Devices and methods for delivering therapeutic substances for the treatment of sinusitis and other disorders

• US 7,410,480 B2
• Filed: 09/23/2005
• Issued: 08/12/2008
• 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., Makower, Joshua, Walke, Amrish Jayprakash, Muni, Ketan P., Chang, John Y., Facteau, William M.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US11/234,395
• Publication Number:
  US 20060106361A1
• Time in Patent Office: 1,054 Days
• Field of Search: 604/890.1, 604/891.1, 604/93.1, 604/500, 604506-510, 604/514, 604/516, 606/196, 128/204.12, 128/898, 424/434
• US Class Current: 604/509
• 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 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• 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 5/064 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: A61B 5/416 the spleen
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• 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 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61M 2025/004 : characterized by lumina being arranged circumferentially
• 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
• CPC Class Codes: A61M 31/00 : Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• 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

Abstract

Devices and methods for delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects. An implantable delivery device comprising a reservoir is initianlly attached to a deliver catheter or delivery tool and is introduced into the body and positioned at a desired site. A therapeutic or diagnostic substance is then introduced into the reservoir and the delivery catheter or deliver tool is then removed, leaving the implantable delivery device implanted within the body. The substance is then delivered from the reservoir at a rate that causes the desire diagnostic or therapeutic effect. Also provided are substance eluting stents that elute substance from a selected surface of the stent (e.g., the outer surface) but not from another surface of the stent (e.g., the inner surface).

Claims

1. A method for delivering a substance to a location within a head of a subject, said method comprising:

introducing an implantable substance delivery reservoir comprising an expandable reservoir body in an unexpanded configuration through a nostril of the head, wherein the reservoir is removably coupled with an elongate shaft having a lumen in fluid communication with the reservoir;

positioning the implantable reservoir at a desired location within a paranasal sinus or paranasal sinus ostium of the head;

introducing a therapeutic or diagnostic substance, or a component thereof, through the lumen of the elongate shaft and into the reservoir causing expansion of the expandable reservoir body;

detaching the elongate shaft from the implantable reservoir; and

removing the elongate shaft from the head, thus leaving the implantable reservoir behind such that the therapeutic or diagnostic substance will pass out of the reservoir through at least one aperture located in the expandable reservoir body;

preventing the diagnostic or therapeutic substance from backflowing out of the reservoir after removal of the elongate shaft.

2. A method according to claim 1, wherein the reservoir, when expanded, engages at least one of a paranasal sinus wall or a paranasal sinus ostium in a manner that deters unwanted movement of the reservoir after it has been implanted.

3. A method according to claim 2, wherein at least a portion of the reservoir is positioned within a paranasal sinus and, when expanded, is too large to pass through an opening of that paranasal sinus, thereby deterring unwanted movement of the reservoir.

4. A method according to claim 1, wherein the implantable reservoir further comprises a reservoir lumen in fluid communication with the lumen of the elongate shaft.

5. A method according to claim 4, wherein the step of preventing backflow comprises clamping, clipping, ligating, tying or compressing the reservoir lumen to prevent substance that has been introduced in the reservoir from backflowing out of the reservoir lumen.

6. A method according to claim 4, wherein the step of preventing backflow comprises allowing, after the substance is introduced into the reservoir, a closure apparatus on the reservoir to automatically close to prevent substance from backflowing out of the reservoir lumen.

7. A method according to claim 6, wherein the closure apparatus comprises a one-way valve.

8. A method according to claim 1, wherein at least one of the implantable reservoir or the elongate shaft comprises at least one imageable marker, and wherein the method further comprises imaging the imageable marker.

9. A method according to claim 1, further comprising using an anchoring apparatus coupled with the implantable reservoir to anchor the implantable reservoir to tissue in the head.

10. A method according to claim 1, wherein the at least one aperture comprises multiple apertures or pores in the expandable reservoir body, and wherein the substance passes out of at least some of the apertures or pores.

11. A method according to claim 10 wherein the substance is a substance that will pass through the pores at a known rate.

12. A method according to claim 1, wherein the implantable reservoir is at least partially biodegradable.

13. A method according to claim 1 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 mucolytie 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.

14. A method according to claim 1, wherein the substance comprises a steroid or non-steroidal anti-inflammatory agent.

15. A method according to claim 14, wherein the substance comprises a steroid selected from the group consisting of beclomethasone, flunisolide, fluticasone, triamcinolone, mometasone, aclometasone, desonide, hydro cortisone, betamethasone, clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone, prednicarbate;

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

16. A method according to claim 1, wherein the substance comprises an antimicrobial.

17. A method according to claim 16 wherein the antimicrobial is selected from the group consisting of:

acyclovir, amantadine, am rimantadine, oseltamivir, zanamivir, inoglycosides, amikacin, gentamicin, tobramycin, amoxicillin, amoxicillin/clavulanate, amphotericin B, ampicillin, ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime, cefotaxime, cefotetan, cefpdoxime, ceftazidime, ceftizoxime, cefiriaxone, cefuroxime, cefhroxime axetil, cephalexin, chioramphenicol, clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet, ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazoic, ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillins including penicillin G, pentamidine, piperacillin/tazobactam, rifampin, quinupristin-dalfopristin, ticarcillin/clavulanate, trimethoprim/sulfamethoxazole, valacyclovir, vancomycin, mafenide, silver sulfadiazine, mupirocin, nystatin, triameinolone/nystatin, clotrimazole/betamethasone, clotrimazole, ketoconazole, butoconazole, miconazole, tioconazole, detergent-like chemicals that disrupt or disable microbes, nonoxynol-9, octoxynol-9, benzalkonium chloride, menfegol, and N-docasanol, chemicals that block microbial attachment to target cells, chemical that inhibits entry of infectious pathogens into cells, sulphated polymers, sulponated polymers, carrageenan, antiretroviral agents, PMPA gel, antibodies, genetically engineered or naturally occurring antibodies that combat pathogens, plantibodies, agents which change the condition of the tissue to make it hostile to the microbes, agents which alter mucosal pH, buffer gel, acidform non-pathogenic microbes that kill or inhibit the growth of pathogenic microbes and antimicrobial metals.

18. A method according to claim 1, wherein the implantable reservoir further comprises a tubular member forming a reservoir lumen, wherein introducing the substance or component thereof comprises introducing it through the lumen of the elongate shaft, through the reservoir lumen and through the one-way valve into the reservoir.

19. A method according to claim 1, wherein at least one of the implantable reservoir or the elongate shaft further comprises a guidewire lumen, and wherein the method further comprises, before introducing the reservoir:

inserting a guidewire into the head; and

introducing at least one of the reservoir or the shaft over the guidewire.

20. A method according to claim 19, wherein the guidewire lumen extends from a distal opening in the distal end of the reservoir to a proximal opening in the proximal end of the shaft.

21. A method according to claim 19, wherein the guidewire lumen extends from a distal opening in the distal end of the reservoir to a side opening located between proximal and distal ends of the shaft.

22. A method according to claim 1, wherein the implantable reservoir is configured such that, when expanded, a body fluid may flow through or around the implantable reservoir.

23. A method according to claim 1, at least one wicking member coupled with the implantable reservoir for promoting passage of the substance out of the reservoir by a wicking action.

24. A method according to claim 1, wherein detaching the shaft from the reservoir comprises cutting at a junction of the shaft with the reservoir.

25. A method according to claim 1, wherein detaching the shaft from the reservoir comprises cutting the shaft at a location proximal to a junction of the shaft with the reservoir, wherein a distal portion of the shaft is left in the head, coupled with the implantable reservoir.