Method and apparatus for controlling and steering an electric field
First Claim
1. An implantable electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least first and second spaced apart anode electrodes and one cathode electrode, and electrical circuitry for programing at least two independent anodic (+) constant currents and at least one cathodic (-) constant voltage, said anodic (+) constant currents being coupled to said first and second anode electrodes in said lead and said cathodic voltage being coupled to said third cathode electrode in said lead and said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently adjusting the current flowing from said first and second anode electrodes into said third cathode electrode, thereby steering the size and location of the electric field to recruit only certain target tissue and exclude unwanted tissue.
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Accused Products
Abstract
The electric field steering assembly is used to control the size and/or location of, and/or steer the position of, an electric field in a living creature. The assembly comprises a pulse generator or stimulator, at least one implanted lead coupled to the stimulator and having, at a distal end thereof, at least three spaced apart electrodes, and electrical circuitry for adjusting the current and/or voltage at each electrode. The electrical circuitry is programmed to: 1) electronically change the size and/or location of an electric field established between the electrodes by independently programming the current flowing through of one or more anode (+) electrode(s) from one or more cathode (-) electrode(s), thereby steering the size and location of the electric field to recruit only target certain tissue and exclude unwanted tissue; and, 2) automatically change the voltage amplitude at each anode in response to changes in electrode impedance in order to maintain a constant anodic current, thereby preserving, for the duration of the therapy, the original electric field found to be effective at implant time.
522 Citations
25 Claims
- 1. An implantable electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least first and second spaced apart anode electrodes and one cathode electrode, and electrical circuitry for programing at least two independent anodic (+) constant currents and at least one cathodic (-) constant voltage, said anodic (+) constant currents being coupled to said first and second anode electrodes in said lead and said cathodic voltage being coupled to said third cathode electrode in said lead and said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently adjusting the current flowing from said first and second anode electrodes into said third cathode electrode, thereby steering the size and location of the electric field to recruit only certain target tissue and exclude unwanted tissue.
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3. An electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, and electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue said electrical circuitry being programmed to automatically change the voltage amplitude at each anode in response to changes in electrode impedance in order to maintain a constant anodic current, thereby preserving, for the duration of the therapy, the original electric field found to be effective at implant time.
- 5. An electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, a first implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, and electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue and a second implantable lead having, at its distal end, at least three electrodes, and being coupled to said pulse generator.
- 7. An electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue and a self contained steering mechanism independent of said lead which has a lumen therein, said steering mechanism being introduced through said lumen of said lead for steering or deflecting said distal tip of said lead for guidance and placement of said electrodes on said distal tip of said lead.
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13. An electric field steering assembly of for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, and electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue, said electrodes including a left anode electrode, a center cathode electrode and a right anode electrode and said electric field being steered by establishing a zero voltage on said cathode electrode and forcing a first constant current at one of the other anode electrodes and another constant current at the remaining anode electrode.
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14. An electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, and electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue, said electrical circuitry including means for programming each electrode comprising a cathode enable circuit having an output, an anode enable circuit having an output, current generating means having an output and a D/A converter circuit having an output coupled to said current generating means, said output of said anode enable circuit also being coupled to said current generating means and said output of said current generating means and said output of said cathode enable circuit being coupled to one of said anode electrodes.
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15. An electric field steering assembly for controlling the size and/or location of, and/or steering the position of, an electric field in a living creature, said assembly comprising a pulse generator, at least one implantable lead coupled to said pulse generator and having, at a distal end thereof, at least two spaced apart anode electrodes and one cathode electrode, and electrical circuitry in said pulse generator and coupled to said electrodes for adjusting at least two anodic currents and at least one cathodic voltage at said respective electrodes, said electrical circuitry being programmed to electronically change the size and/or location of an electric field established between said electrodes by independently programming the current flowing through said anode (+) electrode(s) from said cathode (-) electrode, thereby steering the size and location of the electric field to recruit only certain tissue and exclude unwanted tissue, said electrical circuitry including:
- a cathode enable circuit coupled to said cathode electrode;
a first current enable circuit coupled to a first current generator which, in turn, is coupled to a first anode defined by one of said anode electrodes;
a second anode enable circuit coupled to a second current generator which, in turn, is coupled to a second anode defined by the remaining anode electrode.
- a cathode enable circuit coupled to said cathode electrode;
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16. A method for steering and/or controlling the size and position of an electric field in a living creature including the steps of:
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providing a pulse generator; implanting the pulse generator in living tissue providing at least one implantable lead having at least a first anodic electrode, a second anodic electrode and a third cathodic electrode at a distal end thereof; implanting the distal end adjacent a target tissue in the living creature; establishing an electric field between said electrodes; and
,electronically changing the size and/or location of said electric field by independently programming the current flowing through said first and second anodic electrodes from said third cathodic electrode thereby steering the size and location of said electric field to recruit only selected tissue and exclude unwanted tissue. - View Dependent Claims (17, 18)
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19. A method for steering and/or controlling the size and position of an electric field in a living creature including the steps of:
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providing a pulse generator; implanting the pulse generator in living tissue providing at least one implantable lead having at least a first anodic electrode, a second anodic electrode and a third cathodic electrode at a distal end thereof; implanting the distal end adjacent a target tissue in the living creature by steering said distal end of said at least one lead to a desired position adjacent a target nerve by bending said distal end of said lead and rotating said lead and releasably locking said bent distal end of said lead in a selected position adjacent the target tissue; establishing an electric field between said electrodes; and
,electronically changing the size and/or location of said electric field by independently programming the current flowing through said first and second anodic electrodes from said third cathodic electrode thereby steering the size and location of said electric field to recruit only selected tissue and exclude unwanted tissue.
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20. A method for steering and/or controlling the size and position of an electric field in a living creature including the steps of:
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providing a pulse generator; implanting the pulse generator in living tissue providing at least one implantable lead having at least a first anodic electrode, a second anodic electrode and a third cathodic electrode at a distal end thereof; implanting the distal end adjacent a target tissue in the living creature; establishing an electric field between said electrodes; and
,electronically changing the size and/or location of said electric field by independently programming the current flowing through said first and second anodic electrodes from said third cathodic electrode thereby steering the size and location of said electric field to recruit only selected tissue and exclude unwanted tissue, said electric field being established by establishing a zero voltage on said cathodic electrode;
forcing a first constant current at one of said anodic electrodes; and
forcing a second constant current at the remaining anodic electrode; and
said step of steering said electric field is accomplished by changing the voltage and/or currents at the three electrodes.
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21. A method for steering and/or controlling the size and position of an electric field in a living creature including the steps of:
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providing a pulse generator; implanting the pulse generator in living tissue providing at least one implantable lead having at least a first anodic electrode, a second anodic electrode and a third cathodic electrode at a distal end thereof; implanting the distal end adjacent a target tissue in the living creature; establishing an electric field between said electrodes;
electronically changing the size and/or location of said electric field by independently programming the current flowing through said first and second anodic electrodes from said third cathodic electrode thereby steering the size and location of said electric field to recruit only selected tissue and exclude unwanted tissue; and
, maintaining said electric field focused at a target nerve located near said cathodic electrode and said first and second anodic electrodes when changes in impedance occur between said cathodic electrode and said first and second anodic electrodes by automatically changing the positive voltage at said first and second anodic electrodes.
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22. A method for steering and/or controlling the size and position of an electric field in a living creature including the steps of:
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providing a pulse generator; implanting the pulse generator in living tissue providing at least one implantable lead having at least a first anodic electrode, a second anodic electrode and a third cathodic electrode at a distal end thereof; implanting the distal end adjacent a target tissue in the living creature; establishing an electric field between said electrodes;
electronically changing the size and/or location of said electric field by independently programming the current flowing through said first and second anodic electrodes from said third cathodic electrode thereby steering the size and location of said electric field to recruit only selected tissue and exclude unwanted tissue; and
, automatically changing the voltage amplitude at each anodic electrode in response to changes in electrode impedance in order to maintain a constant anodic current, thereby preserving for the duration of the therapy the electric field found to be effective at implant time.
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- 23. For use in an electric field steering assembly, a self contained steering mechanism independent from a stimulating lead, said steering mechanism being introduced through a lumen of the lead for steering or deflecting a distal tip of the lead for guiding and placement of electrodes on the distal tip of the lead, said steering mechanism including a deflectable tip, a highly elastic nickel-titanium alloy tube and an internal pull wire mounted in said tube for facilitating deflection of said deflectable tip and said deflectable tip being defined by a reduced-in-diameter distal end portion of said nickel-titanium alloy tube.
Specification