SYSTEMS AND METHODS FOR TRANSNASAL DILATION OF PASSAGEWAYS IN THE EAR, NOSE OR THROAT

• US 20090312745A1
• Filed: 07/01/2009
• Published: 12/17/2009
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Ha, Hung V., Muni, Ketan P., Lam, Sivette, Kim, Isaac J., Facteau, William M., Goldfarb, Eric, Chang, John Y.
• Granted Patent: US 9,399,121 B2
• Time in Patent Office: Days
• US Class Current: 604/514
• 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 2017/246 for cleaning of the nose
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• 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 25/09 Guide wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A dilation catheter device and system for dilating an opening in a paranasal sinus and/or other passageways within the ear, nose or throat is disclosed. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, shaft markers are disposed on a shaft of the dilation catheter and have a light color to contrast with a dark color of the dilation catheter shaft. The high contrast between the markers and catheter shaft allows for easy viewing of the markers in low light and operation conditions.

Claims

1. A balloon dilation catheter device useable for dilating an opening in a paranasal sinus, the device comprising:

a catheter shaft having a longitudinal axis, an inflation lumen, a distal end, a proximal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, wherein the catheter shaft is dark in color;

an inflatable balloon disposed on the distal shaft section in fluid communication with the inflation lumen, wherein the balloon has a non-circular cross-sectional shape when partially inflated;

a first proximal shaft marker disposed on the proximal shaft section and having a significantly lighter color than the catheter shaft, wherein the first proximal shaft marker allows a user to approximate, using direct visualization of the first proximal shaft marker, a position of the balloon relative to a guide catheter through which the balloon catheter is advanced; and

a first distal shaft marker disposed on the distal shaft section proximal to a proximal end of the balloon and having a significantly lighter color than the catheter shaft, wherein the first distal shaft marker enables a user to approximate, using endoscopic visualization of the first distal shaft marker, a position of the balloon relative to an opening of a paranasal sinus.

2. The device of claim 1, further comprising a second proximal shaft marker disposed on the proximal shaft section distally from the first proximal shaft marker and having a significantly lighter color than the catheter shaft, wherein the first shaft marker has a greater length than the second shaft marker.

3. The device of claim 2, wherein the length of the first proximal shaft marker is equal to a length from a proximal end of the inflatable balloon to the distal end of the catheter shaft, wherein the first shaft marker is spaced from the distal end of the catheter shaft such that it allows the user to approximate when the distal end of the shaft is located at a distal end of the guide catheter and when the proximal end of the balloon exits the guide catheter, and wherein the second proximal shaft marker allows the user to approximate when the distal end of the catheter shaft is located just proximal to a curve in the guide catheter.

4. The device of claim 1, further comprising a second distal shaft marker disposed on the distal shaft section proximal to the first distal shaft marker and having a significantly lighter color than the catheter shaft.

5. The device of claim 4, wherein the first distal shaft marker is disposed at a known distance proximally from the proximal end of the balloon, and the second distal shaft marker is disposed at a known distance proximally from the first distal shaft marker, and wherein the first and second distal shaft marker have different appearances.

6. The device of claim 5, wherein the first distal shaft marker is disposed approximately one centimeter from the proximal end of the balloon and the second distal shaft marker is disposed approximately two centimeters from the proximal end of the balloon.

7. The device of claim 4, further comprising a third distal shaft marker disposed on the distal shaft section at the proximal end of the balloon.

8. The device of claim 1, further comprising:

a first radiopaque marker disposed on the distal shaft section within the balloon; and

a second radiopaque marker disposed on the distal shaft section distally from the first radiopaque marker within the balloon;

wherein the first and second radiopaque markers are disposed a distance apart from one another to indicate the effective length of the inflatable dilator.

9. The device of claim 1, wherein the balloon has an approximately triangular cross-section in a partially inflated state.

10. The device of claim 1, wherein the inflatable dilator is a balloon having a balloon neck extending from the balloon and proximally along the catheter shaft.

11. The device of claim 10, further comprising an endoscopic marker disposed on the distal shaft section and underneath the balloon neck.

12. A system for treating a disease or disorder of the ear, nose or throat of a human or animal subject, the system comprising:

a guide catheter insertable into a head of the subject, the guide catheter having a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening; and

a balloon catheter device, comprising;

a catheter shaft having a longitudinal axis, an inflation lumen, a distal end, a proximal end, a proximal shaft section that is substantially rigid and a distal shaft section that is more flexible than the proximal shaft section, wherein the catheter shaft is dark in color;

an inflatable balloon disposed on the distal shaft section in fluid communication with the inflation lumen, wherein the balloon has a non-circular cross-sectional shape when partially inflated;

a first proximal shaft marker disposed on the proximal shaft section and having a significantly lighter color than the catheter shaft, wherein the first proximal shaft marker allows a user to approximate, using direct visualization of the first proximal shaft marker, a position of the balloon relative to a guide catheter through which the balloon catheter is advanced; and

a first distal shaft marker disposed on the distal shaft section proximal to a proximal end of the balloon and having a significantly lighter color than the catheter shaft, wherein the first distal shaft marker enables a user to approximate, using endoscopic visualization of the first distal shaft marker, a position of the balloon relative to an opening of a paranasal sinus;

wherein the distal portion of the balloon catheter is advanceable out of the distal opening of the guide catheter.

13. The system of claim 12, wherein the balloon catheter includes a guidewire lumen.

14. The system of claim 13, further comprising a guidewire that is advanceable through the guidewire lumen.

15. The system of claim 12, wherein the balloon catheter has an inflation fluid lumen through which inflation fluid passes into and out of the inflatable balloon and wherein the inflation fluid lumen is sized so that, after the inflatable balloon has been inflated to a working diameter, the inflatable balloon will deflate in less than 5 seconds with application of negative pressure to the inflation fluid lumen by a conventional balloon catheter inflation and deflation device.

16. The system of claim 12, further comprising an irrigation catheter sized for advancement through the guide catheter into a paranasal sinus.

17. A method for dilating a natural paranasal sinus ostium of a paranasal sinus of a patient, the method comprising:

advancing a guide catheter into a head of a patient such that a distal end of the guide catheter is positioned within or near a natural paranasal sinus ostium of a paranasal sinus;

inserting an endoscope into the patient'"'"'s head;

advancing a balloon catheter through a lumen of the guide catheter such that a balloon of the catheter passes out of the distal end of the guide catheter;

viewing, with the endoscope, a first distal shaft marker disposed on a shaft of the balloon catheter a first known distance from the balloon;

viewing, with the endoscope, a second distal shaft marker disposed on the shaft a second known distance from the balloon;

approximating a location of the balloon relative to the paranasal sinus ostium, using the first and second distal shaft marker and their known distances from the balloon; and

expanding the balloon of the balloon catheter to remodel or break bone underlying mucusa of the natural paranasal sinus ostium and dilate the ostium.

18. A method as in claim 17, further comprising viewing a first proximal shaft marker during the step of advancing the balloon catheter, wherein when a distal end of the first proximal shaft marker enters a proximal end of the guide catheter a distal end of the balloon catheter shaft is located approximately at the distal end of the guide catheter, and wherein when a proximal end of the distal shaft marker enters the proximal end of the guide catheter a proximal end of the balloon of the catheter is located approximately at the distal end of the guide catheter.

19. A method as in claim 18, further comprising viewing a second proximal shaft marker during the step of advancing the balloon catheter, wherein the second proximal shaft marker is disposed distal to the first proximal shaft marker, and wherein when the second proximal shaft marker is located approximately at the proximal end of the guide catheter, the distal end of the balloon catheter is located immediately proximal to a curve in the distal end of the guide catheter.

20. A method as in claim 17, wherein the first distal shaft marker is located proximal to the balloon and the second distal shaft marker is located distal to the balloon.

21. A method as in claim 20, wherein the first and second distal shaft markers are located proximal to the balloon.

22. A method as in claim 21, wherein the first distal shaft marker is located approximately one centimeter proximal to a proximal end of the balloon, and the second distal shaft marker is located approximately two centimeters proximal to the proximal end of the balloon.

23. A method as in claim 22, further comprising viewing a third distal shaft marker located at the proximal end of the balloon.

24. A method as in claim 17, further comprising advancing a guidewire through the guide and through the ostium before advancing the balloon catheter, wherein the balloon catheter is advanced over the guidewire and through the guide.

25. A method as in claim 17, further comprising:

removing the balloon catheter through the guide catheter;

advancing an irrigation catheter through the guide catheter into the paranasal sinus; and

irrigating the sinus using the irrigation catheter.