Paranasal sinus access implant devices and related tools, methods and kits

摘要

A paranasal sinus access implant device to provide an artificial fluid path in fluid communication with the lacrimal apparatus may be implanted through a fistula opening into the lacrimal apparatus. The implant device may have a conduit with a first longitudinal portion having a larger minimum wall thickness than a minimum wall thickness of a second a second longitudinal portion of the conduit located distal of the first longitudinal portion. Various kits may include a paranasal sinus access implant device and one of more other components for a procedure involving implantation. A method involves use of a cutting tool to cut away tissue to prepare a fistula sized for implantation.

主权项

1. A paranasal sinus access implant device for implantation in a human to fluidly connect a lacrimal apparatus from a location in an orbit to a paranasal sinus through a straight, surgically-formed fistula formed between the lacrimal apparatus in the orbit and the paranasal sinus, the implant device comprising:
a proximal end at a first longitudinal end of the device; a distal end at a second longitudinal end of the device that is longitudinally opposite the first longitudinal end; a head adjacent the proximal end of the implant device; a conduit between the proximal end and the distal end and extending longitudinally along the implant device from adjacent the head toward the distal end of the implant device; an internal passage through the head and the conduit; a length of the implant device longitudinally along the implant device between the proximal end and the distal end in a range of from 8 millimeters to 50 millimeters; a width of the internal passage transverse to the length of the implant device in a range of from 0.25 millimeter to 5 millimeters; the conduit including a first longitudinal portion having a length of at least 3 millimeters and a second longitudinal portion having a length of at least 3 millimeters and being located toward the distal end relative to the first longitudinal portion; the first longitudinal portion of the conduit having a first minimum wall thickness adjacent the internal passage and the first longitudinal portion of the conduit extending from a proximal end of the first longitudinal portion of the conduit adjacent the head to a distal end of the first longitudinal portion of the conduit disposed toward a proximal end of the second longitudinal portion of the conduit; an exterior of the second longitudinal portion of the conduit having an anchoring surface feature including anchor protrusions spaced along the length of the second longitudinal portion of the conduit and recess areas between the anchor protrusions, the length of the second longitudinal portion of the conduit extending from a proximal end of the second longitudinal portion of the conduit at a said anchor protrusion closest to the head to a distal end of the second longitudinal portion of the conduit at a said anchor protrusion farthest from the head; the second longitudinal portion of the conduit having a second minimum wall thickness adjacent the internal passage that is smaller than the first minimum wall thickness, wherein the first minimum wall thickness is at least 0.05 millimeter larger than the second minimum wall thickness and the second minimum wall thickness is at a said recess area and occurs at multiple ones of the recess areas; and the implant device being configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus so that when implanted:
the proximal end of the implant device and the head are disposed in the lacrimal apparatus;the distal end of the implant device is disposed in the paranasal sinus; andthe conduit is disposed through the straight, surgically-formed fistula between the lacrimal apparatus and the paranasal sinus with at least a portion of each of the first longitudinal portion and the second longitudinal portion of the conduit disposed within the straight, surgically-formed fistula with multiple said anchor protrusions disposed within the straight, surgically-formed fistula to engage tissue within the straight, surgically-formed fistula and with the distal end of the second longitudinal portion of the conduit disposed in the paranasal sinus.