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

• US 20060106361A1
• Filed: 09/23/2005
• Published: 05/18/2006
• 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., Facteau, William M., Chang, John Y.
• Granted Patent: US 7,410,480 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 the body of a human or animal subject to diagnose or treat a disorder, said method comprising the steps of:

A) providing an implantable substance delivery device that comprises i) a removable portion comprising an elongate shaft having a lumen and a distal end and ii) an implantable portion comprising a substance delivery reservoir having a first configuration and a second configuration, said reservoir being in communication with the lumen of the removable portion such that a therapeutic or diagnostic substance, or a component thereof, may be introduced through the lumen and into the reservoir, said implantable portion being detachable from the removable portion such that the removable portion may be removed from the subject'"'"'s body leaving the implantable portion within the subject'"'"'s body;

B) introducing the substance delivery device into the subject'"'"'s body while the reservoir is in its first configuration;

C) positioning the implantable portion at a desired location within the subject'"'"'s body;

D) providing a therapeutic or diagnostic substance;

E) introducing the substance, or a component thereof, through the lumen and into the reservoir thereby causing the reservoir to assume the second configuration;

F) detaching the removable portion from the implantable portion; and

G) removing the removable portion from the subject'"'"'s body.

2. A method according to claim 1 wherein the reservoir, when in its second configuration, engages at least one adjacent anatomical structure in a manner that deters unwanted movement of the implantable portion after it has been implanted and wherein:

Step C comprises positioning the implantable portion at a desired location relative to said at least one anatomical structure; and

Step E comprises introducing a sufficient volume of the substance into the reservoir to cause the reservoir to expand to its second configuration thereby engaging said at least one anatomical structure in a manner that deters unwanted movement of the implantable portion.

3. A method according to claim 2 wherein desired location is a location within the subject'"'"'s ear, nose or throat.

4. A method according to claim 3 wherein at least a portion of the reservoir is positioned within a paranasal sinus.

5. A method according to claim 4 wherein at least a portion of the reservoir positioned within a paranasal sinus and, when in its second configuration, is too large to pass through an opening of that paranasal sinus, thereby deterring unwanted movement of the reservoir.

6. A method according to claim 3 wherein the desired location is such that at least a portion of the reservoir is positioned within a Eustachian tube.

7. A method according to claim 3 wherein the desired location is such that at least a portion of the reservoir is positioned within a naso-lacrymal duct.

8. A method according to claim 1 wherein the implantable portion of the device further comprises at least one stent apparatus for stenting an opening or passageway of the subject'"'"'s body.

9. A method according to claim 8 wherein Step C comprises positioning the implantable portion such that the at least a portion of the reservoir is within a paranasal sinus and the stent apparatus is positioned within an opening of that paranasal sinus.

10. A method according to claim 1 wherein the implantable portion further comprises a substance introducing lumenthat is connected to the lumen of the of the removable portion when the removable portion is attached to the implantable portion, and wherein Step E comprises introducing fluid through the lumen of the removable portion, through the substance introducing lumen of the implantable portion and into the reservoir.

11. A method according to claim 10 wherein the implantable portion further comprises a second lumen that provides drainage or ventilation when the implantable portion is implanted within the subject'"'"'s body.

12. A method according to claim 11 wherein the second lumen extends through a stent apparatus and wherein Step C further comprises positioning the stent apparatus at a location whereby the stent apparatus performs a stenting function.

13. A method according to claim 12 wherein Step C comprises positioning the implantable portion such that the at least a portion of the reservoir is within a paranasal sinus, the stent is positioned within an opening of that paranasal sinus and the second lumen provides drainage or ventilation of the paranasal sinus.

14. A method according to claim 11 further comprising the step of clamping, clipping, ligating, tying or compressing the substance introducing lumen of the implantable portion to prevent substance that has been introduced into the reservoir from backflowing out of the reservoir filling lumen.

15. A method according to claim 14 wherein the implantable portion further comprises a closure apparatus that is used to prevent substance from backflowing out of the reservoir filling lumen.

16. A method according to claim 15 wherein the closure apparatus comprises a self sealing needle port and wherein Step C comprises i) inserting a needle through the self sealing needle port, ii) infusing the substance through the needle and into the reservoir and iii) removing the needle thereby allowing the self sealing needle port to seal.

17. A method according to claim 15 wherein the closure apparatus comprises a valve.

18. A method according to claim 17 wherein the valve comprises a check valve that allows fluid to be infused in a first direction into the reservoir during Step C but thereafter prevents fluid from flowing in a second direction out of the reservoir.

19. A method according to claim 15 wherein the closure apparatus comprises an applicator for applying an adhesive to the fill site to close the fill site.

20. A method according to claim 15 wherein the closure apparatus comprises a clip for closing the fill site.

21. A method according to claim 15 wherein the closure apparatus comprises a clamp for closing the fill site.

22. A method according to claim 15 wherein the closure apparatus comprises a ligature for closing the fill site.

23. A method according to claim 15 wherein the closure apparatus comprises a sealing material through which a substance injector may be inserted and withdrawn, said sealing material being operative to substantially seal the tract created therethrough by insertion of the injector after the injector has been removed.

24. A method according to claim 15 wherein the closure apparatus is located with the reservoir.

25. A method according to claim 15 wherein the closure apparatus is located within the substance introducing lumen of the implantable portion.

26. A method according to claim 17 wherein the closure apparatus comprises a duckbill valve.

27. A method according to claim 17 wherein the closure apparatus comprises an elastomeric sleeve valve.

28. A method according to claim 1 wherein the device provided in Step A comprises at least one imageable marker and wherein the method further comprises the step of imaging the imageable marker.

29. A method according to claim 1 wherein the device provided in Step A further comprises an anchoring apparatus for anchoring the implantable portion and wherein the method further comprises the step of using the anchoring apparatus to anchor the implantable portion.

30. A method according to claim 1 wherein the reservoir has at least one substance release location through which substance escapes from the reservoir and wherein Step E comprises introducing the substance, or a component of the substance, through the lumen and into the reservoir causing the reservoir to thereby contain a quantity of the substance in a form that will subsequently be released through the at least one substance release location.

31. A method according to claim 30 wherein the at least one substance release location comprises at least one aperture formed in the reservoir such that substance introduced into the reservoir in Step E will pass out of the reservoir through said at least one aperture.

32. A method according to claim 30 wherein the at least one substance release location comprises at least one barrier that allows a substance having a certain property to pass out of the reservoir through the barrier at a known rate.

33. A method according to claim 32 wherein the certain property is viscosity or a range of viscosities.

34. A method according to claim 32 wherein the certain property is a molecular weight or range of molecular weights.

35. A method according to claim 32 wherein the certain property is an electrical charge.

36. A method according to claim 32 wherein the certain property is osmolarity or a range of osmolarities.

37. A method according to claim 32 wherein the certain property is osmolality or a range of osmolalities.

38. A method according to claim 32 wherein the certain property is the hydrophobic or hydrophilic nature of the substance.

39. A method according to claim 32 wherein the certain property is the presence of a certain chemical group or atom.

40. A method according to claim 32 wherein the barrier comprises a semipermeable barrier.

41. A method according to claim 40 wherein the semipermeable barrier has pores of a known size.

42. A method according to claim 41 wherein the substance is a substance that will pass through the pores at a known rate.

43. A method according to claim 1 wherein the implantable portion is at least partially biodegradable.

44. A method according to claim 1 wherein the implantable portion is not biodegradable.

45. A method according to claim 1 wherein the implantable portion is removable and wherein the method further comprises the step of:

G) removing the implant from the subject'"'"'s body.

46. A method according to claim 45 wherein the implantable portion comprises an anchoring apparatus that engages an adjacent anatomical structure to deter unwanted movement of the implantable portion and wherein Step G further comprises disengaging the anchoring apparatus before removing the implantable portion from the subject'"'"'s body.

47. 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 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.

48. A method according to claim 1 wherein the disorder causes inflammation of the nose or paranasal sinus and wherein the substance comprises a steroid or non-steroidal anti-inflammatory agent that causes reduction of the inflammation.

49. A method according to claim 39 wherein the substance comprises a steroid that is selected from the group of steroids consisting of beclomethasone, flunisolide, fluticasone, triamcinolone, 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.

50. A method according to claim 1 wherein the disorder is caused at least in part by a microbial infection and wherein the substance comprises an antimicrobial.

51. A method according to claim 50 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, cefpodoxime, ceftazidime, ceftizoxime, ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol, clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone, dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet, ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole, 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, 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 non-pathogenic microbes that kill or inhibit the growth of pathogenic microbes and antimicrobial metals.

52. A method according to claim 1 wherein Step C comprises introducing the substance through the lumen and into the reservoir.

53. A method according to claim 1 wherein the reservoir contains a first component of the substance prior to performance of Step C and wherein Step C comprises introducing a second component of the substance into the reservoir such that it combined with the first component, thereby forming said substance within the reservoir.

54. A method according to claim 53 wherein the first component comprises a reconstitutable form of a therapeutic or diagnostic substance and the second component comprises a reconstituting agent which combines with the reconstitutable form of a therapeutic or diagnostic substance to cause the reservoir to contain a reconstituted therapeutic or diagnostic substance that is deliverable from the substance delivery reservoir.

55. A method according to claim 54 wherein the reconstitutable form of a therapeutic or diagnostic substance comprises a dried or lyophilized form of the therapeutic or diagnostic substance and the reconstituting agent comprises a liquid in which the dried or lyophilized form of the therapeutic or diagnostic substance becomes dissolved or suspended such that it is deliverable from the substance delivery reservoir.

56. A method according to claim 53 wherein the first component comprises an inactive form or component of a therapeutic or diagnostic substance and the second component comprises an activating agent which combines with the inactive form or component to cause the reservoir to contain an active therapeutic or diagnostic substance that is deliverable from the substance delivery reservoir.

57. A method according to claim 1 wherein the reservoir comprises a balloon.

58. A method according to claim 57 wherein the implantable portion further comprises a tubular member having alumen, the lumen of said tubular member being initially connected to the lumen of the elongate shaft such that, in Step E, the substance or component thereof may be introduced through the lumen of the elongate shaft, through the lumen of the implantable portion and into the reservoir.

59. A method according to claim 1 wherein the device further comprises a guidewire lumen and Step B comprises i) inserting a guidewire into the subject'"'"'s body and ii) introducing the device over the guidewire.

60. A method according to claim 59 wherein the guidewire lumen extends from a distal opening in the distal end of the device to a proximal opening in the proximal end of the device such that, in Step B. the guidewire extends substantially through the entire length of the device.

61. A method according to claim 59 wherein the guidewire lumen extends from a distal opening in the distal end of the device to a side opening located between the proximal and distal ends of the device such that, in Step B, the guidewire extends only though the portion of the device that extends between the distal opening and the side opening.

62. A method according to claim 1 wherein the implantable portion is configured such that, when the reservoir is in its second configuration, a body fluid may flow through or around the implantable portion.

63. A method according to claim 62 wherein the implantable portion is implanted in a paranasal sinus, Eustachian tube, naso-lacrimal duct or other passageway of the ear, nose, throat or paranasal sinus and wherein mucous passes through or around the implantable portion.

64. A method according to claim 1 further comprising the step of dilating or enlarging an opening of a paranasal sinus and wherein:

the device provided in Step A comprises a stent member attached to said reservoir and wherein the implantable portion is positioned such that all or a portion of the reservoir is within the paranasal sinus and the stent portion is within the dilated or enlarged opening of that paranasal sinus.

65. A method according to claim 64 wherein the stent portion is sized to substantially maintain the dilated or enlarged size of the opening of the paranasal sinus during a postoperative period.

66. A method according to claim 64 wherein the stent portion has a lumen through which air may vent into the paranasal sinus.

67. A method according to claim 64 wherein the stent portion has a lumen through which matter may drain out of the paranasal sinus.

68. A method according to claim 1 wherein the removable portion of the device provided in Step A further comprises a detachment tool for detaching the implantable portion from the removable portion and wherein the method further comprises the step of using said detachment tool to detach the implantable portion from the removable portion.

69. A method according to claim 68 wherein the detachment tool comprises a sheath that is advanceable and is used to push the implantable portion apart from the removable portion.

70. A method according to claim 1 wherein an intraostial portion of the implantable portion of the device is configured to reside within the ostium of a paranasal sinus and wherein Step C comprises positioning the intraostial portion within the ostium of a paranasal sinus.

71. A method according to claim 70 wherein the method further comprises the step of enlarging the ostium prior to performance of Step C.

72. A method according to claim 71 wherein the step of enlarging the ostium comprises:

advancing a guide wire through the nasal cavity, through the ostium of the paranasal sinus and into the interior of the paranasal sinus;

advancing an ostium enlarging apparatus over the guide wire to a position within the ostium of the paranasal sinus; and

using the ostium enlarging apparatus to enlarge the ostium of the paranasal sinus.

73. A method according to claim 72 wherein the ostium enlarging apparatus comprises a balloon and wherein said balloon is inflated to cause dilation of the ostium, thereby increasing the diameter of the ostium.

74. A method according to claim 72 wherein the step of using the ostium enlarging apparatus to enlarge the ostium of the paranasal sinus results in the breaking of bone adjacent to the ostium.

75. A method according to claim 71 wherein the intraostial portion performs a scaffolding function whereby it prevents the enlarged ostium from retracting to a substantially smaller diameter for at least a desired time period.

76. A method according to claim 75 wherein the desired time period is long enough to allow the enlarged ostium to heal such that, thereafter, it will substantially remain at its enlarged diameter without the need for continued scaffolding.

77. A method according to claim 75 wherein the desired time period is from approximately 3 days to approximately 4 week(s).

78. A method according to claim 75 wherein the step of using the ostium enlarging apparatus to enlarge the ostium of the paranasal sinus results in the breaking of bone adjacent to the ostium and wherein the desired time period is long enough to allow the broken bone to heal sufficiently to substantially retain the enlarged diameter of the ostium.

79. A method according to claim 30 wherein the at least one substance release location comprises least one wicking member that carries substance out of the reservoir by a wicking action.

80. A method according to claim 30 wherein the implantable portion is implanted adjacent to a mucosal surface with the substance release location positioned to deposit the substance at a site on the mucosal surface from which the substance will be distributed by mucocilliary action.

81. A method according to claim 80 wherein the at least one substance release location is positioned within a paranasal sinus such that the substance is deposited at a site from which mucocillary action will distribute the substance about the inner wall of the paranasal sinus.

82. A method according to claim 81 wherein the at least one substance release location is positioned to deposit substance on the medial wall of a frontal sinus.

83. A method according to claim 81 wherein the at least one substance release location is positioned to deposit substance on the lateral wall of a maxillary sinus.

84-189. -189. (canceled)