Implant device, tool, and methods relating to treatment of paranasal sinuses

摘要

An implant device is configured to be implanted in a fistula to fluidly connect the lacrimal apparatus and a paranasal sinus. A surgical tool has an implant the implant device mounted on a carrier. Various methods involve a fistula between the lacrimal apparatus and a paranasal sinus. A kit includes an entry device for use to form a fistula and an implant tool for use to implant an implant device following formation of a fistula.

主权项

1. An implant device for implantation in a human through a surgically-formed fistula between a location in the lacrimal apparatus in the orbit and a paranasal sinus to fluidly connect the lacrimal apparatus in the orbit to the paranasal sinus and provide direct medical access to the paranasal for treatment of sinusitis, the implant device comprising:
a proximal fluid communication end at a first longitudinal end of the device; a distal fluid communication end at a second longitudinal end of the device that is longitudinally opposite the first longitudinal end; a conduit extending from adjacent the proximal fluid communication end to adjacent the distal fluid communication end; an internal passage extending between the proximal fluid communication end and the distal fluid communication end and through the conduit; the internal passage having a first end open at the proximal fluid communication end and a second end open at the distal fluid communication end; a length of the device longitudinally along the device between the proximal fluid communication end and the distal fluid communication end in a range of from 2 millimeters to 50 millimeters; a width of the internal passage transverse to the length in a range of from 0.25 millimeter to 5 millimeters; and an exterior of the conduit comprising an anchoring surface feature including protrusion areas and recess areas, the protrusion areas being on a longitudinal portion of the conduit with a proximal end of the longitudinal portion of the conduit at commencement of a closest said protrusion area to the proximal fluid communication end of the implant device being spaced apart from the proximal fluid communication end of the implant device by at least 4 millimeters; the implant device configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus through the fistula to provide access through the internal passage to the paranasal sinus for treatment of sinusitis, wherein:
the proximal fluid communication end is configured to be disposed with the first end of the internal passage opening in the lacrimal apparatus when the implant device is implanted;the distal fluid communication end is configured to be disposed in the paranasal sinus with the second end of the internal passage opening in the paranasal sinus when the implant device is implanted; andthe conduit is configured to be disposed through the fistula with at least a portion of the recess areas disposed within the fistula and with at least a portion of the protrusion areas disposed in the fistula and engaging tissue exposed within the fistula to anchor the implant device.