WO2011113101A1

WO2011113101A1 - An improved palpation monitor

Info

Publication number: WO2011113101A1
Application number: PCT/AU2011/000297
Authority: WO
Inventors: Terence Vardy
Original assignee: Terence Vardy
Priority date: 2010-03-17
Filing date: 2011-03-17
Publication date: 2011-09-22

Abstract

The present invention is directed to a palpation monitor (20) for including a stirrup (21) which is fitted about a limb (11) of a patient (10), the stirrup (21) being coupled to a data collector (22). A plurality of sensors (24) are provided on the stirrup (21) the sensors sending capturing data relating to a number of physiological parameters associated with the patient including pressure exerted on the limb, temperature or humidity. The captured data is stored in the data collector for subsequent analysis to identify palpated features on the limb (11).

Description

AN IMPROVED PALPATION MONITOR

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to a palpation monitor. More particularly, the present, invention relates to a palpation monitor for amputees and persons engaged in physical medicine and medical/surgical procedures.

Discussion of the Background Art

Many manual treatments involve palpatory diagnosis and/or manual manipulation of a patient by a physician/therapist. Therapists are usually trained in such diagnosis and manual manipulations and learnj over a period of time, the pressures that should be applied to a patient.

There is often, considerable variation in palpatory diagnosis and the manual manipulation Of a patient between different physicians/therapists see.W to. apply the same, or similar, diagnosis -and treatment. . In addition, there can also . be considerable variation in the pressures applied to a patient by a single therapist during different diagnosis and/or treatment/surgical sessions. It will be appreciated that the manual manipulation of a patient is generally subject to considerable variation.

Furthermore, not Only does the pressure and technique vary, but the results can vary, For example, one physician/therapist may measure, determine, and diagnose certain characteristics and/or palpated landmarks^ while another may diagnose different characteristics and/or palpated landmarks. The same physician/therapist may even have different outcomes on different days, particularly if each palpatory diagnosis is separated by a substantial period- of time. Yet further,, it is necessary for a trained physician/therapist to perform palpatory diagnosis, as inexperienced people may lack the necessary skills and/or experience. Accordingly, if a patient is rhonjtpring a particular condition, it is necessary for the patient to make frequent visits to the physician/therapist to have the palpatory diagnosis performed.

In some cases, such as for amputees, it is desirable to monitor palpatory diagnosis over a period of time. Typically a physician/therapist keeps a log (e.g. a written log) of each diagnosis for comparison, but differences in other factors (e.g. sensitivity, temperature, etc.) can alter the diagnosis. These variations can hinder, or even prevent, a reliable diagnosis being obtained efficiently, as well as increasing the time taken to compare previous palpation results. Additionally, it is not possible for a physician/therapist to continually measure and/or monitor a patient over a significant period of time, or while the patient is performing most actions (e.g. walking, running, sleeping, etc.).

Clearly it would be advantageous to provide an improved palpation monitor which overcomes or ameliorates one or more of the disadvantages or problems described above, or which at least provides a useful alternative.

SUMMARY OF THE INVENTION

Disclosure of the Invention

Accordingly in one aspect of the present invention; there is provided a palpation monitor comprising:

a stirrup having one or more pressure: sensors, wherein the stirrup is adapted to fit a portion of a body in use; and

a data collector that receives data output from the one or more pressure sensors.

Preferably the stirrup is adapted to fit a portion of a limb and, more preferably, the limb of an amputee. Preferably the stirrup is adapted to fit a truncated leg and or truncated arm (e.g. a leg and/or arm that has been amputated).

The stirrup may comprise flexible strips. In an embodiment, the stirrup comprises flexible sensor strips that have one or more pressure sensors along at least a portion of one or more of the strips. The stirrup may comprise fitting and/or fastening elements such as, for example, straps, Velcro, buttons, clasps, padding, or the like.

The stirrup may be configured to ensure it is fitted in the same orientation each time. The stirrup may also be configured to allow alignment of the stirrup in relation to the portion of the body. Consistent fitting and/or alignment of the stirrup improves comparisons between two results of different fittings, and therefore reduces errors that may be introduced by different fittings. For example, in one fitting a pressure sensor may be located directly adjacent a palpated landmark, where in another fitting, the pressure sensor may be located differently, meaning the pressure sensor is no longer located directly adjacent the palpated landmark. This may cause a therapist and/or operator utilising the monitor to incorrectly determine that the palpated landmark has changed.

Additional sensors and/or data acquisition elements may be utilised. For example, one or more temperature sensors, humidity sensors, pulse sensors, infra-red sensors, ultrasound sensors, and/or GPS locators may be utilised. In an embodiment, the stirrups comprise sensor strips that measure/capture a plurality of different physiological data including pressure, temperature, pulse, individual circulatory patterns, humidity, location, and distance travelled, and speed. However, it will be appreciated that depending on the circumstances, more or less physiological data may be determined (e.g. by using different types and/or quantities of sensors).

The one or more pressure sensors may comprise discrete sensors at specific locations on the stirrup, an array of sensors, and/or a pressure sensing area. Where the one or more pressure sensors comprises a pressure sensing area, preferably the pressure sensing area determines not only pressure, but also the location in the area that the pressure is being applied. The pressure sensor may determine variations in pressure over the area which may be utilised to identify locations of increased pressure and/or palpated landmarks. Preferably the resolution of a pressure sensing area is sufficient to determine the location and intensity of both small and large palpated landmarks. The output from a pressure sensing area may be displayed as a three dimensional image, or as a two dimensional area with markings, gradients, and/or other suitable indicators showing the location and intensity of pressure over the area.

The pressure sensor may be any suitable sensor (or sensing means) such as, for example, capacitance sensors. In an embodiment, capacitance sensors that measure the capacitance between two electrodes are utilised, wherein moving the electrodes closer together or further apart changes their capacitance. Preferably, the palpation monitor also comprises one or more temperature sensors. In an embodiment, the one or more temperature sensors include a thermistor.

The data collector that receives data output from the one or more pressure sensors may receive data output from all of the sensors (e.g. pressure-, temperature, etc.). In an embodiment, the data collector is in electrical communication with the sensors of the stirrup by one or more data cables. Preferably the data cables are light, flexible, and durable. As an alternative to having data cables, the data output from sensor(s) may be transmitted wirelessly (e.g. between the sensors and the data collector).

Additional information as to the patient's ambulatory status may be obtained from real time video systems in sequence with the sensor data collection.

The palpation monitor may further comprise a data analysis device and/or a data storage device. The data collector is preferably communicable with the data analysis device and/or data storage device. Preferably the data analysis device considers received data in real time. The data analysis device may convert the data into a dispiayable form for output to a display. The display may show real time results and/or visual representations of the sensor output(s).

The palpation monitor may further comprise data storage, a computer, and/or an interface device. For example, the data collector may store the data remotely in a computer database, and/or may be interfaced with a handheld device such as a personal digital assistant (PDA) or a phone. The data collector preferably has sufficient storage capacity to store data output from the sensor(s) locally, to be uploaded or downloaded at a later date. This may be utilised for periodic or request based transfers, or for when the data collector is out of range of remote storage (e.g. a suitable computer).

Preferably any communication between the sensor(s) and the data collector, and between the data collector and any other devices (e.g. a computer) is private and secure. The data may be encrypted, and preferably any wireless communication is encrypted to prevent unauthorised access and/or capture of the data.

The sensor output and/or data analysis device may be adapted to identify a person/patient. Such identification may be performed by identifying and comparing distinguishing features such as, for example, palpated landmarks. A combination of physiological variables may be utilised for identification purposes. Identification may be established using vascular mapping, with an initial mapping being stored in a file of a patient, and subsequent mappings being compared for identification purposes. Identification of a patient may automatically open their file in a database for recordation/recordal, comparison, and analysis of output data with historical data.

The palpation monitor may further comprise a manoeuvrable sensor used in conjunction with, or in addition to, the stirrup. The manoeuvrable sensor preferably has one or more pressure sensors and may be used by a person (e.g. a physician, therapist, patient, and/or wearer). For example, the manoeuvrable sensor may be utilised to effect accurate and measurable manual manipulation treatment to a patient.

In many treatments, and diagnosis, a therapist will utilise their fingers and thumbs. In such diagnosis and treatments, the pressure sensors of the manoeuvrable sensor may be applied to the fingers and thumbs of the physician/therapist. In other treatments, the physician/therapist may apply pressure to a patient using the palm of a hand, the forearm, the elbow, or other regions of their body. The manoeuvrable sensor may be worn by the physician/ therapist with one or more pressure sensors over those zones in order to measure pressure applied by the therapist to the patient. The pressure sensors may be of any convenient configuration that can be connected to a monitor. For example, the pressure sensors may be selected from the group consisting of pressure transducers, load cells, piezoelectric sensors and the like.

The pressure sensors may be worn by the physician/ therapist by attaching the pressure sensors to gloves, finger pouches, patches such as may be readily attached to the physician/therapist's clothing (e.g. by hook and loop fastener). The pressure sensors may be attached to an electrical connection on the physician/therapist such as clipped to the physician/therapist's belt or on a suitable vest configured to house the electrical connections.

The manoeuvrable sensor may provide feedback to a physician/therapist in order to allow them to monitor and/or regulate forces applied to a patient during diagnosis and/or manual manipulation. Manual manipulation of the patient by a physician/therapist is preferably conducted by having the pressure sensors at particular pressure zones, the pressure sensors being connected to a monitor that provides feedback to the physician/therapist with respect to the pressure applied to the patient during manual manipulation and diagnosis.

The feedback may be in the form of an audio and/or visual signal that indicates or instructs the physician/therapist to provide more or less pressure to the patient. One of the advantages of providing visual feedback may be that it is possible to display feedback for individual pressure zones so that not only the total pressure is optimised, but also pressure applied from individual zones. By providing feedback specific to individual pressure zones, the balance of the force applied during palpatory diagnosis and manual manipulation may be monitored and/or controlled. One or more reference points may be utilised to identify the location of the sensors/zones, particularly where there are certain known areas of interest.

Data from various treatments and diagnosis may be captured from the data collector and stored and/or compared. Stored data may be compared to design subsequent treatments to optimise therapeutic effects. A physician/therapist may wear a manoeuvrable sensor having pressure sensors on pressure zones, the pressure sensors being connected to a monitor, wherein the monitor includes a recorder for recording and comparing manipulations from a series of therapeutic treatments. The data recorded in may be used to review patient treatments and/or to programme continued treatments in order to optimise healing effects. It will be appreciated that a variety of different recording media and analytical means may be used to record and compare data from a series of therapeutic treatments.

The manoeuvrable sensor may also be utilised for training students/physicians/therapists in a variety of manual manipulation treatments and diagnosis. Manual manipulation of a patient by a physician/therapist wearing the manoeuvrable sensor having pressure sensors on pressure zones may provide feedback for a physician/therapist to train (and learn) techniques for the manual manipulation and diagnosis of a patient.

The palpation monitor may be utilised with a prosthetic/artificial limb, or the like. The palpation monitor may comprise a prosthetic limb having a body receiving portion, wherein the stirrup is located within the body receiving portion, such that it resides adjacent a portion of body received therein. The palpation monitor may then be utilised to provide real time, periodic, and/or continuous monitoring of palpations (and/or other physiological elements), particularly in relation to the adjacent portion of body. In one embodiment of the present invention the one or more sensors could be provided in addition to those on the stirrup could to provide feedback to the patient by applying a vibratory pulse or the like at a point behind the patients ear. In such instance the additional sensors would apply the pulse based on the pressure data obtained from the sensors on the stirrup to assist the user in better guidance of a prosthesis.

The palpation monitor may be powered by any suitable means including via a cable, and/or by a local power source. The local power source may comprise a power storage device (such as a battery and/or supercapacitor), and/or a power generator (such as a kinetic generator that converts movement energy into electricity).

According to a second aspect of the invention, there is provided a method of monitoring palpations, the method comprising the steps of:

identifying a patient; fitting a stirrup of a palpation monitor having one or more pressure sensors onto a portion of the patient;

and collecting data output from the one or more pressure sensors.

Preferably the collected data is stored. Preferably the collected data is compared to historical data (if available). The data output from the one or more pressure sensors may be displayed in real time (or near real time) on a display..

The method may further comprise the step of manual manipulation of a portion of the patient by a physician/therapist. The physician/therapist may wear pressure sensors oh one or more pressure zones, said pressure sensors being connected to a monitor. Preferably the pressure sensor(s) are arranged on a worn element, such as a glove (or partial glove) to enable the physician/therapist free movement. The step of manual manipulation may comprise monitoring feedback.

BRIEF DETAILS OF THE DRAWINGS

In order that this invention may be more readily understood and put into practical effect, reference will now be made to the accompanying drawings, which illustrate preferred embodiments of the invention, and wherein:

Figure 1 illustrates a view of an embodiment of the invention about to be used on a leg amputee.

Figure 2 illustrates a view of an embodiment of the invention about to be used on an arm amputee.

Figure 3 illustrates a view of a manoeuvrable sensor in the form of a partial glove to be v orn on a hand. ^■ .

Figure 4 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 5 is a flow chart illustrating a portion of. a palpation monitor database system. Figure 6 is a flow chart illustrating ^'a portion of a palpation monitor database system.

Figure 7 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 8 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 9 is a flow chart illustrating a portion of a- palpation monitor database system.

Figure 10 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 1 1 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 12 is a flow chart illustrating a portion of a palpation monitor database system.

Figure 13 is a flow chart illustrating a portion of a palpation monitor database system

Figure 14 is a flo chart illustrating a portion of a palpation monitor database system

Figure 15 a schematic diagram depicting a sensor assembly of a palpation monitor database system according to one embodiment of the present invention;

Figure 16 depicts a sensor calibration screen for the manoeuvrable sensor array of a palpation monitor database system aceording to one embodiment of the present invention;

Figure 17A and 17B depict the calibration process for the manoeuvrable sensor array of Figure 3 of a palpation monitor database system according to one embodiment of the present invention;

Figure 18 is a plot of pressures applied through one or more sensors the manoeuvrable sensor array according to one embodiment of the present invention; and

Figures 19A and 19B depict 2D and 3D displays of the sensor data collected from the sensor assembly or manoeuvrable serisor array of a palpation monitor database system according to one embodiment of the present; nvention. DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Figure 1 and 2 illustrate a person 10 having an amputated limb 11. A palpation monitor 20 is shown, including a stirrup 21 , a data collector 22, and cables 23 connecting the data collector to the stirrup 21. The stirrup 21 has a plurality of sensors 24 thereon (only a portion of which are labelled). In an embodiment, the sensors are all (or at least primarily) pressure sensors. However, it will be appreciated that other sensors, such as temperature or humidity sensors, could also be utilised. In use, the stirrup 21 is fitted to the end of the amputated limb 1 1. The pressure sensors 24 are then able to detect and analyse palpated features on the limb 11.

The data collector 22 contains electronics (e.g. PCB, ICs, etc.) to capture data from the sensors 24, and convert them to a streamed signal that can be transmitted. The streamed signal can be transmitted by any suitable means (e.g. by cable, wireless) but is preferably by transmitted using a known protocol, such as USB (wired) or Bluetooth (wireless). The streamed signal may be re.ceived by any suitable device such as, for example, a computer, PDA, phone, or the like, Communication between the data collector 22 and any other device may be encrypted, and may be one way (e.g. from the data collector to the device) or two way (such that the device can send signals and/or instruct the data collector). Where the data collector utilises wireless communication, it preferably has a battery as a power storage device such as, for example, a lithium-ion battery. Although the illustrated embodiment of the data collector 22 is as a standalone box, it is envisaged that the data collector itself could also be a computer (e.g. a laptop) or a handheld device (e.g. a PDA, smart phone, or a proprietary device).

In an embodiment, the data collector 22 has several fitting accessories to enable easy fitment to a person 10. For example, the data collector may be fitted to a person using a belt clip, garter system, or can simply be placed in a pocket. Data transmitted from the data collector 22 is received by a server and processed and stored in a database. Captured data and/or analysis information may be retransmitted to any authorised computer, laptop, or PDA (or other suitable device). A user of the system (e.g. the person 10 or another person such as a therapist, or the like) can preferably view in real time, or at least near real time, the test and/or monitoring data from the palpation monitor 20 being worn by the person 10, The data collector 22 has local storage to store collected data from the sensors 24 even when it is not in communication with a remote data storage device (e.g. server).

The cables 23 are light and unobtrusive, preferably made of a flexible and strong material to ensure a long service life. It is appreciated that with advances in reducing power efficiencies and in miniaturisation that the need for a physical box for the data collector 22 may be reduced, and the requisite electronics could be integral with the stirrup 21.

The sensors 24 may be used to not only capture pressure, but also pulse, temperature, weight distribution/balance, impact pressure, humidity, circulatory patterns, infra-red, ultrasound, and/or absolute identification using vascular mapping.

The palpation monitor 20 may be used by physician/therapist and/or a patient. Preferably the physician/therapist and/or patient can connect directly to the data collector 22, or at least to a server containing information, using a transmitting device through a secure connection via a PDA, phone, laptop, computer, or the like, to connect to a server and extract data once the data stream has been processed by the server. A selectable display of captured data allows the therapist and/or patient to see near real time bio feedback from the system.

Figure 3 illustrates a manoeuvrable sensor 30 fitted to a hand 31 of a wearer. The manoeuvrable sensor 30 has a plurality of pressure sensitive regions/zones 32. Namely, the manoeuvrable sensor 30 has a thumb sensor 32, finger sensors 33, a ring or 'band aid' sensor 34, and a palm sensor 35. The manoeuvrable sensor 30 may be connected to the data collector 22, and used in conjunction with the stirrup 21. For example, a physician/therapist may use the manoeuvrable sensor 30 to manually diagnose and/or treat certain regions. Figure 4 depicts an initialisation procedure for a palpation monitoring system or biofeedback system according to a preferred embodiment of the present invention. As shown on commencement of the initialisation procedure 401 the system determines whether a backup of all system data is necessary 402. In the depicted example the backup is prompted based on the amount of time which has lapsed between successive backups. If the time between backups exceeds a pre-set threshold (in this case the threshold is set to month between successive backups) the system commences a backup by prompting the user to specify a destination such as a drive (e.g. an external hard drive or other removable media e.g. a flash or USB drive or optical storage media such as a CD/DVD) or directory to which the backup is to be stored 403 before proceeding to create the-backup data file.

If the length of time between backups does not exceed the threshold value then the system prompts the user as to whether they wish to perform a backup 404. If the user elects to make a backup, the system then request the user to specify a destination drive (e.g. an external hard drive or removable media g. a flash or USB drive or optical storage media such as a DVD) or directory to which the backup is to be stored 405. Once the user has decided whether or not to create a backup 404 the system then determines whether this is the first time the system has commenced its operation 406, if so, the system proceeds to prompt the user to enter initial system settings 407.

As will be appreciated by those of skill in the art the initialisation procedure is preferably executed in software and could be run on a computer or locally on the palpation monitor 20.

Once the initialisation procedure is complete, the system proceeds to the account creation verification phase per the flow chart illustrated in figure 5. As shown the system prompts the user for their credentials to effect system login 501. e.g. user name and password. Alternatively, other forms of user identification such as, for example, biometric identification i.e. finger print scan, rental scan, voice print verification or combination thereof could be utilised to effect system login. Once logged in the system then determines whether the user has an existing account 502. If so the system then presents the user with the option to change their existing setting 504. Should the user elect to modify their existing settings they are then presented with various setting selections 505.

In event that the user does not have an existing account the system proceeds to create an account for the user 503. During account creation the user has the option to create a voice profile for various functions such as dictation and voice print ID where biometric identification is provided. In addition to the creation of the voice profile the user may also configure a number of personal settings relating to the system. Once the account setup is complete the system then proceeds to step 504 discussed above. It will of course be appreciated by those of skill in the art that for newly created accounts the option to alter existing settings is in all likelihood to be answered in the negative, unless of course the user has exited account set up prematurely in which case they can adjust their setting by entering step 505 as discussed above.

Once the user has set up their account they are then presented with a number of tabs relating to different system functions. The flow charts illustrated in figures 6 to 14: illustrate functionalities provided under various tabs which may be provided in one or more preferred embodiments of the present invention.

Figure 6 in this instance depicts a number of tabs including Digital control 601, add notes 602 and change sensor settings 603. On selection of the tab 601 the digital control and alert settings the user is required to select a subject 604 (e.g. a specific patient associated with a particular palpation monitor 20). Once the system is provided with the relevant subject's details it then requests the user to select the relevant data parameters for a control sequence 607. The system then requests the user to set the event type required and the parameters to trigger the selected event 610. I addition to setting the event type and its trigger, the user is also required to set alerts and the digital device channels for the article prior to a test of the new control and alert settings is performed. Once the user has set the relevant parameters in step 610 the system then saves the settings 613 to the system database 100. Once the parameters are saved the system proceeds to perform a set of tests for the control sequence, the results of which are then presented to the user. The user is then able to select the data from the test data for display 616. The resultant selections are then displayed on screen along with the digital control sequence 619 for comparative analysis.

As with the selection of the -digital control and alerts tab 601 , selection of the add notes and dictation settings tab 602 causes the system to prompt the user to select the desired subject 605. Once the user has selected the desired subject the system prompts the user to select the data to which the addition of notes etc. is to be made 608. On selection of the desired data the user is then required to log into the relevant account (profile) 611. The user is then prompted to select relevant vocal profile 614 before dictating notes into the selected data file 617 for the identified subject. The updated data is then stored 626 to the systems database 100. The user may then select the newly annotated data 622 for review. The selected information is then displayed on screen allowing the user to double check the notes and make any corrections if necessary 624·

As in the cases of the above described tabs selection of the change sensor settings tab 603 again causes the system to request selection of the desired subject/device 606 for which the relevant sendr settings are to be altered. Once the subject/device has been identified the system then prompts the user to select the senor for adjustment 609 from the group of sensors within the stirrup. The user having selected the relevant sensor from the group of sensors within the stirrup they are then able to adjust the settings associated with the selected senor 612. After the settings tor the selected sensor are adjusted the system proceeds to test the new setting 615 prior to saving the new setting 618 locally on the device. The test results along with the new sensor settings are then saved 621 to the systems database 100. The user may then select the data associated with the new senor settings from the test results 623 for display and review 625.

Figure 7 depicts one possible process for data acquisition and analysis under a tab based system according to one embodiment of the present invention. In the depicted example the data acquisition process is initiated via selection of the monitor tab 701. on selection of the monitor tab the system request the user/operator to enter the. relevant information relating to the subject 702. A set of dropdown menus and checkboxes etc. could be provided to assist with entry of this information. The information from step 702 is then used to create a new patient data file or to appended data to an existing patient file as the case maybe 703, which is then stored to the systems database 100. Once the relevant information on the patient subject has been captured, the user js able to start a new data collection session by clicking the begin new session button. On commencement of a new session the system firstly determines whether the senor equipment (i.e. stirrup 21 and a plurality of sensors 24) is connected 704. In the event that the sensor equipment is not connected the system advises the user that the senor equipment is not connected 705.

If the sensor equipment is connected (or connected subsequently as a result of step 705) the system then makes available a sensor data screen 706 which contains a number of tabs relating to the operation of the sensing equipment. In this example the sensor data screen includes two tabs one for actuating a series of test 707 the other for monitoring parameters associated with the patient 708, On selection of the run test tabs 707 the user is able to adjust/verify the current settings 709 for the sensors before selecting a sequence of tests 711 to be performed. In the depicted example the selected tests are run in series and may include, impact tests 713, pressure/balance distribution 715, pulse/temperature and humidity 717, GPS and speed 719 and circulatory tests 721. The system may then perform a vascular mapping for identification purposes 723.

As in the case of the selection of the run tests tab 707 the selection of the monitor patient tab 708 causes the system to prompt the user to adjust and verify the setting 710 associated with the sensing equipment. Once the settings have been verified the user is then free to select one. or more sensor outputs for viewing and/or filter the outputs 712. The user may then select a series of tests to perform from an array of p re-set test if anomalies such as abnormal pressure or temperature are detected 714. The system then performs the selected tests 716, the results collated 718. The user is then queried 722 as to whether the wish to analyse the data collected 720 from the test performed under the run test tab 707 and/or the monitor patient tab 708. In the event that analysis is not required at this particular juncture the collected data 720 my then be stored within the patient's data file for further processing via selection of the analyse data tab 724 i.e. once the current data acquisition session is complete. Selection of the analyse data tab 724 causes the system to compare the data collected at 720 against prior samples for the patient stored in their profile on the database 100 and display the results as a graph construction 725 the resultant construction is then saved 726 to the database 100. As shown if the user's answer to query 722 is in the affirmative the system proceeds immediately to the comparative analysis of step 725 (i.e. comparison may occur in real-time as additional scans of the patient are performed).

Illustrated in figure 8 is a flow chart relating to the display and collection data via the process discussed in relation to figure 7. In this case the collected 801 for example may be displayed to the user on a handheld device such as a PDA, Smartphone or the like. In the illustrated example the user has the option to select data 802 for display on screen 803, or to rerun the test 804. Any data obtained during rescanning on selection of the rerun test option 804 may then be saved 805 to the system database.

Figure 9 depicts the operation of the view patient data 901 and Analysis 902 tabs according to one embodiment of the present invention. As shown selection of the view patient data tab 901 cause the system to requests the user to select the desired subject/patient 903. This could be conducted in a variety of manners such as entry of personal details pertaining to the patient or a patient ID number etc. The user is then required to select the desired data pertaining to the selected subject for subsequent display 905. The selected information is then displayed 907, at which time the user may then be presented with the option to export the selected data for further analysis via programs such as Microsoft Excel or the like.

Selection of the analysis 902 tab in this instance facilitates the commencement of a new data session 904 which requires the user to select the desired patient data and relevant doctor's database (i.e. recent or past data annotated by consulting specialist or patient GP) 906. Once the relevant data for analysis is specified the system then allows the user to set a number parameters associated with the analysis to be performed as well as adding various mathematical calculations (e.g. statistical modelling etc.) to further assist in the analysis of the specified data 908. At this stage the data on the senor/s utilised e.g. configuration etc. may also be utilised as part of the analysis. The user can then select the portions of the analysed data 910 for subsequent display 912 for example the displayed data may simply be a full replay of collected (raw data) or modified data (i.e. post analysis).

With reference to figure 10 there are illustrated a number of additional tabs which may be implemented under the system of the present invention, In this case the additional tabs include a compare tab 001 , an import/export tab 1002, an email tab 1003 and a print tab 1004.

As suggested the print tab 1004 in this instance is provided to enable the user to print 1005 the data they are currently viewing to a printer or to a file (e.g. a PDF file or the like). Likewise the email tab 1003 is provided to allow the user to attach or send the data to a third party via email. Selecting the email tab causes the system to open an email form 1006 with the current data results attached. On completion of the form 1007 by the sender/user the system verifies if an email client^' has been configured 1008, if so the system then queries the user as to whether the wish to encrypt the email 1010. If encryption is desired the system proceeds to apply appropriate encryption 1011 to the email before it is sent 1012. In the event that the email client is not configure the system proceeds to configure the email client 1009, prior to prompting the user for confirmation on whether they wish to use encryption 1010 before sending the email 1012. If no encryption in either case is required then the system proceeds to send the email 1012.

The comparison tab 1001 in this particular example provides the user with the ability compare data from two or more sensors. On selection of the compare tab 1001 the user is provided with displays from two or more sensors 1013 each display can display data for comparison. For each display the user is free to select desired patient data and relevant doctor's database (i.e. recent or past data annotated by consulting specialist or patient's GP) for comparison 1014. The user is also able at this stage to add information as to the type of test being performed e.g. test name etc. The user may then be provided with the optiori to add additional analytical tools ^• to modify the data display such as mathematical calculations etc. 1015. The user is then able to select various portions of the data displayed in each of the displays 1016 (i.e. isolating a portion of the images within each display for display further detail etc,), the ^"resultant selections are then displayed oh screen 1017.

The import export tab 1002 enables the user in this instance to import data , from backups etc. or export the data to a select storage media etc. On selection of the import export tab 1002 the system queries the user as to the type of operation to be performed i.e. import/export 1018. In the illustrated example the system simply queries the user as to whether an import is to be performed if the query is answered in the negative the system assumes that an export is to be performed in which case it requests the user to specify the destination media 1020 to which the data is to be exported e.g. thumb or CD/DVD drive etc. On receipt of the specified destination the system then checks to see if the destination is valid 1022 i.e. thumb drive is mounted, blank CD/DVD inserted into drive etc. If the specified destination is not valid the system requests the user to respecify^' the desired destination 1023. Once the system has determined that the specified destination for the export is -valid it proceeds to export the selected data to the destination 1025. On completion of this operation the system then confirms the export 1027. The system then enables the user to encrypt the data 1029, if encryption is required the system applies the appropriate level of encryption 1030 before confirming completion of the export 1031 whereon the system advises the user that it is safe to: remove/Unmount the relevant destination - media 1032.

In the case of a data import (i.e. the user answers in the affirmative at step 818), the system request the user to specify the drive, directory etc. in which the data to be loaded is located 1019. The system then verifies whether the specified drive or directory is valid 1021 and if the specified import location is not valid the system requests the user to ensure that the specified drive^ is mounted etc. or .whethje^'r the _: directory is correctly specified 1023. Once the system has determined that the specified drive or directory containing the data is valid it proceeds to import the specified data 1024. The system the checks to see if the imported data has been encrypted and if so it proceeds to decrypt the data 1026 before notifying the user of the successful importation of the specified data 1028, i.e. imported data safely stored on system database 100.

Fig 1 1 depicts the operation of a set up tab 1101 according to one embodiment of the present invention. As shown selection of the set up tab 1101 causes the system to determine if a connection to a server is present 1 102 if so the system then asks the user to select the comm port and monitor system 1103 (i.e. the port to which stirrup 2 and plurality of sensors 24 are connected and other operating parameters of the apparatus). Once the comm and monitor settings are established the system then enables the user to adjust the system's data settings to ensure data compatibility 1004, The option to link the system to additional external data sources such as doctor's databases and websites etc, may then be presented to the user 1 05 before the desired settings are written to the system config file 1106. As illustrated In the event that a server connection is not present at step 1102 the system proceeds to check the current port number assigned and ensure that a monitor is system is attached 1107 before requesting the user to manually assign the require settings.

Figure 12 illustrates the functionality of the help tab according to one embodiment of the present invention. As shown selection of the help tab 1201 pulls up a detail html based help system 1202 which may be itemised with help videos, troubleshooting tips and setup instructions which the user is free to browse.

In one embodiment of the present invention patients may be provided access to their data file. Figure 13 depicts one possible arrangement for providing remote access to a patient to their data file for the purposes of biofeedback. As shown the patient is able to remotely log into 1301 the system database 100 utilising a remote access point which could be a standard PC or mobile device such as a smartphone, PDA, IPad or other portable computing device. Once logged in the patient is then provided with limited access 1302 to their data file, in this instance the patient is only able to display select data. The patient is then able to select data utilising their PC or portable computing device 1303 for display 1304, providing them with biofeedback in real-time or near real-time.

The operation of the exit tab 1401 is shown in figure 14; To exit the system the user selects the exit tab 1401 which causes the system to prompt the user to create a backup 1402. If the user elects to create a backup before exiting the system request the user specify a destination (e.g. an external hard drive or removable media g. a flash or USB drive or optical storage media such as ¾ DVD Or directory) to which the backup is to be stored 1403. Once the backup is created the system shuts down 1404. In the event that the user does not wish to perform a backup at step 1403 the system proceeds to shutdown 1404.

Fig 15 depicts one possible arrangement of a sensor assembly (stirrup) 1500 in the form of a tactile sock for use in the palpation monitor of the present invention. As shown the assembly 1500 includes a plurality of elongate members 1501 -t , 50 ₂, 501₃,150 ₄ attached to collar 1502, Each of the elongate members 1501 ¾, 1501₂,1501₃,1.5014 includes a pocket for receipt of a tactile sehsors 1503i, 1503₂,1503₃,1503₄. As shown each of the sensors 1503i, 1503_2l1503₃,1503₄ run the entire length of the elongate member and extend into lower section 1502i of the collar 1502. The tactile sensors 1503i, 15032,15033, 1503₄ are flanked on either side by strips 1504 of silicon foam which have a similar thickness and stiffness as the sehsors 1503i , 15032,1503₃,15034.

The portion of 'the 1503i, 1503₂,1503₃,1503₄ extending into first section 1502i in this case includes the drive electronics 1507 for each sensor which are coupled together to form a sensor array. The sensor array is coupled to a wireless transmitter module 1505 housed in upper section 1502₂ of the collar 1502, also housed in the upper section 1502₂ is battery 1506. The collar 1502 in this instance is designed such that when the sensor assembly is in use the upper section 1502₂ is folded over the lower section 502i to form an envelope which conceals and protect the array's electronics. The envelope in this particular case is formed by the engagement of a one or more Velcro tabs disposed along the upper and lower sections 1502₂, 1502i . In use the collar 1502 is wrapped around and secured to a portion of the truncated limb of a subject. The elongate members 1501₂,15013,15014 extending downwardly along the limb from the collar 1502 such that the sensor pair 1503i, 1503_3l are orthogonal to sensor pair 15032, 1503₄ with the ends of the sensors finishing adjacent the head of the truncated limb. In some cases the ends of the elongate members and the sensors may be overlapped over the head of the truncated limb. The elongate members and sensors maybe held against the skin of the truncated limb by suitable medical adhesives, surgical tape or the like or by the use of a stocking etc.

In one embodiment of the present invention the one or more sensors could be provided in addition to those on the stirrup could to provide feedback to the patient by applying a vibratory pulse or the like at a point behind the patients ear. In such instance the additional sensors would apply a pulse based on the pressure data resulting from the patient use of the prosthesis captured by the sensors on the stirrup in order assist the patient for example with better guidance of a prosthesis.

The construction of the sensor assembly (stirrup) 1500 is advantages as it permits the sensors and other electronic modules to be readily removed from the sock td ^' readily facilitate cleaning of the sock. Regular cleaning is desirable as it prevents sources of irritations to the skin of the limb and subsequent risk of infections developing,

Figure 16 depicts one possible user screen for use in the calibration of the manoeuvrable sensor discussed in relation to figure 3 above. In this case such a user screen could be produced for example on selection of the desired sensor in step 609 of the changes sensor settings or as part of the system set up performed during the setup process depicted in figure 11 , As shown the screen of figure 16 includes a main display 1601 which depicts a left 1602i, and right 1602₂ hand, each hand 1602i, 1602₂ includes a plurality of check boxes 1603 denoting possible sensor positions. In this particular example a number of check boxes on the left hand 602^ have been selected denoting that the sensors have been placed on the tips of the thumb and figures of the users left hand as ell as the thenar. In addition to the check boxes the user is also presented with a number of buttons such as the clear left 1604_ή and clear right 1604₂ which enable the user to clear all check box selections on either hand. In addition to the clear button a set of navigation buttons back I6O6₁, next 1606₂, and cancel I6O6₃. The back and next button allows the user to navigate back and forward between various screens in the present case the back button is greyed out indicating that the back functionality is unavailable. Clicking the next button causes the system to call up the next screen in the calibration process which is discussed in relation to Fig 17A and 17B in greater detail below. Selection of the cancel button as indicated cancels the calibration setup and returns the user to the main selection screen.

Figure 17A depicts one possible arrangement of a calibration test screen 1701 according to one embodiment of the present invention. As shown the calibration screen provides a listing 1702 of all sensors selected via the user screen shown in figure 16 discussed above. The listing in this example not only identifies each sensor but also lists their status as calibrated or un-calibrated. The screen also provides the user with the ability to set the target, pressure for calibration 1703 and the relevant units 1704. A tare button is also provided 1705 for zeroing the pressure sensor when the User is simply resting the sensor 33 and 35 against the calibration sensor 1707 (see Figure 17B).

Once the user clicks the begin button 1706 they are required to press the relevant, digit of the hand (i.e. in the order listed in listing 1702) against the calibration sensor until the pressure in box 1703 is reached (in this case 3lbs of pressure). Once the specified pressure is reached the status of the sensor automatically changes to calibrated. This process is then repeated for each of the remaining sensor 33 and 35.

Figure 18 is a plot of pressure data obtained via the use of the manoeuvrable sensor during for example during the manual assessment of a patient by a clinician. As shown each trace 1801 , 1.802, 1803, 1804, 1805, 1806 represents pressure data obtained from each of the sensors positioned oh the fingers and thumb. As can be seen during such an assessment the clinician, applies various pressures through each of the digits of the hand in order to locate and assess various palpated landmarks. The pressure data is useful as to played back at a later assessments to ensure that the clinician applies the same pressures at each stage of treatment ensuring a more reliable diagnosis. Such data may also be useful in training junior clinicians to enable them to determine appropriate pressures to apply in order to obtain an accurate diagnosis.

Figures 19A and 19B illustrate the various types of displays available to the user. Fig 19A depicts a simple 20 representation of pressure data obtained from the sensors in the sensor array of the type discussed in relation to Figures 1 , 2 and 15 above. As can be seen form this example pressure is localised within a specific region 1901 of pressure sensing area 1902. Fig 19B depicts a 2D 1903 and 3D 1904 representation of the location and magnitude of pressures occurring within the sensing area. As can be seen from the 2D representation there are three main locations 1905, 1907 and 1906 at which pressure is applied with location 1905 having the greatest magnitude ad denoted by the variation in shading while locations 1907 and 1909 having lower magnitudes. This directly correlates to . the 3D version where the point 1905 corresponds to the large spike 906 and points 1907 and 1909 corresponding to the two smaller spikes 1908 and T9 0 respectively.

The palpation monitor has uses in a variety of applications including diagnosis and therapeutic treatment, real time video sequencing activated by the. sensors (e.g. under certain circumstances), feedback from an amputated/truncated limb (e.g. for the most effective fitting of a lower or upper prosthetic limb)_* ensuring better fitting techniques (allowing an improvement in quality of life), industrial/robotics (e.g. having pressure sensors to control how much force to apply), and as a bio feedback system (perhaps in combination with another article such as a helmet and/or vest) having pressure sensitive sensors to detect impact pressure, temperature, pulse, individual circulatory patterns, humidity, location, distance travelled, and speed of the device/wearer.

It is to be understood that the above embodiments have been provided only by way of exemplification of this invention, and that further modifications and improvements thereto, as would be apparent to persons skilled in the relevant art, are deemed to fall within the broad scope and ambit of the present invention described herein.

Claims

1. A palpation monitor comprising:

a stirrup having one or more pressure sensors, wherein the stirrup is adapted to fit a portion of a body in use; and

2. A palpation monitor comprising:

a sensor assembly adapted to fit about a portion of a subjects limb, wherein the sensor assembly includes plurality of sensors; and

a data collector for receiving data from the plurality of sensors.

3. The palpation monitor of claim 2 wherein the sensor assembly includes a pair of strips arranged orthogonal to one another.

4. The palpation monitor of claim 3 wherein the plurality of sensors are disposed in discrete locations along at least one of the strips.

5. The palpation monitor of any one of claim 4 wherein the strips are arranged to form a stirrup.

6. The palpation monitor of any one of claims 2 to 5 wherein the sensor assembly includes fitting and/or fastening elements.

7. The palpation monitor of claim 6 wherein the fitting and/or fastening elements are include one or more of straps, Velcro tabs, buttons, cinches and/or clasps.

8 The palpation monitor of any one of claims 2 to 7 wherein at least some of the sensors are configured to measure physiological characteristics of the subject.

9. The palpation monitor of claim 8 wherein the physiological characteristics include one or more of temperature, pulse, pressure, circulatory patterns, humidity, distance travelled and speed.

10. The palpation monitor of any one of claims 2 to 9 wherein the palpation monitor further includes a GPS transceiver.

11. The palpation monitor of any one of claims 2 to 10 wherein the data from the sensors is wirelessly transmitted to the data collector.

12. The palpation monitor of claim 2 wherein the sensors are coupled together to form a sensor array.

13. The palpation monitor of claim 12 wherein the sensor array defines a pressure sensing area.

14. The palpation monitor of claim 13 wherein data from each sensor within the array is utilised to locate one or more points at which pressure is applied within the pressure sensing area.

15. The palpation monitor of claim 13 wherein data from each sensor in the array is utilised to determine variations in pressure over the pressure sensing area.

16. The palpation monitor of claim 15. wherein the variations in pressure over the pressure sensing area are utilised to locate palpated landmarks.

17. The palpation monitor of claim 15 wherein the pressure sensing area is displayed in a graphical format depicting the variations in pressure over the pressure sensing area.

18. The palpation monitor of claim 16 wherein the pressure sensing area is displayed in a graphical format depicting the palpated landmarks,

19. The palpation monitor of claim 17 or 18 the pressure sensing area is displayed as a three dimensional image.

20. The palpation monitor of claim 17 or 18 wherein the pressure sensing area is displayed as a two dimensional contour map.

21. The palpation monitor of claim 14 wherein the pressure sensing area is displayed in a graphical format depicting with the location and intensity of the one or more points at.which pressure is applied.

22. The palpation monitor any one of claims 1 to 21 wherein the palpation monitor further includes a data analysis device and/or a data storage device coupled to the data collector.

23. The palpation monitor of claim 22 wherein the data analysis device are remote from the data collector and wherein said data collector is adapted to periodically transmits data collected from the plurality of sensors to the data analysis device: for further processing.

24. The palpation monitor of claim 23 wherein the data storage device is remote from the data collector and wherein the data transmitted from the data collector is stored in the data storage device prior to further analysis data analysis device

25! The palpatio monitor of claim 24 wherein the data analysis device is configured to store the results of the further processing in the data storage device.

26. The palpation monitor of any one of claims 23 to.24 wherein the data analysis device is configured to present the results of the further analysis in a graphical format in real time or near real time.

27. The palpation monitor of any one of claims 22 to 26 wherein the data analysis device is a mobije computing device.

28. A prosthetic limb including the palpation monitor of any one of claims 2 to 27.

29. A method of monitoring palpations, the method comprising the steps of: providing a patient with a unique identifier;

fitting a sensor assembly to said, patient wherein the sensor assembly includes plurality of sensors defining a sensing area;

collecting data from each Sensor within the sensing area;

determining based on the collected data variations in pressure .

30:. The method of claim 29 further including the step of determining the magnitude and location of one or more points at which pressure is applied within the pressure sensing area based on the data collected from each sensor.

31. The method of claim 29 further including th step of determining variations in pressure over the pressure sensing area based on the data collected from each sensor.

32. The method of claim 31 wherein the variations in pressure over the pressure sensing area are utilised to locate palpated landmarks_^

; 33. The method of claim 30 .or 31 wherein the pressure sensing area is displayed in a graphical format depicting the variations in pressure oyer the pressure sensing area, .^{' '} . :^' ·^· _ ^■ . , ,

34! The method of claims 32 wherein the pressure sensing area is displayed in a : graphical format depicting the palpated landmarks.

35. The method of claim 33 or 34 the pressure sensing area is displayed as a th r.ee d irhenS ion al^' image . .

36. The method of claim 33 or 34 wherein the pressure sensing area is displayed as a two dimensional contour map.

37† The method of any one of claims 30 to 36 wherein the pressure sensing area is. representative of a cup of a pfoSthetib limb and the magnitude and location of pressures within the pressure ensing area is utilised to evaluate the fit of the ; prosthetic limb to the patie.nt.