132bof barrel132 includesnozzle134, and proximal portion132aincludes open end140 and handles150. Proximal and distal portions132a,132bof barrel132 are designed for mutual engagement therebetween and preferably include a mechanism, such as a thread-fit, pressure-fit or snap fit, to secure the engagement between the two portions132a,132b.As shown inFIG. 3, this mechanism preferably includes mating threaded sections133a,133b,one on each of proximal portion132aand distal portion132b.Preferably, the male portion133aof the threaded section133 is included on proximal portion132aof barrel132, and female threaded portion133bis included on distal portion132b.
This variation ofsyringe130 operates with stand110 by providing a sufficientlywide opening152 to deposit theinjectable substance88 into barrel132. In operation, proximal end146 of plunger144 is inserted intoaperture116 of stand110, the distal portion132bof barrel132 having been removed from the proximal portion132a.Tip148 of plunger144 is positioned sufficiently near the opening end140 to allowsyringe130 to contain the desired amount ofinjectable substance88. The position of tip148 within barrel132 is maintained by the friction between tip148 and the interior of barrel132. Theinjectable substance88 is then prepared and deposited into the syringe throughopening152. Then, distal portion132bof barrel132 is re-assembled onto proximal portion132aof barrel132 andsyringe130 is used in a typical fashion.
It is preferable that proximal portion132aof barrel132 represents a greater portion of the entire barrel132 than does distal portion132b;but the barrel may be divided anywhere, depending on the purpose for which it is divided. For filling the proximal portion132a,the distal portion132bneed only be large enough as necessary to supportnozzle134. This arrangement allows the interior of barrel132 to be filled with as much ofinjectable substance88 as possible before distal portion132bis re-assembled onto proximal portion132b.This arrangement is also advantageous for a kit having several choices of different nozzle assemblies that can be fit onto the proximal portion132a. Preferably, such different nozzles could be differently sized for different applications and a surgeon could choose a nozzle intraoperatively. Most preferably, when connecting the portions132aand132bopening152 abuts the inside surface ofshoulder section138 of distal portion132bwhen distal portion132bis engaged onto proximal portion132a.
In an alternative form of the invention, a recess can be provided in the package which is larger than the feature of the syringe to be held therein (whether it be the nozzle or the proximal plunger portion), as well as deeper so that the syringe can be placed in such large and deep recess and so held in an upright position.
Referring now toFIGS. 4-6, in a preferred embodiment of the present invention stand10 is formed as part ofpackage70. Preferablypackage70 is designed to carrysyringe30. More preferably,package70 is one for a bone cement preparation kit. A kit according to this embodiment of the present invention is generally in the form of a blister pack in which stand10 is connected to package70 atbase12 ofstand10.Stand10 can be located anywhere inpackage70 but, for purposes of stability, is preferably located near the center ofpackage70.Package70 has various compartments for the elements contained therein. Such elements includesyringe30 which is held within asnap channel72 specifically designed to securely holdsyringe30 in a horizontal position withinpackage70. Preferably,package70 also contains acompartment74 designed to hold wet ingredient container60, which is usually in the form of a second syringe. Anadditional compartment76 is also preferably formed withinpackage70 and is dimensioned to securely hold a mixingspatula62 therein. Afourth compartment78 is preferably formed withinpackage70 such that it can hold acannula64 that is specifically adapted for attachment tonozzle34 ofsyringe30.
Additionally, mixingbowl86 is preferably supplied withpackage70. Mixingbowl86 contains a dry ingredient which is part of a bone cement composition. Preferably, the wet ingredient is added to the dry ingredient in mixingbowl86, and the two ingredients are mixed together usingspatula62 to form a bone cement composition.
As shown inFIG. 6, in a preferred embodiment of the current invention,package70 is placed into anouter tray82, which further helps to maintain the sterility ofpackage70 and the components held therein. A lid is then affixed to flange84 ofouter tray82 to seal the components therein. Preferably, the lid is made from Tyvek™, or another material which serves the purpose of sealing the contents ofpackage70 so as to preserve the sterility and integrity of the ingredients. Although it is possible to supply mixingbowl86 withinpackage70, having a corresponding compartment (not shown) formed therein, it is preferred that mixingbowl86 is not included withinpackage70, but is otherwise supplied withpackage70. Such an arrangement is shown inFIG. 6, wherein mixingbowl86, having lid87 affixed thereto, rests or is otherwise secured within a compartment formed in inner blister71. Inner blister71 is then placed inouter blister83 and an outer lid.85 is affixed thereto. The assembledouter blister83 andouter tray82 are each sealed in their own outer pouch (not shown), which is preferably made of foil.Outer tray82 andouter blister83 are then inserted into a carton (not shown), which is typically made from cardboard or other similar material.
A desiccant is preferably included with mixingbowl86, or any other container used to hold a dry ingredient of a bone cement composition used in connection withstand10. The inclusion of a desiccant ensures that the storage environment of the powder is kept dry in order to prevent “aging” of the powder in the presence of free moisture, which would render the powder unusable. In the particular embodiment of the invention described with reference toFIG. 6, desiccant is included with mixingbowl86 by placing a desiccant pack inouter blister83 betweenouter blister83 and inner blister71. Preferably, a desiccant pack containing about 10 grams of color indicating silica gel is supplied, however other available desiccants include those made of clay and calcium chloride. The appropriate amount of desiccant varies with the particular application, the determination of which is generally understood in the art.
In certain applications ofstand10 including apackage portion70, it may be desired to providepackage70 withoutouter package82. In such a case,package70 includes an outer flange.80 to which a lid (not shown) is affixed.
A further aspect of the present invention includes a method for using stand as discussed above. In one such embodiment, stand10 according toFIG. 2 is provided as well as asyringe30.Stand10 is placed on a surface andsyringe30 is inserted into the stand.Stand10 has anaperture16 that securessyringe10 atnozzle34.Stand10 is designed to maintainsyringe30 in an upright position. Theinjectable substance88 is then deposited into thebarrel32 ofsyringe30. This material can be anything that is intended to be injected usingsyringe30 but is preferably an injectable bone cement composition.Plunger44 is then inserted intobarrel32 ofsyringe30.Syringe30 is then removed fromstand10.
In a further embodiment of the present invention, a stand as discussed with reference toFIG. 4 is provided.Stand10 includes apackage portion70 that includescompartment72 for holdingsyringe30 in a horizontal position therein during shipment or storage ofstand10. Preferably,package70 contains additional compartments used to store other devices or containers used in connection withstand10. Preferably,outer tray82 has a lid (not shown) affixed thereto atflange84 thereof. Lid is first removed fromflange84 andsyringe30 is removed fromsnap channel72, where it is contained.Plunger44 is then removed frombarrel32 ofsyringe30 by pullingplunger44 out of saidbarrel32.Plunger44 is then set aside andsyringe30 is inserted intostand10 in an upright position. According to one preferred embodiment discussed above,nozzle34 ofsyringe30 is inserted intoaperture16 ofstand10. In an alternative embodiment, proximal end146 of plunger144 is inserted intoaperture116, which is appropriately formed therein.
In a preferred embodiment of the present invention,spatula62 is included incompartment76, which is preferably in the form of a snap-channel, withinpackage70, and a container60 for a liquid ingredient is heldcompartment74 withinpackage70. Bothspatula62 and container60 are removed frompackage70 and set aside. Preferably, mixingbowl86, which contains a dry ingredient for a bone cement composition, is provided. Mixingbowl86 contains lid87 affixed thereto, which is removed and discarded. The liquid ingredient in container60 is then deposited into mixingbowl86, andspatula62 is used to thoroughly mix the wet ingredient with the dry ingredient to form a bone cement composition. Once a homogeneous mixture is achieved from mixing of the wet and dry ingredients, mixingbowl86 is placed near an appropriate opening ofsyringe30, which will vary by application. If thenozzle34 of syringe is inserted intoaperture16, this opening will beopen end40. Alternatively, ifproximal end142 of plunger144 is inserted intoaperture116, then the mixing bowl will be placed nearopening152. Mixingbowl86 is then tilted such thatinjectable substance88 flows intobarrel32 ofsyringe30. If necessary,spatula62 is used to aid in this process.
Once the desired amount of theinjectable substance88 is transferred intosyringe30,plunger44 is reinserted intobarrel32. In the embodiment of the present invention discussed with reference toFIG. 1,plunger44 is advanced into thebarrel32 until tip48 of theplunger44 contacts the upper surface of theinjectable substance88 contained withinsyringe30. To aid in this process,plunger44 may include an air-release port (not shown) that begins at a small orifice in tip48 ofplunger44 and continues toproximal end46 of theplunger44. This arrangement allows for any air in thesyringe30 above the surface of theinjectable substance88 to escape frominside syringe30 without forcing theinjectable substance88 fromsyringe30 throughnozzle34.
In a preferred embodiment of the present invention,package70 further contains acannula64 heldcompartment78. In this embodiment,cannula64 is removed fromcompartment78 and thensyringe30 is removed fromstand10.Cannula64 is then assembled ontonozzle34 ofsyringe30. Incorporation of male and female thread portions aids in such assembly. This method allows for fast, efficient loading of asyringe30 with aninjectable substance88, that is preferably a rapid-setting bone cement composition. It also allows for more accurate filling ofsyringe30 by a single user.
A stand according to the present invention is preferable regardless of whether or not the bone cement composition is heat-activated, because any fast setting bone cement composition must be quickly mixed and deposited intosyringe30 for injecting into a host before the bone cement composition sets. Furthermore, because bone cements and other additional materials are loaded from the top of the syringe, difficulty may be experienced by a single person attempting to fillsyringe30.
Thesyringe30 referred to throughout can be of any type related to any field of use. In a preferred embodiment,syringe30 relates to medical devices, and more particularly, to devices used in orthopedics, specifically delivery of rapid setting bone cement compositions. However, it is contemplated that variations ofsyringe30, within other fields can be used in conjunction with the present invention.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.