# US 10,869,913 B2 · Methods and apparatus for delivering a therapeutic agent to nasopharyngeal mucosa targets

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- Number: US 10,869,913 B2
- Document ID: US10869913B2
- Status: Granted
- Kind: B2
- Application number: 15/988,801
- Filed: 2018-05-24
- Published: 2018-09-20
- Granted: 2020-12-22
- Earliest claimed: 2011-07-13
- Assignees: The Foundry, LLC
- Applicants: The Foundry LLC
- Inventors: John Morriss; Cary Reich; Hanson Gifford
- Web page: https://patentgrep.com/patent/US10869913B2

## CPC

- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- A61K 9/0043: {Nose}
- A61K 9/122: {Foams; Dry foams (edible foams A61K9/0056)}
- 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})
- C12Y 304/24069: Bontoxilysin (3.4.24.69), i.e. botulinum neurotoxin
- 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)}
- C12Y: ENZYMES

## Abstract

A system for delivering a therapeutic agent to a nasopharyngeal mucosa target comprises a foam generating mechanism, a gas, a therapeutic agent in liquid form that inhibits mucus production, and a delivery device. Actuation of the foam generating mechanism entraps gaseous bubbles from the gas in the liquid thereby forming a foam. The therapeutic agent is dispersed in the foam which has an expanded configuration adapted to fill a nasopharyngeal space and deliver the therapeutic agent to the mucosa targets. The delivery device is for delivering the foam to the nasopharyngeal space. The foam may also have a collapsed configuration for removal from the nasopharyngeal space or for concentration of the therapeutic agent onto the mucosa.

## Claims

### Claim 1

A method of delivering a therapeutic agent to a body cavity, said method comprising:
a) entrapping gaseous bubbles in a liquid thereby forming a foam;
b) dispersing a therapeutic agent in at least one of the liquid or the foam;
c) delivering the foam to the body cavity so that the therapeutic agent is delivered to target tissue in the body cavity;
d) after delivering the foam to the body cavity, adding an anti-foaming agent to the foam, thereby breaking the foam down into a reduced volume configuration for removal from the body cavity; and
e) removing the foam from the body cavity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the target tissue comprises mucous membranes and at least a portion of the foam breaks down to form a coating on the mucous membranes.

### Claim 3 (depends on 2)

The method of claim 2 wherein the foam is configured to form a sticky coating to maintain contact with the mucous membranes.

### Claim 4 (depends on 3)

The method of claim 3, wherein the sticky coating maintains a relatively high concentration of therapeutic agent in contact with the mucous membranes.

### Claim 5 (depends on 2)

The method of claim 2, wherein following delivery at least a portion of the bubbles dissolve to form said coating.

### Claim 6 (depends on 1)

The method of claim 1, wherein the therapeutic agent comprises a toxin configured to inhibit mucus secretions.

### Claim 7 (depends on 6)

The method of claim 6, wherein the toxin comprises botulinum toxin.

### Claim 8 (depends on 1)

The method of claim 1, wherein delivering the foam comprises advancing an elongate shaft into the body cavity and passing the foam therethrough to the target tissue.

### Claim 9 (depends on 8)

The method of claim 8, wherein the body cavity comprises a vagina, and advancing the elongate shaft comprises advancing the elongate shaft into the vagina.

### Claim 10 (depends on 8)

The method of claim 8, wherein the body cavity comprises a bladder, and advancing the elongate shaft comprises advancing the elongate shaft through the urethra into the bladder.

### Claim 11 (depends on 8)

The method of claim 8, wherein the body cavity comprises the rectum, and advancing the elongate shaft comprises advancing the elongate shaft through the anus.

### Claim 12 (depends on 8)

The method of claim 8, wherein the body cavity comprises the ear, and advancing the elongate shaft comprises advancing the elongate shaft through the ear canal.

### Claim 13 (depends on 1)

The method of claim 1, wherein the body cavity comprises a vagina, a bladder, a rectum, or an ear.

### Claim 14 (depends on 1)

The method of claim 1, further comprising retaining the foam in the body cavity for a time period long enough for an effective amount of the therapeutic agent to be absorbed by the target tissue.

### Claim 15 (depends on 1)

The method of claim 1, wherein delivering the foam comprises substantially filling up the body cavity with the foam.

### Claim 16 (depends on 1)

The method of claim 1, wherein entrapping gaseous bubbles in the liquid comprises actuating a foam generating mechanism.

### Claim 17 (depends on 16)

The method of claim 16, wherein the foam generating mechanism comprises a pump.

### Claim 18 (depends on 1)

The method of claim 1, wherein the gaseous bubbles comprise air.

### Claim 19 (depends on 1)

The method of claim 1, wherein the liquid comprises an aqueous solution.

### Claim 20 (depends on 1)

The method of claim 1, wherein the liquid comprises saline.

### Claim 21 (depends on 1)

The method of claim 1, wherein entrapping the gaseous bubbles further comprises adding a surfactant to the liquid thereby lowering surface tension of the liquid so as to facilitate formation of the foam.

### Claim 22 (depends on 1)

The method of claim 1, wherein the surfactant comprises soap, sodium dodecyl sulfate, or polysorbate surfactant.

### Claim 23 (depends on 1)

The method of claim 1, wherein delivering the foam comprises actuating a pump mechanism.

### Claim 24 (depends on 1)

The method of claim 1, wherein removing the foam comprises aspirating the reduced volume configuration foam from the body cavity.
