Source: https://patents.google.com/patent/AU2014209177C1/en
Timestamp: 2019-04-22 02:30:20+00:00

Document:
This application claims the benefit of U.S. provisional patent application no. 61/757,046 entitled “IMPLANT DEVICE, METHOD AND KIT FOR IMPLANTATION BETWEEN THE LACRIMAL SYSTEM AND A PARANASAL SINUS” filed January 25, 2013 and the benefit of U.S. provisional patent application no. 61/891,250 entitled “PARANASAL SINUS ACCESS IMPLANT DEVICES AND RELATED TOOLS, METHODS AND KITS” filed October 15, 2013, the entire contents of each of which is incorporated by reference herein.
This application incorporates by reference each and every portion of the following: international patent application no. PCT/US2011/055456 entitled “IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OF PARANASAL SINUSES” filed October 7, 2011; U.S. nonprovisional patent application no. 13/225,213 entitled “IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OF PARANASAL SINUSES” filed September 2, 2011; U.S. provisional patent application no. 61/528,058 entitled ’’IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OF PARANASAL SINUSES” filed August 26, 2011; U.S. provisional patent application no. 61/404,716 entitled “METHODS AND TOOLS FOR TREATMENT AND PREVENTION OF SINUSITIS” filed October 8, 2010; U.S. provisional patent application no. 61/623,022 entitled “IMPLANTATION TOOLS, TOOL ASSEMBLIES, KITS AND METHODS” filed April 11, 2012; and international patent application no. PCT/US2013/03447 entitled “IMPLANTATION TOOLS, TOOL ASSEMBLIES, KITS AND METHODS” filed March 28, 2013.
Any discussion of documents, acts, materials, devices, articles and the like in this specification is included solely for the purpose of providing a context for the present invention.
It is not suggested or represented that any of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed in Australia or elsewhere before the priority date of each claim of this application.
Paranasal sinus access implant devices may be configured to be implanted in a human to provide fluid access to a paranasal sinus through an internal passage of such a paranasal sinus access implant device. Such paranasal sinus access implant devices have significant potential for performance of medical procedures and treatments of paranasal sinuses, but such potential has not yet been realized, and there is a continued need for implant devices and accompanying procedures that facilitate easy and effective implantation with good anchoring of the implant device, patient comfort, implant device durability post implantation and effective performance of medical procedures. Various aspects of this disclosure relate to paranasal sinus access implant devices, tools and methods for implantation procedures and treatments through implanted implant devices and kits including paranasal sinus access implant devices. For brevity, paranasal sinus access implant devices are sometimes referred to herein as simply implant devices. A first aspect of the disclosure involves an 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.
In this first aspect, the implant device includes: 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 located between the proximal end and the distal end; an internal passage through 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 in a range of from 0.25 millimeter to 5 millimeters; the conduit including a first longitudinal portion and a second longitudinal portion located toward the distal end relative to the first longitudinal portion; the first longitudinal portion of the conduit having a minimum wall thickness (first minimum wall thickness) adjacent the internal passage; and the second longitudinal portion of the conduit having a minimum wall thickness (second minimum wall thickness) adjacent the internal passage that is smaller than the first minimum wall thickness, and wherein an exterior of the second longitudinal portion of the conduit includes an anchoring surface feature including protrusion areas and recess areas and the second minimum wall thickness occurs at one or more locations corresponding with one or more of the recess areas; 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 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 disposed in the paranasal sinus. A number of feature refinements and additional features are applicable to the first aspect of the disclosure. These feature refinements and additional features may be used individually or in any combination within the subject matter of the first aspect or any other aspect of the disclosure. As such, each of the following features may be, but are not required to be, used with any other feature or combination of features of the first aspect or any other aspect of the disclosure.
The first longitudinal portion of the conduit may or may not have a uniform wall thickness. The first longitudinal portion of the conduit may have a smooth exterior surface. The first longitudinal portion of the conduit may have a length of at least 3 millimeters, at least 4 millimeters, at least 5 millimeters, at least 8 millimeters or at least 10 millimeters.
The first longitudinal portion of the conduit may often have a length that is no greater than 20 millimeters, no greater than 15 millimeters, no greater than 12 millimeters or no greater than 10 millimeters.
The first minimum wall thickness may be at least 0.25 millimeter, at least 0.3 millimeter, at least 0.35 millimeter or at least 0.4 millimeter. The first minimum wall thickness may often be no greater than 0.75 millimeter, no greater than 0.6 millimeter, no greater than 0.55 millimeter, no greater than 0.5 millimeter or no greater than 0.45 millimeter. The wall thickness of the first longitudinal portion of the conduit may be substantially the same and equal to the first minimum wall thickness over some portion of or the entire length of the first longitudinal portion.
The protrusion areas may be provided by a single protrusion occurrence feature located to correspond with the interior of the fistula when the implant device is implanted. In more preferred implementations, the protrusion areas include multiple protrusion occurrences spaced on the exterior of the conduit. The protrusion occurrences may have a center-to-center spacing, in one or more directions, of at least 0.5 millimeter, at least 0.75 millimeter, at least 1 millimeter or at least 1.75 millimeters. The protrusion occurrences may have a center-to-center spacing of no greater than 2.5 millimeters, no greater than 2 millimeters or no greater than 1.75 millimeters. The protrusion occurrences may have a center-to-center spacing longitudinally along the conduit. The protrusion occurrences may have a center-to-center spacing that is at least 0.5 times the base width of the protrusion occurrences, or at least 1 times the base width of the protrusion occurrences or at least 2 times the base width of the protrusion occurrences. The protrusion occurrences may have a center-to-center spacing that is no more than 5 times a base width of the protrusion occurrences, no more than 3 times a base width of the protrusion occurrences or no more than 2 times a base width of the protrusion occurrences.
The protrusion areas may be located on a longitudinal portion of the conduit that includes at least a portion of the conduit that will be disposed within a fistula when the implant device is implanted. The protrusion areas may be on a longitudinal portion of the conduit that extends for at least 2 millimeters along the length of the implant device, that extends for at least 3 millimeters along the length of the implant device, that extends for at least 4 millimeters along the length of the implant device, that extends for at least 5 millimeters along the length of the implant device or that extends for at least 8 millimeters along the length of the implant device. A longitudinal portion of the conduit including the protrusion areas may be no longer than 20 millimeters, no longer than 15 millimeters or no longer than 10 millimeters. A longitudinal portion of the conduit including the protrusion areas may be disposed at least 2 millimeters from the proximal end of the device, at least 3 millimeters from the proximal end of the device, or at least 4 millimeters from the proximal end of the device. When the implant device has a head, a longitudinal portion of the conduit including the protrusions may be disposed at least 1 millimeter, at least 2 millimeters or at least 3 millimeters from the head. Providing significant distance between the head and commencement of the protrusion areas permits the head to better “float” on the surface of tissue, which may enhance patient comfort and device performance. The protrusion areas may be disposed along a longitudinal portion of the conduit with the protrusion areas covering no more than 35% of the area along that longitudinal portion of the conduit, no more than 25% of the area along that longitudinal portion of the conduit or not more than 20% of the area along that longitudinal portion of the conduit. Providing significant spacing between protrusion occurrences may permit better engagement of tissue by the anchoring surface feature. Some or all of the protrusion occurrences may be on the second longitudinal portion of the conduit.
The implant device may include a head adjacent to the conduit at the proximal end of the implant device. The implant device may be configured so that when the implant device is implanted, the head is disposed in the lacrimal apparatus, and preferably with the head located in the orbit. The head may beneficially keep the implant device from migrating through the fistula toward the paranasal sinus following implantation of the implant device. The head may comprise 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 flanged tissue engagement surface may be a flat surface. The flanged tissue engagement surface may have non-flat surface features configured to improve seating of the surface against tissue, such as for example to inhibit rotation of the implant device within the fistula after implantation. The head may have a face surface opposite the flanged tissue engagement surface and also disposed away from the conduit and disposed away from tissue engaged by the flanged tissue engagement surface when the implant device is implanted. The face surface may be substantially flat. The face surface may be disposed at the proximal end of the implant device and the internal passage may open at the face surface. The separation distance between the face surface and the flanged tissue engagement surface may be in a range having a lower limit of 0.25 millimeter, 0.5 millimeter or 0.75 millimeter and having an upper limit of 2 millimeters, 1.5 millimeters or 1 millimeter. Such separation distance need not be constant across the flanged tissue engagement surface and face surface. A maximum separation distance between the face surface and the flanged tissue engagement surface may be referred to as the depth of the head, and such depth may be in a range described above for the separation distance between the face surface and the flanged tissue engagement surface. The flanged tissue engagement surface need not be continuous and may be divided into multiple distinct surface portions.
For example, the flanged tissue engagement surface may include a first flanged portion disposed to one side of the internal passage and a second flanged surface portion disposed to a second side of the internal passage that is opposite the first side. Each of the face surface and the flanged tissue engagement surface may have a length dimension that represents a maximum separation distance between points on an outer edge of the respective surface, and may each have a width dimension that is a maximum separation distance between points on the outer edge transverse to the length dimension. The length dimensions of the face surface and the flanged tissue engagement surface may be the same or may be different. The width dimensions of the face surface and the flanged tissue engagement surface may be the same or may be different. The face surface and the flanged tissue engagement surface may have corresponding outer edges. The length dimension of any or all of the face surface, the flanged tissue engagement surface and the head may be larger than a first exterior width of the conduit defined by an extent of the protrusion areas transverse to the length of the implant device, when the implant device includes an anchoring surface feature such as summarized above. The length dimension of any or all of the face surface, the tissue engagement surface and the head may be in a range having a lower limit of 1 millimeter, 2 millimeters, 3 millimeters, 4 millimeters or 5 millimeters and an upper limit of, 10 millimeters, 8 millimeters or 7 millimeters. The width dimension of any or all of the face surface, tissue engagement surface and the head may be in a range having a lower limit of 0.5 millimeter, 1 millimeter, 1.5 millimeters or 2 millimeters and an upper limit of 5 millimeters, 4 millimeters or 3 millimeters. The length dimension of any or all of the face surface, the flanged tissue engagement surface and the head may be at least 1 millimeter, at least 2 millimeters, at least 3 millimeters or at least 4 millimeters larger than such first exterior width of the conduit defined by an extent of the protrusion areas, when the implant device includes an anchoring surface feature such as summarized above. A ratio of the length of any of or all the face surface, the flanged tissue engagement surface and the head to such a first exterior width of the conduit may be at least 2. Such a ratio may be smaller than 4. The width of any or all of the face surface, the flanged tissue engagement surface and the head may be not larger than, or may be smaller than (e.g., by at least 0.1 mm or by at least 0.2 mm), such a first exterior width of the conduit defined by an extent of the protrusion areas, when the implant device includes an anchoring surface feature such as summarized above. A ratio of the length dimension to the width dimension for any or all of the face surface, the flanged tissue engagement surface and the head may be in a range having a lower limit oft, 1.5, 2 or 2.5 and an upper limit of 5, 4, 3 or 2.5, provided of course that the upper limit must be larger than the lower limit. Having a larger length dimension to width dimension on the head is particularly preferred when the head will be located in the orbit between the lacrimal caruncle and the plica semilunaris, because the length dimension may advantageously align in a vertical direction next to the eyeball and will help provide sufficient flanged surface area to effectively anchor the implant device on the proximal end and impede conjunctival tissue from covering the opening into the internal passage of the implant device, compensating for the narrower width. This is particularly advantageous when using polymeric materials of construction as described above.
The implant device is primarily configured for and described herein with primary reference to the implant device being implantable in a fistula that may be formed between the lacrimal apparatus and a paranasal sinus to provide a passage from the lacrimal apparatus to the paranasal sinus. The implant device is also implantable in a fistula that may be formed between the lacrimal apparatus (e.g., from the comer of medial portion of the orbit between the lacrimal caruncle and the plica semilunaris) and the nasal cavity, for example for enhanced drainage of lacrimal fluid, and such applications directed to the nasal cavity are within the scope of the different aspects of the disclosure. A second aspect of the disclosure involves an implantation kit with components for implantation of an implant device to provide an artificial fluid path in fluid communication with the lacrimal apparatus. A kit of the second aspect may include a paranasal sinus access implant device and at least one additional component useful in connection with implantation of the implant device or performance of a medical treatment or procedure through the implant device. A number of feature refinements and additional features are applicable to the second aspect of the disclosure. These feature refinements and additional features may be used individually or in any combination within the subject matter of the second aspect or any other aspect of the disclosure. As such, each of the following features may be, but are not required to be, used within any other feature or combination of features of the first aspect, the second aspect or any other aspect of the disclosure.
The implant device may comprise: a proximal end and a distal end at opposite longitudinal ends of the implant device; a conduit located between the proximal end and the distal end; an internal passage extending through the conduit; a longitudinal length between the proximal end and the distal end of the implant device 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 the implant device being 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.
The implant device may be an implant device of the first aspect of the disclosure or may have any feature or combination of features described for the first aspect of the disclosure, for example even if the implant device is not according to the first aspect. A kit may include any, or any combination of any, apparatuses, tools, devices, products, components or treatment compositions described herein. A kit may include a fluid treatment composition deliverable to a paranasal sinus through the implant device following implantation of the implant device to provide fluid access to the paranasal sinus. Such a fluid treatment composition may be suitable for being conducted to the internal passage of an implant device through manipulation of a fluid dispenser for delivery to a paranasal sinus, for example to treat for sinusitis or some other condition of the paranasal sinus. The treatment composition may be an aqueous irrigation liquid. The treatment composition may be a drug treatment composition. The drug treatment composition may comprise at least one drug for treating sinusitis or other condition of a paranasal sinus. The drug treatment composition may comprise one or more of the following: 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. Some example antibiotics include: sulfa, or sulfonamide, drugs, such as for example sulfacetamide (e.g., in OCUSOL) and sulfisoxazole (e.g., in GANTRISIN®); macrolide drugs, such as for example azithromycin (e.g., in AZACITE®) and erythromycin (e.g., in ERYPED®); aminoglycoside drugs, such as for example tobramycin (e.g., in TOBREX®) and gentamicin (e.g., in GENOPTIC®); fluoroquinolone drugs, such as for example ciprofloxacin (e.g., in C1L0XAN®), besifloxacin (e.g., in BES1VANCE®) and moxifloxacin (e.g., in VI GAM OX®); tetracycline drugs, such as for example oxytetracycline (e.g., in CODEX); and antibiotic drug combinations, such as for example containing a combination of bacitracin, neomycin and polymyxin B (e.g., in OCUSPORE B) and a combination of gramicidin, neomycin and polymyxin B (e.g., in NEOCIN PG). Some example antivirals include gancyclovir (e.g., in ZIRGAN®) and trifluridine (e.g., in VIROPTIC®). Some example steroids include loteprednol (e.g., in LOTEMAX®) and prednisolone (e.g., in PRED FORTE®). Some example anthistimines include ketotifen (e.g., in ALAWAY®), otopatadine (e.g., in PATADAY®) and pinastine (e.g., in ELESTAT®). Some example mast cell stabilizers include nedocromil sodium (e.g., in ALOCRIL®) and lodoxamide (e.g., in ALOMIDE®). Some example anti-fungals include natamycin (e.g., in NATACYN®) and euconzol. Some example mucolyrics include N-acetylcysteine (e.g., in PARVOLEX). Some example NSAID materials include nepafenac (e.g., in NEVANAC®) and bromfenac (e.g., in BROMDAY®). Some example vasoconstrictors include naphazoline (e.g., in NAPHCON A®) and tetrahydrozoline (e.g., in VISENE®) Some example immunosuppressants include cyclosporine (e.g., in RESTASIS®). All of the aforementioned materials include any pharmaceutically acceptable salts thereof.
Forming a fistula for implantation of an implant device to provide a fluid passage between the lacrimal apparatus and a paranasal sinus involves making a hole through a wall of the bone in which the cavity of the paranasal sinus is located. As described herein, such a hole may be made by a sytlet or other solid piercing instrument and then widened as needed to form the fistula to the desired size for implantation of the implant device. For example following the initial piercing to make an initial hole, the hole may be dilated using dilators to make the hole progressively larger until the desired size is obtained. However, it has been found that when forming a fistula for implantation in such a manner, the bone tends to crack and shatter in the vicinity of hole. Although this does not present a medical problem, it has been found that if the bone is kept more in-tact in the vicinity of the hole, then the bone may provide mechanical support to help secure the implant device in place and prevent the implant device from migrating out of the fistula following implantation. Bone integrity in the vicinity of the fistula may be improved by cutting the hole for the fistula rather than piercing and dilating the hole. By cutting through the bone, rather than pushing through the bone, the bone remains more in-tact in the vicinity of the hole and provides better mechanical support to help retain the implant device in place in the fistula following implantation. The implantation kit of the second aspect may include tools useful for cutting a hole for a fistula and implanting an implant device. A kit may include at least one cutting tool for cutting away tissue to form a fistula through which the implant device may be implanted during an implant procedure. Such a cutting tool may include 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. Such a cutting member may have 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. Such a cutting tool may be a drill. A kit may include a cutting tool that may be guidable by a guide member disposable through an internal passage of the cutting tool. The cutting tool may include a hollow cutting member that has 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. The hollow cutting tip of the cutting tool may be configured to make a larger diameter cut to enlarge a smaller-diameter preliminary cut that may have been previously made to accommodate the guide member, or the cutting tool may be configured to make a desired final cut without prior formation of a smaller initial fistula. The cutting member may be configured to be slidably engaged with the guide member with the guide member disposed through a passage in the cutting member with the distal end of the guide member disposed distal of the distal end of the cutting member. A distal end of the guide member may be configured to be disposed in or distal of the fistula such that the cutting member is slidable over the guide member, for example to conduct the cutting tip of the cutting member to cut tissue to size the fistula for implantation of the implant device when a smaller initial fistula has already been formed or to permit retraction of the cutting member while leaving the guide member in place for use to conduct another tool or tools to the location of the fistula, for example an implantation tool for inserting an implant device into the fistula in position for implantation following cutting a fistula of a desired size for implantation. A cutting member of a cutting tool may be or include a hollow needle or a cutting cannula. The cutting member may have a cutting width, or diameter in the case of a circular cut, that is smaller than a maximum exterior width of the conduit of the implant device. The maximum exterior width of the conduit of the implant device may occur at one or more protrusion areas that form part of an anchoring surface feature on the conduit. The cutting width may be at least 0.1 millimeter smaller, at least 0.2 millimeter smaller, at least 0.25 millimeter smaller, at least 0.3 millimeter smaller, at least 0.35 millimeter smaller or at least 0.4 millimeter smaller than the maximum exterior width of the conduit of the implant device. The cutting width may be not more than 1 millimeter, 0.75 millimeter, 0.6 millimeter, or 0.5 millimeter smaller than the maximum exterior width of the conduit. The cutting width may be not larger than 5 millimeters, 4 millimeters, 3.5 millimeters, 3 millimeters, 2.5 millimeters, 2.25 millimeters, 2 millimeters, 1.9 millimeters or 1.8 millimeters. The cutting width may be at least 1 millimeter, 1.5 millimeter, 1.75 millimeter or 1.85 millimeter. A kit may include an implantation guide tool with a proximal end and a distal end and including a guide member extending longitudinally in a direction from the proximal end toward the distal end of the implantation guide tool. The guide member and internal passage may be configured for mounting the implant device on the guide member with the guide member disposed through the internal passage of the implant device with a distal end of the guide member disposed distal of the distal end of the implant device, and the distal end of the guide member may be configured to be disposed in or distal of the fistula such that the implant device mounted on the guide member is slidable on the guide member toward the distal end of the guide member to conduct the implant device into the fistula for implantation. The guide member may be configured for insertion through a passage through a tool (e.g., cutting tool or carrier tool) to guide the tool to the site of a fistula.
The guide member may be any appropriately sized member on which the implant device or a tool to be guided by the guide member may be slidably conducted along the guide member for implantation. The guide member may be a rigid, flexible or malleable material. The guide member may be a solid member, for example a solid guide wire or a stylet. The guide member may be a hollow member, for example the guide member may be or include a needle or cannula. The guide member may include a cutting end at the distal end configured to cut tissue to form at least a portion of the fistula. Such a hollow guide member with a cutting end may be a needle or cutting cannula. Such a hollow guide member with a cutting end may be useful to cut an initial hole that may then be made larger to a desired size for implantation of the implant device. A kit may include a carrier tool, also referred to as an implantation tool, for carrying the implant device during an implantation procedure. Such a carrier tool may include a carrier member with a distal tip, with 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. The carrier tool may include a hand-manipulable handle connected to the carrier member. An implant device may be mountable on the carrier member for implantation of the implant device, 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. When the implant device is mounted for implantation, the carrier member, and the carrier tool, may be disengageable from the implant device for implantation of the implant device during an implantation procedure to provide fluid access to a paranasal sinus. A clearance fit of the carrier member in the internal passage of the implant device when the implant device is mounted on the carrier member for implant placement may be small to ensure a close fit and help prevent lateral deformation of the implant device during implantation. For example such a clearance fit may be no larger than 0.5 millimeter, no larger than 0.4 millimeter, no larger than 0.3 millimeter, no larger than 0.2 millimeter or no larger than 0.1 millimeter. Having a close fit between of the carrier member in the internal passage of the implant device helps prevent accordion-like bunching of the implant device during an implant procedure as the carrier tool with the mounted device may be advanced to advance (push) the carrier member and the mounted implant device into the fistula for implantation.
Any and all parts of a kit may conveniently be contained within a common package, such as a common box, bag or other common packaging enclosure. Some or all components of a kit may be sterilized and sealed within hermetically sealed enclosures, such as for example hermetically sealed bags or wrapping. A third aspect of the disclosure involves a method for performing a medical procedure in relation to a paranasal sinus and/or administering a treatment composition or performing a medical operation through an implanted implant device directed to the paranasal sinus. A number of feature refinements and additional features are applicable to the third aspect of the disclosure. These feature refinements and additional features may be used individually or in any combination within the subject matter of the third aspect or any other aspect of the disclosure. As such, each of the following features may be, but are not required to be, used within any other feature or combination of features of the first aspect, the second, the third aspect or any other aspect of the disclosure. A medical procedure of the method of a third aspect may include implanting an implant device to provide an artificial fluid path in fluid communication with the lacrimal apparatus. The method of the third aspect may involve cutting away tissue to form a fistula for implantation of an implant device, which is particularly advantageous when the fistula is to pass through bone, such as in the case of implant devices designed to provide an artificial fluid passage between the lacrimal apparatus and a paranasal sinus. The cutting away tissue may be to form a fistula of a size to receive at least a portion of a conduit of an implant device, the fistula having a proximal end opening into the lacrimal apparatus, and implanting the implant device with at least a portion of the conduit of the implant device in the fistula. Following the cutting away tissue, the method may include implanting an implant device to fluidly connect the lacrimal apparatus and the paranasal sinus. The implanting may include advancing the implant device into an implantation position using a carrier tool. The implanting may include advancing the carrier tool to have the carrier tool push the implant device into an implant position. The implanting may include sliding the implant device along a guide member or along a carrier member of a carrier tool into an implantation position. The implanting may include disengaging the carrier tool from the implant device positioned in the implant position.
In one variation, a method of the third aspect may comprise: cutting away tissue to form a fistula having a proximal end opening into the lacrimal apparatus and a distal end opening into a paranasal sinus; implanting an implant device to fluidly connect the lacrimal apparatus and the paranasal sinus, the implanting comprising: advancing a carrier tool on which the implant device is mounted to push the conduit into the fistula from the proximal end of the fistula until the implant device is in an implantation position with a distal end of the conduit disposed in the paranasal sinus; and disengaging the carrier tool from the implant device positioned in the implantation position.
In another variation, a method of the third aspect may comprise: cutting away tissue to form a fistula of a size to receive at least a portion of a conduit of an implant device, the fistula having a proximal end opening into the lacrimal apparatus; with a guide member having a distal end disposed in or distal of the fistula, sliding the implant device along the guide member toward the fistula; and disposing at least a portion of the conduit of the implant device in the fistula. A method procedure of the method of the third aspect may be or involve administering a treatment composition to a paranasal sinus through an implant device that fluidly connects the lacrimal apparatus with the paranasal sinus. A method of the third aspect, or a portion thereof may be performed using a kit of the second aspect of this disclosure or parts of such a kit. When the method includes cutting away tissue, the cutting away tissue may comprise cutting the tissue with a cutting tool of such a kit. During the cutting away or some portion thereof, the cutting member may or may not be disposed over and conducted to the location for the cut by the guide member. For example, a preliminary cut may be made for form a preliminary hole of a smaller size, the guide member may be disposed with a distal end in or distal to the preliminary hole, and the cutting member may be slid over the guide member to cut tissue to produce a larger fistula of the desired size for implantation of the implant device. As another example, a single final cut may be made to make a hole of a final desired size for implantation which may be made without the aid of a guide member and without making a preliminary hole. In that regard, a shoulder on the ethmoid bone facing the orbit has been identified that is a convenient landmark for orienting a cut into the ethmoid sinus. The shoulder has been named the shoulder of Willoughby. When the method includes administering a treatment composition to a paranasal sinus the treatment composition may be as described in relation to the kit of the second aspect.
The implant device for the third aspect (or for the second aspect) may include: a proximal end and a distal end at opposite longitudinal ends of the implant device; the conduit located between the proximal end and the distal end; a first internal passage extending between the proximal end and the distal end of implant device and through the conduit, the first internal passage having a first end open at the proximal end of the implant device and a second end open at the distal end of the implant device; a longitudinal length between the proximal end and the distal end of the implant device in a range of from 2 millimeters to 50 millimeters; a width of the first internal passage transverse to the length in a range of from 0.25 millimeter to 5 millimeters; and the implant device being configured to be implanted with the proximal end of the implant device disposed in the lacrimal apparatus.
The implant device for the third aspect may be an implant device of the first aspect of the disclosure or may include any feature or features described with respect to the first aspect of the disclosure, for example even if the implant device is not according to the first aspect.
The implant device may as described with respect to the second aspect or may have any feature or features described in relation to the second aspect.
The terms “lacrimal apparatus” and “lacrimal system” are used interchangeably herein to refer to the collection of physiological components that accomplish the production and secretion of lacrimal fluid to lubricate the eyeball, containment of lacrimal fluid in a reservoir of lacrimal fluid in the orbit and drainage of lacrimal fluid from the orbit to the nasal cavity. The lacrimal apparatus includes the lacrimal glands, the tear drainage system and the reservoir of lacrimal fluid located between the lacrimal glands and the tear drainage system. The reservoir of lacrimal fluid includes the eyelid margins and the conjunctival sac (and including the pool of tears in the lower conjunctival cul-de-sac that is sometimes referred to as the lacrimal lake). The tear drainage system includes the puncta, canaliculi and nasolacrimal duct (including the so-called lacrimal sac located at the top of the nasolacrimal duct) through which excess tears drain to Hasner’s valve and into the nasal cavity. Figure 1 shows generally the lacrimal apparatus. Lacrimal fluid is produced and secreted from lacrimal glands 102 to lubricate the surface of the eyeball 104 disposed within the orbit. Lacrimal fluid forms a coating over the eyeball 104 and is generally contained within the conjunctival sac (the space between the lower eyelid 106, upper eyelid 108 and eyeball 104 that is lined by the conjunctiva). Excess lacrimal fluid is conducted to the vicinity of the medial canthus (medial comer of the eye) and drains through the lacrimal puncta 110 into the lacrimal canaliculi 112 and into the lacrimal sac 114 of the nasolacrimal duct 116. The lacrimal fluid then drains from the nasolacrimal duct 116 through Hasner’s valve and into the nasal cavity.
Figures 2-5 show one embodiment of an implant device, for example that may be implanted through a fistula at the first, second or third routes 130, 132, or 134 shown in Figure 1. As shown in Figures 2-5, an implant device 200 has a proximal end 202 and a distal end 204 located on opposite longitudinal ends of the implant device 200. The implant device 200 includes a head 206 at the proximal end 202 and a conduit 208 extending from the head 206 to the distal end 204. An internal passage 210 extends from the proximal end 202 to the distal end 204, passing through the head 206 and the conduit 208. The internal passage 210 opens at the proximal end 202 and the distal end 204, thereby providing a passage through the entire longitudinal length of the implant device 200. The internal passage 210 of the embodiment shown in Figure 2 has a cylindrical shape with a uniform circular crosssection (transverse to the length of the implant device 200), and the width of the internal passage is equal to the diameter of the circle of the cross-section and is uniform along the length of the implant device 200. The length of the implant device 200 is the minimum distance longitudinally along the implant device 200 between the proximal end 202 and the distal end 204, and will typically be equal to the distance along an axis of the internal passage 210 from the proximal end 202 to the distal end 204. The implant device 200 includes multiple anchor protrusions 212 on an exterior of the conduit 208. In the embodiment shown in Figures 2-5, the anchor protrusions 212 are in the form of spaced circumferential ridges that each extends around the entire circumference of the conduit 208. Adjacent the circumferential ridges of the anchor protrusions 212 are areas of recess 214 on the exterior of the conduit 208.
Figure 10 shows an implant device 700 with a head 702 and a conduit 704. The conduit 704 includes a first longitudinal portion 706 and a second longitudinal portion 708 disposed distal of the first longitudinal portion 706. The first longitudinal portion 706 includes a smooth exterior surface and the second longitudinal portion 708 includes an anchoring surface feature including anchor protrusions 710, in the form of spaced circumferential ridges, and recess areas 712 between the anchor protrusions 710. The length of the first longitudinal portion 706 located before the beginning of the anchoring surface feature of the second longitudinal portion 708 may advantageously be disposed in conjunctival tissue adjacent the head 702 when implanted to “float” for patient comfort. The anchoring features of the second longitudinal portion 708 may advantageously be located a distance from the head 702 so that one or more of the anchor protrusions 710 are located in the vicinity of the paranasal sinus bone wall that is penetrated by the implant device 700 when implanted, preferably with one or more of the anchor protrusions disposed on each side of the bone. In the embodiment shown in Figure 10, the exterior width of the conduit 704 is substantially the same for the whole length of the first longitudinal portion 706 and in the recess areas 712 of the second longitudinal portion 708. The conduit 704 has a circular crosssection, so that the exterior width of the conduit 704 at any location along the conduit 704 is represented by the diameter of the circular cross-section of the conduit 704 at that location.
As shown in Figure 10, the implant device 700 has a length 714 from a proximal end 716 to a distal end 718 of the implant device 700. The beginning of the second longitudinal portion 708 is located a distance 720 distal from the proximal end 716. The anchor protrusions 710 have a width 722 at the base of the anchor protrusions 722 and a height 724 above the adjacent recess areas 712. The anchor protrusions 710 are spaced on a center-to-center spacing 726. The conduit 704 has a maximum exterior width 728 corresponding with the tops of the anchor protrusions 710, equal to the diameter of the circle of the cross-section through the conduit 704 at the top of the anchor protrusions 710. The conduit 704 has a minimum exterior width 730 along the length of the first longitudinal portion 706 and in the recess areas 712 of the second longitudinal portion 708 of the conduit 704, and which is equal to the diameter of the circular cross-section at those locations. The head 702 has a length dimension 732, a width dimension 734 and a depth dimension 736. The implant device 700 has an internal passage 738 extending between the proximal end 716 and the distal end 718 and through the length of the conduit 704. The internal passage 738 has a width 740, which in this embodiment is equal to a diameter of the circular cross-section of the internal passage 738. Figure 11 shows the same implant device 700 as shown in Figure 10 with some exemplary dimensions, in millimeters, for one nonlimiting example for a configuration for the implant device 702.
Figure 21 shows a variation on the implant device 800 of Figure 20. The implant device 800’ of Figure 21 has the same features as the implant device 800 of Figure 20, except that the implant device 800’ includes a plurality of side openings 850 (which may also be referred to as holes, apertures or ports) through the wall of a distal portion of the conduit 804’. The side openings 850 may be located on a portion of the conduit wall that would be disposed in the paranasal sinus when the implant device 800’ is implanted, such that the side openings 850 may provide a passage for fluid communication between the internal passage of the implant device 800’ and the paranasal sinus even if the distal opening of the internal passage at the distal end of the conduit 804’ were to become blocked or restricted for some reason. In the particular implementation shown in Figure 21, the implant device 800’ the side openings 850 are located in a recess area between a pair of circumferential ridges of an anchoring surface feature of the conduit 804’. Figure 21 shows the side openings 850 located in only one recess area between one pair of circumferential ridges, but one or more similar side openings could also or alternatively be located in a more proximal recess area between a different pair of the circumferential ridges.
In Figure 15 a surgical tool, in the form of an entry tool 600 is shown in the process of making a fistula through tissue between the lacrimal caruncle 142 and the plica semilunaris 144. Numbering of anatomical parts is the same as in Figure 1. The fistula is formed through tissue between the conjunctival sac in the orbit and the ethmoid sinus 126. The route for the fistula would be consistent with general fistula route 132 as shown in Figure 1. The entry tool 600 includes a hollow working member 606 with a hollow cutting distal tip 610 with a shape suitable to cut away tissue to form a fistula from the conjunctival sac to the ethmoid sinus 126. The entry tool 600 may also be referred to as a cutting tool and the working member may also be referred to as a cutting member. The entry tool 600 includes a hand- manipulable handle 612. The handle 612 may be advanced or retracted to advance or retract the hollow working member 606. As shown in Figure 15, the distal cutting tip 610 has been advanced from a location in the conjunctival sac between the caruncle 142 and the plica semilunaris 144 to form a fistula between the conjunctival sac and the ethmoid sinus 126. As shown, the fistula passes behind the caruncle 142, canaliculi 112 and nasolacrimal duct 116 to access the ethmoid sinus 126.
The cutting may be performed, for example, with a cutting tool such as a needle or cannula that cuts tissue or a drill that drills out the tissue. A method may include cutting an initial hole at the location of the desired fistula, and then using a guide member and further tools to complete an implantation procedure. For example, the initial cut may be to make a preliminary hole and a larger gauge needle or cutting cannula may be guided by the guide member to cut the fistula to the final desired size for implantation of the implant device. Alternatively, the initial hole that is cut may be of a final desired size for implantation of the implant device. After the hole has been made to the desired size, the guide member may then be used to guide the implant device or a carrier tool on which the implant device is mounted to the fistula for implantation of the implant device. As one example, a small gauge needle may be used to form an initial cut, and a guide wire may then be inserted through the needle and into the fistula to maintain control of the fistula. The smaller gauge needle may then be retracted and the second cutting tool, in the form of a larger gauge needle, may be slid over the guide wire and conducted to the proper location to cut the fistula to the proper size for implantation of the implant device. A kit for performing such an operation my include the implant device, the smaller gauge needle, the guide wire (as the guide member) and the larger gauge needle as the cutting tool for making the fistula to the final desired size. As another example, the initial cutting tool, or a portion thereof may be used as the guide member for the subsequent cutting tool. For example, the initial cut may be made using a smaller gauge needle having a handle, such as a spinal needle or similar design. Following the initial cut, the handle, or head, may be cut off and removed from the smaller gauge needle and a cutting tool in the form of a larger gauge needle may then be slid over the smaller gauge needle to cut the hole to the final desired size for the fistula. The larger gauge needle may then be retracted and the implant device may be slid over the smaller gauge needle and conducted to the proper location for implantation. A kit for performing such an operation may include the implant device, the smaller gauge needle (which serves as the guide member) and the larger gauge needle as the cutting tool for making the fistula to the final desired size. Alternatively, a kit may include a single cutting tool (e.g., hollow needle or cutting cannula) sized to cut a hole of the final desired size through which the implant device is to be implanted, and without enlargement by further cutting or dilation.
The cutting tool 982 and the carrier tool 986 may have internal passages therethrough for insertion of a guide member (e.g., a guide wire). A kit may include such a guide wire or other guide member. A variety of medical treatments and procedures may be performed through a paranasal sinus access implant device implanted to provide access to a paranasal sinus. Fluid treatment compositions may be administered to a paranasal sinus through the implant device. Fluid may be aspirated from a paranasal sinus through the implant device. One or more medical devices may be inserted into the paranasal sinus through the implant device.
The terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms, are intended to be inclusive and nonlimiting in that the use of such terms indicates the presence of some condition or feature, but not to the exclusion of the presence also of any other condition or feature. The use of the terms “comprising”, “containing”, “including” and “having”, and grammatical variations of those terms in referring to the presence of one or more components, subcomponents or materials, also include and is intended to disclose the more specific embodiments in which the term “comprising”, “containing”, “including” or “having” (or the variation of such term) as the case may be, is replaced by any of the narrower terms “consisting essentially of’ or “consisting of’ or “consisting of only” (or the appropriate grammatical variation of such narrower terms). For example, a statement that some thing “comprises” a stated element or elements is also intended to include and disclose the more specific narrower embodiments of the thing “consisting essentially of’ the stated element or elements, and the thing “consisting of’ the stated element or elements. Examples of various features have been provided for purposes of illustration, and the terms “example”, “for example” and the like indicate illustrative examples that are not limiting and are not to be construed or interpreted as limiting a feature or features to any particular example. The term “at least” followed by a number (e.g., “at least one”) means that number or more than that number. The term “at least a portion” means all or a portion that is less than all. The term “at least a part” means all or a part that is less than all.
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 8 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 and a second longitudinal portion located toward the distal end relative to the first longitudinal portion; wherein the first longitudinal portion of the conduit has a length of at least 3 millimeters, and the second longitudinal portion of the conduit has a length of at least 3 millimeters; the first longitudinal portion of the conduit having a first minimum wall thickness adjacent the internal passage; and 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 millimeters larger than the second minimum wall thickness, and wherein an exterior of the second longitudinal portion of the conduit includes an anchoring surface feature including protrusion areas and recess areas and the second minimum wall thickness occurs at one or more locations corresponding with one or more of the recess areas; 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 disposed in the paranasal sinus.
2. An implant device according to Claim 1, wherein the first longitudinal portion of the conduit has a uniform wall thickness.
3. An implant device according to Claim 1 or Claim 2, wherein the first longitudinal portion of the conduit has a smooth exterior surface.
4. An implant device according to any one of Claims 1-3, wherein the length of the first longitudinal portion of the conduit is in a range of from 5 millimeters to 15 millimeters.
5. An implant device according to any one of Claims 1-4, wherein the first minimum wall thickness is in a range of from 0.35 millimeter to 0.55 millimeter.
6. An implant device according to any one of Claims 1-5, wherein the length of the second longitudinal portion of the conduit is in a range of from 5 millimeters to 15 millimeters.
7. An implant device according to any one of Claims 1-6, wherein the second minimum wall thickness is in a range of from 0.15 millimeter to 0.4 millimeter.
8. An implant device according to any one of Claims 1-7, wherein the first longitudinal portion of the conduit has a first maximum exterior width that is at least 0.2 millimeter smaller than a second maximum exterior width of the second longitudinal portion of the conduit.
9. An implant device according to Claim 8, wherein the first maximum exterior width is in a range of from 1.5 millimeters to 2.5 millimeters.
10. An implant device according to Claim 8 or Claim 9, wherein: the first longitudinal portion of the conduit has a first minimum exterior width and the second longitudinal portion of the conduit has a second minimum exterior width; the second minimum exterior width is smaller than the first maximum exterior width; and the first minimum exterior width is larger than the second minimum exterior width.
11. An implant device according to Claim 10, wherein: the first maximum exterior width and the first minimum exterior width are each within a range of from 1.5 millimeters to 2.5 millimeters; the second maximum exterior width is in a range of from 1.75 millimeters to 3 millimeters; the second minimum exterior width is in a range of from 1 millimeter to 2 millimeters; the first minimum exterior width is at least 0.1 millimeter larger than the second minimum exterior width; 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 10 or Claim 11, wherein the first minimum exterior width and the first maximum exterior width are equal.
13. An implant device according to any one of Claims 10-12, wherein: the second minimum exterior width occurs at a location corresponding with the second minimum wall thickness.
14. An implant device according to any one of Claims 10-13, wherein: the second maximum exterior width is in a range of from 1.75 millimeters to 3 millimeters; the second minimum exterior width is in a range of from 1 millimeter to 2 millimeters; the first minimum exterior width is at least 0.1 millimeter larger than the second minimum exterior width; and the second maximum exterior width is at least 0.2 millimeter larger than the first maximum exterior width.
15. An implant device according to any one of Claims 1-14, wherein the protrusion areas have a height relative to the recess areas of at least 0.2 millimeter.
16. An implant device according to any one of Claims 1-15, wherein the protrusion areas are on a longitudinal portion of the second longitudinal portion of the conduit for at least 5 millimeters along the length of the device.
17. An implant device according to any one of Claims 1-16, wherein: the protrusion areas are configured to flexibly deform when contacting the tissue exposed in the fistula when the conduit is inserted through the fistula for implantation; and the protrusion areas comprise at least 3 spaced circumferential ridges, with each said circumferential ridge extending around an entire circumference of the conduit.
18. An implant device according to any one of Claims 1-17, wherein the longitudinal portion of the conduit including the protrusion areas is disposed at least 4 millimeters from the proximal end of the implant device.
19. An implant device according to any one of Claims 1-18, comprising one or a plurality of side openings into the internal passage through the conduit wall of the second longitudinal portion of the conduit, wherein one or more of the side openings is located within one or more of the recess areas.
20. An implant device according to any one of Claims 1-19, 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; wherein 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.
21. An implant device according to any one of Claims 1-20, wherein the length of the implant device is in a range of from 12 millimeters to 30 millimeters.
22. An implant device according to any one of Claims 1-21, wherein the conduit is constructed of polymeric material having a durometer (Shore A) in a range of from 50 to 100.
23. An implant device according to any one of Claims 1-22, wherein: the conduit extends to adjacent the distal end; the internal passage extends from adjacent the proximal end to adjacent the distal end and the internal passage has a first end open at the proximal end and a second end open at the distal end; and when the implant device is implanted, the first end of the internal passage opens in the lacrimal apparatus and the second end of the internal passage opens into the paranasal sinus.
24. A kit for use to treat a paranasal sinus, the kit comprising: a paranasal sinus access implant device according to any one of Claims 1-23; and at least one additional component useful in connection with implantation of the implant device or performance of a medical treatment or procedure through the implant device.
25. A kit according to Claim 24, comprising a fluid treatment composition deliverable to a paranasal sinus through the implant device following implantation of the implant device to provide access to the paranasal sinus.
26. A kit according to Claim 25, wherein the treatment composition is contained in a fluid container of a fluid dispenser manipulable to dispense at least a portion of the treatment composition from the fluid container into the internal passage or through the internal passage directly into a paranasal sinus following implantation of the implant device; the fluid dispenser comprises a fluid ejection member in fluid communication with the treatment composition in the fluid container, the fluid ejection member being insertable in the internal passage of the implant device; and the fluid dispenser is manipulable when the fluid ejection member is inserted in the internal passage of the implant device when the implant device is implanted to eject at least a portion of the treatment composition from a distal end of the fluid ejection member into the internal passage or distal of the internal passage directly into a paranasal sinus.
27. A kit according to Claim 26, wherein the fluid ejection member has an insertion portion configured to be inserted into the internal passage and the insertion portion has a maximum outside width of no larger than 1.5 millimeters.
28. A kit according to Claim 26 or Claim 27, wherein the fluid ejection member is covered with a removable protective cap.
29. A kit according to any one of Claims 24-28, wherein the treatment composition is an aqueous irrigation liquid.
30. A kit according to any one of Claims 24-28, wherein the treatment composition is a drug treatment composition.
31. A kit according to Claim 30, wherein the drug treatment composition comprises at least one drug for treating sinusitis.
32. A kit according to Claim 30 or Claim 31, wherein the drug treatment composition comprises any one or more of the following in any combination: an antibiotic, a steroid, an antiviral, an antihistamine, an anti-fungal, a mast cell stabilizer, a mucolytic, a non-steroidal antiinflammatory drug (NSAID), a vasoconstrictor, and an immunosuppressant.
33. A kit according to any one of Claims 30-32, wherein the fluid container contains a volume of the treatment composition in a range of from 0.1 milliliters to 3 milliliters.
34. A kit according to any one of Claims 24-33, comprising 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.
35. A kit according to Claim 34, 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.
36. A kit according to Claim 34 or Claim 35, 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.
37. A kit according to Claim 36, wherein the cutting width is not more than 0.75 millimeter smaller than the maximum exterior width of the conduit.
38. A kit according to Claim 36 or Claim 37, 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.
39. A kit according to any one of Claims 24-38, 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.
40. A kit according to Claim 39, wherein a clearance fit of the carrier member in the internal passage when the implant device is mounted on the carrier member for implantation is no larger than 0.5 millimeter.
41. An implantation kit according to any one of Claims 24-40, comprising: 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; 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.
ES2249923T3 (en) 2006-04-01 Composition set and kit for use in intraocular surgery.

References: application no. 61
 application no. 61
 application no. 13
 application no. 61
 application no. 61
 application no. 61