Delivery shaft assembly for implant delivery - Patent application

Abstract

A delivery shaft assembly (200) having a proximal end (20) and a distal end (40) is provided for delivery of an ocular implant (230), the delivery shaft assembly (200) comprising a delivery shaft (220) having an inner lumen (222) configured to hold the implant (230), and an adapter (210) configured to attach to an insertion tool (500) at the proximal end (20) of the delivery shaft (220) for placement of the implant (230); the delivery shaft (220) is repeatedly bendable (60), conformable, and has a distal end biased to a curvature in a first plane. the delivery shaft (220) has an axial-longitudinal observation window (258) that allows visualization of the implant (230) from the anterior (52) side of the delivery shaft (220); the delivery shaft (220) has a distal tip section (246) with an atraumatic tip; the delivery shaft (220) is formed from a conformable material that is formed into a bend-resistant tube (250), and the wall (224) of the tube (250) at the distal conformable section (244) has a plurality of flexible slots (252) and / or flexible openings (256-b) that impart bendability.

Description

[Technical Field]

[0001] The present specification presents a delivery shaft assembly for delivering an ocular implant for implantation into a subject. [Background technology]

[0002] Implants are often used to treat conditions where drug treatments are ineffective or unavailable. Techniques for placing implants typically rely on an insertion tool that temporarily holds the implant and provides a long reach for placement at the implant site, as well as a mechanism for ejecting the implant from the inserter. Implants can be very small; for example, implants for treating glaucoma typically have a length of 5 mm and a width of 1 mm. Examples of implants and insertion tools for treating glaucoma are disclosed, for example, in International Publication No. 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 place an implant with an introducer that is minimally traumatic and has sufficient pushing force and flexibility to enter the curved tissue of the eye. A further problem is intraoperative implant visibility, with implants hidden within the introducer needing a solution for visibility under light microscopy before and during placement. [Means for solving the problem]

[0005] Provided herein 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) comprising a delivery shaft (220) having an inner lumen (222) configured to hold an implant (230), and an adapter (210) configured to attach to an insertion tool (500) at the proximal end (20) of the delivery shaft (220) for placement of the implant (230); the delivery shaft (220) is repeatedly bendable (60) and is conformable, and includes a distal conformable section (244) biased to a first plane of curvature; the delivery shaft (220) is provided with an axial-longitudinal observation fenestration (258) that allows visualization of the implant (230) from the anterior (52) side of the delivery shaft (220); the delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; The delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), and the wall (224) of the tube (250) in the distal conformable section (244) is provided with a plurality of flexible slots (252) and / or flexible openings (256-b) that impart bendability.

[0006] The conformable material may be an opaque metal, preferably Nitinol.

[0007] The plurality of flexible slots (252) and / or flexible openings (256-b) may be provided by removing material from the wall (224) of the tube (250), preferably by laser cutting.

[0008] The delivery shaft (220) may further comprise a proximal section (242) adjacent to a conforming distal section (244); - the tube (250) in the proximal section (242) comprises one or more fitting portions (248), or The entire axial length of the proximal portion (242) is non-compliant and straight.

[0009] Each of the compliant portions (248) may include one or more flexible slots (252).

[0010] The observation fenestration (258) may be an axial-longitudinal opening (256-a) located on the forward (52) side of the tube (250).

[0011] the flexible slots (252) of the distal conforming section (244) may be arranged in a restricted row (262) in the rear half (54) of the transverse cross section of the tube (250); the wall (224) of the tube (250) in the distal conforming section (244) further comprises a plurality of flexible openings (256-b) known as stent openings (257, 256-b) that further impart a partial stent-like appearance and bendability to the tube (250); The plurality of stent openings (257, 256-b) are arranged in two axial rows (260', 260"), each of the rows being located on either side of the observation fenestration (258) and the row (262) of flexible slots (252).

[0012] Most or all of the stent openings (257, 256-b) have the same shape; and / or - most or all of the stent openings (257, 256-b) have the same size; and / or - Most or all of the stent openings (257, 256-b) have a triangular, rhomboidal, pentagonal, hexagonal or polygonal shape.

[0013] The tube (250) at the distal tip section (246) may have a pair of axially-longitudinal open slots (270-a, 270-b) extending to the distal end (251) of the tube (250) and defining a pair of restrictive jaws (272, 274); one of the jaws is a jaw (272) positioned at the front (52) and the other of the jaws is a jaw (274) positioned at the rear (54); - one or both of the front jaw (272) and the rear jaw (274) approach at an angle towards the central axis (a-a') of the tube (250); One or both of the front jaw (272) and the rear jaw (274) are arranged with a plurality of radial slits that form living hinges (276).

[0014] The closed ends of the open axial-longitudinal slots (270-a, 270-b) are within the distal tip section (246).

[0015] The tube (250) may have a pair of open axial-longitudinal slots (280-a, 280-b) located on the front (52) and rear (54) sides of the tube (250) and extending to the distal end (251) of the tube (250) to define a pair of retention arms (282, 284) configured to retain the implant (230) prior to deployment; The observation fenestration (258) is one of the axially-longitudinal open slots (280-a) located on the front (52) side of the tube (250).

[0016] The closed ends (253) of the open axial-longitudinal slots (280-a, 280-b) can be in the proximal section (242) or in the distal matching section (244).

[0017] The tube (250) at the distal tip section (246) may be tapered.

[0018] There is further provided a method of manufacturing a delivery shaft assembly (200) as described herein, the method comprising: providing a delivery shaft (220) having a proximal (20) end and a distal (20) end with a lumen (222) configured to hold an implant (230), the delivery shaft (220) being made from a conformable material formed into a bend-resistant tube (250); - introducing a curvature into the distal end of the delivery shaft (220), thereby forming a distal conforming section (244); - forming an atraumatic portion on the distal tip section (246); - introducing a plurality of flexible slots (252) and / or flexible openings (256-b) in the distal conforming section (244) to provide conformability and bendability (60) in a first plane by removal of tubing material from the tube wall (224); - introducing an observation fenestration (258) by removing tubing material from the tubing wall (224); Includes.

[0019] The axial-longitudinal open slots (270-a, 270-b, 280-a, 280-b) and / or living hinges (276) may be introduced by removing tubing material from the tube wall (224). [Brief explanation of the drawings]

[0020] [Figure 1] 1A and 1B are diagrams of a delivery shaft assembly described herein coupled to an insertion tool. In panel A, prior to deployment, an implant is held within the delivery shaft lumen. In panel B, after deployment, the delivery shaft is retracted proximally over the ejection shaft, releasing the implant. [Figure 2] FIG. 1 is a lateral side view of a delivery shaft assembly as described herein. [Figure 2A] 3 is a transverse cross-sectional view of the delivery shaft assembly of FIG. 2 taken through plane A-A'. [Figure 2B] 3 is a transverse cross-sectional view of the delivery shaft assembly of FIG. 2 taken through plane B-B'. [Figure 2C] FIG. 3 is a transverse cross-sectional view of the delivery shaft assembly of FIG. 2 showing the circumference and circumference length (pl). [Figure 2D] FIG. 3 is a transverse cross-sectional view of the delivery shaft assembly of FIG. 2 through the flexible slot, with the slot length (sl) indicated. [Figure 3] FIG. 1 is a plan view of an implant as described herein. [Figure 3A] FIG. 4 is a transverse cross-sectional view of the implant of FIG. 3 through plane CC'. [Figure 4A] Detail of flexible slots in the tube wall. [Figure 4B] Detail of flexible slot with spacers in the tube wall. [Figure 4C] Detail of a flexible opening with spacers in the tube wall. [Figure 4D] Detail of the observation fenestration in the canal wall is shown. [Figure 5] FIG. 10 is a lateral side view of an exemplary delivery shaft assembly described herein with viewing fenestrations and flexible slots in both the proximal and distal conforming sections. [Figure 5A] FIG. 6 is a plan view of a portion of the delivery shaft assembly of FIG. 5. [Figure 5B] 6 shows the delivery shaft assembly of FIG. 5 further comprising a flexible slot in the proximal section. [Figure 6] FIG. 10 is a lateral side view of an exemplary delivery shaft assembly described herein with observation fenestrations and flexible slots in both the proximal and distal conforming sections, and with a flexible opening (stent opening) in the distal conforming section. [Figure 6A] FIG. 7 is a plan view of a portion of the delivery shaft assembly of FIG. 6. [Figure 6B] 7 shows the delivery shaft assembly of FIG. 6 further comprising a flexible slot in the proximal section. [Figure 6C] FIG. 7 is a transverse cross-sectional view of the delivery shaft assembly of FIG. 6 with the flexible slots, flexible openings (stent openings), and viewing fenestrations marked. [Figure 7] FIG. 10 is a lateral side view of an exemplary delivery shaft assembly described herein with both viewing fenestrations and flexible slots in both the proximal and distal conforming sections, and with retention arms. [Figure 7A] FIG. 8 is a plan view of a portion of the delivery shaft assembly of FIG. 7. [Figure 7B] 8 is a plan view of a portion of the delivery shaft assembly of FIG. 7, in which an open axial-longitudinal slot comprises two transverse struts and an axial strut. [Figure 7C]8 shows the delivery shaft assembly of FIG. 7 further comprising a flexible slot in the proximal section. [Figure 8] FIG. 10 is a lateral side view of an exemplary delivery shaft assembly described herein with viewing fenestrations and flexible slots in both the proximal and distal conforming sections and with restrictive jaws. [Figure 8A] FIG. 9 is a plan view of a portion of the delivery shaft assembly of FIG. 8. [Figure 8B] 9 shows the delivery shaft assembly of FIG. 8 further comprising a flexible slot in the proximal section. DETAILED DESCRIPTION OF THE INVENTION

[0021] Before describing the present systems and methods, it is to be understood that the present invention is not limited to the particular systems and methods or combinations described, as these may vary. It is also to be understood that the terms used herein are not intended to be limiting, since the scope of the present invention will be limited only by the claims.

[0022] As used herein, the singular forms "a," "an," and "the" include singular and plural referents unless the context clearly dictates otherwise.

[0023] As used herein, the terms "comprising," "comprise," and "comprised of" are synonymous with "including," "include," or "containing," and "contain," and are inclusive or open-ended and do not exclude additional, unrecited elements, components, or method steps. As used herein, the terms "comprising," "comprise," and "comprised of" should be understood to include the terms "consisting of," "consist," and "consists of."

[0024] The recitation of numerical ranges by endpoints includes all values ​​and fractions subsumed within the respective ranges, as well as the recited endpoints.

[0025] As used herein, the terms "about" or "approximately" when referring to a measurable value such as a parameter, amount, time duration, and the like, are intended to encompass, as appropriate for practice in the disclosed invention, a variation of no more than ±10%, preferably no more than ±5%, more preferably no more than ±1%, and even more preferably no more than ±0.1% of the particular value. It is also to be understood that the value to which the modifier "about" or "approximately" refers is itself specifically and preferably disclosed.

[0026] While the terms "one or more" or "at least one," such as "one or more" or "at least one" of a group of members, are clear in themselves, by way of further illustration, the terms specifically include reference to any one of the members or any two or more of the members, for example, any ≧3, ≧4, ≧5, ≧6, or ≧7, etc. of the members, up to and including all of the members.

[0027] All references cited herein are incorporated by reference in their entirety. In particular, the teachings of all references specifically mentioned herein are incorporated by reference.

[0028] Unless otherwise defined, all terms used in disclosing the present invention, including technical and scientific terms, have the meanings commonly understood by one of ordinary skill in the art to which this invention belongs. With further reference, definitions of terms are included to better understand the teachings of the present invention.

[0029] In the following text, different aspects of the invention are defined in more detail. Each aspect thus defined can be combined with any other aspect or aspects, unless expressly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous can be combined with any other feature or features indicated as being preferred or advantageous.

[0030] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, as would be recognized by one of ordinary skill in the art from this disclosure. Furthermore, as would be recognized by one of ordinary skill in the art, some embodiments described herein may include some features and not include other features included in other embodiments, and combinations of features from different embodiments are intended to form different embodiments within the scope of the present invention. For example, in the claims, any of the claimed embodiments may be used in any combination.

[0031] In describing the present invention, reference is made to the accompanying drawings, which form a part hereof, and which show, by way of example only, specific embodiments in which the present invention may be practiced. Any bracketed or bold reference numerals attached to individual elements are intended to illustrate the element by way of example only and are not intended to be limiting of the individual elements. 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 claims.

[0032] The terms "distal" or "distal" and "proximal" or "proximal" are used throughout this specification and are commonly understood in the art to mean toward (proximal) or away (distal) from the user (practitioner) side of a device. Thus, "proximal" or "proximal" means toward the user side, and thus away from the subject (patient) side. Conversely, "distal" or "distal" means toward the subject side, and thus away from the user side. The term "subject" refers to a human or animal receiving an implant. The term "user" refers to the person (e.g., surgeon, specialist, practitioner) performing the implant.

[0033] The terms "anterior," "posterior," and "lateral" are used throughout this specification and are commonly understood in the art to mean the front of a subject (anterior), the rear of a subject (posterior), and both sides of a subject (lateral). Figure 2A shows the anterior (52), posterior (54), and lateral (56) sides of a cross section of a delivery shaft (250). The term "lateral" refers to a direction transverse to (e.g., perpendicular to) the longitudinal direction. The term "axial" refers to a direction along the longitudinal direction of the tube (250), e.g., axis (a-a'). The term "circumferential" refers to a direction around the exterior of the tube (250), e.g., around the periphery (62).

[0034] Provided herein is a delivery shaft assembly (200) and method of manufacturing the assembly for delivery of an ocular implant (230), for example, as illustrated in Figure 2. The delivery shaft assembly (200) comprises a delivery shaft (220) having a proximal end (20) and a distal end (40) and having an internal lumen (222) configured to hold the implant (230).

[0035] The delivery shaft (220) includes a distal compliant section (244) that can be repeatedly bent (60). The distal compliant section (244) is biased into a curve. The curve of the distal compliant section (244) can be in a first plane, i.e., planar. The bendability of the distal compliant section (244) allows the curved distal compliant section (244) to unbend and open to a straight configuration. The conformability of the distal compliant section (244) allows the distal compliant section (244) to repeatedly open to a straight configuration and return to a curved configuration. The distal compliant section (244) can bend in at least a first plane. Opening to a straight configuration can be achieved by application of an external force, such as a fixed ejection shaft (510).

[0036] The delivery shaft (220) includes a viewing fenestration (258) that allows visualization of the implant (230) within the delivery shaft (220) from the anterior (52) side using reflected light (e.g., under a microscope) (FIG. 2C). The delivery shaft (220) includes a distal tip section (246) that has a transverse profile that decreases distally (40). The distal compliant section (244) connects to the adapter (210) via the proximal section (242) of the delivery shaft (220). The proximal section (242) is straight and may or may not include one or more compliant portions (248). The delivery shaft (220) is formed from a compliant material that is formed into a bend-resistant tube (250). The wall (224) of the tube (250) at the conforming portion (240) includes a plurality of flexible slots (252) and / or flexible openings (256-b) that provide the bendability (60).

[0037] The method of manufacturing the delivery shaft assembly 200 includes providing a bend-resistant tube 250 and shaping the delivery shaft 220 by adding a plurality of flexible slots 252 and / or flexible openings 257 that impart bendability. The curvature of the distal compliant section 244 can be achieved in a number of ways, such as by supporting the lumen (e.g., with a flexible coil spring) and bending the tube 250 along its axial length using, for example, a tube bender. The bending can be performed at room temperature, or the tube's bendability can be temporarily increased by heat treatment.

[0038] An advantage of the delivery shaft assembly (200) is that the delivery shaft (220) has axial (proximal to distal) pushability, which 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 rigidity for pushability. The curvature of the distal conforming section (244) allows the distal tip section (246) to follow the curvature of the eye, reducing the application of forces caused by push-through into the suprachoroidal, subconjunctival, or intrascleral spaces. The bendability of the distal conforming section (244) allows a straight, rigid evacuation shaft (510) to pass through the curved lumen (222) of the distal conforming section (244) to deploy the implant. The conformability of the distal conforming section (244) allows for reversible deformation of the curvature of the distal conforming section (244), allowing the distal tip section (246) to actively follow the various radii of curvature of the eye. If the radius of curvature changes during advancement, the advancing distal tip section (246) can reset its position to conform to the new shape of the advancing curvature. Bleeding during surgery is reduced by closely following and adjusting to the tissue landscape.

[0039] The benefit of providing an observation fenestration (258) is improved visibility of the implant during placement. Delivery shafts are typically made from a transparent polymeric material, which allows for viewing of the implant during insertion. However, because the transparent polymeric material must have good extrudability, the wall thickness is such that visibility of the implant or markers on the implant is impaired. Also, a high intensity light source results in significant reflection, further impairing visibility.

[0040] The flexible slots are individual transverse or lateral (56) slots (252) in the wall (224) of the tube (250) that impart flexibility to the tube. FIG. 4A shows the flexible slots (252) in detail. The flexible slots (252) extend partially around the periphery (62) of the tube wall (224). The lateral length of the slots (sl) is greater than their width (see FIG. 2D). The path of the slots is preferably linear around the periphery (62) of the tube wall (224). The path of the flexible slots (252) can coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible slots (252) can terminate in spacers (254) configured to reduce bending forces (see FIG. 4B). The spacers (254) can be circular.

[0041] In a closed flexible slot 252, the inner edges of the slot form a continuous path. In an open flexible slot 252, the inner edges of the slot form a discontinuous path, and the open ends of the flexible slot 252 may open, for example, to an observation fenestration 258. Most or all of the flexible slots 252 are axially spaced apart.

[0042] The flexible slots (252) are preferably arranged in one or more (e.g., preferably two) rows (262) extending proximally to distally. There can be four or five or more flexible slots (252) in a row. One or more rows of flexible slots (252) can be located only in the posterior (54) half of the transverse cross-section, or one row of flexible slots (252) can be located only in the anterior (52) half of the transverse cross-section. By limiting the flexible slots to these regions, bending can be limited to, or confined to, a first plane, or concentrated in the first plane.

[0043] Flexible openings 257 are individual closed openings 256-b in the wall 224 of tube 250 that enhance the flexibility of tube 250. Flexible openings 257 are closed openings, and the inner edges of the openings form a continuous pathway.

[0044] The flexible openings may be stent openings (257, 256-b). The stent openings provide a partially stented appearance to the vessel. FIG. 4C shows details of the stent openings (257, 256-b). For example, FIGS. 6 and 6A show stent openings (257, 256-b) disposed in the vessel wall of the delivery shaft assembly. The stent openings (257, 256-b) are arranged in one or more (e.g., preferably two) rows (262) extending from proximal to distal. The stent openings (257, 256-b) are spaced apart axially and circumferentially. 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 a triangular, diamond, pentagonal, hexagonal, or polygonal shape. The stent openings (257, 256-b) provide lateral visibility of the implant in addition to increasing the bendability of the tube (250).

[0045] The ocular implant (230) (also known herein as "implant") can be optionally placed in a subject (animal, human) using an insertion tool. In particular, the implant (230) can be an implant for treating glaucoma. In particular, the implant (230) can be an intraocular shunt. The implant (230) can be intended for implantation in a therapeutic target. The therapeutic target can be between the sclera and choroid, i.e., in the suprachoroidal space, between the conjunctiva and sclera (subconjunctival space), or within the sclera (intrascleral space). The implant (230) can be 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, and / or 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.

[0046] 3 and 3A show an exemplary implant (230). The exemplary implant (230) has a longitudinal configuration. The exemplary implant (230) has a proximal end (20) and a distal end (40). The long sides can be straight and parallel. The long sides can be rounded. The proximal and distal ends can be flat and parallel. The end edges can be rounded. The transverse cross section (C-C') (FIG. 3A) can be longitudinal. The implant (220) can have an oval shape in plan view. The implant (220) can have an oval shape in transverse cross section.

[0047] The implant can have one or more markers (205) placed thereon, allowing the user placing the shunt or implant to control the depth of the implant at the treatment target, with a portion remaining in the anterior chamber. Placement of the shunt or implant within the eye is performed using an implant or placement device. The shunt or implant (200) can have a marker (205) located near its proximal end (20), allowing its location to be viewed through the viewing window (258). It will be readily apparent that other markers (205) can be placed on the implant (200) for better visibility, for example, two markers can be placed on the proximal end (20) of the implant (200).

[0048] Typically, the implant (230) has a longitudinal length (i) between 3 mm and 9 mm. The implant (230) can have a thickness (i) between 0.3 mm and 1 mm. The implant (230) can have a width (i) 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. Dimensional indicators are shown in Figures 3 and 3A.

[0049] The implant (200) is located at the distal end (40) of the delivery shaft (240) before the implant. Preferably, the implant (200) is located at least partially within the distal adaptation section (244). The implant (200) can be located only within the distal adaptation section (244).

[0050] The implant can be made of a biocompatible material, such as those described in EP 2517619, which is incorporated herein by reference. It will be readily apparent that the implant can be made of other suitable biocompatible materials, such as silicone. In EP 2517619, the biocompatible material described comprises a porous, biocompatible polymer scaffold defining an array of interconnected pores of the same diameter. 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, a preferred range is between about 25 μm and about 36 μm.

[0051] The delivery shaft 220 has a proximal end 20 and a distal end 40. The delivery shaft 220 has an internal longitudinal lumen 222 that is open at both the proximal end 20 and the distal end 40. The lumen 222 has a longitudinal profile in the transverse (A-A', B-B') cross-section (FIGS. 2A, 2B). The lumen 222 can have an oval profile in the transverse (A-A', B-B') cross-section (FIG. 2A), and the corners can be rounded. The transverse cross-section of the lumen 222 can have a uniform size and shape along the proximal-distal direction in the fitting portion 240. The transverse cross-section of the lumen 222 can have a uniform size and shape along the proximal-distal direction in the proximal section 242. The transverse cross-section of the lumen (222) can have a uniform size and shape along the proximal-distal direction at the distal conforming section (244). The lumen (222) is configured to hold an implant (230).

[0052] The proximal end (20) of the delivery shaft (220) is attached to the adapter (210). As shown, the proximal end extends into the body of the adapter for fixation and stability of the adapter.

[0053] 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 resistance include wall thickness, lumen size, and tube material. Those skilled in the art will readily understand how to impart bend resistance to a tube. For reference, 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. Properties of the tube material may include a modulus of elasticity of less than 310 kpsi. One or more flexible slots 252 and / or flexible openings 257 may be added to the tube 250 to impart bendability, for example, in the first plane 60 or in a plane including or converging on the first plane.

[0054] The use of a metal, bend-resistant tube allows for a reduction in the outer diameter of the delivery shaft (220) compared to one formed from a polymer. A smaller diameter delivery shaft causes less damage to the treatment target. Additionally, it reduces cyclolysis. Furthermore, the metal, bend-resistant tube can be sterilized, for example, by steam and / or by immersion in saline under sterile conditions (e.g., 121°C for 30 minutes) and then stored in saline. This reduces manufacturing costs because the delivery shaft (220) can be sterilized in the same container in which it is sterilized and stored without loss of form or function.

[0055] The bend-resistant tube (250) is made from a compliant material. Compliant means that a leaf spring formed from the material can flexibly deflect from its original shape upon application of a mechanical displacement force and return to its original shape when the mechanical force is removed. A material that exhibits the properties of a leaf spring is a compliant material. When the material is rolled into a tube, the tube is no longer compliant, i.e., bend-resistant. One or more flexible slots (252) and / or one or more flexible openings (257) added to the tube (250) provide the tube (250) with bending and compliant properties. The material can be opaque to light. Examples of suitable materials include metals such as Nitinol.

[0056] As described elsewhere, the delivery shaft (220) includes a distal conforming section (244). The distal conforming section (244) can have a length that is 15 to 35% of the overall length of the exposed delivery shaft (220). The distal conforming section (244) is biased in a curvature that is parallel to the first plane (60). The delivery shaft (220) further includes a distal tip section (246).

[0057] The one or more flexible slots (252) and / or one or more flexible apertures (257) and / or observation fenestrations (258) (and the axial-longitudinal opening slots (270-a, 270-b, 280-a, 280-b), and / or living hinges described elsewhere herein) can be introduced into the tube (250) by any method that removes predetermined areas of the tube wall (224). Exemplary methods include laser cutting, photochemical etching, conventional chipping techniques such as deep drawing, drilling, or milling, high-pressure water jet cutting systems, or any suitable available material removal process. Preferably, laser cutting is used because it allows for very precise and clean removal of material under reasonable economic conditions.

[0058] The delivery shaft (220) and its multiple parts and sections are preferably formed from a unitary tube (250).

[0059] The delivery shaft (220) can have a length in the axial direction (a-a') of 35 to 40 mm, preferably 34 to 37 mm. The 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 millimeters (0.5 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) can have a maximum outer tube width (tw in FIG. 2A) across the sides of 0.9 to 1.3 mm, preferably about 1.05 to 1.25 mm, and more preferably 1.15±0.1 mm. The delivery shaft (240) can have an outer tube height (th in FIG. 2A) across the posterior to anterior sides of 0.5 to 0.7 mm, preferably about 0.52 to 1.24 mm.

[0060] As described elsewhere herein, the distal conforming section (244) is conformable, repeatedly bendable, and biased into a curve. The curve is in a posterior (54) direction. The curve can be in a first plane (60). The curve can have a path that is a circular segment. The curve corresponds to the curvature of the eye. The distal conforming section (244) can have a length of 9 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 curve to the proximal end of the distal tip section (246).

[0061] The distal conforming section (244) can have a maximum outer tube width (tw in FIG. 2A) across the sides of 0.9 mm to 1.3 mm, preferably about 1.05 mm to 1.25 mm, and more preferably 1.15±0.1 mm. The delivery shaft (240) can have an outer tube height (th in FIG. 2A) across the posterior to anterior sides of 0.5 mm to 0.8 mm, preferably about 0.52 mm to 0.62 mm.

[0062] The conformability and flexibility of the distal conforming section 244 can be achieved by a plurality of flexible slots 252. The flexible slots are individual lateral or side 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 lateral length of the slots 56 is greater than their width. The path of the slots is preferably linear. Most or all of the flexible slots 252 in the distal conforming section 244 can be closed slots, i.e., the inner edges of the slots form a continuous path (e.g., Figures 5 and 6). Most or all of the flexible slots 252 in the distal conforming section 244 can be open slots, i.e., the inner edges of the slots open into the observation fenestration 258 (e.g., Figures 7 and 8).

[0063] The path of the flexible slot (252) can coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible slot (252) can terminate in a spacer (254) configured to reduce the force required to bend the distal compliant section (244) (see FIG. 4B). The spacer (254) can be circular.

[0064] Each flexible slot (252) in the distal conforming section (244) can span a portion of the circumferential path (62) of the tube (250) in a transverse cross section (see FIG. 2D). The circumferential path (62) of the tube (250) in a transverse cross section (also known as the circumferential path) refers to the circumferential path of the tube along the transverse cross section (see FIG. 2C). The flexible slot length (sl) in the distal conforming section (244) can be a portion of the length (pl) of the circumferential path (62) of the tube (250) and can range from 1 to 80%. The flexible slot length (sl) can be smaller in an axial region including the observation fenestration (258) than it would be without the observation fenestration.

[0065] The flexible slots (252) of the distal conforming section (244) can be located only in the posterior (54) half of the transverse cross-section or in the anterior half. Any flexible slots (252) of the distal conforming section (244) are axially spaced apart. The flexible slots are preferably arranged in one or more (e.g., preferably two) rows (262) extending from proximal to distal.

[0066] Most or all of the flexible slots (252) in the distal compliant section (244) can be configured to impart bendability to the distal compliant section (244). The flexible slots (252) can be arranged so that the bendability is in at least a first plane, for example, a plane that includes, centers around, or is limited to the first plane.

[0067] The conformability and flexibility of the distal conforming section (244) can be further enhanced by a plurality of separate, closed, flexible openings (256-b) in the wall (224) of the tube (250), known as stent openings (257), which together give the tube (250) a partially stent-like appearance. Figure 4C shows the stent openings (257, 256-b) in detail. Figures 6 and 6A show the stent openings (257, 256-b) positioned in the tube wall of the delivery shaft assembly.

[0068] Most or all of the stent openings (257, 256-b) in the distal conforming section (244) are at least axially spaced apart. Most or all of the stent openings (257, 256-b) are confined to one or more (preferably two) axial rows (260', 260") (see FIG. 6C). The axial rows (260', 260") are positioned (circumferentially) between either side of the observation fenestrations (258) and the rows of flexible slots (252).

[0069] The axial rows (260', 260") can span a portion (260', 260") of the transverse cross-sectional circumferential path (62) of the tube (250) (see Figure 6C). The transverse cross-sectional circumferential path (also known as the circumferential path) (62) of the tube (250) refers to the circumferential path of the tube along the transverse cross-section (see Figure 2C). Each axial row (260', 260") can be a portion, for example, less than 10%, of the length (pl) of the circumferential path (62) of the tube (250).

[0070] The stent openings (257, 256-b) of the distal conforming section (244) can be located only in the lateral (56) sections of the transverse cross-section. Most or all of the stent openings (257, 256-b) of the distal conforming section (244) are at least axially spaced apart.

[0071] Most or all of the stent openings (257, 256-b) can be regularly spaced apart. Most or all of the stent openings (257, 256-b) can have the same shape and / or size. Most or all of the stent openings (257, 256-b) can have a triangular, diamond, pentagonal, hexagonal, or polygonal shape.

[0072] Most or all of the stent openings (257, 256-b) in the distal conforming section (244) may be configured to provide additional flexibility to the distal conforming section (244).

[0073] The presence of the stent opening (257) allows for improved lateral visibility of the implant during surgery, allowing for safe "first time right" implant release.

[0074] At least a portion of the distal adapting section 244 may include an observation fenestration 258, as described below. The observation fenestration 258 may be located exclusively on the forward (52) side of the tube 250. The observation fenestration 258 may be a closed opening 256-a, i.e., the edges of the opening form a closed pathway or an open axial-longitudinal slot 280-a. The observation fenestration 258 may or may not extend proximally 20 into the proximal section 242. The observation fenestration 258 may or may not extend distally 30 into the distal tip section 246.

[0075] The distal tip section (246) is an atraumatic tip configured to penetrate a treatment target. Specifically, it is configured to pry apart tissue, for example, the sclera and choroid (suprachoroidal space), the conjunctiva and sclera (subconjunctival space), or the intrasclera (intrascleral space). The distal tip section (246) is the portion of the delivery shaft (220) where the transverse profile of the canal wall (224) preferably gradually decreases in size distally (40). The reduction in size may result from a beveled tip (e.g., FIGS. 2, 5, 5B, 6, 6B, 7, 7C) or a narrowing of the wall (250) (e.g., FIG. 8B).

[0076] The distal tip section (246) can include a beveled distal end (251) of the tube (250). The beveled distal end of the tube (250) can be formed from an oblique cut at the distal end of the tube (250). Examples of distal tip sections (246) with beveled distal end cuts are shown, for example, in Figures 2, 5, 6, and 7. The beveling is such that the forward (52) side of the lumen (222) of the tube (250) is exposed.

[0077] The distal tip section 246 can comprise a tapered distal end of the tube 250. The tapered distal end of the tube 250 can be formed by introducing a pair of lateral slots 56, open slots 270, at the distal 40 end of the tube 250, thereby forming a pair of jaws 272, 274, and compressing the jaws 272, 274 together. An example of a distal tip section 246 having a tapered distal end of the tube 250 is shown, for example, in FIG. 8. The distal tip section 246 can be non-compliant or compliant, preferably compliant.

[0078] The tube (250) at the distal mating section (244) can include a pair of open axial-longitudinal slots (280-a, 280-b) extending to the distal end (251) of the tube (250) and defining a pair of retention arms (282, 284). The open slots open at the distal end. The pair of retention arms (282, 284) are configured to hold the implant prior to deployment. The pair of retention arms (282, 284) are configured to guide the implant out of the delivery shaft (220) during deployment.

[0079] The closed ends (253) of the axially-longitudinal open slots (280-a, 280-b) can be in the proximal section (242) or in the distal adapting section (244), preferably in the distal adapting section (244).

[0080] The pair of axially-longitudinal open slots (280-a, 280-b) may be opposite each other. The pair of axially-longitudinal open slots (280-a, 280-b) may be disposed diametrically around the tube (250). One axially-longitudinal open slot (280-a) may be disposed on the forward side (52) of the tube (250), and the other axially-longitudinal open slot (280-b) may be disposed on the rearward side (54) of the tube (250). The pair of retention arms (282, 284) may be disposed opposite each other. The pair of retention arms (282, 284) may be disposed diametrically around the tube (250). One of the pair of retention arms (282, 284) may be disposed on each lateral side (56) of the tube (250).

[0081] An open axial-longitudinal slot (280-a) located on the front (52) side of the tube (250) can serve as an observation fenestration (258).

[0082] Along one or both of the open axial-longitudinal slots (280-a, 280-b), the tube (250) may include one or more transverse struts (286), each spanning the periphery of the open axial-longitudinal slot (280-a, 280-b). Along one or both of the open axial-longitudinal slots (280-a, 280-b), the tube (250) may include one or more axial struts (288), each spanning a portion of the axial length of the open axial-longitudinal slot (280-a, 280-b).

[0083] The axial length of one or both of the open axial-longitudinal slots (280-a, 280-b) can be equal to or greater than the axial length of the implant (230). The axial length of one or both of the open axial-longitudinal slots (280-a, 280-b) can be at least 4 mm. One or both of the open axial-longitudinal slots (280-a, 280-b) may or may not extend the length of the canal (250). The upper limit of the axial length can be 8 mm. The circumferential width of each open slot (280-a, 280-b) can be the same or different. The circumferential width of the open slots (280-a, 280-b) can be 30 to 40% or less of the total perimeter (p1) of the canal (250). The axial-longitudinal viewing fenestration (258) can be formed from the anterior open axial-longitudinal slot (280-a). 7, 7A, and 7B show an example of a tube (250) with a pair of axially-longitudinal open slots (280-a, 280-b) that define a pair of retaining arms (282, 284).

[0084] Because the implant (230) is transparent, visibility during surgery can be an issue. The presence of two opposing axial-longitudinal open slots (280-a, 280-b) allows for illumination from below to improve visibility of the entire implant, not just the markers. Additionally, the distal tip section is formed with less tubing, resulting in improved tip precision.

[0085] The tube 250 in the distal tip section 246 can have a pair of open axial-longitudinal slots 270-a, 270-b that extend to the distal end 251 of the tube 250 and define a pair of restrictive jaws 272, 274. The open slots 270-a, 270-b open at their distal ends. One jaw is the forward jaw 272 and the other is the rearward jaw 274. The closed ends 253 of the open axial-longitudinal slots 270-a, 270-b can be in the distal conforming section 244 or in the distal tip section 246, preferably in the distal tip section 246.

[0086] The pair of axially-longitudinal open slots (270-a, 270-b) may be opposite each other. The pair of axially-longitudinal open slots (270-a, 270-b) may be positioned diametrically opposite each other around the tube (250). Both axially-longitudinal open slots (270-a, 270-b) may be positioned on the lateral sides (56) of the tube (250). The pair of restricting jaws (272, 274) may be positioned opposite each other. The pair of restricting jaws (272, 274) may be positioned diametrically opposite each other around the tube (250). One restricting jaw (272) may be positioned on the forward side (52) of the tube (250), and the other restricting jaw (274) may be positioned on the rearward side (54) of the tube (250).

[0087] One or both of the front jaws (272) and rear jaws (274) may approach at an angle toward the central axis (a-a') of the tube (250). One or both of the front jaws (272) and rear jaws (274) may be arranged with a plurality of radial slits forming an integral hinge (276). The axial length of one or both of the axial-longitudinal open slots (270-a, 270-b) may be 1.6 mm to 2 mm. The jaws are flexible and biased toward approximation around the hinge. The maximum circumferential width of each of the axial-longitudinal open slots (270-a, 270-b) may be 30% or less (e.g., 10% to 20%) of the overall circumference (p1) of the tube (250). 8 and 8A show an example of a tube (250) with a pair of axial-longitudinal open slots (270-a, 270-b) that define a pair of restrictive jaws (272, 274).

[0088] The constraining jaws (272, 274) advantageously provide a blunt distal tip section (246) that mechanically separates the treatment tissue during implant placement. The pair of surfaces (anterior and posterior) provided by the jaws support the treatment tissue over a larger surface area compared to beveled tips, resulting in reduced trauma and bleeding. Additionally, the closed jaws retain the implant within the lumen, preventing loss of the implant during storage, transport, and manipulation.

[0089] As described above, at least a portion of the delivery shaft 240 can include an axial-longitudinal observation fenestration 258 (see FIGS. 2B and 4D). The observation fenestration 258 comprises a longitudinal opening in the vessel wall 224 on the anterior 52 side, connecting the lumen 222 to the exterior of the vessel 250. The observation fenestration 258 allows visualization of the implant 230, specifically the marker 205. The observation fenestration 258 allows visualization of the implant 230 relative to the therapeutic target prior to placement. The observation fenestration 258 allows visualization of the placement of the implant 230. The observation fenestration 258 can be located on the anterior 52 side of the vessel 250. The observation fenestration 258 can be limited to the anterior 52 side of the vessel 250.

[0090] The observation fenestrations 258 can span a portion of the transverse cross-sectional circumferential path 62 of the tube 250. The width (ow) of the observation fenestrations 258 can be a fraction of the length (pl) of the circumferential path 62 of the tube 250, for example, in the range of 10 to 35%. In the embodiment of Figure 7, the fraction of the observation fenestrations 258, 270-a can be approximately 30%. In the embodiment of Figure 8, the fraction of the observation fenestrations 258, 256-a can be approximately 14%.

[0091] The width (ow) of the observation window (258) can range from 0.2 mm to 1.0 mm. In the embodiment of FIG. 5, the width (ow) of the observation window (258) can be approximately 0.6 mm. The width (ow) of the observation window (258) can range from 0.2 mm to 1.0 mm. In the embodiment of FIG. 6, the width (ow) of the observation window (258) can be approximately 0.4 mm. In the embodiment of FIG. 7, the width (ow) of the observation window (258) can be approximately 0.8 mm. In the embodiment of FIG. 8, the width (ow) of the observation window (258) can be approximately 0.4 mm.

[0092] An observation fenestration (258) can be disposed in the distal adapting section (244), and optionally in at least a portion of the proximal section (242). The observation fenestration (258) may or may not extend into the distal tip section (246). The axial length of the observation fenestration (258) can be 6 mm or greater. The axial length of the observation fenestration (258) can be less than 12 mm. The observation fenestration (258) can be sized to retain the implant (230) before and during deployment.

[0093] In a particular embodiment, the observation fenestration 258 is an aperture 256-a, as shown in Figures 5A, 6A, and 8A, where the edges of the aperture form a closed passage. In another embodiment, the observation fenestration 258 is an open axial-longitudinal slot 280-a, as shown in Figure 7A.

[0094] The delivery shaft assembly 200 further includes an adapter 210 configured to couple to an insertion tool 500. The implant 230 is disposed at or toward 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 includes a body having a receiving space 212 for a portion of the insertion 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 to allow the ejection shaft 510 of the insertion tool 500 to pass through. The implant 230 is ejected from the delivery shaft 220 by actuation of the insertion tool 500, resulting in delivery of the implant 230 to the therapeutic target. An exemplary delivery shaft assembly (200) is disclosed in International Publication No. WO 2017 / 108498, the disclosure of which is incorporated herein by reference.

[0095] The proximal section 242 is adjacent to the distal mating 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. Bend resistance is an inherent property of the bend-resistant tube 250. Figures 5, 6, 7, and 8 show an embodiment in which the proximal section of the tube 250 is bend-resistant along its entire axial length.

[0096] The proximal section (242) can include one or more compliant portions (248). The one or more compliant portions (248) can be linearly biased. The one or more compliant portions (248) can bend in at least a first plane, for example, within a plane that includes, converges on, or is limited to the first plane. Figures 5B, 6B, 7C, and 8B show an embodiment in which the proximal section tube (250) includes the compliant portion (248).

[0097] When one or more conforming sections 248 are present in the proximal section 242, conformability and flexibility 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 outer periphery (62) of the tube wall 224. The lateral length of the slot (sl) is greater than its width. The slot path is preferably linear. Most or all of the flexible slots 252 in the conforming portion 248 can be closed slots, i.e., the inner edges of the slots form a continuous path.

[0098] Figure 4A shows details of the flexible slot (252). The path of the flexible slot (252) can coincide with a plane parallel to the central axis (a-a') of the tube (250). One or both ends of the flexible slot (252) can terminate in a spacer (254) configured to reduce the force required to bend the compliant portion (248) (see Figure 4B). The spacer (254) can be circular.

[0099] Each flexible slot (252) can span a portion of the circumferential path (62) of the tube (250) in a transverse cross section (see FIG. 2D). The circumferential path (62) of the tube (250) in a transverse cross section (also known as the circumferential path) refers to the circumferential path of the tube along the transverse cross section (see FIG. 2C). The flexible slot length (sl) in the fitting portion (248) of the proximal section (242) can be a portion of the length (pl) of the circumferential path (62) of the tube (250), for example, 1% to 80%, e.g., 1% to 40%.

[0100] The flexible slots (252) of the compliant portion (248) can be located only in the posterior (54) half or only in the anterior (52) half of the transverse cross-section. Most or all of the flexible slots (252) of the compliant portion (248) are axially spaced apart. The flexible slots are preferably arranged in one or more (preferably two) rows extending from proximal to distal.

[0101] Most or all of the flexible slots (252) of the compliant portion (248) can be arranged so that their flexibility is in at least a first plane, for example, in a plane that includes or is centered on the first plane, or is limited to the first plane.

[0102] At least a portion of the proximal portion 242 can include an observation fenestration 258, as described above. The observation fenestration 258 can be located exclusively on the forward side 52 of the tube 250. The observation fenestration 258 can be a closed opening 256-a, i.e., the edges of the opening can form a closed passage or an open axial-longitudinal slot 280-a. The observation fenestration 258 can extend distally 40 into the distal fitting section 244.

[0103] The proximal section (242) can have a length in the axial direction (a-a') of 26 to 30 mm. The length is measured along the central axis (a-a') from the distal end of the adapter (210) to the proximal end of the distal fitting section (244). The proximal section (242) can have a maximum outer tube width (tw in FIG. 2A) across the sides of 0.9 mm to 1.5 mm, preferably about 1.05 mm to 1.25 mm, and more preferably 1.15 ± 0.1 mm. The delivery shaft (240) can have an outer tube height (th in FIG. 2A) across the posterior to anterior sides of 0.5 mm to 0.7 mm, preferably about 0.52 mm to 1.24 mm.

[0104] At least the delivery shaft 220 and optionally the adapter 210 can include a sheath that protects at least the delivery shaft 220 and optionally the adapter 210. The sheath can be made from a heat-shrinkable polymer, such as a polyester heat-shrinkable film.

[0105] This specification provides a method for manufacturing a delivery shaft assembly as described herein. The delivery shaft (220) and multiple portions and sections are preferably formed from a single unitary tube (250). The flexible slots (252) and / or flexible apertures (256-b), observation fenestrations (258), axial-longitudinal open slots (270-a, 270-b, 280-a, 280-b), and / or living hinges (276) can be introduced into the tube (250) by any method that removes tube material from the tube wall (224). Exemplary methods include laser cutting, photochemical etching, deep drawing, conventional chipping techniques such as drilling or milling, high-pressure water jet cutting systems, or any suitable available material removal process. Laser cutting is preferably used because it allows for very precise and clean removal of material under reasonable economic conditions.

[0106] The method for manufacturing a delivery shaft assembly described herein includes: providing a delivery shaft (220) having a proximal (20) end and a distal (20) end and an inner lumen (222) configured to hold an implant (230), the delivery shaft (220) being formed from a conformable material formed into a bend-resistant tube (250); - introducing a curvature into the distal end of the delivery shaft (220), thereby forming a distal conforming section (244); - forming an atraumatic portion on the distal tip section (246); - introducing a plurality of flexible slots (252) and / or flexible openings (256-b) into the distal conforming section (244) to provide conformability and flexibility by removing material from the tube wall (224); - introducing an observation fenestration (258) by removing material from the vessel wall (224); Includes.

[0107] Other features, including the flexible slot (252), flexible opening (257), axial-longitudinal open slots (270-a, 270-b, 280-a, 280-b) and / or living hinge (276) in the proximal section (242), if present, can be introduced by removing tubing material from the tube wall (224).

[0108] The present specification provides a delivery shaft assembly (200) manufactured by one of the methods described herein.

[0109] The insertion tool (500) includes 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) results in the ejection of the implant (230) from the lumen (222) (see panels A and B of Figure 1).

[0110] Distal advancement of the ejection shaft 510 can apply a force to the implant 230, causing it to be ejected from the shaft assembly lumen 220. Alternatively or additionally, retraction of the delivery shaft 220 relative to the fixed ejection shaft 510 causes the implant 230 to be ejected from the shaft assembly lumen 220.

[0111] The insertion tool 500 includes an adapter coupler 520 configured to couple with the adapter 210. The coupling between the adapter coupler 520 and the adapter 210 can be releasable or non-releasable. A non-releasable coupling can be achieved, for example, by providing a receiving member on one side of the adapter coupler 520 or the adapter 210 and a reciprocating stop member on the other side, where the receiving member slides across the stop member in one direction when the parts 520, 210 are coupled, and the receiving member engages the stop member in the other sliding direction to prevent the parts 520, 210 from disengaging. This mechanism is similar to the unidirectional movement of a ratchet mechanism.

[0112] When the implant is ejected by retracting the delivery shaft 220 relative to the fixed ejection shaft 510, the adapter coupler 520 can be slidable relative to the fixed ejection shaft 510. The slidable adapter coupler 520 has an initial position and a deployed position. In the initial position, the slidable adapter coupler 520 positions 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 coupler 520 positions the adapter 210 and the delivery shaft lumen 222 in a proximal-most position. The ejection shaft (510) abuts the implant (230), and the delivery shaft lumen (222) retracts proximally (20), releasing the implant (230). When the implant is ejected by advancing the ejection shaft (510), the ejection shaft (510), which is slidable relative to the fixed adapter coupler (520), exerts an ejection force distally on the implant (230), causing it to be ejected from the lumen (222).

[0113] FIG. 1 presents an example of a portion of an insertion tool 500, showing an inserter housing or chassis 550 (fixed) and a slidable adapter coupler 520 configured to engage with the adapter 210 of the delivery shaft assembly 200. The ejection shaft 510 is disposed in a fixed relationship relative to the housing 550. In this example, the adapter coupler 520 is slidable relative to the housing 550 and is shown in an initial position; however, it should be understood that other configurations of the insertion tool 500 exist, for example, where the adapter coupler 520 is disposed in a fixed relationship relative to the insertion tool housing and the ejection shaft 510 is slidable. In panel A, the insertion tool 500 is shown in the initial position, with the adapter coupler 520 in a distal position. In the initial position, the implant 230 is retained within the delivery shaft lumen 222. In panel B, the insertion tool (500) is shown in the deployed position with the adapter coupler (520) retracted to the proximal (20) position. In the deployed position, the delivery shaft is retracted, thereby ejecting the implant (230) from the delivery shaft lumen (222). An exemplary insertion tool (500) is disclosed in WO 2017 / 108498, the disclosure of which is incorporated herein by reference.

[0114] Implantation of the implant 230 can begin, for example, in an ab interno manner. The implant 230 is held within the delivery shaft lumen 222 of the delivery shaft 220, which is mounted on the ejection shaft 510 of the insertion tool 500. The distal tip section 246 can be used to facilitate penetration of the delivery shaft 220 through the cornea. It should be readily apparent that the distal tip section 246 does not require an incision to be made in the cornea; this can be performed with a separate tool, and the delivery shaft 220 is inserted into the incision. The delivery shaft 220 is directed across the cornea in the anterior chamber of the eye and into the subscleral space. The distal tip section 246 performs atraumatic penetration into the subscleral space. The delivery shaft 220 is retracted relative to the ejection shaft 510 of the insertion tool 500, leaving the implant 230 in place within the subscleral space.

[0115] According to one embodiment, the delivery shaft assembly (200) comprises a delivery shaft (220) having an inner lumen (222) configured to hold an implant (230); the delivery shaft (220) is repeatedly bendable (60) and is conformable, and includes a distal conformable section (244) biased to a first plane of curvature; the delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; the delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), the wall (224) of the tube (250) at the distal conformable section (244) comprising a plurality of flexible slots (252) that provide bendability; the flexible slots (252) of the distal fitting section (244) are arranged in a restricted row (262) in the rear half (54) of the transverse cross section of the tube (250); - The tube (250) is provided with an observation window (258), which is an axial-longitudinal opening (256-a) located on the anterior (52) side of the tube (250) configured to visualize at least a portion of the implant (230) before and during placement.

[0116] Examples of the above-described embodiments are shown in Figures 5 and 5A. Elements of the above-described embodiments are described elsewhere herein. Specific embodiments are highlighted as follows: The majority, and preferably all, of the flexible slots (252) are parallel to a plane perpendicular to the central axis (a-a'). The distal tip section (246) can comprise a beveled distal end (251) of the tube (250).

[0117] The axial-longitudinal opening (256-a) can be at least partially disposed in the distal conforming section (244), and optionally in at least a portion of the proximal section (242). The axial-longitudinal opening (256-a) can extend into the distal tip section (246).

[0118] The flexible slot length (sl) of the distal fitting section (244) may be a portion of the length (pl) of the circumferential path (62) of the tube (250), and may range from 25 to 30% in the axial region of the observation window (258).

[0119] As described elsewhere, the delivery shaft can further include a proximal section (242) adjacent to the distal compliant section (244) and extending proximally relative to the adapter (210). The proximal section (242) may or may not include one or more compliant portions (248). Each flexible slot (252) in the compliant portion (248) can have a lateral length (sl) that is a fraction of the circumferential length (pl) of the tube (250), the fraction ranging from 1 to 80%.

[0120] Most, and preferably all, of the flexible slots (252) may terminate in circular spacers (254) configured to reduce bending forces.

[0121] According to another aspect, the delivery shaft assembly (200) comprises a delivery shaft (220) having an inner lumen (222) configured to hold an implant (230); the delivery shaft is repeatedly bendable (60) and includes a distal conforming section (244) that is conformable and biased to a first plane of curvature; the delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; the delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), the wall (224) of the tube (250) at the distal conformable section (244) comprising a plurality of flexible slots (252) that provide bendability; the tube (250) comprises an observation fenestration (258), which is an axial-longitudinal opening (256-a) located on the anterior (52) side of the tube (250) configured to allow visualization of at least a portion of the implant (230) before and during placement; the flexible slots (252) of the distal fitting section (244) are arranged in a restricted row (262) in the rear half (54) of the transverse cross section of the tube (250); the wall (224) of the tube (250) in the distal conforming section (244) further comprises a plurality of flexible openings (256-b), known as stent openings (257), which provide additional flexibility; The plurality of stent openings (257, 256-b) are arranged in two axial rows (260', 260"), each row located between rows (262) of flexible slots (252) on either side of the observation fenestration (258).

[0122] Examples of the above-described embodiments are shown in Figures 6, 6A-6C. Elements of the above-described embodiments are described elsewhere herein. Specific embodiments are highlighted as follows: The majority, and preferably all, of the flexible slots (252) are parallel to a plane perpendicular to the central axis (a-a') of the tube (250). The distal tip section (246) can comprise a beveled distal end of the tube (250).

[0123] The axial-longitudinal opening (256-a) can be located at least partially in the distal conforming 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).

[0124] The flexible slot length (sl) of the distal adaptation section (244) may be a portion of the length (pl) of the circumferential path (62) of the tube (250) and may range from 13 to 19% in the axial area of ​​the stent opening (257).

[0125] As described elsewhere, the delivery shaft can further include a proximal section (242) adjacent to the distal compliant section (244) and extending proximally relative to the adapter (210). The proximal section (242) may or may not include one or more compliant portions (248). Each flexible slot (252) in the compliant portion (248) can have a lateral length (sl) that is a fraction of the circumferential length (pl) of the tube (250), the fraction ranging from 1 to 80%.

[0126] Most, and preferably all, of the flexible slots (252) in the proximal section (242) may terminate in circular spacers (254) configured to reduce the force required for bending.

[0127] The flexible openings (252) can have the same shape, for example, a polygon. The presence of the stent openings (257) improves lateral visibility of the implant during surgery, allowing for a safe "first time right" release of the implant.

[0128] According to another aspect, the delivery shaft assembly (200) comprises a delivery shaft (220) having an inner lumen (222) configured to hold an implant (230); the delivery shaft (220) is repeatedly bendable (60), is conformable, and comprises a distal conformable section (244) biased in a curvature parallel to a first plane; the delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; the delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), the wall (224) of the tube (250) at the distal conformable section (244) comprising flexible slots (252) that provide bendability; the tube (250) comprises a pair of axial-longitudinal open slots (280-a, 280-b) located on the front (52) and rear (54) sides of the tube (250) and extending to the distal end (251) of the tube (250) and defining a pair of retention arms (282, 284) configured to hold the implant (230) prior to deployment; The tube (250) is provided with an observation fenestration (258) which is an axial-longitudinal open slot (280-a) located on the front (52) side of the tube (250).

[0129] Examples of the above-described embodiments are shown in Figures 7 and 7A. Elements of the above-described embodiments are described elsewhere herein. Specific embodiments are highlighted as follows: Most, and preferably all, of the flexible slots (252) are parallel to a plane perpendicular to the central axis (a-a'). Each flexible slot (252) in the proximal section (242) can be a closed slot. Each flexible slot (252) in the distal conforming section (244) can be an open slot. The distal tip section (246) can comprise a beveled distal end of the tube (250).

[0130] The closed ends 253 of the open axial-longitudinal slots 280-a, 280-b can be in the proximal section 242 or in the distal conforming section 244, preferably in the distal conforming section 244. The maximum circumferential width of each of one or both open axial-longitudinal slots 280-a, 280-b can be 30 to 40% of the total circumferential length (p l ) of the tube 250.

[0131] The flexible slot length (sl) in the distal fitting section (244) may be a portion of the length (pl) of the circumferential path (62) of the tube (250) and may range from 8 to 14% in the axial region of the axial-longitudinal open slots (280-a, 280-b).

[0132] The flexible slot length (sl) in the distal fitting section (244) may be a portion of the length (pl) of the circumferential path (62) of the tube (250), and may range from 1% to 80%, for example, from 31% to 37%.

[0133] As described elsewhere, the delivery shaft can further include a proximal section (242) adjacent to the distal compliant section (244) and extending proximally relative to the adapter (210). The proximal section (242) may or may not include one or more compliant portions (248). Each flexible slot (252) in the compliant portion (248) can have a lateral length (sl) that is a fraction of the circumferential length (pl) of the tube (250), the fraction ranging from 1 to 80%.

[0134] Most, and preferably all, of the flexible slots (252) can terminate in circular spacers (254) configured to reduce the force required for bending. Because the implant (230) is transparent, visibility during surgery can be an issue. The presence of two opposing axial-longitudinal open slots (280-a, 280-b) allows for illumination from below to improve visibility of not only the markers but the entire implant. Additionally, the distal tip section can be formed using less tubing, resulting in improved tip precision.

[0135] According to another aspect, the delivery shaft assembly (200) comprises a delivery shaft (220) having an inner lumen (222) configured to hold an implant (230); the delivery shaft (220) is repeatedly bendable (60), is conformable, and includes a distal conformable section (244) biased with a first plane of curvature; the delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; the delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), the wall (224) of the tube (250) in the proximal section (242) and the distal conformable section (244) comprising a plurality of flexible slots (252) that provide bendability; the tube comprises an observation fenestration (258), which is an axial-longitudinal opening (256-a) located on the anterior (52) side of the tube (250), configured to allow visualization of at least a portion of the implant (230) before and during placement; the tube (250) at the distal tip section (246) comprises a pair of axially-longitudinal open slots (270-a, 270-b) extending to the distal end (251) of the tube (250) and defining a pair of restrictive jaws (272, 274); one jaw is a jaw (272) positioned at the front (52) and the other jaw is a jaw (274) positioned at the rear (54); - one or both of the front jaw (272) and the rear jaw (274) approach at an angle towards the central axis (a-a') of the tube (250); One or both of the front jaw (272) and the rear jaw (274) are arranged with a plurality of radial slits that form living hinges (276).

[0136] Examples of the above-described embodiments are shown in Figures 8 and 8A. Elements of the above-described embodiments are described elsewhere herein. Specific embodiments are highlighted as follows: Most, and preferably all, of the flexible slots (252) are parallel to a plane perpendicular to the central axis (a-a') of the tube (250).

[0137] The closed ends (253) of the open axial-longitudinal slots (270-a, 270-b) can be in the distal tip section (246) or in the proximal section (242), preferably in the distal tip section (246). Movement of the jaws about the hinge is compliant and biases them closed. The maximum circumferential width of each of one or both open axial-longitudinal slots (270-a, 270-b) can be 10 to 20% of the total circumference (p l ) of the tube (250).

[0138] The flexible slot length (sl) in the distal conforming section (244) can be a fraction of the length (pl) of the circumferential path (62) of the tube (250) and can range from 1% to 80%, for example, from 31% to 37%.

[0139] Each flexible slot (252) in the distal conforming section (244) is confined to either the posterior (54) half or the anterior (52) half of the transverse cross section of the tube (250). Most, and preferably all, of the flexible slots (252) are parallel to a plane perpendicular to the central axis (a-a').

[0140] The axial-longitudinal opening (256-a) can be located at least partially in the distal conforming 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).

[0141] As described elsewhere, the delivery shaft can further include a proximal section (242) adjacent to the distal compliant section (244) and extending proximally relative to the adapter (210). The proximal section (242) may or may not include one or more compliant portions (248). Each flexible slot (252) in the compliant portion (248) can have a lateral length (sl) that is a fraction of the circumferential length (pl) of the tube (250), the fraction ranging from 1 to 80%.

[0142] Most, and preferably all, of the flexible slots (252) may terminate in circular spacers (254) configured to reduce the force required for bending.

[0143] The insertion tool (500) can be an implant device such as that described in WO 2017 / 108498. The delivery shaft assembly (200) can include a snap-fit ​​connection element or adapter (210) such as that described in WO 2017 / 108498. For example, WO 2017 / 108498 describes the implant device (500) and delivery shaft assembly (200) on pages 26 to 33, the disclosure of which is 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: the delivery shaft assembly (200) comprises a delivery shaft (220) having an inner lumen (222) configured to hold the ocular implant (230), and an adapter (210) configured to attach to an insertion tool (500) at the proximal end (20) of the delivery shaft (220) for placement of the ocular implant (230); - said delivery shaft (220) is repeatedly bendable and conformable and comprises a distal conformable section (244) biased to a first plane of curvature (60); - the delivery shaft (220) comprises an axial-longitudinal observation fenestration (258) that allows visualization of the ocular implant (230) from the anterior (52) side of the delivery shaft (220); - said delivery shaft (220) comprises a distal tip section (246) having an atraumatic tip; the delivery shaft (220) is formed from a conformable material formed into a bend-resistant tube (250), the wall (224) of the tube (250) at the distal conformable section (244) comprising a plurality of flexible slots (252) and / or flexible openings (256-b) that impart bendability; A delivery shaft assembly (200).

2. The delivery shaft assembly (200) of claim 1, wherein the compatible material is an opaque metal.

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

4. The delivery shaft (220) further comprises a proximal section (242) adjacent the distal fitting section (244); - the tube (250) in the proximal section (242) comprises one or more fitting portions (248), or - the entire axial length of said proximal section (242) is non-conforming and straight; A delivery shaft assembly (200) according to any one of claims 1 to 3.

5. The delivery shaft assembly (200) of claim 4, wherein each of the compliant portions (248) comprises one or more flexible slots (252).

6. The delivery shaft assembly (200) of any one of claims 1 to 5, wherein the observation fenestration (258) is an axial-longitudinal opening (256-a) located on the forward (52) side of the tube (250).

7. the flexible slots (252) of the distal fitting section (244) are arranged in a row (262) restricted in the rear half (54) of the transverse cross section of the tube (250); - the wall (224) of the tube (250) in the distal conforming section (244) further comprises a plurality of flexible openings (256-b) known as stent openings (257, 256-b) which further impart a partial stent-like appearance and flexibility to the tube (250); - the stent openings (257, 256-b) are arranged in two axial rows (260', 260"), each of said rows being located on either side of said observation fenestration (258) and said row (262) of said flexible slots (252); A delivery shaft assembly (200) according to any one of claims 1 to 6.

8. - most or all of the stent openings (257, 256-b) have the same shape; and / or - most or all of said stent openings (257, 256-b) have the same size; and / or - most or all of said stent openings (257, 256-b) have a triangular, rhomboidal, pentagonal, hexagonal or polygonal shape; The delivery shaft assembly (200) of claim 7.

9. - the tube (250) at the distal tip section (246) comprises a pair of axial-longitudinal open slots (270-a, 270-b) extending to the distal end (251) of the tube (250) and defining a pair of restrictive jaws (272, 274); one of said jaws is a jaw (272) positioned at the front (52) and the other of said jaws is a jaw (274) positioned at the rear (54); - one or both of the front (52) positioned jaws (272) and the rear (54) positioned jaws (274) approach at an angle towards the central axis (a-a') of the tube (250); one or both of said forwardly (52) positioned jaw (272) and said rearwardly (54) positioned jaw (274) are arranged with a plurality of radial slits forming living hinges (276); A delivery shaft assembly (200) according to any one of claims 1 to 8.

10. The delivery shaft assembly (200) of claim 9, wherein the closed ends of the open axial-longitudinal slots (270-a, 270-b) are within the distal tip section (246).

11. - the tube (250) comprises a pair of open axial-longitudinal slots (280-a, 280-b) located on the anterior (52) and posterior (54) sides of the tube (250) and extending to the distal end (251) of the tube (250) to define a pair of holding arms (282, 284) configured to hold the ocular implant (230) prior to deployment; - said observation fenestration (258) is one of the axial-longitudinal open slots (280-a) located on the front (52) side of said tube (250); A delivery shaft assembly (200) according to any one of claims 1 to 5.

12. A delivery shaft assembly (200) as described in claim 11, which is based on claim 4, wherein the closed ends (253) of the axial-longitudinal open slots (280-a, 280-b) are located within the proximal section (242) or the distal matching section (244).

13. The delivery shaft assembly (200) of any one of claims 1 to 12, wherein the tube (250) at the distal tip section (246) is beveled.

14. providing a delivery shaft (220) having a proximal end (20) and a distal end (40) with a lumen (222) configured to hold an ocular implant (230), said delivery shaft (220) being made from a conformable material formed into a bend-resistant tube (250); - introducing a curvature into the distal end of the delivery shaft (220), thereby forming a distal adaptation section (244); - forming an atraumatic portion on the distal tip section (246); - introducing a plurality of flexible slots (252) and / or flexible openings (256-b) in said distal conforming section (244) to provide conformability and bendability (60) in said first plane by removal of tubing material from said tube wall (224); - introducing said observation fenestration (258) by removal of tubing material from the wall (224) of said tube; A method of manufacturing a delivery shaft assembly (200) according to any one of claims 1 to 13, comprising:

15. 15. The method of claim 14, wherein the axial-longitudinal open slots (270-a, 270-b, 280-a, 280-b) and / or living hinges (276) are introduced by removing tubing material from the tube wall (224).

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