Nasolacrimal drainage system implants for drug therapy

• US 7,998,497 B2
• Filed: 04/02/2007
• Issued: 08/16/2011
• Est. Priority Date: 03/31/2006
• Status: Active Grant

• Current Assignee: Mati Therapeutics, Inc
• Original Assignee: QT Incorporated
• Inventors: Rapacki, Alan, Reich, Cary, de Juan, Eugene Jr., Gifford, Hanson S. III, Boyd, Stephen, Deem, Mark
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US11/695,545
• Publication Number:
  US 20070243230A1
• Time in Patent Office: 1,597 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0087 colour-coded
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/0026 Ophthalmic product dispenser attachments to facilitate positioning near the eye
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/00 Medicinal preparations characterised by special physical form nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12
• CPC Class Codes: A61K 9/0017 Non-human animal skin, e.g. pour-on, spot-on
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 27/06 : Antiglaucoma agents or miotics
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

Implant devices, systems and methods for insertion into a punctum of a patient optionally comprises a drug core and a sheath body disposed over the drug core. The drug core includes a therapeutic agent deliverable into the eye, and the sheath defines at least one exposed surface of the drug core. The exposed surface(s) of the drug core may contact a tear or tear film fluid and release the therapeutic agent at therapeutic levels over a sustained period when the implant is implanted for use. The implant may include a retention element to retain the drug core and sheath body near the punctum, optionally comprising a shape memory alloy that can resiliently expand. An occlusive element may be attached to the retention element to at least partially occlude tear flow through the canalicular lumen.

Claims

1. An implant for insertion into a punctum of a patient, the implant comprising:

a drug core having a distal end and a proximal end, the distal end of the drug core having a cross-section suitable for insertion into the punctum, the drug core comprising a therapeutic agent deliverable into an eye of the patient;

a sheath disposed over a portion of the drug core to define at least one exposed surface of the drug core, the at least one exposed surface of the drug core located near the proximal end of the drug core to contact a tear or tear film fluid and release the therapeutic agent at a desired therapeutic level over a sustained period when the implant is implanted for use, wherein the sheath is substantially impermeable to the therapeutic agent; and

an implant body at least partially surrounding the sheath and the drug core, the implant body comprising a retention structure having a size suitable to fit at least partially within a canalicular lumen to retain an implanted position of the implant.

2. The implant of claim 1, wherein the retention structure is attached to or around a portion of the drug core to retain the drug core near or in the punctum.

3. The implant of claim 2, wherein the retention structure is attached to the drug core via the sheath.

4. The implant of claim 1, wherein the retention structure comprises a fluid swellable retention element at least partially encapsulated by an intermediate or a distal end portion of the implant body, the fluid swellable retention element configured to expand when implanted in the canalicular lumen.

5. The implant of claim 4, wherein the fluid swellable retention element comprises a hydrogel.

6. The implant of claim 4, wherein the implant body includes an interior surface, the fluid swellable retention element, upon expansion, urging against and being retained by the interior surface.

7. The implant of claim 4, wherein the implant body comprises one or more tabs outwardly deformable upon the expansion of the fluid swellable retention element, the one or more tabs, when outwardly deformed, biasing against at least a portion of a canalicular lumen wall.

8. The implant of claim 1, wherein the retention structure is configured such that, when implanted into the punctum, the retention structure expands for biasing at least a portion of the retention structure adjacent an intermediate or a distal end portion of the implant body against at least a portion of a canalicular lumen wall.

9. The implant of claim 1, comprising a projection extending near the at least one exposed surface to retain the exposed surface near the punctum.

10. The implant of claim 8, wherein the retention structure is expandable from a first profile configuration suitable for insertion into the punctum and a diametrically larger second profile configuration to bias at least a portion of the retention structure against at least a portion of the canalicular lumen wall.

11. The implant of claim 8, wherein the retention structure is attached near the distal end portion of the implant body.

12. The implant of claim 10, wherein the retention structure slides along an outer surface of the sheath as the retention structure expands from the first profile configuration to the diametrically larger second profile configuration.

13. The implant of claim 10, wherein a longitudinal length of the retention structure is shorter in the second profile configuration than the first profile configuration.

14. The implant of claim 10, wherein the retention structure is resiliently expandable and comprises an elastic alloy or a shape memory alloy.

15. The implant of claim 10, wherein the first profile configuration has a cross-sectional size of less than about 0.2 mm in diameter, and the second profile configuration has a cross-sectional size of less than about 2.0 mm in diameter.

16. The implant of claim 1, wherein the retention structure comprises a tubular body including one or more arms separated by one or more slots.

17. The implant of claim 1, comprising an occlusive element mounted to and expandable with the retention structure, the occlusive element inhibiting fluid flow through the punctum.

18. The implant of claim 1, wherein the retention structure is disposed at least partially over the drug core.

19. The implant of claim 1, comprising an occlusive element to inhibit fluid flow into and through the canalicular lumen, wherein the occlusive element covers at least a portion of the retention structure to protect the canalicular lumen from the retention structure.

20. The implant of claim 1, wherein the sheath body comprises a layer disposed over the drug core to inhibit release of the therapeutic agent through the layer.

21. The implant of claim 1, wherein the drug core releases the therapeutic agent through the exposed surface.

22. The implant of claim 1, wherein the drug core releases the therapeutic agent at the desired therapeutic level throughout a time period of at least one week, when the implant body is implanted with the drug core surface exposed to the tear or tear film fluid.

23. The implant of claim 1, wherein the drug core comprises inclusions of the therapeutic agent, and the therapeutic agent is soluble in the drug core to provide a substantially uniform release rate when the drug core is implanted.

24. The implant of claim 1, comprising an occlusive element to inhibit fluid flow through the canalicular lumen.

25. The implant of claim 1, wherein the implant body comprises a cavity, the cavity extending inward from a body proximal end and configured to at least partially receive the drug core.

26. The implant of claim 25, wherein the drug core is removable from the cavity of the implant body, while the retention structure maintains the implanted position of the implant body within the canalicular lumen.

27. The implant of claim 26, wherein a second drag core is attachable within the cavity, while the retention structure maintains the implanted position of the implant body within the canalicular lumen.

28. The implant of claim 1, wherein the retention structure comprises a projection having a cross-sectional size greater than an adjacent implant body portion.

29. The implant of claim 1, comprising an implant body projection extending at least partially from or around a proximal end of the implant body, and configured to seat against an opening of the punctum, when implanted.

30. The implant of claim 1, wherein the implant body comprises one of a canalicular implant-body, a lacrimal sac implant body, or a punctal plug implant body.

31. The implant of claim 4, wherein the fluid swellable retention element expands distally from the distal end portion of the implant body.

32. The implant of claim 4, wherein the implant body includes a cavity into which the fluid swellable retention structure is at least partially disposed.

33. The implant of claim 4, wherein the implant body includes one or more lateral surface voids, sized to allow fluid permeation into the fluid swellable retention element, but inhibit the retention element from expanding out of a perimeter of the implant body.

34. The implant of claim 4, wherein the fluid swellable retention element comprises an absorption capacity of up to about 95% fluid, when implanted.

35. The implant of claim 8, wherein the retention structure extending around a proximal end portion of the implant body defines a smaller average diametrical size than an average diametrical size of the retention structure projecting around the intermediate portion of the implant body.

36. The implant of claim 1, comprising one or more channels extending at least partially through the drug core, the one or more channels including an internal porous surface allowing for delivery of the therapeutic agent.

37. The implant of claim 1, wherein the implant body includes an atraumatic tip, the atraumatic tip generally narrowing near a distal end portion of the implant body to facilitate implantation into the punctum.

38. The implant of claim 2, wherein the retention structure and the drug core are sized to permit fluid flow around an outer surface of the drug core while the retention structure holds canalicular lumen tissue away from the outer surface.

39. The implant of claim 13, wherein the retention structure assumes a three-dimensional cage or coil structure when expanded.

40. The implant of claim 19, wherein the layer has a thickness less than about 0.0015 inches.

41. A kit comprising the implant of claim 1, and a set of instructions for using the implant to treat an eye disease.

42. An implant for insertion into a punctum of a patient, the implant comprising:

a drug core including a therapeutic agent deliverable to an eye of the patient;

a sheath disposed over a portion of the drug core; and

an implant body at leak partially surrounding the drug core, the implant body comprising a retention structure having a size suitable to fit at least partially within a canalicular lumen to retain an implanted position of the implant.

43. An implant for insertion into a punctum of a patient, the implant comprising:

a drug core including a therapeutic agent deliverable to an eye of the patient;

a sheath disposed over a portion of the drug core; and

an implant body at least partially surrounding the drug core, the implant body comprising a projection extending near a proximal end of the drug core and configured to seat against an opening of the punctum when implanted, and a retention structure having a size suitable to fit at least partially within a canalicular lumen.

44. The implant of claim 43, wherein the retention structure is configured such that, when implanted in the canalicular lumen, the retention structure expands for biasing at least a portion of the retention structure against a portion of a canalicular lumen wall.

45. The implant of claim 44, wherein the retention structure is expandable from a first profile configuration, suitable for insertion into the canalicular lumen, to a diametrically larger second profile configuration, suitable to bias at least a portion of the retention structure against at least a portion of the canalicular lumen wall.