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

• US 8,172,828 B2
• Filed: 10/30/2007
• Issued: 05/08/2012
• 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): Ho, Jackie
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US11/928,346
• Publication Number:
  US 20080154237A1
• Time in Patent Office: 1,652 Days
• Field of Search: 604/103.09, 604/103.04, 604/103.05, 606/196, 606/199
• US Class Current: 604/509
• 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 treating sinusitis by dilating a natural, unfractured paranasal sinus ostium of an unfractured paranasal sinus of a patient;

the method comprising;

advancing a balloon catheter into a nasal cavity of the patient, the balloon catheter having an expandable balloon and a shaft having an initial flexibility;

after said advancing, decreasing the flexibility of the shaft by activating a shaft stiffening element;

positioning the balloon with the stiffening element activated within the natural paranasal sinus ostium of a paranasal sinus; and

dilating the ostium by expanding the balloon within the ostium.

2. A method according to claim 1, further comprising removing the stiffening element from the catheter before expanding the balloon.

3. A method according to claim 1 wherein the stiffening element comprises a stylet that is insertable into at least a portion of the catheter shaft.

4. A method according to claim 1 wherein the stiffening element comprises a stiffening member that is attachable to and removable from at least a portion of the flexible catheter shaft.

5. A method according to claim 1 wherein the stiffening element comprises a sleeve that is temporarily positionable over at least a portion of the flexible catheter shaft.

6. A method according to claim 1 wherein the initial flexibility is such that the catheter shaft has a flexural stiffness less than about 200 pound-force per inch over a catheter length of one inch.

7. A method according to claim 1 wherein the stiffening element is selected from the group consisting of:

a spiral element wound around the catheter shaft;

a reinforcing filament substantially parallel to an axis of the catheter shaft;

one or more stiffening rings positioned along the catheter shaft;

a series of controllably stiffening elements positioned along the catheter shaft and a mechanism for controlling friction therebetween;

a hypotube;

a reinforcing braid on the catheter shaft; and

a reinforcing mesh on the catheter shaft.