WO1997015250A1

WO1997015250A1 - Foot orthoses supply system

Info

Publication number: WO1997015250A1
Application number: PCT/AU1996/000663
Authority: WO
Inventors: Teena Marie Lomen; Harry Vontelas; Scott Bruce Charles Cameron; Richard Henry Kobylarz; Matthew John Appleton
Original assignee: Peninsula Podiatric Laboratory Holdings Pty. Ltd.
Priority date: 1995-10-20
Filing date: 1996-10-21
Publication date: 1997-05-01

Abstract

A system for providing a foot orthosis for a person includes a scanning and data entry unit (10) which includes a scanner (12) and data entry unit (14). The data entry unit (12) allows patient details and other information to be keyed in. The scanner (12) scans the foot of the person to acquire shape data relating to said foot. The scanner and data entry unit (10) is remote from a central computer (20) and connected to it by a modem (16) and a communications link (18). The computer (20) has database of parameters of a predetermined number of foot orthoses, and a stock of orthoses in accordance with those parameters is kept at a store (22). Upon receipt of data from a foot scan, the computer conducts a comparison of those data with the parameters in the database, and selects the reference parameters which match those data. An orthosis matching that selection is then supplied from the store (22).

Description

FOOT ORTHOSES SUPPLY SYSTEM

This invention relates to foot orthoses, and in particular relates to a system for the provision of accurately-constructed foot orthoses.

A foot orthosis or orthotic is a shaped element adapted to be located in an item of footwear. By means of foot orthoses, podiatrists are able to realign a patient's skeletal structure, thereby ameliorating or preventing problems with feet, legs, knees, pelvises, backs and any other structure or function affected by foot posture.

Some foot orthoses are obtainable "off the shelf" in such locations as sporting goods stores, but there is a restricted size range, and any person requiring an accurate orthotic would find it necessary to consult a podiatrist.

At present, the method of producing foot orthoses for patients is crude, expensive and slow. Currently, a podiatrist makes a plaster cast of the feet of a patient, which is subsequently sent to a podiatric laboratory. At the laboratory, a technician makes a plaster "positive" from the plaster "negative" provided by the podiatrist. The positive is used as a template which is commonly used in a vacuum-forming process to produce an orthosis.

Human error during one or both of the plaster cast making operations may lead to the final orthotic not being as accurately constructed as desirable. In addition, forefoot and heel posts are not able to be moulded in one piece with the orthotic. Furthermore, the "shape memory" of the plastics material which has been vacuum formed to form the orthotic, may in time cause the orthotic to move away from its originally-moulded shape.

It has been suggested that foot parameters be obtained from a contact scan of a person's feet, those parameters being used to produce an orthotic by cutting a shape from a block of material, using modern techniques such as laser cutting.

However, as such a procedure involves great wastage of material the orthoses produced are still too expensive.

It is an object of this invention to provide an improved system and method for the provision of foot orthoses for a person.

The invention provides a system for providing a foot orthosis to a person, said system including scanning means for scanning the foot of said person to acquire shape data relating to said foot, comparison means for comparing said data or parameters created by analysing said data with reference parameters, and selection means for selecting the reference parameters which match or most nearly match those produced from said data.

The invention also provides a method of providing a foot orthosis to a person, including the steps of:

scanning a foot of said person to provide shape data thereon;

comparing said shape data with reference parameters kept in a database; and

selecting the most appropriate reference parameters in said database on the basis of said comparison.

The invention further provides a method of providing a foot orthosis to a person, including the steps of:

creating a database of reference parameters for a predetermined number of foot orthoses;

stocking said predetermined number of foot orthoses;

scanning a foot of said person to provide shape data thereon; comparing said shape data with said reference parameters in said database;

selecting the most appropriate orthosis from said predetermined number thereof on the basis of said comparison;

withdrawing from stock the selected orthosis; and

providing said orthosis to said person.

The invention further provides a method of providing a foot orthosis for a person, including the steps of:

scanning a foot of said person to provide shape data thereon;

comparing said shape data with parameters on a computer database;

selecting the most appropriate orthosis, on the basis of said comparison, from a stock of a predetermined number of orthoses, which orthoses relate to said reference parameters on said database;

withdrawing from stock said most appropriate orthosis; and

carrying out further processing of said most appropriate orthosis to modify said most appropriate orthosis such that it more closely accords with the said data.

The invention also provides a foot orthosis produced by the system or method of any of the preceding four paragraphs.

Fig. 2 is an end elevation of the target frame of the scanning apparatus of Fig. 1 ; and Fig. 3 is a block diagram of an embodiment of the present invention.

Referring firstly to Fig. 3, the foot orthoses production system according to an embodiment of the present invention includes a scanning and data entry unit 10, which is intended to be remotely located at the premises of a podiatrist.

The scanning and data entry unit 10 includes a scanner 12 and a data entry unit 14. The scanner 12 is adapted to measure details of a patient's feet, in manner to be described hereinafter, and the data entry unit 14 permits details of the patient to be keyed in. The measurement details and the keyed-in patient details, and if desired, any other relevant biomechanical, clinical, or other data, are transmitted via a modem 16 through a telecommunications link 18 to a base or host computer 20 situated at a central location. There is also a store 22, containing a stock of orthoses, details of which will be discussed later in this specification. Each host or base station is capable of receiving data from a plurality of remotely-situated scanning and data entry units 10, and in theory only one host computer 20 may be required to service remote scanning and data entry units 10 located throughout the world. Other considerations may dictate that there are in fact a number of host or base stations, even within a single country.

The scanner unit 12 (Figs 1 and 2) includes a base 26, a main housing 28, and a target frame 30. The main housing 28 includes a window 32 on the side facing the target frame 28; the projector module 34 is able to project, through window

32, "stripes" onto the feet (36, 38) of a patient, which feet are located at the target frame 28 and are supported by a cradle 40. It is felt that 64 stripes will be adequate for the system of this embodiment. A video camera 42, preferably of high resolution, is able to record, through window 32, images of the feet 36, 38, which equates to shape data acquisition. A power supply 44 is also provided in housing 28, and preferably the data entry terminal 14 and modem 16 may also be incorporated in the housing. There may also be a printer (not shown) which may be located in the housing or which may be separate therefrom, but connected to the data entry terminal 14. Such a printer may provide a hard copy record for the podiatrist, or for any other person, of any orthotic order, or other data, made using the system of the present invention.

The system operates as follows. A person will attend the premises of a podiatrist, to obtain foot orthoses suitable for the patient's feet. The details of the person will be entered into the system via the data entry terminal 14. The terminal 14 preferably includes a QWERTY keyboard, a numeric keypad and menu selection keys. It preferably will have a backlit LCD display screen, and will operate a microprocessor, (preferably a 68331) operating on proprietary software. The microprocessor is preferably part of the unit 10, and more preferable in located in housing 28. Preferably, there would be a non-volatile RAM to store setup and calibration information.

Once an operator has entered the details of the patient, and any other relevant data, into the system via the terminal 14 - and that information may include additional information provided by a podiatrist, in relation to special features to be included in an orthotic, such as a angle of a post - measurement of the patient's feet may then be carried out. The operator places the patient's feet 36,38 on the cradle 40, and then press a key to commence data acquisition. It is anticipated that acquisition will take less than one second. After data acquisition, the operator will press a key to transmit the data and the patient data previously keyed in by the operator, through the auto-dial modem 16 and telephone line 18 to the central computer 20. As has been stated, the optional printer allows for the podiatrist to keep a hard copy record of every scanning/order transaction. Desirably, the record also includes a report that the data transfer had been successful.

Other data may also be sent by the practitioner to the central computer 20, and may be used as part of the selection criteria for the appropriate orthosis. Such other data may include clinical data such as foot type, and measurements of the foot commonly taken to make decisions on what sort of orthosis to use. It may also or alternatively include gait data such as supinated/pronated gait, and/or data obtained from other biomechanical measurement tools such as force plates, pressure sensors, three-dimensional gait analysis systems and so on.

The central computer has a database which includes data relating to a predetermined number of foot orthoses, which orthoses are kept in the store 22, and which have been injection moulded in accordance with the data kept on the database. It is felt that approximately 1 ,000 different orthoses will be sufficient to cater for the needs of the vast majority of patients, and for the majority of footwear styles. The details of each of the 1 ,000 or so orthoses are held on the database of the computer 20, in any suitable form, which may be in the form of parameters derived from scans of a person's feet, as hereinbefore described, or from existing positive casts obtained by conventional means; such casts could be scanned using the system of this invention. The parameters may also be derived from existing custom-made orthoses or prototypes, which again could be scanned, from any other database of foot morphology, from fully CAD generated designs, and from the patient scans discussed hereinbefore. When the data on a patient's feet comes into the computer 20 via the telephone lines from a podiatrist, those data will be analysed to produce a reduced set of parameters, which will characterise each measurement. Those parameters are then compared with entries in the database, and the most appropriate of the stock orthoses are selected, given certain rules for selection. Details of the specific orthoses are transmitted to the store 22, the orthoses obtained from stock kept at the store, and are sent by express post or other means direct to the patient, or to a practitioner or other person such as the proprietor or an employee of a shoe store. Each transaction will generate a report and associated billing information at the central location. The report will contain a recommendation for the required orthotic or orthoses.

It can be seen that with the system of the described embodiment of the invention, a person may be provided with accurate foot orthoses, quickly and cheaply, with minimal assessment time being taken. There is no involvement of human error in the assessment procedure, and accordingly the accuracy of each orthotic may be maintained within strict limits. Furthermore, because each of the stock orthoses derives from one of a selected set of parameters which cater for the vast majority if not all of the foot sizes and shapes, it is possible to mould the orthoses using an injection moulding process. In using such a process, not only are the orthoses able to have integral forefoot and heel posts, and not only will they not suffer from "shape memory" problems, they may be moulded from a variety of materials. Thus, the stock orthotic for a particular set of parameters may be available, for example, in a hard material (such as polycarbonate), a softer material (such as ABS), and in a rubbery material, depending on an assessment of the particular patient's needs.

The initial stock in store 22, or any additional stock, such as that discussed later in this specification, is preferably injection moulded from dies created from the database parameters discussed hereinbefore, or from the external material also discussed earlier.

Whilst the embodiment of the invention has been described in relation to the remote location of scanning and data entry units 10 in podiatrists' premises, it should be noted that such units may be located in sports stores, shoe retailers, department stores and so on. A semi-skilled operator could there carry out scans, and as a result soft orthoses - or any other type of orthoses - could be supplied for the person concerned; soft because if as a result on the non- involvement of a podiatrist the orthotic is not exactly right for the foot concerned, the selection of a softer material would obviate that problem. In such a situation, a selection - probably much smaller than that proposed for the central store discussed hereinbefore - of soft-material or other orthoses could be kept at the store shoe outlet or department store, for substantially immediate sale to the customer. It would also be possible, should a practitioner or outlet choose to do so, to store and dispense orthoses from the remote location, having received information from the host computer 20. Of course, while it is desirable for the host computer to be remote from a number of places where foot scanning takes place, it si not essential, and at least in certain areas the computer 20 may be at the same location as the scanning unit 14, and the same could be true for the store 22, although again is would usually be desirable for it to be at a single remote location.

A second embodiment of the invention envisages a method which allows for the production of what may be termed a more customised orthotic. In the second embodiment, the steps of the first embodiment are followed until that which involves the selection of the most appropriate orthotic for the shape data information obtained by scanning. Thereafter, that most appropriate orthotic, provided that it is not one which is exactly correct for the person's foot, is subjected to further processing in order that it accords more exactly with the shape data obtained from the scan of the person's foot.

The type of further processing may take any suitable form, in relation to the particular material from which the orthotic is formed. It is felt that milling may be appropriate in at least some situations, and depending on the circumstances, it would involve the removal of material from the upper portion of an orthotic. Of course, material may be removed from any part of the orthotic. The further processing could also involve the milling out of a negative form, and the pressing of a heated orthosis over the form, to achieve an orthosis having a shape in accordance with established parameters.

It may be advantageous, in selecting the most advantageous pre-moulded orthotic from stock, that one be selected from which material may be removed to obtain a more exact match, although it is conceivable that the further processing could involve the addition of material, or both the addition and removal of material. With this further processing step, a more complete service may be offered to customers. In other respects, the second embodiment is substantially the same as the first embodiment.

Clearly, a finite range of orthoses is held in stock at store 22. A minimum range of a predetermined size would be used at commencement of the system in any area, and a third embodiment of the invention enables that range to be augmented in response to further information about orthoses in accordance with parameters which over time indicate that a particular orthosis should also be manufactured and added to the stock.

The third embodiment of the invention is related to the system previously described as the first embodiment of the invention. A deficiency in the orthoses stock in store 22 may be identified, and it may not be possible to produce a required orthosis by the method of the second embodiment, or it may be desired to add such an orthosis to the stock. The system of the third embodiment would operate as follows.

Data is constantly being added to the database of computer 20 as a result of the operations previously described in this specification. In the third embodiment, the system may be enhanced such that it would respond to such data to identify any deficiencies in the orthoses stock and indicate in response to a particular frequency of appearance on the database of a particular set of parameters or of a particular range of parameters, conforming with a particularly-shaped orthosis, that a new orthosis in accordance with those parameters or that range should be produced and stocked.

As a result of the identification of the deficiency in the orthoses stock, a new die may then be manufactured in accordance with the parameters or range of parameters, and orthoses produced from that die, and placed in stock. In that way, the stock of orthoses may be constantly augmented. Of course, the database would, on production of the new orthosis, have the fact that the orthosis was now available entered on it.

It can be seen that this invention provides a novel system for producing correct foot orthoses for a particular podiatrist's patient, or other customer, which is cheaper, quicker and provides more accurate orthoses than conventional methods.

The claims form part of the disclosure of this specification.

Claims

1. A system for providing a foot orthosis to a person, said system including scanning means for scanning the foot of said person to acquire shape data relating to said foot, comparison means for comparing said data or parameters created by analysing said data with reference parameters, and selection means for selecting the reference parameters which match or most nearly match those produced from said data.

2. A system according to claim 1 , further including a stock of orthoses, said stock of orthoses containing a plurality of orthoses, each of said plurality of orthoses being in accordance with a respective one of said reference parameters, such that an orthosis in accordance with said reference parameters may be obtained from said stock of orthoses.

3. A system according to claim 1 or claim 2, wherein said orthosis is supplied to said person.

4. A system according to claim 2, wherein an orthosis which most closely matches the shape data is obtained from said stock of orthoses, further including processing means for processing said orthosis to cause it to be even more in accordance with the shape data.

5. A system according to claim 4, wherein said processing may involve milling or otherwise shaping said orthosis.

6. A system according to claim 5, wherein said processing involves the milling or shaping of the upper and/or lower portions of the orthosis, or any other portion thereof.

7. A system according to any preceding claim, wherein said orthosis is produced by injection moulding from a die.

8. A system according to claim 4, wherein said processing involves the milling or shaping of a negative cast of said orthosis, and a heated orthosis is pressed over said milled or shaped negative cast.

9. A system according to any preceding claim, wherein said scanning means is located remote from said comparison means.

10. A system according to claim 9, wherein said scanning means is a non- contact scanner for obtaining shape data in relation to a foot, and wherein there is also data entry means for additional data, and associated computer means, to enable shape data and said other data to be transmitted via a telecommunications line to a central computer, on which central computer there is a database containing said reference parameters.

11. A system according to claim 10, wherein said additional data includes information about said person, and/or clinical data, and/or gait data, and/or data obtained from biomechanical tools.

12. A system according to claim 4, wherein said processing involves milling of a negative cast of said orthosis, and pressing a heated orthosis on said milled cast.

13. A system according to any one of claims 10 to 12, wherein said database is adapted to be augmented as a result of the receipt by said computer of shape data and/or other data, said computer operating such that when a predetermined number of inputs of particular data or a range of data occurs, which do no coincide with reference parameters in said database, said computer issues a report that a new set of parameters requires to be entered in the database.

14. A system according to claim 13, wherein as a result of said new set of parameters being included in said database, orthoses in accordance with said new set of parameters are placed in said stock.

15. An orthosis produced by the system of any one of claims 1 to 14.

16. A method of providing a foot orthosis to a person, including the steps of:

scanning a foot of said person to provide shape data thereon;

comparing said shape data with reference parameters kept in a database; and

17. A method according to claim 16, further including the step of providing an orthosis in accordance with said comparison to said person.

18. A method of providing a foot orthosis to a person, including the steps of:

stocking said predetermined number of foot orthoses;

scanning a foot of said person to provide shape data thereon;

comparing said shape data with said reference parameters in said database;

withdrawing from stock the selected orthosis; and

providing said orthosis to said person.

19. A method of providing a foot orthosis for a person according to claim 16 or claim 18, further including the steps of:

monitoring incoming shape data to said database;

detecting particular shape data parameters which do not accord closely with reference parameters;

noting when said particular shape data parameters reach a predetermined number; and

reporting that fact.

20. A method according to claim 19, further including the step of creating a new set of reference parameters in accordance with said particular shape data parameters.

21. A method according to claim 20, further including the steps of causing a die to be created in accordance with said new set of reference parameters, producing an orthosis from said die, and adding said orthosis to said stock of orthoses.

22. A method of providing a foot orthosis for a person, including the steps of:

scanning a foot of said person to provide shape data thereon;

comparing said shape data with parameters on a computer database;

withdrawing from stock said most appropriate orthosis; and carrying out further processing of said most appropriate orthosis to modify said most appropriate orthosis such that it more closely accords with the said data.

23. A method according to any one of claims 16 to 21 , alternatively including the step of utilising said database of reference parameters to construct a die, which may then be used in an injection moulding process to produce an orthosis.

24. A method according to any one of claims 16 to 23, wherein said database of reference parameters includes additional data.

25. A method according to any one of claims 16 to 24, wherein other data additional to said shape data is used in said comparison and selection steps.

26. A method according to claim 25, wherein said other data includes clinical and/or biomechanical data.

27. A method according to any one of claims 16 to 26, wherein said database is remote from said scanning step.

28. A method according to any one of claims 16 to 27, wherein said stock of orthoses is remote from said scanning step.

29. A method according to claim 22, including the further step of supplying said modified most appropriate orthoses to said person.

30. A foot orthosis produced by the method of any one of claims 16 to 29.