Implantable devices and methods for treating sinusitis and other disorders

• US 9,308,361 B2
• Filed: 03/04/2013
• Issued: 04/12/2016
• Est. Priority Date: 01/18/2005
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Muni, Ketan P., Ha, Hung V., Morriss, John H., Bolger, William E., Makower, Joshua, Chang, John Y., Chan, Randy S., Van, Nga K., Clifford, Anton G., Facteau, William M.
• Primary Examiner(s): HAYMAN, IMANI N
• Application Number:
  US13/784,293
• Publication Number:
  US 20130245608A1
• Time in Patent Office: 1,135 Days
• Field of Search: 604/285, 604/500, 604508-510, 604/514, 604/516, 606/196, 606/199
• US Class Current: 1/1
• 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

A method for treating ethmoid disease in human or non-human animal subjects includes inserting a sheath containing an implantable device having an expandable member. The sheath is removed from the implantable device causing the expandable member to expand, allowing for stability of the implantable device in the subject. 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 may also be involved.

Claims

1. A method for treating a human or animal subject, said method comprising the steps of:

(a) forming an opening into at least one ethmoid air cell;

(b) providing or obtaining an implantable device, wherein the implantable device comprises;

(i) a self-expanding member,

(ii) a connector,

(iii) a shaft connecting the self-expanding member and the connector, and

(iv) a delivery sheath having a lumen and a distal end,

wherein the shaft is positioned within the lumen of the delivery sheath

(c) advancing the distal end of the delivery sheath into a nose of the subject to a location adjacent to the opening formed in at least one ethmoid air cell, wherein the self-expanding member is in a constrained configuration within the lumen of the delivery sheath during the act of advancing the distal end of the delivery sheath;

(d) separating the delivery sheath from the self-expanding member, thereby releasing the self-expanding member from the delivery sheath such that the self-expanding member expands to an expanded configuration wherein the self-expanding member contacts with anatomy surrounding the opening formed in the at least one ethmoid air cell;

(e) separating a distal portion of the shaft from a proximal portion of the shaft at a point between the self-expanding member and the connector;

(f) removing the delivery sheath from the shaft; and

(g) allowing the implantable device to remain implanted within the opening formed in the at least one ethmoid air cell.

2. The method according to claim 1 wherein the opening formed in at least one ethmoid air cell the comprises an opening formed in an ethmoid bulla.

3. The method according to claim 1 wherein the opening formed in at least one ethmoid air cell the comprises a channel that has been created in the at least one diseased ethmoid air cell.

4. The method according to claim 1 wherein the step of forming the opening into at least one the ethmoid air cell comprises surgically forming the opening into at least one the ethmoid air cell.

5. The method according to claim 1 wherein the step of forming the opening into at least one the ethmoid air cell comprises performing a needle ethmoidotomy.

6. The method according to claim 5 wherein the step of performing the needle ethmoidotomy comprises:

(i) obtaining an ethmoidotomy needle having a distal tip;

(ii) inserting the ethmoidotomy needle into the subject'"'"'s nose and advancing the ethmoidotomy needle to a position where the distal tip is aligned with an ethmoid bulla;

(iii) pushing the ethmoidotomy needle through at least the ethmoid bulla to form the opening into at least one the ethmoid air cell.

7. The method according to claim 6 wherein the ethmoidotomy needle is pushed through the ethmoid bulla and through a plurality of ethmoid air cells thereby forming a channel that extends through the plurality of ethmoid air cells.

8. The method according to claim 1 wherein the self-expanding member expands to conform to the size and shape of the opening formed into at least the one ethmoid air cell.

9. The method according to claim 1 wherein the self-expanding member comprises material that absorbs endogenous or introduced fluid causing the self-expanding member to swell to the expanded configuration.

10. The method according to claim 1 wherein the implantable device also delivers a therapeutic substance to treat the ethmoid disease.

11. The method according to claim 10 wherein the substance comprises a steroid.

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

beclomethasone;

flunisolide;

fluticasone;

triamcinolone;

budesonide;

loterednol, mometasone, aclometasone, desonide, hydrocortisone, betamethasone, clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone, prednicarbate;

amcinonide, desoximetasone, diflorasone, fluocinolone, fluocinonide, halcinonide, clobetasol, augmented betamethasone, diflorasone, halobetasol, prednisone, dexamethasone, methylprednisolone and salts thereof.

13. The method according to any of claim 10, 11 or 12 wherein the implantable device remains implanted and delivers the substance for at least 7 days.

14. The method according to claim 13 wherein, within the first two days of implantation, the implantable device delivers at least half of the total amount of substance that the implantable device delivers over the 7 days of implantation.

15. The method according to claim 13 wherein the substance comprises mometasone.