Method for creating custom orthopedic supports from computerized data inputs

Information

  • Patent Grant
  • 11259951
  • Patent Number
    11,259,951
  • Date Filed
    Friday, November 1, 2019
    5 years ago
  • Date Issued
    Tuesday, March 1, 2022
    2 years ago
  • Inventors
  • Original Assignees
    • (Jupiter, FL, US)
  • Examiners
    • Lin; Jason
    Agents
    • Collard & Roe, P.C.
Abstract
Systems and methods of measuring feet and designing and creating orthopedic inserts are described. A leg length discrepancy of a user is measured and this data, along with foot size are input into a computer. The computer then creates a computer model of a custom shoe insert based on this information. The computer model is then sent to a 3D printer to print the insert. The insert consists of a base insert with partial correction, and several additional layers that are added successively over time until a full correction is obtained. This eliminates any pain associated with a fully corrective insert, and allows the body to adjust gradually to the correction.
Description
BACKGROUND OF THE INVENTION

This product relates to the field of orthopedic inserts for shoes, sneakers and other footwear.


These product lines are typically divided into two categories. One such category is defined by relatively universal insoles that cushion and provide general support. A previous patent discloses the first adjustable insole, in which the bounce of the insole can be controlled by turning a valve. Other products on the market are those such as manufactured under the brand name Dr. Scholl's.


Most of these products tend to be for comfort or support and are universal in use. They are relatively inexpensive.


At the other end of the spectrum are the devices referred to as supports. These are often made by Podiatrists. Podiatrists take imprints and casts of people's feet and then have inserts designed that are made to correct the weight and imprint of the foot. These inserts are often used to correct for leg length discrepancy (LLD). LLD can often lead to scoliosis, a curvature in the spine. For adolescents going through a growth period, it would be desirable to attempt to prevent and/or treat this scoliosis using progressive foot orthotics.


SUMMARY OF THE INVENTION

One aspect of the present invention is a method of assessing a patient's spinal deformity and/or leg length discrepancy and developing an orthopedic insert to correct for this deformity. This insert can then be attached to shoes or other inserts which correct for other foot problems, such as over- or under-pronation, plantar fasciitis, etc. The invention includes measuring the spinal column and/or legs using any desired method, such as by digital X-ray or digital photography, measuring the patient's feet by any suitable method, and manufacturing the orthopedic insert based on the design. In particular, the manufacturing method includes manufacturing a series of graduated inserts that are used over time to gradually correct for the spinal deformity.


The system, in accordance with one aspect of the present invention, includes measuring and analyzing the spinal column and leg length using a digital camera, and communicating the data regarding any spinal deformity or LLD to a computer that then designs an orthopedic insert for printing on a 3D printer. The digital camera takes a photograph of the patient's body, and using software connected to the camera, measures the patient's leg lengths to determine any leg length discrepancy and/or other anatomic irregularities. The software can be commercial software such as those built into iphone by the Apple Measure app or into an Android phone by the Google Measure app, or the software can be a custom designed program that takes these measurements and formats them to be sent directly to a remote computer for processing. The measurement works by analyzing the distance between two designated points in the viewing area. The user sets the points, and the software calculates the distance between the two points. By measuring both legs, the leg length discrepancy can be determined.


The patient's foot size and shape are also measured and input into the computer. The analysis and the making of the orthopedic insert are performed automatically after measuring. The system can be programmed to create a series of graduated inserts that start off with only minor corrective features, and then build up to full correction over time, to minimize pain and hopefully permanently correct any spinal curvature as the adolescent grows.


In a preferred embodiment, the inserts are created as a series of layers on a base insert. For example, the base insert with a first level of correction is printed, and the user will wear that insert for a specified period of time. Then, when further correction is desired, an additional layer is printed, which is then attached to the base insert. Further layers can be added over time until the full correction has been achieved. These layers can be printed out as needed, or a full set of all of the layers can be printed in a single printing process, and the user can then add the layers to the base insert as needed. The insert and layers can be made of the same material, or the base insert can be made of a different material from the additional layers. Any suitable material for making the inserts and layers could be used.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 illustrates the system according to the invention;



FIG. 2 illustrates a series of shoe inserts created with the method according to the invention;



FIG. 3 illustrates a shoe insert created with the method according to the invention;



FIG. 4 illustrates a shoe insert having a layer provided with a layer of adhesive protected by a peel-off backing according to the invention;



FIG. 5 illustrates the method steps for creating a shoe insert according to the invention; and



FIG. 6 illustrates a method of measuring a leg length discrepancy using a camera on a mobile telephone.





DESCRIPTION OF THE EMBODIMENTS

One object of this invention to create a collateral informational base that is immediately capable of altering the manufacture of inserts on a personal basis in an economic way. This can be particularly important since the cost of inserts by podiatrists typically cost hundreds of dollars, for an end product that probably has a cost of goods of only a few dollars. The computerized instructions for the manufacturing of the insert can be transmitted to a foreign country where these inserts can be made by hand or eventually transmitted to machines that can actually create three dimensional moldings that can then be sold to the consumers at a faction of the cost of present inserts sold by Podiatrists.


It is believed that almost 90% of the population has legs of two different sizes. Typically, people with two differently sized legs learn to compensate for this difference by favoring one side. Experts in the field have shown that this is a primary cause of scoliosis, back problems, hip problems as well as pain in later life. This problem can be immediately eliminated using instant 3D foot inserts in accordance with the various aspects of the present invention.


Traditionally, people have gone to podiatrists to make castings, and from these, to make inserts. This process costs several hundred dollars and requires multiple visits. Most people do not go through this effort and expense, unless they have severe problems. However, the chronic problems do not manifest as major problems until later, and are not detected until permanent damages has been done, for example, to the spinal column.


The present invention offers a simple, easy technology based on 3D printers that are connected to a computer platform to instantly read and identify problems with weight distribution and the size of a person's leg to automatically print out a plastic insert with multiple layers to build upon without the need for casts, multiple visits or large expense.


Referring to FIG. 1, one embodiment of the present invention is illustrated. A person 100 has two legs 102 and two feet 104. The length of the legs 102 and the spinal column curvature is measured and determined using a measuring device 106. The measuring device for the legs can be a laser or any other type of measuring device. For example, a simple tape measure could even be used. Digital X-rays could also be used for the LLD as well as spinal column. In one embodiment, the leg lengths are measured using a digital camera that scans the legs and analyzes the view with software that determines a length of each of the legs, and creates a data file with the leg length information. The digital camera can be embodied in a mobile telephone, that contains a processor and a data storage for calculating the leg length. The length of the legs 102 or the discrepancy between the length of the legs, as well as any spinal curvature data is entered into a processor 108 or imported directly from the digital camera or smartphone. Also entered into a processor 108 is the shoe size or foot bed measurements. The foot bed measurements can be taken with molds that are then scanned and input into the processor as well, or simply a shoe size can be entered, if additional foot corrections are unnecessary. The foot bed measurements can also be made by weight bearing digital X-ray devices 115. The user simply stands on the digital X-ray device 115, which takes the X-ray image of the feet and then sends the image to processor 108 where the exact foot shape and size are calculated.


The information concerning the orthopedic inserts are transmitted from the processor 108 to a 3D printer 112, also known as a rapid prototyping machine. The 3D printer then instantly generates the necessary orthopedic insert or inserts 114. Insert 114 is custom made to compensate for the user's leg length discrepancy as well. The method of the present invention can be performed by a technician entering the leg length discrepancy information and shoe model information directly into a computer connected to the 3D printer, or can take place remotely. This information can then be used for configuration of the computer model and sent to the printer for printing the insert. The printer can be directly connected to the server or can be located remotely. In the remote situation, the printer is connected to a processor which processes the information received from the server to configure the insert for printing. The server sends the data over the internet to the processor which then creates the computer model of the insert using the received data.



FIGS. 2 and 3 show the insert 114 according to the invention, and the various layers 116-120 which can be added on to the insert 114 over time. In one situation, insert 114 is printed initially and worn by the user over a period of time. The user then goes back for periodic checks to the doctor or technician that can print out individual layers 115-120, and adhere them to the original insert 114, to provide added correction. The user can continue the visits and checks, adding layers as needed until full correction has been obtained. The doctor can print several different layers, and try them with the patient before attaching the selected layer to the original.


Insert 114 can be provided with a layer of adhesive 115 for attaching it to a shoe. The additional layers can be placed over the base insert or over any part of the sole, even if it is not covered by the base insert.


In another situation, the insert and all layers 116-120 can be printed at once, and the users can add the individual layers 116-120 at their own discretion. As shown in FIG. 4, each layer 116-120 can be provided on a bottom surface with a layer of adhesive 121 protected by a peel-off backing 122. Alternatively, a liquid adhesive (not shown) can be applied to each layer during application.


The layers can be created with any type of correction in mind, and each layer can have a different shape if needed. The computer can be programmed to create an overall system for correction of anatomical defects in accordance with medical guidelines, so that different aspects are treated at different times. For example, the forefoot and arch could be treated in some layers, with more heel lifting occurring in other layers. Alternatively, each layer can be the same and add height in a uniform manner.



FIG. 5 illustrates the method steps according to the invention. In step 10, a user measures a leg length discrepancy and/or spinal curvature using any desired method: tape measure, X-ray, laser, digital camera with associated software, etc. In step 20, the foot shape and size are measured using weight bearing Digital X-ray devices, which the user stands on to accurately measure the foot shape and size. The image taken by the DR device of the user's foot is sent to a computer which calculates the exact shape and size from the image taken. The amount of leg length discrepancy and spinal curvature data is entered into processor 108 by the user in step 30, along with the foot shape/size data and the number of separate insert layers to be created.


In step 40, processor 108 takes the leg length discrepancy data and configures a computer model for a custom insert for the user. This custom insert consists of a base insert plus successive layers to be added over time, resulting finally in a complete insert that offers a full corrective effect.


In step 50, this computer model is then sent to printer 112 for printing the actual insert and separate layers. The printer 112 can be programmed to print only one insert or layer at a time upon individual commands by the operator to the printer, or can be print the base insert with all of the layers in one printing run. In the instance where separate layers are printed individually, the processor stores the information regarding the insert and layers in the database, and keeps track of which layers have already been printed, so the next successive layer is queued up to print upon a command by the operator. Thus, a completely custom insert with successive corrective layers can be made quickly and inexpensively.



FIG. 6 shows the measurement of the leg length discrepancy of the person 100 using a digital camera 115 built in to a mobile telephone 114. Using software built into the mobile telephone, the user selects points 118, 119 in the viewing frame. The distance d between these points equal a length of one leg 102 of the person 100, and the distance between the points is calculated into a number using the software. Both legs are measured, and the leg length discrepancy is calculated as the difference between the two lengths. This software is commercially available to most versions of mobile telephones. Two applications that utilize this method are the Apple Measure app, and the Google Measure app.


While there have been shown, 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 device illustrated and in its operation may be made by those skilled in the art without departing from the spirit of the invention. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.

Claims
  • 1. A method of developing at least one orthopedic insert for footwear used by a person, the method comprising: measuring and analyzing a spinal column and leg length of the person using a digital camera and associated software to convert image data to data indicating measurement length of the spinal column and legs;measuring a foot size and shape of a person using a weight-bearing digital X-ray device that takes an image of the person's foot when the person stands on the device;receiving in a computer the data indicating measurement length of the spinal column and legs; as well as the foot size and shape of the person;designing in the computer via a processor a computer model of an orthopedic insert based on the data input to the computer, the orthopedic insert comprising a base insert having a partial corrective effect and a plurality of separate layers to be applied on top of the base insert, each one of said plurality of separate layers being configured to achieve a further corrective effect when applied on top of the base insert;transmitting the computer model of the orthopedic insert from the computer to a manufacturing device comprising a 3D printer; andmaking the orthopedic insert comprising the base insert and plurality of separate layers with the manufacturing device based on the computer model in a single printing process, applying adhesive to each one of the plurality of separate layers, and applying a peel-off backing to the adhesive on each one of the separate layers, so that the separate layers can be applied to the base layer at later times.
  • 2. The method according to claim 1, wherein the steps of receiving include receiving the data to data indicating measurement length of the spinal column and legs via a transmission over the internet.
  • 3. The method according to claim 1, wherein the step of receiving includes receiving data regarding a number of additional layers to be manufactured for attachment to the base insert.
STATEMENT OF RELATED CASES

This application is a continuation in part of U.S. patent application Ser. No. 15/872,189, filed on Jan. 16, 2018, which is a continuation in part of U.S. patent application Ser. No. 15/252,892, filed on Aug. 31, 2016 (now U.S. Pat. No. 9,910,425), which is a continuation in part of U.S. patent application Ser. No. 14/666,412 filed on Mar. 24, 2015, now abandoned, which is a continuation-in-part of U.S. patent application Ser. No. 14/030,081, filed Sep. 18, 2013 (now U.S. Pat. No. 9,020,626), which is a continuation of U.S. patent application Ser. No. 11/737,454 filed Apr. 19, 2007 (now U.S. Pat. No. 8,583,272), which is a continuation-in-part of U.S. patent application Ser. No. 11/408,769 filed Apr. 21, 2006, now abandoned, all of which are incorporated herein by reference.

US Referenced Citations (71)
Number Name Date Kind
3791375 Pfeiffer Feb 1974 A
3974491 Sipe Aug 1976 A
4517696 Schartz May 1985 A
4647918 Goforth Mar 1987 A
4734034 Maness et al. Mar 1988 A
4745930 Confer May 1988 A
4813436 Au Mar 1989 A
4856993 Maness et al. Aug 1989 A
4862743 Seitz Sep 1989 A
4876758 Rolloff et al. Oct 1989 A
5033291 Podoloff et al. Jul 1991 A
5079949 Tamori Jan 1992 A
5088503 Seitz Feb 1992 A
5237520 White Aug 1993 A
5253656 Rincoe et al. Oct 1993 A
5323650 Fullen et al. Jun 1994 A
5394626 Brown Mar 1995 A
5449002 Goldman Sep 1995 A
5449256 Sundman Sep 1995 A
5593699 Grassi Jan 1997 A
5640779 Rolloff et al. Jun 1997 A
5678448 Fullen et al. Oct 1997 A
5790256 Brown et al. Aug 1998 A
5945610 Galasso Aug 1999 A
6000082 Nyugen Dec 1999 A
6026351 Takeuchi Feb 2000 A
6141889 Baum Nov 2000 A
6195921 Truong Mar 2001 B1
6216545 Taylor Apr 2001 B1
6331893 Brown et al. Dec 2001 B1
6360597 Hubbard, Jr. Mar 2002 B1
6463351 Clynch Oct 2002 B1
6735547 Yfantis May 2004 B1
6804571 Fullen et al. Oct 2004 B2
6823550 Kantro Nov 2004 B2
7008386 Alaimo et al. Mar 2006 B2
7199866 Gogolla et al. Apr 2007 B2
7206718 Cavanagh et al. Apr 2007 B2
7346418 Lowe Mar 2008 B2
7402148 Brewer Jul 2008 B2
D577478 Peveto et al. Sep 2008 S
7617068 Tadin et al. Nov 2009 B2
7661170 Goode et al. Feb 2010 B2
8036768 Lowe Oct 2011 B2
8117922 Xia et al. Feb 2012 B2
8170705 Koelling et al. May 2012 B2
8290739 Tadin et al. Oct 2012 B2
8819961 Ellis Sep 2014 B1
20010047194 Thompson et al. Nov 2001 A1
20030179362 Osawa et al. Sep 2003 A1
20030191554 Russell et al. Oct 2003 A1
20040029639 Regan Feb 2004 A1
20040044296 Linton Mar 2004 A1
20040133431 Udiljak et al. Jul 2004 A1
20040143452 Pattillo et al. Jul 2004 A1
20040168329 Ishimaru Sep 2004 A1
20060017021 Yoda et al. Jan 2006 A1
20070033750 Cook et al. Feb 2007 A1
20070055405 Koelling et al. Mar 2007 A1
20070118243 Schroeder et al. May 2007 A1
20070250287 Spector Oct 2007 A1
20080010861 Kosmas Jan 2008 A1
20080209636 Riley Sep 2008 A1
20100161076 Pallari Jun 2010 A1
20100262239 Boyden et al. Oct 2010 A1
20120148031 Eaves Jun 2012 A1
20120157830 Boyden Jun 2012 A1
20140309692 Mor et al. Oct 2014 A1
20160046074 Jang et al. Feb 2016 A1
20180296343 Wei Oct 2018 A1
20190320995 Amiri Oct 2019 A1
Foreign Referenced Citations (1)
Number Date Country
2 300 919 Nov 1996 GB
Non-Patent Literature Citations (2)
Entry
International Preliminary Report on Patentability and Written Opinion of the International Searching Authority of PCT/US07/67052, dated Apr. 1, 2008.
Gurney, “Review: Leg Length Discrepancy”, 2002, Elsevier, Gait and Posture 15 (2002), pp. 195-206.
Related Publications (1)
Number Date Country
20200060862 A1 Feb 2020 US
Continuation in Parts (6)
Number Date Country
Parent 15872189 Jan 2018 US
Child 16671273 US
Parent 15252892 Aug 2016 US
Child 15872189 US
Parent 14666412 Mar 2015 US
Child 15252892 US
Parent 14030081 Sep 2013 US
Child 14666412 US
Parent 11737454 Apr 2007 US
Child 14030081 US
Parent 11408769 Apr 2006 US
Child 11737454 US