# US 8,777,926 B2 · Apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasel or paranasal structures

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- Number: US 8,777,926 B2
- Document ID: US8777926B2
- Status: Granted
- Kind: B2
- Application number: 13/840,430
- Filed: 2013-03-15
- Published: 2013-12-05
- Granted: 2014-07-15
- Earliest claimed: 2004-04-21
- Assignees: Acclarent, Inc.
- Applicants: Acclarent, Inc.
- Inventors: John Y Chang; Joshua Makower; Julia D Vrany; Amrish Jayprakash Walke
- Web page: https://patentgrep.com/patent/US8777926B2

## CPC

- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 5/6852: {Catheters}
- 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 17/3403: {Needle locating or guiding means}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61F 2/186: {Nose parts}
- 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 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids}
- A61M 25/0082: {Catheter tip comprising a tool}
- A61M 25/0102: {Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod}
- A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/09: Guide wires
- 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})
- A61B 17/32002: {with continuously rotating, oscillating or reciprocating cutting instruments}
- A61B 17/3421: {Cannulas}
- A61B 2017/22039: {eccentric}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22061: {for spreading elements apart}
- A61B 2018/00327: {Ear, nose or throat}
- A61B 2018/00595: {Cauterization}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61M 25/1006: {Balloons formed between concentric tubes}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 2025/0177: {having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes}
- A61M 2025/1072: {having balloons with two or more compartments}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- A61M 2025/109: {having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow}
- A61M 2029/025: {characterised by the guiding element}
- A61M 2210/0681: Sinus (maxillaris)
- A61M 2210/1028: Larynx
- 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)}
- 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)

## Abstract

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat.

## Claims

### Claim 1

A system for treating a paranasal sinus by dilating a natural or manmade paranasal sinus opening, said system comprising:
(a) an elongate shaft having a proximal end, a distal end and an outer diameter sized to allow the elongate shaft to be inserted into a patient's nose;
(b) an expandable dilation device coupled with distal end of the elongate shaft, the expandable dilation device being expandable from a first configuration to a second configuration;
the elongate shaft being advanceable, with the dilation device in its first configuration, through the patient's nose to a position where the dilation device is positioned within the paranasal sinus opening;
the dilation device being expandable, while positioned within the paranasal sinus opening, from the first configuration to the second configuration, said second configuration being sized to cause dilation of the paranasal sinus opening, wherein said dilation device in said second configuration expands with sufficient force to cause breakage or rearrangement of bone which surrounds the paranasal sinus opening; and
the expandable dilator being thereafter removable from the paranasal sinus opening such that the paranasal sinus opening remains dilated after removal of the dilator therefrom.

### Claim 2 (depends on 1)

A system according to claim 1 wherein the elongate shaft has a curved or bent region which facilitates advancement of the dilation device into the paranasal sinus opening.

### Claim 3 (depends on 2)

A system according to claim 2 wherein the curved or bent region is curved or bent to an angle of up to 135°.

### Claim 4 (depends on 2)

A system according to claim 2 wherein the curved or bent region is curved or bent to an angle selected from: 0°, 30°, 45°, 60°, 70°, 90°, 120° and 135°.

### Claim 5 (depends on 2)

A system according to claim 2 wherein the curved or bent region is malleable such that an operator may form it to a desired bend or curvature at the time of use.

### Claim 6 (depends on 2)

A system according to claim 2 wherein the curved or bent region is formed in the elongate shaft at the time of manufacture.

### Claim 7 (depends on 6)

A system comprising a plurality of devices according to claim 6 wherein each device has a different curved or bent region.

### Claim 8 (depends on 1)

A system according to claim 1 wherein the dilation device comprises an inflatable structure which fills with inflation fluid thereby causing the inflatable structure to expand from the first configuration to the second configuration.

### Claim 9 (depends on 1)

A system according to claim 1 wherein the dilation device comprises an expandable wall defining an internal space therewithin and wherein entry of fluid into the internal space causes the expandable wall to expand, thereby transitioning the dilation device from the first configuration to the second configuration.

### Claim 10

A method for dilating a natural or man-made paranasal sinus opening in a patient, said method comprising the steps of:
(a) obtaining or providing a system which comprises i) an elongate shaft having a proximal end, a distal end and an outer diameter sized to allow the elongate shaft to be inserted into a patient's nose and ii) an expandable dilation device coupled with distal end of the elongate shaft, the expandable dilation device being expandable from a first configuration to a second configuration;
(b) inserting the elongate shaft into the patient's nose and advancing it, with the dilation device in its first configuration, through the patient's nose to a position where the dilation device is positioned within the paranasal sinus opening;
(c) causing the dilation device to expand, while positioned within the paranasal sinus opening, from the first configuration to the second configuration, wherein said expansion from the first configuration to the second configuration causes dilation of the paranasal sinus opening, wherein said dilation device in the second configuration expands with sufficient force to cause breakage or rearrangement of bone which surrounds the paranasal sinus opening; and, thereafter,
(d) removing the dilation device from the paranasal sinus opening such that the paranasal sinus opening remains dilated after removal of the dilation device therefrom.

### Claim 11 (depends on 10)

A method according to claim 10 wherein the elongate shaft has a curved or bent region and wherein the curved or bent region is used during advancement of the device to facilitate positioning of the dilation device within the paranasal sinus opening.

### Claim 12 (depends on 11)

A method according to claim 11 wherein the curved or bent region is curved or bent to an angle of up to 135°.

### Claim 13 (depends on 11)

A method according to claim 11 wherein the curved or bent region is curved or bent to an angle selected from: 0°, 30°, 45°, 60°, 70°, 90°, 120° and 135°.

### Claim 14 (depends on 11)

A method according to claim 11 wherein the curved or bent region is malleable and wherein the operator forms a desired bend or curvature at the time of use.

### Claim 15 (depends on 11)

A method according to claim 11 wherein the curved or bent region is formed in the elongate shaft at the time of manufacture.

### Claim 16 (depends on 15)

A method according to claim 15 wherein a plurality of said systems having differing curved or bent regions are obtained or provided and wherein the operator selects a device having a desired bend or curvature at the time of the procedure.

### Claim 17 (depends on 10)

A method according to claim 10 wherein the dilation device comprises an inflatable structure and wherein the dilation device is caused to expand by causing inflation fluid to fill the inflatable structure thereby causing the dilation device to expand from the first configuration to the second configuration.

### Claim 18 (depends on 10)

A method according to claim 10 wherein the dilation device comprises an expandable wall which defines an internal space therewithin and wherein the dilation device is caused to expand by causing fluid to enter into the internal space causing the expandable wall to expand and thereby transitioning the dilation device from the first configuration to the second configuration.