# US 12,350,488 B2 · System and method for intermittent electrical modulation

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- Number: US 12,350,488 B2
- Document ID: US12350488B2
- Status: Granted
- Kind: B2
- Application number: 17/293,957
- Filed: 2019-11-14
- Published: 2022-01-06
- Granted: 2025-07-08
- Earliest claimed: 2018-11-14
- Assignees: Academisch Ziekenhuis Leiden (H.O.D.N. Lumc)
- Applicants: Academisch Ziekenhuis Leiden (H.O.D.N. Lumc)
- Inventors: Wouter R Van Furth; Nienke R. Biermasz; Amir H. Zamanipoor Najafabadi
- Web page: https://patentgrep.com/patent/US12350488B2

## CPC

- A61N 1/0539: {Anchoring of brain electrode systems, e.g. within burr hole}
- A61N 1/0534: {Electrodes for deep brain stimulation}
- A61N 1/36017: {with leads or electrodes penetrating the skin}
- A61N 1/3606: {adapted for a particular treatment}
- A61N 1/36071: {Pain}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/0546: {Nasal 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

The present invention relates to a system and method, in which a distal end of an electrode is implanted in an organ, such as a pituitary gland, for intermittent electrical stimulation thereof and a proximal end of the electrode is provided with a connection plug, a distal end of which can be attached to a bone adjacent the organ, such an anterior wall of the sphenoid sinus/vomer, and a proximal end of which can be reversibly connected electrically to a wire that is connected electrically to a source of electrical stimulation for the organ.

## Claims

### Claim 1

A percutaneous system intended to be fixed in an osseous structure of a mammalian patient for intermittent electrical stimulation, the percutaneous system comprising:
an electrode or electrode array comprising one or more electrodes including a distal end configured to be implanted in an organ comprising brain tissue of the patient for intermittent electrical stimulation thereof, wherein the organ comprises a pituitary gland, and
an electric connection means configured to be connected to a proximal end of the electrode or electrode array and configured to be surgically fixed, with a dedicated holder, in an osseous structure of the sphenoid bone, the electric connection means reversibly connected electrically to a source of electrical stimulation for the electrode or electrode array.

### Claim 2 (depends on 1)

The system of claim 1, wherein the distal end of the electrode or electrode array is permanently implanted in the organ, and wherein the proximal end of the electrode or electrode array is reversibly connected electrically to the source of electrical stimulation for the organ by a separate electrical connection means or by an induction device.

### Claim 3 (depends on 1)

The system of claim 1, further comprising:
a percutaneous socket coupled to a proximal end of the electric connection means, the socket having a first end comprising a first connector to be connected to the source of electrical stimulation and a second end opposite to the first end, and
a flexible electric connection member securely fastened to, and extending from the second end of the socket, and securely fastened to, and extending from the electrode.

### Claim 4 (depends on 3)

The system of claim 3, wherein the percutaneous socket comprises an anchoring base anchored in the osseous structure.

### Claim 5 (depends on 1)

The system of claim 1, further comprising an insulation enclosure comprising biocompatible materials.

### Claim 6 (depends on 3)

The system of claim 3, wherein the percutaneous socket is adapted to be connected to an external power supply, and an intermediate connector and the electrode being electrically connected by a flexible intermediate connecting element.

### Claim 7 (depends on 1)

The system of claim 1, wherein the distal end of the electrode or electrode array has one or more contact points for electrical stimulation of endocrine tissue of the pituitary gland, the pituitary stalk or the hypothalamus.

### Claim 8 (depends on 7)

The system of claim 7, wherein the distal end of the electrode or electrode array is adapted to: electrically stimulate the pituitary gland to produce and secrete adrenocorticotropic hormone (ACTH); ADH, oxytoxin, and/or alpha-melanocyte stimulating hormone (MSH); and/or electrically stimulate the pituitary gland to stimulate the magnocellular nuclei of the anterior hypothalamus through axons that descend through the pituitary stalk to the pituitary gland.

### Claim 9 (depends on 8)

The system of claim 8, wherein the electrode or electrode array is based on an outside of the pituitary gland, and wherein the electrode or electrode array is located at an outside of a membrane enveloping the posterior pituitary stores, and operable for effecting secretion of endocrine hormones.

### Claim 10 (depends on 9)

The system of claim 9, wherein a distal portion of the electrode or electrode array has a shape memory and thus can form a three-dimensional shape, within, at the outside of the membrane adjacent to, or about the pituitary gland.

### Claim 11 (depends on 10)

The system of claim 10, wherein the distal portion of the electrode or electrode array has a shape memory and thus can form a coil shape when triggered by remote control.

### Claim 12 (depends on 1)

A method for treating a central sensitization disorder in a subject in need thereof, comprising
introducing the system according to claim 1, and
administering to the subject a therapeutically effective electrical impulse through the electrode or electrode array.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the central sensitization disorder comprises chronic pain.

### Claim 14 (depends on 1)

The system of claim 1, wherein the electrode or electrode array is implanted in the organ via an endovascular route or a transsphenoidal route.

### Claim 15

A method for intermittent electrical stimulation, comprising:
implanting a distal end of an electrode or electrode array in an organ comprising brain tissue of a mammalian patient for intermittent electrical stimulation, wherein a proximal end of the electrode or electrode array is provided with a connection plug and the organ comprises a pituitary gland,
attaching the connection plug to the sphenoid bone, wherein the proximal end of the connection plug is reversibly connected electrically to a wire that is connected electrically to a source of electrical stimulation for the electrode or electrode array.

### Claim 16 (depends on 15)

The method of claim 15, wherein the distal end of the electrode or electrode array is permanently implanted.

### Claim 17 (depends on 15)

The method of claim 15, wherein the distal end of the electrode or electrode array is implanted in the brain tissue.

### Claim 18 (depends on 15)

The method of claim 15, wherein the electrode array is provided for interfacing with an organ tissue in situ, the electrode array comprising:
a deformable array of electrodes comprising a plurality of electrodes in electrical communication with a plurality of deformable electrical interconnects and a connector line;
wherein the deformable array of electrodes provides a net bending stiffness of the electrode array low enough that the electrode array is capable of establishing conformal contact with the organ tissue in situ.

### Claim 19 (depends on 15)

The method of claim 15, wherein the distal end of the electrode or electrode array is introduced by moving it:
a. distally through an endovascular route of the patient and then into and through the sinus cavernosus of the patient; and then
b. distally through a perforation in a medial wall of the sinus cavernosus to the organ of the patient and then to and into the organ.

### Claim 20 (depends on 15)

The method of claim 15, wherein the electrode or electrode array is implanted in the organ via an endovascular route or a transsphenoidal route.