WO2013102748A1

WO2013102748A1 - System for indicating pressure(s) on a foot

Info

Publication number: WO2013102748A1
Application number: PCT/GB2012/000924
Authority: WO
Inventors: Roozbeh NAEMI
Original assignee: Staffordshire University
Priority date: 2012-01-04
Filing date: 2012-12-24
Publication date: 2013-07-11
Also published as: GB2498196A; GB201200101D0

Abstract

A system comprising means to measure or monitor, at one or more locations/regions, the pressure on a foot due to wearing a footwear item, and means to indicate data pertaining to said pressures to the wearer of said footwear item. The system may indicate to the wearer that the wearer would benefit from a change of one or more of said panels, orthotic elements or insoles with respect to a footwear member or said footwear item.

Description

System for indicating pressure(s) on a foot.

This disclosure relates to a system of indicating pressures exerted on a body part such as a foot. In one aspect it concerns a system and methodology for indicating to a wearer of an item of footwear or insole, the pressure sustained in one or more regions of the foot as a result of wearing a footwear item or insole. It is particularly, but not exclusively, concerned with pressures exerted on the sole (i.e. plantar) area of the wearer's foot. The indication of pressure may provide the wearer with diagnosis and/or indication of any problems, such as pressure overloading in particular regions of the foot or an unfavourable pressure distribution. It has particular application to patients who have, or are at risk of, foot problems that may result from overloading of pressures, such as those susceptible to foot ulceration e.g. certain diabetic patients.

The disclosure also relates to a system which can be used in conjunction with a footwear item, or an auxiliary footwear component such as an insole, which can receive one or more interchangeable panels. In one aspect, as a result of pressure measurements, the appropriate or optimum configuration of panels or orthotic members can be determined for the footwear item. Alternatively, the appropriate ready-made insole may be indicated.

Foot ulceration is a medical condition that may occur, e.g., in diabetic patients. It is known that high plantar pressure can be a major risk factor in the development of ulcers which may lead further to amputation. Thus, pressure assessments have become an important component in clinical evaluation and prescription. Monitoring of such pressures in a clinic by experienced medical practitioners provides only a brief time window in respect to the actual loading of the foot over the course of a day. Furthermore, a prescription based on pressure assessment in a clinic cannot provide accurate solutions for foot problems, as such methodology is unable to monitor realistic loading of the foot during typical varying daily activity. Furthermore referrals to clinicians can be infrequent, and so any prescribed insole can lose its effectiveness between consecutive visits.

The disclosure provides a solution to the above stated problems.

The disclosure provides a method and system that allows patients to provide self- diagnosis and provide a prescription for readily configurable insoles that can be assembled by patients themselves, or for non-configurable bespoke insoles.

In one aspect is provided a system comprising means to measure or monitor, at one or more locations/regions, the pressure on a foot due to wearing a footwear item, and means to indicate data pertaining to said pressures to the wearer of said footwear item.

The means to indicate data pertaining to said pressures may comprise means to indicate said data in real-time to the wearer.

The pressure measuring or monitoring means may comprise one or more sensors embedded into or onto a sock, insole, or surface of a footwear item.

The system may include diagnosis and/or prescription means.

The means to indicate data pertaining to said pressures to the wearer may comprise means to indicate to the wearer that the wearer would benefit from a change of one or more panels, orthotic elements or insoles with respect to a footwear member or said footwear item.

The footwear item or footwear member may include a compartmentalised surface allowing insertion or removal of one or more replaceable panels. The footwear member may be integral with, or separate to, said footwear- item. The footwear member may be an insole.

The change may comprise the removal, replacement or addition of one or more panels/orthotic elements to said footwear member/item. The means to indicate said pressures may be provided by an auxiliary device located remote or separate to said pressure measuring monitoring means, and said indication means may comprise visual and/or audio indication means.

The system may include means to analyse said measured/monitored pressures and determine/provide said indication. The system may include means to transmit data pertaining to said pressures or indication wirelessly to said auxiliary device.

The means to indicate may comprise mean to select or indicate for one or more plantar regions, whether the pressure range therefor is fair, cautionary or overloaded. The means to indicate may comprise means to indicate to the wearer suitable or optimum orthotic element(s) or insoles to use for said item of footwear, or what a suitable optimum panel is with respect to one or more of each of compartments of a compartmentalised footwear item/member. The means to indicate may comprise means to indicate to the wearer a suitable insole, one or more orthotic elements for said item of footwear, or what a suitable panel is with respect to one or more of each of compartments of a compartmentalised footwear item/member.

The means to indicate may comprise means to indicate/prescribe a configuration of panels for use for said footwear item/member. The indication of configuration may be the optimum configuration for the wearer.

The data transmission or analysis means may be located or locatable on said footwear item. The data transmission means or said data analysis means may be powered or recharged by movement of the wearer's leg or pressure means.

The indication means may indicate for a panel, orthotic element or insole, its shape, material, resilience and/or density.

In the drawings:

Figure 1 shows a schematic representation of an insole. Figures 2a to 2c show various arrangements, which include the use of a

compartmentalised insole.

Figure 3 shows a schematic representation of a system according to one example

including a remote hand held display device.

Figure 1 shows an insole 10 which is provided with a number of compartments,

numbered 1 to 7. In the example shown there are 7 compartments. Each compartment

is effectively a receptacle which may receive one or more panels (not shown). Thus,

the panels are interchangeable. One or more particular panels can be selected to

provide a particular configuration which may provide an optimum configuration for

the wearer in terms of alleviating pressure overloading on particular areas of the sole

of the foot.

The insole may be provided with an integral surface (e.g. located on the upper or

lower surface of the insole) which is instrumented such that it includes a number of

distributed pressure sensors (not shown in the figure). In alternative examples and

arrangements, means for detecting pressures in regions of the foot (e.g. plantar

regions) can be provided by an array of pressure sensors located elsewhere. These

may be located on the upper surface of the insole of the footwear item (separate to the

insole of the figure) or may be provided by e.g., a sensor embedded sock or sock liner.

The insole may be provided as an insole which can be inserted into an item of

footwear or it may be provided as an integral insole of an item of footwear.

In the figure 2a arrangement, a footwear item such as a shoe or boot 1 is provided

with a compartmentalised insole 22 similar to that described with reference to figure

1. The insole is thus integral with the footwear item. On the upper surface of the

insole is located a thin layer 23 which includes an array of pressure sensors. These

may, as an alternative, be provided on the lower surface of the insole. The

compartments may be accessed by the wearer to insert or replace panels.

In the figure 2b arrangement, an insole 22 is proved as an auxiliary footwear

component, which includes a compartmentalised layer similar to that described with

I reference to figure 1. On the upper surface 23 is located a layer having an array of pressure sensors. In this example, the insole can be used with any appropriate hem of footwear; i.e. can be used with more than one footwear item.

In the figure 2c arrangement, a compartmentalised insole 22 is provided either integral with the footwear item, or can be provided as a separate auxiliary component similar to the fig 2b example. A sock 24 is provided, whose lower surface 25 is provided with an array of sensors. The sensor array may alternatively be provided as a separate surface to be laid on top of an insole. Thus, in use, it is located between the wearer's foot or sock, and the top of the shoe insole (or shoe inner surface). In these examples, as the component which has the array of sensors is separate to the compartmentalised (in)sole, it does not have to be worn all the time, but may be used occasionally or at frequent intervals in order to determine pressures and/or offer diagnosis/prescription. This prevents relatively expensive pressure sensor containing components (such as socks) wearing out quickly.

The panels and/or their configurations may be designed based on anatomical landmarks on the plantar surface of the foot while taking into account foot function.

The pressure sensors located on the surface of the insole, sock or shoe surface may be connected to a data acquisition unit adapted to collect data pertaining to measured plantar pressures. The data acquisition unit may be located in the item of footwear.

In one example, data pertaining to the pressures is monitored and analysed. The analysis can provide the wearer with an indication of whether certain areas of the feet (e.g. the sole) are overloaded and thus at risk of developing ulceration.

Furthermore, in one aspect, the analysis can provide the user with an indication that they would benefit from a change of one or more panels of a compartmentalised insole. Such an insole thus provides a more comfortable and/or favourable fit, so as to reduce the problem of pressure overloading in regions of the foot. For example, the optimum configuration of panels can be indicated to the wearer. It must be noted that in other aspects, rather than the use of a compartmentalised sole, the diagnosis or prescription may indicate one or more orthotic members, or a bespoke non- configurable insole to be inserted into a shoe or other footwear item. In other words, in one example, there may be provided one or more insoles, which, although are non- adaptable (not having compartments to receive panels), can be specified as a result of the diagnosis and prescription. Alternatively one or more orthotic elements can be indicated for use with an item of footwear; these may form an interlocking surface. Thus the disclosure is not limited to compartmentalised insoles.

In one aspect, the user is provided with a hand held device which can be used to indicate pressures, diagnosis and/or prescriptions. The wearer of an insole or footwear item can thus be informed of which panels of a compartmentalised sole are to be changed and with which particular panel. Also, the wearer may be prescribed a particular non-configurable insole to use. Thus, the hand held device may be remote from the pressure measuring sensors and/or data acquisition unit. In one example, the data acquisition unit (base unit), may be located in the footwear item such as in a heel. It may be connected to, or include, a transmitting unit that can send data to the hand held unit. For example, the base unit may have Bluetooth or other wireless connectivity with the hand held device.

Figure 3 shows a footwear item 31 provided with a compartmentalised sole 32 having an array of sensors 33 on the upper surface. The sensors are connected to base unit 34 which may include data acquisition means 33 located in the heel region 35 of the sole. There is provided transmitter means 36 to transmit data to a hand held device which includes a display 38.

The base unit may be provided in, e.g., the heel or lumbar region of a footwear item and may be powered by a battery (not shown). Batteries may be recharged by loading or through movement of the leg, i.e. leg swing, or by pressure means. The optimum type of device to provide power may depend on the size and weight of the footwear item and may use pressure rechargeable batteries, piezoelectric generators or other types of energy harvesting device to provide the necessary power for the base unit.

The hand held device may include a visual display and/or an audio unit and again may include means to receive data wirelessly from the base unit. Again it may have appropriate wireless connectivity such as Bluetooth with the base unit. The hand held unit may have a user interface that enables data pertaining to the pressure measurements to be displayed to a wearer of the footwear item/insole.

In one example, the display may be provided with colour coded graphs or column bars showing the pressure at different plantar regions of the foot.

Software may be installed on the hand held device so that it is equipped with an audio system of alarms that notify the user of, e.g., an urgent need to change insole panel configuration.

Real time pressures may be displayed in relation to different regions of the foot. In an example, a map of the foot may be displayed divided into regions. The display may use a colour coding scheme so as to indicate, with respect to each different region, a particular colour representing a pressure range. For example, green may represent a favourable or acceptable pressure range, orange may represent a cautious state and red may indicate overloading.

The skilled person would understand that appropriate analysis of the pressures and/or diagnostic and mathematical modelling functionality may be required to provide to the wearer with an appropriate diagnosis and prescription e.g. an indication that he would benefit from a change of an insole or one or more panels of a

compartmentalised (in)sole, or arrangement of orthotic(s), so as to provide a configuration which alleviates, e.g., pressure at the critical indicated region(s). Thus, the optimum panel configuration may be provided. The system may alternatively indicate a particular orthotic or insole (which may not be compartmentalised) for the wearer to use. In this way, the system additionally provides prescriptions for non- adaptable non-configurable bespoke insoles or orthotic members.

In one example, the display can inform the wearer of the particular panels to use for one or more (or each) compartment. This indication may be in terms of indicating the appropriate panel/orthotic/insole in terms of the appropriate shape of the insert and/or density and/or resilience and/or material etc. This may be via an index number, letter or other index designation. S

The system may be provided with means to determine safe or preferred pressure thresholds.

The interchangeable (e.g. insole) panels as mentioned, can be inserted into a compartmentalised "chassis" e.g. compartmentalised insole. The insole may be custom made to suit the wearer. The interchangeable panels and insole therefor may be interlocking and made in the general shape of a foot. This is achieved in one example by plantar scans using CAD/CAM techniques. Each panel may be provided in different shapes and they may also be provided from different materials thus providing for different resilience/elasticity/compliance. The compliance of each segment can be determined by viscoelastic properties of the material. Mathematic modelling and analysis may be provided to determine which panel(s) to use or the configuration thereof. In one example there are 7 to 12 different compartments, corresponding to appropriate regions of the sole/foot. In another example there may be up to 10 compartments. The insole may be provided as a semi-rigid chassis.

The skilled person would readily be aware that functionality may be provided by any appropriate device. For example the base unit, (which may be located integral with the footwear item) may also analyse the pressure data and formulate diagnosis or prescription so as to provide e.g. indications for panel change and/Or panel configuration.

Of course, the hand held unit may be dispensed with. The indication may be provided by having indication means on the insole or footwear item itself.

Aspects thus provide a wearer of a footwear item, such as a patient, with data pertaining to foot (e.g. plantar) pressures. Furthermore, these can be indicated to the wearer or patient in clear visual terms. The wearer can be provided thus with real time monitoring and diagnosis. The invention provides for an integrated standalone system that provides monitoring, diagnosis and prescription for self assembly of an insole, or selection of a bespoke insole, that can thus provide for substantial autonomy. The system allows (by means of integrated mathematic modelling for example) the selection and indication of appropriate panels/orthotic(s) or insoles to the wearer.

The skilled person would readily understand and envisage that the invention covers a variety of different examples and includes various permutations and combinations of arrangements in terms of components, such as items of footwear, insole and sensor array, and arrangements are not limited to those discussed here. In addition, the skilled person would readily be aware of alternative arrangements with regard to functionality of monitoring, diagnosis, modelling and/or prescription and in particular functionality may be provided or divided between on of more components of the system.

Claims

1. A system comprising means to measure or monitor, at one or more locations/regions, the pressure on a foot due to wearing a footwear item, and means to indicate data pertaining to said pressures to the wearer of said footwear item.

2. A system as claimed in claim 1 wherein said means to indicate data pertaining to said pressures comprises means to indicate said data in real-time to the wearer.

3. A system as claimed in claims 1 or 2 wherein said pressure measuring or monitoring means comprises one or more sensors embedded into or onto a sock, insole, or surface of a footwear item.

4. A system as claimed in claims 1 to 3 including diagnosis and/or prescription means.

5. A system as claimed in claims 1 to 4 wherein said means to indicate data pertaining to said pressures to the wearer comprises means to indicate to the wearer that the wearer would benefit from a change of one or more panels, orthotic elements or insoles with respect to a footwear member or said footwear item.

6. A system as claimed in claims 1 to 5 wherein said footwear item or footwear member includes a compartmentalised surface allowing insertion or removal of one or more replaceable panels.

7. A system as claimed in claims 1 to 6 wherein said footwear member is integral with, or separate to, said footwear item.

8. A system as claimed in claims 1 to 7 wherein said footwear member is an insole.

9. A system as claimed in claims 5 to 8 wherein said change comprises the

removal, replacement or addition of one or more panels, orthotic elements or insoles

to said footwear member/item.

10. A system as claimed in any preceding claim wherein said means to indicate said

pressures is provided by an auxiliary device located remote or separate to said

pressure measuring/monitoring means, and said indication means comprises visual

and/or audio indication means.

Π . A system as claimed in claims 1 to 10 including means to analyse said

measured/monitored pressures and determine and/or provide said indication.

12. A system as claimed in claims 10 or 11 including means to transmit data

pertaining to said pressures or indication, wirelessly to said auxiliary device.

13. A system as claimed in claims 1 to 12 wherein said means to indicate,

comprises means to indicate for one or more plantar regions, whether the pressure

range therefor is fair, cautionary and/or overloaded.

1 . A system as claimed in claims 1 to 13 wherein said means to indicate,

comprises means to indicate to the wearer a suitable insole, one or^' more orthotic

elements for said item of footwear, or what a suitable panel is with respect to one or

more of each of compartments of a compartmentalised footwear item/member.

15. A system as claimed in claims 14 wherein said means to indicate comprises

means to indicate/prescribe a configuration of panels for use for said footwear

item/member.

16. A system as claimed in claims 1 to 15 wherein said indication of configuration

is an optimum configuration for the wearer.

17. A system as claimed in claims 1 to 16 including data acquisition means for

collection of pressure data. i

18. A system as claimed in claims 11 to 17 wherein said data transmission or analysis means is located or beatable on said footwear item.

1 . A system as claimed in claim 11 to 18 wherein said data transmission means or said data analysis means is powered or recharged by movement of the wearer's leg or pressure means.

20. A system as claimed in claims 14 to 19 wherein said indication means indicates for a panel, orthotic element or insole, its shape, material, resilience and/or density.