# US 11,992,681 B2 · Devices, systems, and methods for treating disease using electrical stimulation

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- Number: US 11,992,681 B2
- Document ID: US11992681B2
- Status: Granted
- Kind: B2
- Application number: 17/455,593
- Filed: 2021-11-18
- Published: 2022-05-26
- Granted: 2024-05-28
- Earliest claimed: 2020-11-20
- Assignees: Phagenesis Limited
- Applicants: Phagenesis Limited
- Inventors: Conor Mulrooney
- Web page: https://patentgrep.com/patent/US11992681B2

## CPC

- A61N 1/0519: {Endotracheal electrodes}
- A61N 1/3606: {adapted for a particular treatment}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0546: {Nasal electrodes}
- A61N 1/0548: {Oral electrodes}
- A61N 1/36128: {Control systems}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- 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)

## Abstract

Electrical stimulation devices and associated systems and methods are disclosed herein. In some embodiments, the electrical stimulation device comprises an elongated member configured to be orally or nasally inserted into a patient's pharynx. The device may further include a conductive element carried by a distal portion of the elongated member and configured to deliver stimulation energy to nearby tissue. The device can include a cover configured to move relative to the conductive elements to selectively cover or expose the conductive elements.

## Claims

### Claim 1

A device for delivering an electrical stimulus to nerves proximate a body lumen of a human patient, the device comprising:
an elongated member having a proximal portion configured to be coupled to an energy source and a distal portion configured to be positioned at a treatment site within the body lumen;
a conductive element carried by the distal portion of the elongated member and configured to be electrically coupled to the energy source to deliver an electrical stimulus to nerves proximate the body lumen at the treatment site;
a cover, at least a portion of which is disposed at the distal portion of the elongated member, wherein the cover is movable between (a) a first position in which the cover is positioned over the conductive element, and (b) a second position in which the conductive element is exposed; and
a stop configured to engage the cover to releasably secure the cover in the first position.

### Claim 2 (depends on 1)

The device of claim 1, wherein the cover comprises an elongated shaft configured to be slidably positioned over the elongated member.

### Claim 3 (depends on 1)

The device of claim 1, further comprising a retaining structure fixed to the cover and configured to releasably engage the elongated member to fix a position of the cover relative to the elongated member.

### Claim 4 (depends on 1)

The device of claim 1, further comprising an interface coupled to the cover and configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the interface is configured to be manipulated by an operator to move the cover between the first and second positions.

### Claim 5 (depends on 1)

The device of claim 1, wherein the stop is configured to engage the cover to releasably secure the cover in the second position.

### Claim 6 (depends on 1)

The device of claim 1, wherein the elongated member defines a lumen, and wherein the device further comprises:
an elongated shaft configured to be slidably positioned through the lumen of the elongated member; and
a coupler configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the coupler is configured releasably fix a position of the elongated shaft relative to the elongated member.

### Claim 7 (depends on 6)

The device of claim 6, wherein the elongated shaft has a proximal portion and a distal portion configured to be positioned within the patient's stomach, and wherein the elongated shaft is configured to deliver nutrients to the stomach.

### Claim 8 (depends on 1)

The device of claim 1, wherein the treatment site is within a pharynx of the patient.

### Claim 9 (depends on 1)

The device of claim 1, wherein the electrical stimulus is configured to treat dysphagia.

### Claim 10

A medical device comprising:
a stimulation device configured to be inserted into a body lumen of a patient, the stimulation device comprising an elongated member having a proximal portion, a distal portion, and an electrode carried by the distal portion, wherein the distal portion of the elongated member is configured to be positioned at a treatment site within the body lumen;
a cover, at least a portion of which is disposed at the distal portion of the elongated member, wherein the cover is movable between (a) a first position in which the cover is positioned over the electrode, and (b) a second position in which the electrode is exposed; and
a slider coupled to a proximal end portion of the cover, the slider being configured to be manipulated by an operator to adjust a position of the cover relative to the electrode.

### Claim 11 (depends on 10)

The medical device of claim 10, wherein the cover is configured to slide over the electrode.

### Claim 12 (depends on 10)

The medical device of claim 10, wherein the cover is configured to extend around a full circumference of the elongated member.

### Claim 13 (depends on 10)

The medical device of claim 10, wherein the cover is configured to extend around less than a full circumference of the elongated member.

### Claim 14 (depends on 10)

The medical device of claim 10, wherein the first position is distal of the second position.

### Claim 15 (depends on 10)

The medical device of claim 10, wherein the body lumen of the patient is a pharynx.

### Claim 16 (depends on 15)

The medical device of claim 15, wherein the stimulation device is configured to electrically stimulate nerves proximate an oropharyngeal region of the pharynx to treat dysphagia.

### Claim 17 (depends on 10)

The medical device of claim 10, wherein the electrode is a first electrode, and wherein the stimulation device further comprises a second electrode longitudinally spaced apart from the first electrode along a longitudinal dimension of the elongated member.

### Claim 18

A device for delivering an electrical stimulus to nerves proximate a body lumen of a human patient, the device comprising:
an elongated member having a proximal portion configured to be coupled to an energy source and a distal portion configured to be positioned at a treatment site within the body lumen;
a conductive element carried by the distal portion of the elongated member and configured to be electrically coupled to the energy source to deliver an electrical stimulus to nerves proximate the body lumen at the treatment site;
a cover, at least a portion of which is disposed at the distal portion of the elongated member, wherein the cover is movable between (a) a first position in which the cover is positioned over the conductive element, and (b) a second position in which the conductive element is exposed; and
a stop configured to engage the cover to releasably secure the cover in the second position.

### Claim 19 (depends on 18)

The device of claim 18, wherein the cover comprises an elongated shaft configured to be slidably positioned over the elongated member.

### Claim 20 (depends on 18)

The device of claim 18, further comprising a retaining structure fixed to the cover and configured to releasably engage the elongated member to fix a position of the cover relative to the elongated member.

### Claim 21 (depends on 18)

The device of claim 18, further comprising an interface coupled to the cover and configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the interface is configured to be manipulated by an operator to move the cover between the first and second positions.

### Claim 22 (depends on 18)

The device of claim 18, wherein the stop is configured to engage the cover to releasably secure the cover in the first position.

### Claim 23 (depends on 18)

The device of claim 18, wherein the elongated member defines a lumen, and wherein the device further comprises:
an elongated shaft configured to be slidably positioned through the lumen of the elongated member; and
a coupler configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the coupler is configured releasably fix a position of the elongated shaft relative to the elongated member.

### Claim 24 (depends on 23)

The device of claim 23, wherein the elongated shaft has a proximal portion and a distal portion configured to be positioned within the patient's stomach, and wherein the elongated shaft is configured to deliver nutrients to the stomach.

### Claim 25 (depends on 18)

The device of claim 18, wherein the treatment site is within a pharynx of the patient.

### Claim 26 (depends on 18)

The device of claim 18, wherein the electrical stimulus is configured to treat dysphagia.

### Claim 27

A device for delivering an electrical stimulus to nerves proximate a body lumen of a human patient, the device comprising:
an elongated member having a proximal portion configured to be coupled to an energy source and a distal portion configured to be positioned at a treatment site within the body lumen, the elongated member defining a lumen therethrough;
a conductive element carried by the distal portion of the elongated member and configured to be electrically coupled to the energy source to deliver an electrical stimulus to nerves proximate the body lumen at the treatment site;
a cover, at least a portion of which is disposed at the distal portion of the elongated member, wherein the cover is movable between (a) a first position in which the cover is positioned over the conductive element, and (b) a second position in which the conductive element is exposed;
an elongated shaft configured to be slidably positioned through the lumen of the elongated member; and
a coupler configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the coupler is configured releasably fix a position of the elongated shaft relative to the elongated member.

### Claim 28 (depends on 27)

The device of claim 27, wherein the cover comprises an elongated shaft configured to be slidably positioned over the elongated member.

### Claim 29 (depends on 27)

The device of claim 27, further comprising a retaining structure fixed to the cover and configured to releasably engage the elongated member to fix a position of the cover relative to the elongated member.

### Claim 30 (depends on 27)

The device of claim 27, further comprising an interface coupled to the cover and configured to be positioned at an extracorporeal location when the distal portion of the elongated member is positioned at the treatment site, wherein the interface is configured to be manipulated by an operator to move the cover between the first and second positions.

### Claim 31 (depends on 27)

The device of claim 27, further comprising a stop configured to engage the cover to releasably secure the cover in the first position.

### Claim 32 (depends on 27)

The device of claim 27, further comprising a stop configured to engage the cover to releasably secure the cover in the second position.

### Claim 33 (depends on 27)

The device of claim 27, wherein the elongated shaft has a proximal portion and a distal portion configured to be positioned within the patient's stomach, and wherein the elongated shaft is configured to deliver nutrients to the stomach.

### Claim 34 (depends on 27)

The device of claim 27, wherein the treatment site is within a pharynx of the patient.

### Claim 35 (depends on 27)

The device of claim 27, wherein the electrical stimulus is configured to treat dysphagia.
