Devices, systems and methods useable for treating sinusitis

• US 9,220,879 B2
• Filed: 04/30/2014
• Issued: 12/29/2015
• 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 V., Facteau, William M.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/266,025
• Publication Number:
  US 20140324093A1
• Time in Patent Office: 608 Days
• Field of Search: 604/167.03, 604/103.02, 604/96.01, 604/509, 60410101-10103, 604/523, 604/264, 604/508, 604/915, 604/919, 604/514, 604/20, 606191-194, 606/196, 606/199, 623/1.11
• 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 for treating an anatomical passageway within a patient'"'"'s sino-nasal anatomy, the method comprising:

(a) advancing a guide device into the patient'"'"'s head to position a distal end of the guide device near or within an anatomical passageway within the patient'"'"'s sino-nasal anatomy;

(b) advancing a balloon catheter over or through the guide device to position a balloon of the catheter within the anatomical passageway;

(c) remodeling the anatomical passageway by expanding the balloon within the anatomical passageway to enlarge the anatomical passageway;

(d) introducing irrigation fluid into the patient'"'"'s sino-nasal anatomy using an irrigation device; and

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

2. The method of claim 1, wherein the guide has a lumen, and wherein the act of advancing the balloon catheter comprises advancing the catheter through the lumen of the guide.

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

4. The method of 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 anatomical passageway, wherein the balloon catheter is advanced over the guidewire and through the lumen of the guide.

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

6. The method of claim 5, further comprising removing the guidewire, leaving the sheath in place.

7. The method of claim 6, wherein the irrigation fluid is introduced through the sheath.

8. The method of claim 7, 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 anatomical passageway.

9. The method of claim 1, wherein the irrigation device comprises an irrigation lumen in the balloon catheter and the irrigation fluid is introduced through the irrigation lumen.

10. The method of claim 1, further comprising suctioning fluid out of a paranasal sinus of the patient'"'"'s sino-nasal anatomy using the irrigation device.

11. The method of claim 1, further comprising visualizing the balloon catheter during the method using an endoscope, wherein the endoscope is incorporated with the guide.

12. The method of claim 1, wherein the anatomical passageway is a paranasal sinus opening.

13. The method of claim 12, wherein the paranasal sinus opening has not been previously surgically altered.

14. The method of claim 12, wherein the anatomical passageway is a maxillary sinus ostium.

15. The method of claim 12, wherein the natural paranasal sinus opening is a frontal sinus ostium.

16. The method of claim 15, further comprising remodeling or breaking intact bone underlying mucosa of a frontal sinus outflow tract by expanding the balloon within the outflow tract.

17. The method of claim 12, wherein the natural paranasal sinus opening is a sphenoid sinus ostium.

18. The method of claim 1, further comprising treating an ethmoid sinus.

19. A method for treating an passageway into a patient'"'"'s sinus cavity, the method comprising:

(a) advancing a guide device into the patient'"'"'s head to position a distal end of the guide device near or within a passageway into the patient'"'"'s sinus cavity;

(b) advancing a balloon catheter over or through the guide device to position a balloon of the catheter within the passageway;

(c) remodeling the passageway by expanding the balloon within the passageway to enlarge the passageway;

(d) introducing irrigation fluid into the sinus cavity using an irrigation device; and

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

20. A method for treating a paranasal sinus ostium, the method comprising:

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

(b) advancing a balloon catheter over or through the guide device to position a balloon of the catheter within the paranasal sinus ostium;

(c) remodeling the paranasal sinus ostium by expanding the balloon within the passageway to enlarge the paranasal sinus ostium;

(d) introducing irrigation fluid into a sinus cavity associated with the paranasal sinus ostium using an irrigation device; and

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