Paranasal sinus access implant devices and kit

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DESCRIPTION

Implant device for access to the sinuses and kit Field of the invention

The invention relates to an implant device for access to the paranasal sinuses and a kit that includes the same.

Background of the invention

In the United States alone, 35 million people are treated annually for sinus infections or sinus infections, and 7 million of them will suffer from chronic sinusitis and will have a minimal response to drug therapies subject to medical prescription. Conventional surgical interventions may be expected to offer only moderate symptomatic improvement at best, but not a cure.

Conventional drug therapies include oral administration with pills and nasal topical administration, without any of them being conducive to providing an adequate concentration of medication to the paranasal sinus in question. In addition to medication, habitual sinus irrigation can help clear up debris, irritants and obstructive viscous fluids, but patients are not usually able, in general, to properly perform this procedure at home.

For patients with particularly severe symptoms, surgical drainage has been used as a last resort option. An initial surgical procedure was the Caldwell-Luc procedure, which involved the creation of a permanent fistula from the base of the paranasal sinus to the oral cavity, above the upper frontal incisors. More recently, other surgical access points have been attempted up to the sinuses. A variety of endoscopic techniques have been developed that access the paranasal sinuses through the nose, including functional endoscopic sinus surgery (FESS) and balloon sinuplasty. All these procedures try to increase drainage, but use different routes or tools. The surgical formation of a fistula between the lacrimal apparatus and a paranasal sinus has been identified as a technique that provides direct access to the paranasal sinus, and through which a variety of medical treatments and medical procedures can be directed towards the paranasal sinus. None of these surgical approaches has yet achieved widespread acceptance or success, and millions of patients with chronic sinusitis continue to experience long-term disability and discomfort.

US 2012/089071 A1 discloses an implant device configured to be implanted in a fistula, to fluidly connect the lacrimal apparatus and a paranasal sinus. A kit is also disclosed that includes an input device to form a fistula and an implant tool to implant the implant device after fistula formation.

WO 2010/096822 A2 discloses tear implants and related methods. Tear implants may comprise an implant body configured for insertion, at least partially, through the tear point and into the canaficulus. The implant body may include first and second parts and may extend from a proximal end of the first part, which defines a longitudinal proximal axis, to a distal end of the second part, which defines a longitudinal distal axis. The implant body can be configured so that, when implanted using an integral dilator, there is an angled intersection between the proximal and distal axes. In this way, at least a part of the implant body can be deflected against at least a part of the tear canal, located at or more distal to the canalicular curvature, thereby retaining an implanted position of the tear implant using the anatomical structures.

Summary of the invention

The paranasal sinus access implant devices can be configured to be implanted in a human, and thus provide a fluid access to a paranasal sinus through an internal passage of said paranasal sinus access implant device. Said sinus access implant devices have significant potential to carry out paranasal sinus procedures and medical treatments, but said potential has not yet been achieved, and there is still a need to have implant devices and procedures that accompany them to facilitate simple and effective implantation, providing good anchorage of the implant device, patient comfort, the durability of the implant device after its implantation and the effective execution of medical procedures. Several aspects of the present disclosure concern implant devices for access to the sinuses, tools and methods for carrying out implantation procedures and treatments by means of implanted implant devices and kits that include breast access implant devices. paranasal To summarize, sometimes in this document reference is made to the implant devices for access to the sinuses simply as "implant devices".

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A first aspect of the disclosure involves an implant device useful for implantation in a human and thus fluidly connecting a tear apparatus with a paranasal sinus through a fistula created between the tear apparatus and the paranasal sinus.

It has been found that implant devices can be better retained after implantation if the implant devices include surface anchoring features, including protruding areas and recessed areas along a conduit that must be inserted into the fistula to implant. The anchorage is improved when a maximum external diameter, defined by the protuberant areas to be placed in the fistula, is larger than the diameter of the fistula that was created to receive the implant device conduit. This creates a smooth fit of the duct in the fistula, the tissue tightening towards the recessed areas of the surface anchoring feature. However, said implantation ducts made of relatively flexible plastic materials can be folded upwards, just like an accordion, making it difficult to insert the duct into the fistula for implantation. It has been found that including a thicker duct wall in a proximal part of the implant device duct, as compared to that included in a distal part that is first inserted into the fistula, can facilitate insertion of the duct so significant. In addition, a thicker duct wall in a proximal part of the duct provides added mechanical durability of the duct, adjacent to the proximal end of the implant device, and reduces the possibility of mechanical damage to the proximal parts of the duct due to interactions mechanics that may occur between the implant device and the tools used during an implantation procedure, or during the practice of medical treatments and other procedures after implantation.

The implant device of the first aspect includes all the features of claim 1, that is:

a proximal end at a first longitudinal end of the device; a distal end at a second longitudinal end of the device, which is longitudinally opposite the first longitudinal end; a conduit located between the proximal end and the distal end; an internal passage through the duct;

a length of the implant device longitudinally along the implant device, between the proximal end and the distal end, in a range of 8 meters to 50 meters;

a width of the internal passage transverse to the length, in a range of 0.25 meters to 5 meters; the conduit including a first longitudinal part and a second longitudinal part, located towards the distal end with respect to the first longitudinal part; wherein the first longitudinal part of the conduit has a length of at least 3 mifimeters, and the second longitudinal part of the conduit has a length of at least 3 mifimeters;

the first longitudinal part of the duct having a first minimum wall thickness adjacent to the internal passage; Y

the second longitudinal part of the duct having a second minimum wall thickness adjacent to the internal passage, which is smaller than the first minimum wall thickness; in which the first minimum wall thickness is at least 0.05 meters more than the second minimum wall thickness;

the implant device being configured to implant and fluidly connect the tear apparatus with the paranasal sinus, so that when it is implanted:

the proximal end is arranged in the tear apparatus; the distal end is arranged in the paranasal sinus; Y

the conduit is disposed through the fistula, at least one part of each of the first longitudinal part and the second longitudinal part of the conduit disposed within the fistula being at least one part of the second longitudinal part of the conduit being disposed in the paranasal sinus.

A number of additional features and features improvements can be applied to the first aspect of the disclosure.

The first longitudinal part of the duct may or may not have a uniform wall thickness. The first longitudinal part of the duct may have a smooth outer surface. The first longitudinal part of the conduit can be at least 4 meters long, at least 5 meters long, at least 8 meters long or at least 10 meters long.

The first longitudinal part of the duct can often have a length of no more than 20 meters, no more than 15 meters, no more than 12 meters or no more than 10 meters.

The first minimum wall thickness can be at least 0.25 meters, at least 0.3 meters, at least 0.35 meters or at least 0.4 meters. The first minimum wall thickness can often be no more than 0.75 meters, no more than 0.6 meters, no more than 0.55 meters, no more than 0.5 meters or not more than 0.45 meters. The wall thickness of the first longitudinal part of the conduit can be substantially the same and equal to the first minimum wall thickness over a certain part of or the entire length of the first longitudinal part.

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The second longitudinal part of the duct can have a length of at least 4 millimeters, at least 5 millimeters, at least 8 millimeters or at least 10 millimeters. The second longitudinal part of the duct can often have a length of no more than 30 millimeters, no more than 25 millimeters, no more than 20 millimeters, no more than 15 millimeters, no more than 12 millimeters or no more than 10 millimeters.

The second minimum wall thickness can be no more than 0.6 millimeters, no more than 0.5 millimeters, no more than 0.45 millimeters, no more than 0.4 millimeters, no more than 0, 35 millimeters, no more than 0.3 millimeters, no more than 0.25 millimeters or no more than 0.2 millimeters. The second minimum wall thickness can often be at least 0.1 millimeters, at least 0.15 millimeters or at least 0.2 millimeters. The wall thickness of the second longitudinal part of the conduit can be substantially the same over a certain part or parts of the second longitudinal part of the conduit. The second longitudinal part of the duct may have an exterior that includes a surface anchoring feature that includes protruding areas and recessed areas. The wall thickness at locations that correspond to the recessed areas may be less than the wall thickness at the locations that correspond to the protruding areas. The second minimum wall thickness can be produced in one or more locations that correspond to the one or more of said recessed areas.

The first minimum wall thickness can be at least 0.1 millimeters more, at least 0.15 millimeters or at least 0.175 millimeters more than the second minimum wall thickness. The first minimum wall thickness may have no more than 0.3 millimeters more, no more than 0.25 millimeters more or not more than 0.2 millimeters more than the second minimum wall thickness.

The first longitudinal part of the conduit may have a maximum exterior width (first maximum exterior width) that is smaller than a maximum exterior width of the second longitudinal part of the conduit (maximum maximum external width). The second maximum outer width may have at least 0.1 millimeters more, at least 0.2 millimeters more, at least 0.25 millimeters more, at least 0.3 millimeters more, at least 0.35 millimeters more, at least 0 , 4 millimeters more or at least 0.5 millimeters more than the first maximum exterior width. The second maximum outer width can often be no more than 1 millimeter, no more than 0.75 millimeters, no more than 0.5 millimeters more or no more than 0.4 millimeters more than the second width maximum exterior The first maximum outer width may be at least 1.25 millimeters, at least 1.5 millimeters, at least 1.75 millimeters or at least 2 millimeters. The first maximum exterior width can often be no more than 3 millimeters, no more than 2.5 millimeters, no more than 2.25 millimeters or no more than 2 millimeters. The second maximum outer width may be at least 1.5 millimeters, at least 1.6 millimeters, at least 1.75 millimeters, at least 2 millimeters, at least 2.25 millimeters or at least 2.5 millimeters. The second maximum exterior width may be no more than 5 millimeters, no more than 4 millimeters, no more than 3 millimeters, no more than 2.75 millimeters, no more than 2.5 millimeters or no more than 2.25 millimeters.

The first longitudinal part of the duct can have a minimum outer width (first minimum outer width) and the second longitudinal part of the duct can have a minimum outer width (second minimum outer width) that is smaller than the first maximum outer width. The first minimum outer width may have at least 0.1 millimeters more, at least 0.2 millimeters more, at least 0.25 millimeters more, at least 0.3 millimeters more, at least 0.35 millimeters more, at least 0 , 4 millimeters more or at least 0.5 millimeters more than the second minimum outer width. The first minimum exterior width may be no more than 3 millimeters, no more than 2.5 millimeters, no more than 2.25 millimeters or no more than 2 millimeters. The first minimum outer width may be at least 1 millimeter, at least 1.25 millimeters, at least 1.5 millimeters, at least 1.75 millimeters or at least 2 millimeters. The first longitudinal part of the conduit can have a substantially constant cross section (for example, a constant circular cross section), in which case, the maximum and minimum exterior widths of the first longitudinal part of the conduit are the same (for example, a diameter of constant circular cross section). The second minimum outer width may be no more than 2.5 millimeters, no more than 2 millimeters, no more than 1.75 millimeters or no more than 1.5 millimeters. The second minimum outer width can often be at least 1 millimeter, at least 1.25 millimeters, at least 1.50 millimeters or at least 1.75 millimeters. The second longitudinal part may have a surface geometry in which the second minimum outer width may be smaller than a second maximum external width of the second longitudinal part. The second minimum outer width may correspond to the locations of the second minimum wall thickness.

The conduit may have a cross section circulating in some or all points along the length of the first and second longitudinal portions of the conduit. The first minimum wall thickness and the second minimum wall thickness can be tubular walls.

The conduit can be configured so that an exterior of the conduit comprises a surface anchoring feature that helps anchor the implant device when the device is implanted. The surface anchoring feature includes protruding areas and recessed areas. The second minimum wall thickness can be produced at a location that corresponds to at least one of the lowered areas. The implant device can be configured so that when implanted, the conduit is arranged through the fistula, at least a part of the recessed areas disposed within the fistula, and at least a part of the protuberant areas disposed in the fistula and fixing the exposed tissue inside the fistula to anchor the implant device. The

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Structural and mechanical characteristics of the protuberances in the protuberant areas may affect the anchoring performance of the protuberant areas. The height of the protuberant areas with respect to the recessed areas may affect the effectiveness of the anchorage when the implant device is implanted. A greater height may provide greater anchoring efficiency, but it may also imply that a larger overall width of the implant device must be inserted into the fistula. The protuberant areas may have a height with respect to the recessed areas of at least 0.1 mifimeters, at least 0.2 mifimeters, at least 0.25 mifimeters or at least 0.3 mifimeters. The protuberant areas may have a height with respect to the recessed areas of no more than 2 meters, no more than 1.5 meters, no more than 1 meter, no more than 0.75 meters, no more than 0 , 5 meters or not more than 0.4 meters. The height may be of certain particular protrusions with respect to adjacent recessed areas. The protuberances are also referred to herein as "anchoring protuberances." Said anchoring protrusions may be configured to flexibly deform when the conduit is inserted through the fistula for implantation, for example, to flexibly deform in a direction opposite to the direction of insertion when the anchoring protrusions make contact. with the tissue arranged in the fistula during insertion. After insertion, the anchoring bumps may eventually return to their original shape and extend deeper into the adjacent tissue and thus be better anchored to the implant device. The mechanical properties of the anchoring protrusions can be influenced by the construction materials used. Preferred building materials for protruding areas, and also for other parts of the implant device, are polymeric materials. The polymeric materials may preferably be medical grade materials. Certain preferred polymeric materials are silicones and polyurethanes. For best performance, the construction material should have a stiffness that interacts positively with the tissue near the fistula, for example, to encourage load distribution and good anchorage. A preferred construction material is a polymeric material (for example, silicone or polyurethane) having a durometer (Shore A hardness) in a range that has a lower fimite of 50, 60, 70 or 80 and a higher fimite of 100, 80 , 70 or 60, as long as the upper fimite is larger than the lower fimite. A preferred range is a durometer (Shore A hardness) of 60-100, with a range of 80-100 being more preferred. For certain implementations, the polymeric material has a durometer (Shore A hardness) of approximately 60, approximately 80 or approximately 100. The mechanical properties of the protuberances of the protuberant areas will also be affected by the geometry of the protuberances. The

bumps may have a width that tapers, or narrows, in one direction from a base to a

upper part of the protuberances, the base being a part of a protuberance arranged towards the internal passage of the conduit and an upper part of the protuberance being the extremity of the protuberance that is far from the internal passage of the conduit. The width can be transverse to the length of the duct. The protuberances may have a width at the base that is not more than 2 meters, no more than 1.5 meters, no more than 1.25 meters or no more than 1 meter. One or more of the protuberances may have a width at the base that is at least 0.2 mifimeters, at least 0.3 mifimeters, at least 0.5 mifimeters, at least 0.75 mifimeters or at least

one mifimeter. The bumps may have a width adjacent to the top that is not more than 0.75

times the width of the base, no more than 0.5 times the width of the base, or no more than 0.25 times the width of the base. The bumps may have a width halfway between the base and the top that is not more than 0.8 times the width of the base, not more than 0.7 times the width of the base, not more than 0, 6 times the

width of the base or not more than 0.5 times the width of the base.

The protuberant areas can be provided with a unique protrusion characteristic located to correspond with the inside of the fistula, when the implant device is implanted. In more preferred implementations, the protuberant areas include multiple separate protuberances on the outside of the conduit. The protuberances may have a center-to-center separation, in one or more directions, of at least 0.5 meters, at least 0.75 meters, at least 1 meter or at least 1.75 meters. The protuberances may have a center-to-center separation of no more than 2.5 meters, no more than 2 meters or no more than 1.75 meters. The bumps may have a center-to-center separation longitudinally along the duct. The protuberances may have a center-to-center clearance that is at least 0.5 times the base width of the protuberances, or at least 1 time the base width of the protuberances, or at least 2 times the base width of the protrusions. bumps The protuberances may have a center-to-center separation that is not more than 5 times a base width of the protuberances, not more than 3 times a base width of the protuberances, or not more than 2 times a base width of the bumps.

The protuberant areas may be located in a longitudinal part of the conduit, which includes at least a part of the conduit that will be disposed within a fistula when the implant device has been implanted. The protuberant areas may be in a longitudinal part of the conduit that extends at least 2 mifimeters along the length of the implant device, which extends at least 3 mifimeters along the length of the implant device, which extends at least 4 mifimeters along the length of the implant device, which extends at least 5 mifimeters along the length of the implant device or that extends at least 8 mifimeters along the length of the implant device. A longitudinal part of the duct, which includes the protruding areas, can be no more than 20 mifimeiros, no more than 15 mifimetros or no more than 10 mifimetros. A longitudinal part of the duct, which includes the protruding areas, can be arranged at least

2 meters from the proximal end of the device, at least 3 meters from the proximal end of the device or at least 4 meters from the proximal end of the device. When the implant device has a head, a longitudinal part of the duct, which includes the protuberances, can be arranged in at least

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one My meter, at least 2 miKmeters or at least 3 miKmeters from the head. By providing a significant distance between the head and the beginning of the protruding areas, the head is allowed to "float" better on the tissue surface, which can improve patient comfort and device performance. The protuberant areas may be disposed along a longitudinal part of the duct, covering the protruding areas not more than 35% of the area along said longitudinal part of the duct, not more than 25% of the area along said longitudinal part of the duct or not more than 20% of the area along said longitudinal part of the duct. By providing a significant separation between the protuberances, better tissue fixation can be allowed thanks to the surface anchoring characteristic. Some or all of the protuberances may be on the second longitudinal part of the duct.

The protuberant areas may comprise at least one circumferential flange. By circumferential flange is meant a flange that extends around an entire circumference of the duct. The protuberant areas may comprise at least two, at least three or at least five circumferential flanges. The protuberant areas may comprise a spiral flange. Said spiral flange can extend along a longitudinal part of the duct. The protuberant areas may comprise a ball or may comprise multiple balls. The surface anchoring feature may comprise a textured surface, the protruding areas comprising protruding parts of the textured surface, and the recessed areas comprising recessed portions of the textured surface.

The length of the implant device can be selected to provide a sufficient length of the conduit across the entire length of the fistula plus any desired extension distance in the tear apparatus, proximal to the fistula, and in the paranasal sinus, distal to the fistula . The length of the implant device and / or the duct may be in a range that has a lower limit of 8 millimeters, 10 millimeters or 12 millimeters, and an upper limit of 50 millimeters, 40 millimeters, 30 millimeters, 25 millimeters, 20 millimeters , 15 millimeters or 10 millimeters, as long as the upper limit is greater than the lower limit. A preferred range for certain implementations, when the fistula is between the orbital cavity and the ethmoidal sinus or maxillary sinus, for the length of the implant device and / or for the length of the duct has to be in a range of 10 millimeters to 30 millimeters, with a range of 15 millimeters to 25 millimeters being more preferred. The length of the implant or conduit means the longitudinal dimension along the implant device or the conduit, as appropriate, from the proximal end to the distal end of the implant or conduit device, and may be along a length of longitudinal axis through the internal passage. The length may be a straight line, for example, when the internal passage is straight, or the length may be curved or in some other way, for example, when the internal passage is not linear. When reference is made herein to be transverse to length, the reference is made at a right angle with respect to the longitudinal direction of the length at that point (for example, a right angle with respect to a line of the length or a tangent line with respect to a length curve).

The implant device can be advantageously designed with a conduit of appropriate width dimensions to fit ashen within a desired size of the fistula. The implant device may have a first outer width dimension defined by a maximum extension of the protuberant areas, transverse to the length of the device, the first outer width being in an interval having a lower limit of 0.75 millimeters, 1 millimeter , 1.25 millimeters, 1.5 millimeters, 1.75 millimeters or 2 millimeters, and an upper limit of 8 millimeters, 7 millimeters, 6 millimeters, 5 millimeters, 4 millimeters, 3 millimeters, 2 millimeters or 1.75 millimeters, as long as the upper limit is greater than the lower limit. The conduit may have a second dimension of width defined by the minimum extension of the recessed areas, transverse to the length of the device, and whose second dimension of exterior width will be smaller than the first dimension of exterior width defined by the protruding areas. The second outer width dimension defined by the recessed areas may be smaller than the outer width dimension defined by the protruding areas, by an amount that is in a range that has a lower limit of 0.2 millimeters, 0.25 millimeters , 0.35 millimeters or 0.5 millimeters, and that has an upper limit of 1.5 millimeters, 1 millimeter or 0.75 millimeters. The height of the protuberant areas may be half the difference between the first outer width and the second outer width. Or one of or each of the first outer width and the second outer width may be the diameter of one cm.

The implant device may include one or a plurality of lateral openings through the duct wall of a distal part of the duct, the distal part of which may be or include a part of the duct that is designed to be disposed within a paranasal sinus when Implant the implant device, so as to provide fluid access through the implant device to the paranasal sinus. The lateral openings can be opened towards the internal passage through the conduit, and can provide a passage for fluid communication between the internal passage of the implant device and the paranasal sinus, even if the distal opening of the internal passage at the distal end of the conduit would be blocked or limited for some reason. One or more of the lateral openings may be through a wall of the second longitudinal part of the conduit, and may be through a wall having the second minimum wall thickness. One or more of the lateral openings can be located within one or more recessed areas of a surface characteristic of anchorage of the conduit (for example, between circumferential flanges). With a thinner minimum wall thickness in the second longitudinal part of the conduit than in the first longitudinal part of the conduit, the second longitudinal part of the conduit, and in particular, near a distal end of the second longitudinal part of the conduit, can be more likely to be limited due to

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duct collapse at or near the distal end, and the lateral openings provide alternative fluid access to the paranasal sinus.

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 has been implanted, the head is arranged in the tear apparatus, and preferably, the head being located in the orbital cavity. The head can beneficially retain the implant device, causing it not to move through the fistula into the paranasal sinus after the implant device has been implanted. The head may comprise a flanged tissue fixation surface on one side of the head, disposed toward the conduit and configured to fix the tissue outside and adjacent to the fistula, when the implant device is implanted. The fastening surface of the flanged fabric can be a flat surface. The flanged tissue fixation surface may have surface features that are not flat, configured to improve the settlement of the surface against the tissue, such as for example, to inhibit the rotation of the implant device within the fistula after implantation. The head may have a surface opposite the fixing surface of the flanged tissue, and which is also disposed away from the conduit and disposed away from the tissue fixed by the fixing surface of the flanged tissue when the implant device has been implanted. The face surface can be substantially flat. The face surface can be arranged at the proximal end of the implant device and the internal passage can be opened on the face surface. The separation distance between the face surface and the fixing surface of the flanged tissue may be in a range that has a lower fimite of 0.25 meters, 0.5 meters or 0.75 meters, and which has a higher limit of 2 meters, 1.5 meters or 1 meter. It is not necessary for said separation distance to be constant across the fixing surface of the flanged tissue and the face surface. Reference may be made to the maximum separation distance between the face surface and the flanged tissue fixation surface as the "head depth", and said depth may be in a range described above of the separation distance between the face surface and the fixing surface of the flanged fabric. The fixing surface of the flanged fabric does not need to be continuous, and can be divided into several different surface parts. For example, the fastening surface of the flanged fabric may include a first flanged part, arranged on one side of the internal passage, and a second part of flanged surface, arranged on a second side of the internal passage, which is opposite the first lateral. Each of the face surface and the fixing surface of the flanged fabric can have a length dimension that represents a maximum separation distance between the points on an external edge of the respective surface, and each of them can have a dimension of width which is a maximum separation distance between the points on the outer edge transverse to the length dimension. The length dimensions of the face surface and the fixing surface of the flanged fabric may be the same or they may be different. The width dimensions of the face surface and the fixing surface of the flanged fabric may be the same or they may be different. The face surface and the fixing surface of the flanged fabric may have corresponding outer edges. The length dimension of any or all: the face surface, the fixing surface of the flanged fabric and the head, may be greater than a first outer width of the duct, defined by an extension of the protuberant areas transverse to the length of the device of implant, when the implant device includes a surface anchoring feature, as summarized above. The length dimension of any or all: the face surface, the fabric fixing surface and the head, may be in a range that has a lower fimite of 1 meter, 2 meters, 3 meters, 4 meters or 5 meters, and an upper fimite of 10 meters, 8 meters or 7 meters. The width dimension of any or all: the face surface, the fixing surface of the fabric and the head, can be in a range that has a lower fimite of 0.5 meters, 1 meter, 1.5 meters or 2 meters , and an upper fimite of 5 meters, 4 meters or 3 meters. The length dimension of any or all: the face surface, the fixing surface of the flanged fabric and the head, may be at least 1 meter, at least 2 meters, at least 3 meters or at least 4 meters more than said first outer width of the duct defined by an extension of the protuberant areas, when the implant device includes a surface anchoring feature, as summarized above. A relationship between the length of any or all of them: the face surface, the fixing surface of the flanged fabric and the head, and said first outer width of the duct may be at least 2. Said relationship may be less than 4. The width of any or all: the face surface, the fixing surface of the flanged fabric and the head, may be no more than, or may be less than (for example, at least 0.1 mm or at least 0.2 mm), said first outer width of the duct, defined by an extension of the protuberant areas, when the implant device includes a surface anchoring feature, as summarized above. A relationship between the length dimension and the width dimension of any or all: the face surface, the fixing surface of the flanged fabric and the head, can be in a range that has a lower limit of 1 meter, 1.5 , 2 or 2.5, and an upper fimite of 5, 4, 3 or 2.5, as long as the upper fimite is larger than the lower fimite. In particular, it is preferred to have a dimension of length greater than the dimension of width in the head when the head is to be placed in the orbital cavity between the tear caruncula and the semilunar fold, since the length dimension can be advantageously aligned in a vertical direction, close to the eyeball, and will help provide a surface area sufficiently flanged to effectively anchor the implant device on the proximal end, and thus prevent the connective tissue from covering the opening in the internal passage of the implant device, compensating for the narrowest width. This is particularly advantageous when polymeric building materials are used, as described above.

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The internal passage through the implant device may have a substantially uniform shape along the entire length of the implant device, or it may have a vain shape. The internal passage can be substantially straight from the proximal end of the device to the distal end of the device. The internal passage may have a cross section available for flow (transverse to the length of the device) that is substantially uniform from the proximal end to the distal end of the implant device. The internal passage may have a substantially circular cross section. The internal passage may have a substantially elliptical cross section. The width of the duct (maximum dimension by the cross-section of the internal passage available for the flow) may be in a range that has a lower limit of 0.25 millimeters, 0.5 millimeters or 0.75 millimeters and 1 millimeter, and a Upper limit of 5 millimeters or 4 millimeters or 3 millimeters, 2 millimeters or 1.5 millimeters.

The tear apparatus and a paranasal sinus can be in fluid communication through the internal passage of the implant device, when the implant device has been implanted. The duct can extend from being adjacent to the proximal end of the implant device. The duct can extend to be adjacent to the distal end of the implant device. The internal passage may have a first open end at the proximal end, and a second open end at the distal end, and when the implant device has been implanted, the first end of the internal passage can be opened in the tear apparatus and the second end of the internal passage opens in the paranasal sinus.

The implant device can be configured to perform its implantation by passing the conduit through a fistula between a location in the lacrimal apparatus within the orbital cavity and a paranasal sinus selected from the group consisting of a frontal sinus, an ethmoidal sinus, a maxillary sinus and a sphenoid sinus, a frontal sinus, a maxillary sinus or an ethmoidal sinus being preferable, an ethmoidal sinus or a maxillary sinus being more preferred, and an ethmoidal sinus being particularly preferred. The implant device can be configured to perform its implantation by passing the duct through a fistula between a location in the lacrimal apparatus within the nasolacrimal duct and a paranasal sinus selected from the group consisting of an ethmoidal sinus and a maxillary sinus. The location within the nasolacrimal duct may be inside the tear sac.

Mainly, the implant device is configured for and herein described with major reference to the implant device that can be implanted in a fistula, which can be formed between the tear apparatus and a paranasal sinus, to provide a passage from the tear apparatus to the paranasal sinus. The implant device can also be implanted in a fistula that can be formed between the tear apparatus (for example, from the corner of the internal part of the orbital cavity, between the tear caruncula and the semilunar fold) and the nostril, for example, to carry out a better drainage of the tear fluid, and said applications, directed towards the nostril, are within the scope of the different aspects of the disclosure.

A second aspect of the disclosure involves an implantation kit with components for the implantation of an implant device, to thereby provide an artificial fluid path in fluid communication with the tear apparatus. A kit of the second aspect includes an implant device for access to the paranasal sinuses according to claim 1, and at least one additional useful component, in connection with the implantation of the implant device, or the execution of a medical treatment or procedure. through the implant device.

A number of improvements of the features and additional features may be applied to the second aspect of the disclosure. These improvements of the features and additional features may be used individually or in any combination within the subject matter of the second aspect, or in any other aspect of the disclosure. Thus, each of the following features may be used, although not necessary, with any other feature or combination of features of the first aspect, the second aspect or any other aspect of the disclosure.

The implant device is an implant device of the first aspect of the disclosure and can have any feature or combination of features described for the first aspect of the disclosure.

A kit may include any, or any combination of any apparatus, tools, devices, products, components or treatment compositions described herein.

A kit may include a composition of treatment fluid available in a paranasal sinus through the implant device, after implantation of the implant device, in order to provide fluid access to the paranasal sinus. Said treatment fluid composition may be suitable to be taken to the internal passage of an implant device, by manipulating a fluid dispenser that supplies it to a paranasal sinus, for example, to treat sinusitis or any other breast condition. paranasal The composition of the treatment may be an aqueous irrigation liquid. The composition of the treatment may be a pharmacological composition of treatment. The pharmacological treatment composition may comprise at least one drug to treat sinusitis or any other condition of a paranasal sinus. The pharmacological treatment composition may comprise one or more of the following: an antibiotic, a steroid, an antiviral, an antihistamine, an antifungal, a mast cell stabilizer, a mucolphonic, a non-steroidal anti-inflammatory drug (NSAID), a vasoconstrictor and a immunosuppressant Some example antibiotics include: sulfa drugs or sulfonamides, such

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such as sulfacetamide (for example, in OCUSOL) and sulfisoxazole (for example, in GANTRISIN®); macrolide drugs, such as azithromycin (for example, in AZACITE®) and erythromycin (for example, in ERYPED®); aminoglycoside drugs, such as for example tobramycin (for example, in TOBREx®) and gentamicin (for example, in GENOPTIC®); fluoroquinolone drugs, such as ciprofloxacin (for example, in CILOXAN®), besifloxacin (for example, in BESIVANCE®) and moxifloxacin (for example, in VIGAMOX®); tetracycline drugs, such as for example oxytetracycline (for example, in CODEX); and combinations of antibiotic drugs, such as those containing a combination of bacitracin, neomycin and polymyxin B (for example, in OCUSPORe B) and a combination of gramicidin, neomycin and polymyxin B (for example, in NEOCIn pG). Some example antivmcos include ganciclovir (for example, in ZIRGAN®) and trifluridine (for example, in VIROPTIC®). Some example steroids include loteprednol (for example, in LOTEMAX®) and prednisolone (for example, in PRED FORTE®). Some example antihistamines include ketotifen (for example, in ALAWAY®), otopatadine (for example, in PATADAY®) and pinastine (for example, in ELESTAT®). Some example mast cell stabilizers include nedrochromyl sodium (for example, in ALOCRIL®) and lodoxamide (for example, in ALOMIDE®). Some example antifungals include natamycin (for example, in NATACYN®) and econazole. Some example mucoltics include N-acetylcystem (for example, in PARVOLEX). Some example NSAID substances include nepafenac (for example, in NEVANAC®) and bromfenac (for example, in BROMDAY®). Some example vasoconstrictors include nafazolin (for example, in NAPHCON A®) and tetrahydrozoline (for example, in VISENE®). Some example immunosuppressants include cyclosporine (for example, in RESTASIS®). All the aforementioned substances include any pharmaceutically acceptable salts thereof.

The treatment fluid composition may be disposed within a fluid container, as provided in the kit. The fluid container may contain any desired volume of treatment composition. Said volume may be in a range having a lower limit of 0.1, 0.25, 0.5, 0.75 or 1 milliliters and an upper limit of 5, 3 or 2 milliliters. Said range may be the total treatment composition contained within the fluid container, or it may be the volume of the treatment composition contained within the fluid container that may be supplied from the fluid container, which may be referred to as "usable volume". The volume available refers to the volume of fluid in the fluid container that can be delivered effectively from a fluid dispenser. The delivery volume may be less than the total volume of the treatment composition contained in the fluid container since the residual treatment composition that may remain in the fluid container or within the fluid dispenser, for example, the composition of residual treatment that can adhere to the inner wall surfaces of (for example, the inner wall surfaces of the fluid container, for example, the inner wall surfaces of a syringe barrel) or that remains in the fluid direction portions of said fluid dispenser, between the fluid container and a distal tip of fluid ejection (eg, the fluid remaining in a needle of dispensation).

The fluid container containing the treatment composition may be part of a fluid dispenser. The fluid dispenser can be manipulated 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, after the implant device has been implanted. The fluid container can be provided in the kit by means of a syringe, which can be or be part of said fluid dispenser. The fluid container may include at least a part of a syringe barrel. A fluid dispenser may include a fluid ejection element, which is in fluid communication with the fluid container treatment composition. Said fluid ejection element can be inserted into the internal passage of the implant device, and the fluid dispenser can be manipulated when the fluid ejection element is inserted into the internal passage of the implant device, when the implant device has been implanted. , to eject at least a portion of the treatment composition from a distal end of the fluid ejection element into the internal passage of the implant device, or distal to the distal internal passage, directly towards a paranasal sinus. For example, a distal fluid ejection tip of the fluid ejection element may be arranged in the internal passage, and the treatment composition can be dispensed into the internal passage so that it then flows into the paranasal sinus, or the fluid ejection element it can be inserted through the internal passage until the distal tip is arranged in the distal paranasal sinus of a distal end of the internal passage, and the treatment composition can be dispensed directly into the paranasal sinus. The fluid ejection element can be connected to a syringe, such as through a Luer connection. The fluid ejection element may have an insertion portion configured to be inserted into the internal passage, and said insertion portion may have a maximum exterior width (eg, a diameter) of not more than 1.75 millimeters, of no more 1.5 millimeters, no more than 1.25 millimeters, no more than 1 millimeter or no more than 0.9 millimeters. The fluid ejection element may be or include a hollow needle having a blunt tip (for example, a blunt-tip hypodermic needle). The fluid ejection element can be covered with a removable protective cap. For example, the kit may include a pre-filled syringe containing the composition of the treatment and having a hypodermic needle installed that is covered with a protective cap that protects the needle before use. A kit may include multiple different treatment compositions, and may include multiple fluid containers (eg, multiple syringes), each containing a different treatment composition.

To form a fistula for the implantation of an implant device and thus provide a passage of fluid between the tear apparatus and a paranasal sinus implies creating a hole through a bone wall in which the bone is located.

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paranasal sinus cavity. As described herein, said hole can be made with a stiletto or other solid piercing instrument, and can then be expanded as appropriate to form the fistula until it reaches the desired size, to carry out the implantation of the device for implant. For example, after initial drilling to create an initial hole, the hole can be dilated using dilators that make the hole progressively larger until the desired size is obtained. However, it has been discovered that when a fistula is formed for implantation in such a way, the bone tends to break and crack near the hole. Although this does not present a medical problem, it has been found that if the bone remains more intact near the hole, then the bone can provide mechanical support to help secure the implant device in place and prevent it from moving through outside the fistula after implantation. Bone integrity near the fistula can be improved by cutting the hole of the fistula instead of piercing and dilating the hole. Cutting through the bone, instead of pushing through the bone, it remains more intact near the hole and provides better mechanical support to help retain the implant device in place in the fistula after implantation. The second aspect implantation kit may include useful tools for cutting a hole for a fistula and implanting an implant device.

A kit may include at least one cutting tool to cut the tissue and form a fistula through which the implant device can be implanted during an implantation procedure. Said cutting tool may include a hollow element having a hollow cutting tip at a distal end of the cutting element, configured to cut the tissue and size the fistula for implanting the implant device through the fistula. Said cutting element may have a cutting width that is less than a maximum external width of a conduit of the implant device, configured to be disposed through the fistula during implantation. Said cutting tool can be a drill.

A kit may include a tool that can be guided by a disposable large element through an internal passage of the cutting tool. The cutting tool may include a hollow cutting element having a hollow cutting tip at a distal end of the cutting element, configured to cut the tissue and size the fistula for implanting the implant device through the fistula. The hollow cutting tip of the cutting tool can be configured to create a larger diameter and thus enlarge a preliminary cut of smaller diameter that may have been made previously to accommodate the large element, or the cutting tool can be configured to create a cut desired end without having to form a smaller initial fistula first. The cutting element can be configured to slide slidingly to the grinding element, the grilling element being arranged through a passage in the cutting element, the distal end of the grinding element being arranged distally to the distal end of the cutting element. A distal end of the grinding element can be configured to be arranged in or distal to the fistula, so that the cutting element is slidable on the grinding element, for example, to drive the cutting tip of the cutting element and cut the tissue to size the fistula, so as to implant the implant device when a smaller initial fistula has already been formed, or to allow retraction of the cutting element while leaving the large element in place, and thus use it to drive another tool or tools to the location of the fistula, for example, an implantation tool to insert an implant device into the fistula in its position, to carry out the implantation after cutting a fistula with a size desired for implantation.

A cutting element of a cutting tool can be or include a hollow needle or a cutting cannula. The cutting element may have a cutting width, or diameter in the case of a circular cut, which is less than a maximum external width of the implant device conduit. The maximum external width of the implant device conduit may be in one or more protuberant areas that are part of a surface characteristic of anchoring the conduit. The cutting width may have at least 0.1 millimeters less, at least 0.2 millimeters less, at least 0.25 millimeters less, at least 0.3 millimeters less, at least 0.35 millimeters less or at least 0, 4 millimeters less than the maximum outside width of the implant device duct. The cutting width can be no more than 1 meter, 0.75 millimeters, 0.6 millimeters or 0.5 millimeters smaller than the maximum outside width of the duct. The cutting width can be no more than 5 meters, 4 millimeters, 3.5 millimeters, 3 meters, 2.5 meters, 2.25 meters, 2 meters, 1.9 meters or 1.8 meters. The cutting width can be at least 1 meter, 1.5 meter, 1.75 meter or 1.85 meter.

A kit may include an implanting tool with a proximal end and a distal end and include a large element extending longitudinally in a direction from the proximal end to the distal end of the implanting tool. The grinding element and the internal passage can be configured to mount the implant device on the grinding element, the grinding element being arranged through the internal passage of the implant device, a distal end of the grinding element being disposed distally to the distal end of the implant device, and the distal end of the large element may be configured to be disposed in or distal to the fistula, so that the implant device mounted on the large element is slidable on the large element towards the distal end of the large element, to drive the implant device towards the fistula for implantation. The grinding element can be configured to be inserted through a step by using a tool (for example, a cutting tool or support tool) to guide the tool to the site of a fistula.

In an example of a large element, the large element may be a large wire or a small diameter needle (for example, a 20 gauge spinal needle), a cutting element may be a larger gauge needle through

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from which the gma element (for example, a 12 to 14 gauge spinal needle) can be inserted, and an implant device can have an internal passage through which the gma element (for example, 1 mm) can be inserted.

The gma element can be any element that has a suitable dimension on which the implant device can be slidably driven or a tool have to be guided with the gma element, along the gma element, to implant the device. The gma element can be of a nigged, flexible or malleable material. The gma element may be a solid element, for example, a solid gma wire or stylet. The gma element can be a hollow element, for example, the gma element can be or include a needle or a cannula. The gma element may include a cutting end at the distal end, configured to cut the tissue and thus form at least a part of the fistula. Said hollow gma element with a cutting end may be a cutting needle or cannula. Said hollow gma element with a cutting end can be useful for cutting an initial hole that can be made later, until reaching a desired size to implant the implant device.

A kit may include a support tool, also called an "implantation tool", for carrying the implant device during an implantation procedure. Said support tool may include a support element with a distal tip, the support element being adapted to be arranged through a fistula between the tear apparatus in the orbital cavity and the paranasal fossa, the distal tip being located in the paranasal fossa . The support tool may include a handle that can be manipulated with the hand connected to the support element. An implant device can be mounted on the support element for implanting the implant device, the implant device being mounted between the handle and the distal tip, the support element being arranged through the internal passage and a proximal end being arranged of the implant device towards the handle, and a distal end of the implant device being disposed towards the distal tip of the element.

When the implant device is mounted for implantation, the support element and the support tool can be disengaged from the implant device to implant the implant device during an implantation procedure, and thus provide fluid access to a paranasal sinus. To ensure a clearance adjustment and to help prevent lateral deformation of the implant device during implantation, a clearance adjustment of the support element in the internal passage of the implant device, when the implant device is mounted on the support element To place the implant, it can be small. For example, said slack adjustment may be no more than 0.5 millimeters, no more than 0.4 millimeters, no more than 0.3 millimeters, no more than 0.2 millimeters or no more than 0 , 1 millimeters. By having a closed adjustment of the support element in the internal passage of the implant device, it helps prevent the implant device from folding like an accordion during an implantation procedure, while the support tool with the mounted device The support element and the mounted implant device can be introduced (pushed) towards the fistula to be able to implant it.

Any and all parts of a kit can be conveniently contained within a regular package, such as a regular box, bag or other usual packaging container. Some or all of the components of a kit may be sterilized and sealed in sealed containers, such as, for example, hermetically sealed bags or wrappings.

These and other aspects and features thereof are described in greater detail or will be apparent from the drawings and the description provided below.

Brief description of the drawings

The drawings are included to help understand various aspects of the disclosure and possible improvements in features and additional features applicable to them. The features shown in the drawings are presented for illustrative purposes only, are not necessarily presented to scale and are not necessarily detailed in each case.

Figure 1 is an illustration showing certain example routes for an implant, in order to provide fluid access from the tear apparatus to a paranasal sinus.

Figure 2 is a perspective view of an embodiment of an implant device.

Figure 3 is a side view of the same embodiment of an implant device, as shown in Figure 2.

Figure 4 is a terminal view of the same embodiment of an implant device, as shown in Figure 2.

Figure 5 is a partial perspective view of the same embodiment of an implant device, as shown in Figure 2.

Figure 6 is a partial side view of an embodiment of an implant device.

Figure 7 is a partial side view of an embodiment of an implant device.

Figure 8 is an illustration of cross sections of various configurations for anchoring protrusions of an implant device.

Figure 9 is an illustration of various head configurations of an implant device.

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Figure 10 shows perspective, top, side and terminal views of an embodiment of an implant device. Figure 11 shows perspective, top, side and terminal views of an embodiment of an implant device, showing some possible example dimensions.

Figure 12 shows perspective, top, side and terminal views of an embodiment of an implant device. Figure 13 shows perspective, top, side and terminal views of an embodiment of an implant device, showing some possible example dimensions.

Figure 14 is an illustration showing an embodiment for placing an implant device with a head of the implant device inside the orbital cavity, between the tear caruncula and the semilunar fold.

Figure 15 is an illustration showing the use of a surgical tool, in the form of a cutting tool, to form a fistula between the orbital cavity and an ethmoidal sinus during a surgical procedure.

Figure 16 is an illustration showing the insertion of a large wire after the formation of a fistula during a surgical procedure.

Figure 17 is an illustration showing a large wire in its place, as it rolls to a fistula during a surgical procedure.

Figure 18 is an illustration showing the use of a surgical tool, in the form of a support tool, for implanting an implant device during a surgical procedure. Figure 19 is an illustration showing the placement of an implant device after implantation during a surgical procedure.

Figure 20 illustrates an embodiment of a useful kit for implanting an implant device for access to the paranasal sinuses and for providing medical treatments using said implant device for access to the paranasal sinuses.

Figure 21 is a perspective view of an embodiment of an implant device.

Detailed description

The term "tear apparatus" and "tear system" are used interchangeably herein to refer to the set of physiological components that carry out the production and secretion of tear fluid to lubricate the eyeball, the tear fluid content in a reservoir. of tear fluid in the orbital cavity and drainage of tear fluid from the orbital cavity to the nostril. The tear apparatus includes tear glands, the tear drainage system and the tear fluid reservoir, located between the tear glands and the tear drainage system. The tear fluid reservoir includes the eyelid margins and the conjunctival sac (and that includes the set of tears at the bottom of the lower conjunctival sac, which is sometimes called the "tear sea"). The tear drainage system includes the points, the canaliculi and the nasolacrimal duct (which includes the so-called tear sac, located at the top of the nasolacrimal duct) through which excess tears are drained to the Hasner valve and into the nostril Figure 1 shows, in general, the tear apparatus. The tear fluid is produced and secreted from the tear glands 102 to lubricate the surface of the eyeball 104, disposed within the orbital cavity. The tear fluid forms a coating on the eyeball 104 and is generally contained in the conjunctival sac (the space between the lower eyelid 106, the upper eyelid 108 and the eyeball 104, which is covered by the conjunctiva). The excess tear fluid is conducted to near the inner edge (inner corner of the eye) and drained through the tear points 110 to the tear heaps 112 and into the tear sac 114 of the nasolacrimal duct 116. The tear fluid is then drained from the nasolacrimal duct 116 through the Hasner valve and into the nostril.

As used herein, a fistula between the tear apparatus and a paranasal sinus refers to an artificially created passage, which fluidly connects the tear apparatus with a paranasal sinus. Said fistula can be created surgically. The paranasal sinuses include the frontal sinuses, the maxillary sinuses, the ethmoid sinuses and the sphenoid sinuses, which are cavities contained within the frontal, maxillary, ethmoid and sphenoid bones, respectively. The paranasal sinuses drain into the nasal cavity. Figure 1 also shows the general proximity of the frontal sinus 122, the maxillary sinus 124 and the ethmoidal sinus 126, with respect to the features of the tear apparatus, and certain example fistula routes shown with broken lines. A first example fistula path 130 goes from the orbital cavity to the frontal sinus. A second example fistula path 132 goes from the orbital cavity to the ethmoidal sinus 126. A third example fistula path 134 goes from the orbital cavity to the maxillary sinus 124. A fourth example fistula path 136 goes from the tear sac 114, at the top of the nasolacrimal duct 116, to the ethmoidal sinus 126. A Fifth example fistula path 138 goes from the nasolacrimal duct 116, at a location below the tear sac 114, to the ethmoidal sinus 126. A sixth example fistula path 140 goes from the nasolacrimal duct 116, at a location below the tear sac 114, to the maxillary sinus 124. The example fistula paths shown in Figure 1 have only an illustrative general purpose and not They are intended to show precise locations where the fistula should be formed to connect a part of the tear apparatus with the corresponding paranasal sinus. Although not shown in Figure 1, example fistula routes to the sphenoid sinus include from the orbital cavity to the sphenoid sinus and from the nasolacrimal duct 116 to the sphenoid sinus.

Figures 2-5 show an embodiment of an implant device, for example, which can be implanted through a fistula in the first, second and third routes 130, 132, 134, shown in Figure 1. As shown in

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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, which extends from head 206 to distal end 204. An internal passage 210 extends from proximal end 202 to distal end 204, passing through head 206 and conduit 208. An 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 cross section (transverse with respect 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 longitudinally along the implant device 200, between the proximal end 202 and the distal end 204, and will normally 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 anchoring protrusions 212 on an outside of the conduit 208. In the embodiment shown in Figures 2-5, the anchoring protrusions 212 are in the form of separate circumferential ridges, each extending around the entire circumference of the conduit 208. Adjacent to the circumferential ridges of the anchoring protrusions 212 there are areas recesses 214 on the outside of the duct 208.

The head 206 has a fastening surface of the flanged tissue 216 on one side of the head 206, arranged towards the conduit 208, and whose fastening surface of the flanged tissue 216 is advantageously configured to fix the tissue adjacent to the proximal end of the fistula and prevent so that the proximal end 202 of the implant device 200 moves towards the fistula after implantation. On the side of the head 206, opposite the fixing surface of the flanged fabric 216, there is a face surface 218 of the head 206, whose face surface 218 is disposed away from the tissue fixed by the fixing surface of the flanged fabric 216 when Implant the implant device. The head 206 has a first dimension 220 and a second dimension 222 on the fixing surface of the flanged fabric 216 and the face surface 218. The first dimension 220 is the length of the respective surface, and the second dimension is the width of the respective surface. Such dimensions of length and width can also be called larger and smaller dimensions. The first dimension 220 of a surface 216 and 218 corresponds to the maximum separation distance between the points on the outer edge of the surface (maximum transverse dimension per head), and the second dimension 222 of the surface 216 or 218 corresponds with the maximum separation distance between the points on the outer edge of the surface, which are on a transverse line (perpendicular) to the first dimension. Conveniently, the face surface 218 and the fixing surface of the flanged fabric 216 can be created with corresponding external edges, so that the opposite surfaces 216 and 218 have substantially equal length and width dimensions, although it is not necessary. The first dimension 220 and the second dimension 222 can generally be called the length and width of the head 206, respectively, when the surfaces 216 and 218 have corresponding shapes, as is the case of the embodiment shown in Figures 2-5. When surfaces 216 and 218 do not have corresponding shapes, the length and width dimensions of the head will be different from one or more of the length and width dimensions of surfaces 216 and 218. The head 206 has a depth dimension 223 between surfaces 216 and 218.

Even with reference to FIGS. 2-5, the conduit 208 has a first exterior width 224 which is a maximum exterior width of the conduit 208, as defined by the maximum extensions of the anchoring protrusions 212, transverse to the length of the conduit 208. Conduit 208 has a second exterior width 226 which is a minimum exterior width of conduit 208, defined between the lower parts of the recessed areas 214. In the embodiment shown in Figures 2-5, the height of the anchoring protrusions 212 is equal to half the difference between the first outer width 224 and the second outer width 226 of the conduit 208. In the configuration of the head 206 shown in Figures 2-5, the first dimension 220 of the head is larger than both, the first outer width 224 and the second outer width 226 of the conduit 208, while the second dimension 222 of the head is approximately equal to the second outer width 224 of the duct 208.

Even with reference to Figures 2-5, the anchoring protrusions 212 are in the form of separate circumferential ridges, which have a maximum width that is at the bottom of the flanges located adjacent to the recessed areas 214, and whose width tapers to a minimum at the top of the flanges 212 located away from the recessed areas 214. Other configurations of the anchoring protrusions are possible and not all anchoring protrusions of the implant device need to have the same size, geometry or height. Likewise, the recessed areas may have several configurations, and not all recesses of the implant device need to have the same size or configuration. The implant device 200 has a length 228 that includes the depth 223 of the head 206 and the length of the conduit 208. The anchoring protuberances 212 are on a longitudinal portion 230 of the conduit 208.

Next, as regards Figure 6, an alternative embodiment of a conduit 240 of an implant device having anchoring protrusions 242, in the form of balls or buttons, and recessed areas 244, adjacent to anchoring protrusions 242 is shown The conduit 240 has a first outer width 246, defined by the anchoring protuberances 242, and a second smaller outer width 248, defined by the recessed areas 244. An example of another configuration of the anchoring protrusions is shown in Figure 7. How

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shown in FIG. 7, a conduit 250 of an implant device has anchoring protrusions 252 and recessed areas 254 on the outer surface of the conduit 250. The anchoring protuberances 252 are in the form of a continuous spiral flange, which extends as far as possible. along a part of the longitudinal length of the conduit 250. The conduit 250 has a first outer width 256, defined by the anchoring protuberances 254, and a second outer width 258 smaller, defined by the recessed areas 254. As for the embodiments shown in Figures 2-5, the embodiments of the Conduit shown in Figures 6 and 7 include a height of the anchoring protuberances that is equal to half the difference between the largest and smallest external diameters of the respective conduits. As will be appreciated from the embodiments of Figures 6 and 7, the first outer width is determined as the width of an envelope volume containing the anchoring protuberances.

Figure 8 shows examples of certain forms of anchoring protrusions that include a width that tapers in a direction from the base of the anchoring boss toward an upper part of the anchoring boss. Figure 8 shows cross sections of anchoring boss configurations (referred to as AD), each having a wider width at the base than at the top. The height (H) and width (W) of the base of the anchoring protrusions are indicated in Figure 8.

Figure 9 shows some different example configurations (called EH) of a head of an implant device. For each head configuration, the length dimension (L) and the width dimension (W) of the head configurations are shown. The heads of the EH configurations are shown on an end showing the face surface (surface that is oriented away from the fistula when implanted) and the opening of the internal passage at the proximal end of the implant device. The FH configurations, which are longer than the width, are advantageously configured for use with fistula openings towards the orbital cavity between the inner edge and the inner side of the adjacent eyeball, for example, between the semilunar fold and the tear caruncula, and preferably, extending the head length dimension, generally, in a direction from the lower part of the orbital cavity towards the upper part of the orbital cavity, near the eyeball, and in the H configuration, the concave side of the crescent being arranged towards the eyeball, and the convex side of the crescent arranged towards the tear caruncula.

Figure 10 shows an implant device 700 with a head 702 and a conduit 704. The conduit 704 includes a first longitudinal part 706 and a second longitudinal part 708, disposed distal to the first longitudinal part 706. The first longitudinal part 706 includes a smooth outer surface and the second longitudinal part 708 includes a surface anchoring feature, which includes anchoring protrusions 710 in the form of separate circumferential ridges, and recessed areas 712 between the anchoring protrusions 710. The length of the first longitudinal part 706, located at the beginning of the surface anchoring feature of the second longitudinal part 708, can be advantageously arranged in the connective tissue, adjacent to the head 702, when implanted so that it "floats" for the comfort of the patient. The anchoring features of the second longitudinal portion 708 can be advantageously located at a distance from the head 702, so that one or more of the anchoring protrusions 710 are located near the paranasal sinus bone that is penetrated by the implant device 700 when implanted, preferably having one or more of the anchoring protuberances arranged on each side of the bone. In the embodiment shown in Figure 10, the outer width of the conduit 704 is substantially the same throughout the length of the first longitudinal part 706 and in the recessed areas 712 of the second longitudinal part 708. The conduit 704 has a circular cross-section. , so that the outer width of the conduit 704, at any location along the conduit 704, is represented by the diameter of the cross section of the conduit 704 at said 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 part 708 is located at a distance distal 720 from the proximal end 716. The anchoring protrusions 710 have a width 722 at the base of the anchoring protrusions 722 and a height 724 above the adjacent recessed areas 712. The anchoring protrusions 710 are separated by a separation 726 from center to center. The conduit 704 has a maximum exterior width 728 that corresponds to the upper parts of the anchoring protrusions 710, equal to the diameter of the cross-sectional circle through the conduit 704, at the top of the anchoring protrusions 710. The conduit 704 has a minimum outer width 730 along the length of the first longitudinal part 706 and in the recessed areas 712 of the second longitudinal part 708 of the conduit 704, and which is equal to the diameter of the circular cross-section in said locations The head 702 has a dimension of length 732, a dimension of width 734 and a dimension of depth 736. The implant device 700 has an internal passage 738 extending between the proximal end 716 and the distal end 718 and across the length of the conduit 704. The internal passage 738 has a width 740, which in this embodiment is equal to the 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, of a non-limiting example of a configuration of the implant device 702.

Figure 12 shows an implant device 800 that is similar to the implant device 700 shown in Figures 10 and 11, except that a first longitudinal part of a conduit is included, which has a thicker wall than the recessed areas of the feature surface anchor of a second longitudinal part of the

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conduit. The thicker wall in the first longitudinal part of the conduit provides a stiffness added to said part of the conduit, thus facilitating the pushing of the implant device 800 into place during an implantation procedure, while the thinner wall in the recessed areas of the second longitudinal part of the duct allows that part to deform more easily and enter through a fistula during implantation, and then expand to attach to the tissue and anchor the implant device 800. More specifically, as shown in Figure 12, the implant device 800 includes an 802 head and a conduit 804. The conduit 804 has a first longitudinal portion 806 and a second longitudinal part 808, disposed distal to the first longitudinal part 806. The first longitudinal part 806 includes a substantially smooth outer surface with a substantially constant outer width, which is the diameter of the circular cross-section of the conduit 804 along the first longitudinal part 806. The second longitudinal part 808 includes a surface anchoring feature that includes anchoring protrusions 810 in the form of circumferential ridges, and recessed areas 812 in the spaces between the anchoring protrusions 810. Various dimensions of the implant device 802 are illustrated in Figure 12 , similar to the illustration provided for the implant device 700 of Figure 10. The implant device 800 has a length 814 from a proximal end 816 to a distal end 818 of the implant device 800. The beginning of the second longitudinal part 808 is located at a distance 820 distal from the proximal end 816. The anchoring protrusions they have a width 822 at the base and a height 824 above the adjacent recessed areas 812. The anchoring protrusions are separated by a separation 826 from center to center. The conduit 804, and also the second longitudinal part 808, have a maximum outer width 828 that is located in the upper parts of the anchoring protrusions 810, and which is equal to the diameter of the circular cross-section of the conduit 804, through the upper parts of the anchoring protrusions 810. The conduit 804 and the second longitudinal part 808 of the conduit 804 have a minimum outer width 830 located in the recessed areas 812. The head 802 has a dimension of length 832, a dimension of width 834 and a dimension of depth 836. The implant device 800 has an internal passage 838 extending between the proximal end 816 and the distal end 818 and across the length of the duct 804. The internal passage 838 has a width 840, which in the embodiment shown in Figure 12 is equal to the diameter of the circular cross-section of the internal passage 838.

Even with reference to Figure 12, the wall thickness of the duct 804 (wall thickness between the inner passage 838 and the outer surface of the duct 804) is greater along the first longitudinal part 806 than in the recessed areas 812 of the second longitudinal part 808. The internal passage 838 has a constant width along the length of the conduit 804, so that the largest wall thickness of the conduit 804 along the first longitudinal part 806 derives in an exterior width 842 which is greater than the minimum exterior width 830 of the recessed areas 812. The maximum exterior width 828 in the anchoring protrusions 810 is greater than the exterior width 842 along the first longitudinal part 806. Figure 13 shows some exemplary dimensions, in millimeters, of a non-limiting example of implant device 800.

Figure 21 shows a variant of the implant device 800 of Figure 20. The implant device 800 'of Figure 21 has the same characteristics as the implant device 800 of Figure 12, except that the implant device 800' includes a plurality of lateral openings 850 (which may also be referred to as holes, holes or ports) through the wall of a distal part of the conduit 804 '. The lateral openings 850 can be placed on a part of the duct wall that is arranged in the paranasal sinus when the implant device 800 'was implanted, so that the lateral openings 850 can provide a passage for fluid communication between the internal passage of the implant device 800 'and the paranasal sinuses, even if the distal opening of the internal passage at the distal end of the duct 804' were to be blocked or limited for some reason. In the particular implementation shown in Figure 21, the lateral openings 850 of the implant device 800 'are located in a recessed area between a pair of circumferential flanges of a surface anchoring characteristic of the duct 804'. Figure 21 shows the lateral openings 850 located in only one recessed area between a pair of circumferential flanges, but also or alternatively one or more similar lateral openings may be placed in a more proximal recessed area between a different pair of circumferential flanges.

Figure 14 shows an example of an implant device having a conduit that passes through a fistula formed from the orbital cavity, below the conjunctiva, between the tear caruncula 142 and the semilunar fold 144, and showing a location example of the head 304 of the implant device disposed in the orbital cavity between the tear caruncula 142 and the semilunar fold 144. The head 304 is shown with an elongated configuration, such as, for example, a head configuration shown in any of Figures 25, Figures 10-13 or FH configurations shown in Figure 9.

Next, as for Figures 15-18, some examples of surgical procedures involving the formation of a fistula and the implantation of an implant device to provide access to a paranasal sinus, and some examples of the surgical tools that will be described will be described. They are used with these procedures.

Figure 15 shows a surgical tool, in the form of an input tool 600, in the process of creating a fistula through the tissue between the tear caruncula 142 and the semilunar fold 144. The numbering of the anatomical parts is the same as in figure 1. The fistula is formed through the tissue, between the conjunctival sac of the orbital cavity and the ethmoidal sinus 126. The fistula path is consistent with the general fistula path 132, as shown in Figure 1. The input tool 600 includes an element of

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hollow work 606 with a hollow distal cutting tip 610, which has a suitable shape to cut the tissue and form a ffula from the conjunctival sac to the ethmoid sinus 126. The input tool 600 can also be referred to as the "cutting tool" and the Work item can also be called "cutting element". The input tool 600 includes a manually manipulable handle 612. The handle 612 can be advanced or retracted to advance or retract the hollow work element 606. As shown in Figure 15, the distal cutting tip 610 has been advanced from a location in the conjunctival sac, between the caruncula 142 and the semilunar fold 144, to form a ffstula between the conjunctival sac and the ethmoidal sinus 126. As shown, the ffstula passes behind caruncula 142, channels 112 and nasolacrimal duct 116 to access the ethmoidal sinus 126.

After the input tool 600 has been used to form, first, a ffula to the ethmoidal sinus 126, a large wire or other large element can be inserted through an internal passage that extends through the handle 612 and the hollow work element 606. Figure 16 shows a large wire 620 inserted through the handle 612 and the work element 606. After insertion of the grna wire 620, the input tool 600 can be retracted and removed from the ffstula, leaving the grna wire 620 in place, as it grinds until and through the ffstula, as shown in Figure 17. The grna wire 620 is then available to guide additional grinding tools up to and through the fstula towards the ethmoidal sinus 126.

Next, as for Fig. 18, the grna wire 620 has been used to guide a surgical tool in the form of an implant tool 624. The implant tool 624 can also be referred to as a "support tool." The implant tool 624 includes a hollow work element 626 and a manually manipulable handle 628. The work element 626 may have a distal blunt tip, as shown in Figure 18, since the work element 626 does not have to have to cut additional tissue after forming the fistula using the input tool 600, as long as the ffstula has already formed until it reaches its desired final size. Work tool 626 can also be called "support tool". The implant tool 624 includes an internal passage that passes through the handle 628 and the hollow work element 626. As shown in Figure 18, the large wire 620 has been threaded through the internal passage of the implant tool 624 for guiding the hollow work element 626 to and through the ffstula and into the ethmoidal sinus 126. An implant device 630 is mounted on the hollow work element 626 of the implant tool 624. Figure 18 shows the implant tool 624 having advanced to a point where the distal end of the implant device 630 is near the proximal end of the opening of the fstula that goes into the conjunctival sac. From this position, the implant device 630 can be advanced towards the ffstula, with a head of the implant device 630 arranged adjacent to the conjunctiva, in the conjunctive sac, and extending a distal end of the implant device 630 towards the ethmoid sinus 126 . For example, a surgeon can slide the implant device 630 down, into the hollow work element 626 to place it through the ffstula and implant it, or the surgeon can advance the handle 628 so that it pushes the implant device 630 towards the ffstula, to place the implant. The outer diameter of the hollow work element 626 can be sized to fit closely within the internal diameter of the implant device 630, and thus help prevent the implant device 630 from folding up and laterally, deforming as the implant device towards the ffstula. The handle 628 and the hollow work element 626 form a support of the implant device 630. The handle 628 can be retracted and the hollow work element 626 disengaged from the implant device 630 after the implant device 630 has been properly positioned for implantation through the fstula. Figure 19 shows the implant device 630 implanted and after having disengaged the hollow work element 626 from the implant tool 624. When implanted, the head 632 at the proximal end of the implant device 630 is located adjacent to the conjunctiva, in the conjunctival sac within the orbital cavity, between the caruncula 142 and the semilunar fold 144, and the distal end 634 of the device Implant 630 is placed in the ethmoidal sinus 126. Some anchoring protrusions 636 of the implant device assembly 630 are disposed within the ffula to fix the tissue and help anchor the implant device 630. The implant device 630 can be used to provide access to the ethmoidal sinus 126 and perform medical procedures or treatments, for example, to administer a treatment composition to the ethmoidal sinus or to aspirate fluid from the ethmoidal sinus.

The procedure described with reference to FIGS. 15-19 allows the work element 606 of the input tool 600 to have a larger diameter than the work element 626, so as to form a fistula of an appropriate size and accommodate the implant device 630, which is then implanted at a different stage using the implant tool 624, the implant device 630 being supported on the working element 626, which may advantageously have a smaller diameter than the work element 606 used to form the ffstuia. As an alternative, an intermediate stage can be carried out to dilate the ffstula or cut additional tissue until reaching a desired hole size for implantation, between the stage where a ffstula is first formed with the input tool 600 and where implant implant device 630 using implant tool 624.

Again as for Figure 15, optionally, one or more procedures can be performed before retracting the hollow work element 606. One or more fluids can be injected through the hollow work element 606.

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For example, the contrast medium can be injected through the hollow work element 606 and can be visualized to confirm that the fistula has been formed in the proper location before proceeding to implantation.

The cutting can be done, for example, with a cutting tool, such as a needle or cannula that cuts the tissue, or a drill that drills the tissue. One method may include cutting an initial hole at the location of the desired ffula, and then using a large element and additional tools to complete an implantation procedure. For example, the initial cut can be made to create a preliminary hole, whereby a larger gauge needle or cutting cannula can be guided with the element to cut the ffula to reach the desired final size, in order to implant the implant device . Alternatively, the initial hole that is cut may have the desired final size to implant the implant device. After the hole has been created until reaching the desired size, the large element can then be used to guide the implant device to the fstula, or a support tool on which the implant device is mounted, in order to implant the device of implant As an example, a small gauge needle can be used to form a first cut, and then a large wire can be inserted through the needle and into the fstula to maintain control of the fstula. The small gauge needle can then be retracted and the second needle-shaped cutting tool slid over the large wire and moved to the proper location to cut the fistula until it reaches the proper size to implant the implant device. A kit to perform said operation may include the implant device, the smaller gauge needle, the large wire (as a large element) and the larger gauge needle as a cutting tool to create the fistula until reaching the desired final size. As another example, the initial cutting tool, or a part thereof, can be used as a large element of the subsequent cutting tool. For example, the initial cut can be made using a smaller gauge needle that has a handle, such as a spinal needle or similar design. After the initial cut, the handle or head can be cut and removed from the smaller caliber needle and then a cutting tool shaped like a larger caliber needle can be slid over the smaller needle to cut the hole until the desired size of ffstula. Then, the larger gauge needle can be retracted and the implant device can slide over the smaller gauge needle and be moved to the proper location for implantation. A kit for performing said operation may include the implant device, the smaller gauge needle (which serves as a large element) and the larger gauge needle, which serves as a cutting tool to create the fistula until the desired final size is achieved. Alternatively, a kit may include a single cutting tool (for example, a hollow needle or cutting cannula) sized to cut a hole with the desired final size, through which the implant device is to be implanted, and without having to enlarge it by cutting or dilating it further.

Next, as for Figure 20, an exemplary embodiment of a kit including components for implanting a paranasal access implant device and providing a treatment composition to a paranasal sinus through the implant device is shown. As shown in Figure 20, a kit 968 includes an implant device 970 for access to the sinuses. The implant device 970, for example, may have any design according to or with the features shown or described in relation to any of Figures 2-13, or it may have a different design. The kit also includes a fluid manipulation tool 972 in the paranasal sinuses, which includes a syringe-shaped fluid dispenser 974 and a fluid transmission accessory 976, which includes a hollow needle-shaped fluid ejection element 977 of blunt tip. The fluid transmission accessory 976 includes a fixing structure at a distal end, to be fixed with a head on a proximal end of the implant device 970, and thus facilitate the transmission of the fluid from within a syringe barrel 974, which It will be ejected from a distal tip of the fluid ejection element 977. The syringe 974 includes a piston 978, disposed in the syringe barrel 974 and which is manually manipulable by advancing or retracting a plunger 980, to move the piston 978 into the syringe barrel and create pressure to expel the fluid from the syringe barrel through the fluid transmission accessory 976, or to create a vacuum and suck the fluid through the fluid transmission accessory 976 towards the syringe barrel. The fluid handling tool 972 may be provided with the syringe 974 and the fluid transmission accessory 976, installed as shown in Figure 20, or it may be provided with the syringe 974 and the fluid transmission accessory 976 as parts separated and disassembled that can be installed in the assembly as shown in figure 20. In some preferred implementations, the syringe 974 may be pre-filled with a treatment composition disposed within the syringe barrel 974. Said pre-filled syringe 974 can be provided in kit 968, mounted with the fluid transmission accessory 976, as shown in Figure 20, and preferably with a protective cap covering the fluid transmission accessory 976, and whose cap can be removed by a physician to use the fluid manipulation tool 972 and administer a treatment composition to a patient in which the implant device 970 that provides access to the paranasal sinus has been implanted. A treatment composition disposed in the syringe barrel 974 may be an irrigation fluid or a pharmacological composition, for example, as described above.

Kit 968, as shown in Figure 20, also includes tools to form a ffula between the lacrimal apparatus of the orbital cavity and a paranasal sinus, for example, a frontal, maxillary or ethmoidal paranasal sinus. As shown in Figure 20, the kit 968 includes a cutting tool 982 having a hollow cutting element 984 (for example, a hollow needle) to cut the tissue and form a ffula of a size suitable for implanting the device. 972 implant without enlarging it by cutting or dilating it further. Alternatively, a kit could include a cutting tool with a cutting element of a smaller caliber or a piercing element

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to form a first hole, and one or more additional tools may be included in the kit (for example, a cutting tool with a larger gauge and / or dilator element) to enlarge the initial hole to a desired final size for carry out the implantation. The cutting tool 982, for example, may have a design according to or with the features shown or described in relation to any of Figures 15 or 16, or it may have a different design.

The kit 968 shown in Fig. 20 also includes a support tool 986 having a support element 988, which has an external diameter sized to insert the support element 988 through the internal passage of the implant device 970, in order to mount the implant device 970 on the support element 988 and support the implant device 970 for implantation after having formed the fistula with a desired size. For example, the support tool 986 may have a design according to or that includes any features shown or described in relation to Figure 18, or it may have a different design. The support tool 986 and the implant device 970 can be provided in the kit 968 as separate installable parts, as shown in Figure 20. Alternatively, the support tool 986 and the implant device 970 can be provided in the kit already with the implant device 970 pre-assembled on the support element 988, in a configuration ready for use in an implantation procedure.

The fluid ejection element 977 is configured to be inserted into an internal passage that extends through the implant device 970. After implantation of the implant device 970 that provides access to the paranasal sinus, the fluid ejection element 977 can inserted into the internal passage from the proximal end of the implant device 970, which is arranged in the orbital cavity after it has been installed. After inserting the fluid ejection element 977 into the internal passage of the implant device 970, the plunger 980 can be pushed to advance the piston 978 and cause the syringe cylinder treatment composition 974 to flow into and out from the distal tip of the fluid ejection element 977. The fluid ejection element 977 can be inserted into the internal passage of the implant device 970, so that the distal tip of the fluid ejection element 977 is disposed in the internal passage when the treatment composition is ejected into the internal passage from which can flow the treatment composition to the paranasal sinus. Alternatively, the injection element 977 can be inserted into the internal passage of the implant device 970 until the distal end of the ejection element leaves a distal end of the internal passage to the paranasal sinus, in which case, the treatment composition It can be ejected from the fluid ejection element 977 directly to the paranasal sinus.

The cutting tool 982 and the support tool 986 may have internal passages therein to insert a large element (for example, a large wire). A kit may include said large wire or other gma element.

A variety of medical treatments and procedures can be performed through the implanted device for access to the implanted sinuses to provide access to a paranasal sinus. The treatment fluid compositions can be administered to a paranasal sinus through the implant device. The fluid can be aspirated from a paranasal sinus through the implant device. One or more medical devices can be inserted into the paranasal sinus through the implant device.

The expressions "comprises", "contains", "includes" and "has", and the grammatical variants of said expressions, are intended to be inclusive, since the use of these expressions indicates the presence of some condition or characteristic, but does not exclude the presence of any other condition or characteristic. The expression "at least" followed by a number (for example, "at least one") indicates that number or more than that number. The expression "at least one part" indicates the whole or a part that is smaller than the whole.