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.
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.
The present invention will now be described with reference made to
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.
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
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 (102a) 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
The flat blanks that are consistent with the proper specifications are moved to a rolling station for rolling (102a) 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
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 (104a) 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 (104b). The inspection (104a) 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 (106a) 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 (106b). 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
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.
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.
Number | Date | Country | |
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62528901 | Jul 2017 | US |