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Title:
CUSTOMIZED 3D PRINTED ORTHOTIC DEVICE
Document Type and Number:
WIPO Patent Application WO/2017/208257
Kind Code:
A1
Abstract:
Disclosed is a method of manufacturing a customized 3D printed orthotics for an individual built specifically depending upon the feet's profile comprising: Imaging feet from side, bottom and back and generating a 3D model of the insole through computer software without any scanning or casting. The 3D model thus obtained is transferred to a 3D printer adapted to manufacture the custom orthotic in three different layers.

Inventors:
SAINI, Jiten (198/6, Friends Colony, Jalandhar 8, 144008, IN)
GANDHI, Nitin (931A, Sector 21Panchkula, Haryana 2, 134112, IN)
SHARMA, Jatin (1344, Sector 21Panchkula, Haryana 2, 134112, IN)
Application Number:
IN2017/050208
Publication Date:
December 07, 2017
Filing Date:
May 30, 2017
Export Citation:
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Assignee:
SHAPECRUNCH TECHNOLOGY PRIVATE LIMITED (253-F, 3rd Floor Shahpur Jat, New Delhi 9, 110049, IN)
International Classes:
A43B17/00; B29C67/00; G06F17/50; G06T17/00
Foreign References:
CN104647757A2015-05-27
US20040133431A12004-07-08
Attorney, Agent or Firm:
KAPOOR (Department of Microbiology, Maharshi Dayanand University, Rohtak 1, 124001, IN)
Download PDF:
Claims:
What is claimed is:

1. Disclosed is a method of manufacturing a customized 3d printed orthotic device for a individual comprising:

(a) Imaging feet from side, bottom and back;

(b) extracting data from these images to make a 3d model of the insole;

(c) importing 3d model of the insole in to a 3d printer;

(d) printing the insole layers in a single printing process.

2. The method of claim 1, wherein 3d model of the insole is generated through computer software without any scanning or casting through moulds.

3. The method of claim 1, step (d) comprising a 3D printer adapted to manufacture the custom orthotic from the three-dimensional model of the custom foot orthotic.

4. The orthotic device of claim 1, wherein the individual has one or more of the following foot conditions; bunion, corn, calluses, gout, plantar warts, peeling, redness, itching, burning, blisters, sores, flatfoot (pes planus), athlete's foot, plantar fasciitis, verrucas, fallen arches, raised arch, Morton's neuroma, foot inversion, foot eversion, hammer toes, heel pain, heel spur syndrome or any other undesirable foot condition.

5. The orthotic device of claim 1, wherein the individual has one or more of the following objectives: optimization of foot function, to improve gait, prevention of pathology, to reduce the internal compression in the big toe joint, to reduce the risk of degeneration, to treat musculoskeletal pathologies, to treat compressive knee osteoarthritis, to limit the impact of Rheumatoid Arthritis, to treat compressive medial knee osteoarthritis.

6. A method of generating a electronic 3D model of an insole through a computational device comprising:

(a) processing of image data of the side image of feet to work out arch height, length and metatarsal point length from heel end;

(b) processing the bottom image of the feet to carve out feet profile, heel and mid foot diameter;

(c) processing the back image of feet to check the deviation in achilles tendon from the normal.

7. A customized 3d printed orthotic device to suit individual's foot need comprising:

(a) Layerl made up of cellular urethane foam or silicone;

(b) Layer 2 made up of thermoplastic copolymer or nylon material;

(c) Layer 3 lowermost layer made up of ethylene- vinyl acetate EVA.

8. The orthotic device of claim 1 and 7, wherein the computer is adapted to adjust the cushioning of pressure points in one or more regions based on user inputs or patients need.

9. The orthotic device of claim 7 step (b) wherein the thermoplastic copolymer is TPU or TPE.

10. The orthotic device of claim 7 wherein the Zinc Pyrithione is used as an antimicrobial agent in the first layer.

Description:
TITLE:

Customized 3D Printed Orthotic Device

FIELD OF THE INVENTION:

The present invention relates to external orthotic devices, in particular, methods and systems for constructing custom foot orthotic models and devices used in relieving pain and improving biomechanics of the feet.

BACKGROUND:

Feet can contribute to postural and stress problems throughout the rest of the body which can lead to knee, hip, back and even shoulder & neck pain. Foot orthotics is a specially designed medical device that is worn inside a shoe to control abnormal foot function or accommodate painful areas of the foot. Properly designed foot orthotics may compensate for impaired foot function, by controlling abnormal motion across the joints of the foot. The current process for producing a custom orthotic is slow, expensive and subject to flawed results. For example, with respect to a custom insole, a clinician may take an impression of a patient's foot, using either a plaster cast or a foam impression (in rare instances, complicated hand-held 3D Scanners are used to digitally perform the same function). The impressions are then sent to an offsite orthotics lab which produces the orthotic by hand using the impression and a basic prescription as a guide. The process usually involves hand casting, vacuum forming, or milling from a solid piece, and subsequent manual assembly of several components, such as padding. The process will often take two weeks or more. The clinician must then test the orthotic on the patient to ensure it functions properly, and accurately reflects the prescription. It is difficult and often impractical to make further modifications to the costly orthotic that would enhance efficacy or comfort for the patient. Traditionally foot orthotics were created from plaster casts made from the patient's foot. These casts were made by wrapping dipped plaster or fiberglass strips around the foot to capture the form, then letting it dry and harden. Once the cast was hardened, the doctor would carefully remove it from the patient's foot and ship it, along with a prescription, to an orthotics lab which would use the negative of the cast to create an orthopedic insert.

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.

Recently, companies have developed digital foot scanners that use specialized software to scan a patient's foot and create a "virtual" cast. These scans are made by having the patient place the foot onto a specialized flat image scanner that uses light and software to capture and create a 3D model. This 3D model is then electronically submitted (along with a prescription) to an orthotics lab, where it is used to program a CNC machine that will ultimately produce the orthopedic insert.

The limitations of the above mentioned techniques include heavy cost involved in setting up the machinery. Being a labor intensive job, that too adds up in the costing of the process. And the process is done manually like taking casts over the plaster, which adds error in the final model of the foot orthotics. And scanning of the feet takes a lot of time. Thus, for solving these limitations we have developed an efficient and accurate process of manufacturing an orthotic device.

SUMMARY:

A first aspect of the invention provides a method of manufacturing an orthotic device comprising: Imaging feet from side, bottom and back and generating a 3D model of the insole through computer software without any scanning or casting. The 3D model thus obtained is transferred to a 3D printer adapted to manufacture the custom orthotic in three different layers. An aspect of the invention involves blending of 3D printing technology with knowledge of skilled clinician and orthotic designer. The inventors have realized that 3D printing can be used to form an orthotic. Thereby reducing the time, cost and labour intensiveness of the manufacture of the orthotic compared to conventional manufacturing methods. 3D printing also negates the need for finishing operations such as grinding. Further, utilising 3D printing enables greater design freedom and customisation according to inputs from user and clinician enabling features to be added to the orthotic that would be difficult or impossible to achieve using conventional machining methods. The customized orthotics is built specifically depending upon the profile of feet of the person.

Another aspect of the invention is to remove the need of heavy scanners and excessive computation while making a 3D model and also removing the traditional methods of manufacturing foot orthotics.

Yet another aspect of this invention is to make the process of manufacturing foot orthotics quick, less labor intensive, economical and environmental friendly.

DETAILED DESCRIPTION OF THE DRAWINGS:

Figure 1 Illustrates the way of capturing first image of feet from side view.

Figure 2 Illustrates the way of capturing second image of feet from bottom view.

Figure 3 Illustrates the way of capturing third image of feet from back view.

Figure 4 Illustrates the way of how the variation in Achilles tendon from normal is scrutinized.

Figure 5 Illustrates the 3D model that is generated from data extracted from images. Figure 6 illustrates the 3D printing of 3D model generated from images.

Figure 7 illustrates an exemplary diagram of the orthotic device with three layers of insole.

DETAILED DESCRIPTION:

The orthotic device of the invention provides greater comfort to the user and affords foot care professionals including podiatrists, orthopedists, pedorthists, physical therapists, chiropractors and their technicians, more rapid achievement of treatment objectives with significant time savings and cost reductions.

In the most preferred embodiment of the invention the procedure of making customized 3D printed insoles from images is as follows: first step of the process involves taking three images of feet sequentially - one from side of the feet (Fig 1), one from bottom (Fig 2) and one from backside of the feet (Fig 3). The first image from side wards captures arch height, length and metatarsal point length from heel end; other image from bottom of the feet helps in carving out feet profile and heel diameter and the backside image of the feet is used to measure and check the deviation in Achilles tendon from the normal position (Fig 4).

Dimensions of feet are extracted from three images of the person's feet and then an electronic 3D model is generated from the images (Fig 5). Following this 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 and then this 3D model is imported to a FDM or SLS type 3D printer for manufacturing the insole (Fig 6). The middle or inner support structure is either made up of a Thermoplastic elastomers/ Thermoplastic polyurethanes TPE/TPU or nylon material, which constitutes the second layer of insole. The third layer or lowermost layer of ethylene-vinyl acetate EVA is used; other material with the same property can also be used. And finally upper layer of PORON or silicone is used; other material with the same property can also be used. Upper layer further comprises an anti-fungal protection and sweat soaking material to secure feet from infections. Antimicrobial agent could be ULTRA-FRESH® by Kroy International Inc., MICROBAN® by Microban Products Company or Zinc Pyrithione. Preferably Zinc Pyrithione is used as an antimicrobial agent in the first layer. After that proper cushioning material is used at heel points and other important pressure points depending upon the person's need and complete insole is prepared. Said 3D printed insole (Fig 7) 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 activity or for a particular medical condition described elsewhere.

In a yet another embodiment of the invention 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). 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. However, 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. In accordance with the present invention there is provided a new and improved process and system for manufacturing an orthotic device for an individual. Said customized 3D printed foot orthotics is particularly useful for finding the overall dimensions of the foot. The dimensions of foot include arch length, arch height and heel diameter. The 3D model is further used in giving arch correction and working out a comfortable depth of heel based on the 3D model. Modifications are made in the 3D model to provide extra cushioning to heel, finding regions of foot blisters giving comfort at that point using upper and lower layer of the orthotic device.

The orthotic device of the invention comprises three layers: a) A first layer of material having a foot-contacting surface layer made from material which preferably will not irritate the bottom of a patient's foot made up of cellular urethane foam (PORON) or silicone b) A second layer of material made up of thermoplastic copolymer or nylon material and, c) A third layer of material made up of ethylene-vinyl acetate EVA, or High Density Polyethylene (HDPE) (Fig 7).

In one of the embodiments of the invention foot Orthotic device can be used in multiple applications, including but not limited to: Optimization 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 -Orthotic device is 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 -Orthotic devices 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 -Orthotic device can be used to limit the impact of global conditions such as Rheumatoid Arthritis.

Foot Orthotic device may be used to treat numerous conditions. The type of treatment required dictates the form of the foot orthotic 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 rear foot 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 hyper mobility. May be treated using a rigid 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.

Specific advantages

This invention of customized 3D printed foot orthotics majors in finding the arch length, arch height and giving arch correction and also finding the heel diameter and giving depth of heel providing cushioning, finding regions of foot blisters giving comfort at that point using upper and lower layer.

This invention overall covers protection, comforting, cushioning, caring and keeping the feet healthy.

Our invention is removing the need of scanners, time saving, more accurate than molds/casts and also with the use of different materials we can solve almost all feet pain problems.

Although this description contains many specifics, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the presently preferred embodiments thereof, as well as the best mode contemplated by the inventors of carrying out the invention. It is to be realized that only preferred embodiments of the invention have been described and that numerous substitutions, modifications and alterations are permissible without departing from the spirit and scope of the invention as defined in the following claims.