Devices, systems and methods for delivering fluids through tubular elements

Abstract

A flexible elongate member having the ability to deliver a substance through a media delivery channel defined within a wall thereof. The flexible elongate member may have a tubular wall defining a lumen therethrough, with the media delivery channel formed within the tubular wall. The flexible elongate member may be a reinforced flexible tubular elongate member having a reinforcement layer within a tubular wall thereof. One or more filaments forming the reinforcement layer may be hollow to define the media delivery channel extending through the reinforced flexible tubular elongate member.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 345,572, filed on May 25, 2022, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0003] The present invention relates generally to the field of medical devices. More particularly, the present invention relates to medical devices, systems and methods for delivering and / or deploying devices to anatomical sites, and also delivering additional substances, such as fluid media, to anatomical sites. Even more particularly, the present invention relates to medical devices, systems and methods for delivering and deploying implantable devices, and delivering substances, such as contrast agents, with implantable devices to facilitate implantation of the devices. Background Art

[0004] It is necessary to use minimally invasive techniques, such as devices, systems and methods for delivering and / or deploying implantable devices through the lumen to avoid more complex and more invasive open surgery. Various transluminal techniques that do not require open surgery utilize systems with flexible elongated members that can pass through the lumen from a small insertion opening in the patient's body, such as, navigating to the anatomical part in the body through the vascular system. Such a system can be a multi-catheter / stacked catheter system, which includes a plurality of flexible tubular elongated members stacked in another (coaxially and / or coextensively in another flexible tubular elongated member). Additional substances may need to be delivered with such systems. For example, in order to deliver and / or deploy a device, an imaging system may need to be used, which utilizes contrast agents to deliver to the anatomical part. However, devices, systems, etc. delivered through the lumen are usually faced with strict size restrictions for effective navigation in the body. Therefore, it is usually limited to additional channels or pathways without spaces or spaces for delivering substances to the anatomical part (or removing substances from the anatomical part) in the multi-catheter system. Thus, devices, systems, treatments, etc. that utilize more than one flexible, elongated member may have limited ability to deliver additional substances to the anatomical site through an already maximally sized system.A solution to this challenge would be welcomed within the industry. Summary of the invention

[0005] A summary of the invention is given to aid understanding, and those skilled in the art will appreciate that each of the various aspects and features of the invention may be advantageously used alone in some cases, or in combination with other aspects and features of the invention in other cases. The inclusion or exclusion of elements, components, etc. in this summary is not intended to limit the scope of the claimed subject matter.

[0006] According to various principles of the present invention, a flexible tubular slender member has a tubular wall defining a cavity, through which a medical device can be delivered to an anatomical site, the flexible tubular slender member includes at least one hollow filament, the hollow filament extends from a first end of the flexible tubular slender member to a second end of the flexible tubular slender member within the tubular wall, and the hollow filament defines a medium delivery channel therein, through which a substance can pass within the tubular wall from the first end of the flexible tubular slender member to the second end of the flexible tubular slender member.

[0007] In some embodiments, the tubular wall is a multi-layer wall. In some embodiments, the tubular wall has an outer layer and an inner layer, wherein the hollow filaments extend longitudinally along the flexible tubular elongated member between the outer layer and the inner layer. In some embodiments, the hollow filaments are woven with a plurality of reinforcing filaments to form a reinforcing layer between the outer layer and the inner layer of the flexible tubular elongated member. In some embodiments, more than one of the plurality of reinforcing filaments is hollow, extends from a first end of the flexible tubular elongated member to a second end of the flexible tubular elongated member, and defines a medium transport channel therein, through which a substance can reach the second end of the flexible tubular elongated member from the first end of the flexible tubular elongated member through the medium transport channel.

[0008] In some embodiments, the hollow filaments are embedded within the material of the tubular wall.

[0009] In some embodiments, the hollow filament is one of a plurality of filaments extending longitudinally along the flexible tubular elongated member and within the tubular wall. In some embodiments, the plurality of filaments form a reinforcement layer within the tubular wall. In some embodiments, the hollow filament is one of a plurality of hollow filaments forming a reinforcement layer.

[0010] According to various principles of the present invention, a delivery and / or deployment system for delivering and / or deploying a medical device to an anatomical site includes at least one flexible tubular slender member having a wall defining a cavity and a medium delivery channel defined within the wall, the medium delivery channel extending longitudinally along the flexible tubular slender member between its proximal end and its distal end; and a device for delivering at the distal end of the flexible tubular slender member.

[0011] In some embodiments, the device includes a delivery device having an interior in which a deployable device is positioned. In some embodiments, a cavity defined by a wall of the flexible elongated tubular member is in fluid communication with the interior of the delivery device. In some embodiments, the deployable device is a tissue anchor. In some embodiments, the tissue anchor is biased to transition from a deployed configuration to a deployed configuration when leaving an open distal end of the delivery device. In some embodiments, a medium can be delivered through a medium delivery channel in the wall of the flexible elongated tubular member, into the interior of the delivery device and out of the open distal end of the delivery device.

[0012] In some embodiments, the media delivery channel is formed within a hollow reinforcing filament extending within a wall of the flexible tubular elongated member between the proximal and distal ends of the flexible tubular elongated member.

[0013] According to various principles of the present invention, a method for delivering a substance to the distal end of a reinforced flexible tubular slender member includes delivering the substance through a medium delivery channel defined longitudinally along a hollow reinforcing filament, which extends within the wall of the reinforced flexible tubular slender member between the proximal and distal ends of the reinforced flexible tubular slender member.

[0014] In some embodiments, the method further comprises delivering the substance through a plurality of hollow reinforcing filaments, the hollow reinforcing filaments being braided to form a reinforcement layer within a wall of the reinforced flexible tubular elongated member.

[0015] In some embodiments, the method further includes delivering a contrast agent to the distal end of the enhanced flexible tubular elongated member through a hollow reinforcing filament to determine the position of the enhanced flexible tubular elongated member relative to the tissue. In some embodiments, the method further includes confirming the position of the distal end of the enhanced flexible tubular elongated member relative to the tissue at the anatomical site and implanting an implantable device delivered at the distal end of the enhanced flexible tubular elongated member into the tissue. These and other features and advantages of the present invention will become apparent from the detailed description below, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of various aspects or embodiments, it should be understood that individual aspects may be claimed alone or in combination with various aspects and features of this embodiment or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, orders, and relative sizes reflected in the drawings in the accompanying drawings may vary. For example, the device may be enlarged so that the details are discernible, but is intended to be reduced with respect to, for example, being assembled in a delivery catheter or working channel of an endoscope. In the accompanying drawings, identical or nearly identical or equivalent elements are generally represented by the same reference characters. For clarity and simplicity, not every element is indicated in each figure, and not every element of each embodiment is shown where it is not necessary for a person of ordinary skill in the art to understand the present invention.

[0017] The detailed description will be better understood in conjunction with the accompanying drawings, wherein like reference characters represent like elements, as described below:

[0018] Figure 1A perspective view showing an example of an embodiment of a flexible tubular elongated member having a media transport channel defined within a wall thereof in accordance with various principles of the present invention.

[0019] Figure 2 A perspective view of an example of an embodiment of a device and system formed according to various principles of the present invention is shown in a schematic diagram of a heart.

[0020] Figure 3 Shown as Figure 2 Another perspective view of an example of an embodiment of the apparatus and system is shown in another advanced position.

[0021] Figure 4 Shown along Figure 2 A cross-sectional view of line IV-IV of FIG. 1 , but with the deployable device extending from the delivery device, in FIG. Figure 2 It is shown in the delivery configuration within the delivery device. DETAILED DESCRIPTION

[0022] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the present invention is not limited to the specific embodiments described and may therefore vary. All devices and systems and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the present invention. Each example of the embodiment is provided in an explanatory manner and is not the only way to implement these principles, but is merely an example. Therefore, references to elements or structures or features in the accompanying drawings must be understood as references to examples of embodiments of the present invention and should not be understood as limiting the present invention to the specific elements, structures or features shown. Other examples of ways to implement the disclosed principles will come to mind when reading the present invention. In fact, it is obvious to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used together with another embodiment to produce a further embodiment. Therefore, the present subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0023] It should be understood that the present invention is explained in various levels of detail in this application. In some cases, details that are unnecessary for a person of ordinary skill in the art to understand the present invention or details that make other details difficult to perceive may be omitted. The terms used herein are only used to describe specific embodiments and are not intended to limit the scope beyond the appended claims. Unless otherwise specified, the technical terms used herein are to be understood as commonly understood by a person of ordinary skill in the art to which the present invention belongs. According to the present invention, all devices and / or methods disclosed and claimed herein can be manufactured and performed without excessive experimentation.

[0024] As used herein, "proximal" refers to a direction or position closest to a user (a medical professional or clinician or technician or operator or physician, etc., such terms are used interchangeably herein, are not intended to be limiting, and include automated controller systems or others), etc., and / or closest to a delivery device, and "distal" refers to a direction or position farthest from a user, such as when the device is used (e.g., when the device is introduced into a patient, or during implantation, positioning or delivery), and / or closest to a delivery device. "Longitudinal" means extending along the longer or larger dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but need not be straight and need not maintain a fixed configuration when the element is flexed or bent. "Center" means at least generally bisecting a center point and / or being generally equidistant from a perimeter or border, and "central axis" means a line that at least generally bisects a center point of an opening relative to the opening, and when the opening comprises, for example, a tubular element, a passage, a cavity or a hole, it extends longitudinally along the length of the opening.

[0025] Traditionally, medical devices are delivered and / or deployed transluminally (in vivo, without the need for open surgery) using systems including various flexible elongated members. For example, a medical device can be inserted through a guide catheter (e.g., of a delivery / deployment system) and / or along one or more flexible elongated members or using one or more flexible elongated members. It should be understood that, for convenience and without limitation, the term flexible elongated member or flexible tubular elongated member is generally used herein to refer to elements such as catheters, shafts, sleeves, sheaths, tubes, probes, endoscopes, etc. Typically, the device and / or system navigates to a site in the patient's body, such as an implant / implantation site, a target site, a delivery site, a deployment site, a treatment site, etc., which, for convenience and without limitation, are referred to hereinafter as an anatomical site. The device can be associated with tissue at an anatomical site, such as by attaching, anchoring, implanting, attaching, fixing, coupling, engaging, embedding, maintaining, retaining, grasping, tethering, etc. to or relative to the tissue, and these terms (and their various grammatical forms) are used interchangeably herein and are not intended to be limited. It should be understood that references to delivery and / or deployment herein are intended to include delivery or deployment or both. It should also be understood that, in addition to placement of the device, deployment may include fixation. The delivery / deployment device may be configured to hold and / or carry the device to deliver to the deployment site, and / or promote the deployment of the device relative to the tissue. For example, the delivery / deployment device may be configured to manipulate the device to position and deploy (e.g., implant) relative to the tissue at the anatomical site. It should be understood that terms such as manipulation (and other grammatical forms thereof) may be used interchangeably with such terms (and other grammatical forms thereof) herein, such as navigation, actuation, control, manipulation, manipulation, movement, operation, transfer, conversion, drive, propel, retract, rotate, translate, etc., and are not intended to be limiting.

[0026] Devices and systems are typically delivered transluminally in a multi-component delivery system, in which two, three, four or more flexible, elongated members are positioned one within another (coaxially, concentrically or otherwise positioned one within another and / or side by side with each other, and optionally also within another tubular, elongated member) in a configuration known as a catheter stack delivery system. The flexible, elongated member may include an outer shaft, a delivery shaft, a catheter, a sheath, a probe, a guidewire, a tube, etc., and for convenience and without intent to limit, reference is made herein to the flexible, elongated member. Various flexible, elongated members may be flexible tubular, elongated members made of multiple components or layers, such as two, three or more tubular layers. The use of multiple different layers allows for the provision of flexible, elongated tubular members with various properties. For example, one or more multilayer flexible, elongated tubular members may include an inner layer (referred to herein alternatively as a liner, without intent to limit) made of a lubricating material to facilitate insertion and transportation of medical devices therein and through it. Such an inner layer may be formed of materials such as, but not limited to, polytetrafluoroethylene (PTFE), tetrafluoroethylene and perfluoroalkyl vinyl ether (PFA), perfluoropropyl vinyl ether, perfluoromethyl vinyl ether, fluorinated ethylene propylene (FEP), polyether block amide (PEBA) or copolymers or blends thereof. The inner layer may be formed in a variety of ways, such as an extrusion process, or by molding or coating the material on a mandrel or within another layer (relative to the outer layer) of the flexible tubular elongated member. In some embodiments, the outer layer (which may alternatively be referred to as a jacket, not intended to be limiting) of the multilayer flexible tubular elongated member may be formed of a generally lubricated material, thereby providing the flexible tubular elongated member with a frictionless (or at least friction-reduced) biocompatible outer surface so that the flexible tubular elongated member can be manipulated within a passage / cavity within the patient's body without damaging surrounding tissue. The outer layer can be formed from any of a variety of biocompatible materials, such as nylon, polyurethane, polyether block amide (PEBA), PTFE, high density polyethylene (HDPE), liquid crystal polymer (LCP), or copolymers or blends thereof, in any desired manner, such as by extruding, dipping, painting, brushing, spraying, molding, etc., a coating material on other layers of the flexible tubular elongated member. It should be understood that the flexible tubular elongated member can have different properties (e.g., flexibility, stiffness, wall thickness, elasticity, hardness, etc.) along its length.

[0027] Various devices and systems as described above may utilize enhanced flexible tubular elongated members, such as medical devices for transluminal insertion, guidance, delivery, deployment, etc. within a patient's body. It may be desirable to enhance the flexible elongated member to impart one or more properties or characteristics to the flexible elongated member, such as strength, flexibility (or desired stiffness), enhanced maneuverability, tensile strength, torque transmission capability, steering capability, stability, durability, elasticity, fracture resistance, etc., such as to impart various capabilities required for or selected for the intended use of the enhanced flexible tubular elongated member in complex systems, such as navigation within the body, delivery devices or systems or treatments or therapies, implant devices or systems, manipulation devices or systems, etc. It should be understood that not all properties or characteristics of the enhancement layer may be considered "enhanced", and for convenience and not necessarily limited to the traditional concept of "enhanced", the term enhancement and its other grammatical forms are referenced and used herein.

[0028] The reinforcement layer of the multi-layer flexible tubular elongated member can be formed on the inner layer, or formed separately from the inner layer material applied thereto to form the inner layer. In some embodiments, the reinforcement layer can be embedded in the inner layer. In some embodiments, the outer layer is disposed on the reinforcement layer, such as to enclose or encapsulate the reinforcement layer within the wall of the reinforced flexible tubular elongated member. The outer layer can fill voids or gaps in the reinforcement layer, such as embedding the reinforcement layer in the outer layer and / or forming a sandwich structure including the inner layer, the reinforcement layer and the outer layer.

[0029] The reinforcement layer can be formed, shaped and configured in any desired form to provide or impart desired properties to the flexible tubular elongated member along its length (extending along its longitudinal axis) and / or along a portion of the circumference of the flexible tubular elongated member (around its longitudinal axis). In some embodiments, the reinforcement layer is formed by a plurality of elongated elements (filaments, fibers, strands, bands, etc., referred to as filaments in this article for convenience and not intended to be limiting) extending longitudinally along the length of the flexible tubular elongated member, such as, wire. The reinforcement filaments of the reinforcement layer can be formed by any of the desired materials, such as metals, metal alloys (stainless steel, nickel titanium alloy or other nickel alloys, tungsten alloys, chromium alloys, etc.), polymers, metal polymer composites, etc., but are not limited thereto. The filaments can be formed by linear elastic or non-superelastic or superelastic or shape memory materials, such as those selected based on the intended use of the flexible tubular elongated member. The filaments can have any of various cross-sectional shapes (e.g., circular, flat, rectangular, etc.), such as those that impart desired properties or properties to the reinforcement layer. The diameter or thickness of the filaments is selected based on the intended use of the enhanced flexible tubular elongated member to produce an enhanced flexible tubular elongated member with a desired overall diameter and a desired wall thickness. At least a portion of the reinforcing layer may be coated, such as coated with a polymer coating material, to impart further properties or characteristics required for one or more filaments of the reinforcing layer. The coating may be applied in any of the desired manners, such as extruding (e.g., on each filament), dipping, brushing, brushing, spraying, etc., and is not intended to be limiting.

[0030] In certain embodiments, filaments (single or in pairs or groups of more than two filaments) are woven and / or interwoven and / or wound and / or overlapped with other filaments (single or in pairs or groups of more than two filaments) in any of various patterns, the details of which are not critical for the present invention. It should be understood that the mutual engagement of the parts of the reinforcing layer is not critical for the principle of the present invention. In other words, the filaments of the reinforcing layer can extend longitudinally along the length of the reinforcing flexible tubular elongated member without engaging or otherwise contacting each other, or only some filaments, rather than all filaments contacting each other. In certain embodiments, the reinforcing layer can be a solid braided fabric component encapsulated or embedded in a material (e.g., polymer, thermoplastic, etc.) forming the wall of the flexible elongated member.

[0031] In various surgeries or treatments (these terms are used interchangeably herein and are not intended to be limiting), it may be desirable or necessary to visualize and / or image the anatomical site. For example, in order to facilitate and / or ensure proper navigation, deployment, placement, engagement, implantation, etc. of a device (e.g., an implantable device, such as, but not limited to, a tissue anchor) and / or system relative to the anatomical site, various imaging techniques may be used to image the device and / or system, as well as the anatomical structure to which the device and / or system is positioned relative. Various imaging techniques utilize various substances (e.g., contrast agents or media for fluoroscopy, tomography, etc.) during navigation or at the anatomical site. Such substances may be used to enhance imaging and / or visualization and / or visibility and / or identification of the anatomical site, such as by increasing the contrast of structures or fluids in the body, delineating boundaries between tissues, and / or indicating walls or pathways of anatomical structures based on the flow of contrast substances relative to the anatomical structure.

[0032] Providing a flexible tubular elongated member having more than one layer as described above can result in thicker walls than a single layer tubular element, thereby further increasing the overall size of the system and limiting the space available to provide additional media delivery channels, passages, cavities, etc. (such terms are used interchangeably herein and are not intended to be limiting).

[0033] Furthermore, the use of a reinforcement layer in one or more of the flexible elongated members of the system, as described above, takes up additional space within the walls of the member, thereby increasing the wall thickness of the member and further increasing the overall size of the system and reducing the available space for extending a media delivery channel through the delivery system. However, eliminating the reinforced flexible elongated tubular member may eliminate one or more desirable properties imparted by the reinforced flexible elongated tubular member.

[0034] According to various principles of the present invention, at least one flexible tubular elongated member for a transluminal delivery system includes at least one medium delivery channel within its wall (e.g., between the exterior and interior of the wall and within the thickness of the wall) without adding additional volume or width to the delivery system. By providing a medium delivery channel within the wall of the flexible tubular elongated member, additional media that could not previously be delivered using existing such systems can be delivered without affecting the size of the system. Such a medium delivery channel can extend from the proximal end of the flexible tubular elongated member to the distal end of the flexible tubular elongated member to allow a substance (e.g., a fluid, such as a contrast agent) to pass from the proximal end of the flexible tubular elongated member (e.g., from a source of the substance, such as using a pump) to the distal end of the flexible tubular elongated member. Additionally or alternatively, the channel can be connected to a vacuum source to apply vacuum pressure from the proximal end of the flexible tubular elongated member to the distal end of the flexible tubular elongated member positioned at, for example, a treatment site where suction is desired. It should be understood that references herein to substances, such as contrast agents, are for convenience and are not intended to be limiting, and various other media may be delivered or withdrawn through a channel via a flexible tubular elongate member formed according to various principles of the present invention.

[0035] In some aspects, according to various principles of the present invention, at least one longitudinally extending component of the reinforcing layer of the reinforced flexible tubular elongated member is formed with a medium delivery channel therein. For example, the filaments of the reinforcing layer of the reinforced flexible tubular elongated member can be hollow longitudinally extending filaments through which substances can pass. Hollow filaments are used in the wall of the flexible tubular elongated member as described herein, such as to form a reinforcing layer that allows the delivery medium to pass through some or all of the filaments of the reinforcing layer. The resulting reinforced flexible tubular elongated member has almost the same properties as the conventionally formed reinforcing layer with solid core strands, but also advantageously has the additional ability to deliver substances to anatomical sites through its own generally rigid structure. In addition, such a configuration and structure eliminates the need for additional medium delivery devices or changes to the current and future structural designs of devices and systems due to size constraints and the need to deliver media during surgery.

[0036] In some embodiments, one to all of the solid braids used on the braiding machine to form the braided reinforcement layer of the flexible tubular elongated member can be replaced with hollow braids. Such hollow braids can be braided or otherwise configured relative to each other in the same setting as the conventional solid wires. Once the assembly of the flexible tubular elongated member is completed, the hollow braid (or the entire portion of the catheter wall) can deliver substances through the tubular wall of the flexible tubular elongated member, and the braid extends in the flexible elongated tubular member, thereby allowing other substances (e.g., devices) to be delivered in the cavity defined by the tubular wall. In some embodiments, the flexible tubular elongated member can be assembled into a delivery / deployment system, wherein the most proximal portion of the system (e.g., the handle end) is fluidly connected to a syringe or pump assembly to supply material delivery through the hollow braid in the wall of the flexible tubular elongated member to reach the most distal portion of the system (in the patient's body). Allowing material delivery through the existing wall of the tubular element eliminates the need for other devices for delivering substances. This configuration is particularly useful when surgery is being performed and it is necessary to accurately know / see a given position of a device (e.g., an implantable device) before deploying the device. For example, there is often not enough room / space for an additional separate device to deliver a substance, such as contrast agent, and the ability to remove the implantable device mid-operatively (to allow a separate contrast agent to enter the system) to detect location is not possible or a viable option.

[0037] It should be understood that the principles of the present invention relate to all devices in which the location of the device and / or system is important. According to various principles of the present invention, a medium delivery channel can be formed within the wall of a flexible tubular elongated member without affecting the design, operation, configuration, etc. of other aspects of the flexible tubular elongated member or the system in which the flexible tubular elongated member is provided and / or used. For example, a hollow filament formed according to various principles of the present invention for defining a medium delivery channel therein is easily integrated into the design of a current shaft / catheter (e.g., using a braid to enhance the composition of the shaft). In addition, the use of such a hollow filament does not require a redesign of the composition of the flexible tubular elongated member, except for replacing one to all of the solid braids with a hollow braid formed according to various principles of the present invention. Therefore, the present invention allows the delivery of substances, such as contrast agents or other solutions, through any catheter system that may need or require such substances.

[0038] Turning now to the accompanying drawings, Figure 1 An example of an embodiment of a flexible tubular elongated member 100 to which the principles of the present invention may be applied is shown in FIG. The flexible tubular elongated member 100 shown has a generally tubular wall 110 having a certain thickness through which one or more media delivery channels are formed. In some embodiments, as shown Figure 1As shown, the flexible tubular elongated member is a reinforced flexible tubular elongated member 100 having a tubular wall 110 formed by an inner wall 112 and an outer wall 114 (shown in dotted lines), with a reinforcement layer 120 between the inner wall 112 and the outer wall 114. Although the tubular wall 110 of the flexible tubular elongated member 100 defines a working channel 111 extending longitudinally therethrough (along the longitudinal axis LA of the reinforced flexible tubular elongated member 100), the flexible elongated member formed according to various principles of the present invention need not have such a working channel. In some embodiments, the inner wall 112 is a liner formed within the reinforcement layer 120 or the reinforcement layer 120 is formed on the inner wall 112. For example, the liner may be disposed within a braided catheter, such as to form a liner of the working channel 111 after the braided catheter is formed. The outer wall 114 extends around the reinforcement layer 120, surrounds it, surrounds it, encloses it, covers it, etc. (these terms are used interchangeably herein and are not intended to be limiting). In some embodiments, the reinforcement layer 120 is formed over the reinforcement layer 120 and the inner wall 112, such as by extrusion, to form an outer jacket or layer covering the reinforcement layer 120. The reinforcement layer 120 may be embedded in one or both of the inner wall 112 or the outer wall 114. Further details of the various ways of making such a reinforced flexible tubular elongated member are not critical to the principles of the present invention and are not further described.

[0039] Various configurations of the reinforcement layer 120 are known in the art, any of which may be used in the reinforced flexible tubular elongated member 100 formed according to various principles of the present invention without causing damage thereto. Figure 1 In the example of the embodiment shown in , the reinforcement layer 120 is formed by one or more filaments 122 arranged in any of a variety of ways around the circumference of the reinforced flexible tubular elongated member 100 and extending from its proximal end 101 (not shown, but its approximate position is indicated by the reference numeral 101) to its distal end 103 along the longitudinal axis LA of the reinforced flexible tubular elongated member 100. In some embodiments, the plurality of filaments 122 forming the reinforcement layer 120 may be mutually engaged with each other, such as braided, interwoven, wound, overlapped, etc., and / or may extend along the longitudinal axis LA of the reinforced flexible tubular elongated member 100 in a zigzag, longitudinally, sinusoidally, spirally, etc., individually (spaced apart from each other) or in groups. In some embodiments, the one or more filaments 122 are coiled to form the reinforcement layer 120. Figure 1The reinforcement layer 120 shown in the figure has a first plurality of generally spirally extending, spaced filaments 122a extending in a first direction around the circumference of the reinforced flexible tubular elongated member 100 and stacked on a second plurality of generally spirally extending, spaced filaments 122b extending in an opposite direction around the circumference of the reinforced flexible tubular elongated member 100. However, any or all of the filaments 122a in the first plurality of filaments 122a may be woven (e.g., woven up and down) with any or all of the filaments 122b in the second plurality of filaments 122b, either individually or in groups. For example, individual or pairs or three or more filaments 122 may be woven up and down. The principles of the present invention are not limited by the specific pattern in which the filaments 122 forming the reinforcement layer 120 are engaged (or not engaged) with each other. It should be appreciated that there are a variety of additional or alternative acceptable ways of forming the reinforcement layer 120 of the reinforced flexible tubular elongate member 100 in accordance with the various principles of the present invention.

[0040] As mentioned above, providing Figure 1 The reinforcement layer 120 shown in the figure can increase the thickness of the reinforced flexible tubular elongated member 100. According to various principles of the present invention, the reinforcement layer 120 has a dual purpose of reinforcing the flexible tubular elongated member 100 and providing a medium transport channel 121 through the tubular wall 110 of the reinforced flexible tubular elongated member 100. For example, Figure 1As shown in the detailed view of an example of an embodiment of the reinforced flexible tubular elongated member 100, one or more filaments 122 forming the reinforcement layer 120 can be hollow. The inner diameter of the hollow filaments 122 is selected to allow a substance (e.g., a medium, such as a contrast agent) to be delivered therethrough to the anatomical site to which the reinforced flexible tubular elongated member 100 is navigated (usually delivered transluminally in the patient's body). It should be understood that the size of the hollow filaments 122 can be determined based on a variety of factors, such as the nature of the substance to be passed therethrough, the volume of the substance to be delivered in a given time (including the substance delivery rate), the strength of the material forming the filaments 122 (e.g., to maintain the strength of the reinforcement layer 120 while still providing a passage for the substance to flow through), the overall size of the reinforced flexible tubular elongated member 100, etc. Typically, the reinforcement layer formed by multiple filaments (e.g., braided, interwoven, etc.) is formed of stainless steel (e.g., 304B stainless steel). To allow for the formation of a hollow filament 122 in accordance with various principles of the present invention, the filament 122 may be formed from another material, such as nitinol, tungsten, polyamide, polyetheretherketone (PEEK), or the like, thereby allowing the filament to be formed with a sufficiently small outer diameter and have an internal passageway therethrough to fit within a tubular element for navigation within a patient's body. For example, in some embodiments, one or more filaments 122 of the reinforcement layer 120 can be a hollow wire having an outer diameter of approximately 0.007" (0.0178mm) and an inner diameter of approximately 0.005"-0.006" (0.127mm-0.153mm), and are disposed within a flexible tubular elongated member 100 having an outer diameter of approximately 0.1" (2.54mm) and an inner diameter of approximately 0.08" (2.032mm). It should be understood that the size of the filaments 122 can vary widely, depending on the size of the reinforced flexible tubular elongated member 100. For example, the outer diameter of the filaments 122 used in microcatheters may be as small as 0.001" (25.4μ), while the outer diameter of the filaments 122 used in large endoscopes may be as large as about 0.01" (0.254mm).

[0041] It should also be understood that the number of filaments 122 in the reinforcement layer 120 may be selected based on any of a variety of factors. For example, the number of filaments 122 may be selected to achieve desired mechanical properties for the reinforcement layer 120, to achieve volume requirements relative to the substance being delivered therethrough (e.g., as determined by the anatomical site being imaged in the case of delivery of contrast media), the overall size of the reinforced flexible tubular elongate member 100, etc. In some embodiments, the reinforcement layer 120 includes one or more filaments 122 extending longitudinally along the longitudinal axis LA of the reinforced flexible tubular elongate member 100. For example, in some embodiments, a plurality of filaments 122 (including from two to as many as thirty-two (32) filaments 122 and even as many as sixty-four (64) filaments 122 (including any number of filaments therebetween, or even more) may form the reinforcement layer 120 of a flexible tubular elongate member 100 formed according to various principles of the present invention, wherein one or more of those filaments 122 are hollow with a defined medium delivery channel 121 therethrough.

[0042] The device, system and method of the present invention can be used alone or together with other devices, systems and methods. It should be understood that there are multiple applications of the enhanced flexible tubular elongated member 100 formed according to various principles of the present invention. For example, the principles of the present invention can be applied to devices and systems having one or more flexible tubular elongated members for various transluminal surgeries. As discussed above, the size (e.g., width or diameter) of the device and system for in vivo navigation is usually constrained by the size, shape and contour of the anatomical structure through which the device and system navigate, so that there is no additional space left for the medium delivery channel. Applying the principles of the present invention to at least one flexible elongated member of a system having more than one flexible elongated member provides the ability to deliver a medium (such as, a contrast agent) through components in a system that has been used for other devices or systems. For example, a catheter system can be modified to have one or more channels defined in the wall of at least one catheter of the system. More particularly, an enhanced flexible tubular elongated member having a filament forming its reinforcement layer can be modified according to various principles of the present invention to define a medium delivery channel through one or more of the filaments of the reinforcement layer to create a path for the delivery medium through it. Thus, elements that are typically already present and used in the system (e.g., reinforcing filaments such as braided wires or spaces in their walls) are used to transport substances through the system, thereby eliminating the need for a completely separate and independent catheter assembly for transporting such substances (as is typically required in prior art systems).

[0043] An example of an embodiment of a system and device to which the various principles of the present invention may be applied is a delivery and deployment system 1000 having a plurality of "stacked" flexible tubular elongated members (positioned one coaxially and / or coextensively within another flexible tubular elongated member), such as Figure 2 , Figure 3 and Figure 4 . It should be understood that reference is made to delivery and deployment, but systems incorporating the principles of the present invention need not be limited to either or both of these purposes. The various elongated members of the system 1000 may include a delivery guide sheath 1010, a delivery catheter 1020, a grabber shaft 1030, an anchor depot catheter 1100, and a stylet 1110, any or all of the flexible elongated elements (e.g., catheters, sheaths, shafts, tubes, etc.) that may be steered through a tortuous path through the body to allow transluminal (e.g., transcatheter, as opposed to open surgery) delivery of a medical device within the body, thereby avoiding invasive open surgery. In the example shown, at least one of the flexible elongated members may be a reinforced flexible tubular elongated member formed according to various principles of the present invention to deliver a substance to the distal end 1001 of the system, such as from a source located at the proximal end 1003 (generally indicated, but not precisely shown) of the system 1000.

[0044] The illustrated example of the delivery and deployment system 1000 is configured to deliver and deploy devices and systems for cardiac surgery, such as heart valve repair (e.g., to ensure proper function and closure of a heart valve). More particularly, the illustrated devices and systems are configured to reposition, repair, and / or replace one or more heart valve leaflets and / or chordae tendineae. However, it should be understood that the principles of the present invention may be applied without limitation to other devices and systems, particularly to other devices and systems for transluminal / transcatheter delivery.

[0045] In various surgeries, such as mitral valve treatments where a device is implanted relative to cardiac tissue, the ability to identify whether the device is in perfect contact with the tissue in order to properly engage with the tissue is required. Some devices must be in complete contact with the tissue prior to deployment to ensure proper penetration and implantation into the tissue. For example, if the tissue is not fully contacted initially, a device, such as a tissue anchor, may be deployed incorrectly and may therefore compromise the strength of the anchor implant. One way to facilitate identification of the location of the device and anatomical structure is to use imaging technology in conjunction with a contrast agent. In some cases, the location of a component at one of the innermost (if not the innermost) flexible, elongated members of the system must be accurately determined. However, the internal flexible, elongated members of the stacked system have little room for a delivery channel for the contrast agent. The principles of the present invention are applied to at least one of the flexible, elongated members to allow delivery of contrast agents, thereby facilitating imaging and placement of the component / device to achieve secure positioning of the component and / or implantation of the device, as will now be described in further detail.

[0046] Figure 1An example of an embodiment of a delivery and deployment system 1000 shown in can be delivered to an anatomical site (in this example, a ventricle) by a delivery guide sheath 1010. The delivery guide sheath 1010 can be introduced into the body along with a dilator (not shown, but can be any known dilator) to extend transluminally into the heart, such as through the femoral artery to penetrate the septal wall and enter the ventricle. A delivery catheter 1020 extends within and through the delivery guide sheath 1010 to deliver one or more devices to an anatomical site, such as the heart. In the example shown, a grabber shaft 1030 extends through the delivery catheter 1020 to deliver a device in the form of a leaflet clip spreader 1040 configured to deliver a leaflet clip 1050 to a heart leaflet L. The leaflet clip 1050 is shown having spreader arms 1042 of the leaflet clip spreader 1040, which are arranged in a manner similar to those of FIG. Figure 3 Clamp the leaflet clip 1050 onto the leaflet L. Figure 4 1050 is more clearly shown in the . Additionally, in the illustrated example of an embodiment, a delivery device in the form of an anchor depot 1060 is delivered within and through the leaflet clip opener 1040 to deliver and deploy a deployable device, such as anchor 1070, into the heart (e.g., into cardiac tissue, such as papillary muscle tissue). The anchor depot 1060 may define a cavity therein, and the anchor 1070 may be delivered within the cavity. The anchor depot 1060 may extend distally out of the distal end 1041 of the leaflet clip opener 1040, as shown, for example, Figure 2 , to extend to the desired anatomical site for implantation of the anchor 1070. The anchor 1070 can then extend from the distal end 1061 of the anchor depot 1060 and into the tissue to secure the artificial chord 1080 (e.g., expanded polytetrafluoroethylene (ePTFE) suture) extending from the leaflet clip 1050 to the heart tissue of the ventricle (e.g., to the papillary muscle tissue) to restore proper function of the leaflet L. The artificial chord tensioning and locking device 1090 can be used to set the tension on the artificial chord 1080 as needed, indicated, necessary, etc.

[0047] The anchor depot 1060 is delivered at the distal end 1101 of a generally flexible tubular elongated anchor depot catheter 1100, which is Figure 2 1030 and is shown in dashed lines extending through the grabber shaft 1030. Figure 3 1040 as extending distally out of the distal end 1041 of the leaflet clip opener 1040. Figure 4As shown in cross-section in FIG. 1 , the distal end 1101 of the anchor depot catheter 1100 can be coupled to the proximal end 1063 of the anchor depot 1060, such as by fitting within a counterbore 1065 formed within the proximal end 1063 of the anchor depot 1060. The anchor 1070 (having an artificial chord tensioning and locking device 1090 coupled thereto, such as coupled to the proximal end of the anchor 1070) is delivered at the distal end 1111 of the stylet 1110 (e.g., Figure 4 ). The stylet 1110 and anchor 1070 may be coupled together, such as via a coupling 1112 between the stylet 1110 and the artificial chord tensioning and locking device 1090, in a manner that allows deployment of the anchor 1070 from the anchor library 1060 and adjustment of tension on the artificial chord 1080 via the artificial chord tensioning and locking device 1090.

[0048] It should be understood that the details of the structure and function of the leaflet clip opener 1040, leaflet clip 150, anchor depot 1060, anchor 1070, artificial chord 1080 and artificial chord tensioning and locking device 1090 do not form part of the present invention and are therefore not discussed or described in further detail herein. Detailed descriptions of examples of such devices and systems can be found, for example, in U.S. patent application publication US2021 / 0007847, entitled "Device, System and Method for Clamping Leaflets of a Heart Valve" and published on January 14, 2021; U.S. patent application publication US2021 / 0000597, entitled "For Adjustably Tending Artificial Chords Between Leaflets and Papillary Muscles or Heart Wall" and published on January 7, 2021; and U.S. patent application publication US2021 / 0000597, entitled "For Adjustably Tending Artificial Chords Between Leaflets and Papillary Muscles or Heart Wall" and published on January 7, 2021. U.S. Patent Application Publication No. US2021 / 0000599, entitled “Device, System, and Method for Anchoring Artificial Chordae to Papillary Muscles or Heart Wall,” published on January 7, 2021; U.S. Patent Application Publication No. US2021 / 0000598, entitled “Device, System, and Method for Adjustably Tensioning Artificial Chordae in the Heart,” published on March 31, 2022 Publication 2022 / 0096235; U.S. patent application publication 2023 / 0123832, entitled “Device, system, and method for clamping leaflets of a heart valve” and published on April 20, 2023; U.S. patent application publication US2023 / 0062599, entitled “Device, system, and method for anchoring artificial tendons to cardiac tissue” and published on March 2, 2023; U.S. patent application publication US2023 / 0149170, entitled “Device, system, and method for positioning leaflet clamps” and published on May 18, 2023; and U.S. Provisional Patent Application __ / _______, entitled “Device, system, and method for positioning anchors for artificial tendons”, filed on December 20, 2021 [Attorney Docket No. 2002.2715100, formerly Attorney Docket No. 8150.0817Z], all of which are hereby incorporated by reference in their entirety and for all purposes.

[0049] It should be understood that for convenience, Figure 4 1060 is shown extending from the distal end 1061 of the anchor depot 1060 while the anchor depot 1060 is within the leaflet clip 1050 as a compact depiction of the various stacked components and the configuration of the claws 1072 of the anchor 1070 when deployed. Figure 2 and Figure 4As shown, anchor 1070 is typically positioned within anchor depot 1060 in a generally compact delivery configuration to facilitate delivery through narrow body passages, such as Figure 3 as shown, rather than being Figure 4 Typically, to deploy the anchor 1070, the anchor depot 1060 is extended distally from the leaflet clip spreader 1040 and beyond the distal end 1041 of the leaflet clip spreader 1040, such as Figure 3 Once the anchor library 1060 is in Figure 3 In the position shown, the anchor depot 1060 can be placed in contact with the tissue into which the anchor 1070 is to be implanted, and the anchor 1070 can then be pushed distally out of the anchor depot 1060 and into the tissue. The anchor depot 130 can have a blunt open distal end 1061 (tip or free end) that is sized, shaped, configured, and dimensioned to facilitate pushing the anchor depot 1060 against cardiac tissue to deploy the anchor 1070 out of the anchor depot 1060 and into the tissue at the deployment site, but without potentially pushing the distal end 1061 of the anchor depot 1060 into cardiac tissue as well.

[0050] It is generally desirable for the implantable anchor 1070 to establish a strong grip in or with the tissue so that the anchor 1070 is not inadvertently pulled out of the tissue. Anchors 1070 used in accordance with various principles of the present invention may include a plurality of claws that may be positioned in a delivery configuration (e.g., a compact position that facilitates delivery through narrow body passages, such as Figure 3 The distal ends 1071 of the anchor claws 1072 can each be tapered or pointed or otherwise configured to pierce and penetrate the tissue when pushed against body tissue. Once within the tissue, the claws 1072 can extend radially outward away from their longitudinal axis LA or be transformed into a deployed configuration to secure the anchor 1070 to the body tissue. For example, the claws 1072 can be curled, bent, flexed, bent, etc., such as toward the proximal end of the anchor 1070, such as Figure 4 shown.

[0051] In some embodiments, the tissue anchor 1070 has a claw 1072 that is preformed or biased (e.g., formed of an elastic and / or shape memory material, such as nitinol and / or heat treated) so as to transition from a delivery configuration to a deployed configuration when extending distally out of the anchor depot 1060 without requiring additional force (other than pushing the anchor 1070 out of the anchor depot 1060). In such embodiments, the claw 1072 can be considered to act as a spring to transition the distal end 1071 to the deployed configuration and biased to open to the open configuration substantially automatically without requiring external force to move the anchor claw. In order to ensure proper deployment of such tissue anchors 1070 and adequate engagement within the tissue, close and / or complete contact ("proper" contact, which is generally oriented perpendicular to the tissue surface) of the claw 1072 with the tissue is necessary when deploying the anchor 1070. Lack of contact of the anchor with the tissue generally results in the inability of that portion of the anchor (e.g., the claw) to engage or penetrate the tissue. If the anchor library 1060 and / or the distal end 1071 of such anchor 1070 is not properly engaged with the tissue into which the anchor 1070 is to be implanted, the claw 1072 may move into the deployed configuration without penetrating the tissue. Therefore, it is necessary to determine whether the anchor library 1060 and / or the anchor 1070 is in the desired position relative to the tissue in order to securely implant the anchor 1070 in the tissue.

[0052] According to various principles of the present invention, the anchor library catheter 1100 is configured to deliver a substance, such as a contrast agent, to the distal end 1061 of the anchor library 1060 to confirm the proper positioning of the anchor library 1060 and / or the anchor 1070 before deploying the anchor 1070 from the anchor library. In particular, the anchor library catheter 1100 can be similar to the above-mentioned Figure 1 The flexible tubular elongated member is configured in the manner of one or more substance delivery channels defined within the wall of the anchor depot catheter 1100 and extending between its proximal end 1103 and distal end 1101. In some embodiments, the anchor depot catheter 1100 is a reinforced catheter, and the substance delivery channel is defined by one or more filaments forming a reinforcement layer of the wall of the anchor depot catheter 1100. The proximal end of the substance delivery channel at the proximal end of the anchor depot catheter 1100 (not shown, but in the drawings) is Figure 2 1060) can be connected to a source of a substance to be delivered through a channel within the anchor depot conduit 1100 (e.g., with the aid of a pump, such as those known to those of ordinary skill in the art). The distal end of this substance delivery channel opens at the distal end 1101 of the anchor depot conduit 1100 to deliver the substance to the interior of the anchor depot 1060. Figure 4As shown, a groove 1067 may be formed in the counterbore 1065 in the anchor depot 1060, and the distal end 1101 of the anchor depot catheter 1100 is located in the groove 1067 to allow substances to flow from the medium delivery channel in the wall of the anchor depot catheter 1100 into the interior of the anchor depot 1060 (e.g., the anchor 1070 is delivered to the anatomical site within the anchor depot 1060). The substance delivered by the anchor depot catheter 1100 generally extends axially and distally through the anchor depot 1060 and out of the distal end 1061 of the anchor depot 1060. The flow pattern of the substance when leaving the distal end 1061 of the anchor depot 1060 can be observed using appropriate imaging techniques to determine the position of the distal end 1061 of the anchor depot 1060 relative to the implantation site of the anchor 1070. Therefore, proper positioning of the anchor depot 1060 can be achieved to ensure proper implantation of the anchor 1070 within the target tissue to be implanted.

[0053] The direction or pattern of flow of a substance, such as a contrast agent, from the distal end 101 of an enhanced flexible tubular elongated member 100 (such as formed according to various principles of the present invention) can be visualized to indicate the proximity, position, orientation, etc. of a device to be deployed (e.g., anchor 1070) relative to the tissue in which the device is to be deployed. Thus, a system formed using a flexible tubular elongated member 100 formed according to various principles of the present invention allows a medical professional (e.g., a surgical team, including any automated system) to use the system to implant an anchor 1070 while in contact with tissue or at least when a delivery and deployment device (e.g., anchor depot 1060) is in sufficient contact with tissue to ensure proper deployment of the anchor 1070. Such information is communicated to the medical professional in any of a variety of ways (e.g., visual or audible indications, such as on a delivery system or a separate associated device) to facilitate placement, implantation, etc. of the anchor 1070. For example, such information can be used to guide placement of the anchor and deployment and delivery device prior to deployment of the anchor, and / or to determine whether repositioning is necessary.

[0054] It should be understood that the principles of the present invention are applicable to flexible, elongated members used in conjunction with devices and systems other than the examples described herein. Therefore, although various principles of the present invention are described herein with reference to implantable devices, such as embodiments of tissue anchors and associated devices, systems and mechanisms, the principles of the present invention may be more widely applied to other devices, systems, methods, etc., such as, but not limited to, those configured to be positioned relative to body tissue. The devices, systems and methods described herein can provide robust solutions for patient safety regarding implantable devices or others. In addition, it should be understood that although reference is made herein to the delivery of substances, it should be understood that the extraction of substances from anatomical sites, such as by applying suction or vacuum forces to the medium delivery channels described herein, is also within the scope and spirit of the present invention.

[0055] The above discussion has wide applicability and has been proposed for the purpose of illustration and description, and is not intended to limit the present invention to the form disclosed herein. It should be understood that various supplements, modifications and replacements can be made to the embodiments disclosed herein without departing from the concept, spirit and scope of the present invention. In particular, for those skilled in the art, the principles of the present invention can be embodied in other forms, structures, arrangements, proportions and with other elements, materials and components without departing from its concept, spirit or scope or characteristics. For example, in order to simplify the present invention, the various features of the present invention are combined together in one or more aspects, embodiments or forms. However, it should be understood that the various features of certain aspects, embodiments or forms of the present invention can be combined in alternative aspects, embodiments or forms. Although the present invention is proposed in the form of an embodiment, it should be understood that the various individual features of the present subject do not need to exist in full in order to achieve at least some of the desired characteristics and / or benefits of the present subject or such individual features. It will be understood by those skilled in the art that the present invention can be used in the case of many modifications or changes to the structures, arrangements, proportions, materials, components and others used in the practice of the present invention, which are particularly suitable for specific environments and operating requirements, but do not depart from the principles or spirit or scope of the present invention. For example, an element shown as being integrally formed may be composed of multiple parts or elements shown as multiple parts that can be integrally formed, the operation of the element may be reversed or otherwise changed, and the size or dimensions of the element may vary. Similarly, although the operation or action or procedure is described in a particular order, this should not be understood as requiring such a particular order, or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions described in the claims may be performed in a different order and still achieve the desired result. Therefore, the embodiments disclosed at present should be shown as illustrative and not restrictive in all respects, and the scope of the subject matter claimed is indicated by the attached claims, and is not limited to the previous description or specific embodiments or arrangements described or shown herein. In view of the above, the individual features of any embodiment can be used and can be claimed alone or in combination with the features of the embodiment or any other embodiment, and the scope of the subject matter is indicated by the attached claims, and is not limited to the previous description.

[0056] In the description above and the claims below, the following will be understood. As used herein, the phrases "at least one", "one or more", and "and / or" are open expressions that are both conjunctions and disjunctive in operation. The terms "one", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the term "one" entity as used herein refers to one or more of the entities. Therefore, the terms "one", "one or more", and "at least one" are used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are only used for identification purposes to help the reader understand the present invention, and / or to distinguish the regions of the associated elements from each other, and do not limit the associated elements, particularly the position, orientation, or use of the present invention. Unless otherwise indicated, connection references (e.g., attached, coupled, connected, and joined) are to be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements. In this regard, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.

[0057] The following claims are hereby incorporated into the detailed description by such reference, wherein each claim stands independently as a separate embodiment of the invention. In the claims, the term "comprises / comprising" does not exclude the presence of other elements, components, features, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these features can be advantageously combined, and inclusion in different claims does not mean that the combination of features is not feasible and / or advantageous. In addition, singular references do not exclude the plural. Reference symbols in the claims are provided only as examples of clarification and should not be interpreted as limiting the scope of the limitation claims in any way.

Claims

1. A flexible tubular slender member having a tubular wall defining a cavity through which a medical device can be delivered to an anatomical site, the flexible tubular slender member comprising at least one hollow filament extending within the tubular wall from a first end of the flexible tubular slender member to a second end of the flexible tubular slender member, and the at least one hollow filament defining a medium delivery channel therein, through which a substance can pass within the tubular wall from the first end of the flexible tubular slender member to the second end of the flexible tubular slender member.

2. The flexible tubular elongated member of claim 1, wherein the tubular wall comprises an outer layer and an inner layer, the hollow filament extending longitudinally along the flexible tubular elongated member between the outer layer and the inner layer. 3 . The flexible tubular elongated member according to claim 2 , wherein the hollow filaments are braided with a plurality of reinforcing filaments to form a reinforcing layer between the outer layer and the inner layer of the flexible tubular elongated member.

4. A flexible tubular slender member according to claim 3, wherein more than one of the multiple reinforcing filaments is hollow, extending from the first end of the flexible tubular slender member to the second end of the flexible tubular slender member, and defining a medium transport channel therein, through which a substance can pass from the first end of the flexible tubular slender member to the second end of the flexible tubular slender member.

5. A flexible tubular elongate member according to claim 1, wherein the hollow filaments are embedded within the material of the tubular wall.

6. The flexible tubular elongated member of claim 1, wherein the hollow filament is one of a plurality of filaments extending longitudinally along the flexible tubular elongated member and within the tubular wall.

7. A flexible tubular elongate member according to claim 6, wherein the plurality of filaments form a reinforcement layer within the tubular wall.

8. The flexible tubular elongate member of claim 7, wherein the hollow filament is one of the plurality of hollow filaments forming the reinforcement layer.

9. A delivery and / or deployment system for delivering and / or deploying a medical device to an anatomical site, the delivery and / or deployment system comprising: at least one flexible tubular elongated member having a wall defining a lumen, and a medium delivery passage defined within the wall and extending longitudinally along the flexible tubular elongated member between a proximal end thereof and a distal end thereof; as well as A device is delivered at the distal end of the flexible tubular slender member.

10. The delivery / deployment system of claim 9, wherein the device comprises a delivery device having an interior within which the deployable device is positioned.

11. The delivery / deployment system of claim 10, wherein the lumen defined by the wall of the flexible tubular elongate member is in fluid communication with the interior of the delivery device.

12. A delivery / deployment system according to claim 10 or 11, wherein the medium can be delivered through the medium delivery channel in the wall of the flexible tubular slender member, into the interior of the delivery device and out of the open distal end of the delivery device.

13. A delivery / deployment system according to any one of claims 9 to 12, wherein the medium delivery channel is formed within a hollow reinforced filament, and the hollow reinforced filament extends between the proximal end and the distal end of the flexible tubular slender member within the wall of the flexible tubular slender member.

14. A method for delivering a substance to the distal end of a reinforced flexible tubular slender member, the method comprising delivering the substance through a medium delivery channel defined longitudinally along a hollow reinforced filament, the hollow reinforced filament extending within the wall of the reinforced flexible tubular slender member between the proximal end and the distal end of the reinforced flexible tubular slender member.

15. The method of claim 14, further comprising delivering the substance through a plurality of hollow reinforcing filaments braided to form a reinforcing layer within a wall of the reinforced flexible tubular elongated member.

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