Transnasal inserts and assemblies

Abstract

The present disclosure relates transnasal inserts configured to slide along a nasolacrimal stent, and to self-lock in position relative to the nasolacrimal stent when no force is actively applied thereto. In an example, a transnasal insert comprises a main body that includes at least one stent channel through which a tubular portion of a nasolacrimal stent can extend. The transnasal insert can optionally include a locking plate defining at least one stent opening through which the tubular portion of the nasolacrimal stent can pass as well. The nasolacrimal insert includes at least one inner engagement surface, which can be an inner surface of the stent channel and / or an inner surface of the stent opening, configured to allow sliding of the transnasal insert along the stent when a force is actively applied thereto, but to lock in position when such force is no longer actively applied.

Description

TRANSNASAL INSERTS AND ASSEMBLIESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 772,792, filed March 17, 2025, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to transnasal inserts and transnasal assemblies configured for placement inside a DCR ostium, and to methods of implantation thereof.BACKGROUND

[0003] Nasolacrimal duct (NLD) obstruction is a blockage of the tear ducts, which can cause tearing, mucous secretions and infection of the lacrimal sac. Congenital abnormalities are a common cause of NLD obstruction in the pediatric population, while acquired obstructions are more common in adults. It can also be secondary to trauma, infection, tumors, medical treatment, and more. Treatment options available for NLD obstruction include various medical and surgical interventions and are tailored per case.

[0004] Dacryocystorhinostomy (DCR) is a surgical procedure used to reestablish the flow of tears from the lacrimal sac into the nose when the nasolacrimal duct is blocked. DCR surgery involves the creation of new opening in the nasal bone, termed DCR ostium, and bypassing the blocked nasolacrimal duct by integrating the lacrimal sac with the nasal cavity.

[0005] The surgery is typically considered if less invasive treatments, such as massage and antibiotics, fail to open the tear ducts. A stent is commonly inserted into the nasal cavity during DCR surgery in order to facilitate drainage. This keeps the connection between the eye and nose open during surgery. Possible complications associated with the use of stents in DCR surgery include stent displacement, protrusion and dislocation, and discomfort.SUMMARY

[0006] The scarring of the osteotomy site, potentially occurring months following a successful surgery, is a common complication of DCR surgery. The DCR ostium can close, resulting in post-surgical failure. Thus, it is desirable to provide devices and methods by which patency of a relatively large diameter DCR ostium can be maintained after surgery without closing, preferably while allowing tear drainage from the eye.

[0007] According to some aspects of the disclosure, there is provided a transnasal insert comprising a main body and at least one inner engagement surface. The main body extends between a body proximal end and a body distal end. The main body comprises at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at or proximate to the main body distal end. The at least one stent channel defines a stent channel inner diameter, and is configured to allow extension of a tubular portion of a nasolacrimal stent therethrough. When the nasolacrimal stent extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the nasolacrimal stent when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the nasolacrimal stent when the transnasal insert is not subjected to a force actively applied thereon.

[0008] According to some aspects of the disclosure, there is provided a transnasal assembly comprising a nasolacrimal stent and a transnasal insert. The nasolacrimal stent comprises a tubular portion extending between a stent first end and a stent second end. The transnasal insert comprises a main body and at least one inner engagement surface. The main body extends between a body proximal end and a body distal end. The main body comprises at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at or proximate to the main body distal end. The at least one stent channel defines a stent channel inner diameter, and is configured to allow extension of the tubular portion therethrough. When the tubular portion extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the tubular portion when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the tubular portion when the transnasal insert is not subjected to a force actively applied thereon.

[0009] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0010] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0011] Fig. 1 shows a view in perspective of an exemplary transnasal assembly, including a transnasal insert and a nasolacrimal stent illustrated next to each other.

[0012] Fig. 2 shows a cross-sectional view of the transnasal inset of Fig. 2.

[0013] Fig. 3A shows the anatomy of the human nasolacrimal system that includes a DCR ostium connecting between the lacrimal sac and the nasal cavity.

[0014] Fig. 3B shows a monocanalicular stent implanted in the nasolacrimal system of Fig.3A.

[0015] Fig. 3C shows a transnasal insert slid along the nasolacrimal stent.

[0016] Fig. 3D shows the transnasal insert of Fig. 3C positioned inside a DCR ostium.

[0017] Fig. 3E shows the transnasal insert of Fig. 3D inside scarred tissue developed therearound within the DCR ostium.

[0018] Fig. 4 shows a view in perspective of an exemplary transnasal insert that includes a locking plate.

[0019] Fig. 5 shows a plan view of the locking plate of Fig. 4.

[0020] Fig. 6A-6B show stages in an exemplary implantation procedure of a transnasal assembly that includes the transnasal insert of Fig. 4.

[0021] Fig. 7 shows a view in perspective of an exemplary transnasal assembly, including a bicanalicular nasolacrimal stent and a transnasal insert that includes two stent channels.

[0022] Fig. 8 shows a cross-sectional view of the transnasal inset of Fig. 7.

[0023] Fig. 9A-9C show stages in an exemplary implantation procedure of the transnasal assembly of Fig. 7.

[0024] Fig. 10A-10B show stages in an exemplary implantation procedure of a transnasal assembly that includes a locking plate equipped with two stent openings.

[0025] Fig. 11 shows a view in perspective of an exemplary transnasal insert having a cylindrical main body.

[0026] Fig. 12A shows a cross-sectional of an exemplary transnasal insert having a C-shaped stent channel.

[0027] Fig. 12B shows a cross-sectional of an exemplary transnasal insert having an S-shaped stent channel.

[0028] Fig. 13 A shows a view in perspective of an exemplary transnasal insert that includes a circumferentially-extending retaining slit.

[0029] Fig. 13B shows an exemplary transnasal assembly that includes the transnasal insert of Fig. 13 A.

[0030] Fig. 14A shows a view in perspective of an exemplary transnasal insert that includes a vertically-extending retaining slit.

[0031] Fig. 14B shows a view in perspective of an exemplary transnasal insert that includes an inverted L- shaped retaining slit.

[0032] Fig. 14C shows a view in perspective of an exemplary transnasal insert that includes a multi- segmented retaining slit.

[0033] Fig. 15 shows the transnasal insert of Fig. 14A from an inferior view angle.

[0034] Fig. 16A shows an exemplary transnasal assembly that includes the transnasal insert of Fig. 14A.

[0035] Fig. 16B shows an exemplary transnasal assembly that includes the transnasal insert of Fig. 14B.

[0036] Fig. 16C shows an exemplary transnasal assembly that includes the transnasal insert of Fig. 14C.DETAILED DESCRIPTION

[0037] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should berecognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0038] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0039] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0040] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0041] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner," "outer," "upper," "lower," "inside," "outside,", "top," "bottom," "interior," "exterior," "left," right," and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0042] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower,above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0043] The terms "proximal" and "distal" are defined relative to the use position of a transnasal assembly. In general, the end of the transnasal assembly closest to the eye when implanted in a patient is the proximal end, and the end of the transnasal assembly farthest from the eye (e.g., the end that is inserted into the nasal cavity) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the transnasal assembly. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the transnasal assembly. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0044] The terms "axial direction," "radial direction," and "circumferential direction" have been used herein to describe the arrangement and assembly of components relative to the geometry of a transnasal insert that can be inserted into a DCR ostium. Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description. In particular, where a component or action is described relative to a particular direction, directions parallel to the specified direction as well as minor deviations therefrom are included. Thus, a description of a component extending along an axial direction of the transnasal insert does not require the component to be aligned with a center of the transnasal insert; rather, the component can extend substantially along a direction parallel to a central axis of the transnasal insert.

[0045] As used herein, the terms "integrally formed" and "unitary" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other in a manner that can allow them to be detached from each other without being broken or otherwise deformed.

[0046] As used herein, terms such as "first," "second," and the like are intended to serve as respective labels of distinct components, steps, etc. and are not intended to connote or imply a specific sequence or priority. For example, unless otherwise stated, a step of performing a second action and / or of forming a second component may be performed prior to a step of performing a first action and / or of forming a first component.

[0047] As used herein, the term "substantially" means the listed value and / or property and any value and / or property that is at least 75% of the listed value and / or property. Equivalently, the term "substantially" means the listed value and / or property and any value and / or property thatdiffers from the listed value and / or property by at most 25%. For example, "at least substantially parallel" refers to directions that are fully parallel, and to directions that diverge by up to 22.5 degrees.

[0048] In the present disclosure, a reference numeral that includes an alphabetic label (for example, "a," "b," "c," etc.) is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and / or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and / or characteristics as disclosed herein even when certain such components are not specifically described and / or addressed herein.

[0049] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and assemblies may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0050] Fig. 1 shows a view in perspective of components of transnasal assembly 200. Transnasal assembly 200 comprises a transnasal insert 100, and a nasolacrimal stent 210 configured to extend through the transnasal insert 100. The transnasal insert 100 and the nasolacrimal stent 210 are separated from each other in the example illustrated in Fig. 1, with the transnasal insert 100 shown with partial transparency to expose internal portions thereof. Fig. 2 shows a cross-sectional view of the transnasal insert 100 of Fig. 1.

[0051] Transnasal insert 100 comprises a main body 102 extending between a body distal end 104 and a body proximal end 106. The main body 102 defines a central longitudinal axis Ca (indicated, for example, in Fig. 2), and has a round cross-section at any plane orthogonal to the central longitudinal axis Ca along the length of the main body 102. Main body 102 has a diameter Db, which can be either uniform or non-uniform along its length. The length of main body 102 is defined in the direction of the central longitudinal axis Ca. The main body 102 defines a main body distal end diameter Dbd at the body distal end 104, and a main body proximal end diameter DbPat the body proximal end 106.

[0052] Main body 102 defines a main body outer surface 122, which will therefore have a round cross-section at any plane orthogonal to the central longitudinal axis Ca along the lengthof main body 102. The term "round", as used herein with reference to a cross-sectional shape of main body 102, refers to a circular shape, an elliptic shape, and the like.

[0053] The main body 102 comprises at least one stent channel 108, extending between a stent channel distal opening 110 at or proximate to the body distal end 104, and a stent channel proximal opening 112 at the body proximal end 106. Stent channel 108 defines a stent channel inner surface 124, and has a stent channel diameter Dcthat can be uniform between the stent channel distal opening 110 and the stent channel proximal opening 112. A position which is not necessarily at the body distal end 104 but rather termed to be proximate to the body distal end, refers to a position that is closer to the body distal end 104 than to the body proximal end 106, such as the position of an opening that can be in the form of a slit 140 shown in Fig. 13A and discussed in greater detail below with respect to an exemplary transnasal insert 100h.

[0054] In some examples, main body 102 further comprises at least one tear evacuation channel 116, extending from an evacuation channel distal opening 118 at the body distal end 104, to at least one additional opening proximal to the body distal end 104. The main body 102 can include an inner wall 128 between the at least one stent channel 108 and the at least one tear evacuation channel 116, and an outer wall 130 between the at least one tear evacuation channel 116 and the main body outer surface 122.

[0055] In the example illustrated in Figs. 1-2, four tear evacuation channels 116 are shown, circumferentially disposed around the stent channel 108. However, it is to be understood that any other number of tear evacuation channels 116 is contemplated, including one, two, three, or more than four. When two or more tear evacuation channels 116 are provided, the main body 102 can include at least one rib 114 separating between adjacent tear evacuation channels 116. Each rib can radially extend between the inner wall 128 and the outer wall 130, and axially extend along the length of the tear evacuation channels 116. The term "radial", as used herein, refers to a direction perpendicular to the central longitudinal axis Ca. The term "axial", as used herein, refers to a direction of (or parallel to) the central longitudinal axis Ca. In the illustrated example, each tear evacuation channel 116 is bound between the inner wall 128, the outer wall 130, and two ribs 114 on opposite sides of the tear evacuation channel 116.

[0056] In some examples, the tear evacuation channel 116 extends to an evacuation channel proximal opening 120 at the body proximal end 106, as illustrated in Figs. 1-2. In some examples, the main body 102 further comprises at least one side window 126 extending through the thickness of the outer wall 130 and exposed to a corresponding tear evacuation channel 116, as illustrated in Figs. 1-2. While the exemplary main body 102 illustrated in Figs. 1-2 is shown to include both evacuation channel proximal openings 120 and side windows 126, it isto be understood that this combination is shown by way of illustration and not limitation, and that in some examples, a main body 102 can include evacuation channel proximal openings 120 without side windows 126, and in other examples, a main body 102 can include side windows 126 and not evacuation channel proximal openings 120.

[0057] A tear evacuation channel 116 is configured to provide a flow path between two openings that are axially distanced from each other, such as the evacuation channel distal opening 118 and at least one additional opening which is proximal to the evacuation channel distal opening 118. In some examples, tear evacuation channel 116 extends from an evacuation channel proximal opening 120 to the evacuation channel distal opening 118, without necessarily having a side window 126 exposed to the tear evacuation channel 116, in which case, fluid, such as that of tears, can flow from the evacuation channel proximal opening 120, through the tear evacuation channel 116, and out of the evacuation channel distal opening 118.

[0058] In some examples, tear evacuation channel 116 extends between a side window 126 and the evacuation channel distal opening 118, while it can be sealed at the body proximal end 106 (i.e., not including an evacuation channel proximal opening 120), in which case, fluid, such as that of tears, can flow from the side window 126, into and through the tear evacuation channel 116, and out of the evacuation channel distal opening 118. In some examples, both evacuation channel proximal openings 120 and side windows 126 are provided, as illustrated in Figs. 1-2, in which case, fluid, such as that of tears, can enter into the tear evacuation channel 116 through either the evacuation channel proximal opening 120 and / or the side window 126, and flow towards and out of the evacuation channel distal opening 118.

[0059] Various exemplary implementations for transnasal inserts 100, nasolacrimal stents 210, transnasal assemblies 200, and / or components thereof, can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any assembly, device or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can also be indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any assembly, device or component, including for transnasal insert 100, nasolacrimal stent 210, and / or transnasal assembly 200, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, transnasal insert 100aillustrated in Figs. 1-2 is an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that while the main body 102 of a transnasal insert 100 can be generallyadapted for use in combination with any type of nasolacrimal stent that may pass through one or more of the stent channels 108, the main body 102aof transnasal insert 100aincludes a single stent channel 108 that can be utilized to allow extension of a monocanalicular nasolacrimal stent 210atherethrough.

[0060] Any transnasal insert 100 disclosed herein can be provided either as a separate component, which can be used with a separately supplied nasolacrimal stent, or as part of a transnasal assembly 200 that further includes a nasolacrimal stent 210 for utilization with the transnasal insert 100. Nasolacrimal stent 210 comprises a tubular portion 212 extending from a stent first end 214 to a stent second end 216. The tubular portion 212 defines a stent outer surface 230, and has a stent diameter Dsthat can be generally uniform along the length of the tubular portion 212 between the stent first end 214 and stent second end 216. A nasolacrimal stent 210 can be made of Silicone or another suitable flexible material.

[0061] Fig. 1 shows an exemplary nasolacrimal stent 210a, which is an exemplary implementation of nasolacrimal stent 210, and thus includes all of the features described for nasolacrimal stent 210 throughout the current disclosure, except that the nasolacrimal stent 210ais implemented as a monocanalicular nasolacrimal stent 210a, such that the stent first end 214 is configured to serve as a stent distal end when implanted, closer to (or inside of) the nasal cavity 22 (as will be explained in greater detail below with respect to Figs. 3A-3D), while the stent second end 216 is configured to serve as a stent proximal end when implanted, closer to the eye 10.

[0062] In some examples, monocanalicular nasolacrimal stent 210afurther comprises a punctal anchor 220 at, or in close proximity to, the stent second end 216. When provided, punctal anchor 220 can be formed to include a flange 222 connected to the tubular portion 212 by a stem 224. The stem 224 can extend in a generally orthogonal direction relative to the longitudinal direction or axis defined by the tubular portion 212, and the flange 222 can extend along a plane that is generally orthogonal to the stem 224.

[0063] Figs. 3A-3D show various stages in an exemplary implantation procedure of a transnasal assembly 200, such as the exemplary transnasal assembly 200adescribed above, including transnasal insert 100aand monocanalicular nasolacrimal stent 210a. Fig. 3 A shows the anatomy of the human nasolacrimal system. The nasolacrimal system transports tears from the eye 10 to the nasal cavity 22 through a series of ducts. Tears drain from the eye 10 via the superior and inferior lacrimal punch 14a and 14b, which are small openings on the inner corners of the eyelids near the nose. Superior and inferior small tubes, termed lacrimal canaliculi 16a and 16b, transport tears from the corresponding superior and inferior lacrimal punch 14a and14b, to the lacrimal sac 12. Tears normally travel through the lacrimal sac 12 to the nasolacrimal duct 18, and into the nasal cavity 22.

[0064] Nasolacrimal duct obstruction (NLD) is one of the most common causes of lacrimal drainage disorders, commonly characterized by epiphora (tears), mucous secretions, and / or a lacrimal sac infection (dacryocystitis). Dacryocystorhinostomy (DCR), which is a prevalent surgical method for treating NLD obstruction, involves the creation of a new opening in the nasal bone, termed rhinostomy opening or DCR ostium 20, which allows tears to drain directly into the nasal cavity 22 from the eye 10. A nasolacrimal stent is used in many cases to keep the DCR ostium open after the surgical procedure, so as to mitigate inflammation and scarring that may otherwise close it. Conventional nasolacrimal stents are provided with relatively small diameters, due to the need of passing such stents through the narrow punch and lacrimal canaliculi. The diameters of such stents are usually too small to keep the DCR ostium fully open.

[0065] Fig. 3B shows a monocanalicular nasolacrimal stent 210ainserted into and passed through the DCR ostium 20. A probe (not shown) extending through a lumen of the stent 210 or attached to the stent distal end 214, can be utilized for insertion of the monocanalicular nasolacrimal stent 210a, pushed through one of the lacrimal punch 14, the corresponding canaliculus 16, lacrimal sac 12, DCR ostium 20, and into the nasal cavity 22. The stent first or distal end 214 can be positioned inside or past the nasal cavity 22. After placement of the nasolacrimal stent 210a, the probe can be grasped and pulled down and out of the stent 210a. Other techniques for monocanalicular nasolacrimal stent 210ainsertion can be employed, as known to those skilled in the art.

[0066] In the illustrated example, the monocanalicular nasolacrimal stent 210ais shown to pass through the superior lacrimal punctum 14a and the superior canaliculus 16a. However, it is to be understood that the nasolacrimal stent 210acan be similarly passed through the inferior lacrimal punctum 14b and the inferior canaliculus 16b. As shown, the punctal anchor 220 can be utilized to anchor the nasolacrimal stent 210aagainst the lacrimal punctum 14, so as to prevent the nasolacrimal stent 210afrom sliding down and optionally out of the canaliculus 16. The flange 222 can have a size greater than that of the lacrimal punctum 14 to anchor it against the surface surrounding the punctum 14.

[0067] Fig. 3C shows a subsequent step in the implantation method, of sliding the main body 102 of the transnasal insert 100 over the nasolacrimal stent 210, through the nasal cavity 22, toward the DCR ostium. For example, the stent first end 214 can be approximated toward and inserted into the stent channel proximal opening 112, and the tubular portion 212 can be furtherpassed through the stent channel 108, exiting from the stent channel distal opening 110. The main body 102 of the transnasal insert 100 can then be further slid upwards (i.e., proximally) along the tubular portion 212 of the nasolacrimal stent 210, until it is inserted and passed, at least partially, through the DCR ostium 20, such that the main body outer surface 122 is engaged, at least along a portion thereof, with the walls of the DCR ostium 20, as shown in Fig. 3D. It should be appreciated that the representation of components of transnasal assemblies 200 throughout the figures of this disclosure are not intended to be drawn to scale, but rather are for illustrative purposes. For instance, the diameter of the lacrimal sac 12 has been exaggerated to emphasize anatomical features, wherein its actual diameter is in the order of about l-4mm.

[0068] In some implementations, the diameter of the DCR ostium 20 during implantation is greater than the main body diameter Db, including a maximal value of the body distal end diameter Dbd when the main body is formed as a frustoconical member, as shown for exemplary main body 102a. For example, the diameter of the DCR ostium can be about 20 mm., while the body distal end diameter Dbd, representing a maximal main body diameter Db, is not greater than 15 mm., and in some cases, not greater than 10 mm. In such cases, when the main body 102 is positioned inside the DCR ostium 20, the main body outer surface 122 can be spaced from all sidewalls of the DCR ostium 20 as illustrated in Fig. 3D, or can contact the DCR ostium at one side and remain spaced therefrom at the other side.

[0069] The main body diameter Db is selected according to a desired final opening of the DCR ostium. Thus, an initial opening of about 20 mm. can shrink over time due to a scarring process, for example. If the desired final opening is in the range of about 5 to 8 mm., for example, the main body 102 can be sized accordingly, such that after the scarring process, the opening is closed over the main body 102 as illustrated in Fig. 3E, after which (for example, after a period of several weeks or months) the transnasal insert 100 can be removed from the patient, keeping a final desired diameter of the DCR ostium. Limiting the main body diameter Db allows it to be formed as a lighter component, to limit the gravitational pull force of the main body when implanted, thus enabling the transnasal insert 100 to be retained in position when subjected to smaller retaining forces, such as smaller frictional forces.

[0070] Slidable movement of the transnasal insert 100 (e.g., of its main body 102) over the nasolacrimal stent 210 can be performed, in some implementations, manually, by grasping the transnasal insert 100 and pushing it upwards toward the DCR ostium 20. While the main body 102 is illustrated in Fig. 3D to be relatively smaller in diameter than the DCR ostium, the actual size of the DCR ostium can be, in some cases, similar to or smaller than the body distal enddiameter Dbd, depending on individual patient anatomy, the location of the common canaliculus in relation to the DCR opening, and the like. In such cases, the transnasal insert 100 can be pushed into the DCR ostium 20, so as to press it against the DCR ostium 20, resulting in an implantation configuration similar to that shown in Fig. 3E to begin with.

[0071] Any exemplary transnasal insert 100 of the current disclosure, including any main body 102 and / or locking plate 150 (described in greater detail below with respect to Figs. 4-5, for example) thereof, is configured to be slidably movable over a nasolacrimal stent 210 when pushed thereover, such as by manual force exerted thereon, and to retain its axial position relative to the nasolacrimal stent 210 when push force is no longer applied thereto, such as by releasing the transnasal insert 100. That is to say, when the transnasal insert 100 is no longer actively pushed over the tubular portion 212 of the nasolacrimal stent 210, it is configured to retain its position without spontaneously sliding down along the nasolacrimal stent 210, such as due to gravitational forces or spontaneous movements of the patient that can apply passive forces on the transnasal insert 100.

[0072] The term "actively applied force", as used herein, refers to a force applied on a transnasal insert 100 or a component thereof (such as main body 102 and / or locking plate 150, as will be described in greater detail below with respect to Figs. 4-5, for example), at a magnitude sufficient to cause axial movement of the transnasal insert 100 (or a component thereof, such as main body 102 and / or 150) relative to a nasolacrimal stent extending therethrough. Such a force can be a force manually applied by a user (e.g., clinician), such as by manually pushing against the transnasal insert 100 (or a component thereof, such as main body 102 and / or 150) or grasping it and manually pulling, or by any intermediary device that can be operated by the user to actively apply such push / pull forces.

[0073] Any reference to a force no longer actively applied on the transnasal insert 100, refers to the above-described active forces not being applied to actively push and / or pull the transnasal insert 100 (or a component thereof, such as main body 102 and / or 150), while passive forces, such as due to gravitational forces or spontaneous movements of the patient, which can still act on the transnasal insert 100 (or a component thereof, such as main body 102 and / or 150), are not sufficient to overcome the engagement interaction between the inner engagement surface of the transnasal insert 100 and the outer surface of the nasolacrimal stent.

[0074] One optional manner by which the threshold magnitude of actively applied forces can be measured or estimated, can involve a setup (not shown) in which a nasolacrimal stent 210 is retained (e.g., by a clamp or any other suitable manner) on one end, such that the tubular portion 212 vertically extends from the clamping point, and is passed through the stent channel108 of the transnasal insert 100. Actively applied force can be simulated by grasping the transnasal insert (or a component thereof, such as main body 102 and / or 150), and manually moving it along the tubular portion 212, verifying that simple manual force can indeed cause sliding movement therebetween. Next, the manual force can be terminated, such as by no longer grasping the transnasal insert, so as to verify that passive forces, such as gravitational force of the weight of the transnasal insert 100, will not be able to cause downward (i.e., distally-oriented) movement of the transnasal insert 100 along the tubular portion 212.

[0075] It is to be understood that any reference to forces actively applied on a transnasal insert 100 throughout the specification and the claims, refers to such forces actively applied to any component of the transnasal insert 100 that includes the inner engagement surface, which can be the main body 102 and / or a locking plate 150, unless stated otherwise.

[0076] Any exemplary transnasal insert 100 described herein comprises at least one inner engagement surface configured to engage with the stent outer surface 230, such that when an axially-directed force, such as a push force or a pull force, is applied to the component of transnasal insert 100 that includes the inner engagement surface, it can slide along the tubular portion 212 of the nasolacrimal stent 210, while when no such active force is applied to this component of the transnasal insert 100, the transnasal insert 100 is fixed in position relative to the nasolacrimal stent 210, i.e., prevented from sliding axially along the tubular portion 212.

[0077] In some examples, the transnasal insert 100 is frictionally engageable with the tubular portion 212 of the nasolacrimal stent 210, such that when the tubular portion 212 extends through the stent channel 108, a frictional force is formed between the stent channel 108 and the tubular portion 212, configured to prevent slidable movement of the transnasal insert 100 along the nasolacrimal stent 210 when not actively (e.g., manually) pushed or pulled therealong, yet allow slidable movement of the transnasal insert 100 along the nasolacrimal stent 210 when actively (e.g., manually) pushed or pulled by a user (e.g., a clinician).

[0078] Frictional engagement can be formed between tubular portion 212 of the nasolacrimal stent 210 and the inner engagement surface of the transnasal insert 100, which can be an inner surface of either one of the at least one channel 108 extending through main body 102, or a stent opening 154 of a locking plate 150 which will be described in greater detail below with respect to Figs. 4-5.

[0079] It is to be understood that the term "frictional engagement", as used herein, refers to friction fit or press fit engagement between transnasal insert 100 and the tubular portion 212 of the nasolacrimal stent 210, wherein friction or press fit engagements include any of: engagement between at least one channel 108 and / or at least one stent opening 154 having aninner diameter equal to or slightly less than an outer diameter of the tubular portion 212; engagement of at least one rough surface with another surface; engagement between a surface of a friction layer of at least one channel 108 and / or at least one stent opening 154 with stent outer surface 230; engagement between a surface comprising serrations or other texture with another surface; engagement between protrusions of at least one channel 108 with stent outer surface 230; and any combination thereof.

[0080] In some examples, the inner engagement surface of the transnasal insert 100 is the stent channel inner surface 124. In some examples, the stent channel diameter De can be equal to or smaller than the stent diameter Ds. In some examples, the stent channel diameter De is slightly smaller than stent diameter Ds, meaning that the stent channel diameter De is sufficiently smaller than the stent diameter Ds to form friction-fit between stent channel inner surface 124 and stent outer surface 230, yet not too small so as to allow a user (e.g., a clinician) to manually push or pull the transnasal insert 100 along the tubular portion 212 of the nasolacrimal stent 210 during implantation or retrieval of the transnasal insert 100 (for example, if retrieval of transnasal insert 100 from DCR ostium 20 is required after a specific period of time, such as several weeks or months). In some examples, the stent channel diameter De is within a range of 95% to 100%, inclusive, of the stent diameter Ds. A tubular portion 212 of the nasolacrimal stent 210 can be made of silicone or other flexible material, which can be slightly squeezable to allow it to be squeezed into a stent channel 108 that can be somewhat narrower in diameter, wherein the change in diameters can be sufficient to apply a frictional force that will prevent spontaneous disengagement between the two.

[0081] In some examples, the stent channel inner surface 124 and / or the stent outer surface 230 can be provided as relatively rough or otherwise textured surfaces, to enhance friction engagement therebetween. Surface roughness is a component of surface texture. It is quantified by the deviations in the direction of the normal vector of a real surface from its ideal form. If these deviations are large, the surface is considered rough, and if they are small, the surface is considered smooth. Therefore, the term "smooth", as used herein refers to a surface having minor deviations in the direction of the normal vector of a real surface from its ideal form. Smooth surfaces are substantially unitary / continuous surfaces, free from irregular voids. The term "smooth" is not intended to be limited to the narrow meaning of a substantially planar surface devoid of surface irregularities.

[0082] Surface roughness is typically calculated by a method termed “RA” or roughness average, which represents the arithmetic average of a set of individual measurements of surfaces peaks and valleys (e.g., normal vectors), relative to a mean line (e.g., a real surface),wherein low Ra values represent smooth surfaces. The RA value for any rough surface disclosed herein is selected to provide frictional force that allows the transnasal insert 100 to slide along the tubular portion 212 of the nasolacrimal stent 210 when actively pushed or pulled, such as by a user applying an axial push or pull forces there-against, yet retain the transnasal insert 100 at a fixed position relative to the nasolacrimal stent 210 when not actively pushed or pulled.

[0083] In some examples, both the stent channel inner surface 124 and the stent outer surface 230 are rough surfaces, having similar RA roughness values. In some examples, the stent channel inner surface 124 is provided with greater surface roughness than the stent outer surface 230. Such a configuration can be advantageous for increasing friction engagement between the stent channel inner surface 124 and the stent outer surface 230, while leaving the stent outer surface 230 relatively smooth to refrain from irritating the surrounding anatomy through which the nasolacrimal stent 210 is passed and is in contact with, such as the lacrimal punch 14 and the canaliculi 16.

[0084] In some implementations, as illustrated for exemplary transnasal insert 100athroughout Figs. 1-3D, the main body 102ahas a non-uniform main body diameter Db, exhibiting a frustoconical profile that gradually tapers from a larger body distal end diameter Dbd to a narrower body proximal end diameter DbP(i.e. , Dbd > DbP). Such a profile can facilitate insertion and engagement of the transnasal insert 100 with the DCR ostium 20. The main body 102 can be generally sized such that it defines, at least in one position along its length, a main body diameter Db that is similar to, or slightly greater than, the diameter of the DCR ostium 20.

[0085] When provided with a non-uniform main body diameter Db, such as the tapering main body 102ain the illustrated example, the body distal end diameter Dbd is greater than the diameter of the DCR ostium 20, and the body proximal end diameter DbPis smaller than the DCR ostium 20. As mentioned above, in some implementations, the main body diameter Db at any point along the length of main body 102 is smaller than the diameter of the DCR ostium 20, such that the main body 102 may reside within the DCR ostium 20, spaced from at least one side of the inner wall of DCR ostium 20, as illustrated in Fig. 3D. In alternative implementations, the DCR ostium can be smaller in size than at least a portion of the main body 102, such that body distal end diameter Dbd is greater than the DCR ostium 20. This will allow insertion of the main body 102 into the DCR ostium 20 up to a region of the main body 102 that contacts and is pressed against the walls of the DCR ostium 20, wherein a portion of the main body 102 extends into (and optionally past) the DCR ostium 20 relative to their contactregion, while another portion of the main body 102 extends distally from the contact region, into the nasal cavity 22, similar to the configuration illustrated in Fig. 3E for example.

[0086] In some examples, the main body diameter Db is in the range of about 4 mm. to about 10 mm. at least in one cross-sectional position along the length of the main body 102. In some examples, the main body diameter Db is in the range of about 5 mm. to about 15 mm. at least in one cross-sectional position along the length of the main body 102. In some examples, the main body diameter Db is in the range of about 5 mm. to about 10 mm. at least in one cross-sectional position along the length of the main body 102. In some examples, the main body diameter Db is in the range of about 5 mm. to about 7 mm. at least in one cross-sectional position along the length of the main body 102. In some examples, the main body diameter Db is equal to about 6 mm. at least in one cross-sectional position along the length of the main body 102. In some examples, the body distal end diameter Dbd is at least 1.5 times greater than the body proximal end diameter DbP(i.e. , Dbd > 1.5DbP). In some examples, the body distal end diameter Dbd is at least two times as great as the body proximal end diameter DbP(i.e., Dbd > 2DbP).

[0087] Even when the body proximal end diameter DbPis smaller than the body distal end diameter Dbd, it will still be limited to a minimal value dictated by the desired final opening of the DCR ostium 20. That is to say, the main body diameter Db along at least a proximal portion thereof, such as the portion extending proximally from the contact region with the DCR ostium 20 and intended to reside inside DCR ostium 20, is set to prevent closure of the DCR ostium to a diameter narrower than the main body diameter Db.

[0088] In some examples, the body distal end diameter Dbd is in the range of about 4 mm. to about 15 mm. In some examples, the body distal end diameter Dbd is in the range of about 6 mm. to about 10 mm. In some examples, the body distal end diameter Dbd is in the range of about 7 mm. to about 9 mm. In some examples, the body distal end diameter Dbd is equal to about 8 mm. In some examples, the body proximal end diameter DbPis in the range of about 4 mm. to about 10 mm. In some examples, the body proximal end diameter DbPis in the range of about 4 mm. to about 5 mm. In some examples, the body proximal end diameter DbPis equal to about 4 mm.

[0089] The outer diameter Dsof nasolacrimal stent 210 is usually dictated by the diameter of the upper lacrimal drainage system which includes the punch 14 and / or canaliculi 16 through which such stents need to pass, though the diameter Dsof a nasolacrimal stent 210 can be somewhat greater than the diameter of the lacrimal punch 14 and / or canaliculi 16 due to the inherent ability of such a stent 210 to be slightly squeezed when passed through narrowerpassages, and / or the inherent ability of the punch 14 and canaliculi 16 to expand. In some examples, the stent diameter Dsis in the range of about 0.5 mm. to about 2 mm. In some examples, the stent diameter Dsis in the range of about 0.5 mm. to about 1 mm. In some examples, the stent diameter Dsis in the range of about 0.6 mm. to about 0.7 mm. In some examples, the stent diameter Dsis equal to about 0.64 mm.

[0090] The stent channel diameter Dcis designed to allow passage of the nasolacrimal stent 210. In some examples, the stent channel diameter Dcis within a range of about 60% to about 150% of the stent diameter Ds(i.e. , 0.6Ds< Dc< 1.5DS). In some examples, the stent channel diameter Dcis within a range of about 85% to about 125% of the stent diameter Ds(i.e., 0.75Ds< Dc< 1.25DS). As mentioned above, in some examples, the inner engagement surface of the transnasal insert 100 is the stent channel inner surface 124. In some examples, the stent channel diameter Dcis smaller than the stent diameter Ds. In such cases, the minimal diameter of the stent channel diameter Dcis dictated by the extent to which the tubular portion 212 of the nasolacrimal stent 210 can be internally squeezed.

[0091] In some examples, the stent channel diameter Dcis within a range of ±50% of the stent diameter Ds(i.e., 0.5Ds< Dc< 1.5DS). In some examples, the stent channel diameter Dcis within a range of ±5% of the stent diameter Ds(i.e., 0.95Ds< Dc< 1.05Ds). In some examples, the stent channel diameter Dcis substantially equal to the stent diameter Ds. The stent channel inner surface 124 can serve as the inner engagement surface of the transnasal insert 100 when the stent channel diameter Dcis similar to (i.e., equal to or within a narrow range of) the stent diameter Ds, in implementations wherein interaction therebetween is not necessarily based on press-fit engagement, but rather on surface roughness of at least one of the surfaces 124 and / or 230, as described above.

[0092] In some examples, the stent channel diameter Dcis greater than the stent diameter Ds. In some examples, the stent channel diameter Dcis greater than the stent diameter Dsby at least 10% (i.e., Dc> 1. IDs). In some examples, the stent channel diameter Dcis greater than the stent diameter Dsby at least 20% (i.e., Dc> 1.2DS). In some examples, the stent channel diameter Dcis greater than the stent diameter Dsby at least 25% (i.e., Dc> 1.25DS). When the stent channel diameter Dcis greater than the stent diameter Ds, it may be desirable, in some cases, to limit its maximal diameter to avoid too much "freedom" of movement between the tubular portion 212 and the stent channel 108, so as to reduce undesired tilting of one relative to the other. In some examples, the stent channel diameter Dcdoes not exceed 50% of the stent diameter Ds(i.e., Dc< 1.5DS). In some examples, the stent channel diameter Dcdoes not exceed 30% of the stentdiameter Ds(i.e., Dc< 1.3DS). In some examples, the stent channel diameter Dcdoes not exceed 25% of the stent diameter Ds(i.e., Dc< 1.25DS).

[0093] In some examples, the stent channel diameter Dcis in the range of about 0.5 mm. to about 1.2 mm. In some examples, the stent channel diameter Dcis in the range of about 0.6 mm. to about 2 mm. In some examples, the stent channel diameter Dcis in the range of about 0.6 mm. to about 1 mm. In some examples, the stent channel diameter Dcis in the range of about 0.7 mm. to about 0.9 mm. In some examples, the stent channel diameter Dcis equal to about 0.8 mm.

[0094] As will be described in further detail below, for example with respect to Figs. 4-6B, the stent channel inner surface 124 is not necessarily the inner engagement surface of the transnasal insert 100. Thus, providing a stent channel diameter Dcwhich is greater than the stent diameter Dscan advantageously facilitate easier insertion of the tubular portion 212 of the nasolacrimal stent 210 into the stent channel 108, and easier sliding of the transnasal insert 100 over the nasolacrimal stent 210, for example during advancement into the DCR ostium 20. Moreover, even when the stent channel inner surface 124 does serve as the inner engagement surface of the transnasal insert 100, it can be provided with a stent channel diameter Dcwhich is greater than the stent diameter Dswhen affixation of the transnasal insert 100 relative to nasolacrimal stent 210 relies on a curved shape of the stent channel 108, as will be described in greater detail below with respect to Figs. 12A-12B, for example.

[0095] As shown and described above, the main body diameter Db is significantly larger than the stent channel diameter Dc, sized to keep a minimal desired opening of the DCR ostium even after a scarring tissue is formed therearound. In some examples, main body diameter Db is at least four times as great as the stent channel diameter Dc(i.e., Db > 4DC) at least in one position along its length. In some examples, main body diameter Db is at least five times as great as the stent channel diameter Dc(i.e., Db > 5DC) at least in one position along its length.

[0096] The main body 102 has a main body length Lb defined between the body distal end 104 and the body proximal end 106, which can be equal to or greater than the length of the DCR ostium, such that when the main body 102 extends through DCR ostium 20, as shown for example in Fig. 3D, it will prevent closure along the entire length of the DCR ostium 20. Since in some implementations, a portion of the main body 102 may remain inside the nasal cavity 22, the main body length Lb can be designed, in some implementations, to be longer than the DCR ostium 20. In some examples, the main body length Lb is in a range between 6 mm. and 14 mm. In some examples, the main body length Lb is in a range between 8 mm. and 10 mm. In some examples, the main body length Lb is equal to about 10 mm. The main body length Lbshould not be too short (for example, not less than 6, 8, or 10 mm.) to prevent the closure of the DCR ostium along its entire length. On the other hand, the main body length Lb should not be too long (for example, no more than 10, 12, or 14 mm.) to allow sufficient maneuverability thereof as it is passed through the nasal cavity 22 into the DCR ostium 20, and to prevent it from extending too far into either the lacrimal sac 12 and / or nasal cavity 22.

[0097] When a monocanalicular nasolacrimal stent 210ais utilized, as shown in Fig. 3D for example, the remaining lacrimal punctum 14 and canaliculus 16 through which the stent 210adoes not extend, remain open, which can allow undisturbed evacuation of tears from the eye 10 therethrough, towards the DCR ostium 20 and the transnasal insert 100 residing therein. When the main body 102 is spaced from the walls of the DCR ostium 20, as illustrated for example in Fig. 3D, the tears may flow around the main body 102. However, scarring tissue that may develop over time can block any space between the main body 102 and the DCR ostium 20. Advantageously, when the transnasal insert 100 further comprises one or more tear evacuation channels 116, tears can still flow into and through these channels 116 toward the nasal cavity 22.

[0098] For example, in the implementation illustrated in Fig. 3E, tears can flow from the eye 10, through the inferior lacrimal punctum 14b and the inferior canaliculus 16b, via the lacrimal sac 12, towards the DCR ostium 20. The tears can then enter into the tear evacuation channel 116 through evacuation channel proximal openings 120 and / or through side windows 126, and exit from evacuation channel distal opening 118 and / or side windows 126 (depending on the position of side windows 126 relative to DCR ostium 20) into the nasal cavity 22. Moreover, forming tear evacuation channels 116 between the inner wall 128 and outer wall 130 reduces the weight of the main body 102, thereby lowering gravitational forces that can pull the main body 102 downwards, requiring lower retaining forces (e.g., frictional forces) to maintain the position of the main body 102 within the DCR ostium 20.

[0099] In some examples, transnasal insert 100 further comprises a locking plate 150 that includes at least one stent opening 154 defining a stent opening inner surface 160, which is configured to serve as the inner engagement surface of the transnasal insert 100. Fig. 4 shows a view in perspective of an exemplary transnasal insert 100b. Transnasal insert 100bis an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that the transnasal insert 100bfurther comprises a locking plate 150, such as locking plate 150b. Fig. 4 shows the transnasal insert 100 and the locking plate 150 separated from each other. Fig. 5 shows a plan view of the locking plate 150 of Fig. 4.

[0100] As mentioned, a locking plate 150 of a transnasal insert 100 includes at least one stent opening 154, configured to allow extension of the tubular portion 212 of nasolacrimal stent 210 therethrough. The number of stent opening(s) 154 can match the number of stent channel(s) 108, such that when plate 150 is used in combination with the main body 102, the stent opening 154 can be aligned with the stent channel 108 to allow extension of the tubular portion 212 of nasolacrimal stent 210 through both.

[0101] Locking plate 150 has a plate proximal end 158 facing the main body 102, and an opposite plate distal end 156 facing away from main body 102, such that the stent opening 154 extends between the plate proximal end 158 and the plate distal end 156. The plate 150 defines a plate thickness Tp between the plate proximal end 158 and the plate distal end 156. The plate thickness Tp is significantly smaller than the main body length Lb. In some examples, the plate thickness Tp is smaller than 30% of the main body length Lb (i.e., Tp < 0.3Lb). In some examples, the plate thickness Tp is smaller than 20% of the main body length Lb (i.e., Tp < 0.2Lb). In some examples, the plate thickness Tp is smaller than 10% of the main body length Lb (i.e., Tp < 0. ILb).

[0102] The plate 150 has a plate diameter Dp that can be, in some examples, substantially equal to the main body distal end diameter Dbd, though in other examples, plate diameter Dp can be smaller than or larger than main body distal end diameter Dbd. The plate 150 further defines a plate outer surface 162. The stent opening 154 has a stent opening diameter DL, and defines a stent opening inner surface 160 configured to contact the tubular portion 212 of nasolacrimal stent 210 when extended therethrough.

[0103] When transnasal insert 100 includes a locking plate 150, the stent opening inner surface 160 serves as the inner engagement surface of transnasal insert 100, instead of, or in some examples, in addition to, the stent channel inner surface 124. The stent opening inner surface 160 is configured to engage with the stent outer surface 230, such that when an axially-directed force, such as a push force or a pull force, is applied to the transnasal insert 100, it can slide along the tubular portion 212 of the nasolacrimal stent 210, while when no such active force is applied to the transnasal insert 100, the transnasal insert 100 is fixed in position relative to the nasolacrimal stent 210, i.e., prevented from sliding axially along the tubular portion 212.

[0104] The stent opening inner surface 160 can be configured to serve as an inner engagement surface in the same manner described above for any example of stent channel inner surface 124. In some examples, the stent opening diameter DL can be equal to or smaller than the stent diameter Ds. In some examples, the stent opening diameter DL is slightly smaller than stent diameter Ds, meaning that the stent opening diameter DL is sufficiently smaller than the stentdiameter Ds to form friction-fit between stent opening diameter DL and stent outer surface 230, yet not too small so as to allow a user (e.g., a clinician) to manually push or pull the locking plate 150 along the tubular portion 212 of the nasolacrimal stent 210 during implantation or retrieval of the transnasal insert 100. In some examples, the stent opening diameter DL is within a range of 75% to 100%, inclusive, of the stent diameter Ds. In some examples, the stent opening diameter DL is within a range of 85% to 100%, inclusive, of the stent diameter Ds. In some examples, the stent opening diameter DL is within a range of 90% to 100%, inclusive, of the stent diameter Ds. In some examples, the stent opening diameter DL is within a range of 95% to 100%, inclusive, of the stent diameter Ds.

[0105] In some examples, the stent opening inner surface 160 and / or the stent outer surface 230 can be provided as relatively rough or otherwise textured surfaces, to enhance friction engagement therebetween. In some examples, both the stent opening inner surface 160 and the stent outer surface 230 are rough surfaces, having similar RA roughness values. In some examples, the stent opening inner surface 160 is provided with greater surface roughness than the stent outer surface 230. In some examples, the stent opening inner surface 160 is provided with greater surface roughness than that of the stent channel inner surface 124. In some examples, the stent opening inner surface 160 is provided with greater surface roughness than that of the plate outer surface 162.

[0106] The locking plate 150 is positioned, when in use, distal to the main body 102. In some examples, locking plate 150 and main body 102 are provided as separate components as illustrated in Fig. 4, axially movable towards or away from each other when a nasolacrimal stent 210 extends through both. In some examples, locking plate 150 is integrally formed, or affixed to, the main body 102 (example not shown), such that both the main body 102 and the locking plate 150 are configured to move in unison as a unitary component over a nasolacrimal stent 210.

[0107] In some examples, locking plate 150 further comprises at least one evacuation opening 152, which can be optionally aligned with the at least one evacuation channel distal opening 118 formed at main body 102, to allow evacuation of tears therethrough. An evacuation opening 152 extends from the plate proximal end 158 to the plate distal end 156. In some examples, the number of evacuation openings 152 matches the number of tear evacuation channels 116. In some examples, the shape and size of evacuation openings 152 can be similar to the shape and size of evacuation channel distal opening 118.

[0108] Figs. 4-5 show an example of a locking plate 150 that includes evacuation openings 152 which do not match the number of the tear evacuation channels 116. Specifically, in theillustrated example, locking plate 150 is shown to include a total of eight evacuation openings 152, while the main body 102 is shown to include four tear evacuation channels 116. Moreover, none of the evacuation openings 152 illustrated in Figs. 4-5 is sized or shaped in a similar manner to evacuation channel distal opening 118. The evacuation openings 152 can be formed in any shape, such as circular, rectangular, triangular, curvilinear, or any other shape.

[0109] In some examples, when a locking plate 150 is provided with a plurality of evacuation openings 152, not all evacuation openings 152 have to be similarly shaped. In the example illustrated in Figs. 4-5, the locking plate 150 is shown to include two groups of differently shaped evacuation openings 152: circular evacuation openings 152' and rectangular evacuation openings 152", circumferentially arranged in an alternating manner around the central axis Ca, for example. The plurality of evacuation openings 152 can be equally or non-equally circumferentially spaced from each other. An arrangement of a plurality of evacuation openings 152 can be advantageous in that it does not necessitate the locking plate 150 to be circumferentially aligned with the main body 102. Thus, when a locking plate 150 is approximated to a main body 102, it can assume any angular orientation relative to the main body 102, such that in any angular orientation, at least some of the evacuation openings 152 will be in fluid communication with the tear evacuation channels 116, allowing free flow of tears therethrough.

[0110] Locking plate 150billustrated in Figs. 4-5 is an exemplary implementation of locking plate 150, and thus includes all of the features described for locking plate 150 throughout the current disclosure, except that while the locking plate 150 can be generally adapted for use in combination with any type of nasolacrimal stent that may pass through one or more of the stent openings 154, the locking plate 150bof transnasal insert 100bincludes a single stent opening 154 that can be utilized to allow extension of a monocanalicular nasolacrimal stent 210atherethrough. Thus, a transnasal insert 100bthat includes a locking plate 150bequipped with a single stent opening 154, will usually also include a main body 102aaccording to any example described above, equipped with a single stent channel 108, such that when used in combination with a monocanalicular nasolacrimal stent 210a, for example, the same tubular portion 212 can extend through both the stent channel 108 and the stent opening 154.

[0111] Figs. 6A-6B show stages in an exemplary implantation procedure of a transnasal assembly 200b, which includes a monocanalicular nasolacrimal stent 210aand a transnasal insert 100bequipped with a main body 102 and a locking plate 150b. Insertion of the monocanalicular nasolacrimal stent 210athrough the patient's lacrimal punctum 14, canaliculus 16, lacrimal sac 12, DCR ostium 20 and nasal cavity 22, can be performed in the same mannerdescribed above with respect to Fig. 3B, for example. Similarly, the main body 102 of transnasal insert 100bcan be slid over the tubular portion 212 of the nasolacrimal stent 210, into the DCR ostium 20, in the same manner described above with respect to Figs. 3C-3D, for example. As further shown in Fig. 6A, when a locking plate 150, such as locking plate 150b, is provided, the tubular portion 212 further extends through the stent opening 154 of the locking plate 150, which is distal to the main body 102. The locking plate 150 can be then slid along the tubular portion 212, until it approximates and / or contacts the body distal end 104, as shown in Fig. 6B.

[0112] As mentioned, when actively axially pushed (or pulled), such as by manual force applied to the locking plate 150, this force can overcome the friction-fit between the stent opening inner surface 160 and the stent outer surface 230 to allow axial movement of the locking plate 150 relative to the nasolacrimal stent 210. Since the stent opening inner surface 160 serves as the inner engagement surface of the transnasal insert 100b, when active axial force is no longer applied on the locking plate 150, the friction-fit or press-fit engagement between the stent opening inner surface 160 and the stent outer surface 230 serves to retain the locking plate 150 in position relative to the nasolacrimal stent 210. Thus, after pushing the locking plate 150 up to contact, abut, and / or press against, the main body 102, as shown for example in Fig. 6B, releasing the locking plate 150 will lock it in position, preventing the transnasal insert 100b, as a whole, from being axially displaced relative to the nasolacrimal stent 210.

[0113] As mentioned, in some examples, the stent opening inner surface 160 can serve as an inner engagement surface in addition to the stent channel inner surface 124 serving as an inner engagement surface as well. In such cases, the addition of locking plate 150 can serve as a safety mechanism that adds another safety layer to keep the transnasal insert locked in position. In other examples, the stent opening inner surface 160 can serve as an inner engagement surface while the stent channel inner surface 124 is not necessarily an inner engagement surface as well. For example, the stent channel diameter Dccan be larger than the stent diameter Ds. Specifically, absent of any other inner engagement surface, the main body 102 can, in some examples, axially slide up or down the nasolacrimal stent 210 when no force is applied thereto, posing a potential risk of the main body 102 falling from position if no other locking mechanism is provided. On the other hand, such implementations allow much easier slidable movement of the relatively elongated main body 102 along the nasolacrimal stent 210 to position it inside the DCR ostium 20.

[0114] In such cases, utilization of the locking plate 150 serves to lock the position of the main body 102, which, as shown in the state illustrated in Fig. 6B, will not be able to move further in the distal direction due to the engagement of the stent opening inner surface 160 of locking plate 150 with the outer surface 230 of the nasolacrimal stent 210.

[0115] When the main body 102 includes one or more tear evacuation channels 116, and the locking plate 150 includes one or more evacuation openings 152, tears can flow through the tear evacuation channels 116 as described above, and exit through the evacuation opening 152 into the nasal cavity 22.

[0116] Figs. 6A-6B illustrate utilization of an exemplary transnasal insert 100 having a locking plate 150 which is separate from the main body 102, and is axially movable relative to the main body 102 by being slidable over a tubular portion 212 of a nasolacrimal stent 210 passing through both the main body 102 and the locking plate 150, towards (or away from) the main body 102. However, as mentioned above, in some examples, the locking plate 150 and the main body 102 can be integrally formed, such that the transnasal insert 100 can be provided as a unitary transnasal insert 100 that includes both the main body 102 and the locking plate 150 permanently positioned at the body distal end 104. For example, a unitary transnasal insert 100 can be manufactured as a unitary component to begin with, such as by being 3D printed, injection molded, and the like, or can be formed by manufacturing separate components that can be affixed to each other, such as by gluing, welding, and the like.

[0117] When provided as a unitary transnasal insert 100, the transnasal insert 100 can be slid over the tubular portion 212 of a nasolacrimal stent 210 in the same manner described above with respect to Figs. 3C-3D, for example, wherein, when positioned inside the DCR ostium, the stent opening inner surface 160 of the locking plate 150, which is affixed to main body 102, serves to retain the position of the unitary transnasal insert relative to the nasolacrimal stent 210, as described above.

[0118] Fig. 7 shows a view in perspective of components of an exemplary transnasal assembly 200cthat includes a bicanalicular nasolacrimal stent 210cand an exemplary transnasal insert 100c, shown side by side next to each other. Fig. 8 shows a cross-sectional view of the exemplary transnasal insert 100cof Fig. 7. Transnasal insert 100cis an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that while the main body 102 of a transnasal insert 100 can be generally adapted for use in combination with any type of nasolacrimal stent that may pass through one or more of the stent channels 108, the main body102cof transnasal insert 100cincludes two stent channels 108 that can be utilized to allow extension of a bicanalicular nasolacrimal stent 210ctherethrough.

[0119] A bicanalicular nasolacrimal stent 210c, unlike the monocanalicular nasolacrimal stent 210adescribed above, is configured to extend through both lacrimal punch 14 and both canaliculi 16. When implanted, both the stent first end 214cand the stent second end 216care configured to serve as stent distal ends, distal to the eye 10. The bicanalicular nasolacrimal stent 210c, when in use, can further include a bent portion 218, which can be generally formed at a central region of the nasolacrimal stent 210c, midway between both of the sent ends 214cand 216c, such that the tubular portion 212 of bicanalicular nasolacrimal stent 210cdefines a first tubular portion 212a extending between the bent portion 218 and the stent first end 214c, and a second tubular portion 212b extending between the bent portion 218 and the stent second end 216c.

[0120] As mentioned, the main body 102cof transnasal insert 100cincludes two stent channels 108 that can generally extend parallel to each other. Specifically, a first stent channel 108a extends between a first stent channel proximal opening 112a and a first stent channel distal opening 110a, and a second stent channel 108b extends between a second stent channel proximal opening 112b and a second stent channel distal opening 110b. Each of the two stent channels 108 is configured to allow extension of a corresponding tubular portion 212 therethrough, as described in any example above. Moreover, in some implementations, the stent channel inner surface 124 of any of the stent channels 108a, 108b can serve as the inner engagement surface, according to any of the examples described above.

[0121] In some examples, both stent channels 108a and 108b are similarly formed and sized. In some examples, the stent channel inner surfaces 124 of both stent channels 108a and 108b serve as inner engagement surfaces with the stent outer surface 230 of both tubular portions 212a and 212b, respectively. In some examples, the stent channels 108a and 108b are not identically formed or sized, such that one of the stent channels 108a or 108b can serve as an inner engagement surface with the outer surface 230 of the corresponding tubular portion 212a or 212b extending therethrough, while the other stent channel can be formed to have a stent channel diameter Dclarger than the stent diameter Ds, and not necessarily serve as an additional inner engagement surface.

[0122] Figs. 9A-9C show various stages in an exemplary implantation procedure of a transnasal assembly 200c. Fig. 9A shows a bicanalicular nasolacrimal stent 210cinserted into and passed through the DCR ostium 20. Two relatively rigid probes (not shown) can be attached to the bicanalicular nasolacrimal stent 210c, with portions that can extend from thefirst and second stent ends 214cand 216Cand terminate with or without bulbs on the distal ends of the probes. The probes are passed through both lacrimal punch 14 and canaliculi 16, through the lacrimal sac 12, the DCR ostium 20, and into (and optionally past) the nasal cavity 22. During passing of the probes, their distal ends (that can optionally include the above-mentioned bulbs) can be grasped, either manually or by a tool (such as pinchers or other suitable tools), such that the probes pull the bicanalicular nasolacrimal stent 210ctherewith, and the nasolacrimal stent 210ccan be cut at the portion extending into (and optionally past) the nasal cavity 22 to remove the probes.

[0123] As shown in Fig. 9A, this can result in the first tubular portion 212a extending through the superior lacrimal punctum 14a and the superior canaliculus 16a, and the second tubular portion 212b extending through the inferior lacrimal punctum 14b and the inferior canaliculus 16b, with a bent portion 218 extending between the superior and inferior lacrimal punch 14a and 14b. A bicanalicular nasolacrimal stent 210ccan be devoid of a punctal anchor 220 of the type described above with respect to monocanalicular nasolacrimal stents 210a, as the bent portion 218 looped against the eye 10 serves to prevent the bicanalicular nasolacrimal stent 210cfrom sliding away from the eye 10. Other techniques for bicanalicular nasolacrimal stent 210cinsertion can be employed, as known to those skilled in the art.

[0124] Fig. 9B shows a subsequent step in the implantation method, of sliding the main body 102cof transnasal insert 100cover the bicanalicular nasolacrimal stent 210c, through the nasal cavity 22, toward the DCR ostium. For example, the stent first and second ends 214a, 214b can be approximated toward and inserted into the first and second stent channel proximal openings 112a, 112b, and the first and second tubular portions 212a, 212b can be further passed through the first and second stent channels 108a, 108b, exiting from the first and second stent channel distal openings 110a, 110b. The main body 102ccan then be further slid upwards (i.e., proximally) along the tubular portions 212a, 212b of the nasolacrimal stent 210c, until it is inserted and passed, at least partially, through the DCR ostium 20, such that the main body outer surface 122 is engaged, at least along a portion thereof, with the walls of the DCR ostium 20, as shown in Fig. 9C.

[0125] Figs. 10A-10B show stages in an exemplary implantation procedure of a transnasal assembly 200d, which includes a bicanalicular nasolacrimal stent 210cand a transnasal insert 100dequipped with a main body 102 and a locking plate 150d. Locking plate 150d, shown in a zoomed-in view in Fig. 10A for example, is an exemplary implementation of locking plate 150, and thus includes all of the features described for locking plate 150 throughout the current disclosure, except that while the locking plate 150 can be generally adapted for use incombination with any type of nasolacrimal stent that may pass through one or more of the stent openings 154, the locking plate 150dof transnasal insert 100dincludes two stent openings 154, such as first stent opening 154a and second stent opening 154b, which can be utilized to allow extension of a bicanalicular nasolacrimal stent 210ctherethrough. Thus, a transnasal insert 100dthat includes a locking plate 150dequipped with two stent openings 154a, 154b, will usually also include a main body 102caccording to any example described above, equipped with two stent channels 108a, 108b, such that when used in combination with a bicanalicular nasolacrimal stent 210c, for example, the tubular portions 212a, 212b can extend through both the stent channel 108a, 108b and the stent openings 154a, 154b, respectively.

[0126] Insertion of the bicanalicular nasolacrimal stent 210cthrough the patient's lacrimal punch 14a and 14b, canaliculi 16a and 16b, lacrimal sac 12, DCR ostium 20 and nasal cavity 22, can be performed in the same manner described above with respect to Fig. 9A, for example. Similarly, the main body 102 of transnasal insert 100dcan be slid over the tubular portions 212a, 212b of the nasolacrimal stent 210c, into the DCR ostium 20, in the same manner described above with respect to Figs. 9B-9C, for example. As further shown in Fig. 10A, when a locking plate 150dis provided, the tubular portion 212a, 212b further extend through the stent openings 154a, 154b of the locking plate 150d. The locking plate 150dcan be then slid along the tubular portions 212a, 212b, until it approximates and / or contacts the body distal end 104, as shown in Fig. 10B, such that the stent channel inner surface 124 of one or both stent openings 154a, 154b serves to retain the locking plate 150din position relative to the nasolacrimal stent 210cin the same manner described above with respect to Fig. 9C, for example.

[0127] It is to be understood that a locking plate 150dthat includes two stent openings 154 can be either formed as a separate component from main body 102, axially movable along tubular portion 212a, 212b of a bicanalicular nasolacrimal stent 210c, toward and / or away from the main body 102, as illustrated in Figs. 10A-10B, or can be integrally formed with the main body 102, forming together a unitary transnasal insert 100 that includes two stent channels 108 and two stent openings 154 aligned therewith, which can be utilized in the same manner described above for a unitary transnasal insert 100 that may optionally include a single stent channel 108 and a single stent opening 154.

[0128] Fig. 11 shows a view in perspective of an exemplary transnasal insert 100e. Transnasal insert 100eis an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that while the main body 102 of a transnasal insert 100 can have uniform or non-uniform main body diameter Db along its length, the main body 102eof transnasal insert 100eis generallycylindrical, such that the main body diameter Db is uniform along the length of the main body 102e. Thus, in contrast to the exemplary tapering main body illustrated, for example, in Figs 1-2, the main body distal end diameter Dbd of main body 102eis equal to the main body proximal end diameter DbP.

[0129] In some examples, the main body diameter Db of main body 102eis substantially equal to the diameter of the DCR ostium 20, or is slightly less than the DCR ostium's diameter. In some examples, the main body diameter Db of main body 102eis smaller than the diameter of the DCR ostium 20, such that position locking of the main body 102erelies on the interaction of the inner engagement surface with the nasolacrimal stent, and not necessarily on additional contact interaction between the main body outer surface 122 and the walls of the DCR ostium 20. In such cases, the desired minimal diameter of the DCR ostium 20 can dictate the main body diameter Db, preventing closure of the DCR ostium 20 beyond the main body diameter Db as long as the transnasal insert 100eis retained therein.

[0130] Fig. 12A and 12B cross sectional views of exemplary transnasal insert 100fand 100g, respectively. Each of the transnasal inserts 100fand 100gis an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that while the stent channel 108 of transnasal insert 100 can generally extend along differently shaped paths passing through the main body 102, the stent channel 108 of any of the transnasal inserts 100for 100gis curved between the body proximal end 106 and the body distal end 104.

[0131] For example, in contrast to the exemplary straight or linearly shaped stent channel illustrated, for example, in Figs 1-2, the stent channel 108 of transnasal insert 100fis arched or C-shaped as shown in Fig. 12A. Similarly, an S-shaped stent channel 108 of transnasal insert 100gis illustrated in Fig. 12B. The curved shape of a stent channel 108, such as a C-shaped or S-shaped stent channel 108 in the illustrated examples, is configured to allow its stent channel inner surface 124 to serve as an inner engagement surface, even if the stent channel diameter Dcis larger than the stent diameter Dsand / or if the stent channel inner surface 124 is not necessarily textured to form a rough surface.

[0132] In some examples, the curvature of a curved stent channel 108 is designed not to include regions with a radius of curvature that will prevent the main body 102 from sliding along the nasolacrimal stent 210 when an axial force is actively (e.g., manually) applied thereto. That is to say, when the main body, such as main body 102for 102g, is actively pushed (or pulled) along a tubular portion 212 of a nasolacrimal stent 210, the curved shape of the stent channel 108 will still allow the main body 102 to axially slide along the nasolacrimal stent 210.However, when axial force is no longer applied to the main body 102, the tubular portion 212 extending through the stent channel 108 is forced to assume a curved shape, corresponding to the curvature of the stent channel 108, which causes both surfaces 124 and 230 to engage in a manner that maintains the position of the main body 102 and prevents it from axially sliding along the tubular portion 212.

[0133] In some examples, the main body 102 is stretchable, such that it can transition between an elongated state and a free state, wherein its main body length Lb is longer in the elongated state than in the free state. When the main body 102 is stretched to the elongated state, the stent channel 108 can assume a shape which is more straight or less curved, allowing the main body to axially slide along the nasolacrimal stent 210. When the main body 102 is positioned in the DCR ostium, it may be released to assume its free state, such that the stent channel can revert to its original curved shape, as shown for example in Figs. 12A or 12B, so as to lock the main body 102 in position against the nasolacrimal stent 210. The main body 102 can be forced to assume an elongated state by applying opposite axial forces on the body's distal and proximal ends 104, 106, and / or by applying a radially-inwards directed force against the main body outer surface 122 to squeeze the main body 102 and cause axial elongation thereof.

[0134] It is to be understood that two shapes of a curved stent channel 108 are shown in Figs.12A-12B by way of illustration and not limitation, and that any other curved shape of a stent channel 108 is contemplated, configured to allow axial movement of the main body 102 along a nasolacrimal stent 210 when force is actively applied thereto, and to maintain axial position of the main body 102 relative to the nasolacrimal stent 210 when such force is no longer actively applied to the main body 102.

[0135] While any of the transnasal inserts 100e, 100fand 100gare illustrated in Figs. 11-12B to include a single stent channel 108, it is to be understood that this is shown by way of illustration and not limitation, and that any of the transnasal inserts 100e, 100fand 100gcan similarly include two stent channels 108 as described above with respect to Figs. 7-8, for example.

[0136] While only the main body 102 of any of the transnasal inserts 100e, 100fand 100gis illustrated in Figs. 11-12B, it is to be understood that this is shown by way of illustration and not limitation, and that any of the transnasal inserts 100e, 100fand 100gcan optionally include a locking plate 150 as well, as described above with respect to Figs. 4-5 or 10A, for example.

[0137] While the main body 102 of any of the transnasal inserts 100for 100gis illustrated in Figs. 12A-12B as a tapering or frustoconical body having a non-uniform main body diameter Db, it is to be understood that this is shown by way of illustration and not limitation, and thatany of the main bodies 102for 102gcan be similarly shaped as a cylindrical body having a uniform main body diameter Db, as described above with respect to Fig. 11, for example.

[0138] Fig. 13A is a perspective view of an exemplary transnasal insert 100h. The transnasal insert 100his an exemplary implementation of transnasal insert 100, and thus includes all of the features described for transnasal insert 100 throughout the current disclosure, except that the main body 102hof transnasal insert 100hfurther comprises a retaining slit 140 exposed to the stent channel proximal opening 110, thereby forming a channel between the stent channel proximal opening 110 and the retaining slit 140 through which a tubular portion 212 of a nasolacrimal stent 210 can be passed. In some examples, the retaining slit 140 can be formed along the main body outer surface, as shown in Fig. 13 A, and can extend through any wall of the transnasal insert 100h, such as outer wall 130 and / or inner wall 128 and / or rib 114, such that a channel through which the nasolacrimal stent 210 can be passed extends from the stent channel proximal opening 112 to the retaining slit 140.

[0139] The retaining slit 140 can be formed either instead of, or in addition to, a stent channel distal opening 110 defined at the body distal end 104. In some examples, the main body 102hdoes not include a separate stent channel distal opening 110 at the body distal end 104, in which case the retaining slit 140 serves as the stent channel distal opening, and the stent channel 108 is defined between the stent channel proximal opening 112 and the retaining slit 140. In some examples, the main body 102hincludes both a separate stent channel distal opening 110 at the body distal end 104 and a retaining slit 140, in which case the retaining slit 140 can extend through any walls of the main body main body 102h, such as outer wall 130 and / or inner wall 128, to expose the retaining slit 140 to the channel 108 defined between the opening 110 and 112, and the nasolacrimal stent 210 may be passed, from the from the stent channel proximal opening 112, either towards and through the stent channel distal opening 110 or towards and through the retaining slit 140. Stated otherwise, the retaining slit 140 can be continuous with the stent channel 108, together defining an optional path through which a tubular portion 212 of a nasolacrimal stent 210 can optionally extend.

[0140] In a free state of the retaining slit 140, shown in Fig. 13A, a distance defined between opposite edges 142 of the slit 140 is smaller than the stent diameter Ds. The main body 102hof transnasal insert 100hcan be made of a flexible resilient material, such as Silicone for example, which can be manually squeezed, such as by pressing against opposite side thereof towards each other, forcing the slit edges 142 to extend farther away from each other to allow insertion of the tubular portion 212 of nasolacrimal stent 210 therethrough. Alternatively or additionally, a tool can be used to spread open the retaining slit 140 (distancing the slit edges 142 from eachother) to allow insertion of the tubular portion 212 of nasolacrimal stent 210 therethrough. The slit edges 142 are configured to forcibly press against tubular portion 212 of nasolacrimal stent 210 extending through the slit 140, thereby serving as the inner engagement surface. Thus, when the main body 102his released (i.e., no longer forcibly forcing the slit edges 142 to be actively distanced from each other), the retaining slit 140 resiliently strives to return to its narrower configuration, thereby closing the edges 142 against the tubular portion 212 of nasolacrimal stent 210 at a force that prevents spontaneous slippage of the nasolacrimal stent 210 through the slit 140.

[0141] A nasolacrimal stent 210 of an exemplary transnasal assembly 200his shown in Fig.13B to extend through the transnasal insert 100hof Fig. 13A. In the illustrated example, the tubular portion 212 of nasolacrimal stent 210 is shown to extend from the stent channel proximal opening 112 towards and through the retaining slit 140. The closing force applied by the slit 140 against the tubular portion 212 of nasolacrimal stent 210 is configured to allow the transnasal insert 100hto slide along the tubular portion 212 when actively pushed or pulled, such as by a user applying an axial push or pull forces there-against, yet retain the transnasal insert 100hat a fixed position relative to the nasolacrimal stent 210 when not actively pushed or pulled.

[0142] A retaining slit 140 can be formed so as to have any of a variety of shapes and orientations. An exemplary retaining slit 140his illustrated in Figs. 13A-13B to extend in a circumferential direction along the main body outer surface 122, which can be generally transverse to the axial direction defined between the body proximal 106 and distal 104 end, as illustrated.

[0143] In some examples, the retaining slit 140 is formed along the main body outer surface 122, optionally closer to the body distal end 104 than the body proximal end 106, as illustrated for exemplary retaining slit 140hin Figs. 13A-13B. Nevertheless, it is to be understood that the slit 140 can be formed at other positions, including along the body distal end 104. In some implementations, formation of the retaining slit 140 at the body outer surface 122 instead of the body distal end 104 may be of advantage, as this will force the tubular portion 212 to extend along a non-linear (e.g., curved) path that can improve position retainment when the transnasal insert 100his not actively pushed or pulled. In some examples, a distance defined between opposite edges 142 of the slit 140, in a free state of the slit (e.g., when no stent 210 extends through the slit 140), is smaller than the stent channel diameter Dc.

[0144] It is to be understood that a transnasal insert 100his shown to include a single retaining slit 140 by way of illustration and not limitation, and that, when used as part of a transnasalassembly 200hthat includes a bicanalicular nasolacrimal stent 212, two retaining slits 140 can be formed, such that each of the tubular portions 212a, 212b can extend through a separate retaining slit 140a, 140b. In some examples, a transnasal insert 100hdesigned for use with a bicanalicular nasolacrimal stent 210 can include a combination of a single retaining slit 140, through which one of the tubular portions can extend, and a stent channel proximal opening 112, through which the other tubular portion can extend.

[0145] Fig. 14A is a perspective view of an exemplary transnasal insert 1001, which is similar to any example described herein for transnasal insert 100h, except that a retaining slit 1401of the transnasal insert 1001extends in a vertical direction, which can be generally parallel to the direction of the stent channel 108. In some examples, a retaining slit 140 can vertically extend from the body distal end 104, as shown for retaining slit 1401. Fig. 15 shows the distal end 104 of the transnasal insert 100hof Fig. 14A from an inferior view angle. As shown, the retaining slit 1401is continuous with the stent channel 108, yet may define, in the free state shown in Fig. 15, a width (between opposing slit edges 142) that is smaller than the stent channel diameter Dc.

[0146] Fig. 14B is a perspective view of an exemplary transnasal insert 100’, which is similar to any example described herein for transnasal insert 1001, except that a retaining slit 140’ of the transnasal insert 100’ forms an inverse L- shaped configuration, having a first section 144 extending vertically in a proximal direction from the body distal end 104, and a second section 146 extending in a circumferential direction (e.g., perpendicular to the direction of the first section 144) from a proximal end of the first section.

[0147] Fig. 14C is a perspective view of an exemplary transnasal insert 100k, which is similar to any example described herein for transnasal insert 100’, except that a retaining slit 140kof the transnasal insert 100kfurther includes a third section 148 extending vertically, in a distal direction, from an end of the second section 146 opposite to the first section 144. In some examples, the third section 148 can be parallel to the first section 144. In some examples, the third section 148 can be shorter than the first section 144, so as to terminate proximal to the body distal end 104.

[0148] Figs. 16A, 16B and 16C show exemplary transnasal assemblies 2001, 200] and 200k, respectively, having a nasolacrimal stent 210 extending through corresponding transnasal inserts 1001, 100’ and 100k. For example, a tubular portion 212 of a nasolacrimal stent 210 can be passed through the stent channel 108, and a transnasal insert, such as transnasal insert 1001, can be slid along the tubular portion 212 in a similar manner to that described above with respect to Figs. 3B-3D. When the transnasal insert 1001is at the desired position within theDCR ostium 20, the transnasal insert 1001can be secured over the nasolacrimal stent 210 by pulling the portion of the tubular portion 212 extending from the body distal end 104 sideways, so as to offset it from the stent channel distal opening 110 and into the retaining slit 1401, as illustrated in Fig. 16A.

[0149] When the tubular portion 212 of nasolacrimal stent 210 is positioned inside the retaining slit 1401, it can be further pulled in a proximal direction to position tubular portion 212 at the proximal end of the slit. In some examples, the vertical length of the retaining slit 1401is greater than the stent diameter Ds, such that the tubular portion 212 of the nasolacrimal stent 210 can be secured between slit edges 142 at a position which is distanced from the body distal end 104, to prevent accidental slippage of the nasolacrimal stent 210 out of the retaining slit 1401.

[0150] A similar method can be performed to secure a transnasal insert 1001over the nasolacrimal stent 210, except that, subsequent to pulling the tubular portion 212 to a proximal end of the first section 144 of retaining slit 140J, the tubular portion 212 can be further pulled laterally to an opposite end of the second section 146, as illustrated in Fig. 16B, which can reduce risk of accidental distally-oriented slippage of the tubular portion 212 along and out of the slit.

[0151] Securement of a transnasal insert 100kover the nasolacrimal stent 210 can follow similar steps, except that, subsequent to laterally moving the tubular portion 212 along the second section 146 to an end thereof opposite to the position of the first section 144, the tubular portion 212 can be further slide vertically along the third portion 148 to a distal end thereof, as shown in Fig. 16C, which can further enhance securement while reducing risk of accidental slippage out of the slit.

[0152] Under the regular course of operation and implantation of the transnasal insert 100, scarring may occur in the nasal mucosal lining and / or in the bone tissue. Damage may also occur to other parts of the anatomy (e.g., the lacrimal sac 12, the nasolacrimal duct 18, DCR ostium 20 and / or nasal cavity 22). In order to address such undesired phenomena, drug elution from the transnasal insert 100 to the relevant tissue may be performed, in some examples. Suitable therapeutic agents include anti-inflammatory, anti-scarring (e.g., steroid(s)) and / or antibiotic drugs, which are effective in addressing such damages. Particular drugs may include, but are not limited to: 5 -Fluorouracil, Mitomycin C, dexamethasone, fluticasone and mometasone.

[0153] Thus, in some examples, the transnasal insert 100 is a drug eluting insert. In some examples, at least one drug is deposited onto the transnasal insert 100. In some examples, a pharmaceutical composition is deposited onto the transnasal insert 100.

[0154] In some examples, the pharmaceutical composition is deposited over the main body 102 of the transnasal insert 100. In some examples, the pharmaceutical composition is deposited over an internal surface 123 of the outer wall 130. In some examples, the pharmaceutical composition is deposited over an external surface 125 of the stent channel 108. In some examples, the pharmaceutical composition is deposited over both the internal surface 123 and the external surface 125.

[0155] In some examples, the drug is deposited over the transnasal insert 100 (including any one of the main body 102, internal surface 123 and / or external surface 125) as a liquid composition, such as a solution, emulsion or suspension, and dried thereon to provide the drug eluting insert 100.

[0156] In some examples, the transnasal insert 100 contains a coating, which comprises the pharmaceutical composition. In some examples, the main body 102 contains a coating, which comprises the pharmaceutical composition. In some examples, the internal surface 123 contains a coating, which comprises the pharmaceutical composition. In some examples, the external surface 125 contains a coating, which comprises the pharmaceutical composition.

[0157] In some examples, the pharmaceutical composition comprises at least one drug. In some examples, the drug is selected from the group consisting of: an anti-inflammatory drug, an antiscarring drug, an antibiotic drug and a combination thereof. In some examples, the drug comprises at least one steroid. In some examples, the drug is selected from the group consisting of: 5-Fluorouracil, Mitomycin C, dexamethasone, fluticasone, mometasone and a combination thereof.

[0158] In some examples, the pharmaceutical composition further comprises a matrix. In some examples, the matrix is a biodegradable matrix. The term “biodegradable” as used herein refers to a component which erodes or degrades at its surfaces over time due, at least in part, to contact with substances found in the surrounding tissue fluids, or by cellular action.

[0159] In some examples, the matrix is a biocompatible matrix. The term “biocompatible” as used herein, is intended to describe materials that, upon administration in vivo, do not induce substantial undesirable side effects.

[0160] In some examples, the matrix is a sustained release matrix. The term “sustained” as used herein refers to a pharmaceutical composition which provides prolonged, long or extended release of a therapeutically effective amount of a drug or pharmaceutical composition to the anatomic part(s) as detailed above.

[0161] In particular, the matrix may include a polymer such as, but not limited to, lactic acidbased polymers such as polylactides e.g. poly (D,L-lactide) i.e. PLA; glycolic acid-basedpolymers such as polyglycolides (PGA) e.g. Lactel® from Durect; poly (D,L-lactide-co-glycolide) i.e. PLGA, (Resomer® RG-504, Resomer® RG-502, Resomer® RG-504H, Resomer® RG- 502H, Resomer® RG-504S, Resomer® RG-502S, from Boehringer, Lactel® from Durect); polycaprolactones such as poly(e-caprolactone) i.e. polycaprolactone (PCL e.g. Lactel® from Durect); poly anhydrides; poly(sebacic acid) SA; poly(ricinoleic acid) RA; poly(fumaric acid), FA; poly(fatty acid dimer), FAD; poly(terephthalic acid), TA; poly(isophthalic acid), IPA; poly(p-{ carboxyphenoxy (methane), CPM; poly(p- {carboxyphenoxy} propane), CPP; poly(p-{ carboxyphenoxy }hexane)s CPH; polyamines, polyurethanes, polyesteramides, polyorthoesters {CHDM: cis / trans- cyclohexyl dimethanol, HD:l,6-hexanediol, DETOU: (3,9-diethylidene-2,4,8,10- tetraoxaspiro undecane)}; polydioxanones; poly hydroxybutyrates; poly alkylene oxalates; polyamides; polyesteramides; polyurethanes; poly acetals; poly ketals; polycarbonates; poly orthocarbonates; polysiloxanes; polyphosphazenes; succinates; hyaluronic acid; poly(malic acid); poly(amino acids); poly hydroxy valerates; polyalkylene succinates; polyvinylpyrrolidone; polystyrene; synthetic cellulose esters; polyacrylic acids; polybutyric acid; triblock copolymers (PLGA-PEG-PLGA), triblock copolymers (PEG-PLGA-PEG), poly (N-isopropylacrylamide) (PNIPAAm), poly (ethylene oxide)- poly (propylene oxide)- poly (ethylene oxide) triblock copolymers (PEO-PPO-PEO), poly valeric acid; polyethylene glycol, and mixtures thereof. Each possibility represents a separate embodiment. Additional biodegradable or non-biodegradable polymers that can be used in the depot systems of the present invention include, but are not limited to, polyhydroxyalkylcellulose; chitin; chitosan; polyorthoesters and copolymers, terpolymers; lipids such as cholesterol, lecithin; poly(glutamic acid-co-ethyl glutamate), polyalkaneanhydrides, gelatin, collagen, oxidized cellulose, polyphosphazene, and the like, or mixtures thereof. Each possibility represents a separate example.Some Examples of the Disclosed Implementations

[0162] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0163] Example 1. A transnasal insert comprising:a main body extending along a main body length between a body proximal end and a body distal end, the main body having a main body diameter and defining a main body outer surface, wherein the main body comprises:at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at the main body distal end, the stent channel having a stent channel diameter and defining a stent channel inner surface; andat least one inner engagement surface;wherein the at least one stent channel is configured to allow extension of a tubular portion of a nasolacrimal stent therethrough; andwherein, when the nasolacrimal stent extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the nasolacrimal stent when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the nasolacrimal stent when the transnasal insert is not subjected to a force actively applied thereon.

[0164] Example 2. The transnasal insert of any example herein, particularly example 1, wherein the main body defines a round cross-section at any plane orthogonal to a central longitudinal axis of the main body.

[0165] Example 3. The transnasal insert of any example herein, particularly example 1 or 2, wherein the main body diameter is non-uniform, tapering from a body distal end diameter defined at the body distal end, to a body proximal end diameter defined at the body distal proximal end, wherein the body distal end diameter is greater than the body proximal end diameter.

[0166] Example 4. The transnasal insert of any example herein, particularly any one of examples 1 to 3, wherein the main body diameter is between 4 mm and 15 mm, at least in one cross-sectional position between the body proximal end and the body distal end.

[0167] Example 5. The transnasal insert of any example herein, particularly any one of examples 1 to 3, wherein the main body diameter is between 5 mm and 7 mm, at least in one cross-sectional position between the body proximal end and the body distal end.

[0168] Example 6. The transnasal insert of any example herein, particularly any one of examples 1 to 5, wherein the stent channel diameter is between 0.5 mm and 2 mm.

[0169] Example 7. The transnasal insert of any example herein, particularly any one of examples 1 to 5, wherein the stent channel diameter is between 0.6 mm and 0.7 mm.

[0170] Example 8. The transnasal insert of any example herein, particularly any one of examples 1 to 7, wherein the main body diameter is at least four times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

[0171] Example 9. The transnasal insert of any example herein, particularly any one of examples 1 to 7, wherein the main body diameter is at least five times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

[0172] Example 10. The transnasal insert of any example herein, particularly any one of examples 1 to 9, wherein the main body comprises at least one tear evacuation channel, extending proximally from an evacuation channel distal opening defined at the body distal end.

[0173] Example 11. The transnasal insert of any example herein, particularly example 10, wherein the at least one tear evacuation channel further comprises an evacuation channel proximal opening defined at the body proximal end.

[0174] Example 12. The transnasal insert of any example herein, particularly example 10 or 11, wherein the main body further comprises at least one side window exposed to the at least one tear evacuation channel.

[0175] Example 13. The transnasal insert of any example herein, particularly any one of examples 10 to 12, wherein the at least one tear evacuation channel comprises a plurality of tear evacuation channels, separated from each other by at least one rib.

[0176] Example 14. The transnasal insert of any example herein, particularly any one of examples 1 to 13, wherein the at least one stent channel comprises a single stent channel.

[0177] Example 15. The transnasal insert of any example herein, particularly any one of examples 1 to 14, wherein the at least one stent channel comprises two stent channels.

[0178] Example 16. The transnasal insert of any example herein, particularly any one of examples 1 to 15, wherein the at least one inner engagement surface comprises the stent channel inner surface.

[0179] Example 17. The transnasal insert of any example herein, particularly example 16, wherein the stent channel inner surface comprises a rough surface.

[0180] Example 18. The transnasal insert of any example herein, particularly example 16, wherein the stent channel inner surface is rougher than the main body outer surface.

[0181] Example 19. The transnasal insert of any example herein, particularly example 16 or 17, wherein the at least one stent channel is curved between the stent channel proximal opening and the stent channel distal opening.

[0182] Example 20. The transnasal insert of any example herein, particularly any one of examples 1 to 19, wherein the main body length is between 6 mm and 14 mm.

[0183] Example 21. The transnasal insert of any example herein, particularly any one of examples 1 to 19, wherein the main body length is between 8 mm and 10 mm.

[0184] Example 22. The transnasal insert of any example herein, particularly any one of examples 1 to 21, further comprising a locking plate, wherein the locking plate comprises at least one stent opening configured to allow extension of the tubular portion of the nasolacrimal stent therethrough, and wherein the at least one inner engagement surface comprises a stent opening inner surface defined by the at least one stent opening.

[0185] Example 23. The transnasal insert of any example herein, particularly example 22, wherein the at least one stent opening comprises a single stent opening.

[0186] Example 24. The transnasal insert of any example herein, particularly example 22, wherein the at least one stent opening comprises two stent openings.

[0187] Example 25. The transnasal insert of any example herein, particularly any one of examples 22 to 24, wherein the locking plate further comprises at least one evacuation opening.

[0188] Example 26. The transnasal insert of any example herein, particularly any one of examples 22 to 25, wherein a stent opening diameter defined by the at least one stent opening is smaller than the stent channel diameter.

[0189] Example 27. The transnasal insert of any example herein, particularly any one of examples 22 to 26, wherein the stent opening inner surface is rougher than the stent channel inner surface.

[0190] Example 28. The transnasal insert of any example herein, particularly any one of examples 22 to 27, wherein the locking plate defines a plate thickness which is smaller than 30% of the main body length.

[0191] Example 29. The transnasal insert of any example herein, particularly example 28, wherein the plate thickness is smaller than 20% of the main body length.

[0192] Example 30. The transnasal insert of any example herein, particularly any one of examples 22 to 29, wherein the locking plate is axially movable relative to the main body, when the tubular portion of the nasolacrimal stent extends through both the main body and the locking plate.

[0193] Example 31. The transnasal insert of any example herein, particularly any one of examples 1 to 30, wherein the main body further comprises at least one retaining slit exposed to the stent channel proximal opening, wherein slit edges of the at least one retaining slit are configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

[0194] Example 32. The transnasal insert of any example herein, particularly any one of examples 1 to 30, wherein the stent channel distal opening of the at least one stent channel is aretainment slit comprising slit edges configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

[0195] Example 33. The transnasal insert of any example herein, particularly any one of examples 31 or 32, wherein the at least one retaining slit extends through the main body outer surface.

[0196] Example 34. The transnasal insert of any example herein, particularly any one of examples 31 to 33, wherein the at least one inner engagement surface comprises the slit edges.

[0197] Example 35. The transnasal insert of any example herein, particularly any one of examples 1 to 34, which is a drug eluting transnasal insert and further comprises coating, which comprises a pharmaceutical composition.

[0198] Example 36. The transnasal insert of any example herein, particularly example 35, wherein the pharmaceutical composition comprises at least one drug selected from the group consisting of: an anti-inflammatory drug, an anti-scarring drug, an antibiotic drug and a combination thereof.

[0199] Example 37. The transnasal insert of any example herein, particularly any one of examples 35 to 36, wherein the pharmaceutical composition comprises matrix selected from the group consisting of: a biocompatible matrix, a sustained release matrix, a biodegradable matrix or a combination thereof.

[0200] Example 38. A transnasal assembly comprising:a nasolacrimal stent comprising a tubular portion extending between a stent first end and a stent second end, the tubular portion having a stent diameter and defining an outer stent surface;a transnasal insert comprising:a main body extending along a main body length between a body proximal end and a body distal end, the main body having a main body diameter and defining a main body outer surface, wherein the main body comprises:at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at the main body distal end, the stent channel having a stent channel diameter and defining a stent channel inner surface; andat least one inner engagement surface;wherein the at least one stent channel is configured to allow extension of the tubular portion therethrough; andwherein, when the tubular portion extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the tubular portion when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the tubular portion when the transnasal insert is not subjected to a force actively applied thereon.

[0201] Example 39. The transnasal assembly of any example herein, particularly example 38, wherein the main body diameter is non-uniform, tapering from a body distal end diameter defined at the body distal end, to a body proximal end diameter defined at the body distal proximal end, wherein the body distal end diameter is greater than the body proximal end diameter.

[0202] Example 40. The transnasal assembly of any example herein, particularly example 34 or 35, wherein the main body diameter is between 5 mm and 7 mm., at least in one cross-sectional position between the body proximal end and the body distal end.

[0203] Example 41. The transnasal assembly of any example herein, particularly any one of examples 38 to 40, wherein the stent diameter is between 0.5 mm and 2 mm.

[0204] Example 42. The transnasal assembly of any example herein, particularly any one of examples 38 to 41, wherein the stent channel diameter is within a range of about 50% to about 150% of the stent diameter.

[0205] Example 43. The transnasal assembly of any example herein, particularly any one of examples 38 to 42, wherein the main body diameter is at least four times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

[0206] Example 44. The transnasal assembly of any example herein, particularly any one of examples 38 to 43, wherein the main body further comprises at least one tear evacuation channel, extending proximally from an evacuation channel distal opening defined at the body distal end.

[0207] Example 45. The transnasal assembly of any example herein, particularly example 344, wherein the at least one tear evacuation channel further comprises an evacuation channel proximal opening defined at the body proximal end.

[0208] Example 46. The transnasal assembly of any example herein, particularly example 44 or 45, wherein the main body further comprises at least one side window exposed to the at least one tear evacuation channel.

[0209] Example 47. The transnasal assembly of any example herein, particularly any one of examples 38 to 46, wherein the stent channel inner surface is rougher than the main body outer surface.

[0210] Example 48. The transnasal assembly of any example herein, particularly any one of examples 38 to 47, wherein the nasolacrimal stent is a monocanalicular nasolacrimal stent, and wherein the at least one stent channel comprises a single stent channel.

[0211] Example 49. The transnasal assembly of any example herein, particularly any one of examples 38 to 47, wherein the nasolacrimal stent is a bicanalicular nasolacrimal stent, and wherein the at least one stent channel comprises two stent channels.

[0212] Example 50. The transnasal assembly of any example herein, particularly any one of examples 38 to 49, wherein the at least one inner engagement surface comprises the stent channel inner surface.

[0213] Example 51. The transnasal assembly of any example herein, particularly example 46, wherein the stent channel inner surface is rougher than the stent outer surface.

[0214] Example 52. The transnasal assembly of any example herein, particularly example 50 or 51, wherein the at least one stent channel is curved between the stent channel proximal opening and the stent channel distal opening.

[0215] Example 53. The transnasal assembly of any example herein, particularly any one of examples 38 to 52, wherein the transnasal insert further comprises a locking plate, wherein the locking plate comprises at least one stent opening configured to allow extension of the tubular portion, and wherein the at least one inner engagement surface comprises a stent opening inner surface defined by the at least one stent opening.

[0216] Example 54. The transnasal assembly of any example herein, particularly example 53, wherein the locking plate further comprises at least one evacuation opening.

[0217] Example 55. The transnasal assembly of any example herein, particularly example 53 or 54, wherein a stent opening diameter defined by the at least one stent opening is smaller than the stent diameter.

[0218] Example 56. The transnasal assembly of any example herein, particularly any one of examples 53 to 55, wherein the stent opening inner surface is rougher than the stent channel inner surface.

[0219] Example 57. The transnasal assembly of any example herein, particularly any one of examples 53 to 56, wherein the locking plate is axially movable relative to the main body, when the tubular portion extends through both the main body and the locking plate.

[0220] Example 58. The transnasal assembly of any example herein, particularly any one of examples 38 to 57, wherein the main body further comprises at least one retaining slit exposed to the stent channel proximal opening, wherein slit edges of the at least one retaining slit are configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

[0221] Example 59. The transnasal assembly of any example herein, particularly any one of examples 38 to 57, wherein the stent channel distal opening of the at least one stent channel is a retainment slit comprising slit edges configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

[0222] Example 60. The transnasal assembly of any example herein, particularly any one of examples 38 to 59, wherein the transnasal insert is a drug eluting transnasal insert and further comprises coating, which comprises a pharmaceutical composition.

[0223] Example 61. The transnasal assembly of any example herein, particularly example 60, wherein the pharmaceutical composition comprises at least one drug selected from the group consisting of: an anti-inflammatory drug, an anti-scarring drug, an antibiotic drug and a combination thereof.

[0224] Example 62. The transnasal assembly of any example herein, particularly any one of examples 60 to 61, wherein the pharmaceutical composition comprises matrix selected from the group consisting of: a biocompatible matrix, a sustained release matrix, a biodegradable matrix or a combination thereof.

[0225] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0226] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS1. A transnasal insert comprising:a main body extending along a main body length between a body proximal end and a body distal end, the main body having a main body diameter and defining a main body outer surface, wherein the main body comprises:at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at or proximate to the main body distal end, the stent channel having a stent channel diameter and defining a stent channel inner surface; and at least one inner engagement surface;wherein the at least one stent channel is configured to allow extension of a tubular portion of a nasolacrimal stent therethrough; andwherein, when the nasolacrimal stent extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the nasolacrimal stent when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the nasolacrimal stent when the transnasal insert is not subjected to a force actively applied thereon.

2. The transnasal insert of claim 1, wherein the main body defines a round crosssection at any plane orthogonal to a central longitudinal axis of the main body.

3. The transnasal insert of claim 1 or 2, wherein the main body diameter is non- uniform, tapering from a body distal end diameter defined at the body distal end, to a body proximal end diameter defined at the body distal proximal end, wherein the body distal end diameter is greater than the body proximal end diameter.

4. The transnasal insert of any one of claims 1 to 3, wherein the main body diameter is between 4 mm and 15 mm, at least in one cross-sectional position between the body proximal end and the body distal end.

5. The transnasal insert of any one of claims 1 to 3, wherein the main body diameter is between 5 mm and 7 mm, at least in one cross-sectional position between the body proximal end and the body distal end.

6. The transnasal insert of any one of claims 1 to 5, wherein the stent channel diameter is between 0.5 mm and 2 mm.

7. The transnasal insert of any one of claims 1 to 5, wherein the stent channel diameter is between 0.6 mm and 0.7 mm.

8. The transnasal insert of any one of claims 1 to 7, wherein the main body diameter is at least four times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

9. The transnasal insert of any one of claims 1 to 7, wherein the main body diameter is at least five times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

10. The transnasal insert of any one of claims 1 to 9, wherein the main body comprises at least one tear evacuation channel, extending proximally from an evacuation channel distal opening defined at the body distal end.

11. The transnasal insert of claim 10, wherein the at least one tear evacuation channel further comprises an evacuation channel proximal opening defined at the body proximal end.

12. The transnasal insert of claim 10 or 11, wherein the main body further comprises at least one side window exposed to the at least one tear evacuation channel.

13. The transnasal insert of any one of claims 10 to 12, wherein the at least one tear evacuation channel comprises a plurality of tear evacuation channels, separated from each other by at least one rib.

14. The transnasal insert of any one of claims 1 to 13, wherein the at least one stent channel comprises a single stent channel.

15. The transnasal insert of any one of claims 1 to 14, wherein the at least one stent channel comprises two stent channels.

16. The transnasal insert of any one of claims 1 to 15, wherein the at least one inner engagement surface comprises the stent channel inner surface.

17. The transnasal insert of claim 16, wherein the stent channel inner surface comprises a rough surface.

18. The transnasal insert of claim 16, wherein the stent channel inner surface is rougher than the main body outer surface.

19. The transnasal insert of claim 16 or 17, wherein the at least one stent channel is curved between the stent channel proximal opening and the stent channel distal opening.

20. The transnasal insert of any one of claims 1 to 19, wherein the main body length is between 6 mm and 14 mm.

21. The transnasal insert of any one of claims 1 to 19, wherein the main body length is between 8 mm and 10 mm.

22. The transnasal insert of any one of claims 1 to 21, further comprising a locking plate, wherein the locking plate comprises at least one stent opening configured to allow extension of the tubular portion of the nasolacrimal stent therethrough, and wherein the at least one inner engagement surface comprises a stent opening inner surface defined by the at least one stent opening.

23. The transnasal insert of claim 22, wherein the at least one stent opening comprises a single stent opening.

24. The transnasal insert of claim 22, wherein the at least one stent opening comprises two stent openings.

25. The transnasal insert of any one of claims 22 to 24, wherein the locking plate further comprises at least one evacuation opening.

26. The transnasal insert of any one of claims 22 to 25, wherein a stent opening diameter defined by the at least one stent opening is smaller than the stent channel diameter.

27. The transnasal insert of any one of claims 22 to 26, wherein the stent opening inner surface is rougher than the stent channel inner surface.

28. The transnasal insert of any one of claims 22 to 27, wherein the locking plate defines a plate thickness which is smaller than 30% of the main body length.

29. The transnasal insert of claim 28, wherein the plate thickness is smaller than 20% of the main body length.

30. The transnasal insert of any one of claims 22 to 29, wherein the locking plate is axially movable relative to the main body, when the tubular portion of the nasolacrimal stent extends through both the main body and the locking plate.

31. The transnasal insert of any one of claims 1 to 30, wherein the main body further comprises at least one retaining slit exposed to the stent channel proximal opening, wherein slit edges of the at least one retaining slit are configured topress against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

32. The transnasal insert of any one of claims 1 to 30, wherein the stent channel distal opening of the at least one stent channel is a retainment slit comprising slit edges configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

33. The transnasal insert of claim 31 or 32, wherein the at least one retaining slit extends through the main body outer surface.

34. The transnasal insert of any one of claims 31 to 33, wherein the at least one inner engagement surface comprises the slit edges.

35. The transnasal insert of any one of claims 1 to 34, which is a drug eluting transnasal insert and further comprises coating, which comprises a pharmaceutical composition.

36. The transnasal insert of claim 35, wherein the pharmaceutical composition comprises at least one drug selected from the group consisting of: an antiinflammatory drug, an anti-scarring drug, an antibiotic drug and a combination thereof.

37. The transnasal insert of any one of claims 35 to 36, wherein the pharmaceutical composition comprises matrix selected from the group consisting of: a biocompatible matrix, a sustained release matrix, a biodegradable matrix or a combination thereof.

38. A transnasal assembly comprising:a nasolacrimal stent comprising a tubular portion extending between a stent first end and a stent second end, the tubular portion having a stent diameter and defining an outer stent surface;a transnasal insert comprising:a main body extending along a main body length between a body proximal end and a body distal end, the main body having a main body diameter and defining a main body outer surface, wherein the main body comprises:at least one stent channel extending from a stent channel proximal opening at the main body proximal end to a stent channel distal opening at or proximate to the mainbody distal end, the stent channel having a stent channel diameter and defining a stent channel inner surface; and at least one inner engagement surface;wherein the at least one stent channel is configured to allow extension of the tubular portion therethrough; andwherein, when the tubular portion extends through the transnasal insert, the inner engagement surface is configured to allow axial movement of the transnasal insert along the tubular portion when an axial force is actively applied on the transnasal insert, and to retain axial position relative to the tubular portion when the transnasal insert is not subjected to a force actively applied thereon.

39. The transnasal assembly of claim 38, wherein the main body diameter is non- uniform, tapering from a body distal end diameter defined at the body distal end, to a body proximal end diameter defined at the body distal proximal end, wherein the body distal end diameter is greater than the body proximal end diameter.

40. The transnasal assembly of claim 38 or 39, wherein the main body diameter is between 5 mm and 7 mm, at least in one cross-sectional position between the body proximal end and the body distal end.

41. The transnasal assembly of any one of claims 38 to 40, wherein the stent diameter is between 0.5 mm and 2 mm.

42. The transnasal assembly of any one of claims 38 to 41 , wherein the stent channel diameter is within a range of about 50% to about 150% of the stent diameter.

43. The transnasal assembly of any one of claims 38 to 42, wherein the main body diameter is at least four times as great as the stent channel diameter, at least in one cross-sectional position between the body proximal end and the body distal end.

44. The transnasal assembly of any one of claims 38 to 43, wherein the main body further comprises at least one tear evacuation channel, extending proximally from an evacuation channel distal opening defined at the body distal end.

45. The transnasal assembly of claim 44, wherein the at least one tear evacuation channel further comprises an evacuation channel proximal opening defined at the body proximal end.

46. The transnasal assembly of claim 44 or 45, wherein the main body further comprises at least one side window exposed to the at least one tear evacuation channel.

47. The transnasal assembly of any one of claims 38 to 46, wherein the stent channel inner surface is rougher than the main body outer surface.

48. The transnasal assembly of any one of claims 38 to 47, wherein the nasolacrimal stent is a monocanalicular nasolacrimal stent, and wherein the at least one stent channel comprises a single stent channel.

49. The transnasal assembly of any one of claims 38 to 47, wherein the nasolacrimal stent is a bicanalicular nasolacrimal stent, and wherein the at least one stent channel comprises two stent channels.

50. The transnasal assembly of any one of claims 38 to 49, wherein the at least one inner engagement surface comprises the stent channel inner surface.

51. The transnasal assembly of claim 50, wherein the stent channel inner surface is rougher than the stent outer surface.

52. The transnasal assembly of claim 50 or 51, wherein the at least one stent channel is curved between the stent channel proximal opening and the stent channel distal opening.

53. The transnasal assembly of any one of claims 38 to 52, wherein the transnasal insert further comprises a locking plate, wherein the locking plate comprises at least one stent opening configured to allow extension of the tubular portion, and wherein the at least one inner engagement surface comprises a stent opening inner surface defined by the at least one stent opening.

54. The transnasal assembly of claim 53, wherein the locking plate further comprises at least one evacuation opening.

55. The transnasal assembly of claim 53 or 54, wherein a stent opening diameter defined by the at least one stent opening is smaller than the stent diameter.

56. The transnasal assembly of any one of claims 53 to 55, wherein the stent opening inner surface is rougher than the stent channel inner surface.

57. The transnasal assembly of any one of claims 53 to 56, wherein the locking plate is axially movable relative to the main body, when the tubular portion extends through both the main body and the locking plate.

58. The transnasal assembly of any one of claims 38 to 57, wherein the main body further comprises at least one retaining slit exposed to the stent channelproximal opening, wherein slit edges of the at least one retaining slit are configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

59. The transnasal assembly of any one of claims 38 to 57, wherein the stent channel distal opening of the at least one stent channel is a retainment slit comprising slit edges configured to press against the tubular portion of the nasolacrimal stent when the tubular portion extends through the at least one retaining slit.

60. The transnasal assembly of any one of claims 38 to 59, which is a drug eluting transnasal insert and further comprises coating, which comprises a pharmaceutical composition.

61. The transnasal assembly of claim 60, wherein the pharmaceutical composition comprises at least one drug selected from the group consisting of: an antiinflammatory drug, an anti-scarring drug, an antibiotic drug and a combination thereof.

62. The transnasal assembly of any one of claims 60 to 61, wherein the pharmaceutical composition comprises matrix selected from the group consisting of: a biocompatible matrix, a sustained release matrix, a biodegradable matrix or a combination thereof.

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