# US 10,864,298 B2 · Implantable scaffolds for treatment of sinusitis

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- Number: US 10,864,298 B2
- Document ID: US10864298B2
- Status: Granted
- Kind: B2
- Application number: 16/180,413
- Filed: 2018-11-05
- Published: 2019-04-25
- Granted: 2020-12-15
- Earliest claimed: 2015-06-29
- Assignees: Lyra Therapeutics, Inc.
- Applicants: Lyra Therapeutics, Inc.
- Inventors: Changcheng You; Quynh Pham; Danny Concagh
- Web page: https://patentgrep.com/patent/US10864298B2

## CPC

- A61L 27/34: Macromolecular materials
- A61F 2/186: {Nose parts}
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/58: Materials at least partially resorbable by the body
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61F 2210/0004: bioabsorbable
- A61F 2250/0031: made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61L 2300/222: Steroids, e.g. corticosteroids
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/604: Biodegradation
- A61L 2300/608: having two or more layers
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2210/0681: Sinus (maxillaris)
- 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)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- 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

This disclosure describes, inter alia, materials, devices, kits and methods that may be used to treat chronic sinusitis. More specifically, a drug-eluting scaffold is implanted in the middle meatus to treat chronic sinusitis for weeks to months.

## Claims

### Claim 1

A method of treatment, comprising delivering an expandable multi-filament scaffold comprising a therapeutic agent into the middle meatus of a human patient, wherein the expandable multi-filament scaffold self-expands and is one for which, when submersed in a pH 7.4 PBS buffer solution containing 2 wt % SDS at 37° C. under gentle shaking on a rotary shaker and the buffer solution is removed completely on a weekly basis as a sample for therapeutic agent quantification and replaced with fresh buffer,
(a) a quantity of therapeutic agent released in each sample, relative to a total amount of therapeutic agent originally in the scaffold, ranges from 1% to 10%, beginning with the second week sample and extending up to the twelfth week sample, or
(b) a quantity of therapeutic agent released per unit scaffold area in each sample, beginning with the second week sample and extending up to the twelfth week sample, ranges from 0.05 to 4 μg/mm2/week, where scaffold area is equal to πDL, where D is the manufactured diameter of the scaffold and L is the manufactured length of the scaffold, or
(c) both (a) and (b).

### Claim 2 (depends on 1)

The method of claim 1, wherein the expandable scaffold is delivered to the native middle meatus using a 2 to 4 mm catheter.

### Claim 3 (depends on 1)

The method of claim 1, wherein said therapeutic agent comprises mometasone furoate.

### Claim 4

A method of treatment, comprising delivering an self-expanding multi-filament scaffold comprising a therapeutic agent comprising mometasone furoate into the middle meatus of a subject, wherein the scaffold is one for which, when submersed in a pH 7.4 PBS buffer solution containing 2 wt % SDS at 37° C. under gentle shaking on a rotary shaker and the buffer solution is removed completely on a weekly basis as a sample for therapeutic agent quantification and replaced with fresh buffer, a quantity of therapeutic agent released in each sample, relative to a total amount of therapeutic agent originally in the scaffold, ranges from 1% to 10%, beginning with the second week sample and extending up to the twelfth week sample, and wherein said scaffold delivered to the middle meatus improves sinus patency.

### Claim 5 (depends on 4)

The method of claim 4, wherein said subject is a human patient.

### Claim 6 (depends on 4)

The method of claim 4, wherein the expandable scaffold releases the therapeutic agent for a period of at least 12 weeks.

### Claim 7

A method of treatment, comprising delivering a self-expanding multi-filament scaffold comprising a therapeutic agent comprising mometasone furoate into a subject, wherein the expandable scaffold releases the therapeutic agent for a period of at least 12 weeks, and wherein the multi-filament scaffold is one for which, when submersed in a pH 7.4 PBS buffer solution containing 2 wt % SDS at 37° C. under gentle shaking on a rotary shaker and the buffer solution is removed completely on a weekly basis as a sample for therapeutic agent quantification and replaced with fresh buffer, a quantity of therapeutic agent released in each sample, relative to a total amount of therapeutic agent originally in the scaffold, ranges from 1% to 10%, beginning with the second week sample and extending up to the twelfth week sample, and wherein said scaffold improves sinus patency.

### Claim 8 (depends on 7)

The method of claim 7, wherein said subject is a human patient.