Devices, Systems and Methods for Treating Disorders of the Ear, Nose and Throat

• US 20080132938A1
• Filed: 10/29/2007
• Published: 06/05/2008
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Lamson, Theodore C., Walke, Amrish Jayprakash, Chang, John Y., Vrany, Julia D.
• Granted Patent: US 8,961,495 B2
• Time in Patent Office: Days
• US Class Current: 606/196
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1608 the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
• CPC Class Codes: A61B 17/1679 for the ear
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 50/13 : Trolleys, e.g. carts
• CPC Class Codes: A61B 50/15 : Mayo stands; Tables
• CPC Class Codes: A61B 50/20 : Holders specially adapted for surgical or diagnostic appliances or instruments drapes with means to hold surgical instruments A61B46/23; for catheters A61M25/02
• CPC Class Codes: A61B 90/16 : Bite blocks
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61F 11/202 : Surgical middle-ear ventilation or drainage, e.g. permanent; Implants therefor
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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

Abstract

Sinusitis, mucocysts, tumors, infections, hearing disorders, choanal atresia, fractures and other disorders of the paranasal sinuses, Eustachian tubes, Lachrymal ducts and other ear, nose, throat and mouth structures are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies and endoscopic studies. Access and occluding devices may be used to facilitate insertion of working devices such asendoscopes, wires, probes, needles, catheters, balloon catheters, dilation catheters, dilators, balloons, tissue cutting or remodeling devices, suction or irrigation devices, imaging devices, sizing devices, biopsy devices, image-guided devices containing sensors or transmitters, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting or delivering devices and implants, etc.

Claims

1. A system for dilating a Eustachian tube, said system comprising:

a guidewire that is insertable through the nose and is advanceable into the Eustachian tube through the pharyngeal ostium of the Eustachian tube;

a guidewire anchor for holding the guidewire in a substantially fixed position within the Eustachian tube;

a dilator that is advanceable over the guidewire and useable to dilate the Eustachian tube.

2. A system according to claim 1 wherein the guidewire anchor comprises a balloon on the guidewire.

3. A system according to claim 1 wherein the dilator comprises a balloon catheter.

4. A system according to claim 1 further comprising an imageable marker for marking the location at which the Eustachian tube passes into the middle ear, said marker being useable by the operator to prevent advancement of the guidewire into the middle ear.

5. A system according to claim 4 wherein the imageable marker comprises a radiopaque marker that inserts into the ear canal adjacent to the Eustachian tube to permit the operator to visualize the location of the inferior floor of the ear canal.

6. A system according to claim 4 wherein the guidewire further comprises a marker on the distal tip of the guidewire to enhance the operator'"'"'s ability to track the location of the distal tip of the guidewire relative to anatomical structures of the middle ear.

7. A method for dilating a Eustachian tube in a human or animal subject, said method comprising the steps of:

A) providing a a guidewire that is insertable through the nose and is advanceable into the Eustachian tube through the pharyngeal ostium of the Eustachian tube and a dilator that is advanceable over the guidewire and useable to dilate the Eustachian tube;

B) inserting the guidewire into the Eustachian tube;

C) advancing the dilator over the guidewire and into the Eustachian tube; and

D) using the dilator to dilate the Eustachian tube.

8. A method according to claim 7 wherein the guidewire has an anchor for holding the guidewire in a substantially fixed position within the Eustachian tube and wherein Step B further comprises anchoring the guidewire within the Eustachian tube.

9. A method according to claim 7 further comprising the steps of providing an imageable marker for marking the location at which the Eustachian tube passes into the middle ear, said marker being useable by the operator to prevent advancement of the guidewire into the middle ear;

and

imaging said marker and using the image thereby provided to avoid advancing the guidewire or dilator into the middle ear in a manner that would cause substantial damage to anatomical structures of the middle ear.

10. A method according to claim 9 wherein the imageable marker is inserted into the ear canal adjacent to the Eustachian tube being treated.