Abstract
A lower limb prosthesis comprises an attachment section (10), a shin section (12), a foot section (14), a knee joint (16) pivotally connecting the attachment section (10) and the shin section (12), and an ankle joint (22) pivotally connecting the shin section (12) and the foot section (14). The knee joint includes a dynamically adjustable knee flexion control device (18) for damping knee flexion. The prosthesis further comprises a plurality of sensors (52, 53, 54, 85, 87) each arranged to generate sensor signals indicative of at least one respective kinetic or kinematic parameter of locomotion or of walking environment, and an electronic control system (100) coupled to the sensors (52, 53, 54, 85, 87) and to the knee flexion control device (18) in order dynamically and automatically to modify the flexion control setting of the knee joint (16) in response to signals from the sensors. When the inclination sensor signals indicate descent of a downward incline, the damping resistance of the knee flexion control device (18) is set to a first level during a major part of the stance phase of the gait cycle and to a second, lower level during a major part of the swing phase of the gait cycle. During an interval including a latter part of the stance phase, the knee flexion control device (18) is adjusted so that the damping resistance to knee flexion is between the first and second levels.
Claims
1-16. (canceled)
17. A lower limb prosthesis comprising: an attachment section, a shin section, a foot section, a knee joint pivotally connecting the attachment section and the shin section, the knee joint including a dynamically adjustable knee flexion control device for damping knee flexion, an ankle joint pivotally connecting the shin section and the foot section, the ankle joint including a dynamically adjustable ankle flexion control device for damping ankle flexion, a first sensor associated with the ankle joint and which is operable to generate inclination sensor signals indicative of ground inclination, a second sensor associated with the knee joint and which is operable to generate speed sensor signals indicative of speed of locomotion, and an electronic control system coupled to the sensors and to the knee and ankle flexion control devices in order dynamically and automatically to modify a flexion control setting of the knee joint and a flexion control setting of the ankle joint in response to signals from the sensors, wherein arrangement of the sensors, the electronic control system and the knee and ankle flexion control device is such that when the inclination sensor signals indicate walking on an incline the damping resistance of the knee flexion control device and the damping resistance of the ankle flexion control device are each adjusted jointly based on the ground inclination and the speed of locomotion.
18. A lower limb prosthesis as claimed in claim 17, further comprising one or more further sensor associated with the ankle joint and one or more further sensor associated with the knee joint.
19. A lower limb prosthesis as claimed in claim 18, wherein one or more of the further sensors generate a sensor signal indicative of a shin or ankle bending moment, the arrangement of the sensors, the electronic control devices and the electronic control system being such that, during locomotion, the flexion control settings of the knee joint are adjusted in response to the shin or ankle bending moment.
20. A lower limb prosthesis as claimed in claim 18, wherein one of the sensors associated with the ankle joint is an accelerometer mounted on a prosthetic foot section, the flexion control setting of the knee joint being adjusted in response to signal from the accelerometer.
21. A lower limb prosthesis as claimed in claim 18, wherein signals representative of stride length and/or step rate are generated in the electronic control system in response to signals from the sensors associated with the ankle joint.
22. A lower limb prosthesis as claimed in claim 17, wherein the knee flexion control device comprises a pneumatic piston mounted on a piston rod which is reciprocable in a pneumatic piston chamber having upper and lower parts on opposite sides of the pneumatic piston.
23. A lower limb prosthesis as claimed in claim 22, wherein resistance of the pneumatic piston to flexion is controlled by a needle valve in a passage interconnecting the upper and lower parts of the pneumatic piston chamber, the needle valve having a needle member and being adjustable by an electrical stepper motor and an associated screw-threaded shaft connected to the needle member of the needle valve.
24. A lower limb prosthesis as claimed in claim 22, wherein the pneumatic piston contains a pneumatic bypass passage including a non-return valve which is oriented such that the pneumatic piston provides negligible resistance to knee extension.
25. A lower limb prosthesis as claimed in claim 22, wherein the knee flexion control device further comprises a hydraulic piston mounted on the piston rod which is reciprocable in a hydraulic piston chamber.
26. A lower limb prosthesis as claimed in claim 25, wherein during a stance phase of a walking gait cycle, the knee flexion control device provides predominantly hydraulically controlled flexion and extension and during a swing phase of the walking gait cycle the knee flexion control device provides predominantly pneumatic controlled flexion.
27. A lower limb prosthesis as claimed in claim 17, wherein the ankle joint includes a dynamically adjustable hydraulic ankle flexion control device having a piston which is reciprocable in a cylinder to define upper and lower chambers which are linked by a pair of passages, the hydraulic ankle flexion control device being arranged to provide independent adjustment of dorsi-flexion and plantar-flexion damping resistance.
28. A lower limb prosthesis as claimed in claim 27, wherein the electronic control system is further coupled to the ankle flexion control device in order dynamically and automatically to modify the flexion control setting of the ankle joint in response to signals from the sensors, wherein arrangement of the sensors, the electronic control system and the ankle flexion control device is such that when the inclination sensor signals indicate ascent of the upward incline, the dorsi-flexion damping resistance of the ankle flexion control device decreases as the speed of locomotion increases.
Description
[0034] The invention will now be described by way of example with reference to the drawings, in which:—
[0035] FIG. 1A is a side elevation of a lower limb prosthesis in accordance with the invention;
[0036] FIG. 1B is a longitudinal cross-section of a knee joint of the prosthesis of FIG. 1A;
[0037] FIG. 1C is a schematic representation of hydraulic and pneumatic circuits in a knee flexion control device in the knee joint of FIG. 1B.
[0038] FIG. 1D is a longitudinal cross-section of a foot/ankle assembly of the prosthesis of FIG. 1A;
[0039] FIG. 2 is a block diagram of an electronic control system, together with sensors, for the prosthesis of FIG. 1;
[0040] FIG. 3A is a Venn diagram indicating different activity modes defined within the electronic control system, and their interrelationships;
[0041] FIG. 3B is a finite state diagram indicating the different activity modes defined within the electronic control system, and transitions between the modes;
[0042] FIG. 3C is a flow chart illustrating a typical set of operations performed by the electronic control system and flexion control devices of the prosthesis;
[0043] FIG. 3D is a first series of more detailed finite state diagrams used by the electronic control system;
[0044] FIG. 3E is a second series of more detailed finite state diagrams used by the electronic control system;
[0045] FIGS. 4A to 4D are representations of a multiple-layer matrix group defining relationships between input conditions derived, e.g., from sensed kinetic and kinematic parameters of locomotion, and outputs for flexion control devices forming part of the prosthesis of FIG. 1, FIG. 4A showing a main matrix and FIGS. 4B, 4C and 4D showing lower-level matrices for, respectively, walking up a ramp, walking down a ramp, and walking at different speeds on a level surface;
[0046] FIGS. 5A to 5D are graphs illustrating the variation of selected parameters over the course of the walking gait cycle; and
[0047] FIG. 6 is a composite graph illustrating the variation of knee flexion damping resistance in a ramp down mode.
[0048] Referring to FIG. 1A, a lower limb prosthesis in accordance with the invention has an attachment section 10 for attaching the prosthesis to, for instance, a stump socket (not shown), a shin section 12 and a foot section 14. The shin section 12 is linked to the attachment section 10 by a knee joint 16 which, in this case, is a uniaxial knee joint incorporating a flexion control device 18 housed in a knee cradle 20 to which the shin section 12 is attached. Linking the foot section 14 to the shin section 12 is an ankle joint 22 incorporating an ankle flexion control device which will be described hereinafter.
[0049] The knee joint 16 is shown in more detail in FIG. 1B. Referring to FIG. 1B, the knee joint has a knee chassis 25 to which the attachment section 10 is rigidly mounted and carries a pivot 27 defining a knee axis 28. The shin cradle 20 is attached to the knee chassis 25 by the pivot 27 so that, when the knee joint is flexed, the shin cradle 20 pivots relative to the attachment section 10 about the knee axis 28.
[0050] Pivotally coupled to a posterior part of the knee chassis 25 and to a lower part of the shin cradle 20 by upper and lower control device pivots 30, 32, the knee flexion control device 18 is in the form of a hybrid pneumatic and hydraulic piston and cylinder assembly for controlling both flexion and extension of the knee joint. Being a hybrid control device, it comprises a housing having two cylinders and two pistons, the latter both being mounted on a common piston rod 18R. Referring to FIG. 1B in conjunction with FIG. 1C, a first piston 18A, hereinafter referred to as the “pneumatic piston” is reciprocable in a first pneumatic piston chamber 18B, and a second piston 18C, hereinafter referred to as the “hydraulic piston” is reciprocable in a second, hydraulic chamber 18D. The arrangement and function of the pneumatic piston 18A and associated parts of the flexion control device are generally similar to those of the piston and cylinder assembly disclosed in published British Patent Application GB2280609A. The pneumatic piston 18A contains a bypass passage 18E including a non-return valve which is oriented such that the pneumatic piston 18A resists movement of the piston rod 18R much more during flexion of the knee joint than during extension. Indeed, in this region, resistance to extension is negligible. Resistance of the pneumatic part of the control device 18 to flexion at the knee joint is controlled by a needle valve 18N which is adjustable by a first electrical stepper motor 34 and an associated screw-threaded shaft 34A connected to the needle member of the needle valve. The needle valve 18N lies in a passage 18P in a lower housing part 18F of the control device 18, the passage interconnecting the upper and lower parts of the pneumatic chamber 18B on opposite respective sides of the pneumatic piston 18A, and emerging to the outside at a port (not shown) at the top of the pneumatic chamber 18B. Operation of the motor 34 causes the shaft 34A to move axially so that the needle member moves into or out of a passageway forming part of the passage 18P to vary the orifice area.
[0051] The passage 18P constitutes a second bypass passage interconnecting the chamber spaces on opposite sides of the pneumatic piston 18A. It will be understood, then, that the flexion resistance provided by differential pressure across the piston 18A depends largely on the restriction created by the setting of the needle valve 18N by the motor 34.
[0052] A first hydraulic bypass passage 18L contains a non-return valve 18M oriented so as to close the passage during knee extension movements. The passage 18L also contains an adjustable rotary valve 18O connected via a gear mechanism to a second electric motor 50 mounted on the side of the housing 18F of the knee flexion control device 18. Variable valve 18O has a through-passage which communicates with the bore of the bypass passage 18L to a varying degree depending on the angular position of the valve 18O, the cross-section of the passage being shaped to provide a progressive change in orifice area as the rotatable part of the valve is driven by the motor 50.
[0053] Owing to the orientation of the non-return valve 18M, the first hydraulic bypass passage 18L and its associated adjustable valve 18O control the level of knee flexion resistance due to the hydraulic part of the control device 18 according to the electrical signals controlling the motor 50.
[0054] A second hydraulic bypass passage 18Q in the hydraulic part of the control device 18 has a non-return valve 18S which is oppositely oriented to that of the first bypass passage 18L such that a second rotary valve 18T, which restricts the flow of hydraulic fluid through passage 18Q, controls the resistance to knee extension when activated. In this embodiment of the invention, the second rotary valve 18T is manually presettable.
[0055] The second hydraulic bypass passage 18NQ is branched into two passages 18QA, 18QB which are ported into the hydraulic chamber 18D at different locations so that one of the branches 18QA is covered by the piston 18C as the knee joint nears full extension. The other branch 18QB remains uncovered substantially to full extension. This second branch 18QB has a restriction 18U, whereas the first branch 18QA is open, so that as the piston 18C nears the full extension position, the restriction 18U takes effect over a final portion of the piston stroke, as the piston itself restricts fluid flow through passage 18QB, to provide progressive terminal impact damping. The base resistance to extension is determined by the setting of the manually adjustable second rotary valve 18T.
[0056] Activation of the hydraulic valve 18O is controlled by an electronic control system, as described below, in order that, at least during the stance phase of the walking gait cycle, the knee flexion control device provides predominantly hydraulically controlled flexion and extension, whereas during the swing phase, the control is predominantly pneumatic.
[0057] As part of the electronic control system, the shin cradle 20 carries two strain gauges 52, 53, one mounted on an anterior wall of the cradle 20 and the other on an opposite posterior wall. These sensors are used for measuring the shin bending moment when the prosthesis is loaded. The knee joint also carries a knee angle sensor in the form of a magnetoresistive transducer 54A mounted on the side of the knee control device housing 18F and a magnet 54B on the piston 18A.
[0058] In the upper anterior part of the shin cradle, space is provided for a battery 56 for powering the electronic control system.
[0059] Referring now to FIG. 1D, the preferred prosthesis has a foot keel 62 comprising a rigid carrier 62A. Independently coupled to the rigid carrier 62A are a toe spring 62B and a heel spring 62C. The keel 62 is largely formed from carbon fibre composite material and can be surrounded by a foam cosmetic covering (not shown).
[0060] Coupled to the foot keel 62 is the ankle joint 22 which is substantially cylindrical in shape and coaxial with the shin section 12 (see FIG. 1A), the ankle joint carrying an upper alignment interface 64 in the form of a pyramid-shaped shin connection interface 64 which defines a longitudinal shin connection axis 66. The ankle joint 22 connects the shin section 12 to the foot keel 62A of the foot 60, the mounting to the foot keel 62A being by way of an ankle flexion pivot 70 defining an ankle flexion axis 70A.
[0061] The ankle joint 22 has an ankle joint body 22B which forms the cylinder of an ankle joint piston and cylinder assembly having a piston 74 with upper and lower piston rods 74A, 74B, the lower piston rod being pivotally connected to the foot keel 62A at a second pivotal connection 76, this second pivotal connection defining a second medial-lateral axis which is spaced, in this case, posteriorly from the flexion axis 70A. It will be seen that, as the ankle joint body 22B pivots about the flexion axis 70A, the piston 74 moves substantially linearly in the cylinder formed by the body.
[0062] The cylinder is divided into upper and lower chambers 78A, 78B. These chambers are linked by two bypass passages 80 in the ankle joint body 22B, one of which is visible in FIG. 1D. The other passage does not appear in FIG. 1D since it is located in front of the sectional plane. However, its configuration is almost identical. These two bypass passages 80 each communicate with both the upper chamber 78A and the lower chamber 78B of the cylinder via two valves. Each contains a respective damping resistance control valve 82 which has an associated actuator in the form of a servo motor 84. Operation of the servo motor 84 rotates a valve member of the valve 82 progressively to increase or decrease the orifice area of the valve 82. Each bypass passage 80 also contains a respective non-return valve 86. This adjustable-area orifice valve 82 and the non-return valve 86 are arranged in series in the bypass passage 80, between the upper and lower cylinder chambers 78A, 78B.
[0063] The bypass passage 80 appearing in FIG. 1D has its non-return valve 86 oriented to allow the flow of hydraulic fluid from the lower chamber 78B to the upper chamber 78A. The other bypass passage (not shown) has its non-return valve oriented in the opposite direction. Accordingly, one of the passages 80 is operative during dorsi-flexion and the other during plantar-flexion. Continuous yielding movement of the foot component 14 relative to the ankle joint body 22B about the flexion axis 70A is possible between dorsi-flexion and plantar-flexion limits defined by the abutment of the piston 74 with, respectively, the lower wall and the upper wall of the cylinder containing the piston 74. The level of damping for dorsi-flexion and plantar-flexion is independently and automatically presettable by the respective adjustable-area orifices by means of the electronic control system described below.
[0064] The electronic control system has a sensor 85 in the form of an accelerometer mounted on the foot keel 62A and a two-part ankle flexion angle sensor 87A, 87B, the two parts being mounted in registry with each other on the ankle joint body 22B and the foot keel 62A. The ankle joint casing 22C not only houses the two servo motors 84 for the adjustable damping resistance control valves 82; they also provide space for a processor board 90 and a second battery 92. Wires 94 link the ankle flexion angle sensor 87A, 87B to the processor board 90. Other wires (not shown) link the other sensors, the batteries, and the motors of the knee joint to the processor board 90.
[0065] Referring, now, to FIG. 2, the preferred electronic control system comprises a processor section 100 with three 8-bit microprocessor controllers. (16-bit controllers may be used as an alternative.) The controllers comprise a main controller 102 coupled to two slave controllers, these being a knee controller 104 and an ankle controller 106. Coupled to an input port 102A of the main controller 102 is an analogue to digital converter 108 with a plurality of inputs shown as an input port 108A in FIG. 2. These comprise analogue inputs for receiving sensor signals from the above-described sensors located in different parts of the prosthesis. Accordingly, the data received by the controller 102 is representative of a number of kinetic and kinematic parameters associated with use of the limb in different activity modes. The activity modes, such as level walking, walking on an incline, standing, sitting down, etc. are detected on the basis of such parameters by the main controller 102, as described below, in accordance with preset rules.
[0066] According to further rules stored in the main controller 102, instructions are fed therefrom to the knee controller 104 and the ankle controller 106 which generate control signals for knee and ankle motor drivers 110, 112. The motors 34, 50 associated with the knee joint, as described above with reference to FIG. 1B, exchange signals with the processor section 100 via connections 114 with the first of the drivers 110, including driver signals for driving the knee motors to required positions which are verified by feedback signals via the connections 114. As described above, the knee motors 34, 50 set the valves controlling the movement of the pneumatic piston and the hydraulic piston in the respective parts 18P, 18L of the knee control device 18 (see FIG. 1B).
[0067] Similarly, the ankle motors 84 (described above with reference to FIG. 1D) exchange signals with the processor section 100 via connections 116 to the second driver 112, the signals comprising driving signals and feedback signals in order that the ankle motors 84 set the valves controlling the movement of the hydraulic piston in the ankle joint control device 22H contained in the ankle joint 22, as described above with reference to FIG. 1D.
[0068] A user interface 120, coupled to the processor section 100, comprises a wireless communication section for exchanging wireless signals with a PC or tablet computing device. Programming can also be done by a defined HMI (operator interface) using, e.g. two buttons, an LED, and a beeper, indicating the status of programming.
[0069] The control system uses open architecture, both in hardware and software terms to allow parts to be added or to accommodate, for instance, alternative or additional input and output signals, e.g. for signals from another electronic control system in, e.g. a second lower limb prosthesis in the case of a bilateral amputee. This open architecture provides a technology platform with plug-in modules that can be changed according to requirements. For instance, in the case of a bi-lateral amputee information about the second limb is provided. Sensor data from other sensors may be provided. However, the bilateral option shall not only include communication possibilities for a double transfemoral (above-knee) amputee, for example, but also communication between a transfemoral prosthesis and a transtibial (below-knee) prosthesis which means, in effect, communication between a processor-controlled foot/ankle joint is possible as this is beneficial for the overall gait performance and coordination. Overall sharing of information between different joints and/or components in various combinations and configurations is possible owing to the open-architecture approach.
[0070] The main controller 102 is programmed to derive from the digital representations of the sensor signals kinetic or kinematic parameters of locomotion thereby to measure gait characteristics such as velocity including information about the relevant parameters step rate and stride length, and gait phase, and the step-to-step variability in such characteristics, thereby to produce control signals from the knee and ankle controllers 104, 106 to modify the settings of the knee and ankle joint control devices so as to optimise the gait of the amputee.
[0071] Included in the programming of the main controller 102 is a self-calibrating routine, as described in the above-mentioned EP1334891 and WO2007/110585, for convenient and straightforward modification of the control characteristics for the individual amputee. Velocity, i.e. the speed of locomotion, in particular walking speed or gait cycle frequency, and gait phase are preferably computed from the outputs of the knee angle sensor 54A and the bending moment strain gauges 52, 53, although in some circumstances, these parameters may be derived from the outputs of a gyroscope 88 mounted, e.g. on the shin section and the accelerometer 85 mounted at the foot level. Changes in the walking surface and the velocity of the foot in the global reference frame (kinematic changes) are preferably measured using the signals from the accelerometer 85 and the ankle angle sensor 87 to drive modification of the settings of the control device of the ankle joint 22 (FIG. 1D), as described in the above-mentioned WO2008/103917.
[0072] The main controller 102, collecting data derived from the outputs of sensors associated with both the knee joint and the ankle joint, i.e. from different regions of the prosthesis, allows improved control of the knee joint and ankle joint control devices and advanced analysis of gait and mode based on a combined representation of data relating to different regions of the prosthesis. The main controller 102 sends direct commands and additional gait-related information to the knee controller 104 and the ankle controller 106 which act, effectively, as slave controllers in a hierarchical, distributed control system. The knee controller 104 and the ankle controller 106 do, however, have some autonomy for safety should, for instance, no valid signals be forthcoming from the main controller 102.
[0073] The main controller 102 has a non-volatile memory for storing values of a limb control matrix relating input conditions derived from the sensor signals and output data which is used by the main controller and the slave controllers 104, 106 to determine the control signals for the flexion control devices 18A, 18C, 74. Matrix values can be downloaded for external storage and communication via the user interface 120 as well as being reloaded from external devices. Alternatively, control matrix values may be stored locally in the non-volatile memory of the slave controllers 104, 106, the main controller 102 having access to these values and the ability to change them.
[0074] The processor section 100 operates on a finite-state control basis. Referring to FIG. 3A, the status of the main controller 102 (FIG. 2) is defined according to a series of activity modes. These activity modes are grouped as modes 124 associated with level walking, ramp modes 125, standing modes 126, stairs modes 127, and other modes 128, such as an obstacle mode, a special mode, and an error mode. The intersections of the Venn diagram areas are indicative of the transitions which may be made from one mode to another. Other transitions such as going from ramp down to ramp up directly are also possible. The preferred finite-state control possibilities are shown more clearly in FIG. 3B. In this case, the modes include a Normal Walking mode 130, a Ramp Up mode 132, a Ramp Down mode 134, and so on, as shown in the diagram. The list of modes in the diagram is not exhaustive. The Normal Walking mode is configures as the central point of the diagram. As shown by the interconnections between the different modes, the main controller switches or transitions from one mode to another, according to sensor inputs received as sensor data from the analogue to digital converter (ADC) 108 (FIG. 2). The rules programmed into the main controller 102 then determine how the knee motors 34, 50 and ankle motors 84 (FIG. 2) are driven in response to the change of mode and in response to other changes in the data obtained from the sensors.
[0075] Thus, for instance, as shown in FIG. 3C, the commencement of walking down an incline after a period of walking on the level may be detected and responded to by the following steps: [0076] The foot sensors (the accelerometer 85 and the ankle flexion angle sensor 87 (FIGS. 1D, 2)) generate sensor signals indicative of a change in ground inclination (step 140). [0077] The main controller 102 and/or the ankle controller 106 analyze the digitized versions of the sensor signals and determine that the surface has changed to a downwardly inclined ramp (step 142). [0078] Based on a stored matrix of relationships between, on the one hand, activity mode and kinetic or kinematic parameter values and, on the other hand, respective flexion control resistances, the change in mode is translated into new settings for the knee and ankle motors (step 144). [0079] Via the motor drivers 110, 112, the knee motors 34, 50 and ankle motors 84 (FIG. 2) are driven to the new respective settings which, in this case, involves driving the servomotor 50 to a new setting in which the hydraulic part of the knee joint control device 18 is set to provide intermediate yield in the Ramp Down mode and the pneumatic part of the control device 18 is driven to different settings according to walking speed, in the same way as in the level walking (normal walking) mode (step 146). Concurrently, the ankle motor settings are changed to increase the dorsi-flexion resistance provided by the ankle joint control device and to reduce the plantar-flexion resistance (step 148).
[0080] Similar basic sequences apply to the other mode transitions shown in FIG. 3B, the sensors used and the actions performed being governed according to the sensed modes. In this embodiment, the settings to which the actuators are driven are governed by a 6×5 main matrix, as shown in FIG. 4A, and three N×5 lower level matrices, as shown in FIGS. 4B, 4C and 4D. The matrix rows correspond to different activity modes (listed in the left-hand column in each case), and the matrix columns indicate the settings of the four above-described flexion resistance control device parts, those of the hydraulic part of the knee control device being indicated for the swing and stance phases separately The five primary resistance settings are adapted according to the individual amputee. The normal settings for the ankle joint (foot) plantar-flexion and dorsi-flexion resistances in the FIG. 4A matrix are moderate resistance settings for normal, medium-speed Level Walking as shown in FIG. 4D. The normal setting of the knee joint is that shown in a “Level Velocity” mode in FIG. 4A and is characterised by high hydraulic resistance during stance and low hydraulic resistance during swing, and variation of pneumatic flexion resistance according to walking speed.
[0081] In practice, the matrix for each mode or event is composed of five primary values, as shown in the columns of the tables of FIGS. 4A to 4D. In several instances, bands of values are pre-programmed to provide a range of values from which a particular value is selected in each case to suit the amputee.
[0082] The main modes are those appearing in the left-hand column of FIG. 4A, i.e. Ramp Up, Ramp Down, Level Velocity (Level Walk), Stairs Down, Stand Relaxed, and Sitting. In FIG. 4A, the asterisk (*) indicates the existence of sub-modes, these appearing in FIGS. 4B, 4C and 4D respectively. The values in the body of each matrix represent the level to which flexion (or extension) of the respective joint is resisted. Thus, “VL” means very low resistance, “L” means low resistance, “M” means medium resistance, “H” means high resistance, and “VH” means very high resistance. “M/H” means a resistance level between medium and high resistance, while “H−” is resistance which is a little bit less than high resistance, and “H+” means resistance a little higher than a high resistance. “VL−”, “L−”, “L+” and “VH+” are to be correspondingly interpreted.
[0083] With regard to the knee hydraulic settings, the dollar sign $ at the head of the respective columns means that when the knee control device resistance value is not indicated explicitly (i.e. by a single value) the resistance is switched between two levels, (a) between typically H or H− and M or (b) as the toe is loaded to select the lower value, and as the limb is extended to select the higher value. With regard to the setting of the pneumatic part of the knee control device, the hash sign # at the head of the column indicates that when the resistance value is not explicitly indicated, the pneumatic part of the control device adapts automatically to the speed of walking, regardless of the surface or other conditions.
[0084] Accordingly, in the “Level Velocity” mode, for level walking, the resistance due to the pneumatic part of the knee control device varies from low to high according to walking speed, as shown in FIG. 4D. Indeed, the pneumatic resistance may increase to VH for very fast level walking. Resistance to plantar-flexion and dorsi-flexion at the ankle during the velocity/level walking mode, as indicated in FIG. 4D, according to speed.
[0085] Referring back to the main matrix of FIG. 4A, it will be seen that the resistance values for Ramp Up and Ramp Down differ in certain respects to those for the Velocity/Level Walk mode. Thus, for instance, the resistance to plantar-flexion at the ankle is lower, generally, when descending a ramp than during level walking, and higher when ascending a ramp. Dorsi-flexion resistance at the ankle tends to be higher when descending a ramp and lower when ascending. However, at the same time, these values vary according to speed/velocity and according to the steepness of the ramp, and during transitions between modes, as indicated in the sub-matrices of FIGS. 4B and 4C.
[0086] Referring to FIG. 4C, in both the stance and swing phases of the Ramp Down mode, an intermediate hydraulic resistance level (M) is indicated. This level is set by the knee flexion control device to occur during an interval comprising a latter part of the stance phase and an initial part of the swing phase. Thus, during each gait cycle in the Ramp Down mode, the transition from stance to swing is characterised by a stepwise reduction from the high (H or H−) level to the low (L) level, the interval during which the intermediate (M) level applies spanning the toe-off point at the end of the stance phase. This increased yielding of the knee joint towards the end of the stance phase aids descent. The main benefit in the ramp down mode is that the change between the flexion resistances between high and low (which is the normal profile in other modes) is reduced (high to intermediate and then to low during the end part of the stance phase). This creates, firstly, some extra support as the amputee has some added resistance at the end of stance. Able-bodied people then tend to use their muscles to brake slowly going down a ramp so that they don't accelerate or only accelerate in a controlled matter. The amputee doesn't have this ability with the prosthetic limb. Secondly, the foot and ankle already brake going down a ramp but the additional resistance at the knee at end of the stance phase gives the amputee a feeling of extra security and grip and has the potential beneficially to decelerate the amputee.
[0087] It should be noted that no reduction of flexion damping resistance occurs at the knee during descent of a steep ramp, as shown by the Steep Ramp sub-modes in FIG. 4C. In this sub-mode, there is little or no loading of the toe because the amputee uses knee yield to descend the steep ramp.
[0088] Each basic mode described above with reference to FIGS. 3A and 3B and FIGS. 4A to 4D has associated transition states, as indicated by the more detailed finite state diagram of FIGS. 3D and 3E. In addition, in this embodiment, the basic modes are divided into further sub-modes. To give examples from FIGS. 3D and 3E, therefore, the normal walking mode 130 has three such sub-modes: Normal Steps 130A, Small Steps 130B and Large Steps 130C. There are respective transitions 130T between these sub-modes. As just mentioned, other basic modes include transition states. For example, referring to FIGS. 3E and 4C, the Ramp Down mode 134, in addition to being divided into sub-modes Ramp Down 134A and Steep Ramp Down 134B, has a transition state Transition Ramp Down 134C to allow definition of intermediate settings of the flexion control devices to provide a smoother transition from the Ramp Down mode 134 to the Normal Walking mode 130, and vice-versa. Transitions normally have associated values which are set by interpolation between the values of the starting mode and those of the finishing mode in each case. Additional Ramp Down sub-modes are provided for slow and fast walking velocities.
[0089] Similar sub-modes exist for the Ramp Up mode (see FIG. 3E).
[0090] Additional transition states and corresponding actuator settings (i.e. control device settings) are related to each other in further layers (not shown) of the matrix represented by the table of FIG. 4A. For example, getting up from a chair, as illustrated by the Sit-Down-Stand-Up Mode state 155 in the finite state diagram of FIG. 3D, uses a set of output settings from one layer of the matrix and then, moving to the Stand Relaxed mode 157, from another matrix layer, or moving to the Slow Walking mode (a sub-mode 160A of a Velocity mode 160 (in effect walking which is other than normal walking)) require transition states Transition Sit 155A, Stand Up 155B, and Transition Walking (a sub-mode 157C of the Stand Relaxed mode 157) These transitions avoid the need to compensate for or accommodate sudden changes so that the limb operation is as nearly possible seamless and smooth as the amputee moves from one activity mode to the other. Each matrix has a set of relationships associating and linking modes, events and transitions with different control settings for implementation in real time.
[0091] The control system open architecture allows the programming of additional matrices, e.g. for defining control functions associated with additional events or activities, as well as integration of additional data streams.
[0092] In general, when the control system is operating to indicate a particular activity mode, it will continue to indicate that same mode until it receives a sensor signal which is interpreted as indicating a transition to a different mode.
[0093] The settings stored in the matrices described above with reference to FIGS. 4A to 4D, and the settings at other matrix levels (not shown) of the matrix are adjusted to suit the individual amputee during a calibration program mode. A typical calibration routine for establishing the matrix settings includes:— [0094] 1. Level walking with different velocities [0095] 2. Level walking—starting and stopping [0096] 3. Walking up and down a ramp at different velocities and with different gradients [0097] 4. Walking up and down stairs [0098] 5. Level walking with different disturbances [0099] 6. Sitting down and getting up from and to walking and standing [0100] 7. Other activity modes
[0101] The system does allow for calibration on the basis of tests 1., 2., and, preferably, 3. above only, default values for bands of values that are adjusted according to the level walking values being set for activities associated with tests which have not been carried out, e.g. owing to a lack of facilities.
[0102] The calibration may be performed by a prosthetist feeding settings to the prosthesis using the user interface 120 (FIG. 2). As an alternative, or in addition, depending on the mode of activity in question, a self-adjustment, self-programming or automatic calibration phase may be included whereby the control system provides a series of trial settings for particular activity modes.
[0103] A particular technique used in the calibration program mode of the preferred embodiment makes use of the variation of the shin section bending moment, as sensed by the strain gauges 52, 53 (FIG. 1B) to set plantar-flexion resistance and dorsi-flexion resistance of the ankle flexion control device. In particular, one or both flexion control settings of the ankle joint are modified to achieve a predetermined shin bending moment profile, i.e. the variation of the sensed shin bending moment with time during individual stance phases of the walking gait cycles. Similarly, the ankle joint plantar-flexion resistance and/or dorsi-flexion resistance may be changed in response to the sensed foot angle, as sensed by the angle sensor 87A, 87B (FIG. 1C) at the ankle joint to achieve a predetermined foot angle profile, i.e. variation of foot angle during the stance phase of the walking gait cycle. In some circumstances, the sensed knee angle and foot acceleration may also be used.
[0104] FIGS. 5A to 5D indicate typical profiles for the knee angle, the foot angle, the shin section bending moment, and the global foot acceleration during the gait cycle. The horizontal axis in each graph is time within a gait cycle nominated to the value 1, so that the profile begins with heel contact, progresses through the stance phase to push off (at about 0.6), then continues through the swing phase, and returns to heel contact at 1. Each graph has four plots relating to different combinations of plantar-flexion (PF) and dorsi-flexion (DF) resistance settings, as indicated, a higher number designation for the plots representing higher flexion resistance and a lower number representing a lower respective flexion resistance. The applicants have found that the higher the setting for plantar-flexion resistance, the sharper and more peaked is the foot angle profile (see FIG. 5C). In addition, with high plantar-flexion resistance, the area below the foot angle profile plot is smaller. With higher dorsi-flexion resistance, the area below the foot angle curve becomes rounder and larger. Also, the ratio of plantar-flexion resistance to dorsi-flexion resistance affects the symmetry of the curve and its integral beneath it from a normal value up to the peak, and back to the normal value again. The applicants have found that the combinations of plantar-flexion and dorsi-flexion resistance settings which are preferred, in terms of amputee comfort and effort, were PF6 DF6 and PF8 DF4 which, as can be seen from FIG. 5B, produce lower ankle dorsi-flexion amplitude profiles, both in terms of peak dorsi-flexion and the area under the respective part of the angle profile in the stance phase.
[0105] The electronic control system, described above with reference to FIG. 2, makes use of the sensed foot angle profile by measuring both peak foot angle and the dorsi-flexion integral in a process similar to that described above with reference to FIG. 3B to achieve the preferred foot angle profile by adjusting the ankle joint control device flexion resistances. Accordingly, if the peak dorsi-flexion of the ankle joint during the stance phase exceeds a predetermined threshold value, or the area (corresponding to the integral) under the dorsi-flexion curve with respect to time during the stance phase exceeds a predetermined area threshold, the plantar-flexion resistance of the ankle flexion control device is increased and the stance phase dorsi-flexion resistance is decreased. Similarly, if these peak and area values are too low, the plantar-flexion and dorsi-flexion resistances are driven in the opposite respective directions.
[0106] In the present embodiment, integrals of the foot angle curve (i.e. dorsi-flexion angle of the ankle) are computed as follows: [0107] A first integral, Integral 1, from a first foot angle value up to the peak [0108] A second integral, Integral 2, from the peak down to the crossing of the first foot angle value line again [0109] The ratios of Integral 1 to Integral 2 and the sum of the two integrals obtained for different plantar-flexion and dorsi-flexion resistances are typically as shown in Table 1
TABLE-US-00001 TABLE 1 Integral 1/Integral 2 Integral 1 + Integral 2 “PF 3 DF8” 0.71 56.49 “PF 2 DF 2” 0.83 47.9 “PF 6 DF 6“ 0.94 44.85 “PF 8 DF 8”.sup.1 1.09 40.58 “PF 8 DF 4” 1.2 34.19
[0110] The ankle joint control device resistances are driven to achieve a ratio of Integral 1 to Integral 2 of around 1 when both settings are in an equal range, i.e. bigger than 1 if the plantar-flexion resistance is greater than the dorsi-flexion resistance and smaller than 1 if the dorsi-flexion resistance is greater than the plantar-flexion resistance. The sum of both integrals is larger the larger is the sum of the dorsi-flexion resistance and the smaller is the plantar-flexion resistance. When both plantar-flexion and dorsi-flexion resistance are approximately equal, the lower the settings the larger is the sum.
[0111] Accordingly, the system also uses the ratio of different areas beneath the foot angle profile, respectively when the dorsi-flexion angle is increasing and when it is decreasing, as an input variable for setting the dorsi-flexion and plantar-flexion resistances.
[0112] With regard to the shin bending moment profile shown in FIG. 5B, this is significantly affected by the plantar-flexion and dorsi-flexion resistance settings at the ankle joint. With moderately low plantar-flexion resistance and high dorsi-flexion resistance (PF3 DF8), the moment increases rapidly during the early part of the stance phase and then, towards mid-stance, the gradient is relatively small so that the peak moment is relatively late in the stance phase. In contrast, with relatively high plantar-flexion resistance and somewhat lower dorsi-flexion resistance (PF6 DF6), for example, the gradient in the early stance phase is less steep and there is a step in the region towards mid-stance followed by another period of rapidly increasing moment to the bending moment peak. The area under the bending moment curve during the stance phase is affected by these different profiles, as indicated in Table 2 below, which tabulates the ratio of the curve area for the first, second and third resistance combinations shown in FIG. 5B relative to that for the fourth combination, PF6 DF6. (For completeness, similar ratios are tabulated in Table 2 for the foot angle and the ratio between the foot angle and shin bending moment.)
TABLE-US-00002 TABLE 2 Foot angle ratio in Bending moment ratio Ratio between relation to in relation to foot angle and “PF 6 DF 6” “PF 6 DF 6” bending moment “PF 3 DF 8” 1.34 1.08 0.78 “PF 2 DF 2” 1.15 1.02 0.71 “PF 8 DF 4” 0.83 0.93 0.56
[0113] The electronic control system of FIG. 2 computes the shin bending moment area using signals from the strain gauges 52, 53 (FIG. 1B) to provide an input for setting plantar-flexion and dorsi-flexion resistances.
[0114] An option in the preferred electronic control system is to divide the sensed shin section bending moment profile before the peak into three periods. Thus, the preferred profile has a first period in which the moment increases with a first gradient, followed by a second period in which the moment increases with a second gradient which is significantly less than the first gradient, followed by a third period in which the gradient reverts to a level similar to that of the first period. This is the profile which the applicants have found is most comfortable for the typical amputee. Iterative adjustments of the stance phase plantar-flexion resistance and dorsi-flexion resistance are made to achieve the preferred profile. The preferred profile is also characterised by the third period being at least 80 percent of the second period, in terms of duration.
[0115] In the present embodiment, where the settings indicated by the sensed foot angle are different from those indicated by the sensed bending moment, it is the settings indicated by the bending moment which are given precedence. It is possible, in variants of the invention, to dispense with the sensed foot angle as a control input.
[0116] The adjustments in control device settings described above are performed during the calibration program mode so that subsequently, during locomotion, the plantar-flexion and dorsi-flexion resistances are automatically and dynamically set according to activity mode.
[0117] The control functions described above with reference to FIGS. 5A to 5D are ones performed during level walking. These functions are performed in the same way when walking up slopes and walking down slopes although, under those conditions, values of the parameters illustrated in FIGS. 5A to 5D are different.
[0118] Described above is the stepwise reduction of the knee flexion damping resistance in the Ramp Down mode. Referring to FIG. 6, the variation in the damping resistance at the knee in the Ramp Down mode is illustrated in conjunction with knee angle, shin bending moment, foot angle, and foot acceleration curves. As shown, the flexion resistance 200 is high during the major part of the stance phase. At or immediately after the maximum of the shin bending moment, indicated by the arrow M, the knee flexion resistance is reduced to the intermediate level or an interval which ends at or very shortly after the end of the stance phase indicated by the arrow N, whereupon a further reduction in knee flexion resistance is effected to reduce the resistance level to the low (L) level indicated in FIG. 4C. The flexion resistance reverts to the high level in late swing, to prepare for commencement of the stance phase at heel strike, indicated by the arrow. Actuation of the first step wise reduction in resistance is performed in response to detection of a negative-gradient bending moment, derived from strain gauges mounted on the shin section. The second step wise reduction in flexion resistance is actuated in response to the knee angle reaching a predetermined knee angle threshold in the early part of the swing phase, as sensed, for instance by a piston/senor. Typically, the threshold at which the second step wise reduction in knee flexion resistance is a knee angle of 50 percent of the maximum knee angle achieved during the swing phase. This programmed step wise reduction in knee flexion resistance is not performed in the level velocity or Ramp Up modes. In those modes switching occurs instantaneously between high and low resistance settings towards the end of the stance phase. The duration of the interval during which the flexion resistance is at the intermediate level in the ramp down mode is typically 25 percent of the stance phase duration.
[0119] As shown in FIG. 6, and described above with respect to the stepwise changes in resistance, in some embodiments, the damping resistance of the knee flexion control device may be configured to remain at a single, constant resistance level corresponding to the second, intermediate resistance level (M) for a second period of time.
[0120] In the preferred embodiment described above, the electronic control system has a master microprocessor controller and two slave microprocessor controllers, one for the knee joint and one for the ankle joint. Alternative arrangements are possible. Indeed, all control functions may be performed by a single microprocessor controller, preferably mounted at the knee level, the single controller collecting data from sensors associated with both joints, as in the preferred embodiment, i.e. from different areas of the prosthesis. The single controller would perform advanced analysis of gait and circumstances (i.e. environment, including ground inclination) based on sensor signals from two or more areas of the prosthesis. Additionally, a single controller would monitor the feedback signals from the knee and ankle adjustment motors rather than having such functions performed by slave controllers.
[0121] In a variant of the above-described prosthesis, the electronic control system has a bi-lateral mode to allow intercommunication of two limb prostheses for bilateral amputees. In this case, the user interface 120 (FIG. 2) incorporates a hard-wired interconnection incorporating a UART port for communication with the second prosthesis. A wireless communication port may be used instead. The matrices of FIGS. 4A to 4D are expanded for the bi-lateral mode so that both prostheses are synchronised to provide correct damping levels at the knee and the ankle in each case. The high-yield resistance setting for stance control release is timed to be in phase with the initiation of high-yield resistance in the other prosthesis. Similarly, pneumatic swing controls are also adjusted for different speeds for right and left limbs. Plantar-flexion damping of the ankle is synchronised with dorsi-flexion damping of the other limb to provide natural progression and optimum function.
