Devices, systems and methods useable for treating sinusitis

• US 9,370,649 B2
• Filed: 02/05/2015
• Issued: 06/21/2016
• 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:
  US14/614,799
• Publication Number:
  US 20150209055A1
• Time in Patent Office: 502 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 treating a human or animal subject, the method comprising:

(a) inserting an endoscope into a nostril of the human or animal subject;

(b) inserting at least one tool into the nostril of the human or animal subject, wherein the tool is configured to perform a maneuver within a field of view of the endoscope;

(c) inserting a balloon catheter into the nostril of the human or animal subject, wherein the balloon catheter comprises;

(i) a catheter shaft,

(ii) a balloon mounted on the catheter shaft, wherein the balloon is configured to be positioned within a passageway associated with a paranasal sinus in an unexpanded state, wherein the balloon is expandable to thereby dilate the passageway,

(iii) at least one flexible region configured to enable the balloon catheter to perform a maneuver outside the field of view of the endoscope, and

(iv) at least one position indicating element operable to indicate positioning of the balloon in the passageway;

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

(e) using the balloon catheter to perform a maneuver outside the field of view of the endoscope.

2. The method according to claim 1, wherein using the balloon catheter to perform a maneuver outside the field of view of the endoscope comprises manipulating the flexible region to a flexed position.

3. The method according to claim 1, wherein the passageway comprises an opening of a paranasal sinus, the method further comprising (a) positioning the balloon catheter such that the balloon is within or adjacent to the opening of the paranasal sinus;

and

(b) expanding the balloon to dilate the opening of the paranasal sinus using the balloon.

4. The method according to claim 3, wherein expanding the balloon further comprises expanding the balloon to a cross-sectional dimension of at least 3 mm.

5. The method according to claim 3, wherein expanding the balloon further comprises inflating the balloon to a pressure level of at least 22 atmospheres.

6. The method according to claim 3, wherein expanding the balloon to dilate the opening further comprises breaking bone adjacent to the opening.

7. The method according to claim 1, further comprising radiographically visualizing at least the portion of the balloon catheter that is outside of the field of view of the endoscope.

8. The method according to claim 7, wherein radiographically visualizing the balloon catheter further comprises radiographically visualizing the at least one position indicating element.

9. The method according to claim 1, wherein the at least one tool comprises a guide device.

10. The method according to claim 9, wherein inserting the balloon catheter into the nostril of the human or animal subject further comprises inserting the balloon catheter into the guide device.

11. The method according to claim 10, wherein the balloon catheter has a distal end and wherein the at least one position indicating element is configured to indicate the position of the distal end of the balloon catheter relative to the distal end of the guide device.

12. The method according to claim 1, further comprising cutting or removing tissue from the paranasal sinus using the tool.

13. The method according to claim 1, wherein the balloon has a compliance of between about 0.025 mm per atmosphere to about 0.030 mm per atmosphere.

14. The method according to claim 1, wherein the balloon comprises a polymeric coating.

15. The method according to claim 14, wherein the polymeric coating comprises polymethane, wherein the polymeric coating includes a thickness of approximately 0.002 mm thick.

16. The method according to claim 1, further comprising inserting a guidewire into the nostril of the human or animal subject, wherein the act of inserting the balloon catheter into the nostril of the human or animal subject comprises advancing the balloon catheter along the guidewire.

17. The method according to claim 1, further comprising visualizing the at least one position indicating element via the endoscope while the balloon catheter and the endoscope are positioned within the human or animal subject.

18. A method of treating a paranasal sinus of a human or animal subject, the method comprising:

(a) inserting an endoscope into a nostril of the human or animal subject;

(b) inserting a tool into the nostril of the human or animal subject, wherein the tool is capable of performing a maneuver within a field of view of the endoscope;

(c) inserting a balloon catheter into the nostril of the human or animal subject, wherein the balloon catheter comprises;

(i) a catheter shaft,

(ii) a balloon mounted on the catheter shaft, wherein the balloon is configured to be positioned within an opening of the paranasal sinus in a non-inflated state, and

(iii) at least one flexible region configured to enable the balloon catheter to perform a maneuver outside the field of view of the endoscope;

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

(e) using the balloon catheter to perform a maneuver in the opening of the paranasal sinus, wherein the opening of the paranasal sinus is outside the field of view of the endoscope.

19. The method according to claim 18, wherein the balloon catheter further comprises a first marker positioned to indicate a position of a distal end of the balloon catheter and a second marker positioned to indicate the position of the balloon, wherein the method further comprises visualizing the first and second markers relative to a distal end of the tool.

20. A method of treating a paranasal sinus of a human or animal subject, the method comprising:

(a) inserting an endoscope into a nostril of the human or animal subject;

(b) inserting a tool into the nostril of the human or animal subject, wherein the tool is capable of performing a maneuver within a field of view of the endoscope;

(c) inserting a balloon catheter into the nostril of the human or animal subject, wherein the balloon catheter comprises;

(i) a catheter shaft,

(ii) a balloon mounted on the catheter shaft, wherein the balloon is configured to be positioned within an opening of the paranasal sinus in a non-inflated state, and

(iii) at least one flexible region configured to enable the balloon catheter to perform a maneuver outside the field of view of the endoscope;

(d) manipulating the flexible region of the balloon catheter so that the balloon is outside the field of view of the endoscope;

(e) positioning the balloon in the opening of the paranasal sinus, wherein the opening of the paranasal sinus is outside the field of view of the endoscope; and

(f) expanding the balloon in the opening of the paranasal sinus.