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01/31/08 - USPTO Class 607 |  53 views | #20080027524 | Prev - Next | About this Page  607 rss/xml feed  monitor keywords

Multi-electrode assembly for an implantable medical device

USPTO Application #: 20080027524
Title: Multi-electrode assembly for an implantable medical device
Abstract: A method, system, and apparatus are provided for an electrode assembly comprising a plurality of electrodes for use with an implantable medical device for conducting an electrical signal between the implantable medical device and a target tissue. The electrode assembly includes a helical member and first and second electrodes formed upon the helical member. The first and second electrodes are adapted to deliver the electrical signal. The electrode assembly also includes a first conductive element formed upon the helical member and operatively coupled to the first electrode. The electrode assembly also includes a second conductive element formed upon the helical member and operatively coupled to the second electrode. (end of abstract)



Agent: Timothy L. Scott - Houston, TX, US
Inventors: Steven E. Maschino, Bryan P. Byerman
USPTO Applicaton #: 20080027524 - Class: 607118 (USPTO)

Multi-electrode assembly for an implantable medical device description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20080027524, Multi-electrode assembly for an implantable medical device.

Brief Patent Description - Full Patent Description - Patent Application Claims
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BACKGROUND OF THE INVENTION

[0001]1. Field of the Invention

[0002]This invention relates generally to implantable electrode assemblies, and more particularly to an electrode assembly comprising a plurality of electrodes organized into a helical structure. The electrodes may be operatively coupled to an implantable medical device (IMD).

[0003]2. Description of the Related Art

[0004]As used herein, "stimulation" or "stimulation signal" refers to the application of an electrical, mechanical, magnetic, electro-magnetic, photonic, audio and/or chemical signal to a neural structure in the patient's body. The signal is an exogenous signal that is distinct from the endogenous electrical, mechanical, and chemical activity (e.g., afferent and/or efferent electrical action potentials) generated by the patient's body and environment. In other words, the stimulation signal (whether electrical, mechanical, magnetic, electro-magnetic, photonic, audio or chemical in nature) applied to the nerve in the present invention is a signal applied from an artificial source, e.g., a neurostimulator.

[0005]A "therapeutic signal" refers to a stimulation signal delivered to a patient's body with the intent of treating a disorder by providing a modulating effect to neural tissue. The effect of a stimulation signal on neuronal activity is termed "modulation"; however, for simplicity, the terms "stimulating" and "modulating", and variants thereof, are sometimes used interchangeably herein. In general, however, the delivery of an exogenous signal itself refers to "stimulation" of the neural structure, while the effects of that signal, if any, on the electrical activity of the neural structure are properly referred to as "modulation." The effect of delivery of the stimulation signal to the neural tissue may be excitatory or inhibitory and may potentiate acute and/or long-term changes in neuronal activity. For example, the "modulating" effect of the stimulation signal to the neural tissue may comprise one or more of the following effects: (a) changes in neural tissue to initiate an action potential (afferent and/or efferent action potentials); (b) inhibition of conduction of action potentials (whether endogenous or exogenously induced) or blocking the conduction of action potentials (hyperpolarizing or collision blocking), (c) affecting changes in neurotransmitter/neuromodulator release or uptake, and (d) changes in neuro-plasticity or neurogenesis of brain tissue.

[0006]Thus, electrical neurostimulation or modulation of a neural structure refers to the application of an exogenous electrical signal (as opposed to mechanical, chemical, photonic, or another mode of signal delivery) to the neural structure. Electrical neurostimulation may be provided by implanting an electrical device underneath the skin of a patient and delivering an electrical signal to a nerve such as a cranial nerve. In one embodiment, the electrical neurostimulation involves sensing or detecting a body parameter, with the electrical signal being delivered in response to the sensed body parameter. This type of stimulation is generally referred to as "active," "feedback," or "triggered" stimulation. In another embodiment, the system may operate without sensing or detecting a body parameter once the patient has been diagnosed with a medical condition that may be treated by neurostimulation. In this case, the system may periodically apply a series of electrical pulses to the nerve (e.g., a cranial nerve such as a vagus nerve) intermittently throughout the day, or over another predetermined time interval. This type of stimulation is generally referred to as "passive," "non-feedback," or "prophylactic," stimulation. The stimulation may be applied by an implantable medical device that is implanted within the patient's body. In another alternative embodiment, the signal may be generated by an external pulse generator outside the patient's body, coupled by an RF or wireless link to an implanted electrode.

[0007]Generally, neurostimulation signals that perform neuromodulation are delivered by the implantable device via one or more leads. The leads are generally coupled at a distal end to electrodes, which are coupled to a tissue in the patient's body. Multiple leads/electrodes may be attached to various points of a nerve or other tissue inside a human body for delivery of neurostimulation. Generally, each lead is associated with a separate electrode, particularly when each of the electrodes is intended to perform a different function (e.g., deliver a first electrical signal, deliver a second electrical signal, sense a body parameter, etc.).

[0008]Generally, a single electrode is associated with each lead originating from the IMD. The number of leads that originate from the IMD is limited due to the size constraints of the IMD and of the patient's body. Therefore, a limited number of electrodes using state-of-the-art technology can be used to deliver electrical stimulation from an IMD.

[0009]Further, state-of-the-art medical systems call for performing a stimulation during a time period that is separate from a time period of performing a sensing function for sensing the patient's biological signals. Further, a first lead associated with a first electrode may deliver a therapeutic electrical signal, while a second lead associated with a second electrode may perform data acquisition for sensing of various biometric parameters in the patient's body. This process may be inefficient since the state-of-the-art generally lacks a system for simultaneously delivering an electrical signal to a neural structure and sensing electrical activity, particularly where associated with the neural structure to which the signal is applied. Further, problems with the state-of-the-art also include a limitation on the number of electrodes that may be employed by an IMD to deliver various stages of therapy and/or sensing functions.

[0010]The present invention is directed to overcoming, or at least reducing, the effects of one or more of the problems set forth above.

SUMMARY OF THE INVENTION

[0011]In one aspect, the present invention provides an electrode assembly comprising a plurality of electrodes for use with an implantable medical device for conducting an electrical signal between the implantable medical device and a target tissue. The electrode assembly includes a helical member having a first and a second electrode formed upon the helical member. The first and second electrodes are adapted to deliver the electrical signal. The electrode assembly also includes a first conductive element formed upon the helical member and operatively coupled to the first electrode. The first conductive element is adapted to carry the electrical signal to the first electrode. The electrode assembly also includes a second conductive element formed upon the helical member and operatively coupled to the second electrode.

[0012]In yet another aspect, the present invention includes a method for forming a helical electrode assembly for carrying an electrical signal associated with an implantable medical device. A first layer is formed on a generally flat substrate. In one embodiment, the substrate is generally planar. A first conducting structure is formed upon the first layer. The first conducting structure includes a first electrode and a first lead operatively coupled to the first electrode. A second, non-conductive layer is formed above the first layer. A second conducting structure is formed upon the second, non-conductive layer. The second conducting structure includes a second electrode and a second lead operatively coupled to the second electrode. The method further includes the step of forming the generally flat substrate into a helical structure.

[0013]In another aspect, the present invention includes another method for forming a helical electrode assembly for carrying a signal associated with an implantable medical device. A first layer is formed on a generally flat substrate. A first conducting structure and a second conducting structure are formed upon the first layer. The first conducting structure includes a first electrode and a first lead operatively coupled to the first electrode. The second conducting structure includes a second electrode and a second lead operatively coupled to the second electrode. A second, non-conductive layer is formed such that the first and second leads are substantially covered by the second layer and the first and second electrodes remain exposed. The method also comprises the step of forming the generally flat substrate and first and second layers into a helical structure.

[0014]In yet another aspect, the present invention provides an implantable medical system for providing a therapeutic electrical signal to a target tissue using a helical electrode assembly. The system of the present invention includes an implantable medical device for generating a therapeutic electrical signal. The system also includes a lead assembly operatively coupled to the implantable medical device and adapted to carry the therapeutic electrical signal. The lead assembly comprises first and second lead elements. The system also includes an electrode assembly operatively coupled to the lead assembly. The electrode assembly includes a helical member having first and second electrodes formed thereon. The electrode assembly also includes a first conductive element formed upon the helical member and operatively coupled to the first electrode and to the first lead element. The electrode assembly also includes a second conductive element formed upon the helical member and operatively coupled to the second electrode and to the second lead element. The first and second electrodes are adapted to deliver the electrical signal to tissue of a patient when coupled thereto.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015]The invention may be understood by reference to the following description taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and in which:

[0016]FIG. 1 is a stylized diagram of an implantable medical device implanted into a patient's body for providing stimulation to a portion of the patient's body, in accordance with one illustrative embodiment of the present invention;

[0017]FIG. 2 illustrates a stylized isometric illustration of an electrode assembly in accordance with one embodiment of the present invention;

[0018]FIG. 3 illustrates another isometric depiction of the electrode assembly and an electrode in accordance with one illustrative embodiment of the present invention;

[0019]FIG. 4 illustrates a stylized depiction of the electrode assembly of FIGS. 2 and 3 during fabrication, in accordance with the illustrated embodiment of the present invention;

[0020]FIG. 5 illustrates a flowchart associated with a method for providing the electrode assembly of FIGS. 2-4, in accordance with an illustrative embodiment of the present invention, is provided;

[0021]FIG. 6 illustrates a stylized depiction of the electrode assembly of the present invention in a staggered multi-layered configuration, in accordance with an illustrative embodiment of the present invention;

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