# US 12,251,561 B2 · Minimally invasive dermal electroporation device

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- Number: US 12,251,561 B2
- Document ID: US12251561B2
- Status: Granted
- Kind: B2
- Application number: 17/698,135
- Filed: 2022-03-18
- Published: 2022-07-07
- Granted: 2025-03-18
- Earliest claimed: 2011-06-28
- Assignees: Inovio Pharmaceuticals, Inc.
- Applicants: Inovio Pharmaceuticals, Inc.
- Inventors: Kate Broderick; Jay McCoy; Stephen V. Kemmerrer
- Web page: https://patentgrep.com/patent/US12251561B2

## CPC

- A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation}
- A61N 1/0412: {Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- C12M 35/02: {Electrical or electromagnetic means, e.g. for electroporation or for cell fusion}
- C12N 15/87: Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
- A61K 2039/53: {DNA (RNA) vaccination}
- A61M 2037/0007: {having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents}
- A61N 1/0424: {Shape of the electrode}
- 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)
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The disclosure is directed to a device for electroporating and delivering one or more antigens and a method of electroporating and delivering one or more antigens to cells of epidermal tissues using the device. The device comprises a housing, a plurality of electrode arrays projecting from the housing, each electrode array including at least one electrode, a pulse generator electrically coupled to the electrodes, a programmable microcontroller electrically coupled to the pulse generator, and an electrical power source coupled to the pulse generator and the microcontroller. The electrode arrays define spatially separate sites.

## Claims

### Claim 1

A device for electroporating and delivering one or more antigens, the device comprising:
a housing having a distal tip portion;
a plurality of electrode arrays each coupled to the tip portion, wherein the electrode arrays project from the tip portion and define spatially separate sites, each electrode array includes a plurality of electrodes;
a pulse generator electrically coupled to at least one electrode of each electrode array;
a programmable microcontroller electrically coupled to the pulse generator, wherein each electrode is configured to deliver an electroporating pulse to cells of epidermal tissues, and wherein the microcontroller is configured to adjust parameters of the electroporating pulse of each electrode array independently; and
an electrical power source coupled to the pulse generator and the microcontroller, wherein the electrical power source is a battery carried within the housing and configured to power the pulse generator, wherein the battery allows the device to be portable.

### Claim 2 (depends on 1)

The device of claim 1, wherein the battery is of a battery type selected from a group comprising lithium ion, nickel metal hydride, lead acid, and nickel cadmium.

### Claim 3 (depends on 1)

The device of claim 1, wherein the housing comprises a trigger button for triggering delivery of the electroporating pulse.

### Claim 4 (depends on 1)

The device of claim 1, wherein the electroporating pulse is associated with an electrical potential, and wherein the microcontroller is configured to vary the electrical potential from array to array.

### Claim 5 (depends on 1)

The device of claim 1, wherein the electroporating pulse is associated with an electrical current, and wherein the microcontroller is configured to vary the electrical current from array to array.

### Claim 6 (depends on 1)

The device of claim 1, wherein the electroporating pulse is associated with a duration, and wherein the microcontroller is configured to vary the duration from array to array.

### Claim 7 (depends on 1)

The device of claim 1, wherein the microcontroller is configured to adjust a respective quantity of electroporating pulses for each electrode array independently, and wherein the quantity is 1 to 10.

### Claim 8 (depends on 1)

The device of claim 1, wherein spatially separate sites substantially prevent interference of the antigens when the electroporating pulses are delivered.

### Claim 9 (depends on 1)

The device of claim 1, wherein the plurality of electrodes in each electrode array are arranged in a respective pattern.

### Claim 10 (depends on 1)

The device of claim 1, wherein at least one electrode of the plurality of electrodes in each electrode array includes a tissue-penetrating end with a length of 0.1 mm or less.

### Claim 11 (depends on 1)

The device of claim 1, wherein at least one electrode of the plurality of electrodes in each array includes a tissue-penetrating end with a length of 0.01 mm to 0.04 mm.

### Claim 12 (depends on 1)

The device of claim 1, wherein the electroporating pulses substantially prevent damage in the cells of the epidermal tissues.

### Claim 13 (depends on 1)

The device of claim 1, wherein the electroporating pulses are associated with an electrical potential that is 0.01 V to 70 V, wherein the electrical potential is nearly painless as measured by a visual analog scale.

### Claim 14 (depends on 1)

The device of claim 1, wherein adjoining electrodes are spaced apart from one another at a distance of not more than 1.0 mm.

### Claim 15 (depends on 1)

The device of claim 1, wherein adjoining electrodes are spaced apart from one another at a distance of not than more 1.5 mm.

### Claim 16 (depends on 1)

The device of claim 1, wherein the plurality of electrodes for each electrode array are configured to deliver the electroporating pulses substantially simultaneously.
