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 . A paranasal sinus access implant device useful for implantation in a human to fluidly connect a lacrimal apparatus to a paranasal sinus through a fistula formed between the lacrimal apparatus 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 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;   the conduit including a first longitudinal portion having a length of from 5 millimeters to 12 millimeters and a second longitudinal portion located toward the distal end relative to the first longitudinal portion, the second longitudinal portion having a length of from 5 millimeters to 20 millimeters;   the first longitudinal portion of the conduit having a first maximum exterior width;   the second longitudinal portion of the conduit including an anchoring surface feature with at least 3 spaced circumferential ridges spaced along the second longitudinal portion of the conduit, wherein each said circumferential ridge extends around the entire circumference of the conduit, and with recess areas between the circumferential ridges;   the second longitudinal portion of the conduit having a second maximum exterior width at a said circumferential ridge;   the first longitudinal portion of the conduit being in the absence of said circumferential ridges and the second maximum exterior width being larger than the first maximum exterior width; and   a plurality of side ports through a wall of the second longitudinal portion of the conduit to provide passages for fluid communication between the internal passage and the paranasal sinus, wherein the plurality of side ports are located in a said recess area between a pair of adjacent circumferential ridges;   the implant device configured to be implanted to fluidly connect the lacrimal apparatus to the paranasal sinus so that when implanted:
 the proximal end is disposed in the lacrimal apparatus; 
 the distal end is disposed in the paranasal sinus; and 
 the conduit is disposed through the 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 fistula and with at least a portion of the second longitudinal portion of the conduit including the side ports disposed in the paranasal sinus. 
   
     
     
         2 . (canceled) 
     
     
         3 . An implant device according to  claim 1 , wherein the first longitudinal portion of the conduit has a smooth exterior surface. 
     
     
         4 - 10 . (canceled) 
     
     
         11 . An implant device according to  claim 1 , wherein:
 the first maximum exterior width is within a range of from 1.75 millimeters to 2.25 millimeters;   the second maximum exterior width is in a range of from 2 millimeters to 3 millimeters; and   the second maximum exterior width is at least 0.2 millimeter larger than the first maximum exterior width.   
     
     
         12 . An implant device according to  claim 11 , wherein;
 the circumferential ridges have a height relative to the recess areas in a range of from 0.2 millimeter to 0.5 millimeter; and   the circumferential ridges have a center-to-center spacing in a range of from 1 millimeter to 2 millimeters.   
     
     
         13 - 16 . (canceled) 
     
     
         17 . An implant device according to  claim 12 , wherein:
 the circumferential ridges are configured to flexibly deform when contacting the tissue exposed in the fistula when the conduit is inserted through the fistula for implantation.   
     
     
         18 . An implant device according to  claim 12 , comprising 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;   the head has a first dimension that is a maximum separation distance between points on the outer edge of the flanged tissue engagement surface, the first dimension being larger than an exterior width of the conduit defined by an extent of the protrusion areas transverse to the length of the device; and   the head has a second dimension transverse to the first dimension that is a maximum separation distance between points on the outer edge that are on a line transverse to the first dimension, and a ratio of the first dimension to the second dimension in a range of from 1 to 4.   
     
     
         19 . An implant device according to  claim 18 , wherein the length of the implant device is in a range of from 12 millimeters to 30 millimeters. 
     
     
         20 . An implant device according to  claim 18 , wherein the conduit is constructed of polymeric material having a durometer (Shore A) in a range of from 50 to 100. 
     
     
         21 . (canceled) 
     
     
         22 . A kit for use to treat a paranasal sinus, the kit comprising:
 a paranasal sinus access implant device according to  claim 18 ; and   at least one cutting tool for cutting away tissue to form a fistula through which the implant device may be implanted during an implantation procedure.   
     
     
         23 . A kit according to  claim 22 , comprising a drug treatment composition deliverable to a paranasal sinus through the implant device following implantation of the implant device to provide access to the paranasal sinus. 
     
     
         24 - 29 . (canceled) 
     
     
         30 . A kit according to  claim 23 , wherein the drug treatment composition comprises any one or more of the following in any combination: an antibiotic, a steroid, an anti-viral, an antihistamine, an anti-fungal, a mast cell stabilizer, a mucolytic, a non-steroidal anti-inflammatory drug (NSAID), a vasoconstrictor, and an immunosuppressant. 
     
     
         31 - 32 . (canceled) 
     
     
         33 . A kit according to  claim 22 , wherein the at least one cutting tool comprises a hollow member having a hollow cutting tip at a distal end of the cutting member configured to cut tissue to size the fistula for implantation of the implant device through the fistula. 
     
     
         34 . A kit according to  claim 33 , wherein:
 the cutting member 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; and   the cutting width is not more than 0.75 millimeter smaller than the maximum exterior width of the conduit.   
     
     
         35 . (canceled) 
     
     
         36 . A kit according to  claim 34 , 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. 
     
     
         37 - 38 . (canceled) 
     
     
         39 . An implantation kit according to  claim 36 , comprising:
 a carrier tool for carrying the implant device during an implantation procedure, the carrier tool comprising:
 a carrier member with a distal tip, the carrier member being adapted to be disposed through a fistula between the lacrimal apparatus in the orbit and a paranasal cavity with the distal tip located in the paranasal cavity; and 
 a hand-manipulable handle connected to the carrier member; 
 wherein: 
 the implant device is mountable on the carrier member for implantation with the mounted implant device disposed between the handle and the distal tip with the carrier member disposed through the internal passage and with a proximal end of the implant device disposed toward the handle and a distal end of the implant device disposed toward the distal tip of the member; and 
 when the implant device is mounted for implantation, the carrier is disengageable from the implant device for implant placement of the implant device during an implantation procedure to provide fluid access to a paranasal sinus; and 
   a guide member having a distal end configured to be disposed in or distal of a fistula formed between the lacrimal apparatus and the paranasal sinus;   wherein:
 the cutting tool comprises an internal passage through which the guide member may be inserted such that cutting tool may slidably engaged with the guide member while the distal end of the guide member is disposed in the fistula; and 
 the carrier tool comprises an internal passage through which the guide member may be inserted while the distal end of the guide member is disposed in the fistula to guide the carrier tool to the site of the fistula for implantation of the implant device. 
   
     
     
         40 . An implant device according to  claim 18 , wherein the pair of adjacent circumferential ridges is a most distally located pair of adjacent said circumferential ridges on the conduit. 
     
     
         41 . An implant device according to  claim 40 , wherein the plurality of side ports between the most distally located pair of adjacent circumferential ridges comprises at least 3 said side ports each disposed at a different radial location around a circumference of the conduit between the most distally located pair of adjacent circumferential ridges. 
     
     
         42 . An implant device according to  claim 41 , wherein the plurality of side ports between the most distally located pair of adjacent circumferential ridges comprises at least 2 said side ports each disposed at a different longitudinal location along a length of the conduit between the most distally located pair of adjacent circumferential ridges. 
     
     
         43 . An implant device according to  claim 41 , comprising at least 5 of the circumferential ridges. 
     
     
         44 . An implant device according to  claim 41 , comprising only 5 or only 6 of the circumferential ridges.