Systems and methods for performing prosthetic or therapeutic...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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C607S039000, C607S040000

Reexamination Certificate

active

06701189

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to systems and methods for providing function to otherwise paralyzed muscles.
BACKGROUND OF THE INVENTION
Functional Electrical Stimulation or Function Neuromuscular Stimulation, in short hand, typically refer to prosthetic systems and methods that restore function to muscles in the body that are otherwise paralyzed due to lack of neuromuscular stimulation, e.g., due to spinal cord injury, stroke, or disease. These conditions can break or otherwise disrupt the path or paths by which electrical signals generated by the brain normally travel to neuromuscular groups, to stimulate coordinated muscle contraction patterns. As a result, even though the nerves and muscles are intact, no electrical stimulation is received from the spinal cord, and the associated muscles do not function. Such systems and methods replace the disrupted, physiologic electrical paths, and restore function to the still intact muscles and nerves. Such systems and methods are known, e.g., to restore finger-grasp grasp functions to muscles in the arm and hand, or to restore bladder and bowel control to muscles in the bladder, urethral sphincter, and bowel or to restore a standing function to muscles in the hip and thigh.
Neuromuscular stimulation can perform therapeutic functions, as well. These therapeutic functions provide, e.g., exercise to muscle, or pain relief for stroke rehabilitation, or other surgical speciality applications, including shoulder subluxation, gait training, etc.
While existing systems and methods provide remarkable benefits to individuals requiring neuromuscular stimulation, many quality of life issues still remain. For example, existing systems are function specific, meaning that a given device performs a single, dedicated stimulation function. An individual requiring or desiring different stimulation functions is required to manipulate different function specific stimulation systems. Such systems are not capable of receiving control inputs from different sources, or of transmitting stimulation outputs to different stimulation assemblies. Concurrent performance of different stimulation functions is thereby made virtually impossible.
Furthermore, the controllers for such function specific systems are, by today's standards, relatively large and awkward to manipulate and transport. They are also reliant upon external battery packs that are themselves relatively large and awkward to transport and recharge.
While the controller can be programmed to meet the individual's specific stimulation needs, the programming requires a trained technical support person with a host computer that is physically linked by cable to the controller. The individual requiring neuromuscular stimulation actually has little day to day control over the operation of the controller, other than to turn it on or turn it off. The individual is not able to modify operating parameters affecting his/her day-to-day life.
It is time that systems and methods for providing neuromuscular stimulation address not only specific prosthetic or therapeutic objections, but also address the quality of life of the individual require neuromuscular stimulation.
SUMMARY OF INVENTION
The invention provides improved systems and methods for providing prosthetic or therapeutic neuromuscular stimulation.
One aspect of the invention provides neuromuscular stimulation systems and methods that support different control signal sources. In one embodiment, the systems and methods employ a controller that provides functional neuromuscular stimulation by incorporating in a housing and an output device that can be coupled to an electrode, together with first and second input devices. The first input device is conditioned to receive a control signal from a first signal source. The second input device is conditioned to receive a control signal from a second signal source different than the first signal source. In this arrangement, a microprocessor is also carried by the housing and is coupled to the output device and the first and second input device. The microprocessor includes a processing element operative to generate a signal pattern to an electrode to control at least one neuromuscular stimulation function in response to a control signal received from either the first or second input devices.
According to this aspect of the invention, a user can affect a given one or more neuromuscular stimulation function by actuation, e.g., of either an external control source or a keypad carried by the housing. At least one of the first and second input devices can receive the control signal by wireless transmission or by a cable connection.
Another aspect of the invention provides neuromuscular stimulation systems and methods that support different control signal outputs. In one embodiment, the systems and methods employ a controller that incorporates within a housing a microprocessor and first and second output devices. The microprocessor includes a processing element that operates to generate signal patterns to control neuromuscular stimulation functions. The first output device is coupled to the microprocessor to convey a signal pattern to a first neuromuscular stimulation assembly. The second output device is coupled to the microprocessor to convey a signal pattern to a second neuromuscular stimulation assembly different than the first neuromuscular stimulation assembly.
According to this aspect of the invention, the user can affect a first neuromuscular stimulation function, e.g., by generation of a radio frequency output to an implanted receiver/stimulator, and affect a second neuromuscular stimulation function, e.g., by direct coupling to external leads that are coupled percutaneously to implanted neuromuscular electrodes or or that are coupled to electrodes secured to a skin surface.
At least one of the first and second output devices can convey the signal pattern by wireless transmission or by a cable connection. The microprocessor can enable concurrent selection of conveying a signal pattern to both first and second neuromuscular stimulation assemblies, or the microprocessor can enable selection of conveying a signal pattern to either the first or second neuromuscular stimulation assemblies.
The systems and methods that embody the features of the various aspects of the invention provide effective neuromuscular stimulation to meet a host of prosthetic or therapeutic objections. The systems and methods also provide convenience of operation, flexibility to meet different user-selected requirements, and transportability and ease of manipulation, that enhance the quality of life of the individual that requires chronic neuromuscular stimulation.
Other features and advantages of the inventions are set forth in the following specification and attached drawings.


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NeuroControl Press Release; Jan. 17, 2000; StlM™ System receives CE mark approval.
NeuroControl StlM™ System Brochure; circa Jan. 2000.
The NeuroControl StlM™ System Brochure; circa Jan. 2000.

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