Devices, systems and methods useable for treating sinusitis

• US 9,055,965 B2
• Filed: 03/22/2010
• Issued: 06/16/2015
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Chang, John Y., Makower, Joshua, Vrany, Julia D., Morriss, John H., Muni, Ketan P., Kim, Isaac J., Ha, Hung, Facteau, William M., Walke, Amrish Jayprakash
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US12/729,109
• Publication Number:
  US 20100174138A1
• Time in Patent Office: 1,912 Days
• Field of Search: 604/96.01, 604/101.01, 604/500, 604/514, 600104-107, 600/153, 606191-194
• US Class Current: 1/1
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1657 Bone breaking devices
• CPC Class Codes: A61B 17/1688 for the sinus or nose
• 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 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/3764 with a rotating C-arm having a cone beam emitting source
• CPC Class Codes: A61B 2503/40 Animals
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/1028 Larynx
• 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 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0662 : Guide tubes
• 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 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Sinusitis and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches with flexible or rigid instruments. Various methods and devices are used for remodeling or changing the shape, size or configuration of a sinus ostium or duct or other anatomical structure in the ear, nose or throat; implanting a device, cells or tissues; removing matter from the ear, nose or throat; delivering diagnostic or therapeutic substances or performing other diagnostic or therapeutic procedures. Introducing devices (e.g., guide catheters, tubes, guidewires, elongate probes, other elongate members) may be used to facilitate insertion of working devices (e.g. catheters e.g. balloon catheters, guidewires, tissue cutting or remodeling devices, devices for implanting elements like stents, electrosurgical devices, energy emitting devices, devices for delivering diagnostic or therapeutic agents, substance delivery implants, scopes etc.) into the paranasal sinuses or other structures in the ear, nose or throat. Specific devices (e.g., tubular guides, guidewires, balloon catheters, tubular sheaths) are provided as are methods for manufacturing and using such devices to treat disorders of the ear, nose or throat.

Claims

1. A method of performing a surgery on a paranasal sinus of a human or animal subject, said method comprising the steps of:

a) inserting at least one endoscope;

b) inserting at least one rigid tool capable of performing a maneuver within the field of view of the endoscope;

c) inserting a balloon catheter that has at least one flexible region capable of performing a maneuver outside the field of view of the endoscope, the balloon catheter comprising a catheter shaft, a non-compliant balloon mounted on the catheter shaft, said balloon being positionable within the opening of the paranasal sinus while in a non-inflated state and thereafter inflatable to an inflated state having a diameter of at least about 3 mm such that it will cause dilation of the opening of the paranasal sinus, said balloon having an outer surface comprising a polymeric material and at least one position indicating element useable to determine when the balloon is positioned within the opening of the paranasal sinus so as to cause the desired dilation;

d) using the rigid tool to perform a maneuver within the field of view of the endoscope; and

e) using the at least one tubular device to perform a maneuver outside the field of view of the endoscope.

2. A method according to claim 1 wherein the rigid tool is used to cut or remove tissue.

3. A method according to claim 1 wherein the tubular device comprises a dilator apparatus and wherein Step e comprises using the tubular device to dilate an opening in a paranasal sinus.

4. A method according to claim 1 wherein the tubular device comprises a guidewire.

5. A method according to claim 1 wherein the rigid tool is a guide tool.

6. The method of claim 1, wherein the at least one position indicating element comprises at least one marker on the balloon catheter shaft that is directly or endoscopically visible to the operator.

7. The method of claim 1, wherein the balloon catheter has a distal end and wherein the at least one marker indicating the position of the distal end of the balloon catheter relative to the distal end of a tubular guide through which the balloon catheter device is inserted.

8. The method of claim 1, wherein the at least one marker comprises:

a first marker indicating the position of the distal end of the balloon catheter relative to the distal end of the tubular guide; and

a second marker indicating the position of the balloon relative to the distal end of the tubular guide device.

9. The method of claim 8, wherein the balloon has a proximal end and a distal end and wherein second marker indicates a) the position of the distal of the balloon relative to the distal end of the tubular guide device and b) the position of the proximal end of the balloon relative to the distal end of the tubular guide device.

10. The method of claim 8, wherein the second marker comprises a visible mark having a length that is substantially the same as the length of the balloon.

11. The method of claim 1, wherein the balloon is substantially formed of a material selected from the group consisting of:

polyethylene teraphthelate, nylon and polyamide.

12. The method of claim 1, wherein the balloon is capable of withstanding pressures of more than 22 atmospheres without bursting.

13. The method of claim 1, wherein the balloon is capable of breaking bone located around the opening of the paranasal sinus.

14. The method of claim 1, wherein the at least one position indicating element comprises a radiographically visible component that is useable in conjunction with a radiographic imaging device to determine when the balloon is positioned within the opening of a paranasal sinus so as to cause dilation of said opening.

15. The method of claim 13, wherein the non-compliant balloon has a compliance ranging from 0.025 to 0.030 mm per atmosphere.

16. The method of claim 15, wherein the balloon is coated with a 0.002 inch thick polymethane coating.