SELF-MONITORING COMPRESSION SUPPORTS

Abstract

The present invention relates to deformable supports that provide a compressive force on a human or animal limb or body and can self-determine that force and monitor it. The invention further relates to garments comprising those supports and an associated system for self-determination, monitoring and communicating the compressive force.

Claims

1. A support configured to apply and self-determine compressive force (s) on a human or animal body or limb, the support comprising: a deformable substrate having a first conductive pathway; at least one sensor located in a first sensory zone of the support for measuring impedance resistance across the first conductive pathway; at least one pathway termination point for the sensor; and a detachable microprocessor operably connected with the pathway termination point for receiving resistance data from the sensor, wherein the detachable microprocessor converts the resistance data to pressure data, via an algorithm, which is indicative of a first compressive force applied by the support in the first sensory zone.

2. The support of claim 1, wherein the sensor is a linear extension sensor provided along the first conductive pathway.

3. The support of claim 1, wherein the support further comprises a conductive pin at the termination point.

4. The support of claim 1, wherein a conductive node is provided at each end of the first conductive pathway.

5. The support of claim 4, wherein the nodes function to activate and power the sensor, optionally where activation of the nodes is wireless.

6. The support of claim 1, wherein the sensor is a linear extension sensor integrally formed within the support.

7. The support of claim 1, wherein the support comprises a plurality of linear extension sensors.

8. The support of claim 7, wherein the substrate comprises a conductive pathway corresponding to each linear extension sensor.

9. The support of claim 8, wherein the substrate has two conductive pathways arranged perpendicular to one another; and the support comprises two independently operable sensors located in the first sensory zone for measuring impedance resistance independently across each of the respective perpendicular conductive pathways in the first sensory zone.

10. The support of claim 8, wherein the support comprises a second independent sensor located in a second sensory zone and impedance resistance is measured across a second conductive pathway such that the detachable microprocessor converts that resistance data to pressure data which is indicative of a second compressive force applied in the second sensory zone.

11. The support of claim 10, wherein the support comprises a third sensory zone, wherein a third independent sensor is located in the third sensory zone and impedance resistance is measured across a third conductive pathway such that the detachable microprocessor converts that resistance data to pressure data which is indicative of a third compressive force applied in the third sensory zone.

12. The support of claim 1, wherein each conductive pathway and corresponding sensor is provided by a linear electronic transducer with two termination points.

13. The support of claim 12, wherein the linear electronic transducer comprises a knitted or woven electro-conductive yarn.

14. The support of claim 1, wherein the support further comprises an indicator to communicate compressive force (s) to the user.

15. The support of claim 1, wherein the microprocessor comprises a communication module configured to transmit or receive data remotely.

16. The support of claim 1, wherein the microprocessor has a protective seal for sterilisation.

17. The support of claim 1, wherein the support is an elasticated wrap, bandage, surround, stocking or sleeve.

18. The support of claim 1, wherein the support further comprises at least one surface having an adhesive property to provide temporary self-adhesion.

19. (canceled)

20. The support of claim 1, wherein the support further comprises temperature and/or chemical sensors.

21-23. (canceled)

24. A self-monitoring compression system configured to determine compressive force applied on a human or animal body or limb in at least one sensory zone of a compression support, the self-monitoring compression system being configured to carry out a method, the method comprising: obtaining pressure data in a first sensory zone of the compression support having a first conductive pathway and first sensor therein; measuring impedance resistance across the first conductive pathway; receiving and optionally storing resistance data via a microprocessor and thereafter converting resistance data to pressure data; comparing the pressure data to prescribed data to determine change in compressive force applied by the support, or comparing the pressure data over a pre-determined period of time to determine a statistically relevant change in pressure data indicative of a change in the compressive force; and communicating qualitative and/or quantitative information in relation to the compressive force to a receiver.

25-27. (canceled)

Description

BRIEF DESCRIPTION

[0069] The present invention will now be further described with reference to the accompanying drawings in which:

[0070] FIG. 1 shows a support according to the present invention and shows, as an example, 3 conductive pathways with termination points;

[0071] FIG. 2 shows a further example of a support according to the present invention and shows, as an example, conductive pathway sensor (integral);

[0072] FIG. 3 shows an example of a support of the invention in use;

[0073] FIG. 4 shows yet a further example of the support of the invention with integral sensors; and

[0074] FIG. 5 shows the soft touch technology used at the termination points in some embodiments of the invention.

DETAILED DESCRIPTION

[0075] FIG. 1 shows an embodiment of the support of the invention. The support comprises an inherently compression-based bandage or stocking that supports the limb or body. The substrate material applies a compressive force on a human or animal body or limb by virtue of its elasticity.

[0076] In other embodiments the substrate may be a non-compression based support. A bandage support may be wrapped multiple times around the supported limb and provided with an adjustable fastening or self-adhesive (cohesive) finish.

[0077] The substrate has 3 conductive pathways. There may be more or fewer conductive pathways provided on each support. In this example each of the three pathways has 2 termination points and impedance sensor associated therewith for measuring impedance resistance across the respective conductive pathway. The resistance across each pathway will change as a result of distortion, disruption to the whole or a part of the pathway by stretching or contraction of the material of the support. The sensor for each pathway detects the resistance and is read by electronics within a micro-processor (not shown) or by an integrated or integral electronics data collection device (not shown) which communicates with the micro-processor either of which are operably connected to the sensor. The applicant has developed knitted fabrics which are linear electronic transducers, which act as the support's substrate, inherently providing the features required such that resistance changes can be measured. The LET would provide the substrate, conductive pathways and the sensors needed with two termination points being required one for the supply and one for the return of each pathway. A micro-current is fed from the power source.

[0078] The fabrics used for such application include those described in WO2009/093040. For example, sensor deniers for this application can range between single ply 30/100 dtex (decitex) or up to 2 ply 100 dtex.

[0079] The nature of the electronic connection by the termination point(s) to the electronics of the microprocessor may be via a conductive pin, popper or press stud, magnetic or other type of mechanical method. However, the applicant's associated soft contact sensor technology in which the fabric of the support is seamlessly interconnected with the electronics of a microprocessor or a collection device which is integrated into the support/bandage could also be used and is described further below.

[0080] Alternatively, the electronics interface conjoining the termination points of the pathways could be constructed from a flexible material upon which electronics are sited and which is embedded into the support ether at the time of manufacture of attached, in a permanent manner, at the time of application.

[0081] Furthermore, as an alternative, the collection device could be connected using wireless frequencies to either the micro-processor which is sited within connectivity range of the support and the sensors and is separately attached or carried onto or by a limb or is connected using radio frequency technology to a hand-held or similar type reader device. The microprocessor receives the signal from the sensors and converts the resistance signals into a pressure measurement for each.

[0082] Here, the conductive pathway may be provided by the linear electronic transducer, integrally formed within a support either during manufacture or subsequently as described above.

[0083] In some embodiments the invention may therefore comprise a secondary or alternate sensor. The sensor may be using a flexible or fluid sensory system integrated within the support and which measure pressure from deformity of the system whilst measure surface pressure force, thus measuring longitude, latitude and vertical forces simultaneously the communication of the data being deployed using similar methodologies as described above.

[0084] In another embodiment the sensor may be applied onto the support material using a variety of affixing methods such as etching, printing, bonding, fusing, gluing etc. to adopt the characteristic elongated attributes of the support material to measure the deformation of the sensor as part of the material via a collected signal.

[0085] The fabric substrate comprises one or more row, or course, of extensible woven or knitted fabric, each row comprising stitches. The substrate or support may include a cotton property. Each stitch comprises loops which interconnect with the adjacent stitches within the same row and also the adjacent stitches in the previous and subsequent rows, i.e. those stitches above and below. As a result of stitch interconnectivity, if a force is applied across the fabric, each loop deforms from a substantially circular configuration into an elongate oval configuration enabling the fabric as a whole to stretch in the direction in which the force is applied. Because this deformation arises as a result of the knitted fabric structure, it is apparent even if the yarn itself is inextensible.

[0086] In this example, several rows of the knitted support can be provided in the form of electro-conductive yarn, thereby forming one or more separate conductive pathways. Each of the one or more extensible sensors has two pathways for carrying the electrical displacement signals. In the case of a plurality of sensors, each one is separate to each-other and reacts in a sequential way autonomously as the support is applied along the length of a limb or body. When the support is in an un-extended condition, each adjacent stitch is configured as a substantially closed loop. When the support is stretched, each loop elongates and the number of contact points is reduced thus changing the impedance of the conductive pathway.

[0087] In some embodiments, the knitted fabric may be formed from a low modulus yarn that is typically elastomeric. In that configuration, the fabric can deform further than an equivalent knitted structure formed from an inextensible yarn, because the yarn itself can deform under an applied force. The conductive yarn pathway is threaded through this substrate, and is not elastic but has pockets of longer length. As the adjacent elastic yarn is stretched the conductive yarn extends from a wound configuration to an open configuration. The resistance across the conductive pathway is therefore changed as the fabric is stretched in the direction of the elongated conductive yarn.

[0088] In order to optimise the data received by the microprocessor sensor, the transduction along the pathway in the LET embodiments can be enhanced by providing 2 or more conductive yarns immediately adjacent one another effectively forming the same conductive pathway. Data from the 2 conductive yarns received by the sensors can be averaged to provide a single resistance data value. Alternatively, this arrangement can provide a built-in functioning check. In such a case, the 2 separate resistance measurements can be compared to check that they do not differ by more than a predetermined threshold amount. If they do differ by more than a predetermined amount, this could indicate that at least one of the strands has been damaged and the data received from it should therefore no longer be provided for conversion to pressure data.

[0089] As one skilled in the art will appreciate other variations of electronic transducers may be utilised. In a simple embodiment, a LET with a single conductive pathway may be provided by a conductive yarn and thus only one sensing system is required to be connected to the microprocessor or to a data collection termination point. Such embodiments may be useful with short supports e.g. useful for children, or where the limb or area of body to be supported is very short or limited in length e.g. wrist.

[0090] In FIG. 1 specifically, a zig-zag extends and with a number of peaks separating lengthwise and it creates a displacement of signal going into the return track of the sensor. The tracks are functional in that one track from the termination point to the sensor carries a supply flow of electricity and as the electricity flows through the sensor it's resistance is stabilised and the returning track records the power. When the sensor is stretched it is stretched length ways (left to right) not widthways (top to bottom on the drawing. This causes a resistance change in the sensor (as the power becomes interrupted by the separation of the loops) and it is that change which is measured.

[0091] FIG. 2 shows the same multi-sensor array integral within a support but not requiring the plurality of sensor configuration which creates a zig-zag in FIG. 1. A multi-sensor support arrangement applied to a limb with 3 conductive pathways, this time fixed within a specific zone of the support that requires measurement of resistance. Such pathways, are each extendable within their zone only as the support is applied. Each pathway comprises at least 1 sensor to measure the resistance across the fixed length of the conductive pathway in that particular compression zone and this can be pre-programmed if required into the sensor electronics via the app and then be translated, via the algorithm, to provide a reading of the average pressure exerted across the conductive pathway. Such a pressure measurement may provide data in relation to the specific part of the limb measured, e.g. one may relate to the ankle, whereas another may relate to the shin/calf and a further may relate to under the knee.

[0092] The conduction pathways are knitted with additional conductive yarn which can be held within the support by the elasticity of the support material. When the support is extended (stretched) the additional thread straightens and the resistance created by the loops when flaccid is reduced and the changes are measured as linear extension change and converted by the algorithm to a pressure formulae. When it is in its resting state the electricity flows with enforcement, when it is extended it changes and flows more freely.

[0093] FIG. 3

[0094] In this embodiment the support is wrapped around the limb with a successive overlap. The application of the support is such that the overlap, of each successive length being wrapped upon the preceding, one results in between 33%>50% of the width of the preceding layer subsequently occurring layer upon layer. There is a 50% overlap (if half of the preceding layer is covered). This embodiment creates and applies stability and reinforces the pressure applied by the support. It is possible that the amount of overlap required from 50% to 25/33% (thus shortening the overall length requirement of the support and reduce subsequent manufacturing costs) due to the accuracy of the applied bandage and by moderating the amount of elasticity within the support to provide and maintain the overall compression required of the support as the stretch of the support is applying the required pressure to the limb at the right position.

[0095] FIG. 4

[0096] In this embodiment, the support is shown with integral sensors which may be made during manufacture. The sensors converge at a termination point, housed in a pocket, or it may be a flexible termination point. The connection is via either mechanical or soft touch, as described throughout this disclosure. The data collection technology may include the multi-processor or it may provide a location point for another rigid or flexible interface. In some embodiments the interface may collect the sensor data and store it until the electronics (or a separately introduced set reader) collects the data for extrapolation, processing, reading and/or forwarding on to another device. However, in some embodiments the data would be processed as it is collected, communicated onto another device and may not be stored in its raw form.

[0097] FIG. 4 illustrates the embodiment where one or more pathway termination points (such as the 6 shown here) are comprised within a housing which could be a pocket (that is additional to or formed as part of the support or held by a retaining method which secures an interface for whatever period of time is required). The array of particular pathways as shown is not necessarily limited in number, design or layout and other embodiments are envisaged within the scope of the present application.

[0098] FIG. 5

[0099] In this embodiment the sensor termination points and the opposing interface have raised profiles which, when applied together, ensure that a reliable and constant contact is made and without the requirement of mechanical components. The applicant has shown that repeatable results in data transference can be generated using this embodiment and this data can then be subsequently analysed.

[0100] The force applied to the outer surface or top of the interface is applied by either a pocket covering which has been extended from its resting state and when operational under pressure due to the pocket accommodating the inclusion of the electronics or interface mechanism.

[0101] Alternatively there may be integral location points set within or added subsequently to the support the purpose of which locate the interface into its correct position and force said interface in contact with the sensors terminations points. In another form, mechanical poppers, magnets or snap connectors or other such devices may be adhered onto the termination points to ensure that a solid contact is made and the interface is then snapped into place on the reverse side of the connectors e.g. a female connector on the interface vs. a male connector on the textiles termination points.

[0102] In another embodiment it is possible to utilise an optical connector which has one part embedded within the interface to provide an infra-red or similar signal with the other opposing side having a reflector/reader which aligns the interface and facilitates the transfer of data.

[0103] There are a number of combinations and variations of each of the essential features (and non-essential or additional components) which forms different embodiments and these will be clear to the skilled person as being within the scope of the present invention. Such features may include some or all of the following components:

[0104] Sensors and Staggering of Signals

[0105] Each pathway may be provided with an impedance sensor or one sensor can serve multiple pathways via staggering.

[0106] The sensors can be configured to sense the impedance at regular intervals, for example at intervals of a fraction of a minute or 1 minute, 5 minutes, 10 minutes, 20 minutes, 30 minutes or hourly. For example, if a support is configured with five conductive pathways, pathways A, B, C, D, and E each sensor may be configured to provide a reading every five minutes, but staggered at one minute intervals so that a reading is taken every minute from one of the sensors.

[0107] Furthermore, the sensors can be configured to the requirements of a wearer to provide the best compression to optimally treat the patient wearer's current condition which, in the case of a leg ulcer, changes from application to application and from time period to time period. This may result in a bespoke solution tailored for generic treatment routines or individualised for patient treatment plans. Input into the electronics which record the variances within the sensors is made via a compatible and is programmable by a piece of electronics or software, such as a smart phone or tablet computer which can be operably connected thereto.

[0108] Furthermore, the sensors can be configured to provide additional readings in response to a change in reading in one sensor. In the above example, if the impedance across pathway C changes by more than a predetermined threshold amount, then additional data may immediately be requested for the impedance across pathways D, E, A and B. These data may be obtained sequentially at a minimum temporal spacing, for example at one second intervals.

[0109] Termination Points

[0110] At least one pathway termination point is required at the end of the one or more conductive pathways in all examples shown herein. Where a number of conductive pathways are provided within a single support, all of the conductive pathways may otherwise be grouped for ease of connection or brought together in a single termination point.

[0111] Convenient communication of resistance data from the conductive pathway/sensor may be provided via a conductive stud or pin to the microprocessor.

[0112] Additionally, a rigid or flexible interface may be applied to or formed as part of the support and may contain a data collection facility or which may solely collect and communicate the data either dynamically or after a pre-prescribed period of time or which is in response to a stimulate appeal upon the interface by a configured device which is made to collect the data.

[0113] However, other means of connecting to electronics of the microprocessor are envisaged, including but not limited to the applicant's own developments in fabric-electronic interfacing technology as described in WO2014/188171. In such a case an improved contact interface between the electronics of the microprocessor and termination point of the conductive pathway is formed. For example, a knitted conductive pathway as described previously may terminate at a point within the substrate where a fabric pocket for housing the electronics of the microprocessor is formed. An additional base layer of fabric thickness within the pocket projects the surface of the electrical connectors of the microprocessor, when housed within the pocket, toward the conductive pathway surfaces.

[0114] Further, the electrical connectors of the microprocessor may include shims so they themselves are urged towards the desired points of contact at the termination points in the fabric.

[0115] Microprocessor or Data Collection Interface

[0116] A detachable microprocessor is operably connected with the at least one pathway termination point for receiving impedance resistance data. Data obtained by the sensor or sensors provides a reading of the resistance across at least part of the support and may be received, stored and processed in the same component within the device. The functionality of the microprocessor may range from that of a simple switching technique, without the need for integrated micro-processing to an advanced type of data collection which includes the ability to collect, process and communicate one or more signals concurrently to a receiving device. This latter, more detailed, functionality is described below.

[0117] As an alternative to a microprocessor, a detachable or non-detachable interface constructed of flexible or semi-rigid substrate may comprise minimal electronic componentry. In some embodiments, the power requirement for such electrics is minimal and maybe derived from the haptic or kinetic movement of the individual sufficient to allow the data to be carried into and stored upon the interface. The data may be stored in the interface before the interface then engages with another device to download and/or respond to further operational instructions. As such, it is envisaged that data collection, as compared to data processing, may be undertaken by separate parts of the device in some embodiments of the invention.

[0118] Algorithm

[0119] The microprocessor includes one or more algorithms for converting the impendence resistance data to pressure data to determine the compressive force across one or more parts of the support of the invention.

[0120] The algorithm utilises the measured resistance and the radius of the cylindrical limb or body with Laplace's Law to determine the pressure applied along the conductive pathway.

[0121] Where multiple sensors are provided along a conductive pathway, each sensor measures the resistance across a part of the length of the conductive pathway and each reading can be translated, via the algorithm, to provide a pressure reading for that part of the pathway. These individual readings can then be amalgamated to provide a pressure profile for the full length of the conductive pathway.

[0122] Housing

[0123] In some preferred embodiments there is provided a housing, which accommodates the microprocessor, the power supply and the electronics which perform the algorithm and also a memory in which data can be stored pertaining to the form factor calculated by the algorithm. The memory is configured to store data output from the algorithm and also to store data pertaining to acceptable ranges of pressure applied by the support. The memory provides for a learning capability derived from the data recorded. Therefore, a mean or steady state reading can be retained from a previous use in order to set a correct fitting of the support for a subsequent use. The housing may be formed from plastic or polymer and if conductive connect shims are chosen these may be formed in an integral manner when the housing is moulded and machined or they may be attached as a separate exercise once the housing is formed and the electronics installed. The housing may be encapsulated or sealed to offer a water resistant solution.

[0124] The housing may include the conductive pathway termination point in the form of a conductive pin, stud or soft touch contact membrane which provides an interface between the conductive pathway within the support and the microprocessor in which the algorithm is run.

[0125] The electronics housing may be a tailored touch enabled electronic housing which may additionally be configured to communicate data external to the electronics itself. This communication may be achieved via a range of wireless protocols, e.g. Wi-Fi, RFID, NFC, the internet and/or mobile telecommunications systems, enabling data to be retrieved and monitored remotely by a third party. There may be a LED or similar display on the housing and programmable instruction buttons may also be applied.

[0126] The software running a microprocessor would be updatable via over-the-air updating, it would use wireless technologies to perform self-checking and allow for external instructions to be fed into the electronics in order that greater functionality and/or accuracy and/or flexibility is afforded to the use of the support.

[0127] Display

[0128] In one embodiment the housing comprises a display configured to show a visual representation of the output of the algorithm. This may be a numerical display, showing the numerical value of the pressure applied by the support and/or in one or more distinct zones or areas across the support.

[0129] Alternatively, it may be a simple visual representation of the status of the support. For example, a green light if the pressure lies within acceptable limits, a red light if the pressure exceeds a predetermined upper limit for the acceptable pressure and a blue light if the pressure falls below a predetermined lower limit for the acceptable pressure.

[0130] In some embodiments, the display may be audible and comprise an alarm which initiates an alert when the pressure across the conductive pathway falls outside of the acceptable pressure range set and stored within the memory. The alarm may be configured to repeat whenever the pressure remains outside the acceptable range for more than a predetermined time, which may be a few seconds, a few minutes or an hour or more.

[0131] In another embodiment the displays mentioned above may be located on a mobile devices such as a smart phone, hand help tablet or similar and the data collected may be communicated as raw data transference, pre-processed data transference or full secure data transference whichever is required by the application. Fully developed applications for use with this technology are useable on a mobile device, such as a smart phone such that the operator, user or third party can remotely receive information visually and/or receive audible alarms to indicate when change occurs.