Methods for irrigation of ethmoid air cells and treatment of ethmoid disease

• US 7,785,315 B1
• Filed: 12/12/2007
• Issued: 08/31/2010
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Van, Nga K., Morriss, John H., Ha, Hung V., Clifford, Anton G., Makower, Joshua, Muni, Ketan P., Chan, Randy S., Facteau, William M., Chang, John Y., Bolger, William E.
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US11/955,303
• Time in Patent Office: 993 Days
• Field of Search: 604500-510, 604/514, 604/516, 606/196, 128/204.12, 424/434
• US Class Current: 604/510
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12136 Balloons
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• 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: A61F 11/20 Ear surgery
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Devices, systems and methods for stenting, spacing, draining, ventilating and/or delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects, including methods and systems for treating paranasal sinusitis and ethmoid disease.

Claims

1. A method for treating ethmoid disease in a human or animal subject using an irrigation catheter system that comprises a sheath and an irrigation catheter, the irrigation catheter having an implantable component, a removeable component, a fixed curve and a distal tip, said method comprising the steps of:

inserting the sheath into the nose;

advancing the irrigation catheter through the sheath so that the distal tip of the irrigation catheter exits the sheath and enters into at least one ethmoid air cell with the curve oriented downwardly so as to deter inadvertent penetration of the skull base;

delivering an irrigation fluid through the irrigation catheter and into at least one ethmoid air cell; and

removing the sheath and the removeable component of the irrigation catheter, leaving the implantable component of the irrigation catheter implanted in at least one ethmoid air cell.

2. A method according to claim 1 wherein the irrigation catheter is introduced into at least one ethmoid air cell through an irrigation sheath.

3. A method according to claim 1 wherein the irrigation catheter has a distal tip that is capable of penetrating through the ethmoid bulla and wherein the advancing step comprises advancing the irrigation catheter through the sheath and to a position where its distal tip is adjacent to the ethmoid bulla and further advancing the irrigation catheter causing the distal tip to penetrate through the ethmoid bulla and into at least one ethmoid air cell.

4. A method according to claim 1 wherein the irrigation fluid is delivered at high pressure.

5. A method according to claim 1 wherein the delivery of irrigation fluid causes the irrigation fluid to spread into other ethmoid air cells through natural openings.

6. A method according to claim 5 wherein the fluid spreads into other ethmoid air cells without creating man made openings in those other ethmoid air cells.

7. A method according to claim 5 wherein the fluid spreads into other ethmoid air cells which are not visualized.

8. A method according to claim 1 wherein the irrigation catheter has one or more side holes out of which the irrigation fluid flows and wherein irrigation fluid flows through the irrigation catheter, out of said one or more side holes, and into at least one ethmoid air cell.

9. A method according to claim 1 wherein the implantable component remains implanted in the anatomy for a period of from 1 hour to 90 days.

10. A method according to claim 1 wherein the implantable component remains implanted in the anatomy for a period of from 7 days to 29 days.

11. A method according to claim 1 wherein the implantable component remains implanted in the anatomy for a period of from about 14 days.

12. A method according to claim 1 wherein the implantable component functions as a spacer or stent while implanted in the subject'"'"'s anatomy.

13. A method according to claim 1 wherein the implantable component functions as a substance eluting device while implanted in the subject'"'"'s anatomy.

14. A method according to claim 13 wherein the implantable component elutes a substance selected from the group consisting of:

imageable contrast agents;

diagnostic indicator agents;

antibiotics;

antifungals;

antiparasitics;

antimicrobials;

steroids;

vasoconstrictors;

leukotriene inhibitors;

IgE inhibitors;

anti-inflammatorys;

mast cell stabilizers;

antihistamines;

immunomodulators;

SYK kinase Inhibitors;

chemotherapeutic agents;

antineoplastic agents;

mucolytic agents;

antiproliferative agents;

anti-scarring agents;

agents that thin or otherwise change the viscosity of mucous; and

substances that facilitate remodeling of soft tissue and/or bone and/or cartilage.

15. A method according to claim 1 further comprising the step of:

using fluoroscopy to visualize at least a portion of the method.

16. A method according to claim 1 further comprising the step of:

using endoscopy to visualize at least a portion of the method.

17. A method according to claim 1 further comprising the step of:

using an optical or electromagnetic navigation modality to determine the position of the irrigation catheter during at least a portion of the method.