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 method of using a nasal implant comprising:
inserting a nasal implant into nasal tissue, wherein the nasal implant comprises:
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,
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
after inserting the nasal implant in the nasal tissue, degrading the degradable coating and the implant core,
wherein the degradable coating and the implant core do not comprise a pharmaceutical agent or a drug.
2. The method of claim 1 , wherein delivering the nasal implant to the nasal tissue comprises expanding the first arm and the second arm from the delivery configuration to the deployed configuration.
3. The method of claim 1 , further comprising:
loading the nasal implant into an implant loading chamber of a delivery device; and
advancing the nasal implant from the implant loading chamber to a needle lumen of the delivery device to transition the nasal implant from the deployed configuration to the delivery configuration.
4. The method of claim 3 , wherein the implant loading chamber is in communication with an implant engagement surface disposed between the needle lumen and the implant loading chamber,
wherein the implant engagement surface narrows inwardly toward a center axis of the needle lumen along a direction from the implant loading chamber toward the needle lumen, and
wherein transitioning the nasal implant from the deployed configuration to the delivery configuration comprises engaging the first arm and the second arm with the implant engagement surface while advancing the nasal implant from the implant loading chamber to the needle lumen.
5. The method of claim 3 , wherein delivering the nasal implant to the nasal tissue comprises:
inserting the needle lumen in the nasal tissue; and
moving an actuator relative the needle lumen to cause a push-rod to advance the nasal implant along the needle lumen.
6. The method of claim 5 , wherein inserting the needle lumen in the nasal tissue comprises piercing the nasal tissue with a distal end of the needle lumen.
7. The method of claim 5 , further comprising applying, using a compression element, a distal axial force on the nasal implant to prevent the nasal implant from sliding in a proximal direction as the needle lumen is withdrawn from the nasal tissue, wherein the compression element couples the push-rod to a plunger assembly.
8. The method of claim 1 , further comprising, responsive to inserting the nasal implant into the nasal tissue, positioning a first portion of the nasal implant above a maxillary bone and a second portion of the nasal implant extending beyond an edge of the maxillary bone to provide cantilever support to an upper lateral cartilage and a lower lateral cartilage.
9. The method of claim 8 , wherein the first portion of the nasal implant includes the first arm and the second arm.
10. The method of claim 1 , wherein the central portion comprises a plurality of small projections.
11. The method of claim 1 , wherein the implant core comprises a blunt proximal end.
12. The method of claim 1 , wherein the hydrophobic material is poly(caprolactone).
13. The method of claim 1 , wherein the hydrophobic material covers an entirety of the outer surface of the implant core.
14. The method 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.
15. The method of claim 14 , wherein the first portion of the outer surface includes the central portion of the nasal implant.
16. The method of claim 14 , wherein the first portion of the outer surface includes the central portion and the distal end of the nasal implant.
17. The method of claim 1 , wherein the hydrophobic material has a discontinuous pattern over the outer surface of the implant core.
18. The method of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 10 microns.
19. The method of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 5 microns.
20. The method of claim 1 , wherein the hydrophobic material has a thickness of about 0.1 micron to about 1 micron.