Systems and methods for transnasal dilation of passageways in the ear, nose or throat

• US 10,098,652 B2
• Filed: 06/21/2016
• Issued: 10/16/2018
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Goldfarb, Eric, Chang, John Y., Facteau, William M., Lam, Sivette, Ha, Hung V., Kim, Isaac J., Muni, Ketan P.
• Primary Examiner(s): Medway, Scott
• Application Number:
  US15/187,938
• Publication Number:
  US 20170007281A1
• Time in Patent Office: 847 Days
• CPC Class Codes: 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
• CPC Class Codes: A61B 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A dilation catheter device and system for dilating an opening in a paranasal sinus and/or other passageways within the ear, nose or throat is disclosed. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, shaft markers are disposed on a shaft of the dilation catheter and have a light color to contrast with a dark color of the dilation catheter shaft. The high contrast between the markers and catheter shaft allows for easy viewing of the markers in low light and operation conditions.

Claims

1. A method for dilating a drainage passageway associated with a paranasal sinus of a patient, the method comprising:

advancing a guide catheter into a head of a patient such that a distal end of the guide catheter is positioned within or near the drainage passageway associated with the paranasal sinus;

inserting an endoscope into the patient'"'"'s head;

advancing a balloon catheter through a lumen of the guide catheter such that a balloon of the catheter passes out of the distal end of the guide catheter;

viewing, with the endoscope, a first distal shaft marker disposed on a shaft of the balloon catheter a first known distance from the balloon;

viewing, with the endoscope, a second distal shaft marker disposed on the shaft a second known distance from the balloon;

approximating a location of the balloon relative to the drainage passageway associated with the paranasal sinus, using the first and second distal shaft marker and their known distances from the balloon; and

expanding the balloon of the balloon catheter to remodel or break bone underlying mucosa of the drainage passageway associated with the paranasal sinus and dilate the drainage passageway associated with the paranasal sinus.

2. A method as in claim 1, further comprising viewing a first proximal shaft marker during the step of advancing the balloon catheter, wherein when a distal end of the first proximal shaft marker enters a proximal end of the guide catheter a distal end of the balloon catheter shaft is located approximately at the distal end of the guide catheter, and wherein when a proximal end of the distal shaft marker enters the proximal end of the guide catheter a proximal end of the balloon of the catheter is located approximately at the distal end of the guide catheter.

3. A method as in claim 2, further comprising viewing a second proximal shaft marker during the step of advancing the balloon catheter, wherein the second proximal shaft marker is disposed distal to the first proximal shaft marker, and wherein when the second proximal shaft marker is located approximately at the proximal end of the guide catheter, the distal end of the balloon catheter is located immediately proximal to a curve in the distal end of the guide catheter.

4. A method as in claim 1, wherein the first distal shaft marker is located proximal to the balloon and the second distal shaft marker is located distal to the balloon.

5. A method as in claim 4, wherein the first and second distal shaft markers are located proximal to the balloon.

6. A method as in claim 5, wherein the first distal shaft marker is located approximately one centimeter proximal to a proximal end of the balloon, and the second distal shaft marker is located approximately two centimeters proximal to the proximal end of the balloon.

7. A method as in claim 6, further comprising viewing a third distal shaft marker located at the proximal end of the balloon.

8. A method as in claim 1, further comprising advancing a guidewire through the guide and through the drainage passageway associated with the paranasal sinus before advancing the balloon catheter, wherein the balloon catheter is advanced over the guidewire and through the guide.

9. A method as in claim 1, further comprising:

removing the balloon catheter through the guide catheter;

advancing an irrigation catheter through the guide catheter into the paranasal sinus; and

irrigating the sinus using the irrigation catheter.

11. A method as in claim 9, further comprising inserting an endoscope into the patient'"'"'s head and endoscopically viewing a second marker on a proximal end of the balloon to confirm that the balloon of the dilation catheter passes distally past the distal end of the guide member.

12. A method as in claim 9, further comprising deflating the balloon in from 5 to 10 seconds.

10. A method for dilating a drainage passageway associated with a paranasal sinus of a patient, the method comprising:

advancing a dilation catheter comprising a balloon and a first shaft marker to a position where the first shaft marker is at or near a proximal end of a guide member;

advancing the guide member in combination with the dilation catheter into a head of the patient such that a distal end of the guide member is positioned at or near the drainage passageway;

advancing a distal end of a guidewire out of the distal end of the guide member through the drainage passageway;

advancing the dilation catheter relative to the guide member such that the balloon of the dilation catheter protrudes distally past the distal end of the guide member; and

inflating the balloon to remodel or break bone underlying mucosa of the drainage passageway and thereby dilate the drainage passageway.

13. A method as in claim 10, further comprising confirming endoscopically dilation of the drainage passageway.

14. A method as in claim 10, further comprising:

removing the balloon catheter from the guide member;

advancing an irrigation catheter relative to the guide member into the paranasal sinus; and

irrigating the sinus using the irrigation catheter.

16. A method as in claim 14, further comprising advancing the dilation catheter with respect to the guide member until a distal edge of the first shaft marker is flush with a proximal end of the guide member such that the distal end of the dilation catheter is located proximal to a curved portion of the guide member, wherein the curved portion is at or near the distal end of the guide member.

18. A method as in claim 14, further comprising pre-inserting the guidewire into the dilation catheter.

19. A method as in claim 14, further comprising passing the guidewire into the paranasal sinus and coiling the guidewire within a cavity of the paranasal sinus.

20. A method as in claim 14, wherein the balloon comprises a first radiographic marker at its proximal end and a second radiographic marker at its distal end, the method further comprising fluoroscopic imaging of the first and second radiographic markers to confirm that the balloon is positioned within the ostium.

15. A method for dilating a drainage passageway associated with a paranasal sinus of a patient, the method comprising:

advancing a distal end of a guidewire beyond a distal end of a dilation catheter, wherein the dilation catheter comprises a balloon and a first shaft marker;

advancing the guidewire in combination with the dilation catheter and a guide member into a head of the patient such that a distal end of the guide member is positioned near the drainage passageway;

advancing the guidewire distally past the distal end of the guide member;

advancing the dilation catheter over the guidewire to a position within the drainage passageway; and

inflating the balloon to remodel or break bone underlying mucosa of the drainage passageway to thereby dilate the drainage passageway.

17. A method as in claim 15, further comprising pre-inserting the dilation catheter into the guide member at a position wherein the first shaft marker on the dilation catheter is at or near the proximal end of the guide member.