Devices, systems and methods useable for treating sinusitis

• US 7,803,150 B2
• Filed: 06/10/2005
• Issued: 09/28/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Morriss, John H., Makower, Joshua, Walke, Amrish Jayprakash, Muni, Ketan P., Kim, Isaac J., Facteau, William M., Chang, John Y., Ha, Hung, Vrany, Julia D.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US11/150,847
• Publication Number:
  US 20060210605A1
• Time in Patent Office: 1,936 Days
• Field of Search: 604/96.01, 60410101-10203, 604/508, 604/509, 604/264, 604/523, 604/915, 604/919, 604/514, 606191-194
• US Class Current: 604/514
• 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, 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;

viewing a colored distal portion of the balloon catheter using an endoscope disposed in the patient'"'"'s head;

cracking, rearranging, or breaking bone underlying mucosa of the natural paranasal sinus opening by inflating the balloon within the opening to enlarge the opening; and

deflating the balloon and withdrawing the balloon catheter 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 1, further comprising introducing irrigation fluid into a paranasal sinus through the sinus opening.

4. A method as in claim 3, wherein the irrigation fluid is introduced through a tubular irrigation catheter.

5. A method as in claim 3, wherein the irrigation fluid is introduced through an irrigation lumen in the balloon catheter.

6. A method as in claim 3, further comprising suctioning fluid out of the paranasal sinus.

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

8. A method as in claim 1, wherein the endoscope is incorporated with the guide.

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

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

11. A method as in claim 10, further comprising rearranging, cracking, or breaking bone underlying mucosa of a frontal sinus outflow tract by expanding the balloon within the outflow tract.

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

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

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

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

16. A method as in claim 1 wherein the balloon has a colored region and the endoscope is used to view the colored region.

17. A kit for enlarging a natural paranasal sinus opening that has not been previously surgically altered, the kit comprising:

a guide device having a lumen and dimensions to allow passage of a distal end of the guide device into a patient'"'"'s head to a location in or near a natural paranasal sinus opening, the guide device comprising a tubular proximal portion having a lumen and a distal end and a tubular distal portion having a lumen that is substantially coaxial with the lumen of the first portion and a distal end, said distal portion extending from the distal end of the proximal portion, said distal portion being more flexible than the proximal portion;

a balloon catheter, said balloon catheter being sized to pass through the lumen of the guide device and including at least one endoscopically visible colored portion disposed closer to a distal end than to a proximal end of the balloon catheter; and

an inflation device for inflating the balloon catheter.

18. A kit as in claim 17, further comprising at least one guidewire for passing through the lumen of the guide device, into a paranasal sinus, wherein the balloon catheter passes over the guidewire through the lumen of the guide.

19. A kit as in claim 17, further comprising multiple guide devices, wherein each guide device has a different angle formed by the proximal portion relative to the distal portion of the guide.

20. A kit as in claim 17, further comprising an irrigation catheter configured to pass through the guide device to position a distal end of the irrigation catheter in a paranasal sinus.

21. A kit as in claim 20, further comprising a guidewire, wherein the irrigation catheter and the balloon catheter are each configured to be passed separately over the guidewire through the lumen of the guide device.