Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders

• US 20090005763A1
• Filed: 04/21/2008
• Published: 01/01/2009
• Est. Priority Date: 08/04/2004
• Status: Active Grant

• Current Assignee: Exploramed NC1 Inc (Johnson & Johnson)
• Original Assignee: Exploramed NC1 Inc (Johnson & Johnson)
• Inventors: Makower, Joshua, Walke, Amrish Jayprakash, Chang, John Y., Vrany, Julia D.
• Granted Patent: US 9,039,680 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 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.

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

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

4. A device according to claim 3, 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 polytetrafluororethylene, latex, and nylon.

5. A device 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.

6. A device according to claim 1, wherein the fill site is adapted to be closed after the substance has been introduced into the reservoir.

7. A device according to claim 1, wherein the fill site comprises a port.

8. A device according to claim 1, further comprising a closure apparatus to prevent substance from backflowing out of the fill site after the substance has been introduced into the reservoir.

9. A device according to claim 8, wherein the closure apparatus comprises a self-sealing needle port.

10. A device according to claim 8, wherein the closure apparatus comprises a valve.

11. A device according to claim 10, 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.

12. A device according to claim 8, wherein the closure apparatus comprises an applicator for applying an adhesive to the fill site to close the fill site.

13. A device according to claim 8, wherein the closure apparatus comprises a clip for closing the fill site.

14. A device according to claim 8, wherein the closure apparatus comprises a clamp for closing the fill site.

15. A device according to claim 8, wherein the closure apparatus comprises a ligature for closing the fill site.

16. A device according to claim 1, 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.

17. A device according to claim 16, 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.

18. A device according to claim 16, wherein the barrier is constructed to allow substances having a certain electrical charge to pass through the barrier at approximately the known rate.

19. A device according to claim 16, 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.

20. A device according to claim 16, 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.

21. A device according to claim 16, 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.

22. A device according to claim 16, 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.

23. A device according to claim 1, wherein the barrier comprises a semi-permeable barrier.

24. A device according to claim 23, wherein the semipermeable barrier has pores of a known size.

25. A device according to claim 23 wherein the substance is a substance that will pass through the pores at a known rate.

26. A system that comprises a device according to claim 1 in combination with a pharmaceutically acceptable preparation that contains a substance that will pass through the barrier at approximately a known rate.

27. A system according to claim 26, 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 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.

28. A system according to claim 26, 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.

29. A system according to claim 26, 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.

30. A system according to claim 26, further comprising at least one substance introducing apparatus useable to introduce the pharmaceutically acceptable preparation through the fill site and into the reservoir.

31. A system according to claim 30, wherein the substance introducing apparatus comprises a syringe.

32. A system according to claim 30, wherein the device comprises a measured quantity of the pharmaceutically acceptable preparation that has been preloaded into the substance introducing apparatus.

33. A device according to claim 1, wherein the device is at least partially biodegradable.

34. A device according to claim 1, further comprising a graspable member extending from the device to facilitate grasping and removal of the device.

35. A device 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.

36. A device according to claim 35, wherein introduction of the substance into the reservoir causes the device to transition from its collapsed configuration to its expanded configuration.

37. A device according to claim 1, wherein the device has a generally rectangular cross-sectional configuration.

38. A device according to claim 1, 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.

39. A device according to claim 1, 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.

40. A device according to claim 1, further comprising an apparatus for moving the substance out of the reservoir and/or through the barrier.

41. A device according to claim 40, 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.

42. A system comprising an implantable substance delivery device according to claim 1, 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.

43. A system according to claim 42, 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.

44. A system according to claim 43, 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.

45. A system according to claim 43, 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.

46. 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 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

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.

47. A system according to claim 46, wherein the substance is loaded into the reservoir before the implantable substance delivery device is implanted within the subject'"'"'s body.

48. A system according to claim 46, wherein the substance is loaded into the reservoir after the implantable substance delivery device has been implanted within the subject'"'"'s body.

49. A system according to claim 48, 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.

50. A system according to claim 46, 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.

51. A system according to claim 46, 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.

52. A system according to claim 46, 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.

53. A system according to claim 46, wherein the barrier is constructed to allow substances having a certain electrical charge to pass through the barrier at approximately the known rate.

54. A system according to claim 46, 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.

55. A system according to claim 46, 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.

56. A system according to claim 46, 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.

57. A system according to claim 46, wherein the barrier comprises a semipermeable barrier.

58. A system according to claim 57, wherein the semipermeable barrier has pores of a known size.

59. A system according to claim 57, further comprising a pharmaceutically acceptable preparation that contains a substance that will pass through the barrier at approximately said known rate.

60. A system according to claim 59, 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 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.

61. A system according to claim 59, 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.

62. A system according to claim 59, 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, triamcinolonelnystatin, 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.