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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C607S040000

Reexamination Certificate

active

06625494

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 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 THE 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 universally enable different, user-selectable neuromuscular stimulation functions. In one embodiment, the systems and methods employ a universal controller that is adapted to provide different functional neuromuscular stimulation functions, which can be selected by the user. The controller comprises a housing and an output device that is carried by the housing that can be coupled to an electrode. A microprocessor carried by the housing, which is coupled to the output device. The microprocessor includes a processing element that is operative in first and second modes. In the first mode, the processing element generates a signal pattern to an electrode to control a first neuromuscular stimulation function, e.g., a motor control function. In the second mode, the processing element generates a signal pattern to an electrode to control a second neuromuscular stimulation function that is different than the first neuromuscular stimulation function, e.g., a bladder or bowel control function. An input device carried by the housing is coupled to the microprocessor to enable selection by the user of the first or second modes.
The input device desirably includes a display element on the housing. In this arrangement, the microprocessor is further operative to generate a display on the display element prompting selection of the first or second modes.
The microprocessor can enable selection of either the first or second modes. Desirably, the microprocessor can enable concurrent selection of the first and second modes, so that, e.g., a user can affect a motor control function (for example, a standing function) while simultaneously affecting a bladder control function.
Desirably, the housing is sized and configured to fit comfortably within a hand of the individual, or it can be otherwise sized and configured to be easily carried by the individual, e.g., in a shirt pocket or on a belt.
The systems and methods that embody the features 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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patent: RE36690 (2000-05-01), McGraw et al.
patent: 6163725 (2000-12-01), Peckham et al.
patent: 6315721 (2001-11-01), Schulman et al.
NeuroControl Press Release; Jan. 17, 2000; StIM ™System Receives CE mark approval.
NeuroControl StIM ™ System Brochure; circa Jan. 2000.
The NeuroControl StIM™ System Brochure; circa Jan. 2000.

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