CONTAINER FOR STORING A DENTAL, ESPECIALLY ENDODONTIC INSTRUMENT, KIT AND METHOD

20220031438 · 2022-02-03

    Inventors

    Cpc classification

    International classification

    Abstract

    The present invention relates to a kit comprising

    an endodontic instrument in the form of an endodontic file and
    a container with a lower container part, for receiving the working section (3c) of the endodontic instrument, and an upper container part, for receiving the upper axial end region of the instrument,
    wherein a holder is provided on the upper side of the lower container part, which holder comprises an axial through-opening through which the working section of the instrument is inserted into the lower container part and in which the instrument, in particular the tool shaft of the instrument, is fixed in a clamping manner,
    wherein the upper container part is connected with the lower container part in an airtight manner to form the container, and the interior of the container and the instrument are sterile.

    Claims

    1. Kit, comprising: a single endodontic instrument (1) in the form of an endodontic file, which has a tool shaft (3), on one upper axial end region of which tool shaft (3) a handle or a coupling section for connection to a motor-driven rotary tool is formed and on the other, lower end region of which tool shaft (3) an in particular conically tapered working section (3c) is formed, and a container (2) that is designed as a disposable packaging for storing a single endodontic instrument and has a lower container part (2a), which is open at its top side for receiving the working section (3c) of the instrument (1), and has an upper container part (2b), which is open at its underside for receiving the upper axial end region of the instrument (1), wherein a holder (5) is provided on the upper side of the lower container part (2a), which holder (5) has an axial through-opening (6) through which the working section (3c) of the instrument (1) is inserted into the lower container part (2a) and in which through-hole (6) the instrument (1), in particular the tool shaft (3) of the instrument (1), is positioned radially and/or axially and is fixed in a clamping manner and/or by a latching connection, wherein the upper container part (2b) is connected to the lower container part (2a) in an airtight manner to form the container (2), and wherein the interior of the container (2) and the instrument (1) are sterile, and wherein at least the lower container part (2a) consists of a material dimensionally stable in such a way that the instrument (1) that is inserted into the lower container part (2a) and positioned in the holder (5) can be gripped at its upper end region and pulled out of the lower container part (2a) while being held manually without the lower container part (2a) being deformed by the holding pressure to such an extent that it comes into contact with the working section (3c).

    2. Kit according to claim 1, wherein the lower container part (2a) consists of a dimensionally stable material in such a way that the lower container part (2a) is not or only imperceptibly deformed by the manual holding pressure when an instrument (1) is pulled out.

    3. Kit according to claim 1, wherein the upper container part (2b) consists of the same material as the lower container part (2a) or a material of similar dimensional stability as the lower container part (2a).

    4. Kit according to claim 1, wherein the lower container part (2a) and/or the upper container part (2b) are made of a plastic material, in particular a crystal clear plastic material, and/or have a magnifying area and/or a lens area.

    5. Kit according to claim 1, wherein the lower container part (2a) and/or the upper container part (2b) consist of a material that is transparent to sterilizing radiation and/or of a material, which is transparent to a sterilization gas, in particular to ethylene oxide.

    6. Kit according to claim 1, wherein the lower container part (2a) and/or the upper container part (2b) has an opening, which is closed by a sterilizing membrane and which can be pierced through order to introduce a gaseous or vaporous fluid, in particular hydrogen peroxide, peracetic acid and/or dissolved ozone into the container (2), wherein the sterilizing membrane is pierced by a needle and self-closes after removal thereof.

    7. Kit according to claim 1, wherein the container (2) is formed as a tube, wherein in particular the lower container part (2a) is formed conically tapered at its free, lower end.

    8. Kit according to claim 1, wherein the upper container part (2b) and the lower container part (2a) are plugged together, wherein, in particular, the plug connection between the lower container part (2a) and the upper container part (2b) is designed to be airtight.

    9. Kit according to claim 1, wherein a sealing strip is provided and/or the connection between the lower container part (2a) and the upper container part (2b) is sealed to seal a gap between the lower container part (2a) and the upper container part (2b) in the transition region between the lower container part (2a) and the upper container part (2b).

    10. Kit according to claim 1, wherein the holder (5) completely closes the open top side of the lower container part (2a) with exception of the axial through opening (6).

    11. Kit according to claim 1, wherein the holder (5) consists of an elastic plastic material.

    12. Kit according to claim 1, wherein it is designed for storing an endodontic instrument (1) that has a tool shaft (3) or a coupling section, which consists of or comprises a shaft according to DIN EN ISO 6360-1, in particular an FG-shaft or an elbow shaft or a hand piece shaft according to DIN EN ISO 6360-1.

    13. Kit according to claim 1, wherein fastening means, in particular a thread or parts (11a) of a bayonet lock (11) are formed on the outside of the container (2) in order to fix the container (2) in a receptacle (12) of a holding box (13) or a setting box.

    14. Kit according to claim 1, wherein a transmitting and/or receiving device (10) is provided, which is in particular designed and/or arranged to transmit and/or receive information, preferably about an endodontic instrument (1) that is accommodated by or can be accommodated by the container (2), in particular wirelessly.

    15. Kit according to claim 14, wherein information, in particular about an endodontic instrument that is accommodated or can be accommodated by the container (2), can be stored or is stored in the transmitting and/or receiving device (10), in particular a storage medium thereof.

    16. Kit according to claim 1, wherein the means for determining the state of use and/or the degree of wear of the working portion (3c) of an endodontic instrument (1) that is inserted into the lower container part (2b) are provided on the lower container part (2a) and/or the holder (5), which means are connected or can be connected with display means in order to display the state of use and/or the degree of wear, wherein the means are in particular designed to determine at least one physical property of the working section (3c).

    17. Kit according to claim 16, wherein the means for determining the state of use and/or degree of wear of the working portion (3c) are designed to determine the electrical conductivity/resistance of the working section (3c) and comprise electrical contacts (15, 16), which are in electrical contact with a working section (3c) inserted into the lower container part (2a) at an upper or the lower end region thereof and which are connected and can be connected to the display unit, wherein the electrical contacts are in particular provided in the lower end region of the lower container part (2a) and on the underside of a stop flange (4) of the lower container part (2a) and wherein preferably two upper electrical contacts (16) and two lower electrical contacts (15) are provided on the lower container part (2a), which electrical contacts are in electrical contact with the working section (3c).

    18. Kit according to claim 17, wherein the holder (5) is designed to fix a tool shaft (3) of an endodontic instrument (1) in the lower container part (2a) by means of a latching connection, wherein the tool shaft (3) has a circumferential latching groove (17), with which latching groove (17) latching means in the form of an annular latching tongue or a plurality of latching tongues (18) provided along the circumference of the lower container part (2a) are in latching engagement, wherein the latching means preferably touch the tool shaft (3), are designed to be electrically conductive and are electrically connected to the upper electrical contact (16).

    19. Kit according to claim 1, wherein the endodontic instrument has a tool shaft (3) or coupling section, which consists or comprises of a shaft according to DIN EN ISO 6360-1, in particular an FG-shaft or an angle piece shaft or a hand piece shaft according to DIN EN ISO 6360-1.

    20. Method for storing an endodontic instrument (1) in the form of an endodontic file, which has a tool shaft (3), on one upper axial end region of which tool shaft (3) a handle or a coupling section for connection to a motor-driven rotary tool is formed and on the other, lower end region of which tool shaft (3) an in particular conically tapered working section (3c) is formed, in which a kit according to claim 1 is provided.

    21. Method according to claim 20, wherein the container (2) is made of a material that is transparent to sterilizing radiation and the endodontic instrument (1) is sterilized by exposing the kit to a sterilizing radiation from the outside, or that the container (2) consists of a material, which is transparent to gas and the endodontic instrument (1) is sterilized by being exposed to a sterilization gas, in particular to ethylene oxide.

    22. Method according to claim 21, wherein the kit is exposed to ionizing radiation, in particular UV, X-ray, gamma or electron radiation, for sterilization or that a kit with a container (2) is used and a gaseous fluid is introduced into the container (2) for sterilization.

    23. Method according to claim 20, wherein a plurality of kits containing different endodontic instruments (1) in the form of endodontic files are placed in a setting box, in which adjacent receptacles are provided, in which the containers (2) of the kits are inserted, in particular parallel to one another.

    24. Method according to claim 23, wherein the containers (2) are fixed in a clamping manner in the receptacles (8) of the setting box (7), wherein in particular the setting box (7) in the region of the receptacles and/or the lower container parts inserted into the receptacles (8) has an elasticity, which enables such a clamping fixation.

    25. Method according to claim 23, wherein the lower container parts (2a) are designed conically tapered towards their free ends and the receptacles (8) have a corresponding conicity.

    26. Method according to claim 23, wherein kits are used, the containers (2) of which are provided with optical markings on their upper side, which optical markings correspond to the type and/or size of the endodontic instruments stored therein and/or in the region of the receptacles (8) of the setting box (7) optical markings (9) are provided, which correspond to the type and/or size of the endodontic instruments (1) stored therein, in that, after an endodontic treatment has been carried out and a number of kits have been correspondingly removed from the setting box (7), the setting box (7) is photographed, by means of a recognition software it is recognized, from which receptacles (8) of the setting box (7) the kits have been removed and it is recognized by means of the optical markings (9) associated with the empty receptacles, of which type and size the removed endodontic instruments are, and that the recorded data is thus processed.

    27. Method according to claim 26, wherein the recorded data is fed to a merchandise management and/or goods ordering system and/or a reordering of the missing kits is automatically carried out on the basis of the data.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0053] With regard to further embodiments of the present invention, reference is made to the following design examples with reference to the enclosed drawings. The drawings show:

    [0054] FIG. 1 a first embodiment of a kit according to the invention comprising an endodontic instrument in the form of an endodontic file, which is housed in a container formed according to the invention, in a front view,

    [0055] FIG. 2 the kit according to FIG. 1 with removed upper container part and an endodontic instrument partially pulled out of the lower container part,

    [0056] FIG. 3 the upper container part of the kit from FIG. 2,

    [0057] FIG. 4 a second embodiment of a kit according to the present invention with a removed upper container part, wherein the endodontic instrument is designed for coupling with a rotary-driven tool,

    [0058] FIG. 5 the upper container part of the kit according to FIG. 4,

    [0059] FIG. 6 the kit from FIG. 4, wherein the endodontic instrument is partially pulled out of the lower container part,

    [0060] FIG. 7 the process of inserting the endodontic instrument shown in FIG. 4 into a driven rotary tool,

    [0061] FIG. 8 a setting box according to the present invention for accommodating the kits according to the invention,

    [0062] FIG. 9 a third embodiment of the kit according to the present invention with an endodontic instrument in the shape of an endodontic file, which has a working section with a coupling section comprising a DIN-threat,

    [0063] FIG. 10 a fourth embodiment of a kit according to the present invention with an inserted endodontic file,

    [0064] FIG. 11 a plurality of kits according to the present invention that are inserted into the receptacles of a holder,

    [0065] FIG. 12 a kit according to the present invention inserted into a holder in enlarged view and

    [0066] FIG. 13a holder for a kit according to the present invention in an enlarged view.

    DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

    [0067] In the FIGS. 1 to 3 and FIGS. 4 to 6 two embodiments of a kit according to the invention are shown, the kit consisting of an endodontic instrument 1 and a container 2 that is designed as a disposable package, in which the instrument 1 is stored in a sterile manner. The instrument 1 is designed as an endodontic file in both embodiments and has a tool shaft 3, on one upper axial end region of which a handle 3a (FIGS. 1 to 3), or alternatively a coupling section 3b for connection to a motor-driven rotary tool (see versions of FIGS. 4 to 6) is formed and on the other, lower end region of which a conically tapering working section 3c is formed.

    [0068] The coupling section 3b of the instrument 1 is particularly preferably provided by a shaft according to DIN EN ISO 6360-1 or includes such a shaft.

    [0069] The receptacle 2 for storing the instrument 1 is of tubular shape and has a lower container part 2a that is open on its top side and an upper container part 2b that is open on its underside, which is plugged into the lower container part 2a. For the axial positioning of the upper container part 2b, an outwardly projecting stop flange 4 is formed on the lower container part 2a, against the upper side of which the lower end face of the upper container part 2b comes into contact. The plug connection therein is designed such, that the upper container part 2b cannot detach from the lower container part 2a by itself but instead the upper container part 2b must be pulled of the lower container part 2a in order to open the container 2.

    [0070] As shown in particular in FIG. 1, the arrangement is configured such, that the working section 3c of the endodontic instrument 1 is accommodated in the lower container part 2a and the upper axial end section with the handle 3a/coupling section 3b is accommodated in the upper container part 2b.

    [0071] In order to position the endodontic instrument 1 in the container 2, a holder 5 is provided in the region of the open upper side of the lower container part 2a, which comprises a central axial through-opening 6, through which the working section 3c of the instrument 1 is inserted in the lower container part 2a. The holder 5 is designed as a plastic ring, which is pressed into the lower container part 2a, so that the lower container part 2a is closed by the holder 5, except for the area of its central through-opening 6. The central through-opening has the size adapted to the diameter of the tool shaft 3, so that the instrument 1 is radially positioned in the holder 5 and is smoothing clamped. Furthermore, the arrangement is configured such, that the instrument 1 is also positioned axially in the holder 5 in its inserted state. In the design examples shown in the drawing, axial stop surfaces are provided on the lower container part 2a and/or the holder 5 for this purpose against which the underside of the handle 3a/coupling section 3b of the endodontic instrument 1 comes into contact.

    [0072] According to the invention, the container 2 is made of a plastic material, which is so rigid that it is hardly or only imperceptibly deformed when the lower container part 2a is gripped in order to release the upper container part 2b from it and to pull out the endodontic instrument 1. In this way, it is possible to remove the instrument 1 from the container 2 and optionally connect it to a motor-driven rotary tool without having to touch the working section 3c of the instrument 1. The plastic material of the container 2 therein is selected such, that it is transparent to a sterilizing radiation and is also not affected by it. In this way, it is possible to sterilize the instrument 1 after having inserted it in the container 2. Accordingly, a sterilization in the practice before the treatment is not necessary.

    [0073] In a further design not shown in the drawings it is provided that the lower container part 2a and/or the upper container part 2b comprise an opening, which is closed by a sterilizing membrane that can be pierced in order to introduce a gaseous or vaporous fluid, in particular hydrogen peroxide, peracetic acid and/or dissolved ozone into the container for sterilization, wherein the sterilizing membrane is pierced by the needle and self-closes after the removal of the needle. In this case, a gaseous and/or vaporous fluid, such as for example hydrogen peroxide, peracetic acid and/or dissolved ozone can be introduced into the lower container part and/or the upper container part, for which purpose the corresponding sterilization membrane is pierced. The sterilization membrane therein is self-closing, so that the piercing opening of the needle closes itself again after the needle has been pulled out. This design is particularly useful, if an endodontic instrument 1 is to be reused after cleaning. The sterilization membrane can also be designed in such a way that it is permeable to a vaporous or gaseous sterilization fluid (e.g. such rated steam or air) at the high temperatures prevailing during sterilization in an autoclave, usually >121° C., but is self-closing at room temperature.

    [0074] Furthermore, in a manner not shown, optical markings are provided on the top side of the containers 2, which correspond to the type and/or size of the endodontic instruments stored in them.

    [0075] The rigidity of the tubular containers allows for them to be stored in a setting box 7, such as shown in FIG. 8. The setting box 7 is provided with appropriate receptacles 8, in which the containers 2 can be positioned next to another and in an upright position. Each receptacle 8 of the setting box 7 is provided with an optical marking 9, which indicates the type and/or size of the endodontic instrument 1 to be stored therein. Because of the easy recognition of the optical markings on the containers 2 on one hand and on the setting box 7 on the other hand, an easy allocation is possible. Through the optical markings 9 on the setting box 7 it is further possible to automatically recognize, which endodontic instruments 1 are missing in the setting box 7 after a treatment.

    [0076] The FIGS. 9 and 10 show schematic representations of embodiments of kits according to the invention. Therein, the container 2 is in each case is characterized by the same structure as described above in connection with the first two examples. In particular, these also have an upper container part 2b and a lower container part 2a, a stop flange 4 and a holder 5 with a central through-opening 6. Identical components are marked with identical reference signs.

    [0077] In the case of the containers 2 of the kits according to the FIGS. 9 and 10, the lower container part 2a is in each case designed for receiving the working section of the corresponding dental instrument and the upper container part 2a is in each case configured for receiving the upper axial end region of the corresponding endodontic instrument, which in particular comprises a shaft according to DIN EN ISO 6360-1, or consists of such a shaft.

    [0078] The kit shown in FIG. 9 differs from the kits explained above in that its container 2 is equipped with a transmitting and receiving device 10 that is attached to the inside of the upper container part 2a. As one can see, the transmitting and/or receiving device 10 is partially recessed into the wall of the upper container part 2a of the container 2 and/or inserted into a recess in the wall.

    [0079] In the design example shown, the transmitting and receiving device 10 is provided in the form of an RFID-chip, which can wirelessly receive and transmit data and/or information as well as send it and on which information can be stored. In the present case, information regarding the dental instrument 1 received in the container 2 are stored in the transmitting and receiving device 10, specifically a code for identifying the instrument.

    [0080] It should be noted that a transmitting and receiving device 10 may be provided both instead of or in addition to an optical marking on the container 2.

    [0081] Data stored on the transmitting and receiving device 10 can be read out via the recorded instrument 1 by means of a suitable reader device or reader-and-writer device that is not shown in the Figures and can then, for example, be—in particular automatically—passed on to a management system/program (praxis management program, merchandise management system).

    [0082] Thereby, an accurate and automated control, inventory and ordering is enabled. In combination with patient and treatment data, it is further possible to ensure traceability of patient and/or treatment and/or operation allocation.

    [0083] Further, information regarding the batch documentation (lot-number) of the received endodontic instrument 1 can be stored on the transmitting and receiving device 10. A management system can use the sterilization and/or expiration dates to warn against the use of expired instruments. Further, in the manufacturing and production area it is also used for an integration into an ERP (enterprise resource planning) software system.

    [0084] As a result, advantages for the merchandise management system as well as ERP systems can be attained and reliable traceability of medical devices can be achieved.

    [0085] If one or more kits with containers 2, which have a transmitting and receiving device 10, are used together with a setting box 7, any reader device or reader-and-writer device can also be provided on the setting box 7, in particular be built into it, which is not shown in the Figures.

    [0086] It is emphasized that, in analogy to the design example according to FIG. 9, the containers 2 of all the design examples can also be equipped with a transmitting and receiving device 10.

    [0087] FIG. 10 shows a fourth embodiment of the container 2 according to the invention with an inserted endodontic file 1, wherein only the lower container part 2a of the container 2 is visible. In contrast to the previous embodiments, the endodontic file 1 is not fixed in the lower container part 2a in a clamping manner, but by means of a latching connection and is positioned radially. For this purpose, the tool shank 3 has an annular circumferential latching groove 17, with which latching means that are provided on the lower container part 2a in the form of a plurality of latching tongues 18 that are provided along the circumference of the lower container part 2a are in latching engagement.

    [0088] Furthermore, the lower container part 2a is provided with means for determining the state of use and/or the degree of wear of the working section 3c of the endodontic instrument 1 inserted into the lower container part 2a. These means are provided to determine the electrical conductivity or the electrical resistance of the working section 3c and for this purpose have electrical contacts 15, 16, which are in electrical contact with the working section 3c inserted in the lower container part 2a at an upper and a lower end region of it. In the present design, the electrical contacts are provided at the lower end region of the lower container part 2a and on the underside of the stop flange 4 of the lower container part 2a. The upper electrical contact 16 is electrically connected to the latching tongues 18, which consist of an electrically conductive material and are in contact with the tool shaft 3. The lower electrical contacts 15 are designed in order to come into engagement with the tip of the working section 3c. For this purpose, an electrically conductive and elastically designed membrane is provided, which spans the cross-section of the lower container part 2a.

    [0089] The lower container part can be connected to an electrical circuit via the electrical contacts 15, 16, so that the electrical current flows through the working section 3c. In the electric circuit, display means that are not shown are provided, which show the state of use on the basis of the resistance of the working section 3c detected with respect to its electrical conductivity. Here, it is taken into account, that the endodontic file is subjected to structural changes, especially in the form of settlements, in particular due to repeated bending processes in the curved dental root canal, which lead to a change in electrical conductivity.

    [0090] It is advisable, to provide a holding box on the dentist's chair with the endodontic instruments that are required for the planned procedure. Such a holding box 13 for five endodontic instruments is shown in FIG. 11. Here, it can be seen that the holding box 13 has five receptacles 12, in which the containers 2 of the kit according to the present invention are inserted. In order to fix the containers 2 in the holding box 13 in a secure manner, corresponding fastening means are provided on the outside of the containers and the insides of the receptacles 12. For example, the containers 2 can be screwed into the receptacles. Alternatively, however, a bayonet lock can be provided. The FIGS. 12 and 13 show such a design, in which the corresponding male bayonet catch parts 11a, also called nocks, are formed on diametrically opposite sides of the lower container part 2a and the corresponding bayonet holders 11b are provided in the holding box 13 in the region of the receptacles 12. This type of attachment allows for the required endodontic instruments to be transported and stored fixed in the holding box 13. In addition, the upper container parts 2b can be removed from the lower container parts 2a with one hand, if the holding box is appropriately fixed at the dentist's workplace, for which purpose the holding box 13 in FIG. 13 has a corresponding fastening section 14.