Devices, systems and methods useable for treating sinusitis

• US 8,828,041 B2
• Filed: 03/18/2010
• Issued: 09/09/2014
• 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, Facteau, William M., Walke, Amrish Jayprakash
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US12/727,190
• Publication Number:
  US 20100174308A1
• Time in Patent Office: 1,636 Days
• Field of Search: 604/96.01, 604/101.01, 604/523, 604/264, 60410102-10203, 604/508, 604/509, 604/915, 604/919, 604/514, 606191-194
• US Class Current: 606/196
• 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 system for treating sinusitis in a patient, the system comprising:

(a) a plurality of rigid, or semi-rigid, tubular guide devices, each of which is configured to facilitate advancement of a guidewire, catheter or other device into or through an opening of a paranasal sinus, the guide device comprising;

(i) a tubular proximal portion having a lumen and a distal end, and

(ii) a tubular distal portion having a lumen substantially coaxial with the lumen of the proximal portion and a distal end, the distal portion extending from the distal end of the proximal portion, the distal portion being more flexible than the proximal portion and configured to facilitate transnasal insertion and positioning of the guide device such that the distal end of the distal portion is located within or adjacent to the opening of the paranasal sinus; and

(b) a balloon catheter sized and configured for advancement through any selected one or ones of the tubular guide devices and for use in dilating the opening of the paranasal sinus;

wherein the plurality of guide devices include at least a first guide device having a curved, bent or angled region of a first curvature and a second guide device having a curved, bent or angled region of a second curvature that is different from said first curvature.

2. A system as in claim 1, further comprising a guidewire advanceable through the tubular guide device and into the paranasal sinus or opening of the paranasal sinus, wherein the balloon catheter is advanceable over the guidewire.

3. A system as in claim 1, further comprising a tubular sheath advanceable through the tubular guide device and into the paranasal sinus or opening of the paranasal sinus.

4. A system according to claim 1, wherein the tubular guide device has a length in the range of about 5 inches to about 6 inches, and the balloon catheter has a length in the range or about 8 inches to about 20 inches.

5. A system according to claim 1, wherein the balloon catheter comprises:

(i) a catheter shaft;

(ii) an inflatable balloon; and

(iii) at least one marker that indicates a position of the balloon after it has been inserted into the patient.

6. A system according to claim 5, wherein the at least one marker indicates the position of the balloon relative to the distal end of the tubular guide.

7. A system according to claim 6, wherein the at least one marker comprises:

a first marker indicating the position of the distal end of the balloon catheter relative to the distal end of the tubular guide; and

a second marker indicating the position of the balloon relative to the distal end of the tubular guide device.

8. A system according to claim 7, wherein the balloon has a proximal end and a distal end, and wherein second marker indicates the position of the distal of the balloon relative to the distal end of the tubular guide device and the position of the proximal end of the balloon relative to the distal end of the tubular guide device.

9. A system according to claim 1, wherein the balloon catheter comprises a substantially non-compliant balloon.

10. A system according to claim 9, wherein the balloon is formed of a material selected from the group consisting of:

polyethylene teraphthalate, nylon and polyamide.

11. A system according to claim 9, wherein the balloon is capable of breaking bone located around the opening of the paranasal sinus.

12. A system according to claim 1, wherein the balloon catheter further comprises at least one radiographically visible component that is useable in conjunction with a radiographic imaging device to determine when a balloon of the catheter is positioned within an opening of a paranasal sinus.

13. A system according to claim 1, wherein the balloon catheter has a length of less than about 20 cm.

14. A system according to claim 1, further comprising a plurality of tubular guide devices, the distal portion of each tubular guide device having angle of curvature.

15. A system according to claim 1 wherein the wherein each of the first and second curvatures is within a different curvature range selected from the group consisting of:

(a) from about 5 degrees to about 45 degrees;

(b) from about 30 degrees to about 100 degrees;

(c) from about 70 degrees to about 135 degrees; and

(d) from about 100 degrees to about 120 degrees.

16. A system for treating sinusitis in a patient, the system comprising:

(a) a plurality of tubular guide devices, each of which is configured to facilitate advancement of a guidewire, catheter or other device into or through an opening of a paranasal sinus, the guide device comprising;

(i) a tubular proximal portion having a lumen and a distal end, and

(ii) a tubular distal portion having a lumen substantially coaxial with the lumen of the proximal portion and a distal end, the distal portion extending from the distal end of the proximal portion, the distal portion being more flexible than the proximal portion, wherein both the proximal portion and the distal portion are configured to be of sufficient rigidity to facilitate transnasal insertion and positioning of the guide device such that the distal end of the distal portion is located within or adjacent to the opening of the paranasal sinus, wherein the distal portion is sufficiently flexible to permit deformation of the distal portion by a user; and

(b) a balloon catheter sized and configured for advancement through any selected one or ones of the tubular guide devices and for use in dilating the opening of the paranasal sinus, wherein the balloon catheter comprises a balloon, wherein the balloon is configured to break bone surrounding the opening of the paranasal sinus;

wherein the plurality of guide devices include at least a first guide device having a curved, bent or angled region of a first curvature and a second guide device having a curved, bent or angled region of a second curvature that is different from said first curvature.

17. A system for treating sinusitis in a patient, the system comprising:

(a) a plurality of rigid, or semi-rigid, tubular guide devices, each of which is configured to facilitate advancement of a guidewire, catheter or other device into or through an opening of a paranasal sinus, the guide device comprising;

(i) a tubular proximal portion having a lumen and a distal end, and

(ii) a tubular distal portion having a lumen substantially coaxial with the lumen of the proximal portion and a distal end, the distal portion extending from the distal end of the proximal portion, the distal portion being more flexible than the proximal portion, wherein both proximal portion and distal portion are configured to be of sufficient rigidity to facilitate transnasal insertion and positioning of the guide device such that the distal end of the distal portion is located within or adjacent to the opening of the paranasal sinus; and

(b) a balloon catheter sized and configured for advancement through any selected one or ones of the tubular guide devices and for use in dilating the opening of the paranasal sinus;

wherein the plurality of guide devices include at least a first guide device having a curved, bent or angled region of a first curvature and a second guide device having a curved, bent or angled region of a second curvature that is different from said first curvature.