Nasal implants and systems and method of use
Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools. A tool may include a hand-held implant delivery device that holds, moves, orients, inserts, or shapes an implant. An implant may be a biodegradable, longitudinal implant that may be oriented for implantation by an implant delivery device.
1. A nasal implant comprising:
an implant core comprising:
a distal end,
a proximal end,
a central portion disposed between the proximal end and the distal end, wherein the central portion comprises a plurality of ribs,
a first arm disposed at the distal end, the first arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the first arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration, and
a second arm disposed at the distal end, the second arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the second arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration,
wherein the first and second arms are biased toward their deployed configuration, and
wherein the implant core comprises a degradable material; and
a degradable coating on an outer surface of the implant core,
wherein the degradable coating comprises a hydrophobic material, and
wherein the degradable coating and the implant core do not deliver a pharmaceutical agent or a drug.
2. The implant of claim 1 , wherein the first and second arms are configured to self-expand toward the deployed configuration.
3. The implant of claim 1 , wherein the central portion comprises a plurality of small projections.
4. The implant of claim 1 , further comprising: a blunt proximal end.
5. The implant of claim 1 , further comprising: a plurality of barbs at the proximal end.
6. The implant of claim 1 , wherein the hydrophobic material is poly(caprolactone).
7. The implant of claim 1 , wherein the hydrophobic material covers an entirety of the outer surface of the implant core.
8. The implant of claim 1 , wherein the hydrophobic material covers a first portion of the outer surface of the implant core and does not cover a second portion of the outer surface.
9. The implant of claim 8 , wherein the first portion of the outer surface includes the central portion of the implant.
10. The implant of claim 8 , wherein the first portion of the outer surface includes the central portion and the distal end of the implant.
11. The implant of claim 1 , wherein the hydrophobic material has a discontinuous pattern over the outer surface of the implant core.
12. The implant of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 10 microns.
13. The implant of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 5 microns.
14. The implant of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 1 micron.
15. The implant of claim 1 , wherein the hydrophobic material has a thickness of less than about 10 microns.
16. The implant of claim 1 , wherein the hydrophobic material has a thickness of less than about 5 microns.
17. The implant of claim 1 , wherein the hydrophobic material has a thickness of less than about 1 micron.
18. The implant of claim 1 , wherein the central portion has a flexural rigidity of about 9-130 N-mm 2 .
19. A nasal implant comprising:
an implant core comprising
a distal end,
a proximal end,
a central portion disposed between the proximal end and the distal end,
a first arm disposed at the distal end, the first arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the first arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration, and
a second arm disposed at the distal end, the second arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the second arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration,
wherein the implant core is formed from a first degradable material; and
an outer coating on an outer surface of the implant core, wherein the outer coating is formed from a non-biodegradable hydrophobic material; and
an agent disposed between the implant core and the outer coating.
20. The implant of claim 19 , wherein the agent is selected from the group consisting of: an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, microparticles, a mucolytic, a radiopaque material, a radiopaque agent, radiolabeled agent, a steroid, and a vitamin.
21. The implant of claim 19 , wherein the agent is a bioactive agent and the hydrophobic material is configured to elute one or more bioactive agents selected from the group consisting of: thrombolytics, corticosteroids, vasodilators, antihypertensive agents, antimicrobials or antibiotics, antimitotics, antiproliferatives, antisecretory agents, non-steroidal anti-inflammatory drugs, immunosuppressive agents, growth factors, growth factor antagonists, antitumor and/or chemotherapeutic agents, antipolymerases, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biologic agents, and radiotherapeutic agents.
22. The implant of claim 19 , wherein, after delivery, the implant core degrades over time and the outer coating is non-biodegradable.
23. The implant of claim 22 , wherein the implant core completely degrades while the outer coating remains and does not degrade.
24. The implant of claim 19 , wherein the non-biodegradable hydrophobic material is not bioabsorbable.
25. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of about 0.1 micron to about 10 microns.
26. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of about 0.1 micron to about 5 microns.
27. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of about 0.1 micron to about 1 micron.
28. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of less than about 10 microns.
29. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of less than about 5 microns.
30. The implant of claim 19 , wherein the non-biodegradable hydrophobic material has a thickness of less than about 1 micron.
31. A method of making a nasal implant comprising:
forming an implant core comprising:
a distal end,
a proximal end,
a central portion disposed between the proximal end and the distal end, wherein the central portion comprises a plurality of ribs,
a first arm disposed at the distal end, the first arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the first arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration, and
a second arm disposed at the distal end, the second arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the second arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration,
wherein the first and second arms are biased toward their deployed configuration, and
wherein the implant core comprises a degradable material; and applying a degradable coating on an outer surface of the implant core,
wherein the degradable coating comprises a hydrophobic material, and wherein the degradable coating and the implant core do not deliver a pharmaceutical agent or a drug.
32. The method of claim 31 , wherein the first and second arms are configured to self-expand toward the deployed configuration.
33. The method of claim 31 , wherein the central portion comprises a plurality of small projections.
34. The method of claim 31 , wherein forming the implant core comprises forming a blunt proximal end.
35. The method of claim 31 , wherein forming the implant core comprises forming a plurality of barbs at the proximal end.
36. The method of claim 31 , wherein the hydrophobic material is poly(caprolactone).
37. The method of claim 31 , wherein the hydrophobic material covers an entirety of the outer surface of the implant core.
38. The method of claim 31 , wherein the hydrophobic material covers a first portion of the outer surface of the implant core and does not cover a second portion of the outer surface.
39. The method of claim 38 , wherein the first portion of the outer surface includes the central portion of the implant.
40. The method of claim 38 , wherein the first portion of the outer surface includes the central portion and the distal end of the implant.
41. The method of claim 31 , wherein the hydrophobic material has a discontinuous pattern over the outer surface of the implant core.
42. The method of claim 31 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 10 microns.
43. The method of claim 31 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 5 microns.
44. The method of claim 31 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 1 micron.
45. The method of claim 31 , wherein the hydrophobic material has a thickness of less than about 10 microns.
46. The method of claim 31 , wherein the hydrophobic material has a thickness of less than about 5 microns.
47. The method of claim 31 , wherein the hydrophobic material has a thickness of less than about 1 micron.
48. The method of claim 31 , wherein the central portion has a flexural rigidity of about 9-130 N-mm 2 .
49. A method of making a nasal implant comprising:
forming an implant core comprising
a distal end,
a proximal end,
a central portion disposed between the proximal end and the distal end,
a first arm disposed at the distal end, the first arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the first arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration, and
a second arm disposed at the distal end, the second arm having a proximal end fixed to the central portion and a distal end not fixed to the central portion, the distal end of the second arm being adapted to move away from a central longitudinal axis of the central portion from a delivery configuration toward a deployed configuration,
wherein the implant core is formed from a first degradable material; and
applying an outer coating on an outer surface of the implant core, wherein the outer coating is formed from a non-biodegradable hydrophobic material; and
disposing an agent between the implant core and the outer coating.
50. The method of claim 49 , wherein the implant core is degradable over time and the outer coating is non-biodegradable.
51. The method of claim 50 , wherein the implant core completely degrades while the outer coating remains and does not degrade.
52. The method of claim 49 , wherein the non-biodegradable hydrophobic material is not bioabsorbable.
53. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of about 0.1 micron to about 10 microns.
54. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of about 0.1 micron to about 5 microns.
55. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of about 0.1 micron to about 1 micron.
56. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of less than about 10 microns.
57. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of less than about 5 microns.
58. The method of claim 49 , wherein applying the outer coating provides the non-biodegradable hydrophobic material with a thickness of less than about 1 micron.
59. The method of claim 49 , wherein the agent is selected from the group consisting of: an antibiotic, another antibacterial agent, an antifungal agent, an antihistamine, an anti-inflammatory agent, a cartilage growth inducer, a decongestant, a drug, a growth factor, microparticles, a mucolytic, a radiopaque material, a radiopaque agent, radiolabeled agent, a steroid, and a vitamin.
60. The method of claim 49 , wherein the agent is a bioactive agent and the hydrophobic material is configured to elute one or more bioactive agents selected from the group consisting of: thrombolytics, corticosteroids, vasodilators, antihypertensive agents, antimicrobials or antibiotics, antimitotics, antiproliferatives, anti secretory agents, non-steroidal anti-inflammatory drugs, immunosuppressive agents, growth factors, growth factor antagonists, antitumor and/or chemotherapeutic agents, antipolymerases, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, free radical scavengers, antioxidants, biologic agents, and radiotherapeutic agents.