|
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. |