# US 10,369,337 B2 · Balloon dilation catheter for use in sinus passageways

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- Number: US 10,369,337 B2
- Document ID: US10369337B2
- Status: Granted
- Kind: B2
- Application number: 15/139,052
- Filed: 2016-04-26
- Published: 2017-02-23
- Granted: 2019-08-06
- Earliest claimed: 2009-06-05
- Assignees: Entellus Medical, Inc.
- Applicants: Entellus Medical, Inc.
- Inventors: John R. Drontle; Anthony J. Hanson
- Web page: https://patentgrep.com/patent/US10369337B2

## CPC

- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- 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 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 34/30: Surgical robots
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- 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 2017/246: {for cleaning of the nose}
- 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) 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 balloon dilation catheter for use in a sinus or sinus drainage pathway comprising:
a handle configured to be gripped by an operator;
an inner guide member extending longitudinally from the handle in a distal direction, the inner guide member formed from a substantially rigid metallic hypotube defining a first lumen, the substantially rigid metallic hypotube having a blunt distal end and a proximal end secured within the handle;
a shaft slidably arranged over the inner guide member, wherein a distal portion of the shaft includes an inflatable balloon;
a moveable shaft advancing member disposed in the handle and coupled to the shaft, the moveable shaft advancing member configured to be manipulated by a thumb of an operator of the balloon dilation catheter to advance the shaft over the inner guide member from a retracted state to an extended state; and
wherein a length of the inner guide member projects distally from a distal-most portion of the inflatable balloon within the range of about 0.5 inch to about 2.0 inch in the retracted state.

### Claim 2 (depends on 1)

The balloon dilation catheter of claim 1, wherein the shaft defines a rider lumen and the inner guide member extends through the rider lumen when the shaft is in a fully retracted position.

### Claim 3 (depends on 1)

The balloon dilation catheter of claim 1, wherein the handle defines a slot extending along a longitudinal length of the handle and wherein the moveable shaft advancing member is configured to translate along the slot.

### Claim 4 (depends on 1)

The balloon dilation catheter of claim 1, wherein a distal portion of the inner guide member is malleable and can be shaped by the operator into a desired configuration and maintain the desired configuration while the shaft and inflatable balloon are advanced over the inner guide member.

### Claim 5 (depends on 1)

The balloon dilation catheter of claim 1, wherein the inner guide member has an inner diameter in the range of 0.020 and 0.050 inches.

### Claim 6 (depends on 5)

The balloon dilation catheter of claim 5, wherein the inner guide member has an inner diameter in the range of 0.036 and 0.040 inches.

### Claim 7 (depends on 1)

The balloon dilation catheter of claim 1, wherein the inner guide member has a wall thickness in the range of 0.005 and 0.020 inches.

### Claim 8 (depends on 7)

The balloon dilation catheter of claim 7, wherein the inner guide member has a wall thickness in the range of 0.008 and 0.012 inches.

### Claim 9 (depends on 1)

The balloon dilation catheter of claim 1, wherein the inner guide member includes a curved distal end, wherein the radius of curvature of the curved distal end is between 0.25 and 1.5 inches.

### Claim 10 (depends on 9)

The balloon dilation catheter of claim 9, wherein the inner guide member includes a curved distal end, wherein the radius of curvature of the curved distal end is between 0.75 and 1.25 inches.

### Claim 11 (depends on 1)

The balloon dilation catheter of claim 1, wherein the blunt distal end of the inner guide member has a diameter of between 1 and 3 millimeters.

### Claim 12 (depends on 1)

The balloon dilation catheter of claim 1, further including a tracking element disposed in the handle for use with an image guided surgery system.

### Claim 13 (depends on 1)

The balloon dilation catheter of claim 1, wherein a flexible guide wire is disposed within the first lumen of the inner guide member.
