Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders

• US 9,084,876 B2
• Filed: 03/15/2013
• Issued: 07/21/2015
• Est. Priority Date: 08/04/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Acclarent Incorporated (Johnson & Johnson)
• Inventors: Makower, Joshua, Chang, John Y., Vrany, Julia D., Walke, Amrish Jayprakash
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/838,959
• Publication Number:
  US 20130281982A1
• Time in Patent Office: 858 Days
• Field of Search: 604/500, 604/514, 604/516, 604/890.1, 604/891.1, 604/93.01, 604506-510, 604116-117, 604/96.01, 604/285, 606/196, 606/199, 128/204.12, 128/898, 424/434
• US Class Current: 1/1
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• 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 2017/22061 for spreading elements apart
• 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 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61F 2/18 Internal ear or nose parts, e.g. ear-drums implants for middle ear ventilation or drainage A61F11/202
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• 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 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• 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
• CPC Class Codes: A61M 31/002 : Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 31/005 : for contrast media
• CPC Class Codes: A61M 31/007 : Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: G03G 5/0535 : Polyolefins; Polystyrenes; Waxes
• CPC Class Codes: G03G 5/0539 : Halogenated polymers
• CPC Class Codes: G03G 5/056 : Polyesters
• CPC Class Codes: G03G 5/0564 : Polycarbonates
• CPC Class Codes: G03G 5/0696 : Phthalocyanines
• CPC Class Codes: G03G 5/14726 : Halogenated polymers
• CPC Class Codes: G03G 5/14791 : Macromolecular compounds characterised by their structure, e.g. block polymers, reticulated polymers, or by their chemical properties, e.g. by molecular weight or acidity

Abstract

Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

Claims

1. A method for delivering a substance to a location within a paranasal sinus or nasal cavity, or an opening into a paranasal sinus or nasal cavity of a human or animal subject to treat a disorder, said method comprising the steps of:

obtaining or providing a device that comprises;

a self-expanding structure comprising a plurality of interconnected elongate members which comprise biodegradable material combined with a therapeutic substance, wherein said self-expanding structure is resiliently biased to assume a radially expanded configuration, such that said self-expanding structure is initially constrainable in a radially collapsed configuration from which it will self-expand to the radially expanded configuration when unconstrained; and

an introducer device comprising a tube having a distal end opening and a lumen and a pusher, said self-expanding structure being loaded in the collapsed configuration within said lumen distal to said pusher, wherein the tube is configured to hold the self-expanding structure in the collapsed configuration, against a resilient bias of the self-expanding structure, while the self-expanding structure is loaded into the tube;

inserting the introducer device into the nose to a position where its distal end opening is aligned with the paranasal sinus or nasal cavity or the opening into the paranasal sinus or the opening into the nasal cavity;

causing the pusher to advance, thereby delivering the self-expanding structure out of the distal end opening of the introducer device so that the self-expanding structure self-expands within the paranasal sinus or nasal cavity or the opening into the paranasal sinus or the opening into the nasal cavity; and

leaving the self-expanding structure in place for a period of time over which the biodegradable material degrades and wherein the therapeutic substance is released.

2. A method according to claim 1, wherein the biodegradable material comprises a material selected from a group consisting of:

poly (L-lactic acid) (PLLA), poly (L-glycolic acid) (PLGA), polyglycolide, poly-L-lactide, poly-D-lactide, poly(amino acids), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, polyorthoesters, polyhydroxybutyrate, polyanhydride, polyphosphoester, poly(alpha-hydroxy acid).

3. A method according to claim 1 wherein the self-expanding structure is configured such that, while left in place in the expanded configuration, drainage of mucus or other biological fluid is not substantially blocked by the presence of the self-expanding structure.

4. A method according to claim 3 wherein the self-expanding structure is configured such that, when in the radially expanded configuration, a flow channel extends through the self-expanding structure, whereby mucus or other biological fluid may drain through said flow channel.

5. A method according to claim 4 wherein the self-expanding structure is optionally removable prior to expiration of a predetermined treatment time period.

6. A method according to claim 4 further comprising the step of optionally removing the self-expanding structure prior to expiration of a desired treatment time period.

7. A method according to claim 1 wherein the method is performed in conjunction with enlargement of the opening in the paranasal sinus.

8. A method according to claim 7 wherein the method is performed in conjunction with dilation of the opening in the paranasal sinus.

9. A method according to claim 8 wherein the method is performed in conjunction with dilation of a natural ostium of the paranasal sinus.

10. A method according to claim 8 wherein the opening in the paranasal sinus is dilated by positioning a dilator within the opening in the paranasal sinus and subsequently using the dilator to dilate the opening in the paranasal sinus.

11. A method according to claim 10 wherein the dilator comprises an expandable wall and a hollow interior and, after the dilator has been positioned within the opening in the paranasal sinus, fluid enters the hollow interior thereby causing the expandable wall to expand resulting in dilation of the opening in the paranasal sinus.

12. A method according to claim 11 wherein the dilator comprises a balloon.

13. A method according to claim 1 wherein the self-expanding structure biodegrades over a predetermined treatment time period.

14. A method according to claim 1 wherein the self-expanding structure is positioned within or near an ostium of the paranasal sinus.

15. A method according to claim 1 wherein the substance comprises a steroid.

16. A method according to claim 15 wherein the steroid is selected from:

beclomethasone;

flunisolide;

fluticasone propionate;

triamcinolone acetonide;

budesonide;

loterednol etabonate;

aclometasone;

desonide;

hydrocortisone;

betamethasone;

clocortolone;

desoximetasone;

fluocinolone;

flurandrenolide;

mometasone;

prednicarbate;

amcinonide;

desoximetasone;

diflorasone;

fluocinonide;

halcinonide;

clobetasol;

augmented betamethasone;

halobetasol;

prednisone;

dexamethasone; and

methylprednisolone.

17. A method according to claim 1 wherein the substance comprises mometasone.

18. A method according to claim 1 wherein the method is performed in conjunction with a surgical procedure.

19. A method according to claim 18 wherein the method is performed in conjunction with functional endoscopic sinus surgery.

20. A method according to claim 1 wherein the elongate members comprise biodegradable struts arranged around a central axis, said struts being closer together when in the radially collapsed configuration and further apart when in the radially expanded configuration.