Endodontic instruments

Abstract

A rotatable endodontic file for cleaning/shaping a tooth root canal that includes an elongated shaft having a proximal end portion, a distal end and a tapered working portion having a rotational axis, the working portion extending from the proximal portion to the distal end; the external surface of the shaft working portion having a plurality of parallelogram-shaped cross sections along the working portion.

Claims

1. A rotatable endodontic file for cleaning/shaping a tooth root canal, comprising: an elongated shaft having a proximal end, a proximal end portion, a distal end and a tapered working portion having a file axis, the working portion extending from said proximal end portion to said distal end; an external surface of said shaft working portion being defined mat least two spirals that define at least two opposing side walls of a plurality of parallelogram-shaped cross sections along the working portion, at least one of the plurality of parallelogram-shaped cross sections has a C-shaped or concave geometry along two side walls or along all four side walls, wherein an acute angle of a first parallelogram-shaped cross section of the plurality of parallelogram-shaped cross sections is different or the same as an acute angle of a second parallelogram-shaped cross section of the plurality of parallelogram-shaped cross sections; and wherein the acute angle of the first parallelogram-shaped cross section is larger towards the proximal end portion than the acute angle of the second parallelogram-shaped cross section towards the distal end.

2. An endodontic file according to claim 1, wherein the acute angles of the first and second parallelogram-shaped cross sections range between 50 degrees and 85 degrees.

3. An endodontic file according to claim 1, wherein the file is composed of a material selected from the group consisting of a Nitinol based material, Cu based material, titanium based material and a stainless steel based material.

4. An endodontic file according to claim 3, wherein the material is processed by high temperature, cold temperatures and/or strain.

5. A rotatable endodontic file for cleaning/shaping a tooth root canal, comprising: an elongated shaft having a proximal end, a proximal end portion, a distal end and a tapered working portion having a rotational axis, the working portion extending from said proximal end portion to said distal end; an external surface of said shaft working, portion being defined by at least two spirals that define at least two opposing side walls of a plurality of parallelogram-shaped cross sections that extend along the working portion, at least one of the plurality of the parallelogram-shaped cross sections has a C-shaped or concave geometry along one, two, three, or four side walls, wherein an acute angle of a first parallelogram-shaped cross section of the plurality of parallelogram-shaped cross sections is different or the same as an acute angle of a second parallelogram-shaped cross section of the plurality of parallelogram-shaped cross sections; and wherein the acute angle of the first parallelogram-shaped cross section is larger towards the proximal end than the acute angle of the second parallelogram-shaped cross section towards the distal end.

6. An endodontic file according to claim 5 wherein the acute angles of the first and second parallelogram-shaped cross sections range between 50 degrees and 85 degrees.

7. An endodontic file according to claim 5, wherein the file is composed of a material selected from the group consisting of a Nitinol based material, Cu based material, titanium based material and a stainless steel based material.

8. An endodontic file according to claim 7 wherein the material is processed by high temperature, cold temperatures and/or strain.

9. A rotatable endodontic file for cleaning/shaping a tooth root canal, comprising: an elongated shaft having a proximal end, a proximal end portion, a distal end and a tapered working portion having a file axis, the working portion extending from said proximal end portion to said distal end; an external surface of said shaft working portion being defined by at least two spirals that define at least two opposing side walls of a plurality of parallelogram-shaped cross sections along the working portion, at least two of the plurality of parallelogram-shaped cross sections having an acute angle and an axis of rotation that is asymmetric such that a center of mass is not located along the file axis; wherein a first parallelogram-shaped cross section of the at least two of the plurality of parallelogram-shaped cross sections has a first center of mass and a second parallelogram-shaped cross section of the at least two of the plurality of parallelogram-shaped cross sections has a second center of mass being different from the first center of mass of said first parallelogram-shaped cross section; and wherein both the first center of mass of the first parallelogram-shaped cross section and the second center of mass of the second parallelogram-shaped cross section are not located along the file axis.

10. An endodontic file according to claim 9, wherein the first parallelogram-shaped cross section has an acute angle that is larger towards the proximal end portion than an acute angle of the second parallelogram-shaped cross section towards the distal end.

11. An endodontic file according to claim 10, wherein the acute angles of the first and second parallelogram-shaped cross sections range between 50 degrees and 85 degrees.

12. An endodontic file according to claim 9, wherein the acute angles of the first and second parallelogram-shaped cross sections range between 50 degrees and 85 degrees.

13. An endodontic file according to claim 9, wherein the file is composed of a material selected from the group consisting of a Nitinol based material, Cu based material, titanium based material and a stainless steel based material.

14. An endodontic file according to claim 13, wherein the material is processed by high temperature, cold temperatures and/or strain.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a perspective view of a first embodiment of an endodontic file of the present invention.

(2) FIG. 2 is a perspective view of a second embodiment of an endodontic file of the present invention.

(3) FIG. 3 is a perspective view of a third embodiment of an endodontic file of the present invention.

(4) FIG. 4 is a perspective view of a forth embodiment of an endodontic file of the present invention.

(5) FIG. 4A is a parallelogram-shaped cross section taken across 4A-4A of the endodontic file shown if FIG. 4.

(6) FIG. 5 is a perspective view of a fifth embodiment of an endodontic file of the present invention.

(7) FIG. 5A is a parallelogram-shaped cross section taken across 5A-5A of the endodontic file shown in FIG. 5.

(8) FIG. 6 is a perspective view of a sixth embodiment of an endodontic file of the present invention.

(9) FIG. 6A is a first parallelogram-shaped cross section taken across 6A-6A of the endodontic file shown in FIG. 6.

(10) FIG. 6B is a second parallelogram-shaped cross section taken across 6B-6B of the endodontic file shown in FIG. 6.

(11) FIG. 7 is a perspective view of a seventh embodiment of an endodontic file of the present invention.

(12) FIG. 7A is a first parallelogram-shaped cross section taken across 7A-7A of the endodontic file shown in FIG. 7.

(13) FIG. 7B is a second parallelogram-shaped cross section taken across 7B-7B of the endodontic file shown in FIG. 7.

(14) FIG. 8 is a perspective view of a eighth embodiment of an endodontic file of the present invention.

(15) FIG. 8A is a parallelogram-shaped cross section taken across 8A-8A of the endodontic file shown in FIG. 8.

(16) FIG. 9 is a perspective view of a ninth embodiment of an endodontic file of the present invention.

(17) FIG. 9A is a first parallelogram-shaped cross section taken across 9A-9A of the endodontic file shown in FIG. 9.

(18) FIG. 9B is a second parallelogram-shaped cross section taken across 9B-9B of the endodontic file shown in FIG. 9.

(19) FIG. 10 is a perspective view of a tenth embodiment of an endodontic file of the present invention.

(20) FIG. 10A is a parallelogram-shaped cross section taken across 10A-10A of the endodontic file shown in FIG. 10.

(21) FIG. 11 is a perspective view of an eleventh embodiment of an endodontic file of the present invention.

(22) FIG. 11A is a first parallelogram-shaped cross section taken across 11A-11A of the endodontic file shown in FIG. 11.

(23) FIG. 11B is a second parallelogram-shaped cross section taken across 11B-11B of the endodontic file shown in FIG. 11.

(24) FIG. 12 is a perspective view of a twelfth embodiment of an endodontic file of the present invention.

(25) FIG. 12A is a first parallelogram-shaped cross section taken across 12A-12A of the endodontic file shown in FIG. 12.

(26) FIG. 12B is a second parallelogram-shaped cross section taken across 12B-12B of the endodontic file shown in FIG. 12.

(27) FIG. 12C is a third parallelogram-shaped cross section taken across 12C-12C of the endodontic file shown in FIG. 12.

(28) FIG. 12D is a forth parallelogram-shaped cross section taken across 12D-12D of the endodontic file shown in FIG. 12.

(29) FIG. 12E is a fifth parallelogram-shaped cross section taken across 12E-12E of the endodontic file shown in FIG. 12.

(30) FIG. 12F is a sixth parallelogram-shaped cross section taken across 12F-12F of the endodontic file shown in FIG. 12.

(31) FIG. 12G is a seventh parallelogram-shaped cross section taken across 12G-12G of the endodontic file shown in FIG. 12.

(32) FIG. 12H is an eighth parallelogram-shaped cross section taken across 12H-12H of the endodontic file shown in FIG. 12.

(33) FIG. 12I is a ninth parallelogram-shaped cross section taken across 12I-12I of the endodontic file shown in FIG. 12.

(34) FIG. 12J is a tenth parallelogram-shaped cross section taken across 12J-12J of the endodontic file shown in FIG. 12.

(35) FIG. 12K is an eleventh parallelogram-shaped cross section taken across 12K-12K of the endodontic file shown in FIG. 12.

(36) FIG. 12L is a twelfth parallelogram-shaped cross section taken across 12L-12L of the endodontic file shown in FIG. 12.

(37) FIG. 12M is a thirteenth parallelogram-shaped cross section taken across 12M-12M of the endodontic file shown in FIG. 12.

(38) FIG. 12N is a fourteenth parallelogram-shaped cross section taken across 12N-12N of the endodontic file shown in FIG. 12.

(39) FIG. 12O is a fifteenth parallelogram-shaped cross section taken across 12O-12O of the endodontic file shown in FIG. 12.

(40) FIG. 13 is a perspective view of an eleventh embodiment of an endodontic file of the present invention.

(41) FIG. 13A is a first parallelogram-shaped cross section taken across 13A-13A of the endodontic file shown in FIG. 13.

(42) FIG. 13B is a second parallelogram-shaped cross section taken across 13B-13B of the endodontic file shown in FIG. 13.

(43) FIG. 13C is a third parallelogram-shaped cross section taken across 13C-13C of the endodontic file shown in FIG. 13.

(44) FIG. 13D is a forth parallelogram-shaped cross section taken across 13D-13D of the endodontic file shown in FIG. 13.

(45) FIG. 13E is a fifth parallelogram-shaped cross section taken across 13E-13E of the endodontic file shown in FIG. 13.

(46) FIG. 13F is a sixth parallelogram-shaped cross section taken across 13F-13F of the endodontic file shown in FIG. 13.

(47) FIG. 13G is a seventh parallelogram-shaped cross section taken across 13G-13G of the endodontic file shown in FIG. 13.

(48) FIG. 14 is a first chart showing Cutting Angle versus Cutting Efficiency.

(49) FIG. 15 is a second chart showing Acute Angle of a File on Center versus Void Volume.

(50) FIG. 16 is a third chart showing Void Volume versus Cutting Efficiency.

(51) FIG. 17 is a fourth chart showing Acute Angle of a File Off Center versus Void Volume.

(52) FIG. 18 is a first chart showing Cutting Angle of a File Off Center versus Cutting Efficiency.

DETAILED DESCRIPTION OF THE INVENTION

(53) The invention discloses several novel approaches to parallelogram-shaped cross section and derivatives of parallelogram-shaped cross section for dental instruments (e.g., endodontic instruments such as endodontic files). In this invention, the angles of the parallelogram are ground directly into the file and the acute and obtuse angles of the parallelogram-shaped cross section vary along the axis of the file (FIG. 4).

(54) Another variation of the parallelogram-shaped cross section contains C-shaped or concave geometries along one, two, three or four sides of the parallelogram (FIG. 5).

(55) The invention discloses several novel approaches to parallelogram-shaped cross sections and derivatives of parallelogram-shaped cross section for endodontic files.

(56) The first approach is a parallelogram-shaped cross section that has an axis of rotation that is centered such that the center of mass (centroid) is located at the axis of rotation. In this embodiment, the acute angle is different along the length of the file; preferably, the acute angle is larger at the tip and decreases as it approaches the shank. For example, the tip cross section has an acute angle of 70 degrees and decrease to an acute angle of 60 degrees as it approaches the shank (FIG. 6).

(57) The second approach is a parallelogram-shaped cross section that has an axis of rotation that is off-centered such that the center of mass (centroid) is not located at the axis of rotation. This is sometimes known as an asymmetric cross-section. In this embodiment the acute angle is different or the same along the length of the file. If the acute angle is different along the length of the file; preferably the acute angle is larger at the tip and decreases as it approaches the shank. For example, the tip cross section has an acute angle of 80 degrees and decreases to an acute angle of 70 degrees as it approaches the shank (FIG. 7).

(58) The third embodiment is a parallelogram-shaped cross section that has an axis of rotation that is centered such that the center of mass (centroid) is located at the axis of rotation and has 2 or 4 C-shaped or concave geometries along 2 symmetrical sides or all 4 sides of the cross section (FIG. 8).

(59) In this embodiment the acute angle is different or the same along the length of the file. If the acute angles are different along the length of the file, preferably the acute angle is larger at the tip and decreases as it approaches the shank. For example, the tip cross section has an acute angle of 80 degrees and decrease to an acute angle of 70 degrees as it approaches the shank (FIG. 9).

(60) The fourth approach is a parallelogram-shaped cross section that has a cross section which is off-centered such that the center of mass (centroid) is not located at the axis of rotation (asymmetric cross-section) and has 1, 2, 3 or 4 C-shaped or concave geometries along 1, 2, 3 or 4 sides of the parallelogram (FIG. 10).

(61) In this embodiment the acute angle is different or the same along the length of the file. If the acute angle is different along the length of the file; preferably the acute angle is larger at the tip and decreases as it approaches the shank. For example, the tip cross section has an acute angle of 80 degrees and decrease to an acute angle of 70 degrees as it approaches the shank (FIG. 11).

(62) It is contemplated that the angles located proximate to the tip portion may be at least about 60 degrees and preferably at least about 65 degrees. Furthermore, the angle proximate to the tip portion may be less than about 85 degrees, and preferably less than about 80 degrees. For example, the angles located proximate to the tip portion may range from about 60 to about 85 degrees and preferably from about 65 to about 80 degrees. It is further contemplated that the angles located distally (toward the shank) from the tip portion may be at least about 40 degrees and preferably at least about 50 degrees. Furthermore, the angle located distally (toward the shank) from the tip portion may be less than about 85 degrees, and preferably less than about 80 degrees. For example, the angles located distally (toward the shank) from the tip portion may range from about 40 to about 85 degrees and preferably from about 50 to about 80 degrees.

(63) The lengths of the parallelogram (both on center and off center) may define various desirable ratios (e.g., from about 2:1 to about 1:4, from about 2:1 to about 1:2, from about 1:2 to about 1:1, from about 1:2 to about 4:5) of the helical angles between the acute angle helical angle and the obtuse angle helical angle, the helical angles between a first acute angle helical angle and an adjacent second acute angle helical angle, the helical angles between a first obtuse angle helical angle and an adjacent second obtuse angle helical angle, and/or the offset heights between the acute angle cutting edge and the obtuse angle cutting edge. It is appreciated that in one embodiment, the ratio of the lengths of the edges of the parallelogram may be about 1 (e.g., for the on center design) and/or, the ratio may range from about 1.6 to about 1.1 (e.g., for the off center parallelogram).

(64) In another embodiment, the ratio of the acute angle helical angle and the obtuse angle helical angle may range from about 1.8 to about 1.2 (e.g., for the on center design) and/or the ratio may range from about 1.7 to about 1.1 (e.g., for the off center parallelogram).

(65) In yet another embodiment, the offset heights between the acute angle cutting edge and obtuse angle cutting edge may vary from about 0.17 mm to about 0.05 mm (e.g., for the on center design), and/or the heights may vary from about 0.15 mm to about 0.1 mm (e.g., for the off center parallelogram).

(66) Superelastic materials are typically metal alloys, which return to their original shape after substantial deformation. Examples of efforts in the art towards superelastic materials are found in U.S. Pat. No. 6,149,501, which is herein incorporated by reference for all purposes.

(67) The endodontic instruments disclosed above can be made of shape memory alloys (e.g., NiTi based, Cu based, Fe based, or combinations thereof) in their martensitic state of the present invention may provide more flexibility and increase fatigue resistance by optimized microstructure, which is particularly effective in shaping and cleaning canals with severe curvatures. Superelastic alloys such as nickel titanium (NiTi) or otherwise can withstand several times more strain than conventional materials, such as stainless steel, without becoming plastically deformed.

(68) This invention relates to dental instruments disclosed above. Specifically, this invention relates to endodontic rotary instruments for use in root canal cleaning and shaping procedures. The present invention provides an innovation of endodontic instrument that is made of shape memory alloys (SMA) such as Nickel-Titanium (NiTi) based systems, Cu based systems Fe based systems, or any combination thereof (e.g., materials selected from a group consisting of near-equiatomic Ni—Ti, Ni—Ti—Nb alloys, Ni—Ti—Fe alloys, Ni—Ti—Cu alloys, beta-phase titanium and combinations thereof).

(69) The present invention comprises rotary instruments made of NiTi Shape Memory Alloys, which provide one or more of the following novel aspects:

(70) Primary metallurgical phase in microstructure: martensite is the primary metallurgical phase in the present invention instrument, which is different from standard NiTi rotary instruments with predominant austenite structure at ambient temperature.

(71) Higher austenite finish temperature (the final A.sub.f temperature measured by Differential Scanning calorimetry): the austenite finish temperature is preferably higher (e.g., at least about 3.degree. C.) than the ambient temperature (25.degree. C.); in contrast, most standard superelastic NiTi rotary instruments have austenite finish temperatures lower than ambient temperature.

(72) Due to higher austenite finish temperature, the present invention instrument would not return to the original complete straight state after being bent or deflected; in contrast, most standard superelastic NiTi rotary instruments can return to the original straight form via reverse phase transformation (martensite-to-austenite) upon unloading.

(73) Endodontic instruments made of NiTi shape memory alloys in their martensitic state have significantly improved overall performance than their austenitic counterparts (regular superelastic NiTi instruments), especially on flexibility and resistance against cyclic fatigue.

(74) The strength and cutting efficiency of endodontic instruments can also be improved by using ternary shape memory alloys NiTiX (X: Co, Cr, Fe, Nb, etc) based on the mechanism of alloy strengthening.

(75) Specifically, the present invention instrument has essential and most desired characteristics for successful root canal surgery, including higher flexibility and lower stiffness, improved resistance to cyclic fatigue, higher degree of rotation against torsional fracture, more conforming to the shape of highly curved canals (less likely for ledging or perforation), and minimum possibility of instrument separation in comparison against conventional endodontic instruments made of NiTi shape memory alloy in superelastic condition with fully austenitic phase in microstructure.

Example #1 (On Center File Designs)

(76) 30.06 ISO Tapered files were manufactured with parallelogram-shaped cross sections with constant angles (e.g., constant acute angles generally throughout the working portion of the file). Table 1 provides the measured cutting efficiency for the on center file designs of these tapered files with parallelogram-shaped cross sections with constant angles as compared to a triangle cross section ISO Tapered file (Vortex) . . . .

(77) TABLE-US-00001 TABLE 1 Average Cutting Was it more efficient than File Efficiency (mm/sec) 30.06 Vortex? 80 Deg. 30.06 0.304 No 70 Deg. 30.06 0.443 Yes (by about 10%) 60 Deg. 30.06 0.477 Yes (by about 17%) 65 Deg. 30.06 0.455 Yes (by about 11%) 75 Deg. 30.06 0.387 Statistically the same Vortex 30.06 (60 Deg) 0.403 —

(78) As shown in Table 1 and Charts 1-3 (FIGS. 14-16) for endodontic files having parallelogram-shaped cross sections with constant angles (generally throughout the working portion of the file), the smaller the parallelogram angle resulted in higher the void volume and higher cutting efficiency. The definition of void volume is the amount of free volume between the file and the canal wall.

Example #2 (On Center File Designs)

(79) 30.06 ISO tapered files were manufactured with parallelogram-shaped cross sections with variable angles (e.g., variable acute angles, generally throughout the working portion of the file). Table 2 provides measured cutting efficiency for on center file designs of 30.06 ISO Tapered files, which were manufactured with parallelogram-shaped cross sections having variable angles as compared to a triangle cross section ISO Tapered file (Vortex). FIG. 12 provides an example of one of the endodontic files having a parallelogram-shaped cross sections with variable angles (generally throughout the working portion of the file)

(80) TABLE-US-00002 TABLE 2 Design Average Cutting Efficiency (mm/sec) M4 30.06 80-70 deg. 0.333 M4 30.06 80-60 deg. 0.432 M4 30.06 70-60 deg. 0.391 M4 30.06 70-50 deg. 0.450 30.06 Vortex 0.403

(81) As shown in Table 2: for endodontic files having parallelogram-shaped cross sections with variable angles (generally throughout the working portion of the file), larger cross section angles results in higher cutting efficiency (with the exception of higher angles apically). Furthermore, it is appreciated that larger cross section angles at the tip of the file may reduce void volume while providing more mass at the tip to increase the strength of the file (which reduces file breakage). Desirably, endodontic files having parallelogram-shaped cross sections with variable angles (generally throughout the working portion of the file) include larger cross section angles at or towards the tip portion and lower cross section angles towards the shank.

Example #3 (Off Center File Designs)

(82) 30.06 ISO Tapered files were manufactured with parallelogram-shaped cross sections with constant angles and compared to a triangle cross section ISO Tapered file for cutting efficiency.

(83) As shown in Charts 4-5 (FIGS. 17-18) for off center file designs of 30.06 ISO Tapered files, which were manufactured with parallelogram-shaped cross sections having constant angles, smaller cross section angles results in higher cutting efficiency and higher void volume. FIG. 13 provides an example of one of the endodontic files (off center file design) having a parallelogram-shaped cross sections with constant angles (generally throughout the working portion of the file).

(84) Method of Manufacturing

(85) Examples of efforts in the art directed to methods of manufacturing endodontic instruments may be found in, but not limited to U.S. Patent Application 20110271529, which is herein incorporated by reference for all purposes.

(86) It will be appreciated that functions or structures of a plurality of components or steps may be combined into a single component or step, or the functions or structures of one-step or component may be split among plural steps or components. The present invention contemplates all of these combinations. Unless stated otherwise, dimensions and geometries of the various structures depicted herein are not intended to be restrictive of the invention, and other dimensions or geometries are possible. In addition, while a feature of the present invention may have been described in the context of only one of the illustrated embodiments, such feature may be combined with one or more other features of other embodiments, for any given application. It will also be appreciated from the above that the fabrication of the unique structures herein and the operation thereof also constitute methods in accordance with the present invention. The present invention also encompasses intermediate and end products resulting from the practice of the methods herein. The use of “comprising” or “including” also contemplates embodiments that “consist essentially of” or “consist of” the recited feature.

(87) The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the invention, its principles, and its practical application. Those skilled in the art may adapt and apply the invention in its numerous forms, as may be best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present invention as set forth are not intended as being exhaustive or limiting of the invention. The scope of the invention should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes.