# US 9,039,680 B2 · Implantable devices and methods for delivering drugs and other substances to treat sinusitis and other disorders > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,039,680 B2 - Document ID: US9039680B2 - Status: Granted - Kind: B2 - Application number: 12/107,005 - Filed: 2008-04-21 - Published: 2009-01-01 - Granted: 2015-05-26 - Earliest claimed: 2004-08-04 - Assignees: Acclarent, Inc. - Applicants: Joshua Makower; John Y. Chang; Julia D. Vrany; Amrish Jayprakash Walke - Inventors: Joshua Makower; John Y. Chang; Julia D. Vrany; Amrish Jayprakash Walke - Web page: https://patentgrep.com/patent/US9039680B2 ## CPC - A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient} - 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)} - A61B 5/064: {using markers (A61B5/062 takes precedence)} - A61B 5/411: {Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance} - 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 - 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}) - G03G 5/0535: {Polyolefins; Polystyrenes; Waxes} - G03G 5/0539: {Halogenated polymers} - G03G 5/056: {Polyesters} - G03G 5/0564: {Polycarbonates} - G03G 5/0696: {Phthalocyanines} - G03G 5/14726: {Halogenated polymers} - 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} - A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)} - 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)} - A61B 17/320783: {through side-hole, e.g. sliding or rotating cutter inside catheter} - A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)} - A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis - A61B 2017/22061: {for spreading elements apart} - A61F 2/18: Internal ear or nose parts, e.g. ear-drums {(implants for middle ear ventilation or drainage A61F11/202)} - 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) - A61F 2002/825: {having longitudinal struts} - A61F 2250/0039: differing in diameter - 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)} - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - A61M 31/005: {for contrast media} - A61M 31/007: {Injectors for solid bodies, e.g. suppositories} - A61M 2025/0037: {characterized by lumina being arranged side-by-side} - A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector} - A61M 2210/0681: Sinus (maxillaris) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - G03G: ELECTROGRAPHY; ELECTROPHOTOGRAPHY; MAGNETOGRAPHY - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## 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 ### Claim 1 A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat a disorder, said method comprising the steps of: (a) obtaining or providing a device that comprises: (i) a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance, said reservoir being sufficiently small to fit through an opening into the paranasal sinus, (ii) a catheter coupled with the reservoir for filling the reservoir with the substance, wherein a detachable portion of the catheter is detachable and removable after the reservoir has been filled, thereby leaving a non-detached portion of the catheter connected to the reservoir after the detachable portion of the catheter has been detached and removed, (iii) a closure apparatus comprising a one way valve that allows substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, the detachable portion of the catheter being proximal to the closure apparatus such that the closure apparatus remains with the reservoir after the detachable portion of the catheter has been detached and removed, and (iv) a barrier surrounding at least part of the reservoir such that substance that has been loaded into the reservoir will pass out of the reservoir through the barrier at a known rate, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface; (b) inserting the reservoir of the device into the nasal cavity, paranasal sinus or opening into a paranasal sinus; and (c) thereafter loading the substance into the reservoir, wherein the act of loading the substance into the reservoir includes urging the substance through a lumen extending longitudinally through the reservoir, wherein the lumen is contained within the reservoir. ### Claim 2 (depends on 1) A method according to claim 1, further comprising at least one substance introducing apparatus useable to introduce the substance through a fill site and into the reservoir. ### Claim 3 (depends on 2) A method according to claim 2, wherein the substance introducing apparatus comprises a syringe. ### Claim 4 (depends on 2) A method according to claim 2, wherein the device comprises a measured quantity of the substance that has been preloaded into the substance introducing apparatus. ### Claim 5 (depends on 1) A method according to claim 1, wherein the reservoir comprises a porous material which will hold a quantity of the substance, wherein the porous material is in fluid communication with the lumen. ### Claim 6 (depends on 5) A method according to claim 5, wherein the porous material is a material selected from the group of porous materials consisting of flexible polymer foams, biodegradable polymer foams, non-biodegradable polymer foams, porous PLLA, porous PLGA, porous hydrogel, polyvinyl alcohols, silicone foams, polytetrafluoroethylene, expanded polytetraflurorethylene, latex, and nylon. ### Claim 7 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises a valve. ### Claim 8 (depends on 7) A method according to claim 7, wherein the valve comprises a check valve that allows fluid to be infused in a first direction into the reservoir during but thereafter prevents fluid from flowing in a second direction out of the reservoir. ### Claim 9 (depends on 1) A method according to claim 1, wherein the device has a collapsed configuration and an expanded configuration such that the device may be advanced through a passageway of the body while in its collapsed configuration and thereafter expanded to or is allowed to assume its expanded configuration. ### Claim 10 (depends on 9) A method according to claim 9, wherein introduction of the substance into the reservoir causes the device to transition from its collapsed configuration to its expanded configuration. ### Claim 11 (depends on 1) A method according to claim 1, further comprising an apparatus for moving the substance out of the reservoir and/or through the barrier. ### Claim 12 (depends on 11) A method according to claim 11, wherein the apparatus for moving the substance is selected from the group consisting of an osmotic pump, a mechanical pump, an electro-mechanical pump, a nanotechnology pumping mechanism and an electrical device that emits a current to drive the transport. ### Claim 13 (depends on 1) A method according to claim 1, wherein the reservoir comprises a hollow cavity in fluid communication with the lumen. ### Claim 14 (depends on 1) A method according to claim 1, wherein the reservoir comprises a hollow cavity in combination with a porous material which will hold a quantity of the substance, wherein the hollow cavity and the porous material are in fluid communication with the lumen. ### Claim 15 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises a self-sealing needle port. ### Claim 16 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises an applicator for applying an adhesive to a fill site to close the fill site. ### Claim 17 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises a clip for closing a fill site. ### Claim 18 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises a clamp for closing a fill site. ### Claim 19 (depends on 1) A method according to claim 1, wherein the closure apparatus comprises a ligature for closing a fill site. ### Claim 20 (depends on 1) A method according to claim 1, wherein the barrier has pores sized to allow passage therethrough of the substance at a rate of from 180 micrograms to 260 micrograms of triamcinolone acetonide per 24 hour period. ### Claim 21 (depends on 1) A method according to claim 1 wherein, the substance comprises triamcinolone acetonide and at least one additional agent 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 imunomodulator, an SYK kinase inhibitor, a chemotherapeutic agent, an antineoplastic agent, a mucolytic 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. ### Claim 22 (depends on 1) A method according to claim 1 wherein, the substance comprises triamcinolone acetonide and at least one additional steroid selected from the group consisting of beclomethasone, flunisolide, fluticasone, mometasone, aclometasone, desonide, hydrocortisone, betamethasone, clocortolone, desoximetasone, fluocinolone, flurandrenolide, mometasone, prednicarbate; amcinonide, desoximetasone, diflorasone, fluocinolone, fluocinonide, halcinonide, clobetasol, augmented betamethasone, diflorasone, halobetasol, prednisone, dexamethasone and methylprednisolone. ### Claim 23 (depends on 1) A method according to claim 1 wherein, the substance comprises triamcinolone acetonide and at least one antimicrobial agent selected from the group consisting of acyclovir, amantadine, aminoglycosides, amikacin, gentamicin, tobramycin, amoxicillin, amoxicillin/clavulanate, amphotericin B, ampicillin, ampicillin/sulbactarn, atovaquone, azithromycin, cefazolin, cefepime, cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol, clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline, erythromycin, fluconazole, foscamet, ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole, ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin, penicillin G, pentamidine, piperacillin/tazobactam, rifampin, quinupristin-dalfopristin, ticarcillin/clavulanate, trimethoprim/sulfamethoxazole, valacyclovir, vancomycin, mafenide, silver sulfadiazine, mupirocin, nystatin, triamcinolone/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 and non-pathogenic microbes that kill or inhibit the growth of pathogenic microbes. ### Claim 24 (depends on 1) A method according to claim 1, wherein the device is at least partially biodegradable. ### Claim 25 (depends on 1) A method according to claim 1, further comprising a graspable member extending from the device to facilitate grasping and removal of the device. ### Claim 26 (depends on 1) A method according to claim 1, wherein the device has a substantially rectangular cross-sectional configuration. ### Claim 27 (depends on 1) A method according to claim 1, wherein the reservoir is further configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration that an exterior surface of the reservoir defines at least one projection configured to contact an interior surface of the paranasal sinus. ### Claim 28 (depends on 1) A method according to claim 1, wherein the device has an intraosteal portion that is configured to be implanted within the ostium of a paranasal sinus and an intrasinus portion that is intended to extend into the paranasal sinus. ### Claim 29 A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat sinusitis, said method comprising the steps of: (a) obtaining or providing a system that comprises: (i) a substance delivery device, comprising: (A) a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance, said reservoir being sufficiently small to fit through an opening into the paranasal sinus, wherein the reservoir comprises a porous material disposed about a porous lumen extending longitudinally through the reservoir, and (B) a barrier surrounding at least part of the reservoir such that the barrier substantially encompasses the porous material and at least part of the porous lumen and such that substance that has been loaded into the reservoir will pass out of the reservoir through the barrier at a known rate, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface, (ii) a delivery catheter system comprising a catheter that is coupled with the reservoir for filling the reservoir with the substance, wherein a detachable portion of the catheter is detachable and removable after the reservoir has been filled, thereby leaving a non-detached portion of the catheter connected to the reservoir after the detachable portion of the catheter has been detached and removed, and (iii) a closure apparatus comprising a one way valve that allows substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, the detachable portion of the catheter being proximal to the closure apparatus such that the closure apparatus remains with the reservoir after the detachable portion of the catheter has been detached and removed; (b) using the delivery catheter system to deliver the substance delivery device to a position where the reservoir is positioned in the paranasal sinus; and (c) loading the substance into the reservoir, wherein the act of loading the substance into the reservoir comprises urging the substance through a-the barrier and into the reservoir. ### Claim 30 (depends on 29) A method according to claim 29, wherein the delivery catheter system comprises: (A) a catheter that has a lumen and a distal opening, said substance delivery device being positioned within the lumen of the catheter, and (B) a member positioned within the lumen of the catheter proximal to the implantable substance delivery device; at least one of said catheter and said member being moveable relative to the other so as to expel the implantable substance delivery device out of the distal opening of the catheter. ### Claim 31 (depends on 30) A method according to claim 30, wherein the substance delivery device and the member positioned within the lumen of the catheter have guide wire passageways extending therethrough so as to allow the system to be advanced over a guide wire. ### Claim 32 (depends on 30) A method according to claim 30, wherein the catheter further comprises a second lumen sized to permit a guidewire to pass therethrough, said second lumen being useable to allow the system to be tracked in a previously inserted guidewire. ### Claim 33 A method for delivering a substance to a location within a nasal cavity, paranasal sinus or opening into a paranasal sinus, of a human or animal subject to treat a disorder, said method comprising the steps of: (a) obtaining or providing a device that comprises: (i) a porous lumen having a distal end and a proximal end, (ii) a porous barrier having a distal end and a proximal end, wherein the distal end of the barrier is coupled to the distal end of the lumen, wherein the proximal end of the barrier is coupled to an exterior surface of the lumen at a position distally of the proximal end of the lumen, (iii) a reservoir defined between an exterior surface of the lumen and an interior surface of the barrier and between the proximal end of the barrier and the distal end of the barrier such that the lumen extends the length of the reservoir, wherein the reservoir is substantially free of the substance but may subsequently be loaded with the substance, the reservoir being sufficiently small to fit through an opening into the paranasal sinus, wherein the reservoir is configured such that, when the reservoir is implanted and loaded with said substance, the reservoir will assume a configuration such that the reservoir defines at least one flow channel through which mucus or other biological fluid may drain, wherein the at least one flow channel is defined between an exterior surface of the barrier and an anatomical surface, (iv) a catheter configured to provide the substance to the reservoir, and (v) a closure apparatus coupled to the proximal end of the lumen, wherein the closure apparatus is selectively coupleable to the catheter, wherein the closure apparatus is configured to allow the substance to be introduced through the catheter into the reservoir but prevents the substance from flowing back out of the reservoir, (b) inserting the reservoir of the device into the nasal cavity, paranasal sinus or opening into a paranasal sinus; and (c) thereafter loading the substance into the reservoir, wherein the act of loading the substance into the reservoir includes urging the substance through the lumen.