Apparatus and methods for dilating and modifying ostia of paranasal sinuses and other intranasal or paranasal structures

• US 8,721,591 B2
• Filed: 01/23/2012
• Issued: 05/13/2014
• 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., Walke, Amrish Jayprakash
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/355,758
• Publication Number:
  US 20120184983A1
• Time in Patent Office: 841 Days
• Field of Search: 604/509, 604/510, 604/96.01, 606/192
• US Class Current: 604/96.01
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2018/00327 Ear, nose or throat
• CPC Class Codes: A61B 2018/00595 Cauterization
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2029/025 : characterised by the guiding element
• CPC Class Codes: A61M 2210/0681 : Sinus (maxillaris)
• CPC Class Codes: A61M 2210/1028 : Larynx
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0102 : Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• 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 25/1006 : Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• 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.

Claims

1. A method for improving drainage from an ethmoid sinus having an ostium and one or more adjacent ethmoid air cells in a human or animal subject, said method comprising the steps of:

A) inserting a guide through the ostium and into the ethmoid sinus;

B) advancing an enlarging device over the guide to a position within the ostium and using that enlarging device to enlarge the ostium;

C) advancing a penetrating device into the ethmoid sinus via the enlarged ostium and using that penetrating device to form an opening between the ethmoid sinus and an ethmoid air cell;

D) advancing a guide from the ethmoid sinus, through the formed opening and into the ethmoid air cell; and

E) advancing an enlarging device over the guide of step D to a position within the formed opening and using the enlarging device to enlarge the formed opening.

2. A method according to claim 1 further comprising the steps of:

F) advancing a penetrating device over the guide and using that penetrating device to form a second opening between the ethmoid air cell and a second ethmoid air cell;

G) advancing the guide from the ethmoid air cell, through the second formed opening and into the second ethmoid air cell; and

H) advancing an enlarging device over the guide to a position within the second formed opening and using the enlarging device to enlarge the second formed opening.

3. A method according to claim 2 further comprising the steps of:

I) advancing a penetrating device over the guide and using that penetrating device to form a third opening between the second ethmoid air cell and a third ethmoid air cell;

J) advancing the guide from the second ethmoid air cell, through the third formed opening and into the third ethmoid air cell; and

K) advancing an enlarging device over the guide to a position within the third formed opening and using the enlarging device to enlarge the third opening.

4. A method according to claim 1 further comprising the steps of:

I) retracting the guide into the ethmoid sinus;

J) advancing a penetrating device over the guide and using that penetrating device to form a second opening between the ethmoid sinus and a second ethmoid air cell;

G) advancing the guide from the ethmoid sinus, through the second formed opening and into the second ethmoid air cell; and

H) advancing an enlarging device over the guide to a position within the second formed opening and using the enlarging device to enlarge the second formed opening.

5. A method according to claim 2 further comprising the steps of:

I) retracting the guide into the ethmoid air cell;

J) advancing a penetrating device over the guide and using that penetrating device to form a third opening between the ethmoid air cell and a third ethmoid air cell;

G) advancing the guide from the ethmoid sinus, through the third formed opening and into the third ethmoid air cell; and

H) advancing an enlarging device over the guide to a position within the third formed opening and using the enlarging device to enlarge the third formed opening.

6. A method according to claim 1 wherein, in Step C, the penetrating device is advanced over the guide that was used in Steps A and B.

7. A method according to claim 1 wherein the guide used in Steps D and E is the same guide that was used in Steps A and B.

8. A method according to claim 1 wherein the guide used in Steps A and B comprises a guidewire.

9. A method according to claim 1 wherein the guide used in Steps D and E comprises a guidewire.

10. A method according to claim 1 wherein the enlarging device used in Step E is the same enlarging device that was used in Step B.

11. A method according to claim 1 wherein the enlarging device used in Step B comprises a dilator.

12. A method according to claim 11 wherein the dilator comprises a balloon.

13. A method according to claim 11 wherein the dilator comprises at least two sequential dilators of progressively larger diameter.

14. A method according to claim 11 wherein the dilator comprises a mechanical dilator having a plurality of struts that are alternately moveable between a collapsed configuration and an expanded configuration.

15. A method according to claim 1 wherein the penetrating device comprises a tubular member that has a penetrating distal tip.

16. A method according to claim 1 wherein the penetrating device comprises a mechanical boring device.

17. A method for treating an ethmoid sinus, the method comprising:

A) inserting a guide through a first wall defining a first ethmoid sinus cavity;

B) advancing a penetrating device into the first ethmoid sinus cavity;

C) passing the penetrating device through a second wall, wherein the second wall separates the first ethmoid sinus cavity from a second sinus ethmoid cavity, thereby forming an opening between the first and second sinus ethmoid cavity through the second wall;

D) advancing an enlarging device into the opening formed in the second wall; and

E) enlarging the opening formed in the second wall with the enlarging device.

18. The method of claim 17, wherein the act of inserting a guide through the first wall comprises inserting the guide through an ostium formed in the first wall.

19. The method of claim 17, wherein the enlarging device comprises an expandable feature, wherein the act of enlarging the opening formed in the second wall comprises expanding the expandable feature outwardly.

20. A method for treating an ethmoid sinus, the method comprising:

A) inserting a guide through a first opening in a first wall defining a first ethmoid sinus cavity;

B) advancing an enlarging device along the inserted guide and through a second opening in second wall, wherein the second wall separates the first ethmoid sinus cavity from a second sinus ethmoid cavity, wherein the second opening is positioned to provide fluid communication between the first and second ethmoid sinus cavities; and

C) enlarging the second opening with the enlarging device.