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

• US 8,945,088 B2
• Filed: 04/28/2010
• Issued: 02/03/2015
• Est. Priority Date: 04/21/2004
• Status: Expired due to Fees

• 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): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US12/768,963
• Publication Number:
  US 20100298862A1
• Time in Patent Office: 1,742 Days
• Field of Search: 604/103.09, 604/103.04, 604/103.05, 606/196, 606/199
• US Class Current: 604/524
• 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 diagnosing and/or treating sinusitis or another disorder affecting the nose, paranasal sinuses or other anatomical structures of the ear, nose or throat, said method comprising the steps of:

A) providing a working device comprising;

a proximal end;

a distal end;

at least one flexible element between the proximal end and the distal end, wherein the flexible element includes a plurality of external controllably stiffening elements;

at least one tension member, wherein the tension member is coupled to the controllably stiffening elements; and

a working element on or near the distal end, wherein the working element is selected from the group consisting of balloon catheters, rotating cutters, high frequency mechanical vibrators, rotating drills, sequential dilators, tapered dilators, punches, electrocautery devices, cutters, mechanically expandable members, dilating stents and devices that introduce diagnostic or therapeutic agents;

B) advancing the working device in a nasal cavity while the working device is flexible so that the distal end of the working device is in the vicinity of an opening of a paranasal sinus;

C) actuating the at least one tension member, wherein actuating the at least one tension member causes the actuating of the plurality of external controllably stiffening elements such that the plurality of external controllably stiffening elements increase the stiffness of the at least one flexible element in response to the act of actuating the at least one tension member; and

D) performing a diagnostic or therapeutic procedure using the working device while the at least one flexible element is increased in stiffness.

2. A device for treating a paranasal sinus, the device comprising:

an elongate, at least partially flexible shaft having an exterior surface, a proximal end, a distal end and an outer diameter sized to allow it to be inserted into a patient'"'"'s nose;

a treatment member coupled with the shaft at or near the distal end of the shaft;

at least one shaft stiffening member coupled with the exterior surface of the shaft for stiffening a flexible portion of the shaft, the at least one shaft stiffening member including a plurality of controllable stiffening elements, wherein each controllable stiffening element is oriented beside another controllable stiffening element; and

an actuator, wherein the actuator is directly secured to the at least one shaft stiffening member, wherein the actuator is configured to impose a compressive force on the at least one shaft stiffening member to bring the controllable stiffening elements into contact with each other to thereby selectively stiffen the flexible portion of the shaft.

3. A device as in claim 2, wherein the elongate shaft comprises a catheter, and wherein the treatment member comprises an inflatable balloon.

4. A device as in claim 2, wherein the elongate shaft further comprises a guidewire lumen.

5. A system for treating a paranasal sinus, the system comprising:

a paranasal sinus treatment device, comprising;

an elongate, at least partially flexible shaft having a proximal end, a distal end and an outer diameter sized to allow it to be inserted into a patient'"'"'s nose;

a treatment member coupled with the shaft, the treatment member having a first configuration for advancement to a treatment site and a second treatment configuration; and

at least one shaft stiffening member coupled with the shaft for stiffening a flexible portion of the shaft, the at least one shaft stiffening member including a plurality of external controllable stiffening elements;

an actuator, wherein the actuator is directly coupled to the at least one shaft stiffening member, wherein the actuator is operable to transition the at least one shaft stiffening member between a first position and a second position, wherein the flexible portion of the shaft is flexible when that at least one shaft stiffening member is in the first position, wherein the flexible portion of the shaft is stiff when the at least one shaft stiffening member is in the second position;

wherein the at least one shaft stiffening member assumes a first location when the treatment member is in both the first and second configuration.

6. A system as in claim 5, further comprising a guidewire, wherein the shaft includes a guidewire lumen.