# US 12,178,496 B2 · Treatment of dermal glands by the application of non-thermal energy

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- Number: US 12,178,496 B2
- Document ID: US12178496B2
- Status: Granted
- Kind: B2
- Application number: 17/284,029
- Filed: 2019-10-09
- Published: 2022-01-13
- Granted: 2024-12-31
- Earliest claimed: 2018-10-10
- Assignees: Pulse Biosciences, Inc.
- Applicants: Pulse Biosciences, Inc.
- Inventors: Lauren M. Jauregui Johnston; Edward A. Ebbers; David J. Danitz; Richard L. Nuccitelli; Darrin R. Uecker; Kevin L. Moss; Cameron D. Hinman
- Web page: https://patentgrep.com/patent/US12178496B2

## CPC

- A61B 18/1442: {Probes having pivoting end effectors, e.g. forceps}
- A61B 18/1477: {Needle-like probes}
- A61B 18/1206: {Generators therefor}
- A61B 34/30: Surgical robots
- A61B 90/04: {Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery (protection of eyes against laser radiation A61F9/022)}
- A61B 2017/00154: {pulsed}
- A61B 2017/00172: {Pulse trains, bursts, intermittent continuous operation}
- A61B 2017/00194: {Means for setting or varying the repetition rate}
- A61B 2017/00747: {Dermatology}
- A61B 2018/00083: {low, i.e. electrically insulating}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00196: {reciprocating lengthwise}
- A61B 2018/00452: {Skin}
- A61B 2018/00458: {Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains}
- A61B 2018/00577: {Ablation}
- A61B 2018/00613: {Irreversible electroporation}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00761: {Duration}
- A61B 2018/00767: {Voltage}
- A61B 2018/143: {multiple needles}
- A61B 2018/1467: {using more than two electrodes on a single probe}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2090/0811: {for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument}
- A61B 2090/363: {Use of fiducial points}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Described herein are methods and apparatuses for reducing or eliminating skin glands (e.g., sebaceous, eccrine and apocrine) with an electric treatment. These apparatuses and methods may produce electroporation of cells by applying treatment dose having an energy density sufficient to eliminate or reduce the size of a target gland. Also described herein are methods for treating and/or preventing a disorder of a skin gland. For example, described herein are methods of treating sebaceous hyperplasia.

## Claims

### Claim 1

A system comprising:
a pulse generator configured to generate non-thermal electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds;
an applicator comprising a treatment tip having a plurality of needle electrodes, wherein each needle electrode of the plurality of needle electrodes comprises an un-insulated portion extending from an end of an insulated portion to a distal end of each needle electrode; and
a controller coupled to the pulse generator and configured to apply a treatment dose from the plurality of needle electrodes to eliminate or reduce a size of a target gland within a subject ‘s skin, wherein the treatment dose provides an energy density of 1.5 J/mm3 or less sufficient to eliminate or reduce the size of the target gland by selectively and non-thermally disrupting nuclei, organelles or outer membranes of cells of the target gland without permanently damaging structures outside the target gland.

### Claim 2 (depends on 1)

The system of claim 1, wherein the controller regulates the treatment dose to be up to about 0.9 J/mm3, wherein the plurality of needle electrodes forms a pattern having a width and a height of between 1.4 mm and 5.5 mm.

### Claim 3 (depends on 1)

The system of claim 1, wherein the controller is configured to regulate the treatment dose to have an energy density of between 0.1 J/mm3 and about 0.128 J/mm3.

### Claim 4 (depends on 1)

The system of claim 1, wherein the plurality of needle electrodes is arranged in an array having an area of between 2.25 mm2 and 100 mm2.

### Claim 5 (depends on 1)

The system of claim 1, wherein the treatment tip comprises a retractable treatment tip housing configured to retract to expose the needle electrodes.

### Claim 6 (depends on 1)

The system of claim 1, wherein the insulated portion of at least some of the needle electrodes extends between 0.1 mm and up to about 1 mm from a base of the treatment tip.

### Claim 7 (depends on 1)

The system of claim 1, wherein the uninsulated portion of at least some of the needle electrodes extends between 1 mm and 4 mm from the insulated portion.

### Claim 8 (depends on 1)

The system of claim 1, wherein the controller is configured to regulate the treatment dose at least in part based on a user input.

### Claim 9 (depends on 1)

The system of claim 1, wherein the controller is configured to regulate the treatment dose automatically, optionally, based on a target treatment protocol.

### Claim 10 (depends on 1)

The system of claim 1, wherein the target gland is at least one of a sebaceous gland, an eccrine gland, or an apocrine gland.

### Claim 11 (depends on 1)

The system of claim 1, wherein the system is configured to treat one or more of the following conditions: acne, oily skin, sebaceous hyperplasia, rosacea, rosacea-like dermatitis, lupus miliaris disseminatus faciei (LMDF), xerosis, asteatosis, seborrhea, seborrheic dermatitis, seborrheic-like psoriasis, steatocystoma, hyperhidrosis, bromhidrosis, osmidrosis, chromhidrosis, hidradenitis suppurativa, Fox Fordyce disease, Frey's syndrome, cysts of the gland, and gland tumors.

### Claim 12 (depends on 1)

The system of claim 1, wherein the system is a robotic system.

### Claim 13 (depends on 1)

The system of claim 1, wherein the applicator is coupled to a robotic arm and the controller is configured to operate the robotic arm to place the applicator relative to the target gland.

### Claim 14

A system comprising:
a pulse generator configured to generate non-thermal electrical pulses having an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds;
an applicator comprising a treatment tip having a plurality of needle electrodes; and
a controller coupled to the pulse generator and configured to apply a treatment dose from the plurality of needle electrodes to eliminate or reduce a size of a target gland within a subject ‘s skin by selectively and non-thermally disrupting nuclei, organelles or outer membranes of cells of the target gland, wherein the controller regulates the treatment dose to have a maximum energy density of 1.5 J/mm3 or less.

### Claim 15

A method comprising:
positioning a plurality of needle electrodes so that a target gland in a region of a subject's skin is between two or more electrodes of the plurality of electrodes;
and applying pulsed electrical energy having a pulse duration in sub-microsecond pulse range between the two or more electrodes of the plurality of electrodes, wherein the pulsed electrical energy has an amplitude of at least 0.1 kV and a duration of less than 1000 nanoseconds; wherein the pulsed electrical energy provides an energy density of 1.5 J/mm3 or less, sufficient to eliminate or reduce the size of the target gland by selectively and non-thermally disrupting nuclei.

### Claim 16 (depends on 15)

The method of claim 15, further comprising applying the pulsed electrical energy at an energy density of less than 0.128 J/mm3.

### Claim 17 (depends on 15)

The method of claim 15, wherein the positioning the plurality of electrodes comprises inserting the plurality of electrodes into the region between 1 mm and 5 mm deep.

### Claim 18 (depends on 15)

The method of claim 15, the method comprising inserting an insulated portion of each of the needle electrodes to extend between 0.1 and 4 mm into a tissue to position an uninsulated portion of the needle electrodes at a depth of the target gland.

### Claim 19 (depends on 15)

The method of claim 15, wherein a tissue outside the the target gland comprises at least one of: a portion of epidermis above the target gland, a portion of epidermis adjacent the target gland, one or more portions of dermis adjacent the one or more target glands.

### Claim 20 (depends on 15)

The method of claim 15, wherein the one or more target glands is at least one of a sebaceous gland, an eccrine gland, or an apocrine gland and wherein the method is a method of treating one or more of the following conditions: acne, oily skin, sebaceous hyperplasia, rosacea, rosacea-like dermatitis, lupus miliaris disseminatus faciei (LMDF), xerosis, asteatosis, seborrhea, seborrheic dermatitis, seborrheic-like psoriasis, steatocystoma, hyperhidrosis, bromhidrosis, osmidrosis, chromhidrosis, hidradenitis suppurativa, Fox Fordyce disease, Frey's syndrome, cysts of the gland, and gland tumors.

### Claim 21 (depends on 15)

The method of claim 15, wherein applying the pulsed electrical energy comprises applying for less than 5 minutes.

### Claim 22 (depends on 15)

The method of claim 15, wherein the eliminating the target gland comprises eliminating a full length of the target gland.