In order to enable proper daily application by hemiparetic users and to
provide effective and safe gait, FES systems for the correction of drop foot
should comply with variety of ergonomical, technical and other design
requirements.
For many years, non invasive FES foot drop devices suffer
technical and ergonomical problems which make its problematic for independent
use at home and technically unreliable. In a survey* performed in 2002 among 98
users of non-invasive, drop foot stimulators, the following was found:
· 13% -
Reported that they have no problems
· 72% -
Problem with finding the correct electrode positions
· 58% -
Difficulties with wires and foot-switches
· 2530% of the users ultimately reject the device.
* (Gerard M. Lyons, Thomas Sinkjær, Jane H.
Burridge, and David J. Wilcox, IEEE, Vol.10, no.4, December 2002)
The NESS L300 system addresses these and other existing
traditional barriers, ensuring precise electrode location, wireless
communication, comfortable and safe stimulation and dynamic agait
synchronization. The systems innovative design and features ensure effective
and safe use at the patients home while providing simple, user friendly
configuration and application at the clinic environment.
More specifically, the NESS L300 system offers the following
advantages:
§ All system components communicate
wirelessly by RF, thus avoiding the need for cumbersome wires and connectors,
making the system simple and comfortable to use. The wireless communication also
increases the reliability of the system by avoiding the possible malfunction of
wires and connectors.
§ The unique ergonomic design of the hybrid
orthosis and its ability to be precisely located over the lower leg provides
accuracy and repeatability of electrode placement, thus ensuring constant and
balanced foot movement. Receiving the exact same movement set by the clinician
while using the system daily at home is an essential requirement which has
functional and safety aspects.
§ The Automatic location feature of
the orthosis allows even severely injured hemiplegic patients to put on and
remove the device using one hand only.
§ Level of tightening of the hybrid
orthosis (and thereof the attachment of the electrodes) to the limb is initially
set by the clinician and precisely repeated by the user each time the orthosis
handle is closed on the cradle.
§ An advanced design of the orthosis ensures
comfort for use all day long while providing optimal electrode contact with the
limb at all time.
§ The perfectly balanced, rectangular pulse shape
and the relatively large and qualitative electrodes optimize the comfort of
stimulation and reduce the risk of skin irritation.
§ A miniature remote control unit enables friendly
operation and provides indications of the system status. It eliminates the need
to bend toward the lower leg in order to modify the intensity or turn ON/OFF the
system, and allows operation while standing or walking. Providing on-line audio
and visual indications and allowing system operation while standing or walking
has both functional and safety implications.
§ The system includes a proprietary gait sensor
with dedicated gait software. The software automatically adapts to different
weights pressures and therefore the system can be reliably used by very light
weighed persons as well as by heavy and even obese users. The dynamic gait
recognition algorithms adapt in real time to various gait velocities, rhythms
and styles. Reliability is established even while walking on various terrains
such as carpets, grass, stairs, slopes, obstacles etc. The gait sensors
structure, capsulation and algorithms also compensate for possible changes in
its mechanical and electronic profile caused by the harsh in shoe environment,
thus ensuring long lasting function and safety.
§ The system allows users to walk with a wide
range of shoes. The NESS L300 system supports multiple gait sensors enabling the
user to exchange shoes without the need to transfer the gait sensor from shoe to
shoe. The small transmitter comfortably attaches to the shoe rim.
§ The Gait sensor includes a sophisticated power
management system which allows it to be operated by a small coin battery for
prolonged duration.
§ The hybrid orthosis is cosmetically acceptable
due to its attractive and low profile design. This is especially important when
wearing shorts or a skirt.
§ Replacement of system modules at the patients
home can be easily performed independently by the RF registration automatic
procedure. The patient simply press two buttons of the replaced component to
initiate the procedure, in which the new component is registered to the rest of
the system and the configuration parameters are automatically transmitted
wirelessly to it.
§ The orthosis electrode bases allows simple
process of electrodes emplacement by the paralyzed person.
§ The orthosis RF stimulation unit and the control
unit are rechargeable.
In addition to its advantages in the home setting, the NESS L300 system
optimally adjusted to be used at the clinic environment:
§ A PDA (Portable Digital Assistant) with
proprietary software (the Intelli-Gait software) is used for system
configuration. The software and its unique interface enables user friendly
configuration process of stimulation and gait parameters and tracking of
patients history and gait log up to two years back. It also includes data base
of the system users with its configuration parameters and history.
§ When connected to the control unit, the PDA
transmits the configuration commands wirelessly to the rest of the system. A
special housing (configuration cradle) is provided to allow wireless and
completely mobile configuration process. The configuration is therefore enabled
while the clinician is either distant or in close proximity to the patient and
while the patient is walking inside or outside the clinic.
§ The system support use by multiple patients in
the clinic. For fast re-configuration the clinician simply select the relevant
patient in the PDA database for immediate downloading of his configuration
parameters to the system.
§ In order to preserve the precise electrode
location of each patient and to allow fast restoration of this specific
location, the clinician kit of the system includes disposable Personal panels
that are designed for fast connection and detachment from the orthosis. Upon
connection to the orthosis, the panel accurately locates the electrodes on the
orthosis in the specific arrangement of the patient while establishing the
required mechanical and electrical connection. The Personal panels also ensure
that hygiene is maintained when transferring the system from one patient to the
other. |