Systems for treating disorders of the ear, nose and throat

• US 8,747,389 B2
• Filed: 04/24/2007
• Issued: 06/10/2014
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Goldfarb, Eric, Chang, John Y., Facteau, William M., Lam, Sivette, Ha, Hung V., Kim, Isaac J., Muni, Ketan P.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/789,704
• Publication Number:
  US 20080195041A1
• Time in Patent Office: 2,604 Days
• Field of Search: 128/898, 604/20, 604/22, 604/28, 604/35, 604/504, 604/509, 604/523, 604/891.1, 606/1, 606/155, 606/169, 606/195, 606/198, 606/3, 606/34, 606/41, 606/46, 606/7, 607/46, 607/56, 607/88, 607/89, 623/1.11, 623/1.13, 623/1.42
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• 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 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• 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

Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. 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, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Claims

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

a guide catheter that is insertable into the head of the subject, said 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;

a handle having bore, a portion of the handle being insertable into the proximal opening of the guide catheter such that the bore of the handle is in alignment with the lumen of the guide catheter;

a working catheter having a substantially rigid proximal shaft portion and a distal shaft portion that is sufficiently flexible to assume various shapes and a guidewire lumen;

a guidewire that is advanceable through the guidewire lumen;

a member attached to the guidewire to a) facilitate grasping of the guidewire, b) limit the extent to which the guidewire is advanceable through the guidewire lumen and c) hold the guidewire in a substantially fixed position relative to the working catheter when the guidewire has been fully advanced; and

the working catheter being insertable through the bore of the handle and through the lumen of the guide catheter to a position where some of the distal shaft portion but none of the substantially rigid proximal portion extends out of the distal end of the guide catheter and some of the substantially rigid proximal shaft portion but none of the distal shaft portion extends out of the proximal end of the guide catheter.

2. A system according to claim 1 wherein the working catheter comprises dilation catheter and the working element comprises an expandable dilator that is positionable within a passageway of the ear, nose or throat and useable to dilate that passageway.

3. A system according to claim 2 wherein the expandable dilator comprises a balloon.

4. A system according to claim 2 wherein the expandable dilator is sized to be positioned within the ostium of a paranasal sinus while in a non-expanded state and to be thereafter expanded to an expanded state whereby it causes dilation of the ostium.

5. A system according to claim 4 wherein the working catheter is advanceable at least 2.5 cm beyond the distal end of the guide catheter.

6. A system according to claim 4 wherein the expandable dilator, when in its expanded state, has a diameter in the range of approximately 2.5 mm to approximately 10 mm.

7. A system according to claim 6 wherein the expandable dilator, when in its expanded state, has a diameter in the range of approximately 3.0 mm to approximately 7.0 mm.

8. A system according to claim 1 wherein the working catheter has an overall length of about 21 cm and wherein the substantially rigid proximal shaft portion of the working catheter is at least 12.5 cm in length.

9. A system according to claim 1 wherein the distal shaft portion of the working catheter is in the range between about 5 cm to about 9 cm in length.

10. A system according to claim 8 wherein the substantially rigid proximal shaft portion of the working catheter is about 12.5 cm in length and the distal shaft portion of the working catheter is about 8.7 cm in length.

11. A system according to any of claim 8, 9 or 10 wherein the distal shaft portion of the working catheter includes a distal tip member that extends distal to the working element and is more flexible than the distal shaft portion proximal to the working element.

12. A system according to claim 3 wherein the working catheter has a inflation fluid lumen through which inflation fluid passes into and out of the balloon and wherein that inflation fluid lumen is sized so that, after the balloon has been inflated to its working diameter, the balloon will deflate in les than about 15 seconds with application of negative pressure to the inflation fluid lumen by a conventional balloon catheter inflation and deflation device.

13. A system according to claim 3 wherein the working catheter has:

a inflation fluid lumen through which inflation fluid passes into and out of the balloon;

a guidewire lumen; and

a proximal hub having an inflation port in communication with the inflation lumen and a guidewire port in communication with the guidewire lumen, said inflation port is substantially perpendicular to said guidewire port.

14. A system according to claim 13 wherein the guidewire port is on the proximal end of the hub and the inflation port is on a side of the hub.

15. A system according to claim 13 wherein the guidewire lumen has a lubricious coating or liner disposed therein.

16. A system according to claim 13 wherein the guidewire lumen is coated with a silicone coating.

17. A system according to claim 1 wherein the handle is graspable, along with another device, by a single hand of an operator.

18. A system according to claim 17 wherein the handle is graspable, along with an endoscope, by a single hand of an operator.

19. A system according to claim 1 further in combination with a stabilization device that is attachable to the guide catheter, said stabilization device facilitating control of the guide catheter and endoscope by a single hand of an operator.

20. A system according to claim 1 wherein at least a portion of the handle is shapeable so that it may be deformed to a desired bend or shape by the operator.

21. A system according to claim 1 wherein the member frictionally engages a hub on the working catheter.

22. A system according to claim 1 wherein the distal shaft portion is flexible.

23. A system according to claim 1 wherein the guide catheter is curved.

24. A system according to claim 1 wherein a distal portion of the guide catheter is curved.

25. A system according to claim 23 wherein the guide catheter has a curve in the range of 30 degrees to 110 degrees.

26. A system according to claim 1 wherein the distal shaft portion of the working catheter telescopes out the distal end of the guide catheter.

27. A system according to claim 1 further comprising a second member that is attachable to the working catheter and limits the extent to which the working catheter is advanceable through the guide catheter.

28. A system according to claim 27 wherein the member frictionally engages a hub on the working catheter and the second member frictionally engages a hub on the guide catheter.

29. A system according to claim 27 wherein the second member is permanently attached to the working catheter.

30. A system according to claim 1 wherein the member is permanently attached to the guide catheter.