DEVICES, SYSTEMS AND METHODS USEABLE FOR TREATING SINUSITIS

• US 20100042046A1
• Filed: 08/18/2009
• Published: 02/18/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Muni, Ketan P, Morriss, John H., Makower, Joshua, Walke, Amrish Jayprakash, Kim, Isaac J., Facteau, William M., Chang, John Y., Ha, Hung, Vrany, Julia D.
• Granted Patent: US 8,764,726 B2
• Time in Patent Office: Days
• US Class Current: 604/96.10
• 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 for enlarging a natural paranasal sinus opening that has not been previously surgically altered, the method comprising:

advancing a guide device into the patient'"'"'s head to position a distal end of the guide device near or within a natural paranasal sinus opening;

advancing a balloon catheter over or through the guide device to position a balloon of the catheter within the natural paranasal sinus opening;

remodeling or breaking bone underlying mucosa of the natural paranasal sinus opening by expanding the balloon within the opening to enlarge the opening;

introducing irrigation fluid into the paranasal sinus using an irrigation device; and

removing the balloon catheter, irrigation device and guide device from the head.

2. A method as in claim 1, wherein the guide has a lumen, and wherein advancing the balloon catheter comprises advancing the catheter through the lumen of the guide.

3. A method as in claim 2, wherein at least a portion of the guide is malleable, and wherein the method further comprises shaping the malleable portion.

4. A method as in claim 2, further comprising, before advancing the balloon catheter, advancing a guidewire through the lumen of the guide such that the guidewire extends into or through the natural paranasal sinus opening, wherein the balloon catheter is advanced over the guidewire and through the lumen of the guide.

5. A method as in claim 4, further comprising, after removing the balloon catheter from the patient'"'"'s head, advancing a sheath over the guidewire.

6. A method as in claim 5, further comprising removing the guidewire, leaving the sheath in place.

7. A method as in claim 6, wherein the irrigation fluid is introduced through the sheath.

8. A method as in claim 6, further comprising inserting a different guidewire through the sheath.

9. A method as in claim 8, wherein the sheath has a lumen and a curved portion is inserted through the lumen of the guide to a position where the curved portion of the sheath extends out of the distal end of the guide, and wherein the guidewire is advanced through the lumen of the curved sheath such that the guidewire extends into or through the natural paranasal sinus opening.

10. A method as in claim 1, wherein the irrigation device comprises an irrigation lumen in the balloon catheter and the irrigation fluid is introduced through the irrigation lumen.

11. A method as in claim 1, further comprising suctioning fluid out of the paranasal sinus using the irrigation device.

12. A method as in claim 1, wherein a distal end of the balloon catheter is bent or angled.

13. A method as in claim 1, further comprising visualizing the balloon catheter during the method using an endoscope.

14. A method as in claim 13, wherein visualizing the balloon catheter comprises visualizing at least one marker or band on the catheter.

15. A method as in claim 13, wherein the endoscope is incorporated with the guide.

16. A method as in claim 1, wherein the natural paranasal sinus opening is a maxillary sinus ostium.

17. A method as in claim 1, wherein the natural paranasal sinus opening is a frontal sinus ostium.

18. A method as in claim 17, further comprising remodeling or breaking intact bone underlying mucosa of a frontal sinus outflow tract by expanding the balloon within the outflow tract.

19. A method as in claim 1, wherein the natural paranasal sinus opening is a sphenoid sinus ostium.

20. A method as in claim 1, further comprising treating an ethmoid sinus.

21. A method as in claim 1, further comprising viewing at least one radiopaque marker band on the balloon catheter using fluoroscopy to approximate a location of the balloon relative to the paranasal sinus opening.

22. A method as in claim 1, further comprising viewing at least one distal colored portion of the balloon catheter during the method using an endoscope.

23. A method as in claim 1, wherein the balloon of the balloon catheter comprises a cylindrical balloon.