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Portable assemblies, systems and methods for providing functional or therapeutic neuromuscular stimulation

Portable assemblies, systems and methods for providing functional or therapeutic neuromuscular stimulation description/claims

This application is a divisional application of U.S. patent application Ser. No. 11/056,591, filed 11 Feb. 2005, and entitled “Portable Assemblies, Systems and Methods for Providing Functional or Therapeutic Neuromuscular Stimulation,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/551,945, filed Mar. 10, 2004, and entitled “Steerable Introducer for a Percutaneous Electrode Usable in Association with Portable Percutaneous Assemblies, Systems and Methods for Providing Highly Selective Functional or Therapeutic Neuromuscular Stimulation,” and also claims the benefit of U.S. Provisional Patent Application Ser. No. 60/599,193, filed Aug. 5, 2004, and entitled “Implantable Pulse Generator for Providing Functional and/or Therapeutic Stimulation of Muscles and/or Nerves” which are incorporated herein by reference.

Further, U.S. patent application Ser. No. 11/056,591 is also a continuation-in-part of U.S. patent application Ser. No. 10/777,771, now U.S. Pat. No. 7,120,499, filed Feb. 12, 2004, and entitled “Portable Percutaneous Assemblies, Systems and Methods for Providing Highly Selective Functional or Therapeutic Neurostimulation,” which is incorporated herein by reference.

This invention relates to systems and methods for providing neuromuscular stimulation.

Neuromuscular stimulation can perform functional and/or therapeutic outcomes. While existing systems and methods can provide remarkable benefits to individuals requiring neuromuscular stimulation, many quality of life issues still remain. For example, existing systems perform a single, dedicated stimulation function. Furthermore, these controllers are, by today's standards, relatively large and awkward to manipulate and transport.

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 requiring neuromuscular stimulation, including the ability to enable the end-user to operate the system through a wireless interface.

The invention provides improved assemblies, systems, and methods for providing prosthetic or therapeutic neuromuscular stimulation.

On aspect of the invention provides systems and methods for a neuromuscular stimulation assembly. The assembly comprises a carrier sized and configured to be worn by a user. The carrier includes a tissue facing surface, at least one percutaneous electrode extending from the carrier, circuitry carried on-board the carrier configured to generate a stimulation pulse to the electrode, and the carrier tissue facing surface including an adhesive region, the adhesive region being in contact with the external skin surface.

Another aspect of the invention provides systems and methods for providing a neuromuscular stimulation function. A method may include

a) providing a neuromuscular stimulation assembly comprising a carrier sized and configured to be worn by a user, the carrier including a tissue facing surface and a power input bay, the power input bay being sized and configured to hold a disposable battery for the circuitry that can be released and replaced for powering the circuitry, at least one percutaneous electrode extending from the carrier, circuitry carried on-board the carrier configured to generate a stimulation pulse to the electrode, and the carrier tissue facing surface including an adhesive region, the adhesive region being in contact with the external skin surface,

b) providing instructions furnished by a clinician or caregiver or physician prescribing the release and replacement of the disposable battery according to a prescribed battery replacement regime, the prescribed battery replacement regime comprising the replacement of the disposable battery on a prescribed repeated basis similar to administering a pill under a prescribed pill-based medication regime, and

c) providing a supply of disposable batteries, each battery comprising a dose of power for the circuitry for administration according to the prescribed battery replacement regime.

An additional aspect of the invention provides portable, percutaneous or surface mounted neuromuscular stimulation assemblies, systems and methods that provide electrical connections between muscles or nerves inside the body and stimulus generators or recording instruments temporarily mounted on the surface of the skin outside the body. The assemblies, systems, and methods may, in use, be coupled by percutaneous leads to electrodes, which are implanted below the skin surface, or, alternatively, may be coupled to conventional surface mounted electrodes, and positioned at a targeted tissue region or regions. The neuromuscular stimulation assemblies, systems, and methods apply highly selective patterns of neuromuscular stimulation only to the targeted region or regions, to achieve one or more highly selective therapeutic and/or diagnostic outcomes. The patterns can vary according to desired therapeutic and/or diagnostic objectives. The indications can include, e.g., the highly selective treatment of pain or muscle dysfunction, and/or the highly selective promotion of healing of tissue or bone, and/or the highly selective diagnosis of the effectiveness of a prospective functional electrical stimulation treatment by a future, permanently implanted device. In addition, the controller interface from the user to the neuromuscular stimulation assemblies, systems, and methods may be wireless.

The neuromuscular stimulation assemblies, systems, and methods comprise a skin-worn patch or carrier. The carrier can be readily carried, e.g., by use of a pressure-sensitive adhesive, without discomfort and without affecting body image on an arm, a leg, or torso of an individual.

The carrier carries an electronics pod, which generates the desired electrical current patterns. The pod houses microprocessor-based, programmable circuitry that generates stimulus currents, time or sequence stimulation pulses, and logs and monitors usage. The electronics pod may be configured, if desired, to accept wireless RF based commands for both wireless programming and wireless patient control.

The electronics pod also includes an electrode connection region, to physically and electrically couple percutaneous electrode leads to the circuitry of the electronics pod or to the surface mounted electrodes.

The carrier further includes a power input bay, to receive a small, lightweight, primary cell battery, which can be released and replaced as prescribed. The battery provides power to the electronics pod.

It is contemplated that, in a typical regime prescribed using the neuromuscular stimulation assemblies, systems, and methods, an individual will be instructed to regularly remove and discard the battery (e.g., about once a day or once a week), replacing it with a fresh battery. This arrangement simplifies meeting the power demands of the electronics pod. The use of the neuromuscular stimulation assemblies, systems, and methods thereby parallels a normal, accustomed medication regime, with the battery being replaced at a prescribed frequency similar to an individual administering a medication regime in pill form.

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