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`
`US007967605B2
`
`c12) United States Patent
`Goodis
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,967,605 B2
`Jun.28,2011
`
`(54) ENDODONTIC FILES AND OBTURATOR
`DEVICES AND METHODS OF
`MA.l\UFACTURING SAME
`
`(75)
`
`Inventor: Charles J. Goodis,Albuquerque, NM
`(US)
`
`749,624 A
`1,067,015 A
`1,307,446 A
`2,715,772 A
`2,797,996 A
`
`1/1904 McCullough
`7/1913 Fowler
`6/1919 Kerr
`811955 Fritz
`7/1957 Jaffe et al.
`(Continued)
`
`(73) Assignee: Guidance Endodontics, LLC,
`Albuquerque, NM (US)
`
`CA
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1627 days.
`
`(21) Appl. No.: 11/081,974
`
`(22) Filed:
`
`Mar.16, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2005/0282108 Al
`
`Dec. 22, 2005
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/553,792, filed on Mar.
`16, 2004, provisional application No. 60/648,099,
`filed on Jan. 28, 2005, provisional application No.
`60/648,167, filed on Jan. 28, 2005.
`
`(51)
`
`Int. Cl.
`A61C 5102
`(2006.01)
`(52) U.S. Cl. ....................................................... 433/102
`(58) Field of Classification Search .................. 433/102,
`433/165, 224
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`8/1893 How
`503,744 A
`626,359 A
`6/1899 Atlee
`636,359 A
`11/1899 Schultz
`12/1902 Latham
`716,441 A
`
`100b
`
`FOREIGN PATENT DOCUMENTS
`1111990
`1275836
`(Continued)
`
`OTHER PUBLICATIONS
`
`Brochere, F.,
`the use of high-speed drills],
`[Concerning
`L'Information Dentaire (Nov. 1953) vol. 35(48) pp. 1506-1510.
`
`(Continued)
`
`Primary Examiner- Ralph A Lewis
`(7 4) Attorney, Agent, or Finn Kenyon & Kenyon LLP
`
`(57)
`ABSTRACT
`An endodontic file, or a series of endodontic files, and an
`endodontic obturator or series of obturators, and methods of
`manufacturing same. Regarding the endodontic files, they
`may include a file body extending from a tip region to a shank
`region, at least one helical flute extending from the tip region
`towards the shank region. Each helical flute may have an
`up-sharp cutting edge without a land. For one such set of
`endodontic files, there is included at least a first and a second
`file, each one of the files having a tip and a shank, the first file
`having a tip size that is substantially the same as a tip size of
`the second file, wherein the first file has a different taper
`configuration relative to the taper configuration of the second
`file. The taper configurations of each one of the first and
`second files include at least two different rates of taper, the
`taper configurations of each one of the first and second files
`arranged such that at least one rate of taper closer to the shank
`of the file is smaller than at least one rate of taper closer to a
`tip of the file.
`
`27 Claims, 10 Drawing Sheets
`
`A "'f.
`
`100o
`
`GOLD STANDARD EXHIBIT 2030
`US ENDODONTICS v. GOLD STANDARD
`CASE PGR2015-00019
`
`

`
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`
`US 7,967,605 B2
`Page 2
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`............... 606/79
`
`

`
`US 7,967,605 B2
`Page 3
`
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`

`
`US 7,967,605 B2
`Page 4
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`6/1999 Walia
`8/1999 Dykstra et a!.
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`112000 Euvrard et a!.
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`1112000 Farzin-Nia eta!.
`12/2000 Helium
`112001 Katsuumi et a!.
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`3/2001 Wong eta!.
`4/2001 Riitano et al.
`5/2001 Antelman
`5/2001 Kildea, Jr.
`7/2001 Hashimoto et al.
`7/2001 Pagedas
`8/2001 Farzin-Nia eta!.
`9/2001 McSpadden
`10/2001 Garman
`1112001 Messick
`1112001 Farzin-Nia eta!.
`4/2002 Golomb eta!.
`4/2002 Riitano et al.
`5/2002 Murai eta!.
`5/2002 Cornell
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`CA
`CH
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`FOREIGN PATENT DOCUMENTS
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`9/1997
`0 657 981
`10/1986
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`12/1990
`
`7/2002
`0 780 100 B1
`EP
`WO 02/062251 A2 * 8/2002
`WO
`WO WO 2004/034920 A2 * 4/2004
`OTHER PUBLICATIONS
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`Webers, A., [Drilling machines, turbines, small motors], Dent.
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`L. Stephen Buchanan, "The Art of Endodontics: Files of Greater
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`K.B. Lewis & W.F. Schleicher, The Grinding Wheel-A Textbook of
`Modern Grinding Practice (1976 3d ed) 382-83.
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`product usage, and the development of skin lesions," American Jour(cid:173)
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`100(3) pp. 242-250.
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`pp. 349-353.
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`(Jun. 1988) vol. 9(6) p. 518.
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`1986) vol. 89(6) pp. 485-491.
`
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`
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`370-374.
`
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`dental drill], Prot. Stom. (1971) pp. 89-100 (w/ English language
`abstract).
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`aspects of mechanotherapy], Cahiers de Prothese (Sep. 1991) No. 75,
`pp. 91-101 (w/ English language abstract).
`* cited by examiner
`
`

`
`U.S. Patent
`
`Jun.28,2011
`
`Sheet 1 of 10
`
`US 7,967,605 B2
`
`0
`0
`0
`
`~
`•
`CD
`u..
`
`.. I <(
`
`.......
`.......
`
`..0
`0 .......
`.......
`
`0 .......
`.......
`
`..0
`0
`0 .......
`
`

`
`U.S. Patent
`
`Jun.28,2011
`
`Sheet 2 of 10
`
`US 7,967,605 B2
`
`100
`
`2110
`
`FIG.2
`
`

`
`U.S. Patent
`
`Jun. 28, 2011
`
`Sheet 3 of 10
`
`US 7,967,605 B2
`
`202 203 204
`
`205
`206
`
`200
`
`FIG.3
`
`

`
`U.S. Patent
`
`Jun.28,2011
`
`Sheet 4 of 10
`
`US 7,967,605 B2
`
`120
`
`FIG.4
`
`

`
`27± 0.2
`20.5 ±0.2
`+0.5
`MAXIMUM
`GRINDING LENGTH 12.5 0
`12
`
`f100
`
`MINIMUM
`RADIUS 0.5
`
`104a
`
`104b
`
`00.8 TO 01.00
`
`_j
`
`100a
`
`8
`
`.106b
`
`r106a
`
`~ 4
`L
`0A~11 08
`TAPER: 8% I TAPER: 4%
`TAPER: 2%
`
`0C
`
`001 0E
`
`COMPRESSION ZONE
`ACCORDING TO D1C2450
`ACCORDING TO 01 C2205
`
`?? ..
`
`FIG.5(a)
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`2'
`:=
`
`N
`~CIO
`N
`
`0 ....
`....
`
`('D
`('D
`
`rFJ =(cid:173)
`.....
`Ul
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`

`
`GRINDING TOLERANCE: +0.005 +0.035
`
`PROGRESS PITCH
`
`No
`
`A
`0PTE
`
`08
`
`0C
`
`00
`
`0E
`± 0.015
`
`ON TIP
`
`AT 12mm AT 17mm
`
`0FILL
`
`SLEEVE
`LENGTH
`±0.3
`
`TAPER COLOR
`TIP COLOR CODE RING
`CODE RING & STEPPER
`
`YELLOW
`
`REF. GPAO
`
`lg21:20337301
`lg25:20337307
`lg21:20337301
`lg25:20337307
`lg21:20337301
`lg25:20337307
`
`I
`
`I
`
`I
`I
`I
`
`I
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`~ = :=
`
`N
`QO
`
`~
`
`N
`
`0 ....
`....
`
`rFJ =(cid:173)
`('D a
`0\
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`0.20
`
`0.52
`
`0.68
`
`0.76
`
`20
`
`25
`
`30
`
`0.25
`
`0.57
`
`0.73
`
`0.81
`
`0.70
`
`21-25
`
`RED
`
`GREEN
`
`0.70
`
`1.05
`
`1.20
`
`0.80
`
`0.30
`
`0.62
`
`0.78
`
`0.86
`
`0.87
`
`1.10
`
`1.5
`
`1.00
`
`GRINDING TOLERANCE AFTER VIBRATING: ±0.015
`
`BLUE
`
`DIC0415
`
`DIC0416
`DIC0411
`
`TABLE 2
`
`FIG.5(b)
`
`

`
`27 ± 0.2
`
`20.5 ±0.2
`+0.5
`MAXIMUM
`GRINDING LENGTH 12.5 0
`
`12
`
`100
`
`MINIMUM
`RADIUS 0·5
`
`;
`
`COMPRESSION ZONE
`ACCORDING TO D1C2450
`00.8 TO 01.00
`_l
`
`1 06c
`)
`
`100b7\l
`0CT T 1210 T 0E
`ACCORDING TO D1C2205
`
`T08
`
`0AQ1
`TAPER: 10%
`TAPER: 5%
`TAPER: 2%
`
`FIG.6(a)
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`2'
`:=
`
`N
`~CIO
`N
`
`0 ....
`....
`
`('D
`('D
`
`rFJ =(cid:173)
`.....
`-....l
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`

`
`GRINDING TOLERANCE
`
`+0.005 +0.035
`
`PROGRESS PITCH
`
`No
`
`.0A
`
`.0B
`
`.0C
`
`.00
`
`.0E
`±0.015
`
`ON TIP
`
`AT 12mm AT 17mm
`
`.0FILL
`
`SLEEVE
`LENGTH
`±0.3
`
`TIP COLOR
`CODE RING
`
`TAPER COLOR
`CODE RING
`& STEPPER
`
`30
`
`0.30
`
`0.70
`
`0.90
`
`0.98
`
`0.80
`
`1
`
`1.52
`
`1.75
`
`1.00
`
`21-25
`
`BLUE
`
`GRINDING TOLERANCE AFTER VIBRATING: ±0.015
`
`DIC0415
`
`BLACK
`
`DIC0416
`DIC0411
`
`REF. GPAO
`
`lg21:20337301
`lg25:20337307
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`2'
`:=
`
`N
`~CIO
`N
`
`0 ....
`....
`
`TABLE 3
`
`300
`
`200
`
`100
`
`FIG.6(b)
`
`('D
`('D
`
`rFJ =(cid:173)
`.....
`CIO
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`

`
`27±0.2
`
`20.5 ±0.2
`
`MAXIMUM
`+0.5
`GRINDING LENGTH 12·5 0
`
`12
`
`8
`
`4
`
`MINIMUM
`RADIUS 0.5
`
`s I
`
`I
`
`I
`
`100
`
`! 00.8 TO 01.00
`
`/
`
`s I f I f t 'j 0Ef I COUPRES~NZON: s: 1
`
`ACCORDING TO D1C2450
`
`\ '
`I
`\
`
`ACCORDING TO D1C2205
`
`TAPER: 3%
`TAPER: 2%
`
`FIG.7(a)
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`~ = :=
`
`N
`QO
`
`~
`
`N
`
`0 ....
`....
`
`rFJ =(cid:173)
`('D a
`\0
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`

`
`GRINDING TOLERANCE: +0.005 +0.035
`
`PROGRESS PITCH
`
`No
`
`.0A
`
`.08
`
`.0C
`
`.0D
`
`.0E
`±0.015 ON TIP
`
`AT 12mm
`
`AT 17mm
`
`.0Fill
`
`SLEEVE
`TAPER COLOR
`LENGTH TIP COLOR CODE RING
`CODE RING & STEPPER
`±0.3
`
`REF. GPAO
`
`I
`
`20
`
`0.20 0.44 0.56
`
`0.64
`
`25
`
`0.25 0.49 0.61
`
`0.69
`
`0.60
`
`0.57
`
`0.87
`
`0.99
`
`0.80
`
`21-25
`
`GRINDING TOLERANCE AFTER VIBRATING: ±0.015
`
`lg21 :20337301
`lg25:20337307
`
`lg21 :20337301
`lg25:20337307
`
`YELLOW
`
`RED
`
`WHITE
`
`DIC0415
`
`DIC0416
`DIC0411
`
`TABLE 1
`
`100
`
`200
`FIG.7(b)
`
`~
`00
`•
`~
`~
`~
`
`~ = ~
`
`~ = :=
`
`N
`QO
`
`~
`
`N
`
`0 ....
`....
`
`rFJ =(cid:173)
`('D a ....
`0
`0 .....
`....
`0
`
`d
`rJl
`-....l
`\c
`0'1
`-....l
`
`0.., = u. = N
`
`

`
`US 7,967,605 B2
`
`1
`ENDODONTIC FILES AND OBTURATOR
`DEVICES AND METHODS OF
`MANUFACTURING SAME
`
`RELATED APPLICATIONS
`
`This application claims the benefit of priority to U.S. Pro(cid:173)
`visional Patent Application Nos. 60/553,792 filed Mar. 16,
`2004, 60/648,099 filed Jan. 28, 2005 and 60/648,167 filed
`Jan. 28, 2005, the disclosures of which are fully incorporated 10
`herein by reference thereto.
`
`FIELD OF THE INVENTION
`
`The present invention relates to endodontic files or drill
`bits, to endodontic obturator devices and to methods of manu(cid:173)
`facturing same, particularly, for the performance of root canal
`surgery.
`
`BACKGROUND
`
`2
`ity-may be pressed against, and thereby cut into, certain
`portions of the inner walls of the canal of the root more
`severely than desired, resulting in the undesired removal of
`the inner walls of the canal of the root in these portions. It is
`typically a goal when performing root canal surgery to mini(cid:173)
`mize the removal of the inner wall of the canal of the root.
`Another step during, e.g., root canal procedures, is to obtu-
`rate or fill the void in the canal after the tissue is removed.
`Conventional obturator devices typically employ a constant
`taper. It is found that most canals of roots do not have a
`constant taper and thus conventional obturator instruments
`bind at the top of the canal. Also, conventional obturator
`devices typically have a conical or circle cross-section. This
`does not allow the flow of excess filler material to move out of
`15 the canal and instead pushes the excess filler material out the
`canal and into the body.
`Thus, there is a need for an endodontic file, or a series of
`endodontic files, that perform satisfactorily when used during
`an endodontic surgical procedure such as a root canal proce-
`20 dure. There is also a need for an endodontic obturator device,
`or a series of endodontic obturator devices, that enable a root
`canal to be filled after an endodontic surgical procedure, such
`as a root canal procedure, has been performed using an endo(cid:173)
`dontic file, or a series of endodontic files, of the present
`25 invention.
`
`The performance of root canal surgery is very common in
`the field of endodontics. One step that is performed during
`root canal surgery is removing tissue from the canal of the
`root of a patient's tooth. While various different methods,
`using various different endodontic files, are conventionally
`employed, typically a series of progressively larger and/or
`differently shaped files or drill bits (for the purposes of this
`application, the terms "file and "drill bit" shall be used inter(cid:173)
`changeably) are successively employed by an endodontist 30
`until a satisfactory amount of tissue has been removed from
`the canal of the root of the tooth.
`There are many different types of endodontic files that are
`known in the art or that are currently in the market. However,
`none of these endodontic files, either when used separately or
`in combination with each other, perform satisfactorily. For
`instance, one of the problems experienced by conventional
`endodontic files is that cutting edges disposed on helical
`flutes of the endodontic files provide less than satisfactory
`removal of tissue from the canal of the root of the tooth. Thus,
`when used in certain portions of the canal of the root of a
`tooth, the files do not adequately remove tissue that is desired
`to be removed.
`Furthermore, another problem that is experienced by con(cid:173)
`ventional endodontic files is that they are prone to break 45
`during use. As conventional endodontic files are rotated
`within the canal of the root of a tooth, friction occurs between
`the outer diameter of the file and the inner wall of the canal of
`the root, causing the file to experience torque forces. The
`frictional forces are especially experienced by endodontic
`files because endodontic files are employed in canal of the
`roots of teeth, which are uneven in shape and may curve
`significantly in several directions. Furthermore, these fric(cid:173)
`tional forces are exacerbated when tissue becomes clogged
`within the helical flutes and tissue is unable to be moved out 55
`of the root canal, causing the file to experience still further
`torque forces. These torque forces, if sufficiently large, may
`cause the file to break in the canal of the root. When a file
`breaks within an canal of the root, extracting the broken file
`therefrom may be very problematic.
`Still further, another problem that is experienced by con(cid:173)
`ventional endodontic files is that they remove not merely
`tissue in the canal of the root that is desired to be removed, but
`in some instances, portions of the inner wall of the canal of the
`root that are not desired to be removed. Because of the uneven
`shape and significant curvature of the canal of the root, con(cid:173)
`ventional endodontic files-by virtue of their limited flexibil-
`
`SUMMARY
`
`The present invention, according to the various embodi(cid:173)
`ments described hereinbelow, may relate to an endodontic
`file, a set of endodontic files, a method of manufacturing an
`endodontic file and a method of manufacturing a set of endo(cid:173)
`dontic files. It should be understood that the present invention
`is intended to cover each of these aspects. For instance, in
`35 accordance with various embodiments, the present invention
`relates to an endodontic file, a set of endodontic files, a
`method of manufacturing an endodontic file and a method of
`manufacturing a set of endodontic files wherein the endodon(cid:173)
`tic file(s) or the manufacturing the file(s) may include or
`40 involve features corresponding to the clearance angle of
`same.
`For example, the endodontic file(s) of the present inven(cid:173)
`tion, such as those manufactured in accordance with the
`methods of the present invention, may comprise:
`1) A file body extending from a tip region to a shank region;
`2) At least one helical flute extending along at least a
`portion of the file;
`3) the at least one helical flute having an up-sharp cutting
`edge without a land, wherein the cutting edge defines a non-
`50 negative clearance angle and/or wherein the cutting edge
`defines a clearance angle less than 35 degrees;
`4) wherein the clearance angle of a single file, or in the case
`of a set at least one file, may vary between the tip region and
`the shank region and/or is less than 35 degrees; and
`5) wherein the clearance angle may be formed by a flat
`relief and/or a radial relief.
`In one embodiment, the series or set of endodontic files has
`at least two files with the same tip diameter. In one embodi(cid:173)
`ment, the series or set of endodontic files has at least two files
`60 with tip diameters that are within 0.025 mm of each other, said
`dimension being considered to be the same tip diameter. In
`one embodiment, the series or set of endodontic files has at
`least two files without the same tip diameter.
`In one embodiment, the series or set of endodontic files has
`65 at least two files with the same taper. In one embodiment, the
`series or set of endodontic files has at least two file with tapers
`at similar portions of the file that are within 0.01 mm/mm of
`
`

`
`US 7,967,605 B2
`
`3
`each other, said dimension being considered to be the same
`taper. In one embodiment, the series or set of endodontic files
`has at least two files without the same taper.
`In various embodiments, the present invention includes
`features corresponding to the cutting edges of the endodontic
`files. For instance, along at least a portion of a cutting edge of
`at least one flute, the clearance angle may be one of <35
`degrees, <25 degrees, <15 degrees and <5 degrees. For each,
`may be constant or may vary in the direction from tip to
`shank. In one embodiment, the clearance angle is 0 degrees 10
`and varies in the direction from tip to shank. In one embodi(cid:173)
`ment, the file has a land and varies in the direction from tip to
`shank.
`The clearance angle may vary linearly or non-linearly
`along at least a portion of a cutting edge of at least one flute.
`The clearance angle may vary in equal or unequal portions
`along at least a portion of a cutting edge of at least one flute.
`The clearance angle may increase in the direction from tip to
`shank. Alternatively, the clearance angle may decrease in the 20
`direction from tip to shank. For instance, the clearance angle
`may decreases linearly or non-linearly along at least a