# US 2024/0189132 A1 · Devices, systems, and methods for manipulating nasal tissues

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- Number: US 2024/0189132 A1
- Document ID: US20240189132A1
- Status: Published application
- Kind: A1
- Application number: 18/536,115
- Filed: 2023-12-11
- Published: 2024-06-13
- Earliest claimed: 2022-12-09
- Assignees: Spirair, Inc.
- Applicants: Spirair, Inc.
- Inventors: Eric JOHNSON; James R. KINTZING; Brandon MCCUTCHEON; John BOWER
- Web page: https://patentgrep.com/patent/US20240189132A1

## CPC

- A61F 5/08: Devices for correcting deformities of the nose {; Devices for enlarging the nostril, e.g. for breathing improvement}
- A61L 27/14: Macromolecular materials
- 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)
- 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)

## Abstract

Described herein are devices, systems, and methods for applying a tension force to various tissues. The devices may be delivered in a minimally invasive fashion and used to manipulate tissues in the nose, car, and throat. Force may be maintained by the devices for a time period that allows shaping, compression, or approximation of tissues.

## Claims

### Claim 1

A system for reshaping tissues in a subject comprising:
an elongate tension element; and
a delivery device, the delivery device comprising:
the elongate tension element preloaded therein;
an anchor delivery element configured to couple to at least a portion of the elongate tension element; and
an actuator,
wherein the actuator is configured to advance the anchor delivery element into tissue with a deployed force that is greater than an applied force by a user.

### Claim 2 (depends on 1)

The system of claim 1, wherein a ratio of the deployed force to the applied force ranges from about 2:1 to about 4:1.

### Claim 3 (depends on 1)

The system of claim 1, wherein the actuator is configured to translate rotation motion into linear motion.

### Claim 4 (depends on 1)

The system of claim 1, wherein the actuator comprises a linear gear and a fixed sector gear.

### Claim 5 (depends on 1)

The system of claim 1, wherein the actuator comprises a linear gear and an eccentric sector gear.

### Claim 6 (depends on 1)

The system of claim 1, wherein the elongate tension element comprises a distal anchor, the distal anchor comprising an anchor body and a pivot point, and one or more arms extending from the anchor body.

### Claim 7 (depends on 6)

The system of claim 6, wherein the distal anchor has an insertion configuration and a deployed configuration, and is configured to swivel at the pivot point from the insertion configuration to the deployed configuration upon tensioning the elongate tension element.

### Claim 8 (depends on 6)

The system of claim 6, wherein a distal end of the one or more arms is beveled.

### Claim 9 (depends on 1)

The system of claim 1, wherein the elongate tension element comprises a biodegradable polymer.

### Claim 10 (depends on 9)

The system of claim 9, wherein the biodegradable polymer comprises PDO (Poly(dioxanone)).

### Claim 11 (depends on 1)

The system of claim 1, wherein the elongate tension element has a tensile strength ranging from about 100 MPa to about 800 MPa.

### Claim 12 (depends on 1)

The system of claim 1, wherein the delivery device further comprises a cannula having a curved distal end and an atraumatic tip.

### Claim 13 (depends on 12)

The system of claim 12, wherein the delivery device further comprises a handle and a knob attached to a proximal end of the cannula, and wherein the knob is configured to rotate the cannula about a longitudinal axis of the handle.

### Claim 14 (depends on 13)

The system of claim 13, wherein the knob comprises one or more indicators on a surface thereof configured to orient the curved distal end of the cannula with respect to the longitudinal axis of the handle.

### Claim 15 (depends on 1)

The system of claim 1, wherein the anchor delivery element comprises a cutting tip and an anchor support.

### Claim 16 (depends on 15)

The system of claim 15, wherein the cutting tip is coupled to the anchor support by one or more rivets.

### Claim 17 (depends on 15)

The system of claim 15, wherein the cutting tip is integrally formed with the anchor support.

### Claim 18 (depends on 15)

The system of claim 15, wherein the cutting tip comprises a pocket configured to couple to an enlarged distal end of the distal anchor by an interference fit.

### Claim 19 (depends on 15)

The system of claim 15, wherein the anchor support comprises a seating region configured to couple to at least a portion the distal anchor.

### Claim 20 (depends on 1)

The system of claim 1, wherein the elongate tension element further comprises a plurality of proximal anchors.

### Claim 21 (depends on 1)

The system of claim 1, further comprising a needle at a proximal end of the elongate tension element.

### Claim 22

A method for reshaping one or more nasal tissues in a subject comprising:
advancing a delivery device through the one or more nasal tissues, the delivery device comprising an elongate tension element preloaded therein, an anchor delivery element configured to couple with at least a portion of the elongate tension element, and an actuator;
advancing the anchor delivery element from the delivery device through the one or more nasal tissues with a deployed force that is greater than an applied force by a user; and
deploying the elongate tension element from the anchor delivery element and into a target area of the one or more nasal tissues.

### Claim 23 (depends on 22)

The method of claim 22, wherein a ratio of the deployed force to the applied force ranges from about 2:1 to about 4:1.

### Claim 24 (depends on 22)

The method of claim 22, wherein advancing the delivery device comprises inserting a cannula of the delivery device through an access site in submucosal tissue on a first side of the nasal septum and through the nasal septum to a second side of the nasal septum.

### Claim 25 (depends on 22)

The method of claim 22, further comprising securing a distal anchor of the elongate tension element into nasal cartilage on the second side of the nasal septum, the distal anchor comprising a pivot point and having an insertion configuration and a deployed configuration.

### Claim 26 (depends on 25)

The method of claim 25, wherein securing the distal anchor comprises applying a force to the elongate tension element to swivel the distal anchor at the pivot point from the insertion configuration to the deployed configuration.

### Claim 27 (depends on 26)

The method of claim 26, further comprising:
passing a proximal end of the elongate tension element back through the access site in submucosal tissue to the second side of the nasal septum;
tensioning the elongate tension element to a tensioned state; and
securing the proximal end of the elongate tension element in its tensioned state to tissue on the second side of the nasal septum.

### Claim 28 (depends on 27)

The method of claim 27, wherein the tension element in its tensioned state applies a force ranging from about 4.0 Newtons to about 10 Newtons to the one or more nasal tissues.

### Claim 29 (depends on 22)

The method of claim 22, wherein deploying the elongate tension element is used to treat nasal septal deviation.

### Claim 30 (depends on 22)

The method of claim 22, wherein the elongate tension element comprises a biodegradable polymer, and is configured to biodegrade over a period of at about least six months.
