Patent Application
20190038374
This application claims priority to and benefit of Luxembourg Patent Application No. LU 100021 filed on 13 Jan. 2017.
The present invention relates to improvements in relations to systems, apparatus and methods of measuring and adapting objects for a comfortable engagement with an engaging member, and more particularly to a bio-sensor strip attached an object, a body part or a liner over the body part, to measure parameters between the object and the body part and thus aid in achieving a comfortable and functional fit between the object and the body part. Examples of the objects include prostheses and orthoses, for example the fitting of a prostheses to a stump of the residual limb of a wearer.
The fitting and shaping of the socket of an artificial limb (prosthesis) to ensure that the artificial limb is an accurate fit with the stump of the residual limb with which the artificial limb engages is one of the most important parts of or in the formation of a prosthesis, and also one of the most difficult. The socket serves as an interface between the residual limb and the prosthesis, allowing comfortable weight bearing, movement, and balance. The socket therefore has to be shaped to be a perfect fit, with an adequate or desired surface bearing or loading to prevent painful points of contact. Pain and discomfort may occur from pressure, friction, temperature, or any other physical situation caused by an improperly fitted socket or a misaligned prosthesis. It will be appreciated that friction will lead to an increase in temperature and this can be measured by temperature sensors.
At the same time, the socket needs to be sufficiently tight so that during movement the prosthesis is firmly held in place and does not fall off or twist. The prosthesis also needs to be adjustable to take into account that the volume of the residual limb changes over time. For example, in the first few months after amputation, the stump of the residual limb will change in shape due to changes in fat and muscle distribution.
Currently, in order to make a new prosthesis to fit the stump, a mould of the stump is first taken, and the socket of the prosthesis is shaped according to the shape of the mould, and this shaping process is either manual or executed by a machine under computer control, or a combination of both. Once this rough shaping is completed, the shape of the socket is then fine-tuned, usually manually, to create a comfortable fit with the stump. However, prior art methods of fine-tuning of the shape of the socket to create a comfortable fit to a stump are laborious, empirical and time consuming. The shaping process relies fundamentally on verbal feedback from the wearer with regard to how the prosthesis feels, where the prosthesis is rubbing and the like. Small changes are then made and the fit tried again. Such communication is, however, often imprecise and very simple, with the patient simply indicating generally where discomfort or pain is occurring on the stump. This is made more difficult by the fact that firstly, the nature of the pain or discomfort is that the pain or discomfort usually does not just occur at the point of contact but in an area around the point of contact, so that locating the issue point precisely is very difficult. Secondly, the patient may have to remove the stump from the socket in order to identify the pain point, and once so removed, the pain will tend to soften, again making it more difficult to accurately identify the actual contact point. Moreover, the trauma or the pathology that led to limb loss may itself have caused nerve displacement, so that the place where pain is felt (pain point) and the actual friction or pressure spot may be in two different locations, or have caused reduced sensitivity, so that the patient is unable to give precise information. Furthermore, the psychological trauma or indeed general reluctance of the patient to provide detailed feedback may lead to incorrect or imprecise information. The phenomenon of “phantom limb pain” is also known that will also affect the information provided to a fitting technician by the patient.
There is therefore a need for a system that is able to provide precise, objective and location-specific information about the fit between a residual limb stump and a prosthetic socket.
In an attempt to improve on the prior art approach, U.S. Published Patent Application No. 2014/0063220 discloses a photo-based fitting system in which the patient's residual limb is photographed from many angles to provide a spatial image of the residual limb and facilitate the design and construction of the prosthetic socket. However, this approach does not provide any information on the comfort of the fit between the stump and the socket once the socket has been formed, and really only provides an alternative to taking a mould of the stump for the rough forming of the socket. There is no teaching provided as to how to better fine tune to the fit between the stump and the socket.
Similarly, WO 2014/036029 discloses a viewfinder based system for acquiring data on the stump for which a prosthetics socket needs to be built, but again this does not provide any teaching regarding the fine tuning of the socket to ensure a comfortable fit. It should also be noted that in both cases, the information provided is static and refers to a moment in time, when the photograph was taken and ignores any dynamic data produced during actual continued use of the prosthesis.
U.S. Pat. No. 8,784,340 discloses a further solution to the problem of fitting a prosthetic limb in which a liner is fitted over the stump, the liner having a plurality of pressure sensors embedded therein which are connected to a data acquisition system. However, this solution does not provide any teaching as to how the technician can use the collected data to improve the shape of the socket as the pressure sensors does not provide any precise spatial information which can be used to correlate the pressure data with the shape of the socket. This is made worse by the fact that the liner is fitted to the stump, so at least the liner could only provide information on the shape of the stump rather than the socket, and in any event, due to the nature of the liner and its imprecise fitting, the exact location of the sensors on the stump cannot be ascertained in that system. Finally, in the absence of any adhesive layer or securing mechanism, the liner cannot be prevented from continuously moving, thereby providing incorrect data.
Similarly, U.S. Pat. No. 5,993,400 teaches an apparatus and method for monitoring pressure between the surface of a body part (residual limb) and a contact surface on, for example, a prosthetics socket, a bed or a wheelchair. This apparatus and method employ a plurality of pressure sensors disposed in a matrix array between the contact surface and the body part. The sensors produce analog force signals proportional to pressure, and a monitor receives the analog signals and produces output signals, preferably digital, having pressure data corresponding to the pressure at each sensor. A computer processor receives the output signals from the monitor to create a force profile for the sensor array. The sensors may be scanned as a read event in variety of manners, including periodic, continuous, and triggered scanning. This monitoring apparatus and method is used, for example, to fit prosthetics, to monitor bed-ridden and wheelchair-bound patients, to reduce pain and sores caused by uneven distribution of pressure and to monitor pressure between a cast and a person. The sensors may be mounted on a single sheet or on strips for positioning along the body, and monitoring is accomplished by multiplexing and digitizing the analog force signals.
A number of patent documents are known that teach the design and manufacture of prosthetic sockets using computer aided design. For example, International Patent Application No. WO 2012/083030 teaches above knee (AK) and below the knee (BK) prosthetic sockets and specific manufacturing processes for the production of prosthetic sockets through the automated, computer controlled bi-axial and tri-axial braiding of sockets, over a mold or mandrel made of carved foam, plaster material or wax that is a replica of the patient's truncated limb, and is created by a Computer Aided Design (CAD) file controlling a Numerically Controlled (CNC) machine tool. The prosthetic sockets are manufactured using fibers such as graphite or Kevlar, and high-performance resins, and create a socket which is stronger and lighter weight than conventionally manufactured sockets. Braiding also allows incorporation of woven cloth, tapes and other reinforcements into the braiding process for added strength at selected areas.
U.S. Published Patent Application No. 2010/0023149 teaches a method for evaluating prosthetic sockets (and other objects) which are designed and fabricated with computer aided design and manufacturing software. The shape of the prosthetic socket is accurately scanned and digitized. The scanned data are then compared to either an electronic shape data file, or to the shape of another socket, a positive model of a residual limb (or socket), or a residual limb. Any differences detected during the comparison can then be applied to revise the design or fabrication of the socket, to more accurately achieve a desired shape that properly fits the residual limb of a patient and can be used to solve the inverse problem by correcting for observed errors of a specific fabricator before the prosthetic socket is produced. The digitizing process is implemented using a stylus ball that contacts a surface of the socket to produce data indicating the three-dimensional shape of the socket.
There is a need for a system and method for providing parameters concerning the interaction between a body part and an object, to enable for example the fine tuning of the shape of the socket to fit the stump by providing precise information on the mismatching between the shape of the socket and the shape of the stump. More generally, one or more bio-sensor strips is provided that can be used for identifying difference in shape, load and biosensor profile distribution, as well as the physical characteristics between an object, a body part, i.e. part of a human body, or a liner-covered body part, which is engageable with the object.
The bio-sensor strip of this document is adapted to be located between an object and a body part and comprises one or more of bio-sensors that are disposed on at least one first polymer film. The bio-sensors evaluate properties by measuring parameters at a location between the object and the body part. A plurality of power leads and data leads are connected to the plurality of bio-sensors and to a power and data connector and are adapted to transfer data from the plurality of bio-sensors to a processor. The data transfer can be along leads or fibre-optic cables or can be wirelessly transferred. The bio-sensors can record not only parameters at the locations, but also in some case more general parameters, such as the pulse or heart rate, which are not location-dependent. The bio-sensors can be arranged in a single strip or in an array.
In one aspect, a body part liner is disposed between the bio-sensor strip and the body part but the bio-sensors are still thin enough to measure parameters at this location.
The bio-sensor strip may have a second polymer film disposed on an opposite side of the one or more bio-sensors and the plurality of power leads and data leads to sandwich or encapsulate the bio-sensors.
The bio-sensor strip has one or more markings disposed on one side which are used to determine the location of the bio-sensor strip. A side of the bio-sensor strip in contact with the body part or the body part liner is made in one aspect from polyurethane and the side of the bio-sensor strip in contact with the object is made in one aspect from silicone.
The one or more bio-sensors measure at least one of pressure between the body part and the object, temperature or humidity at the location, or can be used to measure at least one of a pulse or a galvanic response. The galvanic response is indicative of the humidity which will be caused, for example, by sweating or condensation. These parameters are, however, not limiting of the invention.
A method of evaluating properties between a body part and an object is also disclosed in this document. The method comprises affixing one or more the bio-sensor strips to one of the body part, a liner covering the body part or the object, collecting data from the one or more bio-sensor strips, and processing the data from the one or more bio-sensor strips to produce a heat map of the properties between the body part and the object. These properties are indicative of one of fit, interaction or dynamics between the body part and the object.
In one aspect of the method, the recording of the data from the one or more bio-sensor strips is carried out whilst the body part is in motion. This data can be combined with data from a motion sensor and correlating the data from the motion sensor with the data from the one or more bio-sensor strips.
It will be noted that the bio-sensors may also be attached to the body part but what is important is that they are firmly positioned and held in place between the object and the body part.
The one or more bio-sensors can be of different types and include, but not limited to, one or more of pressure sensors, temperature sensor, accelerometers, magnetometers, pedometers, galvanic response sensors, humidity sensors, air flow sensors, electromyography sensors, electrocardiography sensors, oximetry sensors and mechanomyography sensors. Preferably the sensors include a plurality of pressure and temperature sensors. The pressure sensors measure forces at the normal to the surface of the body part, whilst the temperature sensors indicate friction between the body part and the object due to transverse forces along the surface of the body part.
The body parts can be, for example, a stump of an amputated limb, a limb, a bottom sitting on a wheelchair, a back lying on a bed. The objects are in these examples a socket for a prosthesis, an orthotic element, e.g. knee brace, a wheelchair, or a bed. It will be appreciated that the invention has other applications.
A method and apparatus according to the invention has the advantage that by mapping the bio-data onto the socket surface map, the prosthesis fitting technician is provided with an accurate guide of where issues exist at the interface between the stump and the socket, and therefore makes identification of the regions of the socket which need adapting, rectifying, tuning or shaping and the amount required thereof much easier. As a result, the number of iterations to achieve a good fit is reduced resulting in a shorter, more efficient, and more economic prosthesis fitting process. The method and apparatus of the present invention reduce the cost of fitting a new or replacement prosthetic socket, as well as for adjusting existing prosthetic sockets, and achieve comfort for the patient much more quickly.
In a particularly preferred embodiment, a plurality of temperature and pressure sensors are provided on the socket surface for collecting both temperature and pressure data relating to the engagement between the socket and the stump. The use of both temperature and pressure sensors in the stump allows an improved understanding of the engagement between the stump and the socket to be formed, the temperature sensors providing not only biometric information relating to the surface of the stump but also allows temperature compensation of the pressure readings to be carried out, thereby improving their accuracy, as well as other benefits such as obtaining information about sensitive spots which are prone to ulcers and injury.
The bio-sensors may be attached individually to the socket, it being important primarily that the exact location of each sensor in the socket, relative to a reference point, is known. Preferably, however, the bio-sensors are provided in strips or arrays, so that they may be applied to the surface of the socket in a fixed relation to each other. This has the advantage of making the application process quicker whilst at the same time ensuring accurate spacing. Furthermore, by providing the sensors in strips rather than in a web or net, the spacing between the strips can be varied to control the density of the monitoring, so that high resolution monitoring can be carried out in areas of greater interest, namely with respect to pressure or temperature variation. An appropriate pattern of sensors on or in the strip may be used, such as alternating between pressure and temperature sensors, or indeed any other bio-sensor capable of sensing and measuring a physiological or physical variable of interest.
The bio-sensors used in the present system collect bio-data from the prosthesis socket in use. The bio-sensors are thin, preferably less than 1 mm in thickness so that they themselves do not become a source of discomfort for the user and have an impact on data acquisition. Suitable models are available from Interlink Electronics Inc. of California, USA, reference FSR400. This particular model can measure applied force from 0.2N to 20 N and is particularly suited to pressure determination between the stump and the socket. In addition, these bio-sensors can measure resistances from 45 Ω to 45MΩ and vary proportionally according to the force applied over the sensing area (19.635 mm2 approximately). Other useful models include FSR400 Short from Interlink Electronics or HD-001 from IEE in Luxembourg.
Bio-sensors can also be temperature sensors, they too are mechanical transducers and are named Thermistors. Useful thermistor resistances range from 0.4 kΩ to 400 kΩ and they vary according to the temperature to which they are exposed. Suitable sensors such as NTC JT Thermistors, specifically 103 JT-025 are produced by Semitec USA Corp (California, USA).
Depending on the variable of interest, different type of sensors may be used. The preferred embodiment includes a sandwich-type construction, the sensors being placed between two layers of material, which can be made of any suitable polymer, flexible, thin film and be delivered in rolls. There can be one plastic film A comprising two sides A1 and A2, which can be coated with a bio-compatible material on side A1 which will be in contact with the stump skin or a liner and which can be coated with an adhesive material on side A2 which will receive the sensors, as well as the power and data leads thereof and hold them it in place. There can be another plastic film B also comprising two sides B1 and B2, which can be optionally coated with an adhesive material on side B1. Side B1 is intended to fit exactly over side A2 of strip A and thereby sandwich the sensors and leads, and side B2 can be coated with an adhesive material or be composed of an adhesive material and it will be applied and adhere to the socket.
This is in the case of the sensors being applied and adhering to the socket. Other variations of the sensors may be built so that they adhere to the stump or the liner and surface finishes shall be modified to that end.
Plastic film rolls A and B are substantially of the same width or about 1.5 cm to 4 cm and several metres in length, for economic manufacturing; they can be cut later to proper length before use. They can be produced in a high-speed, continuous assembly line which will dispense and place the sensors and power and data leads onto side A2 of film roll A. The assembly line will then dispense and precisely place side B1 of film roll B over side A2 of film roll A and press the two films together so as to create a strip of sandwiched sensors and leads. The continuous sensor strip is then cut at appropriate lengths ranging from about 10 cm to 50 cm to produce individual sensor strips for use. Individual sensor strips, comprising one or more individual bio-sensors 819, 919, are then each fitted with a power and data interface device which is glued, clamped or soldered at one of the extremities of the sensor strip to connect with the power and data leads of the sensor, so as to provide power to the sensors and acquire data from them.
It should be noted that the arrangement and combination of surfaces and finishes described above for all four sides of plastic film rolls A and B is not mandatory and that other constructions may be used, provided the bio-sensors 819, 919 sensors are adequately held in place. Indeed, in a further embodiment the sensor strip could comprise a single plastic film strip, and the sensors and the leads could be treated with an adhesive finish on one side so that proper adhesion to the plastic film would be ensured by the sensors and leads themselves. In this construction, the side of the plastic film facing the socket would have an adhesive finish and the other side facing the stump or liner would have bio-compatible properties. The adhesive is “weak” so that the bio-sensor strip can be removed from one object and re-used on another object. Processes to manufacture bio-sensors in strips or in rolls is achievable through existing know-how and equipment to the persons skilled in the art.
In order that the invention may be well understood, there will now be described some embodiments thereof, given by way of example, reference being made to the accompanying drawings, in which:
The invention will now be described on the basis of the drawings. It will be understood that the embodiments and aspects of the invention described herein are only examples and do not limit the protective scope of the claims in any way. The invention is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the invention can be combined with a feature of a different aspect or aspects and/or embodiments of the invention.
Referring first to
In
In
The camera 211 is mounted above a single point laser device 213 which projects a conventional laser beam 236 onto a conical mirror 215. The laser 213 is arranged to focus the laser beam 236 on the vertex of the conical mirror 215, and the mirror surface of the conical mirror 215 reflects the laser beam 236 outwards from the plane of the base of the mirror 215 so as to project the laser line 201 extending from the plane of the base of the mirror 215. The scanned object, a prosthetic socket 216, is mounted on a fixing base 217 which does not move so that the scanned object remains stationary. A physical origin coordinate 212, identified by a circled cross ⊕ and placed on the surface of the socket 216 provides a spatial reference point which will be useful to orient and align the physical socket 216 with the virtual 3D model of the socket 216 and with the 3D profile of the bio-data.
In use, the devices support frame 210 moves vertically, starting from a top position where the laser 213 focuses its laser beam 236 on the conical mirror 215 and begins to scan the top of the socket 216. A line of laser light, the perimeter of which is represented by points line 201 is projected on the internal area of the socket 216, whereupon the process previously described of laser line acquisition, segmentation, calibration, distance-to-reference point calculation and line coordinates calculation is performed. These data are stored in a computer (not shown) and the motor 207 turns the linear screw 208 which in turn moves the moving support assembly 240 to the next incremental position, thereby lowering the devices support frame 210 one unit of movement (typically in increments of 5 mm, but this is not limiting of the invention). The entire process is repeated again in a new data acquisition stage until the entire socket 216 internal surface is scanned and mapped. At the conclusion of the process the data corresponding to each slice of socket surface is joined and a full 3D map of the lines is formed, thus rendering a virtual image of the socket 216 as previously shown in
It will be inferred that there is a blind spot on socket 216 mapping caused by the devices support frame 210, the arms of which will block the field of view of camera 211. In order to acquire the hidden points on the socket 216 surface, this may be achieved by installing a decoupling mechanism (not shown) between the moving support assembly 240 and the devices support frame 210, which will allow the support arms of the devices support frame 210 to rotate sufficiently, for the previously hidden portion of laser plane 201 to become visible to the camera 211 while the camera 211 stays in the same position.
Strips of bio-sensors 219 are arranged on the inside of the socket 216 and will record various biomedical parameters, as explained below. These bio-sensors 219 are described in more detail in connections with
The laser 313 and the camera 311 are mounted on the device supporting frame 310 that is attached to a moving support assembly 340. The moving support assembly 340 is connected to a linear screw 308 by a bushing 309 so as to be moveable towards and away (more frequently vertically) along the longitudinal axis of the scanned socket 316. The linear screw 308 is attached to the anchor frame 339 which will be attached to a solid, immovable surface or point such as a wall or an appropriate floor-standing apparatus housing 341. The linear screw 308 will be attached to a motor 307, which will rotate the linear screw 308 leading to a movement of the bushing 309 and consequently of the moving support assembly 340 and of all elements (310, 313, 311, 315) connected thereto.
The capturing element in the form of the camera 311 is mounted in a fixed position relative to the laser 313 but unlike the first aspect shown in
In use, the laser 313 and the camera 311 move together to scan and map the interior surface of socket 316. The optical element 315 diffracts the laser light so as to produce a projected laser cone 301 on the surface of the scanned socket 316, where the laser cone 301 is projected, whereupon the process previously described of line acquisition, segmentation, calibration, distance-to-reference point calculation and line coordinates calculation is performed. These data are stored in a computer (not shown) and the motor 307 moves to the next incremental position, thereby moving the devices support frame 310 one unit of movement (typically but not limiting of the invention, 5 mm), and the entire process is repeated again until the entire socket 316 surface is scanned and mapped. At the conclusion of the process the data corresponding to each slice of socket surface is joined and a full 3D map of the lines is formed, thus rendering a virtual image of the socket 316 as shown in
Unlike the first aspect shown in
A third aspect of the invention is shown in
In
In
However, in this second aspect shown in
Similar issues occur with the third aspect of the invention shown in
The relative orientation/position and origin of the field of views of the cameras 311 is known and thus by identifying a given physical reference (i.e. a point 301 of the projected laser beam) in the captured image by both cameras 311, it is possible to infer the relative position of the point 301 of the projected laser beam 337 to the reference axis. The reference axis has an origin between the cameras 311. This same physical reference of the point 301 captured by both of the cameras 311 is represent by different pairs of pixels in the two-dimensional images taken by the cameras 311 and it is this difference combined with the position and orientation between cameras 311 that enables the calculation of the three-dimensional position of the points 310on the projected laser beam 337.
To find the relative position between both of the cameras 311 (after being placed in the camera mount), several images of a given reference figure should be captured simultaneously by both cameras 311, at different distances and orientation to the cameras 311. For example, the given reference figure could be a chessboard, but this is not limiting of the invention. By identifying key-points in this reference figure in both of the captured images (either by manually picking or automatic processing) and previously knowing their real/physical distances between key points in the reference figure, it is possible to mathematically determine the relative position between the field of view of both of the cameras 311.
Both the sockets 316 in
It will be appreciated that the use of the two cameras 311, 511, 711 in the third aspect of the invention means that both cameras 311, 511, 711 need to be calibrated in order to know the precise relative position and pose between the two cameras 311, 511, 711 and the lens distortion in each of the two cameras. These parameters are always different due to manufacturing variability.
To calibrate the cameras 311, 511, 711 and to compensate for difference in the lens parameters of the cameras 311, 511 and 711, a method based on Zhang. “A Flexible New Technique for Camera Calibration” published in IEEE Transactions on Pattern Analysis and Machine Intelligence, 22(11):1330-1334, 2000, is used. This method requires a custom-designed camera mount which holds both cameras 311, 511, 711 and the laser 313, 513, 713 i.e. the same laser that will be used in the laser scanner system. In the calibration, a chessboard design placed in a flat surface is used as a reference figure. The dimensions of the squares of the chessboard is known. A number of pictures are taken simultaneously from both of the cameras 311, 511, 711 in which the chessboard is placed at different distances to the cameras 311, 511, 711 and at different orientations.
The corners of the chessboard of every pair of images taken from the cameras 311, 511, 711 are detected. The number of squares of the chessboard are known and thus it is simple to match the corners detected by both of the stereo images taken from the two cameras 311, 511, 711. The chessboard plane is considered to be at z=0, only leaving the problem to be solved only in this plane (with origin in one of the corners of the chessboard).
Each of the images is automatically processed in order to find the chessboard patterns, acquiring one conversion from the image corner pixels to the real 3D positions of the chessboard. This enables the computation of the intrinsic lens parameters for each of the cameras 311, 511, 711 (i.e. distortion coefficients), by trying to minimize the 2D<->3D re-projection error in all images. After carrying out this calculation, it is possible to use these 2D-3D correspondences to calculate the transformation matrix between the images from the two cameras 311, 511, 711.
This calibration enables the computation of the matrix which projects the images of both cameras 311, 511, 711 onto a common image plane, i.e., to rectify the images. This process makes it easier to find correspondences between the stereo images because the process aligns the image in such a way that theoretically it is only necessary to search along a single line (if the calibration is accurate, correspondent points are in the same row of the rectified images). After constructing the undistorted and coplanar image planes, the 3D reconstruction can be achieved by triangulation.
The power leads and data leads 820 made, for example, of silver ink are not illustrated in this
Side B1 of polymer film 825 on
The side A1 of the plastic film 824 will have one or more markings 830 on the surface. These markings are illuminated by the light source 220, 320 to locate the bio-sensors on the inside of the socket 216, 316 as explained previously. In one non-limiting aspect, the markings are multi-coloured roundels (concentric circles). The different colours are used to indicate differing positions or the different types of bio-sensors within the socket 216, 316. Currently, at least two markings per strip are required to uniquely identify the position of the bio-sensor strip 819, but a single marking could be acceptable.
Before use, the bio-sensor strips 819 are covered on the adhesive side with a peelable cover if dispensed in pre-cut strips, or not covered if they are dispensed in rolls. In use, the peelable covers are removed, the bio-sensor strips 820 are cut to the right size, if needed, and the bio-sensor strips 820 are applied to the internal surface of the prosthetic socket 216, 316, in the orientation best determined by the prosthetic fitting technician's experience.
The biosensor strips 819 can measure different types of biodata, which include but are not limit to pressure between the stump skin and the prosthetic socket surface, or temperature. In one non-limiting example, the biosensor strips are formed of a force sensing resistor comprising at least one polymer layer whose resistance varies on application of a pressure. The change in the resistance can be measured, for example, by a bridge circuit. In one aspect of the bio-sensor a plurality of polymer layers is used with different characteristics to allow a wide range of different pressures to be measured.
Furthermore, the spacing between the bio-sensor strips 921 can be adjusted to vary the resolution of the data obtained the bio-sensor strips 921 can be arranged closer together or even on top of each other with an offset in areas where greater data resolution is required. When evaluating pressure, a correct fit between the stump 932 and the socket 916 will produce uniform pressure distribution across certain areas of the surface of the socket 916, depending on the socket type, while a poor fit will produce areas of altered pressure which will be evidenced by more concentrated curves in the bio-data profile 929, in zones where this should not occur.
It will be appreciated that absolute values from the bio-sensors are not required. The values can be normalised or otherwise mathematically manipulated with respect to the maximum value recorded.
Artificial colour may be added to the bio-data profile 929 to create a heat map and thus illustrate the areas of pressure. Shifts in the colour may be used to differentiate between areas of equally uncomfortable areas of increased or reduced pressure, such as red for higher pressure, and blue for lower pressure. The prosthesis technician can therefore identify high pressure areas of the socket 916 which need fine tuning and shaping back as well as areas of lower pressure which indicate regions of the socket 916 which need building up. Other types of bio-data of interest may be represented using the same method.
The arrangement of the bio-sensors 919 on the bio-sensor strips 921 enables the system to be wearable, non-invasive, autonomous (with long battery time), modular, flexible (with different placement of sensors), scalable (more sensors as needed), and versatile (different type of modules/sensors).
The images of the bio-sensor strips 921 are drawn on the surface of the stump 932 to indicate their location in relation to the stump 932. The real origin coordinates 912 are actually or virtually drawn on the scanned socket 916 and the scanning and data acquisition apparatus produces the 3D image of the scanned socket 906.
An example can serve to illustrate this in more detail. Suppose the prosthesis is an artificial leg or an artificial arm. In use, the patient with the artificial leg is made to walk (in the case of a leg) or move (in case of an artificial arm) for a certain amount of time until sufficient bio-sensor data has been obtained from the bio-sensors 919 to produce the virtual 3D bio-data profile 930 comprising bio-data profile curves 929 of the pressure, temperature or any other bio-data of interest. The position of these bio-data profile curves 929 is known by reference to virtual origin coordinates 905 of the 3D bio-data profile 930.
It is also possible to combine the bio-sensor data with data from one of more inertial motion units which is carried by the patient and attached to the limb. The inertial motion unit will have three, six or nine axes and provide information about the changes in the data as the patient moves. This data can be used to characterise potential gait anomalies.
Furthermore, a light grid may be projected onto the patient's stump or over the surface of the actual socket 916 which is calibrated to the 3D socket model so as to help the prosthetic fitting technician to correlate the 3D image with the actual socket surface of the socket 916 and hence help identify the areas that need adjustment on the actual socket surface.
The purpose of the layering of the various data maps is to evidence the areas where pressure, temperature or other data are more intense, and which may indicate areas of pain or discomfort for the person wearing the prosthesis, or less intense which may indicate areas which lack support.
In
In
In
The alignment of the socket surface map 1106 and/or the 3D bio-data profile 1130 over the object of interest can be achieved by using the same origin coordinate in the real object (real origin coordinate 1112), in the socket surface map 1106 (virtual origin coordinate 1105) and in the 3D bio-data profile 1130 (virtual origin coordinate 1105), or by resorting to a best match algorithm, that computes the best geometrical match between two 3-dimensional objects.
The method will now be described with respect to the flow diagrams shown in
The method for creating the surface map is shown in
The present invention comprising the use of the bio-sensors, the mapping of the internal surface of the prosthetic socket, the generation of bio-data related to socket/stump fit and the identification of socket areas which require adjustment represents several economic and comfort benefits. The method is non-invasive, unobtrusive and does not require a clinician's attendance. It saves considerable time in the fitting process, thereby reducing cost and increasing the patient's quality of life.
| Number | Date | Country | Kind |
|---|---|---|---|
| 100021 | Jan 2017 | LU | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/050892 | 1/15/2018 | WO | 00 |
