WO2017208256A1 - Dispositif orthopédique personnalisé et imprimé en 3d à densité variable - Google Patents

Dispositif orthopédique personnalisé et imprimé en 3d à densité variable Download PDF

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Publication number
WO2017208256A1
WO2017208256A1 PCT/IN2017/050207 IN2017050207W WO2017208256A1 WO 2017208256 A1 WO2017208256 A1 WO 2017208256A1 IN 2017050207 W IN2017050207 W IN 2017050207W WO 2017208256 A1 WO2017208256 A1 WO 2017208256A1
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WO
WIPO (PCT)
Prior art keywords
foot
insole
feet
model
orthotic device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IN2017/050207
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English (en)
Inventor
Jiten SAINI
Nitin Gandhi
Jatin SHARMA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shapecrunch Technology Private Ltd
Original Assignee
Shapecrunch Technology Private Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shapecrunch Technology Private Ltd filed Critical Shapecrunch Technology Private Ltd
Publication of WO2017208256A1 publication Critical patent/WO2017208256A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B7/00—Footwear with health or hygienic arrangements
    • A43B7/14—Footwear with health or hygienic arrangements with foot-supporting parts
    • A43B7/28—Adapting the inner sole or the side of the upper of the shoe to the sole of the foot
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/003—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined characterised by the material
    • A—HUMAN NECESSITIES
    • A43—FOOTWEAR
    • A43B—CHARACTERISTIC FEATURES OF FOOTWEAR; PARTS OF FOOTWEAR
    • A43B17/00—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined
    • A43B17/14—Insoles for insertion, e.g. footbeds or inlays, for attachment to the shoe after the upper has been joined made of sponge, rubber, or plastic materials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00—Processes of additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing
    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06T—IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T17/00—Three-dimensional [3D] modelling for computer graphics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • B29C64/106—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material
    • B29C64/118—Processes of additive manufacturing using only liquids or viscous materials, e.g. depositing a continuous bead of viscous material using filamentary material being melted, e.g. fused deposition modelling [FDM]

Definitions

  • the present invention relates to external orthotic devices, in particular, methods and systems for constructing variable density custom foot orthotic models and devices used in relieving and alleviating undesirable conditions of feet.
  • Foot related problems are becoming a common issue all over the world. Structural deformities in the foot can have serious implications on daily activities and lifestyle. About 50% of the adult population worldwide experience restrictions in activities such as exercising, working, and walking due to foot pain. Foot related issues include bunion, corn, calluses, gout, plantar warts, peeling, redness, itching, burning, blisters and sores, Flatfoot (Pes Planus), athlete's foot, plantar fasciitis, verrucas caused by a viral infection found on the soles of the feet or between toes, fallen arches a common complaint in which the arch of the foot collapses and becomes flat such condition cause lot of discomfort to the patients.
  • Orthotics are common treatments used to offer pain relief and stabilize foot deformities, restrict unnecessary motion of the foot and ankle, and relieve areas of excessive pressure.
  • the proper fitting of orthotics is essential because ill-fitting footwear can further introduce deformities in the foot.
  • insoles are used for many other purposes like running, walking, playing cricket and other sports. Foot related problems are found in all age groups and gender. Foot related issues are more prevalent in individuals whose work demand long hours of standing or walking. Women are more vulnerable to foot problems than men, because of sustained use of narrow-fitting shoes that squeeze the toes and from high-heels that cramp the forefoot and pose risks for arch and ankle. Pain in a child's foot or ankle is also becoming common this should never be ignored. It could be due to abnormal gait and should be evaluated by a foot and ankle clinician and corrected immediately through an external orthotic device.
  • the region of support may be a profiled region designed to support the foot and provide correct positioning of the foot.
  • the region of relief may be a soft/cushioned region aimed to reduce a force applied to a specific region of a patient's foot so as to relieve pain.
  • a foot orthosis may be used to support a foot post surgery, to improve gait of a user, and/or to provide relief from conditions such as pressure ulcers.
  • a first aspect of the invention provides a method of manufacturing an orthosis comprising: providing electronic 3D data defining dimensions and shape of an orthosis.
  • the 3D data also demarcates region in need of softening/cushioning or hardening for support according to user or clinicians input.
  • the 3D data includes both a region of support and or relief.
  • the region of support may be a profiled region designed to support the foot to different levels and provide correct positioning of the foot.
  • the region of relief may be a soft/cushioned region aimed to reduce a force applied to a specific region of a patient's foot so as to relieve pain.
  • This 3D data is uploaded onto a 3D printer to get the finished product.
  • Another aspect of the invention involves the blending of 3D printing technology with knowledge of skilled clinician and orthosis designer.
  • the inventors have realised that 3D printing can be used to form an orthosis. Thereby reducing the time, cost and labour intensiveness of the manufacture of the orthosis compared to conventional manufacturing methods. 3D printing also negates the need for finishing operations such as grinding. Further, utilising 3Dprinting enables greater design freedom and customisation enabling features to be added to the orthosis that would be difficult or impossible to achieve using conventional machining methods.
  • Figure 1 illustrates the side view of an insole depicting if any person is having heel pain, that portion is filled with either a soft material or density of insole material is reduced to make it more soft and extra cushioning is added to it.
  • Figure 2 illustrates the isometric view of an insole depicting, either harder material is used or density of insole material is increased to make the arch support region hard and firm making it proper for arch support.
  • Figure 3 illustrates the cut section of insole at which sheets of glass fibers can be placed and then again printing with the insole material can be started, making it a part of insole and creating a hard and firm insole.
  • Figure 4 illustrates the 3D printing mechanism where infill percentage can be varied over a particular region and density can be varied.
  • a new and improved process and system for manufacturing a variable density orthotic device for an individual is particularly useful for patients having diabetes, such individuals are affected by feet neuropathy. Reducing density at soft or sensitive points of their feet along with cushioning can keep their feet more safe. Similarly, individuals having corns/calluses in their feet, can be benefited by selectively altering the compressibility of a portion of the insole with a layer of cushioning, it can protect that region from external forces and also from getting worse.
  • the insole can be hardened from the arch support area as shown in Figure 2 at point b and the heel area can be softened as shown in Figure 1 at point a and forefoot region and add extra layer of cushioning for better running experience.
  • the insole can be softened at the metatarsal and mid region.
  • the insole can be designed to provide additional support for the ball of the foot, the arch of the foot, and/or the heel of the foot.
  • Varying density of 3D printed material along with adding cushioning layers can enhance the purpose of orthotics. Said printing method can substantially reduce cost of adding extra layers of cushioning. Further, in case of pain affected areas very low thickness of cushioning material can be used.
  • a variable density 3D printed the sole is thin but it is still wearable providing all the comforts which a general insole provides like arch support, heel and forefoot cushioning, pressure distribution and biomechanics correction.
  • Foot related issues include bunion, corn, calluses, gout, plantar warts, peeling, redness, itching, burning, blisters and sores, Flatfoot (Pes Planus), athlete's foot, plantar fasciitis, verrucas caused by a viral infection found on the soles of the feet or between toes, fallen arches a common complaint in which the arch of the foot collapses and becomes flat such condition cause lot of discomfort to the patients.
  • Few more issues with the foot include; raised arch, Morton's neuroma, foot inversion, foot eversion, hammer toes, heel pain, heel spur syndrome, etc.
  • a raised arch may cause other problems such as corns, calluses or heel pains inasmuch as walking pressure is not properly distributed as compared to a normal foot.
  • Other problems such as hammer toes may be caused by the type of footwear that is used, such as high heels or very tight shoes.
  • foot deficiencies may also cause problems or deficiencies in other parts of the body, particularly in the legs and the back of a person.
  • foot Orthoses can be used in multiple applications, including but not limited to: * Optimisation of function -Either for sports or to compensate for congenital or acquired abnormality. For example, to improve gait in a child with Down's syndrome.
  • Prevention of pathology -Orthoses are sometimes used to prevent either a structural change or a specific pathology. For example, to reduce the internal compression in the big toe joint to reduce the risk of degeneration.
  • Treatment of specific active pathology -Orthoses can be used to treat Musculoskeletal pathologies both in the feet and higher up, for example to treat compressive knee osteoarthritis.
  • Treatment of local manifestations of systemic conditions -Orthoses can be used to limit the impact of global conditions such as Rheumatoid Arthritis.
  • Foot orthoses may be used to treat numerous conditions.
  • the type of treatment required dictates the form of the foot orthosis required.
  • Conditions and potential treatments include but are not limited to: Compressive Medial Knee Osteoarthritis. May be treated using an orthotic with a fairly low arch and a full length lateral wedge. Plantar Fasciitis. May be treated using an orthotic with a higher arch and a medial rearfoot wedge. Mortons neuroma. May be treated using a softer orthotic with a dome under the ball of the foot. Child with Down's syndrome and hypermobility. May be treated using a ngid orthotic with a high heel cup and medial and lateral flanges.
  • Adult with rheumatoid arthritis May be treated with an orthotic formed to the shape of a foot but made as a relatively soft device.
  • the invention provides a variable density 3D printed insole is fully customized, built according to a profile of feet of a person and also according to its use case whether it is required for a physical activities or for a particular medical condition like corns/calluses, feet pain, plantar fasciitis or feet neuropathy. Dimensions of feet are extracted from three images of the person's feet and then an electronic 3D model is generated from the images. After that according to the person's need, density of 3D printed material is varied over the complete insole reducing the need of extra cushioning.
  • Each shape and feature in the cushioning structure is determined deliberately either by the user or the computer system. Shapes and features in the cushioning structure can be seamlessly adjusted as needed by the computer system or the user.
  • the process of making customized 3D printed insoles is as follows: three images of person's feet are taken from three different sides: side, bottom and back. Data is extracted from all these images like arch length, arch height, arch contours is extracted from side image, from bottom image- heel diameter, feet width, feet outline and feet contours while from back image of the feet, Achilles tendon deviation is checked from normal. From all this data, an electronic 3D model is generated in the form of hexagonal basic structures similar to a Honey bee cell. In the next step of the method the areas for increased support or compressibility/cushioning are identified and the model of the orthosis is divided into regions according to the level of support or compressibility required using a CAD package.
  • Glass fibres are sometimes used to make the structure firm in case of flexible material.
  • the 3D orthosis model is then exported to a software from which a 3D printer can operate. This will often be software supplied with the relevant 3D printer.
  • the software is then used to add data related to the region of hardness required in the insole based on the user's needs or as per the clinicians prescription. Now the data is exported to fdm based 3D printer where density can be varied over specific regions depending upon the purpose for which insole is needed whether for sports activities or any clinical /medical condition Figure 4.
  • thermoplastic elastomers are used for hardening/softening the insole.
  • Common materials that are used in insoles to improve cushioning energy include thermoplastic rubbers, which are actually a class of copolymers or a physical mix of polymers (usually a plastic and a rubber). It may be foam rubbers such as latex and cellular polymers such as polyethylene (PE), ethylene vinyl acetate (EVA), polyurethane (PU), and polyvinyl chloride (PVC).
  • PE polyethylene
  • EVA ethylene vinyl acetate
  • PU polyurethane
  • PVC polyvinyl chloride
  • Synthetic polymers or rubber when used alone have certain disadvantages e.g Ethylene vinyl acetate (EVA) offers good cushioning and shock absorption, but tends to suffer high compression set, meaning that these properties deteriorate rapidly during wear.
  • Polyethylene (PE) and polyvinyl chloride (PVC) can provide reasonable cushioning and shock absorption but polyethylene (PE), like ethylene vinyl acetate (EVA), suffers high permanent compression set. Latex rubber foams tend to be too soft and “bottom out” under low loads— they offer little cushioning or shock absorption and they primarily serve to protect the foot.
  • Polyurethane (PU) foam and viscoelastic polyurethane's (PUs) offer good cushioning and shock absorption properties.
  • polyurethane's (PUs) can be bulky, lose their properties when wet and are susceptible to creep and fatigue degradation which involves the increase in deformation with time under constant stress, thereby rendering them ineffective.
  • Density at a specific region of the insole is generally changed by changing the infill percentage of the material while it gets condensed layer by layer forming the 3D structure.
  • density of the material can be changed at that point as shown in Figure 4 where density is varied over arch support region.
  • sheet of glass fiber or carbon fiber is used as shown in Figure 3 at plane C to make the structure more firm and strong.

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  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Computer Graphics (AREA)
  • Geometry (AREA)
  • Software Systems (AREA)
  • General Physics & Mathematics (AREA)
  • Theoretical Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Footwear And Its Accessory, Manufacturing Method And Apparatuses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'un dispositif orthopédique à densité variable pour un individu, comprenant une région supplémentaire de densité, de compressibilité, de dureté et de souplesse variables. Le procédé comprend l'imagerie des pieds de côté, par le dessous et de dos, puis l'extraction des données de ces images afin d'obtenir un modèle 3D, généré par logiciel, de la semelle intérieure. Les régions de la semelle intérieure nécessitant un ramollissement ou un durcissement sont sélectionnées et délimitées sur le modèle 3D en fonction du profil du pied. Ce modèle 3D personnalisé de la semelle intérieure est alors importé vers une imprimante 3D. L'imprimante 3D exécute l'impression de la semelle intérieure en une seule pièce en faisant varier la densité de matière au niveau des régions sélectionnées ou requises.
PCT/IN2017/050207 2016-06-03 2017-05-30 Dispositif orthopédique personnalisé et imprimé en 3d à densité variable Ceased WO2017208256A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201611019222 2016-06-03
IN201611019222 2016-06-03

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WO2017208256A1 true WO2017208256A1 (fr) 2017-12-07

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020033997A1 (fr) * 2018-08-14 2020-02-20 Travis Eadie Système de fabrication de semelle intérieure personnalisée
CN111259464A (zh) * 2020-03-02 2020-06-09 重庆嵘安医疗器材有限公司 一种3d打印足部模型数据库的建立方法
EP3952688A4 (fr) * 2019-04-11 2022-12-07 Epione Innovations Inc. Orthèse à densité variable
WO2022257626A1 (fr) * 2021-06-09 2022-12-15 清锋（北京）科技有限公司 Procédé de fabrication de correcteur de pied et correcteur de pied
US11684104B2 (en) 2019-05-21 2023-06-27 Bauer Hockey Llc Helmets comprising additively-manufactured components
US11779821B2 (en) 2014-05-13 2023-10-10 Bauer Hockey Llc Sporting goods including microlattice structures
US11900537B2 (en) 2020-05-25 2024-02-13 Technologies Shapeshift 3D Inc. Method and device for constraining shape deformation of 3D objects
EP4353111A1 (fr) * 2022-10-13 2024-04-17 Christian Tausch Semelle intérieure de chaussure, en particulier semelle intérieure personnalisée et/ou orthopédique, procédé de fabrication d'une semelle intérieure de chaussure et produit programme informatique
US12059366B2 (en) 2018-11-02 2024-08-13 University Of Derby Joint orthosis with resiliently deformable hinge
CN119502315A (zh) * 2025-01-09 2025-02-25 北京航空航天大学 一种评价增材制造矫形鞋垫功能的仿体及其自动构建方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014014977A2 (fr) * 2012-07-18 2014-01-23 Tow Adam P Systèmes et procédés de fabrication de dispositifs multipropriétés personnalisés anatomiquement
WO2015169942A1 (fr) * 2014-05-09 2015-11-12 Materialise N.V. Procédés et appareils de conception de chaussures
WO2016066750A1 (fr) * 2014-10-31 2016-05-06 Rsprint N.V. Conception de semelle intérieure

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014014977A2 (fr) * 2012-07-18 2014-01-23 Tow Adam P Systèmes et procédés de fabrication de dispositifs multipropriétés personnalisés anatomiquement
WO2015169942A1 (fr) * 2014-05-09 2015-11-12 Materialise N.V. Procédés et appareils de conception de chaussures
WO2016066750A1 (fr) * 2014-10-31 2016-05-06 Rsprint N.V. Conception de semelle intérieure

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11779821B2 (en) 2014-05-13 2023-10-10 Bauer Hockey Llc Sporting goods including microlattice structures
US11794084B2 (en) 2014-05-13 2023-10-24 Bauer Hockey Llc Sporting goods including microlattice structures
US11844986B2 (en) 2014-05-13 2023-12-19 Bauer Hockey Llc Sporting goods including microlattice structures
WO2020033997A1 (fr) * 2018-08-14 2020-02-20 Travis Eadie Système de fabrication de semelle intérieure personnalisée
US12059366B2 (en) 2018-11-02 2024-08-13 University Of Derby Joint orthosis with resiliently deformable hinge
EP3952688A4 (fr) * 2019-04-11 2022-12-07 Epione Innovations Inc. Orthèse à densité variable
US11684104B2 (en) 2019-05-21 2023-06-27 Bauer Hockey Llc Helmets comprising additively-manufactured components
US12369668B2 (en) 2019-05-21 2025-07-29 Bauer Hockey Llc Helmets comprising additively-manufactured components
CN111259464A (zh) * 2020-03-02 2020-06-09 重庆嵘安医疗器材有限公司 一种3d打印足部模型数据库的建立方法
US11900537B2 (en) 2020-05-25 2024-02-13 Technologies Shapeshift 3D Inc. Method and device for constraining shape deformation of 3D objects
WO2022257626A1 (fr) * 2021-06-09 2022-12-15 清锋（北京）科技有限公司 Procédé de fabrication de correcteur de pied et correcteur de pied
EP4353111A1 (fr) * 2022-10-13 2024-04-17 Christian Tausch Semelle intérieure de chaussure, en particulier semelle intérieure personnalisée et/ou orthopédique, procédé de fabrication d'une semelle intérieure de chaussure et produit programme informatique
CN119502315A (zh) * 2025-01-09 2025-02-25 北京航空航天大学 一种评价增材制造矫形鞋垫功能的仿体及其自动构建方法

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