Systems and methods for transnasal dilation of passageways in the ear, nose or throat

Patent metadata

Field	Value
Publication number	US-10874838-B2
Application number	US-201715417712-A
Country	US
Kind code	B2
Filing date	Jan 27, 2017
Priority date	Apr 21, 2004
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

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.

First claim

What is claimed is:

1. A method of using a dilation catheter system to treat a patient, the dilation catheter system comprising:
(a) a guide catheter that is insertable into a head of a subject, wherein the guide catheter comprises:
(i) a shaft,
(ii) a proximal opening,
(iii) a distal opening, and
(iv) a lumen extending between the proximal opening and the distal opening;

(b) a handle, wherein the handle is configured to couple with the guide catheter;
(c) a working catheter, wherein the working catheter comprises:
(i) a proximal shaft portion,
(ii) a flexible distal shaft portion, and
(iii) a guidewire lumen, wherein the working catheter is insertable through the lumen of the guide catheter to a position where some of the distal shaft portion but none of the proximal portion extends out of the distal opening of the guide catheter;

(d) a guidewire that is advanceable through the guidewire lumen; and
(e) a first member attached to the guidewire, wherein the first member is configured to facilitate manipulation of the guidewire, wherein the first member is further configured to limit the extent to which the guidewire is advanceable through the guidewire lumen;

the method comprising:
(a) grasping the handle and inserting the distal opening of the guide catheter into a nasal cavity of the patient adjacent to a targeted passageway associated with drainage of a paranasal sinus of the patient;
(b) advancing the first member so the guidewire advances through the guidewire lumen such that a distal portion of the guidewire extends past the flexible distal shaft portion of the working catheter into the targeted passageway of the patient; and
(c) advancing the working catheter within the lumen of the guide catheter such that a portion of the flexible distal shaft portion extends out through the distal opening of the guide catheter into the targeted passageway of the patient.

2. The method of claim 1 , wherein the working catheter comprises an expandable dilator located on the flexible distal shaft portion, wherein advancing the working catheter further comprises advancing the expandable dilator within the targeted passageway of the patient.

3. The method of claim 2 , wherein the expandable dilator comprises a balloon.

4. The method of claim 3 , further comprising expanding the balloon while the balloon is located within the targeted passageway of the patient.

5. The method of claim 4 , wherein working catheter defines an inflation fluid lumen in fluid communication with the balloon, wherein expanding the balloon further comprises transmitting fluid through the inflation fluid lumen into the balloon.

6. The method of claim 5 , further comprising deflating the balloon by removing fluid from the balloon via the inflation fluid lumen.

7. the method of claim 6 , further comprising removing the balloon from the targeted passageway of the patient.

8. The method of claim 6 , further comprising removing the guidewire from the targeted passageway of the patient.

9. The method of claim 1 , wherein the guidewire lumen has a lubricious coating or liner disposed therein.

10. The method of claim 1 , wherein the working catheter has an overall length of about 21 cm, wherein the proximal shaft portion of the working catheter is at least 12.5 cm in length.

11. The method of claim 1 , wherein the handle is sized and configured to be grasped by a single hand of an operator, wherein the act of grasping the handle comprises grasping the handle with only a single hand.

12. The method of claim 1 , further comprising attaching the guide catheter to a stabilization device, wherein the stabilization device is configured to facilitate control of the guide catheter and an endoscope by a single hand of an operator.

13. The method of claim 1 , further comprising deforming the handle into a desired bend or shape.

14. The method of claim 1 , wherein advancing the working catheter further comprises the first member frictionally engaging a hub on the working catheter.

15. The method of claim 1 , wherein at least a distal portion of the guide catheter is curved.

16. The method of claim 1 , wherein advancing the working catheter further comprises telescoping the distal shaft portion out of the distal end of the guide catheter.

17. The method of claim 1 , further comprising coupling the handle with the proximal opening of the guide catheter such that a bore defined by the handle is in alignment with the lumen of the guide catheter.

18. The method of claim 17 , further comprising inserting the working catheter through the bore of the handle.

19. A method of using a dilation catheter system to treat a patient, the dilation catheter system comprising:
(a) a guide catheter that is insertable into a head of a subject, wherein the guide catheter defines a working catheter lumen;
(b) a working catheter, wherein the working catheter defines a guidewire lumen, wherein the working catheter is insertable through the working catheter lumen of the guide catheter;
(c) a guidewire that is advanceable through the guidewire lumen of the working catheter; and
(d) a stop member attached to the guidewire, wherein the stop member is configured to facilitate manipulation of the guidewire, wherein the stop member is further configured to limit the extent to which the guidewire is advanceable through the guidewire lumen of the working catheter;

the method comprising:
(a) advancing the guide catheter into the nasal cavity of the patient such that a distal end of the guide catheter is adjacent to a targeted passageway in the head of the patient;
(b) advancing the stop member and the guidewire such that the guidewire is advanced into the targeted passageway of the patient; and
(c) advancing the working catheter along the guidewire and within the working catheter lumen of the guide catheter, thereby advancing the working catheter into the targeted passageway of the patient.

20. A method of using a dilation catheter system to treat a patient, the dilation catheter system comprising:
(a) a guide catheter that is insertable into a head of a subject, wherein the guide catheter defines a working catheter lumen, wherein a proximal portion of the guide catheter defines a longitudinal axis;
(b) a handle, wherein the handle is configured to couple with the guide catheter, wherein the handle defines a bore, wherein the working catheter lumen of the guide catheter is in alignment with the bore;
(c) a working catheter, wherein the working catheter defines a guidewire lumen, wherein the working catheter is insertable through the working catheter lumen of the guide catheter;
(d) a guidewire that is advanceable through the guidewire lumen; and
(e) an actuating member attached to the guidewire, wherein the actuating member is configured to facilitate actuation of the guidewire;

the method comprising:
(a) grasping the handle and inserting the guide catheter into a nasal cavity of a patient adjacent to a target passageway in the head of the patient;
(b) advancing the guidewire via the actuating member so that a distal portion of the guidewire extends distally past a distal end of the working catheter into the targeted passageway of the patient; and
(c) advancing the working catheter along the guidewire such that a distal portion of the working catheter is within the targeted passageway of the patient.

Assignees

• Acclarent Inc

Inventors

• Goldfarb Eric
• Chang John Y
• Facteau William M
• Lam Sivette
• Ha Hung V
• Kim Isaac J
• Muni Ketan P

Classifications

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61M25/0041

  pre-formed, e.g. specially adapted to fit with the anatomy of body channels (urethral catheters A61F2/04) · CPC title

• A61M2025/1086

  having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves · CPC title

• A61M25/10

  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 title

• A61M2210/0618

  Nose · CPC title