Patent Application
20080283526
The present application relates to packaging for elongated devices, such as medical devices, each package containing different devices or different sizes of the same devices. The individual packages are suitable for assembly by the user into a procedure kit. In particular the application is directed to elongated devices for use in dental procedures and, in a particular embodiment, instruments and materials used in endodontic procedures.
In numerous medical procedures and particularly dental procedures the physician dentist or dental technician will use several different tools and various different sizes of particular tools. In a dental root canal procedure the crown of a diseased tooth is opened in order to allow access to the canal in the tooth to be cleaned and then filled. The dental practitioner removes the pulp material forming the nerve of the tooth at issue, carefully prepares the canal that contained the nerve material, and other pulp tissues and obturates or fills and seals the canal. After the crown is opened, a series of very elongated flexible instruments, commonly called files, are used to clean out and shape the root canal. Each file is rotated either manually or by a powered dental handpiece and reciprocated in the canal by the clinician. Files of increasingly larger diameters or varying contours or tapers are used in sequence, to achieve the desired cleaning and shaping. After the canal is prepared and the tissue and nerves are removed, it is solidly filled with a filling material, which typically comprises a waxy, rubbery compound known as gutta percha. The gutta percha can be manually introduced into the canal or an instrument, referred to as a compactor, can be inserted into the prepared canal and rotated and reciprocated to compact the gutta percha therein. The portion of the canal above the gutta percha is then filled with a protective cement. A crown may be placed over the tooth. A dental post may be placed into the newly prepared root canal to provide support for the coronal aspect of the tooth.
In performing the root canal procedure there is an ongoing need for kits which would allow the practitioner to assemble, prior to performing the procedure, all of the tools or materials required or which might be required. These tools and materials are typically provided in bulk or single use packaging and end up being scattered on surrounding tables, trays and cabinet surfaces.
As an example, endodontic files used to clear and shape the canal are commonly supplied to the clinician in kits which comprise several files of increasing diameter generally ranging from 0.08 mm at the tip (size 08) to 1.40 mm at the tip (size 140). The kits typically contain a number of files of increasing diameter so that the files from a particular kit may be used in sequence by the clinician in accordance with the requirements of the particular canal being cleaned. Also, in the conventional kits, the working length of each file in the kit is tapered, at an included angle of between about ½ and 4 degrees, the tapers of all of the files in the kit being the same.
The endodontic procedure includes the steps of inserting a selected one of the instruments in the above described kit into the root canal and rotating and reciprocating the instrument so as to extirpate the canal and form the canal into a general conical configuration including a relatively wide crown portion and an apex at the inner end of the root canal, and withdrawing the selected first one of the instruments from the canal and inserting a selected second one of the instruments in the canal, with the selected second one of the instruments having a larger diameter and a taper which differs from that of the selected first one of the instruments, and rotating and reciprocating the selected second one of the instruments so as to extirpate the canal and further form the canal into a general conical configuration. The second file is then is withdrawn from the canal and a third file having a larger diameter and a taper which differs from that of the selected second file is inserted in the canal and rotated and reciprocated in order to extirpate the canal and further form the canal into a general conical configuration.
Many devices, particularly elongated products are packed in containers holding several of the products, for example U.S. Pat. No. 3,372,802, U.S. Pat. No. 3,648,891, U.S. Pat. No. 3,815,734, U.S. Pat. No. 4,266,667 and U.S. Pat. No. 6,902,064. Devices used in dental procedures may be packaged in a bulk package (i.e. 1 dozen, 20 units, etc) such that the practitioner must removed the desired product from the package and assemble the tools and materials needed for a procedure. U.S. Pat. No. 5,429,243 to Woelk et al. shows a packaging box for receiving a plurality of elongated objects such as small bottles or ampoules. U.S. Pat. No. 3,759,375 to Nappi shows a shipping package containing multiple disposable swabs, each swab in a trough in a separable section. Other patents show various different trays for receiving tools for use in dental procedures such as U.S. Design Pat. 288,846 and U.S. Pat. No. 4,333,567 to Leonard. U.S. Pat. No. 4,353,694 shows a tray with multiple compartments of different sizes and shapes for receiving the various instruments and materials used in a procedure. A further alternative is a single package which includes several products (a starter drill, a finishing drill and multiple dental posts) for use in placing posts following a root canal procedure (U.S. Pat. No. 7,195,485). U.S. Pat. No. 5,653,590 is directed to a kit of endodontic instruments, namely different diameter and different taper files for use in a root canal procedure but does not discuss how these tools are packaged.
There are also patents disclosing multiple containers provided with structure or shape so that they can be nested together. For example, U.S. Pat. No. 6,857,530 shows bottles having nesting shapes which are then held together by an external wrapper. U.S. Pat. No. 4,165,812 shows four containers which when assembled form a structure with a circular periphery, each bottle comprising one-quarter of the cylindrical structure. Each one of the bottles has two flat sides, one flat side having a protrusion and the other flat side having a mating indentation. When assembled the protrusion on one bottle rests in the indentation on the adjacent bottle for forming the integral cylindrical arrangement. U.S. Pat. Nos. 5,007,540 and 5,115,916 to Beasley show four containers each having a triangular cross section. Two of the three sides of each container have the mating halves of a hook and loop attachment system secured thereto such that when nested together around a central core structure the four containers form a square structure with four separate compartments.
In accordance with the invention herein disclosed all of the tools and materials necessary for the dental procedure are provided in individual elongated containers, preferably square or rectangular in cross section. The containers are configured to hold thin, elongated devices, such as a series of containers for different size endodontic files, gutta percha, swabs, absorbent paper points, posts, etc. Additional attachable individual containers may be provided to hold various liquids, powdered materials or paste used in the procedure along with tools to apply those materials.
The containers all have structure on two or more sides thereof to allow them to all be assembled together into a single structure so that the practitioner can assemble his own procedure kit. This allows the user to assemble a series of different sized devices or different devices (files, guta percha, absorbent points, etc.) in a small assembled structure for easy access, to vary the components of the structure as required for each procedure and to remove an empty container or a container with the incorrect contents from the assembly and replace it with a proper device or material.
In a dental procedure, such as an endodontic procedure, the clinician will use many different tools, different sized tool and materials to prepare the tooth, access the root, clean out the root canal, treat the cleared canal to prevent infection and fill and close the treated canal. The various tools, which may be disposable or reusable, and materials may be provided in various different bulk packaging or sterile individual packaging. These packaged tools and materials may be placed on a stand adjacent the procedure area or a procedure tray may be used to receive the various different tools and materials for a procedure. However, a more preferred approach is for each of the various tools, or a set of various sized tools, and the materials to be initially provided in their own single procedure container and the containers be configured so that they can be assembled into a procedure tray by the dentist or support staff prior to each procedure. The individual tools, sets of tools and/or materials can be provided by the manufacturer in containers as described herein so that they can be assembled by the dentist, or the clinician may have multiple empty containers such as described herein so that they can be filled and a procedure tray can be assembled. Alternatively, some of the tools or materials may be provided by the manufacturer in individual containers as set forth herein while the clinician may have compatible empty containers for receiving additional tools or materials. In any event, a procedure tray comprising multiple separate containers can be assembled with the compartments thereof (i.e., the container contents) placed in an order or orientation to the other tools and materials most convenient to the dentist.
The invention contemplates using containers of various different cross sections not limited to four-sided containers as well as solid containers with shallower internal areas for placement of liquids or paste-like materials.
While
If different sized containers are used, in order to make them compatible for assembly it is preferred that they all have a width based on a smallest standard size, the larger sizes having widths that are multiples of the smallest container width. For example, referring to
In preferred embodiments the containers 10, 30 are elongated hollow rectangular structures. However, the invention contemplates that the use of shorter containers 40 which have a hollowed internal area shallow in depth to make the contents, such as liquids or gels, more accessible to the users. It is also contemplated that shallow containers and elongated containers could be combined in an assembled structure such as shown in
