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

Abstract

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.

1 - 39 . Canceled 
     
     
         40 . A kit useful for implantation of an implant device in a human to fluidly connect a lacrimal apparatus from a location in an orbit to a paranasal sinus through a fistula formed between the lacrimal apparatus and the paranasal sinus, the kit comprising:
 the implant device for implantation to fluidly connect a lacrimal apparatus from the location in the orbit to 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 conduit between the proximal end and the distal end; 
 an internal passage through the conduit; 
 a length of the implant device longitudinally along the device between the proximal end and the distal 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; 
 a head adjacent the conduit at the proximal end, wherein the head comprises a flanged tissue engagement surface on a side of the head disposed toward the conduit and configured to engage tissue outside of and adjacent to the fistula when the implant device is implanted; 
 an anchoring surface feature on a portion of an exterior of the conduit including protrusion areas and recess areas; and 
 wherein the implant device is configured to be implanted with the proximal end of the implant device disposed in the lacrimal apparatus and 
 at least a portion of the conduit disposed in a fistula opening into the lacrimal apparatus; 
   a drill for cutting away tissue to form the fistula for implantation of the implant device during an implantation procedure to implant the implant device to fluidly connect the lacrimal apparatus and the paranasal sinus;   an implantation tool configured to carry the implant device for inserting the implant device into the fistula during the implantation procedure; and   a guide member to dispose in the fistula to guide the implantation tool to the fistula during the implantation procedure, wherein the implantation tool has a second internal passage to receive therethrough the guide member.   
     
     
         41 . A kit according to  claim 40 , further comprising a needle configured for forming an initial hole to be enlarged by the drill to form the fistula for implantation of the implant device. 
     
     
         42 . A kit according to  claim 40 , wherein the drill has a cutting width that is smaller than a maximum exterior width of a conduit of the implant device configured to be disposed through the fistula during implantation. 
     
     
         43 . A kit according to  claim 42 , wherein the cutting width is from 0.1 millimeter to 0.75 millimeter smaller than the maximum exterior width of the conduit. 
     
     
         44 . A kit according to  claim 43 , wherein the cutting width is in a range of from 1.5 millimeters to 2.5 millimeters and the maximum exterior width of the conduit of the implant device is in a range of from 2.0 to 2.75 millimeters. 
     
     
         45 . A kit according to  claim 40 , wherein the protrusion areas have a height relative to the recess areas of at least 0.25 millimeter. 
     
     
         46 . A kit according to  claim 45 , wherein the protrusion areas are on a longitudinal portion of the conduit for at least 5 millimeters along the length of the implant device. 
     
     
         47 . A kit according to  claim 40 , wherein the length of the implant device is in a range of from 10 millimeters to 40 millimeters. 
     
     
         48 . A kit according to  claim 40 , wherein the conduit is constructed of polymeric material having a durometer (Shore A) in a range of from 50 to 100.