# US 11,110,210 B2 · Self-expanding devices and methods therefor

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- Number: US 11,110,210 B2
- Document ID: US11110210B2
- Status: Granted
- Kind: B2
- Application number: 17/075,572
- Filed: 2020-10-20
- Published: 2021-02-04
- Granted: 2021-09-07
- Earliest claimed: 2007-12-18
- Assignees: Intersect ENT, Inc.
- Applicants: Intersect ENT, Inc.
- Inventors: Donald J. Eaton; Bin Huang; Anthony J. Abbate; Gail M. Zaler; David C. Gale
- Web page: https://patentgrep.com/patent/US11110210B2

## CPC

- A61L 31/022: {Metals or alloys}
- A61B 17/24: for use in the oral cavity, larynx, bronchial passages or nose (for medical inspection of cavities or tubes in the body A61B1/00); Tongue scrapers
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61F 2/18: Internal ear or nose parts, e.g. ear-drums {(implants for middle ear ventilation or drainage A61F11/202)}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2/86: Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F 2/89: the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 5/08: Devices for correcting deformities of the nose {; Devices for enlarging the nostril, e.g. for breathing improvement}
- A61K 9/70: Web, sheet or filament bases {; Films; Fibres of the matrix type containing drug (hollow drug-filled fibres A61K9/0092)}
- A61L 31/10: Macromolecular materials
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61P 27/00: Drugs for disorders of the senses
- A61B 2017/3454: {Details of tips}
- A61F 2/186: {Nose parts}
- A61F 2/9522: {Means for mounting a stent or stent-graft onto or into a placement instrument}
- A61F 2/9524: {Iris-type crimpers}
- A61F 2002/048: {Ureters}
- A61F 2002/91508: {the meander having a difference in amplitude along the band}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/005: using adhesives
- A61F 2220/0058: soldered or brazed or welded
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/003: differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F 2250/006: modular
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

## Claims

### Claim 1

A method of treating one or more sinus conditions in a patient, the method comprising:
dilating a paranasal sinus region with an expandable balloon, wherein an expandable device is detachably coupled around the expandable balloon;
delivering the expandable device to the dilated paranasal sinus region, wherein the expandable device disengages from the expandable balloon, wherein the expandable device is configured to expand from a first compressed configuration to a second expanded configuration for conformation against sinus tissue, and wherein the expandable device is at least partially coated with a drug eluting layer comprising a drug, the drug eluting layer configured to release the drug at a daily dosage of about 500 μg or less per day; and
withdrawing the expandable balloon from the paranasal sinus region after dilation.

### Claim 2 (depends on 1)

The method of claim 1, wherein the expandable device comprises one or more biodegradable polymer filaments arranged to form repeating diamond-shaped pattern and wherein a distal end of the expandable device and a proximal end of the expandable device are defined by each of the diamond shapes.

### Claim 3 (depends on 1)

The method of claim 1, wherein the expandable device is self-expanding.

### Claim 4 (depends on 1)

The method of claim 1, wherein the expandable device has a compressed diameter in the first compressed configuration and an expanded diameter in the second expanded configuration, and wherein the ratio of the expanded diameter to the compressed diameter is from about 2:1 to about 20:1.

### Claim 5 (depends on 1)

The method of claim 1, wherein the drug comprises a therapeutic agent comprising one or more selected from the group consisting of: anti-inflammatory agents, anti-allergens, antibiotics, anti-cholinergic agents, antihistamines, anti-infectives, anti-platelet agents, anti-coagulants, antithrombic agents, anti-scarring agents, anti-proliferative agents, chemotherapeutic agents, anti-neoplastic agents, decongestants, healing promoting agents, vitamins, hyperosmolar agents, immunomodulators, and immunosuppressive agents.

### Claim 6 (depends on 5)

The method of claim 5, wherein the drug is an anti-inflammatory agent that comprises mometasone furoate, fluticasone propionate, or both.

### Claim 7 (depends on 1)

The method of claim 1, wherein the drug eluting layer is configured to release the drug over a period of time between about 5 days to about 120 days.

### Claim 8 (depends on 1)

The method of claim 1, wherein the drug eluting layer comprises a release rate modifier.

### Claim 9 (depends on 1)

The method of claim 1, wherein delivering the expandable device comprises delivering the expandable device to an ethmoid sinus cavity or ostium, a maxillary sinus cavity or ostium, a frontal sinus cavity or ostium, a sphenoid sinus cavity or ostium, or an osteomeatal complex.

### Claim 10 (depends on 1)

The method of claim 1, wherein the one or more biodegradable polymer filaments comprise poly-(lactide-co-glycolide).

### Claim 11 (depends on 1)

The method of claim 1, wherein the one or more biodegradable polymer filaments comprise paclitaxel.