• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    a method for making a non-superelastic non-linear file in an adjusted manner is described a method for making a non-linear superplastic file comprising the steps of providing a superplastic file with a shaft and a geometric axis of the file; providing a fixing device including a groove that is defined by one or more displacement elements, the file groove configured to receive the rod; inserting at least a portion of the stem into the fixing device along the groove of the file, the portion of the stem including a first portion of the stem; placing the first stem portion in contact with a first displacement element of one or more displacement elements in such a way that the first stem portion is offset from the geometric axis of the file, thereby forming a first displaced portion of the stem ; heat the stem portion while inserted in the fixture to a temperature of at least about 300 ° C for a period of time of at least about one minute to adjust the shape of the stem portion, thereby forming a file adjusted nonlinear.
    公开号:BR112014011906B1
    申请号:R112014011906-6
    申请日:2012-11-16
    公开日:2020-10-06
    发明作者:Dan Ammon；Vincente Shotton；Yon Gao；Randall Maxwell
    申请人:Dentsply International, Inc；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [0001] The present invention relates to a method for treating a dental instrument and, specifically, to a rotary file suitable for shaping and cleaning root canals. BACKGROUND OF THE INVENTION
    [0002] Endodontic instruments (including files and countersinks) are used to clean and shape the root canals of infected teeth. They can be either in rotation mode or alternating in the channel by dentists, either manually or with the help of a hand-held pen on which the instruments are mounted. Instruments are generally used in sequence (depending on different root canal surgery techniques) in order to obtain the desired result in cleaning and shaping. The endodontic instrument is subjected to substantial cyclic bending and torsional stresses as it is used in the process of cleaning and shaping a root canal. Due to the complex curvature of the root canals, a variety of unwanted procedural accidents such as step formation, transport, drilling, or separation of the instrument can be found in the practice of endodontics.
    [0003] Currently, endodontic rotary instruments made from Shape Memory Alloys (SMA) have shown better overall performance than stainless steel counterparts. However, the occurrence of unwanted procedural accidents mentioned above has not been drastically reduced. Therefore, new endodontic instruments with improved general properties are needed, especially flexibility and fracture resistance both because of cyclic fatigue and torsional overload.
    [0004] U.S. Patent 4,889,487 discusses an endodontic file with one or more elongated arc-shaped curves to be used to widen and shape the root canal. Since not all root canals have the same geometry, a conventional tapered file typically produces one. circular cross section, thereby limiting the removal of dentin and soft tissue from the channel to an opening of the channel of a dimension corresponding to the circular cross section of the conventional file. This patent discusses crimping of the file between the stamping element to shape the file in the desired bending radius. The problem with crimping a file is that the tool used to crimp can potentially damage the flute of the file, thus making it less efficient at cutting. Another problem with crimping a file is that it inherently weakens the file in that crimped area, thus making it more susceptible to breakage within the channel. U.S. patent 7,713,059 discusses an instrument for cleaning and / or shaping and / or widening the passage to a root canal. This design with an internal volume enclosed by the instrument and its external contour is liable to change due to the forces exerted on it during work.
    [0005] A possible advantage of the present invention compared to conventional rotary files is a method for forming a non-superplastic file. Another possible advantage of the present invention compared to conventional rotary files is a method for forming a non-linear file (e.g., a non-superelastic non-linear file) that can change shape and geometry both by expanding and collapsing during modeling of a root canal. Also, by modeling the rotary file with this process of using a fixture to adjust the shape in an alloy with shape memory (for example, NiTi), it is possible to prevent the flute from being damaged, as well as to maintain the geometry by the entire process of preparing a root canal. SUMMARY OF THE INVENTION
    [0006] The present invention seeks an improvement over prior art endodontic instruments by providing an improved process for manufacturing endodontic instruments. In one aspect, the present invention provides a method for making a non-linear superplastic file comprising the steps of: providing a superplastic file with a shaft and a geometric axis of the file; providing a fixing device including a file groove to be defined by one or more displacement elements, the file groove configured to receive the rod; inserting at least a portion of the stem into the fixing device along the groove of the file, the portion of the stem including a first portion of the stem; placing the first portion of the stem in contact with a first displacement element of one or more displacement elements in such a way that the first portion of the stem is displaced from the geometric axis of the file, thereby forming a first displaced portion of the stem; heat the stem portion while inserted into the fixture to a temperature of at least about 300 ° C for a period of time of at least about 1 minute to adjust the shape of the stem portion, thereby forming a non linearly adjusted.
    [0007] In another aspect, the present invention contemplates a method for making a non-linear superplastic file comprising the steps of: providing a superelastic linear file with a shaft and a geometric axis of the file; providing a fixture including an inner element and a protective element, at least one of the inner element and the protective element having a file groove that is defined by one or more displacement elements, the file groove being configured to receive the shank and at least a portion of the file groove extending along a non-linear path of the file predetermined in a spiral shape; inserting at least a portion of the stem into the fixing device along the groove of the file, the portion of the stem including a first portion of the stem; placing the first portion of the stem in contact with a first displacement element of one or more displacement elements in such a way that the first portion of the stem is offset from the geometric axis of the file, thereby forming a first displaced portion of the stem, the first displaced portion of the stem and the geometric axis of the file defining a foreground; placing a second portion of the stem portion in contact with a second displacement element of one or more displacement elements in such a way that the second portion of the stem is offset from the geometric axis of the file, thereby forming a second displaced portion of the stem , the second displaced portion of the stem defines a second plane different from the first plane; and heating the stem portion to a temperature of at least about 300 ° C for a period of time of at least about 5 minutes to adjust the shape of the stem portion, thereby forming an adjusted non-linear file.
    [0008] In another aspect, the present invention contemplates a non-linear file comprising a geometric axis of the file and a rod with a proximal end and a tip with a working portion between them; the stem having at least one displaced portion including a first displaced portion, the first displaced portion being displaced from the geometric axis of the file, such that the first displaced portion and the geometric axis of the file define a foreground.
    [0009] In another aspect, the present invention contemplates a non-linear file comprising a geometric axis of the file and a rod with a proximal end and a tip with a working portion between them; the stem having at least one displaced portion including a first displaced portion and a second displaced portion, each of the first displaced portion and the second displaced portion being displaced from the geometric axis of the file, such that the first displaced portion of the stem and the The file's geometric axis defines a foreground and the second displaced portion defines a different background from the foreground.
    [00010] In another aspect, the present invention contemplates a method for cleaning and shaping a tooth root canal, the tooth including a tooth pulp chamber and a layer of dentin generally surrounding the tooth pulp chamber, the root canal having a proximal portion adjacent to the pulp chamber of the tooth and tapering to a portion of the apex adjacent to the tooth, the dentin / pulp interface usually defining the root canal wall, comprising the steps of: inserting the non-linear file into the root canal adjusted including a geometric axis of the file and a stem with a proximal end and a tip with a working portion between them, the stem having at least one displaced portion including a first displaced portion, the first displaced portion being displaced from the geometric axis of the file , in such a way that the first displaced portion and the geometric axis of the file define a foreground; rotate, alternate or oscillate vertically or any combination of these and axially advance the non-linear file within the root canal; placing the first displaced portion in contact with the root canal wall in such a way that the first displaced portion collapses to minimize removal of the dentin layer, thereby expanding a second displaced portion to increase surface contact with the remaining pulp chamber to its removal.
    [00011] In another aspect, the present invention contemplates a method for cleaning and shaping a root canal of a tooth, the tooth including a pulp chamber of the tooth and a layer of dentin generally surrounding the pulp chamber of the tooth, the root canal having a proximal portion adjacent to the pulp chamber of the tooth and tapering to a portion of the apex adjacent to the tooth, the dentin / pulp interface in general defining the root canal wall, comprising the steps of: inserting the non-linear file of adjusted shape including a geometric axis of the file and a stem with a proximal end and a tip with a working portion between them, the stem having at least one displaced portion including a first displaced portion and a second displaced portion, each of the first portion displaced and the second displaced portion being displaced from the geometric axis of the file, in such a way that the first displaced portion of the stem and the geometric axis of the file define a the foreground and the second displaced portion define a background different from the foreground; rotate, alternate, oscillate vertically, or any combination of these and axially advance the non-linear file within the root canal; placing a first portion of the continuous displaced portion in contact with the root canal wall in such a way that the first displaced portion collapses to minimize removal of the dentin layer, thereby expanding a second portion of the continuous displaced portion to increase surface contact with the remaining pulp chamber for removal.
    [00012] In another aspect, the present invention contemplates a method for making a non-superplastic file comprising the steps of: providing a superplastic file with an austenitic end-of-transformation temperature; and heating at least a portion of the superplastic file to a temperature of about 300 ° C to about 600 ° C for a period of time from about 5 minutes to about 120 minutes to change the final austenitic transformation temperature, for example middle of this forming the non-superplastic file; wherein the final austenitic transformation temperature of the non-superplastic file is about 20 ° C to about 40 ° C.
    [00013] In yet another aspect, any aspect of the present invention can be further characterized by one or any combination of the following features: in which, in the heating step the stem portion is heated to a temperature of about 300 ° C at about 650 ° C for a period of time from about 1 minute to about 45 minutes to adjust the shape of the stem portion, thereby forming the nonlinear file in an adjusted manner; where, in the heating step the stem portion is heated to a temperature of about 350 ° C to about 600 ° C for a period of time from about 3 minutes to about 30 minutes to adjust the shape of the portion of the stem, thereby forming the nonlinear file in an adjusted manner; wherein, in the heating step the stem portion is heated to a temperature of about 450 ° C to about 550 ° C for a period of time from about 5 minutes to about 20 minutes to adjust the shape of the portion of the stem, thereby forming the nonlinear file in an adjusted manner; further comprising the step of cooling the stem portion to form the nonlinear file in an adjusted manner and heating at least a portion of the nonlinear file in an adjusted manner cooled to a temperature of about 300 ° C to about 600 ° C for a time period of about 20 minutes to about 120 minutes to change the final austenitic transformation temperature, thereby forming a non-superelastic nonlinear file in an adjusted manner, and in which the altered austenitic final transformation temperature of the file adjusted non-superelastic nonlinear is about 20 ° C to about 40 ° C; further comprising the step of cooling the stem portion to form the adjusted nonlinear file and heating at least a portion of the adjusted nonlinear file cooled to a temperature of about 400 ° C to about 500 ° C for a time period of about 40 minutes to about 70 minutes to change the final austenitic transformation temperature, thereby forming a non-superelastic nonlinear file in an adjusted manner, and in which the altered austenitic final transformation temperature of the file adjusted non-superelastic nonlinear is about 20 ° C to about 40 ° C; further comprising the step of bringing a second portion of the stem into contact with a second displacement element of one or more displacement elements in such a way that the second portion of the stem is displaced from the geometric axis of the file, thereby forming a second portion displaced stem, where the first displaced portion of the stem and the geometric axis of the file define a first plane and the second displaced portion defines a second plane different from the first plane; wherein one or more displacement elements additionally include a second displacement element and the file groove is further defined by a pair of guide elements to receive a guide portion of the stem between them, the pair of guide elements being configured to prevent the guide portion of the stem from being displaced from the geometric axis of the file while the first displacement element displaces the first portion of the stem from the geometric axis of the file and the second displacement element displaces a portion of the stem towards the geometric axis of the file; wherein the first displacement element, the second displacement element, and the pair of guide elements defining the file groove form a predetermined non-linear curved file path that guides the stem portion in a general C-shaped profile; wherein one or more displacement elements additionally include a second displacement element and a third displacement element, and the file groove is further defined by a pair of guide elements to receive a guide portion of the stem between them, the pair of guide elements being configured to prevent the guide portion of the stem from being displaced from the geometric axis of the file while the first displacement element displaces the first portion of the stem off the geometric axis of the file, the second displacement element displaces a second the stem portion out of the first displacement element and back through the geometric axis of the file, and the third displacement element displaces a third portion of the stem of the second displacement element and towards the geometric axis of the file; wherein the first displacement element, the second displacement element, the third displacement element, and the pair of guide elements that define the file groove form a predetermined non-linear curved file path with at least two arcuate portions that orient the rod portion for a general S-shaped profile; wherein the file slot defines a first non-linear path of the predetermined file and at least one of one or more displacement elements is movable with respect to the geometric axis of the file, so that the file slot is a slot of the configured variable file to define the first path of the predetermined non-linear file or a second non-linear path of the predetermined file that is different from the first non-linear path of the predetermined file; wherein one or more displacement elements include at least two displacement elements that are movable both independently and simultaneously with respect to the geometric axis of the file, so that the file slot is a variable file slot configured to define the first non-movable path. linear of the predetermined file or a second non-linear path of the predetermined file that is different from the first non-linear path of the predetermined file; wherein the file groove extends along the inner element, the protective element, or a portion of both the inner element and the protective element in a spiral manner; wherein the protective element covers at least partially the portion of the file groove extending in a spiral manner so that, upon insertion of the stem portion into the fixing device, the stem portion is kept within the groove of the file ; wherein the inner element includes a geometric axis of the fastening device which is generally collinear with the geometric axis of the file, such that the portion of the file groove extending in a spiral manner is continuously displaced from the geometric axis of the file. fixing device, hereby continuously displacing a corresponding portion of the rod extending there from the geometric axis of the file; wherein the stem includes a length of the stem and at least about 50% of the length of the stem is continuously displaced radially from the geometric axis of the file; wherein the first displaced portion extends between a first portion of the stem and a second portion of the stem defining a curve with a ridge between them, the ridge being displaced from the first portion of the stem and the second portion of the stem, each of the first the stem portion and the second stem portion being generally located around the geometric axis of the file, so that the non-linear file includes a general C-shaped profile; wherein the at least one displaced portion additionally includes a second displaced portion away from the geometric axis of the file, the first displaced portion extends between a first stem hole and a second stem portion defining a first curve with a first crest between them and the second displaced portion extends between the second portion of the stem and a third portion of the stem defining a second curve with a second crest between them, each of the first portion of the stem and the second portion of the stem being generally located around the geometric axis of the file, so that the non-linear file includes a general S-shaped profile; wherein the first displaced portion and the second displaced portion define a continuous displaced portion that extends in a spiral manner that is continuously displaced radially from the geometric axis of the file; wherein the stem includes a length of the stem and the continuous displaced portion extends in the form of a spiral along at least about 50% of the length of the stem; wherein the continuous displaced portion extends between a first portion of the stem and a second portion of the stem, the second portion of the stem being further displaced from the geometric axis of the file than the first portion of the stem and the second portion of the stem being located closer to the tip than the first portion of the stem; wherein the distance between the stem and the geometric axis of the file continuously increases from the first portion of the stem to the second portion of the stem; wherein at least a portion displaced during the rotation of the non-linear file forms an opening of the channel with an overall perimeter greater than the general perimeter of an opening of the channel formed by a conventional linear file with a similar taper of the file and a length of the stem similar to the same depth of the root canal during its modeling and cleaning; wherein the at least a portion displaced during the rotation of the non-linear file forms an opening of the channel with a general perimeter greater than the general perimeter of an opening of the channel formed by a conventional linear file with a similar taper of the file and a length of the rod similar to the same depth of the root canal during its modeling and cleaning; wherein at least a portion displaced during the rotation of the non-linear file forms an opening of the channel with an overall perimeter smaller than the general perimeter of an opening of the channel formed by a conventional linear file with a taper of the conventional file and a length of the shank similar to the same depth of the root canal during its modeling and cleaning; wherein at least one displaced portion includes a first displaced portion and a second displaced portion, the first portion displaced during the rotation of the non-linear file forms an opening of the channel with an overall perimeter greater than the general perimeter of an opening of the channel formed by a conventional linear file with a similar taper of the file and a length of the stem similar to the same depth of the root canal during its modeling and cleaning, and the second portion displaced during the rotation of the non-linear file forms an opening of the canal with a perimeter general smaller than the general perimeter of a canal opening formed by a conventional linear file with a taper of the conventional file and a length of the stem similar to the same depth of the root canal during its modeling and cleaning; where, in the heating step, the temperature is from about 300 ° C to about 600 ° C for a period of time from about 5 minutes to about 120 minutes to change the final austenitic transformation temperature, by means of thereby forming the non-superplastic file, and in which the altered austenitic transformation end temperature of the non-superplastic file is from about 20 ° C to about 38 ° C; where, in the heating step, the temperature is about 400 ° C to about 500 ° C for a period of time from about 40 minutes to about 70 minutes to change the final austenitic transformation temperature, by means of thereby forming the non-superplastic file, and in which the altered austenitic end-temperature of the non-superplastic file is from about 20 ° C to about 35 ° C; further comprising the step of cooling the portion of the non-superplastic file and heating at least a portion of the non-superplastic file cooled to a temperature of about 300 ° C to about 650 ° C for a period of time from about 1 minute to about 45 minutes to adjust the shape of the stem portion, thereby forming an adjusted non-superelastic non-linear file; further comprising the step of cooling the portion of the non-superplastic file and heating at least a portion of the non-superplastic file cooled to a temperature of about 350 ° C to about 600 ° C for a period of about 3 minutes at about 30 minutes to adjust the shape of the stem portion, thereby forming an adjusted non-superelastic non-linear file; wherein the non-superplastic wire includes an alloy with shape memory; wherein the shape memory alloy includes nickel and titanium; wherein the shape memory alloy is a nickel-titanium-based binary alloy; where the shape memory alloy is a nickel-titanium-based ternary alloy; where the nickel-titanium-based ternary alloy is of the formula Ni-Ti-X, where X is Co, Cr, Fe or Nb; wherein the shape memory alloy includes a copper-based alloy, an iron-based alloy or a combination of both; where the shape memory alloy is copper based and includes CuZnAl or CuAINi; wherein the shape memory alloy is iron-based alloy and includes FeNiAl, FeNiCo, FeMnSiCrNi or FeNiCoAlTaB; further comprising the step of providing a cable and attaching the cable to a portion of the non-linear rotating file; wherein the cable is located distally from the groove (s), groove (s), or any combination thereof; further comprising the step of providing a cable and attaching the cable to a portion of the non-linear hand file; or any combination of these.
    [00014] It should be noted that the aspects and examples referenced are not limiting, since there are others with the present invention, as shown and described here. For example, any of the aspects or features described herein of the invention can be combined to form other unique configurations, as described here, demonstrated in the drawings, or otherwise. BRIEF DESCRIPTION OF THE DRAWINGS
    [00015] Figures IA - 1 C are elevational views of typical endodontic instruments with varying degrees of file taper.
    [00016] Figure 2 is a cross-sectional elevational view of a human molar tooth showing the root system and the coronal area penetrated by a hole to expose the root canal system.
    [00017] Figure 3 is a Differential Scanning Calorimetry (DSC) curve showing phase transformation temperatures of the present invention.
    [00018] Figure 4 is a diagrammatic representation of a bend tester for measuring stiffness of root canal instruments described in ISO 3630-1: 2008, Dentistry - Root - canal instrument - Part I: General requirements and test methods) . The bend tester includes a 1 'reversible gear, a 2' stop, a 3 'torque measuring device, and a 4' handle pin.
    [00019] Figure 5 is a graph showing the test results of the test method shown in figure 4.
    [00020] Figure 6 is a diagrammatic representation of a tester used to test the bend-rotation fatigue resistance of endodontic instruments.
    [00021] Figure 7 is a schematic graph of the relationship between different NiTi microstructures (austenitic vs. martensitic) and life under medium cyclic fatigue of rotating endodontic instruments made from alloy with NiTi shape memory.
    [00022] Figure 8 is a diagrammatic representation of a torque tester used to measure resistance to torsion fracture and angular deflection described in ISO 3630-1: 2008, Dentistry - Root- canal instrument - Part I: General requirements and test methods). The Torque Tester includes a 1 "reversible gear motor, a 2" hardened steel jaw chuck, a 3 "soft brass jaw chuck, a 4" torque measuring device, and a linear ball bearing 5 ". The Torque Tester additionally includes Details of the Test Chuck, which includes a chuck with T" hardened steel claws and 2 "soft brass.
    [00023] Figure 9 is a schematic graph of the relationship between different metallurgical structures and average "maximum degree of rotation for fracture" of endodontic rotary instruments made of alloy with NiTi shape memory.
    [00024] Figure 10 is a schematic graph of the relationship between different metallurgical structures and average "peak torque" of rotating endodontic instruments made of alloy with NiTi shape memory.
    [00025] Figure 11 shows a root with a highly curved channel and a complex channel shape.
    [00026] Figures 12A-12C show various embodiments of the present invention including non-linear two-dimensional files with adjusted shape.
    [00027] Figure 13 shows another embodiment of the present invention including a fixing device for forming the nonlinear file in an adjusted form of figures 12A.
    [00028] Figure 14 shows another embodiment of the present invention including a variable clamping device for forming the nonlinear files in a manner adjusted to figures 12A-12C.
    [00029] Figures 15A-16C show another embodiment of the present invention including a clamping device for forming multiple non-linear files in an adjusted manner.
    [00030] Figure 17 shows a longitudinal cross-section of a root canal using an adjusted non-linear file of the present invention during tooth preparation.
    [00031] Figure 18 shows a longitudinal cross section of a tooth preparation using a conventional linear file during its rotation in the root canal of figure 17.
    [00032] Figure 19A shows a longitudinal cross-section of a tooth preparation using the non-linear file adjusted in figure 17 during its rotation in the root canal of figure 17.
    [00033] Figure 19B shows the preparation of the tooth of figure 19A made along the cross section A-A.
    [00034] Figure 20 shows another embodiment of the present invention including non-linear three-dimensional file with adjusted shape.
    [00035] Figures 21 -23 show another embodiment of the present invention including a fixing device for forming the nonlinear file in a manner adjusted to figure 20. DETAILED DESCRIPTION OF THE INVENTION
    [00036] Superelastic materials are typically metal alloys that return to their original shape after substantial deformation. Examples of efforts in the art with respect to superelastic materials are seen in US 6,149,501, which is incorporated herein by reference for all purposes.
    [00037] Superelasticity can generally be defined as a complete return to the original position after deformation. However, in the industry, it is realized that less than 0.5% of permanent deformation (after stretching by 6% stretching) would be acceptable. For example, if the file does not return to its original position, it can no longer be considered a Superelastic Memory League (SMA) (for example, it cannot be considered a Superelastic SMA if it does not return to a general position. original, such as a generally straight position). Superelastic alloys such as nickel titanium (NiTi), or otherwise, can withstand several times more deformation than conventional materials, such as stainless steel, without becoming plastically deformed.
    [00038] This invention relates to dental instruments in general. Specifically, this invention relates to endodontic instruments for use in root canal cleaning and shaping procedures. The present invention relates to an endodontic instrument innovation that is made from shape memory alloys (SMA) such as Nickel-Titanium (NiTi) based systems, Cu based systems, Fe based systems, or any combination of these ( for example, materials selected from a group consisting of NiTi, Ni-Ti-Nb alloys, Ni-Ti-Fe alloys, Ni-Ti-Cu alloys, beta-phase titanium close to equiatomics and combinations thereof).
    [00039] In a first embodiment, the present invention relates to a method for forming an endodontic instrument made of shaped memory alloys in a non-superelastic martensitic state. The non-superplastic file can provide more flexibility and greater resistance to fatigue through an optimized microstructure, modeling and effectively cleaning root canals.
    [00040] In another embodiment, the present invention includes an endodontic instrument made from a shape-shaped memory alloy in a predetermined non-linear design, and methods for making it. The adjusted non-linear superplastic file can provide greater capacity to change the shape and geometry, both expanding and collapsing, during modeling and cleaning of channels.
    [00041] Referring to the drawings, figures 1a-1 C show elevational views of typical dental instruments generally indicated by the numbers 10A, 10B and 10C used to model and / or clean root canals of a tooth. Figure 2 shows the endodontic instrument in Figure 1A being positioned in one of the root canals of a tooth. While in this position, the endodontic instrument is typically subjected to substantial cyclic bending and torsional stresses as used in the process of cleaning and shaping a root canal.
    [00042] An endodontic file is a good example of a product that is subjected to fatigue failure and in which a product failure is a serious event. Endodontic files 10A, 10B, and 10C, each generally having an elongated stem portion 12 with a proximal end 14 to which it can be attached to a handle 16 (usually made of plastic) shown in Figure IA, or which can be fixed at an attachment end 17 for attachment to a hand held pen (for example, a rotating device) shown in figures 1B and 1C. The stem portion of file 12 (e.g., working portion) is configured to be inserted and removed in the root canal of the tooth. As shown in figures 1a-1 C, endodontic files can be formed with different lengths and / or various file conicities. More particularly, the distal end 18 of files 10A and 10C has a smaller diameter compared to the proximal end 14 and is typically pointed. For example, it is realized that the diameter may be smaller so that the portion of the stem 12 includes more than about 0% taper, preferably from about 1% to about 10% taper, and above all preferably from about 2% to about 6% taper. However, as shown in figure 1 B, it is further realized that the stem portion 12 may include about 0% taper although still having a smaller diameter at the distal end 18 (e.g., tip) of file 10B.
    [00043] As defined herein, the length of the file refers to the length of the stem from the proximal end to the tip of the file in a normal state in relation to the geometric axis of the file (for example, the distance along the geometric axis of the file). file from the proximal end to the tip of the file). Nail length refers to the actual length of the nail from the proximal end to the tip of the file in a normal state (for example, the distance along the nail from the proximal end to the tip of the file). For example, a non-linear file will generally have a shank length that can be greater than its file length in a normal state (due to the curved portions) while a linear file will generally have a shank length that can generally be the same as yours. file length in a normal state.
    [00044] Figure 2 illustrates a typical tooth 20, in this case it is a molar, with several roots 22A and 22B, which in a healthy tooth is filled with pulp material 21A and is generally surrounded by dentin 21B with a dentin / pulp interface between he 21C. The dentin / pulp interface usually defines root channels 22A and 22B. When this pulp material becomes infected, the tooth is considered an abscess and the pressure generated by the abscess causes severe toothache. Endodontists treat this disease by performing a root canal procedure in which root canals 22A and 22B are cleaned of pulp material. For this, a hole 24 is drilled in the crown of tooth 26 to provide access to root canals 22A and 22B. An endodontist inserts a file 10 through hole 24 into the channels to facilitate removal of the pulp material. Figure 2 shows the tooth free of pulp material.
    [00045] The endodontic tools 10A-10C of figures 1a-1 C and 2 are, as previously stated, an example of a type of instrument that requires a high degree of flexibility along with resistance to cyclic fatigue and torsional load. It can be seen that if, in the process of treating a root canal 22a, an inferior portion of the dental file 10A-10C is broken in the canal, then the endodontist faces a serious problem, particularly if the root canal below the broken portion is not has been completely cleaned of infected pulp material. It is therefore important in the manufacture of endodontic files to provide files that have great flexibility and at the same time high resistance to fatigue.
    [00046] It is important to understand that the endodontic file shown in figures 1a-1 C and 2 and the use of it is, for example, only to adjust the need for the structural material for use in the construction of the stem portion 12 to obtain high flexibility and, most importantly, high resistance to fatigue. It is important to understand that the invention here does not pertain to endodontic files per se, but, it concerns methods of treating material, and particularly treating an alloy to produce a metal with ideal characteristics for use in the manufacture of endodontic tools and other medical devices and similar doctors who require high resistance to fatigue.
    [00047] Non-Superelastic Instrument and Methods of its Manufacture
    [00048] The present invention includes an instrument (for example, endodontic file) made of alloys with shape memory in its martensitic state, and methods for its manufacture. The martensitic state of the non-superplastic file can allow more flexibility and greater resistance to fatigue through an optimized microstructure, modeling and effectively cleaning root canals at the same time.
    [00049] An alloy with shape memory is an alloy that "resembles" its original shape that is capable of returning to its pre-formed shape by heating. More particularly, a desirable feature of the shape memory alloy (for example, NiTi-based alloy) in "shape memory" (or martensitic state) form, may be the temperature above which the folded materials will be straight again. For example, it may be necessary to heat the material above its final austenitic transformation temperature (Af) to obtain its preformed shape (for example, a completely straight position).
    [00050] Alloys with shape memory can be considered superelastic at this "application" temperature (for example, temperature above Af) since they are able to return to their original shape (for example, preformed shape such as their straight position original, original curved position or otherwise). In addition, by cooling (for example, using dry ice, liquid nitrogen, or otherwise) the SMA material in a deformed shape (eg, bending the material), the material can remain in the deformed position. Once the SMA material is removed from the cold environment, the material will return to a straight shape at room temperature.
    [00051] Desirably, martensite can be the primary metallurgical phase in the instrument of the present invention, which is different from standard NiTi rotary instruments with austenite structure predominant at room temperature. It is realized that the martensitic phase can be present in an amount greater than 0%, preferably greater than about 25%, and preferably greater than about 50% at room temperature. In addition, the martensitic phase can be present in an amount between about 25% and about 100%, preferably between about 50% and about 100%, and above all preferably between about 75% and about 100% at room temperature. It is further realized that the martensitic phase may be the only phase present (for example, M phase) at room temperature, although not required.
    [00052] Optionally, the austenitic phase can be present at room temperature. When included, the austenitic phase can be present as an internal region (for example, the region of the instrument's core) that can generally be surrounded by the martensitic phase as an outer layer (for example, the surface layer of the instrument) at room temperature. It is also noticed that the martensitic phase and the austenitic phase, when included) can be present dispersed throughout the instrument at room temperature.
    [00053] Typical superelastic NiTi rotary instruments are believed to have lower austenitic transformation temperatures than room temperature (25 ° C). Desirably, in a embodiment of the present invention, a non-superplastic file can be provided with an austenitic end-of-transformation temperature (the final Af temperature measured by Differential Scanning Calorimetry) greater than the ambient temperature (25 ° C). More particularly, the austenitic end-of-transformation temperature can be at least about 3 ° C, at least about 5 ° C, at least about 7 ° C, preferably at least about 10 ° C, and more preferably at least about 12 ° C higher than room temperature (25 ° C). In addition, it is realized that the austenitic end-of-transformation temperature can be less than about 60 ° C, less than about 50 ° C, preferably less than about 40 ° C, and more preferably less than 38 ° C. For example, the final austenitic transformation temperature can range from about 28 ° C to about 60 ° C, from about 30 ° C to about 50 ° C, preferably from about 32 ° C to about 40 ° And more preferably from about 35 ° C to about 38 ° C or from about 37 ° C to about 40 ° C.
    [00054] Because of the higher end-of-austenitic transformation temperature, the instrument of the present invention cannot fully return to its original shape (for example, straight state) after being bent or deflected. This is contrary to conventional superelastic NiTi rotary instruments, which can return to their original shape (for example, straight state) through reverse phase transformation (martensite to austenite) by discharging due to the Af of the conventional instrument being less than the temperature environment.
    [00055] Endodontic instruments made from alloys with memory of NiTi shape in martensitic state (for example, non-superelastic state may have greater total performance in relation to its austenitic counterparts (for example, conventional superelastic NiTi instruments), especially regarding flexibility and resistance against cyclic fatigue.
    [00056] The resistance and cutting efficiency of endodontic instruments can be increased by providing ternary alloys with NiTiX shape memory (X: Co, Cr, Fe, Nb, etc.) based on the alloy's hardening mechanism in a non-superelastic state .
    [00057] Specifically, in an embodiment of the present invention, the non-superelastic instrument has improved and desired characteristics for successful root canal surgery, including greater flexibility and less stiffness, greater resistance to cyclic fatigue, greater degree of rotation against torsional fracture, more conformational to the shape of highly curved channels (less likely to form steps or perforation), minimal possibility of separation of the instrument, and / or otherwise, compared to conventional endodontic instruments formed from an alloy with shape memory in superelastic condition ( for example, in a totally austenitic phase in the microstructure) and / or generally being linearly modeled.
    [00058] In an embodiment of the present invention, endodontic instruments made of shape memory alloys (for example, NiTi) in their martensitic state (non-superelastic state) can be manufactured by one of the following methods described here.
    [00059] A method (for example, Method 1) of forming a non-superplastic file may comprise the steps of heat-treating a file (for example, the flutes of a file stem) after being manufactured according to a design predetermined mechanic (that is, after the process of grinding the flute in a typical file making process).
    [00060] This method for forming the non-superelastic Instrument can include a post-heat treatment with a heating step at a temperature of at least about 300 ° C, at least about 350 ° C, preferably at least about 400 ° C , and more preferably at least about 450 ° C. In addition, it was realized that the heating step may include heating to a temperature less than about 650 ° C, less than about 600 ° C, preferably less than 550 ° C, and more preferably less than 525 ° C. For example, the heating step may include heating to a temperature ranging from about 300 ° C to about 650 ° C (for example, from about 300 ° C to about 600 ° C), from about 350 ° C at about 600 ° C (for example, from about 370 ° C to about 510 ° C), preferably from about 400 ° C to about 550 ° C, and more preferably from about 450 ° C to about 525 ° C.
    [00061] The heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time of at least about 1 minute, preferably at least about 3 minutes, and more preferably at least about 5 minutes to adjust the shape of the superplastic file, thereby forming an adjusted non-linear file. In addition, it is realized that the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time less than about 45 minutes, preferably less than about 30 minutes, and more preferably less than about 20 minutes. For example, the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time from about 1 minute to about 45 minutes, preferably from about 3 minutes to about 30 minutes, and more preferably about 5 minutes to about 20 minutes.
    [00062] The heat treatment process to form a non-superelastic instrument may include heating the superelastic instrument for a period of time of at least about 5 minutes, preferably at least about 30 minutes, and more preferably at least about 40 minutes . In addition, it is realized that the heat treatment process for forming a non-superelastic instrument may include heating the superelastic instrument for a period of time less than about 200 minutes, preferably less than about 120 minutes, and more preferably less than about 90 minutes. For example, the heat treatment process to form a non-superelastic instrument may include heating the superelastic instrument for a period of time from about 5 minutes to about 200 minutes (for example, from about 5 minutes to about 120 minutes or from about 10 minutes to about 60 minutes), preferably from about 30 minutes to about 120 minutes, and more preferably from about 40 minutes to about 90 minutes (e.g., about 40 minutes to about 70 minutes) minutes). Typically, the heating step occurs under a controlled atmosphere. Preferably, the controlled atmosphere may include (for example, consist of) a reactive gas (for example, oxygen, air, or otherwise), although not required. When included, reactive gas, such as air, reacts with the surface of the instrument so that an oxidation layer (eg, blue oxidation layer) can be formed. Optionally, the controlled atmosphere can include (for example, consist) a non-reactive gas (for example, helium, neon, argon, krypton, xenon, and / or radon).
    [00063] As previously mentioned, the post-heat treatment step (for example, additional thermal process) of Method 1 can be used after the process of making a traditional NiTi rotary file (for example, flute grinding) using wire Regular superelastic NiTi. More particularly, an additional thermal process can be carried out after the flute sharpening process (from a traditional NiTi rotary file manufacturing process) so that a post-heat treatment takes place at a temperature range of 370 ~ 510 ° C for a period of time (typically 10-60 minutes, depending on file size, taper, and / or file design requirement). It is noticed that nickel-rich precipitates can form during this post-heat treatment process. Correspondingly, the Ti / Ni ratio may increase and a desired end austenitic transformation temperature (the final Af temperature) will be reached. After the post-heat treatment, a file handle (for example, brass, steel, and the like), or otherwise, can be installed.
    [00064] In another embodiment of the present invention, endodontic instruments made of shaped memory alloys (for example, NiTi) in their martensitic state (non-superelastic state) can be manufactured by one of the following methods described here.
    [00065] Another method (for example, Method 2) of forming a non-superelastic instrument may comprise the steps of heat-treating a file (for example, the flutes of a file stem) during the manufacture of the superelastic instrument (for example, example, during the grinding process) so that the temperature of the instrument can be higher than the final austenitic transformation temperature.
    [00066] This method may include heat treatment (simultaneous) for SMA wire (s) before and / or during the sharpening process, so that grinding can be directly applied to martensitic SMA wires (for example, NiTi). However, it is noticed that wires of martensitic SMA (for example, NiTi) can be heated to a temperature higher than their final austenitic transformation temperatures during the grinding process. Therefore, martensitic SMA wires (for example, NiTi) can temporarily transform into superelastic wires (a more rigid structure in the austenitic state) to facilitate the grinding process during the instrument manufacturing process. Advantageously, the instruments can return to the martensitic state at room temperature after the flute grinding process.
    [00067] For example, in one embodiment, method 2 may include a non-superplastic wire. The non-superplastic wire can be provided in a manufacturing environment with a temperature higher than its final austenitic transformation temperature (at least 25 degrees C). The non-superplastic wire can transform into superelastic at this higher temperature), forming flutes and grooves around the file to form the rotating (semi-finished) file. In addition, the rotating (semi-finished) file can be removed from the manufacturing environment at a higher (warmer) temperature. The non-superplastic wire can form a non-superelastic rotating file at room temperature at about 25 ° C (or above).
    [00068] It is believed that a NiTi alloy-shaped memory alloy generally has two primary crystallographic structures, which depend on temperature (ie, austenite at higher temperatures and martensite at lower temperatures). This transformation phase without temperature-dependent diffusion will be from martensite (M) to austenite (A) (for example, M—> A) during heating. In addition, it is clear that a reverse transformation from austenite to martensite (A — ► M) can be initiated by cooling. In another embodiment, an intermediate phase (R) can appear during phase transformations, that is, both (M) -> (R) - »(A) during heating and (A) -> (R) -> ( M) during cooling. The R phase is defined as an intermediate phase between the austenitic phase (A) and the martensitic phase (M). However, it is clear that during the transformation, both the martensitic and austenitic phases may be present in addition to the optional R phase.
    [00069] Phase transformation temperatures can be determined using Differential Scanning Calorimetry (DSC) curves as shown in figure 3. For example, Af (austenitic transformation end temperature) can be obtained from the graphical baseline intersection with the extension of the maximum slope line of the peak of the heating curve. The Affinal temperature of an endodontic instrument made from shape memory alloys was measured in a DSC test in accordance with ASTM Standard F2004-05 "Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis", as using rates heating or cooling time of 10 ± 0.5 ° C / minutes with purging gas for both helium and nitrogen, except that the fluted segment cut from the rotary instrument sample does not need any additional thermal annealing process (ie 850 ° C for 30 minutes in vacuo), which is typically used to measure ingot transition temperatures to a fully austenitic condition.
    [00070] More particularly, figure 3 provides a schematic curve of Differential Scanning Calorimetry (DSC) of an alloy with shape memory (nickel-titanium) in both the heating and cooling cycle. Af (end temperature of austenitic transformation). As (austenitic transformation start temperature), Mt- (martensitic transformation end temperature), Ms (martensitic transformation start temperature) can be obtained from the graphic intersection of the baseline with the extension of the peak peak slope line curve. The start temperature of martensitic transformation (Ms) being defined as the temperature at which the transformation from austenite to martensite begins during cooling. The final temperature of martensitic transformation (Mf): the temperature at which the transformation from austenite to martensite ends during cooling; start temperature of austenitic transformation (As) being defined as the temperature at which the transformation from martensite to austenite begins during heating. The final austenitic transformation temperature, (Af) being defined as the temperature at which the transformation from martensite to austenite ends during heating.
    [00071] Experimental results have shown that the present invention (for example, an additional heat treatment process for the formation of endodontic instruments) results in desirable characteristics. More particularly, endodontic instruments made of alloys with NiTi-shaped memory in their martensitic state may include one or more of the following characteristics desired for root canal surgery: (1) greater flexibility and less rigidity; (2) greater resistance to cyclic fatigue; (3) greater degree of rotation against torsional fracture; (4) more conformational to the profile of the curved channel, especially for root canals with considerable curvature and complex profile, and combinations of these with respect to conventional superelastic instruments of similar shape and / or size.
    [00072] For example, in order to compare the impact of different metallurgical structures (austenite vs. martensite), two different instrument samples were made using different thermal processing in order to represent two different structures: (1) superelastic instruments with fully microstructure austenitic and (2) instrument with martensitic microstructure. In a specific example based on DSC measurements, the final Af temperatures for these two instruments with different microstructures are 17 ° C (for instrument (1) with fully austenitic microstructure) and 37 ° C (for instrument (2) with microstructure), respectively. All instrument samples were of the same geometric design. All tests were performed at room temperature ~ 23 ° C.
    [00073] I. Rigidity test: Showing greater flexibility and less rigidity in endodontic instruments made of alloys with NiTi shape memory in their martensitic state compared to alloys with NiTi shape memory in their austenitic state.
    [00074] In this stiffness test, the stiffness of all instruments in the sample was determined by twisting the instrument from the root canal to 45 0 using the tester shown in figure 4.
    [00075] As shown in the test results in figure 5, rotary instruments with martensitic microstructure at room temperature exhibit greater flexibility and less rigidity (indicated by lower peak torque when bending). In comparison with the regular superelastic instrument with the final Af temperature 17 ° C, the instruments with the martensitic microstructure (the final Af temperature ~ 37 ° C) showed a 23% reduction in bending torque. The lower stiffness of martensitic instruments can be attributed to the smaller Young modulus of martensite (about 30-40 GPa) whereas austenite is about 80-90 GPa at room temperature.
    [00076] Figure 5 shows a schematic graph of the relationship between different NiTi microstructures (regular or austenitic vs. martensitic superelastic) and average peak torque of rotating endodontic instruments made from alloy with NiTi shape memory in bending test. As can be seen from figure 5, lower peak torque (less rigid or more flexible) can be achieved by a martensitic microstructure, which is indicated by the higher Af (austenitic transformation end temperatures). In one embodiment, the peak torque ratio (flexibility / stiffness) of the non-superelastic rotary file to the superelastic rotary file can be less than about 1: 0.9 (for example, less than about 1: 0.85, and preferably less than about 1: 0.8) at about 25 ° C.
    [00077] II. Rotation and bending fatigue test: Showing longer life under fatigue in endodontic instruments made of alloys with NiTi shape memory in its martensitic state
    [00078] In this folding test, the fatigue strength of all instruments in the sample is measured by a folding rotation fatigue test machine as shown in figure 6. According to the test results shown in figure 7, life under medium cyclic fatigue of instruments in the martensitic state (Af 37 ° C temperature) is about 3 times that of its austenitic counterpart (Af 17 ° C temperature).
    [00079] As shown in the diagrammatic representation of figure 6, a tester can be used to test the fatigue strength under bending-rotation of endodontic instruments. The sample of the endodontic rotating instrument can generally be rotated freely in a simulated stainless steel channel with controlled radius and curvature.
    [00080] The schematic graph in figure 7 shows the relationship between different NiTi microstructures (austenitic vs. martensitic) and life under medium cyclic fatigue of rotating endodontic instruments made from alloy with NiTi shape memory. More particularly, figure 7 shows that greater life under cyclic fatigue can be achieved by a martensitic microstructure at room temperature, which is indicated by the higher Af (austenitic end of transformation temperature). It is realized that the ratio of the total number of cycles to fatigue (resistance against cyclic fatigue) from the non-superelastic rotary file to the superelastic rotary file can be at least about 1.25: 1 (for example, at least about 1, 5: 1, preferably at least about 2: 1) at about 25 ° C.
    [00081] III. Torque Test: Showing a higher degree of rotation against torsional fracture in endodontic instruments made of alloys with NiTi shape memory in its martensitic state
    [00082] In this Torque Test, the fracture resistance of root canal instruments is performed to measure the maximum average degree of rotation against torsional fracture using the tester as shown in figure 8. According to the test results in the figures 9 and 10, instruments with a martensitic microstructure exhibit a greater degree of rotation and peak torque against torsional fracture than their austenitic counterparts.
    [00083] It is clear that most of the separation of the instrument may have been caused by both cyclic fatigue and torsional fracture; therefore, the separation of instruments made from memory alloys with martensitic microstructure can be significantly reduced according to the test results on the folding rotation fatigue test machine (II) and Torque Test (III).
    [00084] The schematic graph in figure 9 shows the relationship between different metallurgical structures and the average “maximum degree of rotation for fracture” of endodontic rotary instruments made of alloy with NiTi shape memory. More particularly, figure 9 shows that a greater degree of rotation can be achieved by martensitic microstructure. It is realized that the ratio of the maximum degree of rotation to fracture (torsional property) of the non-superelastic rotary file to the superelastic rotary file can be at least about 1.05: 1 (for example, at least about 1.075: 1, preferably at least about 1.1: 1) at about 25 ° C.
    [00085] The schematic graph in figure 10 shows the relationship between different metallurgical structures and average “peak torque” of rotating endodontic instruments made of alloy with NiTi shape memory. More particularly, figure 10 shows that greater resistance to torque can be achieved by a martensitic microstructure. It is realized that the peak torque ratio (torsional resistance) of the non-superelastic rotary file to the superelastic rotary file can be at least about 1.05: 1 (for example, at least about 1.075: 1, preferably at least about 1.09: 1) at about 25 ° C.
    [00086] IV. Endodontic instruments made of alloys with NiTi shape memory in their martensitic state show greater conformation to a curved channel profile compared to conventional superelastic instruments of similar shape and / or size.
    [00087] Without introducing step formation, transport, and / or drilling, it is clear that instruments formed from alloys with shape memory in their martensitic microstructure can be used in cleaning and modeling the highly curved channel, as shown in figure 11. Advantageously, these instruments tend to be more conformational to the curvature of the root canal due to (1) high flexibility due to the presence of martensite; (2) better ability to reorient and self-accommodate the martensitic variants due to the low symmetry of the monoclinic crystalline structure of martensite in relation to the cubic crystalline structure of austenite under dynamic stresses applied during root canal surgery.
    [00088] A secondary heat treatment can be used to further control the stiffness of the non-superplastic file by providing one or more curves in it, while optimizing the properties of the file material. This can be accomplished by heat treatment of the non-superplastic file with certain parameters to adjust the stiffness of the file (for example, by making the non-superplastic file more rigid or less rigid. For example, in one embodiment, a nonlinear non-superelastic file in a adjusted can be formed by additional heat treatment of a non-superplastic file using the heat treatment method described here of forming a nonlinear file in an adjusted way, although not required. It is realized that the heat treatment process to form a non-linear file adjusted shape (for example, discussed below) can generally include positioning the non-superplastic file on a fixture so that the non-superplastic file can be oriented in a non-linear path of the file and heat the fixture including the non-superplastic file at a temperature of about 300 ° C to about 650 ° C (for example, about 450 ° C to about 550 ° C) for a period of time from about 1 minute to about 45 minutes (for example, about 3 minutes to about 30 minutes, and preferably about 5 minutes to about 20 minutes), thereby establishing the shape of the non-superplastic file to form a non-superelastic non-linear file in an adjusted way when used after the non-superelastic heat treatment process,
    [00089] It can be seen that the invention can also be described with reference to one or more of the following combinations.
    [00090] A. A method for making a non-superelastic rotary file comprising the steps of: (i) providing a superelastic rotary file with an austenitic end-of-transformation temperature; and (ii) heating the superelastic rotary file to a temperature of at least about 300 ° C, for a period of time of at least about 5 minutes to change the final austenitic transformation temperature, thereby forming the rotary file not superelastic; wherein the altered austenitic end-of-transformation temperature of the non-superelastic rotating file is greater than about 25 ° C.
    [00091] B. The method according to claim 1, wherein the modified end-austenitic transformation temperature of the non-superelastic rotating file is greater than 27 ° C (for example, between about 27 ° C and 35 ° C) .
    [00092] C. The method according to claim 1 or 2, wherein the modified end austenitic transformation temperature of the non-superelastic rotary file is greater than 30 ° C (for example, between about 30 ° C and 35 ° Ç).
    [00093] D. The method according to any one of the preceding claims, wherein the modified end-of-austenitic transformation temperature of the non-superelastic rotary file is greater than 33 ° C (for example, between about 33 ° C and 35 ° Ç).
    [00094] E. The method according to any one of the preceding claims, wherein the modified end-of-austenitic transformation temperature of the non-superelastic rotary file is greater than 35 ° C (for example, between about 35 ° C and 40 ° Ç).
    [00095] F. The method according to any of the preceding claims, wherein the altered austenitic end-of-transformation temperature of the non-superelastic rotary file is greater than 37 ° C (for example, between about 37 ° C and 45 ° Ç).
    [00096] G. The method according to any of the preceding claims, wherein, in the heating step, the temperature varies from about 300 ° C to about 600 ° C.
    [00097] H. The method according to any of the preceding claims, wherein, in the heating step, the temperature varies from about 370 ° C to about 510 ° C.
    [00098] I. The method according to any of the preceding claims, wherein, in the heating step the time period varies from about 5 minutes to about 120 minutes.
    [00099] J. The method according to any of the preceding claims, wherein, in the heating step the time period varies from about 10 minutes to about 60 minutes.
    [000100] K. The method according to any of the preceding claims, wherein the superelastic rotary file includes an alloy with shape memory.
    [000101] L. The method according to any of the preceding claims, wherein the shape memory alloy includes nickel and titanium.
    [000102] M. The method according to any one of the preceding claims, wherein the shape memory alloy is a binary nickel-titanium based alloy.
    [000103] N. The method according to any of the preceding claims, wherein the shape memory alloy is a ternary nickel-titanium based alloy.
    [000104] O. The method according to any one of the preceding claims, wherein the nickel-titanium-based ternary alloy is of the formula Ni-Ti-X in which X is Co, Cr, Fe or Nb
    [000105] P. The method according to any of the preceding claims, wherein the shape memory alloy includes a copper based alloy, an iron based alloy or a combination of both.
    [000106] Q. The method according to any of the preceding claims, wherein the shape memory alloy is the copper based alloy including CuZnAl or CuAINi.
    [000107] R. The method according to any of the preceding claims, wherein the shape memory alloy is the iron based alloy including FeNiAl, FeNiCo, FeMnSiCrNi, or FeNiCoAlTaB.
    [000108] S. The method according to any of the preceding claims, wherein the peak torque ratio (flexibility / stiffness) of the non-superelastic rotary file to the superelastic rotary file is less than about 8: 9 to about 25 ° C.
    [000109] T. The method according to any of the preceding claims, wherein the ratio of the total number of fatigue cycles (resistance against cyclic fatigue) of the non-superelastic rotary file to the superelastic rotary file is at least about 1, 25: 1 at about 25 ° C.
    [000110] U. The method according to any one of the preceding claims, wherein the ratio of maximum degree of fracture rotation (torsional property) of the non-superelastic rotary file to the superelastic rotary file is at least about 1.05: 1 at about 25 ° C.
    [000111] V. The method according to any of the preceding claims, wherein the peak torque ratio (torsional resistance) of the non-superelastic rotary file to the superelastic rotary file is at least about 1.05: 1 about 25 ° C.
    [000112] W. The method according to any of the preceding claims, further comprising the step of providing a cable and attaching the cable to a portion of the non-superelastic rotating file.
    [000113] X. The method according to any of the preceding claims, wherein for binary NiTi, the nickel weight percentage can vary from about 45% to about 60% (for example, about 54.5% at about 57%) with a balance of the titanium composition being about 35% to about 55% (e.g., about 43% to about 45.5%).
    [000114] Y. The method according to any of the preceding claims, wherein for ternary NiTiX, the element X may be less than 15% (for example, less than about 10%) in weight percentage.
    [000115] Z. A method for making a non-superelastic rotary file comprising the steps of (i) providing a non-superplastic wire with an austenitic end-of-temperature greater than about 25 ° C; (ii) heating the non-superplastic wire to a manufacturing temperature that is higher than the final austenitic transformation temperature; and (iii) forming flute (s), groove (s), or a combination of both around the superelastic wire to form a rotating file; wherein the rotating file is not superelastic at a temperature ranging from about 25 ° C to about the final austenitic transformation temperature.
    [000116] AA. The method according to claim 23, wherein the final austenitic transformation temperature of the non-superelastic rotary file is greater than 26 ° C (for example, between about 26 ° C and 35 ° C).
    [000117] BB. The method according to claim 23, wherein the final austenitic transformation temperature of the non-superelastic rotary file is greater than 27 ° C (for example, between about 27 ° C and 35 ° C).
    [000118] CC. The method according to claim 23 or 24, wherein the final austenitic transformation temperature of the non-superelastic rotary file is greater than 30 ° C (for example, between about 30 ° C and 35 ° C).
    [000119] DD. The method according to any one of the preceding claims, wherein the final austenitic transformation temperature of the non-superelastic rotary file is greater than 33 ° C (for example, between about 33 ° C and 40 ° C).
    [000120] EE. The method according to any one of the preceding claims, wherein the final austenitic transformation temperature of the non-superelastic rotary file is greater than 35 ° C (for example, between about 35 ° C and 40 ° C).
    [000121] FF. The method according to any of the preceding claims, wherein the end temperature of austenitic transformation of the non-superelastic rotary file is greater than 37 ° C (for example, between about 37 ° C and 45 ° C).
    [000122] GG. The method according to any one of the preceding claims, wherein, in the heating step, the manufacturing temperature varies from about 5 ° C to about 200 ° C.
    [000123] HH. The method according to any one of the preceding claims, wherein, in the heating step, the manufacturing temperature varies from about 10 ° C to about 50 ° C.
    [000124] II. The method according to any of the preceding claims, wherein the non-superplastic wire includes an alloy with shape memory.
    [000125] JJ. The method according to any of the preceding claims, wherein the shape memory alloy includes nickel and titanium.
    [000126] KK. The method according to any of the preceding claims, wherein the shape memory alloy is a nickel-titanium-based binary alloy.
    [000127] LL. The method according to any of the preceding claims, wherein the shape memory alloy is a ternary nickel-titanium based alloy.
    [000128] MM. The method according to any one of the preceding claims, wherein the nickel-titanium-based ternary alloy is of the formula Ni-Ti-X in which X is Co, Cr, Fe or Nb
    [000129] NN. The method according to any of the preceding claims, wherein the memory-based alloy includes a copper-based alloy, an iron-based alloy or a combination of both.
    [000130] OO. The method according to any of the preceding claims, wherein the shape memory alloy is the copper based alloy including CuZnAl or CuAINi.
    [000131] PP. The method according to any of the preceding claims, wherein the shape memory alloy is the iron based alloy including FeNiAl, FeNiCo, FeMnSiCrNi or FeNiCoAlTaB.
    [000132] QQ. The method according to any of the preceding claims, further comprising the step of providing a cable and attaching the cable to a portion of the non-superelastic rotating file.
    [000133] RR. The method according to any of the preceding claims, wherein the cable is located distally from the groove (s), groove (s), or any combination thereof.
    [000134] SS. A method for making a non-superelastic rotary file comprising the steps of providing a superelastic rotary file with an austenitic end-of-transformation temperature; and heating the superelastic rotary file to a temperature of at least about 300 ° C for a period of time of at least about 5 minutes to change the final austenitic transformation temperature, thereby forming the non-superelastic rotary file; wherein the altered austenitic end-of-transformation temperature of the non-superelastic rotating file is greater than about 25 ° C. Nonlinear Instruments and Methods of Manufacturing
    [000135] The present invention additionally contemplates non-linear instruments (for example, endodontic instruments) and methods for forming these. A file design can be produced using a fixture to deflect portions of a conventional file (for example, linear file), so that the file geometry can be arranged in a predetermined non-linear finished shape, and by heating the file to form a non-linear file in an adjusted way. More particularly, establishing the shape of a file in a desired geometry (for example, generally non-linear) to better distribute the surface contact with the pulp material and / or infected root canal material with respect to the root canal wall ( eg dentin / pulp interface), during cleaning and / or modeling of root canals with various curvatures (for example, extreme curvature). In a desirable aspect, the non-linear shaped file can be configured to expand, thereby ensuring that the root canal walls are clean (for example, removing pulp and / or infected material) while minimizing dentin and / or pulp materials. In another desirable aspect, the nonlinear shaped file can be configured to collapse upon contact with one or more portions of the root canal wall when the root canal wall is narrower than the folds of the rotating nonlinear shaped file to reduce removal excessive dentin and / or pulp materials. In addition, the present invention may include a method of forming a non-linear file, which can be accomplished by placing the conventional file in a fixture and then placing the fixture together with the file in a heated chamber to adjust the shape of the file in predetermined geometry, hereby forming an adjusted nonlinear file.
    [000136] Figures 12A, 12B, and 12C show various files (e.g., dental file) of the present invention in a non-linear shape. Non-linear files 20, 108 and / or 110 of figures 12A-12C, respectively, generally extend along a geometric axis of the file 26 and include a portion of the elongated non-linear stem 22 with a tip 28, a proximal end 24 and a lot of work between them. The proximal end 28 may be attached to a cable (not shown) or may include an attachment end 27 for attachment to a hand-held pen (for example, a rotating device). The stem 22 includes at least one displaced portion 30 and preferably a plurality of displaced portions 30 (e.g., curved) where at least a portion of the stem 22 extends along a different geometric axis from the geometric axis of the file 26, for example. in the meantime getting generally non-linear. In a preferred embodiment, the portion of the non-linear rod 22 extends in a common plane (for example, in a two-dimensional space).
    [000137] It is realized that non-linear files can include a plurality of offsets 30 (for example, at least about 2 offsets, at least about 3 offsets such as in non-linear files 20 and 108, at least about 4 offsets such as non-linear file 110, or otherwise). More particularly, the nonlinear file 20 may have a geometry similar to a general C shape profile, a general S shape profile, a generally sinusoidal shape profile or otherwise modeled nonlinear profile. It is realized that the non-linear file may have a stem length generally less than 22 and / or a generally greater taper of the file than the non-linear file 108 or may include a generally longer stem length 22 and / or a generally smaller taper file than in non-linear files 20 and 110, although not required. Optionally, the end point 28 can be displaced from the geometric axis of the file 26 (figures 12A and 12B) or can extend along the geometric axis of the file 26 (figure 12C).
    [000138] Generally, the displaced portion 30 may include a section of the stem 22 that generally extends between two locations along the geometric axis of the file. For example, the displaced portion may extend between a first location of the stem 34A where the stem begins to extend outside the geometric axis of the file 26 and a second location of the stem 34B where the stem returns to the geometric axis of the file 26. In addition, it is realized that the displaced portion may extend into the stem end portions or up to them 22 (e.g., tip 28, proximal end 24, and / or otherwise). The displaced portion 30 may include a ridge 32. The ridge 32 may generally be an outermost point on the corresponding displaced portion 30 along the portion of the stem 22 with the greatest distance from the geometric axis of the file 26. This maximum distance (e.g. maximum displacement) between the crest 32 and the geometric axis of the file 26 can be defined by the displacement distance of the crest 36.
    [000139] In an embodiment with a plurality of displaced portions 30, each displaced portion 30 (for example, 30A, 30B, etc.) can include a crest 32 (for example, 32A, 32B, etc.) and a displacement of corresponding crest. For example, as seen in figure 12, stem 22 includes a first displaced portion 30A (defining a first lower curve) with a first ridge 32A (apex of the curve), a second displaced portion 30B (defining a second upper curve) with a crest 32B (apex of the curve), and a third offset 30C with a crest 32C (the tip 28 of the file). In the first displaced portion 30A, the stem 22 extends outside the geometric axis of the file 26 (for example, increasing the travel distance) at a location of the stem 34A (for example, near the proximal end 24 of the file 20) and it continues to be moved off the geometric axis of the file 26 to its outermost point on the first ridge 32A of the first displaced portion 30A. From the first ridge 32A, the rod 22 extends towards the geometric axis of the file 26, in such a way that the amount of displacement decreases (in relation to the first displacement distance of the ridge 36A) until the rod 22 extends up to and / or through the geometric axis of the file 26 at the location of the stem 34B (for example, inflection point). The stem 22 extends through the geometric axis of the file 26 at the location of the stem 34B to define the second displaced portion 30B through which the stem 22 once again continues to extend outside the geometric axis of the file 26 (e.g. increasing the travel distance) to the outermost point of the second displaced portion 30B on the second ridge 32B. From the second crest 32B, the rod 22 extends towards the geometric axis of the file 26, in such a way that the amount of displacement decreases (in relation to the second displacement distance of the crest 36B) until the rod 22 extends to the geometric axis of file 26 at the location of the stem 34C. The stem 22 then extends through the geometry axis of the file 26 at the location of the stem 34C and continues to extend outside the geometry axis of the file 26 (for example, increasing the travel distance) to define the third displaced portion 30C with a third crest 32C (with a third displacement distance of the crest 36C) at the tip 28 of the non-linear file 20.
    [000140] Figure 12B shows a non-linear file 108 with a geometry generally similar to the non-linear file 20 of figure 12A. Non-linear file 108 may differ from non-linear file 20 in which non-linear file 108 may include a shorter stem length and / or length of the general file. Figure 12C shows a non-linear file 110 with length of the stem and / or overall file length generally similar to the non-linear file 20 of figure 12A. The non-linear file 110 may differ from the non-linear file 20 in which the non-linear file 110 may include an additional offset portion, thereby forming multiple curves (e.g., four curves) so that the non-linear file 110 includes two pairs of upper and lower curves, each curve generally extending to and / or transitioning through the geometric axis of the file.
    [000141] Preferably, although not required, the displacement distance of the ridge decreases from a displaced portion to another displaced portion the closer the displaced portion can be with respect to the tip 28 of the non-linear file 20. For example, in the figure 12, the first travel distance of the ridge 36A may be greater than the second travel distance of the ridge 36B, which may be greater than the third travel distance of the ridge 36C. However, it is noticed that the distance of displacement of the ridge can vary from one displaced portion to another displaced portion or it can be the same. In addition, it is realized that the distance of displacement of the crest can increase or decrease from a displaced portion to another displaced portion regardless of the location of the displaced portion in relation to the tip 28, the proximal end 24 of the file 20, one or more adjacent displaced portions, and / or otherwise.
    [000142] It is understood that the stem 22 can be displaced from the geometric axis of the file 26 along the displaced portion 30 in an amount greater than about 0.0 mm, preferably greater than about 0.05 mm, and more preferably greater than 0.5 mm. In addition, it is realized that the stem 22 can be displaced from the geometric axis of the file 26 along the displaced portion 30 in an amount less than about 7 mm, preferably less than about 6 mm, and more preferably less than about 5 mm. For example, the stem 22 can be displaced from the geometric axis of the file 26 along the displaced portion 30 in an amount greater than 0.0 mm to about 7 mm, preferably from about 0.05 mm to about 6 mm, and more preferably from about 0.5 mm to about 5 mm.
    [000143] The present invention can include a fixture 40 to form the non-linear file 20. The fixture 40 can be supplied in various sizes with any width, length, and / or thickness sufficient to accommodate a dental instrument in accordance with with the present invention. In one embodiment, the fixture 40 includes a base 41 with a top surface 42 (for example, a generally flat surface), a bottom wall 43, a forward wall 44, and left and right side walls 45. A The base includes one or more displacement elements 46 that define a non-linear path of the file to receive a conventional dental instrument (for example, file 10A, 10B, 10C, or otherwise). The base 41 can include a plurality of displacement elements 46 arranged around the base 41 that when brought into contact by the stem 22, one or more portions of the stem 22 can be deflected off or towards the geometric axis of the file 26. Optionally, the base 41 can additionally include one or more guide elements 48 which help to maintain the portions of the stem 22 along the geometric axis of the file 26. It is realized that one or more of the displacement elements 46 of the guide elements or a combination of both can be integral or separate from the base 41. In addition, it is realized that one or more of the displacement elements 46, the guide elements or a combination of both can be physically fixed to the base or adjustable to change the non-linear file path thereby defined. In a specific embodiment, as shown in figure 13, the base 41 includes a plurality of guide elements 48 with a first pair of corresponding guide elements 50A and 50B and a second pair of guide elements 52A and 52B and a plurality of elements displacement 46 with a first displacement element 54, a second displacement element 56, a first pair of corresponding displacement elements 58A and 58B, and a second pair of corresponding displacement elements 60 A and 60B.
    [000144] The displacement elements 46 and guide elements 48 (for example, pins or otherwise), when included in figure 13, extend upwards (for example, generally perpendicularly) to the base 41 and can be located in a configuration to define a predetermined non-linear file path. It is realized that as a conventional file (for example, generally a linear file) is directed to one or more of the displacement elements 46 and guide elements 48, one or more portions of the stem 22 can be displaced out of the geometric axis of the file 26 (for example, towards the back wall 43 or front wall 44) or towards the geometric axis of the file 26, so that the portions of the stem 22 can conform to the path of the device's predetermined non-linear file clamp 40 to orient the conventional file shaft in a non-linear shape (for example, a curved file).
    [000145] More specifically, a conventional file can be inserted into the fixture 40, in such a way that the tip 18 can first be extended through the first pair of matching guide elements 50A, 50B and then through the second pair of corresponding guide 52A, 52B. Each guide element of the corresponding pair can be spaced sufficiently to allow the rod 12 to pass between them, while generally maintaining the file along the geometric axis of the file 26. As such, there can generally be little or no displacement of the file. geometric axis rod of file 26, since the conventional file is guided through each pair of guide elements 46. As the tip 18 of the conventional file continues to be inserted in the fixing device, the tip 18 can make contact with the first displacement element 54A, which preferably deflects the tip 18 off the geometric axis of the file 26 (for example, towards the bottom wall 43 or the front wall 44, generally along the top surface 42 and in a common plan). Similarly, as the remaining displacement elements 46 come in contact with the tip 18 (as well as several sections of the stem 12), portions of the conventional file continue to deflect towards the geometric axis of the file or outwards 26 to the tip 18 reach the last displacement element 46 (for example, extending through it) (for example, the corresponding displacement element pair 60A, 60B) in such a way that the rod 12 of the conventional file can be oriented in the predetermined way which is defined by the path of the nonlinear file of the fixture 40. Then, the conventional file being positioned along the path of the nonlinear file of the fixture 40 can be subjected to a heat treatment process discussed below, to adjust the shape of one or more conventional files, thereby forming one or more non-linear files in an adjusted manner (for example, non-linear file 20 of figure 12A, non-linear file 108 of fig. 12B, non-linear file 110 of figure 12C, or otherwise).
    [000146] Several files of conventional dimensions can be accommodated by varying the insertion depth in the fixing device, so that the tip 18 extends (for example, make contact) until the last displacement element 46, the optional guide element 48, the end of the clamping device, or any displacement element / guide element between them, until the conventional file is oriented in the predetermined form. In addition, the guide elements, the displacement elements, or a combination of both can be fixed to the base 41 with sufficient spacing to define the predetermined file path while being able to accommodate several files sized with different thicknesses, conicities, materials and / or lengths.
    [000147] It is understood that, in another embodiment, the present invention can accommodate several files sized with different thickness, taper, materials and / or lengths, providing an adjustable fixture 70 with one or more adjustable displacement elements 76, one or more adjustable guide elements 78, or a combination of both. Adjustable elements 76 and 78 can be configured to allow repositioning of at least one element along the top surface 42 of the base 41. More particularly, the fixture 70 shown in figure 14, can include one or more (for example, two) displacement elements (e.g., pins) movable in at least one direction (different direction such as transversely between the bottom wall 43 and the front wall 44) to realize the desired finished nonlinear geometry of the file.
    [000148] By doing so, one or more adjustable elements can be repositioned, generally across, in relation to the geometric axis of the file 26 (for example, towards the back wall 43 or the front wall 44) to accommodate a longer stem thicker, a thinner stem, a stem with a greater taper of the file, a stem with a lesser taper of the file, or combinations of these. For example, at least one displacement element and / or guide elements (for example, 50A, 52A, 58A, 60A) of the corresponding displacement elements and / or corresponding guide elements can be transversely repositioned with respect to the other corresponding offset and / or corresponding guide element (eg 50B, 52B, 58B, 60B), respectively, to increase or decrease the spacing between them, thereby allowing the fixture to accommodate conventional files with various shank thicknesses . In addition, one or more adjustable elements can be repositioned, generally transversely, in relation to the geometric axis of the file 26 (for example, towards the back wall 43 or the front wall 44) to increase or decrease the displaced portion 30 transversely, thereby increasing or decreasing the ridge displacement distance, respectively. For example, by transversally repositioning at least one displacement element 46 (for example, 54, 56), the stem 22 can be further moved off the geometric axis of the file 26, thereby forming a greater fold (for example, curve) with a greater travel distance.
    [000149] Optionally, or additionally, one or more adjustable elements can be repositioned, generally longitudinally, in relation to the geometric axis of the file (for example, towards the left or right side walls 45) to accommodate files of various lengths or for increase or decrease the longitudinal distance of the displaced portion 30. It is contemplated that the longitudinal distance of the displaced portion 30 can be defined as the distance along the geometric axis of the file 26 between two adjacent portions of the stem that intersect the geometric axis of the file 26 (for example, the distance along the geometric axis of the file 26 between locations of the stem 34A and 34B, location of the stem 34C and the tip 28, or otherwise). For example, the longitudinal spacing between the first pair of corresponding guide elements 50A, 50B and the second pair of corresponding displacement elements 60A, 60B can be increased or decreased, generally longitudinally, with respect to the left and right side walls 45 for accommodate larger or smaller rods 22, respectively. In addition, the longitudinal distance of the displaced portion 30 can be increased or decreased by increasing or decreasing the longitudinal space between two or more of the displacement elements 46, the guide elements 48, or combinations of each, respectively. For example, spacing between the second pair of guide elements 52A, 52B and the displacement element 56 can be increased or decreased, generally longitudinally, with respect to the left and right side walls 45, thereby increasing the longitudinal distance between them . In this example, increasing or decreasing the longitudinal distance of a displaced portion may also include transverse displacement of the rod 22 by a displacement element (e.g., displacement element 54), although not required.
    [000150] Figure 14 shows a specific example of an adjustable clamping device 50 with similar features described in clamping device 40, and additionally including a first adjustable displacement element 76A and a second adjustable displacement element 76B. The adjustable displacement elements 76A and 76B can be configured to be adjusted transversely (for example, towards the rear and front walls 43.44) to increase and / or decrease the displaced portions 30A, 30B in relation to the geometric axis of the file 26. The adjustable displacement element 76 can be adjusted (or readjusted) before, during, and / or after insertion of the conventional file into the fixing device 50 to obtain the desired file path to form the predetermined patterned non-linear file.
    [000151] As mentioned earlier, fixture 50 may include adjustable guide elements (not shown). For the purposes of this disclosure, the adjustable element may include an adjustable displacement element, an adjustable guide element, or a combination of both. The adjustable element (for example, adjustable displacement element 76) can be fixedly fixed to the base 41, which allows the adjustable element to be movable in a portion of the slot 78 (78A, 78B) when a different path of the predetermined file may be desired , to accommodate a different sized conventional file, or otherwise, and combinations thereof. It is realized that the portion of the slot 78 can be provided transversely (for example, generally perpendicularly) in relation to the geometric axis of the file 26 (for example, extending towards the front or rear walls 43,44 as shown in figure 14), longitudinally (for example, generally parallel) with respect to the geometric axis of the file 26 (for example, extending towards the left or right side walls 45), diagonally, or otherwise.
    [000152] Once one or more of the adjustable elements have been moved to a desired position to form at least a portion of the predetermined file path, the adjustable element can be temporarily fixed in the desired position in order to maintain the portion of the path of the file predetermined file. The adjustable element can then be repositioned to form a different file path, if desired. It is realized that any adjustable fixture can be used sufficiently to removably fix the adjustable element.
    [000153] In another embodiment of the present invention, a clamping device may be provided to form one or more non-linear patterned files. As shown in a specific example, 15A-16C provides a fixture 80 that can include a base element 81 with a top surface 82, a bottom wall 83, a front wall 84, and left and right side walls 85 The top surface 82 may include at least one groove 90 defining a predetermined file path for receiving a conventional file (for example, generally a linear file). Preferably, the clamping device 80 may include a plurality of file grooves 90, which may be similar or vary from one file groove 90 to another. As shown in figures 15A-16C, the fixture 80 includes a plurality of similar grooves 90. The groove of the file 90 can be formed in a recessed valley of the top surface 82. The groove of the file 90 can extend (for example, example, in general transversely) to one or both of the bottom walls 83 and front walls 84 so that an opening in the respective top and / or bottom walls can extend therefor as shown in figure 16B. With the file groove extending through at least one of the rear and front walls 83,84 it may be desirable to accommodate a portion of the cable 16, an attachment end 17, the extreme end 18, or otherwise, which they can be positioned outside or partially outside the fixing device 80. It is further realized that the groove of the file 90 can extend completely on the front surface 82, in such a way that any end of the groove of the file 90 does not extend through the both rear and front walls 83.84. In this case, the groove 90 may additionally include a portion sufficiently spaced to accommodate the cable portion 16, the attachment end 17, or otherwise.
    [000154] In addition, the groove of file 90 can be of any size or length sufficient to accommodate several sized files. The width and / or height of the file groove 90 can generally correspond to at least the widest and / or thickest portion of the file stem (for example, usually close to the proximal end of the file) so that the movement of the file ( for example, transversal and / or rotational) can be limited or substantially eliminated. It is possible that the height of the file slot 90 may be less than the height (e.g., thickness) of the file when the protective element 100 additionally includes a corresponding space (e.g., the file slot) to accommodate one or more portions of the file. file that can extend above the top surface 82.
    [000155] Preferably, the top surface 82 of the clamping device 81 and / or the base of the file groove 90 can be generally flat, although not required. It is understood that the top surface 82, the base of the groove 90, or a combination of both may vary (for example, tilting, curving and / or otherwise) to accommodate one or more files with equal degrees of taper of the file or different. As such, the height of the file groove can remain constant or vary depending on whether the top surface 82 and / or the base of the file groove 90 remains generally flat or vary to accommodate various dimensions of the file (e.g., taper, height , file thickness and / or other file shape). Desirably, the groove of the file 90 generally complements the width and / or height of the file, so that the movement of the file (for example, longitudinally, transversely, radially, or otherwise) can be limited or substantially resisted in one or more portions of the file groove 90 (for example, since the file is oriented in a desired position and / or shape in the predetermined file path).
    [000156] The fixture 80 may also include one or more displacement portions 86, one or more guide portions 88, or a combination of both that define the predetermined file path and the groove 90. As discussed earlier, the portion displacement 86 can generally be configured to move the rod 22 from or towards the file 26 geometrical axis while the guide portion 88 can generally be configured to hold the rod 22 and / or proximal end 24 generally along the geometry axis of file 26.
    [000157] Preferably, the fixing device 80 may include a plurality of grooves 90, each being defined by one or more displacement portions 86 with a first pair of corresponding displacement portions 92A, 92B and a second pair of displacement portions corresponding 94A, 94B. The fixing device 80 can additionally include one or more guide portions 88 with a first pair of corresponding guide portions 96A, 96B and a second pair of corresponding guide portions 98A, 98B to further define each groove 90. Together, the portions displacement 86 and guide portions 88 can be positioned to define groove 90 and a file path determined therein to receive and orient portions of a conventional file in a predetermined non-linear shape (for example, with one or more curves such as usually an S-shape, C-shape, or otherwise).
    [000158] The fixture 80 may additionally include a protective element 100 configured to match the base element 81. The protective element 100 may include a base surface 101, a top surface 102, a bottom wall 103 , a front wall 104, and left and right side walls 105. Matching of the base element 81 and the protective element 100 can be carried out by means of an attachment feature. The attachment feature can be any known structure that is capable of removably securing the protective element 100 to the base element 81 in order to generally keep the file within the groove of the file 90, while limiting or substantially eliminating the movement of the file. file on it. In a non-limiting example shown in figures 15A-16C, the fixture 80 additionally includes an attachment feature 102 with projecting portions 104, which can be configured to be received by corresponding opening portions 106, thereby maintaining in general the base element 81 with respect to protective element 100 in a closed position. More particularly, after one or more conventional files are oriented in one or more grooves of the file 90, the protective element 100 can be placed on the base element 81, such that the openings 106 of the protective element 100 are generally aligned with the master portions 104. The protective element 100 can then be lowered onto the base element 81, in such a way that the top surface 82 of the base element 81 can be located proximally on the base surface 101 of the base element. protection 101. It is realized that at least a portion of the top surface 82 can make contact with at least a portion of the base surface 101, and preferably a substantial portion of the top surface 82 can make contact with a substantial portion of the top surface base 101, although not required. Since the protective element 100 has been attached to the base element 81 via the attachment feature, one or more files located on it (for example, with one or more file slots 90) are generally held in place, so that the movement of the file within the groove 90 can be reduced or substantially eliminated. As such, preferably, the projecting portion 104 includes a shape and size (for example, generally cylindrical, or otherwise) that can be sized to complement the opening 104, such that, since the projecting portion 104 is received by opening 104, there may generally be little or substantially no movement in opening 106. Then, one or more conventional files positioned in one or more grooves of file 90, so as to be oriented along the path of the non-linear file of the fixing device 80, can be subjected to a heat treatment process, discussed below to adjust the shape of one or more conventional files, thereby forming one or more non-linear files in an adjusted manner (for example, non-linear file 20 of figure 12A, non-linear file 108 of figure 12B, non-linear file 110 of figure 12C, or otherwise).
    [000159] Optionally, the fixture 80 can include one or more adjustable elements (not shown). When included, the adjustable elements can be movable (and temporarily fixed) to provide various designs of the file groove.
    [000160] As shown in figure 17, a longitudinal cross-sectional view of a portion of tooth 120 including dentin 122 is generally provided, generally involving a root canal 124 (e.g. pulp and / or nerve tissue) with a root canal wall 125, the root canal 124 being prepared (for example, cleaned and / or shaped) by an embodiment of the present invention including an adjusted non-linear file 126. The preparation (for example, cleaning and / or shaping) of the root canal 124 may include an operator moving forward (for example, propelling) (while rotating, shifting, oscillating vertically, or otherwise, and combinations thereof) the non-linear file 126 generally towards the apex 128 of the root canal 124 to remove an infected area that may include the pulp along with bacteria, decayed nerve tissue and related fragments of tooth 120. Once root canal 124 has been cleaned, root canal 124 can be reformed and / or enlarged to allow for better or filling access next.
    [000161] It is noticed that, during the removal of the infected area of the root canal 124 and surrounding area, the non-linear file 126 can typically encounter some resistance, as the portions of the non-linear file 126 make contact with the material to be be removed (for example, dentin, pulp, nerve tissue and / or infected material) on the tooth. This resistance of the file and optionally any force downward by the operator towards the apex of the root canal during use of the non-linear file can cause the non-linear file to expand (for example, it generally increases at least a displaced portion 130), collapse ( for example, it generally decreases at least a displaced portion 130), or a combination of both. Expansion and / or collapse of the displaced portion 130 can generally occur in the transverse direction, in the longitudinal direction, or a combination of both, in relation to the geometric axis of the file, so that superficial contact with the root canal (for example, the material to be removed) can be increased. More particularly, as file resistance occurs (for example, by placing dentin and / or root canal wall in contact), one or more displaced portions may be deformed along a path of less resistance (for example, in towards the pulp material), so that dentin removal can be minimized, while maximizing contact with the pulp material, thereby maximizing the removal of the pulp material.
    [000162] Figure 18 shows a longitudinal cross-sectional view similar to the root canal 124 shown in Figure 17 while being cleaned and / or modeled using a comparable conventional linear file 132 (for example, generally, similar stem length, thickness and taper ). It is believed that, due to the linear shape of the linear file 132, the opening of the root canal 134 (e.g., file cleaning path) is generally formed with a diameter generally equivalent to the diameter of the shaft of the linear file 132. The linear file 132A and linear file 132B show various positions of linear file 132 during rotation. As shown in the various positions of the linear file 132A, 132B, there may generally be little or substantially no widening of the opening of the root canal 134 (e.g., file cleaning path) during rotation of the conventional linear file 132 (e.g., the opening of the root canal 134 is generally formed with a diameter substantially similar to the diameter of the shaft of the linear file 132), as shown in figure 18.
    [000163] As such, the non-linear file 126 of the present invention can provide greater surface contact of the material to be removed within the root canal chamber 124, thereby increasing the removal of the material while cleaning and / or modeling it, compared to a conventional linear file comparable with generally the same width as the file as well as the taper of the file.
    [000164] Figures 19A show another longitudinal cross section of the tooth preparation shown in Figure 17 including the same non-linear file 126 through various positions during a rotation of the non-linear file 126 generally at the same depth within the root canal 124. A figure 19B shows a cross section AA of the tooth preparation shown in figure 19A. Figures 19A and 19B include a non-linear file 126A in a first position (for example, at about 0 degrees of rotation and about 360 degrees of rotation), a non-linear file 126B in a second position (for example, a about 90 degrees of rotation), a 126C non-linear file at a third position (for example, about 180 degrees of rotation), and a 126D non-linear file at a fourth position (for example, about 270 degrees of rotation) rotation).
    [000165] The non-linear file 126 can be configured to create an opening of the root canal 136 with a diameter D (for example, width) greater than the diameter (for example, width) of the stem of the non-linear file 126. It is perceived that the diameter D can be the same or can be different at different depths along the opening of the root canal 136. Typically, when referring to the diameter D of the opening of the root canal 136 with respect to the diameter of the file stem, both diameters they are usually taken at the same relative depth (for example, cross section) as the root canal.
    [000166] The non-linear file 126 can be configured to create a root canal opening with a diameter at least about 10% larger, at least about 25% larger, at least about 50% larger, and at least about 75% larger than the diameter (for example, width) of a root canal opening created by the stem of the non-linear file 126. In addition, the non-linear file 126 can be configured to create a root canal opening with a diameter less than about 1,000% larger, less than about 750% larger, less than about 500% larger, and less than about 200% larger than the diameter of a root canal opening created by the stem of the non-linear file 126. For example , the non-linear file 126 can be configured to create a root canal opening with a diameter ranging from about 10% to about 1,000%, from about 25% to about 750%, from about 50% to about 500%, and from about 75% to about 200% larger than the diameter of an opening in the c root anal created by the stem of the non-linear file 126. Desirably, the non-linear file 126 can be configured to create an opening of the root canal with a diameter ranging from about 100% to about 1,000%, and preferably about 200% about 500% larger than the stem diameter of the non-linear file 126. It is realized that the non-linear file 126 can be configured to create an opening of the root canal with a diameter (for example, width) greater than 1,000% of the diameter (for example, width) of a root canal opening created by the stem of the non-linear file 126 depending on the downward force of the operator towards the apex of the root canal, the size and / or shape of the root canal, the stiffness of the file , the size and / or shape of the displaced nonlinear file, or otherwise, and combinations thereof. In a specific example, as shown in figure 19B, a generally oval shaped root canal opening 136A with an opening wall 137A can be formed from the rotation of the non-linear file 126. As mentioned earlier, the shape of the oval shaped root canal opening it can generally be influenced by various parameters such as the shape of the root canal 124 (e.g., root canal wall 138), or otherwise. The generally oval shaped root canal opening 132 may include a longitudinal diameter (for example, generally along the cross section A-A) and a transverse diameter. More particularly, the longitudinal diameter (for example, from non-linear file 126C to non-linear file 126A) can have a diameter of at least about 200% (for example, at least about 300%) greater than the diameter of the shank of the non-linear file 126 and the transverse diameter (for example, from the non-linear file 126D to the non-linear file 26B) can have a diameter of at least about 100% (for example, at least about 200%) greater than the diameter of the stem of the non-linear file 126.
    [000167] The non-linear file can be configured to form an opening of the root canal with a diameter being at least about 10% (for example, 0.1 times), at least about 25%, at least about 50% , and at least about 75% larger than a diameter of a root canal opening formed by a conventional linear file (e.g., with generally similar stem length, thickness, and non-linear file taper 126). In addition, the non-linear file can be configured to form a root canal opening with a diameter
    [000168] which is less than about 1,000% (for example, 10 times), less than about 750%, less than about 500%, and less than about 200% greater than a diameter of a root canal opening formed by a conventional linear file (for example, with a rod length, thickness, and generally similar non-linear file taper 126). For example, the non-linear file can be configured to form a root canal opening with a diameter ranging from about 10% to about 1,000%, from about 25% to about 750%, from about 50% to about 500%, and from about 75% to about 200% larger than a diameter of a root canal opening formed by a conventional linear file (for example, with a stem length, thickness, and generally non-linear file taper 126). In a specific example to compare root canal cleaning and / or modeling as shown in the root channels 124 of figures 18 and 19B, it is realized that the non-linear file 126 of the present invention can be configured to provide greater surface contact with the root canal 124, in such a way that an opening of the root canal 136 can be formed with a diameter D that can be greater than the diameter P of the opening of the root canal 134 formed by the conventional linear file 132 (for example, with a stem length, thickness , and generally similar nonlinear file taper 126).
    [000169] In another mode, the design and material for the non-linear file can be configured to adapt to the shape of the root canal that is at least equal to the geometry of the natural root canal.
    [000170] In yet another embodiment, the present invention can include a non-linear file (for example, dental file) that extends from a geometric axis of the file in at least two different planes (for example, three-dimensional space (3D) ) and methods for their formation. Fig. 20 shows a non-linear file 140 (e.g., corkscrew shape, or otherwise) that generally extends along a central geometric axis of the file 146 and may include a portion of the elongated non-linear stem 142 with a tip 148, a proximal end 144, and a working portion between them. The proximal end 144 may be attached to a handle (not shown) or may include an attachment end 147 for attachment to a hand-held tooth pen (for example, a rotating device). Similar to the coplanar (for example, two-dimensional) non-linear files discussed above, the three-dimensional (for example, 3D) non-linear file 140 can be formed in various predetermined non-linear shapes with different stem lengths, widths and / or taper of the file.
    [000171] Advantageously, the stem 142 can include at least a displaced portion 150 with at least a portion of the stem 142 being displaced from the geometric axis of the file 146 along at least two different planes, thereby forming a generally non-linear file (For example, 3D) 140. The displaced portion 150 may include a ridge 152, which can generally be the outermost portion of the stem 142 along the displaced portion 150 with respect to the geometric axis of the file 146. The distance (e.g. transverse distance) from the geometric axis of the file 146 to the ridge 152 (for example, an inner edge 156 of the ridge 152) can be defined by the travel distance of the ridge 154 (for example, the maximum travel distance of the displaced portion 150).
    [000172] It is realized that the stem 142 can extend outside the geometric axis of the file 146 (and optionally return to the geometric axis of the file 146) to form a single displaced portion 150 with a bend, curve, and / or otherwise. In addition, shank 142 may extend out and back from the geometric axis of file 146 multiple times to form a plurality of displaced portions 150, with a plurality of curves and / or folds similar to non-linear files 20, 108, 110. The displaced portion (s) 150 may extend between any portion of the stem 142, (for example, generally between the proximal end 144 and the extreme end 148). Desirably, stem 142 can include a generally continuous displaced portion 150A as shown in figure 20. In this specific embodiment, the continuous displaced portion 150A of stem 142 can extend from a location of stem 156 to tip 148. As the continuous displaced portion 150A of shank 142 is extended outside the geometric axis of the file 146 along a path of the displaced file, a continuous displacement distance 158 can be provided by defining a distance that the shank 142 (e.g., inner edge of the shank) 142) is displaced from the geometric axis of the file 146. The displaced portion 150A of the stem 142 can be continuously displaced (for example, along the path of the displaced file) from the geometric axis of the file 146 (for example, generally radially) displaced), thereby defining a general spiral-like shape.
    [000173] It is realized that the displaced portion 150 of the stem 142 can be displaced from the geometric axis of the file 146 (e.g., displacement distance 158) in an amount greater than about 0.0 mm, preferably greater than about 0 , 05 mm, and more preferably greater than 0.5 mm. Furthermore, it is realized that the displaced portion 150 of the stem 142 can be displaced from the geometric axis of the file 146 in an amount less than about 7 mm, preferably less than about 6 mm, and more preferably less than about 5 mm . For example, the displaced portion 150 of stem 142 can be displaced from the geometric axis of file 146 in an amount greater than 0.0 mm to about 7 mm, preferably from about 0.05 mm to about 6 mm, and more preferably from about 0.5 mm to about 5 mm.
    [000174] It is further realized that at least about 10%, preferably at least about 25%, and more preferably at least about 50% of the stem 142 (e.g., along one or more longitudinal portions of the stem between the proximal end and the tip) can be continuously displaced radially from the geometric axis of the file 146. In addition, it is realized that less than about 100%, preferably less than about 95%, and more preferably less than about 90% of the stem 142 (for example, along one or more longitudinal portions of the stem between the proximal end and the tip) can be continuously displaced radially from the geometric axis of the file 146. For example, from about 10% to about 100% , preferably from about 25% to about 95%, and more preferably from about 5% to about 90% of the stem 142 (e.g., along one or more longitudinal portions of the stem between the proximal end and the tip ) can be continuously located radially from the geometric axis of the file 146.
    [000175] In this specific example shown in figure 20, the spiral-shaped non-linear file 140 includes a continuous displaced portion 150A. Desirably, the continuous displaced portion 150A includes a greater displacement distance 158 as the continuous displaced portion 150A extends towards tip 148. When included, the continuous displaced portion 158A extends from the geometric axis of file 146 in one location of the stem 194 and continues to be moved along the remaining portion of the stem 142 to the tip 148, thereby forming a portion to the spaced part 159 extending along the geometric axis of the file 146.
    [000176] In another embodiment of the present invention with an expandable and / or collapsible design, as discussed here, a generally fluted file being formed involving the non-linear file in a non-linear shape (for example, by spiral) resulting in a folding three-dimensional instead of a two-dimensional fold as shown previously.
    [000177] The present invention can include a fixing device to form a non-linear shaped file extending around at least two planes (for example, with a three-dimensional space). As shown in a specific example, figures 21 -23 provide a fixture 160 that can include an inner element 162 with a first end 164, a second end 166, an outer surface 168, and a file slot 170 define a path of the predetermined non-linear file to receive a conventional file (for example, a generally linear file). The inner element 162 can be a generally cylindrically shaped element, or otherwise, a shaped element. The inner element 162 generally extends along a geometric axis of the fixing device 163. Desirably, since the stem 142 is received by the inner element 162, the geometric axis of the file 163 can extend along the geometric axis of the stem 146 or at least can generally be parallel to the geometric axis of the stem 146, although not required. Generally, the inner element 162 can be sufficiently dimensioned with a thickness (for example, width and / or diameter) capable of receiving a file groove 170 formed as a recessed trough along the external surface 168. The recessed trough of the file groove 170 may include side walls 172 and a base surface 174 extending between them to a portion of the base of side walls 172. Desirably, the thickness (e.g., diameter) of inner element 162 (e.g., generally including the groove of the file 170) can be greater than the thickness (for example, width and / or diameter) of the stem 142 of the non-linear file 140. The greater thickness of the inner element 162 allows the formation of the groove 170 to be sufficiently dimensioned to receive the stem 142 while providing one or more displacement portions for displacing one or more portions of the stem 142 positioned within the groove 170 of the inner element 142.
    [000178] The groove of the file 170 can extend (for example, generally longitudinally) along any portion of the inner element 162, however, preferably, the groove of the file 170 can extend along the outer surface 168 of the first end 164 to second end 166 of inner element 162, although not required. More particularly, as shown in figures 22A and 22B, the file groove 170 can additionally include a first opening 176 at the first end 164 for receiving the conventional file and can extend around the inner element 162 through it to a second opening 178 at the second end 166. With the file slot 170 extending through at least one of the first and second ends 164, 166 it may be desirable to accommodate a portion of the handle (not shown), an attachment end 147, the end end 148 , or otherwise, which can be positioned outside or partially outside the fixture 160. It is further realized that the groove of the file 170 can extend completely on the outer surface 168, in such a way that no end of the groove of the file 170 extends through the first and second ends 164, 166. In this case, the groove 170 may additionally include a portion sufficiently spaced to accommodate the portion the cable, the attachment end, or otherwise.
    [000179] In addition, the groove of file 170 can generally be sized to any size or length sufficient to accommodate files of various dimensions. It is realized that the width and / or height of the file slot 170 can complement the corresponding portion of the file stem to be received by the file slot 170. Desirably, the width and / or height of the file slot corresponds at least to wider and / or thicker portion of the file shank (for example, usually close to the proximal end of the file) so that the movement of the file can be limited or substantially resisted, since the conventional file is positioned within the groove of the file file 170. It is possible that the height of the file slot 170 may be less than the height (for example, thickness) of the file, if a protective element is included with a corresponding space such as a slot of the corresponding file (not shown) to accommodate one or more portions of the file that can extend above the outer surface 168.
    [000180] The height of the file slot 170 can generally be constant throughout the length of the file slot 170, although not required. However, it is realized that the height of the file slot 170 may vary (for example, the base 174 and / or the outer surface 168 may tilt, bend, fold and / or otherwise) to accommodate various dimensions of the file (for example, example, file taper, height, thickness, and / or otherwise, file). Desirably, the file groove 170 generally complements the dimensions of the file (e.g., width and / or height) so that the movement of the file (e.g., longitudinally, transversely, radially, or otherwise) can be limited or substantially resisted in one or more portions of the file slot 170 (for example, since the file is oriented in the predetermined file path of the file slot 170 and in a desired position and / or shape). For example, as shown in figures 22A and 22B, the height of the groove 170 can vary from the first end 164 to the second end 166 with the first end 164 with a greater height of the file groove (to accommodate the proximal end 144 of the file not linear 140 generally with a larger file width) than the second end 166 with a smaller file slot height (to accommodate the tip 148 of non-linear file 140 generally with a smaller file width). It is contemplated that the height of the file slot 170 may in general be inversely related to the travel distance 158 or the travel distance of the ridge. As such, the continuous displaced portion 150 of stem 142 near the proximal end 144 may have a shorter displacement distance with respect to the continuous displaced portion 150 of stem 142 near tip 148 with a greater displacement distance. Desirably, the height of the file slot 170 generally decreases from the first end 164 to the second end 166 to accommodate the taper of the conventional file, so that the top portion of the file (for example, the top of the file generally extends between the top portions of the side walls of the groove 172) it can generally be flush with the top surface 168 of the inner element 162, although not required. However, it is realized that the file height can extend above or below the top of the file slot 170.
    [000181] The inner element 162 may also include one or more displacement portions 180, one or more guide portions 182, or a combination of both that define the path of the predetermined non-linear file and the slot 170. As discussed earlier, the displacement portion 180 can generally be configured to move stem 142 off or towards the geometric axis of the file 146, while guide portion 182 can generally be configured to hold stem 142 and / or proximal end 144 generally along of the geometric axis of the file 146.
    [000182] As mentioned earlier, the groove of the file 170 can be formed as a recessed valley along the outer surface 168 so that the groove of the file 170 can extend in a curled type (e.g. spiral) around of the cylindrically shaped inner element 162. The groove 170 can be partially wound around the inner element 162, or it can be rolled around the inner element 162 one or more times. As shown in figure 21-22B, the groove of file 170 can extend along a complete spiral (for example, from the first end 164 to a portion of the middle 184 of the inner element 162) and can continue to extend along a partial spiral (for example, from the middle portion 184 to the second end 166) around the inner element 162. The inner element 162 can also include travel distance of the fixture 186, which can be defined by the distance between the base 174 of the file slot 170 and the geometric axis of the fixture 163 (and / or the geometric axis of the fixture 146, when collinear). Similar to the travel distance 158, the travel distance of the fixture 186 defines one or more portions of the stem 142 that can be displaced from the geometric axis of the file 146. More particularly, in a specific non-limiting example as shown in figures 21 - 22B, the inner element 162 may include a travel distance of the continuous fixture 186 (e.g., variable) generally extending from a first portion 190 of the inner element 162 near the first end 164 to the second end 166 of the inner element 162. The internal element 162, including the travel distance of the continuous clamping device 186, can result in the non-linear file 140 with an opening 192 extending longitudinally, generally along the geometric axis of the file 146. It is noticed that the resulting opening 192 generally extends from a location of the stem 194 to the end of the stem 142 (e.g., tip 148). However, the present invention may not be limited to a single and / or continuous displaced portion 150 and may include a plurality of displaced portions 150, such that stem 142 can be displaced from the geometric axis of the file and then resumed to it 146 one or more times as discussed here. Desirably, displacement portions 180, guide portions 182 can be positioned to define a groove 170 and a file path determined therein to receive and orient portions of a conventional file in a predetermined non-linear shape (for example, with one or more curves such as a general spiral shape, corkscrew shape, or otherwise).
    [000183] The fixture 160 may additionally include a protective element 200 configured to match the inner element 162. The protective element 200 may include an inner surface 202, an outer surface 204, each generally extending between a first end 206 and second end 208. Generally, the protective element 200 can be configured to match the inner element 162, thereby at least partially closing the groove of the file 170. Desirably, the inner surface 102 of the protection element 200 substantially or completely closes the file slot 170 while at the same time providing an opening and / or through hole at one or both ends of the file slot 170 (for example, at the first and / or second ends 164,166 of the inner element 162) to allow that stem 142 passes through them. Still, it is realized that the inner surface 202 to be configured to match (for example, matches or complements) the outer surface 168 of the inner element 162. As shown in figures 21 and 23, the protective element 200 may include a generally cylindrical through hole 210 which is defined by the inner surface 202. The cylindrical through hole 210 can be sufficiently spaced to receive the inner element 162 and the stem 142 extending through it, as shown in figures 21. Typically, the spacing between the outer surface 168 of inner element 162 and inner surface 204 of protective element 200 can be minimized to maintain substantially at least a portion of the stem 142 within the groove of the file 170, so that the stem 142 can generally be maintained along the path of the predetermined non-linear file. More particularly, the spacing between the outer surface 168 of the inner element 162 and the inner surface 204 of the protective element 200 can be minimized to substantially reduce or prevent movement (e.g., radially) of the stem 142 within the groove of the file 170. A external shape of the protection element 200 can be cylindrically shaped equally, however, any shape and / or size of the protection element 200 is contemplated.
    [000184] Matching of the inner element 162 and the protection element 200 can be carried out using any attachment device known in the art. The attachment device can be by friction fit or any other attachment device. The attachment device can be any known structure that is capable of removably securing the protective element 200 to the inner element 162 in order to generally keep the stem 142 within the groove of the file 170. Optionally, this can also be accomplished by also limiting or eliminating substantially the movement of the rod 142 therein. Then, the file (for example, stem 142) being positioned inside the groove of the file 170 so as to be oriented along the path of the non-linear file of the fixture 160, can be subjected to a heat treatment process, discussed then, to adjust the shape of the conventional file, thereby forming a non-linear file in an adjusted shape (for example, three-dimensional spiral file 140 or otherwise).
    [000185] In a specific example of forming the non-linear file 140, as shown in figure 21, the method may include wrapping a corrugated spiral file (for example, nickel and titanium file) around the inner element (for example, pin spiral). Place the protective element (for example, tube cap) on the inner element comprising the fluted file, so that the inner element comprising the fluted file can be inserted through the opening of the protective element, thereby maintaining the fluted file in a spiral configuration. Optionally, the protective element can be placed on the inner element before inserting the fluted file into the fixing device (for example, file slot). Heat the mounting of the fixing device including the fluted file in a heating device (for example, oven), so that the fluted file can be shaped in the spiral configuration around the internal element.
    [000186] As discussed earlier, the process of producing the dental instrument in an adjusted manner may include placing a conventional file (for example, NiTi corrugated linear file) in a folding fixture, thereby orienting the conventional file in a predetermined shape (for example, non-linear shape) and then with heat treatment of adjusted shape (discussed below) the folding fixture to adjust the shape of the conventional file, thereby forming a non-linear file of adjusted shape corresponding to the predetermined form. The number of curves (for example, displaced portions) and / or the location of the curves can be chosen from a plurality of configurations, in addition to those described here. The design of the clamping device and / or the process of establishing the file shape can be produced in various configurations to form a non-linear file and / or mass production of non-linear files of the type and design disclosed here, or otherwise. More particularly, the design of the inner element can be varied in a plurality of configurations to form spirals, or otherwise, with a greater or lesser diameter, degree of general taper (other than file taper), more or less spirals, or otherwise.
    [000187] Generally, the method of forming the nonlinear file in an adjusted manner may include 1) providing a conventional file (e.g., linear file) with a geometric axis of the file; 2) providing a fixture with a predetermined non-linear file path (for example, 2D, 3D, or otherwise); 3) insert the conventional file into the fixing device so that a first portion of the conventional file (for example, file shank) can be moved from the geometric axis of the file in a foreground (for example, to form a two-dimensional non-linear file ); 4) optionally displacing a second portion of the conventional geometric file axis with a second plane being different from the first plane (for example, to form a non-linear three-dimensional file); and 5) thermally treat the non-linear file, thereby forming an adjusted non-linear file.
    [000188] It is understood that the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature of at least about 300 ° C, preferably at least about 350 ° C, and more preferably at least about 450 ° C. In addition, it is realized that the heat treatment process for forming a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature of less than about 600 ° C, preferably less than about 550 ° C and above all preferably less than 500 ° C. For example, the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature of about 300 ° C to about 650 ° C, preferably from about 350 ° C to about 600 ° C, and more preferably from about 450 ° C to about 550 ° C.
    [000189] The heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time of at least about 1 minute, preferably at least about 3 minutes, and more preferably at least about 5 minutes to adjust the shape of the superplastic file, thereby forming an adjusted non-linear file. In addition, it is realized that the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time less than about 45 minutes, preferably less than about 30 minutes, and more preferably less than about 20 minutes. For example, the heat treatment process to form a nonlinear file in an adjusted manner may include heating a superplastic file to a temperature for a period of time from about 1 minute to about 45 minutes, preferably from about 3 minutes to about 30 minutes, and more preferably about 5 minutes to about 20 minutes.
    [000190] Adjusted parameters for the heat treatment process can include heating the material (eg nickel titanium, or otherwise) to a temperature of about 300 ° C to about 600 ° C (eg about 400 ° C to about 550 ° C), or otherwise, for a period of time from about 1 minute to about 45 minutes (for example, about 1 minute to about 30 minutes), or other way. In a preferred embodiment of the present invention for setting a file shape, a typical set shape temperature and time in the heating apparatus (eg oven) can be approximately 500 ° C (+/- 50 ° C) for 10 minutes (+/- 5 minutes) that allows the file to take a different permanent shape (for example, non-linear shape).
    [000191] After heat treatment with adjusted shape, the non-linear file can be cooled naturally. The cooling step may include gradually reducing the temperature of the heating apparatus, tempering and / or cooling the air from the non-linear file both directly and while in the fixture. Preferably, once the heat treatment with adjusted shape has been completed in the heating apparatus, the fixing device can be removed from the heating apparatus and allowed to cool in the air. Then, once the clamping device has been cooled, the file can be removed from the clamping device, thereby forming an adjusted non-linear file that can be permanently shaped in an unprecedented non-linear geometry.
    [000192] The adjusted shaped endodontic file (for example, rotary files) contemplated here may include one or more curves along the length of the nail shank to ensure maximum surface contact with the root canal as it is cleaned and shaped during a root canal procedure. It is well known that root canals in a tooth structure are not uniform in cross-section. Most root canals are irregular in geometry and can have several cross-sectional geometries including elliptical, stripped, elongated, narrow, etc. With conventional files (for example, linear files), the cross section of the file is generally circular in geometry and therefore will typically remove most of the root canal dentin to ensure that all of the root canal walls are clean and shaped or less the root canal dentin because both the file is undersized and the root canal geometry is too large to allow the conventional file to clean it. Having an adjusted non-linear file, the file can be configured to "expand", thereby maximizing surface contact (for example, increasing the overall perimeter of the non-linear file during rotation) with the root canal walls that are being cleaned, or "collapsing" thereby reducing surface contact (for example, decreasing the overall perimeter of the non-linear file during rotation) if the wall of the root canals is narrower than the curves of the modeled file. General perimeter of the non-linear file during rotation, alternation, vertical oscillation, or otherwise, and a combination of these can be defined as the distance around the perimeter of the opening formed by the non-linear file during its rotation with respect to a specific depth of the file within the root canal. It is realized that the expansion and / or collapse of the non-linear file can occur in response to the geometry of the root canal wall 138 (for example, dentin / pulp interface) changing in the radial direction over various depths (for example, longitudinal direction) ) of the root canal. For example, as shown in figures 19A-19B, an opening of the root canal 136A with an opening wall 137A can be formed during rotation, alternation, vertical oscillation, or otherwise, and combining these from non-linear file 126 to a depth represented by the cross section AA. The distance around the wall of the opening 137A defines the general perimeter of the opening of the root canal 136A with respect to the depth of the non-linear file in the cross section A-A. More particularly, the opening of the root canal 136 defines the hole / opening created by the non-linear file during rotation, alternation, vertical oscillation, or otherwise, and a combination of these and the opening wall 137 defines the material (e.g., dentin , pulp or otherwise, material) / hole interface.
    [000193] Generally, during expansion of the non-linear file, the amplitude (for example, displacement distance) of at least a displaced portion (for example, portion of the curve) can increase (for example, increasing the displacement distance), for example thereby generally increasing the overall perimeter formed during the rotation of the non-linear file. It is noticed that by increasing the general perimeter during the rotation of the non-linear file, the superficial contact with the root canal can increase, in such a way that a larger opening of the root canal can be formed. Generally, during the collapse of the non-linear file, the amplitude of at least a portion of the curve can decrease (for example, decreasing the travel distance), thereby generally decreasing the overall perimeter formed during the rotation of the non-linear file. It is noticed that by decreasing the general perimeter formed during the rotation of the non-linear file, the superficial contact with the root canal can decrease in such a way that a smaller opening of the root canal can be formed. Desirably, one or more portions of the non-linear file can expand while one or more other portions collapse, thereby optimizing the surface contact of the non-linear file with the root canal, so that the amount of material root canal removed can be increased with compared to a generally similar linear file. Thus, the adjusted nonlinear file can expand and / or collapse where necessary within the root canal to optimize root canal cleaning and / or modeling with respect to the root canal wall geometry.
    [000194] Factors such as file stiffness can affect the cleaning and / or modeling of a root canal. The amount of stiffness of the adjusted nonlinear file can be optimized to ensure that the file expands naturally when the nonlinear file is modeling and / or cleaning a relatively large portion of the root canal and / or collapses when the nonlinear file is modeling and / or cleaning a relatively small portion of the root canal by several variables. In one embodiment, the stiffness of the curves (for example, displaced portions) can be controlled by the cross-sectional design of the file. With conventional rotary linear files, the shanks can be available with a taper of the file where the diameter of the stem generally increases with a certain diameter of the tip from the tip of the file (with a certain diameter of the tip) along the length of the stem. file (or at least a portion of it). File taper can generally be defined by the rate of increase in diameter along the length of the file stem. For example, a file with a 4% taper will generally have about a 0.04 mm diameter increase around every 1.0 mm in length of the stem portion of the tip of the file. With tightly shaped non-linear files that can be configured to expand and / or collapse into one or more displaced portions, surface contact with the root canal wall can generally be increased over a similar conventional file (for example, file linear) with a similar taper. Therefore, the ability to increase the overall perimeter of the opening of the channel formed by the non-linear file during rotation or otherwise, the taper of the file can be reduced (for example, reducing the stiffness of the stem) in the non-linear file in an adjusted manner , thereby reducing the resistance to cyclic fatigue and flexibility of the non-linear file. Typically, in order to obtain a similar overall perimeter of a channel opening using a conventional linear file, the taper of the file is greatly increased (for example, increasing the stiffness of the stem), thereby increasing the resistance to cyclic fatigue and flexibility of the non-linear file. As such, the adjusted nonlinear file can include a lesser degree of taper of the file to form a channel opening with a general perimeter than a conventional linear file with a greater degree of taper of the file to form a channel opening with the same general perimeter.
    [000195] Non-linear file stiffness can be optimized by increasing the mass in the cross section (for example, greater taper or thicker rod) to make the non-linear file more rigid or decreasing the mass in the cross section (for example, less taper or thinner rod) to make the non-linear file less rigid. Increasing the mass in the cross section can substantially reduce or restrict the expansion or collapse of a displaced portion of the file stem, while decreasing the mass in the cross section can increase the expansion or collapse of the displaced portion of the file stem. Optionally, or in addition, by adjusting the mass of the cross section, the stiffness of the non-linear file can be optimized by increasing the number of displaced portions (for example, increasing the stiffness) or decreasing the number of displaced portions (for example, decreasing the stiffness) . In addition, stiffness of the non-linear file can be optimized by increasing the deflection of the displaced portions with respect to the longitudinal geometric axis of the non-linear file (for example, the distance from the longitudinal geometric axis of the file to the deflection crest) to increase the stiffness or decrease the amount of deflection of the displaced portions with respect to the longitudinal geometric axis of the non-linear file (for example, the distance from the generally longitudinal geometric axis of the non-linear file to the crest and / or inner edge of the displaced portion of the stem) to decrease the stiffness.
    [000196] A secondary heat treatment can be used to further control the stiffness of the curves, optimizing the properties of the file material. This can be accomplished by heat treatment of the file with shape adjusted to certain parameters to adjust the stiffness of the file (for example, making the file more rigid or less rigid). For example, in one embodiment, a nonlinear shaped nonlinear file can be formed by additional heat treatment of an adjusted nonlinear file using the heat treatment method described here to form a non-superplastic file, although not required . It is realized that the heat treatment process to form a non-superplastic file can generally include heating a superplastic file to a temperature of about 300 ° C to about 600 ° C (for example, about 400 ° C to about 500 ° C ° C) for a period of about 20 minutes to about 120 minutes (for example, about 35 minutes to about 80 minutes, and preferably about 40 minutes to about 70 minutes), thereby increasing the final austenitic transformation temperature above 20 ° C (for example, greater than about 25 ° C, and preferably greater than 30 ° C, between about 20 ° C and about 60 ° C, between about 20 ° C and about 40 ° C, preferably between about 30 ° C and about 40 ° C, and more preferably between 35 ° C and about 40 ° C) when used after the adjusted shape heat treatment process.
    [000197] Another method to control stiffness is by the chemical composition of Nickel Titanium by adding a tertiary element in nickel titanium such as Fe, Cu, Cr, etc., or by varying the percentages of nickel, titanium or the tertiary element or other way, as discussed here.
    [000198] It is realized that the heating step for non-superelastic heat treatment and / or non-linear heat treatment can be performed by any known heating medium (electric heating process, radiation or induction heating, or can be supplied with a heated fluid such as steam or oil, or otherwise, and any combination thereof) sufficient to heat the instruments to the temperatures described here. In a preferred embodiment, the heating step may include heating the instrument in an oven under a controlled atmosphere as discussed here.
    [000199] In another embodiment, the heating step may include heating (for example, selectively heating) an instrument (for example, one or more portions of the instrument) while optionally inserted in a fixture (for the purpose of changing or maintain a desired profile) described here. Temperature control is generally very important in such processes in order to achieve or maintain a desired metallurgical state and / or to perform heat treatment steps such as nitriding and the like. Resistance heating, in which an electric current passes through the instrument in order to generate heat, can be, since resistance heating can be very fast and very controllable, so that precise temperatures can be reached and / or selected regions the heated instrument.
    [000200] The heating step when using resistance heating can also include placing the instrument in contact with a liquid or gaseous fluid during the course of a training and treatment process. This fluid can comprise a tempering fluid used to control the temperature of the instrument, or it can comprise a treatment fluid such as a species that can be chemically reactive with the metal of the instrument; such treatment fluids may comprise nitriding fluids, or otherwise. Otherwise, this fluid can comprise a treatment fluid such as a species that can be chemically non-reactive with the metal of the instrument.
    [000201] Heating by electrical resistance can be understood as a process in which a continuous or alternating electric current is applied directly to an instrument in order to cause the heating of this instrument. Generally, an electric current can be applied directly to the instrument and / or the fixture when included in order to heat this instrument. In one embodiment, the heated instrument or portions of the instrument can be subjected to heat to maintain the configuration of the instrument while positioned on the fixture in a non-linear orientation described here (for example, with heat treatment in an adjusted manner). In other instances, heating changes the metallurgical state of the instrument. More particularly, heating by electrical resistance may allow selective heating for one or more portions of the instrument, or may provide heating of the entire instrument to alter the metallurgical state of the instrument or portions thereof as discussed here (for example, non-superelastic heat treatment). It is realized that one or more portions of the instrument can be selectively heated so that one or more portions of the instrument include a larger At- to form a non-superelastic portion while one or more different portions of the instrument can include a different Af (for example , non-superelastic or superelastic portion). In addition, it is realized that one or more portions of the instrument can be selectively heated so that one or more portions of the instrument include a larger Af to form a non-superelastic portion while one or more different portions of the instrument can include a lower Af for form a superelastic portion. The degree of heating can be controlled with greater precision by controlling the flow of electrical current. Subsequent to this, the electric current is terminated, and the instrument is allowed to cool. The cooling profile can be controlled by using quenching agents.
    [000202] It is noticed that when heating the instrument using resistance heating, a pair of spaced electrode contacts, which forms a junction that leads electrically to the instrument or a portion between it, is in electrical communication with an electrical power source (for example, a generator, batteries, or otherwise). Once the contacts are positioned around the instrument, electricity will pass between the spaced contacts, thereby providing sufficient heat to carry out the specific heat treatment. As discussed earlier, in some examples, if only certain portions of the instrument have to undergo a heat treatment cycle, the contacts can be arranged in such a way as to distribute electrical current only to those portions of the instrument. Accordingly, all such modalities are within the scope of this invention. Also, in some instances, certain portions of an instrument can be subjected to specific heat treatment steps separate from the heat treatment steps applied to the rest of the instrument. For example, a total instrument can be heat treated in a way that induces a first metallurgical transition in it (for example, non-superelastic heat treatment), and selected portions of this instrument then portrayed to convert those selected portions into a specific geometry (for example, treatment non-linear thermal file) and / or a second metallurgical state. For example, an instrument can thus be processed to produce a high hardness element with selected areas of low hardness in them.
    [000203] It is further realized that functions or structures of a plurality of components or steps can be combined into a single component or step, or the functions or structures of a step or component can be divided between multiple steps or components. The present invention contemplates all such combinations. Unless stated otherwise, dimensions and geometries of the various structures represented here should not be restrictive of the invention, and other dimensions or geometries are possible. Furthermore, while a resource of the present invention can be described in the context of only one of the illustrated modalities, that resource can be combined with one or more other resources of other modalities, for any given application. It is also clear from the foregoing that the manufacture of the exclusive structures here and their operation also constitute methods according to the present invention. The present invention also concerns intermediate and final products resulting from the practice of the methods here. The use of "comprising" or "including" also contemplates the modalities that "consists essentially of" or "consists of" reported resource.
    [000204] The explanations and illustrations presented here are intended to integrate those versed in the technique with the invention, its principles and its practical application. Experienced in the art, they can adapt and apply the invention in its numerous forms, which may be better suited to the requirements of a particular use. Thus, the specific embodiments of the present invention presented are not intended to be exhaustive or limiting the invention. The scope of the invention, therefore, should be determined not with reference to the description presented, but should instead be determined with reference to the appended claims, along with the total scope of the equivalents to which such claims relate. The disclosures of all articles and references, including patent applications and publications, are incorporated into the reference for all purposes.
    权利要求:
    Claims (12)
    [0001]
    1. Method for manufacturing a non-superelastic non-linear file in an adjusted way, characterized by the fact that it comprises the steps of: (i) providing a superelastic file with a rod (22) and a file axis (26); (ii) providing a fixing device (40, 50) including a file groove (90) being defined by one or more displacement elements (46), the file groove (90) configured to receive the rod (22); (iii) inserting at least a portion of the stem (22) into the fixing device (40, 50) along the groove of the file (90), the portion of the stem (22) including a first portion of the stem (22); (iv) placing the first stem portion (22) in contact with a first displacement element (54A) of one or more displacement elements (46), such that the first stem portion (22) is displaced from the axis geometric of the file (26), thereby forming a first displaced portion of the stem (22); (v) heating the rod portion (22) while inserted in the fixture (40, 50) to a temperature of 450 ° C to 550 ° C for a period of time of at least about 1 minute to about 45 minutes to adjust the shape of the stem portion (22), thereby forming an adjusted non-linear file, and (vi) additionally comprising the step of cooling the stem portion (22) to form the adjusted non-linear file and heat at least a portion of the nonlinear file suitably cooled to a temperature of about 300 ° C to about 600 ° C, for a period of time from about 20 minutes to about 120 minutes to change the temperature of final austenitic transformation, thereby forming an adjusted non-superelastic non-linear file, and in which the modified final austenitic transformation temperature of the adjusted non-superelastic non-linear file is from 20 ° C to 40 ° C.
    [0002]
    2. Method according to claim 1, characterized by the fact that it additionally comprises the step of cooling the portion of the stem (22) to form the non-linear file in an adjusted manner and to heat at least a portion of the non-linear file in an adjusted manner, cooled to a temperature of about 400 ° C to about 500 ° C for a period of time from about 40 minutes to about 70 minutes to change the final austenitic transformation temperature, thereby forming a non-linear non-linear file adjusted superelastic, and in which the modified final austenitic transformation temperature of the adjusted non-superelastic non-linear file is from about 20 ° C to about 40 ° C.
    [0003]
    Method according to claim 1 or 2, characterized in that it further comprises the step of placing a second portion of the rod (22) in contact with a second displacement element (54B) of one or more displacement elements ( 46), such that the second portion of the stem (22) is offset from the geometric axis of the file (26), thereby forming a second portion of the stem (22), wherein the first portion of the stem (22) ) and the geometric axis of the file (26) define a first plane and the second displaced portion defines a second plane different from the first plane.
    [0004]
    Method according to any one of the preceding claims, characterized by the fact that, in the heating step, the stem portion (22) is heated to a temperature of about 300 ° C to about 650 ° C, preferably about 350 ° C to about 600 ° C, and more preferably about 450 ° C to about 550 ° C for a period of about 1 minute to about 45 minutes to adjust the shape of the stem portion (22) , thereby forming the nonlinear file in an adjusted manner.
    [0005]
    Method according to any one of the preceding claims, characterized by the fact that it additionally comprises the step of cooling the portion of the stem (22) to form the nonlinear file in an adjusted manner and heat at least a portion of the nonlinear file in an adjusted cooled to a temperature of about 300 ° C to about 600 ° C, for a period of time from about 30 minutes to about 120 minutes to change the final austenitic transformation temperature, thereby forming a non linearly adjusted non-superelastic, and where the final modified austenitic transformation temperature of the adjusted non-superelastic non-linear file is from about 20 ° C to about 40 ° C.
    [0006]
    6. Method according to any one of the preceding claims, characterized by the fact that it additionally comprises the step of cooling the portion of the stem (22) to form the nonlinear file in an adjusted manner and heat at least a portion of the nonlinear file in an adjusted cooled to a temperature of about 400 ° C to about 500 ° C, for a period of time from about 40 minutes to about 70 minutes to change the final austenitic transformation temperature, thereby forming a non adjusted non-superelastic linear shape, and where the altered austenitic transformation end temperature of the adjusted non-superelastic non-linear file is from about 20 ° C to about 40 ° C.
    [0007]
    Method according to any one of the preceding claims, characterized by the fact that one or more displacement elements (46) additionally include a second displacement element (54B) and the file groove (90) is additionally defined by a pair of guide elements to receive a guide portion of the stem (22) between them, the pair of guide elements being configured to prevent the guide portion of the stem (22) from being displaced from the geometric axis of the file (26), while the first displacement element (54A) displaces the first portion of the stem (22) off the geometric axis of the file (26) and the second displacement element (54B) displaces a portion of the stem towards the geometric axis of the file (26) .
    [0008]
    8. Method according to any one of the preceding claims, characterized by the fact that the first displacement element (54A), the second displacement element (54B), and the pair of guide elements defining the file groove (90) form a path of the predetermined non-linear curved file that guides the stem portion (22) in a general C-shaped profile.
    [0009]
    Method according to any one of the preceding claims, characterized by the fact that one or more displacement elements (46) additionally include a second displacement element (54B) and a third displacement element, and the file groove (90) is further defined by a pair of guide elements to receive a guide portion of the stem (22) between them, the pair of guide elements being configured to prevent the guide portion of the stem (22) from being displaced from the geometric axis of the file (26), while the first displacement element (54A) displaces the first portion of the nail (22) off the geometric axis of the file (26), the second displacement element (54B) displaces a second portion of the nail (22 ) out of the first displacement element (54A) and back through the geometric axis of the file (26), and the third displacement element displaces the third portion of the stem (22) from the second displacement element (54B) and towards to the geometric axis of the file (26).
    [0010]
    10. Method according to any of the preceding claims, characterized by the fact that the first displacement element (54A), the second displacement element (54B), the third displacement element, and the pair of guide elements that define the file groove (90) form a predetermined non-linear curved file path, with at least two arched portions that guide the stem portion (22) in a general S-shaped profile.
    [0011]
    11. Method according to any one of the preceding claims, characterized by the fact that the file groove (90) defines a first predetermined non-linear file path and at least one or more displacement elements (46) are movable in relation to the axis geometric shape of the file (26) so that the file slot (90) is a variable file slot (90) configured to define the first predetermined non-linear file path or a second predetermined non-linear file path that is different from the first path of the predetermined non-linear file.
    [0012]
    12. Method according to any one of the preceding claims, characterized by the fact that one or more displacement elements (46) include at least two displacement elements that are movable both independently and simultaneously in relation to the geometric axis of the file (26). so that the file slot (90) is a variable file slot (90) configured to define the first predetermined non-linear file path or a second predetermined non-linear file path that is different from the first predetermined non-linear file path.
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    法律状态:
    2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61C 5/42 (2017.01), C21D 6/00 (2006.01), C21D 9/0 |
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-03-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-08-18| B09A| Decision: intention to grant|
    2020-10-06| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/11/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/300,506|US8916009B2|2011-05-06|2011-11-18|Endodontic instruments and methods of manufacturing thereof|
    US13/300,506|2011-11-18|
    PCT/US2012/065469|WO2013074896A1|2011-11-18|2012-11-16|Endodontic instruments and methods of manufacturing thereof|
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