Devices, systems and methods for treating disorders of the ear, nose and throat

• US 8,961,495 B2
• Filed: 10/29/2007
• Issued: 02/24/2015
• 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., Lamson, Theodore C., Walke, Amrish Jayprakash
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US11/926,565
• Publication Number:
  US 20080132938A1
• Time in Patent Office: 2,675 Days
• Field of Search: 604/94.01, 604/514, 604/516, 606/196, 606/110
• US Class Current: 604/514
• 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 method for dilating a Eustachian tube in a human or animal subject, said method comprising the steps of:

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

B) inserting the guidewire through the pharyngeal ostium and into the Eustachian tube proximal of the middle ear;

C) expanding the anchor from a first configuration to a second configuration to anchor the guidewire within the Eustachian tube;

D) advancing the dilator over the guidewire and into the Eustachian tube such that the dilator is positioned proximal to the anchor of the guidewire; and

E) using the dilator to dilate the Eustachian tube while the dilator is positioned proximal to the anchor of the guidewire.

2. A method according to claim 1 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.

3. A method according to claim 2 wherein the imageable marker is inserted into the ear canal adjacent to the Eustachian tube being treated.

4. The method of claim 1, wherein the dilator is a dilating balloon and further comprising expanding the balloon to dilate the Eustachian tube.

5. The method of claim 4, wherein a stent is loaded on the dilating balloon.

6. The method of claim 5, wherein the stent is self-expanding.

7. The method of claim 5, wherein the stent is pressure-expandable.

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

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

B) inserting the guidewire through the pharyngeal ostium and into the Eustachian tube proximal of the middle ear;

C) expanding the anchor from a first configuration to a second configuration;

D) pulling the anchor proximally to anchor the guidewire within the Eustachian tube;

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

(F) ceasing advancement of the dilator to position the dilator proximal to the anchor; and

(G) using the dilator to dilate the Eustachian tube at a position proximal to the anchor.

9. A method according to claim 8 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 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.

11. The method of claim 8, wherein the dilator is a dilating balloon and further comprising expanding the balloon to dilate the Eustachian tube.

12. The method of claim 11, wherein a stent is loaded on the dilating balloon.

13. The method of claim 12, wherein the stent is self-expanding.

14. The method of claim 12, wherein the stent is pressure-expandable.

15. A method for operating a surgical device, wherein the surgical device comprises a working device, a first anchor distal portion of the working device, and a second anchor proximal of the working device, said method comprising the steps of:

A) inserting the surgical device through an opening within a patient'"'"'s ear, nose, or throat, such that the working device is positioned within the opening and the first anchor is positioned distal of the opening and the second anchor is positioned proximal of the opening;

B) expanding the first anchor such that the first anchor is larger than the opening in the expanded position;

C) expanding the second anchor such that the second anchor is larger than the opening in the expanded position; and

D) actuating the working device within the opening.

16. The method of claim 15, wherein the working device comprises a balloon.

17. The method of claim 15 further comprising pulling the anchor proximally when the anchor is in the second position.

18. The method of claim 15, wherein the surgical device comprises a second anchor proximal to the working device, wherein the second anchor is expanded from a first position to a second position, wherein the second anchor is larger than the opening in the second position.

19. The method of claim 15 wherein the anchor is a balloon.

20. The method of claim 15 wherein the surgical device is inserted within the Eustachian tube.