Methods for treating ethmoid disease

• US 7,419,497 B2
• Filed: 10/04/2006
• Issued: 09/02/2008
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: 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., Van, Nga K.
• Primary Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US11/544,009
• Publication Number:
  US 20080015540A1
• Time in Patent Office: 699 Days
• Field of Search: 604/500, 604508-510, 604/514, 604/516, 606/196, 128/204.12, 424/434
• US Class Current: 606/196
• 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, said method comprising the steps of:

pushing a sinus needle having a sheath through the ethmoid bulla to create an opening into at least one ethmoid air cell;

removing the sinus needle from the sheath;

inserting an implantable device having an inflatable reservoir through the sheath;

removing the sheath;

delivering a therapeutic substance into the reservoir; and

allowing the reservoir to remain implanted for an implantation period of from about 1 hour to about 90 days.

2. A method according to claim 1 wherein the advancing step comprises pushing a sinus needle having a sheath through the ethmoid bulla;

the method further comprises removing the sinus needle from the sheath;

the inserting step comprises inserting the implantable device having the inflatable reservoir through the sheath;

the method further comprises removing the sheath; and

the filling step comprises filling the inflatable reservoir with a therapeutic substance, wherein an implantation period is about 1 hour to about 90 days.

3. A method according to claim 1 wherein the implantable device has also has a position maintaining member that abuts, engages or attaches to an adjacent anatomical structure to maintain the reservoir in a desired position.

4. A method according to claim 3 wherein the position maintaining member comprises at least one projection that frictionally engages an adjacent anatomical structure so as to deter migration or passage of the reservoir back out of the opening.

5. A method according to claim 4 wherein said at least one projection has a collapsed position and an extended position and wherein the method further comprises:

maintaining said at least one projection in the collapsed position while the implantable device is inserted through the opening and, thereafter,

causing said at least one projection to transition to the extended position whereby said at least one projection mechanically contacts at least one adjacent anatomical structure.

6. A method according to claim 5 wherein the step of causing said at least one projection to transition to the extended position comprises retracting a sheath so as to allow said at least one projection to assume the extended position.

7. A method according to claim 1 further comprising the step of removing the implantable device after an implantation period.

8. A method according to claim 7 wherein the implantable device comprises at least one projection that mechanically contacts at least one adjacent anatomical structure and wherein the step of removing the implantable device comprises pulling the implantable device out of the opening with sufficient force to overcome a resilient force in the at least one projection.

9. A method according to claim 1 wherein the penetrator comprises an elongate member having a curve and a sharp distal tip and wherein the step of advancing a penetrator through the ethmoid bulla to create an ethmoidotomy opening into at least one ethmoid air cell is performed with the curve oriented in a manner that causes the distal tip of the penetrator to advance on a trajectory that is substantially parallel to or divergent away from the adjacent skull base.

10. A method according to claim 1 wherein the penetrator is advanced through a plurality of ethmoid air cells, thereby forming an opening into a plurality of ethmoid air cells.

11. A method according to claim 1 wherein the reservoir is inflated with an inflation fluid that comprises a diagnostic or therapeutic substance and wherein the reservoir is constructed such that a diagnostically or therapeutically effective amount of the substance will elute from the reservoir while the implantable device is implanted.

12. A method according to claim 11 wherein the substance is selected from the group consisting of:

wherein the substance is selected from the group consisting of;

an imageable contrast agent;

a diagnostic indicator agent;

an antibiotic;

an antifungal;

an antiparasitic;

an antimicrobial;

a steroid;

a vasoconstrictor;

a leukotriene inhibitor;

an IgE inhibitor;

an anti-inflammatory;

a mast cell stabilizer;

an antihistamine;

an immunomodulator;

an SYK kinase Inhibitor

a chemotherapeutic agent;

an antineoplastic agent;

a mucolytic agent;

an antiproliferative agent;

an anti-scarring agent;

an agent that thins or otherwise changes the viscosity of mucous; and

a substance that facilitates remodeling of soft tissue and/or bone and/or cartilage.

13. A method according to claim 7 wherein the implantation period is about 7 to about 29 days.

14. A method according to claim 7 wherein the implantation period is about 7 days to about 14 days.

15. A method for treating ethmoid disease according to claim 1 wherein the step of delivering a therapeutic substance into the reservoir results in substantial filling of the reservoir.