# US 10,118,012 B2 · System and method for anesthetizing eustachian tube

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- Number: US 10,118,012 B2
- Document ID: US10118012B2
- Status: Granted
- Kind: B2
- Application number: 14/928,423
- Filed: 2015-10-30
- Published: 2017-05-04
- Granted: 2018-11-06
- Earliest claimed: 2015-10-30
- Assignees: Acclarent, Inc.
- Applicants: Acclarent, Inc.
- Inventors: Siddhi K. Desai; Hung V. Ha; Ketan P. Muni; Randy S. Chan; Andy Nguyen; Mina Wai-Bing Chow; Mei Pader
- Web page: https://patentgrep.com/patent/US10118012B2

## CPC

- A61M 19/00: Local anaesthesia (syringes therefor A61M5/00); Hypothermia (A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36)
- A61F 11/20: Ear surgery
- A61F 11/202: {Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0662: {Guide tubes}
- 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})
- A61M 29/00: Dilators with or without means for introducing media, e.g. remedies
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61B 1/00: Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes (examination of body cavities or body tracts using ultrasonic, sonic or infrasonic waves A61B8/12; endoscopic instruments for taking cell samples or for biopsy A61B10/04); Illuminating arrangements therefor (for the eyes A61B3/00)
- 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 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00331: {with preformed bends}
- A61B 2017/00787: {Surgery of the ear}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2217/007: with irrigation system
- A61M 25/0023: {by the form of the lumen, e.g. cross-section, variable diameter}
- A61M 25/0041: {pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04)}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 2025/0036: {with more than four lumina}
- A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less}
- A61M 2025/0073: {Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow}
- A61M 2025/0175: {having telescopic features, interengaging nestable members movable in relations to one another}
- A61M 2025/1095: {with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft}
- A61M 2210/0675: Eustachian tube
- 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)}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A system for delivering a fluid to a Eustachian tube (ET) of a patient includes a guide member and a tubular member. The guide member includes a shaft having a proximal portion, a distal portion, and a bend at the distal portion. The bend is configured to provide access to an opening in the ET. The system further includes a tubular member comprising a proximal end, a distal end, and a lumen extending therebetween. The tubular member is sized to fit within the ET. One or both of the tubular member and the guide member comprises a first stop member configured to engage the other of the tubular member or the guide member. The first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

## Claims

### Claim 1

A system for delivering a fluid to a Eustachian tube (ET) of a patient, the system comprising:
(a) a guide member, wherein the guide member comprises a shaft having a proximal portion and a distal portion and a lumen extending therebetween, wherein the guide member further comprises a bend at the distal portion, wherein the bend is configured to provide access to an opening in the ET, wherein the guide member, including the shaft and the bend, is rigid; and
(b) a tubular member configured to be positioned within the lumen of the guide member, wherein the tubular member comprises a proximal end, a distal end, and a lumen extending therebetween, wherein the tubular member is sized to fit within the ET, wherein one or both of the tubular member and guide member comprises a first stop member configured to engage the other of the tubular member or the guide member, wherein the first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

### Claim 2 (depends on 1)

The system of claim 1, wherein the tubular member comprises a proximal portion and a distal portion, wherein the proximal portion is stiffer than the distal portion.

### Claim 3 (depends on 1)

The system of claim 1, wherein the tubular member comprises a proximal portion having a first cross-sectional dimension and distal portion comprising a second cross-sectional dimension, wherein the first cross-sectional dimension is greater than the second cross-sectional dimension.

### Claim 4 (depends on 3)

The system of claim 3, wherein the first cross sectional dimension is between about 0.03 inches and about 0.060 inches, wherein the second cross-sectional dimension is between about 0.015 inches and about 0.040 inches.

### Claim 5 (depends on 1)

The system of claim 1, wherein the first stop member is configured to prevent the distal end of the tubular member from extending past the distal portion of the guide member by a predetermined amount.

### Claim 6 (depends on 5)

The system of claim 5, wherein the predetermined amount comprises between about 5 mm and about 25 mm.

### Claim 7 (depends on 1)

The system of claim 1, wherein the first stop member comprises a flange on the tubular member.

### Claim 8 (depends on 1)

The system of claim 1, wherein the first stop member comprises a proximal portion of the guide member.

### Claim 9 (depends on 1)

The system of claim 1, further comprising a sheath, wherein the tubular member is configured to be inserted into the sheath and the sheath is configured to be inserted into the guide member.

### Claim 10 (depends on 9)

The system of claim 9, wherein the sheath is configured to lockingly receive the proximal portion of the guide member to prevent relative movement between the sheath and the guide member.

### Claim 11 (depends on 9)

The system of claim 9, further comprising a second stop member, wherein the second stop member is disposed on the sheath.

### Claim 12 (depends on 9)

The system of claim 9, wherein the sheath includes a hub including a recess, wherein the recess is configured to receive the proximal portion of the guide member.

### Claim 13 (depends on 1)

The system of claim 1, wherein the tubular member comprises a preformed bend at or near the distal end.

### Claim 14 (depends on 1)

The system of claim 1, wherein the shaft of the guide member consists essentially of stainless steel.

### Claim 15 (depends on 1)

The system of claim 1, wherein the tubular member comprises a plurality of apertures at or near the distal end, wherein the tubular member comprises a flow limiting member disposed in the lumen, wherein the flow limiting coincident with at least a portion of the apertures.

### Claim 16 (depends on 15)

The system of claim 15, wherein the flow limiting element comprises a sponge member.

### Claim 17

A method of treating a Eustachian tube (ET) of a patient using a guide member and a tubular member, wherein one or both of the guide member and tubular member comprises a stop member configured to limit a restrict advancement of the tubular member relative to the guide member, wherein the method comprises:
(a) directing the guide member into an oro-nasal cavity of the patient;
(b) directing the tubular catheter into the oro-nasal cavity of the patient;
(c) advancing at least part of a distal portion of the guide member adjacent to or into an opening of the ET;
(d) advancing the tubular member relative to the guide member such that a distal end of the tubular member is positioned coincident with at least a portion of the ET; and
(e) directing a fluid through the tubular member and out of the tubular member and onto at least a portion of the ET.

### Claim 18 (depends on 17)

The method of claim 17, wherein the fluid comprises an anesthetic.

### Claim 19

A method of treating a Eustachian tube (ET) of a patient using a guide member and a dilation catheter, wherein the method comprises:
(a) directing the guide member into an oro-nasal cavity of the patient;
(b) directing the dilation catheter into the oro-nasal cavity of the patient;
(c) advancing at least part of a distal portion of the guide member into an opening of the ET;
(d) advancing the dilation catheter relative to the guide member such that an expandable element of the dilation catheter is positioned distal to a distal end of the guide member;
(e) expanding the expandable element to thereby dilate the ET;
(f) venting the anatomical structures that are positioned distal to the expandable element; and
(g) delivering a fluid to the ET.

### Claim 20 (depends on 19)

The method of claim 19, wherein the dilation catheter comprises a ventilation lumen including a first opening positioned distal to the expandable element and a second opening positioned proximal to the expandable element.