Delivery shaft assembly for delivering an implant - Patents.com

Abstract

A delivery shaft assembly (200) is provided having a proximal end (20) and a distal end (40) for delivery of an ocular implant (230), the delivery shaft assembly (200) including a delivery shaft (220) having a lumen (222) configured to hold the implant (230) and an adapter (210) at the proximal end (20) of the delivery shaft (220) configured to attach to an inserter tool (500) for deployment of the implant (230), the delivery shaft assembly (200) including a distal flexible section (244) that is repeatedly bendable, flexible, and curvedly biased in a first plane (60), the delivery shaft (220) including a distal flexible section (244) at least partially disposed in the distal flexible section (244) and extending from a front (52) of the delivery shaft (220). The delivery shaft (220) includes a distal tip section (246) having an atraumatic distal tip, the wall (224) of the tube (250) at the distal flexible section (244) is provided with a plurality of flexible slots (252) that impart bendability, the wall (224) of the tube (250) at the distal tip section (246) includes a pair of notches (270-a, 270-b) that define a limiting flap (272) and an extension body (274), the limiting flap (272) and the extension body (274) cooperating to form a wedge-shaped distal tip, the limiting flap (272) being movable about a living hinge (276) between an open state and a closed state and being biased to the closed state.

Description

[Technical field]

[0001] Provided herein is a delivery shaft assembly for delivery of an ocular implant for implantation in a subject. [Background technology]

[0002] Implants are frequently used to treat conditions where medical treatments have become ineffective or unavailable. Techniques for implant placement typically rely on an inserter tool to temporarily hold the implant and provide an elongated extension for placement at the implantation site, and a mechanism for release from the inserter. Implants can be very small, for example, an implant for the treatment of glaucoma typically has a length of 5 mm and a width of 1 mm. Examples of implants and inserter tools for the treatment of glaucoma are disclosed, for example, in WO 2017 / 108498. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2017 / 108498 Summary of the Invention [Problem to be solved by the invention]

[0004] A problem in the art is how to introduce and deploy an implant with an introducer that is minimally traumatic yet provides sufficient pushing force and flexibility to enter the curved tissue of the eye. Yet another problem is visibility of the implant during surgery; an implant hidden within an introducer requires a solution for visibility under a light microscope before and during deployment. [Means for solving the problem]

[0005] Provided is a delivery shaft assembly (200) having a proximal end (20) and a distal end (40) for delivery of an ocular implant (230); - the delivery shaft assembly (200) includes a delivery shaft (220) having a lumen (222) configured to hold an implant (230) and an adapter (210) at a proximal end (20) of the delivery shaft (220) configured to attach to an inserter tool (500) for deployment of the implant (230); - the delivery shaft (200) includes a distal flexible section (244) that is repeatedly bendable, flexible, and curvedly biased in a first plane (60); - the delivery shaft (200) is provided with an axial longitudinal viewing bore (290) disposed at least partially in the distal flexible section (244) to allow visualization of the implant (230) from the front (52) side of the delivery shaft (220); the delivery shaft (200) includes a distal tip section (246) having an atraumatic distal tip; - the wall (224) of the tube (250) at the distal flexible section (244) is provided with a plurality of flexible slots (252) which provide bending properties; - the wall (224) of the tube (250) at the distal tip section (246) includes a pair of notches (270-a, 270-b) that define a limiting flap (272) and an extension body (274), which cooperate to form a wedge-shaped distal tip, the limiting flap (272) being movable about a living hinge (276) between an open state and a closed state, and which is biased to the closed state.

[0006] The viewing aperture (290) may be defined by an inner edge (292) that is continuous.

[0007] The sight hole (290) can be surrounded by a boundary (294), which is the area of ​​the delivery shaft (220) tube (250) wall around the sight hole (290), where the boundary is continuous.

[0008] The boundary (294) can have two opposing long sides (294a, 294b), with each boundary long side (294a, 294b) at the distal flexible section (244) gradually decreasing in width toward the distal end (40) of the distal flexible section (244).

[0009] The viewing perforations (290) may be continuous and span at least a portion of the distal flexible section (244) and at least a portion of the distal tip section (246).

[0010] The delivery shaft assembly (200) of any one of claims 1 to 5, wherein the plurality of flexible slots (252) are spaced apart at least longitudinally.

[0011] Each flexible slot (252-a, 252-b) of the plurality of flexible slots (252) can have a net slot path (282) that includes one or more inclined portions (284), and a pair of longitudinally adjacent flexible slots (252-a, 252-b) each includes one or more inclined portions (284-a, 284-b), and a plane perpendicular to the central longitudinal axis (a-a') of the tube (250) intersects both longitudinally adjacent flexible slots (284-a, 284-b).

[0012] The radial perimetric integrity may be equal to or greater than 50% at all locations along the longitudinal length of the distal flexible section (244), and the radial perimetric integrity is the ratio of the perimeter of the wall material in a plane perpendicular to the central axis (a-a') of the tube (250) at the distal flexible section (244) compared to the perimeter (pl) of the intact tube (250) in the same plane.

[0013] The net slot path (282) of each flexible slot (252) in the distal flexible section (244) may preferably include two inclined portions (284-a, 284-b) connected at the rear side (54) of the tube (250) by a vertical portion (284-a, 284-b), with each flexible slot (252) in the plurality having the same net slot path (282).

[0014] Each inclined portion (284-a, 284-b) can extend into a vertical portion (284-a, 284-b) toward the front side (52) of the delivery shaft (220), and optionally, each front side (52) vertical portion (284-a, 284-b) terminates in a round opening (254-a, 254-b). The angle of inclination alpha of each inclined portion (284-a, 284-b) can be the same and is between 55 and 65 degrees.

[0015] The distance (sd) between adjacent flexible slots (252) may be the same for multiple flexible slots (252) and is a value in the range of 0.20 to 0.30 mm.

[0016] The plurality of flexible slots (252) in the distal flexible section (244) may be arranged into a set of narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) and a set of wider flexible slots (252-f, 282-f); - the narrower (252-e1, 282-e1, 252-e2, 282-e2) and wider (252-f, 282-f) flexible slots may alternate and be spaced apart longitudinally; - each wider flexible slot (252-f, 282-f) may include one continuous inclined portion (284-f); - each narrower flexible slot (252-e1, 282-e1, 252-e2, 282-e2) can include two continuous sloped portions (284-e1, 284-e2) spaced apart by an intact section (283-e) of the tube (250) wall at the rear side (54) of the tube (250).

[0017] The angle alpha of inclination of each inclined portion (284-e1, 284-e2, 284-f) may be the same and may be between 55 and 65 degrees.

[0018] The curvature of the distal flexible section (244) may include a radius of between 30 and 50 mm. [Brief description of the drawings]

[0019] [Figure 1] 1A-1D are diagrams of a delivery shaft assembly as described herein coupled to an inserter tool, in which in panel A before deployment, an implant is held in the delivery shaft lumen, and in panel B after deployment, the delivery shaft has been withdrawn proximally over the ejection shaft and the implant has been released. [Diagram 2] FIG. 2 is a lateral side view of a delivery shaft assembly as described herein. [Figure 2A] FIG. 3 is a plan view of a portion of the delivery shaft assembly of FIG. 2. [Figure 2B] 3 is a cross-sectional view of the delivery shaft assembly of FIG. 2 taken through plane A-A'. [Figure 2C] 3 is a cross-sectional view of the delivery shaft assembly of FIG. 2 taken through plane B-B'. [Figure 2D] FIG. 3 is a cross-sectional view of the delivery shaft assembly of FIG. 2 showing the circumference and circumference length (pl). [Figure 2E] FIG. 1 is a flat (net) view of a flexible slot showing the slot path length (sl). [Diagram 3] FIG. 1 is a plan view of an implant as described herein. [Figure 3A] FIG. 4 is a cross-sectional view of the implant of FIG. 3 taken through plane CC'. [Figure 4A] FIG. 13 is a detailed view of the angled portion of the flexible slot on the tube wall. [Figure 4B] FIG. 13 is a detailed view of a sloped portion of a flexible slot that includes and terminates in a round opening. [Figure 4C] FIG. 11 is a detailed view of the observation perforation in the tube wall. [Diagram 5]1 is a net representation of the distal flexible section and distal tip section of the delivery shaft / tube wall, illustrating a serpentine configuration of the flexible slot. [Figure 6] 6A-6C are diagrams of net representations of details of portions of the slot path of the net representation of FIG. 5. [Figure 7] FIG. 6 is a net representation of a detail of the angled portion of the slot path of the net representation of FIG. 5 showing angle alpha and slot width (sw). [Figure 8] FIG. 6 is a diagram of a net representation of the two slot paths of FIG. 5 showing spacing. [Figure 9] FIG. 6 is a diagram of a net representation of the two slot paths of FIG. 5 where the paths intersect with a vertical axis. [Figure 10] 1 is a net representation of the distal flexible section and distal tip section of the delivery shaft / tube wall, illustrating a shark-shaped configuration of the flexible slots. [Figure 10A] 11A-11C are diagrams of net representations of details of portions of the slot path of the net representation of FIG. 10. [Figure 10B] FIG. 10B is a detailed view of the flexible slot of FIG. 10A showing the slot path lengths (sl1 and sl2). [Figure 11] FIG. 1 is a plan view (front-back) of the observation perforation. [Figure 12] FIG. 1 is a plan view (front-back) of a bounded observation perforation. [Figure 13] FIG. 13 is a plan view (anterior-posterior) of a viewing fenestrations having a boundary of gradually varying width in the distal direction. [Figure 14] FIG. 13 depicts a flexible slot distal flexible section that gradually increases in length in the distal direction. [Figure 15A] Photograph showing damage to the distal flexible section when the inner edge of the perforation is not continuous and no border is present. [Figure 15B] Photograph showing damage to the distal flexible section when the inner edge of the perforation is not continuous and no border is present. [Figure 16] Photographs showing damage to the distal flexible section when radial circumferential integrity is below threshold. [Figure 17] Radial Circumferential Integrity Revealed. Illustrated planar cross sections (A, B, C) through different axial positions of the distal flexible section of panel D are presented in panels A to C, with panels A1 to C1 showing the corresponding intact sections of the tube wall allowing the determination of the radial circumferential integrity expressed as a length percentage. [Figure 18] FIG. 13 is an isometric view of the distal end of the delivery shaft with the limiting flap in an occluded state. [Figure 19] FIG. 13 is an isometric view of the distal end of the delivery shaft with the limiting flap in an open position. [Figure 20] FIG. 4 is a detailed view of the limiting flap. [Figure 21] FIG. 2 is a detailed view of the extension body. [Figure 22] FIG. 13 is a lateral side view of the delivery shaft showing the tilt angle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Before describing the systems and methods of the present invention, it is to be understood that the invention is not limited to particular systems and methods or combinations, as such systems and methods, and combinations, may take various forms. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the invention is not limited except as by the claims.

[0021] As used herein, the singular forms "a," "an," and "the" include both singular and plural referents unless the context clearly dictates otherwise.

[0022] As used herein, the terms "comprising," "comprises," and "comprised of" are synonymous with "including," "includes," or "containing," and "contains," and are inclusive or open-ended, and do not exclude additional, unrecited members, elements, or method steps. It will be appreciated that as used herein, the terms "comprising," "comprises," and "comprised of" include the terms "consisting of," "consists," and "consists of."

[0023] The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within the respective ranges, as well as the recited endpoints.

[0024] The terms "about" or "approximately" as used herein when referring to measurable values ​​such as parameters, amounts, durations, and the like, are intended to encompass variations of the specified value and therefrom of ±10% or less, preferably ±5% or less, more preferably ±1% or less, and even more preferably ±0.1% or less. It is to be understood that the values ​​contemplated by the modifiers "about" or "approximately" are themselves disclosed as specific and preferred.

[0025] While the terms "one or more" or "at least one," such as one or more or at least one member of a group of members, are themselves explicit, by way of further illustration, these terms include reference to, among other things, any one of these members or any two or more of these members, such as, for example, any of ≧3, ≧4, ≧5, ≧6, or ≧7 of these members, and up to all of these members.

[0026] All references cited herein are incorporated herein by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated by reference.

[0027] Unless otherwise defined, all terms used in disclosing the present invention, including scientific and technical terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As a further guide, definitions of terms are included to better understand the teachings of the present invention.

[0028] In the following passages, different aspects of the invention are defined in more detail. Each aspect so defined may be combined with any other aspect or aspects, unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.

[0029] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described with respect to that embodiment is included in at least one embodiment of the invention. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification may, but do not necessarily, all refer to the same embodiment. Moreover, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments, particular features, structures, or characteristics can be combined in any suitable manner. Moreover, as would be apparent to one of ordinary skill in the art from this disclosure, some embodiments described herein include some features that are not included in other embodiments, and combinations of features of various embodiments are intended to be within the scope of the invention and form various embodiments. For example, in the claims, any of the claimed embodiments can be used in any combination.

[0030] In describing the present invention, reference is made to the accompanying drawings, which form a part of this specification, and which show by way of example only specific embodiments that allow the present invention to be practiced. The bracketed or bold reference numbers accompanying each element are merely illustrative of the element and are not intended to limit the respective element. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

[0031] The terms "distal" or "distal to" and "proximal" or "proximal to" are used throughout this specification and are terms commonly understood in the art to mean closer (proximal) or farther (distal) from the user's (surgeon's) side of the device. Thus, "proximal" or "proximal to" means closer to the user's side and thus further from the subject's (patient's) side. Conversely, "distal" or "distal to" means closer to the subject's side and thus further from the user's side. The term "subject" refers to a human or animal receiving an implant. The term "user" refers to a person (e.g., surgeon, specialist, medical practitioner) performing the implantation.

[0032] The terms "front," "rear," and "lateral" are used throughout this specification and are understood in the art to mean the front side of a subject (front), the back side of a subject (rear), and the side of a subject (lateral). FIG. 2A illustrates the front (52), rear (54), and lateral (56) sides of a cross-section of a delivery shaft (250). The term "lateral" means a direction transverse to (perpendicular to) the longitudinal direction. The term "axial" means the longitudinal direction of the tube (250), e.g., along axis (a-a'). The term "circumferential" means a direction around the exterior of the tube (250), e.g., around perimeter (62).

[0033] The tube (250) can be represented as a "net" (280). A net (280) is a two-dimensional representation of a three-dimensional object known in the art. The net is obtained by unfolding the tube (250) along an imaginary longitudinal cut and flattening it. The longitudinal axis (b-b') of the net (280) is parallel to the central axis (a-a') of the tube (250). An example of a representation of the net (280) is shown in Figures 5 and 10, which show the distal flexible section (244) and the distal tip section (246).

[0034] Provided herein is a delivery shaft assembly (200) for delivery of an ocular implant (230), for example as illustrated in FIG. 2, and a method of manufacturing the same. The delivery shaft assembly (200) has a proximal end (20) and a distal end (40), the delivery shaft assembly (200) including a delivery shaft (220) having a lumen (222) configured to hold the implant (230). The delivery shaft (220) includes a distal flexible section (244) that is repeatedly bendable (60). The distal flexible section (244) is biased into a curve. The delivery shaft (220) is provided with a viewing hole (290) (FIGS. 2A, 2C) that allows visualization of the implant (230) within the delivery shaft (220) from the anterior (52) side by both light reflecting off the implant face and light reflecting through the translucent body of the implant. The implant (230) can be visualized particularly clearly under an optical microscope. The delivery shaft (220) includes a distal tip section (246) having a limiting flap (272) and an extension body (274). The distal flexible section (244) is connected to the adapter (210) through a proximal section (242) of the delivery shaft (220). The proximal section (242) is straight and may or may not include one or more flexible portions. The delivery shaft (220) is formed from a flexible material (i.e., flexible in the normal direction as a sheet of this material) that is formed into a bend-resistant tube (250). The wall (224) of the tube (250) at the distal flexible section (244) is provided with a plurality of flexible slots (252) that provide bendability (60).

[0035] The method of manufacturing the delivery shaft assembly (200) includes providing a bend resistant tube (250) and forming the delivery shaft (220) by adding a number of flexible slots (252) that provide bendability. Other manufacturing steps are described elsewhere herein.

[0036] An advantage of the delivery shaft assembly (200) is that the delivery shaft (220) has axial (proximal to distal) pushability that allows the user to push the delivery shaft (220) across the eye without significant buckling. The use of a bend-resistant tube (250) provides inherent stiffness for pushability. The bendability of the distal flexible section (244) allows the distal tip section (246) to follow the curvature of the eye and reduce the force application caused by pushing into the suprachoroidal, subconjunctival, or scleral lumen. The bendability of the distal flexible section (244) allows for less force to pass a straight, fixed ejection shaft (510) through the lumen (222) at the distal flexible section (244), thus allowing the implant to be deployed. The bendability of the distal flexible section (244) allows for passage of a straight fixed ejection shaft (510) through the curved lumen (222) at the distal flexible section (244), thus allowing the implant to be deployed. The flexibility of the distal flexible section (244) allows for curved, reversible deformation of the distal flexible section (244) that allows the distal tip section (246) to actively follow different radii of curvature of the eye. As the radius of curvature changes during advancement, the distal tip section (246) can reposition to fit the new configuration of the advancing curvature. By faithfully following and adapting to the contours of the tissue, intraoperative bleeding is reduced.

[0037] The benefit of providing a viewing hole (290) is improved visibility of the implant during deployment. Delivery shafts are typically manufactured from a transparent polymeric material that allows the implant to be viewed during insertion. However, because the transparent polymeric material should have good compressibility, the wall thickness becomes such that visibility of the implant or markers thereon is hindered. Increasing the intensity of the light source causes high reflections that further hinder visualization.

[0038] The flexible slots (252) are individual slots in the wall (224) of the tube (250) that provide flexibility to the tube. Details of the flexible slots (252) are shown in Figures 2E, 4A, 6-9, and 10A. The path length (sl) of the slot (Figure 2E) is greater than the width (sw) of the slot (sl) (Figures 7, 10A). The path length (sl) is the distance around the outside of the tube from one closed end of the flexible slot (252) to the other closed end. The flexible slots (252) are preferably closed. In a closed flexible slot (252), the inner edge of the slot forms a continuous path. A closed flexible slot (252) does not open into, for example, the observation perforation (290), thereby allowing the observation perforation (290) to be defined by a continuous inner edge (292). As described elsewhere herein, the continuous inner edge (292) prevents failure of the distal flexible section (244) during deflection forces applied by the ejection shaft (510), resulting in a more resilient delivery shaft.

[0039] A plurality of flexible slots (252) are disposed in the distal flexible section (244). The proximal section (242) may or may not have a plurality of flexible slots (252) disposed therein. If the proximal section (242) has a plurality of flexible slots (252), these slots may be disposed in the flexible portion of the proximal section (242).

[0040] One or both ends of the flexible slots (252) may include and terminate in rounded openings (254) configured to reduce bending forces (see FIG. 4B). The rounded openings (254) may have a circular configuration. Most or all of the flexible slots (252) are at least axially spaced apart.

[0041] Each flexible slot (252) has a slot path that represents the shape of the slot around the tube (250). The slot path may be described by reference to its three-dimensional shape and / or by reference to the appearance of a two-dimensional net (280) of the tube (250). A "net slot path" is the path of a flexible slot (252) represented by the appearance of this path on the net (280) of the wall of the distal flexible section (244). Examples of net representations are shown in Figures 5 and 10.

[0042] Net slot route is - at least one "inclined portion" (e.g., Figs. 6, 7, 284) which is straight and arranged at an incline with respect to the longitudinal axis (b-b') of the net (280); - at least one "vertical part" (e.g., 286, 288 in Fig. 6, Fig. 7) which is straight and arranged perpendicular to the longitudinal axis (b-b') of the net (280); - at least one "parallel section" straight and arranged parallel to the longitudinal axis (b-b') of the net (280); - a round opening (254) at one or both ends, One or more of the aforementioned sections may be joined together (e.g., end to end) to form a continuous net slot path.

[0043] The ocular implant (230) (also known herein as "implant") may be any implantable in a subject (animal, human) using an inserter tool. In particular, the implant (230) may be an implant for the treatment of glaucoma. In particular, the implant (230) may be an intraocular shunt. The implant (230) may be for implantation into a therapeutic target. The therapeutic target may be between the sclera and the choroid, i.e., in the suprachoroidal space, between the conjunctiva and the sclera (subconjunctival space), or in the sclera (scleral space). The implant (230) is an implant as described in WO 2017 / 108498. In particular, the implant may be as described on page 13, line 1 to page 14, line 5, on page 15, line 27 to page 16, line 4, and / or on page 21, line 25 to page 22, line 21 of WO 2017 / 108498, which is incorporated herein by reference.

[0044] An exemplary implant (230) is depicted in Figures 3 and 3A. The implant (230) has a longitudinal configuration. The implant (230) has a proximal end (20) and a distal end (40). The long edges can be straight and parallel. One long edge can be wider (e.g., 8% to 12%) than the opposite end. The long edges can be rounded. The proximal and distal ends can be flat and parallel. The edges of these ends can be rounded. The cross-section (C-C') (Figure 3A) can be longitudinal. The implant (230) can have an oval shape in plan view. The implant (220) can have an oval shape in cross-section. In cross-section, the short sides can be rounded. The implant (230) can be transparent or translucent when hydrated. The implant (230) can be opaque when in a non-hydrated state and can be transparent or translucent when hydrated.

[0045] The implant may be placed with one or more markers (205) provided on the implant to allow the user deploying the shunt or implant to control the depth of the implant within the treatment target while leaving a portion of the implant in the anterior chamber. Placement of the shunt or implant within the eye is performed using an implantation or deployment device. The shunt or implant (200) may have markers (205) around its proximal end (20) so that the location of the markers (205) can be confirmed through the viewing hole (290). It will be readily appreciated that for clearer visibility, other markers (205) may be provided on the implant (200), for example, two markers may be provided on the proximal end (20) of the implant (200).

[0046] Typically, the implant (230) has a longitudinal length (il) between 3 and 9 mm. The implant (230) may have a thickness (it) between 0.3 and 1 mm. The implant (230) may have a width (iw) between 0.5 and 2 mm. In a preferred embodiment, the implant is 5 mm long, 0.6 mm thick, and 1.1±0.2 mm wide. Dimensional indicators are illustrated in Figures 3 and 3A.

[0047] The implant (200) is positioned at the distal end (40) of the delivery shaft (240) prior to implantation. Preferably, the implant is positioned at least partially in the distal flexible section (244). The implant can be positioned exclusively in the distal flexible section (244).

[0048] The implant can be made of a biocompatible material. The biocompatible material can be such as that described in EP-B-2517619, which is incorporated herein by reference. It will be readily appreciated that the implant can be made of other suitable biocompatible materials, such as silicone. The biocompatible material described in EP-B-2517619 is porous and includes a biocompatible polymer scaffold that defines an array of multiple interconnected pores having similar diameters. Typically, the average diameter of the pores is between about 20 μm and about 90 μm, preferably between about 25 μm and about 75 μm. For use in the implants of the present invention, the preferred range is between about 25 μm and about 36 μm.

[0049] The delivery shaft 220 (also referred to herein as tube 250) has a proximal end 20 and a distal end 40. The delivery shaft 220 has a longitudinal lumen 222 disposed therein that opens at both the proximal end 20 and the distal end 40. The lumen 222 has an elongated profile in the transverse (A-A', B-B') cross section (FIGS. 2B, 2C). The lumen 222 can have an oval profile in the transverse (A-A', B-B') cross section (FIGS. 2B, 2C) and can have rounded corners. The cross section of the lumen 222 can have a uniform size and shape along the proximal-distal direction within the flexible portion. The cross section of the lumen 222 can have a uniform size and shape along the proximal-distal direction within the proximal section 242. The cross-section of the lumen (222) can have a uniform size and shape along the proximal-distal direction within the distal flexible section (244). The lumen (222) is configured to hold an implant (230).

[0050] The proximal end (20) of the delivery shaft (220) is attached to the adapter (210). As shown, the proximal end can extend into the body of the adapter to anchor itself and achieve stability.

[0051] The delivery shaft (220) is formed from a bend-resistant tube (250). Bend-resistant means exhibiting little or no bending along the axial direction. Factors that contribute to bend-resistant include wall thickness, lumen size, and material of the tube. Those skilled in the art will readily understand how to make a tube bend-resistant, and as a guide, a tube made from a metal (e.g., pure metal, metal alloy, Nitinol) with a maximum outer width of 0.96 mm and a wall thickness of 0.05 mm is bend-resistant. For example, one or more flexible slots (252) are added to the tube (250) to impart bendability (60) in a first plane (FIG. 2) or to a range of planes including or centered on the first plane.

[0052] The use of metal allows for a reduction in the outer diameter since metal has good manufacturability, i.e., geometric tolerances can be more precisely controlled. A delivery shaft with a reduced diameter will cause less damage to the treatment target. In addition, cyclodissection will also be reduced. Furthermore, the metal tube can be sterilized, for example, by steam and / or by immersion in saline under sterile conditions (e.g., at 121° C. for 30 minutes) and then stored in this saline solution. This reduces manufacturing costs since the delivery shaft (220) can be sterilized without loss of form or function in the same container in which it will be sterilized and stored.

[0053] One or more flexible slots 252 added to the tube 250 impart bendability to the otherwise bend-resistant tube 250. It is contemplated that the material may be optically impermeable. Examples of suitable materials include metals such as Nitinol.

[0054] As described elsewhere herein, the delivery shaft (220) includes a distal flexible section (244). The distal flexible section (244) can have a length between 8% and 90%, preferably between 10% and 35%, of the total length of the exposed delivery shaft (220). The distal flexible section (244) is biased in a curved shape parallel to the first plane (60). The delivery shaft (220) further includes a distal tip section (246).

[0055] The one or more flexible slots (252), observation perforations (290), cutouts (270-a, 270-b), and / or living hinges described elsewhere herein may be introduced into the tube (250) by any method that removes areas of the tube wall (224). Exemplary methods include laser cutting, photochemical etching, deep drawing, conventional cutting techniques such as drilling or milling, high pressure water jet cutting systems, or any suitable available material removal process. Laser cutting is preferably used since it allows for very precise and clean material removal under reasonable economical conditions.

[0056] The delivery shaft (220) and each of the portions and sections are preferably formed from a single piece of tubing (250).

[0057] The delivery shaft (220) may have a length in the axial (a-a') direction of 30 mm to 45 mm, preferably 38 mm to 42 mm.

[0058] This length is measured along the central axis (a-a') from the proximal end of the delivery shaft to the distal end of the distal tip section (246). A few (0.5 mm to 6 mm) millimeters of the proximal end of the delivery shaft (220) are typically embedded within the distal end of the adapter (210). The delivery shaft (240) can have a maximum outer tube width across its transverse side (tw in FIG. 2B) of 0.9 mm to 1.3 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.10±0.04 mm. The delivery shaft (240) can have an outer tube height across its posterior-anterior side (th in FIG. 2B) of 0.5 mm to 0.9 mm, preferably about 0.6 mm to 0.8 mm, preferably 0.70±0.04 mm.

[0059] As described elsewhere herein, the distal flexible section (244) is flexible, repeatedly bendable, and biased to a curve. The curvature is in a posterior (54) direction. The curvature can be in a first plane (60). The curvature can have an arc-shaped path. The curvature may not correspond to the curvature of the eye as described elsewhere herein. The distal flexible section (244) can have a length along the axis (a-a') of 5 mm to 40 mm, preferably 5 mm to 12 mm. The length is measured along the central axis (a-a') from the distal end of the curvature to the proximal end of the distal tip section (246).

[0060] The distal flexible section (244) can have a maximum outer tube width across its transverse side (tw in FIG. 2C) of 0.9 mm to 1.3 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.15±0.1 mm. The delivery shaft (240) can have an outer tube height across its posterior-anterior side (th in FIG. 2B) of 0.5 mm to 0.9 mm, preferably about 0.6 mm to 0.8 mm, more preferably 0.70±0.04 mm.

[0061] The delivery shaft (220) includes a distal flexible section (244) that is repeatedly bendable (60). The distal flexible section (244) is biased into a shape that includes a curve. The bendability of the distal flexible section (244) allows the curved distal flexible section (244) to repeatedly bend or unbend to a greater extent to accommodate the shape of the eye and open into a linear configuration (i.e., become completely straight). The distal flexible section (244) can only bend or unbend in a first plane. The opening into a linear configuration can be achieved by application of an external force, such as to the fixed delivery shaft (510) or the implant (230). The curvature can include a radius of 30 to 50 mm, preferably 34 to 40 mm (e.g., follow a circular arc having this radius).

[0062] The curvature of the distal flexible section (244) also determines the tilt of the distal tip section (246). The tilt is a measure of how far the distal tip section (246) points in the rearward (54) direction (see FIG. 22). The angle of tilt (delta) is the angle between a line (cax) parallel to and tangent to the rearward (54) side of the extension body (246) and also parallel to the central longitudinal axis of the tube (250) and the front edge (52) of the tube (250) at the proximal section (242). Preferably, the tilt (delta) is between 4 and 20 degrees in the curved state.

[0063] Although the above-mentioned range of curvatures does not match the curvature of the eye, it nevertheless improves visualization of the implant as it provides a flatter surface to the microscope compared to a smaller radius of curvature. Furthermore, the larger diameter compared to the diameter of the eye reduces the risk of touching the iris or lens during passage across the eye. The flexibility of the distal flexible section (244) allows the sheath to curve and match the curvature of the eye when it enters the tissue inside (supraciliary space). The above-mentioned range of curvatures provides a natural tendency to bend that facilitates penetration into the supraciliary body without interfering with tissue targeting. This curvature ensures that the distal tip section (246) is oriented in an optimal posterior (54) direction and does not align too far posterior (54) that would cause it to twist when a compressive force is applied.

[0064] As described above, a plurality of flexible slots (252) are disposed in the distal flexible section (244). The number of flexible slots (252) in the distal flexible section (244) can be between 10 and 50. The width (sw) of the flexible slots (252) in FIG. 7 can be between 0.03 mm and 0.12 mm. The distance (sd) between adjacent flexible slots (252) can be between 0.05 mm and 0.30 mm.

[0065] Each flexible slot (252) has a slot path that represents the shape of the slot around the wall (224) of the tube (250). The slot path can be described by reference to its three-dimensional shape and / or by reference to the appearance of a two-dimensional net (280) of the tube (250). The "net slot path" (282) is the path of the flexible slot (252) represented by the appearance of this path on the net (280) of the wall of the distal flexible section (244) as described above. In particular, the tubular wall of the distal flexible section (244) can be represented as a net (280). The net (280) is a two-dimensional representation known in the art for representing three-dimensional objects. The net is obtained by unfolding the distal flexible section (244) along an imaginary longitudinal cut in the tube and flattening it. The longitudinal axis (b-b') of the net (280) is parallel to the central axis of the distal flexible section (244). Examples of net (280) representations are shown in FIGS.

[0066] In the distal flexible section (244), the net slot path is: - at least one "inclined portion" (284, 284-a, 284-b) which is straight and inclined with respect to the longitudinal axis (b-b') of the net (280); - at least one "vertical portion" (286, 288-a, 288-b) which is straight and perpendicular to the longitudinal axis (b-b') of the net (280); - at least one "parallel section" straight and arranged parallel to the longitudinal axis (b-b') of the net (280); One or more of the above sections may be joined together (e.g., end to end) to form a continuous net slot path. Examples of angled sections (284, 284-a, 284-b) and vertical sections (286, 288-a, 288-b) are shown in FIG. 6.

[0067] Preferably, in the distal flexible section (244), the net slot path is straight and includes at least one inclined portion (284, 284-a, 284-b) disposed at an incline with respect to the net (280) longitudinal axis (b-b'); - at least one "vertical portion" (286, 288-a, 288-b) which is straight and perpendicular to the longitudinal axis (b-b') of the net (280); - at least one "parallel section" straight and arranged parallel to the longitudinal axis (b-b') of the net (280); One or more of the above sections are joined together (e.g., end to end) to form a continuous net slot path.

[0068] When a portion of the net slot path (282) is inclined, it means that the central axis (284ax) of the inclined portion (284, 284-a, 284-b) extends to intersect the net (280) longitudinal axis (b-b') at an angle. This is exemplarily depicted in Figures 7 and 10A. The inclination means an angle that is neither 0 degrees, nor 90 degrees, nor 180 degrees. The inclination can have an angle alpha that is between 10 and 80 degrees, preferably between 20 and 70 degrees, preferably between 55 and 65 degrees.

[0069] When a portion of the net slot path (282) is vertical, it means that the central axis (288ax) of the vertical portion (286, 288-a, 288-b) extends and intersects the net (280) longitudinal axis (b-b') at 90 degrees, as exemplarily depicted in FIG.

[0070] A flexible slot (252) can be longitudinally separated from its neighboring flexible slot (252) by a distance (sd). In other words, a net slot path (282-a) can be longitudinally separated from its neighboring net slot path (282-b) by a distance (sd). This is illustratively depicted in FIG. 8. The value of sd can range from 0.20 mm to 0.3 mm.

[0071] The distance (sd) may be the same between a majority of pairs of flexible slots (252) in the distal tip section (246). In other words, the distance (sd) may be the same between a majority of pairs of corresponding net slot paths (282-a, 282-b) in the distal tip section (246).

[0072] The distance (sd) can be the same between every pair of flexible slots (252) in the distal tip section (246). In other words, the distance (sd) can be the same between every pair of net slot paths (282-a, 282-b) in the distal tip section (246).

[0073] In addition to being longitudinally separated, adjacent flexible slots (252) may be circumferentially separated around tube (250). In other words, at least some of the flexible slots (252) may preferably be arranged in two or more longitudinally extending rows (262-a, 262-b). This is illustrated in FIG. 10A. One row (262-a) of flexible slots (252-f, 282-f) may be arranged only in one circular arc, and another row (262-a) of flexible slots (252-f, 282-f) may be arranged only in another circular arc.

[0074] The plurality of flexible slots (252) in the distal flexible section (244) may be arranged in a "serpentine configuration." This serpentine configuration is illustrated in FIG. 5. In the serpentine configuration, the net slot path (282) of each flexible slot (252) in the distal flexible section (244) includes one or more inclined portions (284-a, 284-b), preferably two inclined portions. Flexible slots are illustrated in FIGS. 6-9. When two inclined planes (284-a, 284-b) are present, each of them spans at least a portion (preferably all) of the lateral side (56) of the distal flexible section (244). The inclination angle (alpha) of one inclined portion (284-a) may be 55 to 65 degrees, and the inclination angle (alpha) of the other inclined portion (284-b) may be 55 to 65 degrees. Preferably, both inclination angles are the same. Both inclined portions (284-a, 284-b) can be preferably connected to the rear side (54) of the tube (250) by a vertical portion (286). Each inclined portion (284-a, 284-b) can extend into a vertical portion (288-a, 288-b) towards the front side (52). Each front side (52) vertical portion (288-a, 288-b) can terminate in a round opening (254-a, 254-b). The round opening (254-a, 254-b) can abut the border (294) of the observation hole (258) (FIG. 13A). In the serpentine configuration, each and every flexible slot (252) can have the same path shape or be identical. In the serpentine configuration, the flexible slots (252) are spaced apart in the longitudinal (axial) direction. The distance (sd) between adjacent flexible slots (252) can be the same for multiple flexible slots (252). The value of sd can be in the range of 0.20 to 0.30 mm. The number of flexible slots (252) in the serpentine configuration can be between 25 and 35. The width (sw) of the flexible slots (252) in the serpentine configuration (e.g., FIG. 7) can be 0.03 mm to 0.08 mm. The length (sl) of the flexible slots (252) (e.g., FIG. 2E) can be 2 mm to 3 mm.

[0075] The plurality of flexible slots (252) in the distal flexible section (244) may be arranged in a "shark configuration." The shark configuration is illustrated in FIG. 10. In the shark configuration, there are two main sets of flexible slots (252, 282), narrower (252-e1, 282-e1, 252-e2, 282-e2) and wider (252-f, 282-f). These flexible slots are illustrated in FIG. 10A. The narrower (252-e1, 282-e1, 252-e2, 282-e2) and wider (252-f, 282-f) flexible slots are alternately spaced apart in the longitudinal (axial) direction. The distance (sd) between adjacent longitudinal flexible slots (252) in the shark configuration may be the same for the plurality of flexible slots (252). The value of sd can range from 0.05 mm to 0.30 mm. Figure 10A shows the distance (sd) between adjacent flexible slots (252) (narrower vs. wider), and the value of sd can range from 0.05 mm to 0.1 mm. Figure 10A shows the distance (sd1) between adjacent flexible slots (252) (narrower vs. narrower), and the value of sd1 can range from 0.25 mm to 0.3 mm.

[0076] The width (sw1) of the narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) is smaller than the width of the wider flexible slots (252-f, 282-f). The width (sw1) of the narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) can be 0.03 mm to 0.08 mm. The width (sw2) of the wider flexible slots (252, 252-f, 282-f) can be 0.08 mm to 0.12 mm.

[0077] In the shark configuration, the net slot path (282-e1, 282-e2) of each narrower flexible slot (252-e1, 252-e2) includes two continuous sloped portions (284-e1, 284-e2) spaced apart by an intact section (283-e) of the tube (250) wall at the rear side (54) of the tube (250). Each of the two continuous sloped portions (284-e1, 284-e2) is at least partially disposed on the lateral side (56) of the tube (250). The length (sl1) (e.g., FIG. 10B) of each continuous sloped portion (284-e1, 284-e2) of the narrower flexible slot (252-e1, 252-e2) can be 2 mm to 3 mm.

[0078] In the shark configuration, the net slot path (282-f) of each wider flexible slot (252-f) in the distal flexible section (244) includes one continuous angled portion (284-f) that is at least partially disposed on the rear side (54) of the tube (250). The length (sl2) (e.g., FIG. 10B) of each continuous angled portion (284-f) of the wider flexible slot (252-f) can be 0.7 mm to 1.24 mm.

[0079] The inclination angle (alpha) of each inclined portion (284-e1, 284-e2) of the narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) may be 55 to 65 degrees. The inclination angle (alpha) of the inclined portion (284-f) of the wider flexible slot (252-f) may be 55 to 65 degrees. The angle of each inclined portion (284-e1, 284-e2) of the narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) and the inclination angle of the inclined portion (284-f) of the wider flexible slots (252-f, 282-f) may be the same. The angle alpha is marked on the narrower flexible slots (252-e1, 282-e1) in FIG. 10A.

[0080] The number of narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) in the shark configuration can be between 15 and 25 (one narrower flexible slot includes two inclined portions (252-e1, 282-e1 and 252-e2, 282-e2)). The number of wider flexible slots (252, 252-f, 282-f) in the shark configuration can be between 15 and 25.

[0081] Each end of the narrower flexible slots (252-e1, 282-e1, 252-e2, 282-e2) and / or each wider flexible slot (252-f, 282-f) may or may not include a terminating rounded opening (254). Preferably, each narrower flexible slot (252-e1, 282-e1, 252-e2, 282-e2) has the same slot path. Preferably, each set of wider flexible slots (252-f, 282-f) has the same slot path.

[0082] In a preferred configuration, each pair of adjacent flexible slots (252-a, 252-b) includes one or more angled portions (284-a, 284-b), and a plane perpendicular to the longitudinal axis (a-a') intersects both adjacent flexible slots (252-a, 252-b). In a preferred configuration, each pair of adjacent net slot paths (282-a, 282-b) includes one or more angled portions (284-a, 284-b), and an axis (c-c') perpendicular to the net (280) longitudinal axis (b-b') (net (280) perpendicular axis (c-c')) intersects both net slot paths (282-a, 282-b). This is illustratively depicted in FIG. 9.

[0083] As shown in Figure 9, each pair of adjacent net slot paths (282-a, 282-b) includes one or more angled portions (284-a, 284-b), and an axis (c-c') perpendicular to the net (280) longitudinal axis (b-b') (net (280) vertical axis (c-c')) intersects both net slot paths (282-a, 282-b) at points 290-a1, 290-a2, 290-b1, 290-b2. The ability of the net (280) vertical axis (c-c') to intersect at least two net slot paths is a result of the one or more angled portions present in each net slot path and the distance (sd) between the flexible slots (252) (or between corresponding net slot paths (282-a)).

[0084] The plurality of individual slots (252) in the distal flexible section (244) may be arranged such that their radial circumferential integrity is greater than or equal to a threshold value of 50%, and preferably greater than or equal to 60%. Preferably, the radial circumferential integrity is greater than or equal to the threshold value at every location (i.e., at every location) along the longitudinal length of the distal flexible section (244). The upper limit of the threshold value may be 90%, and preferably 85%. The radial circumferential integrity is the ratio of the perimeter (pl) of the wall material present in a plane perpendicular to the central axis (a-a') of the tube (250) at the distal flexible section (244) compared to the perimeter (pl) of the intact tube (250) in the same plane. FIG. 17 illustrates cross-sections in three different planes (A, B, C) perpendicular to the central axis (a-a') of the tube (250) at the distal flexible section (244) when multiple flexible slots (252) are arranged in a serpentine configuration. Each of the planes A-C shows the wall material (dotted lines) present on a three-dimensional model of the tube (250) at the three different planes (A-C), and panels A1-C1 illustrate two-dimensional cross-sections in the three different planes (A-C) and the radial circumferential integrity determination values ​​expressed as percentages. The radial circumferential integrity varies as a function of longitudinal position and remains equal to or greater than 60%. The radial circumferential integrity is determined by the distance (sd) between adjacent flexible slots (252) and by the slot path, which typically includes at least one angled portion (284, 284-a, 284-b).

[0085] The inventors have found that the integrity of the distal flexible section (244) is maintained during deployment of the implant when the individual slots in the distal flexible section (244) have a radial circumferential integrity equal to or greater than a threshold value at any location (i.e., at all locations) along the longitudinal length of the distal flexible section (244). Before reaching the target tissue, the implant is compressed inside the lumen. During deployment, high friction inhibits passage through the lumen (222). When friction is too high, the flexible slots open too wide, as shown in FIG. 16, resulting in the ejection shaft (510) passing through the wall of the tube (250) and causing mechanical failure. To solve this problem, the radial circumferential integrity needs to be greater than a predetermined threshold value, and it has been found that failure as shown in FIG. 16 appears significantly when there is a location where the radial circumferential integrity falls below the threshold value, for example, when all the flexible slots are positioned perpendicular to the central axis (a-a').

[0086] The plurality of flexible slots (252) in the distal flexible section (244) can be configured to provide a gradation of flexibility in the longitudinal direction. Preferably, the plurality of flexible slots (252) in the distal flexible section (244) are arranged such that the distal flexible section (244) is more flexible toward the distal end (40) than toward the proximal end (20). The gradation of flexibility can be achieved, for example, by using flexible slots (252) with a longer (path) length toward the distal end (40) than toward the proximal end (20). The gradation can be a linear change.

[0087] This is illustrated in Figure 14, which shows a net (280) in the wall of the distal flexible section (244) including several flexible slots (252-p, 252-q) and representative net slot paths (282-p, 282-q). The flexible slots (252-p) / net slot paths (282-p) located at the proximal end (20) have a shorter length (pd is greater than qd) compared to the flexible slots (252-q) / net slot paths (282-q) located at the distal end (40).

[0088] It has been found that when the distal flexible section (244) has a higher flexibility toward the distal end (40) compared to toward the proximal end (20), this results in an improved and more uniform curvature of the distal flexible section (244) during insertion compared to when there is no flexibility gradient, in which case bending will be of lesser curvature at both the distal and proximal ends of the distal flexible section (244), which may cause tissue damage during insertion.

[0089] The distal tip section (246) is an atraumatic wedge-shaped end configured to enter into the treatment target. In particular, the wedge-shaped end is configured to tear tissue, for example, the sclera to the choroid (in the case of the suprachoroidal space), the conjunctiva to the sclera (in the case of the subconjunctival space), or the sclera into the sclera (in the case of the scleral space). The distal tip section (246) is the portion of the delivery shaft (220) where the transverse profile of the tube wall (224) preferably gradually decreases in size in the distal (40) direction. The distal tip section (246) can include a flat-terminated distal end (advancing edge) (251) of the tube (250) that presents an edge rather than a point to the tissue.

[0090] The distal tip section (246) can include a tapered distal end of the tube (250). The tapered distal end of the tube (250) can be formed by introducing a pair of side-by-side (56) open slots (270) into the distal (40) portion of the tube (250), thereby forming a pair of jaws (272, 274), and compressing the jaws (272, 274) together. Examples of distal tip sections (246) having tapered distal ends of the tube (250) are illustrated, for example, in Figures 5, 10, 18, 19, and 20.

[0091] The tube (250) can include a pair of notches (270-a, 270-b) in the distal tip section (246) that define a limiting flap (272) and an extension body (274). The limiting flap (272) can be disposed on the anterior (52) side of the tube (250). The extension body (274) can be disposed on the posterior (54) side of the tube (250). The limiting flap (272) and extension body (274) cooperate to form a wedge-shaped distal tip. The wedge advancement edge (251) provides linear tissue contact as compared to a needle tip. Thus, the distal tip section (246) allows for atraumatic penetration into the subscleral space.

[0092] The limiting flap (272) and the extension body (274) can be positioned diametrically opposite one another. The limiting flap (272) and the extension body (274) can be positioned diametrically opposite one another about the tube (250).

[0093] The notches (270-a, 270-b) extend to the distal end (251) of the tube (250). The notches (270-a, 270-b) are open at the distal end (40). The notches (270-a, 270-b) can be opposite each other. The notches (270-a, 270-b) can be diametrically opposed around the tube (250). Both notches (270-a, 270-b) can be located on the lateral side (56) of the tube (250). The closed ends (253) of the notches (270-a, 270-b) can be in the distal flexible section (244) or in the distal tip section (246), preferably in the distal tip section (246).

[0094] The restriction flap (272) can have anterior (52) and posterior (54) surfaces that are flat over all or most of its length. An exemplary restriction flap (272) is shown in detail in FIG. 20. The lateral (56) edges of the restriction flap (272) toward the proximal portion can include a longitudinal curvature in the posterior direction. The lateral (56) edges of the restriction flap (272) toward the distal portion can be flat. The advancing edge (251) of the distal tip section (246) provides the lateral (56) edges for tearing tissue.

[0095] The proximal end of the limiting flap (272) may include a region having a constant width in the distal direction. The constant width region width (rfw2) may be 0.8 mm to 1 mm. The distal end of the limiting flap (272) preferably tapers distally to the blunt advancing edge (251). The blunt advancing edge (251) of the limiting flap (272) may have a width (rfw1) of 0.3 mm to 0.65 mm. The limiting flap (272) may have a bullet-like profile.

[0096] The restriction flap (272) may be movable between an open state and a closed state. In the open state, the implant (230) may pass through the lumen (222) and out of the delivery shaft for deployment. In the closed state, passage of the implant (230) through the lumen (222) is prevented. An exemplary distal tip section (246) having the restriction flap (272) in a closed state is shown in FIG. 18. An exemplary distal tip section (246) having the restriction flap (272) in an open state is shown in FIG. 19. The restriction flap (272) is biased to the closed state. The restriction flap (272) may be moved from the closed state to the open state by application of an axial force from the implant (230). This force in the distal direction causes the implant to push the restriction flap (272) open from within the lumen (222). In the occluded state, the restriction flap (272) is angled toward the rear (54) to at least partially block exit from the lumen. In the occluded state, the restriction flap (272) is angled toward the central axis (a-a') of the tube (250).

[0097] The restriction flap (272) may be joined to the distal end of the distal flexible section (244) through a living hinge (276). A living hinge is illustrated in FIG. 20. The living hinge is preferably a constricted neck (277) of the tube (250). The constricted neck (277) has a (lateral) width (rfw3) that is less than the width (rfw2) of the restriction flap (272) where the restriction flap (272) joins the constricted neck (277) (rfl1). The (lateral) width (rfw3) across the constricted neck (277) may be 0.5 mm to 0.8 mm. The width (rfw2) of the restriction flap (272) where the restriction flap (272) joins the constricted neck (277) may be 0.8 mm to 1 mm. The axial length (rfl1) of the constriction neck (277) may be between 0.1 mm and 0.3 mm.

[0098] The observation perforations (290) may extend into the restriction flap (272) to allow visualization of the implant during deployment. The portion of the observation perforations (290) in the restriction flap (272) may have a v-shape or a u-shape. The portion of the observation perforations (290) in the restriction flap (272) may have a contour that follows the contour shape of the restriction flap.

[0099] The extension body (274) may have front (52) and rear (54) surfaces that are flat over all or most of its length. An exemplary extension body (274) is shown in FIG. 21. The lateral (56) edges toward the proximal portion of the extension body (274) may include a longitudinal curvature (upward) in the rearward direction. The lateral (56) edges toward the distal portion of the extension body (274) may be flat. The extension body (274) preferably tapers distally toward the blunt forward edge (251). The proximal end of the extension body (274) may or may not include a portion that has a constant width in the distal direction. The extension body (274) may have only one state, which is an open state. The longitudinal axis of the extension body (274) may be parallel to the central longitudinal axis (a-a') of the tube. The extension body (274) may have a bullet-like profile. The proximal end of the elongated body (274) can have a (lateral) width (ebw2) of 0.9 mm to 1.3 mm. The advancing edge (251) of the elongated body (274) can have a (lateral) width (ebw1) of 0.5 mm to 0.85 mm. The advancing edge (251) of the elongated body (274) can have a rounded outer edge to reduce tissue trauma.

[0100] The limiting flap (272) and extension body (274) advantageously provide a blunt ended distal tip section (246) that forms a wedge to mechanically split the treatment tissue during implant deployment. The pair of faces (front and back) provided by the limiting flap (272) and extension body (274) support the treatment tissue over a larger area compared to a conventional needle tip, thereby reducing trauma and bleeding. Additionally, the closed limiting flap (272) retains the implant within the lumen, preventing loss of the implant during storage, shipping, and handling.

[0101] As mentioned above, at least a portion of the delivery shaft (240) can be provided with axial-longitudinal observation perforations (290) (see Figs. 2A, 4C, 5, 10, 11 to 13A, 18, 19). The observation perforations (290) comprise a longitudinal opening (256) in the tube wall (224) on the front (52) side and connect the lumen (222) to the exterior of the tube (250). The observation perforations (290) allow visualization of the implant (230), in particular the markers (205). The observation perforations (290) allow visualization of the implant (230) relative to the treatment target prior to deployment. The observation perforations (290) allow visualization of the deployment of the implant (230). The observation perforations (290) can be located on the front (52) side of the tube (250). The viewing hole 290 may be confined to the front 52 side of the tube 250. The inner edge 292 of the opening 256 forms a closed path.

[0102] The observation perforations (290) may be located at least partially in the distal flexible section (244). The observation perforations (290) preferably extend from the distal flexible section (244) into the distal tip section (246). The observation perforations (290) may or may not extend from the distal flexible section (244) into a portion of the proximal section (242).

[0103] The sight perforations (290) may be defined by a continuous inner edge (292). For example, FIG. 11 shows a continuous inner edge (292). A continuous inner edge means that the edge is not interrupted by one or more flexible slots that would interrupt its continuity. The edge is the space between the inner and outer surfaces of the tube (250). The inner longitudinal edges (292a, 292b) of the sight perforations (290) may in particular be continuous edges. The inner longitudinal edges (292a, 292b) of the sight perforations (290) may in particular be straight edges. The inventors have found that the continuous inner edge (292) of the sight perforations (290) prevents damage to the flexible section (244) when the delivery shaft (220) is withdrawn over the ejection shaft (510) or when the ejection shaft (510) is advanced into the delivery shaft (220). Because the distal flexible section (244) is biased into a curve and the ejection shaft (510) is straight, a deflection force is applied by the ejection shaft (510) to the front side (52) of the distal flexible section (244). It has been found that if the inner edge (292) of the observation perforations (290) is not continuous, the deflection force can cause failure of the distal flexible section (244) (FIGS. 15A and 15B).

[0104] The observation perforation (290) may be defined or surrounded by a boundary (294), which is the area of ​​the wall of the tube (250) of the delivery shaft (220) around the observation perforation (290). By wall, we mean the inner and outer surfaces of the tube (250) and the thickness of the tube material therebetween. The boundary (294) is illustrated, for example, in Figures 12, 13, and 13A. The boundary is continuous or intact, i.e., not interrupted by one or more flexible slots. In the example of Figure 13A, the round opening (254) of the flexible slot (252) abuts the outer longitudinal edge of the boundary within the distal flexible section (244).

[0105] The border has opposing long sides (294a, 294b). Each border long side (294a, 294b) is adjacent to an inner longitudinal edge (292a, 292b) of the observation hole (290). The border long sides (294a, 294b) are joined at both ends by short sides. The border proximal short side is preferably straight. The border distal short side is preferably formed from the limiting flap (272).

[0106] Each boundary longer side (294a, 294b) can have a width (bw) dimension. The width of each boundary longer side (294a, 294b) can be constant longitudinally within the distal flexible section (244), as shown, for example, in FIG. 12. The width of each boundary longer side (294a, 294b) can gradually decrease within the distal flexible section (244) toward its distal end, as shown, for example, in FIG. 13.

[0107] Each boundary edge (294a, 294b) may have a width (bw) that has a minimum value in the range of 0.2 mm to 0.5 mm, preferably 0.25 mm to 0.40 mm, within the distal flexible section (244). Where the width of each boundary edge (294a, 294b) gradually decreases within the distal flexible section (244) towards its distal end, the maximum width (bw1) at the distal flexible section (244) may have a value in the range of 0.3 mm to 0.4 mm, and the minimum width (bw2) at the distal flexible section (244) may have a value in the range of 0.2 mm to 0.3 mm.

[0108] The presence of a boundary reduces the incidence of structural failure of the distal flexible section during deployment of the implant. It has been observed that when the implant is released from the ejection shaft (510) at a predetermined angle and speed, the flexible slot (252) opening into the observation hole (290) may mechanically fail, causing the ejection shaft (510) to break through the observation hole (290) (FIGS. 15A and 15B). This failure is considered an unacceptable risk. This mechanical failure problem has been solved by the presence of a continuous (uninterrupted) boundary (294).

[0109] By having a gradually decreasing boundary width toward the distal end, the flexibility of the distal flexible section (244) at the distal end is gradually increased compared to the proximal end. It has been found that when the distal flexible section (244) is more flexible toward the distal end (40) compared to toward the proximal end (20), this results in an improved, more uniform curvature of the distal flexible section (244) compared to when there is no flexibility gradient. Without the flexibility gradient, bending would be of less curvature at both the distal and proximal ends of the distal flexible section (244), which may cause tissue damage during insertion.

[0110] The observation perforation (290) may span a portion of the cross-sectional circumferential path (62) of the tube (250). The width (ow) of the observation perforation (290) (FIGS. 2C, 4C, 11) may be equal to or greater than 0.3 mm. This width (ow) may be less than 0.5 mm. A size between 0.3 mm and 0.5 mm ensures good visibility of the implant. The width (ow) of the observation perforation (290) is shown in FIGS. 2C, 4C, and 11. The axial or longitudinal length (ol) of the observation perforation (290) may be equal to or greater than 6 mm. This length (ol) may be less than 20 mm. Preferably, the axial or longitudinal length is between 6 mm and 7 mm. The axial or longitudinal length (ol) can be greater than the axial or longitudinal length of the implant to ensure full visualization of the implant and delivery shaft (510). The observation perforations (290) can be sized to retain the implant (230) before and during deployment.

[0111] The delivery shaft assembly 200 further includes an adaptor 210 configured to couple to an inserter tool 500. The implant 230 is disposed at or toward the distal end 40 of the delivery shaft 220. The adaptor 210 is disposed at the proximal end 20 of the delivery shaft 220. The adaptor 210 has a body provided with a receiving space 212 for a portion of the inserter tool 500 and an opening 214 connecting the receiving space 212 to a lumen 222 of the delivery shaft 220 (see FIG. 2). The lumen 222 is configured for passage of an ejection shaft 510 of the inserter tool 500 therethrough. The implant 230 can be ejected from the delivery shaft 220 by actuation of the inserter tool 500, thereby delivering the implant 230 to a treatment target. An exemplary delivery shaft assembly (200) is disclosed in International Publication No. WO 2017 / 108498, which is incorporated by reference herein.

[0112] The proximal section (242) is adjacent to the distal flexible section (244) and extends proximally to the adapter (210). The proximal section (242) can be straight along its entire axial length. The proximal section (242) of the tube (250) can be bend-resistant along its entire axial length. Bending resistance is an inherent attribute of the bend-resistant tube (250). Examples of the tube (250) at the proximal section being bend-resistant along its entire axial length are shown in Figures 5, 6, 7, and 8.

[0113] The proximal section (242) can include one or more flexible segments. The one or more flexible segments can be biased to be straight. The one or more flexible segments can bend in at least a first plane, such as a plane that includes or is centered around the first plane, or the bending is limited to the first plane.

[0114] When one or more flexible segments are present in the proximal section (242), flexibility and bendability are achieved by a plurality of flexible slots (252). The flexible slots are individual transverse or lateral (56) slots (252) in the wall (224) of the tube (250). The flexible slots extend partially around the circumference (62) of the tube wall (224). The transverse length (sl) of the slot is greater than its width. The slot path is preferably straight. Most or all of the flexible slots (252) in the flexible segments are closed slots, i.e., the inner edge of the slot forms a continuous path.

[0115] The flexibility slot (252) is shown in detail in FIG. 4A. The path of the flexibility slot (252) can coincide with a plane parallel to the central axis (a-a') of the tube (250). The flexibility slot includes a round opening (254) at one or both of its ends (see FIG. 4B). The round opening (254) can have a circular configuration.

[0116] Each flexible slot (252) can span a portion of the cross-sectional circumferential path (62) of the tube (250). The cross-sectional circumferential path (also known as the circumferential path) (62) of the tube (250) refers to the outer path of the tube along the cross-section (see FIG. 2D). The flexible slot length (sl) in the flexible portion of the proximal section (242) can be a fraction of the length (pl) of the circumferential path (62) of the tube (250), e.g., 1% to 80%, e.g., 1% to 40%.

[0117] The flexibility slots (252) in the flexible portion may be located only in the rear (54) half or only in the front (52) half of the cross section. Most or all of the flexibility slots (252) in the flexible portion are axially spaced apart. The flexibility slots are preferably arranged in one or more (preferably two) rows extending in a proximal to distal direction.

[0118] Most or all of the flexible slots (252) in the flexible portion can bend at least in a first plane, for example, in a plane that includes or is centered around the first plane, or this bending is limited to the first plane.

[0119] As described above, at least a portion of the proximal section (242) can be provided with a viewing perforation (290). The viewing perforation (290) can be confined to and disposed on the front (52) side of the tube (250). The viewing perforation (290) can be a closed opening (256), i.e., the edges of the opening form a closed path. The viewing perforation (290) can extend distally (40) into the distal flexible section (244).

[0120] The proximal section (242) may have a length in the axial (a-a') direction of 26 mm to 30 mm, measured along the central axis (a-a') from the distal end of the adapter (210) to the proximal end of the distal flexible section (244). The proximal section (242) may have a maximum outer tube width across its transverse side (tw in FIG. 2A) of 0.9 mm to 1.5 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.15±0.1 mm. The delivery shaft (240) may have an outer tube height across its posterior-to-anterior side (th in FIG. 2A) of 0.5 mm to 0.7 mm, preferably about 0.52 mm to 1.24 mm.

[0121] The delivery shaft 220 or tube 250 may be polished. Polishing of the delivery shaft 220 or tube 250 may be accomplished by mechanical polishing, chemical polishing (etching), or a combination of mechanical and chemical polishing. Polishing may include: - Providing smoother curves and rounded edges which prevent crack formation; - Rounding the edges to avoid tissue trauma; - removing burrs to avoid tissue trauma; - Elimination of oxidized surface of Nitinol after molding, - chemical polishing to give the lumen (222) a light reflective finish; Because the hydrated implant (230) is transparent or translucent, light passing through the implant is reflected back towards the user, thereby enhancing the visual contrast between the implant and the one or more markers (205).

[0122] Chemical polishing can be achieved by treatment in an acid bath.

[0123] A protective sheath may be disposed over at least the delivery shaft 220 and, optionally, the adapter 210. The sheath may be made from a heat shrinkable polymer, such as a polyester heat shrink film.

[0124] Provided below is a method of manufacturing the delivery shaft assembly described herein. The delivery shaft (220) and each of the portions and sections are preferably formed from one piece of tubing (250). The flexible slots (252), sight holes (290), notches (270-a, 270-b), and / or living hinges (276) are introduced into the tube (250) by any method for removing tubing material from the tube wall (224). Exemplary methods include laser cutting, photochemical etching, deep drawing, conventional cutting techniques such as drilling or milling, high pressure water jet cutting systems, or any suitable material removal process available. Laser cutting is preferably used since it allows for very precise and clean material removal under reasonable economical conditions.

[0125] The method of manufacturing a delivery shaft assembly described herein includes: - introducing a plurality of flexible slots (252) in the distal flexible section (244) by removal of tube material from the tube wall (224) to impart flexibility and bendability; - introducing an observation hole (290) by removal of tube material from the tube wall (224), - introducing other features, including flexible slots (252), notches (270-a, 270-b), and / or living hinges (276) in the proximal section (242), if present, by removing tube material from the tube wall (224); - introducing an oval transverse profile in the tube (250) of the delivery shaft (220), which can be accomplished by any number of methods, such as by inserting a mandrel having an oval transverse profile into the lumen (222) of the cylindrical tube (150) and applying radial pressure at elevated temperature (e.g., 500 degrees C); - introducing a curvature in the distal flexible section (244), which can be done by any number of methods, such as molding at high temperature (e.g., 500°C); - inducing the bias of the limiting flap (272) into the closed state, which can be done by any number of methods, such as molding the limiting flap (272) into the closed state at high temperature (e.g. 500°C); - polishing the cut tubes, said polishing can be carried out by any number of methods, such as mechanical polishing and / or chemical polishing (etching), - attachment to the adapter (210), which can be done by any number of methods, such as using an adhesive; The present invention includes one or more of the above, preferably all of the above.

[0126] The inserter tool (500) is provided with an ejection shaft (510) configured to be received by the lumen (222) of the delivery shaft assembly. The ejection shaft (510) can be configured to abut the implant (230). Movement of the delivery shaft (220) and / or the ejection shaft (510) causes release of the implant (230) from the lumen (222) (see panels A and B of FIG. 1). The ejection shaft (510) is preferably straight. The ejection shaft (510) de-curves the curvedly biased distal flexible section (244).

[0127] Advancement of the ejection shaft (510) in the distal (40) direction can apply a force to the implant (230), ejecting the implant (230) from the lumen (220) of the shaft assembly. Alternatively, or in addition, withdrawal of the delivery shaft (220) relative to the fixed ejection shaft (510) ejects the implant (230) from the lumen (220) of the shaft assembly.

[0128] The inserter tool (500) is provided with an adapter coupling (520) configured to couple with the adapter (210). The coupling between the adapter coupling (520) and the adapter (210) can be releasable or non-releasable. A non-releasable coupling can be achieved, for example, by providing a flexible member on one of the adapter coupling (520) or the adapter (210) and a reciprocating stop member on the other, where during coupling the flexible member slides over the stop member in one direction and the parts (520, 210) and the flexible member engage the stop member in the other sliding direction to prevent release of the parts (520, 210). This mechanism is similar to the unidirectional movement of a ratchet mechanism.

[0129] The adapter coupling 520 can be slidable relative to the fixed ejection shaft 510 when the implant is released by withdrawal of the delivery shaft 220 relative to the fixed ejection shaft 510. The slidable adapter coupling 520 has a ready position and a deployed position. In the ready position, the slidable adapter coupling 520 places the adapter 210 and the delivery shaft lumen 222 in a distal-most position. The fixed ejection shaft 510 can abut the implant 230 and the delivery shaft lumen 222 can cover the implant 230. In the deployed position, the slidable adapter coupling 520 places the adapter 210 and the delivery shaft lumen 222 in a proximal-most position. The ejection shaft (510) abuts against the implant (230) and the delivery shaft lumen (222) is withdrawn in a proximal (20) direction, releasing the implant (230). When the implant is ejected by advancement of the ejection shaft (510), the ejection shaft (510), which is slidable relative to the fixed adapter coupling (520), applies a distal ejection force to the implant (230), ejecting the implant (230) from the lumen (222).

[0130] An example of a portion of an inserter tool (500) is provided in FIG. 1, which illustrates an inserter housing or housing (550) (fixed) and a slidable adapter coupling (520) configured to engage the adapter (210) of the delivery shaft assembly (200). The ejection shaft (510) is disposed in a fixed relationship with the housing (550). In this example, the adapter coupling (520) is slidable relative to the housing (550) and is shown in a ready position, but it is recognized that there are other configurations of the inserter tool (500) in which, for example, the adapter coupling (520) is disposed in a fixed relationship with the inserter tool housing and the ejection shaft (510) is slidable. Panel A shows the inserter tool (500) in a ready position, with the adapter coupling (520) in a distal (40) position. In the ready position, the implant (230) is held within the delivery shaft lumen (222). Panel B shows the inserter tool (500) in a deployed position with the adapter coupling (520) retracted to a proximal (20) position. In the deployed position, the delivery shaft is retracted, thereby releasing the implant (230) from the delivery shaft lumen (222). An exemplary inserter tool (500) is disclosed in WO 2017 / 108498, which is incorporated by reference herein.

[0131] Implantation of the implant (230) can proceed using, for example, an ab interno method. The implant (230) is held within the delivery shaft lumen (222) of the delivery shaft (220) mounted on the ejection shaft (510) of the inserter tool (500). The distal tip section (246) can be used to facilitate penetration of the delivery shaft (220) through the cornea. It will be readily appreciated that the distal tip section (246) does not need to provide an incision into the cornea, which can be made by a separate tool, and the delivery shaft (220) inserted into the incision created. The delivery shaft (220) is guided into and across the anterior chamber of the eyeball to the iridocorneal angle and into the subscleral space. The distal tip section (246) allows for atraumatic penetration into the subscleral space. The delivery shaft (220) is retracted relative to the ejection shaft (510) of the inserter tool (500), leaving the implant (230) in place within the subscleral space.

[0132] The inserter tool (500) can be an implantation device as described in WO 2017 / 108498. The delivery shaft assembly (200) can include a snap-on connection element or adapter (210) as described in WO 2017 / 108498. For example, WO 2017 / 108498 describes the implantation device (500) and the delivery shaft assembly (200) on pages 26 to 33, which are incorporated herein by reference.

Claims

1. A delivery shaft assembly (200) having a proximal end (20) and a distal end (40) for delivery of an ocular implant (230), comprising: a delivery shaft assembly (200) comprising a delivery shaft (220) having a lumen (222) configured to hold the implant (230) and an adapter (210) at the proximal end (20) of the delivery shaft (220) configured to attach to an inserter tool (500) for deployment of the implant (230); the delivery shaft (220) includes a distal flexible section (244) that is repeatedly bendable, flexible, and curvedly biased in a first plane (60); the delivery shaft (220) is provided with axial longitudinal viewing bores (290) at least partially disposed in the distal flexible section (244) to allow visualization of the implant (230) from the front (52) side of the delivery shaft (220); the delivery shaft (220) includes a distal tip section (246) having an atraumatic distal tip; the wall (224) of the tube (250) in the distal flexible section (244) is provided with a plurality of flexible slots (252) that provide bendability; the wall (224) of the tube (250) at the distal tip section (246) includes a pair of notches (270-a, 270-b) that define a limiting flap (272) and an extension body (274), the limiting flap (272) and the extension body (274) cooperating to form a wedge-shaped distal tip, the limiting flap (272) being movable about a living hinge (276) between an open state and a closed state and being biased to the closed state; A delivery shaft assembly (200).

2. The delivery shaft assembly (200) of claim 1, wherein the sight hole (290) is defined by an inner edge (292) that is continuous.

3. the sight hole (290) is surrounded by a boundary (294), which is a region of the wall of the tube (250) of the delivery shaft (220) around the sight hole (290); the boundary is continuous; The delivery shaft assembly (200) of claim 1 or 2.

4. 4. The delivery shaft assembly (200) of claim 3, wherein the boundary (294) has two opposing long sides (294a, 294b), and each long boundary side (294a, 294b) in the distal flexible section (244) gradually decreases in width toward the distal end (40) of the distal flexible section (244).

5. 3. The delivery shaft assembly (200) of claim 1 or 2, wherein the observation perforations (290) are continuous and span at least a portion of the distal flexible section (244) and at least a portion of the distal tip section (246).

6. The delivery shaft assembly (200) of any one of claims 1 to 2, wherein the plurality of flexible slots (252) are spaced apart at least longitudinally.

7. 3. The delivery shaft assembly (200) of claim 1 or 2, wherein each flexible slot (252-a, 252-b) of the plurality of flexible slots (252) has a net slot path (282) including one or more inclined portions (284), each of a pair of longitudinally adjacent flexible slots (252-a, 252-b) includes one or more inclined portions (284-a, 284-b), and a plane perpendicular to a central longitudinal axis (a-a') of the tube (250) intersects both longitudinally adjacent flexible slots (252-a, 252-b).

8. a radial circumferential integrity of greater than or equal to 50% at all locations along the longitudinal length of said distal flexible section (244); The radial circumferential integrity is the ratio of the perimeter of the wall material in the distal flexible section (244) in a plane perpendicular to the central axis (a-a') of the tube (250) compared to the perimeter (p1) of the intact tube (250) in the same plane. The delivery shaft assembly (200) of claim 1 or 2.

9. 8. The delivery shaft assembly (200) of claim 7, wherein the net slot path (282) of each flexible slot (252) in the distal flexible section (244) includes two inclined portions (284-a, 284-b) connected on the rear side (54) of the tube (250), and each flexible slot (252) of the plurality has the same net slot path (282).

10. 10. The delivery shaft assembly (200) of claim 9, wherein each inclined portion (284-a, 284-b) extends into a vertical portion (284-a, 284-b) toward the front side (52) of the delivery shaft (220), and optionally, each front side (52) vertical portion (284-a, 284-b) terminates in a round opening (254-a, 254-b).

11. The delivery shaft assembly (200) of claim 9, wherein the angle alpha of inclination of each inclined portion (284-a, 284-b) is the same and is between 55 and 65 degrees.

12. 10. The delivery shaft assembly (200) of claim 9, wherein the distance (sd) between adjacent flexible slots (252) is the same for all flexible slots (252) in the plurality and is a value in the range of 0.20 to 0.30 mm.

13. The plurality of flexible slots (252) in the distal flexible section (244) are narrower flexible slots (252-e 1 , 282-e 1 , 252-e 2 , 282-e 2 ) and a set of wider flexible slots (252-f, 282-f), Narrower than the above (252-e 1 , 282-e 1 , 252-e 2 , 282-e 2 ) and wider (252-f, 282-f) flexible slots alternate and are longitudinally spaced apart; each wider flexible slot (252-f, 282-f) includes one continuous sloped portion (284-f); Each narrower flexible slot (252-e 1 , 282-e 1 , 252-e 2 , 282-e 2 ) at the rear side (54) of said tube (250) are two continuous inclined portions (284-e) spaced apart by an intact section (283-e) of the wall of the tube (250). 1 , 284-e 2 ), including The delivery shaft assembly (200) of claim 7.

14. Each slope part (284-e 1 , 284-e 2 14. The delivery shaft assembly (200) of claim 13, wherein the angles alpha of the inclinations of the shafts (284-f) are the same and are between 55 and 65 degrees.

15. The delivery shaft assembly (200) of claim 1 or 2, wherein the curvature of the distal flexible section (244) comprises a radius of between 30 and 50 mm.

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