# US 2024/0189596 A1 · Medical stimulator and method of stimulation

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- Number: US 2024/0189596 A1
- Document ID: US20240189596A1
- Status: Published application
- Kind: A1
- Application number: 18/522,030
- Filed: 2023-11-28
- Published: 2024-06-13
- Earliest claimed: 2022-12-09
- Applicants: The Alfred E. Mann Foundation for Scientific Research
- Inventors: Brian Vernon Mech; Neil Talbot; Robert Greenberg; Brian R. Dearden; Brian Shelton; Valma Klein; Sahar Elyahoodayan; Joseph Calderon; William Brandt
- Web page: https://patentgrep.com/patent/US20240189596A1

## CPC

- A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)}
- A61N 1/3606: {adapted for a particular treatment}
- A61N 1/36085: {Eating disorders or obesity}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)}
- A61N 1/0548: {Oral electrodes}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0556: {Cuff electrodes}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/36114: {Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362)}
- 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

A medical device includes: one or more stimulation leads configured to stimulate at least a person's vagus nerve to treat, via the stimulation of the person's vagus nerve, both obesity and one or more medical conditions comorbid with the obesity; and a controller coupled to the one or more stimulation leads and configured to control and drive the stimulation provided by the one or more stimulation leads.

## Claims

### Claim 1

A medical device, comprising:
one or more stimulation leads configured to stimulate at least a person's vagus nerve to treat, via the stimulation of the person's vagus nerve, both obesity and one or more medical conditions comorbid with the obesity; and
a controller coupled to the one or more stimulation leads and configured to control and drive the stimulation provided by the one or more stimulation leads.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the one or more stimulation leads comprise a first electrode and a second electrode, the first and second electrodes being configured to provide electric stimulation to the person's vagus nerve and to be positionable so that the first electrode is more proximal to a head of the person than the second electrode is to the person's head.

### Claim 3 (depends on 2)

The medical device of claim 2, wherein the first and second electrodes are configured to be controllably changeable between at least a first configuration, in which the first electrode is a cathode and the second electrode is an anode, and a second configuration, in which the first electrode is an anode and the second electrode is a cathode.

### Claim 4 (depends on 2)

The medical device of claim 2, further comprising a third and fourth electrode, the third and fourth electrodes being configured to provide electric stimulation to the person's vagus nerve and to be positionable so that the third electrode is more proximal to the person's head than the fourth electrode is,
wherein the first electrode and the fourth electrodes are cathodes, and the second and third electrodes are anodes, and
wherein the first and second electrodes are configured with the third and fourth electrodes so that the first and second electrodes can be controlled and driven independently from the third and fourth electrodes.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein the one or more stimulation leads comprise:
a first stimulation lead comprising a first set of electrodes on the first stimulation lead and configured to stimulate the person's vagus nerve; and
a second stimulation lead comprising a second set of electrodes on the second stimulation lead and configured to stimulate at least one selected from among the person's vagus nerve, a branch of the vagus nerve, a heart, a baroreceptor, a renal nerve, a splenic nerve, a carotid sinus nerve, parenchyma tissue, a pancreas, a pancreatic nerve, a spinal cord, a hypoglossal nerve, an ansa cervicalis, a pharyngeal nerve, a cranial nerve, a nerve innervating a liver, and a phrenic nerve.

### Claim 6 (depends on 5)

The medical device of claim 5, wherein the second set of electrodes are configured to stimulate the person's vagus nerve or a branch of the vagus nerve, and the first and second stimulation leads are shaped and sized so that the second set of electrodes are positionable farther from the controller than the first set of electrodes are positionable from the controller.

### Claim 7 (depends on 5)

The medical device of claim 5, wherein the first and second stimulation leads are separately coupled to the controller.

### Claim 8 (depends on 5)

The medical device of claim 5, wherein the first and second stimulation leads are bifurcated from a common lead and are coupled to the controller via the common lead.

### Claim 9 (depends on 1)

The medical device of claim 1, wherein the one or more stimulation leads comprise a stimulation lead comprising a first set of electrodes at a first position along the stimulation lead and a second set of electrodes at a second position along the stimulation lead and separated from the first position.

### Claim 10 (depends on 1)

The medical device of claim 1, further comprising:
one or more sensors communicatively coupled to the controller and configured to measure one or more biomarkers and/or one or more biophysical properties; and/or
a communication device communicatively coupled to the controller and configured to receive information from an external device.

### Claim 11 (depends on 10)

The medical device of claim 10, comprising the one or more sensors, wherein the one or more sensors are configured to be implanted in the person.

### Claim 12 (depends on 10)

The medical device of claim 10, comprising the one or more sensors, wherein the one or more sensors are configured to be operated externally from the person.

### Claim 13

A method of treating obesity in a person, the method comprising:
selecting one configuration of electrodes in a medical device from among at least the following two selectable configurations of electrodes:
a first configuration of electrodes wherein a cathode electrode is more proximal to a head of the person than an anode electrode is to the person's head, and
a second configuration of electrodes wherein a cathode electrode is more distal to the person's head than an anode electrode is to the person's head; and
providing electric stimulation to a vagus nerve of the person utilizing the selected one configuration of electrodes.

### Claim 14 (depends on 13)

The method of claim 13, further comprising:
changing the configuration of electrodes from the selected one configuration to an other one configuration of the two selectable configurations of electrodes; and
providing electric stimulation to the vagus nerve utilizing the other one configuration.

### Claim 15 (depends on 14)

The method of claim 14, wherein the changing of the configuration of electrodes is in response to a rate of weight loss of the person being below a set threshold rate.

### Claim 16 (depends on 14)

The method of claim 14, wherein the changing of the configuration of electrodes is in response to a rate of weight loss of the person being above a set threshold rate.

### Claim 17 (depends on 14)

The method of claim 14, wherein the changing of the configuration of electrodes is in response to a change in one or more biomarkers and/or a change in one or more biophysical properties.

### Claim 18 (depends on 13)

The method of claim 13, wherein the method further comprises treating one or more medical conditions comorbid with obesity by providing stimulation to at least one selected from among the vagus nerve, a branch of the vagus nerve, a heart, a baroreceptor, a renal nerve, a splenic nerve, a carotid sinus nerve, parenchyma tissue, a pancreas, a pancreatic nerve, a spinal cord, a hypoglossal nerve, an ansa cervicalis, a pharyngeal nerve, a cranial nerve, a nerve innervating a liver, and a phrenic nerve.

### Claim 19 (depends on 18)

The method of claim 18, wherein the one or more medical conditions comprise at least one selected from among epilepsy, sleep apnea, obstructive sleep apnea, central sleep apnea, diabetes, hypertension, heart failure, depression, gastroesophageal reflux disease, hypercholesterolemia, pelvic floor disorders, chronic inflammation, auto-immune diseases, and asthma.

### Claim 20 (depends on 18)

The method of claim 18, wherein the treating the one or more medical conditions comprises stimulating a portion of the vagus nerve, or a branch of the vagus nerve, different from a portion of the vagus nerve that the electric stimulation is provided to for treating obesity.