US20190009318A1 - Method for manufacturing a metal insert for a collar device - Google Patents

Method for manufacturing a metal insert for a collar device Download PDF

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Publication number
US20190009318A1
US20190009318A1 US16/027,663 US201816027663A US2019009318A1 US 20190009318 A1 US20190009318 A1 US 20190009318A1 US 201816027663 A US201816027663 A US 201816027663A US 2019009318 A1 US2019009318 A1 US 2019009318A1
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Prior art keywords
metallic
unit
collar
flat
blank
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US16/027,663
Inventor
Ryan Nadeau
Sal Perfetto
Roger Moore
Thomas Gedge Williams
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Springfield Spring Corp
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Springfield Spring Corp
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Priority to US16/027,663 priority Critical patent/US20190009318A1/en
Assigned to Springfield Spring Corporation reassignment Springfield Spring Corporation ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MOORE, ROGER, NADEAU, RYAN, PERFETTO, SAL, WILLIAMS, THOMAS GEDGE
Publication of US20190009318A1 publication Critical patent/US20190009318A1/en
Abandoned legal-status Critical Current

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21DWORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D11/00Bending not restricted to forms of material mentioned in only one of groups B21D5/00, B21D7/00, B21D9/00; Bending not provided for in groups B21D5/00 - B21D9/00; Twisting
    • B21D11/10Bending specially adapted to produce specific articles, e.g. leaf springs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21DWORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D5/00Bending sheet metal along straight lines, e.g. to form simple curves
    • B21D5/002Positioning devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21DWORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D53/00Making other particular articles
    • B21D53/16Making other particular articles rings, e.g. barrel hoops
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B21MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21DWORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21D53/00Making other particular articles

Definitions

  • One such solution that has been presented is a collar device that an individual can wear on his or her neck that applies pressure on the jugular veins.
  • the brain When an athlete, for example, receives an impact against his or her head, the brain may slosh into the skull, and the impact of this collision of the brain and skull may cause a concussion.
  • a compression force is applied to the jugular vein, blood may flow more slowly from the brain, causing there to be a small, additional amount of blood that stays in the brain.
  • By increasing the amount of blood in the brain it effectively provides an additional cushion in between the brain and the skull, which reduces the likelihood of the brain sloshing into the skull and therefore reduces the likelihood of a traumatic brain injury.
  • the present invention addresses these shortcomings of the art by providing a new and unique process of forming and stress relieving compression springs intended to effect mild compression of the human jugular veins in order to provide a reduced risk of traumatic brain injury by concussive force.
  • the compression spring formed in accordance with the process of the present invention is preferably a metallic spring that is used as an insert in a collar device.
  • the metallic spring is inserted into a collar device so as to be encased in a plastic and/or padded structure that can be of greater comfort to the user.
  • a method of making a metallic spring insert for use in a collar device comprises providing a flat, metallic blank unit, rolling the flat, metallic blank unit into a collar-shaped metallic unit, and stress relieving the collar-shaped metallic unit to form the metallic spring insert.
  • the flat, metallic blank unit has a curved shape including a first end section and a second end section each having a curvature of a first direction, and a center section in between the first end section and the second end section having a curvature of a second direction.
  • the flat, metallic blank unit may have a length between approximately and 150 and 400 millimeters.
  • the method further comprises prior to providing a flat, metallic blank unit, laser cutting a plurality of flat, metallic blank units from a metallic sheet, each of the plurality of flat, metallic blank units uniformly having the curved shape.
  • the method may additionally or alternatively comprise prior to rolling the flat, metallic blank unit into the collar-shaped metallic unit, labeling the flat, metallic blank unit with one or more of a size indicator or a lot identification number.
  • the flat, metallic blank unit is made from 301 stainless steel and has a thickness of between approximately 0.025 inches and 0.032 inches.
  • the method further comprises prior to rolling the flat, metallic blank unit into the collar-shaped metallic unit, inspecting the metallic blank unit to confirm that the metallic blank unit is within one or more size parameters, the one or more size parameters comprising one or more of a length, width and thickness of the metallic blank unit.
  • rolling the flat, metallic blank unit into the collar-shaped metallic unit is performed by an industrial rolling machine configured to receive an input of the one or more predetermined parameters corresponding to one or more intended attributes of the collar-shaped metallic unit and configured to execute a rolling program that is configured to roll the flat, metallic blank unit to a rolled, collar shape according to the input one or more predetermined parameters.
  • the one or more predetermined parameters may comprise one or more of a diameter of the collar-shaped metallic unit, a width of a gap between a first end and a second end of the collar-shaped metallic unit, a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the collar-shaped metallic unit, and a surface profile.
  • stress relieving the collar-shaped metallic unit to form the metallic spring insert comprises placing the collar-shaped metallic unit into a stress relief container, and subjecting the collar-shaped metallic unit to a predetermined temperature for a predetermined length of time.
  • the stress relief container may comprise an aluminum ring having dimensions configured to correspond to dimensions of the collar-shaped metallic unit, and configured to constrain the collar-shaped metallic unit while it is subjected to the predetermined temperature for the predetermined length of time.
  • the predetermined temperature is between 600° F. and 650° F. and the predetermined length of time is between 30 and 90 minutes. In one embodiment of the method, the predetermined temperature is approximately 650° F. and the predetermined length of time is approximately 90 minutes. Stress relieving the collar-shaped metallic unit to form the metallic spring insert further comprises after completion of the predetermined amount of time, removing the metallic spring insert from the stress relief container and cooling the metallic spring insert.
  • the method comprises inspecting the metallic spring insert to determine that the metallic spring insert meets one or more required characteristics after being stress relieved, the one or more required characteristics comprising one or more of a width of a gap between a first end and a second end of the metallic spring insert, a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the metallic spring insert, a surface profile and tensile strength, and wherein inspecting is performed by one or more of a calibrated tensile testing apparatus, a hoop gauge or a pin gauge.
  • the method may further comprise performing a load test on the metallic spring insert using a spring force measurement device to determine if the metallic spring insert meets a predetermined load requirement.
  • the metallic spring insert is configured to be inserted into a collar device to be worn on a user's neck and is configured to effect a mild compression of the user's jugular veins in order to reduce a risk of brain injury by concussive force.
  • the diameter of the collar-shaped metallic unit is between approximately 60 and 150 millimeters
  • the width of the gap between the first end and the second end of the collar-shaped metallic unit is between approximately 10 and 30 millimeters
  • the vertical distance between the bottom-most tip of the first end and the bottom-most tip of the second end of the collar-shaped metallic unit is between approximately 0 and 1.25 millimeters.
  • FIG. 1 shows a flow chart of a process for manufacturing metal inserts in accordance with an embodiment of the invention.
  • FIGS. 2A-2D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a first embodiment of the present invention.
  • FIG. 3A-3D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a second embodiment of the present invention.
  • FIGS. 4A-4D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a third embodiment of the present invention.
  • FIGS. 5A-5D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a fourth embodiment of the present invention.
  • FIGS. 6A-6D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a fifth embodiment of the present invention.
  • FIGS. 7A-7D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a sixth embodiment of the present invention.
  • FIGS. 8A-8D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a seventh embodiment of the present invention.
  • FIGS. 9A-9D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with an eighth embodiment of the present invention.
  • FIGS. 1-9D The present invention will now be described with reference made to FIGS. 1-9D .
  • the present invention relates to a method for fabrication of metal insert components for all sizes of formed collar devices used for medical purposes to prevent head injuries, including for example a NeuroshieldTM product.
  • laser blank metal cut units are visually confirmed, rolled to specification, stress relieved under constraint, inspected to attributes and strength characteristics, verified to conformance, packed and shipped.
  • FIG. 1 illustrates one embodiment of a process for manufacturing the metal inserts for insertion into a collar device.
  • the metallic insert may be made from 301 stainless steel, including, for example, 301 super full hard stainless steel per ASTM A666-15. It is envisioned that other metals may be used in other embodiments of the invention.
  • the metallic inserts can be manufactured from “blanks” having a particular size and shape that are cut from a larger piece of material. As used herein, “blanks” refer to a series of cut forms matching the specified dimensions. For example, a sheet of 301 stainless steel, having a length of approximately ten feet and a width between approximately 4 and 12.25 feet can be provided and blanks can be laser cut from the sheet.
  • the thickness of the stainless steel blank is preferably approximately 0.025′′ (0.635 mm)+/ ⁇ 0.002′′ (0.05 mm) per ASM 2242.
  • Examples of several such blanks 200 , 300 , 400 , 500 , 600 , 700 , 800 , 900 having varying sizes are shown in FIG. 2A (size 11), FIG. 3A (size 12), FIG. 4A (size 13), FIG. 5A (size 14), FIG. 6A (size 15), FIG. 7A (size 16), FIG. 8A (size 17) and FIG. 9A (size 18).
  • the size numbers as used herein refer to the size of the collar device that the metal insert is to be inserted or overmolded into. For example, the “size 12” insert is for use in a collar device of twelve inches.
  • the thickness of the stainless steel blank, and therefore the insert may vary depending on the intended size of the insert. For example, inserts of between 11 and 14 inches may be made from a 0.025 inch thick blank, and inserts of between 15 and 18 inches may be made from a 0.032 inch thick blank.
  • the blanks preferably have a curved shape with multiple curved sections.
  • the blanks 200 , 300 , 400 , 500 , 600 , 700 , 800 , 900 include a convexly curved section on each end of the blank with a concavely curved section in the center of the blank.
  • the remaining portion of the ten feet long flat laser cut material after the blanks have been removed referred to as the “skeleton”, is preferably preserved, in the event there is ever a question regarding the properties of a particular insert cut from a particular sheet.
  • the blanks can be received and inventoried ( 101 ) to begin fabricating the metallic inserts.
  • the flat blanks can be inspected ( 102 a ) to confirm that each blank meets the proper specifications prior to rolling the blank into the metallic insert. For example, if a size 12 metallic insert 310 , as shown in FIGS. 3B-3D is to manufactured, the blank 300 can be inspected to verify the blank 300 has the proper length (e.g., 231.72 mm+/ ⁇ 0.25 mm) and width (e.g., 18 mm+/ ⁇ 0.13 mm in the center of the blank). The inspection can be done using laser equipment for enhanced precision.
  • a blank does not meet the proper specifications, it can be set aside or discarded ( 102 b ).
  • the blanks may be labeled with markings to include the insert size and traceable lot number.
  • the labeling is made on the interior surface of blank 200 , 300 , 400 , 500 , 600 , 700 , 800 , 900 or the interior surface of the insert 210 , 310 , 410 , 510 , 610 , 710 , 810 , 910 , but in alternative embodiments, the labeling can be etched onto the side of the blank that will become outer arc of the formed insert. By labeling the outer arc of the insert, during rolling and over-molding, the size can be easier to see during operation. The location of the etching/labeling does not have a bearing on the fit or function of the insert.
  • the flat blanks that are consistent with the proper specifications are moved to a rolling station for rolling ( 102 a ) the blanks into the collar-shape required for the insert.
  • the rolling equipment may be a programmable industrial roller so as to enable a user to input the particular parameters required for the rolled insert, and execute a rolling program to roll the insert to those parameters.
  • the parameters may include the diameter of the insert, the insert gap, the twist and the surface profile.
  • the insert diameter ( 310 a ) is preferably approximately 83.28 mm+/ ⁇ 0.25 mm.
  • the insert gap ( 310 b ) refers to the distance between the two ends of the blank 300 after the metallic insert 310 has been rolled, and in this particular embodiment, is preferably a maximum of 29.27 mm.
  • the term “twist” refers to the vertical distance between the bottom-most tip of one end of the insert and the bottom-most tip of the other end of the insert.
  • the twist is preferably approximately 0.27 mm+/ ⁇ 1.00 mm.
  • the surface contour is preferably approximately 0.381 mm for each of the inserts 210 , 310 , 410 , 510 , 610 , 710 , 810 , 910 shown in the Figures.
  • the rolled inserts are then subjected to a stress release process ( 103 ).
  • Rolled inserts are placed into a stress relief container (or SRC).
  • the stress relief container includes a size specific dimensional aluminum ring used to constrain a roll-formed insert while being subjected to oven temperatures.
  • a first rolled insert or a small batch of rolled inserts can be subjected to the stress relief process before the other inserts and tested for quality, to confirm the stress relief process parameters are suitable.
  • the inserts After being placed in the aluminum ring, the inserts are stressed relieved in the stress relief containers at a temperature of typically 600° F.-650° F. or more for typically between 30 minutes and 90 minutes. In a preferred embodiment, the stress relief is done at 650° F. for 90 minutes. For larger inserts, a higher temperature and/or time can be utilized.
  • the stress relief containers containing insert rings are removed and cooled, preferably until the stress relief containers are cool to the touch.
  • a final “fit” is performed, in which the insert is twisted to a more uniform condition, as the hand-rolling operation is exact and cannot be validated until semi-automation begins.
  • the metal inserts are inspected ( 104 a ) to ensure that the insert meets the required parameters.
  • a calibrated tensile testing apparatus is utilized to determine physical strength characteristics post stress relief.
  • the measured characteristics include the insert gap, twist, surface profile and tensile strength.
  • the measurement characteristics should be consistent with the parameters previously programmed for the rolling process.
  • the surface profile can be measured using a “hoop” gauge that can capture the insert, which is a circular tool possessing the inner diameter of the injection molding core. There is one hoop for each size of insert. When the insert is placed on the hoop, any free space between the insert and its corresponding hoop can be visually detected.
  • a pin gauge is used to determine that deflection insert-space-to-hoop (e.g., 0.381 mm). In a preferred embodiment, the tensile strength is approximately 250,000 psi. If any insert does not meet the one or more of the required characteristics, it can be removed from the batch ( 104 b ).
  • the inspection ( 104 a ) also includes an inspection for burrs or tool marks. Preferably, any burrs that are present on the insert are removed. Any burr or tool mark on the insert should be less than 10% of the thickness of the metal.
  • a load test ( 106 a ) is also performed on the metal inserts using a spring force measurement device.
  • Each insert has a target load of a compression force equal to 1.50 lb+/ ⁇ 0.25 lb. If any insert does not meet the load requirements, it can be removed from the batch ( 106 b ).
  • the spring force can be incrementally modified to suit desired clinical outcomes.
  • the inserts that have the required characteristics can be surface cleaned ( 107 ), boxed ( 108 ), labeled with bar codes ( 109 ) and shipped ( 110 ) to requirements.
  • FIGS. 2A-9D Examples of metallic blanks and metallic inserts of different sizes formed in accordance with the process of the present invention are shown in FIGS. 2A-9D .
  • FIGS. 2A-2D show a metal blank 200 that is formed into a metal insert 210 for a collar device of a first size (e.g., “size 11”) and the metal insert 210 in accordance with a first embodiment of the present invention.
  • the metal blank 200 may have a length ( 200 a ) of approximately 213.5 to 214 mm and a width in the center ( 200 b ) of approximately 18 mm.
  • the metal insert 210 formed from the metal blank 200 may have various additional approximate dimensions ⁇ (30°), 210 a (77.5 mm), 210 b (38.75 mm), 210 c (29.92 mm), 210 d (14.71 mm), 210 e (0 to 1 mm), 210 f (2.4 mm) and 210 g (3.36 mm).
  • FIGS. 3A-3D show a metal blank 300 that is formed into a metal insert 310 for a collar device of a second size (e.g., “size 12”) and the metal insert 310 in accordance with a second embodiment of the present invention.
  • the metal blank 300 may have a length ( 300 a ) of approximately 231.5 to 232 mm and a width in the center ( 300 b ) of approximately 18 mm.
  • the metal insert 310 formed from the metal blank 300 may have various additional approximate dimensions ⁇ (30°), 310 a (83.28 mm), 310 b (42.28 mm), 310 c (29.27 mm), 310 d (14.5 to 15 mm), 310 e (0.27 to 1.27 mm), 310 f (2.08 mm) and 310 g (3.29 mm).
  • FIGS. 4A-4D show a metal blank 400 that is formed into a metal insert 410 for a collar device of a third size (e.g., “size 13”) and the metal insert 410 in accordance with a third embodiment of the present invention.
  • the metal blank 400 may have a length ( 400 a ) of approximately 253 mm and a width in the center ( 400 b ) of approximately 18 mm.
  • the metal insert 410 formed from the metal blank 200 may have various additional approximate dimensions ⁇ (30°), 410 a (88.77 mm), 410 b (45 mm), 410 c (23 to 28 mm), 410 d (12.7 to 12.9 mm), 410 e (0 to 1 mm), 410 f (2.21 mm) and 410 g (3.69 mm).
  • FIGS. 5A-5D show a metal blank 500 that is formed into a metal insert 510 for a collar device of a fourth size (e.g., “size 14”) and the metal insert 510 in accordance with a fourth embodiment of the present invention.
  • the metal blank 500 may have a length ( 500 a ) of approximately 274.28 mm and a width in the center ( 500 b ) of approximately 18 mm.
  • the metal insert 510 formed from the metal blank 500 may have various additional dimensions ⁇ (30°), 510 a (93.15 mm), 510 b (47.21 mm), 510 c (15.75 to 20.75 mm), 510 d (9.25 mm), 510 e (0 to 1 mm), 510 f (1.99 mm) and 510 g (3.76 mm).
  • FIGS. 6A-6D show a metal blank 600 that is formed into a metal insert 610 for a collar device of a fifth size (e.g., “size 15”) and the metal insert 610 in accordance with a fifth embodiment of the present invention.
  • the metal blank 600 may have a length ( 600 a ) of approximately 290.17 mm and a width in the center ( 600 b ) of approximately 18 mm.
  • the metal insert 610 formed from the metal blank 600 may have various additional approximate dimensions ⁇ (30°), 610 a (105.8 mm), 610 b (53.71 mm), 610 c (38.5 to 43.5 mm), 610 d (20.87 mm), 610 e (0 to 1 mm), 610 f (2.79 mm) and 610 g (3.15 mm).
  • FIGS. 7A-7D show a metal blank 700 that is formed into a metal insert 710 for a collar device of a sixth size (e.g., “size 16”) and the metal insert 710 in accordance with a sixth embodiment of the present invention.
  • the metal blank 700 may have a length ( 700 a ) of 308.5 mm and a width in the center ( 700 b ) of approximately 18 mm.
  • the metal insert 710 formed from the metal blank 700 may have various additional dimensions ⁇ (30°), 710 a (111.75 mm), 710 b (56.69 mm), 710 c (39 to 44 mm), 710 d (21.08 mm), 710 e (0 to 1 mm), 710 f (2.98 mm) and 710 g (3.29 mm).
  • FIGS. 8A-8D show a metal blank 800 that is formed into a metal insert 810 for a collar device of a seventh size (e.g., “size 17”) and the metal insert 810 in accordance with a seventh embodiment of the present invention.
  • the metal blank 800 may have a length ( 800 a ) of 323.5 mm and a width in the center ( 800 b ) of approximately 18 mm.
  • the metal insert 810 formed from the metal blank 800 may have various additional approximate dimensions ⁇ (30°), 810 a (112.88 mm), 810 b (57.25 mm), 810 c (28.25 to 33.25 mm), 810 d (15.59 mm), 810 e (0 to 1 mm), 810 f (3.21 mm) and 810 g (3.81 mm).
  • FIGS. 9A-9D show a metal blank 900 that is formed into a metal insert 910 for a collar device of an eighth size (e.g., “size 18”) and the metal insert in accordance with an eighth embodiment of the present invention.
  • the metal blank 900 may have a length ( 900 a ) of 347.5 mm and a width in the center ( 900 b ) of approximately 18 mm.
  • the metal insert 910 formed from the metal blank 900 may have various additional dimensions ⁇ (30°), 910 a (115.39 mm), 910 b (58.4 mm), 910 c (12.5 to 17.5 mm), 910 d (7.5 mm), 910 e (0 to 1 mm), 910 f (2.5 mm) and 910 g (4.3 mm).
  • the inserts manufactured in accordance with the process of the present invention may possess different dimensions and physical characteristics than the particular dimensions and characteristics shown in the Figures without deviating from the scope of the invention. Additional configurations of the insert can be provided in alternative sizes and to suit different anatomies and physiologies.

Abstract

A method of manufacturing a metallic spring insert for use in a collar device is provided. The method comprises providing a flat, metallic blank unit, rolling the flat, metallic blank unit into a collar-shaped metallic unit, and stress relieving the collar-shaped metallic unit to form the metallic spring insert. The metallic spring is inserted into a collar device so as to be encased or inserted into a collar device to be worn on a user's neck and is configured to effect a mild compression of the user's jugular veins in order to reduce a risk of brain injury by concussive force.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • The present application claims the benefit of U.S. Provisional Patent Application No. 62/528,901, filed Jul. 5, 2017, which is hereby incorporated by reference in its entirety.
  • BACKGROUND OF THE INVENTION
  • The dangers of traumatic brain injury caused by concussive force have emerged as a substantial public health concern over the past decade. Public awareness of the risks presented by playing sports such as hockey, football and soccer for example, has increased. As a result, solutions have been sought that will enable athletes and other individuals who participate in activities that present these risks, to continue these activities while minimizing or eliminating the risk of a traumatic brain injury.
  • One such solution that has been presented is a collar device that an individual can wear on his or her neck that applies pressure on the jugular veins. When an athlete, for example, receives an impact against his or her head, the brain may slosh into the skull, and the impact of this collision of the brain and skull may cause a concussion. If a compression force is applied to the jugular vein, blood may flow more slowly from the brain, causing there to be a small, additional amount of blood that stays in the brain. By increasing the amount of blood in the brain, it effectively provides an additional cushion in between the brain and the skull, which reduces the likelihood of the brain sloshing into the skull and therefore reduces the likelihood of a traumatic brain injury.
  • However, such a collar device is difficult to manufacture. It requires the creation of a spring component that can apply the appropriate amount of pressure to the jugular veins and maintain the appropriate shape and size of the collar that is to be worn by the user, which presents several challenges.
  • SUMMARY OF THE INVENTION
  • The present invention addresses these shortcomings of the art by providing a new and unique process of forming and stress relieving compression springs intended to effect mild compression of the human jugular veins in order to provide a reduced risk of traumatic brain injury by concussive force. The compression spring formed in accordance with the process of the present invention is preferably a metallic spring that is used as an insert in a collar device. The metallic spring is inserted into a collar device so as to be encased in a plastic and/or padded structure that can be of greater comfort to the user.
  • In accordance with the present invention, a method of making a metallic spring insert for use in a collar device is provided. The method comprises providing a flat, metallic blank unit, rolling the flat, metallic blank unit into a collar-shaped metallic unit, and stress relieving the collar-shaped metallic unit to form the metallic spring insert.
  • In accordance with an embodiment of the method, the flat, metallic blank unit has a curved shape including a first end section and a second end section each having a curvature of a first direction, and a center section in between the first end section and the second end section having a curvature of a second direction. The flat, metallic blank unit may have a length between approximately and 150 and 400 millimeters. In a further embodiment of the method of the present invention, the method further comprises prior to providing a flat, metallic blank unit, laser cutting a plurality of flat, metallic blank units from a metallic sheet, each of the plurality of flat, metallic blank units uniformly having the curved shape. The method may additionally or alternatively comprise prior to rolling the flat, metallic blank unit into the collar-shaped metallic unit, labeling the flat, metallic blank unit with one or more of a size indicator or a lot identification number.
  • In accordance with a further embodiment of the method of the present invention, the flat, metallic blank unit is made from 301 stainless steel and has a thickness of between approximately 0.025 inches and 0.032 inches.
  • In accordance with a further embodiment of the method of the present invention, the method further comprises prior to rolling the flat, metallic blank unit into the collar-shaped metallic unit, inspecting the metallic blank unit to confirm that the metallic blank unit is within one or more size parameters, the one or more size parameters comprising one or more of a length, width and thickness of the metallic blank unit.
  • In accordance with a still further embodiment of the method of the present invention, rolling the flat, metallic blank unit into the collar-shaped metallic unit is performed by an industrial rolling machine configured to receive an input of the one or more predetermined parameters corresponding to one or more intended attributes of the collar-shaped metallic unit and configured to execute a rolling program that is configured to roll the flat, metallic blank unit to a rolled, collar shape according to the input one or more predetermined parameters. The one or more predetermined parameters may comprise one or more of a diameter of the collar-shaped metallic unit, a width of a gap between a first end and a second end of the collar-shaped metallic unit, a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the collar-shaped metallic unit, and a surface profile.
  • In accordance with an additional or alternative embodiment of the method of the present invention, stress relieving the collar-shaped metallic unit to form the metallic spring insert comprises placing the collar-shaped metallic unit into a stress relief container, and subjecting the collar-shaped metallic unit to a predetermined temperature for a predetermined length of time. The stress relief container may comprise an aluminum ring having dimensions configured to correspond to dimensions of the collar-shaped metallic unit, and configured to constrain the collar-shaped metallic unit while it is subjected to the predetermined temperature for the predetermined length of time. In certain embodiments of the method, the predetermined temperature is between 600° F. and 650° F. and the predetermined length of time is between 30 and 90 minutes. In one embodiment of the method, the predetermined temperature is approximately 650° F. and the predetermined length of time is approximately 90 minutes. Stress relieving the collar-shaped metallic unit to form the metallic spring insert further comprises after completion of the predetermined amount of time, removing the metallic spring insert from the stress relief container and cooling the metallic spring insert.
  • In accordance with further embodiments of the method of the invention, the method comprises inspecting the metallic spring insert to determine that the metallic spring insert meets one or more required characteristics after being stress relieved, the one or more required characteristics comprising one or more of a width of a gap between a first end and a second end of the metallic spring insert, a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the metallic spring insert, a surface profile and tensile strength, and wherein inspecting is performed by one or more of a calibrated tensile testing apparatus, a hoop gauge or a pin gauge. The method may further comprise performing a load test on the metallic spring insert using a spring force measurement device to determine if the metallic spring insert meets a predetermined load requirement.
  • In accordance with an aspect of the method of the present invention, the metallic spring insert is configured to be inserted into a collar device to be worn on a user's neck and is configured to effect a mild compression of the user's jugular veins in order to reduce a risk of brain injury by concussive force.
  • In accordance with embodiments of the method of the present invention, the diameter of the collar-shaped metallic unit is between approximately 60 and 150 millimeters, the width of the gap between the first end and the second end of the collar-shaped metallic unit is between approximately 10 and 30 millimeters and the vertical distance between the bottom-most tip of the first end and the bottom-most tip of the second end of the collar-shaped metallic unit is between approximately 0 and 1.25 millimeters.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 shows a flow chart of a process for manufacturing metal inserts in accordance with an embodiment of the invention.
  • FIGS. 2A-2D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a first embodiment of the present invention.
  • FIG. 3A-3D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a second embodiment of the present invention.
  • FIGS. 4A-4D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a third embodiment of the present invention.
  • FIGS. 5A-5D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a fourth embodiment of the present invention.
  • FIGS. 6A-6D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a fifth embodiment of the present invention.
  • FIGS. 7A-7D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a sixth embodiment of the present invention.
  • FIGS. 8A-8D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with a seventh embodiment of the present invention.
  • FIGS. 9A-9D show a blank metal unit to be formed into a metal insert for a collar device and the metal insert in accordance with an eighth embodiment of the present invention.
  • DETAILED DESCRIPTION OF THE INVENTION
  • The present invention will now be described with reference made to FIGS. 1-9D.
  • The present invention relates to a method for fabrication of metal insert components for all sizes of formed collar devices used for medical purposes to prevent head injuries, including for example a Neuroshield™ product.
  • Specifically, laser blank metal cut units are visually confirmed, rolled to specification, stress relieved under constraint, inspected to attributes and strength characteristics, verified to conformance, packed and shipped.
  • FIG. 1 illustrates one embodiment of a process for manufacturing the metal inserts for insertion into a collar device.
  • In a preferred embodiment, the metallic insert may be made from 301 stainless steel, including, for example, 301 super full hard stainless steel per ASTM A666-15. It is envisioned that other metals may be used in other embodiments of the invention. The metallic inserts can be manufactured from “blanks” having a particular size and shape that are cut from a larger piece of material. As used herein, “blanks” refer to a series of cut forms matching the specified dimensions. For example, a sheet of 301 stainless steel, having a length of approximately ten feet and a width between approximately 4 and 12.25 feet can be provided and blanks can be laser cut from the sheet. The thickness of the stainless steel blank is preferably approximately 0.025″ (0.635 mm)+/−0.002″ (0.05 mm) per ASM 2242. Examples of several such blanks 200, 300, 400, 500, 600, 700, 800, 900 having varying sizes are shown in FIG. 2A (size 11), FIG. 3A (size 12), FIG. 4A (size 13), FIG. 5A (size 14), FIG. 6A (size 15), FIG. 7A (size 16), FIG. 8A (size 17) and FIG. 9A (size 18). The size numbers as used herein refer to the size of the collar device that the metal insert is to be inserted or overmolded into. For example, the “size 12” insert is for use in a collar device of twelve inches. The thickness of the stainless steel blank, and therefore the insert, may vary depending on the intended size of the insert. For example, inserts of between 11 and 14 inches may be made from a 0.025 inch thick blank, and inserts of between 15 and 18 inches may be made from a 0.032 inch thick blank. As shown in the Figures, the blanks preferably have a curved shape with multiple curved sections. In the embodiments shown in the Figures, the blanks 200, 300, 400, 500, 600, 700, 800, 900 include a convexly curved section on each end of the blank with a concavely curved section in the center of the blank.
  • After the blanks are cut from the sheet, the remaining portion of the ten feet long flat laser cut material after the blanks have been removed, referred to as the “skeleton”, is preferably preserved, in the event there is ever a question regarding the properties of a particular insert cut from a particular sheet.
  • After the flat blanks have been removed from the stainless steel sheet, the blanks can be received and inventoried (101) to begin fabricating the metallic inserts. The flat blanks can be inspected (102 a) to confirm that each blank meets the proper specifications prior to rolling the blank into the metallic insert. For example, if a size 12 metallic insert 310, as shown in FIGS. 3B-3D is to manufactured, the blank 300 can be inspected to verify the blank 300 has the proper length (e.g., 231.72 mm+/−0.25 mm) and width (e.g., 18 mm+/−0.13 mm in the center of the blank). The inspection can be done using laser equipment for enhanced precision. If a blank does not meet the proper specifications, it can be set aside or discarded (102 b). The blanks may be labeled with markings to include the insert size and traceable lot number. In the embodiments shown in FIGS. 2A-9D, the labeling is made on the interior surface of blank 200, 300, 400, 500, 600, 700, 800, 900 or the interior surface of the insert 210, 310, 410, 510, 610, 710, 810, 910, but in alternative embodiments, the labeling can be etched onto the side of the blank that will become outer arc of the formed insert. By labeling the outer arc of the insert, during rolling and over-molding, the size can be easier to see during operation. The location of the etching/labeling does not have a bearing on the fit or function of the insert.
  • The flat blanks that are consistent with the proper specifications are moved to a rolling station for rolling (102 a) the blanks into the collar-shape required for the insert. The rolling equipment may be a programmable industrial roller so as to enable a user to input the particular parameters required for the rolled insert, and execute a rolling program to roll the insert to those parameters. The parameters may include the diameter of the insert, the insert gap, the twist and the surface profile. For the metallic insert 310 shown in FIGS. 3B-3D, the insert diameter (310 a) is preferably approximately 83.28 mm+/−0.25 mm. The insert gap (310 b) refers to the distance between the two ends of the blank 300 after the metallic insert 310 has been rolled, and in this particular embodiment, is preferably a maximum of 29.27 mm. As used herein, the term “twist” refers to the vertical distance between the bottom-most tip of one end of the insert and the bottom-most tip of the other end of the insert. When the formed insert 310 is placed on a flat surface 310, for example, one end of the insert 310 rests on the flat surface but the other end may be elevated off of the flat surface at a particular height, which is referred to as the “twist” or “tip-to-twist”. In the present embodiment for a size 12 insert 310, the twist is preferably approximately 0.27 mm+/−1.00 mm. The surface contour is preferably approximately 0.381 mm for each of the inserts 210, 310, 410, 510, 610, 710, 810, 910 shown in the Figures. After the appropriate parameters have been input, the blanks can be rolled (102 a) into the collar-shaped insert meeting the particular set of parameters.
  • The rolled inserts are then subjected to a stress release process (103). Rolled inserts are placed into a stress relief container (or SRC). The stress relief container includes a size specific dimensional aluminum ring used to constrain a roll-formed insert while being subjected to oven temperatures. In one embodiment of the invention, a first rolled insert or a small batch of rolled inserts can be subjected to the stress relief process before the other inserts and tested for quality, to confirm the stress relief process parameters are suitable.
  • After being placed in the aluminum ring, the inserts are stressed relieved in the stress relief containers at a temperature of typically 600° F.-650° F. or more for typically between 30 minutes and 90 minutes. In a preferred embodiment, the stress relief is done at 650° F. for 90 minutes. For larger inserts, a higher temperature and/or time can be utilized. After the stress relief process is completed, the stress relief containers containing insert rings are removed and cooled, preferably until the stress relief containers are cool to the touch. At the end of the stress relief process, a final “fit” is performed, in which the insert is twisted to a more uniform condition, as the hand-rolling operation is exact and cannot be validated until semi-automation begins.
  • Following the stress relief (103), the metal inserts are inspected (104 a) to ensure that the insert meets the required parameters. A calibrated tensile testing apparatus is utilized to determine physical strength characteristics post stress relief. The measured characteristics include the insert gap, twist, surface profile and tensile strength. The measurement characteristics should be consistent with the parameters previously programmed for the rolling process. The surface profile can be measured using a “hoop” gauge that can capture the insert, which is a circular tool possessing the inner diameter of the injection molding core. There is one hoop for each size of insert. When the insert is placed on the hoop, any free space between the insert and its corresponding hoop can be visually detected. A pin gauge is used to determine that deflection insert-space-to-hoop (e.g., 0.381 mm). In a preferred embodiment, the tensile strength is approximately 250,000 psi. If any insert does not meet the one or more of the required characteristics, it can be removed from the batch (104 b). The inspection (104 a) also includes an inspection for burrs or tool marks. Preferably, any burrs that are present on the insert are removed. Any burr or tool mark on the insert should be less than 10% of the thickness of the metal.
  • A load test (106 a) is also performed on the metal inserts using a spring force measurement device. Each insert has a target load of a compression force equal to 1.50 lb+/−0.25 lb. If any insert does not meet the load requirements, it can be removed from the batch (106 b). The spring force can be incrementally modified to suit desired clinical outcomes.
  • Upon completion of the various tests of the physical characteristics of the metallic inserts, the inserts that have the required characteristics can be surface cleaned (107), boxed (108), labeled with bar codes (109) and shipped (110) to requirements.
  • Examples of metallic blanks and metallic inserts of different sizes formed in accordance with the process of the present invention are shown in FIGS. 2A-9D.
  • FIGS. 2A-2D show a metal blank 200 that is formed into a metal insert 210 for a collar device of a first size (e.g., “size 11”) and the metal insert 210 in accordance with a first embodiment of the present invention. The metal blank 200 may have a length (200 a) of approximately 213.5 to 214 mm and a width in the center (200 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 210 formed from the metal blank 200 may have various additional approximate dimensions Θ (30°), 210 a (77.5 mm), 210 b (38.75 mm), 210 c (29.92 mm), 210 d (14.71 mm), 210 e (0 to 1 mm), 210 f (2.4 mm) and 210 g (3.36 mm).
  • FIGS. 3A-3D show a metal blank 300 that is formed into a metal insert 310 for a collar device of a second size (e.g., “size 12”) and the metal insert 310 in accordance with a second embodiment of the present invention. The metal blank 300 may have a length (300 a) of approximately 231.5 to 232 mm and a width in the center (300 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 310 formed from the metal blank 300 may have various additional approximate dimensions Θ (30°), 310 a (83.28 mm), 310 b (42.28 mm), 310 c (29.27 mm), 310 d (14.5 to 15 mm), 310 e (0.27 to 1.27 mm), 310 f (2.08 mm) and 310 g (3.29 mm).
  • FIGS. 4A-4D show a metal blank 400 that is formed into a metal insert 410 for a collar device of a third size (e.g., “size 13”) and the metal insert 410 in accordance with a third embodiment of the present invention. The metal blank 400 may have a length (400 a) of approximately 253 mm and a width in the center (400 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 410 formed from the metal blank 200 may have various additional approximate dimensions Θ (30°), 410 a (88.77 mm), 410 b (45 mm), 410 c (23 to 28 mm), 410 d (12.7 to 12.9 mm), 410 e (0 to 1 mm), 410 f (2.21 mm) and 410 g (3.69 mm).
  • FIGS. 5A-5D show a metal blank 500 that is formed into a metal insert 510 for a collar device of a fourth size (e.g., “size 14”) and the metal insert 510 in accordance with a fourth embodiment of the present invention. The metal blank 500 may have a length (500 a) of approximately 274.28 mm and a width in the center (500 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 510 formed from the metal blank 500 may have various additional dimensions Θ (30°), 510 a (93.15 mm), 510 b (47.21 mm), 510 c (15.75 to 20.75 mm), 510 d (9.25 mm), 510 e (0 to 1 mm), 510 f (1.99 mm) and 510 g (3.76 mm).
  • FIGS. 6A-6D show a metal blank 600 that is formed into a metal insert 610 for a collar device of a fifth size (e.g., “size 15”) and the metal insert 610 in accordance with a fifth embodiment of the present invention. The metal blank 600 may have a length (600 a) of approximately 290.17 mm and a width in the center (600 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 610 formed from the metal blank 600 may have various additional approximate dimensions Θ (30°), 610 a (105.8 mm), 610 b (53.71 mm), 610 c (38.5 to 43.5 mm), 610 d (20.87 mm), 610 e (0 to 1 mm), 610 f (2.79 mm) and 610 g (3.15 mm).
  • FIGS. 7A-7D show a metal blank 700 that is formed into a metal insert 710 for a collar device of a sixth size (e.g., “size 16”) and the metal insert 710 in accordance with a sixth embodiment of the present invention. The metal blank 700 may have a length (700 a) of 308.5 mm and a width in the center (700 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 710 formed from the metal blank 700 may have various additional dimensions Θ (30°), 710 a (111.75 mm), 710 b (56.69 mm), 710 c (39 to 44 mm), 710 d (21.08 mm), 710 e (0 to 1 mm), 710 f (2.98 mm) and 710 g (3.29 mm).
  • FIGS. 8A-8D show a metal blank 800 that is formed into a metal insert 810 for a collar device of a seventh size (e.g., “size 17”) and the metal insert 810 in accordance with a seventh embodiment of the present invention. The metal blank 800 may have a length (800 a) of 323.5 mm and a width in the center (800 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 810 formed from the metal blank 800 may have various additional approximate dimensions Θ (30°), 810 a (112.88 mm), 810 b (57.25 mm), 810 c (28.25 to 33.25 mm), 810 d (15.59 mm), 810 e (0 to 1 mm), 810 f (3.21 mm) and 810 g (3.81 mm).
  • FIGS. 9A-9D show a metal blank 900 that is formed into a metal insert 910 for a collar device of an eighth size (e.g., “size 18”) and the metal insert in accordance with an eighth embodiment of the present invention. The metal blank 900 may have a length (900 a) of 347.5 mm and a width in the center (900 b) of approximately 18 mm. In an exemplary embodiment, the metal insert 910 formed from the metal blank 900 may have various additional dimensions Θ (30°), 910 a (115.39 mm), 910 b (58.4 mm), 910 c (12.5 to 17.5 mm), 910 d (7.5 mm), 910 e (0 to 1 mm), 910 f (2.5 mm) and 910 g (4.3 mm).
  • The inserts manufactured in accordance with the process of the present invention may possess different dimensions and physical characteristics than the particular dimensions and characteristics shown in the Figures without deviating from the scope of the invention. Additional configurations of the insert can be provided in alternative sizes and to suit different anatomies and physiologies.
  • While there have been shown and described and pointed out fundamental novel features of the invention as applied to preferred embodiments thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices and methods described may be made by those skilled in the art without departing from the spirit of the invention. For example, it is expressly intended that all combinations of those elements and/or method steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. Moreover, it should be recognized that structures and/or elements and/or method steps shown and/or described in connection with any disclosed form or embodiment of the invention may be incorporated in any other disclosed or described or suggested form or embodiment as a general matter of design choice.

Claims (20)

What is claimed:
1. A method of making a metallic spring insert for use in a collar device, comprising:
providing a flat, metallic blank unit,
rolling the flat, metallic blank unit into a collar-shaped metallic unit, and
stress relieving the collar-shaped metallic unit to form the metallic spring insert.
2. The method according to claim 1, wherein the flat, metallic blank unit has a curved shape including a first end section and a second end section each having a curvature of a first direction, and a center section in between the first end section and the second end section having a curvature of a second direction.
3. The method according to claim 2, further comprising, prior to said providing a flat, metallic blank unit, laser cutting a plurality of flat, metallic blank units from a metallic sheet, each of the plurality of flat, metallic blank units uniformly having the curved shape.
4. The method according to claim 1, wherein the flat, metallic blank unit is made from 301 stainless steel and has a thickness of between approximately 0.025 inches and 0.032 inches.
5. The method according to claim 1, further comprising: prior to said rolling the flat, metallic blank unit into the collar-shaped metallic unit, inspecting the metallic blank unit to confirm that the metallic blank unit is within one or more size parameters, the one or more size parameters comprising one or more of a length, width and thickness of the metallic blank unit.
6. The method according to claim 2, further comprising: prior to said rolling the flat, metallic blank unit into the collar-shaped metallic unit, labeling the flat, metallic blank unit with one or more of a size indicator or a lot identification number.
7. The method according to claim 1, wherein rolling the flat, metallic blank unit into the collar-shaped metallic unit is performed by an industrial rolling machine configured to receive an input of the one or more predetermined parameters corresponding to one or more intended attributes of the collar-shaped metallic unit and configured to execute a rolling program that is configured to roll the flat, metallic blank unit to a rolled, collar shape according to the input one or more predetermined parameters.
8. The method according to claim 7, wherein the one or more predetermined parameters comprise one or more of:
a diameter of the collar-shaped metallic unit,
a width of a gap between a first end and a second end of the collar-shaped metallic unit,
a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the collar-shaped metallic unit, and
a surface profile.
9. The method according to claim 1, wherein said stress relieving the collar-shaped metallic unit to form the metallic spring insert comprises:
placing the collar-shaped metallic unit into a stress relief container, and
subjecting the collar-shaped metallic unit to a predetermined temperature for a predetermined length of time.
10. The method according to claim 9, wherein the stress relief container comprises an aluminum ring having dimensions configured to correspond to dimensions of the collar-shaped metallic unit, and configured to constrain the collar-shaped metallic unit while it is subjected to the predetermined temperature for the predetermined length of time.
11. The method according to claim 10, wherein the predetermined temperature is between 600° F. and 650° F. and the predetermined length of time is between 30 and 90 minutes.
12. The method according to claim 10, wherein the predetermined temperature is approximately 650° F. and the predetermined length of time is approximately 90 minutes.
13. The method according to claim 9, wherein said stress relieving the collar-shaped metallic unit to form the metallic spring insert further comprises:
after completion of the predetermined amount of time, removing the metallic spring insert from the stress relief container and cooling the metallic spring insert.
14. The method according to claim 1, further comprising:
inspecting the metallic spring insert to determine that the metallic spring insert meets one or more required characteristics after being stress relieved, the one or more required characteristics comprising one or more of a width of a gap between a first end and a second end of the metallic spring insert, a vertical distance between a bottom-most tip of the first end and a bottom-most tip of the second end of the metallic spring insert, a surface profile and tensile strength,
wherein said inspecting is performed by one or more of a calibrated tensile testing apparatus, a hoop gauge or a pin gauge.
15. The method according to claim 14, further comprising:
performing a load test on the metallic spring insert using a spring force measurement device to determine if the metallic spring insert meets a predetermined load requirement.
16. The method according to claim 1, wherein the metallic spring insert is configured to be inserted into a collar device to be worn on a user's neck and is configured to effect a mild compression of the user's jugular veins in order to reduce a risk of brain injury by concussive force.
17. The method according to claim 1, wherein the flat, metallic blank unit has a length between approximately and 150 and 400 millimeters.
18. The method according to claim 8, wherein the diameter of the collar-shaped metallic unit is between approximately 60 and 150 millimeters.
19. The method according to claim 8, wherein the width of the gap between the first end and the second end of the collar-shaped metallic unit is between approximately 10 and 30 millimeters.
20. The method according to claim 8, wherein the vertical distance between the bottom-most tip of the first end and the bottom-most tip of the second end of the collar-shaped metallic unit is between approximately 0 and 1.25 millimeters.
US16/027,663 2017-07-05 2018-07-05 Method for manufacturing a metal insert for a collar device Abandoned US20190009318A1 (en)

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US3313552A (en) * 1963-10-18 1967-04-11 Hughes Tool Co Belleville spring and seal ring
US4761979A (en) * 1984-05-30 1988-08-09 Mitsubishi Denki Kabushiki Kaisha Roller bending apparatus equipped with a curvature measuring unit
JP2000160235A (en) * 1998-11-19 2000-06-13 Nsk Ltd Method for straightening deformation of ring-like member
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