Methods for treating sinus ostia using balloon catheter devices having a bendable balloon portion

• US 9,289,582 B2
• Filed: 02/25/2013
• Issued: 03/22/2016
• Est. Priority Date: 02/25/2013
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Suehara, Satoru
• Primary Examiner(s): Rosen, Eric
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/776,057
• Publication Number:
  US 20140243876A1
• Time in Patent Office: 1,121 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00013 using optical means
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 17/24 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 2017/003 Steerable
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 5/08 Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method for use with a balloon catheter device that includes a selectively bendable portion with a balloon disposed thereon, a control device for controlling bending of the selectively bendable portion, and a camera located at an end of a distal portion, includes inserting the distal portion into the nostril while the distal portion is straight; viewing an image provided by the camera; stopping insertion of the distal portion after the ethmoidal bulla is viewed in the image; articulating the distal portion in an upward direction to view the opening to the frontal sinus ostium or a downward direction to view the opening to the maxillary sinus ostium using the control device; inserting the distal portion into the frontal sinus ostium or the maxillary sinus ostium while the distal portion remains in the bent position; and inflating the balloon in the frontal sinus ostium or the maxillary sinus ostium.

Claims

1. A method comprising:

providing a balloon catheter device that includes;

a selectively bendable portion with a balloon disposed thereon,

a control device for controlling bending of the selectively bendable portion,

a camera located at an end of a distal portion of the balloon catheter device such that the camera moves along with movement of the selectively bendable portion by operating the control device, and

a camera advancement control configured to control movement of the camera between a non-extended state and an extended state, wherein the camera is located at the end of the distal portion of the balloon catheter device in the non-extended state, wherein the camera is advanced beyond the end of the distal portion of the balloon catheter device in the extended state;

inserting the distal portion into the nostril while the distal portion is straight;

viewing an image provided by the camera;

stopping insertion of the distal portion after the ethmoidal bulla is viewed in the image;

articulating the distal portion in an upward direction to view the opening to the frontal sinus ostium or a downward direction to view the opening to the maxillary sinus ostium using the control device;

inserting the distal portion into the frontal sinus ostium or the maxillary sinus ostium while the distal portion remains in the bent position; and

inflating the balloon in the frontal sinus ostium or the maxillary sinus ostium.

2. The method of claim 1 wherein the step of articulating the distal portion is performed so as to bend the distal portion in an upward direction to view the opening to the frontal sinus ostium.

3. The method of claim 2 further comprising placing the balloon catheter device in such a position, before the step of inserting the distal portion into the nostril, so that the distal portion can bend in an upward direction.

4. The method of claim 1 wherein the step of bending the distal portion is performed so as to bend the distal portion in a downward direction to view the opening to the maxillary sinus ostium.

5. The method of claim 4 further comprising placing the balloon catheter device in such a position, before the step of inserting the distal portion into the nostril, so that the distal portion can bend in a downward direction.

6. The method of claim 1 further comprising deflating the balloon in the frontal sinus ostium or maxillary sinus ostium.

7. The method of claim 6 further comprising removing the distal portion from the frontal sinus ostium or maxillary sinus ostium while the distal portion remains in the bent position.

8. The method of claim 7 further comprising viewing the frontal sinus ostium or maxillary sinus ostium using the camera after the steps of inserting the distal portion into the frontal sinus ostium or maxillary sinus ostium, inflating the balloon, deflating the balloon, and removing the distal portion in order to determine whether the method was effective to expand the frontal sinus ostium or maxillary sinus ostium.

9. The method of claim 8 further comprising repeating the steps of inserting the distal portion into the frontal sinus ostium or maxillary sinus ostium and inflating the balloon if the step of viewing the frontal sinus ostium or maxillary sinus ostium resulted in a determination that the method was not effective to expand the frontal sinus ostium or maxillary sinus ostium.

10. The method of claim 1 further comprising viewing the nasal septum and middle turbinate using the camera.

11. The method of claim 10 further comprising advancing the distal portion through the middle nasal meatus.

12. The method of claim 1 further comprising advancing the distal portion while in the bent position along the groove formed between the ethmoidal bulla and the uncinate process.

13. The method of claim 1 wherein the step of stopping insertion of the distal portion is performed when the distal portion appears to have passed the uncinate process and appears to closely approach the ethmoidal bulla as determined by viewing the image using the camera.

14. The method of claim 1 wherein the step of inserting the distal portion into the frontal sinus ostium or maxillary sinus ostium is performed by viewing the inside of the frontal sinus ostium or maxillary sinus ostium using the camera as the distal portion is advanced through the frontal sinus ostium or maxillary sinus ostium, and stopping insertion of the distal portion into the frontal sinus ostium or maxillary sinus ostium when an inside of the frontal sinus ostium or maxillary sinus ostium is no longer visible using the camera.

15. The method of claim 1 wherein the selectively bendable portion only articulates on a single plane and in a single direction from a non-articulated position.

16. The method of claim 1 further comprising approaching the distal end of the balloon catheter device to the ethmoidal bulla until nearly touching it, then articulating the selectively bendable portion.