# US 10,765,848 B2 · Device and formulation for topical treatment of pain affecting the vulvar area of the female human genital organ

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- Number: US 10,765,848 B2
- Document ID: US10765848B2
- Status: Granted
- Kind: B2
- Application number: 15/351,036
- Filed: 2016-11-14
- Published: 2017-03-02
- Granted: 2020-09-08
- Earliest claimed: 2014-05-15
- Assignees: Gruenenthal GmbH
- Applicants: Gruenenthal GmbH
- Inventors: Andre Dimino; Marco Pappagallo; Michael Richardson; Franz Gerstheimer; Emilio Garcia Quetglas; Jacqueline Delfgaauw; Andreas Scholz; Johannes Niel Van
- Web page: https://patentgrep.com/patent/US10765848B2

## CPC

- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61L 15/44: Medicaments
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 23/02: Local anaesthetics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/432: Inhibitors, antagonists (A61L2300/402 - A61L2300/43 take precedence)
- A61M 2210/14: Female reproductive, genital organs
- 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)}
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to a device for the topical treatment of pain affecting the vulvar area of the female human genital organ, a formulation for use in the device according to the invention, and a kit comprising the device according to the present intention. Additionally, the present invention relates to a method of topical treatment of pain affecting the vulvar area of the female human genital organ, said method using the device according to the present invention. The device is a layered article shaped to be placed in use inside a female undergarment and at least partially in skin contact with the female vulvar area and comprises a topical formulation.

## Claims

### Claim 1

A device for the topical treatment of pain affecting the vulvar area of the female human genital organ, wherein the device is a layered article shaped to be placed in use inside a female undergarment and at least partially in skin contact with the female vulvar area, said article having a longitudinal direction, a transverse direction, a front end, a back end, and two longitudinal sides, and said device comprises at least:
a) a formulation-impermeable outer layer having an outer surface and an inner surface;
b) a formulation-impermeable rim layer, wherein said formulation-impermeable rim layer is superimposed on the inner surface of the formulation-impermeable outer layer and does not cover an inner section thereof thereby defining a channel extending in the longitudinal direction of the article;
c) a carrier layer having an inner carrier surface and a skin-contacting surface, said carrier layer being superimposed on the formulation-impermeable rim layer and the channel such that the inner carrier surface faces in a direction of the formulation-impermeable rim layer and the channel;
d) a topical formulation comprising at least one active agent for treating pain affecting the vulvar area of the female human genital organ;
wherein the carrier layer is at least partially impregnated with the topical formulation and/or at least one dispensing unit is positioned interposed between the formulation-impermeable outer layer and the formulation-impermeable rim layer adjacent to the channel and said dispensing unit contains a topical formulation to be released into the channel.

### Claim 2 (depends on 1)

A method of treating vulvodynia, wherein the method comprises the step of topically applying an active agent to the female vulvar area with the device according to claim 1.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the channel has a lower end facing the back end of the device and extending in essentially traversal direction, and the dispensing unit is positioned adjacent to a lower end of the channel.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the dispensing unit is pressure-activated.

### Claim 5 (depends on 1)

The device according to claim 1, wherein the dispensing unit comprises a reservoir comprising topical formulation contained in a rupturable pouch.

### Claim 6 (depends on 1)

The device according to claim 1, wherein the channel has an upper end facing the front end of the device and the width of the channel is increased at least in sections of the channel along its length in a direction towards the front end compared to the width of the channel at the lower end.