FIELD

The present invention relates to an apparatus for the rehabilitation, assistance and/or augmentation of arm strength in a user.

BACKGROUND

Partial paralysis affects a significant number of people around the World, whether as result of an inherited condition or due to an injury. In some instances, partial paralysis may be the result of a stroke. In other instances, partial paralysis may be result of an injury to the brachial plexus nerve—a network of neurons originating from the spinal cord which carries the motor and sensory information between the brain and the upper limbs.

Brachial Plexus Injury (BPI) may for example be caused by an inflammatory disease, by a tumour impinging on the brain, during childbirth, or by traumatic injury and typically leads to functional impairment and disability to one or more of the upper limbs.

Direct effects of BPI are muscle atrophy, pain and somatosensory deficit. BPI can also affect the patients psychologically.

BPI patients require early and prolonged treatment. Surgical reinnervation is often necessary to repair an injury caused due to muscle denervation.

However, physical therapy is required before and after the surgical reinnervation in order to prevent the development of muscular contracture, joint stiffness and secondary deformities in the affected arm, since denervated muscle can develop atrophy within weeks.

Currently, physical therapy is provided for BPI patients immediately on their diagnosis to prevent the development of muscle contracture, joint stiffness and secondary deformities, with muscle stretching the primary task given by therapists to avoid muscular atrophy.

Orthosis devices are used in physical therapy and include braces, splints, or other external devices which function to support the limbs or spine of a user or to prevent and assist relative movement.

More recently, the emergence of robotic technology has been introduced to assist users in the rehabilitation of stroke patients.

However, there are a number of drawbacks with conventional equipment.

For example, although current systems are capable of providing sufficient power to anatomical joints for performing various upper arm movements, these systems are bulky and not portable. Hence, these devices are limited to laboratory or clinical environments and not capable of providing physical therapy for BPI patients while they are at home.

Moreover, conventional robotic equipment requires a muscle activity signal to control and operate. However, in the case of users with complete paralysis of the given limb, such a muscle activity signal is not present.

SUMMARY

According to a first aspect, there is provided a wearable orthosis apparatus for use in the rehabilitation, assistance and/or augmentation of arm strength in a user, comprising:

a support arrangement for supporting the apparatus on the user, such that the apparatus can be carried by the user;

a linkage arrangement coupled to the support arrangement and configured for coupling to an arm of a user; and

an actuation arrangement coupled to the linkage arrangement and configured to move the linkage arrangement and thereby manipulate the user's arm in response to a user input signal.

The apparatus may comprise or take the form of an exoskeleton.

Beneficially, embodiments of the apparatus provide a lightweight and portable device suitable for being carried by the user, facilitating rehabilitation of the arm for people with partial paralysis in a home setting. In the case of Brachial Plexus Injury (BPI), embodiments of the apparatus are capable of providing an active force to perform flexion and extension of the elbow joint, thereby reducing the occurrence of muscle contracture and joint stiffness while also functioning to stabilise the arm in a similar manner to a conventional splint used in rehabilitation process for BPI patients. Embodiments of the apparatus may alternatively be used for assistance of people with arm weakness, such as older people, to perform activities of daily life such as carrying and/or lifting; and/or as an augmentative device to increase the arm capability in industrial or military environments, thereby reducing metabolic cost and/or fatigue.

The user input signal may comprise a signal resulting from a force applied to the linkage arrangement by the user.

The user input signal may be generated by a sensor arrangement.

The sensor arrangement may comprise a sensor.

The sensor may comprise an accelerometer.

The user input signal may comprise a signal from a switch or other input device operated by the user, in particular but not exclusively using the user's other arm.

As described above, the apparatus comprises a support arrangement for supporting the apparatus on the user.

Beneficially, the support arrangement permits the apparatus to be carried by the user, in contrast to conventional fixed station rehabilitation equipment. Embodiments of the present invention thus permit rehabilitation therapies to be carried out by the user themselves in a home environment.

The support arrangement may comprise a back plate.

The back plate may support the mass of the linkage arrangement and the actuation arrangement on the user.

Users with reduced or no feeling in their arm are known to be adversely affected by postural balance issues due at least in part to the lack of feedback from the affected arm, balance issues which can be exacerbated by any unbalanced load on one side of the user's body. Beneficially, the back plate distributes the weight of the apparatus across the back of the user, such that the user will not feel weight a significant unbalanced load on one side of their body due to the asymmetric location of the apparatus on one arm.

The back plate may be constructed from any suitable material.

In particular embodiments, the back plate is constructed from a carbon fibre composite material.

Beneficially, the provision of a back plate which is constructed from a carbon fibre composite material reduces the weight to be carried to be user while being sufficiently strong to carry the mass of the other components of the apparatus, including amongst other things the linkage arrangement and the actuation arrangement.

The support arrangement may comprise one or more strap.

The support arrangement may comprise one or more shoulder strap.

In particular embodiments, the support arrangement comprises two shoulder straps.

The shoulder strap(s) may be coupled to the back plate.

The or each shoulder strap may be disposed through a slot in the back plate.

The shoulder strap, or in embodiments comprising a plurality of shoulder straps at least one of the shoulder straps, may be adjustable. For example, a slide adjuster or other suitable adjuster may be provided to permit the shoulder strap to be adjusted. Beneficially, the provision of adjustable shoulder straps permits the apparatus to be adapted to the user's anthropometry.

A clasp may be provided to secure the shoulder straps together.

The support arrangement may comprise one or more waist strap.

In particular embodiments, the support arrangement comprises two waist straps.

The waist strap, or in embodiments comprising a plurality of waist straps at least one of the waist straps, may be adjustable. For example, a slide adjuster or other suitable adjuster may be provided to permit the shoulder strap to be adjusted.

Beneficially, the provision of adjustable waist straps permits the apparatus to be adapted to the user's anthropometry.

A clasp may be provided to secure the waist straps together.

The support arrangement may take other forms. For example, at least part of the support arrangement may be integrally formed with a garment, such as a jacket, suitable for being worn by the user.

As described above, the linkage arrangement is coupled to the support arrangement and configured for coupling to an arm of the user.

The linkage arrangement may comprise a first linkage element.

The first linkage element may take the form of a shoulder rod.

The first linkage element may be coupled to the back plate.

The first linkage element may be coupled to the back plate by a coupler.

The first linkage element may be coupled to the back plate such that the first linkage element extends vertically or substantially vertically relative to the user.

The first linkage element may be rotatable about a vertical or substantially vertical axis relative to the user.

In use, rotation of the first linkage element relative to the vertical or substantially vertical axis may provide a first degree of freedom of the apparatus.

The first linkage element may be rotatably coupled at a first end to the coupler and at a second end to a coupler block, such that the shoulder rod is rotatable about the vertical or substantially vertical axis relative to the user.

The first linkage element may be rotatably coupled at the first end to the coupler by a bearing, e.g., a roller bearing, and at the second end to the coupler block by a bearing, e.g., a roller bearing.

The first linkage element may be constructed from any suitable material.

In particular embodiments, the first linkage element may be constructed from steel, more particularly but not exclusively structural steel.

The linkage arrangement may comprise a second linkage element.

The second linkage element may take the form of angled shoulder rod.

The second linkage element may extend horizontally or substantially horizontally relative to the user.

The second linkage element may be rotatable about a horizontal or substantially horizontal axis relative to the user.

The second linkage element may be rotatably coupled to the coupler block.

The second linkage element may be rotatably coupled at a first, proximal, end to the coupler block and at a second, distal, end to the third linkage element.

The second linkage element may be rotatably coupled at the first, proximal, end to the coupler block by a bearing, e.g., a roller bearing, and at the second, distal, end to the third linkage element by a bearing, e.g., a roller bearing.

In use, rotation of the second linkage element may provide a second degree of freedom of the apparatus.

The second linkage arrangement may be constructed from any suitable material.

In particular embodiments, the second linkage arrangement is constructed from aluminium alloy.

The linkage arrangement may comprise a third linkage element.

The third linkage element may take the form of a shoulder link.

The third linkage element may be coupled at a first, proximal, end to the distal end of the second linkage element and at a second, distal, end to the fourth linkage element.

The third linkage element may be curved. The third linkage element may be curved such that, in use, the third linkage element extends in an anterior direction (towards the user's front) such that the distal end of the third linkage element is disposed above, and rests on, the user's clavicle.

The third linkage element may be configured to pivot about a third axis to provide a third degree of freedom of the apparatus.

The third linkage element may comprise a unitary component. The third linkage element may be custom built to match the user's anthropometry.

Alternatively, the third linkage element may be adjustable to match the user's anthropometry. For example, the third linkage element may comprise a plurality of components coupled by a slider coupling or in a telescopic relationship.

The third linkage arrangement may be constructed from any suitable material.

In particular embodiments, the third linkage arrangement is constructed from aluminium alloy.

The linkage arrangement may comprise a fourth linkage element.

The fourth linkage element may take the form of an upper arm member.

The fourth linkage element may be configured to pivot about a fourth axis to provide a fourth degree of freedom of the apparatus.

The fourth linkage element may be coupled at a first, upper, end to the third linkage element and at a second, lower, end to the actuator arrangement of the apparatus.

The fourth linkage element may be coupled at the first, upper, end to the third linkage element by a bearing, e.g. a roller bearing, and at the second, lower, end to the actuator arrangement of the apparatus by a bearing, e.g. a roller bearing.

The fourth linkage element may be adjustable to match the user's anthropometry.

The fourth linkage element may comprise a first upper arm element and a second upper arm element.

The first upper arm element and the second upper arm element may be coupled together by a slider coupling.

The first upper arm element and the second upper arm element may alternatively be arranged in a telescopic relationship.

Alternatively, the third linkage element may comprise a unitary component. The third linkage element may be custom built to match the user's anthropometry, such as by additive manufacture or other suitable method of manufacture.

The fourth linkage arrangement may be constructed from any suitable material.

In particular embodiments, the fourth linkage arrangement is constructed from aluminium alloy.

The linkage arrangement may comprise a fifth linkage element.

The fifth linkage element may take the form of lower arm member.

The fifth linkage element may be coupled at a first, upper, end to the actuator arrangement of the apparatus.

The fifth linkage element may be adjustable to match the user's anthropometry. The fifth linkage element may comprise a first lower arm element and a second lower arm element.

The first lower arm element and the second lower arm element may be coupled together by a slider coupling.

The first lower arm element and the second lower arm element may alternatively be arranged in a telescopic relationship.

Alternatively, the fifth linkage element may comprise a unitary component. The fifth linkage element may be custom built to match the user's anthropometry, such as by additive manufacture or other suitable method of manufacture.

The fifth linkage arrangement may be constructed from any suitable material.

In particular embodiments, the fifth linkage arrangement is constructed from aluminium alloy.

The linkage arrangement may comprise a shoulder joint assembly configured to provide three degrees of freedom of movement.

The shoulder joint assembly may be passive.

The linkage arrangement may comprise an arm assembly configured to provide two degrees of freedom of movement.

The arm assembly may be active.

Beneficially, embodiments of the apparatus are capable of five degrees of freedom of movement, the first linkage element, second linkage element, and third linkage element forming a shoulder joint assembly of the apparatus providing three degrees of freedom of movement while the fourth linkage element and fifth linkage element form an arm assembly of the apparatus providing two degrees of freedom of movement.

In particular embodiments, the shoulder joint assembly is passive, that is it is not directly driven by the actuation arrangement and the elbow joint defined by the arm assembly is active, that is it is directly driven by the actuation arrangement.

In particular embodiments, one or more spring element or other resilient element may be provided to stabilise free movement of the shoulder joint assembly.

The one or more spring element or other resilient element may form part of the support arrangement of the apparatus.

Beneficially, the provision of one or more spring element or other resilient element may improve the stability of the apparatus and may support the position of the linkage arrangement.

The tension and/or length of the one or more spring element or other resilient element spring may be selected according to the user's anthropometry.

The linkage arrangement may comprise a cuff.

The cuff may be configured for coupling the apparatus to the user's lower arm. In use, force generated by the actuator arrangement is transferred to the arm through the cuff, delivering the required assistive torque to the users elbow joint.

The cuff may be coupled to, or form part of, the lower arm member.

One or more adjustable strap may be provided to secure the lower arm to the cuff.

At least part of the sensor arrangement may be disposed in, or mounted on, the cuff.

For example, the sensor of the sensor arrangement may be disposed in, or mounted on, the cuff.

As described above, the actuation arrangement is coupled to the linkage arrangement and configured to operate the linkage arrangement and thereby manipulate the arm in response to the user input signal.

In use, the actuation arrangement may be used for power assisted rehabilitation of the arm for people with paralysis, for example as a result of a stroke or injury as part of their treatment within a clinic, medical establishment or in a home setting. The apparatus may be used for assistance of people with arm weakness, such as older people, to perform activities of daily life such as carrying and/or lifting. The apparatus may be used as an augmentative device to increase the arm capability in industrial or military environments, thereby reducing metabolic cost and/or fatigue.

The actuation arrangement may comprise a rotary drive.

The rotary drive may comprise a motor.

The motor may comprise an electric motor.

The motor may comprise a direct current (DC) electric motor.

In particular embodiments, the motor comprises a brushless DC electric motor (a “BLDC” motor).

Beneficially, the use of a BLDC motor provides a high power-to-weight ratio while also providing a sufficiently fast response time to meet the user need for responsiveness.

The actuation arrangement may comprise a gear arrangement.

The gear arrangement may be interposed between the rotary drive and the linkage arrangement.

The gear arrangement may comprise a strain wave gear drive.

In particular embodiments, the gear arrangement comprises a harmonic Drive®.

In particular embodiments, the gear arrangement may be configured to provide a gear reduction ratio of 1:100. However, the gear arrangement may be configured to provide any suitable gear reduction ratio.

Beneficially, the provision of a strain wave gear drive provides a gear drive which is compact, has low backlash, high gear reduction ratio and low weight for the given gear ratio.

The actuation arrangement may comprise a coupler for attaching the non-moving parts of the rotary drive and the gear arrangement. The coupler may be configured to attach a housing of the rotary drive to a housing of the gear arrangement. The coupler may, for example, comprise an attachment plate.

The actuation arrangement may comprise a coupler for coupling the moving parts of the rotary drive and the gear arrangement. The coupler may be configured to attach a drive shaft of the rotary drive to an output shaft of the gear arrangement. In embodiments where the gear arrangement comprises a strain wave gear drive, the coupler may be configured to attach the drive shaft of the rotary drive to the flex spline of the strain wave gear drive.

The actuation arrangement may comprise a sensor arrangement comprising a sensor configured to sense the user input signal applied to the apparatus by the user.

The sensor may be configured to sense a mechanical force applied to the cuff by the user.

The sensor may comprise an accelerometer.

The actuation arrangement may comprise a controller configured to actuate an actuation arrangement of the apparatus in response to the user input signal to operate the linkage arrangement, and thereby manipulate the user's arm in response to the user input signal.

The controller may comprise an encoder.

The controller may comprise a rotary encoder.

In particular embodiments, the controller may comprise a magnetic rotary encoder.

Beneficially, the magnetic rotary encoder provides high accuracy and low footprint.

The encoder may be incorporated into an encoder housing.

The encoder may be configured to measure the position of the linkage arrangement.

The controller may comprise a magnet.

The apparatus may comprise, or may be operatively associated with, a position controller. In use, the position controller may be configured to control the position of the output shaft of the gear arrangement.

In particular embodiments, the position controller comprises a software based PID (Proportional Integral Derivative) position controller.

A digital PID controller may be implemented in a 32-bitARM microcontroller unit (MCU).

The controller may comprise anti-windup and/or output saturation limit features.

The controller may comprise a derivative filter. Beneficially, the provision of a derivative filter mitigates or reduces noise.

The MCU may comprise a 12-bit analogue to digital converter (ADC).

The MCU may comprise a 10-bit digital-to-analogue converter (DAC) for communicating with external devices.

In use, the output from the magnetic encoder—an analogue voltage—is digitised by the ADC in the MCU and then converted into degrees based on a calibration curve. The output of the controller may then be given to the ESCON controller via the DACport in the MCU. The control algorithm is implemented in a timer interrupt to run at a sampling frequency of 1000 Hz.

The position controller may be configured to operate as a cascading control system consisting of an inner and outer control loop. The inner loop may be implemented in the ESCON board and corresponds to a motor speed controller that maintains the required speed of the rotary drive.

The outer loop may monitor the current shaft position of the output shaft of the gear arrangement.

Based on the differences between the reference position and current position, the controller may generate a corresponding voltage which is sent as an input to the speed controller via the DAC port in MCU.

On receiving the input from the DAC, the speed controller may then control the speed and direction of the rotary drive.

When there is no error between the reference position and feedback position, the output from the PID controller becomes zero and thus brings the motor to an idle position.

The apparatus may comprise an electronics enclosure.

The electronics enclosure may be disposed on the back plate.

The electronics enclosure may house the control arrangement for the apparatus.

The apparatus may comprise an onboard power supply.

The onboard power supply may comprise a battery.

The onboard power supply may comprise a rechargeable battery pack.

The onboard power supply may be supported by the support arrangement.

The onboard power supply may be disposed in the electronics enclosure.

According to a second aspect, there is provided an actuation arrangement for a wearable orthosis apparatus for use in the rehabilitation, assistance and/or augmentation of arm strength in a user, the actuation arrangement comprising:

a sensor arrangement comprising a sensor configured to sense a user input signal applied to the apparatus by a user, the user input signal comprising a pressure force applied to a linkage arrangement of wearable orthosis apparatus; and

a controller configured to actuate an actuation arrangement of the apparatus in response to the user input signal to operate a linkage arrangement, and thereby manipulate the user's arm in response to the user input signal.

A third aspect relates to use of the apparatus to rehabilitate arm strength in a user.

In use, the apparatus may be used for power assisted rehabilitation of the arm for people with paralysis, for example as a result of a stroke or injury as part of their treatment within a clinic, medical establishment or in a home setting.

A fourth aspect relates to use of the apparatus to rehabilitate, assist and/or augment arm strength in a user.

In use, the apparatus may be used for assistance of people with arm weakness, such as older people, to perform activities of daily life such as carrying and/or lifting. The apparatus may be used as an augmentative device to increase the arm capability in industrial or military environments, thereby reducing metabolic cost and/or fatigue.

In particular embodiments, the apparatus further comprises a movement limiter arrangement.

The movement limiter arrangement may comprise one or more safety stop.

The movement limiter arrangement may be configured to limit movement of the elbow joint to the natural limit of movement of the user's elbow, e.g. 0 to 130 degrees.

Alternatively or additionally, the movement limiter arrangement may comprise a software algorithm. The software algorithm may be configured to check the range of motion continuously. If the range of motion exceeds the set limits, the software may be configured to turn off the power to the rotary drive.

The apparatus may comprise a safety switch, e.g. an electrical switch, provided to the user to shut off the power to the rotary drive in case of an emergency.

Beneficially, the movement limiter arrangement and the switch ensure the safety of the apparatus for the user.

It should be understood that the features defined above or described below may be utilised, either alone or in combination with any other defined feature.

