Devices, systems and methods useable for treating sinusitis

• US 10,500,380 B2
• Filed: 07/17/2017
• Issued: 12/10/2019
• 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 J.
• Primary Examiner(s): Neal, Timothy J
• Application Number:
  US15/651,101
• Publication Number:
  US 20180001065A1
• Time in Patent Office: 876 Days
• Field of Search: None
• 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 using a dilation catheter system to treat a patient, the dilation catheter system comprising:

(a) a steerable guide catheter comprising;

(i) a proximal portion, wherein the proximal portion extends along a longitudinal axis,

(ii) a distal end, and

(iii) a controllably deformable region, wherein the controllably deformable region is located between the proximal portion and the distal end, wherein the controllably deformable region is configured to deflect the distal end relative to the longitudinal axis; and

(b) an expandable dilator slidably disposed relative to the steerable guide catheter, wherein the expandable dilator is configured to translate relative to the guide catheter from a first position to a second position, wherein the expandable dilator is located proximal to the distal end of the steerable guide catheter in the first position, wherein the expandable dilator located distal to the distal end of the steerable guide catheter in the second position; and

the method comprising;

(a) deforming the controllably deformable region such that the distal end of the steerable guide catheter is adjacent to a targeted passageway associated with drainage of a paranasal sinus of the patient;

(b) inserting the distal end of the steerable guide catheter into a nasal cavity of the patient; and

(c) actuating the expandable dilator through the guide catheter from the first position to the second position such that the expandable dilator extends into the targeted passageway of the patient.

2. The method of claim 1, further comprising expanding the expandable dilator while the expandable dilator is in the second position within the targeted passageway of the patient.

3. The method of claim 2, further comprising withdrawing the steerable guide catheter and the expandable dilator from the patient.

4. The method of claim 1, wherein the steerable guide catheter further comprises a pull wire attached to the distal end of the steerable guide catheter.

5. The method of claim 4, wherein deforming the controllably deformable region comprises actuating the pull wire proximally.

6. The method of claim 5, wherein the steerable guide catheter further comprises a pull wire terminator connecting the pull wire and the distal end.

7. The method of claim 1, wherein the expandable dilator comprises a balloon catheter.

8. The method of claim 1, wherein the expandable dilator comprises a mechanical dilator.

9. The method of claim 1, wherein the act of deforming is performed before the act of inserting.

10. The method of claim 1, wherein the expandable dilator defines a guidewire lumen, wherein the dilation catheter system further comprising a guidewire slidably housed within the guidewire lumen of the expandable dilator, the method further comprising distally advancing the guidewire distally past the guidewire lumen and the distal end of the steerable guide catheter while the expandable dilator is in the first position.

11. The method of claim 1, wherein the expandable dilator further comprises a stent.

12. The method of claim 1, wherein the distal end of the steerable guide catheter comprises a radiopaque marker.

13. The method of claim 1, wherein the expandable dilator comprises a radiopaque marker.

14. The method of claim 1, wherein the proximal portion is rigid.

15. A method of using a dilation catheter system to treat a patient, the dilation catheter system comprising:

(a) a steerable guide catheter comprising;

(i) a proximal portion extending along a longitudinal axis,

(ii) a distal end,

(iii) a controllably deformable region, wherein the controllably deformable region is located between the proximal portion and the distal end, wherein the controllably deformable region is configured to deflect relative to the longitudinal axis, and

(iv) a pull wire coupled near the distal end, wherein the pull is configured to actuate proximally to bend the controllably deformable region relative to the longitudinal axis; and

(b) an expandable dilator slidably disposed within the steerable guide catheter, wherein the expandable dilator is configured to actuate through the guide catheter from a first position to a second position, wherein the expandable dilator is located within the steerable guide catheter in the first position, wherein the expandable dilator is distal relative to the distal end of the steerable guide catheter in the second position; and

the method comprising;

(a) inserting the distal end of the steerable guide catheter into a nasal cavity of the patient;

(b) actuating the pull wire proximally, thereby deforming the controllably deformable region to enable positioning of the distal end of the steerable guide catheter adjacent to a targeted passageway associated with drainage of a paranasal sinus of the patient; and

(c) actuating the expandable dilator through the guide catheter along the deformed deformable region, from the first position to the second position, such that the expandable dilator extends into the targeted passageway of the patient.

16. The method of claim 15, wherein the expandable dilator defines a guidewire lumen, wherein a guidewire a slidably disposed within the guidewire lumen.

17. The method of claim 15, wherein the expandable dilator comprises a balloon.

18. The method of claim 15, further comprising removing the expandable dilator and the steerable guide catheter from the targeted passageway.

19. The method of claim 15, wherein the pull wire terminates into a pull wire anchor.

20. A method of using a dilation catheter system to treat a patient, the dilation catheter system comprising:

(a) a steerable guide catheter comprising;

(i) a proximal portion, wherein the proximal portion extends along a longitudinal axis,

(ii) a distal end, and

(iii) a controllably deformable region located between the proximal portion and the distal end, wherein the controllably deformable region is configured to deflect the distal end relative to the longitudinal axis; and

(b) an expandable dilator slidably disposed relative to the steerable guide catheter, wherein the expandable dilator is configured to translate past the distal end of the steerable guide catheter; and

the method comprising;

(a) deforming the controllably deformable region such that the distal end of the steerable guide catheter is positioned for insertion into a targeted passageway associated with drainage of a paranasal sinus of the patient;

(b) inserting the distal end of the steerable guide catheter into a nasal cavity of the patient; and

(c) actuating the expandable dilator relative to the guide catheter, along the deformed deformable region, such that the expandable dilator extends into the targeted passageway of the patient.