Delivery shaft assembly for delivering an implant

Abstract

A delivery shaft assembly (200) is provided for delivering an ocular implant (230) and has a proximal end (20) and a distal end (40), wherein: the delivery shaft assembly (200) includes: a delivery shaft (220) having an end cavity (222) configured to hold the implant (230); and an adapter (210) located at the proximal end (20) of the delivery shaft (220) and configured to attach to an inserter tool (500) for deploying the implant (230); the delivery shaft (220) includes a distal compliant segment (244) capable of repeated bending and conforming to the ocular implant. The delivery shaft (220) is compliant and biased into a curved portion in the first plane (60); the delivery shaft (220) is provided with an axial longitudinal viewing window (258) to allow viewing 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 a damage-resistant tip; the delivery shaft (220) is formed of a compliant material that is formed into a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) and / or flexible openings (256-b) in the distal compliant section (244) to impart flexibility.

Description

Technical Field

[0001] This article describes a delivery axis assembly for delivering ocular implants to implant them into a subject. Background Technology

[0002] Implants are commonly used to treat diseases that are unresponsive to or unavailable drug treatments. The techniques used to place implants typically rely on an inserter tool, which temporarily holds the implant and provides an elongated extension for placement at the implantation site and a mechanism for withdrawal. Implants can be very small; for example, implants for treating glaucoma typically have a length of 5 mm and a width of 1 mm. An example of an implant and inserter tool for treating glaucoma is disclosed, for instance, in WO 2017 / 108498.

[0003] One problem in this field is how to introduce and deploy implants using a minimally invasive introducer while providing sufficient thrust and flexibility to access the curved tissues of the eye. Another problem is the visibility of the implant during surgery; implants hidden within the introducer require solutions that allow them to be visible under an optical microscope before and during deployment. Summary of the Invention

[0004] This document provides a delivery axis assembly (200) for delivering an ocular implant (230), the delivery axis assembly (200) having a proximal end (20) and a distal end (40), wherein:

[0005] - The delivery shaft assembly (200) includes: a delivery shaft (220) having a lumen (222) configured to hold an implant (230); and an adapter (210) located at the proximal end (20) of the delivery shaft (220) and configured to attach to an inserter tool (500) to deploy the implant (230);

[0006] - The delivery shaft (220) includes a distal compliant segment (244) which is repeatedly flexible, compliant and biased as a flexural portion in a first plane (60);

[0007] - The delivery axis (220) is provided with an axial longitudinal viewing window (258) to allow viewing of the implant (230) from the front (52) side of the delivery axis (220);

[0008] - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip;

[0009] - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) and / or flexible openings (256-b) in the distal compliant section (244) to impart flexibility.

[0010] The compliant material can be an opaque metal, preferably nitinol.

[0011] Multiple flexible grooves (252) and / or flexible openings (256-b) can be provided by removing material from the wall (224) of the tube (250), preferably by laser cutting.

[0012] The delivery shaft (220) may also include a proximal segment (242) adjacent to the compliant distal portion (244), wherein:

[0013] - The tube (250) includes one or more compliant portions (248) in the proximal segment (242), or

[0014] - The total axial length of the proximal segment (242) is non-compliant and straight.

[0015] Each compliant portion (248) may include one or more flexible grooves (252).

[0016] The observation window (258) can be an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250).

[0017] The flexible grooves (252) in the distal compliant section (244) can be arranged in a row (262) which is confined within the rear (54) half of the transverse cross section of the tube (250);

[0018] The wall (224) of the tube (250) may be further provided with a plurality of flexible openings (256-b) in the distal compliant section (244), the flexible openings (256-b) being referred to as support openings (257, 256-b), the plurality of flexible openings (256-b) further giving the tube (250) a partially support-like appearance and flexibility; and

[0019] - Multiple bracket openings (257, 256-b) can be configured as two axial rows (260', 260"), each row positioned on either side of the observation window (258) and positioned between rows (262) of the flexible groove (252).

[0020] Most or all bracket openings (257, 256-b) have the same shape, and / or

[0021] - Most bracket openings (257, 256-b) or all bracket openings (257, 256-b) have the same size, and / or

[0022] - Most or all bracket openings (257, 256-b) have triangular, rhomboid, pentagonal, hexagonal or polygonal shapes.

[0023] The tube (250) may include a pair of axial-longitudinal opening slots (270-a, 270-b) extending to the distal end end (251) of the tube (250) in the distal tip section (246), the pair of axial-longitudinal opening slots (270-a, 270-b) defining a pair of limiting claws (272, 274);

[0024] - One gripper is a front (52) positioned gripper (272), and the other gripper is a rear (54) positioned gripper (274);

[0025] - One or both of the front jaws (272) and the rear jaws (274) are closed at an angle toward the central axis (a-a') of the tube (250); and

[0026] One or both of the front gripper (272) and the rear gripper (274) are provided with a plurality of radial slits, the plurality of radial slits forming a movable hinge (276).

[0027] The closed ends of the axial-longitudinal open slots (270-a, 270-b) are located in the distal tip section (246).

[0028] The tube (250) may include a pair of axial-longitudinal opening slots (280-a, 280-b) disposed on the front (52) side and rear (54) side of the tube (250) and extending to the distal end (251) of the tube (250) defining a pair of retaining arms (282, 284), the pair of retaining arms (282, 284) configured to retain the implant (230) prior to deployment; and

[0029] The observation window (258) is one of the axial-longitudinal opening slots (280-a) provided on the front (52) side of the tube (250).

[0030] The closed end (253) of the axial-longitudinal open slot (280-a, 280-b) can be located in the proximal end section (242) or in the distal compliant section (244).

[0031] The tube (250) at the distal end (246) can be beveled.

[0032] A method for manufacturing a delivery shaft assembly (200) as described herein is also provided, the method comprising:

[0033] - Provides a delivery shaft (220) having a proximal end (20) and a distal end (20), the delivery shaft 200 including a lumen (222) configured for holding an implant (230), wherein the delivery shaft (220) is made of a compliant material formed as a bend-resistant tube (250);

[0034] - A bend is introduced at the distal end of the delivery shaft (220) to form a distal compliant segment (244);

[0035] - A damage-resistant portion is formed in the distal tip section (246);

[0036] - By removing tube material from the wall (224) of the tube, a plurality of flexible grooves (252) and / or flexible openings (256-b) are introduced in the distal compliant section (244) to impart compliance and bendability in the first plane (60);

[0037] - An observation window (258) is introduced by removing tube material from the tube wall (224).

[0038] Axial-longitudinal openings (270-a, 270-b, 280-a, 280-b) and / or movable hinges (276) can be introduced by removing tube material from the tube wall (224). Attached Figure Description

[0039] Figure 1 This is a view of the delivery axis assembly attached to the inserter tool as described herein. In image A before deployment, the implant is held within the lumen of the delivery axis. In image B after deployment, the delivery axis is retracted proximally on the discharge axis, and the implant is released.

[0040] Figure 2 This is a side view of the delivery axis assembly as described in this article.

[0041] Figure 2A yes Figure 2 The transverse cross-sectional view of the delivery shaft assembly passing through plane A-A'.

[0042] Figure 2B yes Figure 2 The transverse cross-sectional view of the delivery shaft assembly passing through plane B-B'.

[0043] Figure 2C yes Figure 2 The delivery shaft assembly is indicated by a transverse cross-sectional view of the perimeter and perimeter length (pl).

[0044] Figure 2Dyes Figure 2 A transverse cross-sectional view of the delivery shaft assembly passing through a flexible groove, indicating the groove length (sl).

[0045] Figure 3 This is a plan view of the implant described in this article.

[0046] Figure 3A yes Figure 3 A transverse cross-sectional view of the implant passing through the plane C-C'.

[0047] Figure 4 A shows details of the flexible grooves on the pipe wall.

[0048] Figure 4 B shows details of a flexible groove with spacers on the pipe wall.

[0049] Figure 4 C shows details of the flexible openings with spacers in the pipe wall.

[0050] Figure 4 D shows details of the observation window on the tube wall.

[0051] Figure 5 This is a side view of an exemplary delivery shaft assembly having both an observation window and a flexible groove in the distal compliant section, as described herein.

[0052] Figure 5A yes Figure 5 A plan view of a portion of the delivery shaft assembly.

[0053] Figure 5B It shows Figure 5 The delivery shaft assembly also has a flexible groove in the proximal section.

[0054] Figure 6 This is a side view of an exemplary delivery shaft assembly, as described herein, in which observation windows and flexible grooves are provided in both the proximal and distal compliant sections, and a flexible opening (bracket opening) is provided in the distal compliant section.

[0055] Figure 6A yes Figure 6 A plan view of a portion of the delivery shaft assembly.

[0056] Figure 6B It shows Figure 6 The delivery shaft assembly also has a flexible groove in the proximal section.

[0057] Figure 6C yes Figure 6 The delivery shaft assembly is marked with a transverse cross-sectional view of the row of flexible slots, flexible openings (bracket openings), and observation windows.

[0058] Figure 7 This is a side view of an exemplary delivery shaft assembly, as described herein, in which observation windows and flexible grooves are provided in both the proximal and distal compliant sections, and a retaining arm is provided.

[0059] Figure 7A yes Figure 7 A plan view of a portion of the delivery shaft assembly.

[0060] Figure 7B yes Figure 7 A plan view of a portion of the delivery shaft assembly, wherein the axial-longitudinal opening slot is provided with two transverse supports and an axial support.

[0061] Figure 7C It shows Figure 7 The delivery shaft assembly also has a flexible groove in the proximal section.

[0062] Figure 8 This is a side view of an exemplary delivery shaft assembly, as described herein, in which observation windows and flexible grooves are provided in both the proximal and distal compliant sections, and a pair of limiting grippers are provided.

[0063] Figure 8A yes Figure 8 A plan view of a portion of the delivery shaft assembly.

[0064] Figure 8B It shows Figure 8 The delivery shaft assembly also has a flexible groove in the proximal section. Detailed Implementation

[0065] Before describing the systems and methods of the present invention, it should be understood that the invention is not limited to the specific systems, methods, or combinations described, as such systems, methods, and combinations can certainly vary. It should also be understood that the terminology used herein is not intended to be limiting, as the scope of the invention will be limited only by the appended claims.

[0066] Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” used herein include both singular and plural indicators.

[0067] As used herein, the terms “including,” “comprising,” or “containing,” “including,” and are inclusive or open-ended, and do not exclude additional, non-enumerated components, elements, or method steps. It will be understood that the terms “including,” “comprising,” and “consisting of,” as used herein, include the terms “composed of,” “consisting of,” and “containing.”

[0068] The range of values ​​referenced by an endpoint includes all numbers and fractions contained within the corresponding range, as well as the endpoint being referenced.

[0069] As used herein, the terms “about” or “approximately” when referring to measurable values ​​such as parameters, quantities, durations, etc., are intended to include variations of + / -10% or less, preferably + / -5% or less, more preferably + / -1% or less, and even more preferably + / -0.1% or less, provided such variations are suitable for implementation in the disclosed invention. It should be understood that the values ​​referred to by the modifier “about” or “approximately” are themselves specifically and preferably disclosed.

[0070] Although the terms “one or more” or “at least one”, such as one or more components or at least one component in a group of components, are self-explanatory, by way of further example, the terms specifically include reference to any one of the components, or any two or more components of the components, such as, for example, any ≥3, ≥4, ≥5, ≥6 or ≥7 components of the components and up to all of the components.

[0071] All references cited in this specification are incorporated herein by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated by reference.

[0072] Unless otherwise specified, all terms used in disclosing this invention, including technical and scientific terms, have the meanings commonly understood by one of ordinary skill in the art to which this invention pertains. Further guidance, including terminology definitions, is provided to better understand the teachings of this invention.

[0073] The various aspects of the invention are defined in more detail in the following paragraphs. Unless expressly indicated to the contrary, each aspect so defined may be combined with any other one or more aspects. In particular, any feature indicated as preferred or advantageous may be combined with any other one or more features indicated as preferred or advantageous.

[0074] Throughout this specification, references to "one embodiment" or "implementation" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in different places throughout this specification do not necessarily refer to the same embodiment, but may refer to the same embodiment. Furthermore, as will be apparent to those skilled in the art based on this disclosure, particular features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. Moreover, as will be understood by those skilled in the art, although some embodiments described herein include certain features but not others included in other embodiments, combinations of features from different embodiments are intended to be within the scope of the invention and form different embodiments. For example, in the appended claims, any claimed embodiment can be used in any combination.

[0075] In the present description of this invention, reference is made to the accompanying drawings, which form part of the invention, and are illustrated only in the drawings by way of specific embodiments in which the invention may be practiced. The bracketed or bold reference numerals affixed to the various elements are illustrative by way of example only and are not intended to limit the elements. It should be understood that other embodiments may be used and structural or logical changes may be made without departing from the scope of the invention. Therefore, the following detailed description should not be construed as limiting, and the scope of the invention is defined by the appended claims.

[0076] The terms “distal” or “distal of…” and “proximal” or “proximal of…” are used throughout this specification and are generally understood in the art to refer to the side of the device facing (proximal) or away from (distal) the user (practitioner). Therefore, “proximal” or “proximal of…” means the side facing the user, and thus, the side away from the subject (patient). Conversely, “distal” or “distal of…” means the side facing the subject, and thus, the side away from the user. The term “subject” refers to a person or animal receiving the implant. The term “user” refers to a person performing the implantation (e.g., surgeon, specialist, practitioner).

[0077] The terms “anterior,” “posterior,” and “lateral” are used throughout the specification and are terms commonly understood in the art to refer to the frontal side (anterior), the rearal side (posterior), and the two sides (lateral) of the subject. Figure 2AThe front (52), rear (54), and lateral (56) sides are indicated on the cross-section of the delivery shaft (250). The term "transverse" refers to a direction transverse to (e.g., perpendicular to) the longitudinal direction. The term "axial" refers to the longitudinal direction of the tube (250), such as along the axis (a-a'). The term "peripheral" refers to a direction surrounding the outside of the tube (250), such as around the periphery (62).

[0078] This article provides, for example, a method Figure 2 The present invention illustrates a delivery shaft assembly (200) for delivering an ocular implant (230) and a method for manufacturing the delivery shaft assembly (200). The delivery shaft assembly (200) has a proximal end (20) and a distal end (40) and includes a delivery shaft (220) having an end cavity (222) configured to hold the implant (230).

[0079] The delivery shaft (220) includes a distal compliant segment (244) capable of repeated bending (60). The distal compliant segment (244) is biased into a bent portion. The bent portion of the distal compliant segment (244) may be located in a first plane, i.e., planar. The bendability of the distal compliant segment (244) allows the bent distal compliant segment (244) to unbend and open into a linear form. The compliance of the distal compliant segment (244) allows the distal compliant segment (244) to repeatedly open into a linear form and return to a bent form. The distal compliant segment (244) may be bent at least in the first plane. Opening into a linear form can be achieved by applying an external force, such as by applying an external force through a fixed discharge shaft (510).

[0080] The delivery axis (220) is provided with an observation window (258). Figure 2C This allows the implant (230) within the delivery shaft (220) to be viewed from the front (52) side by reflected light (e.g., under a microscope). The delivery shaft (220) includes a distal tip segment (246) having a reduced lateral profile in the distal (40) direction. A distal compliant segment (244) is connected to the adapter (210) via a proximal segment (242) of the delivery shaft (220). The proximal segment (242) is straight and may include one or more compliant portions (248) or may not include one or more compliant portions (248). The delivery shaft (220) is formed of a compliant material that is formed as a bend-resistant tube (250). The wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) and / or flexible openings (256-b) in the compliant portion (240) to impart bendability (60).

[0081] A method for manufacturing a delivery shaft assembly (200) includes providing a bend-resistant tube (250) and forming the delivery shaft (220) by adding a plurality of flexible grooves (252) and / or flexible openings (257) to impart bendability. Bending of the distal compliant segment (244) is achieved in various ways, for example, by supporting the inner cavity (e.g., using a flexible helical spring) and bending the tube (250) along its axial length using, for example, a tube bender. Bending can be performed at ambient temperature, or the bendability of the tube can be temporarily improved by heat treatment.

[0082] The advantage of the delivery shaft assembly (200) is that the delivery shaft (220) has pushability in the axial (proximal to distal) direction, allowing the delivery shaft (220) to be pushed by the user without significant bending across the eye. The use of the bend-resistant tube (250) provides natural stiffness for pushability. The curvature of the distal compliant segment (244) allows the distal tip segment (246) to follow the curvature of the eye, thereby reducing the force applied by pushing into the suprachoroidal space, subconjunctival space, or intrascleral space. The flexibility of the distal compliant segment (244) allows a straight and fixed discharge shaft (510) to pass through the lumen (222) in the distal compliant segment (244) with reduced force, thus enabling implant deployment. The flexibility of the distal compliant segment (244) allows a straight and fixed discharge axis (510) to pass through the curved cavity (222) within the distal compliant segment (244), thus enabling implant deployment. The compliance of the distal compliant segment (244) allows for reversible deformation of the curve within the distal compliant segment (244), enabling the distal tip segment (246) to actively conform to different radii of curvature of the eye. Because the radius of curvature changes during advancement, the advancing distal tip segment (246) can reposition itself to meet new forms of advancement curvature. Close conformation and adjustment to tissue form reduces intraoperative bleeding.

[0083] The advantage of providing a viewing window (258) is improved visibility of the implant during deployment. Delivery axes are typically made of a transparent polymeric material that allows the implant to be seen during insertion. However, the wall thickness of the transparent polymeric material reduces the visibility of the implant or markings on it because good maneuverability is required. Increasing the intensity of the light source leads to increased reflection, which further reduces visual effectiveness.

[0084] Flexible grooves are discrete transverse or lateral (56) grooves (252) in the wall (224) of the tube (250) that impart flexibility to the tube. Details of the flexible grooves (252) are as follows: Figure 4 As shown in A, the flexible groove (252) extends partially around the periphery (62) of the tube wall (224). The lateral length (sl) of the groove is greater than its width (see Figure 1). Figure 2DThe groove path is preferably straight around the periphery (62) of the tube wall (224). The path of the flexible groove (252) may coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible groove (252) may terminate at a spacer (254) configured to reduce bending forces (see...). Figure 4 In B), the spacer (254) can be circular.

[0085] In a closed flexible groove (252), the inner edges of the groove form a continuous path. In an open flexible groove (252), the inner edges of the groove form a discontinuous path; the open end of the flexible groove (252) can lead to, for example, an observation window (258). Most or all of the flexible grooves (252) are spaced apart in the axial direction.

[0086] The flexible grooves (252) are preferably arranged in one or more (e.g., preferably two) rows (262) extending in a proximal-to-distal direction. Four or more flexible grooves (252) may be present in a single row. One or more rows of flexible grooves (252) may be located only within the rear (54) half of the transverse cross-section, or a row of flexible grooves (252) may be located only within the front (52) half of the transverse cross-section. By confining the flexible grooves to these regions, bending can be confined to a first plane, or to a series of planes including or centered on the first plane.

[0087] The flexible opening (257) is a discrete closed opening (256-b) in the wall (224) of the tube (250) that enhances the flexibility of the tube (250). The flexible opening diameter (257) is a closed opening—the inner edge of which forms a continuous path.

[0088] Flexible openings can be support openings (257, 256-b). Support openings give the tube a partially support-like appearance. Details of support openings (257, 256-b) are available in... Figure 4 As shown in C. Support openings (257, 256-b) are provided in the tube wall of the delivery shaft assembly, for example in... Figure 6 and Figure 6AAs shown in the diagram. The stent openings (257, 256-b) are arranged in one or more rows (262) extending in a proximal-distal direction. The stent openings (257, 256-b) are spaced apart in the axial and peripheral directions. Most or all of the stent openings (257, 256-b) may have the same shape and / or size. Most or all of the stent openings (257, 256-b) may have triangular, rhomboid, pentagonal, hexagonal, or polygonal shapes. The stent openings (257, 256-b) provide lateral visibility of the implant in addition to the flexibility of the reinforcing tube (250).

[0089] An ocular implant (230) (also referred to herein as an “implant”) can be any implantable device capable of being placed in a subject (animal, human) using an inserter tool. In particular, the implant (230) can be an implant for the treatment of glaucoma. In particular, the implant (230) can be an intraocular shunt. The implant (230) can be implanted into a therapeutic target. The therapeutic target can be located between the sclera and choroid, i.e., the suprachoroidal space, or between the conjunctiva and sclera (subconjunctival space) or within the sclera (intrascleral space). The implant (230) is an implant as described in WO2017 / 108498. In particular, the implant may be as described in WO 2017 / 108498, page 13, line 1 to page 14, line 5, and / or page 15, line 27 to page 16, line 4, and / or page 21, line 25 to page 22, line 21, which is incorporated herein by reference.

[0090] Exemplary implant (230) in Figure 3 and Figure 3A The implant (230) is depicted in the figure. The implant (230) has a longitudinal form. The implant (230) has a proximal end (20) and a distal end (40). The long edges may be straight and parallel. The long edges may be rounded. The proximal and distal ends may be planar and parallel. The edges of the ends may be rounded. Transverse cross-section (C-C') Figure 3A The implant (220) can be elongated. The implant (220) can be elliptical in a plan view. The implant (220) can also be elliptical in a cross-sectional view.

[0091] The implant may have one or more markings (205) thereon, allowing the user deploying the shunt or implant to control the depth of the implant in the treatment target, such that a portion of the implant remains in the anterior chamber. The shunt or implant is placed intraocularly using an implantation or deployment device. The shunt or implant (200) may have markings (205) located in its proximal end (20), allowing its position to be seen through an observation window (258). It will be readily understood that additional markings (2) may be provided on the implant (200) for better visibility; for example, two markings may be provided at the proximal end (20) of the implant (200).

[0092] Typically, the implant (230) has a longitudinal length (il) between 3 mm and 9 mm. The implant (230) may have a thickness (it) between 0.3 mm and 1 mm. The implant (230) may have a width (iw) between 0.5 mm and 2 mm. In a preferred embodiment, the implant is 5 mm long, 0.6 mm thick, and 1.1 mm wide. Size indicators are provided. Figure 3 and Figure 3A As shown in the image.

[0093] The implant (200) is located in the distal end (40) of the delivery shaft (240) prior to implantation. Preferably, the implant (200) is at least partially located in the distal compliance segment (244). The implant (200) may be located only in the distal compliance segment (244).

[0094] The implant can be made of a biocompatible material. The biocompatible material can be, for example, those described in EP-B-2517619, which is incorporated herein by reference. It will be readily understood that the implant can be made of other suitable biocompatible materials, such as silicone. In EP-B-2517619, the biocompatible material described is porous and includes a biocompatible polymer scaffold defining an array of interconnecting pores with 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 the implant used in this invention, a preferred range is between about 25 μm and about 36 μm.

[0095] The delivery shaft (220) has a proximal end (20) and a distal end (40). The delivery shaft (220) is provided with an internal longitudinal cavity (222) open at both the proximal end (20) and the distal end (40). The cavity (222) has a longitudinal profile in a transverse (A-A', B-B') cross-section. Figure 2A , Figure 2BThe inner cavity (222) can have an elliptical profile in the transverse (A-A', B-B') cross-section. Figure 2A The corners may be rounded. The transverse cross-section of the lumen (222) may have a consistent size and shape in the compliant portion (240) along the proximal-distal direction. The transverse cross-section of the lumen (222) may have a consistent size and shape in the proximal segment (242) along the proximal-distal direction. The transverse cross-section of the lumen (222) may have a uniform size and shape in the distal compliant segment (244) along the proximal to distal direction. The lumen (222) is configured to hold the implant (230).

[0096] The proximal end (20) of the delivery shaft (220) is attached to the adapter (210). As shown in the figures, the proximal end may extend into the body of the adapter to secure it and maintain stability.

[0097] The delivery shaft (220) is formed of a bend-resistant tube (250). Bending resistance refers to exhibiting minimal or no bending along the axial direction. Factors affecting bending resistance include the tube's wall thickness, the tube's internal dimensions, and the tube's material. Those skilled in the art will readily understand how to make a tube bend-resistant, and as a guideline, a tube made of 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. The properties of the tube material can include an elastic modulus below 310 kpsi. One or more flexible grooves (252) and / or flexible openings (257) are added to the tube (250) to impart bendability, for example, in a first plane (60), or in a series of planes including or centered on the first plane.

[0098] Compared to those bent tubes formed of polymers, the use of metal bent tubes allows for a reduction in the outer diameter of the delivery shaft (220). A smaller diameter delivery shaft introduces less damage to the treatment target. Furthermore, ciliary body detachment gaps are reduced. Additionally, the metal bent tube can be sterilized, for example, under sterile conditions (e.g., 121 degrees Celsius for 30 minutes) by steam and / or immersion in saline solution and then stored in a saline solution. This reduces manufacturing costs because the delivery shaft (220) can be sterilized in the same container where it will be sterilized and stored without loss of shape or function.

[0099] The bending-resistant tube (250) is made of a compliant material. Compliance means that a leaf spring formed from this material can be flexibly deflected from its original shape by the application of a mechanical displacement force and return to its original shape when the mechanical force is released. Materials with leaf spring properties are compliant. When the material is rolled into a tube, the tube is no longer compliant, i.e., the tube is bending-resistant. One or more flexible grooves (252) and / or one or more flexible openings (257) added to the tube (250) also impart bending properties to the tube (250) and, consequently, compliant properties. The material may be opaque. Examples of suitable materials include metals such as nitinol.

[0100] As mentioned elsewhere, the delivery shaft (220) includes a distal compliant segment (244). The length of the distal compliant segment (244) may be 15% to 35% of the total exposed length of the delivery shaft (220). The distal compliant segment (244) is biased as a bend parallel to the first plane (60). The delivery shaft (220) also includes a distal tip segment (246).

[0101] One or more flexible slots (252) and / or one or more flexible openings (257) and / or observation windows (258) (along with axial-longitudinal opening slots (270-a, 270-b, 280-a, 280-b) and / or movable hinges described elsewhere herein) may be introduced into the tube (250) by any method for removing the area of ​​the tube wall (224). Exemplary methods include laser cutting, photochemical etching, deep pressing, conventional cutting techniques such as drilling or milling, high-pressure water jet cutting systems, or any suitable material removal process available. Laser cutting is preferred because it allows for very accurate and clean material removal under reasonable economic conditions.

[0102] The delivery shaft (220) and the various sections and parts are preferably formed by a single tube (250).

[0103] The length of the delivery shaft (220) in the axial (a-a') direction can be 35 mm to 40 mm, preferably 34 mm to 37 mm.

[0104] The length is measured along the central axis (a-a') from the proximal terminal end of the delivery shaft to the distal end of the distal tip section (246). A few millimeters (0.5 mm to 4 mm) of the proximal end of the delivery shaft (220) are typically embedded in the distal end of the adapter (210). The delivery shaft (240) may have a maximum outer tube width across the lateral portion of 0.9 mm to 1.3 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.15 mm ± 0.1 mm. Figure 2AThe delivery shaft (240) may have an outer tube height spanning from the rear to the front portion of 0.5 mm to 0.7 mm, preferably about 0.52 mm to 1.24 mm. Figure 2A (tw in the middle).

[0105] As mentioned elsewhere in this text, the distal compliant segment (244) is compliant, capable of repeated bending, and biased into a curved portion. The curved portion is in the posterior (54) direction. The curved portion may be located in the first plane (60). The curved portion may have a path as a circular segment. The curved portion conforms to the curvature of the eye.

[0106] The distal compliant segment (244) may have a length of 9 mm to 12 mm along the axial direction (a-a'). The length is measured along the central axis (a-a') from the distal end of the bend to the proximal end of the distal tip segment (246).

[0107] The distal compliant section (244) may have a maximum outer tube width across the lateral side of 0.9 mm to 1.3 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.15 mm ± 0.1 mm. Figure 2A The delivery shaft (240) may have an outer tube height spanning the rear-to-front portion of 0.5 mm to 0.8 mm, preferably about 0.52 mm to 0.62 mm. Figure 2A (th in the middle).

[0108] The compliance and flexibility of the distal compliant section (244) can be achieved by a plurality of flexible grooves (252). The flexible grooves are discrete transverse or lateral (56) grooves (252) in the wall (224) of the tube (250). The flexible grooves extend partially around the wall (224) of the tube. The transverse length (sl) of the groove is greater than its width. The groove path is preferably straight. Most or all of the flexible grooves (252) in the distal compliant section (244) can be closed, i.e., the inner edges of the grooves form a continuous path (e.g., Figure 5 and Figure 6 Most or all of the flexible grooves (252) in the distal compliant segment (244) may be open, i.e., the inner edges of the grooves open outward into the observation window (258) (e.g., Figure 7 and Figure 8 ).

[0109] The path of the flexible groove (252) may coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible groove (252) may terminate at a spacer (254), which is configured to reduce the force required to bend the distal compliant section (244) (see [reference]). Figure 4B). The spacer (254) may be circular.

[0110] Each flexible groove (252) in the distal compliant section (244) may span a portion of the peripheral path (62) of the transverse cross-section of the tube (250) (see Figure 2D The peripheral path (also known as the perimeter path) of the transverse cross section of the pipe (250) (62) refers to the outer path of the pipe along the transverse cross section (see...). Figure 2C The length (sl) of the flexible groove in the distal compliant section (244) can be a portion of the length (pl) of the peripheral path (62) of the tube (250), and can range from 1% to 80%. The length (sl) of the flexible groove in the axial region including the observation window (258) is smaller than that in the axial region excluding the observation window (258).

[0111] The flexible grooves (252) in the distal compliant section (244) may be located only in the rear (54) half or the front half of the transverse cross section. Each flexible groove (252) in the distal compliant section (244) is spaced apart in the axial direction. The flexible grooves are preferably arranged in one or more (e.g., preferably two) rows (262) extending in the proximal to distal direction.

[0112] Most or all of the flexible grooves (252) in the distal compliant segment (244) may be configured to impart flexibility to the distal compliant segment (244). The flexible grooves (252) may be arranged such that there is flexibility at least in a first plane, for example, flexibility in a series of planes including or centered on the first plane, or flexibility limited to the first plane.

[0113] The compliance and flexibility of the distal compliant section (244) can be further enhanced by a plurality of discrete closed flexible openings (256-b) in the wall (224) of the tube (250), which are referred to as support openings (257). These openings (256-b) together give the tube (250) a partially support-like appearance. Details of the support openings (257, 256-b) are described in... Figure 4 As shown in C. The support openings (257, 256-b) located in the tube wall of the delivery shaft assembly are... Figure 6 and Figure 6A As shown in the image.

[0114] Most or all of the support openings (257, 256-b) in the distal compliant section (244) are spaced apart at least axially. Most or all of the support openings (257, 256-b) are limited to one or more (preferably two) axial rows (260', 260”) (see See Figure 6C The axial rows (260', 260") are positioned (peripherally) between the observation windows (258) and a row of flexible grooves (252).

[0115] Axial rows (260', 260”) may span a portion (260', 260”) of the peripheral path (62) of the transverse cross section of the tube (250) (see) Figure 6C The peripheral path (also known as the perimeter path) of the transverse cross section of the pipe (250) (62) refers to the outer path of the pipe along the transverse cross section (see...). Figure 2C Each axial row (260', 260”) may be a portion of the length (pl) of the peripheral path (62) of the tube (250), for example, less than 10%.

[0116] The bracket openings (257, 256-b) in the distal compliant section (244) may be located only within the lateral (556) portion of the transverse cross section. Most or all of the bracket openings (257, 256-b) in the distal compliant section (244) are spaced apart at least in the axial direction.

[0117] Most or all of the bracket openings (257, 256-b) may be regularly spaced. Most or all of the bracket openings (257, 256-b) may have the same shape and / or size. Most or all of the bracket openings (257, 256-b) may have triangular, rhomboid, pentagonal, hexagonal, or polygonal shapes.

[0118] Most or all of the support openings (257, 256-b) in the distal compliant section (244) can be configured to further impart flexibility to the distal compliant section (244).

[0119] The presence of the stent opening (257) improves lateral visualization of the implant during surgery, thereby allowing the implant to be safely and "accurately" released in one go.

[0120] As described below, at least a portion of the distal compliant section (244) may be provided with an observation window (258). The observation window (258) may be limited to and provided on the front (52) side of the tube (250). The observation window (258) may be a closed opening (256-a), i.e., the edge of the opening forms a closed path, or an axial-longitudinal opening groove (280-a). The observation window (258) may extend into the proximal section (242) in the proximal direction (20) or may not extend into the proximal section (242) in the proximal direction (20). The observation window (258) may extend into the distal tip section (246) in the distal direction (30) or may not extend into the distal tip section (246) in the distal direction (30).

[0121] The distal tip segment (246) is a damage-resistant tip portion, configured to access the treatment target. Specifically, the distal tip segment (246) is configured to pry open tissues, such as the sclera and choroid (suprachoroidal space), or the conjunctiva and sclera (subconjunctival space), or the intrascleral space (intrascleral space). The distal tip segment (246) is part of a delivery axis (220) in which the dimensions of the transverse profile of the tube wall (224) decrease, preferably gradually, in the distal (40) direction. This reduction in size may be due to the beveled tip (e.g., Figure 2 , Figure 5 , Figure 5B , Figure 6 , Figure 6B , Figure 7 , Figure 7C This is caused by, or by the narrowing of the wall (250) (e.g.) Figure 8B Caused by ).

[0122] The distal tip segment (246) may include a beveled distal end (251) of the tube (250). The beveled distal end of the tube (250) may be formed by a diagonal cut at the distal end of the tube (250). An example of a distal tip segment (246) having a beveled distal end cut is, for example, in... Figure 2 , Figure 5 , Figure 6 , Figure 7 The slope exposes the front (52) side of the inner cavity (222) of the tube (250).

[0123] The distal tip section (246) may include a gradually narrowing distal end of the tube (250). The gradually narrowing distal end of the tube (250) may be formed by introducing a pair of lateral (56) groove openings (270) at the distal end (40) of the tube (250), thereby forming a pair of grippers (272, 274), and by compressing the grippers (272, 274) together. For example, in Figure 8 The illustration shows an example of a distal tip section (246) having a gradually narrowing distal end of a tube (250). The distal tip section (246) can be non-compliant or compliant, preferably compliant.

[0124] The tube (250) may include a pair of axial-longitudinal opening slots (280-a, 280-b) extending to the distal end portion (251) of the tube (250), the pair of axial-longitudinal opening slots (280-a, 280-b) defining a pair of retaining arms (282, 284). The opening slots open at the distal end. The pair of retaining arms (282, 284) are configured to retain the implant prior to deployment. The pair of retaining arms (282, 284) are configured to guide the implant out of the delivery axis (220) during deployment.

[0125] The closed end (253) of the axial-longitudinal opening groove (280-a, 280-b) can be located in the proximal end section (242) or in the distal compliant section (244), preferably in the distal compliant section (244).

[0126] The pair of axial-longitudinal opening slots (280-a, 280-b) may be opposite to each other. The pair of axial-longitudinal opening slots (280-a, 280-b) may be arranged around the tube (250) in diameter. One axial-longitudinal opening slot (280-a) may be located on the front side (52) of the tube (250), and the other axial-longitudinal opening slot (280-b) may be located on the rear side (54) of the tube (250). The pair of retaining arms (282, 284) may be arranged opposite to each other. The pair of retaining arms (282, 284) may be arranged around the tube (250) in diameter. Each of the pair of retaining arms (282, 284) may be located on each lateral side (56) of the tube (250).

[0127] An axial-longitudinal opening groove (280-a) provided on the front (52) side of the tube (250) can be used as an observation window (258).

[0128] The pipe (250) along one or two axial-longitudinal opening slots (280-a, 280-b) may each be provided with one or more transverse supports (286) spanning the periphery of the axial-longitudinal opening slots (280-a, 280-b). The pipe (250) along one or two axial-longitudinal opening slots (280-a, 280-b) may each be provided with one or more axial supports (288) spanning a portion of the axial length of the axial-longitudinal opening slots (280-a, 280-b).

[0129] The axial length of one or two axial-longitudinal opening slots (280-a, 280-b) may be equal to or greater than the axial length of the implant (230). The axial length of one or two axial-longitudinal opening slots (280-a, 280-b) may be at least 4 mm. One or two axial-longitudinal opening slots (280-a, 280-b) may extend the length of the tube (250) or not. The upper limit of the axial length may be 8 mm. The peripheral width of each opening slot (280-a, 280-b) may be the same or different. The peripheral width of the opening slots (280-a, 280-b) may be equal to or less than 30% to 40% of the total peripheral length (pl) of the tube (250). An axial-longitudinal observation window (258) may be formed by the anterior axial-longitudinal opening slot (280-a). An example of a tube (250) having a pair of axial-longitudinal opening slots (280-a, 280-b) defining a pair of retaining arms (282, 284) is shown in Figure 7 , Figure 7A , Figure 7B The information is provided in the text.

[0130] Because the implant (230) is transparent, visibility during surgery may be problematic. The presence of two opposing axial-longitudinal opening slots (280-a, 280-b) allows for illumination from below, improving visibility of the entire implant, not just the marker. Furthermore, the distal tip segment is formed with fewer tubes, thus increasing the fineness of the tip.

[0131] The tube (250) may include a pair of axial-longitudinal opening slots (270-a, 270-b) extending to the distal end (251) of the tube (250) in the distal tip section (246), the pair of axial-longitudinal opening slots (270-a, 270-b) defining a pair of restraining jaws (272, 274). The opening slots (270-a, 270-b) are open at the distal end. One jaw is a front (52) positioned jaw (272), and the other jaw is a rear (54) positioned jaw (274). The closed ends (253) of the axial-longitudinal opening slots (270-a, 270-b) may be located in the distal compliant section (244) or in the distal tip section (246), preferably in the distal tip section (246).

[0132] The pair of axial-longitudinal opening slots (270-a, 270-b) can be opposite to each other. The pair of axial-longitudinal opening slots (270-a, 270-b) can be arranged around the tube (250) in diameter. Both axial-longitudinal opening slots (270-a, 270-b) can be provided on the lateral side (56) of the tube (250). A pair of limiting jaws (272, 274) can be arranged opposite to each other. The pair of limiting jaws (272, 274) can be arranged around the tube (250) in diameter. One limiting jaw (272) can be provided on the front side (52) of the tube (250), and the other limiting jaw (274) can be provided on the rear side (56) of the tube (250).

[0133] One or both of the front jaws (272) and the rear jaws (274) may close at an angle toward the central axis (a-a') of the tube (250). One or both of the front jaws (272) and the rear jaws (274) may be provided with a plurality of radial slits forming a movable hinge (276). The axial length of one or both axial-longitudinal opening slots (270-a, 270-b) may be 1.6 mm to 2 mm. The jaw movement around the hinge is compliant and biased to be in a closed state. The maximum peripheral width of each of the one or two axial-longitudinal opening slots (270-a, 270-b) may be equal to or less than 30% (e.g., 10% to 20%) of the total peripheral length (pl) of the tube (250). An example of a tube (250) having a pair of axial-longitudinal opening slots (270-a, 270-b) defining a pair of limiting jaws (272, 274) is shown in Figure 8 , Figure 8A The information is provided in the text.

[0134] The limiting grippers (272, 274) advantageously provide a distal tip segment (246) with a blunt end, which mechanically pries open the treatment tissue during implant deployment. Compared to a beveled tip, the pair of surfaces (anterior and posterior surfaces) provided by the grippers support the treatment tissue with a larger surface area, thereby reducing trauma and bleeding. Furthermore, the closed grippers hold the implant within the lumen, preventing loss of the implant during storage, transportation, and handling.

[0135] As previously mentioned, at least a portion of the delivery axis (240) may be provided with an axial-longitudinal viewing window (258) (see above). Figure 2B and Figure 4D). The observation window (258) includes a longitudinal opening in the tube wall (224) on the anterior (52) side, which connects the lumen (222) to the outside of the tube (250). The observation window (258) allows visualization of the implant (230), particularly the marker (205). The observation window (258) allows visualization of the implant (230) relative to the treatment target prior to deployment. The observation window (258) allows visualization of the deployment of the implant (230). The observation window (258) may be located on the anterior (52) side of the tube (250). The observation window (258) may be limited to the anterior (52) side of the tube (250).

[0136] The observation window (258) may span a portion of the periphery path (62) of the cross-section of the tube (250). The width (ow) of the observation window (258) may be a portion of the length (pl) of the periphery path (62) of the tube (250), for example, in the range of 10% to 35%. Figure 7 In the example, the portion of the window (258, 270-a) that can be observed can be approximately 30%. Figure 8 In the example, the portion of the window (258, 256-a) that is observed can be approximately 14%.

[0137] The width (ow) of the window opening (258) can be observed to be within the range of 0.2mm to 1.0mm. Figure 5 In the example, the observation window (258) width (ow) can be approximately 0.6 mm. The observation window (258) width (ow) can range from 0.2 mm to 1.0 mm. Figure 6 In the example, observe that the width (ow) of the window (258) can be approximately 0.4 mm. Figure 7 In the example, observe that the width (ow) of the window (258) can be approximately 0.8 mm. Figure 8 In the example, observe that the width (ow) of the window (258) can be approximately 0.4 mm.

[0138] An observation window (258) may be located in the distal compliant segment (244) and optionally in at least a portion of the proximal segment (242). The observation window (258) may extend into the distal tip segment (246) or may not extend into the distal tip segment (246). The axial length of the observation window (258) may be equal to or greater than 6 mm. The axial length of the observation window (258) may be less than 12 mm. The observation window (258) may be sized to hold the implant (230) before and during deployment.

[0139] In a specific example, observe the window opening (258) as follows, for example, in Figure 5A , Figure 6A , Figure 8A The opening (256-a) is shown in the figure; the edges of the opening form a closed path. In another example, the window (258) is observed as follows, for example... Figure 7A The axial-longitudinal opening groove (280-a) is shown in the figure.

[0140] The delivery shaft assembly (200) also includes an adapter (210) configured for coupling to an inserter tool (500). An implant (230) is disposed at or near the distal end (40) of the delivery shaft (220). The adapter (210) is disposed at the proximal end (20) of the delivery shaft (220). The adapter (210) has a body having a receiving space (212) for a portion of the inserter tool (500) and an opening (214) connecting the receiving space (212) to a cavity (222) of the delivery shaft (220) (see [link]). Figure 2 The lumen (222) is configured to allow the discharge shaft (510) of the inserter tool (500) to pass through it. The implant (230) can be withdrawn from the delivery shaft (220) by actuation of the inserter tool (500), thereby delivering the implant (230) to the treatment target. An exemplary delivery shaft assembly (200) is disclosed in WO2017 / 108498, which is incorporated herein by reference.

[0141] The proximal end section (242) is adjacent to the distal compliant section (244) and extends proximal to the adapter (210). The proximal end section (242) may be straight along its entire axial length. The proximal end section (242) of the tube (250) may be bend-resistant along its entire axial length. Bending resistance is an inherent characteristic of the bend-resistant tube (250). An example of the tube (250) having bending resistance along its entire axial length in the proximal end section is shown in Figure 5 , Figure 6 , Figure 7 and Figure 8 As shown in the image.

[0142] The proximal segment (242) may include one or more compliant portions (248). The one or more compliant portions (248) may be biased along a straight line. The one or more compliant portions may be bent at least in a first plane, for example, bent in a series of planes including or centered on the first plane, or limited to bending in the first plane. An example of the tube (250) including compliant portions (248) in its proximal segment is shown in... Figure 5B , Figure 6B , Figure 7C and Figure 8B As shown in the image.

[0143] In the presence of one or more compliant portions (248) in the proximal end section (242), compliance and flexibility are achieved by a plurality of flexible grooves (252). The flexible grooves are discrete transverse or lateral (56) grooves (252) in the wall (224) of the tube (250). The flexible grooves extend partially around the periphery (62) of the wall (224) of the tube. The transverse length (sl) of the groove is greater than its width. The groove path is preferably straight. Most or all of the flexible grooves (252) in the compliant portion (248) may be closed, i.e., the inner edges of the grooves form a continuous path.

[0144] Details of the flexible groove (252) are in Figure 4 As shown in A. The path of the flexible groove (252) may coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible groove (252) may terminate at a spacer (254), which is configured to reduce the force required to bend the compliant portion (248) (see Figure A). Figure 4 B). The spacer (254) may be circular.

[0145] Each flexible groove (252) may span a portion of the peripheral path (62) of the transverse cross-section of the tube (250) (see Figure 2D The peripheral path (also called the perimeter path) of the transverse cross section of the pipe (250) (62) refers to the outer path of the pipe along the transverse cross section (see...). Figure 2C The length (sl) of the flexible groove in the compliant portion (248) of the proximal end section (242) may be a portion of the length (pl) of the peripheral path (62) of the tube (250), for example, 1% to 80%, or 1% to 40%.

[0146] The flexible grooves (252) in the compliant portion (248) may be located only in the rear (54) half of the transverse cross section or only in the front (52) half of the transverse cross section. Most or all of the flexible grooves (252) in the compliant portion (248) are spaced apart in the axial direction. The flexible grooves are preferably arranged in one or more (preferably two) rows extending in the proximal to distal direction.

[0147] Most or all of the flexible grooves (252) in the compliant portion (248) may be arranged such that they are flexible at least in the first plane, for example, flexible in a series of planes including the first plane or centered on the first plane, or limited to being flexible in the first plane.

[0148] As described above, at least a portion of the proximal section (242) may be provided with an observation window (258). The observation window (258) may be limited to and provided on the front (52) side of the tube (250). The observation window (258) may be a closed opening (256-a), i.e., the edge of the opening forms a closed path, or an axial-longitudinal opening groove (280-a). The observation window (258) may extend distally (40) into the distal compliant section (244).

[0149] The length of the proximal end section (242) in the axial (a-a') direction can be 26 mm to 30 mm. This length is measured along the central axis (a-a') from the distal end of the adapter (210) to the proximal end of the distal compliant section (244). The proximal end section (242) can have a maximum outer tube width across the lateral portion of 0.9 mm to 1.5 mm, preferably about 1.05 mm to 1.25 mm, more preferably 1.15 mm ± 0.1 mm. Figure 2A The delivery shaft (240) may have an outer tube height spanning from the rear to the front side of 0.5 mm to 0.7 mm, preferably about 0.52 mm to 1.24 mm. Figure 2A (th in the middle).

[0150] At least the delivery shaft (220) and the optional adapter (210) may be provided with a sheath to protect at least the delivery shaft (220) and the optional adapter (210). The sheath may be made of a heat-shrinkable polymer such as polyester heat-shrinkable film.

[0151] This document provides a method for manufacturing a delivery shaft assembly as described herein. The delivery shaft (220), as well as its portions and segments, is preferably formed from a tube (250). Flexible grooves (252) and / or flexible openings (256-b), observation windows (258), axial-longitudinal openings (270-a, 270-b, 280-a, 280-b), and / or movable hinges (276) are introduced into the tube (250) by any method for removing tube material from the tube wall (224). Exemplary methods include laser cutting, photochemical etching, deep pressing, conventional cutting techniques such as drilling or milling, high-pressure water jet cutting systems, or any suitable material removal process available. Laser cutting is preferred because it allows for very accurate and clean material removal under reasonable economic conditions.

[0152] A method for manufacturing a delivery shaft assembly as described herein includes:

[0153] - Provides a delivery shaft (220) having a proximal (20) end and a distal (20) end and an end cavity (222) configured to hold an implant (230), wherein the delivery shaft (220) is formed of a flexible material formed as a bend-resistant tube (250);

[0154] - A bend is introduced at the distal end of the delivery shaft (220) to form a distal compliant segment (244);

[0155] - A damage-resistant portion is formed in the distal tip section (246);

[0156] - By removing tube material from the tube wall (224), multiple flexible grooves (252) and / or flexible openings (256-b) are introduced in the distal compliant section (244) to impart compliance and bendability;

[0157] - An observation window (258) is introduced by removing tube material from the tube wall (224).

[0158] Other features may be introduced by removing tube material from the tube wall (224), including flexible grooves (252), flexible openings (257), axial-longitudinal openings (270-a, 270-b, 280-a, 280-b) and / or movable hinges (276) in the proximal end section (242).

[0159] This document provides a delivery shaft assembly (200) manufactured by one of the methods described herein.

[0160] The inserter tool (500) is provided with a discharge shaft (510) configured to be received by a delivery shaft assembly cavity (222). The discharge shaft (510) may be configured to abut an implant (230). Movement of the delivery shaft (220) and / or the discharge shaft (510) results in the release of the implant (230) from the cavity (222). (See also...) Figure 1 (Image A and Image B).

[0161] Advancement of the discharge shaft (510) in the distal (40) direction can apply force to the implant (230), thereby causing the implant to be withdrawn from the shaft assembly cavity (220). Alternatively or additionally, retraction of the delivery shaft (220) relative to the stationary discharge shaft (510) causes the implant (230) to be withdrawn from the shaft assembly cavity (220).

[0162] The inserter tool (500) is provided with an adapter connector (520) configured to connect with the adapter (210). The connection between the adapter connector (520) and the adapter (210) can be releasable or non-releasable. A non-releasable connection can be achieved, for example, by providing a compliant member on one of the adapter connector (520) or the adapter (210) and a reciprocating stop member on the other of the adapter connector (520) or the adapter (210), wherein the compliant member slides on the stop member in one direction during connection of the components (520, 210) and engages with the stop member in another sliding direction to prevent the components (520, 210) from being released. This mechanism is similar to a unidirectional ratchet mechanism.

[0163] When the implant is withdrawn by retracting the delivery shaft (220) relative to the fixed discharge shaft (510), the adapter connector (520) can slide relative to the fixed discharge shaft (510). The slidable adapter connector (520) has a ready position and a deployment position. In the ready position, the slidable adapter connector (520) positions the adapter (210) and the delivery shaft cavity (222) in the most distal position. The fixed discharge shaft (510) can abut against the implant (230) and the delivery shaft cavity (222) can cover the implant (230). In the deployment position, the slidable adapter connector (520) positions the adapter (210) and the delivery shaft cavity (222) in the most proximal position. The discharge shaft (510) abuts against the implant (230) and the delivery shaft cavity (222) is retracted in the proximal (20) direction and the implant (230) is released. When the implant is withdrawn by the advance of the discharge shaft (510), the discharge shaft (510), which is slidable relative to the fixed adapter connector (520), applies a withdrawal force on the implant (230) in the distal direction, thereby withdrawing the implant from the lumen (222).

[0164] exist Figure 1An example of a portion of an inserter tool (500) is provided, showing an inserter housing or base (550) (fixed) and a slidable adapter connector (520) configured to engage with an adapter (210) of a delivery shaft assembly (200). The discharge shaft (510) is positioned in a fixed relationship with the housing (550). In this example, the adapter connector (520) is slidable relative to the housing (550) and is shown in a ready position; it should be understood that other configurations of the inserter tool (500) exist, in which, for example, the adapter connector (520) is positioned in a fixed relationship with the inserter tool housing and the discharge shaft (510) is slidable. In Figure A, the inserter tool (500) is shown in a ready position; the adapter connector (520) is located in a distal (40) position. In the ready position, the implant (230) is held within the delivery shaft lumen (222). In Figure B, the inserter tool (500) is shown in the deployment position; the adapter connector (520) is retracted to the proximal (20) position. In the deployment 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 herein by reference.

[0165] Implantation of the implant 230 can be performed, for example, via an internal approach. The implant (230) is held within the delivery shaft lumen (222) of the delivery shaft (220), which is mounted on the discharge shaft (510) of the inserter tool (500). A distal tip segment (246) can be used to facilitate corneal penetration of the delivery shaft (220). It will be readily understood that the distal tip segment (246) does not require an incision to enter the cornea, and this can be accomplished by inserting the delivery shaft (220) into the made incision using a separate tool. The delivery shaft (220) is guided into and through the anterior chamber of the eye to the iridocorneal angle and into the subscleral space. The distal tip segment (246) provides damage-resistant puncture access to the subscleral space. The delivery axis (220) retracts relative to the discharge axis (510) of the inserter tool (500), thereby positioning the implant (230) in the subscleral space.

[0166] According to one aspect, the delivery shaft assembly (200) includes a delivery shaft (220) having an endometrium (222) configured to hold an implant (230), wherein:

[0167] - The delivery shaft (220) includes a distal compliant segment (244) which is repeatedly flexible, compliant and biased into a flexural portion in a first plane (60);

[0168] - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip;

[0169] - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) in the distal compliant section (244) to impart flexibility;

[0170] - The flexible grooves (252) in the distal compliant section (244) are arranged in rows (262), said rows (262) being confined within the rear (54) half of the transverse cross section of the tube (250);

[0171] - The tube (250) includes an observation window (258), which is an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250), and the observation window (258) is configured to visualize at least a portion of the implant (230) before and during deployment.

[0172] Examples of the aspects mentioned above are in Figure 5 and Figure 5A The figure is shown in the middle. The elements of the aspects mentioned above have been described elsewhere in this document. Certain aspects are emphasized below. Most of the flexible grooves (252), preferably all of the flexible grooves (252), are parallel to a plane perpendicular to the central axis (a-a'). The distal tip section (246) may include the beveled distal end (251) of the tube (250).

[0173] The axial-longitudinal opening (256-a) may be at least partially provided in the distal compliant section (244) and optionally in at least a portion of the proximal section (242). The axial-longitudinal opening (256-a) may not extend into the distal tip section (246).

[0174] The length (sl) of the flexible groove in the distal compliant section (244) can be a part of the length (pl) of the peripheral path (62) of the tube (250), and the range can be 25% to 30% in the axial region of the observation window (258).

[0175] As described elsewhere, the delivery shaft may also include a proximal segment (242) adjacent to and extending proximal to the adapter (210) of the distal compliant segment (244). The proximal segment (242) may include one or more compliant portions (248), or may not include one or more compliant portions (248). Each flexible groove (252) in the compliant portion (248) may have a lateral length (sl) that is a portion of the circumferential length (pl) of the tube (250) ranging from 1% to 80%.

[0176] Most of the flexible grooves (252), preferably all of them, may terminate at a circular spacer (254) that reduces bending force.

[0177] According to another aspect, the delivery shaft assembly (200) includes a delivery shaft (220) having an endometrium (222) configured to hold an implant (230), wherein:

[0178] - The delivery shaft includes a distal compliant segment (244) which is repeatedly flexible, compliant, and biased as a flexural portion in a first plane (60);

[0179] - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip;

[0180] - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) in the distal compliant section (244) to impart flexibility;

[0181] - The tube (250) includes an observation window (258), which is an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250), and the observation window (258) is configured to visualize at least a portion of the implant (230) before and during deployment;

[0182] - The flexible grooves (252) in the distal compliant section (244) are arranged in rows (262), and the rows (262) are confined within the rear (54) half of the transverse cross section of the tube (250);

[0183] - The wall (224) of the tube (250) is further provided with a plurality of flexible openings (256-b) in the distal compliant section (244), which are called support openings (257), and the plurality of flexible openings (256-b) further impart flexibility;

[0184] - Multiple bracket openings (257, 256-b) are arranged in two axial rows (260', 260"), each row being positioned on either side of the observation window (258) and between rows (262) of the flexible groove (252).

[0185] Examples of the aspects mentioned above are in Figure 6 , Figures 6A to 6C The figure is shown in the middle. The elements of the aspects mentioned above have been described elsewhere in this document. Certain aspects are emphasized below. Most of the flexible grooves (252), preferably all of the flexible grooves (252), are parallel to a plane perpendicular to the central axis (a-a') of the tube (250). The distal tip section (246) may include the angled distal end of the tube (250).

[0186] The axial-longitudinal opening (256-a) may be at least partially provided in the distal compliant section (244) and optionally in at least a portion of the proximal section (242). The axial-longitudinal opening (256-a) may not extend into the distal tip section (246).

[0187] The length (sl) of the flexible groove in the distal compliant section (244) can be a part of the length (pl) of the peripheral path (62) of the tube (250), and can be in the range of 13% to 19% in the axial region of the support opening (257).

[0188] As described elsewhere, the delivery shaft may also include a proximal segment (242) adjacent to and extending proximal to the adapter (210) of the distal compliant segment (244). The proximal segment (242) may include one or more compliant portions (248) or may not include one or more compliant portions (248). Each flexible groove (252) in the compliant portion (248) may have a lateral length (sl) that is a portion of the circumferential length (pl) of the tube (250) ranging from 1% to 80%.

[0189] Most of the flexible grooves (252) in the proximal end section (242), preferably all of them, may terminate at a circular spacer (254) configured to reduce the force required for bending.

[0190] The flexible opening (252) can have the same shape, such as a polygon. The presence of the stent opening (257) improves the lateral visualization of the implant during surgery, thereby allowing the implant to be safely and "accurately" released in one go.

[0191] According to another aspect, the delivery shaft assembly (200) includes a delivery shaft (220) having an endometrium (222) configured to hold an implant (230), wherein:

[0192] - The delivery shaft (220) includes a distal compliant segment (244) which is repeatedly flexible, compliant and biased as a flexural portion in a first plane (60);

[0193] - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip;

[0194] - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) in the distal compliant section (244) to impart flexibility;

[0195] - The tube (250) includes a pair of axial-longitudinal opening slots (280-a, 280-b) disposed on the front (52) side and the rear (54) side of the tube (250) and extending to the distal end (251) of the tube (250) defining a pair of retaining arms (282, 284) configured to retain the implant (230) prior to deployment;

[0196] - The tube (250) includes an observation window (258), which is an axial-longitudinal opening groove (280-a) provided on the front (52) side of the tube (250).

[0197] Examples of the aspects mentioned above are in Figure 7 and Figure 7A The figure is shown in the diagram. The elements of the aspects mentioned above have been described elsewhere in this document. Certain aspects are emphasized below. Most, or preferably all, of the flexible grooves (252) are parallel to a plane perpendicular to the central axis (a-a'). Each flexible groove (252) in the proximal end section (242) may be closed. Each flexible groove (252) in the distal compliant section (244) may be open. The distal tip section (246) may include the angled distal end of the tube (250).

[0198] The closed end (253) of the axial-longitudinal opening groove (280-a, 280-b) may be located in the proximal end section (242) or in the distal compliant section (244), preferably in the distal compliant section (244). The maximum circumferential width of each of the one or two axial-longitudinal opening grooves (280-a, 280-b) may be 30% to 40% of the total circumferential length (pl) of the tube (250).

[0199] The length (sl) of the flexible groove in the distal compliant section (244) can be a part of the length (pl) of the peripheral path (62) of the tube (250), and can be in the range of 8% to 14% in the axial region of the longitudinal opening groove (280-a, 280-b).

[0200] The length (sl) of the flexible groove in the distal compliant section (244) can be a portion of the length (pl) of the peripheral path (62) of the tube (250), and can range from 1% to 80%, for example, 31% to 37%.

[0201] As described elsewhere, the delivery shaft may also include a proximal segment (242) adjacent to and extending proximal to the adapter (210) of the distal compliant segment (244). The proximal segment (242) may include one or more compliant portions (248) or may not include one or more compliant portions (248). Each flexible groove (252) in the compliant portion (248) may have a lateral length (sl) that is a portion of the circumferential length (pl) of the tube (250) ranging from 1% to 80%.

[0202] Most of the flexible grooves (252), preferably all of them, may terminate in a circular spacer (254) configured to reduce the force required for bending. Since the implant (230) is transparent, visibility during surgery may be problematic. The presence of two opposing axial-longitudinal opening grooves (280-a, 280-b) allows for illumination from below to improve visibility of the entire implant, not just the marker. Furthermore, the distal tip segment is formed with fewer tubes, thus increasing the fineness of the tip.

[0203] According to another aspect, the delivery shaft assembly (200) includes a delivery shaft (220) having an endometrium (222) configured to hold an implant (230), wherein:

[0204] - The delivery shaft (220) includes a distal compliant segment (244) which is repeatedly flexible, compliant and biased as a flexural portion in a first plane (60);

[0205] - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip;

[0206] - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) that impart flexibility in the proximal end section (242) and the distal compliant section (244);

[0207] - The tube includes an observation window (258), which is an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250), and the observation window (258) is configured to visualize at least a portion of the implant (230) before and during deployment;

[0208] - The tube (250) includes a pair of axial-longitudinal opening slots (270-a, 270-b) in the distal tip section (246) extending to the distal end end (251) of the tube (250), the pair of axial-longitudinal opening slots (270-a, 270-b) defining a pair of limiting claws (272, 274);

[0209] - One gripper is a front (52) positioned gripper (272), and the other gripper is a rear (54) positioned gripper (274);

[0210] - One or both of the front jaws (272) and the rear jaws (274) are closed at an angle toward the central axis (a-a') of the tube (250);

[0211] One or both of the front jaw (272) and the rear jaw (274) are provided with a plurality of radial slits forming a movable hinge portion (276).

[0212] Examples of the aspects mentioned above are in Figure 8 and Figure 8A The figure is shown in the middle. The elements of the aspects mentioned above have been described elsewhere in this document. Some aspects are emphasized below. Most of the flexible grooves (252), preferably all of the flexible grooves (252), are parallel to a plane perpendicular to the central axis (a-a') of the tube (250).

[0213] The closed end (253) of the axial-longitudinal open slots (270-a, 270-b) can be located in the distal tip section (246) or in the proximal end section (242), preferably in the distal tip section (246). The gripper movement around the hinge is compliant and biased to be in a closed state. The maximum circumferential width of each of the one or two axial-longitudinal open slots (270-a, 270-b) can be 10% to 20% of the total circumferential length (pl) of the tube (250).

[0214] The length (sl) of the flexible groove in the distal compliant section (244) can be a part of the length (pl) of the peripheral path (62) of the tube (250) and can be in the range of 1% to 80%, for example 31% to 37%.

[0215] Each flexible groove (252) in the distal compliant section (244) is confined within the rear (54) half or front (52) half of the transverse cross-section of the tube (250). Most of the flexible grooves (252), preferably all of them, are parallel to a plane perpendicular to the central axis (a-a').

[0216] The axial-longitudinal opening (256-a) may be at least partially provided in the distal compliant section (244) and optionally in at least a portion of the proximal section (242). The axial-longitudinal opening (256-a) may not extend into the distal tip section (246).

[0217] As described elsewhere, the delivery shaft may also include a proximal segment (242) adjacent to and extending proximal to the adapter (210) of the distal compliant segment (244). The proximal segment (242) may include one or more compliant portions (248) or may not include one or more compliant portions (248). Each flexible groove (252) in the compliant portion (248) may have a lateral length (sl) that is a portion of the circumferential length (pl) of the tube (250) ranging from 1% to 80%.

[0218] Most or preferably all flexible grooves (252) may terminate at a circular spacer (254), which is configured to reduce the force required for bending.

[0219] The inserter tool (500) can be an implantation device as described in WO 2017 / 108498. The delivery shaft assembly (200) can include a one-touch assembly connector or adapter (210) as described in WO 2017 / 108498. For example, WO 2017 / 108498 describes an implantation device (500) and a delivery shaft assembly (200) on pages 26 to 33, which are incorporated herein by reference.

Claims

1. A delivery shaft assembly (200) for delivering an ocular implant (230), the delivery shaft assembly (200) having a proximal end (20) and a distal end (40), wherein: - The delivery shaft assembly (200) includes: a delivery shaft (220) having a lumen (222) configured to hold the implant (230); and an adapter (210) located at the proximal end (20) of the delivery shaft (220) and configured to attach to an inserter tool (500) to deploy the implant (230). - The delivery shaft (220) includes a distal compliant segment (244) that is repeatedly flexible, compliant, and biased as a flexural portion in a first plane (60); - The delivery axis (220) is provided with an axial longitudinal viewing window (258) to allow viewing of the implant (230) from the front (52) side of the delivery axis (220). - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip; and - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) and / or flexible openings (256-b) in the distal compliant section (244) to impart flexibility; and in: The tube (250) includes a pair of axial-longitudinal opening slots (270-a, 270-b) extending to the distal end portion (251) of the tube (250) in the distal tip section (246), the pair of axial-longitudinal opening slots (270-a, 270-b) defining a pair of limiting jaws; wherein one jaw is a front jaw (272) positioned forward (52) and the other jaw is a rear jaw (274) positioned backward (54); one or both of the front jaw (272) and the rear jaw (274) are closed at an angle toward the central axis (a-a') of the tube (250); and one or both of the front jaw (272) and the rear jaw (274) are provided with a plurality of radial slits forming a movable hinge (276).

2. The delivery shaft assembly (200) according to claim 1, wherein, The compliant material is an opaque metal.

3. The delivery shaft assembly (200) according to claim 1 or 2, wherein, The plurality of flexible grooves (252) and / or flexible openings (256-b) are provided by removing material from the wall (224) of the tube (250).

4. The delivery shaft assembly (200) according to claim 1, wherein, The delivery axis (220) also includes a proximal segment (242) adjacent to the distal compliant segment (244), wherein: - The tube (250) includes one or more compliant portions (248) in the proximal segment (242), or - The total axial length of the proximal segment (242) is non-compliant and straight.

5. The delivery shaft assembly (200) according to claim 4, wherein, Each compliant section (248) includes one or more flexible grooves (252).

6. The delivery shaft assembly (200) according to claim 1, wherein, The closed ends of the axial-longitudinal opening grooves (270-a, 270-b) are located in the distal tip section (246).

7. The delivery shaft assembly (200) according to claim 1, wherein, The observation window (258) is an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250).

8. The delivery shaft assembly (200) according to claim 1, wherein: - The flexible grooves (252) in the distal compliant section (244) are arranged in rows (262), the rows (262) being confined within the rear (54) half of the transverse cross-section of the tube (250). - The wall (224) of the tube (250) is further provided with a plurality of flexible openings (256-b) in the distal compliant section (244), the flexible openings (256-b) being referred to as support openings (257, 256-b), the flexible openings (256-b) further giving the tube (250) a partial support-like appearance and the bendability; - The plurality of bracket openings (257, 256-b) are arranged in two axial rows (260', 260''), each axial row being positioned on either side of the observation window (258) and between the rows (262) of the flexible groove (252).

9. The delivery shaft assembly (200) according to claim 8, wherein: - Most or all of the said bracket openings (257, 256-b) have the same shape, and / or - Most or all of the said bracket openings (257, 256-b) have the same size, and / or - Most or all of the said bracket openings (257, 256-b) have a triangular, rhomboid, pentagonal, hexagonal or polygonal shape.

10. The delivery shaft assembly (200) according to claim 1, wherein, The tube (250) is beveled at the distal end section (246).

11. The delivery shaft assembly (200) according to claim 1, wherein, The compliant material is nickel-titanium.

12. The delivery shaft assembly (200) according to claim 1, wherein, The plurality of flexible grooves (252) and / or flexible openings (256-b) are provided by removing material from the wall (224) of the tube (250) by laser cutting.

13. A delivery axis assembly (200) for delivering an ocular implant (230), the delivery axis assembly (200) having a proximal end (20) and a distal end (40), wherein: - The delivery shaft assembly (200) includes: a delivery shaft (220) having a lumen (222) configured to hold the implant (230); and an adapter (210) located at the proximal end (20) of the delivery shaft (220) and configured to attach to an inserter tool (500) to deploy the implant (230). - The delivery shaft (220) includes a distal compliant segment (244) that is repeatedly flexible, compliant, and biased as a flexural portion in a first plane (60); - The delivery axis (220) is provided with an axial longitudinal viewing window (258) to allow viewing of the implant (230) from the front (52) side of the delivery axis (220). - The delivery shaft (220) includes a distal tip section (246) with a damage-resistant tip; and - The delivery shaft (220) is formed of a compliant material that forms a bend-resistant tube (250), and the wall (224) of the tube (250) is provided with a plurality of flexible grooves (252) and / or flexible openings (256-b) in the distal compliant section (244) to impart flexibility; and in: The tube (250) includes a pair of axial-longitudinal opening slots (280-a, 280-b) disposed on the front (52) side and the rear (54) side of the tube (250) and extending to the distal end (251) of the tube (250), the pair of axial-longitudinal opening slots (280-a, 280-b) defining a pair of retaining arms (282, 284) configured to retain the implant (230) prior to deployment; wherein the observation window (258) is one of the axial-longitudinal opening slots (280-a) disposed on the front (52) side of the tube (250).

14. The delivery shaft assembly (200) according to claim 13, wherein, The compliant material is an opaque metal.

15. The delivery shaft assembly (200) according to claim 13 or 14, wherein, The plurality of flexible grooves (252) and / or flexible openings (256-b) are provided by removing material from the wall (224) of the tube (250).

16. The delivery shaft assembly (200) according to claim 13, wherein, The delivery axis (220) also includes a proximal segment (242) adjacent to the distal compliant segment (244), wherein: - The tube (250) includes one or more compliant portions (248) in the proximal segment (242), or - The total axial length of the proximal segment (242) is non-compliant and straight.

17. The delivery shaft assembly (200) according to claim 16, wherein, Each compliant section (248) includes one or more flexible grooves (252).

18. The delivery shaft assembly (200) according to claim 16, wherein, The closed end (253) of the axial-longitudinal opening groove (280-a, 280-b) is located in the proximal end section (242) or in the distal compliant section (244).

19. The delivery shaft assembly (200) according to claim 13, wherein, The observation window (258) is an axial-longitudinal opening (256-a) provided on the front (52) side of the tube (250).

20. The delivery shaft assembly (200) according to claim 13, wherein: - The flexible grooves (252) in the distal compliant section (244) are arranged in rows (262), the rows (262) being confined within the rear (54) half of the transverse cross-section of the tube (250). - The wall (224) of the tube (250) is further provided with a plurality of flexible openings (256-b) in the distal compliant section (244), the flexible openings (256-b) being referred to as support openings (257, 256-b), the flexible openings (256-b) further giving the tube (250) a partial support-like appearance and the bendability; - The plurality of bracket openings (257, 256-b) are arranged in two axial rows (260', 260''), each axial row being positioned on either side of the observation window (258) and between the rows (262) of the flexible groove (252).

21. The delivery shaft assembly (200) according to claim 20, wherein: - Most or all of the said bracket openings (257, 256-b) have the same shape, and / or - Most or all of the said bracket openings (257, 256-b) have the same size, and / or - Most or all of the said bracket openings (257, 256-b) have a triangular, rhomboid, pentagonal, hexagonal or polygonal shape.

22. The delivery shaft assembly (200) according to claim 13, wherein, The tube (250) is beveled at the distal end section (246).

23. The delivery shaft assembly (200) according to claim 13, wherein, The compliant material is nickel-titanium.

24. The delivery shaft assembly (200) according to claim 13, wherein, The plurality of flexible grooves (252) and / or flexible openings (256-b) are provided by removing material from the wall (224) of the tube (250) by laser cutting.

25. A method for manufacturing a delivery shaft assembly (200) according to claim 3 or 15, the method comprising: - The delivery shaft (220) is provided having a proximal end (20) and a distal end (40), the delivery shaft (220) including the lumen (222) configured to hold the implant (230), wherein the delivery shaft (220) is made of a compliant material formed as a bend-resistant tube (250); - A bend is introduced at the distal end of the delivery shaft (220) to form a distal compliant segment (244). - A damage-resistant tip is formed in the distal tip section (246); - By removing tube material from the wall (224) of the tube, the plurality of flexible grooves (252) and / or flexible openings (256-b) are introduced in the distal compliant section (244) to impart compliance and bendability in the first plane (60); - The observation window (258) is introduced by removing tube material from the tube wall (224).

26. The method of claim 25, wherein, The axial-longitudinal opening grooves (270-a, 270-b, 280-a, 280-b) and / or the movable hinge (276) are introduced by the step of removing tube material from the wall (224) of the tube.

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