# US 11,027,126 B2 · Systems and methods for direct current nerve conduction block

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- Number: US 11,027,126 B2
- Document ID: US11027126B2
- Status: Granted
- Kind: B2
- Application number: 16/397,310
- Filed: 2019-04-29
- Published: 2019-10-17
- Granted: 2021-06-08
- Earliest claimed: 2017-04-03
- Assignees: Presidio Medical, Inc.
- Applicants: Presidio Medical, Inc.
- Inventors: Douglas Michael Ackermann; Kenneth Wu
- Web page: https://patentgrep.com/patent/US11027126B2

## CPC

- A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/20: continuous direct currents
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36071: {Pain}
- H01B 1/02: mainly consisting of metals or alloys
- H01B 1/122: {Ionic conductors}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- H01B: CABLES; CONDUCTORS; INSULATORS; SELECTION OF MATERIALS FOR THEIR CONDUCTIVE, INSULATING OR DIELECTRIC PROPERTIES (selection for magnetic properties H01F1/00; waveguides H01P {; printed circuits H05K})

## Abstract

Disclosed herein are systems and methods for nerve conduction block. The systems and methods can utilize at least one renewable electrode. The methods can include delivering a first direct current with a first polarity to an electrode proximate nervous tissue sufficient to block conduction in the nervous tissue. Delivering the first direct current can place the nervous tissue in a hypersuppressed state at least partially preventing conduction of the nervous tissue after cessation of delivering of the first direct current. The nervous tissue can be maintained in the hypersuppressed state for a desired period, such as at least about 1 minute.

## Claims

### Claim 1

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising titanium nitride or tantalum, the at least one electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one electrode sufficient to at least partially block conduction in a nerve, wherein an amount of charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one electrode sufficient to increase the amount of charge in the at least one electrode, and
a sensor configured to determine the state of stored charge of the at least one electrode, and wherein the controller is further configured to receive data from the sensor and discontinue at least one of the first current signal or the second current signal when an amount of water is being electrolyzed.

### Claim 2 (depends on 1)

The system of claim 1, wherein the at least one electrode is housed in an insulated enclosure.

### Claim 3 (depends on 1)

The system of claim 1, wherein the system is devoid of any mechanically moving parts.

### Claim 4 (depends on 1)

The system of claim 1, wherein the at least one implantable electrode comprises high surface area to volume structures.

### Claim 5 (depends on 4)

The system of claim 4, wherein the high surface area to volume structures are selected from the group consisting of: roughened surfaces, woven surfaces, patterned surfaces, reticulated foam structures, porous sintered bead structures, and nano- or micro-patterned structures.

### Claim 6 (depends on 4)

The system of claim 4, wherein the high surface area to volume structures comprise roughened surfaces.

### Claim 7 (depends on 4)

The system of claim 4, wherein the high surface area to volume structures comprise micro-patterned structures.

### Claim 8 (depends on 4)

The system of claim 4, wherein the high surface area to volume structures comprise nano-patterned structures.

### Claim 9 (depends on 1)

The system of claim 1, wherein the sensor comprises a reference electrode.

### Claim 10 (depends on 1)

The system of claim 1, wherein the sensor is configured to measure voltage or potential at the at least one implantable electrode.

### Claim 11

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising a high charge carrying capacity material configured to be spaced apart from a nerve interface by an ionic component, the at least one implantable electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one implantable electrode sufficient to at least partially block conduction in a nerve, wherein an amount of stored charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one implantable electrode sufficient to increase the amount of stored charge of the at least one implantable electrode; and
a sensor configured to determine the state of charge of the at least one implantable electrode, wherein the controller is further configured to receive data from the sensor and discontinue at least one of the first current or the second current when an amount of water is being electrolyzed.

### Claim 12 (depends on 11)

The system of claim 11, wherein the system is devoid of any mechanically moving parts.

### Claim 13 (depends on 11)

The system of claim 11, wherein the at least one implantable electrode is at least partially surrounded by an electrolyte solution.

### Claim 14 (depends on 11)

The system of claim 11, wherein the high charge carrying capacity material comprises titanium nitride.

### Claim 15 (depends on 11)

The system of claim 11, wherein the controller is configured to maintain the nerve in a hypersuppressed state at least partially preventing conduction of the nerve for at least about 10 minutes after cessation of delivering of the first current.

### Claim 16

A method for nerve block of a patient utilizing a chargeable electrode, comprising:
generating a first current of a first polarity through a titanium nitride or tantalum implanted electrode proximate a nerve sufficient to at least partially block conduction in the nerve, wherein the electrode generates current in an ionic component proximate the at least one electrode sufficient to create at least a partial block in the nerve and decrease the amount of stored charge in the implanted electrode;
generating a second current of a second polarity opposite the first polarity through the implanted electrode;
dynamically sensing the amount of the stored charge in the implanted electrode while delivering the first current; and ceasing delivery of the first current when the amount of the stored charge is sensed to reach a pre-determined threshold value; and
discontinuing at least one of the first current signal or the second current signal when an amount of water is being electrolyzed,
wherein the second current increases the amount of the stored charge of the implanted electrode to recharge the implanted electrode.

### Claim 17 (depends on 16)

The method of claim 16, wherein the amount of water is being electrolyzed is a predetermined threshold amount of water.

### Claim 18 (depends on 16)

The method of claim 16, wherein the implanted electrode comprises high surface area to volume structures.

### Claim 19 (depends on 18)

The method of claim 18, wherein the high surface area to volume structures are selected from the group consisting of: roughened surfaces, woven surfaces, patterned surfaces, reticulated foam structures, porous sintered bead structures, and nano- or micro-patterned structures.

### Claim 20 (depends on 18)

The method of claim 18, wherein the high surface area to volume structures are selected from the group consisting of: roughened surfaces, woven surfaces, patterned surfaces, reticulated foam structures, porous sintered bead structures, and nano- or micro-patterned structures.

### Claim 21

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising titanium nitride or tantalum, the at least one electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one electrode sufficient to at least partially block conduction in a nerve, wherein an amount of charge in the at least one electrode decreases and generates current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one electrode sufficient to increase the amount of charge in the at least one electrode,
wherein the at least one electrode is housed in an insulated enclosure.

### Claim 22

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising a high charge carrying capacity material configured to be spaced apart from a nerve interface by an ionic component, the at least one implantable electrode configured to be in electrical communication with the current generator; and
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one implantable electrode sufficient to at least partially block conduction in a nerve, wherein an amount of stored charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one implantable electrode sufficient to increase the amount of stored charge of the at least one implantable electrode,
wherein the controller is configured to maintain the nerve in a hypersuppressed state at least partially preventing conduction of the nerve for at least about 10 minutes after cessation of delivering of the first current.

### Claim 23

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising a high charge carrying capacity material configured to be spaced apart from a nerve interface by an ionic component, the at least one implantable electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one implantable electrode sufficient to at least partially block conduction in a nerve, wherein an amount of stored charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient;
generate a second current with a second polarity proximal to the at least one implantable electrode sufficient to increase the amount of stored charge of the at least one implantable electrode;
receive data relating to the state of charge of the at least one implantable electrode; and
receive data regarding when an amount of water is being electrolyzed, and discontinue at least one of the first current or the second current when a predetermined threshold amount of water is being electrolyzed.

### Claim 24

A system for nerve block of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising a high charge carrying capacity material, the at least one implantable electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one implantable electrode sufficient to at least partially block conduction in a nerve, wherein an amount of stored charge in the at least one electrode is configured to decrease and generate current proximate the at least one electrode when the electrode is implanted within the patient;
generate a second current with a second polarity proximal to the at least one implantable electrode sufficient to increase the amount of stored charge of the at least one implantable electrode;
receive data relating to the state of charge of the at least one implantable electrode; and
receive data regarding when an amount of water is being electrolyzed, and discontinue at least one of the first current or the second current when a predetermined threshold amount of water is being electrolyzed.

### Claim 25 (depends on 24)

The system of claim 24, wherein the high charge carrying capacity material comprises titanium nitride or tantalum.

### Claim 26

A system for alleviating pain of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising titanium nitride or tantalum, the at least one electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one electrode sufficient to at least modulate conduction in a nerve, wherein an amount of charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one electrode sufficient to increase the amount of charge in the at least one electrode, and
a sensor configured to determine the state of stored charge of the at least one electrode, and wherein the controller is further configured to receive data from the sensor and discontinue at least one of the first current signal or the second current signal when an amount of water is being electrolyzed.

### Claim 27 (depends on 26)

The system of claim 26, wherein the at least one electrode is housed in an insulated enclosure.

### Claim 28 (depends on 26)

The system of claim 26, wherein the system is devoid of any mechanically moving parts.

### Claim 29 (depends on 26)

The system of claim 26, wherein the at least one implantable electrode comprises high surface area to volume structures.

### Claim 30 (depends on 28)

The system of claim 28, wherein the high surface area to volume structures are selected from the group consisting of: roughened surfaces, woven surfaces, patterned surfaces, reticulated foam structures, porous sintered bead structures, and nano- or micro-patterned structures.

### Claim 31 (depends on 28)

The system of claim 28, wherein the high surface area to volume structures comprise roughened surfaces.

### Claim 32 (depends on 28)

The system of claim 28, wherein the high surface area to volume structures comprise micro-patterned structures.

### Claim 33 (depends on 28)

The system of claim 28, wherein the high surface area to volume structures comprise nano-patterned structures.

### Claim 34

A system for treating pain of a patient utilizing a capacitive chargeable electrode, comprising:
a current generator;
at least one implantable electrode comprising a high charge carrying capacity material configured to be spaced apart from a nerve interface by an ionic component, the at least one implantable electrode configured to be in electrical communication with the current generator;
a controller configured to signal the current generator to:
generate a first current with a first polarity proximal to the at least one implantable electrode sufficient to modulate conduction in a nerve, wherein an amount of stored charge in the at least one electrode is configured to decrease and generate current in an ionic component proximate the at least one electrode when the electrode is implanted within the patient; and
generate a second current with a second polarity proximal to the at least one implantable electrode sufficient to increase the amount of stored charge of the at least one implantable electrode; and
a sensor configured to determine the state of charge of the at least one implantable electrode, wherein the controller is further configured to receive data from the sensor and discontinue at least one of the first current or the second current when an amount of water is being electrolyzed.

### Claim 35 (depends on 34)

The system of claim 34, wherein the system is devoid of any mechanically moving parts.

### Claim 36 (depends on 34)

The system of claim 34, wherein the at least one implantable electrode is at least partially surrounded by an electrolyte solution.

### Claim 37 (depends on 34)

The system of claim 34, wherein the high charge carrying capacity material comprises titanium nitride.

### Claim 38 (depends on 34)

The system of claim 34, wherein the controller is configured to maintain the nerve in a hypersuppressed state at least partially preventing conduction of the nerve for at least about 10 minutes after cessation of delivering of the first current.

### Claim 39

A method for treating pain of a patient utilizing a chargeable electrode, comprising:
generating a first current of a first polarity through a titanium nitride or tantalum implanted electrode proximate a nerve sufficient to modulate conduction in the nerve, wherein the electrode generates current in an ionic component proximate the at least one electrode sufficient to alleviate pain in the patient and decrease the amount of stored charge in the implanted electrode;
generating a second current of a second polarity opposite the first polarity through the implanted electrode;
dynamically sensing the amount of the stored charge in the implanted electrode while delivering the first current; and ceasing delivery of the first current when the amount of the stored charge is sensed to reach a pre-determined threshold value; and
discontinuing at least one of the first current signal or the second current signal when an amount of water is being electrolyzed,
wherein the second current increases the amount of the stored charge of the implanted electrode to recharge the implanted electrode.

### Claim 40 (depends on 39)

The method of claim 39, wherein the amount of water is being electrolyzed is a predetermined threshold amount of water.

### Claim 41 (depends on 39)

The method of claim 39, wherein the implanted electrode comprises high surface area to volume structures.
