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

• US 8,777,926 B2
• Filed: 03/15/2013
• Issued: 07/15/2014
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Walke, Amrish Jayprakash, Chang, John Y, Vrany, Julia D
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US13/840,430
• Publication Number:
  US 20130325052A1
• Time in Patent Office: 487 Days
• Field of Search: 264/285, 264/339, 264/DIG.30, 264/DIG.66, 425/2, 604/516, 604/528, 604/509, 604/510, 604/96.01, 600/114, 606/192
• 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 system for treating a paranasal sinus by dilating a natural or manmade paranasal sinus opening, said system comprising:

(a) an elongate shaft having a proximal end, a distal end and an outer diameter sized to allow the elongate shaft to be inserted into a patient'"'"'s nose;

(b) an expandable dilation device coupled with distal end of the elongate shaft, the expandable dilation device being expandable from a first configuration to a second configuration;

the elongate shaft being advanceable, with the dilation device in its first configuration, through the patient'"'"'s nose to a position where the dilation device is positioned within the paranasal sinus opening;

the dilation device being expandable, while positioned within the paranasal sinus opening, from the first configuration to the second configuration, said second configuration being sized to cause dilation of the paranasal sinus opening, wherein said dilation device in said second configuration expands with sufficient force to cause breakage or rearrangement of bone which surrounds the paranasal sinus opening; and

the expandable dilator being thereafter removable from the paranasal sinus opening such that the paranasal sinus opening remains dilated after removal of the dilator therefrom.

2. A system according to claim 1 wherein the elongate shaft has a curved or bent region which facilitates advancement of the dilation device into the paranasal sinus opening.

3. A system according to claim 2 wherein the curved or bent region is curved or bent to an angle of up to 135°

.

4. A system according to claim 2 wherein the curved or bent region is curved or bent to an angle selected from:

0°

, 30°

, 45°

, 60°

, 70°

, 90°

, 120° and

135°

.

5. A system according to claim 2 wherein the curved or bent region is malleable such that an operator may form it to a desired bend or curvature at the time of use.

6. A system according to claim 2 wherein the curved or bent region is formed in the elongate shaft at the time of manufacture.

7. A system comprising a plurality of devices according to claim 6 wherein each device has a different curved or bent region.

8. A system according to claim 1 wherein the dilation device comprises an inflatable structure which fills with inflation fluid thereby causing the inflatable structure to expand from the first configuration to the second configuration.

9. A system according to claim 1 wherein the dilation device comprises an expandable wall defining an internal space therewithin and wherein entry of fluid into the internal space causes the expandable wall to expand, thereby transitioning the dilation device from the first configuration to the second configuration.

10. A method for dilating a natural or man-made paranasal sinus opening in a patient, said method comprising the steps of:

(a) obtaining or providing a system which comprises i) an elongate shaft having a proximal end, a distal end and an outer diameter sized to allow the elongate shaft to be inserted into a patient'"'"'s nose and ii) an expandable dilation device coupled with distal end of the elongate shaft, the expandable dilation device being expandable from a first configuration to a second configuration;

(b) inserting the elongate shaft into the patient'"'"'s nose and advancing it, with the dilation device in its first configuration, through the patient'"'"'s nose to a position where the dilation device is positioned within the paranasal sinus opening;

(c) causing the dilation device to expand, while positioned within the paranasal sinus opening, from the first configuration to the second configuration, wherein said expansion from the first configuration to the second configuration causes dilation of the paranasal sinus opening, wherein said dilation device in the second configuration expands with sufficient force to cause breakage or rearrangement of bone which surrounds the paranasal sinus opening; and

, thereafter,

(d) removing the dilation device from the paranasal sinus opening such that the paranasal sinus opening remains dilated after removal of the dilation device therefrom.

11. A method according to claim 10 wherein the elongate shaft has a curved or bent region and wherein the curved or bent region is used during advancement of the device to facilitate positioning of the dilation device within the paranasal sinus opening.

12. A method according to claim 11 wherein the curved or bent region is curved or bent to an angle of up to 135°

.

13. A method according to claim 11 wherein the curved or bent region is curved or bent to an angle selected from:

0°

, 30°

, 45°

, 60°

, 70°

, 90°

, 120° and

135°

.

14. A method according to claim 11 wherein the curved or bent region is malleable and wherein the operator forms a desired bend or curvature at the time of use.

15. A method according to claim 11 wherein the curved or bent region is formed in the elongate shaft at the time of manufacture.

16. A method according to claim 15 wherein a plurality of said systems having differing curved or bent regions are obtained or provided and wherein the operator selects a device having a desired bend or curvature at the time of the procedure.

17. A method according to claim 10 wherein the dilation device comprises an inflatable structure and wherein the dilation device is caused to expand by causing inflation fluid to fill the inflatable structure thereby causing the dilation device to expand from the first configuration to the second configuration.

18. A method according to claim 10 wherein the dilation device comprises an expandable wall which defines an internal space therewithin and wherein the dilation device is caused to expand by causing fluid to enter into the internal space causing the expandable wall to expand and thereby transitioning the dilation device from the first configuration to the second configuration.