# US 10,307,519 B2 · Sinus dilation catheter

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- Number: US 10,307,519 B2
- Document ID: US10307519B2
- Status: Granted
- Kind: B2
- Application number: 15/290,930
- Filed: 2016-10-11
- Published: 2017-02-02
- Granted: 2019-06-04
- Earliest claimed: 2011-06-29
- Assignees: Entellus Medical, Inc.
- Applicants: Entellus Medical, Inc.
- Inventors: John R. Drontle; Anthony J. Hanson; Paul Lesch
- Web page: https://patentgrep.com/patent/US10307519B2

## CPC

- A61M 1/76: {Handpieces (specially for suction-irrigation A61M1/774, aspiration tips A61M1/84)}
- 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
- A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence)
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61B 2017/246: {for cleaning of the nose}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- 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)

## Abstract

A balloon dilation catheter includes a substantially rigid inner guide member and a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member. To treat a sinus cavity of a subject using the balloon dilation the substantially rigid inner guide member is advanced into a drainage pathway of the sinus (e.g., frontal recess or maxillary sinus) of the subject via a nasal passageway. The shaft and balloon are advanced in a distal direction over the substantially rigid inner guide member to place the balloon in the drainage pathway. The balloon is inflated to expand or otherwise remodel the drainage pathway.

## Claims

### Claim 1

A method of treating a sinus cavity of a subject using a balloon dilation catheter having a substantially rigid inner guide member and a handle disposed along a proximal portion thereof, the substantially rigid inner guide member extending distally from the handle for a pre-determined distance, the balloon dilation catheter further comprising a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide member and further coupled to an advancer knob disposed in the handle comprising:
advancing the substantially rigid inner guide member transnasally;
positioning a ball tip of the substantially rigid inner guide member behind and in contact with an uncinate process;
directing the ball tip along a lateral side of the uncinate process while in contact with the uncinate process until the ball tip is positioned behind a lower aspect of the uncinate process;
directing the ball tip into a maxillary sinus ostium;
advancing the advancer knob of the handle to advance the shaft and balloon in a distal direction over the substantially rigid inner guide member to place the balloon across the maxillary sinus ostium; and
inflating the balloon.

### Claim 2 (depends on 1)

The method of claim 1, further including determining a position of the ball tip behind the uncinate process, wherein determining the position of the ball tip includes observing through the uncinate process a light emitted from the ball tip.

### Claim 3 (depends on 2)

The method of claim 2, wherein the light is emitted from a light fiber positioned within the substantially rigid inner guide member.

### Claim 4 (depends on 1)

The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend with a distal leg that is between about 10 and about 12 millimeters in length.

### Claim 5 (depends on 4)

The method of claim 4, wherein the substantially rigid inner guide member is directed into a nasal cavity prior to reaching the uncinate process of the subject in a tip up orientation.

### Claim 6 (depends on 1)

The method of claim 1, further including inserting a distal portion of a maxillary seeker into the maxillary sinus ostium prior to positioning the ball tip of the substantially rigid inner guide member behind the uncinate process.

### Claim 7 (depends on 1)

The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend of between about 115 and 125 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

### Claim 8 (depends on 1)

The method of claim 1, wherein a distal portion of the substantially rigid inner guide member includes a bend of about 135 degrees and about 10 to 12 millimeters of the substantially rigid inner guide member is distal to the bend.

### Claim 9 (depends on 1)

The method of claim 1, wherein directing the ball tip along a lateral side of the uncinate process includes directing the ball tip to a position next to the lowest 20% of the uncinate process.

### Claim 10 (depends on 1)

The method of claim 1, further including, after directing the ball tip into the maxillary sinus ostium but before inflating the balloon, pulling the substantially rigid inner guide member anteriorly and inferiorly such that the uncinate process is further deflected.

### Claim 11 (depends on 1)

The method of claim 1, further including inflating the balloon a second time when the balloon lies across the maxillary sinus ostium.

### Claim 12 (depends on 1)

The method of claim 1, wherein the handle includes a suction vent port configured to increase or decrease a suction force at the ball tip of the inner guide member.

### Claim 13 (depends on 12)

The method of claim 12, wherein the balloon dilation catheter is configured to allow a single hand to grasp the handle and position the substantially rigid inner guide member within the anatomy, advance the shaft and balloon over the substantially rigid inner guide member, and alter the amount of suction force at the ball tip of the inner guide member without the single hand releasing the handle.

### Claim 14 (depends on 1)

The method of claim 1, further comprising an inflation lumen extending through the handle, wherein a portion of the inflation lumen extending through the handle is folded back upon itself to form an S-shape.

### Claim 15 (depends on 1)

The method of claim 1, further including, before directing the ball tip into a maxillary sinus ostium, inflating the balloon while a distal end portion of the balloon is within an ethmoidal infundibulum.

### Claim 16

A method of dilating an ethmoidal infundibulum of a subject using a balloon dilation catheter having a substantially rigid inner guide member and a handle disposed along a proximal portion thereof, the substantially rigid inner guide member extending distally from the handle for a pre-determined distance, the balloon dilation catheter further comprising a movable shaft coupled to a balloon that is slidably mounted on the substantially rigid inner guide and further coupled to an advancer knob disposed in the handle member comprising:
advancing the substantially rigid inner guide member transnasally;
positioning a ball tip of the substantially rigid inner guide member behind and in contact with an uncinate process at a first location within the ethmoidal infundibulum;
advancing the advancer knob of the handle to advance the shaft and balloon in a distal direction over the substantially rigid inner guide member to place at least a portion of the balloon within the ethmoidal infundibulum; and
inflating the balloon.

### Claim 17 (depends on 16)

The method of claim 16, further including repositioning the balloon at a second location in the ethmoidal infundibulum and inflating the balloon.

### Claim 18 (depends on 17)

The method of claim 17, wherein the first location is behind an inferior aspect of the uncinate process and the second location is behind a superior aspect of the uncinate process.

### Claim 19 (depends on 16)

The method of claim 16, wherein no portion of the balloon is placed within a maxillary sinus ostium.
