The present invention is directed to an expandable intraluminal electrode assembly.
Neuromodulation, which involves delivering electrical impulses to neural target sites, has become an important therapeutic method and is an option when other forms of treatment, such as drug administration, are ineffective. Neuromodulation has revolutionized the treatment of several neurological disorders, such as movement disorders and chronic pain and has been described in U.S. Pat. No. 6885,888 for treating heart contractility. Technical and mechanical limitations, however, create obstacles to the final application of such methods in patients. For example, one obstacle is in the invasive nature of neuromodulation, which requires open surgery.
As such, there is a need for further approaches for neuromodulation, particularly minimally invasive approaches.
In an embodiment, the present invention provides an intraluminal electrode assembly comprising a cannulated tube and a plurality of wires disposed in the cannulated tube. Each of the plurality of wires has one of a plurality of electrical contacts at a distal end thereof. The plurality of wires assumes a radially constrained configuration within the cannulated tube in a retracted position and a radially extended configuration outward of the cannulated tube in a deployed position. The electrode assembly further comprises a spring wire connecting the plurality of electrical contacts together to collectively form a substantially circular configuration in a deployed position.
The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only. It should be understood that the present invention is in no way limited to the particular arrangement or inclusion of components depicted in the accompanying drawings and wherein:
Referring to
Although electrode assembly 10 is not necessarily limited to any particular use, the substantially circular configuration of the distal end of deployed plurality of wires 30 allows electrode assembly 10 to be used for intraluminal purposes, such as transvascular electrical neuromodulation of a target site adjacent to a vessel. Specifically, referring to
In a preferred embodiment, plurality of wires 30 comprises six to eight wires. Further preferably, each of the plurality of electrical contacts 40 of the plurality of wires 30 can be selectively activated such that select electrical contacts 40 on one segment of the arc of the distal end of the plurality of wires 30 can be activated to apply focused electrical signals on a desired side of a vessel. The selective powerability over each electrical contact 40 may be achieved by employing a system including a programmer coupled via a conductor to a telemetry antenna. The programmer is capable of sending signals via the telemetry antenna to control the electrical signal delivered to electrical contacts 40. Such a system permits the selection of various pulse output options after electrode assembly 10 is positioned using telemetry communications. The present invention also contemplated radio-frequency systems to selectively power electrical contacts 40.
As will be understood by one of skill in the art, the independent powerability of electrical contacts 40 also provides a practitioner with means of modifying or steering the direction and locus of application of electrical signals to precisely target portions of the target region to achieve desired therapy. For example, with reference to
Referring to
The present invention also provides an electrode assembly system including electrode assembly 10 and further including components useful in identifying, monitoring, or affecting a target region. For example, such a system could include a component for lesioning and temperature monitoring, and/or a component that has a fiberoptic monitor which allows telemetric intracranial monitoring capabilities, and/or a microelectrode recording component, and/or a sensing component to incorporate a feedback mechanism to assist in determining whether electrical contacts 40 should be adjusted. With respect to a sensing component, a sensor can be incorporated with the electrode assembly system according to the present invention. The sensors can be used with a closed-loop feedback system in order to automatically determine the level of electrical signal to apply to provide the desired therapy. The sensors may be implanted or positioned in or at a portion of the patient's body suitable for detecting characteristics, symptoms or attributes of the condition or disorder being treated, for example, such as electrical brain activity, cerebral blood flow, and/or vital signs or other chemical and electrical activity of the body. Sensors suitable for use in a system according to the present invention include, for example, those disclosed in U.S. Pat. No. 5,711,316, which is incorporated by reference herein. In cases where the attribute of the symptom is the electrical activity of the brain, stimulating electrodes may be intermittently used to record electrical activity. Alternatively, one or more electrodes implanted or positioned within the brain may serve as a sensor or a recording electrode. When necessary, these sensing or recording electrodes may deliver stimulation therapy to the target region. The output of an external feedback sensor may communicate with a pulse generator through a telemetry down-link. Any sensing functions in accordance with the present invention can be performed locally, distally, or remotely from the target site. The present invention also contemplates use of electrode assembly 10 integrated with imaging methods known in the art such as X-rays, computer tomography, magnetic resonance imaging, and functional magnetic resonance imaging.
Electrode assembly 10 may also be implemented within a drug delivery system to provide chemical stimulation utilizing a drug, pharmaceutical, or therapeutic agent. In this embodiment, the signal generator is replaced with or includes a pump and electrical contacts 10 are replaced with a drug ports. The pump may be implanted below the skin of a patient and may have a port into which a hypodermic needle can be inserted through the skin to inject a quantity of a liquid, such as a drug, pharmaceutical, or therapeutic agent. The liquid agent is delivered from a pump through a catheter port into a catheter. Alternatively, the pump may be located outside of the patient's body. The catheter is positioned to deliver the liquid agent to specific infusion sites in the brain or other target site. Alternatively, electrode assembly 10 may be combined with a drug delivery system to provide both chemical and electrical signals to target regions.
Referring to
In an exemplary method of using catheter 80 in a pulmonary artery, catheter 80 is delivered and implanted in a manner similar to the delivery and implantation process used in currently available pulmonary artery catheters. Referring to
The foregoing description has been set forth merely to illustrate the invention and are not intended as being limiting. Each of the disclosed aspects and embodiments of the present invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. In addition, unless otherwise specified, none of the steps of the methods of the present invention are confined to any particular order of performance. Further, although electrode assembly 10 is occasionally described with respect to neuromodulation, electrode assembly 10 is not limited to this particular use. Modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art and such modifications are within the scope of the present invention. For example, although catheter 80 is described as have a balloon lumen 71 with a balloon 72 at the distal end thereof, other embodiments can include catheter 80 having multiple lumens without a balloon. Furthermore, all references cited herein are incorporated by reference in their entirety.
The present application claims priority to U.S. Provisional Application No. 60/608,513, filed on Sep. 10, 2004, which is incorporated by reference herein.
Number | Name | Date | Kind |
---|---|---|---|
4718423 | Willis et al. | Jan 1988 | A |
4776349 | Nashef et al. | Oct 1988 | A |
4976711 | Parins et al. | Dec 1990 | A |
5318592 | Schaldach | Jun 1994 | A |
5411546 | Bowald et al. | May 1995 | A |
5653734 | Alt | Aug 1997 | A |
5707400 | Terry, Jr. et al. | Jan 1998 | A |
6058331 | King | May 2000 | A |
6266564 | Hill et al. | Jul 2001 | B1 |
6292695 | Webster, Jr. et al. | Sep 2001 | B1 |
6564096 | Mest | May 2003 | B2 |
20020107553 | Hill et al. | Aug 2002 | A1 |
20030004549 | Hill et al. | Jan 2003 | A1 |
20030181951 | Cates | Sep 2003 | A1 |
20030181958 | Dobak, III | Sep 2003 | A1 |
20030216792 | Levin et al. | Nov 2003 | A1 |
20040019364 | Kieval et al. | Jan 2004 | A1 |
20040030362 | Hill et al. | Feb 2004 | A1 |
20040210295 | Brushey | Oct 2004 | A1 |
20040230255 | Dobak, III | Nov 2004 | A1 |
20050149156 | Libbus et al. | Jul 2005 | A1 |
20060079945 | Libbus et al. | Apr 2006 | A1 |
Number | Date | Country | |
---|---|---|---|
20060058597 A1 | Mar 2006 | US |
Number | Date | Country | |
---|---|---|---|
60608513 | Sep 2004 | US |