System and method for treatment of eustachian tube from middle ear approach

Patent metadata

Field	Value
Publication number	US-11944518-B2
Application number	US-202017106318-A
Country	US
Kind code	B2
Filing date	Nov 30, 2020
Priority date	Oct 30, 2015
Publication date	Apr 2, 2024
Grant date	Apr 2, 2024

Abstract

A dilation catheter includes a shaft and an expandable element. The shaft includes a proximal portion and a distal portion. The distal portion includes a tip and a bend. The tip is sized and configured to pass through an isthmus of a Eustachian tube (ET). The bend is proximal to the tip. The bend is formed at an angle configured to provide insertion of the tip into the isthmus of the ET via an ear canal associated with the ET. The expandable element is disposed at the distal portion of the shaft. The expandable element is configured to transition between a non-expanded state and an expanded state. The expandable element in the non-expanded state is configured for insertion into the ET via the isthmus. The expandable element in the expanded state is configured to dilate the ET.

First claim

We claim:

1. A dilation catheter, comprising:
(a) a rigid proximal body, the rigid proximal body comprising:
(i) an inflation port, and
(ii) an elongate portion extending distally from the inflation port along a longitudinal axis, the elongate portion defining a first section of an inflation lumen, the first section of the inflation lumen being in fluid communication with the inflation port, the elongate portion further defining a first portion of an injection lumen;

(b) an inflatable balloon configurated to transition between a deflated state and an inflated state; and
(c) a distal shaft extending distally from the elongate portion of the rigid proximal body, the distal shaft being coupled with the inflatable balloon, the distal shaft defining a second section of the inflation lumen, the second section of the inflation lumen being in fluid communication with the first section of the inflation lumen and the inflatable balloon, the distal shaft being configured to transition from an initial angle relative to the longitudinal axis to a selected angle relative to the longitudinal axis, the distal shaft being configured to access a targeted anatomical passageway of a patient without buckling in the selected angle,
the rigid proximal body further comprising an injection port located proximally relative to the elongate portion, the injection lumen being in communication with the injection port.

2. The dilation catheter of claim 1 , the distal shaft being dimensioned to be inserted into an Isthmus of the patient.

3. The dilation catheter of claim 2 , the distal shaft being dimensioned to be inserted into a Eustachian Tube of the patient.

4. The dilation catheter of claim 1 , the distal shaft comprising a polyether block amide material.

5. The dilation catheter of claim 1 , the elongate portion comprising a first cross-sectional dimension, the distal shaft comprising a first portion having a second cross-sectional dimension, the second cross-sectional dimension being smaller than the first cross-sectional dimension.

6. The dilation catheter of claim 5 , the distal shaft further comprising a tapered outer surface.

7. The dilation catheter of claim 1 , the distal shaft comprising a distal tip located distal relative to the inflatable balloon.

8. The dilation catheter of claim 7 , the distal tip extending along a profile to define an oblique angle with the inflatable balloon.

9. The dilation catheter of claim 1 , the distal shaft further defining a second portion of the injection lumen, the injection lumen being fluidly isolated from the inflation lumen.

10. The dilation catheter of claim 1 , the elongate portion further comprising a steel hypotube and an outer shaft portion housing the steel hypotube, the steel hypotube defining the first section of the inflation lumen.

11. The dilation catheter of claim 1 , the distal shaft comprising an outer surface defining an opening in communication with the inflation lumen, the outer surface being in fluid communication with the inflatable balloon.

12. The dilation catheter of claim 1 , the inflatable balloon and the distal shaft being dimensioned to access a Eustachian Tube of a patient via a peri-tympanic approach.

13. The dilation catheter of claim 12 , the inflatable balloon and the distal shaft being dimensioned to access a Eustachian Tube of a patient via a myringotomy approach.

14. A dilation catheter, comprising:
(a) a rigid proximal body, the rigid proximal body comprising:
(i) an inflation port, and
(ii) an elongate portion extending distally from the inflation port along a longitudinal axis, the elongate portion defining a first section of an inflation lumen, the first section of the inflation lumen being in fluid communication with the inflation port;

(b) an inflatable balloon configurated to transition between a deflated state and an inflated state; and
(c) a distal shaft extending distally from the elongate portion of the rigid proximal body, the distal shaft being coupled with the inflatable balloon, the distal shaft defining a second section of the inflation lumen, the second section of the inflation lumen being in fluid communication with the first section of the inflation lumen and the inflatable balloon, the distal shaft being configured to transition from an initial angle relative to the longitudinal axis to a selected angle relative to the longitudinal axis, the distal shaft being configured to access a targeted anatomical passageway of a patient without buckling in the selected angle,
the inflatable balloon and the distal shaft being dimensioned to access a Eustachian Tube of a patient via a pre-tympanic approach and a myringotomy approach.

Assignees

• Acclarent Inc

Inventors

• Chan Randy S
• Muni Ketan P
• Ha Hung V
• Nguyen Andy
• Sudhoff Holger
• Lam Sivette
• Dean Marc
• Poe Dennis S

Classifications

• A61F11/202 Primary

  Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor · CPC title

• A61B1/002

  having rod-lens arrangements (A61B1/055 takes precedence) · CPC title

• A61B1/07

  using light-conductive means, e.g. optical fibres · CPC title

• A61B1/227

  for ears, i.e. otoscopes · CPC title

• A61B17/24 Primary

  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 · CPC title