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

• US 20050245906A1
• Filed: 08/04/2004
• Published: 11/03/2005
• Est. Priority Date: 04/21/2004
• Status: Active Grant

• Current Assignee: Acclarent Incorporated (Johnson & Johnson)
• Original Assignee: Exploramed NC1 Inc (Johnson & Johnson)
• Inventors: Makower, Joshua, Walke, Amrish Jayprakash, Chang, John Y., Vrany, Julia D.
• Granted Patent: US 7,361,168 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• 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 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 substance reservoir that may be loaded with a substance that is therapeutically effective to diagnose or treat the disorder and ii) a barrier that will limit the rate at which a substance will flow out of the reservoir;

B) providing a substance that is useable to diagnose or treat the disorder;

C) introducing the substance into the reservoir; and

D) implanting the device at a location within the subject'"'"'s body such that the substance will be delivered by the implanted device to a location within the subject'"'"'s body.

2. A method according to claim 1 wherein the reservoir of the device comprises a hollow cavity.

3. A method according to claim 2 wherein the hollow cavity comprises a tube.

4. A method according to claim 1 wherein the reservoir of the device comprises a porous material which will hold a quantity of the substance.

5. A method according to claim 4 wherein the porous material comprises a sponge.

6. A method according to claim 1 wherein the reservoir of the device comprises a hollow cavity in combination with a porous material which will hold a quantity of the substance.

7. A method according to claim 6 wherein the porous material is located adjacent to the hollow cavity such that the substance may be initially introduced into the hollow cavity and thereafter absorbed or transported into the porous material.

8. A method according to claim 1 wherein the device further comprises a fill site through which the substance is introduced into the reservoir in Step C.

9. A method according to claim 8 further comprising the step of:

E) closing the fill site after the substance has been introduced into the reservoir in Step C.

10. A method according to claim 8 wherein the fill site comprises a port.

11. A method according to claim 8 wherein the fill site comprises a tube through which the substance may be introduced into the reservoir.

12. A method according to claim 11 further comprising the step of removing at least a portion of said tube after the substance has been introduced into the reservoir.

13. A method according to claim 11 further comprising the step of clamping, clipping, ligating, tying or compressing the tube after the substance has been introduced into the reservoir.

14. A method according to claim 8 wherein the implant further comprises a closure apparatus to prevent substance from backflowing out of the fill site after the substance has been introduced into the reservoir.

15. A method according to claim 14 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.

16. A method according to claim 14 wherein the closure apparatus comprises a valve.

17. A method according to claim 16 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.

18. A method according to claim 14 wherein the closure apparatus comprises an applicator for applying an adhesive to the fill site to close the fill site.

19. A method according to claim 14 wherein the closure apparatus comprises a clip for closing the fill site.

20. A method according to claim 14 wherein the closure apparatus comprises a clamp for closing the fill site.

21. A method according to claim 14 wherein the closure apparatus comprises a ligature for closing the fill site.

22. A method according to claim 14 wherein the closure apparatus comprises a self sealing material through which a needle may be inserted and which will substantially seal the tract created therethrough by the needle after the needle is removed.

23. A method according to claim 1 wherein the barrier will allow a substance having a certain property to pass out of the reservoir through the barrier at a known rate.

24. A method according to claim 23 wherein the certain property is viscosity or a range of viscosities.

25. A method according to claim 23 wherein the certain property is a molecular weight or range of molecular weights.

26. A method according to claim 23 wherein the certain property is an electrical charge.

27. A method according to claim 23 wherein the certain property is osmolarity or a range of osmolarities.

28. A method according to claim 23 wherein the certain property is osmolality or a range of osmolalities.

29. A method according to claim 23 wherein the certain property is the hydrophobic or hydrophilic nature of the substance.

30. A method according to claim 23 wherein the certain property is the presence of a certain chemical group or atom.

31. A method according to claim 1 wherein the barrier comprises a semipermeable barrier.

32. A method according to claim 31 wherein the semipermeable barrier has pores of a known size.

33. A method according to claim 32 wherein the substance is a substance that will pass through the pores at a known rate.

34. A method according to claim 1 wherein the device is at least partially biodegradable.

35. A method according to claim 1 wherein the device is not biodegradable.

36. A method according to claim 1 wherein the device is removable and wherein the method further comprises the step of:

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

37. A method according to claim 36 wherein the device has a graspable member extending therefrom and wherein Step E comprises grasping the graspable member and pulling the device to cause removal of the device.

38. 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.

39. 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.

40. 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.

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

42. A method according to claim 1 wherein the antimicrobial is selected from the group consisting of:

acyclovir, amantadine, aminoglycosides, 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, 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 non-pathogenic microbes that kill or inhibit the growth of pathogenic microbes and antimicrobial metals.

43. A method according to claim 1 wherein Step C is performed prior to Step D.

44. A method according to claim 1 wherein Step C is performed after Step D.

45. A method according to claim 1 wherein the device provided in Step A further comprises a frame and wherein Step D comprises positioning the implant such that the frame maintains the implant in a desired shape.

46. A method according to claim 1 wherein the implant provided in Step A further comprises a frame that has a collapsed configuration and an expanded configuration and wherein the device is advanced into the nose or paranasal sinus while the frame is in its collapsed configuration and, thereafter, the frame is expanded to or is allowed to assume its expanded configuration.

47. A method according to claim 46 wherein the substance is passed through the fill site and into the reservoir after the frame has been expanded to or allowed to assume its expanded configuration.

48. A method according to claim 1 wherein the implant has a generally round cross-sectional configuration_[AW1].

49. A method according to claim 1 wherein the implant has a generally rectangular cross-sectional configuration_[AW2].

50. A method according to claim 1 wherein the implant has an outer surface and, when implanted and loaded with substance, the outer surface of the implant has peaks which contact adjacent anatomical tissue and valleys that remain spaced away from anatomical tissue.

51. A method according to claim 50 wherein Step D comprises placing the device within a natural or man made passageway that is lined with mucosal tissue such that the peaks are in contact with mucosal tissue and the valleys are a spaced distance away from mucosal tissue.

52. A method according to claim 51 wherein the natural or man made passageway is located in a nasal cavity, paranasal sinus, Eustachian tube, nasolacrimal duct or other passageway lined with ciliated mucosa and wherein the valleys remain a spaced distance away from the adjacent ciliated mucosa so as not to interfere with mucocillary transport by that tissue.

53. A method according to claim 1 wherein the device is configured such that, when the device is implanted and loaded with substance, the device is configured so as to define at least one flow channel and wherein the device is positioned in Step D such that mucous or other biological fluid will drain through the at least one flow channel.

54. A method according to claim 1 wherein the disorder is sinusitis or another disorder of the ear, nose, throat or paranasal sinus and wherein Step D comprises implanting the device in the nose, eustachian tube, ear and/or paranasal sinus.

55. A method according to claim 54 wherein the device is implanted such that an intraostial portion of the device resides within an ostium of a paranasal sinus and an intrasinus portion of the device extends into the paranasal sinus.

56. A method according to claim 55 wherein there is at least one indentation in the intraostial portion of the device such that at least a portion of the ostium is received within said at least one indentation.

57. A method according to claim 55 wherein the intrasinus portion of the device has a nonexpanded configuration that is small enough to be pass through the ostium and an expanded configuration that is too large to pass through the ostium.

58. A method according to claim 55 wherein introduction of the substance into the reservoir in Step C causes the intrasinus portion of the implant to expand from its non-expanded configuration.

59. A method according to claim 58 wherein the intrasinus portion of the device is advanced into the sinus and, thereafter, Step C is carried out thereby causing the intrasinus portion of the device to expand in situ to its expanded configuration.

60. A method according to claim 59 wherein the in situ expansion of the intrasinus portion of the device causes the intrasinus portion of the device to be retained within the sinus for at least a time period during which it is desired for the device to deliver the substance within the sinus.

61. A method according to claim 55 wherein the intraostial portion of the device substantially blocks the ostium.

62. A method according to claim 55 wherein the method further comprises enlarging the ostium prior to performance of Step D.

63. A method according to claim 55 comprising:

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;

using the ostium enlarging apparatus to enlarge the ostium of the paranasal sinus; and

thereafter performing Step D.

64. A method according to claim 63 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.

65. A method according to claim 63 wherein the step of using the ostium enlarging apparatus to to enlarge the ostium of the paranasal sinus results in the breaking of bone adjacent to the ostium.

66. A method according to claim 63 wherein the device implanted in Step D has an intraostial portion that resides within the ostium of the paranasal sinus after said ostium has been enlarged and wherein the intraostial portion of said device performs a scaffolding function whereby it prevents the enlarged ostium from retracting to a substantially smaller diameter for at least a desired time period.

67. A method according to claim 64 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.

68. A method according to claim 67 wherein the desired time period is from approximately 7 days to approximately 4 week(s).

69. A method according to claim 66 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.

70. A method according to claim 69 wherein the desired time period is from approximately 7 days to approximately 9 week(s).

71. A method according to claim 1 wherein the implantable substance delivery device comprises:

a container portion which defines the reservoir therein and at least one wall of said container portion which comprises said barrier;

at attachment portion that attaches the container portion to bone and/or soft tissue; and

wherein the device is initially attached to a delivery catheter device that is constructed to deliver the device to a desired implantation site within the body and to attached said attachment portion to adjacent bone or soft tissue and to thereafter release the device such that the catheter may be removed leaving the device at the implantation site.

72. A method according to claim 71 wherein Step D comprises:

advancing the catheter having the device attached thereto into the body to the implantation site;

using the delivery catheter device to attach the attachment portion to bone and/or soft tissue adjacent to the implantation site;

detaching the device from the delivery catheter device; and

removing the delivery catheter device leaving the implantable substance delivery device at the implantation site.

73. A method according to claim 72 wherein Step C is performed before Step D.

74. A method according to claim 72 wherein Step C is performed after Step D.

75. A method according to claim 72 wherein the delivery catheter device is configured to infuse the substance into the reservoir and wherein Step C is carried out by infusing the substance through the delivery catheter device and into the reservoir before the delivery catheter device has been detached from the reservoir.

76. A method according to claim 72 wherein the attachment portion comprises a screw and wherein the step of using the delivery catheter device to attach the attachment portion to bone and/or soft tissue adjacent to the implantation site comprises rotating the delivery catheter device so as to screw the screw into bone and/or soft tissue.

77. A method according to claim 1 further comprising the step of:

E) repeating Step C.

182. A method according to claim 1 wherein Step D comprises positioning a guide wire within the subject'"'"'s body and subsequently advancing the implantable substance delivery device over the guide wire.

183. A method according to claim 182 wherein the guide wire is inserted through a nostril to a location within the nose, nasal cavity, paranasal sinus, ostium of a paranasal sinus, Eustachian tube or nasolacrimal duct and wherein the implantable substance delivery device is advanced over that guide wire to said location.

184. A method according to claim 182 wherein the implantable substance delivery device is initially disposed on or in a delivery catheter and wherein the delivery catheter, having the implantable substance delivery device disposed thereon or therein, is advanced over the guidewire and the implantable substance delivery device is then separated from the delivery catheter.

185. A method according to claim 1 wherein the implantable substance delivery device is initially disposed on or in a catheter and wherein Step D comprises advancing the catheter, having the implantable substance delivery device disposed thereon or therein, to a location within the subject'"'"'s body and thereafter separating the implantable substance delivery device from the catheter.

186. A method according to claim 185 wherein the catheter having the implantable substance delivery device disposed thereon or therein is inserted through a nostril to a location within the nose, nasal cavity, paranasal sinus, ostium of a paranasal sinus, Eustachian tube or nasolacrimal duct and the implantable substance delivery device is then separated from the catheter.

78. A device for delivering a substance to a location within the body of a human or animal subject to diagnose or treat a disorder, said device comprising:

a reservoir that is substantially free of the substance but which may subsequently be loaded with said substance;

a fill site through which the substance may be loaded into the reservoir; and

a barrier located in relation to the reservoir such that substance that has been loaded into the reservoir will pass out of the reservoir and through the barrier at a known rate.

79. A device according to claim 78 wherein the reservoir comprises a hollow cavity.

80. A device according to claim 79 wherein the hollow cavity comprises a tube.

81. A device according to claim 78 wherein the reservoir comprises a porous material which will hold a quantity of the substance.

82. A device according to claim 81 wherein the porous material comprises a sponge.

83. A device according to claim 81 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.

84. A device according to claim 78 wherein the reservoir comprises a hollow cavity in combination with a porous material which will hold a quantity of the substance. [Also add the potential for multiple cavities.]

85. A device according to claim 81 wherein the porous material is located adjacent to a hollow cavity such that the substance may be initially introduced into the hollow cavity and thereafter absorbed or transported into the porous material.

86. A device according to claim 78 wherein the fill site is adapted to be closed after the substance has been introduced into the reservoir.

87. A device according to claim 78 wherein the fill site comprises a port.

88. A device according to claim 78 wherein the fill site comprises a tube through which the substance is introduced into the reservoir.

89. A device according to claim 88 wherein at least a portion of said tube is removable after the substance has been introduced into the reservoir.

90. A device according to claim 88 further comprising a device for clamping, clipping, ligating, tying or compressing the tube after the substance has been introduced into the reservoir.

91. A device according to claim 78 further comprising a closure apparatus to prevent substance from backflowing out of the fill site after the substance has been introduced into the reservoir.

92. A device according to claim 91 wherein the closure apparatus comprises a self sealing needle port.

93. A device according to claim 91 wherein the closure apparatus comprises a valve.

94. A device according to claim 93 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.

95. A device according to claim 91 wherein the closure apparatus comprises an applicator for applying an adhesive to the fill site to close the fill site.

96. A device according to claim 91 wherein the closure apparatus comprises a clip for closing the fill site.

97. A device according to claim 91 wherein the closure apparatus comprises a clamp for closing the fill site.

98. A device according to claim 91 wherein the closure apparatus comprises a ligature for closing the fill site.

99. A device according to claim 91 wherein the closure apparatus comprises a self sealing material through which a needle may be inserted and which will substantially seal the tract created therethrough by the needle after the needle is removed.

100. A device according to claim 78 wherein the barrier is constructed to allow a substance that has a certain property to pass out of the reservoir through the barrier at approximately a known rate.

101. A device according to claim 100 wherein the barrier is constructed to allow substances of a certain viscosity or a range of viscosities to pass through the barrier at approximately the known rate.

102. A device according to claim 100 wherein the barrier is constructed to allow substances of a certain molecular weight or within a certain range of molecular weights to pass through the barrier at approximately the known rate.

103. A device according to claim 100 wherein the barrier is constructed to allow substances having a certain electrical charge to pass through the barrier at approximately the known rate.

104. A device according to claim 100 wherein the barrier is constructed to allow substances of a certain osmolarity or within a certain range of osmolarities to pass through the barrier at approximately the known rate.

105. A device according to claim 100 wherein the barrier is constructed to allow substances of a certain osmolality or within a certain range of osmolalities to pass through the barrier at approximately the known rate.

106. A device according to claim 100 wherein the wherein the barrier is constructed to allow substances that contain a certain chemical group or atom to pass through the barrier at approximately the known rate.

107. A device according to claim 100 wherein the wherein the barrier is constructed to allow substances that have certain hydrophilic or hydrophobic properties to pass through the barrier at approximately the known rate.

108. A device according to claim 78 wherein the barrier comprises a semipermeable barrier.

109. A device according to claim 108 wherein the semipermeable barrier has pores of a known size.

110. A device according to claim 109 wherein the substance is a substance that will pass through the pores at a known rate.

111. A system that comprises a device according to claim 78 in combination with a pharmaceutically acceptable preparation that contains a substance that will pass through the barrier at approximately a known rate.

112. A system according to claim 111 further comprising a data compilation, algorithm or mathematical formula which relates certain substances, solutions, suspensions or various dilutions thereof, to certain rates at which said substances, solutions, suspensions or various dilutions thereof will pass through the barrier.

113. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula comprises a table.

114. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula comprises a database.

115. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula is provided in written form.

116. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula is provided in electronically readable form.

117. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula comprises a computer disc.

118. A system according to claim 112 wherein the data compilation, algorithm or mathematical formula is provided in the form of an electronic calculator or other electronic device that is programmed to receive data input by the user and to provide, in response to said data, information relating to certain substances, solutions, suspensions or various dilutions thereof, to certain rates at which said substances, solutions, suspensions or various dilutions thereof will pass through the barrier.

119. A system according to claim 118 wherein the user inputs information identifying one or more drugs or other substances which are to be delivered by the implantable substance delivery device and wherein the electronic calculator or electronic device provides information selected from:

diluents or solvents to be used in preparing the drug or other substance for loading into the implantable substance delivery device;

information on infectious organisms, diseases, disorders and conditions that may be treated by the drug or other substance;

drug or substance interaction warnings;

warnings regarding possible side effects of the selected drug or other substance; and

the known rates at which the selected drug or other substance, when loaded into the implantable substance delivery device at one or more concentrations, will pass through the barrier.

120. A system according to claim 111 wherein the pharmaceutically acceptable preparation contains at least one substance 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.

121. A system according to claim 111 wherein the pharmaceutically acceptable preparation contains at least one substance that is a steroid selected from the group 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.

122. A system according to claim 111 wherein the pharmaceutically cceptable preparation contains an antimicrobial agent selected from the group consisting of:

acyclovir, amantadine, aminoglycosides, 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, 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.

123. A system according to claim 111 further comprising at least one substance introducing apparatus useable to introduce the pharmaceutically acceptable preparation through the fill site and into the reservoir.

124. A system according to claim 123 wherein the substance introducing apparatus comprises a syringe.

125. A system according to claim 123 wherein the substance introducing apparatus includes an indicator which indicates when a predetermined volume of the pharmaceutically acceptable preparation is contained within the substance introducing apparatus.

126. A system according to claim 125 wherein the predetermined volume is a volume that will substantially fill the reservoir.

127. A system according to claim 111 wherein the device comprises a measured quantity of the pharmaceutically acceptable preparation that ahs been preloaded into the substance introducing apparatus.

128. A system according to claim 123 which includes more than one substance introducing apparatus for repeated loading of substance into the reservoir.

129. A device according to claim 78 wherein the device is at least partially biodegradable.

130. A device according to claim 78 wherein the device is not at least partially biodegradable.

131. A device according to claim 78 further comprising a graspable member extending from the device to facilitate grasping and removal of the device.

132. A device according to claim 78 further comprising a frame.

133. A device according to claim 132 wherein the frame is constructed to maintain the device in a desired shape following implantation.

134. A device according to claim 78 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.

135. A device according to claim 134 wherein introduction of the substance into the reservoir causes the device to transition from its collapsed configuration to its expanded configuration.

136. A device according to claim 78 wherein the device has a generally round cross-sectional configuration.

137. A device according to claim 78 wherein the device has a generally rectangular cross-sectional configuration.

138. A device according to claim 78 wherein the device has an outer surface and, when implanted and loaded with substance, the outer surface of the implant has peaks which contact adjacent anatomical tissue and valleys that remain spaced away from anatomical tissue.

139. A device according to claim 138 wherein the device is intended for implantation within the nose or paranasal sinus of the subject such that the peaks are in contact with mucosal tissue and the valleys are a spaced distance away from mucosal tissue.

140. A device according to claim 139 wherein the device is to be implanted next to cilliated mucosa and wherein the valleys are configured such that the outer surface of the device within said valleys remains fat enough away from the ciliated mucosa so as not to interfere with mucocillary transport by that tissue.

141. A device according to claim 78 wherein the device is configured such that, when the device is implanted and loaded with substance, the device will assume a configuration that defines at least one flow channel through which mucous or other biological fluid may drain.

142. A device according to claim 78 wherein the device has an intraostial 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.

143. A device according to claim 142 wherein there is at least one indentation in the intraostial portion of the device such that at least a portion of the ostium may be received within said at least one indentation.

144. A device according to claim 142 wherein the intrasinus portion of the device has a nonexpanded configuration that is small enough to be passed through the ostium and an expanded configuration that is too large to pass through the ostium.

145. A device according to claim 142 wherein the introduction of the substance into the reservoir causes the intrasinus portion of the implant to expand from its non-expanded configuration to its expanded configuration.

146. A device according to claim 145 wherein the fill site is located and configured such that the substance may be introduced through the fill site and into the reservoir after the intrasinus portion of the device has been advanced into the sinus, thereby causing the intrasinus portion of the device to expand in situ to its expanded configuration.

147. A device according to claim 145 wherein the fill site comprises a fill tube that extends into a nasal cavity or out of the nares of the subject when the device is positioned with its intraostial portion within the ostium of a paranasal sinus and its intrasinus portion within the paranasal sinus.

148. A device according to claim 145 wherein the intrasinus portion of the device is configured such that when the intrasinus portion is in its expanded configuration it will not inadvertently pass through the ostium and out of the sinus.

149. A device according to claim 78 further comprising an apparatus for moving the substance out of the reservoir and/or through the barrier.

150. A device according to claim 149 wherein the apparatus for moving the substance is selected from the group consisting of:

an osmotic pump, a mechanical pump, an electromechanical pump, a nanotechnology pumping mechanism and an electrical device that emits a current to drive the transport.

151. A system comprising an implantable substance delivery device according to claim 78 further in combination with a delivery catheter device useable for delivering the implantable substance delivery device to an implantation site within the subject'"'"'s body.

152. A system according to claim 151 wherein the delivery catheter system comprises:

a catheter that has a lumen and a distal opening, said implantable substance delivery device being positioned within the lumen of the catheter; and

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.

153. A system according to claim 152 wherein the implantable 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.

154. A system according to claim 152 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.

155. A system for delivering a substance to a location within the body of a human or animal subject to diagnose or treat a disorder, said system comprising:

an implantable substance delivery device comprising a) a container portion which defines the reservoir therein, said container portion having at least one wall which comprises a barrier through which the substance will pass out of the reservoir and b) an attachment portion that attaches the container portion to bone and/or soft tissue; and

a delivery catheter constructed i) to deliver the implantable substance delivery device to a desired implantation site within the subject'"'"'s body, ii) to attach said attachment portion to adjacent bone or soft tissue and iii) to thereafter release the implantable substance delivery device such that the catheter may be removed leaving the implantable substance delivery device implanted within the subject'"'"'s body.

156. A system according to claim 155 wherein the substance is loaded into the reservoir before the implantable substance delivery device is implanted within the subject'"'"'s body.

157. A system according to claim 156 wherein the substance is loaded into the reservoir after the implantable substance delivery device has been implanted within the subject'"'"'s body.

158. A system according to claim 157 wherein the delivery catheter device is configured to infuse the substance into the reservoir before the delivery catheter device has been detached from the implantable substance delivery device.

159. A system according to claim 155 wherein the attachment portion comprises a screw and wherein the delivery catheter device is rotatable so as to screw the screw into bone and/or soft tissue.

160. A system according to claim 156 wherein the barrier is constructed to allow a substance that has a certain property to pass out of the reservoir through the barrier at approximately a known rate.

161. A system according to claim 156 wherein the barrier is constructed to allow substances of a certain viscosity or a range of viscosities to pass through the barrier at approximately the known rate.

162. A system according to claim 156 wherein the barrier is constructed to allow substances of a certain molecular weight or within a certain range of molecular weights to pass through the barrier at approximately the known rate.

163. A system according to claim 156 wherein the barrier is constructed to allow substances having a certain electrical charge to pass through the barrier at approximately the known rate.

164. A system according to claim 156 wherein the barrier is constructed to allow substances of a certain osmolarity or within a certain range of osmolarities to pass through the barrier at approximately the known rate.

165. A system according to claim 156 wherein the barrier is constructed to allow substances of a certain osmolality or within a certain range of osmolalities to pass through the barrier at approximately the known rate.

166. A system according to claim 156 wherein the wherein the barrier is constructed to allow substances that contain a certain chemical group or atom to pass through the barrier at approximately the known rate.

167. A system according to claim 156 wherein the barrier comprises a semipermeable barrier.

168. A system according to claim 167 wherein the semipermeable barrier has pores of a known size.

169. A system according to claim 156 further comprising a pharmaceutically acceptable preparation that contains a substance that will pass through the barrier at approximately said known rate.

170. A system according to claim 169 wherein the pharmaceutically acceptable preparation contains at least one substance 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.

171. A system according to claim 169 wherein the pharmaceutically acceptable preparation contains at least one substance that is a steroid selected from the group 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.

172. A system according to claim 169 wherein the pharmaceutically acceptable preparation contains an antimicrobial agent selected from the group consisting of:

acyclovir, amantadine, aminoglycosides, 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, 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.

173. 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) using at least one access device to gain access the location within the body;

B) inserting an implantable substance delivery device over at least one access device that had been inserted in Step A such that the implantable substance delivery device becomes positioned at a location within the body, said implantable substance delivery device comprising a substance reservoir that may subsequently be loaded with a diagnostic or therapeutic substance; and

C) introducing a diagnostic or therapeutic substance into the reservoir after performance of Step B.

174. A method according to claim 173 wherein at least one access device used in Step A is selected from the group consisting of guidewires, steerable guidewires, catheters, steerable catheters, guide catheters, steerable guide catheters, ports, introducers and sheaths.

175. A method according to claim 173 further comprising the step of enlarging an opening or passageway within the body.

176. 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 access device to access the location within the body;

B) inserting an implantable substance delivery device over the access device to the location within the body, wherein the implantable substance delivery device comprises i) a substance reservoir that may subsequently be loaded with a substance that is therapeutically effective to diagnose or treat the disorder and ii) a barrier that will limit the rate at which a substance will flow out of the reservoir;

C) providing a substance that is useable to diagnose or treat the disorder; and

, thereafter,

D) introducing a quantity of the substance into the reservoir of the device that was inserted in Step B.

177. A method according to claim 176, wherein the access device is selected from the group consisting of:

guidewires, steerable guidewires, catheters, steerable catheters, guide catheters, steerable guide catheters, ports, introducers and sheaths.

178. The method of claim 176 further comprising the step of enlarging an opening of the location within the body.

179. A device designed for implantation within a man made or natural anatomical passageway to maintain the patency of a passageway while allowing a fluid to flow adjacent to at least some locations on the wall of the passageway, said device comprising:

a body comprising at least two spaced-apart contact members that are positionable in frictional engagement with the wall of the passageway such that the body of the device is held in a substantially stationary position within the passageway and fluid may continue to flow adjacent to the wall of the passageway and past the device in areas between the contact members.

180. A device according to claim 179 wherein said device elutes at least on diagnostic or therapeutic substance.

181. A device according to claim 180 wherein the device is designed such that, when implanted in the passageway, a flow of fluid through the passageway distributes the substance eluted from the device to another location within the body.