Methods for enlarging ostia of paranasal sinuses

• US 8,858,586 B2
• Filed: 01/18/2007
• Issued: 10/14/2014
• 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 V., Facteau, William M., Walke, Amrish Jayprakash
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US11/655,794
• Publication Number:
  US 20070135789A1
• Time in Patent Office: 2,826 Days
• Field of Search: 604/96.01, 604104-109, 606191-194, 606/167.03, 606/103.02, 606/196, 606/199, 623/1.11
• US Class Current: 606/196
• 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 using a balloon that has a non-expanded configuration and an expanded configuration to dilate a natural paranasal sinus ostium that has not previously been surgically altered, the natural paranasal sinus ostium being formed by mucosa with unfractured bone underlying the mucosa, said method comprising the steps of:

(A) advancing an elongate guide having a distal end and a lumen to a position within or near the natural paranasal sinus ostium

(B) inserting a balloon catheter through the lumen of the elongate guide to position a balloon of the balloon catheter beyond the distal end of the guide and within the natural paranasal sinus ostium;

(C) expanding the balloon within the natural paranasal sinus ostium sufficiently to break, remodel, or rearrange the bone underlying the mucosa of the ostium thereby enlarging the natural paranasal sinus ostium to an enlarged ostium; and

(D) deflating the balloon, removing the balloon catheter from the enlarged ostium, and removing the elongate guide from near the ostium.

2. A method according to claim 1 wherein the guide has a curve and wherein the advancing step comprises advancing the balloon through the lumen of the guide and around the curve.

3. A method according to claim 1 wherein at least a portion of the guide is malleable and wherein the method further comprises the step of:

shaping a malleable portion of the guide.

4. A method according to claim 3 wherein the guide comprises a flexible guide catheter and a malleable outer tube through which the balloon catheter extends.

5. A method according to claim 1 wherein the inserting step comprises:

inserting the elongate guide to a first position; and

advancing a guidewire through the lumen of the elongate guide such that the guidewire extends into or through the natural paranasal sinus ostium,

wherein the advancing step further comprises advancing the balloon catheter over the guidewire to a position where the balloon is positioned within the natural paranasal sinus ostium.

6. A method according to claim 1 wherein a distal end of the balloon catheter is bent or angled.

7. A method according to claim 1 further comprising using an endoscope for visualization.

8. A method according to claim 1 further comprising advancing the balloon through a lumen of a stabilizing member.

9. A method according to claim 1 wherein the natural paranasal sinus ostium is a maxillary sinus ostium.

10. A method according to claim 1 wherein the natural paranasal sinus ostium is a frontal sinus ostium.

11. A method according to claim 1 further comprising treating an ethmoid sinus.

12. A method according to claim 1 wherein the balloon catheter has at least one distance marking or marker band.

13. A method according to claim 1, wherein the balloon comprises a cylindrical balloon having a first end and a second end with a cylindrical surface therebetween, and wherein the inflation of the balloon within the natural paranasal sinus ostium radially expands the cylindrical surface against the surrounding ostium.

14. A method according to claim 13, wherein a diameter of the inflated cylindrical balloon is sufficiently greater than a diameter of the natural paranasal sinus ostium.

15. A method according to claim 1, wherein the enlarging of the ostium, the deflating of the balloon, and the removing of the balloon catheter are included in a procedure performed while the patient is disposed in a clinical working environment.

16. A method of claim 1, wherein the method is performed on a patient suffering from sinusitis and wherein enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, outflow from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.

17. A method of claim 1, wherein the enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, drainage of mucus from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.

18. A method for treating sinusitis of a patient having a paranasal sinus with an associated ostium, the ostium being a natural paranasal sinus ostium that has not previously been surgically altered, the natural paranasal sinus ostium formed by mucosa with unfractured bone underlying the mucosa, the method comprising the steps of:

advancing an elongate guide having a distal end and a lumen to a position within or near the natural paranasal sinus ostium;

advancing a balloon of a balloon catheter through the lumen of the elongate guide to position the balloon beyond the distal end of the guide and within the natural paranasal sinus ostium;

enlarging the natural paranasal sinus ostium to an enlarged ostium by inflating the balloon within the natural paranasal sinus ostium sufficiently to break, remodel, or rearrange the bone underlying the mucosa of the ostium; and

deflating the balloon, removing the balloon catheter from the enlarged ostium, and removing the elongate guide from near the ostium.

19. A method according to claim 18 wherein the guide has a curve and wherein the advancing step comprises advancing the balloon through the lumen of the guide and around the curve.

20. A method according to claim 19 wherein at least a portion of the guide is malleable and wherein the method further comprises the step of:

shaping a malleable portion of the guide.

21. A method according to claim 20 wherein the guide comprises a flexible guide catheter and a malleable outer tube through which the balloon catheter extends.

22. A method according to claim 18 wherein the inserting step comprises:

inserting the elongate guide to a first position; and

advancing a guidewire through the lumen of the elongate guide such that the guidewire extends into or through the natural paranasal sinus ostium,

wherein the advancing step further comprises advancing the balloon catheter over the guidewire to a position where the balloon is positioned within the natural paranasal sinus ostium.

23. A method according to claim 18 wherein a distal end of the balloon catheter is bent or angled.

24. A method according to claim 18 further comprising using an endoscope for visualization.

25. A method according to claim 18 further comprising advancing the balloon through a lumen of a stabilizing member.

26. A method according to claim 18 wherein the natural paranasal sinus ostium is a maxillary sinus ostium.

27. A method according to claim 18 wherein the natural paranasal sinus ostium is a frontal sinus ostium.

28. A method according to claim 18 further comprising treating an ethmoid sinus.

29. A method according to claim 18 wherein the balloon catheter has at least one distance marking or marker band.

30. A method according to claim 18 wherein the balloon comprises a cylindrical balloon having a first end and a second end with a cylindrical surface therebetween, and wherein the inflation of the balloon within the natural paranasal sinus ostium radially expands the cylindrical surface against the surrounding ostium.

31. A method according to claim 30 wherein a diameter of the inflated cylindrical balloon is sufficiently greater than a diameter of the natural paranasal sinus ostium.

32. A method according to claim 18 wherein the enlarging of the ostium, the deflating of the balloon, and the removing of the balloon catheter are included in a procedure performed while the patient is disposed in a clinical working environment.

33. A method according to claim 18 wherein the enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, outflow from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.

34. A method according to claim 18 wherein the enlarging of the ostium is performed so that, after the deflating of the balloon and removing of the balloon catheter and the elongate guide, drainage of mucus from the paranasal sinus is enhanced such that the sinusitis of the patient is mitigated.