Method, system and orthotic insole for producing an orthotic insole or shoe insole

Abstract

A method and apparatus for generating custom manufactured orthotic insoles or shoe inserts for footwear. Information relating to pressure exerted on the human foot bottom is used to custom produce orthotic insoles or shoe inserts for the individual by using softer materials or different structural components selectively located at specific individual's pressure points to relieve pressure on the foot at these points. Pressure readings taken of the individual's foot identify the pressure points of the foot. The pressure points are quantified and the foot is mapped onto a pressure map in a grid format. After mapping, structural components corresponding to specific pressure values are placed in the orthotic insole based on the mapping. The compression unit is made via a 3D printing method based on the individual's pressure readings and results derived using an electronic pressure pad with pressure responsive sensors.

Description

[0001] This application is a divisional application of Chinese patent application No. 201880024470.8, the original application being filed on February 14, 2018, with a priority date of February 14, 2017. The international application number is PCT / US2018 / 018237, and the date of entry into the Chinese national phase was October 11, 2019. The invention is entitled "Method for producing orthotic insoles by 3D printing using foot pressure measurement and material stiffness and / or structure to relieve foot pressure".

[0002] Cross-reference to related applications

[0003] This application is based on and claims priority to U.S. Provisional Application No. 62 / 458,946, filed February 14, 2017, the entire contents of which are incorporated herein by reference. Technical Field

[0004] This invention relates to pedorthics for the prevention and relief of foot problems, and is particularly applicable to orthotic insoles customized for individuals. Background Technology

[0005] Foot problems and related expenses cost millions of dollars. If foot problems weaken certain activities, they can waste hours of work time. Foot problems can stem from medical conditions, work conditions requiring standing or walking, physical activity, and more. Therefore, foot problems can develop due to medical conditions, work activities, or leisure activities.

[0006] Orthography is a technique related to the design, manufacture, fitting, and modification of footwear, orthotic insoles, and foot appliances, designed to help alleviate foot pain or disabling conditions. For those practicing various orthotic techniques, the goal is to provide protection and comfort to the consumer / patient. One of the main methods to achieve this goal is to reduce pressure in the areas of greatest impact. Historically, this has been achieved through orthotic insoles and / or external modifications to footwear.

[0007] A traditional approach to providing protection and comfort to consumers or patients is to cushion the sole of the foot using orthotic insoles or insoles inserted into footwear. Some products also reduce pressure by modifying removable orthotic insoles or insoles, which adapt to the inside of the shoe by removing selected components of the orthotic insole or insole.

[0008] In the prior art, there are generally two methods for manufacturing orthotic insoles. In the first method, a mold is made of the foot to essentially provide a "template" for the final orthotic insole. According to this method, a rigid thermoplastic material is typically heated to soften it, and then the softened thermoplastic material is molded onto the foot mold, causing the thermoplastic material to take the shape of the mold (and thus the shape of the foot), and then it is cooled to harden again. In the second method, a mold is formed from the foot mold, and using well-known injection molding techniques, a heated thermoplastic or thermosetting polymer is typically pressed into the mold cavity, where it cools and hardens to form the shape of the cavity.

[0009] Recently, 3D printing technology has been largely used for the custom production of orthotic insoles or shoe insoles without the aforementioned processing steps of creating a mold, heating thermoplastic material, and then shaping or injecting it into a mold. Instead, data defining the shape of the orthosis is input into a 3D printer to produce a finished product in the same way as any 3D-printed product. However, unlike the present invention, the finished product in the prior art is essentially the same as that produced by the thermoforming process of thermoplastics described in the prior art to produce a rigid insert that fits the user's foot. Commonly assigned U.S. Patent No. 7,493,230 discloses a method and apparatus for generating orthotic insoles or shoe insoles for footwear using information relating to pressure applied by the sole of the foot, the information relating to removable components of the orthotic insole or shoe insole. Embodiments include methods and apparatus for generating orthotic insoles or insoles for footwear, including receiving data corresponding to a pressure map of the foot from a pressure plate; identifying high relative pressure regions exceeding a predetermined relative pressure level within the pressure map; and associating data related to the high relative pressure regions with an orthotic insole or insole comprising a removable orthotic insole or insole component corresponding to the pressure map. In some embodiments, a report of associated data related to the high relative pressure regions is generated. In a further embodiment, the report provides information related to the removable component of the orthotic insole or insole associated with the high relative pressure regions.

[0010] While the aforementioned products and methods result in reduced foot pressure, there is a desire for a method and system in which 3D printing technology can be used to extract pressure information from existing pressure maps and selectively alter the structure and / or material stiffness at selected areas of a custom orthotic insole or shoe insole, thereby enabling personalized orthotic shoes, orthotic insoles, or shoe insoles. Summary of the Invention

[0011] The advantage of this invention is a method and apparatus for generating customized orthotic insoles or shoe insoles. The method and apparatus of this invention use information related to the pressure exerted on the sole of a person's foot to relieve pressure on these points by selectively manufacturing different structural components at pressure points tailored to that individual. In a basic configuration, the structural components may include, for example, individual compression units having a generally compressible lattice structure, i.e., an interlaced structure of compressible material arranged in a regularly repeating three-dimensional configuration, as more fully shown in the figures. Pressure readings acquired for an individual's foot identify pressure points on that foot. In a preferred embodiment, pressure points are quantified and the foot is "mapped" in the form of a grid on a pressure map. After mapping, structural components corresponding to specific pressure values ​​are placed in the orthotic insole based on the mapping. In a preferred embodiment, the compression units are fabricated via a 3D printing method based on individual pressure readings and results obtained using an electronic pressure plate utilizing a pressure-responsive sensor. The object of this invention is to relieve foot pressure in high-pressure areas of the foot by adjusting the stiffness, softness, and / or structure of the orthotic insole material. Attached Figure Description

[0012] Figure 1 This is a basic block diagram of the system according to the present invention; and

[0013] Figure 2 This is a flowchart illustrating the basic steps of the present invention;

[0014] Figure 3 A bottom view of an orthotic insole or shoe insert made according to the method of the present invention is shown;

[0015] Figure 4 A left view is shown of an orthotic insole or shoe insert made according to the method of the present invention;

[0016] Figure 5 A right view is shown of an orthotic insole or shoe insert made according to the method of the present invention;

[0017] Figure 6 A top perspective view of an orthotic insole or shoe insert made according to the method of the present invention is shown;

[0018] Figure 7 The structure of the compression unit is shown in more detail, wherein thirteen compression units are adjacent to each other, typically corresponding to, for example, in... Figure 3 The thirteen-unit configuration shown at the heel section;

[0019] Figure 8 The diagram illustrates a single compression unit;

[0020] Figure 9 and Figure 10 The structure of the compression unit is shown in more detail;

[0021] Figure 11 Twenty-nine individual compression units are shown;

[0022] Figure 12 A single compression unit is shown;

[0023] Figure 13 It shows Figure 12 The internal structure 1204 of the compression unit 310 shown; and

[0024] Figures 14 to 20 Additional examples of configurations of compression units that can be used and are covered by the appended claims are shown, but are not limited to. Detailed Implementation

[0025] The concept upon which this invention is based is to manufacture custom-made orthotic insoles or insoles using 3D printing based on pressure measurements of an individual's foot. In a preferred embodiment, after an individual stands on an electronic pressure plate that uses pressure sensors to receive pressure analysis of their foot, the pressure measurements are mapped to create a data model of the foot. This data model is then fed into a 3D printer to create a custom-made orthotic insole or insole that provides varying degrees of pressure relief to the foot by selectively placing individual compression units within the insole or insole, wherein specific compression units are selected for use at specific locations based on their pressure relief capabilities. Orthotic insoles or insoles that can relieve load and help alleviate high pressure at different locations of the indicated foot can be produced through material structure, material hardness, material softness, or combinations thereof. This invention is not limited to using sensor devices for pressure measurement. That is, any method of obtaining pressure measurements, including but not limited to thermo-pressure measuring devices, or manual methods such as Harris foot embossing machines (e.g., methods of obtaining data and manually inputting it into the system), can be used to obtain pressure measurements and still fall within the scope of the claimed invention.

[0026] Multicolor foot pressure data of the scanned individual is collected by a foot scanner. Using pressure point analysis readings from electronic pressure plates, the readings from each sensor determine the hardness of various areas on the orthotic insole or insole. Softer areas of the orthotic insole or insole relieve pressure at those points to harder areas. This invention quantifies the variation and gradient of foot pressure emitted by a specific foot by assigning and allocating numerical pressure values ​​within a specified range to each pressure reading (by way of example and not limitation, the range can be 1 to 15, where 1 is the lowest pressure and 15 is the highest pressure). Certain areas of the orthotic insole or insole can utilize harder and / or softer materials to accommodate the various pressure readings of an individual's foot. Where foot pressure measurements are higher, the orthotic insole material can be softer to help relieve load and alleviate excessive pressure, transferring pressure to other areas.

[0027] Alternatively (or in addition to altering the hardness or softness of the material), certain areas of orthotic insoles or insoles can be structurally modified (e.g., yield strength, yield parameters, weaving techniques) to respond differently to varying pressures to accommodate higher or lower pressure readings of an individual's foot.

[0028] This invention can utilize the softness, stiffness, and / or material structure of materials, individually or in any combination, to produce orthotic insoles or insoles. Each pressure reading from the sensor is associated with a different structure, stiffness, or combination thereof, thereby directly harmonizing the production of the orthotic insole or insole with the results of foot pressure analysis. This invention converts the CAD (Computer-Aided Design) model of the orthotic insole or insole into a grid of varying sizes (as an example, not a limitation, e.g., a 1cm × 1cm grid; a 1 / 4cm × 1cm grid; etc.), where each individual grid file corresponds to a pressure sensor. Based on this matrix, individual structures at grid locations, or a specified number of different structural combinations, can be created based on the emitted scan data (as an example, not a limitation, there can be a single individual structure at a specific grid location, or 3 different combinations, 6 different combinations, 10 different combinations—the more combinations, the higher the "resolution" of the orthotic insole, and any number of combinations can be utilized, whether small (including a single structure at a single grid location) or large). Each point on the grid is assigned a pressure number, and structures or combinations of structures are placed accordingly at the grid location. After the pressure map data is assigned to individual models within the grid / matrix, the individual models are then identified by their pressure numbers, and a specified number (e.g., 6, 7, 8, ... n) of merged models are created. A specially designed scanning strategy and internal support structure are then assigned to the specified number of pressure models (e.g., 6) to create a pressure response model for the orthotic insole.

[0029] The preferred method for transferring available foot pressure analysis data from an electronic pressure plate to a 3D printer is via stereolithography (STL). Since the 1990s, stereolithography models have been used in medicine to create accurate 3D models of various anatomical regions of a patient based on computer-scanned datasets. An exemplary conventional pressure plate device for implementing this invention is... The pressure plate is available from Aetrex Worldwide in Teaneck, New Jersey. It is used in conjunction with... The system is a digital pressure analysis system that accurately acquires pressure readings from a person's feet. This technology uses a 0.25cm... 2 The pressure sensor can accurately identify which areas of a person's foot absorb the greatest pressure and / or impact when standing.

[0030] When using a pressure plate, a person stands on the pressure plate for 10 to 30 seconds or some other suitable amount of time, and the sensor sends a signal to the computer to plot and visualize the foot. The pressure plate has over 3,700 sensors, but typically only about half of its end contacts the foot. In most cases, each foot encounters 800-1,200 sensors, and the technology provides a reading for each sensor based on the force applied to it, thus creating a "pressure map" of the foot. Similar to a fingerprint, this reading is personalized, and the pressure distribution often varies from person to person.

[0031] According to a preferred embodiment of the invention, a pressure sensor scans the foot, and then stereolithography and a processor are used to process the scan data. The processor is configured to convert the data into input to a 3D printer that produces a custom-designed orthotic insole or insole that can reduce excessive foot pressure where needed based on individual pressure measurements, as described in more detail below. A system and method for obtaining foot pressure analysis data and its mapping to a specific foot are described in U.S. Patent No. 7,493,230, which is incorporated herein by reference in its entirety.

[0032] Under the preferred STL method, the file format will allow the 3D shape to be readable by both the 3D printer software and hardware. The transfer format may require programming adjustments and / or editing, including but not limited to manual adjustments and / or editing, depending on the communication method between the specific 3D printer used and the software components used; that is, the application programming interface (API) it provides for the 3D printer, which may include its subroutine definitions, protocols, and other tools for adjusting and / or creating application software.

[0033] Alternative data transmission formats can be used, including but not limited to manual data transmission.

[0034] Figure 1 This is a basic system diagram illustrating the system of the present invention. From... Figure 1 As can be seen, the pressure sensor 10 used for foot pressure measurement, such as an electronic pressure plate sensor (e.g., an AETREX iStep NOVA foot scanner), is coupled to a processor 12 configured with code according to the present invention. This code causes the processor to perform stereolithography on the data output from the pressure sensor 10 and output 3D printer data, which configures the 3D printer 14 to produce a custom orthotic insole corresponding to the foot pressure measurement performed by the pressure sensor 10.

[0035] Figure 2 It is a description of Figure 1 The flowchart illustrates the steps of the system execution to create a custom orthotic insole or shoe insole. In step 20, a foot is placed on a pressure sensor, and a pressure reading corresponding to the foot is acquired and output to the processor. In step 22, the processor receives the pressure data and uses stereolithography to convert it into 3D printer data, which instructs the 3D printer how to create the custom orthotic insole or shoe insole. In step 24, the 3D printer receives the 3D printer data and creates the custom orthotic insole based on it. The process ends in step 26.

[0036] Now for reference Figure 3-20 The invention describes an orthopedic insole or shoe insole and a method for manufacturing the same. Figure 3-6 The diagram shows a bottom view, left view, right view, and top perspective view of an orthotic insole or shoe insole insert made according to the method of the present invention. For example, in Figure 1As can be seen, the entire orthotic insole or insole insert is made of different types of compression unit structures 302, 304, 306, 308, 310, 312, 314, 316, 318, and 320. According to the invention, each type of compression unit is made with a different structure, and each structure determines the pressure response of each compression unit. For example, as discussed in further detail below, compression unit type 302 utilizes larger, more flexible elements in its structure, making it easier to compress and thus giving it a greater pressure response and a softer “feel” when placed under the foot. In contrast, compression unit type 310 utilizes a smaller, stronger, and more compact structure, making it less compressible and thus giving it a smaller pressure response and a firmer “feel” when placed under the foot. Each of the compression unit structures 302, 304, 306, 308, 310, 312, 314, 316, 318, and 320 is different in some way, such that, in this example, ten different pressure responses can be assigned to various locations on the grid of the orthotic insole to achieve a very precise and high-resolution pressure response across the entire surface of the orthotic insole or insole. It should be understood that these ten compression unit structures are provided for illustrative purposes only, and given the information contained herein, those skilled in the art can develop many other alternative compression unit structures that provide a specific desired pressure response, and all such alternatives and modifications fall within the scope of the invention claimed herein.

[0037] Figure 7 and Figure 8 The structure of the compression unit 302 is shown in more detail. Figure 7 The diagram shows thirteen compression units 302 that are adjacent to each other, which roughly correspond to, for example, in... Figure 3 The configuration of thirteen units is shown at the heel section. Figure 8 A single compression unit 302 is shown. As illustrated, each compression unit 302 includes a generally circular top portion 802, a generally circular bottom portion 804, and, in this example, four generally spiral or coiled flexible elements 806 connecting the circular top portion 802 and the circular bottom portion 804, as shown. In a preferred embodiment, the material used to make the compression unit 302 is an elastic material that can bend but not break when compressed. Examples of such materials include (but are not limited to) TPU (thermoplastic polyurethane), nylon, and TPE (thermoplastic elastomer).

[0038] As can be understood from the above description and accompanying drawings, when a force is applied downwards to the top portion 802, the spiral element 806 deforms in the downward direction, thereby allowing the top portion 802 to move downwards, thus providing a "sponge-like" feel to the sole of the foot. Because the material is elastic, when the pressure on the top portion 802 is reduced downwards, the spiral element 806 biases back towards its rest position, thereby also causing the top portion 802 to move upwards towards its rest position.

[0039] Figure 9 and Figure 10 The structure of the compression unit 306 is shown in more detail. For example... Figure 9 As shown in the optimal configuration, each compression unit 306 comprises a combination of four smaller versions of compression units 302, which are connected together to form a generally square unit, the details of which will be combined with... Figure 10 To provide an optimal description, in this example, each compression unit 306 occupies approximately the same "occupancy space" as each compression unit 302; in other words, four smaller versions of compression unit 302 are connected together to form a single compression unit 306, which occupies substantially the same amount of space as compression unit 302. In a preferred embodiment, the elastic material used for compression unit 302 is also used for compression unit 306 (in fact, for all compression units), so that it is not necessary to use different materials with different elasticity levels, but rather to vary the pressure response based on the structure used rather than the material used. This simplifies the 3D printing process because there is no need to change the material used for 3D printing.

[0040] Those skilled in the art will understand that by using a greater amount of elastic material and a higher structural density in compression unit 306 than in compression unit 302, compression unit 306 will be less easily compressed and therefore has a smaller pressure response than compression unit 302.

[0041] Figure 11-13 The structure of the compression unit 310 is shown in more detail. Figure 11 Twenty-nine individual compression units 310 are shown; Figure 12 A single compression unit 310 is shown, and Figure 13 It shows Figure 12 The internal structure 1204 of the compression unit 310 shown is as follows. Figure 12 As shown, the compression unit 310 includes an external "mesh" structure 1202 connected to and surrounding the polyhedral-shaped internal structure 1204. (As in...) Figure 13 As can be seen from the optimal configuration, the polyhedral internal structure 1204 is a relatively dense structure. Compared to compression units 302 or 306, this relatively dense structure will withstand more downward pressure for compression, and as... Figure 12As shown, when coupled to and surrounded by the external mesh structure 1202, the compressibility of this relatively dense structure is even lower. Compression unit 310 also occupies the same space as a single compression unit 302 or 306.

[0042] Figure 14-20 Additional examples of configurations of compression units that can be used and are covered by the appended claims are shown in a non-limiting manner. As is known in the art, instructions can be given to a 3D printer to create elements of virtually any shape that can be modeled and input into the printer; the compression units described in detail above and shown in the accompanying drawings are provided only as examples, and the claims herein are intended to cover not only the configurations illustrated and described, but also any configuration of compression units that can provide different degrees of pressure response based on their structure and composition.

[0043] It should also be understood that materials with different elasticities can be selectively used throughout the orthotic insole; that is, these materials do not have to be the same for each compression unit. However, if the 3D printer uses a single material for all compression units, it provides a simpler structure.

[0044] Any software steps described herein can be implemented using standard, well-known programming techniques. The novelty of the above embodiments lies not in specific programming techniques, but in the use of the described steps and the various structures, materials, material hardness / softness, etc., disclosed to achieve the described results. The software programming code embodying the invention is typically stored in a permanent storage device. In a client / server environment, such software programming code can be stored using a storage device associated with a server. The software programming code can be embodied on any of a variety of known media used with data processing systems, such as USB drives, DVDs, jump drives, or hard disk drives. The code can be distributed on such media or distributed via some type of network from the memory or storage device of one computer system to another computer system used by a user of another computer system. Techniques and methods for embodying software program code on physical media and / or distributing software code via a network are well-known and will not be discussed further herein.

[0045] It will be understood that each element in the diagram, and combinations of elements in the diagram, can be implemented by a system based on general-purpose and / or special-purpose hardware that performs the specified function or steps, or by a combination of general-purpose and / or special-purpose hardware and computer instructions.

[0046] These program instructions can be provided to the processor to create a machine, such that the instructions, which execute on the processor, form components for implementing the functions specified in the diagram. The processor can execute computer program instructions to perform a series of operational steps to produce a computer-implemented process, such that the instructions, which execute on the processor, provide steps for implementing the functions specified in the diagram. Therefore, Figure 1-2 It supports combinations of components for performing a specified function, combinations of steps for performing a specified function, and program instruction components for performing a specified function.

[0047] While the principles of the invention have been described herein, those skilled in the art will understand that this description is by way of example only and is not intended to limit the scope of the invention. Therefore, the appended claims are intended to cover all modifications of the invention that fall within the true spirit and scope of the invention.

Claims

1. A method for determining a corrective insole, comprising: receiving pressure point data of a foot using a pressure analysis device; generating information for configuring a 3D printing device to print a corrective insole, the corrective insole comprising a plurality of compression units at specific locations of the corrective insole that are related to locations indicated by the pressure point data, each compression unit having a physical structure comprising a lattice structure having flexible connecting elements formed therein, each compression unit being directly connected to and forming a continuous interdependent lattice network with its adjacent compression unit(s) such that pressure applied to one unit disperses weight to all units in the network, wherein at least one compression unit comprises: a circular top portion and an opposite circular bottom portion, such that the circular top portion and the circular bottom portion connect the compression unit to its adjacent compression unit, wherein the circular top portion and the circular bottom portion are interconnected by a plurality of helical or spiral flexible elements, wherein generating the information comprises determining a pressure number for each location indicated by the pressure point data, and wherein each compression unit is selected to correspond to each pressure number such that the lattice structure varies depending on the pressure number.

2. The method of claim 1, further comprising causing the 3D printing device to print the corrective insole based on the information.

3. The method of claim 1, wherein, each pressure number is an integer value within a specified numerical range.

4. The method of claim 1, wherein, printing locations of the corrective insole that are related to pressure point data indicating a higher level of pressure using a material that is softer than a material used in other locations of the corrective insole.

5. The method of claim 1, wherein, the locations within the pressure map are defined by a grid of grid locations having equal dimensions.

6. The method of claim 5, wherein, each compression unit has dimensions that are the same as dimensions of each grid location.

7. The method of claim 1, wherein, a plurality of compression units are combined to make a compression unit combination.

8. The method of claim 1, wherein, different compression unit combinations comprise different physical structures.

9. A corrective insole produced according to the method of any one of claims 1-8.

10. A system for determining a corrective insole, comprising: a foot pressure sensor configured to sense pressure points of a foot placed thereon and generate pressure point data corresponding to the sensed pressure points; a processor coupled to the foot pressure sensor and configured to receive the pressure point data and generate information for configuring a 3D printing device to print a corrective insole, the corrective insole comprising a plurality of compression units at specific locations of the corrective insole that are related to locations indicated by the pressure point data, each compression unit having a physical structure comprising a lattice structure having flexible connecting elements formed therein, each compression unit being directly connected to and forming a continuous interdependent lattice network with its adjacent compression unit(s) such that pressure applied to one unit disperses weight to all units in the network, wherein at least one compression unit comprises: a circular top portion and an opposite circular bottom portion, such that the circular top portion and the circular bottom portion connect the compression cell to its adjacent compression cell, wherein the circular top portion and the circular bottom portion are connected to each other by a plurality of helical or spiral flexible elements, wherein the processor is configured to determine a pressure number for each identified pressure point location within the pressure map, and wherein each compression cell is selected to correspond to each pressure number, such that the lattice structure varies depending on the pressure number.

11. The system of claim 10, further comprising: a 3D printer coupled to the processor to receive the information and configured to form a custom orthotic insole or shoe insert based on the information.

12. An orthotic shoe insole or sockliner comprising compression units placed and adapted to produce a foot bottom pressure response customized to a particular individual's foot, wherein one or more of the compression units have a physical structure comprising a flexible element in a spiral or helical shape, wherein, At least one compression cell includes a mesh structure connected to and surrounding a polyhedral shaped internal structure.

13. The orthotic shoe insole or sock insole of claim 12, wherein, The compression cells are the same size and placed in a grid.

14. The orthotic shoe insole or sock insole of claim 12, wherein, Each compression cell is selected from a compression cell type, and wherein each compression cell type has a different structure indicative of a plantar pressure response.

15. The orthotic shoe insole or sock insole of claim 12, wherein, At least one compression cell includes a circular top portion and a circular bottom portion connected by helical or spiral flexible elements.

16. The orthotic shoe insole or sock insole of claim 12, wherein, The helical or spiral flexible elements are biased to return toward their resting position when a force is applied downward to the compression cell.

17. The orthotic shoe insole or sock insole of claim 12, wherein, At least one compression cell is formed by a combination of compression cells of four smaller versions of a compression cell type connected together to form a substantially square cell.

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